Chemicals | Monthly bulletin | January 2023

Europe

The harmonised classification determining titanium dioxide as carcinogenic has been annulled

On 23^rd November 2022, a judgment by the General Court was published which annuls the Commission Delegated Regulation of 2019 related to the harmonised classification of titanium dioxide. The finding of the Court is as follows:

• The Commission made an error in its assessment of the reliability and acceptability of the study on which the classification was based.
• The contested classification and associated labelling infringed the criteria according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.
• The contested classification and labelling are intended to identify and notify a carcinogenic hazard of titanium dioxide which, in the RAC Opinion, was classified as ‘non-intrinsic in a classical sense’.
• The carcinogenicity hazard is linked solely to certain respirable titanium dioxide particles, when they are present in a certain form, physical state, size and quantity, it occurs only in lung overload conditions and corresponds to particle toxicity.

For more information, consult the press release nº 190/22 here.

Additional recent updates regarding REACH Regulation

The following table provides a summary of some recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

Other interesting links about REACH from the ECHA’s website

• Registry of restriction intentions until outcome - ECHA (europa.eu)
• Registry of SVHC intentions until outcome - ECHA (europa.eu)
• Substance evaluation - CoRAP - ECHA (europa.eu)
• Adopted opinions and previous consultations on applications for authorisation - ECHA (europa.eu)
• Applications for authorisation - current consultations - ECHA (europa.eu)
• Current calls for comments and evidence - ECHA (europa.eu)
• Authorisation List - ECHA (europa.eu)
• ECHA's completed activities on restriction
• Submitted restrictions under consideration
• Assessment of regulatory needs list

Additional recent updates regarding CLP Regulation

The following table provides a summary of some recent updates (non-exhaustive) regarding Regulation (EC) No 1272/2008 (CLP):

Other interesting links about CLP from the ECHA’s website

• Registry of CLH intentions until outcome - ECHA (europa.eu)
• Harmonised classification and labelling consultations - ECHA (europa.eu)

Hexachlorobenzene under POP Recast Regulation

On 23^rd  November 2022, the European Commission published Commission Delegated Regulation (EU) 2022/2291 which amended Annex I to Regulation (EU) 2019/1021 on Persistent Organic Pollutants.

The below table summarises the relevant points:

Amendment to Annex IV and V on Persistent Organic Pollutants Regulation

On 12^th November 2022, the European Commission published Regulation (EU) 2022/2400 of the European Parliament and of the Council of 23 November 2022 amending Annexes IV and V to Regulation (EU) 2019/1021 on Persistent Organic Pollutants.

The main points covered in the amendments are as follows:

• The insertion of the Article 21a related to transitional provision of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and dioxin-like polychlorinated biphenyl (dl-PCBs).
• The addition of the following substance in the Annex IV to Regulation (EU) 2019/1021: Dicofol, Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, as set out in Annex I and Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds.
• Replacement of the following rows in the Annex IV to Regulation (EU) 2019/1021:
  • Alkanes C₁₀-C₁₃, chloro (short-chain chlorinated paraffins) (SCCPs)
  • Tetrabromodiphenyl ether C₁₂H₆Br₄O, Pentabromodiphenyl ether C₁₂H₅Br₅O, Hexabromodiphenyl ether C₁₂H₄Br₆O, Heptabromodiphenyl ether C₁₂H₃Br₇O and Decabromodiphenyl ether C₁₂Br₁₀O
  • Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF)
  • Hexabromocyclododecane
• Several amendments to Part 2 of Annex V to Regulation (EU) 2019/1021.

On 22^nd December 2022, the corrigendum to Regulation (EU) 2022/2400 was published.

UK

Possible extension to the REACH submission deadline

On 29^th November 2022, the Department for Environmental, Food & Rural Affairs (Defra) published a summary of responses and government response related to consultations on extending current UK REACH submission deadlines.

After considering the responses, the UK government intends to introduce legislation that would facilitate the extension of submission deadlines across all tonnage bands by 3 years. This legislation is subject to the consent of the Scottish and Welsh governments.

For more information, please visit the GOV.UK website here.

Amendment to Persistent Organic Pollutants Regulation

On 6^th December 2022, the Persistent Organic Pollutants (Amendment) (EU Exit) Regulations 2022 (S.I. 2022/1293) which amends Regulation (EU) 2019/1021 on persistent organic pollutants was published.

The main points covered in this amendment are as follows:

• Addition of point 3 to the entry related to bis(pentabromophenyl) ether (decabromodiphenyl ether; decaBDE) in Annex I, Part A which allows for the use of decaBDE in aircraft, motor vehicle and electric and electronic equipment.
• Corrigendum to the entry related to perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X and perfluorooctane sulfonic acid and its derivatives (PFOS) C8F17SO2X in Part A of Annex 1 to the EU Regulation which confer functions on EU entities which no longer have functions in the United Kingdom.

Miscellaneous

Miscellaneous technical publications relating to chemicals

The latest publications in relation to chemical materials are summarised in the table below: