Commission Delegated Regulation (EU) 2020/11Show full title

Commission Delegated Regulation (EU) 2020/11

of 29 October 2019

amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards information relating to emergency health response

(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 Articles 45(4) and 53(1) thereof,

Whereas:

(1) Regulation (EC) No 1272/2008 was amended by Commission Regulation (EU) 2017/542(2) to add certain requirements for the submission of information relating to emergency health response and for the inclusion of a ‘unique formula identifier’ in the supplemental information provided on the label of a hazardous mixture. The amendments are expressed to apply from 1 January 2020, but importers and downstream users are only required to start complying with the new rules in stages, according to a series of compliance dates depending on the use for which a mixture is placed on the market. The first such compliance date is 1 January 2020.

(2) After adoption of Regulation (EU) 2017/542, several drafting suggestions were made during discussions with national authorities and other stakeholders with a view to facilitating implementation of the new rules introduced by that Regulation and clarifying their meaning. The new rules introduced by that Regulation should therefore be amended to allow for a more streamlined interpretation of them, to improve internal coherence and to mitigate some unintended consequences that have only become apparent since adoption of that Regulation. In particular, since the unique formula identifier (UFI) may need to be updated frequently, the new rules should provide for the UFI to be shown either on the label of the hazardous mixture or on its packaging in close proximity to the label. Article 31(5) of Regulation (EC) No 1272/2008 already also includes the option of putting all the label elements on the packaging rather than on a label. In addition, Article 29(3) of Regulation (EC) No 1272/2008 addresses the situation where a mixture is supplied without any packaging.

(3) In addition to the drafting suggestions, national authorities and other stakeholders have raised certain issues concerning the workability of the new rules introduced by Regulation (EU) 2017/542, for example the effects of high variability in mixture composition due to the natural origin of components, the difficulty of knowing the exact composition of products in cases involving complex supply chains, and the impact of multiple suppliers of mixture components with the same technical properties and hazards. Once any solutions needed to address these issues have been developed, any resulting changes to the new rules will have to be made before the first compliance date when importers and downstream users are required to start complying with the new rules as regards mixtures for consumer use. It is therefore appropriate to defer the first compliance date from 1 January 2020 to 1 January 2021 in order to allow sufficient time to develop the necessary solutions and make any necessary changes to the new rules. This postponement does not affect the need for Member States to have their systems operational in good time before 1 January 2021 in order to allow importers and downstream users sufficient time to prepare for their submissions before that date.

(4) Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(5) The date of application of this Regulation should be deferred in order to align it with the date of application of Regulation (EU) 2017/542,

HAS ADOPTED THIS REGULATION:

(1)

OJ L 353, 31.12.2008, p. 1.

(2)

Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response (OJ L 78, 23.3.2017, p. 1).