The Cosmetics Directive 76/768 includes the simplifying of procedures and streamlining terminology and strengthening certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.
The new directive will act as an extra layer of legislation on top of REACH and CLP and aims to ensure that consumers’ health is protected and that they are well informed by monitoring the labelling of products.
“The aim is to simplify the legal framework for economic activities in the EU which was identified as one of the key issues on the better regulation agenda in the Commission Communication "Better regulation for growth and jobs in the European Union.”
To ensure compliance, industry professionals will need to be prepared for the increased responsibility that this regulation imposes and requirements for all cosmetics placed on the market from the 11th of July are as follows:
Nominate a 'Responsible person'
First and foremost the regulation requires that each cosmetic product is linked to a responsible person (RP). This can be either the manufacturer, the importer or the distributor. The manufacturer and the importer can delegate this responsibility to a third party.
Product Information File
Next the 'RP' should ensure an information file is kept for each cosmetic product which should be maintained throughout the life of the product and be located at an address which is to appear on the label of the product including details like its composition, proof of claims made, declaration of compliance with good manufacturing practice and report any undesirable effects.
Safety Report
Prior to placing any cosmetic product on the market, the RP must ensure a full safety assessment is undertaken. The Regulation splits this into Part A and Part B. Part A contains the Cosmetic Product Safety Information and includes data on formulation, packaging, exposure and normal and reasonably foreseeable uses. Part B contains the Cosmetic Product Safety Assessment. An assessor will review the data in Part A and a provide an opinion as to whether the product is safe to go to market.
Nanomaterials
Cosmetic products that contain nanomaterials must be notified to the EC six months before the product is placed on the market and must be clearly indicated in the list of ingredients with each ingredient being followed by the word ‘nano’.
Restriction on Product Claims
Any labelling and advertising of cosmetic products “shall not be used to imply that products have characteristics or functions which they do not have.” Furthermore the European Commission is to consult the SCCS and other relevant authorities to produce a list of common criteria for claims. This list could restrict the claims made about cosmetic products.
Animal Testing
The Regulation prohibits the testing of animals in the EU for finished products and ingredients or combinations of ingredients. Also products where the final formulation has been the subject of animal testing or products containing ingredients or combinations of ingredients which have been the subject of animal testing cannot be placed on the market. Alternative testing procedures must be adopted.