Restrictions on the use of ingredients in cosmetic products are part of the ongoing work to evaluate all chemical substances used in production to ensure their safety, and if necessary to ban their use by adding them to Annex II of Regulation (EC) No 1223/2009. In line with this activity, we have the forthcoming amendment of the cosmetics legislation which will add a number of substances to Annex II, i.e. the list of substances banned in cosmetic products is extended.
Before indicating the substances to be added to Annex II, it is necessary to know the connection between the regulation on cosmetic products and the one foreseen for chemical substances (Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures).
The link is established by Article 15 of Regulation 1223/2009 regulating substances classified as CMR substances. It sets out measures to ensure the safety of cosmetics in relation to substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR). Exposure to CMR substances can occur via cosmetics, chemicals, food, medicines, and therefore a comprehensive approach is needed, involving both the Scientific Committee on Consumer Safety (SCCS) and other relevant bodies (European Chemicals Agency (ECHA), the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA). The work made allows us have of the document Orientations of the EU for the evaluation of the global exhibition to substances CMR in cosmetic products, that facilitates interpretation of the regulation regarding the restriction of substances with arrangement to the Regulation on cosmetics and in other sectors.
Depending on the identified risks to human health, ingredients in cosmetic products are banned or restricted, and legislation will also be amended if there is a potential risk to human health or adaptation is necessary as a result of technical and scientific progress.
In view of the above, the various ingredients are subject to a scientific risk assessment by the Scientific Committee on Consumer Safety (SCCS), which issues opinions on the health and safety risks (chemical, biological, mechanical and other physical risks) of non-food consumer products, in this case for cosmetic products and their related ingredients or services such as, for example, non-permanent tattoos or artificial tanning.
In this specific case, the substances that will be added to Annex II of Regulation 1223/2009 can be found in the following link: The security of the cosmetic products in the European Union - AINIA
The draft regulation is necessary to incorporate cosmetic ingredients into the list in Annex II. These are substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) by Regulation (EU) 2024/197, adopted on the basis of the CLP Regulation, which will be and will apply from 1 September 2025. Therefore, the amendment of Regulation (EC) No 1223/2009 on cosmetics is necessary to incorporate the new classification of CMR substances.
From the cosmetics sector's point of view, it is essential to keep an eye on legislative proposals and to pay attention to the opinions and opinions of the SCCS, as they anticipate those measures that will have an impact on the regulatory framework applicable to cosmetic products.