The fast-growing cosmetic industry has become a huge part of our everyday routines, whether that be through personal care products or make-up. In order to protect consumers from any possible risks associated with these products, cosmetics are regulated in the EU under Regulation (EC) No 1223/2009.
In this article we will be discussing the European regulatory requirements for allergen labelling of cosmetic products, but firstly, let’s get acquainted with allergens. Allergens are substances (usually proteins) which are normally tolerated by most people, but are capable of triggering the immune system of certain individuals, leading to an allergic reaction.
According to EU regulation, there are 26 allergens which require mandatory labelling. These allergens must be labelled if present at concentrations above 0.01% in rinse-off cosmetic products, and above 0.001% in leave-on products. If one of the mandatory allergens are present in a number of different ingredients in your product, the total concentration of the allergen must be calculated to ensure it is below the thresholds mentioned. In cases where it exceeds the threshold, the allergen must be labelled.
Common sources of allergens in cosmetics include preservatives and fragrances. For example, thiazolinones are common preservatives in cosmetics which for some people may cause skin irritation. Fragrances require an International Fragrance Association (IFRA) certificate to show that the fragrance conforms with standards and is safe. As the IFRA certificate sets out maximum limits for fragrances for different product categories, manufacturers can use this to ensure the level in their product is permitted. Annex II of Cosmetic Regulation (EC) No 1223/2009 contains a list of substances which are prohibited in cosmetic products. In August 2019, common fragrance ingredients Lyral, Atranol and Chloroatranol were added to the list of banned substances. Products already on the market, containing these ingredients may be sold until August 23rd 2021. Currently, fragrances must be labelled under the general term ‘PARFUM’ and do not need to be specified. As a result, consumers suffering from an allergic reaction caused by the fragrance will not be able to identify the specific fragrance ingredient which caused it.
In 2012, the Scientific Committee on Consumer Safety (SCSS) released a scientific opinion on fragrance allergens in cosmetic products, stating that 16% of eczema patients in the EU are sensitised to fragrance ingredients, with 1-3% of the everyday EU population experiencing allergic reactions to common fragrances. The SCSS recommended additional labelling of fragrance allergens, to protect consumers by providing enough information at the time of purchase of the product. In addition, in 2014 the European Commission (EC) proposed amending Annex II of Cosmetic Regulation by including mandatory individual labelling of 90 fragrance allergens. A number of natural extracts such as Citrus sinensis peel oil, Lavandin officinalis oil, and Jasmin grandiflorum oil were also included in this proposal. These natural extracts will need to be declared in full alongside any fragrance allergens they have, meaning that some ingredients may end up end up being double-labelled, by listing the whole plant as well as some of the potential allergens it contains.
This caused quite a controversy amongst industry, as they expressed concerns regarding readability of ingredients lists. Industry reaction resulted in an alternative suggestion of e-labelling instead of labelling on the package. However, this poses potential issues as it would require consumers to have internet access at time of purchase. To follow up on this, the EC ran a new public consultation on additional fragrance labelling in November 2019. This consultation sought out public views on the preferred option of additional fragrance allergen labelling online through QR codes, web links or bar codes rather than on the physical label.
Whilst e-labelling may restrict consumers without internet access at the point of purchase, it certainly would assist industry with regards to spacing and readability issues on cosmetic packaging. RNI will keep you updated on how the EU plans to move forward with allergen labelling in cosmetic products.
Watch this space!
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