Labelling Requirements for Cosmetic Products under European Regulation 1223/2009
Introduction
The European Union has established rigorous guidelines to ensure the safety and quality of cosmetic products on the market. Central to these guidelines is the European Cosmetics Regulation 1223/2009, which governs the sale of finished cosmetic products within the EU. This regulation is designed to protect the health and safety of consumers while ensuring the free movement of products across European borders. One of the key aspects of this regulation is labelling, which provides vital information about the product’s origin, safety, and intended use. Article 19 of the regulation outlines the mandatory labelling requirements for cosmetic products, ensuring that all products placed on the EU market are properly identified and that consumers can make informed decisions.
In this article, we will explore the key mandatory labelling requirements under Article 19 of the European Cosmetics Regulation 1223/2009, discussing the significance of each piece of information and the responsibilities of manufacturers and responsible persons (PRs) to comply with these regulations.
1. Name and Address of the Responsible Person (PR)
The responsible person (PR) is a central figure in the regulation of cosmetic products. According to Article 19 of the regulation, every cosmetic product placed on the EU market must clearly display the name and address of the responsible person. The PR is either a natural or legal person established within the EU who ensures that the cosmetic product complies with the requirements of Regulation 1223/2009. This person assumes responsibility for the safety and quality of the product, as well as for meeting all legal obligations related to its sale.
The responsible person must ensure that the cosmetic product:
- Complies with the safety assessment requirements.
- Is manufactured according to good manufacturing practices (GMP).
- Has appropriate labelling and packaging.
- Is correctly notified in the Cosmetic Product Notification Portal (CPNP) before being placed on the market.
The PR’s name and address must be indelibly, easily legible, and visible on the product packaging. This requirement ensures that consumers or regulatory authorities can contact the PR in case of issues, such as safety concerns or product recalls.
2. Country of Origin
The country of origin refers to the country in which the cosmetic product was manufactured or assembled. This information must also be included on the product label, as it provides consumers with transparency regarding where the product comes from. The purpose of indicating the country of origin is to help trace the product back to its manufacturing site, especially in the event of product recalls or investigations into safety concerns.
While not all countries require the indication of origin on product packaging, the EU’s regulations demand it for cosmetics. For multinational brands or products manufactured in third countries, this is an important part of ensuring traceability and safety compliance.
3. Nominal Content
The nominal content refers to the amount of product contained in the package. This information must be provided in grams (g) for solid products or millilitres (ml) for liquid products. The nominal content should be clearly visible on the packaging and must not be misleading to the consumer.
For cosmetic products, the nominal content is critical because it helps consumers understand how much product they are purchasing. This information is especially important for products that are intended to be used in specific quantities, such as shampoos, conditioners, or face creams. Accurate and transparent labelling also allows for better price comparison between different brands or product types.
It is important to note that the nominal content should reflect the amount of product in the packaging, not including any packaging material or air space within the container. For example, a bottle of liquid shampoo labelled as containing 250 ml should have exactly that amount of liquid, not counting any excess air space or packaging.
4. Minimum Durability Date (MDD) and Period After Opening (PAO)
The Minimum Durability Date (MDD), commonly known as the expiration date, is an essential labelling element for certain cosmetic products. It refers to the date until which the cosmetic product is guaranteed to remain safe and effective when stored correctly. For products with a shelf life of more than 30 months, the MDD must be indicated clearly on the label.
For products with a shelf life of less than 30 months, the Period After Opening (PAO) symbol must be displayed. This symbol represents the length of time after opening the product during which it can still be used safely. The PAO symbol is typically accompanied by a number, such as “6M” for six months or “12M” for twelve months, to indicate the safe usage period after the product has been opened.
Some cosmetic products, such as single-dose applications or fragrances, are exempt from displaying an MDD or PAO. These products generally have a lower risk of degradation because they are less likely to be exposed to environmental factors like air or light. Additionally, products with a high alcohol content, such as perfumes, do not usually require an MDD or PAO due to their inherent stability.
5. Special Precautions for Use and Warnings
Each cosmetic product may have specific precautions for use or warnings depending on its ingredients, intended use, and the potential risks associated with it. Article 19 requires that these precautions be clearly displayed on the product label, ensuring consumers are informed about any necessary safety measures when using the product.
For example, a product containing a high concentration of essential oils might require a warning advising consumers to avoid contact with eyes or to perform a patch test before use. Similarly, a hair dye product may include a warning to do a patch test 48 hours before use to avoid allergic reactions.
These warnings are particularly important for products intended for sensitive areas of the body, such as the eyes or mucous membranes. Additionally, products containing certain ingredients, such as allergens or preservatives, must clearly list these substances on the label to help individuals with allergies or sensitivities avoid potential reactions.
6. Batch Number
A batch number is a unique identifier that allows the manufacturer to trace the production batch of a product. The inclusion of a batch number on cosmetic products is mandatory under the regulation, and it is vital for ensuring product traceability.
In the event of a safety issue or product recall, the batch number allows authorities and manufacturers to quickly identify and remove potentially harmful products from the market. For example, if a batch of face cream is found to be contaminated with a harmful substance, the batch number helps pinpoint the specific products that need to be recalled.
The batch number must be printed on the product packaging in a clear, legible format and should be easily distinguishable from other information on the label.
7. Function of the Product
Every cosmetic product must have its function clearly indicated on the packaging. This function must describe the purpose of the product in a way that avoids confusion and potential misuse. For instance, the label of a shampoo would include the function as “cleanses and nourishes hair,” while a moisturizer might indicate “hydrates and soothes skin.”
Indicating the function of the product helps consumers make informed choices, ensuring that they select the right product for their needs. Clear function labelling also helps avoid misuse. For example, a product intended for use on the body should not be confused with one intended for use on the face.
8. List of Ingredients (INCI List)
The List of Ingredients, also known as the INCI list (International Nomenclature of Cosmetic Ingredients), is one of the most important aspects of cosmetic labelling. The INCI list provides a detailed breakdown of all the ingredients used in the product, listed in descending order of their weight or concentration.
The regulation mandates that ingredients used in cosmetic products be listed on the packaging to ensure full transparency. Ingredients are listed according to their INCI name, which is an internationally recognized naming system that standardizes the identification of ingredients. This system helps consumers and regulatory bodies easily recognize and understand the ingredients used in a cosmetic product.
Ingredients that make up less than 1% of the total product weight can be listed in any order after those making up more than 1%. However, certain ingredients, such as allergens or preservatives, may require specific mention regardless of their percentage in the formulation. This is especially important for individuals with allergies or sensitivities.
The INCI list helps consumers avoid ingredients that may cause irritation or allergic reactions, making it a critical part of cosmetic product labelling. For example, a consumer with a known sensitivity to parabens would be able to quickly identify the presence of these chemicals on the label.
Conclusion
The labelling requirements outlined in Article 19 of the European Cosmetics Regulation 1223/2009 serve as a cornerstone for ensuring the safety, transparency, and traceability of cosmetic products on the European market. By providing key information such as the responsible person’s contact details, the product’s country of origin, its ingredients, and specific usage instructions, these labelling requirements empower consumers to make informed decisions while also enabling manufacturers and regulatory authorities to monitor product safety and quality.
For manufacturers and distributors, compliance with these labelling obligations is not just a legal requirement but also an essential step in building trust with consumers. Clear, accurate, and easily readable labelling ensures that cosmetic products can be used safely and responsibly, helping to maintain public confidence in the cosmetics industry.
How TOXLAB Can Support Your Cosmetics Product Registration in the EU and UK
Entering the European and UK markets with your cosmetic products requires compliance with a series of strict regulatory requirements to ensure safety, quality, and transparency. Navigating through the maze of regulations, including those set out by the European Cosmetics Regulation 1223/2009 for the EU and the UK Cosmetics Regulation 2020, can be a complex process. This is where TOXLAB can provide invaluable support, offering a range of services that facilitate the smooth registration and market access for your cosmetic products in both regions.
TOXLAB is a reputable provider of regulatory, safety, and compliance services, specializing in cosmetic products. Their expertise can guide you through the registration processes, ensuring that your products meet the legal requirements for both the European Union (EU) and the United Kingdom (UK) markets.
How TOXLAB can assist your business in navigating the regulatory landscapes of the EU and UK, covering everything from product safety assessments to regulatory compliance and market access.
- Understanding EU & UK Cosmetics Regulations
Before diving into how TOXLAB can assist, it’s important to understand the two main regulatory frameworks that govern cosmetic products in the EU and UK.
EU Cosmetics Regulation 1223/2009
The European Union’s Cosmetics Regulation 1223/2009 is the cornerstone of cosmetic product safety and compliance within the EU. It lays down the rules and obligations that all cosmetic products must adhere to before being placed on the market. The regulation covers a wide range of topics, including:
- Product safety and testing: Ensuring that cosmetic products are safe for human health.
- Labelling requirements: Outlining the mandatory information that must appear on cosmetic product labels, such as the name and address of the responsible person, the ingredients, warnings, and the minimum durability date.
- Cosmetic Product Notification Portal (CPNP): Before being sold, all cosmetic products must be notified through the CPNP, an online platform that provides EU member states with important product details.
UK Cosmetics Regulation 2020
After Brexit, the UK established its own regulatory framework for cosmetics, which is largely based on the EU Cosmetics Regulation but with a few notable differences. The UK Cosmetics Regulation 2020 applies to all cosmetic products sold in Great Britain (England, Scotland, and Wales). Northern Ireland follows the EU Cosmetics Regulation due to the Northern Ireland Protocol.
The main requirements include:
- Product safety assessments: Just like in the EU, products must undergo safety evaluations to ensure they do not pose any risk to consumers.
- Responsible Person: A UK-based Responsible Person must be designated for each product.
- Product Registration: Cosmetics sold in Great Britain must be registered with the UK Submit system (the UK equivalent of the EU’s CPNP).
- Key Services Provided by TOXLAB
TOXLAB specializes in helping businesses ensure that their cosmetic products meet the regulatory requirements for both the EU and UK markets. Here are some of the key services they provide to support your cosmetic product registration:
- a) Safety Assessment and Cosmetic Product Safety Report (CPSR)
One of the most critical requirements for both the EU and UK is that all cosmetic products must undergo a safety assessment to ensure they do not pose a risk to human health. This assessment is an essential part of both the EU Cosmetics Regulation 1223/2009 and the UK Cosmetics Regulation 2020.
TOXLAB’s role:
TOXLAB offers comprehensive safety assessments in line with both EU and UK regulations. Their expert toxicologists conduct thorough safety evaluations based on the formulation and intended use of your product. This includes:
- Toxicological profile of individual ingredients.
- Microbiological testing to ensure the product is free from harmful bacteria or fungi.
- Dermal irritation and sensitization testing (if applicable).
- Risk assessments for specific product types, such as color cosmetics, hair dyes, or sunscreens.
Once the assessment is completed, TOXLAB will provide you with a Cosmetic Product Safety Report (CPSR), which is a mandatory document under both regulations. This report certifies that your product is safe for use and provides critical information for the product’s registration.
- b) Product Information File (PIF) Preparation and Maintenance
Both the EU and UK require that a Product Information File (PIF) be maintained for each cosmetic product placed on the market. The PIF is a comprehensive dossier that includes various documents about the product, such as:
- Product composition (ingredients).
- Manufacturing process and Good Manufacturing Practices (GMP) documentation.
- Safety assessment (CPSR).
- Labelling information (ensuring it complies with regulatory requirements).
TOXLAB’s role:
TOXLAB assists in preparing and organizing the PIF to ensure that it complies with the regulatory requirements of both the EU and UK. They ensure that the PIF is properly compiled, containing all the necessary documentation and data. Additionally, TOXLAB can provide ongoing maintenance of the PIF, ensuring that it is kept up to date with any changes in regulations, formulations, or packaging.
- c) Notification of Cosmetic Products
In the EU, cosmetic products must be notified through the Cosmetic Product Notification Portal (CPNP) before being placed on the market. Similarly, in the UK, cosmetic products must be registered via the UK Submit system.
TOXLAB’s role:
TOXLAB offers assistance in notifying your cosmetic products through the CPNP for EU markets and the UK Submit system for the British market. The process includes providing detailed information about the product, such as:
- Name and address of the responsible person.
- Product category and function.
- Full list of ingredients (INCI names).
- Safety data and certifications.
TOXLAB will guide you through the registration process, ensuring that all the necessary documents are submitted and that your product complies with the notification requirements for both the EU and UK markets.
- d) Labelling Compliance and Review
As part of the EU Cosmetics Regulation 1223/2009 and the UK Cosmetics Regulation 2020, cosmetic products must comply with strict labelling requirements. These include the mandatory listing of ingredients, the inclusion of safety warnings, the name and address of the responsible person, and more.
TOXLAB’s role:
TOXLAB offers labelling compliance services to ensure that your product packaging meets all the necessary requirements for both markets. Their experts will review your labels and packaging to ensure they:
- Include all required information, such as the name and address of the responsible person, the batch number, the function of the product, the ingredients, and the expiry date or Period After Opening (PAO) symbol.
- Meet the language requirements for each market.
- Adhere to the specific regulatory nuances of both the EU and UK markets.
By having TOXLAB review your labels, you can ensure that your products will not face delays in registration or potential fines for non-compliance.
- e) Post-Market Surveillance and Compliance
Once your cosmetic products are placed on the market, it is essential to maintain compliance with the ongoing regulatory requirements. This includes monitoring the safety of the product, handling consumer complaints, and managing any required product recalls.
TOXLAB’s role:
TOXLAB offers post-market surveillance services to ensure that your cosmetic products continue to meet the regulatory standards and remain compliant throughout their lifecycle. This includes:
- Monitoring market feedback and consumer complaints.
- Managing product recalls if a safety issue arises.
- Updating product safety reports if new scientific data or regulations come into play.
- Ensuring continued compliance with GMP and regulatory updates.
- Why Choose TOXLAB for Your EU & UK Cosmetic Product Registration?
The regulatory landscape for cosmetics in the EU and UK is dynamic and can be difficult to navigate. TOXLAB offers a comprehensive and streamlined solution for cosmetic product registration, safety, and compliance. Here are some key reasons why TOXLAB is the ideal partner for your cosmetic product’s registration and market access:
- Expertise and Experience: TOXLAB has a team of highly qualified toxicologists, regulatory experts, and compliance specialists who understand the intricacies of both EU and UK regulations.
- Customized Support: TOXLAB tailors its services to meet the specific needs of your business and products, offering flexible solutions for companies of all sizes.
- Efficiency and Reliability: TOXLAB has a proven track record of successfully helping clients meet regulatory requirements on time, ensuring that products can enter the market quickly and without delays.
- Global Reach: With a deep understanding of international regulations, TOXLAB is well-equipped to handle cosmetics registrations in other markets beyond the EU and UK, helping brands expand globally.
Ensuring that your cosmetic products meet the regulatory requirements for the EU and UK markets can be a daunting task. However, with the help of TOXLAB, you can navigate the complex landscape of product safety, registration, and compliance with confidence. From safety assessments to post-market surveillance, TOXLAB offers end-to-end support that ensures your cosmetic products are fully compliant and ready for sale in these lucrative markets.
By partnering with TOXLAB, you can streamline your product registration process, avoid costly mistakes, and focus on growing your business while TOXLAB takes care of the regulatory details.
Visit Our Website: www.toxlab.co
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