Regulation
(EC) No. 1223/2009 on cosmetic products provides that perfume, aromatic
compositions and their raw materials shall be referred to, in the list of
ingredients on the packaging, as 'parfum' or 'aroma'. However, 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. Moreover, Annex II lists substances which are prohibited in
cosmetics, including some fragrance allergens.
In June 2012, Scientific Committee on Consumer Safety (SCCS) adopted a new
opinion on fragrance allergens in cosmetic products (SCCS/1459/11).
They 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.
Among fragrance allergens established in humans, SCCS identified 12
chemicals and 8 natural extracts of special concern as each of them gave rise
to at least 100 reported cases of contact sensitisation.
Finally, SCCS indicated that three fragrance allergens (HICC, atranol and
chloroatranol) should not be used in cosmetics.
So, following the SCCS opinion, there
are several areas in which further scientific work is needed, in particular the
refinement of the dermal sensitisation Quantitative Risk Assessment (QRA), for
which work is ongoing.
In addition, in the areas where SCCS
opinion already provides sufficient basis, EU Commission propose to amend Annex
III and Annex II of Cosmetics Regulation in order to ensure adequate
consumer information and to protect the consumer against the strongest
allergens.
All interested parts, including authorities of the Member States, manufacturers of cosmetic
products, producers of the substances concerned and relevant industry and
consumers associations, are invited to
submit their comments on the proposed measures and on their possible economic
impact by 14th May 2014 at the latest.
