Amendment of Regulation (EU) 844/2012
Date: 27 January 2020
On 24 January 2020, EU Commission published the regulation (EU) 2020/103 to amend the regulation (EU) 844/2012.
The main changes are the additional time for the preparation of the draft renewal report by the RMS and for circulating the RAR by EFSA.
The RMS have now 13 months (instead of 12 months) for its evaluation and the preparation of renewal assessment report, whereas EFSA has now 3 months (instead of 30 days) for circulating the RAR.
These additional evaluation times lead to a reduced submission time for the applicants. It applies to those active substances for which the approval period expires on or after 13 May 2023. Concerned applicants must submit the supplementary dossier three months earlier; i.e. 33 months before the expiry date of the approval of the a.s. (formerly 30 months).
According to the new regulation, the RMS must also submit a proposal on a harmonised classification of the active substance to ECHA at the latest at the time of submission of the draft renewal assessment report. In case a proposal has already been submitted to ECHA, the RMS should limit the proposal to the parts that are not covered. In the case of an already existing opinion the RMS should justify that the opinion remains valid. The preamble point 7 of regulation (EU) 2020/103 elaborates that “Indicative timelines should be defined to ensure that the opinion of the Committee for Risk Assessment of the Agency is available to the Authority prior to the adoption of its conclusion under Article 13 of Regulation (EU) No 844/2012”. So, our recommendation is that applicants should discuss the final deadlines for submission with the respective RMS, especially when an ECHA opinion is already available and this opinion should not be changed/re-evaluated.