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Document 32024R2564
Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
C/2024/3992
OJ L, 2024/2564, 30.9.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
Official Journal |
EN L series |
2024/2564 |
30.9.2024 |
COMMISSION DELEGATED REGULATION (EU) 2024/2564
of 19 June 2024
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (1), and in particular Article 37(5) thereof,
Whereas:
(1) |
Part 3, Table 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation. |
(2) |
Proposals to introduce harmonised classification and labelling of certain substances and to update or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (‘the Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment (RAC) of the Agency adopted, after having taken account of the comments received from the parties concerned, the following opinions (2) on those proposals:
|
(3) |
The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinions of 18 March 2022 concerning benthiavalicarb-isopropyl, 2,3-epoxypropyl neodecanoate, multi-walled carbon tubes, hexyl salicylate, in the RAC opinions of 2 June 2022 concerning silver massive, silver powder and silver nano and in the RAC opinions of 1 December 2022 concerning n-hexane and copper. The additional information has been assessed by the Commission and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. |
(4) |
With regard to the substance copper flakes (coated with aliphatic acid) (index number 029-019-01-X (3)), its entry for its classification as hazardous for the aquatic environment should be amended to be in accordance with the more generic entry copper [specific surface area > 0,67 mm2/mg] (index number 029-026-00-0), inserted in the Annex. |
(5) |
With regard to the substance granulated copper (4) (index number 029-024-00-X), its entry should be deleted as it is covered by the more generic entry copper [specific surface area > 0,67 mm2/mg] (index number 029-026-00-0), inserted in the Annex. |
(6) |
Acute Toxicity Estimates (ATE) are mainly used to determine the classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. The inclusion of harmonised ATE values in the entries listed in Annex VI to Regulation (EC) No 1272/2008 facilitates the harmonisation of the classification of mixtures and provides support for enforcement authorities. Following further scientific assessment, an ATE value for the inhalation route has been derived for fenpropidin (index number 612-299-00-0), in addition to those proposed in the RAC opinions for other substances. That ATE value should be inserted in the penultimate column of Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008. |
(7) |
The entries corresponding to index numbers 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5 have been replaced by the entries for perboric acid, sodium salt [1] perboric acid, sodium salt, monohydrate [2] perboric acid (HBO(O2)), sodium salt, monohydrate [3] sodium peroxoborate [4] sodium perborate [5] (index number 005-022-00-4), for perboric acid (H3BO2(O2)), monosodium salt trihydrate [1] perboric acid, sodium salt, tetrahydrate [2] perboric acid (HBO(O2)), sodium salt, tetrahydrate [3] sodium peroxoborate, hexahydrate [4] (index number 005-023-00-X) and for sodium peroxometaborate (index number 005-024-00-5) and should therefore be deleted. |
(8) |
In light of the RAC opinions, it is appropriate to introduce, update or delete the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions and following the further assessments. |
(9) |
Regulation (EC) No 1272/2008 should therefore be amended accordingly. |
(10) |
Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under this Regulation. Suppliers should, however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 May 2026 However, substances and mixtures may be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 June 2024.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj.
(2) The opinions are accessible via the following website: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/name/-/ecNumber/-/casNumber/-/dte_receiptFrom/-/dte_receiptTo/-/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/-/dte_withdrawnTo/-/sbm_expected_submissionFrom/-/sbm_expected_submissionTo/-/dte_finalise_deadlineFrom/-/dte_finalise_deadlineTo/-/haz_addional_hazard/-/lec_submitter/-/dte_assessmentFrom/-/dte_assessmentTo/-/prc_regulatory_programme/-/.
(3) See RAC Opinion of 1 December 2022 concerning copper [specific surface area > 0,67 mm2/mg], listed above;
(4) Ibidem.
ANNEX
Part 3, Table 3 of Annex VI to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
the following entries are inserted following the consecutive order of the index numbers corresponding to each entry:
|
(2) |
the entries corresponding to index numbers 005-005-00-1, 016-022-00-9, 016-094-00-1, 029-019-01-X, 601-037-00-0, 604-020-00-6, 605-001-00-5, 607-001-00-0, 607-043-00-X, 607-094-00-8, 607-198-00-3, 607-315-00-8, 607-432-00-4, 613-272-00-6, 616-127-00-5 and 617-008-00-0 are replaced by the following entries respectively:
|
(3) |
the entries corresponding to index numbers 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5 and 029-024-00-X are deleted. |
ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj
ISSN 1977-0677 (electronic edition)