European Cosmetic Import Regulations
Importing a foreign cosmetic brand into the European Union is a complex process requiring compliance with strict regulations. Furthermore, the ability to sell under the label of ‘organic’ requires surpassing even more regulatory standards. All regulations are designed to protect consumers and cosmetic sellers must be in compliance with these standards in order to sell their products within the EU.
Many businesses hoping to market in the European Union choose to do so through a company of hired professionals who are more adept at market regulations and governmental requirements. USA France, LLC, Dba Cosmetic Export with its partners specializes in helping cosmetic sellers find success within the EU. They provide services throughout the entire process from packaging labels to product development and testing. Companies such as these understand the strict regulatory guidelines and are prepared to help you design a marketable product.
Here is what we can do in order to incorporate your cosmetics into the French and European market.Although it is necessary for pharmaceutical products, marketing authorization is not necessary for cosmetics in France and Europe. The product, however, must be in compliance with regulations that ensure they are in no way dangerous or potentially harmful to the health of those who will use them.
Marketing of your products requires:
Informing the European Commission of your products. This process is made possible by the New European Products Notification Portal (CPNP).
Availability of the Product Information File (PIF), whose accessibility must be available at the products address (also listed on the label).
Consistent updates to the PIF as they become necessary.
Compliance with all laws and regulations that control label requirements.
Information regarding the PIF:
The marketer is responsible for the maintenance of an up-to-date Product Information File (PIF). This file must be readily available for review at the address provided on the product label. The PIF must include information relating to the components of the product, its safety and its quality. So also, any potential negative side effects must be explained and the expected effect (purpose) of the product must be included. Products manufactured within the European Union are under the responsibility of the person or company selling the cosmetic as their brand. Products that are imported from outside of the EU are under the responsibility of the importer.
The PIF must include:
Explanation of the cosmetic.
Details pertaining to the product’s safety. This includes:
Product Make-up that identifies all ingredients and chemical additions.
Product characteristics o Information regarding the Challenge Test o Source and details of packaging material.
Any possible negative side effects that may occur from product use.
Details regarding the safety testing o The manufacturing process and declaration of good manufacturing practice.
Evidence of product claim veracity.
The PIF must be available for verification at any moment. Therefore it must be up to date and continually available for review by authorities and regulators.Listed are three reliable and well-known inspection organizations:
Inspectors of the ANSM
Inspectors from the Ministry of Health
Inspectors of the Department of Direction of Protection of the Populations.
Resistance to comply with regulations and availability of PIF can result in market withdrawal, charges, and imprisonment.
Those wishing to navigate the process on their own need to know and understand the various regulations so that they can legally produce and sell their products in the EU.According to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products cosmetic products are , “substances or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.” The movement and sale of these products within the EU is lawful only when such movement is in compliance with Regulation No 1223/2009.
To ensure market compliance, a responsible person within the community, who is knowledgeable in market regulations, must be designated for each product sold. So also, for a period of three years after product production, the product must be traceable to its place of production. This regulation ensures that in the case of any ‘bad’ product, thorough investigation of said product’s source will be possible. A product’s designated ‘responsible person’ will be held accountable for the availability of such information. Furthermore, the responsible person must ensure that any necessary product recall is advertised and withdrawn from the market.
Annexes II and III provide an extensive list of prohibited and restricted colorants, preservatives, and UV filters. These lists are intended to ensure that only cosmetics products of the highest quality and safety standards are made available to consumers within the EU.Proper product labeling is also required of cosmetics. Labels must be written legibly in permanent ink to ensure that consumers are aware of the product makeup both before and after they purchase. This requirement further enforces the safety standards of product production and holds producers accountable for ingredients used in and with the production of their products.
Label information must include:
A registered address of the person responsible for the product (the same address at which the PIF can be accessed).
The products place of origin.
Weight and/or volume of the product.
An expiration date.
Proper storage conditions.
Instructions for proper use.
Identification linked to when product was manufactured.
The language of aforementioned information is to be determined by the Member State in which the product is available.
To ensure that products are safe, before marketability and production products must undergo a series of tests. Results of this information will be provided on the PIF. The person responsible for the product is also responsible for overseeing these tests and providing accurate assurance that the marketed cosmetics are safe for human use. Testing ensures the reliability of claims.
All testing must be led by an expert sanctioned by those responsible for regulation. The ANSM has the right to recall any product that they deem hazardous or potentially hazardous to human health at any time.
To ensure product shelf-life quality a challenge test must be performed in order to provide proof of a product’s ability to withstand biological growth. A second stability test must also be performed in order to determine product use-by/expiration dates.
A series of safety testing must also be performed. A patch test which determines skin tolerance to products must be performed. A wait time of general 24-48 hours is required to measure skin durability when in contact with the product. A test regarding eye irritability should also be performed. Regular use tests, sensitivity tests, photo toxicity tests, and efficacy tests must also be performed in order to provide evidence of product safety and usability. The European Union requires that claims such as ability to moisturize, weight loss, and anti-aging effects be proven.
Animal Testing is prohibited in the European Union. Therefore, no product or combinations of products or ingredients that have been tested on animals are permitted for sale in the EU market.