On 8 July 2025, the European Commission announced an Omnibus Proposal aimed at simplifying procedures and requirements for chemical products. Central to this initiative is a proposed amendment to several key regulations, including Regulation (EC) No 1223/2009 on cosmetic products. The changes seek to alleviate regulatory burdens and enhance legal clarity.
Background: cosmetics industry concerns over rigidity
Since the implementation of the Cosmetic Products Regulation in 2013, industry stakeholders have raised concerns over perceived rigidity in its interpretation and administrative burden. One of the most pressing issues is the classification of an increasing number of common cosmetic ingredients – particularly natural substances such as tea tree oil and spearmint oil – as CMRs (carcinogenic, mutagenic, or reprotoxic). The classification of these common ingredients impacts the formulation of over 70% of cosmetics, most of which rely on fragrance components derived from essential oils.
Other concerns include the failure to consider exposure routes in risk assessments (e.g., substances classified as hazardous based on ingestion being banned from dermal use as well) and the burdensome pre-notification process for nanomaterials (Article 16). The infrequent updates to the EU’s ingredient glossary (Article 33) and the complexity of the process for obtaining exemptions under Article 15 for substances classified as CMRs are also among the topics that the industry is questioning.
Additionally, the current regulation lacks a defined procedure for introducing new substances such as colorants and preservatives (Article 3).
In response to these growing challenges, the Commission hosted a “Reality Check” with stakeholders in May 2025, who agreed on the need for a reform of the regulation. July’s Omnibus Proposal is a direct result of these consultations.
Key amendments to the Cosmetics Regulation
Amendments to Article 14
The proposed amendment includes the addition of Article 14a. The new article introduces a defined process for requesting the inclusion of substances (used as colorants, preservatives, or UV filters) into the relevant annexes of the Cosmetics Regulation.
This amendment provides greater legal clarity for applicants and is expected to foster innovation in the industry.
Amendments to Article 15
The revision of Article 15 seeks to simplify the derogation process for substances classified as CMR 1A or 1B without altering the fundamental principle that such classification triggers a ban in cosmetic products unless a derogation request is submitted and the derogation is granted.
Furthermore, it is now clarified that CMR classification of a constituent of a natural complex substance does not automatically lead to a ban, though SCCS assessment may still be required.
Importantly, the ban will now only apply when the CMR classification is based on dermal exposure, so that if a substance has CMR properties only when it is inhaled or digested, but not if it comes into contact with the human skin (i.e. dermal exposure) it should not be banned from the use in cosmetics on the basis of Article 15.
Amendments to Article 16
The six-month pre-notification requirement for nanomaterials required under Article 16 will be abolished. The cosmetic products containing nanomaterials should not be considered less safe than other cosmetic products as they undergo the appropriate safety assessment under the responsibility of the Responsible Person. Instead, relevant data will be included in the Cosmetic Product Safety Report. Therefore, the removal of the relevant paragraphs from Article 16 of the Cosmetic Products Regulation will be complemented by corresponding amendments to Annex I of the Regulation.
Amendments to Article 22
The revision of Article 22 removes the requirement for Member States to review and report on their market surveillance activities every four years, reducing administrative burden. This obligation is now considered redundant due to the ICSMS system, which enables efficient real-time sharing of product investigation data among authorities and the Commission.
Amendments to Article 33
The glossary of common ingredient names under Article 33 will be discontinued, and the article will be removed from the Regulation. Instead, labels will rely on the internationally recognized nomenclature (INCI).
This approach will be reflected throughout the whole Cosmetics Regulation, including Annexes II–VI.
Amendment to Annex I
As stated above, Annex I has been revised to require the Part A of the Cosmetic Product Safety Report to include the specification of nanomaterials present in the formula, including their chemical names (IUPAC) and other descriptors as specified in the preamble to Annexes II to VI, size of particles, physical and chemical properties.
What’s next?
The proposal will undergo legislative scrutiny by the European Parliament and Council of the EU.
Do you need assistance in placing your cosmetic products in the EU, UK, US, or Canadian market? Contact us.
References
European Commission. (2025). Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products. Retrieved on 8 July 2025.
European Commission. (2025). Annexes to the COM(2025)531 proposal. Retrieved on 8 July 2025.
European Commission. (2025). Commission staff working document accompanying the COM(2025)526 and COM(2025)531 Proposals for Regulations. Retrieved on 8 July 2025.
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