Experts in Cosmetic and Hair Care Safety and Efficacy

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

• The validity of your formula with respect to European cosmetic regulations;
• Have defined a person responsible for marketing;
• Declare your product on the CPNP portal (Cosmetic Products Notification Portal);
• Have a complete and valid cosmetic file.

The documents to be provided depend on the type of cosmetic product you want to put on the market but overall you must provide:

• Information on the finished product (formula, stability, tests, manufacturing, labels...)
• Information on raw materials (composition, safety data sheet, technical sheet...)
• Packaging information (primary: in direct contact with your product, secondary,...)

The Cosmetic File (DIP) (Product Information File (PIF) in English) is a requirement of Cosmetic Regulation (EC) No. 1223/2009, 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 (PIF) in English) is a requirement of cosmetic regulation (EC) No. 1223/2009, 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, requiring a thorough knowledge of the requirements of the cosmetic regulation.The person responsible must ensure before the marketing of his cosmetic product:

• That safety be assessed on the basis of appropriate information,
• That a report on the safety of the cosmetic product be established,
• That the safety assessment be properly carried out by a person with the appropriate qualifications and expertise.

The content of the DIP is specified in article 11 of the cosmetic regulation. This file includes the following information:

• A description of the cosmetic product, including the qualitative and quantitative formula of the product, the exact name of the product, code names, identification names or formulas to unambiguously identify the product and to establish a clear link between the cosmetic product and its DIP;
• The product safety report prepared in accordance with Annex I of the Cosmetic Regulation;
• A description of the manufacturing and packaging method as well as a declaration of compliance with Good Manufacturing Practices (GMP);
• Evidence of the claimed effect when justified by the nature or effect of the product;
• Data relating to animal experiments carried out by the manufacturer, its agents or suppliers and relating to the development or evaluation of the safety of the cosmetic product or its ingredients, including any animal testing carried out to meet the legislative or regulatory requirements of third countries or carried out under other legislation or regulations (REACH...).

The DIP should be updated with relevant information collected over the life of the product.

The person responsible may be:

• The manufacturer (if established in the Community)
• The importer (if the manufacturer of the product is established outside the European Union)
• The distributor (if he markets a cosmetic product under his name or brand)
• A person or a company (who is designated by the manufacturer or by the importer)

The person responsible must guarantee, for each cosmetic product placed on the European market, compliance with the obligations applicable to his product established in Cosmetic Regulation (EC) 1223/2009.The person responsible is obliged to ensure that the cosmetic product meets the requirements of Regulation 1223/2009/EC.The status of “responsible person” may be granted automatically, or result from a written contract.

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The CPNP (Cosmetic Products Notification Portal), is an online notification portal, where the person responsible for marketing is required to register their product. This declaration must allow the identification of:

• Of the product (category specification and full product names);
• Of the person responsible (with his address where the cosmetic file is kept);
• From the country of origin in case of import;
• The Member State in which the cosmetic product is to be placed on the market;
• Contact details of a natural person to contact if necessary;
• The presence of substances in the form of nanomaterials;
• Carcinogenic, Mutagenic or Reprotoxic (CMR) substances of category 1A or 1B (by the name and the CAS number (Chemical Abstracts Service) or the EC number);
• Framework formulation allowing prompt and appropriate medical treatment in case of disorders.

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Assessing the safety of your cosmetic product is an important part of your cosmetic document.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 contains two parts (A and B), one of which, part B, must be signed by a qualified expert who has a diploma or other title attesting to a university course of theoretical and practical education. in pharmacy, toxicology, medicine or in a similar discipline, or training recognized as equivalent by a Member State.

All claims used for a cosmetic product must fall within the definition of a cosmetic product: “any substance or mixture intended to be brought into contact with the superficial parts of the human body (epidermis, hair and hair systems, nails, lips and external genitals) or with the teeth and the external genitals) or with the teeth and the oral mucous membranes in order, exclusively or mainly, to clean them, to perfume them, to modify their appearance, to protect them, to maintain them in good condition or to correct body odor.” A cosmetic product does not may not be presented as having curative or preventive properties in respect of human diseases, the product in this case falling under the definition of the medicine.In addition, care must be taken that the claims are not misleading for consumers.Product claims must comply with regulation 655/2013. This regulation is based on six main criteria:

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

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Cosmetovigilance is a system for monitoring and recording adverse effects associated with the use of cosmetics. It makes it possible to identify adverse effects in order to better prevent them.Cosmetovigilance is applied to all cosmetic products after they are placed on the market and must contain:

• The reporting of all side effects and the collection of information concerning them;
• The recording, evaluation and exploitation of information relating to these effects for the purpose of prevention;
• The carrying out of all studies and all work concerning the safety of use of cosmetic products;
• The implementation and monitoring of corrective actions, if necessary.
  

The labels of each unit of cosmetic product made available on the market (paid units or free samples), must include the following information in a legible, clearly understandable and indelible manner, in the national or official language (s) of the State concerned (s) or official language (s) of the State concerned (s).

• The name or the company name and the address of the responsible person established in the Community;
• The country of origin of the products when they are imported;
• The capacity;
• The date of minimum durability (DDM);
• The duration of use after opening or “Period After Opening (PAO)”, this period is indicated by a symbol representing an opened jar of cream, followed by the duration of use (expressed in months and/or years). means that the cosmetic product can be stored for 12 months after opening;
• Special precautions for use and warnings;
• The manufacturing lot number;
• The function of the product (moisturizer, shampoo, ... );
• The list of ingredients expressed under their INCI name (in order from highest to lowest concentration).

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• Any false or misleading claims for the consumer (“proven effectiveness” without testing)
• Any claims not supported by a bibliography or test
• Any claims denigrating competing products (“paraben-free”, this claim implies that all paraben-containing products are bad)
• Any claims that give the cosmetic product properties that make it fall outside the definition of a cosmetic product
• Any claims that suggest to the consumer that it is a plus when it is an obligation imposed by the cosmetic regulation (not tested on animals for example)

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Allergens are substances identified as being able to cause allergic reactions when their concentrations exceed a certain threshold. They must be mentioned on the product label (in the INCI formula) 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.).

Good Manufacturing Practices (GMP) are guidelines giving practical and organizational advice to ensure product quality and guidelines for the production, control, storage and shipping of cosmetic products.The ISO 22716 standard is the reference text for cosmetic GMP.Article 8 of Cosmetic Regulation (EC) 1223/2009 requires that every cosmetic product placed on the European market has been manufactured according to Good Manufacturing Practices (GMP). Manufacturing practices to ensure a high level of protection of human health.

The duration of the tests depends on many factors, the type of product, the type of test, the type of test, the claim (s) sought,... Based on these criteria, CosmoCare helps you to best define the tests that meet your expectations. For example, a Patch Test lasts 48 hours, a standard use test between 3 and 4 weeks.

For a product to be considered “ORGANIC”, 3 important criteria must be checked:

• The% of natural ingredients or of natural origin
• The% of vegetable ingredients of organic origin (from organic farming)
• The% of ingredients of organic origin (from organic farming) in the finished product.

Many certification bodies exist today allowing you to use the “BIO” claim.

The success of marketing a cosmetic product depends on many factors, its level of attraction, its price, the number of points of sale in which we can find the product,... Many companies wrongly consider that the regulatory part (the cosmetic file) is a constraint, but it can allow you to stand out from the competition. Indeed, a serious and complete cosmetic file can facilitate you in obtaining new distribution networks and facilitate your expansion. Cosmocare supports you in your approaches and advises you in the development of your cosmetic products.