EU Cosmetics Regulation
EU Cosmetics Regulation – meet the requirements of Regulation EC 1223/2009 with SGS.
Cosmetic Products Regulation EC 1223/2009 came into force in 2009, took full effect from 11 July 2013 and supersedes Directive 76/768/EEC. Compliance with the Cosmetics Regulation is compulsory for products offered for sale within the EU.
What is a cosmetic product?
A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body, or with the teeth and mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.
Regulation EC 1223/2009 compliance checklist
We manage your compliance to the Cosmetic Products Regulation by devising a compliance checklist to assist your firm in gaining or maintaining its foothold in the EU. Our experts can assist you every step of the way, including:
- Notification via the European Electronic Portal
- Product Information File (PIF)
- Detailed Cosmetic Safety Assessment (CSA)
- Roles and responsibilities of the Responsible Person
- Country of origin
- Reporting of serious adverse effects
- Carcinogenic, Mutagenic and Toxic for Reproduction substances (CMRs)
Notification via the European electronic portal
The product notification process is simplified with the introduction of a single harmonized ‘e-notification’ system for all markets in which the product is sold.
Data review for the product information file (PIF)
Now standardized across the EU, all PIFs must comply with EC 1223/2009 Article 11. The PIF must be kept for 10 years after the last batch of the product is placed on the market.
Broadly speaking, the EU Cosmetic Regulation does not apply to tissue and hygiene products, but exceptions do occur, on a product by product basis.
Tissue and hygiene products are classed as an article, not a substance or mixture. It is these, substances and mixtures, which must comply with Regulation EC 1223/2009. We can advise you in more detail on the need for compliance where a finished product includes a substance or preparation.
Our fully equipped, state of the art facilities (in Europe, Asia & the USA) offer full testing for compliance to the EU cosmetic regulation.