The Regulation of Cosmetic Products

When marketing a cosmetic product, the brand must ensure that its products comply with the regulations in force. Due to environmental and health concerns, this trade is closely monitored to guarantee consumer safety. The brand must therefore ensure that it complies with certain obligations and steps defined by European authorities.

What Are the Regulations for Placing a Cosmetic Product on the Market?

What Is Placing a Cosmetic Product on the Market?

A cosmetic product is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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 (Article L. 5131-1 of the Public Health Code).

Placing on the market refers to “the first making available of a cosmetic product on the Community market”, that is, the European Economic Area.

These products must not harm human health (Article L. 5131-4 of the Public Health Code). They are not subject to prior market authorization. However, they are mainly regulated by European Union standards through the Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products, which came into force on July 11, 2013. These provisions are directly applicable in all European Union member states. Cosmetic products are also governed by the Public Health Code (CSP).

What Are the Obligations Related to Placing a Cosmetic Product on the Market?

Through these obligations, the absence of risk for the consumer relies on the safety of raw materials (ingredients or “substances”) and the finished product, the quality of manufacturing techniques and market surveillance.

In essence, brands must comply with several obligations to conform to current regulations:

• Identify a responsible person;
• Establish precise provisions on product composition;
• Ensure the quality of cosmetic products throughout manufacturing;
• Implement safety assessment;
• Make a complete product file available to authorities (PIF);
• Respect the ban on animal testing in cosmetics;
• Implement transparent product labeling;
• Comply with product notification as a prerequisite for marketing;
• Ensure cosmetovigilance and market surveillance;
• Communicate with competent authorities.

Identification of the Responsible Person

An Identified Responsible Person: Who Is Concerned?

Cosmetic companies include:

• Perfumery such as perfumes or eau de toilette;
• Hygiene and toiletry products such as shower gels or deodorants;
• Hair products such as shampoos or styling mousses;
• Beauty and care products such as makeup or baby products.

These companies must identify a responsible person for their cosmetic products to be marketed (Article 4 of the Regulation). This responsible person can be:

• The manufacturer established in the Community;
• Each importer for each imported cosmetic product placed on the market, i.e., originating from a third country;
• The distributor when placing a cosmetic product on the market under their name or brand, or when modifying a product already on the market in such a way that its compliance with applicable requirements may be affected.

Role of the Responsible Person

The person identified as responsible ensures compliance with current regulations and laws:

• By declaring their cosmetic product to the National Agency for the Safety of Medicines and Health Products (ANSM), when it concerns the manufacturer (Articles L. 5131-2 and R. 5131-1 of the CSP);
• By making a new declaration in case of modification of the initial declaration (Article L. 5131-2 of the CSP);
• By immediately notifying non-compliant products;
• By making available an information file for each product (PIF) regularly updated (Article 5 of the Regulation);
• By communicating its serious adverse effects (Article 23 of the Regulation – Article L. 5131-5 CSP).

Before being made available within the European space, every cosmetic product must be notified to the European Commission via an IT portal called Cosmetic Products Notification Portal (CPNP).

Regulations Relating to the Manufacturing of Cosmetic Products

Rules for the Composition of Cosmetics

The composition of these products is very strictly regulated by the European Union. “Annex II of the Regulation lists the prohibited substances in the composition of cosmetic products.”Annex III, IV, V and VI of the Regulation list the substances, colorants, UV filters and preservatives authorized in the composition of cosmetic products. Furthermore, Article 15 of the regulation prohibits the presence of substances classified as carcinogenic, mutagenic or reprotoxic of categories IA, IB or II except for exemptions.

These annexes are regularly updated by the European Commission based on the opinions of an independent committee of experts, called the Scientific Committee on Consumer Safety (SCCS).

An Obligation of Quality Throughout Its Manufacturing

The placing on the market of cosmetic products must comply with Good Manufacturing Practices (GMP) whose principles are defined by ANSM (Article L. 5131-4 of the CSP) and the standard NF EN ISO 22716, published in 2008.

Regulations Relating to the Labeling of Cosmetic Products

Article 19 of the regulation requires brands to include a list of mandatory information on the packaging and container of the cosmetic product:

• Name and address of the manufacturer;

• The list of ingredients in descending order of weight at the time of their incorporation, preceded by the word “ingredients”;

• The minimum durability date preceded by the phrase “best used before the end of” and/or pictogram in the form of an hourglass followed by the date. For products with a shelf life of more than 30 months, the Period After Opening (PAO) must be mentioned, preceded by the PAO symbol with a pictogram in the form of an open jar;

• The nominal content at the time of packaging, indicated in weight or volume;

• The batch number or reference allowing identification of the manufacture;

• The function of the product, unless it is clear from the presentation of the product;

• Special precautions for use if necessary;

• The indication of the country of origin for products imported from third countries.

An ingredient is understood as “any substance or mixture intentionally used in the cosmetic product during the manufacturing process”.

In addition, these mentions must be written in French in a manner that is easily readable, clearly understandable and indelible (Article R.5131-4-III of the CSP).

More generally, during the presentation of a cosmetic product, brands must be cautious about the use of claims in order to avoid falling into hidden “advertising”, for example.

The Control of a Cosmetic Product’s “Life”

Cosmetic products are subject to control during the safety assessment of the finished product, resulting in a report (Article 10 of the Regulation). This includes the physical and chemical characteristics of the product, the toxicological profile of the substances, microbiological quality… (the exhaustive list of this information is in Annex 1 of the Regulation).

The “ANSM controls the safety of health products throughout their lifecycle. It has the power to issue formal notices to the responsible person in case of serious doubt about the safety of a cosmetic product (Article L. 5131-6 CSP). This authority develops several activities in France and on behalf of the European Union. For instance, it oversees the inspection of establishments engaged in manufacturing, importing, distribution, pharmacovigilance activities and those conducting clinical trials. Following these activities, it can make health policing decisions on behalf of the” French State such as product or batch recalls.

The General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF) works closely with this authority to ensure compliance with cosmetic product legislation.

In case of non-compliance with current legislation, the judge has sanctioning power provided for in Articles L. 5431-2 to 5431-9 of the CSP. For example, the omission of serious adverse effects of a cosmetic product is punishable by two years of imprisonment and a fine of 30,000 euros.

Note that consumers are increasingly using tools like Yuka to decipher cosmetic product labels. This tool allows consumers to directly check the potential impact on health and the environment of cosmetic products. Thus, when Yuka gives them a bad rating, it can influence consumer habits and ultimately sales.

Placing a Cosmetic Product on the Market: What Responsibility?

In case of a defect in a cosmetic product, the consumer of this product could initiate a non-contractual liability action based on the liability for defective products under Article 1245 and following of the Civil Code.

To do this, several conditions must be met:

• A cosmetic product (considered as movable property);
• A placement on the market, meaning that the producer must have voluntarily released it;
• A product must be defective, meaning it does not provide the safety that one can legitimately expect;
• A damage;
• A causal link between the defect and the damage.

Finally, contractual liability can also be engaged on the basis of the warranty against hidden defects (Article 1641 of the Civil Code).

The European regulation of cosmetic products is “the most rigorous in the world” according to the Federation of Beauty Enterprises (Febea). Thus, cosmetic products used in usage tests must comply with current regulations.

Trustt is a SaaS software dedicated to the development of cosmetic brands. Through its services, you can implement usage tests on your cosmetic products in full compliance with the law. Trustt is a simple solution to clear up any doubts you have about your various strategies!