2018 Revisions to EU Cosmetic Regulations

2018 Revisions to EU Cosmetic Regulations

New additions to the interpretation of EU cosmetic regulations legislation will affect cosmetic products claiming to be ‘free from’ (Annex III) or ‘hypoallergenic’ (Annex IV).


These guidelines will be used to determine on a case-by-case basis if a cosmetic product complies with Regulation No 655/2013. Requirements for ‘free from’ and ‘hypoallergenic’ claims will start to apply in July 2019.

‘Free from’ claims (Annex III)

Prospector Knowledge‘s table summarises the changes to the interpretations to ‘free from’ claims in cosmetics:

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)

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

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. 

Table: Prospector


‘Hypoallergenic’ claims (Annex IV)

The claim ‘hypoallergenic’ should not guarantee a complete absence of risk of an allergic reaction or give the impression that it does.

‘Hypoallergenic’ can only be used when the cosmetic product does not contain any known allergens or allergen precursors. These include substances or mixtures:

 identified as sensitisers by the Scientific Committee of Consumer Safety (SCCS) and other official risk assessment committees

 falling under the classification of skin sensitisers of Category 1, Sub-category 1A or Sub-category 1B of the CLP Regulation

 identified by the company on the basis of the assessment of consumer complaints

 generally recognised as sensitisers in scientific literature

 for which relevant data on their sensitising potential are missing.


Table courtesy of Prospector.

Image courtesy of Unsplash.


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