Quick Understandable EU Cosmetic Regulations 1223/2009 for Market Entry
Welcome to the fourth article in the Regulatory and Scientific series.
The EU Cosmetic Regulations 1223/2009* is a comprehensive legislative framework that governs the safety and labelling of cosmetic products within the EU market. This regulation, which came into full effect on July 11, 2013, aims to ensure a high level of protection for human health while simplifying the regulatory environment for businesses.
Key Objectives and Scope of the EU Cosmetic Regulations
The primary objective of the EU Cosmetic Regulations is to safeguard consumer health by ensuring that cosmetic products are safe for use. This regulation applies to all EU marketed products defined as cosmetics by Article 2* of said regulations which includes skincare, haircare, makeup, and personal hygiene products.
Main Provisions and Actions to Take
1. Safety Assessment and Product Information File (PIF)
As per Article 3*, a cosmetic product made available onto the EU market must be “…safe for human health when used under reasonably and foreseeable conditions of use…”.
Actions: As such, every cosmetic product must undergo a safety assessment (Article 10)* and results must be documented in a Product Information File (PIF) Article 11*.
The PIF must be readily accessible to EU regulatory authorities once products have been notified and subsequently launched onto the EU market.
2. Responsible Person
A “Responsible Person” (RP) is accountable for the compliance of each cosmetic product in the EU under Article 5*.
Actions: To place a cosmetic product on the EU market, a Brand owner must designate an RP within the EU (Article 4)* and must note their various obligations to fulfil.
3. Notification and CPNP
The Cosmetic Products Notification Portal (CPNP) is a centralised IT system which facilitates market surveillance, ensures transparency and informs all “EU Member States” of cosmetic products present on the EU market.
Actions: Before a cosmetic product can be sold in the EU, it must be notified on the CPNP Portal – Article 13*.
4. Labelling Requirements
Article 19* of the regulation mandates specific labelling requirements which MUST be on each cosmetic product label artwork (see below).
Actions: All of these mentions are discussed in detail in our EU Hot Topics course and should you need further guidance, feel free to book a FREE Consultation with us.
5. Restrictions on Substances
Certain substances are prohibited or restricted in cosmetic products in Annexes II and III respectively of the regulation.
Actions: This means that substances deemed not safe for use can NOT be used in cosmetics (Annex II) and those restricted, must be used within the conditions as stated in Annex III.
Positive Lists (Annexes IV – VI) are for colorants of the products, preservatives and UV-filters respectively.
Actions: you can only use those listed in these Annexes IV – VI for the aforesaid functions and within the restrictions laid down.
6. Animal Testing
The EU cosmetic regulations enforces a ban on animal testing for cosmetic products as well as their ingredients, and promotes alternative methods for safety assessment.
Actions: Therefore, you must do due diligence on your raw material suppliers to ensure they have not tested their raw materials on animals.
Detailed Examination of Key Provisions
1. Safety Assessment and Product Information File (PIF)
The safety assessment (Article 10*) is a critical component of the regulation. It involves a thorough evaluation of the cosmetic product’s ingredients, their concentrations, and potential interactions as well as systemic exposure and so forth.
The Product Information File (PIF) (Article 11*) must include detailed information such as the qualitative and quantitative composition of the product, the physical and chemical characteristics of the raw materials, the stability of the cosmetic product under reasonably foreseeable conditions of storage, etc.
2. Responsible Person
The Responsible Person (Article 4*) plays a pivotal role in ensuring compliance with the regulation.
This individual or entity must be established within the EU and is responsible (Article 5*) for maintaining the PIF, ensuring the product is safe, complying with labelling and ingredient requirements, certifying good manufacturing practices (GMP), carrying out notifications, validating claims, giving information to the public and monitoring cosmetovigilance.
The Responsible Person is also the point of contact for any inquiries from regulatory authorities.
3. Notification and CPNP
The Cosmetic Products Notification Portal (CPNP) (Article 13*) is an online platform where manufacturers and importers must submit information about their products before they are placed on the market. This notification includes details such as the product’s category, name, ingredient listing, artwork, Responsible Person’s contact information etc.
The CPNP helps centralise and streamline the notification process and enhances market surveillance.
4. Labelling Requirements
Labelling (Article 19*) is a crucial aspect of the EU cosmetic regulations, aimed at providing consumers with essential information about the cosmetic product.
Labels must include the statement of identity or product function, nominal content at time of filling, the list of ingredients in descending order of weight, the name and address of the Responsible Person, etc. Additionally, any precautions for use, warnings and a batch number for product identification must be clearly indicated.
The language used must be that of the EU member state where the products will be sold.
5. Restrictions on Substances
The EU regulation includes strict controls on the use of certain substances in cosmetic products. The restrictions in the Annexes II – VI are based on scientific assessments conducted by the Scientific Committee on Consumer Safety (SCCS) to ensure that cosmetic products do not pose a risk to human health.
6. Animal Testing
One of the most significant aspects of Regulation 1223/2009 is the ban on animal testing. This ban applies to both finished cosmetic products and their ingredients. The regulation encourages the use of alternative methods for safety assessment, such as in vitro testing and computer modelling. This move aligns with the EU’s commitment to animal welfare and the development of innovative testing methods.
Impact on the Industry
The implementation of the EU Cosmetic Regulations 1223/2009 has significantly impacted the cosmetic industry. It has harmonised the regulatory landscape across EU member states, reduced administrative burdens and fostered a single market for cosmetics. Companies now benefit from clearer guidelines and a more predictable regulatory environment.
Moreover, the regulation has driven innovation within the industry. For example, the ban on animal testing has spurred the development of alternative testing methods, leading to advancements in scientific research and technology. Companies are now investing in new techniques to ensure the safety of their products without the need for animal testing.
Conclusion
The EU Cosmetic Regulations 1223/2009 represents a robust framework designed to protect consumers and ensure the safety of cosmetic products. By adhering to these regulations, companies can confidently market their products within the EU, knowing they meet stringent safety and quality standards.
If you liked this article and wish to know more about the EU Cosmetic Regulations and placing your products on the EU market then why not check out our EU Hot Topics training course which offers more valuable insights.
Should you need guidance on creating an artwork and/or a go to EU market strategy, book a FREE Consultation with us … we’ll be happy to help.
