The Cosmetic Industry presented a new skin absorption study considering different aqueous solutions of boron species : boric acid (5%, pH 3.7), borax or tetraborate (5%, pH 9.3) and disodium octaborate tetrahydrate (10%, pH 7.6).

From the very low results presented on percutaneous absorption (about 0.2%), it seems that a restriction of the pH of aqueous solutions of boric acid to neutral or slightly alkaline pH, in order to minimise percutaneous absorption of boron derivatives, is not justified.

As a consequence, it seems reasonable to propose the attached table on the regulation for boric acid, borates and tetraborates to be included in Annex III, part 1 of Directive 76/768/CEE.

PROPOSED ANNEX III - PART 1; Regulation for boric acid, borates and tetraborates

			RESTRICTIONS
Reference Number.	Substance	Field of application and/or use		Maximum authorised concentration in the finished cosmetic product	Other limitations and requirements	Conditions of use and warnings which must be printed on the label
a	b	C		d	e	f
1a	Boric acid, borates and tetraborates	a) Powder b) Products for oral hygiene c) Other products (except bath products and products for waving hair)		a) 5% (expressed as boric acid) b) 0.1% (expressed as boric acid) c) 3% (expressed as boric acid)	a) - Not to be used in products for children under three years of age. - Not to be used on damaged/ unhealthy skin, if the free soluble borate level exceeds 1,5% (expressed as boric acid). c) - Not to be used in products for children under three years of age - Not to be used on damaged/ unhealthy skin, if the free soluble borate level exceeds 1,5% (expressed as boric acid).	a) – Do not use for children under three years of age. - Do not use on damaged/unhealthy skin. b) Avoid ingestion c) – Do not use for children under three years of age - Do not use on damaged/unhealthy skin
1b	Tetraborates	a) Bath products b) Products for waving hair		a) 18% b) 8%		a) Do not use for bathing children under three years of age. b) Rinse thoroughly