REACH Dossier Updates: Associations Urge Lengthening of Deadlines in Proposed Legislation

Associations have criticized what they regard as overly tight deadlines for updating their registration dossiers. The EC defined the deadlines in its Draft implementing regulation – Ares(2019)7784994. The associations expressed their reservation as part of the Feedback period from December 18–January 15, 2020.

For example, the European Non-Ferrous Metals Association, Eurometaux, noted that dossier updates could be very complex. When a formula changes, so could its classification, risks to human health and the environment, and usage. The six-month deadline permitted in the draft would be far too short, said Eurometaux.

The complexity argument was also made by the European Chemical Industry Council (CEFIC). It noted that several actors are usually involved in an update, which makes rapid agreement difficult to reach. CEFIC published its recommendations in July of last year.

In fact, the current regulatory draft calls for update deadlines of 3, 6, and 12 months. A three-month period is granted when, for example, only the status of the manufacturer or its address changes. It becomes more complex when the composition of the chemical changes or the safety data sheet must be updated. In such cases, the registrant is granted a 6- to 12-month deadline.

Regardless of the deadlines ultimately included in the legislation, the requirement for registrants to update their dossiers is stated in Article 22 of REACH: “Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases.”

In any case, errors in the registration dossiers have been repeatedly found in the past. It’s usually a case of missing data, which, according to BfR president Andreas Hensel (nur in deutsch), leaded to scientific uncertainty and complicated the evaluation of health risks. As a result, the ECHA has initiated an action plan and will examine the dossiers more closely in the future. The draft implementing regulation should also provide more legal surety in this regard.

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