Division 3.3 Microbiological quality

United Kingdom

The aim of that section of the cosmetic product safety report is to determine the acceptable microbiological specifications of the raw materials (substances or mixtures) and finished product from a microbiological point of view. In accordance with Annex I to Regulation (EC) No 1223/2009, particular attention is to be paid to the microbiological specifications of cosmetic products intended to be used on sensitive body parts and on specific populations. In addition, information regarding microbiological quality is essential in order to justify the effectiveness of the preservation system and justify the indicated minimum durability of the cosmetic product stored under appropriate conditions and period-after-opening (PAO) ^f1 of the finished product in terms of safety.

The microbiological specifications of the raw materials (substances or mixtures) and cosmetic product are to form part of the safety assessment. Particular attention is to be paid to the microbiological specifications of cosmetic products intended to be used around the eyes, on mucous membranes in general, on damaged skin (e.g. skin care products suitable for atopic or irritated skin), on children under three years of age, on elderly people or on persons with compromised immune responses.

Annotations

Footnotes

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” ’.

Notes on Division 3

Footnotes

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.