Are Cosmetic Endocrine-Disruptor Checks Sufficient? EU Commission Issues Long-Awaited Position

Industry no doubt welcomes the Commission’s long-overdue review of the European Cosmetics Regulation as it pertains to chemicals with endocrine-disrupting properties. The report concludes that the existing regulatory framework is adequate to evaluate and manage suspected endocrine disruptors, while putting stakeholders on notice that a number of prioritized ingredients will be up for review in 2019.   

The European Commission has finally completed its review of the Cosmetics Regulation as it relates to substances with endocrine-disrupting properties, and for industry at least, the wait was worth it.

The EU’s Cosmetics Regulation, which in July 2013 replaced the Cosmetics Directive of 1976, includes a provision requiring the regulation's review by the time community or internationally agreed criteria are available for identifying endocrine disruptors, or “at the latest” by Jan. 11, 2015.

As it happened, the anticipated criteria emerged later than the 2015 deadline, and both came well in advance of the mandated Cosmetics Regulation review.

In June 2016, the Commission unveiled criteria for identifying endocrine disruptors in the specific areas of plant protection and biocidal products. (Also see "EC Releases Endocrine-Disruptor Criteria, Drawing Heavily On WHO Definitions" - HBW Insight, 24 Jun, 2016.)

Based on a World Health Organization definition, the controversial criteria informed sector-specific regulations adopted in September 2017 and April 2018. (Also see "EU Endocrine Disruptor Guidance Open For Comments; Benefit Cosmetics Recall; More News In Brief" - HBW Insight, 11 Dec, 2017.)

They also were taken into account in the Commission’s review of existing cosmetics regulations.

Published Nov. 7, the Commission’s assessment concludes that “the Cosmetics Regulation provides the adequate tools to regulate the use of cosmetic substances that present a potential risk for human health and to take the appropriate regulatory measures based on a scientific assessment of available data concerning human health.”

That should come as a relief to cosmetics industry members.

Further, the Commission notes that while other sectors (e.g., the biocide and pesticide industries) are governed by legislation that specifically targets endocrine-disrupting chemicals with calls for special controls, the Cosmetics Regulation lacks any such provisions – and rightly so, according to the report.

“The experience collected since the entry into application of the Cosmetics Regulation has not revealed elements which would justify deviating from the regime designed by the legislator to address the safety concerns related to the use of endocrine disruptors in cosmetics,” the Commission says.

The Commission points out that mechanisms exist under current regulations for restricting or prohibiting use of substances in cosmetic products based on unacceptable risk profiles.

For example, substances flagged as carcinogenic, mutagenic or toxic to reproduction (CMR) under the EU’s Classification, Labeling and Packaging regulation are automatically banned from use in cosmetics unless they meet specified criteria, including a favorable safety decision from the Scientific Committee on Consumer Safety (SCCS) and data showing a lack of alternative ingredient options. (Also see "EU Watch: Next Steps Re Controversial CMR Ban Approach, Fragrance Allergens Labeling " - HBW Insight, 10 Jul, 2018.)

If endocrine disruptors are not caught up in automatic CMR bans, they still can be subject to restrictions or prohibitions – and added to the Cosmetics Regulation’s respective Annexes II and III – based on SCCS opinions issued in the course of the committee’s routine ingredient review functions.

“The cornerstone of the existing legislative framework is the scientific risk assessment of cosmetic ingredients carried out by the SCCS,” the Commission says.

It cites regulatory action taken on selected parabens in recent years as an example of restrictions imposed on cosmetic ingredient use, on a case-by-case basis, in accordance with SCCS’ evaluation of suspected endocrine-disrupting substances. (Also see "Europe Bans Preservative Mixture MCI/MI In Leave-On Cosmetics" - HBW Insight, 26 Sep, 2014.)

Suspect Cosmetic Ingredients Will Undergo Review

The Commission notes a screening study it commissioned from an independent contractor and published in June 2016 in the context of its biocide/pesticide regulatory work, which identified just a handful of substances used in cosmetics that are potentially endocrine disruptors (depending on the criteria used to identify them) and have not yet been regulated on those or other safety grounds.

There are caveats, however. For example, the Commission notes that lack of endocrine-disrupting evidence is not equivalent to negative evidence.

In terms of next steps, the Commission says it will establish a priority list of potential endocrine disruptors in cosmetic products by the first quarter of 2019.

Industry reps and other stakeholders will be given opportunities to submit data, which then will be presented to the SCCS for substance evaluations “in the shortest delay.”

The Commission will take regulatory action on ingredients as warranted, based on SCCS’ assessments.

Animal-Testing Ban Complicates Matters

There is one major obstacle to generating new data regarding cosmetic ingredients’ endocrine-disrupting potential – namely, the Cosmetics Regulation’s animal-testing ban.

“The SCCS has confirmed that it can assess the safety of cosmetic ingredients with respect to their endocrine-disrupting activity, subject to the restrictions imposed by the animal testing ban for cosmetic products,” the Commission notes.

It refers stakeholders to SCCS’ Notes of Guidance for Testing of Cosmetic Ingredients and Their Safety Evaluation, designed to help steer companies in their safety substantiation efforts, including the delivery of data to SCCS for consideration in its reviews.

The latest iteration of that guidance, published Nov. 7, includes updated perspectives on the alternative methods landscape under the EU’s animal-testing ban. (Also see "EU’s SCCS Reissues Guidance On Cosmetic Ingredient Testing With Updated Non-Animal Method Perspectives" - HBW Insight, 14 Nov, 2018.)

SCCS affirms that “no validated alternative method is yet available for reproductive toxicity that covers all different phases of the reproductive cycle.”

The committee continues, “Due to the animal testing ban under the Cosmetic Regulation, it is now out of scope to test cosmetic ingredients in vivo for endocrine disruption. Cosmetic ingredients therefore can be assessed for endocrine activity in a stepwise approach using data generated outside the cosmetic field or, for a new cosmetic ingredient, using [new approach methodologies].”

Such methodologies, including use of in silico models, read-across, in vitro assays and other non-animal techniques, have limitations at present, SCCS says.

The Commission issued its review of the Cosmetics Regulation the same day it announced an updated strategy for tackling endocrine-disruptor regulation across all areas of its purview.