REACH: Quality of Registration Dossiers

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  • Published: 17 January 2014
  • Copyright: Wiley-VCH Verlag GmbH & Co. KGaA
  • Source / Publisher: European Chemicals Agency (ECHA)
thumbnail image: REACH: Quality of Registration Dossiers

ECHA has concluded compliance checks for over 1000 registration dossiers over 1000 tonnes submitted for the first registration deadline. 69 % of the evaluated dossiers were found to be non-compliant.

For the first registration deadline, industry had to register all substances manufactured or imported in quantities of more than 1000 tonnes per year and also the most hazardous substances. Registration due date was 1 December 2010.
REACH requires ECHA to check at least 5 % of registrations per tonnage band for compliance. The Agency used concern-based and random selection to pick out the registration dossiers to be evaluated. For the selected dossiers, they conducted either an overall compliance check (approximately 30 % of the cases) or a targeted one (70 % of the cases). By end of 2013, ECHA concluded 1130 compliance checks or 5.7 % of the total number of registration dossiers over 1000 tonnes.

The two main reasons for shortcomings of 69 % of all evaluated dossiers were deficiencies in the information regarding identification and composition of the substance, and insufficient justification for not submitting the required studies or missing information in the chemical safety report.

Where ECHA has issued the decision as a result of the compliance check, registrants must provide the requested information within the set deadline so that they can demonstrate their chemicals can be used safely. ECHA is cooperating with the Member States to make sure that the decisions are respected.

Also of interest:
ECHA webpage:

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