SAFETY OF A COSMETIC PRODUCT:
Today, in our ‘Expert’s View’ column, we address questions regarding the safety of a cosmetic product:
Is it necessary to demonstrate the safety of a cosmetic product before it is placed on the market?
This would be the short answer:
No, for two reasons.
1) Nowhere in the Regulations does it state that their safety must be demonstrated
2) A cosmetic product does not necessarily have to be harmless.
One of the objectives of the Regulation is to achieve a a high level of protection for human health. We know that, under certain conditions of use, cosmetic products can cause adverse effects. For this reason, appropriate measures must be taken to prevent this. In addition to designing a suitable formula, an assessment must be carried out. This is done through specific studies to determine the extent of the potential risks associated with their use. With all this in mind, it will be possible to to set out the warnings and other information appearing on the product’s labelling. Consequently, the occurrence of adverse effects may be attributed to misuse of the product. This would thereby exonerate the person responsible. Assessing risk is not the same as demonstrating safety.
If you’d like to find out more about the safety of a cosmetic product, you should carry on reading…
Further information on the safety of a cosmetic product:
The Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products sets out, in less than two pages – Annex I, Part A – all the required information on the the safety of a cosmetic product before they are placed on the market. Given the wide variety of marketable cosmetic products, it is clear that the content of these two pages requires correct interpretation. This is necessary both to achieve the Regulation’s safety objectives and to apply it to the characteristics of the cosmetic product we wish to develop. Accurate interpretation is crucial to the viability of its development.
The term appears only once in the Regulations: safety -in recital 41 of the introduction, and without referring to its justification-. On the contrary, the security term appears 71 times. The Regulations therefore place particular emphasis on the need to achieve a a high level of protection for human health (safety). But this is not necessarily based on the safety of a cosmetic product, but rather on the understanding of the potential causes of toxicity. And in the shot of appropriate measures to prevent them.
«Cosmetic products are not necessarily harmless»
Cosmetic products are not necessarily harmless. Some claims imply the presence of certain ingredients that may cause injury. Yet this does not prevent them from being marketed. For example, if we wish to develop a product for deep cleansing of the skin, we must bear in mind that the formula will contain a certain amount of surfactants, which are harmful to the ocular mucosa. The Regulation states that, in this case, the extent of the injury would need to be assessed if the product were accidentally introduced into the eye – which would not necessarily constitute misuse. The results of a HET-CAM test would enable the appropriate measures to be taken to prevent unwanted adverse effects. If, for example, the irritant effect is high, a clear warning should be included stating: «avoid contact with the eyes». Or, where appropriate, it might even be recommended to «rinse thoroughly with water should such contact occur».
The legal framework: the Annexes to the Regulation
All the information requested in Part A of Annex I is directly related to the potential toxic effects. The declaration of the formula – paragraph 1 – guarantees the absence of unauthorised substances. The stabilitythe microbiological quality and the impurity declaration -sections 2, 3 and 4- would ensure the absence of undeclared substances and microorganisms in the formulation, which could potentially trigger unwanted adverse effects. The toxicological profile of the constituent substances – sections 7 and 8 – enables us to identify potential risks. All this information, assessed in relation to the environment and conditions of use – sections 5 and 6 – enables us to to establish a sound theoretical basis on which the presumption of safety in the use of the cosmetic product is founded.
Sections 9 and 10 call for human studies to support the theoretical basis for their safety and to assess the extent of the risks associated with their use. We are not talking about proving, since In science, proving something can be difficult and usually requires highly complex experimental protocols applied to a very large number of cases. And that remains beyond the scope of a cosmetic product.
A partner in marketing: advice from an expert Safety Data Sheet assessor
Before considering the development of a cosmetic product, certain parameters must be established. The main ones are the intended function, the site of application, the amount applied, the area treated, the frequency of use, the duration of treatment and the target population. Once these parameters are known, the necessary and sufficient tests can be designed to verify the product’s safety. The physicochemical characteristics, stability, impurities and toxicity of its components will also be taken into account.
The advice from an expert assessor of the dossier, before commencing the development of a cosmetic product, this will enable us to agree on the tests required to verify its safety for use, in accordance with the Regulation, so that there are no surprises at the end of the development process.
To ensure the the viability of a cosmetic product, it is necessary to address the issues that matter. Set aside the issues that are not. And, above all, distinguish between the two. That is what expert advice should provide us with.
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- The expert opinion was drafted in 2012 for the former GTF M. Camps website, against a backdrop of uncertainty regarding the interpretation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. To this day, these issues remain of great relevance to the cosmetics sector.