Art.8 of the EU Cosmetics Regulation stipulates that the manufacturing of cosmetic products must comply with GMP. Furthermore, the standard has quasi-legal status as it was published in the Official Journal of the EU (see also ISO 22716 available from Beuth Verlag).

According to Article 10 of the EU Cosmetics Regulation, a safety assessment is required for cosmetic products. This must be carried out by a suitably qualified person before the product is placed on the market. As part of the safety assessment, the regulation also requires a preservative efficacy test. (see Annex I point 3 of the EU Cosmetics Regulation)

If, for instance, an examination for food safety criteria according to Regulation (EC) No. 2073/2005 provides unsatisfactory results and also taking into account Article 14 of Regulation (EC) No. 178/2002 it is considered an unsafe food, the food must be withdrawn or recalled from the market.

Regulation (EU) No 1169/2011 is also known as the Food Information Regulation (FIR). It governs any information that concerns food and is made available to the end consumer. It includes, among other things, requirements for mandatory nutrition and allergen labeling.

The Regulation (EC) No 1223/2009 is the overarching EU cosmetics regulation. It contains rules that every cosmetic product must meet in order to be placed on the market in the EU. The aim of the regulation is to achieve a high level of health protection and a functioning internal market for trade in cosmetic products. The Regulation (EC) No 1223/2009 has direct legal effect in all EU member states and applies to importers, manufacturers, and distributors of cosmetic products.

According to Regulation (EU) No 1169/2011 (Food Information Regulation, FIR), there is a labeling requirement for substances that may cause allergies or intolerances for both packaged and unpackaged foods. The main regulations are governed by Article 21 of the FIR. The manner of labeling non-prepackaged foods is regulated by the Provisional Food Information Supplementary Regulation (VorlLMIEV).
The substances to be declared and products made from them are listed in Annex II of Regulation (EU) No 1169/2011.

Essential contents of the GMP standard ISO 22716 include regulations regarding the areas of

• Personnel, premises & equipment
• Manufacturing & quality of the end products
• Handling of deviations & complaints
• Documentation of all activities

The regulations of the GMP standard must be adhered to in all activities related to cosmetic products to comply with the GMP requirements. This includes manufacturing, storage, shipping, and monitoring.