Conquering the European Market for Cosmetic Products: Expert Advice

Cratia took part in the XVIII Specialized Conference “Beauty Tech. Innovations in Manufacturing: Raw Materials and Technologies.” Maksym Bagrieiev, managing partner of Cratia, shared his knowledge and advice on launching cosmetic products in the European market.

Maxim noted that the technical regulation of cosmetic products in Europe is based on the principle of the “single market.” A cosmetic product that has undergone conformity assessment gains access to the markets of all 27 EU member states, as well as the markets of the European Economic Area and countries with which mutual recognition agreements have been concluded. Thus, compliance with EU requirements grants access to nearly 550 million consumers in 32 countries. This constitutes one of the world’s largest markets.

However, before entering a product into the European market, it is essential to carefully adhere to the rules and requirements set for the cosmetic industry in the European Union. It’s important to remember that, in addition to general rules, there are national requirements that can vary among EU member states. For instance, language requirements and certain product specifications may differ from one country to another.

Maxim emphasized the critical issue of legal responsibility for violating regulations. As he noted, each EU member state can establish its own levels of penalties for breaches of cosmetic legislation. For instance, Italy may impose criminal liability and fines for violations of cosmetic regulations.

Entering a product into the EU’s single market can be a challenge, but, according to Maksym Bagrieiev, this path is entirely achievable, and the result is worth the effort.

Maxim proposed the following roadmap for exporting cosmetics to the EU:

1. Verify whether the product qualifies as cosmetic, according to the definition in Regulation EC 1223/2009.
2. Check the product’s composition for compliance with the requirements outlined in Annexes II, III, IV, V, and VI.
3. Assess all EU legislative acts applicable to the product.
4. Implement good manufacturing practices (GMP) in production.
5. Develop and prepare a Product Information File (PIF) containing the Cosmetic Product Safety Report (CPSR).
6. Appoint a responsible person in the EU and notify the product.
7. Monitor safety and periodically review the product’s information file.

Regarding verifying whether a product qualifies as cosmetic, one should refer to the definitions and clarifications provided by Regulation 1223 for cosmetic products:
Cosmetic product is any substance or mixture intended to be applied to the external parts of the human body (epidermis, hair, nails, lips, external genital organs), teeth, and the oral mucous membranes, predominantly for the purposes of cleaning, fragrancing, changing appearance, protecting, maintaining in good condition, or correcting body odours.
A substance or mixture that falls under the definition of cosmetic products but is intended for ingestion, inhalation, injection, or implantation into the human body is not considered a cosmetic product.

Additionally, the EU has adopted guidelines and guidance documents to assist in classifying borderline products that straddle the line between cosmetic products, medicines, medical devices, and disinfectants.

When checking the composition of a cosmetic product, it’s important to note that EU Regulation 1223/2009 undergoes several changes each year. Therefore, it’s crucial to refer to the current edition of the Regulation.

At the next stage, you should assess which legislative requirements apply to your cosmetic product. These requirements can be broadly categorized as primary, supplementary, and national.

Primary requirements include the Regulation 1223/2009 itself, as well as implementing decisions regarding the filling of the Cosmetic Product Safety Report (CPSR), regulations concerning claims, a glossary of ingredient names, and regulations that establish a list of CMR substances (substances that are carcinogenic, mutagenic, or toxic to reproduction) and other requirements. Additionally, the REACH Regulation applies to cosmetic products, requiring cosmetic product manufacturers to register substances used in their products with the European Chemicals Agency (ECHA) if the quantity exceeds 1 ton per year.

Other regulations may apply to cosmetic products depending on their form, characteristics, and intended use. For example, if a cosmetic product is supplied in aerosol form, the requirements of Directive 75/324/EEC concerning aerosol dispensers will apply.

One essential component of European regulation is the national legislation of EU member states, which may add additional requirements for cosmetic products. For instance, France has the Anti-Waste Law, which imposes extra requirements on product composition, packaging, and labeling.

Regarding Good Manufacturing Practices (GMP) for entering the European market, Maksym noted that a quality management system must be developed, but certification is not mandatory. The advantages of certifying the system include an objective assessment of the company by a competent independent party, process improvement, and the ability to provide confirmation to foreign partners.

As for where to get certified, Maksym explained that certification should be obtained only from bodies accredited to the international standard ISO/IEC 17021 in Ukraine or the EU. The National Accreditation Agency of Ukraine (NAAU) is a signatory to a multilateral agreement on mutual recognition with the European Accreditation (EA) and the International Accreditation Forum (IAF). Thus, NAAU accreditation is equivalent to European accreditation and recognized in more than 80 countries worldwide.

The Product Information File (PIF) is a demonstration of the requirements for the safety and quality of the product. The file consists of five parts:

1. Description of the product and data for its identification.
2. Cosmetic Product Safety Report (CPSR).
3. Description of manufacturing methods and a statement of compliance with GMP requirements.
4. If necessary, confirmation of claims.
5. Information about any animal testing conducted.

The key component of the PIF is the Cosmetic Product Safety Report (CPSR), which is divided into Part A and Part B.

When asked about which tests to conduct and where, Maxim explained that at a minimum, you should confirm stability and compatibility with packaging, microbiological purity, and testing of preservatives (challenge test). Additional tests, such as dermatological tests, may also be required. All testing should be conducted in accredited laboratories in Ukraine or the EU.

Continuing the presentation, Maksym emphasized that Part B of the safety report must be signed by an expert with toxicological, pharmaceutical, or medical education recognized in the EU.

The list of information required on the labeling of cosmetic products is specified in Article 19 of the Regulation.

A separate and interesting aspect is claims made about the product. Claims are promises of any results from using a cosmetic product, such as “moisturizes the skin” or “reduces wrinkles.” The EU takes a very strict stance on any claims, scrutinizing not only the labeling but also supporting documents, websites, and advertisements. According to Regulation 655/2013, to make any claims about a cosmetic product, you need scientific substantiation, such as laboratory or consumer studies.

Maksym provided an example of working with claims for a cosmetic cream containing collagen and pomegranate extract. He noted that some claims, such as how collagen affects the aging process, are impossible to scientifically substantiate. Therefore, it’s essential to carefully analyze each claim and seek alternative ways to formulate them.

The language of labeling on cosmetic products is also determined by the legislation of the EU member state where the product becomes available to the end user. Since there are twenty-four official languages in the EU, this can create labeling challenges.

Regarding the responsible person in the EU, this can be an importer, distributor, or another entity. This person acts as the contact point with EU regulatory authorities and consumers and performs the notification of the cosmetic product. Maxim mentioned that if a manufacturer chooses an importer to act as the responsible person, that importer effectively gets exclusivity since their name and address will be on the labeling.

After the product is notified, it can be placed on the market in EU member states.

During the post-market period, manufacturers of cosmetic products have several responsibilities, including maintaining a quality management system, monitoring adverse effects, and updating the product information file. Maxim Bagreev urged manufacturers to regularly check the compliance of their products with banned substances, as European legislation can change several times a year, and to adhere to regulatory requirements and implement practices to ensure the safety and quality of their products.

“Cratia” offers certification services for cosmetic products in Ukraine and the EU, including:

• Development and implementation of GMP according to ISO 22716.
• Development of the Product Information File (PIF).
• Preparation of the Cosmetic Product Safety Report (CPSR).
• Outsourcing the Responsible Person service in the EU.
• Development of labeling, instructions, and promotional materials.
• Organization of laboratory tests.
• Product notification.

We have excellent knowledge of Ukrainian and EU legislation and extensive experience in conducting these procedures. We will take on the management and organization of the process, help you prepare the document package, and conduct the procedure within tight deadlines.

We provide free initial consultations. Contact us by phone at +38 (044) 332-42-94, 221-71-29, or email us at info@cratia.ua. You can also arrange a meeting with us in our office.