Article

ECHA Publishes Draft Guidance on Annex VIII to CLP

Posted on: May 16, 2018

by Ancuta Rusu, PhDECHA Annex VIII CLP

Earlier this year, ECHA published the formal Partner Expert Group (PEG) consultation on the draft guidance on Annex VIII to CLP, an extensive document with some aspects requiring additional clarification.

What is contained in the Annex VIII draft guidance?

The guidance addresses concerns raised during the February Workshop on Implementation of Annex VIII to CLP, such as the fact that the legislation at the national level in each EU Member State (MS) may establish conditions complementary to the annex through national legislation.

Importers

Importers from outside of the EU have received various recommendations, and the guidance recommends that the EU importer and non-EU supplier enter into a contractual agreement to cover the details of the submission approach chosen.

Exporters

Exporters are exempt from the submission if the formulated mixture is not placed on the EU market. However, if the product is stored in a temporary warehouse before being exported outside of the EU, this may qualify as placing on the market and the Annex VIII obligations would therefore apply. This would be the case if – for example – the formulator sells to a third party who stores the mixture in the warehouse before delivering it to a non-EU company.

During the workshop, companies also stated that it is difficult for suppliers to know all the uses of their products in the supply chain. They also expressed their worries over whether customers will be willing to provide the required information. In response, the guidance is encouraging companies to try to gather all relevant information about the final use of their mixtures. If new information about the use of the mixture becomes available after the submission, the information submitted under Annex VIII needs to be updated accordingly.

The draft was sent to the Partner Expert Group (PEG) for a written consultation and the final guidance is expected to be available in December. You can read the draft in full here.

Next Steps

UL’s global Regulatory Assurance Team contains a dedicated team of leading industry experts in Europe, who have a comprehensive understanding of the CLP Regulation, and can help you navigate the complex, ever changing regulatory landscape to understand and execute your compliance obligations. You can take a look at our full suite of regulatory services, and talk to an expert, here.

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Useful Information

ECHA’s Ongoing Guidance Consultations

Guidance on labelling and packaging in accordance with CLP Draft Version 4.0  (May 2018) (PDF)

Keywords

Annex VIII, CLP, PEG, Poison Centre, Draft Guidance


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