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

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

3. 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

4. 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

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

6. 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

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

8. 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

9. 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

10. 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)

11. 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)

12. 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

13. 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

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

15. 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

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

17. 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

18. 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

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

20. Thank you for your attention!