Omnibus Regulation 2019

The REACH Regulation and its Consequences for Brand Owners

Although the REACH Regulation (EC No 1907/2006) mainly pertains to the registration ofsubstances by their manufacturers or their EU representatives, the Cosmetic Industry (manufacturers of finished products, brand owners and their importers to the EU) also have to comply with some provisions of this piece of legislation.

What is the REACH Regulation?

As explained by the EU Commission, REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four processes of REACH, namely the registration, evaluation, authorization and restriction of chemicals.

“No data no market”: the REACH Regulation places responsibility on industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database in the European Chemicals Agency (ECHA) in Helsinki.

One of the main reasonsfor developing and adopting the REACH Regulation wasthat a large number of substances have been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, and yet there is insufficient information on the hazards that they pose to human health and the environment. There is a need to fill these information gaps to ensure that industry is able to assess hazards and risks of the substances, and to identify and implement the risk management measures to protect humans and the environment.

Having entered into force in 2007, REACH provisions are being phased-in over 11 years. The first phase in 2010 was dedicated to substances produced or imported above 1000 tons per year. The second phase in 2013 was for substances produced or imported above 100 tons per year. Finally, the last phase, scheduled in 2018, aims to register substances between 10 and 100 tons, and between 1 and 10 tons. Each tonnage band comeswith specific requirements: the more a substance is used, the bigger its safety dataset will be. Substances produced or imported below 1 ton are exempted from registration. The tonnage bands outlined above are expressed per ‘legal entity’ (meaning the brand owner if located in the EU and the importer otherwise).

What are brand owners’ legal obligations?

The substance manufacturer has the legal obligation to collate data, prepare registration dossiers related to the relevant tonnage band and register their substances in the ECHA database. The exercise of registering a substance can be extremely expensive for the substance manufacturer, which most of the time, partners with other manufacturers of the same substances to reduce its costs and administrative burdens.

Cosmetic manufacturers, brand owners and importers of finished cosmetic products are considered as downstream users. Downstream users do not have to register the substances on behalf of their substance manufacturers and are therefore exempted from the vast majority of provisions laid down by the REACH Regulation. However, downstream users have to ensure that the REACH Regulation is properly respected by their suppliers and can only market products made of substances effectively registered in the ECHA database.

How brand owners can comply with these legal obligations?

Brand owners not making the cosmetics themselves could simply pass this issue on their contract manufacturers. The contract manufacturer would sign a statement (see template reported in annex) saying that all substances used in the products are REACH-compliant meaning that they are either registered or exempted from registration (e.g. used below the threshold of 1 ton per year).
This statement would then be provided to the importer.

Brand owners making their own cosmetic products should contact each of their raw material manufacturers and get a statement signed to confirm that the substances contained in raw materials are either registered or exempted from registration (e.g. used below the threshold of 1 ton per year). This is raw material manufacturers’ responsibility to ensure that the substances they use are REACH compliant. On the basis of all these documents received from raw materials manufacturers, a brand owner can then prepare its own declaration stating that its cosmetic products are REACH compliant. This is the declaration that would be provided to the importer.

On the basis of this statement, your importer may ask further questions on your products formulae.
Indeed, in theory the importer being a legal entity in the sense of the REACH Regulation, it has to ensure that non-registered substances are not used above the threshold of 1 ton per year. This evaluation is complex and implies both a good understanding of the formulae sold by each of its brand owners and a fine estimate of the quantities already placed on the EU Market.

Any questions?


  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

    View all posts