Cosmetic ingredients and the impact of REACH

Contrary to popular belief, REACH stands in addition to the Cosmetics Directive, 76/768/EEC, including all the amendments over the years. In general, cosmetic ingredients must first meet the requirements of the REACH regulation and then also meet any additional requirements for the Cosmetics Directive. Cosmetic mixtures sold by retailers will usually be supplied in containers (for example, mascara and lipstick) or on carriers (for example, cleansing wipes). There are some exemptions to the registration requirement, for example active biocides listed in the Biocidal Products Directive, (98/8/EC). The Cosmetic Directive 76/768/EEC will be replaced by the Cosmetic Products Regulation (EC) No 1223/2009 from July 2013 to ensure the continued health and safety of the use of chemicals in cosmetic formulations, but this does not overlap with what cosmetic ingredient and product suppliers need to do to comply with REACH. In addition to the brunt of the EU Cosmetic Directive 76/768/EEC, the REACH Regulation (EC) No 1907/2006 came into force in 2007 and complicated the regulatory mix that applies to cosmetic ingredients and products. For cosmetic ingredients, REACH filled a void to ensure that any potential environmental effects as well any possible risks to workers through exposure during the manufacturing and use of cosmetics are regulated. It also introduced an additional requirement to communicate the presence of any substances of very high concern that could be found in the packages, containers and applicators that may also form part of the finished cosmetic product – namely an article under REACH. Under REACH, cosmetic products can fall into different scopes dependent on whether they are categorised as ‘mixtures’ – or more precisely ‘mixtures in a container’ or ‘mixtures on a carrier’ where the container or carrier such as a nonwoven wipe is deemed as an ‘article’, a separate entity under REACH – or as articles in their own right. REACH obligations for the cosmetic industries are reliant on two important factors: the nature of your product and your position within the supply chain. For example, formulators of cosmetic mixtures would have different obligations under REACH than importers of cosmetic products in the finished state to be placed on the market.

Cosmetic ingredient obligations

If finished cosmetic products are supplied from within the EU, the EU manufacturer or importer of the cosmetic ingredients carries out any necessary registration work. Registration is based on tonnage levels and applies from 1 tonne per year, per ‘legal entity’ per substance in the cosmetic ingredient. Where applicable (above 10 tonnes per annum) the registration includes the submission of a chemical safety report (CSR) which is a risk assessment in all but name. However, the CSR does not need to include the consideration of the risks to human health where substances are used in cosmetics, as this is covered within the scope of the Cosmetic Directive 76/768/EEC. Many substances commonly used in cosmetic ingredients will have been registered in 2010 and many more will have been registered by the end of May 2013. Suppliers of hazardous substances registered at 10 tonnes per year or more are required to provide Exposure Scenarios – summaries of the risk assessment on the identified uses in the registration dossier – to their customers so if you have not received any of these yet, you will soon. These Exposure Scenarios are based on the information in the registrant’s CSR. They are annexed to the Safety Data Sheet, thus producing an extended Safety Data Sheet. The extension to the Safety Data Sheet should complement the information in the 16 sections of the main SDS. It should provide more detail on the uses registered by the manufacturer or importer which they support in their supply chain. As downstream users, manufacturers of cosmetics will need to ensure that their site practices are safe and that exposure is within the acceptable limits described in the relevant exposure scenario(s), both for workers and the environment alike. In many cases those described in the exposure scenario are more rigorous than those that happen in practice. If you chose to use a raw material outside of the scope of an exposure scenario, you would need to do your own assessment to prove that it is being used safely and notify the European Chemicals Agency (ECHA) that you have done so – outing your head above the parapet that you are using a hazardous substances outside the scope of what a supplier has assessed. The exposure scenario may also include information about onward supply, but if the product you supply is the “mixtures in the finished state, intended for the final user” as defined under the cosmetics legislation, then there are no obligations to communicate information further down the chain as the communication obligations required by the cosmetics legislation kick in instead. Careful interpretation of the terms “finished state” and “final user” may be required to see if your products qualify. Even so, some actors in the supply chain may well demand information, such as a safety data sheet, for all products they receive. In addition to this communication exemption from REACH, cosmetic ingredient suppliers also benefit from an exemption from the Authorisation and Restriction requirements of REACH, if they have been applied because the substance presents a hazard to human health (e.g. it is a CMR or shows endocrine disrupting properties). However, this exemption does not hold if the substance is subject to an Authorisation or Restriction due to its environmental properties, such as it persists or bio-accumulates in the environment. Although REACH aims to minimise negative effects such as higher costs and difficulties in ingredients sourcing, while maximising the benefits of improved knowledge, consumer confidence, innovation and enhanced transparency along the supply chain, there are still some issues faced by the cosmetic industry. These concerns include the non-availability of certain ingredients or the increased costs for data generation which can result in the reduction in the number of sources of supply of ingredients, and can even lead to the loss of some ingredients and product formulation. Additionally, there may also be discontinued use of some ingredients as the cost of registration may be too high and passing this associated cost to end users can reduce the willingness of customers to buy products.