Product claim: Hypoallergenic

Commission Regulation (EU) No 655/2013 and the Technical Document on Cosmetics Claims (Annex IV)


What are hypoallergenic claims? 
Hypoallergenic is defined as “having a decreased tendency to provoke an allergic reaction”. 


When can I make a hypoallergenic claim?
You may think that so long as your product does not contain any perfume nor food allergens you may use a hypoallergenic claim. However, only in situations when the cosmetic product has been created to minimise its allergic potential may the term "hypoallergenic" be used. 

A very low allergenic potential of the product should have been verified and confirmed by the responsible person using scientifically sound and statistically reliable data (such as evaluating post-marketing surveillance data). In light of fresh information, this assessment should be regularly updated.

The presence of known allergens or allergy precursors should be completely avoided in cosmetic products that make this claim, in particular of substances or mixtures:

• identified as sensitizers by the SCCS or former committees assessing the safety of cosmetic ingredients;
• identified as skin sensitizers by other official risk assessment committees;
• falling under the classification of skin sensitizers of category 1, sub-category 1A or sub-category 1B, on the basis of new criteria set by the CLP Regulation18 ;
• identified by the company on the basis of the assessment of consumer complaints;
• generally recognized as sensitizers in scientific literature; or
• for which relevant data on their sensitizing potential are missing.

Due to how strict hypoallergenic claims are, we generally do not recommend using this claim.

How does SkinConsult check hypoallergenic claims?
Every product formula undergoes SCCS and CLP checks by SkinConsult. This means that we know if your product contains any ingredient that is a skin sensitiser or an allergen. When SkinConsult checks the hypoallergenic claim on artwork, this will be cross referenced with SCCS and CLP checks we have performed before. We will tell you if your hypoallergenic claim is not substantiated by the annex checks.

However, if you want to make a hypoallergenic claim, it is the responsible person who is held accountable for such a claim. It is not SkinConsult’s responsibility to ensure that indeed no allergens or pre-allergenic substances are present in the product, and if a customer experiences an allergic reaction/unwanted health effect from the products, it is entirely your responsibility. 


The use of the claim "hypoallergenic" does not guarantee a complete absence of risk of an allergic reaction and the product should not give the impression that it does.

This means that claims like the following examples are not allowed:

• Allergy-free
• This product uses a perfume which is free from allergens
• Free from allergenic substances
• Free from sensitizing substances
  
  

We hope to have informed of hypoallergenic claims, what they are and when you are allowed to use this claim in accordance to EU legislation. If you wish to know more about other claims, please check out other pages on our knowledge base. Please do not hesitate to contact us if you have any other questions about hypoallergenic claims: office@skinconsult.com.

Remember, safety first!