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As required by the EU Cosmetics Regulation (EC No 1223/2009, Article 20), the acceptability of a claim made on a cosmetic product is determined by its compliance with the common criteria. Established by the EU Commission and the EU Member States, these six common criteria (namely Legal compliance, Truthfulness, Evidential Support, Honesty, Fairness and Informed decision-making) are reported in Regulation EU No 655/2013.1

The EU Commission and the EU Member States published a revised version of the guidelines for the application of the common criteria.2 This new version contains two additional annexes, one on ‘free from’ claims (annex III) and one on the ‘hypoallergenic’ claim (annex IV). In summary, these new annexes introduce the following changes in the management of cosmetic claims:

Annex III: ‘Free from’ claims

Type of ‘Free from’ claim Status Reasoning ‘Free from’ + ingredient prohibited by the EU Cosmetics Regulation ⊗ E.g. ‘Heavy metals free’ Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed. ‘Free from’ + ingredient or ingredients category that are present in the product ⊗ E.g. ‘Free from formaldehyde’ (if the product contains formaldehyde releasers) If it is claimed on the product that it [does not] contain[s] a specific ingredient, the ingredient shall be deliberately [absent] present. ‘Free from’ + ingredient not supposed to be present in the product ⊗ E.g. ‘Preservative free’ (if the product is a fine fragrance containing high amounts of alcohol or bath salts, not expected to contain preservatives) Claims shall not attribute to the product concerned specific characteristics if similar products possess the same characteristics. ‘Free from allergenic / sensitizing substances’ ⊗ A complete absence of the risk of an allergic reaction cannot be guaranteed and the product should not give the impression that it does. “Free from” claims or claims with similar meaning should not be allowed when they imply guaranteed properties of the product, based on the absence of (an) ingredient(s), which cannot be given. ‘Free from’ + ingredients category (e.g. fragrance, preservative, colorant) OK/ ⊗ E.g. ‘Preservative free’ is wrong if the product contains an ingredient, not in the official list of preservatives (Annex V) but having antimicrobial properties. E.g. ‘Fragrance free’ is wrong if the product contains an ingredient that exerts a perfuming function, regardless of its other possible functions in the product. This claim is acceptable except if the product contains an ingredient having properties of this ingredients family as a side function. ‘Free from’ + an ingredient or an ingredients family that are legally used ⊗ E.g. ‘Parabens free’ Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used. ‘Free from’ claims that allow an informed choice to a specific target group or groups of end users OK E.g. ‘Free from alcohol’ in a mouthwash intended as a family product. E.g. ‘Free from animal-derived ingredients’ in Vegan products. Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice.

Annex IV: ‘Hypoallergenic’ claim

The claim “hypoallergenic” can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential. Evidence to support the claim must be available by verifying and confirming a very low allergenic potential of the product through scientifically robust and statistically reliable data (for example reviewing post-marketing surveillance data, etc.).

A product claiming to be ‘hypoallergenic’ will not contain known allergens or allergens precursors.

By making reference to the SCCS Memorandum SCCS/1567/15,3 these guidelines make useful clarifications about tests performed in healthy human volunteers such as the Human Repeated Insult Patch Tests (HRIPT). This version of the guidelines is less stringent than its initial draft and brings clarifications: hazard assessment of ingredients via HRIPTs is unethical and should be strictly prohibited. However, tolerance studies of a cosmetic product in humans are acceptable. Ideally, the use of Repeated Open Application Tests (ROAT) should be preferred to HRIPTs conducted on a finished cosmetic product.

The legal status of these guidelines was rather unclear and a legal review has been performed by Ms. Sylvie Gallage of Hogan Lovells LLP, a lawyer and specialist of this topic.

On the one hand, it was confirmed that this document is a working document that has no legal status and, therefore, is not deemed legally-binding.

On the other hand, these guidelines will be used by the National Authorities and Courts of Justice to determine on a case-by-case basis if a cosmetic product complies with Regulation EU No 655/2013.

Therefore, and to stay on the safe side, it is strongly recommended that cosmetic brands comply with these guidelines. Requirements laid down in Annex III and IV of these guidelines will start to apply in July 2019. While it is awkward to provide a deadline for a non-legally-binding document, the National Authorities and Courts of Justice will likely start to use these guidelines as a reference from this date.

References

Regulation EU No 655/2013 [PDF] Technical document on cosmetic claims [PDF] SCCS Memorandum SCCS/1567/15

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