February 8, 2024. REACH refers to Regulation (EC) 1907/2006 on the registration, evaluation, authorization, and restriction of chemicals. It started applying in 2007, replacing the previous regulatory framework for chemicals. The main objective of REACH is to protect human health and the environment from harmful substances. At the same time, it aims at promoting competitiveness and innovation within the European Union.
The European Chemicals Agency
REACH established the creation of the European Chemicals Agency (ECHA), an agency of the European Union based in Helsinki (Finland). ECHA is responsible for the implementation of REACH and other laws related to chemicals, such as the Classification, Labelling and Packaging (CLP) Regulation. To this end, ECHA performs the following tasks:
- Management of the database where companies register chemicals;
- Coordination of the evaluation of information included in the registration dossiers;
- Oversight of the process for the identification and restriction of substances of very high concern (SVHC);
- Development of independent scientific opinions and advice to European Commission.
Registration, evaluation, authorization, and restriction of chemicals
According to REACH, companies manufacturing or importing a chemical above one ton per year must register it with ECHA. The registration must include information about the properties and uses of such substances, their hazards and the related risk management measures. Companies are responsible for keeping the registration dossier up to date. Consequently, ECHA reviews the registrations to check compliance and evaluate the safety of substances.
Moreover, any EU countries or the European Commission can propose to restrict the manufacture and use of certain substances at the EU level, as France intends to do for Octocrylene. The restriction proposal undergoes a public consultation. Thereafter, the ECHA Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) provide their opinions that the European Commission will consider adopting the restriction. Restricted chemicals are added to Annex XVII to REACH.
Lastly, REACH establishes an authorization process for substances of very high concern (SVHC). Such substances are included in Annex XIV to REACH and cannot be placed on the EU market after the sunset date unless they receive authorization from the European Commission for a specific use and under certain conditions.
How horizontal legislation affects cosmetic products
REACH is a horizontal legislation that applies to chemicals on their own, in mixtures, and contained in products. Therefore, it may affect vertical legislation, such as Regulation 1223/2009 on cosmetics. This effect can occur in different ways: REACH can directly restrict the use of certain substances in cosmetic products to address risks not covered by the EU Cosmetics Regulation, as for D4, D5, and D6 and intentionally added microplastics. Similarly, substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) are normally banned in cosmetics through the Omnibus Acts. Furthermore, REACH bans and authorization requests might make chemicals used in cosmetics unavailable in the supply chain.
Lastly, multiuse substances, which can potentially be used in cosmetics, could be tested on animals if the testing is for REACH purposes.
References:
- ECHA. Understanding REACH. Retrieved on 22/01/2024
- European Commission. REACH Regulation. To protect human health and the environment against the harmful effects of chemical substances. Retrieved on 22/01/2024
- EUR-Lex. (2023). Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Retrieved on 22/01/2024
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