Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amends Regulation (EU) No 844/2012 as regards the provisions necessary for the implementation of the renewal procedure for active substances under Regulation (EC) No 1107/2009.
A 3-month additional time is allowed to the rapporteur Member State for preparing the draft renewal assessment report of the active substance (RAR) and the dossier of harmonised classification and labelling submitted to the European Chemicals Agency (ECHA). In consequence, the European Food Safety Authority (EFSA) will also have these 3 additional months for preparing its conclusion. In return, the period allowed to the applicants will be reduced by 3 months between the submission of the application of renewal and the submission of the supplementary dossiers.
Thus, supplementary dossiers should be submitted no later than 33 months, instead of 30 months, before the expiry of the approval.
The rapporteur Member State will have 13 months, instead of 12 months, to prepare and submit the renewal assessment report (RAR) to the Commission and to EFSA. Additional information requests to the applicants and consultation of EFSA and other member states do not lead to an extension of the period of 13 months.
The rapporteur Member State should submit at the latest at the time of submission a proposal to ECHA to obtain an opinion on harmonised classification of the active substance at least for the following hazard classes:
- acute toxicity,
- skin corrosion/irritation,
- serious eye damage/eye irritation,
- respiratory or skin sensitisation,
- germ cell mutagenicity,
- reproductive toxicity,
- specific target organ toxicity, single exposure,
- specific target organ toxicity, repeated exposure,
- hazardous to the aquatic environment.
The Committee for Risk Assessment from ECHA should adopt the opinion within 13 months from the submission of the dossier.
These new implementations apply to renewal procedures of active substances for which the approval period expires on or after 13 May 2023, excepted the substances for which supplementary dossiers have already been submitted before 17 January 2020.
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