In order to achieve efficacy, active ingredients are used. The consensus is that the addition of an active ingredient helps to obtain desired activities. Active ingredients are tested through and through, using in vitro, ex vivo and in vivo technologies to make sure the activity is there. But does the addition of such a proven active ingredient really suffice? No, the activity of a cosmetic formulation is a product of the combination of an active ingredient together with the overall cosmetic formulation.

Depending on the desired activity, the active ingredient needs to penetrate into those areas in the skin where it should elicit its activity. A skin lightening active ingredient, which claims to have an effect on melanocytes, those cells which produce melanin, should be able to penetrate to the bottom of the epidermis, for instance. This is where the melanocytes reside. This means that the cosmetic formulation, should facilitate the active ingredient’s penetration to these regions. Formulating this skin lightening active ingredient into a simple ‘carbopol gel’ will not be sufficient, for example. The cosmetic formulation should be developed smartly and with a clear goal.

Despite the clear relationship between active ingredient and the formulation it is contained in, ‘ingredient claims’ seem to be commonplace in the cosmetic industry. Ingredient claims are claims where the efficacy of the active ingredient is highlighted on the cosmetic packaging and other means of marketing the cosmetic product (website etc.). The wording used is chosen to convince the consumer of using the product. This is often done in such a way that the consumer gets the impression that the efficacy of the active ingredient contained is relevant for the cosmetic product as a whole.

When it comes to the topic of cosmetic claims, there is no going around the cosmetic legislation. The cosmetic claim legislation in the European Union (EU) is representative for the worldwide situation and quite elaborate on the topic of cosmetic claims legislation. In Commission Regulation (EU) 655/2013, common criteria for the justification of claims used in relation to cosmetic products have been defined. A Technical Document, which provides guidance for the application of above regulation is regularly updated by the sub-working group on claims in the European Union. Although this Technical Document is not legally binding, it does provide a few tips on how to interpret and apply the common criteria. In 655/2013, relevant to ingredient claims, the following is stated: “Ingredient claims referring to the properties of a specific ingredient shall not imply that the finished product has the same properties when it does not.” In the accompanying Technical Document, this statement is illustrated with: “The claim ‘contains moisturising aloe vera’ or prominently picturing aloe vera should not be made if the product itself has no moisturising effect.“

The above does not give any room for interpretation, but another of the common criteria in 655/2013, ‘evidential support’, makes the situation more complex; “A claim extrapolating (explicitly or implicitly) ingredient properties to the finished product shall be supported by adequate and verifiable evidence, such as by demonstrating the presence of the ingredient at an effective concentration.” Under this same criterion following is stated as well: “Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and information available depending on the nature of the claim and the prevailing general knowledge of the end users.” Unfortunately, the Technical Document does not provide information on how to interpret these points in the context of their explanation of ‘aloe vera’, as described above.

So, the answer to the question still seems to be open. Do or don’t cosmetic brands need to perform efficacy studies on their finished cosmetic formulations? Can they rely on the information provided about the efficacy of the active ingredient or do they have to prove it themselves?

In general, the worldwide consensus is to prove the cosmetic claims. It is therefore advisable to perform efficacy studies with the final cosmetic formulation. However, costs are high and performing efficacy studies is time consuming. Both factors are often decisive in choosing not to perform efficacy studies, but to rely on the activity of the active ingredient. Smart wording is used to both appeal to consumers and be acceptable to the competent authorities.

In the context of the above, it is important to know how the competent authorities interpret the legislation. In September 2016 the EU published a report on product claims made based on common criteria in the field of cosmetics; 21 member states of the EU took part. In-market controls were performed during one calendar year. Almost 39,000 cosmetic claims were evaluated, of which 3,730 were found to be non-compliant with 655/2013. As for ‘ingredient claims’, the report makes an interesting statement: “….claims highlighting the function of one of the substances to be the function of the final product. Due to the low concentration of the substance in the product, its effectiveness could not be achieved and evidential support for the function claimed by the manufacturer was considered insufficient.“

In line with the above, an interesting recent example from the EU stems from the Netherlands: a skincare brand made claims on ‘skin renewal’ on the basis of the presence of Retinyl Palmitate in their formulations. The Dutch advertising standards authority (Reclame Code Commissie) decided that the claim made, was not acceptable, because no proof could be given for ‘skin renewal’ properties for the particular concentration of Retinyl Palmitate in the cosmetic formulations concerned. In this case too, no point was made about the fact that no efficacy studies were performed with the final products and only the lack of a sufficient concentration of the active ingredient was deemed relevant.

Concluding from the above, merely making ‘ingredient claims’, making sure that the concentration of the active ingredients is the same as the concentration which was used by the active ingredient supplier in his efficacy studies, might be sufficient for the competent authorities. In above-mentioned 2016 report from the EU one other statement is made, though. Among the most frequently reported corrective measures, the following is mentioned: “Instruction to the responsible person to conduct new studies to get enough evidence to retroactively support the claims.“

Legislation and the competent authorities are wooly and seemingly inconsistent, but it is important to realize that the consumer is the final judge. It is hard to satisfy the modern day consumer. The consumer is receptive of interesting marketing approaches by the cosmetic industry, but wants results too. Marketing probably helps selling a cosmetic product for the first time, but the consumer will only buy it a second and consecutive times, when she or he is satisfied with it. For an important part, consumer satisfaction comes from the efficacy of the cosmetic product.

The cosmetic product should be formulated smartly, containing effective concentrations of active ingredients. This is a prerequisite of the ability to make efficacy claims. The wording used is another hugely important factor in successfully making efficacy claims. The body of evidence of the cosmetic claim should be reflected in the actual wording, describing the efficacy.

Depending on the exact wording of the cosmetic claim, it is clearly advisable to perform efficacy studies. If there is a lack of time and/or money, making it impossible to perform efficacy studies, it is important to comply to the cosmetic legislation. Although the legislation differs in different regions, one important part of the text in EU’s 655/2013 is valid worldwide: “Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and information available depending on the nature of the claim and the prevailing general knowledge of the end users.” With correct wording, ‘the weight of evidence’ will possibly be deemed enough when evidence can be shown that the cosmetic formulation concerned, both contains a sufficient concentration of active ingredient(s) and is formulated in such a way that it facilitates penetration of the active ingredient(s) to those areas in the skin where it can elicit its activity.

In the cosmetic industry, making false claims is like driving too fast. Many people seem to do so, but the chance of ‘getting caught’ is only small. Self-regulation is a great asset in the cosmetic industry, where our industry is extremely active in educating itself in doing the right thing. The consumer is most important of all, though. Cosmetic brands can only thrive, when the consumer is satisfied with them. Consumer satisfaction is based on many aspects of a brand, efficacy being among the more important factors.