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Thursday, 13 December 2018
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Raw materials & technologies

REACH: After registration is before registration

Wednesday, 5 December 2018

31 May 2018 marked the end of the final transition phase for registration of substances in the low-tonnage bands under REACH. What do companies need to consider now?

REACH: After registration is before registration. (Source: Gajus - Stock.Adobe)

REACH: After registration is before registration. (Source: Gajus - Stock.Adobe)

By Kerstin Heitmann, UMCO

Only those companies, which had submitted registration dossiers for their manufactured or imported substances by that deadline, are allowed to keep manufacturing or importing those substances (apart from a few exceptions).

To ensure the availability of key raw materials for the supply chains, the ECHA went some way towards helping many registrants get across the last few metres. It provisionally accepted incomplete dossiers from companies, which could justify why they were unable to complete them, e.g. laboratories were unable to process orders on time due to the high number of enquiries. These registrants have been granted a certain grace period in which to complete the dossiers, and meanwhile the substances concerned may be manufactured and imported as REACH-compliant.

REACH-compliant without registration number?

A registration number on a safety data sheet proves to the downstream user that the substance in question has been properly registered. However, this does not apply to substances for which incomplete dossiers were submitted – they will not be issued a registration number until the ECHA recognises the dossier as being complete.

Despite these emergency solutions on the part of ECHA, far fewer than the expected 30,000 substances were registered. The actual figure was less than 22,000. It is still unclear whether these substances will be absent from the European market in the future. In some cases, demand will be met from existing inventory but, even then, the registration number will still be missing. Where possible, substances have been replaced by registered substances or by substances exempted from registration.

As a downstream user, therefore, you should not expect all raw materials purchased in the EU to have registration numbers. That said, those which do not have one will be deemed REACH-compliant if your supplier can explain the absence of a substance’s registration number in terms of an exemption, an inventory sell-off, or an incomplete dossier that was submitted on time. If you are in doubt, however, you should request a declaration from him.

Registration after the deadline

Companies may continue submitting registration dossiers even after the end of the transition phase. Joint registration with data and cost sharing can proceed as before, too. However, such companies have been required to cease manufacture/import after 31 May of this year and may only resume these activities once they have received a registration number.

The deadline is not the end of the matter – Evaluations by competent authorities

REACH registration may be one of the biggest headaches for companies, but it would be a disastrous mistake to believe that the end of the transition phase signals the end of your dealings with REACH. On the contrary, things only really get started then. All registrants are obliged to keep their dossiers up to date and to update them when they have new information on properties or uses.

At the same time, ECHA and Member State competent authorities will be working on the submitted information to identify gaps and to eliminate or clear up suspected risks. Where necessary, they will be able to initiate risk-mitigation measures (e.g. restriction, authorisation).

The ECHA will be evaluating dossiers for REACH compliance (dossier evaluation). Substance evaluations by the Member States will be carried out under the terms of the Community Rolling Action Plan (CoRAP). This means that the competent authorities will evaluate not only individual dossiers, but all the information available on a given substance. If they find gaps in the information, they will request the registrants to fill them in accordingly, an activity that may necessitate studies above and beyond those stipulated in Annexes VII to X. If they come to the conclusion that risks are not being adequately managed, they can propose appropriate measures at EU level. This is usually done via the Registry of Intentions (RoI). The RoI can contain a proposal for harmonised classification, for a restriction on the use in question, or for inclusion of a substance on the candidate list, possibly with a later authorisation requirement and far-reaching consequences for all users in Europe.

A further type of evaluation will also be carried out by the Member States under the Risk Management Option Analysis (RMOA). Here, too, the conclusions may lead to additional legal regulations or RoIs.

Industry participation

The ECHA website will list the relevant activities being pursued by the competent authorities and will also publish some of the reports. It is possible and in some cases also desirable for affected companies and industry representatives to contact the competent authorities and to facilitate the whole process by contributing information. This should not only be understood as the task of the registrants but also, and more especially, as being in the interest of the downstream users, who are usually affected to a much greater extent by the measures. This is because the competent authorities often lack critical necessary information about the uses that would otherwise help them to implement measures in a targeted and proportionate manner from a socio-economic point of view.

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