Cosmetic regulatory services from labelling and registration to marketing

In the European Union, a cosmetic product is defined under Regulation 1223/2009. The assessment of whether a product qualifies as a cosmetic is made on a case-by-case basis, taking into account all of its characteristics. Cosmetic products can include a wide range of items such as skin creams, soaps, perfumes, make-up, hair care products, shaving products, dental care products, nail care products and sun care products. These products are intended for a variety of personal care and hygiene purposes.

Navigating the regulatory environment for cosmetics in Europe, which is among the most stringent in the world, presents a significant challenge. Despite these difficulties, Europe remains a very lucrative market for cosmetics products, competing with the US as one of the world leaders in cosmetics sales. However, ensuring compliance with the EU Cosmetic Regulation, along with various other European and national regulations, is crucial for any company and brand looking to enter this market.

To launch a cosmetic product in the EU market, it must meet all regulatory requirements and be represented by an EU Responsible Person based within Europe. Medfiles offers comprehensive support, from initial consultation to full compliance management, to navigate these regulatory complexities successfully.

regulatory services for cosmetic ingredients

A cosmetic ingredient is any chemical substance or preparation of synthetic or natural origin that is used in the formulation of cosmetic products. Before introducing a new cosmetic ingredient on the market, it is important to determine whether its use is permitted in cosmetic products, or whether entry on the market requires prior authorisation by the authority. In the EU, the key statute is Regulation (EC) 1223/2009 on cosmetic products. The use of certain substances, such as colorants, preservatives, and UV-filters in cosmetic products requires prior authorisation from the European Commission. Also, for the use of nanomaterials in cosmetic products, special rules apply. For all other types of cosmetic ingredients, the company itself ensures the safe use of the new ingredient by different categories of users. The safety must be established without experimental animal testing. Therefore, your safety evaluation is crucial to be successful on the competitive EU cosmetic market.

We are happy to help you with all matters concerning new cosmetic ingredients and their market access requirements in the EU. With our audited partners, we can help with cosmetic ingredient regulatory matters around the world.

Regulatory positioning and identifying the need for cosmetic ingredient registration

We will determine for you whether a cosmetic ingredient can be placed on the EU market without a separate authorisation procedure, or whether it is a new ingredient that requires a formal regulatory safety assessment and approval. We can also consult the authority on your behalf if the cosmetic substance is a borderline case.

No cosmetic ingredient registration is needed – in-house safety dossier

GAP Analysis and Literature Reviews
We will review existing documents and evaluate and compare them with the requirements of authorities in the EU. After the analysis, we will provide a report showing which information is already compliant, what information is needed for the in-house safety dossier, or which points still need to be supplemented in the in-house safety dossier.

We will also conduct comprehensive literature reviews on your behalf to ensure that all existing necessary information are to be included in the in-house safety dossier.

Cosmetic ingredient registration is needed – application dossiers

GAP Analysis and Literature Reviews
We will review existing documents and evaluate and compare them with the requirements of authorities in the EU. After the analysis, we will provide a report showing which information is already compliant, what information is needed for the application, or which points still need to be supplemented in the application.

We will also conduct comprehensive literature reviews on your behalf to ensure that all existing necessary information must be included in the application dossier.

Consulting assistance prior to the dossier preparation

Before writing the in-house safety dossier or a formal application dossier and submitting it to the authorities, we will help you collect missing information and research. We will guide you on what you need to do to obtain this information and assess the quality and suitability of your existing data and research results for a future in-house safety dossier or application.

Studies

Through our extensive network of research laboratories and research institutes, we can find the right organisation for you to produce the necessary research results.

In-house safety dossiers or applications for registration

We can write background information, product information and all scientific safety sections for the in-house safety dossier or the application in accordance with the EU legislation and guidelines. We can conduct exposure and safety assessments for the cosmetic ingredient. If you wish, we will communicate with the authorities on your behalf during the application process and submit the application dossier on your cosmetic ingredient to the Scientific Committee on Consumer Safety (SCCS) of the European Commission. Where required, with our audited partners we can provide you with safety data sheets (SDS) for your ingredient in accordance with EU chemical legislation. 

REACH registration of cosmetic ingredient

Cosmetic ingredient may need an EU registration under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation ((EC) No 1907/2006). Based on the information we have received from you, we can determine whether your cosmetic ingredient requires a REACH registration in the EU. More detailed regulatory requirements related to REACH, REACH questionnaires and REACH registrations can be obtained through us from our audited partner.

Applications for INCI names of cosmetic ingredients

International Nomenclature Cosmetic Ingredient (INCI) names are typically used for a cosmetic ingredient because they are internationally recognised systematic names to identify cosmetic ingredients. It is a uniform system of labelling names for cosmetic ingredients. This recognition enables the cosmetic industry to track the regulatory status of ingredients on a global basis. INCI names are also used in the EU Cosmetics Ingredients database (CosIng). The INCI name can be applied for the ingredient following the assessment of its safety and fitness of use.

We can prepare for you the required documentation for the INCI name application. If you wish, we can also submit the application to the Personal Product Care Council (USA) and take care of the communication. It is important to know that just because an ingredient has an INCI name it does not mean that the ingredient has been approved for cosmetics or that it is safe.

Regulatory services for cosmetic products

Regulatory positioning

Cosmetic products must adhere to strict requirements before they can be sold in the EU. The regulations ensure that all cosmetics available on the market are safe and properly labelled. Sometimes regulatory positioning and classification of a product is not clear, and also national aspects such as possibility to a medicinal classification play a role.

At Medfiles, we provide expert guidance to help you navigate these complex requirements, ensuring that your products achieve and maintain compliance. Our services include detailed assessments of your product formulations on an EU and national level.

Cosmetic Product Safety Reports (CPSRs)

Any cosmetic products sold in the EU must have their own CPSR, which provides information on the product’s safety based on its expected use. This needs to include detailed information on the product’s toxicology, exposure levels, and more, so that it is clear that the product does not pose any risk to human health.

At Medfiles, we can prepare and compile a CPSR for your product so that it meets the regulatory standards. We use the Cosmedesk program to prepare our detailed and reliable safety reports, together with our in-house toxicology expertise, so you can be sure of the safety of your product.

Labelling, claims and marketing texts’ review

The EU Cosmetics Regulation stipulates that the responsibility for ensuring accurate and compliant labels falls on the responsible person. The design and edition of labels remain an essential exercise for cosmetic brand owners. Labels must include certain elements translated into all official languages of the countries where the products are sold. A clear and compliant label not only aids consumers in making informed purchases but also protects their health by ensuring all important information is easily accessible, readable, and understandable at the time of purchase.

We at Medfiles can help you to review your product labels and translate them into certain local languages. A label review is a comprehensive compliance check of packaging and labels, where experts scrutinise everything from claims to warnings and the ingredient list, taking into account the national guidelines and practices.

Moreover, only certain claims are allowed for cosmetic products’ labels and marketing. We can help you to find the suitable claims for your product that you may use and check that your product marketing is in line with the requirements. Our experts have a client-oriented perspective, and they can, together with you, find the best solutions for your product.

Understanding the Cosmetics Product Information File (PIF) in the European Union

The PIF contains detailed data on the safety and compliance of a cosmetic product, and it is mandatory in the EU. The PIF needs to be updated as necessary and must be accessible to regulatory authorities upon request.

Medfiles can compile and review PIFs to ensure regulatory compliance for your product.

Notifying the product to the Cosmetic Products Notification Portal (CPNP)

The CPNP is a centralised European notification system that is used by national competent authorities and poison control centres. Notification to the CPNP provides these bodies with product details such as ingredient lists.

At Medfiles, we can review your information for accuracy and submit CPNP notification for you. We can also provide advice and updates to your products’ notifications for any formulation or ingredient changes. Medfiles is at your service for efficient and complete CPNP notifications.

Acting as responsible person for cosmetic products on your behalf

All cosmetic products in the market in the EU must have a responsible person (RP) who ensures compliance with the legislation. The RP must also ensure the safety and regulatory compliance of the product.

At Medfiles, we can act as the RP for your product and ensure that all documentation and regulatory requirements are covered so your product can easily and quickly enter the market. See also:

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for more information please contact

Mervi Reini
Marketing Manager
+358 20 744 1502

📅 Book a free 30-minute meeting with the team

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