Human tolerance studies for the cosmetics sector - In our country, the necessary requirements to obtain a permit from the health authorities are legislated, allowing us to carry out the following activities clinical trials to study the effect and efficacy of medicines in humans. In the case of cosmetic products, There is no legislation defining the requirements for assessing, in human beings, the safety or effectiveness. However, the companies providing the testing services follow standard procedures. The aim? To avoid unnecessary risks to volunteers participating in these tolerance studies.
It is clear that the information contained in the first 9 paragraphs of Part A of Annex I of the new Regulation 1223/2009 on cosmetic products, is a solid basis on which the presumption of safety of a cosmetic product can be based. But its verification will require a study in humans, the target population for these products. Section 10 (Cosmetic product information) also affects safety. Because it refers to the contribution of existing studies on human volunteers to risk assessments.
In some discussion forums, service offers or magazine articles, this topic is referred to. And it is common for different terms to be used to express the same idea, such as clinical studies, clinical trials, o safety testing in humans. In the world of cosmetics, the following have always been carried out tolerance studies in humans. However, until the appearance of the Regulation, their consideration has not been generalised. This is perhaps why we have used medical terminology to refer to these studies.
According to the WHO, Clinical studies are medical research studies in which people participate as volunteers. And clinical research studies or clinical trials are a means of developing new treatments and medicines for diseases. Both clinical studies and clinical trials are medical in nature. They are aimed at the study of diseases and their treatment. In cosmetic products we should refer to the safety assessments such as safety studies or safety trials in volunteers.
In order to carry out clinical trials, in the study of medicinal products, there is legislation that requires a series of requirements to be met. These requirements are followed in order to obtain authorisation from the health authorities. In the case of clinical trials, which are not investigating medicines but other therapeutic strategies, authorisation is also required from the ethics committee of the hospital where the trial is being conducted. In the case of cosmetic products, in our country does not exist, so far, none legislation regulating the tests they may carry out to assess their safety or efficacy.
Recommendations for human tolerance studies of cosmetic products:
In the absence of a legislative framework, the companies offering these services are security assessment, The results of these studies tend to follow an adaptation of procedures used in studies of medicinal products.
The tolerance studies y human testing of cosmetic products should take into account the following requirements:
- The studies are conducted on healthy volunteer subjects, who sign their consent to participate. An internal ethics committee assesses the risk of each study. Depending on the substances and mixtures that make up the cosmetic product, the area and frequency of application, etc. And these risks are measured to avoid subjecting volunteers to unnecessary risks.
- The entire study is performed under medical supervision, either by a general practitioner or by a specialist (dermatologist, ophthalmologist, dentist, etc.), depending on the site of application and function.
- In case of any undesirable reaction, the application shall be discontinued.
- The company carrying out the test has an insurance policy to guarantee compensation in the event of a serious incident.
- Volunteers are allowed a reasonable amount of time between two studies.
- No human study should be conducted if equivalent results could be obtained by other means.
Some conclusions
Finally, it should be noted that it is not possible to carry out safety studies of cosmetic products on children. In the paediatric population, products should only be tested for use if their safety has been previously established.
It is therefore desirable to follow guidelines or standards. At least as long as there is no legislation in our country that establishes the necessary requirements for assessing the safety and efficacy of cosmetic products on humans. And for that, we must implement appropriate measures to minimise risks to which the volunteers participating in the studies are subjected.
If you need more information on how to conduct human tolerance studies of cosmetics, do not hesitate to contact us. Our proposal? Solutions!
- The Expert Opinion was written in 2012 for the former GTF M. Camps website. It coincided with a context of doubts regarding the interpretation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. Today, these issues are still of great relevance for the cosmetics sector.