Division 3.3.2 Microbiological quality of the finished cosmetic product

United Kingdom

Concerning microbiological susceptibility, there is a difference between three product categories:

(1)

low microbiological risk products (e.g. products with an alcohol content > 20 %, products based on organic solvents, high/low-pH products), for which neither a preservation challenge test nor microbiological quality tests on the finished product are necessary. A scientific justification is to be provided, however;
(2)

single-use products, and products which cannot be opened (e.g. for which the packaging allows dosing the product without it coming in contact with the air), for which only microbiological quality tests on the finished product are necessary. A scientific justification is to be provided, however;
(3)

all other products, for which both a preservation challenge test and microbiological quality tests on the finished product are necessary.

Specific ‘Guidelines on Microbiological Quality of the Finished Product’ are provided in the SCCS Notes of Guidance^f1.

Annotations

f1: The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8^th Revision, SCCS/1501/12, and its subsequent updates.

f1: The ‘date of minimum durability’ is the date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain safe; the PAO is the period of time after opening for which the product can be used without any harm to the consumer. See ‘Practical implementation of Article 6(1)(c) of the Cosmetics Directive (76/768/EEC): Labelling of product durability: “period of time after opening” ’.