Cosmetic products. Defined categories of cosmetic products which are relevant for the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (face, lips, skin eyes, nails, oral and similar products)
Draft Order of the Minister for Health of the Republic of Lithuania amending Order No 288 of the Minister for Health of the Republic of Lithuania of 15 May 2001 approving Lithuanian Hygiene Norm HN 64-1:2001.
Cosmetic products and personal hygiene products: maximum permissible level of microbial contamination (5 pages, in English)
The objective of Hygiene Norm is to define microbiological qualitative and quantitative limits for finished cosmetic products in order to ensure their microbiological safety. Microbiological limits are based on the Lithuanian standard LST EN ISO 17516:2015 Cosmetics Microbiology - Microbiological limits (ISO 17516:2014) and the 9th Revision of SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. Two separate categories of cosmetic products are defined: Category 1: products specifically intended for children under 3 years and care products of eyes, mucous membranes and Category 2: products, not involved in Category 1.
The probability of microbiological contamination for some cosmetic products is extremely low due to product characteristics to create a hostile environment for survival or growth of microorganisms. Responsible person (manufacturer, distributor, importer) has obligation to perform a microbiological risk assessment of the cosmetic products and to identify microbiologically low-risk products, whose environment denies the physical and chemical requirements for growth or survival of microorganisms. Therefore, products that comply with the characteristics outlined in Lithuanian standard LST EN ISO 29621:2011 Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products (ISO 29621:2010) do not require routine microbiological testing. In the suspected cases of microbiological contamination of microbiologically low- risk products market surveillance authorities, in accordance with the requirements of legal act must organize microbiological testing which should be provided by accredited testing laboratory.