Several
boron compounds have been classified as CMR 1B substances. They are already
covered by entries 1a and 1b in Annex III of Regulation (EC) No 1223/2009.
According to opinion SCCS/1345/10, sodium
perborate and perboric acid can be considered as “hydrogen peroxide” releasing
substances and thus are covered by entry 12 of Annex III, Regulation (EC) No 1223/2009.
The conditions for exception
to the prohibition rule laid down in Article 15, paragraph 2, of Regulation
(EC) No 1223/2009 have not been fulfilled.
So, it is necessary to amend entries 1a, 1b and 12 of Annex III of
Cosmetics Regulation, in order to indicate that those boron compounds, sodium perborate and
perboric acid, classified as CMR 1B, are
not allowed anymore for use in cosmetics.
Furthermore,
a clarification on the whole group of borates is needed. Borate are
metal salts of boric acid and comprise the following family of chemicals: i.a.
potassium borate, zinc borate, sodium tetraborate decahydrate, sodium
tetraborate pentahydrate, sodium tetraborate (anhydrous borax), disodium
octaborate (anhydrous), disodium octaborate tetrahydrate, and sodium
metaborate.
These
compounds, on contact with water form boric acid which
is classified as CMR 1B.
SCCS is of the opinion that all the substances
mentioned above (borates, tetraborates and octaborates) as well as other boric
acid salts/esters reported in CosIng database such as MEA-borate,
MIPA-borate, potassium borate, trioctyldodecyl borate and zinc borate, break in the product due to contact with
water into boric acid.
So, these
compounds must be considered to have chemical, biological and toxicological
properties similar to boric acid, and general
restrictions applicable to boric acid should apply to the whole group of
borates.
