On July 11, 2013, new EU Cosmetics Regulations (EC No 1223/2009) will replace the old Cosmetics Directive (76/768/EEC). This is intended to harmonize and simplify regulations across member states. We have summarized some of the key changes:
Cosmetic Product Safety Report – CPSR will be a mandatory part of the Product Information File (PIF) and will contain all safety-related information about the product.
Responsible Person – New regulations place clearly defined legal obligations on a ‘Responsible Person’ to ensure that the product placed on the market is compliant. This person will serve as the primary contact for all inquiries regarding the product’s compliance and will have his/her name and contact information on the label. Contact FPR for assessing the eligibility requirements of a ‘Responsible Person’ in your company and what his/her obligations entail.
Nanomaterials – Notification of such ingredients must be submitted six months before placing the product on the market. In addition, they will need to be identified on the product label by using the ingredient name followed by ‘nano’ in brackets. FPR consultants can identify these ingredients according to the new EU definition and help you meet all the new requirements.
Labeling – The country of origin must be indicated on the label. A new ‘hour glass’ symbol will be used to indicate products with durability of less than 30 months and a date of minimum durability will need to be specified.
Notification – A new centralized electronic notification system called Cosmetic Products Notification Portal (CPNP) will replace the old method of notifying national authorities.
Animal Testing – Animal testing has been banned in the EU since the 7th Amendment of the Cosmetics Directive in 2009, however certain exemptions for testing repeated-dose toxicity, reproductive toxicity, and toxicokinetics were available; these are no longer granted as of March 11, 2013. Currently, the EU is having a difficult time with finding reasonable alternatives to animal testing. Initiatives like the Safety Evaluation Ultimately Replacing Animal Testing (SEURAT), started in 2011, have begun to look for testing methods to replace animal testing. Note that all alternative testing must be validated and endorsed by the EU Reference Laboratory on Alternatives to Animal Testing (EURL ECVAM) or other international testing validation authorities (e.g. OECD or ICCVAM).
There is no doubt that the new regulations will have a great impact on companies doing business in Europe. Generally speaking, the cosmetic regulations in the EU are tightening up. FPR consultants have an up-to-date knowledge of the EU cosmetic regulations and the experience to help your company excel in the changing regulatory climate.