As 11 July 2013 fast approaches, are you ready to ensure compliance with Regulation 1223/2009 on cosmetic products? This new Regulation replaces the Cosmetics Directive 76/768 and is an extra layer of legislation on top of REACH and CLP.

The Regulation incorporates the following new requirements for all products placed on the market from 11 July 2013:

Responsible Person

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

The RP should ensure a product information file is kept for each cosmetic product. This should detail its composition, proof of claims made, declaration of compliance with good manufacturing practice and report any undesirable effects. This file 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

Cosmetic 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


Cosmetic products that contain nanomaterials must be notified to the European Commission six months before the product is placed on the market. All nanomaterials must be clearly indicated in the list of ingredients with each ingredient being followed by the word ‘nano’. If the European Commission has any concerns regarding the safety of a particular nanomaterial, it must request that the Scientific Committee on Consumer Safety (SCCS) provides an opinion on the safety of such nanomaterial for its stated use

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 European Union 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 can not be placed on the market. Alternative testing procedures must be adopted.

The Regulation aims to ensure that consumers’ health is protected and that they are well informed by monitoring the composition and labelling of products. However, to ensure compliance, the cosmetics industry needs to be prepared for the increased burden that this Regulation imposes.