Regulatory news in brief
TPA 20 (UE regulation 2023/1434)
Update of annex VI of the CLP by revision of the harmonized classifications of boron compounds and 2-ethylhexanoic acid (2-EHA) as well as its salts. These new classifications will be applicable on February 1, 2025..
TPA 19 (UE regulation 2023/1434)
These are Notes 11 and 12 relating to the additivity of the danger for the lightness of reproduction.
Note 11 is specific to Borates and Note 12 applies to 2-EHA and may also be assigned to other substances. These notes inform us that the classification of mixtures as toxic for reproduction is mandatory when the sum of the concentrations of the different substances in the mixture placed on the market is equal to or greater than 0.3%.
Note X applicable to 2-EHA indicates that the classification is only based on the dangerous properties related to the common structure of the substances. The substances covered by this note must therefore be self-classified in order to take into account the dangers linked to structural functions.
Publication of Regulation 2023/707 amending Regulation (EC) No 1272/2008
This regulation concerns the hazard classes and the criteria for classification, labeling and packaging of substances and mixtures. New hazard classes and criteria have been introduced regarding environmental toxicity, persistence, mobility and bioaccumulation.
New EUH phrases appear:
EUH380: May cause endocrine disruption in humans
EUH381: Suspected of causing endocrine disruption in humans
EUH430: May cause endocrine disruption in the environment
EUH431: Suspected of causing endocrine disruption in the environment
EUH440: Accumulates in the environment and in living organisms, including humans
EUH441: Accumulates strongly in the environment and in living organisms, including humans
EUH450: May cause long-term diffuse contamination of water resources
EUH451: May cause very long-term diffuse contamination of water resources
This new regulation will be mandatory for substances on May 1, 2025 and May 1, 2026 for mixtures. A transition period is planned for substances and mixtures already on the market on the above dates.
For substances it is 18 months. For mixtures it is 2 years.
TPA 18 (UE regulation 2022/692)
update of Annex VI with substances for which harmonized classification and labeling opinions have been adopted by the Committee for Risk Assessment (RAC) in 2020. It adds 39 new entries, in revised 17 entries and deleted one. This regulation is applicable from 23 November 2023..