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 line with its Chemicals Strategy for Sustainability, which aims to boost innovation for safe and sustainable chemicals and to address the health and environmental challenges caused by the most harmful chemicals (see our previous blog on this here), the European Commission launched a public consultation regarding proposals for the targeted revision of the Regulation on 28 March 2022. The Commission intends to use the inputs received from this consultation to assess the relevance of proposed new measures to improve the safety and sustainability of cosmetic products.
The consultation is open until 20 June 2022, and seeks input on several issues, including expanding the default prohibition of the use in cosmetic products of a broader range of chemicals, updating risk assessment requirements, and refining cosmetic product labelling requirements. Input from the consultation and stakeholder workshops will help to shape the Commission’s formal proposals for revision of the Regulation, which are expected to be published in late 2022.
We consider each of the Commission’s proposals in more detail below, including the impact that any changes to the Regulation could have on cosmetic product businesses with operations in the UK.
1. Strengthened generic approach to risk management:
The use in cosmetic products of chemicals with carcinogenic, mutagenic or reprotoxic (CMR) effects is generally prohibited. However, the use of other chemicals in cosmetic products is currently only prohibited if the product cannot be considered “safe 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 product’s specific use.
In line with the Chemicals Strategy for Sustainability, the Commission is considering bolstering this generic approach to risk management so that the “most harmful” chemicals, including those which may affect the immune, neurological or respiratory systems, or chemicals toxic to a specific organ (even if non-CMR), will be banned by default, with limited exceptions under conditions defined by law. This could mean that certain chemicals could not be used in cosmetic products at any level, even if the product might currently be assessed as safe – for example where the substance is included in 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 is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment or health”. The Commission acknowledges that the criteria for “essential” use will need to be properly defined, and has already commenced stakeholder workshops with a view to publishing further guidance by the end of 2022.
2. Risk assessment for unintentional combination effects:
Substances may cause adverse effects to human health when combined, even if the individual substances are considered safe. Currently, risk assessment is only required in relation to intentional mixtures of chemical substances (for example, the commercial combination of chemicals within a particular product), and does not need to take into account the potential exposure of the end consumer to chemical substances from multiple product sources. The Commission is considering expanding risk assessment requirements to require consideration of unintentional co-exposure to chemicals from different sources, for example to account for possible interactions between different personal hygiene products when used in conjunction by consumers.
3. Aligning the definition of nanomaterial with broader chemicals regulation:
“Nanomaterials” are sometimes used in cosmetic products as they are often associated with greater strength or conductivity. Under the Regulation, they must be assessed for safety and labelled if used in cosmetic products. However, nanomaterials are defined more broadly in other chemicals regulation, including REACH, the Biocidal Product Regulation and the Medical Devices Regulation. The Commission is considering updating the definition used in the Cosmetic Products Regulation, either discretely or to cross-refer to other sectoral legislation.
4. Refining labelling requirements with digital options in mind:
Generally, product information required to be provided to consumers must be labelled on the container and/or the packaging of a consumer product. In order to improve consumer understanding, by avoiding overloading labels with information and making them easier to read, the Commission is consulting on the most effective ways (for example, on-pack only, through digital labelling such as QR codes, or a combination) to communicate information regarding certain key information about the product, including the details of the responsible person, safety warnings, and the full ingredients list.
5. Streamlining scientific assessments of cosmetic products:
Currently, the Scientific Committee on Consumer Safety of the European Commission performs technical assessments and provides scientific expert input on the safety of non-food consumer products (including cosmetics). Meanwhile, other chemicals legislation requires technical input from other agencies. The Commission is considering moving the SCCS’s operations to a centralised European agency (for example, the European Chemicals Agency) to improve the efficiency, transparency and consistency of chemical safety assessments across different sectors.
UK impact: Divergence ahead?
The Regulation forms part of the body of retained EU law and therefore continues to have effect in the UK following its withdrawal from the European Union, with modifications for the continued domestic application of its provisions (for example, the requirement for a UK-based responsible person for products placed on the market in Great Britain after 31 December 2020).
Any changes to the substance of the Regulation would not automatically form part of UK law. If the EU regime changes, but the UK one does not, there is an obvious potential for an increased regulatory burden on multinational cosmetic product businesses with operations in the EU and the UK.
The UK government has not yet announced any plans to revise the UK cosmetic product regulatory regime, although divergences have already started to emerge. For example, while the EU has recently restricted the use of Methyl-N-methylanthranilate (M-N-MA) in cosmetic products, the UK has not – such that, for now, it may continue to be used in products placed on the market in Great Britain (but not Northern Ireland). This is subject to further assessment by the UK Scientific Advisory Group on Chemical Safety.