Deadlines for Dossier Updates: Industry and Governments React to EU Proposal

Industry associations and EU member states consider the deadlines proposed by the EU for updates of registration dossiers unrealistic. They expressed this opinion in statements published after the CARACAL meeting at the beginning of July.

For example, Eurometaux, the European Association of Non-Ferrous Metals Producers and Recyclers, highlighted the complexity of the interconnections involved. It noted that every individual data record to be updated affects other criteria, such as classification and risk assessment. Accordingly, says Eurometaux, it is not simply a matter of creating a new compilation of data in the dossier, but of ensuring the consistency of data across several levels – between the IUCLID file and chemical safety reports.

Concerns about the deadlines were also expressed by SMEunited, an organization devoted to the interests of 12 million companies with about 50 million employees, mostly craftpersons, across Europe. SMEunited succeeded UEAPME (European Association of Craft, Small and Medium-Sized Enterprises) in November 2018. Representatives of  SMEunited regard the deadlines as too short because smaller companies generally outsource updates to service providers. To obtain additional time buffers, they therefore call for longer deadlines, specifically a change from one month to three months.

In its statement, the Finnish Safety and Chemicals Agency (TUKES) warned about unclear terminology. For example, the exact meaning of “monitoring and tracking systems,” as given in Article 2 of the planned implementing regulation, must be clarified. And the expression “a use no longer relevant” also needs an explanation. The leaders of the Finnish agency have also uncovered contradictions. For example, Article 1 allows six months for an update of the chemical safety report, but Article 6 of the same document allows only one month for an update.

The Irish Health and Safety Authority (HSA) is also irked by the formulation of Article 2 of the planned implementing regulation, which requires companies to provide “monitoring and tracking systems” that would allow them to identify any changes related to chemicals at all times. Article 36 of REACH states only that companies should “assemble and keep available all information.” According to the HSA, the phrase “monitoring and tracking systems” is a further development of the definition in REACH and therefore requires an explanation.

All objections and comments will be discussed at the next CARACAL meeting in November.

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