A safety assessment is required for all cosmetic products entering the EU market. EU cosmetics legislation (EC 1223/2009) is based on the safety of the raw materials contained in the product. Therefore, the basis for the safety assessment is a thorough ev

The type of product influences how the user interacts with its ingredients.

For example:

Eye cream should not contain substances that irritate the eyes.

Shower gel is rinsed off, so the impact on the body is less than when using body lotion.

Aerosol products can be inhaled and toothpaste can be swallowed.

Only the safest raw materials for children are used in the manufacture of children's products.

During the assessment, either the tests required by law are carried out or the available information is analysed. An expert checks the product sample and the preliminary information provided about the product.

The following information is required to carry out a safety assessment:

·         GMP certification of the producer from the manufacturer (a declaration is possible)

·         formula and INCI names of the ingredients - the exact formula with the exact percentage content (not a ‘range’, but the exact content) of the ingredients

·         Material Safety Data Sheet of raw materials and Specifications of raw materials, especially for perfumes, all allergens contained must be declared in MSDS §2 Certificate of Allergens

·         document from the manufacturer confirming that the composition does not contain CMR and nano materials (declaration possible).

·         document from the manufacturer confirming that the composition does not contain ingredients that have been tested on animals and that the final product has not been tested on animals either (declaration possible).

·         specifications of the packaging materials

·         description of the manufacturing process

·         specifications for the final product (results of analyses of the final product, including physical and chemical indicators and microbiology)

·         stability data of the final product

·         preservation Efficacy Test, Challenge Testing

·         dermatological Test, Patch test - dermatological tests (if any)

·         product labels - labelling/label designs According to the regulation, the responsible person must be listed first on the labels

·         Details of the responsible person in the EU and details of the product notification on the CPNP portal.

The cost of the safety assessment depends on several factors, such as:

The amount of raw materials - each material is assessed separately.

The type of product, route of exposure and method of application influence the assessment.

Target group – products intended for specific groups, such as children, require a more detailed assessment.

In special cases, such as the use of aerosol products or products that may come into contact with human skin (toothpastes), the scope of the assessment may be expanded.

Based on the results of the assessment, the product receives one of the following statements:

The product is safe and can be sold without restrictions.

This product is safe when certain warnings or restrictions are observed.

This product is unsafe and cannot be accepted on the market.

The product must not contain raw materials included in the list of prohibited substances in the EU Cosmetics Regulation (EC 1223/2009) or substances whose concentration exceeds the permissible limits.