EU Amends CLP Regulation on Substances and Mixtures

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, Labeling 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 ≤ 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 dusts 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.

There are two effective dates:

• December 1, 2019 for pitch, coal tar, high temperature (CAS 65996-93-2)
• October 1, 2021 for other provisions (Corrigendum of February 25, 2020, Official Journal of the EU)

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