Chemicals legislation is quite a vivid regulatory arena. As is the case in the science of Chemistry itself there is also no standstill in chemicals legislation. Most of the relevant regulations are subject to chronic revisions. In order to keep up with the actual legislation beyond the efforts of a loose-leaf collection, the series CSL: Consolidated Substances Legislation has been created. This is the consolidated version of the European Cosmetics Regulation (August 2018).
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
Article 2 Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
(a) ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours;
(b) ‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
(c) ‘mixture’ means a mixture or solution composed of two or more substances;
(d) ‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;
(e) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;
(f) ‘end user’ means either a consumer or professional using the cosmetic product;
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.
- Quote paper
- Stefanie Merenyi (Author), 2018, COSMETICS: Regulation (EC) No 1223/2009, Munich, GRIN Verlag, https://www.grin.com/document/274383
