No to patch tests, yes to in vitro tests

The regulations

At European level, the cosmetics sector is regulated by Reg. 1223/2009. In the Regulation, however, only product safety assessment is mentioned and the only test included as mandatory, if relevant, is the challenge test.

According to the reference legislation, the manufacturer is therefore not obliged to carry out tests on cosmetics, apart from the challenge test, as these are optional.

For any product there is no obligation of dermatological tests or in vitro tests; the essential condition is that the product does not harm the consumerand the only obligation is to prepare and have a PIF that proves the safety of the product and be able to support the information declared on the label.

The risks

In addition, cosmetic products to be marketed must not be previously authorized by third parties and arenot subject to controls by agencies or authoritiesbefore being placed on the market, there is areal danger of exposing the consumer to risks, making him a guinea pig of the product.

The risk for companies is to incur, in case of reporting of adverse events according to the Colipa “Sue reporting guidelines”, in eventual recalls or withdrawal of the product, with consequent economic damage, image up to criminal sanctions.

Consequently, in the evaluation of safety, in which several aspects must be taken into account, it often becomes essential, especially in the presence of certain substances or chemical-physical characteristics of the product, to carry out supporting tests. As specified, these tests are not compulsory by law, but are carried out voluntarily by the cosmetic company to confirm the good skin tolerability of the products.

The different types of tests

There are in vivo studies (e.g., patch test, stinging test, in-use test) conducted under strictly controlled conditions, under the supervision of a physician; individuals voluntarily participating in the study must be in good health and properly informed of the purpose of the investigation.

This testing methodology, however, shifts the role of product “guinea pig” from the end consumer, to the informed volunteer!

There are therefore many doubts about the ethicality of this practice because, while fully respecting the ethical principles set out in the Declaration of Helsinki, the real risk is to create any allergic reactions or permanent sensitization on the volunteer.

Therefore, a more step-by-step approach with less risk is to make an initial assessment of the product by relying on in vitro tests that follow standard protocols and are able to provide important predictive information. Combining several in vitro tests as part of an Integrated Testing Strategy (ITS) for safety assessment provides greater predictivity to the analytical approach and is a solid foundation for safety assessment.

This type of approach also allows to test several formulations simultaneously and make a preliminary assessment on the tolerability of the product and therefore on the passage to the next step that could be the in vivo test.

The solution

A strategy consisting of a preliminary in vitro test with the Dermal Irritection® method and subsequent dermatological test using Patch test at 48 hours of exposure on 12 volunteers.

The testing of possible dermal irritation caused by a cosmetic product, among the evidence that the Company must produce for its Product Information File, is of fundamental importance.