The quality assessment of a cosmetic product It is, in some cases, a necessary step prior to placing the product on the market. To determine when it is necessary to assess the quality of a cosmetic product, one must understand Articles 20 and 21 of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, relating to the product claims y product safety, respectively.
All cosmetic products have a intended function. But on certain occasions, questions arise specific demands which complement it. Good examples of this include hypoallergenicity, non-comedogenicity, water resistance or a certain effect that lasts for a specific period of time.
Any claims whose non-fulfilment could lead to undesirable consequences require further investigation.It is understood that, for this reason, they might change the security settings of the cosmetic product. In this context, it will be necessary to assess the quality of a cosmetic product. For example, in the case of a sun cream claiming a sun protection factor of 30, the consumer relies on the accuracy of this figure. If the factor were lower than stated, the protection against a given level of exposure would be less than indicated. Consequently, the consequences of overexposure could be attributed to the inaccuracy of certain information, rather than to the misuse of the cosmetic product. In this case, the sun protection factor will be verified through a human trial.
Those would also require further study claims that indicate a quantifiable activity. For example, a cream claiming to have a 24-hour moisturising effect would need to undergo an efficacy trial on humans to verify the accuracy of this claim. In this case, non-compliance would relate more to Article 20 of the Regulation than to the safety provisions.
Further information on the quality assessment of a pCosmetic product:
Any cosmetic product, when it comes into contact with the surface of the human body, has a intended function. For example: cleaning them, protecting them or keeping them in good condition. These claims, which are implicit in the intended function, stem from the recognised activity of the substances or mixtures of which the product is composed. Thus, for example, the cleansing activity of surfactants is universally accepted and there is an extensive body of literature on the subject. A cosmetic product containing these substances may, of course, claim to have a cleansing effect. And there is no need to verify this through human trials. It is quite another matter, however, assess safety in use.
The legal framework for quality assessment: Articles 20 and 21 of the Regulation
Article 20 of the Regulation refers to product claims. Paragraph 1 states that No characteristics or functions shall be attributed to the product which it does not possess. This article provides for the future establishment of common criteria to justify the use of claims.
In any case, it is to be hoped that these criteria will comply with the the general rule that one should not have to check what has already been checked. And indeed, framework formulas are credited with obvious claims such as, for example, moisturising or oral cleansing. Is a study really needed to prove that a product containing 20% of oils and waxes and 20% of certain silicones has a moisturising effect? Or… is it necessary to test the plaque-removing effect of a toothpaste containing 55% of abrasives? The answer is no. In fact, we must not put anyone at risk, even if it is minimal, the participants in this study to corroborate the evidence.
In addition to claims relating to the intended function, certain cosmetic products feature more specific claims. These require separate analysis. Such claims are usually linked to specific, quantifiable data on which the user bases their decision to use the product. The the falsity of these claims may lead to the onset of adverse effects -those of us who fail to comply with the provisions of the Safety Regulations-, such as the assignment of functions that the product does not have (Article 21). In this second case, there could also be a breach of the General Law on the Protection of Consumers and Users.
Let’s look at two examples…
- Let us imagine that a moisturiser for sensitive skin is to be marketed with the label «hypoallergenic». This claim does not imply the absence of allergic reactions when the product is used. In fact, it claims a reduction in the likelihood of such reactions. The first requirement, before any study is undertaken, is that no substance or mixture should contain any known allergens. Once this has been confirmed, a hypoallergenicity study must be carried out on humans. This serves to verify that there are no other substances – typically impurities – with allergenic potential. If the claim is false, it could lead to unwanted adverse effects.
2. Let us suppose that we wish to market a moisturising cream and claim that this effect lasts between 60% and 80% for 24 hours after application. Based on its composition, we could claim the moisturising effect. However, the quantification of both the effect and its duration must be verified through a human study. To this end, an objective method will be used: in this case, corneometric measurements, for example. The essays of this type of study they must never be based on the subjective sensory assessments of the patient being treated.
Under no circumstances may claims be made which, whilst true, lend themselves to a biased interpretation. For example, if we claim that the cream in question increases hydration by up to 60%, it could be the case that, in the study, only one subject showed this value. Whilst the other 29 in the sample might range from 20% to 40%. The claim would not be false, but the response of a single individual is not representative of a population. And tThe demands must focus on a significant proportion of the same.
Conclusion on the quality assessment of a cosmetic product
It is very important to devise a suitable strategy for the development of a cosmetic product before work begins, in order to ensure its viability.
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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.