Europe – What kind of testing is mandatory for cosmetic products in the EU?

Testing represents an important part of a cosmetic product registration process. Cosmetic products have to undergo all the required testing defined in the EU Cosmetics Regulation (EC) 1223/2009 in order to be compliant and more importantly, to prove they are safe for use under reasonably foreseeable conditions.

There are three main types of testing for cosmetic products in the EU as defined under Regulation 1223/2009. Testing is usually the most time consuming part of the cosmetic product registration process, so it is important to have that in mind before starting the compliance process.

1. Physical, chemical and microbiological testing

All cosmetic products sold in the EU have to be produced according to the good manufacturing practice (GMP). GMP requires that very batch of cosmetic products is tested for microbiological, physical and chemical properties in order to ensure safety and quality of each batch.

Microbiological specifications of the finished cosmetic product have to include the total count of aerobic mesophilic microorganisms, which covers bacteria as well as yeast and moulds. There are two kinds of maximum limits allowed, depending on the type of cosmetic product.

For products, which are intended for children under three years of age, the eye area or the mucous membranes, the limit for total count is 100 CFU per g or ml.

For all other products, the limit is higher, 1000 CFU per g or ml. Furthermore, products have to be investigated for four most common pathogens – Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Escherichia Coli, and the absence of these pathogens in 1 g or 1 ml has to be proven.

Physical and chemical parameters are chosen based on the type of product formulation, but some of the most commonly investigated parameters are viscosity, density, pH, phase separation, physical state and organoleptic properties (odour, colour)…