The editorial articles for this issue were prepared by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMES (DG GROW). DG GROW manages a cosmetic ingredient database and the Cosmetic Product Notification Portal, and when needed, they mandate the Scientific Committee on Consumer Safety to provide a risk assessment on cosmetic ingredients.
The Scientific Committee on Consumer Safety plays a vital role in the Commission’s ongoing work on Endocrine Disruptors
To address potential risks for human health, the cosmetic products regulation (Regulation (EC) N°1223/2009) lays down a system of restrictions and bans on the use of certain substances in cosmetics based on a scientific risk assessment carried out by the Scientific Committee on Consumer Safety (SCCS).
Scientific concerns about the endocrine-disrupting properties of substances used in cosmetic products are, like other substances of concern for human health, addressed in the risk assessment of the SCCS. Endocrine disruptors are chemical substances that can alter the functioning of the endocrine (hormonal) system and negatively affect the health of humans or animals.
Conclusions are made on whether endocrine/hormonal activities are linked to the critical endpoint for assessing the safety of these substances for consumers, including vulnerable groups such as children when applicable.
On 7 November 2018, the Commission adopted the review of Regulation (EC) No 1223/2009 on cosmetic products regarding substances with endocrine-disrupting properties. The report took stock of how substances considered as potential endocrine disruptors were tackled under the cosmetics regulation – namely, banned or restricted on a case-by-case basis following their safety assessment by the SCCS. The overall conclusion is that the cosmetic regulation provides the adequate tools to regulate the use of cosmetic substances that present a potential risk for human health.
The Commission also committed to establishing a priority list of potential endocrine disruptors not already covered by the bans in the cosmetics regulation by the end of March 2019 for risk assessment. The starting point for this priority list was the result of the screening study that was conducted to support the impact assessment in the field of plant protection products and biocides. The screening study identified 6 substances (benzophenone-3, kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan and resorcinol) used in cosmetic products as potentially having endocrine-disrupting properties that were not covered by an existing or ongoing prohibition.
The Commission presented the preliminary list to the working group on cosmetic products in December 2018. Working group members were invited to comment on the list and submit other substances of concern considered as potential endocrine disruptors along with argumentation for this consideration.
Following working group members’ input, a final list of 28 substances was consolidated and split into two groups. ‘Group A’ consists of 14 substances deemed as a higher priority for assessment as they are undergoing substance evaluation under REACH for endocrine disruptors concerns or the scientific evidence has already confirmed endocrine disruptors concerns. Group B consists of 14 substances where either no scientific evidence has been initiated or the outcome of the scientific evidence is of an environmental endocrine disruptors concern and not a human health one. Group B also contains substances that have recently been evaluated by the SCCS and found safe, and/or Substances that have been recently classified as Carcinogenic, Mutagenic and Reprotoxic substances under Classification, Labelling and Packaging of substances and mixtures where corresponding risk assessment/management measures are in place to prohibit/restrict their use in cosmetic products.
A first call for data related to the 14 substances found in Group A has been launched. (See below) Upon receipt of sufficient data, the Commission will mandate the SCCS to evaluate the substances as soon as possible. If needed, the Commission will then take appropriate action to prohibit or restrict the use of the different substances in cosmetics.
Additional calls for data related to the 14 substances found in Group B are planned for the future, taking into consideration any relevant developments.
Call for data on ingredients with potential endocrine-disrupting properties used in cosmetic products open through 15 October 2019
To prepare requests for scientific opinions to the Scientific Committee on Consumer Safety, the Directorate General Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) has launched a call for data, open to any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned and consumers associations.
The call is for relevant scientific information including data regarding all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products and/or an indication of the suggested safe concentration limits for the following ingredients: Benzophenone-3, kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan, resorcinol, octocrylene, triclocarban, butylated hydroxytoluene (BHT), benzophenone, homosalate, benzyl salicylate, genistein and daidzein in the framework of Regulation (EC) 1223/2009.
- Read more on the call for data on ingredients with potential endocrine-disrupting properties used in cosmetic products
Share your views on the EU’s response to Endocrine Disruptors by 10 July 2019
In order to address the concerns on the coherence of the EU legal framework, the Commission launched a cross-cutting Fitness Check on endocrine disruptors, which will contribute to the assessment of whether EU chemicals legislation delivers its objective to protect human health and the environment by minimising the overall exposure to endocrine disruptors. Stakeholders, ranging from public authorities and industry to NGOs and the general public, may participate in this Fitness Check by providing their feedback on a Roadmap until 10 July 2019, and the SCCS is planning to do so.
The Fitness Check will assess the situation in the EU today and compare it with the situation in 1999, when the first Community Strategy for endocrine disruptors was published. Significant progress in understanding and regulating endocrine disruptors has been made since then, and the EU is today recognised as one of the global leaders in dealing with these chemicals.
Later this year, the Commission plans to hold a Public Consultation, which will be accessible on the Commission’s central consultation web page ‘Have your Say’ for 12 weeks in 23 EU languages. It will be possible to reply in any of the 24 official EU languages. An Annual Forum on endocrine disruptors is also foreseen in October. The Opinion is expected to be adopted by mid-year 2020.