In the European Union (EU), a cosmetic marketing claim is regulated under EU Regulation (EC No. 655/2013). The Annex III – ‘free from’ claims were added on the July 3, 2017 to the list of regulations to be effective/mandated from July 1, 2019. At the same time the Annex IV ‘hypoallergenic’ claim was introduced.

What are these annexes all about? What do they mean in actuals? Let’s get into the details.

Annex III: “Free From” Claims

According to Annex III, a ‘free-from’ claim used for a cosmetic ingredient is forbidden, unless the ingredient is deemed as illegal for use by the EC. Following are the examples of claims which will no longer be allowed with the shift in regulations:

• “free from corticosteroids” claims – These claims are banned as per the EU regulations
• “free from preservatives” claims – These claims are not allowed if the ingredient is not supposed to be present in the product or is not a part of the official list of preservatives
• “free from allergenic/sensitizing substances” claims – A product is not allowed to give a guaranteed picture of allergy free product
• “free from parabens” claims – These claims denigrate entire family of ingredients which are legal for use
• “free from heavy metals” claims – These claims are mere Regulatory requirements which are required to be fulfilled

Annex IV: “Hypoallergenic” Claims

If a cosmetic product is designed to minimize allergenic potential, only then “hypoallergenic” claims can be used. Necessary evidences must be presented to verify and confirm the allergenic potential of the product supported by robust and scientific data. In simple words, the ‘hypoallergenic’ claiming product must not contain any known allergens or allergen precursors. As per the EC, allergens must be completely avoided if the product is:

1. Classified as sensitizer by the EC’s Scientific Committee on Consumer Safety (SCCS)
2. Skin sensitizers of category 1, sub-category 1A or sub-category 1B, as per CLP criteria
3. Generally categorized as a sensitizer
4. Contains missing data related to its sensitizing potential

Since, ‘hypoallergenic’ never guarantees complete absence of allergy, therefore, a product must not give any such impression.

As the new cosmetic claim requirements mentioned in Annex III – ‘free from’, and Annex IV – ‘hypoallergenic’ will be applicable from July 1, 2019, manufacturers have very less time to understand and adhere to them. Decode them with an expert assistance. Stay informed. Stay compliant.