All EU manufacturers, all EU importers or their suppliers of chemical substances have an obligation to submit a registration to the European Chemicals Agency (ECHA) for each substance manufactured or imported per year per company (legal entity) in the EU. The registration obligation applies to volumes per substance and per legal entity above 1000 kg /year.
A substance may be exempted from registration obligations. When a substance is not exempted, EU manufacturers and first importers into the EU are responsible to ensure registration of the substance by themselves or for example their suppliers. In most cases substances are already registered by consortia of the chemical industry and companies can participate in existing registrations by buying a letter of access to the registration dossier of the particular consortium for that substance.
Next to substances in mixtures and formulas substances in articles also fall within the scope of REACH. The REACH Regulation defines articles as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.
Packaging components as used for cosmetics, laundry and household products, biocides etc. are affected by REACH if these components contain substances of Very High Concern (SVHC) under the Candidate List and Annex XIV of the REACH Regulation 1907/2006 and its amendments.
Please note that some product categories such as medicines, food, feed and biocide active substances are exempted from REACH registration and authorization of substances,because other regulations apply instead.
REACH applies to the total combined portfolio of all products placed on the EU market by a single legal entity. The complexity of managing REACH compliance increases significantly when a product portfolio grows, more (global) suppliers and (3rdparty) manufacturers, and multiple first importers into the EU are involved. For cosmetic products, REACH compliance is preferably managed by the EU Responsible Person (RP), since the RP is already having most and up-to-date raw material and product details in his possession.
TRC can support you with the following REACH compliance services:
1. Identification of all individual substances that are produced/repacked/imported and sold in the EU with their cumulative weight across a complete cosmetics portfolio
2. Verification of substance REACH status; and verification of REACH statements of suppliers
3. Issuance of REACH compliance reports and REACH compliance statements
4. If needed, we can contact consortia/lead registrants under REACH for possibilities, timelines and costs to participate through a Letter of Access
5. If needed, advise in decision making for registration, reformulation and/or to replace existing suppliers for alternative suppliers that have registered under REACH
6. If needed in exceptional cases, REACH registration of a new substance may be needed where we can inform you about the next steps and refer you to specialized service providers