Regulatory divergence

When Brexit became effective in January 2021, Great Britain (GB) adopted its own regulation on cosmetic products – the UK Cosmetics Regulation (Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain). The legal text mirrored that of EU Cosmetics Regulation (EC) 1223/2009 and only minor labelling amendments were necessary for products to be compliant both in the EU and GB (England, Scotland and Wales). However, recent changes to EU requirements for salicylic acid and titanium dioxide have caused divergence between the two regulations. Typically used in rinse-off hair products and body lotion (salicylic acid), and loose face powder and hair spray (titanium dioxide), the requirements affect the product types where these ingredients can be used, their maximum concentrations of use or their purity criteria. Details of the changes can be found in Commission Regulation (EU) 2021/850 of 26 May 2021 amending and correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

Scientific opinions

Amendments to the EU Cosmetics Regulation are based on the opinions of the EU Scientific Committee on Consumer Safety (SCCS). These opinions impact the cosmetic ingredients which get added to, restricted in, or removed from, the annexes of the EU Regulation.

Amendments to the UK Cosmetics Regulation are based on the opinions of the Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS), which is the SCCS equivalent in the UK.

The opinions of these two bodies may sometimes differ, and they may also have different timings for publication. This creates regulatory divergence. In the best-case scenario, where both SCCS and SAG-CS issue comparable opinions on a given ingredient, divergence may only span a few months until the changes are implemented in both regulations. In the worst-case scenario, where opinions differ, some ingredients will be differently regulated in the UK and in the EU. Manufacturers will then need to decide whether to create two different formulas to be able to sell their products in both the EU and GB markets, or to pursue a universal solution by following the strictest of the two regulations.

Fate of salicylic acid and titanium dioxide in UK

At the moment, the fate of salicylic acid and titanium dioxide in the UK is unknown. SAG-CS would need to assess the substances before anything is implemented in the UK Cosmetics Regulation; and the outcome and timing of this assessment cannot be predicted. However, as the EU Regulation on these ingredients is stricter than the UK, companies complying with the EU requirements should also be able to sell them on the GB market.

Cosmetics regulatory consultants

TSG can help you plan ahead to identify the ingredients in your formulations that may be affected by divergence. We can also guide you in choosing alternative ingredients as well as support you in finding the best solution to remain competitive. Get in touch at [email protected] for an informal chat with our regulatory consultants.