Draft legislation aimed at amending the Annex V entry for butyl- and propyl- parabens, implementing the SCCS opinion, was voted on at the European Commission's Standing Committee in February.
The restrictions concern the maximum permitted concentration of these substances.
The SCCS opinion on fragrance allergens from 2012 is now also the subject of a Commission public consultation.
The EC states on its website that 26 fragrance allergens listed in Annex III of the Cosmetics Regulation shall be mentioned in the list of ingredients in addition to the term 'parfum' or 'aroma', if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
According to Dr Christopher Flower, Director-General at CTPA, following this the Commission will consider what legislative action to take, if any. However, no draft legislation on fragrance has been voted at the Standing Committee.
In that opinion the SCCS:
1) Updated the list of fragrance allergens that the consumer should be made aware of when they are present in cosmetic products, while confirming that the 26 fragrance allergens currently regulated for individual labelling are still of concern.
The SCCS also indicated that substances known to be transformed, through air oxidation (prehaptens) or/and bioactivation (prohaptens), into allergens which are more potent than the parent substance should be treated as equivalent to those allergens.
2) Identified, among fragrance allergens established in humans, 12 chemicals and 8 natural extracts of special concern as each of them gave rise to at least 100 reported cases of contact sensitisation. For these substances, a maximum limit of concentration in the cosmetic product should be fixed. In addition, the consumer should be informed of their presence in the cosmetic product.
3) Indicated that three fragrance allergens: 3 and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC), atranol and chloroatranol (the two latter being components of oak moss and tree moss extracts) should not be present in cosmetics.
Cracking down on allergens
According to the Committee, allergy to fragrance ingredients affects 1 to 3% of the European population.
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 in 2014.
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.