EU Publishes Amendment to CLP Regulation on Substances and Mixtures

The European Union (EU) has published the 14th adaption to technical and scientific progress (ATP-14) to Regulation (EC) 1272/2008, the Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation).

ATP-14 contains several important changes, including:
1. Requirement for a statement on packaging labeling 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. Addition of 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. Deletion of 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. 12 entries revised in Table 3 to Part 3 of Annex VI. This includes the revision to pitch, coal tar, high temperature (CAS 65996-93-2) in point 6 below

5. Addition of 17 new entries to Table 3 under Part 3 of Annex VI, including the following:
a. Titanium dioxide (powder form containing 1% or more of particles with an aerodynamic diameter ≤ 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
b. Two entries for polycyclic aromatic hydrocarbons (PAHs) – benzo[rst]pentaphene (CAS 189-55-9) and dibenzo[b,def]chrysene (CAS 189-64-0)
c. Diisohexyl phthalate (DIHP, CAS 71850-09-4)

6. Clarification on 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 and upheld by the judgment of the Court of Justice in Case C-691/15P. 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)

Stakeholders should be aware ATP-14 provides specific notes for the classification and labeling of titanium dioxide to avoid unjustified classification of non-hazardous forms of the substance. It is possible for some hazardous dusts and droplets to form during the use of titanium dioxide-containing mixtures. Therefore, labels on the packaging of these products must contain the appropriate statements (point 1 above) to inform users of the precautionary measures.

The updates were published in Commission Delegated Regulation (EU) 2020/217 of October 4, 2019, on February 18, 2020 and amended by corrigendum of October 25, 2020. The effective date for the changes relating to pitch, coal tar and high temperature came into effect on December 1, 2019. The other provisions of ATP-14 will come into effect on October 1, 2021.

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