The Cosmetic Products Regulation (EC) No 1223/2009 (the Regulation) is the main regulatory framework for finished cosmetic products placed on the EU market. In accordance with his Chemicals Strategy for Sustainabilitywhich aims to drive innovation for safe and sustainable chemicals and address the health and environmental challenges caused by the most harmful chemicals (see our previous blog on this topic here), the European Commission has launched a public inquiry consultation concerning the proposals for the targeted revision of the Regulation on 28 March 2022. The Commission intends to use the contributions received from this consultation to assess the relevance of the new measures proposed to improve the safety and sustainability of cosmetic products.
The consultation is open until June 20, 2022 and invites comments on several issues, including expanding the default ban on the use in cosmetics of a broader range of chemicals, updating risk assessment requirements and refinement of labeling requirements for cosmetic products. Inputs from the consultation and stakeholder workshops will help shape the formal proposals for the revision of the Commission Regulation, which are expected to be published at the end of 2022.
We look at each of the Commission’s proposals in more detail below, including the impact any changes to the regulations could have on cosmetics companies operating in the UK.
1. Reinforced generic approach to risk management:
The use in cosmetic products of carcinogenic, mutagenic or reprotoxic chemical substances (CMR) effects is generally prohibited. However, the use of other chemicals in cosmetic products is currently prohibited only if the product cannot be considered “harmless to human health when used under normal or reasonably foreseeable conditions of use”. This risk must be assessed on a case-by-case basis, taking into account the specific use of the product.
In line with the Chemicals Strategy for Sustainability, the Commission is considering strengthening this generic approach to risk management so that the “most harmful” chemicals, including those that can affect the immune, neurological or respiratory systems, or toxic chemicals for a specific organ (even if not CMR), will be prohibited by default, with limited exceptions under the conditions defined by law. This could mean that certain chemicals could not be used in cosmetics at any level, even if the product could currently be assessed as safe – for example when the substance is included at very low concentrations.
In this context, the Commission is also considering introducing a concept of “essential use”. In cosmetic products, the “most harmful” substances would only be allowed to be used exceptionally and under very strict conditions, for example “if their use is necessary for health, safety or critical to the functioning of society and if there is no acceptable alternative from an environmental or health point of view”. The Commission agrees that criteria for “essential” use will need to be properly defined and has already launched workshops with stakeholders with a view to publishing further guidance by the end of 2022.
2. Risk assessment of unintended combined effects:
The substances can cause adverse human health effects when combined, even if the individual substances are considered safe. Currently, risk assessment is only required for intentional mixtures of chemicals (e.g. the commercial combination of chemicals in a particular product) and does not need to consider potential consumer exposure to chemicals from multiple product sources. The Commission is considering extending the risk assessment requirements to require consideration of unintentional co-exposure to chemicals from different sources, for example to take into account possible interactions between different personal hygiene products when used together by consumers.
3. Align the definition of nanomaterials with broader chemicals regulation:
“Nanomaterials” are sometimes used in cosmetic products because they are often associated with greater resistance or conductivity. Under the regulations, they must be assessed for their safety and labeled if used in cosmetic products. However, nanomaterials are defined more broadly in other chemicals regulations, including REACH, the Biocidal Products Regulation and the Medical Devices Regulation. The Commission is considering updating the definition used in the Cosmetics Regulation, either discreetly or by cross-reference to other sectoral legislation.
4. Refine labeling requirements with digital options in mind:
Generally, product information that must be provided to consumers must be labeled on the container and/or packaging of a consumer product. In order to improve consumer understanding, avoiding overloading labels with information and making them more readable, the Commission is carrying out a consultation on the most effective means (e.g. on the packaging only, via digital labeling such as QR codes, or a combination) to communicate information regarding certain key product information, including contact details of the responsible person, safety warnings and a full list of ingredients.
5. Rationalization of scientific evaluations of cosmetic products:
Currently, the European Commission’s Scientific Committee for Consumer Safety carries out technical assessments and provides scientific expert advice on the safety of non-food consumer products (including cosmetics). Meanwhile, other chemicals legislation requires technical input from other agencies. The Commission is considering transferring the operations of the SCCS to a centralized European agency (eg the European Chemicals Agency) in order to improve the efficiency, transparency and consistency of chemical safety assessments in different sectors.
Impact in the United Kingdom: Divergence to come?
The Regulation forms part of the body of retained Community law and therefore continues to have effect in the United Kingdom after its withdrawal from the European Union, with modifications for the continued national application of its provisions (e.g. the requirement of ‘a UK-based responsible person for products placed on the market in Britain after 31 December 2020).
Any changes to the substance of the regulations would not automatically become part of UK law. If the EU regime changes, but the UK does not, there is a clear potential for increased regulatory burden for multinational cosmetics companies operating in the EU and the UK.
The UK government has yet to announce plans to overhaul the UK cosmetics regulatory regime, although discrepancies have already started to emerge. For example, while the EU recently restricted the use of methyl-N-methylanthranilate (MN-MA) in cosmetics, the UK has not – so for now, it may continue to be used in products marketed in Great Britain (but not Northern Ireland). This is subject to further assessment by the UK Scientific Advisory Group on Chemical Safety.