Requirements check
PPE and safety gear
UK: PPE is regulated by Regulation (EU) 2016/425 as retained in GB law (enforced via the PPE (Enforcement) Regulations 2018) and requires UKCA marking — there is no separate uk-ppe id in this dataset, so treat uk-ukca as carrying that requirement and verify. PPE risk categories drive the conformity route: Category I is self-declared; Categories II and III need an EU notified body / UK approved body (III also needs ongoing production oversight). Sunglasses are Category I PPE in the EU/UK. US: consumer safety gear falls under general CPSC rules — bicycle helmets have a mandatory CPSC standard (16 CFR 1203); workplace PPE is governed by OSHA with ANSI/NIOSH standards, which is out of this dataset's scope. Smart PPE (sensors, comms) picks up the electronics bundles via attributes. Medical/PPE crossover claims (e.g. surgical masks) move you into medical device territory — out of scope.
European Union4 instruments
The EU's baseline safety law for consumer products, applicable since 13 December 2024. It replaces the General Product Safety Directive and adds duties around traceability, online selling, recalls and having a responsible economic operator in the EU.
Key obligations
- 01Only place safe products on the market. Safety is assessed against the product's characteristics, packaging, instructions, the consumers who will use it, its appearance (food-imitating products) and, where relevant, cybersecurity features.source
- 02A product may only be placed on the EU market if there is a responsible economic operator established in the EU — an EU manufacturer, importer, authorised representative or fulfilment service provider (Article 16).source
- 03Carry out an internal risk analysis and draw up technical documentation; keep product identification and traceability information available (manufacturers, importers and distributors each have tiered duties).source
- 04Report accidents caused by your products and notify dangerous products to the authorities through the Safety Business Gateway.source
The EU's enforcement framework for product rules. Its Article 4 is the practical blocker for online sellers: since 16 July 2021, most CE-marked goods can only be placed on the EU market if an economic operator established in the EU is responsible for compliance tasks — and that operator's contact details must accompany the product.
Key obligations
- 01A product covered by the Article 4 list may only be placed on the EU market if there is an economic operator established in the Union responsible for the Article 4 tasks (applies since 16 July 2021).source
- 02That operator can be: the manufacturer established in the EU; an importer (where the manufacturer is not established in the EU); an authorised representative with a written mandate; or an EU-established fulfilment service provider handling the products (Article 4(2)).source
- 03The operator's tasks (Article 4(3)): verify that the EU Declaration of Conformity and technical documentation exist and keep the DoC available; provide information and documentation to authorities on request; inform authorities when a product presents a risk; cooperate on corrective action.source
- 04The name, registered trade name or trade mark and contact details (including postal address) of the Article 4 operator must be indicated on the product or on its packaging, the parcel or an accompanying document (Article 4(4)).source
CE framework for equipment worn or held for protection against health or safety risks — gloves, eyewear, helmets, respirators, fall protection. The conformity route depends on the risk category: self-assessment for Category I, notified-body type-examination for Categories II and III.
Key obligations
- 01Ensure PPE is designed and manufactured in accordance with the essential health and safety requirements of Annex II, and carry out the conformity assessment procedure applicable to its risk category (Article 8).source
- 02Draw up the technical documentation (Annex III) and the EU Declaration of Conformity, and affix the CE marking (Article 8(2)).source
- 03Classify the PPE correctly per Annex I: Category I (minimal risks, e.g. superficial mechanical injury), Category II (risks that are neither minimal nor Category III), Category III (risks that may cause death or irreversible damage to health, e.g. harmful substances, falls from height).source
- 04Supply instructions and information (storage, use, cleaning, maintenance, performance limits) with each item of PPE, in the required language.sourceUnverified — check source
The EU's chemicals regulation. For physical-product (article) sellers the practical duties are: communicating Candidate List substances of very high concern (SVHCs) above 0.1% down the supply chain and to consumers, notifying ECHA in some cases, and respecting the Annex XVII restrictions. Full chemical registration applies to substance manufacturers/importers, not typical article sellers.
Key obligations
- 01Article 33(1): if an article contains a Candidate List SVHC above 0.1% weight by weight, provide recipients (businesses in the supply chain) with sufficient information for safe use — at minimum the name of that substance. This applies per article within a complex product.source
- 02Article 33(2): on request from a consumer, provide the same safe-use information (at minimum the substance name) within 45 days, free of charge.source
- 03Article 7(2): EU producers/importers of articles must notify ECHA when a Candidate List substance is present above 0.1% w/w AND its total quantity in those articles exceeds 1 tonne per producer/importer per year — no later than 6 months after the substance is added to the Candidate List. Notification is not required where exposure of humans and the environment can be excluded.source
- 04Notify articles containing Candidate List SVHCs above 0.1% w/w to ECHA's SCIP database (a duty under the Waste Framework Directive, submitted via ECHA).sourceUnverified — check source
Documents you will need
Deduplicated across everything above
- Technical documentationBased on an internal risk analysis; must describe the product and its safety-relevant characteristics. No EU Declaration of Conformity is required under the GPSR itself.source
- Traceability informationProduct identification (type/batch/serial) plus manufacturer and EU responsible operator contact details must accompany the product.source
- Written mandate (when using an authorised representative)The authorised representative must hold a written mandate covering the Article 4 tasks.source
- EU Declaration of Conformity + technical documentation availabilityThe EU operator must be able to verify these exist and produce them for authorities on request.source
- EU Declaration of ConformitySupplied with the PPE or via a web link indicated in the instructions; kept 10 years.source
- Technical documentation (Annex III)Risk analysis, design details, test reports, and the EU type-examination certificate where applicable.source
- Instructions and information of the manufacturerUse, storage, maintenance, performance limits, accessories/spare parts information.source
- Supplier declarations / full material disclosuresEvidence that Candidate List SVHCs are below 0.1% w/w per article, or the basis of your Article 33 communications.source
- Article 33 safe-use communicationsRecords of the information passed to recipients and provided to consumers within the 45-day deadline.source
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