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Document 32021R0643
Commission Delegated Regulation (EU) 2021/643 of 3 February 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 1 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/643 of 3 February 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 1 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/643 of 3 February 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 1 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)
C/2021/441
OJ L 133, 20.4.2021, p. 5–8
(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
20.4.2021 |
EN |
Official Journal of the European Union |
L 133/5 |
COMMISSION DELEGATED REGULATION (EU) 2021/643
of 3 February 2021
amending, for the purposes of its adaptation to technical and scientific progress, Part 1 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
(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 53(1) thereof,
Whereas:
(1) |
Member States and stakeholders have requested that a number of the notes set out in subsection 1.1.3 of Part 1 of Annex VI to Regulation (EC) No 1272/2008 be amended. |
(2) |
The Commission accepts that the wording of those notes needs to be improved. Some of the notes related to substances are inaccurate and bring in some uncertainty as to the correct interpretation of legal obligations. In particular, some of those notes could be interpreted as not requiring the substances with respect of which those notes apply to be classified at all under certain conditions, whereas, in fact, they should not be covered by the harmonised classification and labelling but should still be subject to classification in accordance with Title II of Regulation (EC) No 1272/2008 (self-classification). |
(3) |
Regulation (EC) No 1272/2008 should therefore be amended accordingly, |
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Regulation (EC) No 1272/2008
Part 1 of Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.
Article 2
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 February 2021.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX
Part 1 of Annex VI to Regulation (EC) No 1272/2008 is amended as follows:
(1) |
in point 1.1.3.1, notes J to R are replaced by the following:
(*1) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).’;" |
(2) |
in point 1.1.3.2, Notes 8 and 9 are replaced by the following:
The classification as a carcinogen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %.
The classification as a mutagen shall apply unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %.’ |
(*1) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).’;”