ANNIKA KAUSCHAT
Customer Service Consultant, SGS, Germany

Abstract

In the European Union, under Annex III to Regulation 1223/2009, 26 allergenic fragrances must be listed on the ingredients list of a cosmetics product if they exceed proscribed amounts. This requirement relates to the need to protect consumers from a range of allergic reactions – from hives to anaphylaxis. Following opinion SCCS/1459/11 of the Scientific Committee on Consumer Safety, this list could be expanded to cover 82 substances, including a variety of pure substances and natural extracts. We look at the reasons behind this possible expansion and the best route forward for manufacturers and suppliers to ensure compliance in cosmetic products when operating in Europe.

INTRODUCTION
Consumers may be allergic to ingredients in a cosmetic product but not everyone will react in the same way. To help consumers choose safe products, authorities in Europe require manufacturers to indicate certain allergens on the list of ingredients.

The US Food and Drug Administration (FDA) website lists a wide variety of allergenic reactions that people can experience when using cosmetics, ranging from hives to anaphylaxis (1). The problem is everyone reacts differently and what may cause a life-threatening reaction in one person, will have no effect on another. Consumers need to be able to look on the ingredients list and see if there is an allergen that could accidentally harm them.

This problem is made worse by incorrect label information. A study published by the Council of Europe and its European Directorate for the Quality of Medicines & Healthcare (EDQM) in December 2020 found that 7.7% of cosmetic products did not comply with current regulations governing the use of allergenic fragrance compounds. Of the 932 samples that were evaluated, 544 were marked ‘perfume-free’ and yet 3.1% ...