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Cosmetics

Archive



The gap between free competition and regulatory compliance


May, 18, 2016

 

Biocidal products and cosmetics

Cosmetic, medicinal and biocidal products are subjected under different, independently applicable regulations which let manufacturers, attorneys and competent authorities large margins of interpretation concerning product categorization and accuracy of advertising claims. In general, products placed on the European market can only be cosmetic, medicinal or biocidal and never two or even three of them at the same time. Claims referring to these products shall of course always be in compliance with the respective, applicable law. According to the European Commission (EC) borderline guidance document (“Manual on the Scope of Application of the Cosmetics Regulation No.1223/2009 (Art. 2.1a)”) which is legally not binding but widely used as reference, also in court, claims like antiseptic, antimicrobial or antibacterial are allowed as secondary claims for oral hygiene products where the primary purpose is of a cosmetic nature. However, in the same document it is stated that a mouthwash would be a medicinal product where the intended use is to treat or prevent mouth and pharynx diseases. Furthermore, to point out the gap of opinions, the Irish national competent authority goes a step further by saying that the descriptors “prevention of disease”, “protection from contamination” and “protection from infection” mandatorily lead products in the borderline area with medicinal, medical and cosmetic products and they should not even be permitted as secondary claims for cosmetic products (“Irish borderline guideline”).
As several companies currently offer oral care products with claims like “antimicrobial mouthwash for a better oral hygiene” using these claims gives the impression that this practice is widely tolerated caused by the legal confusion in the European Commission (EC) as well as in the industry and in national authorities. Future decisions of European courts naturally cannot be foreseen, but at least there are first tendencies already visible. There is a German court decision from December 2013 (Higher Regional Court (“Oberlandesgericht”, OLG) Hamm, AZ 4U 70/13). The defendant, a German company, placed a mouthwash on the market containing the ingredient chlorhexidine digluconate (CHG). This ingredient is permitted as preservative according to the European Cosmetics Regulation (EC) No. 1223/2009 up to a concentration of 0.03%. Since CHG is also well known as antimicrobial agent and the active component of several medicinal products (which requires a separate approval) the defendant used the antimicrobial characteristic of his product related to that ingredient (“Special Medical Mouthwash (Chlorhexidine)”) for marketing purposes. For that reason, the court decided that the product has to be classified as medicinal and not as cosmetic product whereas the permitted use as preservative according to the Cosmetics Regulation has not been relevant. In fact, the main reason for the verdict has been the “false” intended use of CHG. This particular case shows clearly how careful companies have to be in regards to their product labeling.

In summary, it can be said that there are several similar products on the European market using terms like antiseptic or antimicrobial where the differences between primary and secondary claim is blurred and a case-by-case decision by the competent authorities is inevitable. The Regulation (EC) No. 655/2013 predefines guidelines for advertising claims as laid down by Article 20 of the Regulation (EC) No. 1223/2009.


Controversy on “Free of” claims: Information of customers or denigration of ingredients?

The widely used free of advertising claims for cosmetic products are currently under controversial discussion in Europe whereas several competent authorities promote the complete ban of these marketing tools, especially the claim paraben free which has been prevailed since the beginning of the Europe wide safety discussion ten years ago and subsequent campaigns by several consumer organizations. The main argument of the free of-opponents is the so-called “denigration” of ingredients which are legally used for cosmetics as described within the Regulation (EU) No. 655/2013 (on common criteria for the justification of claims): Claims related to cosmetic products shall be “objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used”. However, this argument can be practically applied to any free of-claim, e.g. alcohol free, perfume free, etc. According to the European expert group SCCS (Scientific Committee in Consumer Safety) there is no scientific proof that parabens, used as preservatives in cosmetics for over 90 years, are generally harmful to human health whilst some parabens are prohibited (Commission Regulation (EU) No. 1004/2014 April 18, 2015) and others are still approved for cosmetic products. As stated by the cosmetics industry, these claims shall serve the end consumers of making an informed and quick buying decision. Such claims are therefore essential for an adequate communication between manufacturers and consumers. For the purpose of further clarification, the official Guideline to the Regulation (EU) No. 655/2013 has been set up in order to explain and substantiate the vaguely formulated Articles of this Regulation by means of concrete examples on what shall be permitted and what not. This particular topic is also currently under discussion between representatives of the competent authorities and cosmetics industry.

There is, to MDSS’ knowledge, still no legally binding decision at this time.