Recent ATPs and the 8th Amendment

By: David Steinberg, Steinberg & Associates

Posted: January 29, 2010, from the February 2010 issue of Cosmetics & Toiletries.

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On Oct. 12, 2009, two changes were made to Annex III, again involving hair dye chemicals. These changes are shown in Table 3. First, the following phrases were replaced in part 1 of Annex III, in column b of reference number 8: p-Phenylenediamine, its N-substituted derivatives and its salts; N- substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II; and replaced with: N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311 and 1312 in Annex II. Also, in column b of reference 9, the following phrases: Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II; were replaced with: Methylphenylenediamines, their N-substituted derivatives and their salts (1), with the exception of the substance under reference number 9a in this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II.

Finally, in reference number 14, column d and paragraph a in column f, the 0.3% maximum authorized concentration in finished cosmetic products was deleted.

Hair Warning in Annex III
The most recent ATP was published on Oct. 28, 2009. This amended Annex III, Parts 1 and 2, to include warnings for safety.

In Part 1 under references 8 and 8a, in column f, points (a) and (b), the text can cause an allergic reaction is replaced by the warning shown in Figure 1. Under reference 9, the text in column f is replaced with the warning shown in Figure 1 but the text includes the additional statements: Contains phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows; For professional use only; and Wear suitable gloves. Since these hair dyes are to be used by professionals who are exposed to them more often than consumers, the warnings are included to caution against using the dyes on hair anywhere other than on the head.

Under reference 9a, the text in column f is again replaced by the warning in Figure 1 with the same statements added in reference 9; also, under references 8a and 9a, in column f, points (a) and (b), the phrase The mixing ratio is printed on the label is added.

Under reference 16 in column f, and under reference numbers 202 and 203, in column f, point (a), the phrase Can cause allergic reaction is replaced by the warning in Figure 1; the same warning also is added under reference number 22, in column f, sub-points 1 and 2 of point (a), and under references 193 and 205, in column f, point (a). In part 2 of Annex III, the phrase Can cause allergic reaction is replaced by the warning in Figure 1 in the following instances: in reference 3 of column f, points (a) and (b); under references 5, 6, 12, 19, 21, 22, 25 and 33, in column f; and under references 10, 11 and 16, in column f, point (a).

Under reference numbers 4, 20, 26, 32, 34- 39 and 44, column f, the warning in Figure 1 is added. Also, under references 10, 11 and 16, column f, point (b) is deleted; and under reference numbers 27, 48 and 56, in column f, and under reference numbers 31, 49, 50 and 55, in column f, the warning in Figure 1 is added.

On Dec. 16, 2009, another ATP was issued extending the provisional listing of the 31 hair dye substances in Annex III, part 2, for another year.