October 8, 2019
The 14th ATP (Adaptation to Technical Progress) to the CLP regulation, which includes amendments to Annexes II, III and VI, has been adopted by the European Commission. The delegated Act will now be put forward to the European Parliament and the Council of Ministers, who will have two months to raise any objections; if there are no objections, the Act is expected to be published early in 2020, with the changes becoming a legal requirement 18 months later.
Largely, the 14th ATP amends Annex VI, including the addition of harmonised ATE (Acute Toxicity Estimate) values for a number of substances. More notably, the amendment also includes the much-disputed Annex VI entry for Titanium dioxide (CAS No 13463-67-7); the entry applies to respirable TiO2 particles and the minimum classification of Carcinogenic Category 2, H351 (inhalation) will need to be applied to the substance when it is in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm. In accordance with the newly added Note 10, for mixtures containing the substance, the classification as a carcinogen would apply when the mixture itself is in powder form and contains 1% or more of Titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.
As some hazardous dust may be produced during the use of some mixtures that contain TiO2, Annex II to CLP introduces the requirement to warn users via the product label using supplemental label statements:
- For liquid mixtures containing 1 % or more of Titanium dioxide particles with aerodynamic diameter equal to or below 10 μm: EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’
- For solid mixtures containing 1% or more of titanium dioxide: EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’
Titanium dioxide is used widely across multiple industries in a range of product types, including paints, coatings, printing inks and plastics, and concerns remain over the potential negative impact that the harmonised classification and required label warnings will have, in particular with regards to misleading the general public and loss of consumer trust.
Recommended actions:
- Review the Commission adoption to determine if any of your products are affected by the amendment: https://ec.europa.eu/info/law/better-regulation/initiatives/c-2019-7227_en
- Consider reclassifying your substances and mixtures according to the new or amended Annex VI changes
- Update EU Labels and SDSs by the deadline. New information on the hazards trigger providing the updated SDS versions to all recipients to whom in the EU the substance or mixture has been supplied within the preceding 12 months
Reference(s):
- CARACAL: https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2385
- EU Commission adoption: https://ec.europa.eu/info/law/better-regulation/initiatives/c-2019-7227_en
Key words:
- CLP
- ATP
- ATE