European Guidelines Now In Effect For ‘Free From,’ ‘Hypoallergenic’ Cosmetic Claims

According to Cosmetics Europe, at least “several” EU Member States are expected to be monitoring the marketplace for compliance with guidance developed by a European Commission working group, key aspects of which – concerning “free from” and “hypoallergenic” claims – went into effect 1 July.

“Paraben-free” is among claims that should not be used on cosmetic products in Europe, as of 1 July, 2019, under guidance updated by a European Commission working group two years ago.

A Cosmetics Europe spokesperson confirmed in a 15 July email that provisions of the technical document related to “free from” and “hypoallergenic” claims – annexes III and IV, respectively – became applicable at the start of July.

The trade organization recommended in October 2017 that its member companies adhere to the guidance in their marketing activities.

Cosmetics Europe has a seat on the Commission’s Working Group on Cosmetic Products, which endorsed the document following its development by a sub-working group on claims. Other industry groups, including the European Federation for Cosmetic Ingredients, also have representation on the working group, along with the European Consumer Organization (BEUC) and all EU Member States.

A European Commission rep said the cosmetics industry is encouraged to follow the guidance, but “ultimately, it is for the national competent authorities and national courts to assess on a case-by-case basis which claims made in relation to cosmetic products are allowed.”

According to the guidance, companies should not claim that a cosmetic product is free of an ingredient or class of ingredients that is prohibited under the Cosmetics Regulation (1223/2009), such as corticosteroids, or ingredient(s) that typically would not be found in a product of that sort – eg, preservatives in a fine fragrance, as fine fragrances rarely require preservatives to prevent contamination due to their high alcohol content.

Further, companies should refrain from making preservative-free claims for products that contain any substance known to have a protective effect against microorganisms, even if the substance is not listed as an approved preservative in Annex V of the Cosmetics Regulation, the technical document states.

Experts have observed that cosmetics promoted as preservative-free often appear to be relying on substances with antimicrobial properties, even if they aren’t traditional go-tos for the job. (Also see "FDA Analysis Of Non-Traditionally Preserved Cosmetics Indicates Likely Contamination Source " - HBW Insight, 21 Jul, 2018.)

Importantly, the EU guidelines also hold that claims conveying a denigrating message about an ingredient or group of ingredients based on a “presumed negative [safety] perception” should be avoided.

The authors cite “free from parabens” as an example, given that use of some parabens is considered safe and is thus permitted at restricted levels under the Cosmetics Regulation. (Also see "EU Working Group: Cosmetics Should Be 'Free From' Denigrating Ingredient Claims" - HBW Insight, 28 Aug, 2017.)

“Considering the fact that all cosmetic products must be safe, the claim 'free from parabens' should not be accepted, because it is denigrating the entire group of parabens,” they say.

Similarly, the working group says claims highlighting the absence of triclosan or phenoxyethanol, for example, should not be used because those ingredients can be safely and lawfully used in cosmetics.

As for “hypoallergenic” claims, such statements should be reserved for cosmetic products designed to minimize allergic potential, and responsible persons should have evidence on hand to demonstrate the products’ “very low allergenic potential,” according to the technical document.

Such items should be formulated without known allergens or allergen precursors, as identified by the Scientific Committee on Consumer Safety or other authoritative risk-assessment bodies, designated as such under the EU’s Classification, Labeling and Packaging Regulation, highlighted by consumer complaints or recognized generally in scientific literature, the authors say.

Questions of how hypoallergenic is defined and commonly understood by consumers have been central to false advertising litigation in the US in recent years. (Also see "Target Cruises Past Hypoallergenic Cosmetic Suit, But Other Defendants On Rockier Road" - HBW Insight, 15 Aug, 2018.)

“The companies should consider whether consumers, in the respective country, understand the claim ‘hypoallergenic.’ If necessary, further information or clarification regarding its meaning should be made available,” the guidance states.

Not An Official Commission Document

A European Commission rep noted in a 16 July email that companies have had two years to bring their marketing into compliance with the claims guidelines, while noting, “It was also agreed that products placed on the market before July 2019 should continue to be sold, provided that there are no safety issues involved.”

Further, the spokesperson emphasized that the guidance is not an official Commission document. It was designed to support compliance with Regulation No. 655/2013, which sets out common criteria for the justification of claims used on cosmetic products, clarification required by the preceding Cosmetics Regulation.

The instrument is not legally binding. The Commission rep said the cosmetics industry is encouraged to follow the guidance, but “ultimately, it is for the national competent authorities and national courts to assess on a case-by-case basis which claims made in relation to cosmetic products are allowed.”

According to Cosmetics Europe, at least “several” Member State authorities are using the document as a reference in their market surveillance activities.

“Cosmetics Europe will continue to monitor the implementation of this guidance at national level, via its national associations,” the rep said.