EU Amends CLP Regulation on Substances and Mixtures

The EU has published ATP-14 to amend the CLP Regulation. Except for the substance pitch, coal tar, high temperature, which has been effective since December 2019, the other revisions will become effective on October 1, 2021.

On February 18, 2020, the European Union (EU) published Commission Delegated Regulation (EU) 2020/217 of October 4, 2019, to amend and correct Regulation (EC) 1272/2008 on Classification, Labelling, and Packaging of Substances and Mixtures, also known as the CLP Regulation.

This amendment is the 14th adaption to technical and scientific progress (ATP-14) to the CLP Regulation. It contains, inter alia, several important changes:

1. Requiring a statement on the label of the packaging for liquid mixtures containing 1% or more of titanium dioxide particles with an aerodynamic diameter less than or equal to 10 µm, or solid mixtures containing 1% or more of titanium dioxide, in new section 2.12 to Part 2 of Annex II ‘Special rules for supplemental label elements for certain mixtures’

2. Adding new hazard statements for EUH211 and EUH212 in EU languages to Part 3 of Annex III ‘Supplemental label elements/information on certain mixtures’:

• EUH211 ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist’

• EUH212 ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust’

3. Deleting two substances (Index numbers 604-083-00-X and 611-159-00-6) in Table 3 to Part 3 of Annex VI ‘List of harmonized classification and labeling of hazardous substances’

4. Revising 12 entries in Table 3 to Part 3 of Annex VI – this includes the revision to pitch, coal tar, high temperature (CAS 65996-93-2)

5. Adding 17 new entries to Table 3 under Part 3 of Annex VI, including the following:

• Titanium dioxide (powder form containing 1% or more of particles with an aerodynamic diameter ≤ of 10 µm, CAS 13463-67-7) – the classification as carcinogenic 2 by inhalation applies only to mixtures in powder form containing 1% or more of titanium dioxide which is in the form of, or incorporated in, particles with an aerodynamic diameter ≤ 10 µm.

• Two entries for polycyclic aromatic hydrocarbons (PAHs) – benzo[rst]pentaphene (CAS 189-55-9) and dibenzo[b,def]chrysene (CAS 189-64-0) , Diisohexyl phthalate (DIHP, CAS 71850-09-4)

6. Clarifying the classification of pitch, coal tar, high-temperature (CAS 65996-93-2) in Annex VI resulting from the judgment of the General Court in Case T-689/13 (EU: T:2015:767) and upheld by the judgment of the Court of Justice in Case C-691/15P (EU: C:2017:882) – this substance is no longer classified as Aquatic Acute 1 and Aquatic Chronic 1 but maintains its classification as Carcinogenic 1A, Mutagenic 1B and Reprotoxic 1B (Toxic for Reproduction 1B)

It is important to note that ATP-14 provides specific notes for the classification and labeling of titanium dioxide to avoid unjustified classification of non-hazardous forms of the substance. As some hazardous clouds of dust and droplets could be formed during the use of titanium dioxide-containing mixtures, labels on the packaging of these products must contain the appropriate statements (point 1 above) to inform users of the precautionary measures.

Reference: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e18075daff