Repeated mistakes in REACH dossiers, says ECHA

By Katie Bird

- Last updated on GMT

Related tags European union European chemicals agency

Repeated mistakes in dossiers submitted to the European Chemicals Agency (ECHA) under the new REACH legislation have prompted the body to release guidelines.

As part of its progress report, the organisation has described how the dossiers should be prepared in order to avoid some of the most common mistakes.

Under the new chemicals legislation REACH, all chemicals produced or imported into the European Union at quantities of more than one tonne must be registered.

A dossier then must be prepared for each substance which is then sent to the ECHA to be checked, before the relevant member state will evaluate whether the substance poses a threat to human health or the environment if deemed necessary.

The Agency has now received 406 registration dossiers, from an expected 25,000 before the November 30 deadline.

According to the agency, just over 400 dossiers is slightly more than the agency had estimated to receive by this point in time.

Errors in dossiers

One of the most common errors in the dossiers is the poorly justified omission of testing data, the agency said.

The agency allows the omission of testing data under strict conditions (if it is not scientifically necessary, if it is not technically possible and is substance-tailored testing applies) but according to ECHA some dossiers did not include testing data and could not justify why.

In five out of 16 of the dossiers testing data for repeated dose toxicity and reproductive toxicity were not included and insufficient justification, was given, it said.

In addition, the agency said summaries of test reports did not include enough detailed information. In a number of cases it was impossible to make independent assessments of the study and often meant consulting the full study report was necessary.

There were also problems relating to the exact definition and identification of the substance in question.

According to EHCA, the naming information provided in the dossiers was insufficient on a signficant proportion of the dossiers.

The information provided must allow unambiguous identification of the substance, the body argued, referring individuals to the guidance document ‘Guidance for identification and naming of substances under REACH’.

To access EHCA’s progress report please click here​.

Related topics Formulation & Science

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