EU/719
WTO/TBT
CE European Union
  • 13 - Environment and health protection, Safety
  • B20 - Safety
  • C60A - Labelling
2020-07-11
2020-05-13

Hazardous mixtures

Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures in order to improve the workability of information requirements related to emergency health response accompanied by an Annex (6 page(s), in English; 28 page(s), in English)

According to Article 45(1) of the CLP Regulation, EU Member States' appointed bodies shall be responsible for receiving information from importers and downstream users on the hazardous chemical mixtures they place on the market. Commission Regulation (EU) No 2017/542 amended the CLP Regulation by adding an Annex harmonising the information to be provided relating to emergency health response ("Annex VIII").

Annex VIII was adopted in March 2017. Shortly before adoption, EU Member States and industry stakeholders called for amendments of Annex VIII before its compliance date, for reasons of serious workability concerns (notably the difficulty or impossibility of knowing the exact composition of products in cases where raw materials with highly variable or unknown composition are used, where multiple suppliers are being used for components that are stored in the same recipient, or where complex supply chains are involved). The Commission services commissioned a study to assess the legitimacy of the claims and the impact on duty holders and concluded that an amendment of Annex VIII was indeed necessary. The amendment would constitute a second amendment to the Regulation, after the adoption of Regulation (EU) 2020/11, which deferred the compliance date for mixtures for consumer use and aimed at a more streamlined interpretation of the rules, improving internal coherence and mitigating some unintended consequences that had only become apparent since the adoption of Regulation (EU) 2017/542.

The Commission is now proposing to amend Annex VIII of Regulation (EC) 1272/2008 in order to solve the workability issues.

The enclosed act and annex (replacing the current Annex VIII) improve the workability of information requirements related to emergency health response. The amendment of Annex VIII addresses the concerns raised, i.e. the difficulty or impossibility of knowing the exact composition of products in cases where raw materials with highly variable or unknown composition are used, where multiple suppliers are being used for components that are stored in the same recipient, or where complex supply chains are involved, as well as the impossibility to know in advance which exact bespoke mixtures will be placed on the market.

This proposed act introduces a general solution with the concept of an interchangeable component group, as well as more sector specific solutions for gypsum, ready mixed concrete, cement and petroleum products and bespoke paints.  This draft act and annex are closely interlinked with the "Draft Commission Delegated Regulation amending Article 25 of Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards bespoke paints" that contains the addition of paragraph (8) to Article 25 providing for a solution for bespoke paints. The latter constitutes only part of the solution, namely the consequence for the labelling obligations in Article 25 of Regulation (EC) 1272/2008 of the non-necessity to create a UFI for bespoke paints. The non-necessity to create a UFI for bespoke paints, being the other part of the solution, is stipulated in proposed amendment of Annex VIII.