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Substances in articles Art. 33 of REACH | Orgalime

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Information Note Art  33 REACH Sept 2018 Orgalime

Communication obligations on substances in articles Article 33 of Regulation (EC) No 1907/2006 | Information Note

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)

This information note provides a descriptive summary (no interpretation) of the requirements of 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) and provides readers with an overview of common existing practices within the industry to meet them. The information note addresses the following main points:

- It takes stock of common existing practices of implementation of the communication obligations on substances in articles of REACH Regulation.
- It considers those practices in light of the European Court of Justice (ECJ) judgment related to case C-106/14 of 10th 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 object (as was the Commission’s, ECHA and industry’s common understanding 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).

In the next pages, the following issues are tackled: 1. General introduction on the relevant terminology and definitions;

2. Description of the requirements of Article 33 of REACH; 3. Overview of common existing practices among the industry and how these should be amended following the European Court of Justice judgment.
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