In order to be sold legally within the European Union, a cosmetic product must comply with the EU Cosmetics Regulation (EC) No. 1223/2009, which sets out a number of requirements relating to the safety, labeling, and packaging of cosmetic products. Additionally, any individual substances used in the cosmetic product must also comply with the EU's REACH regulation (EC) No. 1907/2006. Failure to comply with these regulations can result in legal penalties, as well as potential harm to consumers and the environment.

The REACH Regulation (EC/1907/2006) concerns the Registration, Evaluation, Authorisation, and Restriction of Chemicals. Companies that manufacture or import cosmetic products into the EU must ensure that the cosmetic substances they use comply with REACH requirements, as well.

This includes registering the substances they introduce to the market, as well as providing information on the safety of the substances they use in their products, and ensuring compliance with the Authorization List (Annex XIV) and Restriction List (Annex XVII) of REACH Regulation.

Registration of cosmetic substances

As a cosmetic product importer, it is your responsibility to track the annual volume of each substance included in the cosmetic products you import. You must ensure that each substance imported in quantities exceeding 1 ton per year is pre-registered or registered with the European Chemical Agency (ECHA). The same substance may be present in multiple products.

Note that there are substances exempted from registration under REACH.

If you import a substance in quantities exceeding 10 tonnes per year, you must ensure that the registration dossier includes a Chemical Safety Report (CSR), which addresses the environmental and occupational aspects of the substance's use. However, CSR does not need to address the risk to human health caused by the use of the substance in your cosmetic products, as this aspect is covered by the Cosmetic Product Safety Report.

The duty to register applies regardless of whether you subsequently sell the substance on the market or use it in your own processes.

Non-EU suppliers may appoint a REACH-only representative to submit pre-registration/registrations. If the importer also imports the substance from other non-EU suppliers, the importer still must register the tonnage imported from these non-EU suppliers unless these have appointed only representatives to cover the respective imports. The importer must be able to document to enforcement authorities upon request, which of their imports are covered by the registration of the only representative and which are covered by their own registration.

To avoid REACH registrations, EU cosmetics importers/manufacturers have to ensure that all substances (either in cosmetics formulations or finished products) have been properly registered by their suppliers and that their tonnage and uses are covered by the existing registration. The substance must not only be the same, but it must proceed from the same supply chain in which the substance was registered.

Compliance with Authorization List (Annex XIV), Restriction List (Annex XVII), and Candidate List

It is crucial to stay up-to-date on the latest developments regarding REACH and its associated lists. This can involve monitoring the Candidate List for any substances that may eventually be added to the Authorization List or subject to further restrictions, as well as ensuring compliance with any existing restrictions listed in Annex XVII.

In summary, it must be checked whether each substance present in the cosmetic products is included in the Authorization List, Candidate List, and/or Restriction List. Cosmetic businesses must stay informed of any updates or changes to the lists that may affect their operations.

Authorization List (Annex XIV)

The Authorization List, also known as Annex XIV of the European Union's REACH regulation, comprises substances that are deemed to be of very high concern due to their hazardous properties, such as carcinogenicity, mutagenicity, and toxicity to reproduction. Once a substance is included in this list, it cannot be placed on the market or used unless authorization is obtained. However, obtaining authorization can be a long and difficult process, and it is not possible to obtain one for cosmetic use.

Cosmetic products that contain substances subject to authorization only because they meet the criteria in Article 57(a), (b), or (c) (referring to CMR substances) or because they are identified in accordance with Article 57(f) only because of hazards to human health, are exempted from the authorization requirement in Annex XIV.

On the contrary, cosmetic products containing substances subject to authorization, because they meet the criteria in Article 57 (d) and (e) (referring to PBT and vPvB) as well as because they are identified in accordance with Article 57(f) because of hazards to the environment, MUST comply with the authorization requirement. Note that, substances subject to authorization for the above environmental reasons AND are under 0,1%, are exempt from authorization requirements.

Restriction List (Annex XVII)

A substance on its own, in a mixture, or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market, or used unless it complies with the conditions of that restriction. This shall specify if the restriction shall not apply to product and process-orientated research and development, as well as the maximum quantity exempted.

Cosmetic products containing substances subject to this restriction list, only because of hazards to human health, are exempted from the restriction requirement. To the contrary, cosmetic products containing substances subject to the restriction list (Annex XVII), because of hazards to the environment, MUST comply with any REACH restriction requirement.

A very well-known REACH restriction applicable to cosmetic products is the restricted use of decamethylcyclopentasiloxane (D5). D5 has been added to REACH Annex XVII restricted substance list (entry) 70 since January 2018 which means that it shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020. Moreover, there are also generic restrictions concerning all mixtures (including cosmetics). An example is the restricted use of perfluorocarboxylic acids with 9-14 carbon atoms in the chain (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related substances (annex XVII, entry 60).

Candidate List

The Candidate List, on the other hand, is a list of Substances of Very High Concern (SVHCs) that may be recommended for inclusion in the Authorization List. Substances can be included in the Candidate List if they meet the criteria for classification as substances of very high concern, such as being persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB).

The obligations related to substances on the Candidate List mainly concern communication, such as informing customers if the substance is present in an article¹ and providing instructions on the safe use of the product. Specifically, if the substance is included in an article in the content above 0.1% w/w, consumers must be informed about it upon request (free of charge within 45 days from the supplier of the goods), professional users must be informed without asking for it, and companies that supply articles to professional customers must make notifications to ECHA and SCIP database. In terms of the notification to ECHA, this must be done in case both the following conditions are met (a) The substance is present in their relevant articles above a concentration of 0.1% w/w. (b) The substance is present in these relevant articles in quantities totaling over one tonne per year.

The cosmetic product itself (i.e. the formulation/mixture) is not considered an article. However, cosmetic packaging (e.g., the bottle, jar, pump, box, etc.) is considered an article and so it is within the scope of REACH regulation. This means that if the packaging contains SVHC (>0.1% w/w) the above requirements (for articles containing SVHC "substances listed in the Candidate list") must be met.

What is more, with regard to cosmetic products, according to the French anti-waste law for the circular economy (AGEC), suppliers who place onto the market products (including cosmetics) should inform the consumer electronically, in an open format, easily reusable and usable by an automated processing system of the presence of the substance included in the Candidate list of Substances of Very High Concern (SVHC), if this substance is present at a concentration higher than 0.1% (in weight) in the formulation and packaging.

With regard to chemical products, substances on the candidate list must be listed in safety data sheets for chemical products from a concentration of 0.1% w/w.

Overall, the inclusion of substances in the Candidate List does not necessarily mean that they will be included in the Authorization List. However, it indicates that these substances are being closely monitored and may be subject to further regulatory action in the future, such as restriction or even a ban.

¹ (Article 3(3) of the REACH Regulation defines an article 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. It follows from this definition that an article is an object made from one or more substances or mixtures which were given a specific shape, surface or design during the production process.)