Cosmetics Regulation EU 1223/2009

Cosmetics Regulation EU 1223/2009 provides the main regulatory framework for cosmetics and personal care products placed on the market in the EU.

The regulation replaces the previous Cosmetic Directive 76/768/EC which had been in force since 1976, so various updates were needed, including:

• Stricter safety requirements.
• A designated “Responsible Person”
• Centralised notification portal for product registration
• Reporting of serious undesirable effects (SUE)
• New rules for nanomaterials

The EU Cosmetics Regulation applies to finished products but refers to expectations regarding the ingredients used.  For example, some ingredients are restricted for safety reasons and annexes to the regulation list more than 1300 specifically prohibited substances (Annex II) and over 250 restricted ones (Annex III).  Some ingredient categories are subject to specific rules and only those on the approved list may be used.  These are colours (Annex IV), preservatives (Annex V) and UV filters (Annex VI).

Detailed guidance on the information required in a Cosmetic Product Safety Report (CPSR) is given in Annex I, including the toxicological profile for each ingredient.  This should pay special attention to local exposure (skin and eye) but should also address any potential routes of absorption leading to systemic exposure.  A margin of safety (MoS) is calculated from a no observed adverse effects level (NOAEL). 

THE ANIMAL TESTING BAN

The EU Cosmetics Regulation includes an animal testing ban that has been in full effect since 2013.  The ban, covered in Article 18, covers:

• Animal testing on finished products and ingredients within the EU
• Marketing products and ingredients in the EU that have been tested on animals anywhere in the world

WHAT ABOUT TESTING INGREDIENTS FOR REACH?

REACH makes provision for the safety of cosmetic ingredients to be assessed using animal-free approaches, but there are some caveats.  These include testing that may be considered essential to protect the safety of manufacturing workers, who need to handle chemicals in a neat or highly concentrated form.  ECHA issued some clarification in 2014, and detailed guidance on the use of non-animal approaches in 2017, but it is still a hotly debated topic and has been contested by some large companies.  In our experience, a variety of approaches are adopted throughout the industry in Europe and beyond, with many companies avoiding the need for any animal testing using Weight of Evidence approaches. 

BREXIT

The UK played an integral part in the development and implementation of the EU animal testing ban.  Industry organisations advise that there are no plans to revert to animal testing for cosmetic products or to change the current requirements of REACH, whatever the outcome of the Brexit negotiations. To keep up to date on the current status, we recommend checking the latest Brexit news on the website of trade body the Cosmetic Toiletry & Perfume Association (CTPA).

REGULATORY CONSULTANCY

The safety assessment of a cosmetic product should be done by a qualified professional and includes the consideration of existing safety data, identifying potential needs for additional testing to fill any knowledge gaps.  If you don’t have this expertise within your company, we can provide you with regulatory consultancy through our carefully selected partner organisations.