The European Commission adopted an amendment to the CLP Regulation on 25 April.
These additions can be summarised as follows:
- A ‘Note X’ has been added to Part 1, section 188.8.131.52 of Annex VI, which indicates that: ‘The classification of 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 […]’
- Two notes have been added to section 184.108.40.206 of Annex VI:
- Note 11 mentions the need to classify mixtures as reproductive toxicant ‘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 also mentions such a need, but in the case where ‘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’
The Commission Delegated Regulation is available here, and its Annex by following this link.
This information was kindly provided by MedTech Europe.