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ECHA conducts checks on 5% of 2010 registration dossiers
20
Jan '14
ECHA has now concluded compliance checks for over 1,000 registration dossiers over 100 tonnes submitted for the first registration deadline. 69% of the evaluated dossiers were found to be non-compliant. Where ECHA has issued the decision as a result of the compliance check, registrants must provide the requested information so that they can demonstrate their chemicals can be used safely.

By 1 December 2010, the industry registered the substances manufactured or imported in quantities of more than 1000 tonnes per year and also carcinogenic, mutagenic or toxic to reproduction substances above 1 tonne per year, and substances dangerous to aquatic organisms or the environment above 100 tonnes per year.

REACH requires ECHA to check at least 5% of registrations per tonnage band for compliance. ECHA set itself a target to have 5% of the over 100 tonnes dossiers submitted for the 2010 deadline checked, at least partially, by the end of 2013.

The Agency used both concern-based and random selection to pick out the registration dossiers to be evaluated. For the selected dossiers, ECHA 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 100 tonnes submitted for the first registration deadline. 69% of all evaluated dossiers were found to be non-compliant.

The two main reasons for shortcomings 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. 

"This is an important milestone which helps all registrants to better understand their legal requirements. When interpreting the outcome it is good to bear in mind that the Agency electronically screened the dossiers to identify those with potential concerns and targeted the majority of the compliance checks on dossiers with the most apparent shortcomings. It is therefore not a surprise that a high proportion required a formal decision," says Geert Dancet, ECHA's Executive Director.

Registrants in receipt of decisions have an obligation to provide the requested information by updating their initial registration dossier within the set deadline so that they can demonstrate the safe use of their chemicals. ECHA is cooperating with the Member States to make sure that the decisions are respected.

European Chemicals Agency

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