Regulation (CE) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (hereinafter European Cosmetics Regulation) makes it mandatory for the manufacturer to ensure that a report on the safety of the cosmetic product is drawn up, including data on its stability.
To this end, there are a number of studies, some of them mandatory for this compliance, and some others recommended to further enhance the safety of the product.
Mandatory tests
Among these studies, we find:
Stability-Compatibility with the packaging. It guarantees the stability of the product in normal and foreseeable conditions of storage. The most common protocol for the stability test and which assesses the expiry date and/or the PAO (Period After Opening) is the accelerated stability test or ageing test.
- Accelerated stability test or ageing test. It is performed over a period of 12 weeks by keeping the product under two conditions: Room temperature and extreme temperature (in oven at 40 – 45º). If this period is exceeded under these conditions, it can be equated to what would happen in 36 months in normal conditions. According to the European Cosmetics Regulation, if the product exceeds this study, it is not mandatory to indicate the expiry date, but the PAO, during which the product is safe and can be used without harm to the consumer, shall be included.
Microbiological quality. It can be divided into two studies: Microbiological quality study of the product and preservative efficacy test (Challenge test).
Microbiological quality. It can be divided into two studies: Microbiological quality study of the product and preservative efficacy test (Challenge test).
Recommended tests
These tests are not mandatory by regulation, but they are highly recommended, although they can sometimes become mandatory depending on claims indicated on the labelling. An example of a claim that makes the performance of a test mandatory would be “dermatologically tested”. This claim cannot be supported by any documentation other than a clinical trial conducted under the supervision of a dermatologist.
Some of these studies are related to the safety of the product and others to the efficacy they claim:
- Safety: Patch Test, In Use Test, Open Test, Phototoxicity Test, among others.
- Efficacy: SPF, Skin regeneration, Depigmenting activity, Anti-wrinkle activity…
At Sigillum KS we can help you with any of these studies, both mandatory and recommended for greater reliability of your product. Ask us!