Version in force , Modified +2,805 −55§
Amended by Regulation (EU) 2024/2865 32024R2865 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
Two new paragraphs, 1a and 1b, have been added empowering the Commission to adopt delegated acts on digital label elements in Annex I section 1.6 and on further requirements for digital labelling under Articles 34a and 34b, including factors such as digital readiness, innovation, technological neutrality and consistency with other Union acts.
Paragraph 2 has been expanded to add the Commission as an actor cooperating with Member States, and to widen the list of substances and criteria subject to harmonisation efforts to include endocrine disruptors, persistent/mobile/toxic and very persistent/very mobile substances, alternative approaches such as non-animal test methods, and the assessment of new criteria for immunotoxic and neurotoxic substances.
A new paragraph 3 has been added requiring the Commission to regularly evaluate alternative approaches, including non-animal test methods referenced in Regulation (EC) No 1907/2006, and to adopt delegated acts updating Annex I, with a preferred 18-month timeframe from inclusion of non-animal data criteria at UN level.
Cited: Art. 53, v2 (external, EUR-Lex) · Art. 53, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
texts differ too much for an inline diff; shown separately
Previous version, in force 1 December 2023 02008R1272-20231201
Article 53 Adaptations to technical and scientific progress 1. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph. 2. Member States and the Commission shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances at the level of the UN.
this version, in force 10 December 2024 02008R1272-20241210
Article 53 Adaptations to technical and scientific progress 1. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph. 1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6 of Annex I in order to include the label elements that may be put on a digital label only, provided that GHS does not require such label elements to appear on the physical label. When adopting those delegated acts, the Commission shall take into account the level of digital readiness among all population groups in the Union, societal needs and the need for a high level of protection of human health and the environment. 1b. In order to adjust to technological changes and future developments in the field of digitalisation, the Commission is empowered to adopt delegated acts in accordance with Article 53a to supplement this Regulation by laying down further details on the requirements for the digital labelling referred to in Articles 34a and 34b. Those details shall cover, in particular, the IT solutions which may be used, and the alternative means for providing the information. When adopting such delegated acts, the Commission shall: (a) ensure consistency with other relevant Union acts; (b) encourage innovation; (c) ensure technological neutrality by not imposing constraints or requirements with regard to choices of technology or equipment, within the bounds of compatibility and interference avoidance; (d) take into account the level of digital readiness among all population groups in the Union, as well as the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals; (e) ensure that digitalisation does not compromise the protection of human health and the environment. 2. The Commission, acting on behalf of the Union, and the Member States shall, in a manner appropriate to their role in the relevant UN fora, cooperate with a view to promoting the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic and very persistent and very mobile substances as well as the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances. 3. The Commission shall regularly evaluate the development of alternative approaches such as the alternative methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, in particular non-animal test methods, and adopt delegated acts in accordance with Article 53a to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation to adapt the criteria, preferably within 18 months from the date the criteria for non-animal data being included in harmonised criteria for classification and labelling at the level of the UN.