CMR derogations, nanomaterials in scope of EU cosmetics regulation simplification

Chemical Watch News

Leaked omnibus proposal to relieve ‘unnecessary compliance’ burden

Cosmetic products Regulation
Chemical restrictions
Chemical notification/ registration
Product registration/ notification
EU

Cosmetics - woman applying makeup © Isuru stock.adobe

The European Commission is planning to propose significant changes to parts of the Cosmetic Products Regulation (CPR) to address compliance obligations raised by the chemicals industry, according to major documents seen by Chemical Watch News & Insight.  

The EU executive’s proposal takes the form of a 100-page draft Commission staff working document and a 52-page explanatory memorandum, forming part of the highly anticipated chemicals omnibus package due on 8 July.   

The package also includes key updates to the CLP and fertilising products regulations.  

As part of its simplification agenda, the Commission says it aims to "relieve the cosmetics manufacturers, especially SMEs, from the unnecessary compliance and administrative burden" by addressing five core concerns raised during a recent industry workshop:  

  • the lack of clear and comprehensive procedure for adding colourants, preservatives and UV filters to annexes IV-VI of the CPR;  
  • Article 15 – the procedure for banning and requesting derogations for CMR substances;  
  • pre-notification requirements for products containing nanomaterials (Article 16);  
  • publication of the glossary of cosmetic ingredients in the Official Journal of the EU; and   
  • outdated or obsolete reporting obligations.  

The Commission is also proposing changes to market surveillance reporting (Article 22) to ease pressure on member states.  

Earlier this month, the EU executive confirmed that work on the full revision of the CPR and its simplification under the omnibus would proceed in parallel.  

Omnibus amendments

The Commission said the amendments would "maintain the high level of safety of cosmetic products made available to consumers on the EU market, while setting out in a more explicit manner the current requirements and [ways of] reducing the unnecessary reporting obligations for businesses and the competent authorities".    

It plans to establish a procedure for adding colourants, preservatives and UV filters to the CPR annexes to facilitate the process and accelerate the use of new cosmetic ingredients.  

It also intends to detail the existing derogation procedure for substances classified as carcinogenic, mutagenic or reprotoxic (CMR) in cosmetic products, "considering the experience gained over more than ten years of practice".   

Digitialising the glossary of common ingredient names will, according to the Commission, "ensure accurate and up-to-date labelling, reduce regulatory risks and [minimise] compliance errors".   

Meanwhile, removing the current pre-notification requirements for cosmetic products containing nanomaterials – in addition to standard product notification – will reduce the administrative burden on businesses and member states.  

The proposed measures will allow industry "to shift financial and human resources from compliance and administrative tasks to R&D and innovation", the Commission said, adding that these changes give companies the opportunity to be more competitive in the EU and global arena.  

From the CPR’s application date of 2013, the Commission has adopted more than 50 amendments to ensure consumer safety, harmonise market rules and promote a level playing field within the cosmetics sector.   

The complexity of the regulation, combined with challenging economic conditions, led to a Reality Check workshop on cosmetics on 16 May. The Commission said 226 stakeholders joined the online meeting to share views on regulatory issues, with more than 50 submitting written feedback that it factored into the proposal.