# Complir - Full Content > This file contains the full text of all guides, case studies, and research published by Complir. It is intended for use by large language models and retrieval systems. # EU Toy Safety Regulation: What Changed and When It Applies Source: https://www.complir.io/resources/guides/eu-toy-safety-regulation-guide Category: Guide The EU Toy Safety Regulation (EU) 2025/2509 (TSR) is the new legal framework for toys sold in the European Union. Adopted on **26 November 2025** and in force since **1 January 2026**, it replaces the Toy Safety Directive 2009/48/EC, which has governed toy safety in the EU since 2011. The new rules apply in full from **1 August 2030**, and they change three things fundamentally: which chemicals are allowed in toys, how compliance is documented (a Digital Product Passport replaces the familiar paper trail), and how digital and connected toys are assessed. If you manufacture, import, or sell toys in the EU, the transition window is already running. Four and a half years sounds generous. For companies managing hundreds of SKUs across multiple suppliers, it is not: every toy in your range needs to be reassessed against stricter chemical rules and equipped with a machine-readable product passport before the deadline. ## From Directive to Regulation Why the shift in legal instrument raises the compliance bar across all 27 member states The shift from a directive to a regulation is not a technicality. A directive must be transposed into 27 national laws, which produced years of divergence in how member states interpreted and enforced toy safety rules. A regulation applies directly and identically across the entire EU, the same mechanism the EU used when it replaced the General Product Safety Directive with the [General Product Safety Regulation (EU) 2023/988 (GPSR)](/resources/guides/gpsr-compliance-guide-product-companies) in 2024. For toy companies, this means one set of rules, one enforcement logic, and far less room for market-by-market interpretation. It also means the compliance bar is set centrally, and it has been set noticeably higher. ## Why did the EU replace the Toy Safety Directive? The European Commission's evaluation of Directive 2009/48/EC found two persistent weaknesses: the directive could not keep pace with new scientific evidence on harmful chemicals, and enforcement struggled with the volume of non-compliant toys entering the EU through online sales. Toys were the second most-notified product category in the EU's Safety Gate rapid alert system in 2025, accounting for **16%** of a record **4,671 alerts**, according to the [European Commission's Safety Gate annual report](https://op.europa.eu/webpub/just/safety-gate-2025-report/en/). The TSR addresses both weaknesses directly: a dynamic mechanism for banning hazardous substances, and a digital enforcement infrastructure built around the product passport. ## The Key Changes Dynamic chemical bans, a mandatory Digital Product Passport, and new duties for connected toys ### Stricter chemical rules, applied dynamically The most significant substantive change is chemical. According to the European Commission, the TSR bans substances from toys as soon as they are classified as hazardous, including chemicals that disrupt hormones, harm the respiratory system, cause skin allergies, or damage specific organs. The regulation also strengthens the existing prohibition on carcinogenic, mutagenic, and reprotoxic (CMR) substances. Two bans stand out for their supply chain impact: - **PFAS**: the intentional use of per- and polyfluoroalkyl substances ("forever chemicals") in toys is prohibited. - **Bisphenols**: the presence of bisphenols in toys is prohibited, extending well beyond the previous restrictions on bisphenol A. The regulation also tightens rules on fragrance allergens. The Appendix to Annex II prohibits **59 listed fragrance allergens** unless their presence is technically unavoidable under good manufacturing practice and does not exceed 10 mg/kg, and requires **65 further allergens** to be labelled, including in the digital product passport, when present above that threshold. Preservatives may only be used where they are allowed in leave-on cosmetics under the EU Cosmetics Regulation (Annex II, Part III, point 14 of the TSR). The word "dynamically" matters here. Under the old directive, adding a substance restriction was slow. Under the TSR, hazard classification triggers the ban. For quality teams, this means chemical compliance for toys stops being a static checklist and becomes a moving target that must be monitored continuously. ### A Digital Product Passport for every toy Under the TSR, all toys placed on the EU market will be required to carry a Digital Product Passport (DPP) containing safety and compliance information, accessible online via a QR code or other data carrier. The toy DPP is the first mandatory product passport applied to an entire consumer product category, arriving ahead of most categories planned under the [Ecodesign for Sustainable Products Regulation (EU) 2024/1781 (ESPR)](/resources/guides/espr-ecodesign-regulation-explained). Article 19 of the TSR requires the manufacturer to create a digital product passport for each toy, and the passport replaces the EU declaration of conformity that toys carried under the old directive. Where the passport contains all required information, it can also serve as the declaration of conformity under other EU legislation applying to the toy, such as RoHS, the Radio Equipment Directive, or the Cyber Resilience Act (Article 19(5)). Customs authorities will be able to check the passport for toys sold online and imported into the EU, which closes the enforcement gap that has let non-compliant toys flow into the market through e-commerce channels. For a deeper look at how product passports work across categories, see our [Digital Product Passport guide](/resources/guides/digital-product-passport-guide). ### Digital, connected, and app-enabled toys The TSR extends safety assessment beyond physical and chemical hazards. For toys in scope of the AI Act, the Cyber Resilience Act, or the Radio Equipment Directive, Article 25(2)(c) requires the safety assessment to take account of children's particular vulnerabilities, and the regulation's recitals state that assessments should, where appropriate, cover risks that digitally connected toys pose to mental health. Cybersecurity itself is not regulated by the TSR: connected toys must instead comply with the Cyber Resilience Act (EU) 2024/2847, which the TSR cross-references, and internet-connected toys that speak, film, or track location fall into the CRA's "important products" class with stricter conformity assessment. If your range includes anything with a chip, a microphone, an app, or a connection, your technical documentation now spans two regulations, not one. ### Obligations across the supply chain Like GPSR, the TSR assigns explicit obligations to every economic operator: manufacturers, importers, distributors, and online marketplaces. Marketplaces and customs gain new tools to verify compliance through the DPP, which means retailers and platforms will increasingly push documentation requirements upstream to brands and manufacturers. Companies selling through Amazon, Zalando, or similar channels should expect passport data to become a listing requirement, not just a legal one. ## Timeline The milestones from adoption in 2025 to full application in August 2030 | Date | Milestone | Status | |------|-----------|--------| | 26 November 2025 | Regulation (EU) 2025/2509 adopted | Confirmed | | 12 December 2025 | Published in the Official Journal of the EU | Confirmed | | 1 January 2026 | Entry into force; institutional and delegated-act provisions begin applying | Confirmed | | 1 August 2030 | TSR applies in full; Directive 2009/48/EC repealed | Confirmed | ## Is the Toy Safety Regulation already in force? Yes, the TSR entered into force on **1 January 2026**, but its substantive requirements do not apply to products until **1 August 2030**. Under Article 59, Articles 28 to 44 and Articles 49 to 55 apply from 1 January 2026; these cover the institutional machinery (notification of conformity assessment bodies, delegated powers, committee procedure, and penalties) rather than product requirements. Until 1 August 2030, toys must continue to comply with Directive 2009/48/EC. ## Can I still sell toys that comply with the old directive after 2030? Yes. Under Article 57(1) of the TSR, member states may not impede the making available of toys placed on the market in conformity with Directive 2009/48/EC before 1 August 2030, and the regulation sets no sell-off end date for that stock. EC type-examination certificates issued under the directive remain valid until **1 February 2031** unless they expire earlier (Article 57(3)). "Placed on the market" refers to each individual unit's first making available in the EU, so production runs after the deadline must comply with the TSR regardless of when the model was designed. ## Does the new regulation apply in the UK? No. The TSR applies to the EU and EEA market. Great Britain retains its own Toys (Safety) Regulations 2011, and toys sold there follow UKCA or recognized CE rules; Northern Ireland follows EU rules under the Windsor Framework. Companies selling in both markets will need to manage diverging toy safety requirements, a divergence that will grow as the TSR's chemical rules take effect. See our [UKCA marking guide](/resources/guides/ukca-marking-guide) for the GB side of the picture. ## How to Prepare A practical sequence for reassessing a toy portfolio before the 2030 deadline Four and a half years is enough time if the work starts from structured product data. It is not enough time to do this manually across a large catalogue. [Konges Sløjd](/resources/case-studies/konges-sloejd-partnership), the Danish children's brand selling in 90 countries, is a useful reference point for the scale problem: children's product portfolios routinely require risk assessments by the hundreds, and the TSR effectively re-opens every one of them. > Quote from Complir Team, Product Compliance at Complir: The 2030 deadline reads like a documentation project, but it is a data project. The passport requires structured, machine-readable compliance data for every toy, and the chemical bans require material-level knowledge of every supplier input. Teams that keep treating toy compliance as a folder of PDFs will spend 2029 in a fire drill; teams that structure their product data once will answer the TSR, GPSR, and DPP questions from the same foundation. This portfolio-wide reassessment is exactly the kind of work that breaks manual compliance processes, and it is why we built Complir to run classification, risk assessment, and supplier document retrieval from a single structured record per product. ## Key Takeaways What the Toy Safety Regulation changes and why the winners start now The EU Toy Safety Regulation (EU) 2025/2509 replaces the Toy Safety Directive 2009/48/EC and applies in full from **1 August 2030**. Chemical compliance becomes dynamic: hazard classification now triggers bans automatically, including prohibitions on PFAS and bisphenols. Every toy on the EU market will need a Digital Product Passport accessible by QR code, checkable by customs and marketplaces. Digital and connected toys face new cybersecurity and mental-health assessment duties. And because the passport requires structured product data, the companies that win the transition will be the ones that treat this as a data project starting now, not a documentation sprint in 2029. If reassessing an entire toy portfolio against the TSR while keeping up with GPSR and the incoming ESPR passports sounds like more than your team can absorb, [see how Complir automates product classification, chemical risk mapping, and supplier documentation collection across your full catalogue](https://complir.io). ## Sources & References - Regulation (EU) 2025/2509 of the European Parliament and of the Council of 26 November 2025 on the safety of toys and repealing Directive 2009/48/EC: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2025/2509/oj) - European Commission, "Stronger toy safety rules enter into force," 23 December 2025: [European Commission](https://single-market-economy.ec.europa.eu/news/stronger-toy-safety-rules-enter-force-2025-12-23_en) - Directive 2009/48/EC on the safety of toys: [EUR-Lex](https://eur-lex.europa.eu/eli/dir/2009/48/oj) - General Product Safety Regulation (EU) 2023/988: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2023/988/oj) - Ecodesign for Sustainable Products Regulation (EU) 2024/1781: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2024/1781/oj) - Cyber Resilience Act (EU) 2024/2847: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2024/2847/oj) - European Commission, Safety Gate Annual Report 2025: [Publications Office](https://op.europa.eu/webpub/just/safety-gate-2025-report/en/) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # EUDR Compliance: Requirements and the 2026 Deadline Source: https://www.complir.io/resources/guides/eudr-compliance-guide Category: Guide **The EU Deforestation Regulation (EUDR), formally Regulation (EU) 2023/1115, prohibits placing on the EU market, making available, or exporting seven commodities and their derived products unless they are deforestation-free, produced legally in the country of origin, and covered by a due diligence statement.** After two postponements, large and medium-sized companies must comply from **30 December 2026**, and micro and small enterprises from **30 June 2027**. If your portfolio includes anything made from wood, rubber, palm oil, soy, cocoa, coffee, or cattle-derived materials, EUDR applies to you even if you have never thought of your company as being in the "forest commodities" business. Furniture, toys with wooden parts, tyres, leather goods, chocolate, and paper packaging placed on the market as a product in its own right can all fall in scope. With the December 2026 deadline now firm and the European Commission's simplification package published in May 2026, the preparation window is the second half of 2026. This guide covers what the regulation requires, who must do what, and how to get ready. ## What is the EU Deforestation Regulation (EUDR)? The EU Deforestation Regulation is an EU regulation that requires companies to prove that specific commodities and derived products they place on the EU market or export from it did not come from land deforested or degraded after **31 December 2020**. It was adopted on 31 May 2023, entered into force on 29 June 2023, and replaces the EU Timber Regulation (EU) No 995/2010. Unlike a product safety regulation such as the [General Product Safety Regulation (GPSR)](/resources/guides/gpsr-compliance-guide-product-companies), the EUDR regulates the origin of raw materials rather than the characteristics of the finished product. Compliance is demonstrated through supply chain traceability: knowing exactly which plots of land your materials came from, and being able to show it. As part of the [EU Green Deal](/resources/guides/eu-green-deal-compliance), it sits alongside a wave of sustainability legislation that is moving compliance obligations upstream into the supply chain. Two amendments have reshaped the timeline and obligations since adoption. Regulation (EU) 2024/3234 postponed the original application date by one year, and Regulation (EU) 2025/2650, adopted on 19 December 2025, postponed it again while simplifying who must submit due diligence statements. The core obligations, the commodity scope, and the penalty regime remain intact. ## Scope: Commodities and Covered Products Seven commodities, one Annex, and a scope defined by customs codes The EUDR covers seven commodities: cattle, cocoa, coffee, oil palm, rubber, soya, and wood. It also covers products derived from them, listed in Annex I of the regulation by customs (HS) code. Derived products include leather, chocolate, tyres, furniture, charcoal, palm-oil derivatives, and paper products, among many others. Two scope notes matter for product companies. First, scope is determined by the Annex I HS code list, not by intuition: a product either falls under a listed code or it does not. Second, Regulation (EU) 2025/2650 removed printed products such as books from the scope. A draft delegated act published with the Commission's May 2026 simplification package proposes further targeted revisions to Annex I: 17 product codes added (including instant coffee and certain palm-oil derivatives), three removed (including retreaded tyres and cattle leather), and one clarified. The public feedback period closed on 1 June 2026 and the act is pending formal adoption, so the final list may still change. Note that paper and cardboard packaging placed on the market as a product in its own right can fall in scope, on top of the obligations it already carries under [Extended Producer Responsibility schemes](/resources/guides/extended-producer-responsibility-eu-guide). The same physical item increasingly triggers more than one EU compliance regime. ## Timeline: Key EUDR Dates From entry into force to the firm December 2026 deadline | Date | Milestone | Status | |------|-----------|--------| | 29 June 2023 | Regulation (EU) 2023/1115 enters into force | Confirmed | | 30 December 2024 | Original application date | Superseded by Regulation (EU) 2024/3234 | | 30 December 2025 | First postponed application date | Superseded by Regulation (EU) 2025/2650 | | 22 May 2025 | Commission adopts country benchmarking classification | Confirmed | | 4 May 2026 | Commission publishes simplification review (COM(2026) 191 final), updated guidance, and draft delegated act | Confirmed | | 30 December 2026 | Application for large and medium-sized operators and traders | Confirmed | | 30 June 2027 | Application for micro and small enterprises and natural persons | Confirmed | According to the European Commission, the May 2026 simplification measures are expected to reduce annual compliance costs by roughly **75%** compared with the original 2023 estimates. The EU Information System, a dedicated tool on the TRACES platform, is operational: a production server where submitted due diligence statements have legal value, and an acceptance server for training, familiarisation, and testing. The system operates under Commission Implementing Regulation (EU) 2024/3084, with an update pending to reflect the amended EUDR provisions. ## Who Must Comply Operators, traders, and the 2025 simplification The EUDR distinguishes between two roles. An **operator** is any company that places a relevant product on the EU market for the first time or exports it from the EU. A **trader** is any company in the supply chain, other than the operator, that makes the product available on the market. Both roles carry obligations, but the weight sits with operators. Regulation (EU) 2025/2650 simplified the chain significantly: only the business that first places a relevant product on the EU market is responsible for submitting the due diligence statement. Companies further down the chain no longer submit new statements for the same product; they rely on the reference numbers of statements already submitted upstream. Micro and small primary operators benefit from a one-off simplified declaration instead of repeated submissions. For non-EU brands, the practical consequence is that their EU importer typically becomes the operator and carries the due diligence obligation. For EU retailers with own-brand products sourced outside the EU, the retailer itself is usually the operator. That makes EUDR readiness a direct function of how well you can extract verifiable origin data from your suppliers. This is where most companies feel the pain first: not in understanding the regulation, but in collecting the evidence. Chasing suppliers for documents at scale is already the hidden cost of compliance work. It is the same challenge that led companies like [Flying Tiger Copenhagen](/resources/case-studies/flying-tiger-compliance), which launches around 500 new products per month across 44 countries, to run supplier document collection as a structured workflow in Complir rather than an email thread. > Quote from Complir Team, Product Compliance at Complir: EUDR is not really a new kind of obligation; it is a new document type dropped into a supplier data pipeline most companies never built. Teams that treat geolocation coordinates as one more attachment to chase over email will spend 2027 firefighting. Teams that treat origin data as structured product data, requested once, validated on arrival, and reused across every SKU that shares a supply chain, will barely notice the deadline. ## The Three Core Requirements Deforestation-free, legally produced, and covered by a due diligence statement Article 3 of the EUDR sets three cumulative conditions. Relevant products may only be placed on the EU market or exported if they are: 1. **Deforestation-free**, meaning produced on land that was not subject to deforestation or forest degradation after **31 December 2020**. 2. **Produced in accordance with the relevant legislation of the country of production**, covering areas such as land use rights, environmental protection, labour rights, and tax and anti-corruption rules. 3. **Covered by a due diligence statement (DDS)** submitted through the EU Information System before the product is placed on the market or exported. Meeting these conditions requires a due diligence system with three steps: collecting information (Article 9), assessing risk (Article 10), and mitigating risk where it is more than negligible (Article 11). The Commission's May 2026 package added supporting tools for this exercise, including repositories of producing-country legislation for legality assessments and a framework for recognising certification schemes as inputs to risk assessment. Certification can inform your risk assessment, but it does not replace your own due diligence. ## What must a due diligence statement include? A due diligence statement must include the operator's identity and EORI number where applicable, a description of the product with its HS code and quantity, the country of production, the geolocation of all plots of land where the relevant commodities were produced, and a declaration that due diligence was carried out and no or only negligible risk was found. Geolocation is the requirement that surprises most teams. Article 9(1)(d) of the EUDR requires geolocation coordinates for every plot of land where the relevant commodities a product contains were produced. The regulation's own definition of geolocation in Article 2(28) sets the precision: latitude and longitude coordinates using at least six decimal digits, with polygons required for plots larger than four hectares. The Information System accepts coordinates individually, drawn on a map, or in bulk in the GeoJSON standard format. For cattle, geolocation covers the establishments where the animals were kept. For a quality or regulatory team, this means your supplier data requests need to go beyond certificates and test reports. You need plot-level coordinates flowing from the farm or forest through every tier of your supply chain to your product record. ## What is EUDR country benchmarking? Country benchmarking is the EUDR's system for classifying every country as low, standard, or high risk for deforestation, which determines how much due diligence effort is required. The European Commission adopted the first classification on **22 May 2025** through Commission Implementing Regulation (EU) 2025/1093. Belarus, Myanmar, North Korea, and Russia were classified as high risk. Around 50 countries, including major producers such as Brazil, Indonesia, and Malaysia, were classified as standard risk, and roughly 140 countries, including all EU Member States, the UK, the US, and China, as low risk. The European Parliament adopted a resolution objecting to the classification methodology in July 2025, but the objection is not binding for an implementing act: Implementing Regulation (EU) 2025/1093 remains in force and the classifications remain valid. The Commission has indicated it will review the benchmarking, so sourcing teams should treat country risk categories as reviewable rather than permanent. Sourcing from low-risk countries qualifies for simplified due diligence under Article 13: you must still collect the required information, including geolocation, but you are not obliged to run the full risk assessment and mitigation steps. Standard-risk and high-risk sourcing requires the full exercise, with products from high-risk countries subject to enhanced checks by authorities. ## Penalties and Enforcement Fines of at least 4% of EU turnover, confiscation, and market bans Member State authorities enforce the EUDR, and Article 25 sets the penalty framework. Fines must be proportionate to the environmental damage and the value of the products concerned, with a maximum of **at least 4% of the operator's or trader's annual EU-wide turnover**. Authorities can also confiscate the products and the revenues gained from them, and non-compliant companies can face temporary exclusion from public procurement and, for serious infringements, temporary prohibition from placing relevant products on the market. Enforcement begins with the application dates: 30 December 2026 for large and medium companies, 30 June 2027 for micro and small enterprises. Checks are risk-based, with authorities required to inspect a higher share of operators sourcing from high-risk countries. ## How to Prepare Before December 2026 Five steps that cover the ground between now and the deadline ## Does the EUDR apply to products already on the market? Products placed on the market before the relevant application date are generally not subject to the due diligence obligation, with specific transitional rules for timber products previously covered by the EU Timber Regulation. The decisive moment is when a product is first placed on the EU market, so goods entering your warehouse and the market after 30 December 2026 need a due diligence statement even if they were ordered earlier. Verify the transitional provisions for your specific situation, as the rules differ by commodity history. ## Key Takeaways What to remember about EUDR going into the second half of 2026 The EUDR is in force today and applies to large and medium companies from **30 December 2026**. The seven-commodity scope reaches deep into ordinary consumer product portfolios: furniture, toys, tyres, leather, chocolate, coffee, and paper packaging are all candidates. Compliance stands on three legs: deforestation-free origin after the 31 December 2020 cut-off, legal production, and a due diligence statement with plot-level geolocation. The December 2025 amendment reduced the burden by making only the first placer on the market responsible for the DDS, and the May 2026 simplification package added guidance, legality repositories, and certification recognition. Penalties reach at least 4% of EU turnover, so treating this as a procurement-only topic is a risk in itself. If your team is already stretched chasing supplier documentation for declarations of conformity and test reports, EUDR adds a new document type to the same broken process. Complir runs supplier document retrieval as a structured workflow: suppliers see exactly what is needed and in what format, incoming documents are classified automatically, and gaps are visible per product. [See how Complir automates supplier document collection and regulatory monitoring](https://complir.io). ## Sources & References - Regulation (EU) 2023/1115 on deforestation-free products: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2023/1115/oj) - Regulation (EU) 2025/2650 amending Regulation (EU) 2023/1115 as regards certain obligations of operators and traders: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2025/2650/oj) - Commission Implementing Regulation (EU) 2025/1093 on country benchmarking: [EUR-Lex](https://eur-lex.europa.eu/eli/reg_impl/2025/1093/oj) - Regulation on Deforestation-free Products: [European Commission, DG Environment](https://environment.ec.europa.eu/topics/forests/deforestation/regulation-deforestation-free-products_en) - The Information System of the Deforestation Regulation: [European Commission Green Forum](https://green-forum.ec.europa.eu/nature-and-biodiversity/deforestation-regulation-implementation/information-system-deforestation-regulation_en) - Implementing the EU Deforestation Regulation: [European Commission Green Forum](https://green-forum.ec.europa.eu/nature-and-biodiversity/deforestation-regulation-implementation_en) - Commission simplification review of the EUDR, COM(2026) 191 final, 4 May 2026: [European Commission press release](https://ec.europa.eu/commission/presscorner/detail/en/ip_26_941) - Delay until December 2026 and other developments in the implementation of the EUDR: [Access2Markets, European Commission](https://trade.ec.europa.eu/access-to-markets/en/news/delay-until-december-2026-and-other-developments-implementation-eudr-regulation) - Deforestation law: Parliament adopts changes to postpone and simplify measures: [European Parliament press release, 11 December 2025](https://www.europarl.europa.eu/news/en/press-room/20251211IPR32168/deforestation-law-parliament-adopts-changes-to-postpone-and-simplify-measures) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # Digital by Default: What Omnibus IV Means for Product Compliance Source: https://www.complir.io/resources/guides/omnibus-iv-digital-by-default Category: Guide Omnibus IV is the EU's fourth simplification package for product rules. On **9 June 2026**, the Council of the EU and the European Parliament reached a provisional agreement to make product compliance information **digital by default** across the Single Market, amending **20 pieces of EU product legislation** to move compliance off paper and onto digital channels. The headline framing is "less paperwork." That is true, but it undersells what is happening. The deeper shift is from compliance as a stack of documents to compliance as a body of structured, living data, generated, maintained, and shared digitally across a product's life. Companies organised around the document will feel friction. Companies organised around the data will move faster. This article explains what was actually agreed, what is genuinely new, what is *not* changing, and why the underlying direction matters more than the individual measures. ## What Omnibus IV Agreed The digitalisation strand of the EU's fourth simplification package Omnibus IV is a European Commission simplification package proposed on **21 May 2025**. On **9 June 2026**, the Council presidency and Parliament negotiators reached a provisional political agreement on its digitalisation strand. The new rules apply the "digital by default" principle to existing product legislation, allowing compliance information that today must be printed to be provided and exchanged digitally instead. One point of precision that matters for planning: this is a *provisional* agreement, not yet law. Before it applies, the text still has to be formally endorsed by both the Council and the Parliament, pass legal-linguistic revision, and be published in the EU Official Journal. The substance is now stable enough to prepare for, but the final text and dates can still move. ## What "Digital by Default" Changes Five recurring shifts across twenty product laws The agreement covers two linked instruments: a draft Regulation amending seven existing regulations, and a draft Directive amending thirteen existing directives, twenty product laws in total, spanning areas such as machinery, personal protective equipment, gas appliances, pressure equipment, RoHS, marine equipment, the Battery Regulation, and the Ecodesign for Sustainable Products Regulation (ESPR). Across those laws, the recurring changes are consistent: **Digital EU Declaration of Conformity (DoC).** The Declaration of Conformity, the manufacturer's formal statement that a product meets EU requirements, can be provided digitally, including via an internet address or machine-readable code such as a QR code, rather than as a printed document travelling with the product. **Digital instructions for use.** Manufacturers may provide instructions in digital form instead of on paper, under sector-specific conditions and with safeguards for end users. **A mandatory digital contact point.** Manufacturers must provide a digital contact, a freely accessible online channel such as an email address or a website contact form. It cannot require registration, a dedicated app, or disclosure of personal data simply to reach the economic operator. **Digital exchanges with authorities.** Communication between economic operators and national market surveillance authorities can move to electronic channels, replacing paper-based correspondence. **Common specifications as a fallback.** Where harmonised standards are missing, insufficient, or not available in time, the Commission can adopt "common specifications" as an alternative route to demonstrating conformity. This is explicitly framed as an exceptional, last-resort mechanism, not a replacement for the established standardisation process. ## The Safeguards Paper does not disappear entirely The agreement is deliberately not a blanket "everything becomes a QR code" rule. Two safeguards are built in. First, where there is a risk of serious harm to consumers, safety information must still be available in paper form. Second, essential safety information and on-product warnings remain physical where the underlying acts require them. The simplification targets the *administrative* layer (declarations, instructions, formal correspondence), not the critical safety content a user needs in their hands at the moment of use. This is worth stating clearly in any internal discussion, because the "paper is dead" reading overstates the change and creates avoidable compliance risk. ## What Is Not Changing Keeping the picture honest next to the DPP Because Omnibus IV sits next to high-profile rules like the [Digital Product Passport](/resources/guides/digital-product-passport-guide), it is easy to over-read. A few boundaries keep the picture honest: - It does **not** change Digital Product Passport timelines. The battery passport still applies from **18 February 2027**, the detergents DPP from **23 September 2029**, and the toy DPP from **1 August 2030**. - It does **not** create new DPP data fields or a universal DPP obligation. Those are set in sector-specific delegated acts, not in this package. - It does **not** make all instructions and safety information QR-only. Scope stays sector-specific, and paper safeguards remain. - It does **not** replace harmonised standards. Common specifications are a fallback, not the new default. There is one neat point of convergence worth noting. Where another EU law already requires a Digital Product Passport for a product, certain Declaration of Conformity and instruction information can be stored *only* in that passport, rather than duplicated across separate systems. That is a small but telling signal: the EU is starting to treat the digital passport as the single place compliance information lives. ## Data, Not Documents Why the direction of travel matters more than the measures Strip away the legal mechanics and a pattern emerges. A Declaration of Conformity you can auto-generate, serve through a web link or QR code, keep current across a product's life, and, where a passport exists, store in one canonical location, is no longer a document in any meaningful sense. It is a *view* onto underlying compliance data. That reframes the core question for any product business. The hard part stops being "where is the right PDF, in the right language, with the right version" and becomes "is our compliance *data* structured, current, sourced from suppliers we trust, and ready to be served on demand to a customer, a marketplace, or an authority." Most companies today are not organised this way. Compliance lives in shared drives, email threads, supplier attachments, and spreadsheets, a document-centric setup that worked when the deliverable was a binder. As the EU moves the deliverable to a live digital channel, that setup becomes the bottleneck. > Quote from Complir Team, Product Compliance at Complir: "Digital by default" sounds like a formatting change, but it quietly raises the bar on data quality. A printed Declaration of Conformity hides a multitude of sins; the moment that same statement is served live through a QR code and, eventually, a Digital Product Passport, the underlying data has to be correct, current, and traceable to a supplier. The teams that win are not the ones that digitise their PDFs. They are the ones that treat every product as a single structured compliance record the document can simply render. The organisations that will adapt cleanly are the ones that can do five things as a matter of routine: collect compliance information from suppliers in a structured, repeatable way; maintain a single source of truth for each product's regulatory data; generate Declarations of Conformity automatically from that data; provide direct digital access via web links or QR codes; and share that information with customers and authorities, feeding it into Digital Product Passports as those obligations arrive. None of this is a new legal requirement created by Omnibus IV. It is the operating model the regulation's direction of travel quietly rewards. ## What To Do Now Operational preparation that pays off regardless of the final text For most product businesses, the right preparation is not legal, it is operational, and it is worth starting before the text is final, because it pays off regardless of the exact wording. ## Frequently Asked Questions Common questions about Omnibus IV and digital by default ## Is Omnibus IV now law? No. As of June 2026 it is a provisional political agreement. It still requires formal endorsement by the Council and Parliament, legal-linguistic revision, and publication in the Official Journal before it applies. The final text may differ from the agreed version. ## Does "digital by default" mean no more paper at all? No. Where there is a risk of serious harm, safety information must still be available on paper, and essential warnings remain on the product. The change targets declarations, instructions, and formal correspondence, not critical safety content. ## What is a digital Declaration of Conformity? It is the same legal statement of conformity, made available digitally, for example through an internet address or a machine-readable code such as a QR code, instead of, or in addition to, a printed copy travelling with the product. The [CE marking](/resources/guides/ce-marking-requirements) obligation behind it does not change. ## Does this change the Digital Product Passport deadlines? No. Omnibus IV does not alter DPP timelines. The battery passport still applies from 18 February 2027, detergents from 23 September 2029, and toys from 1 August 2030. ## What are common specifications? Common specifications are technical specifications the Commission can adopt to provide a route to conformity when harmonised standards are unavailable or insufficient. Under Omnibus IV they are an exceptional fallback, not a replacement for the standardisation process. ## Which products are affected? The package amends 20 EU product laws, including rules on machinery, personal protective equipment, gas appliances, pressure equipment, RoHS, marine equipment, the Battery Regulation, and [ESPR](/resources/guides/espr-ecodesign-regulation-explained). The specific effects vary by sector. ## The Bottom Line The document is becoming a rendering of the data behind it Omnibus IV's "digital by default" agreement is a simplification measure on paper and a structural signal in practice. The EU is steadily making the *digital channel*, web links, QR codes, and ultimately Digital Product Passports, the place compliance information lives. The document is becoming a rendering of the data behind it. The work that follows is not about managing more documents. It is about managing compliance data well enough that the document can generate itself, stay current, and be served to anyone who asks. That is the capability we built Complir around: a single, structured compliance record per product, with Declarations of Conformity generated from it and supplier evidence collected into it, so that as the EU's digital requirements arrive, the data is already there to meet them. If your compliance information still lives across drives, inboxes, and spreadsheets, the digital-by-default shift is a good reason to change that now, while it is still preparation, not catch-up. See how [Complir maps every product to every applicable regulation](/#solution). ## Sources & References - [Council of the EU, "Simplification: Council and Parliament strike deal to help growing businesses thrive and accelerate digitalisation" (press release, 9 June 2026)](https://www.consilium.europa.eu/en/press/press-releases/2026/06/09/simplification-council-and-parliament-strike-deal-to-help-growing-businesses-thrive-and-accelerate-digitalisation/) - [European Commission, Omnibus IV package overview](https://single-market-economy.ec.europa.eu/publications/omnibus-iv_en) - [Commission proposal COM(2025) 504, Regulation on digitalisation and common specifications (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52025PC0504) - [Commission proposal COM(2025) 503, Directive on digitalisation and common specifications (EUR-Lex)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52025PC0503) - [Council of the EU, "Council agrees positions on digitalisation and common specifications" (press release, 24 September 2025)](https://www.consilium.europa.eu/en/press/press-releases/2025/09/24/simplification-council-agrees-positions-on-digitalisation-and-common-specifications-as-well-as-on-small-mid-caps-to-boost-eu-competitiveness/) - [Regulation (EU) 2024/1781 (ESPR), EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1781) - [Regulation (EU) 2023/1542 (Battery Regulation), EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1542) --- *This article is for informational purposes only and does not constitute legal advice. Omnibus IV is a provisional agreement and its scope, transition periods, and dates may change before adoption. Consult a qualified compliance advisor for guidance specific to your products and markets.* --- # UKCA Marking: A Practical Guide for Manufacturers Selling in Great Britain Source: https://www.complir.io/resources/guides/ukca-marking-guide Category: Guide UKCA (UK Conformity Assessed) is the conformity mark for products placed on the market in Great Britain. It was introduced after the UK left the EU as Great Britain's equivalent of [CE marking](/resources/guides/ce-marking-requirements). If you sell physical products into England, Scotland, or Wales, UKCA is the regime you need to understand. There is one important twist that a lot of online guidance has not caught up with. The UK government has granted indefinite recognition of CE marking in Great Britain for most consumer product regulations. The **Product Safety and Metrology etc (Amendment) Regulations 2024** made the change permanent for **21 product regulations**, meaning manufacturers can continue to use a CE-marked product in GB without applying a UKCA mark for those categories. UKCA is now effectively voluntary for the bulk of consumer goods, and mandatory only for a narrow set of excluded sectors. This guide covers what UKCA is, where it applies, when it is genuinely required, how the conformity assessment process works, what the rules look like in Northern Ireland, and how UK REACH fits into the picture. It is updated for the current state of the GB regime in 2026. ## What is UKCA marking? The GB-only successor to CE, owned by OPSS, MHRA, and HSE depending on sector UKCA marking is the conformity mark used to indicate that a product complies with the applicable product safety legislation in Great Britain. It is the GB-only successor to CE marking, introduced after Brexit as part of the UK's post-EU product regulation framework. The mark itself is the letters "UKCA" placed on the product, the packaging, or the accompanying documentation, in accordance with the rules in the underlying sector-specific regulations. It indicates that the manufacturer has carried out the required conformity assessment and that the product meets GB legal requirements. UKCA marking is geographically restricted: it applies to products placed on the Great Britain market only (England, Scotland, and Wales). Northern Ireland operates under a different regime under the Windsor Framework, in which EU rules continue to apply for manufactured goods. ### Who regulates UKCA? Different UK government bodies own different parts of the GB product regulatory system. Three matter most for UKCA-related questions: - **Office for Product Safety and Standards (OPSS)**: part of the Department for Business and Trade, established in January 2018. OPSS is the central regulator for most consumer product safety in Great Britain and the enforcement authority for a wide range of product regulations. - **Medicines and Healthcare products Regulatory Agency (MHRA)**: responsible for the medical devices regime in the UK, including UKCA-related obligations for medical devices. - **Health and Safety Executive (HSE)**: responsible for UK REACH and a range of chemical, machinery, and workplace product regulations. OPSS is the regulator most manufacturers deal with day-to-day for general consumer products. ## The CE recognition twist Why UKCA is voluntary for most consumer goods today This is the most consequential point in any honest UKCA guide today, and it is where most online content is out of date. When UKCA was introduced after Brexit, the expectation was that it would replace CE marking in Great Britain entirely. That has not happened. Instead, after a series of deadline extensions, the UK government legislated to make CE marking indefinitely acceptable in GB for most product categories. In **May 2024**, Parliament passed the Product Safety and Metrology etc (Amendment) Regulations 2024, which extended recognition of the CE marking (and the reversed-epsilon marking for measuring instruments) indefinitely across **21 product regulations**. The practical effect: for the regulations covered by this indefinite recognition, manufacturers can place a CE-marked product on the GB market without applying a separate UKCA mark. UKCA remains a valid option, but it is no longer the only path. Manufacturers can choose between UKCA and CE for these categories. The 21 regulations covered by indefinite CE recognition are administered by the Department for Business and Trade (18 regulations) plus three other departments. They cover the bulk of everyday consumer products: toys, electrical equipment, machinery, personal protective equipment (PPE), gas appliances, pressure equipment, simple pressure vessels, recreational craft, lifts, equipment for potentially explosive atmospheres (ATEX), radio equipment, electromagnetic compatibility (EMC), aerosol dispensers, noise emissions from outdoor equipment, pyrotechnics, non-automatic weighing instruments, measuring instruments, and measuring container bottles. Three further regulations come from other departments: the Restriction of Hazardous Substances Regulations 2012 (RoHS, Defra), the Ecodesign for Energy-Related Products Regulations 2010 (DESNZ), and the Explosives Regulations 2014 (HSE). There is also a related fast-track provision in the 2024 regulations: manufacturers can affix the UKCA marking and draw up a UK Declaration of Conformity that lists compliance with the relevant EU legislation, provided the product meets EU essential requirements and, where third-party assessment is required, has been conformity assessed by an EU-recognised conformity assessment body. This lets manufacturers who prefer the UKCA route avoid duplicating notified body work for products they have already CE-assessed. This is good news for most manufacturers, because it means CE compliance work continues to deliver GB market access for the same products. Where it stops being good news is for the categories that the indefinite recognition does not cover, which still require the UKCA route. ## When UKCA is actually required The seven excluded categories where CE alone is not enough Indefinite CE recognition does not apply to every product category. For the following sectors, UKCA (or a separate UK-specific regime) is the relevant path, and CE alone is not sufficient to place products on the GB market: - **Medical devices**: administered by the MHRA under a separate framework. CE-marked medical devices currently retain access to the GB market under transitional arrangements (the cut-off dates vary by device class and the EU legislation under which the CE mark was issued). In early 2026, the MHRA launched a consultation on whether to make CE recognition for medical devices indefinite. As of this writing, that consultation is ongoing and the future regime for medical devices in GB is not finalised. - **Construction products**: handled separately by the Department for Levelling Up, Housing and Communities (and its successor departments) rather than under the general OPSS framework. The construction products regime in GB has its own marking and conformity assessment route. - **Marine equipment**: regulated under the Merchant Shipping (Marine Equipment) Regulations. - **Rail products**: interoperability and safety requirements for the GB rail network are administered separately. - **Cableways** installations. - **Transportable pressure equipment**: administered by the Vehicle Certification Agency (VCA) and others under a separate regime. - **Unmanned aircraft systems** (UAS / drones): regulated under the Civil Aviation Authority's UAS framework. If your product falls into one of these categories, the indefinite CE recognition does not apply and you need to look at the specific UK regime for your sector. For most consumer product manufacturers, none of these will apply, but if any one of them does, the UKCA-route obligation is real and binding. ## Does UKCA apply to all consumer products? No. UKCA is required only for the categories not covered by indefinite CE recognition: medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment, and unmanned aircraft systems. For everything else (toys, electrical equipment, machinery, PPE, RoHS-covered products, and the rest of the 21 regulations), CE marking remains a valid GB market-access route and UKCA is voluntary. ## How UKCA conformity assessment works The familiar CE-style pathway, designated standards, and UK Approved Bodies For products that are placed on the GB market under the UKCA route, the conformity assessment process follows the same logic as CE marking: it inherits the EU's New Legislative Framework module structure, which the UK retained when it transposed EU product law into domestic law after Brexit. The core steps are familiar to anyone who has done CE marking: 1. **Identify the applicable UK product regulations**, for example the Toys (Safety) Regulations 2011, the Supply of Machinery (Safety) Regulations 2008, the Electromagnetic Compatibility Regulations 2016, the Radio Equipment Regulations 2017, and so on. These are the UK domestic versions of the EU directives the same products are subject to. 2. **Identify the applicable designated standards**, the UK equivalent of EU harmonised standards. The UK government publishes a list of designated standards for each sector. Compliance with a designated standard gives a presumption of conformity with the corresponding regulation. 3. **Choose the conformity assessment procedure**: for most consumer products this is internal production control, allowing self-declaration. For higher-risk products or products outside the scope of designated standards, third-party conformity assessment by a UK Approved Body is required. 4. **Compile technical documentation**: the technical file that demonstrates how the product meets the applicable requirements. This is structurally identical to the CE marking technical file and uses the same evidence (test reports, risk assessments, material declarations, designs). 5. **Draw up a UK Declaration of Conformity (UK DoC)**: the manufacturer's formal statement of compliance with applicable GB regulations. 6. **Affix the UKCA mark** to the product (or packaging or documentation, depending on the sector rules). The marking itself must be at least **5 mm in height** (unless a sector-specific rule sets a different minimum), clearly visible, legible, and indelible. Under a current labelling easement, the UKCA mark can be applied on a label affixed to the product or on an accompanying document until **23:00 on 31 December 2027**. After that, in most cases, the mark must be affixed to the product itself or to the packaging, though the government has signalled further flexibility (including digital labelling) may follow in additional legislation. ### UK Approved Bodies A UK Approved Body is the GB equivalent of an EU notified body: a third-party conformity assessment body that has been designated by a UK national accreditation authority to assess products against specific regulations. UK Approved Bodies are listed in the UK Market Conformity Assessment Bodies (UKMCAB) database. EU notified bodies do not automatically qualify as UK Approved Bodies. If your product requires third-party assessment for UKCA, that assessment must be carried out by a body designated under the UK system. ### UK Declaration of Conformity The UK DoC is the manufacturer's formal compliance statement and is required for products UKCA-marked under most regulations. It mirrors the EU DoC in content (identifying the manufacturer, the product, the applicable regulations, the designated standards used, the conformity assessment route, and a signature from a responsible person) but it references UK regulations rather than EU ones. > Quote from Complir Team, Product Compliance at Complir: The teams that handle UKCA well do not handle it as a one-off Brexit clean-up project. They treat it as a multi-market mapping problem: every product, every applicable regulation, in every market it sells into. Once that structure is in place, indefinite CE recognition is just a routing rule; without it, every UK regulatory shift restarts the spreadsheet exercise. ## Importer and distributor obligations The economic-operator structure mirrors the EU regime The UKCA regime distinguishes economic operators in the same pattern the EU framework does: - **Manufacturers** carry out the conformity assessment, draw up the technical documentation and UK DoC, and affix the UKCA mark. - **Importers** placing a product from outside Great Britain on the GB market must verify that the manufacturer has met its obligations, that the technical documentation exists, that the UK DoC has been drawn up, and that the UKCA mark is affixed where required. Importers must also identify themselves on the product or accompanying documentation with their name and a GB contact address. - **Distributors** must verify that the product bears the required marking and is accompanied by the relevant documents before making it available on the GB market. As in the EU regime, an importer or distributor that places a product on the GB market under its own name or trademark (or modifies a product in a way that may affect compliance) is treated as a manufacturer and assumes the full manufacturer obligations. ### Authorised representative for non-UK manufacturers A non-UK manufacturer can appoint a UK-based authorised representative to carry out specified tasks on its behalf. The authorised representative does not assume the manufacturer's product liability but acts as the manufacturer's GB contact point, holds the technical documentation, and liaises with UK market surveillance authorities. For sectors where the authorised representative role is mandatory, the appointment must be in writing and reference the specific tasks delegated. ## Northern Ireland under the Windsor Framework Different rules, EU rather than GB conformity, and the UKNI mark Northern Ireland sits outside the GB market for product regulation purposes. Under the Windsor Framework, agreed between the UK and the EU and formally adopted by the UK on **24 March 2023**, relevant EU rules for manufactured products continue to apply in Northern Ireland. What this means in practice: - Products placed on the Northern Ireland market must meet EU product requirements, not GB requirements. - CE marking is required for products subject to EU conformity marking rules. - UKNI marking is a separate UK-issued marking used in specific circumstances, but it never appears alone; it is always applied alongside the CE mark. - A product placed on the NI market under EU rules is treated as in conformity with the corresponding GB rules under "unfettered access" arrangements for qualifying Northern Ireland goods, which can then move freely to the GB market. The UKCA mark, by contrast, is not valid for the Northern Ireland market on its own. ### When is UKNI used? UKNI marking is required when a UK-based notified body has carried out the mandatory third-party conformity assessment for a product being placed on the NI market. In that case, the manufacturer applies both the CE marking and the UKNI marking. The UKNI marking signals that the third-party assessment was done by a UK body rather than an EU notified body, which matters because the EU does not recognise UK notified bodies as part of its own framework. Two consequences follow from this: 1. A product with CE + UKNI markings cannot be placed on the EU market. For EU access, the conformity assessment must be done by an EU-recognised notified body, and only the CE mark is applied. 2. UKNI marking is therefore only useful for NI access, not for general EU market access. Most non-UK manufacturers selling into Europe go through an EU notified body and use CE alone. ## UK REACH The GB chemicals regime running parallel to EU REACH UK REACH is a separate regime from UKCA, but the two are often conflated in informal conversation. It is worth understanding the distinction. UK REACH is the UK's chemicals regulation regime, the GB equivalent of the EU's Regulation (EC) No 1907/2006 (REACH). It is administered by the Health and Safety Executive (HSE), not OPSS. It governs the registration, evaluation, authorisation, and restriction of chemical substances manufactured in or imported into Great Britain in quantities of one tonne per year or more. UK REACH applies in Great Britain. Northern Ireland continues to follow EU REACH under the Windsor Framework. ### Transitional registration deadlines UK REACH inherited a stock of substances from EU REACH at Brexit. Companies that had EU REACH registrations could "grandfather" those registrations into the UK system, but they remain subject to a transitional UK registration process with deadlines staggered by tonnage and hazard profile. The original transitional registration deadlines were **27 October 2026**, **27 October 2028**, and **27 October 2030**. The UK government has since announced that these deadlines will be extended by three years, to **27 October 2029**, **27 October 2030**, and **27 October 2031**, in response to industry feedback on the cost and complexity of duplicating EU REACH registrations under UK REACH. Companies that submitted a Downstream User Import Notification (DUIN) by the original 27 October 2021 deadline are obliged to register only if they wish to continue importing the notified substance after the relevant transitional deadline. ### Practical implications If your products contain chemical substances regulated under REACH, you have parallel obligations under [EU REACH](/resources/guides/reach-compliance-guide) (for the EU market) and UK REACH (for Great Britain). Each regime maintains its own SVHC candidate list, its own restriction list (UK REACH Annex XVII for GB), and its own authorisation list. Day-to-day, the two regimes have remained closely aligned in substance restrictions, but they do diverge: substances added to the EU SVHC list, for example, do not automatically appear on the UK SVHC list, and vice versa. ## What is changing next The Product Regulation and Metrology Bill The UK government is in the process of updating the wider product regulatory framework. The Product Regulation and Metrology Bill was published in draft on **4 September 2024** and is making its way through the legislative process. As currently proposed, it would give the government enhanced powers to update product regulations by secondary legislation, including powers to align GB rules with EU rules where appropriate, or to diverge from them. The eventual shape of this legislation is not yet finalised, and its impact on the UKCA regime over the next several years should be tracked rather than assumed. ## How to decide: UKCA, CE, or both A short decision tree for the GB market For most manufacturers, the practical decision tree is short. For most consumer product manufacturers, the simplest course is: continue to use CE marking for GB; track the seven excluded categories for any product that touches them; treat UK REACH as a separate chemical-regime obligation regardless of which conformity mark you use. ## Frequently asked questions What teams ask most often when sizing up a UKCA programme ## Is UKCA marking still required in 2026? UKCA marking is required for products that fall into the categories not covered by indefinite CE recognition: medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment, and unmanned aircraft systems. For most other product categories, UKCA marking is voluntary because CE marking is recognised indefinitely in Great Britain under the Product Safety and Metrology etc (Amendment) Regulations 2024. ## Does UKCA replace CE marking? Not in practice. UKCA was originally intended to replace CE marking in Great Britain after Brexit, but the UK government has indefinitely extended CE recognition for 21 product regulations. CE marking remains valid for placing most products on the GB market. ## Is CE marking still valid in the UK? CE marking is valid for placing products on the Great Britain market for the 21 product regulations covered by indefinite recognition, and is also required for the Northern Ireland market under the Windsor Framework. For the seven categories not covered by indefinite GB recognition (medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment, unmanned aircraft systems), the relevant UK-specific regime applies in GB. ## What products must be UKCA marked? The UKCA route applies to products covered by GB product regulations that have not been brought under indefinite CE recognition. In current practice this means construction products, marine equipment, rail products, cableways, transportable pressure equipment, unmanned aircraft systems, and (pending the outcome of the MHRA consultation) medical devices. ## Is UKCA marking required in Northern Ireland? No. The UKCA marking is for Great Britain only. Products placed on the Northern Ireland market must meet EU product requirements under the Windsor Framework and are CE-marked, with UKNI marking in specific cases involving UK third-party conformity assessment. ## What is UKNI marking? UKNI is a UK-issued marking used alongside CE marking when a UK-based notified body has carried out mandatory third-party conformity assessment for a product placed on the Northern Ireland market. UKNI marking never appears alone; it is always applied with the CE mark. A product carrying CE and UKNI markings cannot be placed on the EU market. ## Who enforces UKCA in the UK? For most consumer products the Office for Product Safety and Standards (OPSS), which sits within the Department for Business and Trade, is the central enforcement authority. Medical devices are enforced by the MHRA. UK REACH is enforced by the HSE. Local authority Trading Standards services carry out most front-line enforcement activity on behalf of OPSS. ## What is UK REACH and is it the same as UKCA? UK REACH is a separate regulatory regime covering chemical substances manufactured in or imported into Great Britain. It is the GB equivalent of EU REACH and is administered by the HSE. UKCA is the product conformity marking regime for GB and is administered primarily by OPSS. They overlap in product chemical content rules but are administered separately. ## Do I need a UK authorised representative? Non-UK manufacturers can appoint a UK-based authorised representative to carry out specified compliance tasks on their behalf. Whether this is mandatory depends on the specific product regulation; for some sectors it is, and the appointment must be in writing. The authorised representative holds the technical documentation, acts as the GB contact for market surveillance authorities, and can carry out a defined set of tasks on the manufacturer's behalf, but does not take on manufacturer liability. ## What is a UK Approved Body? A UK Approved Body is a third-party conformity assessment body designated by a UK national authority to assess products for compliance with specific UK product regulations. UK Approved Bodies are listed in the UK Market Conformity Assessment Bodies (UKMCAB) database. They are the GB equivalent of EU notified bodies. EU notified bodies do not automatically qualify as UK Approved Bodies for the GB regime. ## What this means for your business Three things to take away from where the UKCA regime sits in 2026 First, UKCA is no longer the urgent CE-replacement project it was initially framed as. For the 21 product regulations covered by indefinite CE recognition, your existing CE-route technical files and CE marking deliver GB market access. The UKCA work most manufacturers were preparing for between 2021 and 2024 has, for the bulk of consumer products, been overtaken by the indefinite recognition decision. Second, UKCA still matters for the seven categories that fall outside indefinite recognition. If your portfolio touches medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment, or unmanned aircraft systems, the UKCA-route obligation is binding and the technical file work is real. Third, Northern Ireland and UK REACH are not afterthoughts. They are separate parallel regimes that overlap with UKCA but have their own rules. The Windsor Framework keeps EU rules in place for NI; UK REACH keeps a separate UK chemicals regime running alongside EU REACH; both have their own enforcement authorities and their own moving deadlines. For a wider view of how the EU side of the picture is moving, see our companion guides on the [EU Green Deal compliance landscape](/resources/guides/eu-green-deal-compliance) and the [Digital Product Passport](/resources/guides/digital-product-passport-guide). For manufacturers selling across Europe and the UK, this is fundamentally a multi-market mapping problem. Every product needs to know which markings, which technical files, which declarations, and which chemical-regime obligations apply in each market (EU, GB, NI) and which categories sit outside the common path. The teams that handle this well do not handle it by working harder on each SKU; they handle it by structuring product data once and mapping each product to the right regulations per market automatically. If your team is rebuilding compliance documentation every time a product moves into a new market, or reacting to UK regulatory shifts like the indefinite CE recognition decision after the fact, that is a workflow problem, not a team problem. Complir maps every product to the regulations that apply in each of your markets, including GB and NI, and re-assesses automatically when those regulations move. [See how Complir handles UKCA, CE, and Northern Ireland compliance across a multi-market product portfolio.](https://complir.io) ## Sources & References - Using the UKCA marking: [GOV.UK guidance](https://www.gov.uk/guidance/using-the-ukca-marking) - UKCA marking, conformity assessment and documentation: [GOV.UK guidance](https://www.gov.uk/guidance/ukca-marking-conformity-assessment-and-documentation) - Placing UKCA or CE marked products on the market in Great Britain: [GOV.UK guidance](https://www.gov.uk/guidance/placing-ukca-or-ce-marked-products-on-the-market-in-great-britain) - Placing manufactured products on the market in Great Britain: [GOV.UK guidance](https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain) - Product regulations by sector and current approaches to product marking, UKCA and CE regimes: [GOV.UK publication](https://www.gov.uk/government/publications/product-regulations-by-sector-and-current-approaches-to-product-marking-ukca-and-ce-regimes/product-regulations-by-sector-and-current-approaches-to-product-marking-ukca-and-ce-regimes) - Continued recognition of EU requirements, including CE marking, for placing products on the GB market: [GOV.UK publication](https://www.gov.uk/government/publications/continued-recognition-of-eu-requirements-including-ce-marking-for-placing-products-on-the-gb-market/continued-recognition-of-eu-requirements-including-ce-marking-for-placing-products-on-the-gb-market) - UK Government announces extension of CE mark recognition for businesses: [GOV.UK announcement](https://www.gov.uk/government/news/uk-government-announces-extension-of-ce-mark-recognition-for-businesses) - Using the UKNI marking: [GOV.UK guidance](https://www.gov.uk/guidance/using-the-ukni-marking) - Placing CE, or CE and UKNI marked products on the market in Northern Ireland: [GOV.UK guidance](https://www.gov.uk/guidance/placing-ce-or-ce-and-ukni-marked-products-on-the-market-in-northern-ireland) - Placing manufactured goods on the market in Northern Ireland: [GOV.UK guidance](https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-northern-ireland) - Office for Product Safety and Standards: [GOV.UK organisation page](https://www.gov.uk/government/organisations/office-for-product-safety-and-standards) - UK REACH, notification of status as a GB-based downstream user or distributor under EU REACH (DUIN): [HSE guidance](https://www.hse.gov.uk/reach/duin.htm) - Recognising your EU REACH registrations under UK REACH (grandfathering): [HSE guidance](https://www.hse.gov.uk/reach/grandfathering-registrations.htm) - The Product Safety and Metrology etc. (Amendment) Regulations 2024: [legislation.gov.uk](https://www.legislation.gov.uk/ukdsi/2024/9780348260311/contents) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements vary by product category, market, and specific circumstances. UK regulation in this area has changed materially several times since Brexit and continues to evolve. Consult a qualified legal professional or your UK regulator for compliance guidance specific to your situation.* --- # RoHS Compliance: A Practical Guide for Manufacturers Source: https://www.complir.io/resources/guides/rohs-compliance-guide Category: Guide RoHS (Restriction of Hazardous Substances) is the EU law that restricts ten hazardous substances in electrical and electronic equipment (EEE) placed on the EU market. The current legal text is **Directive 2011/65/EU**, often called RoHS 2, as amended by Delegated Directive (EU) 2015/863, which added four phthalates and is sometimes called RoHS 3. Compliance is mandatory for manufacturers, importers, and distributors of in-scope products, and it sits inside the [CE marking](/resources/guides/ce-marking-requirements) conformity assessment rather than alongside it. The substance list itself has not been expanded since **2015**, but lead exemptions, category-specific deadlines, and the overlap with [REACH](/resources/guides/reach-compliance-guide) continue to evolve. RoHS is best treated as a living obligation, not a one-time check. ## What RoHS Is Directive 2011/65/EU and its three iterations RoHS is the Restriction of Hazardous Substances Directive, an EU law that limits the use of ten specific hazardous substances in electrical and electronic equipment sold in the EU. Its purpose is to reduce the environmental and health impact of EEE, particularly when products reach end of life and become waste. The directive has gone through three iterations: - **RoHS 1**: Directive 2002/95/EC, the original 2003 directive that restricted six substances - **RoHS 2**: Directive 2011/65/EU, the 2011 recast that expanded scope and integrated RoHS into the CE marking framework - **RoHS 3**: Delegated Directive (EU) 2015/863, which added four phthalates to Annex II of RoHS 2 When people today say "the RoHS Directive" or "RoHS compliant," they almost always mean Directive 2011/65/EU as amended. RoHS 2 is the legal instrument; RoHS 3 is an amendment to its substance list, not a separate directive. ## Who enforces RoHS? RoHS is implemented and enforced at Member State level. Each EU country designates national market surveillance authorities that can request technical documentation, test products, and impose corrective measures. The European Commission oversees the directive itself, including the Annex III and Annex IV exemptions process that decides which substance-application pairs are technically impractical to substitute today. ## The 10 Restricted Substances Maximum concentration values at homogeneous-material level The RoHS Directive restricts the following ten substances at the homogeneous material level. The maximum concentration values (MCVs) are set out in Annex II of Directive 2011/65/EU as amended by 2015/863. | # | Substance | Abbreviation | MCV (by weight) | |---|-----------|--------------|-----------------| | 1 | Lead | Pb | 0.1% | | 2 | Cadmium | Cd | 0.01% | | 3 | Mercury | Hg | 0.1% | | 4 | Hexavalent chromium | Cr(VI) | 0.1% | | 5 | Polybrominated biphenyls | PBB | 0.1% | | 6 | Polybrominated diphenyl ethers | PBDE | 0.1% | | 7 | Bis(2-ethylhexyl) phthalate | DEHP | 0.1% | | 8 | Butyl benzyl phthalate | BBP | 0.1% | | 9 | Dibutyl phthalate | DBP | 0.1% | | 10 | Diisobutyl phthalate | DIBP | 0.1% | A few details that matter in practice: - **Homogeneous material** is the testing unit, not the product. A homogeneous material is one that cannot be mechanically disjointed into different materials, for example a single polymer layer or a single solder joint. A product that is RoHS-compliant overall can still fail testing if any one homogeneous material exceeds its MCV. - **The four phthalates (DEHP, BBP, DBP, DIBP)** were added by Delegated Directive (EU) 2015/863 and applied to most EEE from **22 July 2019**. For Category 8 (medical devices) and Category 9 (monitoring and control instruments), application was extended to **22 July 2021**. - **Exemptions exist** for specific applications where substitution is technically impractical. They are listed in Annex III (general exemptions) and Annex IV (medical and monitoring exemptions) of Directive 2011/65/EU. Each exemption has its own expiry date and renewal cycle. ## Who Has to Comply EEE in scope and the three economic-operator roles RoHS applies to all electrical and electronic equipment placed on the EU market, with limited exclusions for military equipment, equipment designed for use in space, large-scale stationary industrial tools, large-scale fixed installations, and certain transport equipment, as set out in Article 2(4) of the directive. Since **22 July 2019**, RoHS has operated under "open scope": Category 11 ("Other EEE not covered by any of the categories above") was added, and any EEE not explicitly excluded is in scope. The eleven categories listed in Annex I are: 1. Large household appliances 2. Small household appliances 3. IT and telecommunications equipment 4. Consumer equipment 5. Lighting equipment 6. Electrical and electronic tools 7. Toys, leisure and sports equipment 8. Medical devices 9. Monitoring and control instruments (including industrial) 10. Automatic dispensers 11. Other EEE not covered by any of the categories above The categories are functional rather than enumerated: there is no fixed list of products that fall under "small household appliances," for example. Manufacturers determine which category applies based on the product's intended function. The directive distinguishes three economic operators, each with a defined set of obligations: - **Manufacturers** (Article 7): companies that design or manufacture EEE under their own name or trademark. They must ensure compliance, draw up technical documentation, complete the internal production control procedure, draw up the EU Declaration of Conformity, and affix the CE marking. - **Importers** (Article 9): companies that place EEE from outside the EU on the EU market. Importers must verify that the manufacturer has met its obligations, that the technical documentation exists, that the DoC has been drawn up, and that the CE marking is affixed. They must also indicate their own name and contact address on the product or its packaging. - **Distributors** (Article 10): companies that make EEE available on the market without altering it. Distributors must verify that the CE marking is affixed and that the product is accompanied by the required documents before placing it on the market. There is one important catch. Article 11 of Directive 2011/65/EU ("Cases in which obligations of manufacturers apply to importers and distributors") provides that an importer or distributor "is considered a manufacturer for the purposes of this Directive" and is subject to the manufacturer obligations under Article 7 where it places EEE on the market under its own name or trademark, or modifies EEE already on the market in a way that may affect compliance. This is the rule that catches many private-label retailers off guard. ## Does RoHS apply to imported products? Yes. Importers placing EEE from outside the EU on the EU market must verify that the product meets RoHS requirements, that the manufacturer has prepared the technical documentation, and that the CE mark is affixed. If an importer places the product under its own name or trademark, or modifies it in a way that affects compliance, the importer is treated as a manufacturer under Article 11 and takes on the full manufacturer obligations of Article 7. ## RoHS and CE Marking Inside the conformity assessment, not alongside it If you sell EEE in the EU, RoHS compliance is part of the CE marking conformity assessment, not a separate exercise. Article 7(b) of Directive 2011/65/EU requires manufacturers to carry out the internal production control procedure set out in Module A of Annex II to Decision No 768/2008/EC, the standard self-declaration procedure used across most CE-marking directives. In practice this means: 1. You compile the technical documentation that demonstrates RoHS compliance. 2. You draw up an EU Declaration of Conformity covering RoHS and any other applicable directives (EMC, Low Voltage, Radio Equipment, and so on). 3. You affix the CE mark to the product. 4. You retain the documentation for ten years after the product is last placed on the market. The CE mark on an in-scope EEE product implicitly declares RoHS compliance. There is no separate "RoHS mark" required by EU law. A product cannot be CE-marked if it falls within RoHS scope and fails to meet RoHS substance limits. > Quote from Complir Team, Product Compliance at Complir: Mapping which directives apply to which product (RoHS, EMC, Radio Equipment, GPSR, REACH) is one of the most repetitive parts of compliance work, and the part product teams most often underestimate when they plan a launch. The teams that scale CE marking don't grind through that mapping per SKU; they structure product data once so every applicable regulation, every applicable standard, and every supporting test report falls out of the system automatically. ## Is RoHS certification mandatory? RoHS compliance is mandatory for in-scope EEE sold in the EU, but there is no government-issued RoHS certificate. Compliance is self-declared by the manufacturer through technical documentation and the EU Declaration of Conformity. What people commonly call a "RoHS certificate" is a self-declaration document, typically issued at the supplier or manufacturer level. The legal instrument of conformity under EU law is the EU Declaration of Conformity drawn up per Annex VI of Directive 2011/65/EU. ## RoHS Documentation Technical file, EU DoC, and supplier evidence There is no government-issued "RoHS certificate." RoHS is a self-declaration regime: you certify your own product based on a documented assessment, and you retain that documentation in case a market surveillance authority asks for it. Three documents matter. ### 1. The technical file (per EN IEC 63000:2018) EN IEC 63000:2018 is the current harmonised standard for RoHS technical documentation. It replaced EN 50581:2012, which was withdrawn. Following EN IEC 63000:2018 gives you a presumption of conformity with the documentation requirements of the directive. A RoHS technical file typically contains a general description of the product, a bill of materials at homogeneous-material granularity, and supporting evidence for each material: supplier declarations, full material declarations, test reports, or analytical data. It also documents the product's overall conformity assessment and the rationale linking the evidence to that conclusion. ### 2. The EU Declaration of Conformity (per Annex VI) Annex VI of Directive 2011/65/EU sets out the required content of the EU DoC for RoHS. It includes the manufacturer's identification, the product identification, a statement that the product conforms to the directive, references to the harmonised standards used, and the place and date of issue with the signature of the responsible person. The DoC for RoHS is usually combined with the DoC for the other directives the product complies with, producing a single combined EU DoC for the CE marking. This is permitted and is generally recommended over separate per-directive declarations. ### 3. Supplier evidence You can only declare what your suppliers can prove. Most manufacturers collect a combination of supplier RoHS declarations, full material disclosures (often in IPC-1752A or IEC 62474 format), and analytical test reports for higher-risk components. Whatever you collect, the evidence has to be specific enough that an auditor can trace any homogeneous material in the product back to a supporting document. A common confusion point: when buyers ask suppliers for a "RoHS CoC" or "RoHS certificate," what they're usually asking for is a supplier declaration of RoHS conformity, not a third-party certificate. The terminology is sloppy across the industry, but the underlying document is a written statement from the supplier that their part meets the RoHS substance limits. ## How long must I keep RoHS documentation? Manufacturers and importers must keep the technical documentation and EU Declaration of Conformity for **ten years** after the product was last placed on the EU market. The same retention rule applies to the supporting supplier evidence cited in the technical file. National market surveillance authorities can demand the file during that window and expect it to be made available promptly in a language the authority can understand. ## RoHS vs REACH Two regimes, overlapping scope RoHS and [REACH](/resources/guides/reach-compliance-guide) are often confused because both restrict hazardous substances in products sold in the EU. They are different laws with different scopes. **RoHS** restricts ten specific substances in electrical and electronic equipment, at the homogeneous material level, with hard concentration limits. Scope is narrow (EEE only); the restrictions are absolute, subject to specific exemptions. **REACH** (Regulation (EC) No 1907/2006) covers chemical substances generally. It works through a different set of mechanisms: registration of substances manufactured or imported above one tonne per year per company, communication of substances of very high concern (SVHCs) in articles, SCIP notification, and restrictions and authorisations on specific uses. REACH applies to almost any product sold in the EU, not just EEE. In practice, an EEE manufacturer typically has to comply with both. RoHS sets a hard ceiling on the ten restricted substances in your EEE; REACH adds obligations around SVHC communication, SCIP database submission, and substance restrictions under Annex XVII. The two regimes overlap on substances like lead and certain phthalates but use different thresholds, scope rules, and reporting mechanisms. ## A Practical RoHS Workflow Five steps to stay compliant at portfolio scale For a single SKU, RoHS is manageable on a spreadsheet. For hundreds of SKUs across dozens of markets, it isn't. The work that breaks teams isn't the first compliance assessment; it's keeping every SKU's documentation current as suppliers change, materials change, exemptions expire, and you launch into new markets. For a sense of what compliance at retail scale looks like, see how [Flying Tiger Copenhagen handles compliance across 500 new products a month and 44 markets](/resources/case-studies/flying-tiger-compliance). A repeatable RoHS process tends to follow five steps. This last step is where compliance most often fails, not because teams don't care, but because the manual workload makes continuous monitoring impossible. The fix is to structure the underlying product data well enough that re-assessment is automatic when something changes. ## What This Means for Your Business The risk in RoHS is rarely the law itself RoHS is one of the more stable regulatory regimes you'll deal with: the substance list has been unchanged since 2015, and the documentation requirements are well-defined. The risk in RoHS isn't the law changing; it's keeping your product portfolio's documentation current as suppliers, materials, and markets shift around it. Three things to take away: - RoHS compliance is self-declared, but the burden of proof sits with you. The technical file has to be defensible at homogeneous-material granularity, not just a top-level supplier statement. - RoHS doesn't sit alone. It is part of the [CE marking](/resources/guides/ce-marking-requirements) conformity assessment for EEE, and it overlaps with [REACH](/resources/guides/reach-compliance-guide) on hazardous substances. Treating these regulations in isolation creates duplicate work and gaps. - The teams that stay compliant at portfolio scale don't do it by working harder on each SKU. They do it by structuring product data once, then automating mapping, documentation generation, and change monitoring on top of that data. If your team is rebuilding RoHS technical files in spreadsheets every time a supplier changes, or chasing supplier declarations across email threads, the bottleneck isn't your team; it's the workflow. Complir automates the product-to-regulation mapping, generates the technical file and EU Declaration of Conformity from structured product data, and continuously flags SKUs affected by exemption renewals or supplier changes. [See how Complir handles RoHS documentation across a multi-market product portfolio](https://complir.io). ## Sources & References - Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast): [consolidated text, EUR-Lex](https://eur-lex.europa.eu/eli/dir/2011/65/2025-01-01/eng) - Commission Delegated Directive (EU) 2015/863 amending Annex II to Directive 2011/65/EU as regards the list of restricted substances: [EUR-Lex (OJ L 137, 4.6.2015)](https://eur-lex.europa.eu/eli/dir_del/2015/863/oj/eng) - Decision No 768/2008/EC on a common framework for the marketing of products: [EUR-Lex (OJ L 218, 13.8.2008)](https://eur-lex.europa.eu/eli/dec/2008/768%281%29/oj/eng) - Regulation (EC) No 1907/2006 (REACH): [EUR-Lex, current consolidated version](https://eur-lex.europa.eu/legal-content/EN/AUTO/?uri=CELEX:02006R1907-20251023) - European Commission: [RoHS Directive overview](https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive_en) - European Commission: [RoHS FAQ key guidance document (PDF)](https://environment.ec.europa.eu/system/files/2021-01/FAQ%20key%20guidance%20document%20-%20RoHS.pdf) - EN IEC 63000:2018: technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances (CENELEC harmonised standard) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # PPWR Explained: What the EU's New Packaging Regulation Means for Product Companies Source: https://www.complir.io/resources/guides/ppwr-explained Category: Guide **The Packaging and Packaging Waste Regulation (EU) 2025/40 (known as PPWR) is the EU's new packaging law. It entered into force on 11 February 2025 and applies from 12 August 2026**, replacing the 1994 Packaging and Packaging Waste Directive (94/62/EC). PPWR sets binding rules on packaging design, recyclability, recycled content, reuse, restricted substances, labelling, and Extended Producer Responsibility, and it applies to every economic operator that places packaging or packaged products on the EU market, regardless of where the company is established. For most product companies, the practical implication is the same: every SKU now carries packaging-level obligations that need to be tracked, documented, and updated as the regulation phases in through 2030 and beyond. This article walks through what PPWR is, who has to comply, the core requirements in plain language, the key dates, and what to start doing now. ## What Is PPWR? A regulation, not a directive, and a step change from the 1994 framework The Packaging and Packaging Waste Regulation (EU) 2025/40 is an EU-wide regulation governing all packaging placed on the EU market. It was published in the Official Journal of the European Union on **22 January 2025** and entered into force 20 days later, on **11 February 2025**. Most of its provisions become applicable from **12 August 2026**, after an 18-month transition period. PPWR replaces the Packaging and Packaging Waste Directive 94/62/EC, which had governed EU packaging rules since 1994. Two structural changes matter: - **It is a regulation, not a directive.** That means PPWR applies directly in every Member State without being transposed into national law. The same rules (same articles, same definitions, same thresholds) apply from Lisbon to Helsinki. PPWR is built around the principle of free movement of compliant packaging across the single market, harmonising rules at EU level so that compliant packaging cannot be blocked by additional national requirements that conflict with the regulation. - **It introduces measurable, market-wide targets.** Where the old directive set goals at Member State level, PPWR sets binding requirements at the product level: recyclability grades, recycled content percentages, reuse rates, empty-space caps, and substance limits. PPWR sits inside the broader [EU Green Deal](/resources/guides/eu-green-deal-compliance) and the EU's Circular Economy Action Plan. It is closely connected to other ongoing regulatory work, including the [Ecodesign for Sustainable Products Regulation (ESPR)](/resources/guides/espr-ecodesign-regulation-explained) and the [Digital Product Passport](/resources/guides/digital-product-passport-guide), and is one of the central instruments through which the EU intends to reduce packaging waste and increase circularity. ## Who Has to Comply With PPWR? Producers, importers, distributors, marketplaces, and non-EU companies selling in PPWR applies to every economic operator that places packaging (or a packaged product) on the EU market. According to the [European Commission](https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste/packaging-packaging-waste-regulation_en), this includes manufacturers, importers, distributors, fulfilment service providers, and online marketplaces facilitating sales into the EU. There is no general size-based exemption from PPWR's product requirements. The regulation does provide lighter administrative rules for micro-enterprises (broadly, those placing less than 10 tonnes of packaging on the EU market per year), but the core packaging design, substance, and labelling rules apply regardless of company size. ### Does PPWR apply to non-EU companies? Yes. If your company manufactures outside the EU but places packaged products on the EU market (directly or through a distance seller, fulfilment provider, or marketplace), PPWR obligations apply to you. Non-EU producers selling into a Member State via distance contracts may be required by that Member State to appoint an authorised representative for [Extended Producer Responsibility (EPR)](/resources/guides/extended-producer-responsibility-eu-guide) purposes; the practical detail is set in national law within the harmonised PPWR framework. The regulation also explicitly captures online sales. Online marketplaces are required, under Article 45 of PPWR, to verify that traders selling packaging or packaged products into a given Member State are registered with that Member State's producer register. Fulfilment service providers carry duties relating to handling, warehousing, and packing of packaged products in line with PPWR's product requirements. ## Key PPWR Requirements at a Glance Six areas that turn packaging from a procurement decision into a regulated product PPWR's requirements span six areas: substances, recyclability, recycled content, reuse, restricted formats and empty space, labelling, and EPR. The summary below uses the regulation as published; specific dates and thresholds are detailed further down. ### Restricted substances in packaging Article 5 of PPWR sets restrictions on substances of concern in packaging. The sum of the concentrations of **lead, cadmium, mercury, and hexavalent chromium** resulting from substances present in packaging or packaging components must not exceed **100 mg/kg**. The cap applies from 12 August 2026. Article 5 also restricts **per- and polyfluoroalkyl substances (PFAS)** in food-contact packaging. The limits are 25 parts per billion (ppb) for any individual non-polymeric PFAS measured by targeted analysis, 250 ppb for the sum of non-polymeric PFAS, and 50 parts per million (ppm) for total organic fluorine; the latter captures polymeric PFAS. The PFAS restrictions apply from 12 August 2026 to any food-contact packaging placed on the EU market after that date, even if the packaging itself was manufactured earlier. ### Recyclability Article 6 of PPWR requires that, by **1 January 2030**, all packaging placed on the EU market must be designed for recycling and meet a recyclability performance grade (**A, B, or C**) set out in the regulation, with detailed assessment criteria in delegated acts. Packaging that does not meet at least the lowest qualifying grade will not be allowed on the EU market from 2030 onward. From **1 January 2038**, packaging classified as grade C is phased out, leaving only grades A and B on the market. The exact percentage thresholds for each grade are set out in PPWR's annexes and the supporting delegated acts; product companies should track the delegated acts as they are adopted. ### Recycled content in plastic packaging Under Article 7 of PPWR, from 1 January 2030 plastic packaging placed on the EU market must contain a minimum share of post-consumer recycled plastic. The headline 2030 targets are: - **30%** recycled content in single-use plastic beverage bottles - **30%** in contact-sensitive plastic packaging made primarily of PET - **10%** in contact-sensitive plastic packaging made of plastics other than PET - **35%** in other plastic packaging not covered above Higher targets apply from 1 January 2040. For example, single-use plastic beverage bottles rise to **65% recycled content**. The European Commission must report on implementation by 12 February 2032 and may revise the 2040 targets in light of recyclate availability and market conditions. Recycled content is calculated as an average per manufacturing plant and per year, using the methodology set out in PPWR's delegated acts. ### Reuse targets Article 29 of PPWR introduces binding reuse targets for specific packaging types. From 1 January 2030, final distributors of beverages (covering both alcoholic and non-alcoholic categories) must make at least **10% of the beverages they sell available in reusable packaging within a reuse system**, rising to **40% by 1 January 2040**. Milk and other beverages requiring aseptic technology due to microbiological sensitivity are exempt from these targets, and several categories (including wine, aromatised wine products, spirit drinks, and milk products) are exempt from mandatory deposit-and-return obligations. For transport, industrial, and e-commerce packaging, Article 29 sets a reuse rate of at least **40% by 1 January 2030, rising to 70% by 1 January 2040**. In addition, from 1 January 2030 transport packaging used between business sites within the EU must in principle be reusable. A reuse system means a defined organisational, technical, and financial arrangement that ensures the packaging is reused multiple times, including reverse logistics, cleaning, and inspection. ### Empty space and restricted formats To reduce over-packaging, Article 8 of PPWR limits the empty space ratio of grouped, transport, and e-commerce packaging to a maximum of **50%**. The cap takes effect from **1 January 2030**, in line with the calculation methodology to be set in a Commission implementing act (which the Commission must adopt by 12 February 2028). The 50% empty space cap does not apply to reusable packaging. Article 25 of PPWR, together with Annex V, prohibits certain single-use plastic packaging formats from 1 January 2030. The banned formats include single-use plastic packaging for unprocessed fresh fruit and vegetables under defined weight thresholds, single-serve plastic packaging for condiments, sauces, sugar, coffee creamer and similar in the HoReCa sector, single-use plastic miniature toiletries provided in the hotel and accommodation sector, and very lightweight plastic carrier bags. For points 1 to 4 of Annex V, composite packaging with a plastic content of 5% or less by weight is exempt from these specific bans. ### Labelling Article 12 of PPWR introduces **harmonised packaging labels** showing material composition, with pictograms designed to help consumers sort waste correctly. Reusable packaging must carry a specific reuse label, and packaging containing recycled content must indicate the recycled share where claimed. The harmonised labelling rules apply from **12 August 2028**, or 24 months after the entry into force of the Commission implementing act establishing the harmonised label specifications, whichever is later. The Commission must adopt those implementing acts by 12 February 2027. ### Extended Producer Responsibility PPWR harmonises core elements of [Extended Producer Responsibility (EPR)](/resources/guides/extended-producer-responsibility-eu-guide) for packaging across all Member States. Producers (defined broadly to include manufacturers, brand owners, importers, and distance sellers) must register with the national producer register in every Member State where they place packaging on the market, and contribute financially to the collection, sorting, and treatment of packaging waste. PPWR introduces **mandatory eco-modulation** of producer fees based on packaging recyclability performance. What PPWR does not fully harmonise is the operational layer: fee amounts, registration mechanics, collection schemes, and additional national modulation criteria continue to run through each Member State's national EPR system. Member States may also require non-EU producers selling into their territory under distance contracts to appoint an authorised representative for EPR purposes. There is no exemption from EPR registration for micro-enterprises, although they may benefit from lighter administrative obligations under PPWR. ## The PPWR Timeline Key dates from 2025 entry into force through 2040 The August 2026 application date is a milestone, not the finish line. The hardest deadlines for most product companies (recyclability grades, recycled content, reuse, format bans) sit on **1 January 2030**, with further tightening through 2038 and 2040. | Date | Milestone | Status | | ---------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------- | | 22 January 2025 | PPWR published in the Official Journal | Confirmed | | 11 February 2025 | PPWR enters into force | Confirmed | | 12 August 2026 | Most provisions apply, including substance restrictions (heavy metals, PFAS in food-contact packaging) | Confirmed | | 12 February 2027 | Deadline for Commission to adopt implementing acts on harmonised packaging label format (Article 12) | Confirmed | | 12 February 2028 | Deadline for Commission to adopt the methodology for calculating empty space ratio (Article 8) | Confirmed | | 12 August 2028 | Harmonised packaging labelling rules apply (or 24 months after the implementing act, whichever is later) | Confirmed | | 1 January 2030 | Recyclability grade A/B/C requirement (Article 6); recycled content targets for plastic packaging (Article 7); 10% beverage reuse and 40% transport/industrial/e-commerce reuse targets (Article 29); 50% empty space cap (Article 8); Annex V single-use plastic bans (Article 25) | Confirmed | | 1 January 2038 | Recyclability grade C phased out; only grades A and B remain on the EU market | Confirmed | | 1 January 2040 | Higher recycled content targets apply for plastic packaging (e.g. 65% for single-use plastic beverage bottles); beverage reuse rises to 40% and transport/e-commerce reuse to 70% | Confirmed | > Quote from Complir Team, Product Compliance at Complir: The 2030 milestones look distant on paper, but every team we work with that has actually run the numbers reaches the same conclusion: if the packaging redesign and supplier qualification work hasn't started in 2026 or early 2027, hitting the recyclability grades and recycled-content thresholds on time is a coin flip. PPWR is fundamentally a structured-data problem: material composition, recycled share, recyclability grade, and reuse-system status, mapped per SKU per market. The companies that will land it cleanly are the ones treating it that way today, not the ones still tracking packaging in spreadsheets. ## How to Prepare for PPWR Four steps to take in 2026, before the 2030 cliff The August 2026 application date is the floor, not the ceiling, of PPWR work. Substance restrictions and the EPR framework apply from day one. Recyclability grades, recycled content, reuse, and format bans land in 2030, but the data, design, and supplier work behind those rules takes years. ## Frequently Asked Questions Common PPWR questions from product companies ## What is the difference between PPWR and the old Packaging and Packaging Waste Directive? PPWR is a regulation, while the previous PPWD was a directive. The directive set goals that each Member State implemented through its own national law, leading to fragmentation; PPWR applies the same binding rules directly in every Member State. PPWR also goes further substantively: it sets product-level targets for recyclability, recycled content, reuse, and restricted formats that did not exist under the directive. ## Does PPWR apply to non-EU companies? Yes. PPWR applies to any economic operator that places packaging or a packaged product on the EU market, regardless of where the company is established. Member States may require non-EU producers selling into their territory under distance contracts to appoint an authorised representative, particularly to handle EPR registration and compliance, with the practical detail set in national law within the harmonised PPWR framework. ## When does PPWR start applying? PPWR entered into force on 11 February 2025. Most provisions apply from 12 August 2026, after an 18-month transition period. Specific obligations (most notably the recyclability grade, recycled content, reuse targets, empty space cap, and Annex V single-use plastic bans) apply from 1 January 2030. Higher recycled content targets and the phase-out of recyclability grade C extend into 2038 and 2040. ## What happens if my packaging is not compliant with PPWR? Under PPWR, non-compliant packaging may not be placed on the EU market. Article 47 requires Member States to lay down rules on penalties for infringements, which must be effective, proportionate, and dissuasive. In practice, non-compliance can result in market surveillance actions, sales bans, removal of products from marketplaces, and administrative fines applied at Member State level. ## Does PPWR replace national EPR rules for packaging? PPWR harmonises core EPR obligations (including the producer definition, mandatory registration, financial responsibility, and eco-modulation of fees based on recyclability), but the operational details continue to run through each Member State's national EPR scheme. Producers still need to register with each national scheme in which they place packaging on the market. PPWR sets the baseline rules; national authorities run the systems. ## What This Means for Your Business Packaging is now a SKU-level, multi-market data problem PPWR is not a single deadline; it is a multi-year programme that turns packaging from a procurement decision into a regulated, data-intensive part of every product. Four implications stand out for product companies: - **Packaging is now a SKU-level data problem.** Material composition, recyclability grade, recycled content share, reuse-system status, and substance compliance all need to be known and documented per packaging unit, not estimated at portfolio level. - **The 2030 milestones drive 2026–2027 decisions.** Recyclability grades, recycled content targets, reuse infrastructure, and Annex V format bans all need lead time; supplier qualification, redesign, and reverse-logistics setup do not happen overnight. - **EPR exposure expands.** Every EU Member State you sell into is a registration to manage, and non-EU producers face authorised-representative obligations on top of that. - **Cross-functional ownership is unavoidable.** Packaging, quality, regulatory, sourcing, and operations teams all touch PPWR, and they need a shared, structured view of packaging compliance across markets. For companies managing thousands of SKUs across multiple EU markets, like [Flying Tiger Copenhagen](/resources/case-studies/flying-tiger-compliance), the underlying challenge is the same one PPWR makes urgent: structured, market-by-market packaging data that updates as regulations and products change. That is precisely the problem [Complir](https://complir.io) was built to solve, by automating the mapping between packaging data, regulatory requirements, and per-market documentation, so PPWR readiness becomes a workflow rather than a fire drill. **[See how Complir maps every product to every applicable regulation across your EU markets](https://complir.io/book-demo).** ## Sources & References - Regulation (EU) 2025/40 of the European Parliament and of the Council on packaging and packaging waste: [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng) - Packaging and Packaging Waste Regulation overview: [European Commission, DG Environment](https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste/packaging-packaging-waste-regulation_en) - Packaging waste, policy area page: [European Commission, DG Environment](https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste_en) - PPWR Guidance Document: [European Commission, DG Environment](https://environment.ec.europa.eu/publications/guidance-document-packaging-and-packaging-waste-regulation-ppwr_en) - PPWR Frequently Asked Questions: [European Commission, DG Environment](https://environment.ec.europa.eu/publications/faq-packaging-and-packaging-waste-regulation-ppwr_en) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # CE Marking Requirements: A Practical Guide for Product Companies Source: https://www.complir.io/resources/guides/ce-marking-requirements Category: Guide CE marking is a manufacturer's self-declaration that a product meets every applicable EU rule before it is placed on the EU or EEA market. It is required only for product categories covered by EU harmonisation legislation – and for those products, the requirements are non-negotiable. To CE mark a product, a company must identify every applicable directive or regulation, run the conformity assessment specified by each one, compile a technical file, sign an EU Declaration of Conformity, and affix the CE mark visibly to the product. Get any of those wrong and the product is not legally on the market – even if it carries the symbol. This guide walks through the CE marking requirements that apply across product categories, the specific changes that took effect in **2025 and 2026**, and the practical questions teams ask when they sit down to actually do this work. ## What CE Marking Is – and What It Is Not The legal frame, in plain language The CE marking is a regulatory conformity marking established by Article 30 of [Regulation (EC) No 765/2008](https://eur-lex.europa.eu/eli/reg/2008/765/oj/eng). By affixing it, the manufacturer declares – under their own legal responsibility – that the product conforms to all applicable EU harmonisation legislation. There is no central EU certificate, no government body that issues CE marking, and no third-party seal of approval at the EU level. Three points routinely confuse newcomers to the topic: - CE marking is **not a quality mark**. It signals legal conformity with EU rules – not that a product is better, safer, or higher quality than alternatives. - CE marking is **not a country-of-origin indicator**. A product made in China, the United States, or Vietnam can – and often must – carry the CE mark if it falls under harmonisation legislation and is placed on the EU market. - CE marking is **not optional** for products that fall within scope. If your product category is covered by an EU harmonisation directive or regulation that mandates CE marking, the marking is a legal precondition for placing the product on the EU/EEA market. ## Is CE marking the same as a quality mark? No. CE marking is a regulatory conformity declaration – not a quality endorsement. The European Commission states explicitly that CE marking "is not a quality indication or a certification mark." It signals that the manufacturer has fulfilled its legal obligations under applicable EU rules. ## When CE Marking Is Required Scope is set by EU harmonisation legislation, not company size CE marking is required only where a specific EU harmonisation regulation or directive provides for it. Article 30(2) of Regulation (EC) No 765/2008 makes this explicit: the CE marking "shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product." The product categories covered by CE marking sit under more than **30 separate pieces** of harmonisation legislation. The most widely encountered include: - **Machinery Regulation (EU) 2023/1230** (replaces the Machinery Directive 2006/42/EC; applies from 20 January 2027, with provisions on notified bodies applying from 20 January 2024) - **Low Voltage Directive 2014/35/EU** (electrical equipment within voltage limits) - **Electromagnetic Compatibility Directive 2014/30/EU** - **Radio Equipment Directive 2014/53/EU** - **Toy Safety Regulation (EU) 2025/2509** (replaces Directive 2009/48/EC – see below) - **Medical Devices Regulation (EU) 2017/745** and **IVDR (EU) 2017/746** - **Personal Protective Equipment Regulation (EU) 2016/425** - **Construction Products Regulation (EU) 2024/3110** (replaces Regulation (EU) No 305/2011; entered into force 7 January 2025, applies to most construction products from 8 January 2026) - **RoHS Directive 2011/65/EU** (restriction of hazardous substances in EEE) - **Pressure Equipment Directive 2014/68/EU** - **Gas Appliances Regulation (EU) 2016/426** - **Recreational Craft Directive 2013/53/EU** - **Pyrotechnic Articles Directive 2013/29/EU** The full, authoritative list is maintained on the [European Commission's single market pages](https://single-market-economy.ec.europa.eu/single-market/goods/ce-marking_en) and is the only source you should rely on when scoping a new product. CE marking sits alongside – but does not replace – adjacent horizontal rules such as the [General Product Safety Regulation (GPSR)](/resources/guides/gpsr-compliance-guide-product-companies), [REACH](/resources/guides/reach-compliance-guide), and the [Extended Producer Responsibility schemes](/resources/guides/extended-producer-responsibility-eu-guide) that often apply to the same product. ## Which products need CE marking? A product needs CE marking only if it falls within the scope of EU harmonisation legislation that mandates it. This typically includes toys, machinery, electrical and electronic equipment, radio equipment, medical devices, personal protective equipment, construction products, gas appliances, pressure equipment, recreational craft, pyrotechnics, and several other categories. Cosmetics, foodstuffs, chemicals, textiles, and most furniture do not require CE marking – they are governed by other regulatory frameworks. The mistake teams make most often is assuming a product is "outside CE scope" because it is small, simple, or sold in low volumes. Scope is determined by **product category**, not by commercial size. ## The Five Core CE Marking Requirements The pathway every product must pass through Across the more than 30 directives and regulations that mandate CE marking, the same five-step compliance pathway applies. The European Commission's [Blue Guide on the implementation of EU product rules](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=oj:JOC_2022_247_R_0001) (Commission Notice C/2022/247) sets it out as follows: 1. **Identify the EU rules that apply to the product.** Many products fall under several directives and regulations simultaneously – a connected radio toy, for example, is covered by the Toy Safety Regulation, the Radio Equipment Directive, RoHS, and (where applicable) GPSR. 2. **Identify the essential requirements.** Each directive or regulation lists "essential requirements" – what the product must achieve. Compliance is typically demonstrated by applying harmonised standards, references to which are published in the *Official Journal of the EU*. 3. **Choose the correct conformity assessment procedure.** The procedure is set by the directive itself and depends on the product category and risk class. 4. **Compile the technical documentation.** This is the file that justifies the Declaration of Conformity. It must be made available to market surveillance authorities on request. 5. **Issue the EU Declaration of Conformity and affix the CE marking.** Both are the manufacturer's responsibility; both carry legal consequences. > Quote from Complir Team, Product Compliance at Complir: The five-step pathway is the work CE marking was designed to require – but rebuilding it in spreadsheets and shared drives for every product launch is a tax on growth, not a compliance strategy. The teams that scale CE marking treat it as a structured-data problem: every directive, every applicable standard, every test report mapped once and reused across SKUs and markets. The companies that do this well don't have larger compliance teams – they have better compliance infrastructure. ## Self-Certification vs. Notified Body What a manufacturer can do alone, and what requires third-party assessment Conformity assessment for CE marking is structured around the modules defined in [Decision No 768/2008/EC](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008D0768) of the European Parliament and of the Council – the so-called New Legislative Framework reference Decision. The Decision lists conformity assessment modules from **A** (internal production control – full self-assessment) through **H** (full quality assurance, with notified body involvement at every stage). Which module applies depends on the directive or regulation governing your product, not on the manufacturer's preference. As a working rule: - **Self-certification (Module A)** is permitted when the directive itself allows it, typically for lower-risk product categories. The manufacturer performs the conformity assessment internally, compiles the technical file, signs the Declaration of Conformity, and affixes the CE mark. - **Notified body involvement** is required when the directive specifies it – usually for products with higher risk profiles. Examples include most medical devices above Class I, certain pressure equipment, lifts, in-vitro diagnostics, and a subset of machinery. In those cases, the **four-digit identification number** of the notified body must appear next to the CE marking. A "notified body" is a conformity assessment body officially designated by an EU Member State and listed in the Commission's [NANDO database](https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en). Notified bodies are not regulators – they are independent assessment bodies that test, audit, or certify products and quality systems against the requirements of a specific directive. ## Can I CE mark my product myself? Yes – if the directive or regulation that applies to your product permits self-certification. For many lower-risk consumer products, the manufacturer is allowed to perform conformity assessment internally without notified body involvement. The legal responsibility, however, is identical either way: by affixing the CE mark, the manufacturer takes on full responsibility for the product's conformity with all applicable EU rules. ## What Goes in the Technical File The evidentiary backbone of CE marking Technical documentation is the evidentiary backbone of CE marking. If a market surveillance authority asks why a product was placed on the market with the CE mark, the technical file is the answer. The Blue Guide and most New Legislative Framework directives align on what the file must contain: - A general description of the product and its intended use - Design and manufacturing drawings, schematics, and component lists - Identification of every applicable EU directive or regulation - A list of harmonised standards applied (or other technical specifications used to demonstrate conformity) - Risk analysis and risk assessment results - Test reports and calculations supporting compliance - The EU Declaration of Conformity - Notified body certificates and reports, where applicable - The name and address of the manufacturer and any authorised representative ## How long do I need to keep CE technical documentation? Most EU harmonisation directives require manufacturers to keep technical documentation and the EU Declaration of Conformity for **ten years** from the date the last unit of the product was placed on the EU market. Some directives – including the Medical Devices Regulation for certain device classes – require longer retention. The applicable period is set by the specific regulation governing your product, not by a single horizontal rule. ## How to Affix the CE Marking The graphic, the placement, the rules The graphical specification for CE marking is fixed by **Annex II of Regulation (EC) No 765/2008**. Three rules govern its application: - The marking must be affixed **visibly, legibly, and indelibly** to the product. Where this is not possible due to the product's nature, the marking may be applied to the packaging and accompanying documents. - The minimum height is **5 mm**, unless the directive applicable to the product specifies otherwise. When enlarged or reduced, the proportions of the graphic must be preserved. - Where the conformity assessment involves a notified body, the body's four-digit identification number must follow the CE marking. The CE marking must be affixed **before** the product is placed on the EU market. Affixing the mark to a product that does not meet the applicable essential requirements – or to a product not covered by harmonisation legislation at all – is prohibited under Article 30 of Regulation (EC) No 765/2008. ## What Changed in 2025–2026 GPSR, the new Toy Safety Regulation, ESPR, and the new CPR CE marking is a stable framework, but the underlying directives and regulations are not. Four changes in the past 18 months matter for any team scoping CE marking work in 2026. **The [General Product Safety Regulation (EU) 2023/988 (GPSR)](/resources/guides/gpsr-compliance-guide-product-companies)** has applied since **13 December 2024**. GPSR does not require CE marking itself – it covers the safety of consumer products generally, including products outside CE scope. But GPSR adds technical documentation, traceability, and "responsible person" obligations that interact with CE marking. For a CE-marked product placed on the EU market, GPSR's requirements layer on top of the relevant CE directive's requirements rather than replacing them. For non-harmonised consumer products – those outside CE scope – GPSR is now the primary safety rulebook. **The Toy Safety Regulation (EU) 2025/2509** was adopted on 26 November 2025 and entered into force on **1 January 2026**. It replaces Directive 2009/48/EC. The new regulation introduces tighter chemical restrictions, a digital product passport requirement for toys, and stricter online marketplace duties. It applies from **1 August 2030** – a transition period of approximately four and a half years, during which toys complying with Directive 2009/48/EC may continue to be placed on the market. **The [Ecodesign for Sustainable Products Regulation (EU) 2024/1781 (ESPR)](/resources/guides/espr-ecodesign-regulation-explained)** establishes the framework for the [EU Digital Product Passport (DPP)](/resources/guides/digital-product-passport-guide). The first DPP requirements will apply to specific product categories through delegated acts, beginning with batteries (under the EU Battery Regulation) and expanding to textiles, electronics, furniture, and other priority categories. DPP is not a CE marking requirement – but for many product categories that already require CE marking, DPP will become the new layer of mandatory documentation infrastructure. Companies that have invested in structured CE marking workflows are better positioned for DPP than companies whose compliance documentation lives in PDFs and email threads. **The Construction Products Regulation (EU) 2024/3110** entered into force on **7 January 2025** and replaces Regulation (EU) No 305/2011. Most of its provisions apply from **8 January 2026**, while Article 92 (penalties) applies from 8 January 2027. The new regulation reshapes CE marking obligations for construction products and introduces a digital product passport for the sector. Companies in scope should track the transitional provisions closely as harmonised standards under the new regime are progressively published. | Date | Milestone | Status | |------|-----------|--------| | 13 December 2024 | GPSR (Regulation (EU) 2023/988) becomes applicable | In force | | 7 January 2025 | New Construction Products Regulation enters into force | In force | | 8 January 2026 | New CPR provisions start to apply for most products | Confirmed | | 1 January 2026 | Toy Safety Regulation (EU) 2025/2509 enters into force | In force | | 20 January 2027 | Machinery Regulation (EU) 2023/1230 starts to apply | Confirmed | | 1 August 2030 | Toy Safety Regulation 2025/2509 becomes applicable | Confirmed | ## CE vs. UKCA in 2026 What the UK still recognises, and where it diverges For companies selling into Great Britain (England, Wales, and Scotland), the practical reality in 2026 is that CE marking is – for most product categories – sufficient. Through the [Product Safety and Metrology etc (Amendment) Regulations 2024](https://www.gov.uk/government/news/uk-government-announces-extension-of-ce-mark-recognition-for-businesses), the UK Parliament removed the time limit on CE recognition, establishing **indefinite recognition** of the CE marking for 21 product regulations covering Great Britain. The UKCA mark remains an option for those categories, but it is not mandatory. **Northern Ireland** operates under the Windsor Framework, where EU rules continue to apply directly. Several product categories are excluded from the indefinite CE recognition policy and have separate UK regimes – including medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment, and unmanned aircraft systems. For those categories, UK-specific marking and conformity assessment rules apply. Teams scoping a UK launch should always check the [most recent guidance on gov.uk](https://www.gov.uk/guidance/using-the-ukca-marking) for their specific product category. ## Do I still need CE marking for the UK in 2026? For most consumer product categories, the UK government recognises CE marking indefinitely for goods placed on the market in Great Britain – meaning a CE-marked product can be sold in GB without UKCA marking. Several categories (including medical devices, construction products, and marine equipment) are excluded from this recognition and require UKCA or UK-specific certification. Northern Ireland follows EU rules under the Windsor Framework, so CE marking remains required there. ## What This Means for Your Compliance Team Three shifts to plan for now Three takeaways for any team that owns CE marking inside a growing product company: If your team is rebuilding the CE marking pipeline manually for every product launch – chasing supplier documentation, mapping regulations in spreadsheets, and assembling technical files by hand – that is exactly the workflow Complir's AI compliance platform was built to automate. [See how Complir maps every product to every applicable regulation across markets](https://complir.io). ## Sources & References - Regulation (EC) No 765/2008 of the European Parliament and of the Council – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2008/765/oj/eng) - Decision No 768/2008/EC on a common framework for the marketing of products – [EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008D0768) - Regulation (EU) 2019/1020 on market surveillance and compliance of products – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2019/1020/oj) - Commission Notice – The 'Blue Guide' on the implementation of EU product rules 2022 (C/2022/247) – [EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=oj:JOC_2022_247_R_0001) - Regulation (EU) 2023/988 on general product safety (GPSR) – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2023/988/oj/eng) - Regulation (EU) 2025/2509 on the safety of toys – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2025/2509/oj/eng) - Regulation (EU) 2023/1230 on machinery – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2023/1230/oj) - Regulation (EU) 2024/1781 establishing a framework for the setting of ecodesign requirements for sustainable products (ESPR) – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2024/1781/oj) - Regulation (EU) 2024/3110 laying down harmonised rules for the marketing of construction products – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2024/3110/oj/eng) - European Commission – CE marking overview – [single-market-economy.ec.europa.eu](https://single-market-economy.ec.europa.eu/single-market/goods/ce-marking_en) - European Commission – New Legislative Framework – [single-market-economy.ec.europa.eu](https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en) - UK Government – Using the UKCA marking – [gov.uk](https://www.gov.uk/guidance/using-the-ukca-marking) - UK Government – Extension of CE mark recognition for businesses – [gov.uk](https://www.gov.uk/government/news/uk-government-announces-extension-of-ce-mark-recognition-for-businesses) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # REACH Compliance Explained: What Product Companies Actually Need to Do Source: https://www.complir.io/resources/guides/reach-compliance-guide Category: Guide REACH compliance is the ongoing obligation to register chemical substances, screen finished products for substances of very high concern (SVHCs), respect Annex XVII restrictions, and – when required – submit data to ECHA's SCIP database. It applies to any company that manufactures, imports, or supplies products on the EU market, regardless of where the company itself is based. The regulation that governs it, **Regulation (EC) No 1907/2006**, is one of the most consequential pieces of chemical legislation in the world, and for most consumer product companies the operational reality lives not in chemical registration but in the obligations that apply to finished articles – textiles, electronics, toys, cosmetics packaging, furniture, homeware. Two things make 2026 a heavier REACH year than most. ECHA added two more substances to the Candidate List on 4 February 2026, taking the total to **253 SVHCs**. And Annex XVII picks up new enforceable entries later this year, including restrictions on undecafluorohexanoic acid (PFHxA) and related substances applying from **10 October 2026**. If your compliance workflow depends on someone manually scanning ECHA bulletins every few months, 2026 will stress-test it. ## What REACH Is The EU's horizontal chemical regulation REACH is the EU regulation that governs how chemicals are produced, placed on the market, and used inside the European Economic Area. The acronym stands for **R**egistration, **E**valuation, **A**uthorisation and **R**estriction of Chemicals. The regulation is Regulation (EC) No 1907/2006, applicable across the EU since 1 June 2007. The regulation is administered by the **European Chemicals Agency (ECHA)**, headquartered in Helsinki, which maintains the registrations, the Candidate List of SVHCs, the Authorisation List (Annex XIV), the restrictions list (Annex XVII), and the SCIP database. Enforcement, however, sits with each EU Member State – national authorities run inspections, issue penalties, and coordinate through ECHA's Forum for Exchange of Information on Enforcement. Importantly for product companies: REACH does not only regulate chemicals sold as chemicals. It regulates substances on their own, substances in mixtures, and **substances in articles** – meaning it reaches into every finished product placed on the EU market. ## Who REACH Applies To Obligations by economic operator role REACH applies to four types of economic operators, each with distinct obligations: - **Manufacturers** – companies that produce chemical substances in the EU - **Importers** – companies established in the EU that bring substances, mixtures, or articles from outside the EU onto the EU market - **Downstream users** – companies that use a substance, either on its own or in a mixture, in the course of their industrial or professional activities - **Distributors** – companies that store and place substances on the market for third parties For most brands and retailers selling finished consumer products, the operational obligations come primarily from being an importer, a downstream user, or a supplier of articles. The exact classification matters: it determines which obligations apply, who bears the registration cost, and how supplier data has to flow through the chain. ### Do non-EU brands need REACH compliance? Yes – and the route most non-EU manufacturers take is the **Only Representative**. Under Article 8 of REACH, a non-EU manufacturer or producer of articles may appoint a natural or legal person established in the EU to fulfil the obligations of importers under REACH. The Only Representative takes on all importer duties: registration, safety data sheet provision, record-keeping, and supply-chain information. EU-based importers of that non-EU manufacturer's products are then treated as downstream users rather than importers, which removes the registration burden from them. Appointing an Only Representative is optional, not mandatory. But without one, every EU importer bringing the non-EU company's products into the bloc has to handle their own registrations and obligations – which quickly becomes unmanageable for brands selling through multiple EU partners. ### What's the difference between a "substance" and an "article" under REACH? A **substance** is a chemical element or compound – the things that get registered in bulk under Article 6. An **article**, under REACH Article 3(3), is an object whose function depends more on its shape, surface, or design than on its chemical composition. A T-shirt, a plastic toy, a laptop, a leather sofa – all articles. This distinction is everything for consumer product companies. You generally don't register articles – you register the substances inside them (and only if you manufacture or import the substance itself above one tonne per year, or if the substance is intended to be released from the article under normal use). What you do for articles is screen them against the Candidate List, respect Annex XVII restrictions, communicate SVHC information down the chain under Article 33, and – where applicable – notify SCIP. ## The Five REACH Obligations What actually matters for product companies REACH is a large regulation. For most product companies, five concrete obligations carry the weight. ### 1. Registration – Article 6 Manufacturers and importers of chemical substances in quantities of **one tonne or more per year per company** must register those substances with ECHA. The registration dossier is submitted electronically via REACH-IT and must contain, for substances in the 1–10 tonnes/year band, the information listed in Annex VII of REACH – physicochemical, toxicological, and ecotoxicological data. Heavier bands (10–100, 100–1,000, above 1,000 tonnes/year) require progressively more information, including chemical safety reports. A substance generally cannot be manufactured, imported, or placed on the EU market until a registration number has been issued. For most consumer product brands, registration is handled upstream – by chemical suppliers or by the Only Representative of a non-EU manufacturer. But you still need to know which substances in your supply chain are registered, and to request safety data sheets where the regulation requires them. ### 2. SVHC communication – Article 33 This is the obligation that touches every consumer product company, whether you know it or not. Under Article 33 of REACH, any supplier of an article containing a substance on the Candidate List in a concentration above **0.1% weight by weight (w/w)** must provide sufficient information to allow safe use of the article – at minimum, the name of the substance. Two flavours of this obligation apply in parallel: - **Business-to-business:** information flows down the supply chain automatically. Your supplier must tell you, and you must tell your customers. - **Business-to-consumer:** on request from a consumer, the supplier has **45 days** to respond with the same information. The 0.1% threshold is calculated at the **article level** – not at the level of the finished product if the product is made of several articles. A zipper containing cadmium above 0.1% is a separate article from the jacket it's sewn into, and both need to be assessed independently. This is where compliance teams most often trip up. ### 3. SCIP notification – Waste Framework Directive Article 9(1)(i) The **SCIP database** (Substances of Concern In articles as such or in complex objects (Products)) is ECHA's public database of articles containing Candidate List substances above 0.1% w/w placed on the EU market. The notification obligation isn't in REACH itself – it's in Article 9(1)(i) of the Waste Framework Directive 2008/98/EC – but it applies to the same Candidate List substances at the same 0.1% threshold, which is why it sits at the centre of most companies' REACH programmes. Every EU supplier of an article that triggers the Article 33 threshold must also notify ECHA via SCIP before placing it on the EU market. Importers are exempt from SCIP notification in their capacity as importers – but the moment they become suppliers of those articles inside the EU, the obligation kicks in. ### 4. Annex XVII restrictions **Annex XVII** is the list of outright restrictions – substances that cannot be manufactured, placed on the market, or used under specified conditions, regardless of concentration (in some entries) or above specific thresholds (in most). Entries relevant to consumer product companies include: - **Entries 51, 52, and 72** – phthalates in plasticised materials, with the core restriction at 0.1% by weight individually or in any combination in any plasticised material - **PFHxA entry** – undecafluorohexanoic acid, its salts, and PFHxA-related substances, applying from **10 October 2026** - Category-specific limits for textiles intended to be washed during normal use, for childcare articles, and for cosmetics-adjacent products Annex XVII entries are the most operationally sensitive of all REACH obligations for consumer product brands – they are **absolute prohibitions**, not communication duties. A product containing a restricted substance above threshold cannot be placed on the market at all, and national authorities can order withdrawal or recall. ### 5. Authorisation – Annex XIV A smaller list than Annex XVII, but a heavier obligation where it applies. **Annex XIV** contains substances that require prior authorisation before they can be placed on the market or used, even for industrial uses. Each entry has two dates: - A **latest application date** – the deadline for submitting an authorisation application if you want to continue using the substance past its sunset date - A **sunset date** – the date from which placing on the market and use of the substance is prohibited unless an authorisation has been granted For finished-article brands, direct interaction with Annex XIV is rare. But if a supplier upstream holds (or needs) an authorisation for a substance used in your product, the ripple effect on your supply is very real – which is why authorisation tracking belongs in any serious compliance programme. ## What Changed in 2026 Candidate List growth and the PFHxA restriction ECHA updates the Candidate List twice a year, typically in January and June, though off-cycle updates happen. The **February 2026 update** added two substances – n-Hexane and 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF) and its salts – bringing the total Candidate List to **253 entries**. n-Hexane is notable because it's the first substance added based on neurotoxicity under the "equivalent level of concern" provision, rather than under the classical CMR or PBT criteria. The next update is expected in June 2026. On the restriction side, **10 October 2026** is the effective date of the PFHxA restriction, which covers PFHxA, its salts, and PFHxA-related substances in certain uses. PFAS restrictions more broadly are accelerating: a separate Annex XVII entry on PFAS in firefighting foams introduces compliance triggers in late 2026, including a labelling requirement for foams above a 1 mg/L sum-of-PFAS threshold. > Quote from Complir Team, Product Compliance at Complir: Running Candidate List checks twice a year used to be enough. With 253 SVHCs and restrictions accelerating, high-volume brands launching hundreds of new products a month across dozens of markets need continuous monitoring, not spreadsheet sweeps. That is exactly the scale at which Complir is built to automate SVHC screening and Annex XVII checks. ## How REACH Interacts with Other Regulations The overlap with GPSR, CE, DPP, and UK REACH REACH doesn't sit in a silo. For product companies, it overlaps with at least four other regimes: - [**GPSR**](/resources/guides/gpsr-compliance-guide-product-companies) – General Product Safety Regulation (EU) 2023/988, applicable since 13 December 2024, requires products to be safe. Chemical content is explicitly part of that assessment, which means REACH screening feeds directly into GPSR compliance. - **CE marking** – REACH sits alongside CE marking rather than inside it. A product can carry the CE mark under the New Legislative Framework while still failing REACH Annex XVII, and vice versa. - [**Digital Product Passport (DPP)**](/resources/guides/digital-product-passport-guide) – the data you already assemble for SCIP, Article 33, and Annex XVII screening is a strong foundation for the structured product records that DPP will require as [ESPR](/resources/guides/espr-ecodesign-regulation-explained) delegated acts are adopted. - **UK REACH** – since Brexit, the UK operates its own REACH regime (a mirror of the EU text with separate registrations, Candidate List decisions, and enforcement). Companies selling into both GB and the EU need to manage both regimes, and divergence between them is growing. ## A Practical REACH Workflow Five steps to go from nothing to audit-ready For a quality or regulatory manager picking up REACH compliance from scratch, the work breaks into five concrete steps. ## Frequently Asked Questions Common REACH questions for product teams ## What is the difference between REACH and RoHS? REACH is a horizontal chemical regulation applying to virtually all substances and articles on the EU market. RoHS (Directive 2011/65/EU) is a product-specific regime that restricts specific hazardous substances in **electrical and electronic equipment (EEE)**. A laptop must comply with both: RoHS for restricted substances like lead and certain phthalates in its EEE components, and REACH for SVHC communication, SCIP notification, and any Annex XVII entries that apply beyond what RoHS already covers. ## Does REACH apply to non-chemical products like textiles and toys? Yes. REACH applies to substances in articles – meaning finished goods. Textiles, toys, electronics, furniture, leather goods, jewellery, and homeware are all in scope. The main obligations for article suppliers are Article 33 communication, SCIP notification, and respecting any Annex XVII entries applicable to their product category. ## What happens if I miss an SVHC communication deadline? Article 33 is enforced at the Member State level. Penalties vary significantly – from administrative fines in the low thousands to, in some jurisdictions, criminal sanctions. More commonly, the operational risk is that a customer or marketplace requests an SVHC declaration you can't produce, which leads to delisting or blocked shipments. The 45-day consumer response window is often the first point of friction teams encounter. ## Do I need to notify SCIP if I already comply with Article 33? Yes – they are separate obligations. Article 33 is about communicating information to customers; SCIP is about submitting data to ECHA's public database. The trigger – an SVHC above 0.1% w/w in an article placed on the EU market – is the same, but the obligation is discharged in two different places. Most compliance programmes build a single screening pipeline that feeds both outputs. ## What are the penalties for REACH non-compliance? Each EU Member State sets its own penalties, which must be "effective, proportionate, and dissuasive" under the general EU law requirement. In practice, fines range from administrative penalties to substantial amounts – for example, up to €4 million and/or imprisonment for certain infringements in some Member States – and several jurisdictions include criminal liability for serious or repeated breaches. ## REACH Compliance at Scale Why manual workflows break for growing portfolios For a brand with a stable, narrow product range, REACH compliance is demanding but manageable – a quality manager, a spreadsheet, a set of supplier declarations, and a recurring check against each Candidate List update. For brands launching hundreds of new products a year across dozens of markets, the picture changes. Every Candidate List update (253 SVHCs and counting) has to be traced back through the product portfolio. Every new Annex XVII entry has to be checked against every active SKU. Every supplier change has to be re-screened. This is the compliance reality Complir was built for. Structured product records per SKU, continuous monitoring of the Candidate List and Annex XVII, automatic flagging of affected products when a regulation changes, and audit-ready Article 33 and SCIP documentation generated from one source of truth – so your team spends time on decisions, not on manual screening. If your team is chasing Candidate List updates across hundreds of SKUs and running SVHC screening in spreadsheets, see how [Complir automates REACH monitoring across your product portfolio](/#solution). ## Sources & References - Regulation (EC) No 1907/2006 – REACH full text on [EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1907-20140410) - Directive 2008/98/EC – Waste Framework Directive (SCIP basis) on [EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008L0098-20180705) - European Chemicals Agency – [Understanding REACH](https://echa.europa.eu/regulations/reach/understanding-reach) - ECHA – [Candidate List of substances of very high concern for Authorisation](https://echa.europa.eu/candidate-list-table) - ECHA – [Summary of obligations resulting from inclusion of SVHCs in the Candidate List](https://echa.europa.eu/candidate-list-obligations) - ECHA – [SCIP database](https://echa.europa.eu/scip-database) - ECHA – [Authorisation List (Annex XIV)](https://echa.europa.eu/authorisation-list) - ECHA – [Substances restricted under REACH (Annex XVII)](https://echa.europa.eu/substances-restricted-under-reach) - European Commission – [REACH Regulation](https://environment.ec.europa.eu/topics/chemicals/reach-regulation_en) - European Commission – [REACH enforcement](https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/reach-enforcement_en) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # Digital Product Passport (DPP): What It Is, Who Needs One, and When Source: https://www.complir.io/resources/guides/digital-product-passport-guide Category: Guide The Digital Product Passport (DPP) is a structured digital record – attached to a physical product via a QR code or similar data carrier – that stores information about the product's identity, composition, supply chain, and sustainability. It is introduced by the EU's [Ecodesign for Sustainable Products Regulation](/resources/guides/espr-ecodesign-regulation-explained) (EU) 2024/1781 (ESPR), which entered into force on 19 July 2024 and will progressively apply to most physical products sold in the EU. The first mandatory digital passport – the battery passport – takes effect on 18 February 2027 under the EU Battery Regulation (EU) 2023/1542. The European Commission's central DPP registry is scheduled to go live on 19 July 2026, and the first ESPR product-specific delegated acts (starting with iron and steel) are expected to be adopted in 2026, with textiles and tyres following in 2027. If you make or import consumer products for the EU market, a DPP will affect your business within the next three to five years – and the preparation work starts with your product data. ## What Is the Digital Product Passport? A digital identity card for every product on the EU market The Digital Product Passport is a digital identity card for a physical product. It carries structured information about what the product is, what it is made of, where its components came from, how it performs on sustainability metrics, and how it can be repaired, reused, or recycled. That information is accessible to consumers, businesses, repairers, recyclers, and market surveillance authorities via a data carrier – typically a QR code – printed on the product or its packaging. The DPP is established by the Ecodesign for Sustainable Products Regulation (EU) 2024/1781. ESPR is a "framework" regulation, meaning it sets the rules of the game but leaves the specific DPP requirements – which product data fields, which performance thresholds, which labelling – to category-by-category delegated acts that the European Commission adopts over time. Put simply: ESPR says every in-scope product will eventually need a DPP. The delegated acts say what that DPP looks like for your specific product category, and when it becomes mandatory. ### Why the EU introduced the DPP The European Commission's goal with the DPP is to make products more circular – easier to repair, reuse, and recycle – and to give everyone in the value chain, from consumers to customs authorities, a reliable way to check what a product actually contains. Today, most of that information is scattered across suppliers, factories, internal spreadsheets, and paper documents. A recycler who wants to know what plastic a casing is made of, or a consumer who wants to know whether a garment contains hazardous substances, usually cannot find out. The DPP is the EU's structural answer: one standardised, machine-readable record per product, accessible via a scannable identifier, covering the full range of product data relevant to sustainability and compliance. It also serves an enforcement function. Once the central registry and product-level DPPs are in place, market surveillance authorities, customs officials, and online marketplaces can verify compliance at scale – not one product at a time. ## Which Products Will Need a DPP Scope, priorities, and the 2025–2030 roadmap Almost every physical product sold in the EU is eventually in scope. ESPR covers all products placed on the EU market or put into service, with limited exceptions for food, feed, medicinal products, and a few other categories. What matters for most companies is the order in which the Commission rolls out the delegated acts. ### Batteries come first (February 2027) The battery passport is technically separate from ESPR – it comes from the EU Battery Regulation (EU) 2023/1542. But in practice it operates as the DPP system's proof-of-concept. From **18 February 2027**, a digital battery passport, retrievable via a QR code, is mandatory for all electric vehicle batteries, industrial batteries, and light-means-of-transport batteries placed on the EU market with a capacity greater than 2 kWh. ### ESPR priority products (2026–2029) The Commission's ESPR Working Plan 2025–2030, adopted on 16 April 2025, named the first priority product categories. Each delegated act includes a minimum 18-month transition period before requirements become enforceable. | Product Group | Delegated Act Target | Estimated Compliance Date | |---|---|---| | Iron and steel (intermediate) | 2026 | ~2028 | | Textiles and apparel | 2027 | ~Late 2028 / 2029 | | Tyres | 2027 | ~2029 | | Furniture | 2028 | ~2030 | | Aluminium (intermediate) | 2028 | ~2030 | | Mattresses | 2029 | ~2031 | That means a textile brand should expect DPP obligations to bite in 2028 or 2029, not the day the delegated act is published. ### What about products not yet on the priority list? If your product category is not in the 2025–2030 Working Plan, you are not obligated yet. But the Commission has signalled that electronics, detergents, chemicals, and many other categories will follow in subsequent working plans. Treat the priority list as the starting menu, not the whole menu. ## What Data a DPP Contains The categories of information and who can access them ESPR does not prescribe a single DPP data set – that is the job of each product-specific delegated act. However, the regulation sets the categories of information a DPP may require, and the Commission has signalled which fields will feature across most categories: - **Product identity** – unique product identifier, model, manufacturer, EU economic operator, place of manufacture. - **Material composition** – substances of concern, recycled content, origin of key materials. - **Environmental performance** – carbon footprint, energy use, durability, reparability score. - **Supply chain** – components, suppliers (where applicable), tier transparency. - **End-of-life** – repair instructions, spare parts availability, disassembly guidance, recycling information. - **Compliance** – declarations of conformity, certifications, test reports relevant to the product's regulatory requirements. Who can see which fields is also regulated. ESPR provides for differentiated access rights – some information is public, some is restricted to repairers and recyclers, and some is accessible only to market surveillance authorities. The specifics are set in each delegated act. ## How a DPP Works in Practice Data carriers, unique identifiers, and the EU registry Three technical components sit behind every DPP. **A data carrier** – typically a QR code, but ESPR allows for other machine-readable formats. It is physically attached to the product, its packaging, or its accompanying documents. Scanning the carrier resolves to the product's DPP. **A unique product identifier**, linked to a unique operator identifier (the economic actor placing the product on the market) and a unique facility identifier (where it was manufactured). These identifiers must be issued in accordance with internationally recognised standards, which is where GS1 and CEN/CENELEC technical work come in. **A central EU registry**, operated by the European Commission. According to the Commission's published roadmap, the registry is scheduled to launch on **19 July 2026**. The registry does not store the full product data – it stores the unique identifiers and the links to where the data lives. Manufacturers and importers remain responsible for hosting, maintaining, and updating the underlying product information. This architecture has an important consequence: the DPP is not a new EU database you upload data to. It is a standardised pointer to your own product data. If your product data is scattered, inconsistent, or out-of-date, the DPP will expose it – publicly – to consumers, retailers, marketplaces, and authorities. > Quote from Complir Team, Product Compliance at Complir: The DPP is not a compliance problem – it is a product-data problem disguised as one. Companies like Flying Tiger Copenhagen, launching 500 new products a month across 44 countries, already rely on structured per-product records to stay ahead of EU regulation. That same foundation is what the DPP will require from every product company. ## Digital Product Passport Timeline The key dates every product company should know Dates marked "Expected" are indicative timelines from the European Commission's published Working Plan and are subject to the formal adoption process. Dates marked "Confirmed" are fixed in adopted regulation text. | Date | Milestone | Status | |------|-----------|--------| | 19 July 2024 | ESPR (EU) 2024/1781 enters into force | Confirmed | | 16 April 2025 | ESPR Working Plan 2025–2030 adopted | Confirmed | | 19 July 2026 | Central EU DPP registry launches | Expected | | 2026 | Iron and steel delegated act | Expected | | 18 February 2027 | Battery passport becomes mandatory under Regulation (EU) 2023/1542 | Confirmed | | 2027 | Textiles and tyres delegated acts | Expected | | 2028 | Furniture and aluminium delegated acts | Expected | | 2029 | Mattresses delegated act | Expected | ## How to Prepare for the DPP Five steps product companies can take today Most companies looking at the DPP for the first time ask the same question: "What do we need to build?" The honest answer is that until your category's delegated act is adopted, you cannot build the final DPP. But you can – and should – start preparing now, because the underlying work is the same regardless of which fields the delegated act eventually mandates. ### When should companies start preparing for the DPP? Now. Structuring your product data, mapping supplier inputs, and assigning internal ownership are steps that pay off the day you start them – regardless of when your category's delegated act is adopted. Companies that wait for final delegated acts will find themselves scrambling to restructure their entire product data landscape under deadline pressure. ## Frequently Asked Questions Common questions about the Digital Product Passport ## What is a Digital Product Passport? A Digital Product Passport is a structured digital record attached to a physical product, accessible via a data carrier such as a QR code, that stores information about the product's identity, composition, supply chain, sustainability performance, and end-of-life options. It is introduced by the EU's Ecodesign for Sustainable Products Regulation (EU) 2024/1781. ## Is the Digital Product Passport mandatory? Yes – but not for every product at the same time. The DPP becomes mandatory product category by product category, as the European Commission adopts delegated acts under ESPR. The battery passport is mandatory from 18 February 2027. Iron and steel, textiles, tyres, furniture, aluminium, and mattresses are on the 2026–2029 adoption roadmap. Other categories will follow in subsequent ESPR working plans. ## Who is responsible for creating a Digital Product Passport? Under ESPR, the economic operator placing the product on the EU market is responsible for the DPP. For EU manufacturers, that is the manufacturer. For products imported into the EU, the importer is responsible. The DPP data must be accurate, maintained, and accessible throughout the product's life cycle. ## What is the difference between a battery passport and a Digital Product Passport? The battery passport is established by the EU Battery Regulation (EU) 2023/1542, not by ESPR. It applies specifically to electric vehicle, industrial, and light-means-of-transport batteries with a capacity above 2 kWh, and becomes mandatory on 18 February 2027. The Digital Product Passport under ESPR is the broader, framework-level system that will apply across most product categories over the coming years. The two systems are designed to be interoperable, and the battery passport is widely viewed as the blueprint for the DPPs that follow. ## Does the Digital Product Passport apply to imported products? Yes. ESPR applies to products placed on the EU market or put into service, regardless of where they are manufactured. Importers of non-EU products carry the DPP obligation for those products once they enter the EU. This is the same scope principle that governs CE marking, [GPSR](/resources/guides/gpsr-compliance-guide-product-companies), and most other EU product regulations. ## Will the DPP require new software? Not necessarily new software – but it will require product data to be structured, centralised, and maintainable. Many companies already hold the underlying data across PIM, PLM, ERP, and supplier systems. The work is connecting those sources into a single per-product record, keeping it up to date, and exposing the right fields to the right audiences when the delegated acts require it. Companies with scattered, spreadsheet-driven product data are the most exposed and have the most work ahead. ## Key Takeaways What the DPP means for your business The Digital Product Passport is coming – gradually, by product category, starting with the battery passport in February 2027 and expanding across ESPR priority products through 2029. The DPP is not a new database you upload to; it is a standardised pointer to the product data you already (should) hold. That makes product data quality the single biggest determinant of how painful DPP compliance becomes. The preparation work is not speculative. Structuring your product data, mapping supplier inputs, and assigning internal ownership are steps that pay off the day you start them – regardless of when your category's delegated act is adopted. If mapping regulations across your product portfolio and maintaining a single source of truth for product data is already consuming your team's time, the DPP is going to intensify the pressure. See how [Complir automates regulation-to-product mapping and structured product records](/#solution) – it is exactly the foundation the DPP will require. ## Sources & References - Regulation (EU) 2024/1781 – Ecodesign for Sustainable Products Regulation (ESPR) – [EUR-Lex full text](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng) - Ecodesign requirements for sustainable products – [EUR-Lex summary](https://eur-lex.europa.eu/EN/legal-content/summary/ecodesign-requirements-for-sustainable-products.html) - ESPR Working Plan 2025–2030 – [European Commission, Green Forum](https://green-forum.ec.europa.eu/implementing-ecodesign-sustainable-products-regulation_en) - Regulation (EU) 2023/1542 – Sustainability rules for batteries and waste batteries – [EUR-Lex full text](https://eur-lex.europa.eu/eli/reg/2023/1542/oj/eng) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # Extended Producer Responsibility (EPR) in the EU: A 2026 Guide for Product Companies Source: https://www.complir.io/resources/guides/extended-producer-responsibility-eu-guide Category: Guide **Extended Producer Responsibility (EPR) is the EU policy principle that makes producers financially – and often operationally – responsible for what happens to their products once consumers are done with them.** If you place packaging, electronics, batteries, textiles, or a growing list of other product types on the EU market, EPR obligations almost certainly apply to you. This guide explains what EPR is, which product streams it covers, what's changing in 2026, and why getting it right has become materially harder – and more expensive – over the past two years. It is a 2026 snapshot of one of the fastest-moving areas of EU product regulation, with the Packaging and Packaging Waste Regulation taking effect in August 2026, the new Batteries Regulation already in force, and textile EPR rolling out across Member States through 2027–2028. ## Which products are covered by EPR? EPR in the EU applies to a growing list of product streams. The most established are packaging, electrical and electronic equipment (WEEE), and batteries, with newer or expanding schemes for textiles, tyres, furniture, single-use plastics, and end-of-life vehicles. Exact categories and fee structures are set by each Member State, so the same product can carry different EPR obligations from one EU market to the next. ## What does EPR mean for product companies? For product companies, EPR means registering with the relevant national scheme in every market where you sell, reporting the volumes and materials you place on the market, and paying fees that increasingly vary with how recyclable or sustainable your product is. It usually also requires accurate, SKU-level material data, an authorised representative in markets where you have no local entity, and ongoing tracking as new streams such as textiles come into force. ## What Is Extended Producer Responsibility? The "polluter pays" principle, operationalised across the EU Extended Producer Responsibility is a policy tool that extends a producer's financial or operational responsibility for a product to cover the post-consumer stage – collection, sorting, recycling, and disposal of the waste it generates. It operationalises the "polluter pays" principle in EU waste policy. The legal foundation sits in Article 8 and Article 8a of the **Waste Framework Directive (Directive 2008/98/EC)**. Article 8a, introduced in the 2018 revision, sets the general minimum requirements that every national EPR scheme in the EU must meet – covering producer registration, reporting, financial contributions, and oversight of the Producer Responsibility Organisations (PROs) that administer the schemes. In practice, EPR works like this: instead of municipalities absorbing the full cost of waste collection and recycling, producers pay a fee for every unit they put on the market. The fee funds the infrastructure that handles the product at end-of-life – and, increasingly, is modulated based on how recyclable or sustainable the product is. ## Who Has EPR Obligations in the EU? The definition of "producer" is broader than it sounds Under most EU EPR schemes, a *producer* is any legal entity that – regardless of the selling technique used, including distance selling – **first places a product on the national market of a Member State**. That typically includes: - Manufacturers that sell under their own brand - Importers bringing products into a Member State from outside - Distributors or retailers that import or sell under a private label - Online sellers and marketplaces, including distance sellers based outside the EU - Fulfilment service providers, in some Member States Non-EU companies placing products on the EU market generally need to appoint an **Authorised Representative for EPR** in each Member State where they sell – a local legal entity that registers the producer and handles the EPR obligations on their behalf. The exact rules differ by stream (PPWR, WEEE, and the Batteries Regulation each handle this differently) and by Member State. There is no EU-wide de minimis threshold. A few Member States apply minimum turnover or volume thresholds for specific streams, but the baseline assumption should be: if you place an in-scope product on a national market, you have to register – often *before* the first unit ships. ## Which Product Categories Fall Under EPR? EPR is not one law – it's a principle applied across many EPR is not a single law. It is a policy principle applied through specific product-stream regulations, each with its own rules, fees, registers, and reporting obligations. The main EU-level streams today are: | Stream | Governing instrument | |---|---| | Packaging and packaging waste | Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) | | Electrical and electronic equipment | WEEE Directive 2012/19/EU | | Batteries | Batteries Regulation (EU) 2023/1542 | | Textiles and footwear | Revised Waste Framework Directive (2025 revision) | | End-of-life vehicles | Directive 2000/53/EC (revision pending) | | Single-use plastics | Directive (EU) 2019/904 | National schemes go further. France, under the Anti-Waste for a Circular Economy Law (*Loi AGEC*), now runs EPR schemes across more than a dozen product categories – including furniture, toys, sports equipment, DIY products, and tobacco products – most of which have no EU-wide equivalent yet. For a product company with a diverse portfolio, this matters enormously. A single SKU can trigger EPR obligations under two or three different schemes in the same country. A child's electronic toy sold in France, for example, would fall under packaging EPR, WEEE, batteries (if applicable), toys EPR, *and* a separate EPR contribution on the printed instruction leaflet. ## What's Changing in 2026 PPWR, batteries, WEEE, and textiles – all in motion at once ### Packaging: the PPWR takes effect The **Packaging and Packaging Waste Regulation, Regulation (EU) 2025/40**, entered into force on 11 February 2025 and **starts to apply from 12 August 2026**. It replaces the previous Packaging and Packaging Waste Directive (94/62/EC) and directly harmonises packaging rules across all 27 Member States – rather than relying on national transpositions. For EPR specifically, the PPWR strengthens and standardises producer registration, reporting, and oversight of PROs. Key implications for producers: - **All packaging placed on the EU market must be recyclable by 2030**, meeting harmonised design-for-recycling criteria. Packaging that fails these criteria will face higher EPR fees or market restrictions. - **Eco-modulation of fees becomes mandatory** across Member States. Packaging that is difficult to recycle will attract higher fees; compliant designs get reduced fees. - **Minimum recycled content requirements** apply to plastic packaging, with tighter thresholds phased in through 2030 and 2040. - **A new EU-level Authorised Representative for packaging** is required for non-EU producers, in addition to existing national representatives. ### Batteries: EPR in force since August 2025 **Regulation (EU) 2023/1542** (the Batteries Regulation) fully replaced the old Batteries Directive (2006/66/EC) from 18 August 2025. Article 56 places extended producer responsibility on all battery producers – including those who prepare batteries for re-use or repurposing – making them operationally and financially responsible for end-of-life battery management. Every producer placing batteries on a Member State's market must be registered there, either directly or through an EPR Authorised Representative. The Regulation also introduces a [battery passport](/resources/guides/digital-product-passport-guide) for certain categories, stricter collection rate targets, and performance and durability requirements – all layered on top of the EPR obligation. ### WEEE: stable framework, growing enforcement The **WEEE Directive (2012/19/EU)** remains the governing instrument for electrical and electronic equipment. It has been in place since 2012 and has not undergone major structural change, but enforcement – particularly around marketplace sellers and distance sellers – has intensified across most Member States. Any company placing EEE on an EU market must register in each country, pay EPR fees based on the volume and category of equipment, and ensure take-back and recycling obligations are met through a PRO or directly. ### Textiles: EPR becomes EU-wide The **revised Waste Framework Directive entered into force on 16 October 2025**, establishing an EU-wide EPR obligation for textiles and footwear for the first time. Member States have **20 months to transpose** the revision into national law and **30 months to establish operational EPR schemes** – meaning textile EPR schemes should be live across the EU by late 2027 or 2028. Under the new framework, textile and footwear producers will pay a fee per item placed on the market, with fees eco-modulated based on circularity and sustainability criteria. France already has a mature textile EPR scheme under the AGEC Law, operated by Refashion, with eco-fees typically ranging from a few cents to a few euros per item depending on category. The Netherlands established its own scheme in 2023. For most other Member States, 2026 and 2027 will be about setting up or scaling national schemes from scratch. > Quote from Complir Team, Product Compliance at Complir: The pattern we see at companies like [Flying Tiger Copenhagen](/resources/case-studies/flying-tiger-compliance) – 500 new products a month across 44 countries – is that manual EPR tracking breaks down exactly at the point where the product catalogue or the market footprint grows beyond what one person can hold in their head. That is the problem Complir was built to solve. ## How EPR Fees Work: Eco-Modulation Why compliance is moving upstream into product design Historically, EPR fees were flat or weight-based. The direction of travel across every stream is toward **eco-modulation** – fees that vary based on the environmental performance of the product. In practice, this means: - A plastic bottle made from recycled PET with a widely recyclable cap pays a lower fee than one made from virgin multi-layer plastic. - A polyester garment with fibre-to-fibre recyclability pays less than one with mixed-fibre content and non-removable trims. - A battery designed for easier disassembly and higher recovery pays less than one that is not. Eco-modulation is now a hard requirement under the PPWR, the Batteries Regulation, and the revised Waste Framework Directive. It pulls the compliance question into product design – not just end-of-market paperwork. For product teams, this creates a meaningful feedback loop: decisions made by designers, sourcing teams, and packaging engineers directly affect what the finance team pays in EPR fees six months later. Most organisations are not yet set up to give designers visibility into that downstream cost – but they will need to be. ## EPR Country by Country Why harmonisation is still a long way off Even with PPWR and the revised Waste Framework Directive pushing toward harmonisation, EPR remains stubbornly national. Each Member State runs its own registers, its own PROs, its own fee schedules, and its own reporting cadence. A few examples: - **Germany** runs packaging EPR through the **Central Packaging Register** (Stiftung Zentrale Stelle Verpackungsregister, ZSVR) and its LUCID system. Every producer must register with LUCID before placing any packaged goods on the German market. - **France** runs the widest range of EPR schemes in the EU – covering packaging, WEEE, batteries, textiles, furniture, toys, and more – most administered by a network of state-approved PROs (*éco-organismes*) such as CITEO for packaging and Refashion for textiles. - **Spain, Italy, Austria, the Netherlands, Belgium, Sweden**, and most other Member States each have their own packaging and WEEE registers, with different reporting formats and deadlines. For a company selling into even a handful of EU markets, this means multiple registrations, multiple sets of reporting obligations, and multiple fee calculations per product – every year, across every scheme the product touches. ## Key EPR Dates to Know A timeline of what's already in force and what's coming | Date | Milestone | Status | |------|-----------|--------| | 5 July 2018 | Revised Waste Framework Directive introduces Article 8a minimum EPR requirements | In force | | 18 August 2025 | Batteries Regulation (EU) 2023/1542 EPR obligations begin | In force | | 16 October 2025 | Revised Waste Framework Directive (textiles EPR basis) enters into force | In force | | 12 August 2026 | Packaging and Packaging Waste Regulation (EU) 2025/40 starts to apply | Confirmed | | By mid-2027 | Deadline for Member States to transpose textile EPR into national law | Confirmed | | By late 2027 / 2028 | Operational textile EPR schemes expected across Member States | Expected | | 2030 | All packaging placed on the EU market must meet recyclability criteria under PPWR | Confirmed | ## How to Prepare for EPR at Portfolio Scale Five steps product companies can take today For a single product in a single market, EPR is paperwork. For a portfolio of hundreds or thousands of SKUs sold across 20 or 40 European markets, it becomes an ongoing operations problem – and one that most compliance and quality teams are not resourced to handle alongside their other regulatory work. ## Frequently Asked Questions Common questions about EPR obligations ### Is EPR the same as a recycling fee? Not exactly. The EPR fee often *funds* the recycling system, but EPR is a broader legal obligation that includes registration, reporting, and – depending on the scheme – take-back responsibilities. Paying a fee without registering is still non-compliance. ### Do online marketplaces have EPR obligations? Yes, increasingly. Several Member States already require marketplaces to verify that third-party sellers are registered for EPR, or to take on the obligation themselves if the seller is not. This is codified across multiple streams, and both the PPWR and the Batteries Regulation reinforce it. ### Does EPR apply to B2B products? In many cases, yes. WEEE covers both household and non-household EEE. Industrial and automotive batteries are within the scope of the Batteries Regulation. Industrial packaging is covered by the PPWR. The B2B / B2C distinction often affects the *scheme* and *fee*, not whether EPR applies at all. ### What happens if we don't register? Penalties vary by Member State but can include fines, product recalls, bans on selling in the market, and personal liability for directors. Marketplaces increasingly de-list sellers that can't provide an EPR registration number. Enforcement has tightened materially since 2023. ### How do we know which EPR schemes apply to our products? That's the hard part – and the reason most companies over-spend on external consultants. It requires mapping every product (and every component, including packaging and documentation) to every applicable scheme in every market you sell in, then keeping that mapping current as schemes evolve. ### Do non-EU companies need an Authorised Representative for EPR? In most cases, yes. Non-EU producers placing products on an EU national market typically need to appoint a local Authorised Representative in each Member State where they sell, for each EPR stream that applies. The exact rules differ by stream – PPWR, WEEE, and the Batteries Regulation each handle Authorised Representatives slightly differently – and some Member States impose additional requirements of their own. ## Making EPR Manageable Why product data is the foundation for every EPR stream EPR isn't getting simpler. Between the PPWR, the new Batteries Regulation, the textile EPR rollout, and the upcoming revision of the End-of-Life Vehicles Directive, the number of product streams with EPR obligations is growing – and the fees themselves are increasingly tied to product-level design data. Structuring that data now is how you stop EPR from becoming a bottleneck to international expansion. The symptoms of a manual approach are familiar: spreadsheets per country, registrations missed when new markets are added, fee surprises at year-end when volumes are reconciled, and no clear answer when a marketplace asks for the registration number. This is the challenge that led us to build **Complir**. Complir structures product data from your existing systems (PIM, PLM, suppliers), maps every SKU to the applicable regulations – EPR schemes and the [General Product Safety Regulation (GPSR)](/resources/guides/gpsr-compliance-guide-product-companies) included – across every market you sell in, and keeps that mapping current as schemes evolve. When a new scheme comes online – a new Member State activating textile EPR, for example – Complir flags the affected products automatically, rather than waiting for the gap to surface in an audit. If mapping EPR obligations across a growing product portfolio is starting to outrun spreadsheets, [book a 30-minute walkthrough of Complir](/book-demo) to see how we handle it. ## Sources & References - **Directive 2008/98/EC** (Waste Framework Directive), consolidated text including Article 8 and Article 8a – [EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02008L0098-20180705) - **Regulation (EU) 2025/40** (Packaging and Packaging Waste Regulation) – [EUR-Lex summary](https://eur-lex.europa.eu/EN/legal-content/summary/packaging-and-packaging-waste-from-2026.html) - **Regulation (EU) 2023/1542** (Batteries Regulation) – [EUR-Lex](https://eur-lex.europa.eu/eli/reg/2023/1542/oj) - **Directive 2012/19/EU** on Waste Electrical and Electronic Equipment (WEEE) – [EUR-Lex](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32012L0019) - **Revised Waste Framework Directive** (textile and food waste revision, in force 16 October 2025) – [European Commission](https://environment.ec.europa.eu/news/revised-waste-framework-directive-enters-force-2025-10-16_en) - **Directive (EU) 2019/904** on single-use plastics – [EUR-Lex](https://eur-lex.europa.eu/eli/dir/2019/904/oj) - **European Commission – Waste Framework Directive overview** – [environment.ec.europa.eu](https://environment.ec.europa.eu/topics/waste-and-recycling/waste-framework-directive_en) --- *This article is for informational purposes only and does not constitute legal advice. EPR obligations vary by product category, scheme, and Member State. Consult a qualified compliance advisor for guidance specific to your products and markets.* --- # ESPR Explained: What the Ecodesign for Sustainable Products Regulation Means for Your Business Source: https://www.complir.io/resources/guides/espr-ecodesign-regulation-explained Category: Guide The Ecodesign for Sustainable Products Regulation (ESPR) is a European Union framework regulation – published as Regulation (EU) 2024/1781 – that sets the rules for making products sold in the EU more durable, repairable, recyclable, and transparent. It entered into force on 18 July 2024 and replaces the previous Ecodesign Directive (2009/125/EC), which only covered energy-related products. ESPR expands the scope to virtually all physical products placed on the EU market. If you manufacture, import, or sell consumer products in the EU, ESPR will affect your business. The first obligations – including a ban on destroying unsold clothing and footwear – take effect on 19 July 2026. Product-specific requirements will follow through delegated acts rolling out between 2026 and 2030. ## When does ESPR come into force? ESPR entered into force on 18 July 2024, but its obligations phase in over several years. The first concrete requirement, a ban on the destruction of unsold clothing and footwear, applies from 19 July 2026 for large companies. Product-specific ecodesign rules and Digital Product Passport requirements then follow through delegated acts rolling out between 2026 and 2030, starting with priority groups such as textiles, iron and steel, aluminium, and electronics. ## Which products does ESPR cover? Because ESPR is a framework regulation, it can apply to almost any physical product placed on the EU market, with the specific rules set group by group through delegated acts. The first ESPR Working Plan for 2025 to 2030 prioritises textiles and apparel, furniture, tyres, iron and steel, aluminium, and certain electronics. Energy-related products currently regulated under the old Ecodesign Directive move into the ESPR framework over time. ## What Is ESPR? The framework regulation behind EU product sustainability ESPR is a framework regulation. That means it does not set specific product requirements itself. Instead, it establishes the legal basis and the rules the European Commission will use to adopt delegated acts – secondary legislation that defines ecodesign requirements for specific product groups. This is an important distinction. Unlike a regulation that lists every requirement upfront, ESPR creates the machinery for requirements to be developed product group by product group, based on detailed technical assessments. Think of ESPR as the operating system, and delegated acts as the applications that run on it. The regulation's scope is broad. According to the European Commission, ESPR covers all products placed on the EU market or put into service, including components and intermediate products. The only exceptions are food, feed, medicinal products, and a handful of other categories explicitly excluded in the regulation text. ### How is ESPR different from the old Ecodesign Directive? The original Ecodesign Directive (2009/125/EC) applied exclusively to energy-related products – appliances, lighting, motors, and similar equipment. ESPR fundamentally expands this scope in three ways. First, it covers nearly all physical products, not just energy-related ones – textiles, furniture, steel, aluminium, tyres, and many more. Second, it introduces the [Digital Product Passport (DPP)](/resources/guides/digital-product-passport-guide) as a mandatory information tool. Third, it adds circularity-focused requirements like repairability, durability, and recycled content alongside traditional energy efficiency criteria. ## What Does ESPR Actually Require? Performance and information requirements for products ESPR delegates the specifics to product-level delegated acts, but the regulation defines two categories of requirements that those delegated acts can impose. **Performance requirements** set minimum thresholds products must meet. These can cover parameters such as durability, reusability, repairability, energy and resource efficiency, recycled content, carbon footprint, and restrictions on substances that inhibit circularity. The regulation lists 20 potential parameters – delegated acts will select which apply to each product group. **Information requirements** mandate that products carry specific data. At a minimum, these include a Digital Product Passport and information about [Substances of Concern](/resources/guides/reach-compliance-guide) present in the product – their identity, location in the product, concentration, and instructions for safe use and end-of-life management. ### What is the Digital Product Passport? The Digital Product Passport (DPP) is a structured digital record attached to each product – typically accessible via a QR code, NFC chip, or RFID tag – that stores sustainability and compliance data throughout the product's lifecycle. The DPP must be machine-readable and comply with standardised data formats. The type of data a DPP contains will vary by product group, but it is expected to cover material composition, environmental performance indicators, durability information, repairability scores, substances of concern, and end-of-life handling instructions. The EU DPP Registry – the central infrastructure that underpins the system – is set to become operational by 19 July 2026. The DPP is not just a label. It creates a digital thread linking the product to its compliance data, accessible to consumers, businesses, market surveillance authorities, and recyclers. For product companies, this means building and maintaining structured, standardised product data at a level most have not needed before. ## Which Products Are Covered – and When? Priority product groups and the 2025–2030 Working Plan On 16 April 2025, the European Commission published its first ESPR and Energy Labelling Working Plan for 2025–2030. This plan identifies the priority product groups that will receive delegated acts first. The priority list includes both new product categories (covered for the first time under ecodesign rules) and energy-related products carried over from the previous directive: | Product Group | Delegated Act Target | Estimated Compliance Date | |---|---|---| | Iron and steel | 2026 | ~2028 (18-month transition) | | Textiles (apparel focus) | Q2 2027 | ~Late 2028/2029 | | Aluminium | 2027 | ~2029 | | Tyres | 2027 | ~2029 | | Furniture | 2028 | ~2030 | | Mattresses | 2029 | ~2031 | *Note: Each delegated act includes a minimum 18-month transition period before requirements become enforceable. Estimated compliance dates are based on this minimum transition.* In addition, the Working Plan carries forward 16 energy-related product groups from the previous Ecodesign Directive, including dishwashers (2026), electric vehicle chargers (2028), fridges and freezers (2028), electric motors (2028), and mobile phones and tablets (2030). The plan also introduces two horizontal requirements that cut across multiple product groups: repairability rules (targeted for 2027, potentially covering consumer electronics and small household appliances) and recycled content and recyclability requirements for electrical and electronic equipment (2029). A mid-term review is planned for 2028, at which point the Commission may add additional product groups – footwear, paints, detergents, lubricants, and chemical products are all mentioned as candidates for future preparatory studies. Separately, batteries are covered under the EU Battery Regulation (EU) 2023/1542, not ESPR. The Battery Passport – the first mandatory DPP in the EU – applies from 18 February 2027. > Quote from Complir Team, Product Compliance at Complir: Managing product compliance across multiple categories, each with its own delegated act timeline and requirements, is exactly the kind of portfolio-scale challenge that companies like Flying Tiger Copenhagen – with 500 new products per month across 44 countries – face daily. It's the challenge that led us to build Complir. ## The Ban on Destroying Unsold Products ESPR's most immediate obligation One of ESPR's most immediate obligations does not wait for delegated acts. Article 23 of the regulation introduces a general duty for all economic operators to take reasonable measures to prevent the need to destroy unsold consumer products. Article 25 goes further. From **19 July 2026**, large enterprises are prohibited from destroying unsold clothing, clothing accessories, and footwear listed in Annex VII of the regulation. Medium-sized enterprises have until **19 July 2030**. Micro and small enterprises are exempt. The European Commission adopted the final delegated regulation on derogations in early 2026, defining 10 circumstances under which destruction remains permitted – including products that are dangerous, non-compliant with law, damaged, or have manufacturing defects. Alongside the destruction ban, a disclosure requirement applies. Large companies must publicly report the quantity of unsold consumer products they discard each financial year, starting from the first full financial year after the implementing act's date of application – confirmed by the Commission to be February 2027. ### Does the destruction ban apply to all products? Not yet. The initial ban covers clothing, clothing accessories, and footwear only. However, Article 25 of ESPR empowers the Commission to extend the ban to other product groups through delegated acts. The Working Plan does not specify a timeline for extending the destruction ban beyond textiles and footwear, but the regulatory framework is in place to do so. ## How to Prepare for ESPR Five steps to take today ESPR's phased rollout gives companies time – but the companies that start preparing now will have a significant advantage. ### When should companies start preparing for ESPR? Now. Even though most product-specific requirements won't be enforceable until 2028 or later, the data infrastructure needed to comply – structured product records, supplier data collection processes, substances of concern tracking – takes significant time to build. Companies that wait for final delegated acts will find themselves scrambling to restructure their entire product data landscape under deadline pressure. The best way to prepare for ESPR is to get your product data in order today. ## Frequently Asked Questions Common questions about ESPR compliance ## Does ESPR apply to non-EU companies? Yes. ESPR applies to all products placed on the EU market, regardless of where they are manufactured. If a product is sold in the EU – whether by an EU-based company or imported from a third country – it must comply with the applicable ecodesign requirements and carry a DPP once the relevant delegated act is in force. ### What is the difference between ESPR and the EU Battery Regulation? The EU Battery Regulation (EU) 2023/1542 is a standalone regulation that establishes its own sustainability, labelling, and due diligence requirements for batteries – including the Battery Passport, mandatory from 18 February 2027. ESPR covers the broader product landscape. While both regulations introduce Digital Product Passports, they are separate legal instruments with separate requirements. ## What happens if a company doesn't comply with ESPR? ESPR follows the standard EU enforcement model: Member States are responsible for market surveillance and setting penalties, which must be effective, proportionate, and dissuasive. Specific penalty amounts and enforcement mechanisms will vary by Member State. Non-compliance could also result in products being blocked from the EU market or removed from sale. ### Will ESPR affect products already on the market? This depends on the specific delegated act. ESPR empowers the Commission to set requirements that apply to products placed on the market after a given date – not retroactively to existing stock. However, once a delegated act is in force, any new product placed on the market must comply, including new production runs of existing product designs. ## What This Means for Your Business Key takeaways and next steps ESPR is the EU's most ambitious product sustainability regulation to date. It will reshape how products are designed, documented, and tracked across their lifecycle. Three things matter most for product companies right now. First, the destruction ban for unsold clothing and footwear hits on **19 July 2026** – that is the first hard deadline for large enterprises. Second, the DPP Registry goes live in mid-2026, signalling that the technical infrastructure for Digital Product Passports is being built now. Third, the Working Plan gives clear visibility into which product groups face requirements first – textiles, steel, aluminium, tyres, furniture, and mattresses are all on the 2026–2029 roadmap. The common thread across all of these: structured product data is the foundation. Without it, meeting DPP requirements, tracking substances of concern, and generating audit-ready documentation becomes a manual, error-prone scramble for every delegated act that applies to your portfolio. Most products in scope for ESPR also fall under the EU's [General Product Safety Regulation (GPSR)](/resources/guides/gpsr-compliance-guide-product-companies), so the same product records that satisfy ecodesign and DPP requirements should also support your general safety obligations. If your team is spending more time wrestling with product data and regulatory mapping than getting products to market, [book a walkthrough of Complir's product-to-regulation mapping workflow](/book-demo). ## Sources & References - Ecodesign for Sustainable Products Regulation (EU) 2024/1781 – [Official Journal of the EU (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2024/1781/oj/eng) - Ecodesign requirements for sustainable products – [EUR-Lex Summary](https://eur-lex.europa.eu/EN/legal-content/summary/ecodesign-requirements-for-sustainable-products.html) - Implementing the Ecodesign for Sustainable Products Regulation – [European Commission Green Forum](https://green-forum.ec.europa.eu/implementing-ecodesign-sustainable-products-regulation_en) - 2025–2030 ESPR Working Plan – [European Commission Green Forum](https://green-forum.ec.europa.eu/news/2025-2030-working-plan-2025-07-11_en) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # GPSR Compliance: The General Product Safety Regulation Explained (2026) Source: https://www.complir.io/resources/guides/gpsr-compliance-guide-product-companies Category: Guide The General Product Safety Regulation (EU) 2023/988 – known as GPSR – is the EU's overhaul of consumer product safety law. It replaced the decades-old General Product Safety Directive (2001/95/EC) and has applied across all EU Member States since 13 December 2024. If you manufacture, import, distribute, or sell non-food consumer products on the EU market, GPSR applies to you – regardless of where your company is based. GPSR matters now more than ever because enforcement is ramping up. Market surveillance authorities across the EU are actively using their expanded powers, the Safety Gate system is processing record numbers of product safety notifications, and [online marketplaces](/resources/research/temu-cosmetics-study) like Amazon have begun requiring GPSR compliance documentation from sellers. Companies that haven't adapted risk product delistings, recalls, and fines. ## What is GPSR? GPSR is the EU's General Product Safety Regulation, Regulation (EU) 2023/988, the baseline safety law for non-food consumer products sold in the EU. It replaced the General Product Safety Directive (2001/95/EC) and has applied in all 27 Member States since 13 December 2024. GPSR covers any consumer product that is not already governed by stricter sector-specific rules, and it applies to manufacturers, importers, distributors, and online marketplaces regardless of where they are based. ## What are the GPSR requirements? The core GPSR requirements are: appoint an EU-based responsible person for every product, carry out and document an internal risk analysis, keep technical documentation available for market surveillance authorities, label products with identification and contact details, and report serious incidents through the Safety Business Gateway within two working days. Online marketplaces have additional obligations: register with the Safety Gate portal, name a single point of contact, and act on dangerous-product notifications. ## What is GPSR compliance? GPSR compliance means being able to demonstrate, for every product on the EU market, that it is safe and that the regulation's obligations are met before an authority or marketplace asks. In practice that requires a designated responsible person, an up-to-date technical file and risk analysis per product, correct labelling, and a process for monitoring regulatory changes and reporting incidents. For companies with large portfolios, this is a structured-data problem rather than a paperwork exercise. ## What Changed from the Old Directive Understanding the shift from GPSD to GPSR The previous General Product Safety Directive (GPSD) served as the EU's safety net for consumer products since 2001. GPSR doesn't just update it – it fundamentally expands the scope and sharpens the obligations. Three changes stand out. First, GPSR is a regulation, not a directive. That means it applies directly and uniformly across all 27 EU Member States – no more variation in how countries interpret the rules. Second, it introduces the concept of a mandatory "responsible person" established in the EU for every product on the market. Third, it imposes specific obligations on online marketplaces for the first time, closing a gap that allowed unsafe products to reach consumers through e-commerce channels. For product companies, the shift from directive to regulation means one set of rules, one compliance standard, and less ambiguity. But it also means tighter enforcement and higher expectations. ### Does GPSR apply to all consumer products? GPSR applies to all products placed on or made available on the EU market that are intended for consumers – or likely to be used by consumers – under reasonably foreseeable conditions. This includes products used in the context of providing a service. Products covered by specific EU harmonisation legislation (such as toys, electronics, or medical devices) are partially exempt: GPSR fills the gaps where sector-specific rules don't address particular safety aspects. Food, feed, medicinal products, and plants are excluded entirely. ### How is GPSR different from CE marking requirements? CE marking applies to product categories covered by specific EU directives and regulations – think the Toy Safety Directive, the Low Voltage Directive, or the Machinery Regulation. GPSR is the safety net underneath all of those. If your product falls under a CE marking directive, you still need to comply with that directive, but GPSR adds requirements on areas like traceability, internal risk analysis, and the responsible person obligation that the sector-specific rules may not cover. For products not covered by any CE marking directive – such as furniture, clothing, or household items – GPSR is the primary safety law. ## Who Needs to Comply Obligations by economic operator role GPSR defines obligations for every economic operator in the supply chain – manufacturers, importers, distributors, fulfilment service providers, and online marketplaces. Here's what each role requires. **Manufacturers** bear the heaviest obligations. Under Article 9 of GPSR, manufacturers must ensure their products are safe before placing them on the market. This means conducting an internal risk analysis, preparing technical documentation that demonstrates safety, and ensuring products carry the required identification and contact information – including a type, batch, or serial number, the manufacturer's name, postal address, and email address. Where the product's size makes this impractical, the information must appear on the packaging or an accompanying document. **Importers** must verify that the manufacturer has fulfilled these obligations before placing a product on the EU market. Under Article 11, importers must ensure that the product bears the required markings and is accompanied by safety information in a language easily understood by consumers in each Member State where it will be sold. **Distributors** must act with due care. Under Article 12, distributors must verify that the product bears the required identification and that the manufacturer and importer (where relevant) have complied with their labelling and information obligations. **Online marketplaces** face new requirements under Article 22. Marketplace providers must register with the Safety Gate portal, designate a single point of contact for market surveillance authorities, and take down products flagged as dangerous. This is a significant change – marketplaces can no longer claim to be passive intermediaries when it comes to product safety. > Quote from Complir Team, Product Compliance at Complir: We work with retailers and brands managing hundreds or thousands of SKUs across multiple markets – companies like [Flying Tiger Copenhagen](/resources/case-studies/flying-tiger-compliance), which launches 500 new products every month across 44 countries. GPSR compliance at that scale requires structured product data and automated tracking, not spreadsheets and manual checks. ## The Responsible Person Requirement GPSR's biggest change for non-EU companies Article 16 of GPSR introduces what is arguably the most impactful new requirement: every product placed on or made available on the EU market must have a responsible person established in the EU. The responsible person is the economic operator who takes accountability for the product's compliance with GPSR. This can be the manufacturer (if EU-based), the authorized representative, the importer, the distributor, or the fulfilment service provider. If none of these is established in the EU, the product cannot legally be placed on the market. ### What does the responsible person actually do? The responsible person's duties under Article 16(2) include verifying that technical documentation has been drawn up – including a risk analysis and a list of applicable standards – making this documentation available to market surveillance authorities on request, cooperating with authorities when a product presents a risk, and informing authorities when they have reason to believe a product is dangerous. The responsible person's name, trade name or trademark, and contact details (postal and electronic) must appear on the product, its packaging, the parcel, or an accompanying document. ### Why does this matter for non-EU companies? For manufacturers based outside the EU – whether in China, the US, the UK, or elsewhere – the responsible person requirement means they must either establish an EU presence themselves or formally appoint an EU-based partner (such as an authorized representative or importer) to fulfil this role. Products without a designated responsible person in the EU are non-compliant, full stop. ## Technical Documentation and Risk Analysis What you need to prepare for every product GPSR requires manufacturers to prepare technical documentation for every product. This isn't optional, and it isn't a box-ticking exercise – it must contain a genuine analysis of possible risks and the solutions adopted to eliminate or mitigate them. Under Article 9, the technical documentation must include at least a general description of the product and its essential characteristics relevant to safety, an analysis of possible risks related to the product, and a list of relevant EU harmonised standards or other technical specifications used to address safety requirements. Market surveillance authorities can request this documentation at any time, and the responsible person must be able to provide it. For companies managing large product portfolios, this requirement translates to hundreds or thousands of individual technical files – each of which must be kept up to date as products change or new risks emerge. ### What counts as a risk analysis under GPSR? GPSR doesn't prescribe a single methodology for risk analysis. However, the analysis must consider foreseeable use and reasonably foreseeable misuse of the product. It should address risks related to the product's characteristics – including its composition, packaging, assembly instructions, and maintenance – as well as the effect on other products where combined use is reasonably foreseeable. The analysis must also consider the presentation of the product, its labelling, any warnings or instructions, and the categories of consumers at risk, especially vulnerable groups such as children and elderly persons. ## Product Recalls and Consumer Rights Stronger remedies and faster reporting GPSR significantly strengthens the framework for product recalls. When a product is recalled, economic operators must directly notify affected consumers – where contact details are available – and offer a remedy. Article 37 establishes what the regulation calls a "product safety recall remedy right," requiring operators to offer consumers a choice between repair, replacement, or a full refund, free of charge. Incidents involving serious risks must be reported to authorities within two working days through the Safety Business Gateway – the business-facing portal of the EU's Safety Gate system. The Safety Gate system has seen significantly increased activity since GPSR took effect, reflecting both heightened market surveillance and more proactive reporting by economic operators. ## Enforcement and Penalties What happens when you don't comply Article 44 of GPSR requires Member States to lay down rules on penalties for infringements that are "effective, proportionate and dissuasive." The regulation does not set specific fine amounts – that is left to each Member State – but the direction is clear: penalties are getting stricter. Several Member States are introducing substantial fines. Beyond fines, enforcement actions can include product withdrawals, recalls, and – for online sales – delisting from marketplaces. Market surveillance authorities also have expanded powers under GPSR to order products removed from the market, require modifications, and mandate that economic operators take corrective actions. For companies selling on platforms like Amazon or Zalando, non-compliance can result in swift product takedowns. ## How to Prepare A practical starting point for your team If your company hasn't yet adapted to GPSR, here's where to focus. If mapping GPSR requirements across a growing product portfolio is consuming your team's time, [book a walkthrough of Complir's regulatory mapping and documentation workflow](/book-demo) for consumer product companies. ## Sources & References - General Product Safety Regulation (EU) 2023/988 – [EUR-Lex Official Text](https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0988) - EU Access2Markets – GPSR Overview – [European Commission](https://trade.ec.europa.eu/access-to-markets/en/news/eus-general-product-safety-regulation-gpsr-new-era-consumer-protection) - U.S. Commercial Service – EU Consumer Goods GPSR – [Trade.gov](https://www.trade.gov/market-intelligence/eu-consumer-goods-general-product-safety-regulation-gpsr) - EU Regulation 2023/988 Detailed Guidance – [GOV.UK](https://www.gov.uk/government/publications/general-product-safety-regulations-northern-ireland/eu-regulation-2023988-on-general-product-safety-detailed-guidance) - GPSR: Responsible Person Role – [PRODlaw.eu](https://prodlaw.eu/2024/06/gpsr-focus-responsible-person-role/) --- *This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.* --- # A child must never come to harm! Source: https://www.complir.io/resources/case-studies/konges-sloejd-partnership Category: Case Study Customer: Konges Sløjd Industry: Children's Products & Fashion Location: Copenhagen, Denmark Key metrics: 2,000 Product lines per year, 27 Languages supported, 5 Seasonal collections, 12 Years of growth ## The Challenge Child safety demands zero tolerance for compliance gaps When your entire business revolves around products for children and is built on responsible production and high standards of quality and function, compliance is a matter of life and death. That is why Konges Sløjd chose to partner with Complir. Konges Sløjd is a Danish success story. Over 12 years, the company has grown into a global supplier of children's clothing, toys and bedroom furniture, sold around the world in 27 languages. With a foundation built on high-quality products and strong ethical standards, compliance is essential. Nine months ago, Konges Sløjd entered into a partnership with Complir. > Quote from Thomas Ernfeldt, COO at Konges Sløjd: With products for children, we touch on everything related to standards and legislation, across regions and national borders. It is absolutely unacceptable to us if a child were to be seriously harmed by one of our products – and it is also a significant risk factor for us as a business. That is why compliance is a core function at Konges Sløjd. Konges Sløjd is a relatively small company, but with an extremely broad product portfolio. Some 2,000 product lines are presented each year across five seasonal collections, sold to retailers worldwide. The regulatory requirements the company must meet are already extensive – and they are only growing more complex. ## The Solution AI-driven compliance that replaces manual work ## Extensive data in – precise documentation out The challenge for Konges Sløjd is the sheer volume of data required for each product: certificates of origin, test reports, and labelling information. At the same time, the documentation that must be produced and distributed to customers, retailers and authorities is becoming increasingly demanding. This is exactly where an AI-driven compliance system like Complir proves invaluable. > Quote from Thomas Ernfeldt, COO at Konges Sløjd: When we launch a new product, it has typically been in development for around 18 months. During that time it passes through a series of critical sub-processes with tight deadlines. Having Complir replace what was otherwise a large amount of manual work frees up time that we can invest in quality assurance and product development instead. And it will only get better as we train the system further. The initial focus with Complir was the translation module for packaging texts – a low-hanging fruit – and the company expanded its language range from 17 to 27 languages. Because this type of text must be precise and follow specific rules, Konges Sløjd previously relied on manual checks and external translation agencies. Complir uses AI to translate and verify labels and markings into virtually any language. ## Complir speeds up processes > Quote from Line Galsgaard, Senior Compliance Specialist at Konges Sløjd: In this area alone, we have already seen significant savings in both time and money, because texts no longer need to be sent in and out of the house. At the same time, we went from 17 to 27 languages in just one season – it was remarkable to experience how quickly we could suddenly work. And speeding up processes is precisely where Konges Sløjd sees the greatest gains. Complir was not introduced as a cost-cutting exercise, but as a way to work more intelligently. > Quote from Thomas Ernfeldt, COO at Konges Sløjd: AI is not a cost-cutting exercise where machines replace people in our organisation. The whole point is to free up time to invest in product quality and safety – areas that require sharp human minds. We are better placed to do that when Complir takes on a range of routine processes for us. ## The Results A growing toolbox with clear ambitions ## A toolbox under expansion Following the success with translations, the ambition is now for Complir to become the central system where all compliance data is stored, from where it can be made available to employees and distributed throughout the IT architecture, depending on how it is needed. > Quote from Line Galsgaard, Senior Compliance Specialist at Konges Sløjd: This is a toolbox under expansion, and we have no doubt that it is going to work brilliantly. Ultimately, the hope is that Complir will be able to read a product from a description or even an image, and from that precisely describe which standards, tests, documentation and labelling requirements we need to consider – a kind of preliminary risk assessment based on data from previously completed projects. The implementation of Complir has also taught us to be more precise in our formulations. The more precise we are, the better the model is trained, and the broader our use of it can be. Complir will of course never be able to carry out tests itself, but we expect the system to assist with all standardised documentation and test preparation once it is fully matured. > Quote from Line Galsgaard, Senior Compliance Specialist at Konges Sløjd: When we train the AI model, we are simultaneously learning to be more precise in our own formulations. That is a double benefit. The goal is for all compliance work to start and end in Complir. The implementation of Complir has been both smooth and enriching. Although the rollout is only nine months old, there is broad agreement at Konges Sløjd that this is the right way forward. > Quote from Thomas Ernfeldt, COO at Konges Sløjd: I absolutely love the people behind Complir. They are nerds in the best possible way. They have proven that their model works in practice, that they are ambitious about their product, and that they are ready with improvements and development that goes far beyond the initial sale. --- # Flying Tiger Copenhagen leads the way with AI-first product compliance Source: https://www.complir.io/resources/case-studies/flying-tiger-compliance Category: Case Study Customer: Flying Tiger Copenhagen Industry: Retail & Consumer Goods Location: Copenhagen, Denmark Key metrics: 500+ New products launched monthly, 44 Markets served globally, 20 Languages supported, 13 Product categories ## The Challenge Managing compliance at extreme scale Flying Tiger Copenhagen launches around 500 new products every month across 44 markets and 20 languages. This makes the company one of the most complex players in retail – not least because it must simultaneously navigate a rapidly growing body of global legislation. There is always a lot going on at Flying Tiger Copenhagen. Every month, around 500 new products are launched across 13 categories and 44 markets – all carefully planned around holidays, seasons, and special campaigns, where it is absolutely critical that products are ready on store shelves on time. On top of this, Flying Tiger Copenhagen has its own in-house design department, ensuring that the assortment is always on-brand and reflects Flying Tiger Copenhagen's distinctive universe. This also means that the majority of products in stores are designed and produced specifically for Flying Tiger Copenhagen, leaving no room for delays or errors in the supply chain. At the same time, requirements for documentation, control, and reporting across all product categories have grown significantly in recent years – and this development is far from over. At Flying Tiger Copenhagen, there is no doubt: the current rise in regulation is only the beginning. As a result, compliance has become a decisive competitive parameter for Flying Tiger Copenhagen. In short, everything – from regulatory documentation to content declarations, labeling, and product labels – must be so well organized that it can be retrieved with just a few clicks for each individual product in the assortment. > Quote from Trine Pondal, Director of Sustainability and Social Responsibility at Flying Tiger Copenhagen: We are currently seeing legislation and requirements for virtually all products increase rapidly – and this applies not only in the EU, but globally. Where compliance previously primarily concerned consumer safety, today sustainability and traceability are also driving legislation. It is a worldwide phenomenon. With the escalation of legislation and documentation requirements we expect, many companies will simply drown in processes if they do not put the right compliance systems in place. That is why Flying Tiger Copenhagen entered into a special partnership with Complir in 2024 to develop a completely new AI-driven compliance system. The system is not only designed to keep track of all details related to Flying Tiger Copenhagen's products, but also to monitor current and upcoming legislation – ensuring that Flying Tiger Copenhagen is always ahead of requirements for labeling, traceability, content declarations, and labels. ## The Solution AI-driven compliance that moves at retail speed ## Need for speed is a competitive advantage Compliance is not just about knowing upcoming legislation. To a large extent, it is also about being able to store existing knowledge and quickly retrieve precise documentation for each individual product – tailored to regulatory requirements in each market. If this fails, the consequences are tangible: products stuck at the border, longer time-to-market, and the need for significantly more staff in the compliance function. > Quote from Mathilde Blander Bjerregaard, Director of Product, Packaging & Quality Compliance at Flying Tiger Copenhagen: All in all, Complir gives us several advantages. We respond faster across the entire value chain, save internal resources, and gain peace of mind – so we can focus on innovation and new business areas. A concrete example is Spain, where authorities impose particularly strict documentation requirements. > Quote from Mathilde Blander Bjerregaard, Director of Product, Packaging & Quality Compliance at Flying Tiger Copenhagen: If we cannot provide the required documentation, the goods simply won't be allowed in. That's why compliance is a strong competitive parameter. There is a built-in 'need for speed' – especially in a seasonal business like ours. We can only deliver on time if we have 100 percent control over compliance for every single product. ## A special beginning for both Flying Tiger Copenhagen and Complir For Complir, Flying Tiger Copenhagen is the company's first customer, and Flying Tiger Copenhagen has effectively acted as an incubator for the business – not in the form of capital, but by opening doors, providing a physical desk, and dedicating man-hours to joint idea development and sparring. > Quote from Mathilde Blander Bjerregaard, Director of Product, Packaging & Quality Compliance at Flying Tiger Copenhagen: Complir came to us with expertise in law, compliance, and AI that we could see was hard to find elsewhere. That made it almost obvious to invite the company in for a joint development project that we could both benefit greatly from. We started the collaboration with a wish list of 10–11 points – areas where we were struggling. These were typically characterized by manual work and a lack of systematization, where knowledge resided with individuals and functioned more as routines than as actual systems. During the development phase, Complir worked as an internal team at Flying Tiger Copenhagen, gaining access to map all workflows and needs. In this way, Complir's software was created in collaboration with one of the most complex and demanding companies in the retail sector. As Flying Tiger Copenhagen does not have its own internal IT development team, the collaboration has been of great value – especially because there are no existing systems on the market that are 100 percent focused on compliance in the same way as Complir. > Quote from Mathilde Blander Bjerregaard, Director of Product, Packaging & Quality Compliance at Flying Tiger Copenhagen: With Complir, we get a solution that is almost tailor-made for us, while still being easy to scale and adapt to companies similar to ours. Our clear assessment is that if we had tried to solve our challenges with other IT systems, it would have been both time-consuming and costly. ## The Results Concrete savings and a platform for the future ## The benefits are already visible – and growing Already today, Flying Tiger Copenhagen is seeing concrete results. One area is the translation of labels and product markings, which is extremely sensitive in terms of correct wording. Previously, the company used an external translation agency, but the task is now handled by Complir's AI-driven translation module. In this area alone, the shift delivered significant cost savings and improved turnaround times. > Quote from Mathilde Blander Bjerregaard, Director of Product, Packaging & Quality Compliance at Flying Tiger Copenhagen: It's not a huge amount in isolation, but it's only the beginning – and the first very concrete saving. Another area is product labeling. Previously, data was handled manually in Excel spreadsheets – for example, for drink bottles, where markings such as CE, food approval, and dishwasher safety were tracked manually. With Complir, Flying Tiger Copenhagen can now identify deviations automatically. > Quote from Mathilde Blander Bjerregaard, Director of Product, Packaging & Quality Compliance at Flying Tiger Copenhagen: If 95 out of 100 drink bottles are labeled the same way, but five are not, the AI engine can quickly identify the deviations instead of us manually reviewing Excel sheets. Then we can assess and act. It provides overview and, not least, peace of mind to think ahead with new ideas. ## A time thief disappears – in more than one sense Two upcoming features are expected to deliver even greater benefits. One is the implementation of the new EU legislation EUDR, which requires direct upload of product data to a shared EU system in order for products to enter the market at all. The other is the integration of Complir directly into the purchasing of new products. The goal is for Flying Tiger Copenhagen to quickly track applicable legal requirements and ensure that regulatory demands, labels, and markings align from the very beginning. > Quote from Trine Pondal, Director of Sustainability and Social Responsibility at Flying Tiger Copenhagen: It has been fantastic to develop Complir together. We have gained a system based on our concrete needs – and Complir has had the opportunity to develop their solution in one of the most complex retail companies imaginable, with many products, high speed, and 44 markets. It will save us a great deal of time – both now and in the long term. --- # What's hiding inside cosmetics sold on Temu? Source: https://www.complir.io/resources/research/temu-cosmetics-study Category: Research New EU regulations such as ESPR and EPR require transparency, which retailers and online stores in particular often struggle to deliver as processes are often manual or outdated. Complir automates the work - so businesses can stay compliant and ahead of regulations and legislation, reduce risk and keep products on the shelves. To demonstrate how Complir works, we conducted a study of cosmetics products at Temu. We chose Temu as a case study as several studies have shown challenges with compliance and legislation for products sold on the platform. In addition, we were inspired by the new initiative from the Danish Safety Technology Authority (Sikkerhedsstyrelsen), which aims to use AI tools to screen Temu for illegal products. In this way, we demonstrate how easy it is to get an overview of any complications in a product category and how far we have already come with our AI tools. In our study of 600 cosmetic products sold at Temu, we found that 93% of the products pose medium to high chemical risk. 15% of products list no ingredients at all, which violates EU regulations, and 29% list fewer than 5 ingredients, which does not meet transparency standards. Ingredients are often listed in random order, ignoring EU regulations that require listing in descending order of concentration (EU Cosmetics Regulation (EC) No 1223/2009). One of the benefits of Complir is the user interface, which provides an instant and visual overview of where there may be challenges with the product portfolio. Here is the visual overview of the 600 cosmetic products from Temu, grouped into three categories: Lips, Eyes and Face, represented by different color groups, as shown in the data visualization below. Each category includes different product types, such as lipsticks, eyeshadows and foundations, with 40 products in each type. In the visualization, each bubble represents a product, with its size corresponding to the total number of ingredients. The analysis also assesses whether the products are safe to use. The answer to this can be revealed by pressing the "show risk colors" button in the visualization. The risk calculation of each product is based on the first 4 chemicals on the ingredient list, assuming that they represent the highest concentration. Products with fewer than 5 ingredients are shown as gray bubbles, while red bubbles indicate high risk chemical profiles, yellow indicates a medium risk profile, and green represents a neutral risk profile. The results are visualized as follows: Our analysis shows that 29% of products list fewer than 5 ingredients. As typical cosmetic products contain between 15 to 50 ingredients, this suggests incomplete ingredient lists. Furthermore, 15% of the products analyzed provide no ingredient lists at all. This is not in line with EU regulations that require full ingredient disclosure in descending order of concentration (EU Cosmetics Regulation (EC) No 1223/2009). An example of how important the correct order in the ingredient list is concerns Methylparaben, a preservative with strict use restrictions. Among the 600 products, 123 were found to contain Methylparaben, with 120 having it among the top 3 ingredients. This suggests concentrations likely to exceed the EU maximum permitted levels of 0.4% when used alone or 0.8% when combined with other parabens. Among the 600 products analyzed, 41% were classified with a high-risk chemical profile, 37% with a medium-risk profile, and 7% with a low-risk profile. 15% of products did not receive a rating due to incomplete data, as in cases where an eyeliner listed only one ingredient, such as water. Now let's dive into the ~500 chemicals identified across cosmetics. In the data visualization below, the size of each bubble reflects the frequency of a chemical's occurrence across products, while its color indicates the average risk score for that chemical across the products in which it occurs. Our analysis shows that while only 9 chemicals are classified as high risk and 26.25% as medium risk, the majority (72%) are considered low risk. However, many products still receive a chemical score as high risk due to the presence and frequency of these 9 chemicals classified as posing significant health or environmental risks. The 'medium risk' category (yellow) includes products with a neutral, medium and high risk profile. ![Conclusion](/images/complindus-cosmetics.png) ## How we did the analysis Complir has automated processes for collecting data. And normally, collecting and analyzing the products on Temu would take a few hours to set up. However, this didn't prove possible on Temu due to various verification tests (e.g. 'I'm not a robot' checks) and other tools that block data collection. We could have developed an AI-driven data collection tool here, which would take 1–2 weeks. But since such a tool would never be 100 percent generic, but would have to be customized to a website's specific blocks, we chose to collect data manually for the purpose of this analysis. How we analyzed the data: We used the European Commission's cosmetic ingredients database (CosIng) to identify and verify chemical names, including potential misspellings. CAS numbers (unique identifiers for chemical substances) of these chemicals were cross-checked against the European Chemicals Agency (ECHA) database for hazard information. To enhance our analysis, we applied the Complir engine, which uses Generative AI to describe chemicals, identify relevant legislation, assess risks based on ECHA hazard data, and justify risk assessments. Once Complir is set up - including automated data collection - any webshop will have a full overview of potential risks and non-compliance with regulations and legislation in an instant - and of course be able to continuously ensure that all products comply with standards. --- # How EU's Green Deal is transforming product compliance Source: https://www.complir.io/resources/guides/eu-green-deal-compliance Category: Guide The European Green Deal is the EU's policy framework for making the bloc climate-neutral by 2050. For product companies, it is reshaping how businesses design, manufacture, and manage products by reducing waste, improving resource efficiency, and increasing transparency in product supply chains. ## Why does the Green Deal matter for product compliance? The Green Deal is more than just an environmental strategy; it is a legal and operational shift for businesses. The EU is tightening regulations on product design, materials, and end-of-life management to promote a circular economy where waste is minimized, and materials are reused or recycled. For companies, this means compliance is not just about avoiding penalties. It is about adapting to a more sustainable and transparent market. Consumers and regulators are increasingly holding businesses accountable for the environmental footprint of their products. ## Key regulations under the Green Deal Several major regulations have already been introduced or are in the pipeline under the Green Deal. These directly affect how businesses manage product compliance: ### 1. Ecodesign for Sustainable Products Regulation (ESPR) The [ESPR](/resources/guides/espr-ecodesign-regulation-explained) is set to replace the existing Ecodesign Directive and will introduce new rules on product design, durability, and recyclability. It aims to make products more sustainable and resource-efficient by setting design requirements such as: - Minimum lifespan and repairability standards. - Limits on harmful substances. - Requirements for recycled content and material traceability. ### 2. Extended Producer Responsibility (EPR) [EPR](/resources/guides/extended-producer-responsibility-eu-guide) holds businesses accountable for the environmental impact of their products throughout the entire lifecycle, from production to disposal. Under the Green Deal, EPR is expanding to cover more product categories and stricter reporting requirements. - Affects industries like packaging, electronics, textiles, and batteries. - Companies must track and report product volumes and pay fees based on recyclability and environmental impact. ### 3. EU Batteries Regulation The Batteries Regulation sets out requirements for battery production, labeling, and recycling to reduce environmental harm. - Minimum recycled content requirements. - Battery carbon footprint declarations. - Collection and recycling targets. ### 4. WEEE Directive (Waste Electrical and Electronic Equipment) The WEEE Directive requires producers of electronic and electrical equipment to manage and finance the collection and recycling of their products at end-of-life. - Applies to electronics like smartphones, computers, and home appliances. - Sets recycling and recovery targets for electronic waste. ### 5. REACH Regulation The [REACH Regulation](/resources/guides/reach-compliance-guide) governs the registration, evaluation, authorization, and restriction of chemicals in products. Under the Green Deal, stricter rules on hazardous substances and chemical content are being introduced. - Increased testing and disclosure requirements. - Bans on certain high-risk chemicals. ## How product compliance is changing under the Green Deal The Green Deal is making product compliance more complex and data-driven: - **Increased Reporting Requirements:** Companies must provide detailed data on product materials, production processes, and end-of-life impact. - **Higher Costs:** EPR fees and new sustainability standards are increasing operational costs. - **Supply Chain Transparency:** Companies must trace and disclose product components and production data to meet legal and consumer expectations. The Green Deal is not just about avoiding fines. It is about staying in business. Companies that adapt quickly will secure market access, meet customer expectations, and avoid supply chain disruptions. Success means simplifying product data, designing for sustainability, and treating compliance as a gateway to global markets, not just a legal hurdle. See how [Complir maps product data to changing regulatory requirements](/#solution).