REACH — Registration, Evaluation, Authorisation and Restriction of Chemicals — is the European Union's primary chemical regulation, entered into force in 2007 and enforced by the European Chemicals Agency. REACH affects virtually every category of product that contains chemicals — which, for regulatory purposes, means almost everything. Foreign manufacturers who export cosmetics, personal care products, cleaning products, ingredients, or raw materials to the EU market need to understand how REACH applies to their products and what structural compliance steps are required before products can legally enter the EU.
Who REACH covers and why it applies to non-EU manufacturers
REACH places the primary compliance obligation on the EU importer of a substance or mixture — not on the non-EU manufacturer. For a non-EU company that manufactures a product and sells it to EU importers, the REACH obligation technically falls on the EU-based importer, not on the manufacturer itself. However, this creates a practical problem: EU importers are increasingly unwilling to accept supply relationships where the non-EU manufacturer has not pre-qualified their substances under REACH, because the importer bears liability for the compliance of the products they bring into the EU. The practical effect is that non-EU manufacturers who want to maintain supply relationships with EU buyers need to address REACH at the substance level, not just at the finished product level.
The Only Representative option for non-EU manufacturers
REACH provides a mechanism for non-EU manufacturers to take on the EU registration obligation directly through an Only Representative (OR). An OR is an EU-based legal entity appointed by the non-EU manufacturer to register the manufacturer's substances in the EU REACH system on their behalf. By appointing an OR, the non-EU manufacturer shifts the formal REACH registration obligation from their EU importers to the OR, simplifying the compliance relationship across their entire EU distribution network. This is particularly valuable for manufacturers who sell to multiple EU buyers, because without an OR, every EU importer would need to independently register the same substances.
Substances of Very High Concern and restriction lists
REACH identifies Substances of Very High Concern (SVHCs) — chemicals with carcinogenic, mutagenic, reprotoxic, persistent, bioaccumulative, or other serious hazard properties. The SVHC list, published by ECHA, is updated regularly and now contains several hundred substances. Products exported to the EU that contain SVHCs above certain thresholds are subject to notification and, in some cases, authorization requirements. Non-EU manufacturers of cosmetics and personal care products should regularly cross-reference their ingredient lists against the current SVHC candidate list, because an ingredient that was compliant when originally formulated may have been added to the SVHC list in a subsequent update.
How REACH intersects with EU cosmetics regulation
EU Regulation 1223/2009 on cosmetic products operates alongside REACH and has its own set of ingredient restrictions in Annex II (prohibited substances), Annex III (restricted substances), and Annex IV through VI covering colorants, preservatives, and UV filters. A cosmetic ingredient that is permitted under REACH may still be prohibited under the Cosmetics Regulation, and vice versa. Foreign cosmetic brands entering the EU market need to review their formulations against both the REACH SVHC list and the Cosmetics Regulation annexes. The responsible person designated under EU cosmetics law is responsible for the product information file, which must document compliance with both frameworks.
How FDABridge supports EU compliance for cosmetic brands
FDABridge manages EU cosmetic facility registration and Responsible Person designation for non-EU cosmetic brands entering the European market. We assist clients with MoCRA registration in the US and EU cosmetics compliance simultaneously, simplifying multi-market entry. Visit fdabridge.com/eu-cosmetics to learn about our EU cosmetics services or fdabridge.com/apply/eu-cosmetics to get started.
Need help entering the EU market?
See our EU cosmetics page for Responsible Person assignment and CPNP registration support.