Cosmetic products safety assessment

Preparation of Product Information File, Safety Assessment and laboratory testing of cosmetic product

When placing products on the EU market, the preparation of a Product Information File (PIF) is necessary, and an integral part of the documentation is the Safety Assessment Report. Our regulatory department can compile complete documentation in accordance with Regulation (EU) 1223/2009 on cosmetic products, and it can prepare documentation for any market in the world to which the product export is planned.

Furthermore, before placing the product on the market, extensive tests need to be performed, and test results are an integral part of the Product Information File. Sample Control is accredited and authorised to test cosmetic products, in order to make all analyses necessary when placing products on the EU market, as well as in other markets of the world.

Within the laboratory it is possible to perform over 2000 different analyses, depending on the needs (product type, composition, target market...). Generally speaking, the basic analyses that need to be done for the cosmetic product are listed below.

Analysis of the wholesomeness of the product

When placing the product on the market, an analysis of the wholesomeness of the product is necessary, which most often implies testing: organoleptic characteristics of the product, microbiological quality of the product, pH value and peroxide number, the proportion of heavy metals, potential impurities that may be present in the product from raw materials and/or packaging (the test parameters depend on the type of raw materials and the packaging in which the product is placed).

Preservative Efficacy Testing (Challenge tests)

For formulations with a high proportion of the aqueous phase, that is, for formulations that are suitable for the development of microorganisms, it is necessary to test the efficacy of preservation, which can determine whether the product is suitable for or resistant to the development of microorganisms. In addition, it can be determined to what extent the preservative used is effective in combating the growth of individual microorganisms. This analysis is of paramount importance when deciding on the type of packaging for a cosmetic product.

Stability testing

Before placing a cosmetic product on the market, extensive tests of the stability of the cosmetic product should be performed to determine whether the product will be stable within the intended shelf-life under normal conditions of use, storage and transportation.

Among other performed tests (the influence of temperature freezing, vibrations in transport, compatibility with packaging, UV radiation, etc.), a real-time test is carried out to determine the stability of the product. Thus, for example, if the foreseen shelf-life is one year, the product is monitored for a period of one year on the parameters that are deemed relevant, and in view of the characteristics of the product.

When the product is to be marketed in the shortest possible period of time, it is possible to foresee the shelf-life of the product with accelerated stability tests, whereby the product is exposed to extreme conditions, depending on the geographical area where the product is planned to be sold, as well as on the characteristics of the product itself (e.g. for an estimated shelf-life of 2 years, the test is performed over a period of 3 months).

Clinical trials of products and proof of cosmetic claims

Depending on the method of communication of the brand, that is, the requirements of the client, it is possible to perform various tests to prove claims about the effectiveness that are communicated for the product. For example, if it is communicated that the product is allergen-free and has been dermatologically tested, it is necessary to carry out an analysis on all known allergens that can be expected in the product and dermatological tolerability tests. Furthermore, if it is communicated that the product has a sun protection factor, then it is necessary to prove it by appropriate testing. It is also possible to perform the following tests to prove effectiveness: measuring biochemical parameters such as strength and elasticity, hydration levels, cellulite intensity, wrinkle intensity, luminosity and intensity of skin pigmentation before and after use of the product, and testing user satisfaction.

Responsible person for the cosmetic product

Only cosmetic products for which a legal or natural person in the European Union has been designated as a 'responsible person' may be placed on the market.

In the event that the client does not know the EU legislation from which certain obligations and responsibilities arise, or the client (legal or natural person) is not based in the EU or for some other reason does not want to be the responsible person for cosmetic products, a partner of Sample Control may assume the role of responsible person and all obligations defined in Regulation (EU) 1223/2009 on cosmetic products.

The responsible person must:

• check the safety assessment and safety report of the cosmetic product;

• keep documentation with product data (10 years);

• electronically submit a cosmetic product notification to the European Commission (CPNP application);

• electronically submit a cosmetic product notification for products containing substances in the form of nanomaterials to the European Commission (CPNP application);

• ensure the declaration of cosmetic products in accordance with legal regulations;

• collect data on the serious undesirable effects of the cosmetic product (resulting from the use of the cosmetic product).