COSMETICS: Regulation (EC) No 1223/2009

Table of contents of the consolidated version

1. List of corrigenda and amendments considered in this consolidated version

2. Recitals (no longer part of the consolidated version)

3. Text of the regulation

3.1 CHAPTER I

3.1.1 SCOPE AND DEFINITIONS

3.1.1.1 Article 1 Scope and objective

3.1.1.2 Article 2 Definitions

3.2 CHAPTER II

3.2.1 SAFETY, RESPONSIBILITY, FREE MOVEMENT

3.2.1.1 Article 3 Safety

3.2.1.2 Article 4 Responsible person

3.2.1.3 Article 5 Obligations of responsible persons

3.2.1.4 Article 6 Obligations of distributors

3.2.1.5 Article 7 Identification within the supply chain

3.2.1.6 Article 8 Good manufacturing practice

3.2.1.7 Article 9 Free movement

3.3 CHAPTER III

3.3.1 SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION

3.3.1.1 Article 10 Safety assessment

3.3.1.2 Article 11 Product information file

3.3.1.3 Article 12 Sampling and analysis

3.3.1.4 Article 13 Notification

3.4 CHAPTER IV

3.4.1 RESTRICTIONS FOR CERTAIN SUBSTANCES

3.4.1.1 Article 14 Restrictions for substances listed in the Annexes

3.4.1.2 Article 15 Substances classified as CMR substances

3.4.1.3 Article 16 Nanomaterials

3.4.1.4 Article 17 Traces of prohibited substances

3.5 CHAPTER V

3.5.1 ANIMAL TESTING

3.5.1.1 Article 18 Animal testing

3.6 CHAPTER VI

3.6.1 CONSUMER INFORMATION

3.6.1.1 Article 19 Labelling

3.6.1.2 Article 20 Product claims

3.6.1.3 Article 21 Access to information for the public

3.7 CHAPTER VII

3.7.1 MARKET SURVEILLANCE

3.7.1.1 Article 22 In-market control

3.7.1.2 Article 23 Communication of serious undesirable effects

3.7.1.3 Article 24 Information on substances

3.8 CHAPTER VIII

3.8.1 NON-COMPLIANCE, SAFEGUARD CLAUSE

3.8.1.1 Article 25 Non-compliance by the responsible person

3.8.1.2 Article 26 Non-compliance by distributors

3.8.1.3 Article 27 Safeguard clause

3.8.1.4 Article 28 Good administrative practices

3.9 CHAPTER IX

3.9.1 ADMINISTRATIVE COOPERATION

3.9.1.1 Article 29 Cooperation between competent authorities

3.9.1.2 Article 30 Cooperation regarding verification of product information files

3.10 CHAPTER X

3.10.1 IMPLEMENTING MEASURES, FINAL PROVISIONS

3.10.1.1 Article 31 Amendment of the Annexes

3.10.1.2 Article 32 Committee procedure

3.10.1.3 Article 33 Glossary of common ingredient names

3.10.1.4 Article 34 Competent authorities, poison control centres or assimilated entities

3.10.1.5 Article 35 Annual report on animal testing

3.10.1.6 Article 36 Formal objection against harmonised standards

3.10.1.7 Article 37 Penalties

3.10.1.8 Article 38 Repeal

3.10.1.9 Article 39 Transitional provisions

3.10.1.10 Article 40 Entry into force and date of application

Objectives and Themes

The primary objective of this document is to provide a consolidated version of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, establishing regulatory compliance rules for market availability and consumer safety.

• Safety and legal responsibility for cosmetic products within the European Community market.
• Procedures for safety assessments, product information files, and mandatory notifications.
• Restrictions and prohibitions regarding specific chemical substances, nanomaterials, and animal testing.
• Requirements for consumer information, including labelling and product claims.
• Market surveillance, administrative cooperation between authorities, and final implementation provisions.

Excerpt from the Book

Summary of Chapters

CHAPTER I: SCOPE AND DEFINITIONS: Establishes the fundamental rules, objectives, and legal definitions necessary for interpreting the regulation.

CHAPTER II: SAFETY, RESPONSIBILITY, FREE MOVEMENT: Outlines the safety obligations of products and the specific roles and liabilities of manufacturers, distributors, and responsible persons.

CHAPTER III: SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION: Details the requirements for mandatory safety reporting, documentation of product information, and product notification to the Commission.

CHAPTER IV: RESTRICTIONS FOR CERTAIN SUBSTANCES: Defines limitations for specific chemical substances, including CMR substances and nanomaterials.

CHAPTER V: ANIMAL TESTING: Sets out the legal framework prohibiting the use of animal testing for cosmetic product development and evaluation.

CHAPTER VI: CONSUMER INFORMATION: Regulates labeling requirements, permissible product claims, and public access to safety information.

CHAPTER VII: MARKET SURVEILLANCE: Governs the oversight mechanisms for market monitoring and the reporting of serious undesirable effects.

CHAPTER VIII: NON-COMPLIANCE, SAFEGUARD CLAUSE: Specifies the enforcement powers and administrative measures for handling non-compliant products.

CHAPTER IX: ADMINISTRATIVE COOPERATION: Establishes protocols for collaboration between Member States and the Commission regarding regulatory enforcement.

CHAPTER X: IMPLEMENTING MEASURES, FINAL PROVISIONS: Covers the adaptation of technical annexes, committee procedures, and transition timelines.

Keywords

Cosmetic Products, Regulation (EC) 1223/2009, Consumer Safety, Responsible Person, Product Information File, Nanomaterials, CMR Substances, Animal Testing, Market Surveillance, Labelling, Product Claims, Chemical Legislation, European Union, Compliance, Good Manufacturing Practice.

Frequently Asked Questions

What is the primary scope of this regulation?

The regulation provides a consolidated legal framework for cosmetic products to be made available on the European market, ensuring a high level of protection for human health and the proper functioning of the internal market.

Who is responsible for the safety of a cosmetic product?

A designated legal or natural person within the Community must act as the 'responsible person' to ensure the product complies with all relevant obligations set forth in the regulation.

What documentation must be maintained for each product?

The responsible person must maintain a 'product information file' (PIF) that includes, among other things, the cosmetic product safety report, a description of the manufacturing method, and proof of any claimed effects.

How are nanomaterials managed under this regulation?

Products containing nanomaterials must be notified to the Commission six months prior to being placed on the market, unless they were already on the market before specific dates, and must meet rigorous safety requirements.

What is the status of animal testing in this regulation?

The regulation strictly prohibits animal testing for finished cosmetic products and ingredients within the Community to meet regulatory requirements, promoting the use of validated alternative methods.

Which criteria are used for labeling cosmetic products?

Labelling must include the responsible person's details, nominal content, date of minimum durability (or period after opening), usage precautions, the function of the product, and a full list of ingredients.

What happens in case of non-compliance?

Competent authorities have the power to require the responsible person to take corrective actions, including withdrawal or recall of the product, if it is found to be in non-conformity with the safety or regulatory requirements.

What is the role of the Scientific Committee on Consumer Safety (SCCS)?

The SCCS is consulted by the Commission for technical and scientific advice, particularly concerning the safety of ingredients, CMR substances, and the evaluation of potential health risks associated with cosmetic products.