Requirements check
Cosmetics
IMPORTANT CAVEAT: the EU Cosmetics Regulation 1223/2009 (responsible person, safety assessment, Product Information File, CPNP notification, ingredient labelling) is the primary law and is beyond this dataset's electronics focus — flag as 'additional sector rules apply'. The UK has an equivalent retained Cosmetics Regulation (notification via SCPN). US: cosmetics are regulated by the FDA under the FD&C Act as amended by MoCRA (facility registration, product listing, adverse-event reporting) — also beyond this dataset; note that cosmetics are expressly excluded from the CPSC's 'consumer product' definition, which is why us-cpsa-general and us-cpsia are not listed. Prop 65 still applies to cosmetics sold in California. Medicinal or therapeutic claims (treats eczema, SPF drugs in the US) move the product into drug regulation — out of scope. Children's play make-up must satisfy toy safety law in the EU/UK on top of cosmetics law (hence the forChildren additions) — verify. Powered beauty devices (LED masks, facial brushes) are electronics — use the consumer-electronics category for the device. REACH substance duties still apply to cosmetic ingredients, though most human-health restrictions are handled by cosmetics law — verify overlaps.
European Union3 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
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
- 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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