Regulating suncare

Upcoming reforms for safer, more sustainable chemicals

As part of its Zero Pollution ambition and to protect people and the environment more effectively, the EU is bolstering its extensive regulatory framework for chemicals with a dedicated Chemicals Strategy for Sustainability. As part of this strategy, there are various potential reforms on the horizon which we should be aware of as sunscreen developers:
• Expected new guidelines on the regulation on the Classification, Labelling and Packaging of Chemicals (CLP), which will define new hazard classes, are at the final negotiation stage and could be implemented before June 2024. The most significant development here is that the new hazard classes will include criteria for identifying endocrine disruptors.
• Steps to revise the REACH framework (Registration, Evaluation, Authorization and Restriction of Chemicals) were initiated in 2021. Implementation was originally planned for between 2025 and 2027 but due to the complexity and importance of the initiative, the revisions are on hold to allow sufficient preparation and discussion time. Potential reforms here will apply across all industries and will include regulations and guidelines for specific products such as cosmetics. A key topic currently under discussion, and of pertinence to suncare, is the possible introduction of a Mixed Assessment Factor (MAF) when assessing chemicals for risks. MAF refers to the combined human and environmental impact of chemicals, or “cocktail effect”. Including this in risk assessments will increase the calculated margin substances need to achieve to be considered safe, so if it does become a become reality, it will have significant implications for cosmetic ingredients such as UV filters.
• REACH reform could also see further restrictions on PFAs (Per- and polyfluoroalkyl substances) which are used in many industry sectors. Proposed restrictions would apply to some 10,000 substances which do not biodegrade, including Trifluoroacetic acid (TFA) which is known to be used in synthetic peptides in cosmetics. Under the proposals, a full ban on PFAs would be implemented 18 months after the regulation was adopted. A committee opinion on PFAs is expected during 2024 with potential entry into force in 2025/26. However, as these substances are so widely used across industry and there is considerable feedback to consider, this timescale could change. Proposals on restricting PFAs are not limited to Europe however – the USA is also active on this topic, so this should be considered a global challenge.
• As an industry, we should also anticipate revisions to the EU’s Cosmetic Products Regulation. The timelines could be extended, but adoption is expected by early 2026, with revisions applying in full in 2027 or 2028. Topics currently under discussion, include an updated definition for nanomaterials, which could mean about 200 more ingredients falling into this classification.  

Preparing for a clean and circular economy

The EU’s 2020 Circular Economy Action Plan (CEAP) comprises initiatives along products’ entire life cycles. It focuses on product design, advocates for circular economy processes, promotes sustainable consumption, and strives to prevent waste while maximising retention of resources. The plan encompasses two overlapping components – sustainable design and substantiating green claims.

More sustainable design processes

In March 2022, as part of its sustainable product policy, the EU published its proposed Ecodesign for Sustainable Products Regulation (ESPR). This will set a framework for specific product groups, with the goal of making items more sustainable, resource efficient and carbon neutral from the outset. Timelines for adoption are still to be confirmed, but when it comes into force, physical goods, components, and intermediate products will have to comply with specific ecodesign requirements to be placed on the EU market. Topics which may be particularly relevant to suncare products include restrictions on the presence of substances thatinhibit circularity, the use of recycled content, waste generation, and carbon and environmental footprint.

Guards against “green washing”

To give consumers and businesses the data they need to make more informed buying choices, the ESPR also includes proposals for a new “Digital Product Passport”, providing information on a product’s environmental sustainability and impact in an easily scannable format. In line with this drive for transparency, a “Green Claims” directive was proposed and published in March 2023. Its stated aim is to protect and empower EU consumers, by ensuring that environmental claims in business to consumer communications, including product labels, are credible and can be substantiated. The proposal will apply to EU and non-EU traders an under this directive, any green claims will have to be supported with primary information, when available, and verified by a third-party assessment body. Claims will also need to be based on recognised Life Cycle Analysis approaches and environmental scoring labels will need to have been established under EU law.

Supporting sustainable innovation in suncare

While there may be uncertainty about the precise details and timings of upcoming legislation, what is certain is that new requirements need new approaches – at every level in the suncare industry. From reviewing concentrations and combinations of specific UV filters and other ingredients in sunscreens to finding alternatives; or from taking steps to reduce packaging or energy use in production processes to providing more transparent and verifiable information, it is wise to think ahead. Dsm-firmenich monitors the regulatory landscape constantly. As well as taking steps to analyse and improve the sustainability of their own ingredients throughout their value chains in response, they also provide tools to help suncare developers prepare for anticipated change. For example, their bespoke reporting card system provides tangible and comparable data on the environmental and social impact of the products, their origins and supply chains and their certifications, based on recognised independent benchmarks. The formulations support also includes access to an online “Optimiser” tool – a virtual laboratory environment where producers can assess various criteria at the same time, such as the SPF performance and the environmental impact of different UV filter combinations and concentrations. This platform draws on established knowledge and data and can be updated in the light of new regulatory developments and scientific findings.

Conclusion

Adapting to new regulatory requirements and the needs of a greener, circular economy may seem quite the challenge. But for the sake of our planet, it is a challenge we must rise to, and if we all take steps as stakeholders, we can ensure that our industry is fit for the future.