The revised EU Cosmetics Legislation Giulia Ciarlo Unit “Cosmetics and Medical Devices” SOCIAL DIALOGUE PERSONAL SERVICES - Plenary Meeting 18 June 2009

Cosmetics Directive 76/768/EEC Purpose of the Cosmetics Directive: Safeguarding public health Ensuring free circulation of cosmetic products

Basic principles Directive addressed to Member States who have to transpose it into national law Safety guaranteed through in-market control (no pre-marketing authorization, but manufacturer responsibility) Member States cannot restrict market access for products complying with the Directive 12

Ensuring safety Art. 2: General safety-obligation Regulation of ingredients Labelling of ingredients Product information requirements, including safety assessment by manufacturer Notification of manufacturing/importing site

Regulation of substances (I) The “negative lists”: Annex II : prohibited substances (over 1300) Annex III : substances subject to restrictions and conditions (over 150) 5

Regulation of substances (II) The “positive lists”: Only listed substances are allowed for: Coloring agents (annex IV) Preservatives (annex VI) UV filters (annex VII) 7

Risk assessment, risk-management Permanent adaptation of Directive: Identification of the need to regulate an ingredient Safety file provided by the Industry Risk assessment by an independent Scientific Committee Proposal by the Commission to adapt Directive Vote of the Member States Adoption by the Commission

Product Information File Legal requirements: Qualitative/quantitative composition of product Physicochemical and microbiological specifications of ingredients and product Manufacturing methods Safety-assessment (for whole product) Undesirable health-effects

Labelling requirements Purpose: informing consumer, facilitating enforcement What information? Ingredients ( “INCI”) Nominal Content Precautions to be observed in use Period-after-opening Address of manufacturer/importer

Market Surveillance Member States are responsible for the surveillance of their market Cooperation and exchange of information through Platform of European Market Surveillance Authorities for Cosmetics (PEMSAC)

Committees Scientific Committee for Consumer Safety, SCCS (scientific experts) Working Group on Cosmetics (Member States + Industry, Consumers’ Groups and Animal Protection Groups  transparency) Standing Committee on Cosmetic Products (Member States)

Revision of the Cosmetics Directive New Cosmetics legislation in the form of a Regulation Introduction of new definitions Cosmetics Products Safety Assessment New rules on substances: CMR and nanomaterials Simplified notification Enhancement of market surveillance

New definitions "End user" means either consumers or professionals using the cosmetic product "Serious undesirable effect" means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death

Cosmetics Products Safety Assessment Minimum requirements listed in Annex I Obligation to keep a product information file readily accessible to the competent authorities remains

CMR substances No change for CMR 2 (old 3) CMR 1A and 1B - use possible if : The substance complies with the food safety requirements They are no suitable alternatives The request is for a particular use in cosmetic product The substance is found safe by the SCCS. Re-evaluation every 5 years Only for newly classified substances Specific labelling to avoid misuse

Nanomaterials A cosmetics-specific definition that can easily be adapted to scientific and international progress Labelling Pre-market notification

Simplified notification for all cosmetic products One centralized notification system at the EU level Managed by the EC For Competent Authorities and Anti-poison Centres

Market Surveillance MS obligation to perform in-market controls Obligation to communicate serious undesirable effects to competent authorities Communication on request of the list of products containing a specific substance and its concentration, if such substance raises concerns

New Cosmetics Regulation Adoption: expected after summer Application date: 3 ½ years after adoption

Thank you for your attention! http://ec.europa.eu/enterprise/cosmetics/index_en.htm Giulia.Ciarlo@ec.europa.eu