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Legal Alerts

December 12, 2016

New Guidelines on Microbiological Control of Cosmetic Products Tighten Criteria for Cosmetics Manufacturers

Legal Alerts
Healthcare

Recent Development

The Turkish Medicines and Medical Devices Agency (TİTCK) published on its website the Guidelines on Microbiological Control of Cosmetic Products Version 1.0 (the “Guidelines”, Kozmetik Ürünlerin Mikrobiyolojik Kontrolüne İlişkin Kılavuz Sürüm 1.0), based on the Cosmetics Law and the Cosmetics Regulation.

What the Guidelines say

With the purpose of ensuring the compliance of cosmetic products with microbiological quality standards, the Guidelines introduce new obligations for cosmetics manufacturers regarding manufacturing and laboratory standards and provide guidance on microbiological controls.

The Guidelines provide certain obligations for cosmetics manufacturers, including the following:

  • Compliance with Good Manufacturing Practices and certain ISO quality standards should be ensured.
  • Microbiological controls should be carried out and supervised by qualified staff, such as microbiologists or other experts.
  • Preservative substances should be used at the minimum level that allows for effective use, and certain equipment in the laboratories should comply with national or international standards.

The Guidelines also provide guidance on the procedure for microbiological controls and include a detailed list of microorganisms that should not be contained in cosmetic products, along with certain measures to be taken in laboratories to prevent contamination.
For the full text of the Guidelines, please click here (in Turkish).

Actions to consider

Cosmetics manufacturers should take note of these new requirements and take the necessary steps to ensure compliance.