FAQ

To import a cosmetic product into Europe, it must comply with Cosmetic Regulation (EC) No. 1223/2009, regardless of its country of origin. To import a product into Europe, be sure to:

• The validity of your formula and your labels,
• Have defined a person responsible for placing the product on the market,
• Declare your product on the CPNP portal,
• Have a complete and valid cosmetic file.

The Product Information File (PIF) is a requirement of the Cosmetic Regulation (EC) Nº1223/2009, it is essential to be able to put a cosmetic product on the European market. It compiles all the information relating to your cosmetic product including a safety assessment signed by a qualified expert.
The content of the PIF is specified in article 11 of the Cosmetic Regulation, and it must be updated with relevant information collected over the life of the product. This obligation falls on the person responsible for placing the product on the market.
The PIF must be available in paper or electronic format (at the address on the label) and must be stored for 10 years from the date the last batch of the cosmetic product was placed on the market.

The time it takes to receive your cosmetic file obviously varies from one file to another.

This time will depend in particular on the current status of the documents required for its design. Cosmocare advises its customers to carry out a preliminary analysis that allows them to assess the veracity of the documents in your possession at a lower cost. Once all the documents have been checked and validated (stability, microbiological data, tests, claims, etc.) you will receive the cosmetic file within 15 days.

The CPNP (Cosmetic Products Notification Portal) is a European online notification portal.

The person responsible for placing the product on the market is required to register all its products and to update its notifications during the life of the products. This is a mandatory step as stipulated in article 13 of the Cosmetic Regulation (EC) No. 1223/2009.

Assessing the safety of your cosmetic product is a mandatory part of your cosmetic dossier, as explained in article 10 of the Cosmetic Regulation (EC) Nº1223/2009. The purpose of this assessment is to demonstrate that the product is safe for human health when used under normal or reasonably foreseeable conditions of use. It must be signed by a qualified expert holding a diploma or other title attesting to a university degree in theoretical and practical education in pharmacy, toxicology, medicine or in a similar discipline, or a training recognized as equivalent by a Member State.

The labels of each unit of the cosmetic product made available on the market (paid units or free samples) must be legible, clearly understandable and indelible in the national or official language (s) of the State concerned.
The mandatory elements are listed in article 19 of the Cosmetic Regulation (EC) Nº1223/2009.
In addition to the list of ingredients in INCI format, other information must appear such as the function of the product, the person responsible, the country of origin (if outside the European Union), the capacity, etc.
We offer support ranging from the establishment of the INCI list to the complete revision of the labels. Do not hesitate to contact us.

Allergens are substances that are identified as being able to cause allergic reactions. They must be mentioned on the product label (in the INCI ingredients list) if they are present in the finished cosmetic product:

• at a rate greater than 10 ppm (0.001%) for non-rinsed products (creams, perfumes, etc.) ),
• at a rate greater than 100 ppm (0.01%) for rinsed products (shower gel, shampoo, etc.).

Allergens are generally present in perfumed compositions, but also in most vegetable raw materials.

Cosmetic products are defined by Cosmetic Regulation (EC) Nº1223/2009 as follows:
“any substance or mixture intended to be brought into contact with the superficial parts of the human body (epidermis, hair and capillary systems, nails, lips and external genitals) or with teeth and oral mucous membranes in order, exclusively or mainly, to clean them, to perfume them, to modify their appearance, to modify their appearance, to protect them, to maintain them in good condition or to correct body odours”.
A cosmetic product cannot be presented as having curative or preventive properties in respect of human diseases, the product falling under the definition of the drug in this case.
Thus, claims made on a cosmetic product cannot fall outside of this definition. In addition, it is necessary to ensure that the claims are not misleading for consumers. They must also comply with Regulation (EU) Nº655/2013. This is based on six main criteria:

• Compliance with legislation,
• Truthfulness,
• Evidence,
• Sincerity,
• Fairness,
• Informed choice.

All claims must be duly substantiated by documentation and/or clinical tests on the finished product and/or its active ingredients, based on the claims selected. We offer you varied and comprehensive clinical tests for a peaceful launch on the market.

Safety tests are implemented for various purposes, including ensuring good skin compatibility, good conservation and durability.
In addition, they are also used to validate the use for specific targets such as sensitive skin, children etc.
Efficacy tests, on the other hand, make it possible to justify cosmetic claims made on the finished product in order to be in line with the regulation and thus provide evidence of the effectiveness of the product. There are all sorts of them out there, and our team of experts will guide you in choosing the best options.
However, there are tests linking both the effectiveness and safety aspects such as the use test under dermatological control during which the product is tested by an adequate panel of volunteers under normal conditions of use as it will be used once on the market.

The list of mandatory tests varies according to the type of product, the area and frequency of use, and the consumers targeted by the product. A minimum of safety tests must be carried out on the finished product to verify good skin tolerance and the good preservation and durability of the product. We can guide you through this important step, do not hesitate to ask us questions.

Numerous tests exist, and we will be happy to support you in choosing which tests to carry out according to the claims of your products. There are both in vivo tests and ex vivo tests, which aim to demonstrate, for example, the anti-hair loss effect, hydration, hair growth, density improvement, protection of hair against heat, etc.

The duration of the tests depends on many factors: the type of product, the type of test, the claim (s) sought, etc. Based on these criteria, Cosmocare helps you to best define the tests that correspond to your expectations. We offer tailor-made services whose duration of the tests may vary according to your objectives. For example, a Patch Test lasts 48 hours, a standard use test between 3 and 4 weeks. Hair tests generally last 90 to 150 days, which is equivalent to that of the hair cycle.

A chemical product is governed by various regulations including REACH, CLP, general product safety.
Before placing a chemical product on the market (room perfume, candle, diffusers, detergents, etc.), obligations are to be expected:

• Allocation of a UFI code,
• Writing FDS,
• Notification to poison control centers,
• Adequate labelling,
• Human health safety assessment.

We support you in all these procedures quickly and transparently.