Why is the EU Cosmetics Regulation Being Reviewed?
The Cosmetics legislation is almost 50 years old, in fact 46 years old this year. It was first adopted in 1976 as a Council Directive (Directive 76/768/EEC) and since then has been substantially amended and reviewed. It is only in 2009 that the Directive became a Regulation, applying with harmonisation across all EU Member States and including important changes such as centralised notification of all cosmetic products placed on the EU market and new rules for the use of nanomaterials. The EU Cosmetics Regulation is seen as a gold standard in regulating cosmetic products and is a reference text for many other global regions.
The Cosmetics Regulation is now under review again. However, to understand this new revision fully, one needs to go back to the European Green Deal (EGD). The European Green Deal announced and published in December 2019 is probably the most significant horizontal policy initiative ever in the EU. It sets to transform the EU’s economy for a sustainable future and confirms the EU as a Global Leader. The EGD will generate a multitude of horizontal legislative and policy initiatives, bringing together multiple industry sectors under umbrella frameworks. As part of the EGD and its Zero pollution ambition, the EU Commission adopted the Chemicals Strategy for Sustainability (CSS) in October 2020. Amongst its 50 + measures, the CSS provided a trigger for the revision of REACh (Registration, Evaluation and Authorisation of Chemicals), the Classification Labelling Packaging (CLP) Regulation and the Cosmetics Products Regulation (CPR). And there we are, the upcoming revision of the CPR is a direct legislative consequence from the CSS.
The Chemicals Strategy for Sustainability
Key principles of the CSS are the concept of GRA (Generic Risk Management Approach) and ‘essential use’. In essence, this is just another way of saying ‘hazard based bans’. Whilst such an approach already exists in REACH and the CPR for Carcinogenic, Mutagenic and Reprotoxic (CMR) Category 1 substances, the CSS proposes to use a same approach for substances classified under CLP as endocrine disruptors, PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative) – and possibly even more hazard categories in the future.
Once a substance is classified under one or more of these hazard categories (i.e. it is identified as a ‘most harmful substance’), a derogation from the GRA ban would only be possible for uses of the chemical that are considered as ‘essential’ for health and safety or the functioning of the society and when there are no alternative substances available.
Scope of the CPR revision
There have been speculations for a while whether the CPR would be undergoing a full or a targeted revision. It is now expected that the European Commission will aim at a targeted revision addressing only topics relating to the CSS directly:
1) “One substance, One Assessment” (OSOA);
2) Extend the generic approach to risk management (GRA) from CMRs (carcinogenic, mutagenic, reprotoxic) to expected new hazard classes in CLP;
3) Align the definition of nanomaterial with an horizontal definition; and
4) Digital labelling options.
Is it good news?
There are some important red flags for the cosmetics sector. The exemption in CLP for finished cosmetic products being one. Finished cosmetics products have benefited since 2009 when CLP came into force, from a derogation regarding hazard labelling. This may be at risk. Additionally, there is a worry that numerous substances could be automatically banned from use in cosmetics owing to their hazard classification and based upon the GRA bans and “essential use” criterion.
In terms of timeline, in Q4 2021, the European Commission published an Inception Impact Assessment on the Revision of the Cosmetic Products Regulation. A public consultation is expected imminently.
Written by Marie Kennedy