Regulatory And Toxicological Analysis

The Product Information File (PIF) brings together all the technical information relating to the (1) ingredients present in the formula such as safety data sheets, microbiological analysis, allergen declarations, (2) the formula such as the qualitative and quantitative declaration, impurities, stability, test reports (3) to packaging such as technical and safety sheets for containers and their materials.

The marketer must gather all these elements from the various suppliers and stakeholders so that the toxicologist can carry out an assessment of the safety of the product.

The safety assessment or report is carried out by a qualified toxicologist. He checks all the technical elements of the PIF including the contents of the cosmetic product packaging (labels, boxes) and ensures that they comply with the regulations in force.

The notification is made on the European cosmetics portal (CPNP) and makes it possible to declare the distribution of the product as well as to define the responsible person.

In order to guarantee the safety of a cosmetic product, the following tests are mandatory: 

• Skin tolerance test (patch test)
• Eye irritation test (for products in contact with eyes)
• Microbiological analysis (challenge test)
• Compatibility test (with packaging)

Depending on the formula, desired claims, audience and area of ​​application of the product, further testing may be required to ensure product safety.

A claim can be a text, an image or any graphic element used to highlight a product and its possible benefits. Claims on cosmetic products must always be demonstrated with scientific proof.

In the case of an ingredient claim, for example, “ collagen has moisturizing properties ”, the claim can be demonstrated through clinical studies in the scientific literature and/or through COSING, the European database of cosmetic ingredients and substances.

In the case of a claim on the cosmetic product, for example, “ the product helps keep the skin moisturized”, the claim can be demonstrated by an efficacy test such as corneometer or tewameter.

The use of claims is regulated and subject to controls by the authorities in place in your country.

An efficacy test is required in the following cases: 

• you want to make claims on your formula, for example, “ anti-aging effect ”, “ removes blackheads ”, etc.
• your product is intended for a specific use, for example, a sunscreen product, intimate care, etc.
• your product is aimed at a specific audience, for example, children, pregnant women, etc.

The choice of the type of efficacy test can be defined according to the formula, the desired claims, your marketing needs (positioning of the product on the market, user target) and your budget.

These regulatory procedures must be carried out before the product is placed on the market. In general, the technical elements constituting the PIF are gathered from the validated product formula, the same for the various test reports. The safety assessment by the toxicologist can only be carried out once all the tests have been carried out and the graphic elements relating to the packaging are ready. Finally, the notification is made last.