The evaluation process of existing active substances is governed by the Review Programme (Commission Delegated Regulation (EU) No 1062/2014) which, for each active, determines the timeline and Member State competent authority responsible for the evaluation (eCA). The European Commission (Commission) is now seeking to amend that system, by a draft delegated regulation and annex, in preparation for the UK leaving the EU on March 29, 2019 (Brexit).
In absence of a transitional agreement between the UK and the remaining EU member states – EU law will cease to apply to and in the UK. It is not certain that such a withdrawal agreement will be concluded in time. In any event, the reallocation of the active substance review responsibilities is necessary because the draft Withdrawal Agreement currently being negotiated provides that the UK’s competent authority (the HSE) may not act as an eCA.
The 18 active substance dossiers scheduled for evaluation by the HSE would be reallocated to the Czech Republic (4), Germany (4), Sweden (2), France (2), Italy (2), Austria (1), Hungary (1), Switzerland (1) and Poland (1). The authorities have until December 31, 2020 to submit their conclusions and assessment reports to ECHA. Such reallocations will increase the workload of these competent authorities and potentially lead to further interruptions in an already chronically delayed Review Programme. The measure would also allow each new evaluating competent authority to, “[n]otwithstanding the stage of evaluation of the application”, request fees for services provided and obliges it to reject any application for which those fees are not paid. One can only hope that no more than a fair proportion of fees will be charged, given that fees will already have been paid to the HSE.
The draft measure is planned to be adopted as a delegated act under Articles 83 and 89(1) of the Biocidal Products Regulation (BPR). The relevant expert group (E03125 – Competent Authorities for Biocidal Products) has been previously consulted and the Commission is currently collecting feedback on the draft measure until October 11, 2018. Companies affected by the reallocation should seriously consider submitting comments. Thereafter, the Commission adopts the measure but the European Parliament and Council have 2 months to object. If no objection is raised, the measure enters into force. As per the Interinstitutional register of delegated acts, the planned adoption date is “Q1 2019”, which would be just in time for Brexit.
Preparations in other areas of EU chemical regulation are well underway: Similar reallocations concerning the evaluation of substance under the REACH Regulation already occurred at the beginning of the year. The latest update to the CoRAP indicates that substances which were initially scheduled for evaluation by the UK’s HSE have been assigned to the competent authorities of other Member States.