The Regulation 1223/2009 is the main legislative framework governing the manufacture, marketing and safety of cosmetic products in the European Union (EU) . This regulation has been designed to ensure that cosmetic products available on the European market are safe for consumers, and establishes clear and strict requirements for manufacturers, distributors and those responsible for these products.
In this article, we will take an in-depth look at Regulation 1223/2009, its main provisions and its impact on the cosmetics industry. This regulation is a key regulation on cosmetic products in the European Union.
Introduction to Regulation 1223/2009
Regulation (EC) No 1223/2009 of the European Parliament and of the Council, adopted on 30 November 2009, entered into force on 11 July 2013, replacing Directive 76/768/EEC. This new legal framework was developed to harmonise regulations relating to cosmetic products within the European market, eliminating disparities between Member States and strengthening safety controls.
The main objective of Regulation 1223/2009 is to protect human health by applying strict rules on the composition, labelling and safety assessment of cosmetic products before they are placed on the market. To this end, it establishes a series of responsibilities for cosmetic product manufacturers, as well as a control system based on shared responsibility between the competent national authorities and manufacturers.
The regulation assigns responsibilities to any natural or legal person who markets cosmetic products in the European Union, ensuring that both manufacturers and importers are designated as 'responsible persons' to ensure compliance with legal obligations.
Definition and Scope of the Regulation
Regulation (EC) No 1223/2009 of the European Parliament and of the Council is a fundamental regulation governing the marketing of cosmetic products in the European Union.
This regulation establishes a clear and detailed framework to ensure that all cosmetic products available on the European market are safe for consumers. Its provisions include a precise definition of what constitutes a cosmetic product, as well as the requirements necessary for its marketing, safety and health protection.
The regulation defines a cosmetic product as any substance or mixture intended to be applied to external parts of the human body, including the skin, hair, nails, lips and external genital organs, as well as teeth and oral mucosa, with the main purpose of cleaning, perfuming, modifying their appearance, protecting them, keeping them in good condition or correcting body odours. This definition is crucial to differentiate cosmetic products from other products such as medicines, which are subject to different regulations.
Main provisions of Regulation 1223/2009
1. Definition of Cosmetic Product
One of the first important aspects of the regulation is the clear definition of what constitutes a cosmetic product. According to the regulation, a cosmetic product is "any substance or mixture intended to be placed in contact with the external parts of the human body [...] or with the teeth and oral mucosa, for the exclusive or main purpose of cleaning them, perfuming them, modifying their appearance, protecting them, keeping them in good condition or correcting body odours".
This definition establishes a clear distinction between cosmetic products and medicinal products, which has significant implications for applicable regulations and marketing requirements.
2. Responsibility of the Manufacturer or Importer
The regulation assigns legal responsibility to the “person responsible” for the product, which may be the manufacturer or the importer in the case of products from outside the European Union.
This responsible person must ensure that the product complies with all applicable regulations before it is placed on the European market. Their duties include:
• Ensure that a safety assessment of the cosmetic product is carried out.
• Maintain a Product Information File (PIF) containing all relevant data about the product, including its composition, safety testing, and the report of a qualified assessor.
• Notify the European Commission about the product before it is placed on the market through the Cosmetic Product Notification Portal (CPNP).
3. Safety Assessment
One of the central pillars of Regulation 1223/2009 is the obligation to carry out a safety assessment before any cosmetic product can be placed on the market.
This assessment should be conducted by a qualified evaluator with a degree in pharmacy, toxicology, medicine or a related field, and should take into account both the individual ingredients of the product and its end use.
The security assessment must be documented in a report, which forms part of the PIF , which must be available to the competent authorities of the Member States in the event of an inspection.
4. Good Manufacturing Practices (GMP)
To ensure the quality and safety of cosmetic products, the regulation requires all manufacturers to comply with Good Manufacturing Practices (GMP) , which are aligned with the ISO 22716 standard. These practices cover all stages of production, from the selection of raw materials to the storage and distribution of the final product, ensuring that cosmetic products are manufactured under controlled and standardized conditions.
5. Substance Restrictions
Regulation 1223/2009 includes a list of prohibited and restricted substances that cannot be used in cosmetic products, or that can only be used under certain conditions. These lists are regularly updated to include new substances that may pose a risk to human health. The regulation also sets out specific prohibitions on the use of animal-derived ingredients in cosmetic products, especially those obtained through the slaughter of animals.
6. Requirements for the Marketing of Cosmetic Products
For a cosmetic product to be marketed in the European Union, it must comply with a series of requirements established in Regulation (EC) No 1223/2009. These requirements are essential to ensure the safety and protection of consumers' health. The main requirements include:
● Definition and Classification : The product must comply with the definition of a cosmetic product according to the regulation and be appropriately classified.
● Safety and Health Protection : Before being placed on the market, the product must undergo a safety assessment by a qualified assessor. This assessment must consider both the individual ingredients and the end use of the product.
● Consumer Information : Product labelling must provide clear and understandable information, including the name and address of the person responsible, the net content, the best-before date or PAO symbol, the list of ingredients and any precautions for use.
● Manufacturing and Quality Control : Manufacturers must follow Good Manufacturing Practices (GMP) to ensure that products are manufactured under controlled and standardized conditions.
● Labeling and Presentation : Labeling must be clear, legible and understandable, and must comply with the standards established in the regulation.
7. Animal Testing
A key aspect of Regulation 1223/2009 is the complete ban on animal testing for final cosmetic products as well as cosmetic ingredients. This ban has been a milestone in animal protection and has driven the development of alternative testing methods to ensure product safety without resorting to animal testing.
8. Labeling and Transparency for the Consumer
The regulation sets out clear requirements on the information that must be provided to consumers through the labelling of cosmetic products. Mandatory information includes:
• Name and address of the person responsible for the product.
• Weight or volume of the contents.
• Minimum duration date or PAO (Period After Opening) symbol.
• List of ingredients using the INCI nomenclature (International Nomenclature of Cosmetic Ingredients).
• Precautions for use, if any.
Furthermore, labelling must be clear, legible and understandable for consumers, thus guaranteeing their right to be informed about what they are buying and using.
9. Market Surveillance and Product Withdrawal
The regulation also establishes market surveillance mechanisms that allow competent authorities to monitor the compliance of cosmetic products with current regulations. In the event that a product does not comply with the requirements or represents a risk to health, the person responsible for the product must take corrective measures, which may include withdrawing the product from the market.
10. Annexes and Additional Provisions of the Regulation
Regulation (EC) No 1223/2009 includes several annexes and additional provisions that provide specific details on the marketing of cosmetic products in the European Union.
These annexes are essential to understand the technical and legal requirements that cosmetic products must meet. The main annexes include:
● Annex I : Establishes the requirements for the evaluation of the safety and health protection of cosmetic products.
● Annex II : Lists substances prohibited in the formulation of cosmetic products.
● Annex III : Details the substances that are permitted under certain restrictions.
● Annex IV : Provides a list of colorants permitted in cosmetic products.
● Annex V : Lists the permitted preservatives.
● Annex VI : Includes permitted UV filters.
In addition to these annexes, the regulation contains additional provisions establishing specific rules for the marketing of cosmetic products, ensuring that all products meet safety and quality standards before reaching the consumer.
Application and Validity of the Regulation in the European Union
Regulation (EC) No 1223/2009 is applicable in all Member States of the European Union and has been valid since 11 July 2013. This regulation is mandatory for all natural or legal persons placing cosmetic products on the market in the European Union, ensuring a high level of health protection and safety for consumers.
The European Commission The European Commission is responsible for the application and enforcement of the Regulation throughout the European Union. In addition, Member States are responsible for implementing and enforcing the Regulation in their respective territories. This includes market surveillance and taking corrective action in the event that products are detected that do not comply with the established requirements.
In summary, Regulation (EC) No 1223/2009 is a comprehensive regulation governing the marketing of cosmetic products in the European Union, setting clear rules for safety, health protection, consumer information, manufacturing and quality control, and product labelling. Its application in all Member States ensures a harmonised and safe market for cosmetic products in the EU.
Impact of Regulation 1223/2009 on the Cosmetics Industry
Regulation 1223/2009 has had a significant impact on the cosmetics industry, raising safety and quality standards. Companies must invest in rigorously assessing their products and creating efficient traceability systems to meet the requirements of the regulation. This has led to greater transparency and trust between consumers and cosmetic brands, while encouraging innovation in the development of safer and more sustainable products.
Conclusion
EU Regulation 1223/2009 is a comprehensive legal framework that ensures the safety of cosmetic products on the European market. By setting clear requirements on safety assessment, labelling, animal testing and good manufacturing practices, this regulation protects consumer health and encourages transparency and accountability within the cosmetics industry.
It is essential that cosmetic manufacturers, distributors and product managers understand and comply with this regulation to avoid penalties and ensure success in the competitive EU beauty products market.
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