The UV filters under regulatory pressure

At dsm-firmenich, we are committed to working with our valued partners – our customers, suppliers, and industry stakeholders – to develop and deliver safe, effective, and sustainable sun care to consumers. This includes staying up to date with all the latest regulations worldwide and knowledge sharing with our networks, as well as contributing useful information and data to relevant authorities whenever we can help.

Recently, an important topic of conversation has been the regulatory pressures on UV filters in Europe, with regards to their use in cosmetics, and their potential impacts on consumer health evaluated under the EU Cosmetics Regulation (EC) No 1223/2009 and on human health and the environment evaluated under Regulation (EC) 1907/2006 (Registration, Evaluation, Authorisation and Restriction of Chemicals, REACH).

Cosmetic products: assessing substances with suspected endocrine-disrupting properties

Substances with endocrine-disrupting properties – termed ‘endocrine disruptors’ (EDs) – are chemical substances that alter the functioning of the endocrine (or hormonal) system and thereby adversely affect the health of humans and animals.

The EU Cosmetics Regulation does not yet have specific provisions for EDs. However, it provides a regulatory framework with the aim of ensuring a high level of protection of human health, laying down a system of restrictions on the use of certain substances in cosmetics.

On 7 November 2018, the EU Commission reported a review of Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products (the Cosmetics Regulation) with regards to suspected endocrine-disrupting substances.

Certain categories of ingredients (i.e. colorants, preservatives and UV filters) can only be used in cosmetic products if authorised, via inclusion in the respective positive lists of the Cosmetics Regulation (Annexes IV, V and VI). These Annexes may be amended by the EU Commission as a consequence of a new or revised scientific risk assessment by an independent committee, the Scientific Committee on Consumer Safety (SCCS).

Potential endocrine-disrupting substances are in scope of a scientific risk assessment by the SCCS as laid down in the ‘SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation’ (NoG). Note, potential Eds might also be subject to regulatory measures under the EU REACH Regulation, if they have suspected adverse effects on human health or the environment.

As part of the 2018 review by EU member states, a list of potential EDs for further evaluation was created. After consolidation, this priority list consisted of 28 substances, for which the European Commission put out a call for data.

Based on the availability of relevant data, the European Commission mandated the SCCS to evaluate those substances. Next, if needed, it will take action to prohibit or restrict the use of the substances in cosmetics. The SCCS's risk assessment addresses scientific concerns about the endocrine-disrupting properties of each substance in cosmetics, and judges whether endocrine/hormonal activities are linked to critical endpoints to assess the safety of the substances for consumers.

The 28 substances were split into two groups:

• Group A – 14 substances including the four UV-filters Benzophenone 3 (BP-3), 4-Methylbenzylidene camphor (4-MBC), Octocrylene and Homosalate,  to be assessed after a 3-month public consultation period ending on 15 October 2019.
• Group B – 14 substances including the UV filter Ethylhexyl Methoxycinnamate (OMC), to be assessed later, after a public consultation period ending on 15 November 2021.

Final SCCS opinion on Octocrylene

Following the call for information on Octocrylene, data on the UV filter were submitted by prominent bodies including the European Federation for Cosmetic Ingredients (EFfCI) and Cosmetics Europe.

To summarise, the SCCS concluded that there is not sufficient evidence on the endocrine-related effects to be used in a human health risk assessment and that at the current use levels, the risk of endocrine-disrupting effects on humans is negligible.

Accordingly, the final SCCS opinion, which was announced on 31 March 2021, stated that Octocrylene is “safe at concentrations of up to 10% when used individually or together as a UV filter in cosmetic products, i.e. in sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick”. Based on the most recent SCCS NoG also considering spray applications, this was complemented to add that Octocrylene is safe at concentrations of up to 9% when used in sunscreen propellant sprays for the body.

The EU Commission followed the SCCS opinion presented above, and the respective amendment entered into force on 28 July 2022. 

SCCS opinion on Homosalate

The call for data on Homosalate also drew considerable interest, and contributors again included EFfCI UV filter consortium members and Cosmetics Europe.

Based on the available data, on 24 June 2021, the SCCS concluded that “the use of Homosalate as a UV filter in cosmetic products is safe for the consumer up to a maximum concentration of 0.5% Homosalate in the final product”.

This recommendation was a significant restriction and much lower than had been anticipated, sparking further discussion and deliberation among data contributors. SCCS  reassessed an OECD 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) on Homosalate for the safety evaluation. This study (2013) had been requested by the European Chemicals Agency (ECHA) for the EU REACH dossier update and showed some shortcomings in the execution and consequently in the interpretation of results. As the study had been conducted shortly before the respective deadline of animal testing for consumer safety and marketing ban in Europe, it could not be repeated.

Based on ongoing discussions, on 2 December 2021, the SCCS provided revised scientific advice on Homosalate, recommending a maximum allowed concentration of 7.34% in facial care products: “On the basis of safety assessment, and considering the concerns related to potential endocrine-disrupting properties of Homosalate, the SCCS is of the opinion that Homosalate is safe as a UV filter at concentrations up to 7.34% in face cream and pump spray”.

We are awaiting the final adoption from the European Commission of a restriction to face products (non-spray and pump spray products) only up to a maximum concentration of 7.34% for Homosalate.

Call for data on Ethylhexyl Methoxycinnamate

On 15 February 2021, the European Commission launched its call for any interested parties to submit scientific data mainly related to the  potential EDs listed in Group B, including the UV filter Ethylhexyl Methoxycinnamate (Octylmethoxycinnamate (OMC) / Octinoxate).

Data was provided ahead of the 15 November deadline by the EFfCI UV filter consortium members, and Cosmetics Europe submitted a risk assessment dossier including new dermal absorption data.

Now that the consultation period has concluded, we await announcement of the preliminary opinion from the SCCS, which is anticipated on 15 August 2022. Subsequently, there will be a two-month window for further comments from data contributors and the wider industry.

Based on the available safety data, and considering the concerns related to its potential endocrine-disrupting properties, DSM considers OMC as safe. Considering that the SCCS assessed the safety of OMC in 2001 without any concern of endocrine disruption, and similarly no concerns were raised in the ECHA evaluation on human health in 2017, we hope that the SCCS will agree.

Beside those activities in the EU and because of Brexit, the government of the United Kingdom established an Office for Product Safety and Standards (OPSS). The OPSS also launched a call for data on five suspected EDs in cosmetics on 14 April 2022 with a submission deadline by 31 May 2022. As part of that list, data for the UV filters Octocrylene, Homosalate and BP-3 have been requested. Again, data have been provided by EFfCI UV filter consortium members. We are awaiting any further updates to advice and the final adoption from the OPSS.

UV filters under REACH regulation

In this blog, we have predominantly focused on the EU Cosmetics Regulation. However, under EU REACH, the ECHA is also assessing a selection of UV filters for their impacts on human health and the environment. Below is a shortlist of recent updates:

• A long-term fish study and an amphibian study have confirmed that OMC does not have endocrine-disruptive properties. However, some morphological changes in fish liver have triggered a new CLP self-classification as Aquatic Chronic 2.
• Long-term studies for the impact of Octocrylene on the environment have been requested by ECHA and are still ongoing.
• Further study requests on Homosalate and Ethylhexyl Salicylate have been brought to the European Court of Justice for a decision with respect to the animal testing and marketing ban for cosmetic ingredients in Europe. A recently performed environmental study on daphnia reproduction has triggered a new CLP self-classification of Ethylhexyl Salicylate as Aquatic Chronic 1.
• Environmental studies requested by the ECHA for butyl-methoxydibenzoylmethane (BMDBM), namely a Daphnia reproduction test and fish early-life-stage toxicity test, revealed no toxic effects, and the current self-classification as Aquatic Chronic 4 has been revoked.