On July 11th 2023 Regulations 2023/1434 and 2023/1435, corresponding to the 19th and 20th ATPs respectively, have been published on the official EU journal. These Regulations amend Regulation 1272/2008 (CLP).
The 19th ATP updates Annex VI to Regulation 1272/2008 (CLP) by adding three new notes:
Note X:
The classification for the hazard class(es) in this entry is based only on the hazardous properties of the part of the substance which is common to all substances in the entry. The hazardous properties of any substances in the entry also depend on the properties of the part of the substance which is not common to all substances in the group. The latter must be evaluated to assess whether more severe classification(s) (i.e. a higher category) or a broader scope of the same classification (additional differentiation, target organs and/or hazard statements) might apply for the hazard class(es) in the entry
Note 11:
The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual boron compounds that are classified as reproductive toxicant in the mixture as placed on the market is ≥ 0,3 %
Note 12:
The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual substances covered by this entry in the mixture as placed on the market is equal to, or above, the applicable generic concentration limit for the assigned category, or a specific concentration limit given in this entry
Of particular relevance are Note 11 and Note 12, which modify the classification criteria as Reprotoxicant of mixtures containing substances with Note 11 or Note 12 as part of their harmonized classification.
The 20th ATP updates Annex VI to CLP by modifying four entries with the addition of Note 11 to boric acid (Index: 005-007-00-2), diboron trioxide (Index: 005-008-00-8) and various disodium salts (Index: 005-011-00-4) and, among other changes, by adding Note X and 12 to 2-ethylhexanoic acid and its salts (Index: 607-230-00-6).
Both ATPs will come into force on 31st of July 2023. The new notes, introduced by the 19th ATP, will be applied in the amended Annex VI entries of 20th ATP for the first time.
Regarding the 20th ATP, it will apply after February 1st 2025, but can be applied voluntary starting from July 31st 2023.
Trace One has planned a regulatory analysis of the 19th and 20th ATPs, and will keep you updated on it.
Click these links to read the full text of the 19th and 20th ATPs: