According to the Committee, allergy to fragrance ingredients affects 1 to 3% of the European population.
In 1999, the EC initially identified 26 fragrance allergens whereby measures were introduced in the Cosmetics Directive 76/768/EEC that required manufacturers to list these ingredients individually on the label of cosmetic products containing them, when they are present in the product above certain low concentrations.
The last update on fragrance allergens was done in 2003 (including additional substances to Annex III), but the Commission’s services requested the SCCS to review this issue.
Taking the consultations into account, the proposed changes to the Regulation in the form of an implementing act will be subject to a vote by the Member States in the standing Committee on Cosmetics.
Once the measures are approved by the Member States, the European Parliament and the Council will have three months to exercise their right of scrutiny. If the proposal is not opposed the formal adoption of those changes is expected at the end of 2014/beginning 2015.
Since the 90's, much more information on fragrance allergens has become available, which prompted the European Commission to review the current knowledge and to check whether the list of fragrance allergens relevant for consumers needed to be modified and whether safe limits could be established for the most frequent allergens.
The SCCS published its opinion, identifying 26 ingredients already outlined by the SCCNFP, an additional 30 individual chemicals and 26 natural extracts.
Its list also features fragrance ingredients likely to cause allergies in humans, as identified on the basis of evidence from animal studies and analysis of chemical structures.
The Commission’s services propose in the public consultation that three substances which were found to be unsafe should be banned from cosmetic products,
Additional allergens should be subject to the obligation of individual labelling on the package of a cosmetic product.
In other words, they have to be mentioned in the list of ingredients, in addition to the words ‘parfum’ or ‘aroma’. Because of the widespread use of fragrances it may be very difficult to avoid them all. It is therefore important to avoid those to which a person is already sensitised.
"Further scientific work is needed to define safe concentration limits of chemicals of special concern," the EC states on its website.