Orgalime Information Note on Article 33 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): communication obligations on substances in articles

Published: September 2018
Hard copy languages: English
Electronic copy languages: English

This information note provides a descriptive summary (no interpretation) of the requirements stemming from article 33 of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation regarding communication on substances in articles in the supply chain and to consumers. It describes relevant terminology and definitions, and provides readers with an overview of common existing industry practices.

The note addresses the following main points:

  • It takes stock of common existing practices in the industry for implementing the communication obligations of REACH on substances in articles.
  • It considers those practices in light of the European Court of Justice (ECJ) judgment related to case C-106/14 of 10 September 2015 that clarified the scope of the communication obligations under Article 33 of REACH further to different views of six Member States and the European Commission on how to calculate the relevant concentration threshold for complex articles. The ECJ ruled that the given concentration threshold of 0.1% does not apply to the entire complex of very complex objects (as was the understanding of the Commission, the European Chemicals Agency ECHA and industry so far), but to each article included in the complex or very complex object (i.e. object made up of more than one article).
  • It includes the latest update of the related ECHA Guidance on requirements for substances in articles, which incorporates the changes following the ECJ judgment and was completed in June 2017. Note: the interpretation from ECHA is challenged by several industry sectors in particular against the principle of proportionality established in Article 5 of the EU Lisbon Treaty (the measure shall not exceed what is necessary to achieve the given objective).