Sylvie Gallage-Alwis examines the European Commission’s consultation on the regulation of cosmetic products on

By Sylvie Gallage-Alwis

Sylvie’s article was published in the June 2022 print edition of Liability, Risk & Insurance on 

The European Commission’s consultation on the regulation of cosmetic products remains open until 21 June 2022. The consultation will gather consumer, expert and industry “information, views and experience on how the EU’s Cosmetics Product Regulation could be improved in order to ensure human health and the functioning of the internal market.”

The European Commission says that the review of this regulation was prompted by a “Fitness Check on endocrine disruptors and a status Report/Review on the use of nanomaterials in cosmetics identified”. The consultation document notes that these identified “a number of shortcomings in and related to the Cosmetic Products Regulation”. Particular issues identified included, “the lack of specific provisions for endocrine disruptors” and “the applicability of a generic approach on risk management (GRA) for other harmful substances”. The document also notes “the potential diverging opinions from committees responsible for the assessment of chemicals and the lack of coherence between legislations on the definition of nanomaterials.”

While the consultation says that its “target audience” for the review is wide, in reality it will primarily be of interest to industry players and NGOs concerned about the environmental and health issues relating to endocrine disruptors.

This is, in fact, the second stage of the review process, since the initial Inception Impact Assessment (IIA) ran from 4 October 2021 until 1 November 2021. The responses to this have already been made public. These published responses show that interest in the issue was largely amongst industry associations affected, and NGOs groups with an interest in the area. The IIA states that a key issue to be addressed is that the:

Cosmetics Product Regulation is not yet aligned to the approaches announced under the [EU’s Chemicals Strategy for Sustainability] to implement the generic approach to risk management and the essential uses concept intended to address those risks. Similarly, other than CMRs, the Cosmetic Products Regulation does not have requirements to protect humans or the environment from combination effects of the most hazardous chemicals due to the simultaneous exposure to multiple chemicals, whether from cosmetics or other sources.”

It’s clear that the revised regulation will address these issues, so as to come into alignment with the EU’s wider sustainable chemicals strategy.

The initial consultation had 98 responses, and at the time of writing the second consultation has just 46 responses, so a well-argued individual response could have a meaningful impact on the process. The ongoing second phase of the review was launched on 29 March 2022 and will run until 21 June 2022. 

One of the key issues being consulted upon is the definition of nanomaterials. While Cosmetics Regulation provides a definition, there is another definition of nanomaterials under EC Recommendation 2011/696/EU. There are also a number of competing definitions at play in different EU member states.  For example, France has a distinct definition of nanomaterials under Article R. 523-12 of the French Environmental Code.  Which definition applies in a given case may also depend on the industrial sector concerned.

Precisely how the relevant definition is to be interpreted is also an issue that needs clarification. The definition given the Cosmetic Products Regulation as it stands, holds that a “nanomaterial” should meet three criteria, namely that it is insoluble and bio-persistent, composed of an external dimension on a scale of 1 to 100 nm and that it should be intentionally manufactured.

There is quite a bit of debate about the correct way to apply these criteria. This inevitably leads to legal uncertainty which can create issues between regulators and manufacturers. The requirement that a nanomaterial be “intentionally manufactured” is also quite a subjective criteria, since it goes into the area of mental intent, which is not always an easy thing to prove. A clearer and more objective definition would be welcomed by many.

In terms of the possible ways to resolve these issues relating to definitions, the IIA says that “options may include replacing the current definition used in the Cosmetic Products Regulation by the horizontal one laid down in Commission Recommendation 2011/696/EU of 18 October 2011 or with an updated one as announced in the [EU’s Chemicals Strategy for Sustainability], or modifying it to bring it in line with the new or revised horizontal, broad definition.” Other proposed regulatory changes relate to the labelling of products, including electronic labelling.

The review of the Cosmetics Product Regulation and the related consultation is fundamentally driven by the EU Green Deal and the EU’s wider chemicals sustainability strategy, which has a goal to “better protect the public and the environment against hazardous chemicals and encourage innovation in developing safe and sustainable alternatives”.

In terms of the potential economic impact of the changes, the IIA notes that “Some changes to the Cosmetic Products Regulation will probably reduce costs for industry, for instance on nanomaterials and through improvements in the risk assessment and management of harmful substances. Other changes might lead to increased costs for industry, including SMEs, throughout the supply chain. This would be a result of the introduction of stricter rules on the most harmful chemicals such as endocrine disruptors, preparation of exemption dossiers and generation of safety data, and the need for reformulation of cosmetic products.”

Manufacturers outside the EU which export to the EU should also take careful note of the consultation. The IIA says that “This targeted revision aims to provide EU industry with a global competitive advantage in terms of economic sustainability and legal clarity, and also to increase competitiveness at a global level, since the new rules will have an impact on cosmetic imports from non-EU countries.”

While the general direction of travel is already clear, there is a lot to play for in terms of which policy options are chosen and precisely how they will be implemented. It’s not too late for companies concerned to have an impact on the process.

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