(Utkast) Kommisjonens gjennomføringsforordning om endring av gjennomføringsforordning (EU) nr. 540/2011 og (EU) nr. 820/2011 med hensyn til vilkårene for godkjenning av det aktive stoffet terbutylazin
(Draft) Commission Implementing Regulation amending Implementing Regulations (EU) No 540/2011 and (EU) No 820/2011 as regards the conditions of approval of the active substance terbuthylazine
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 1.4.2021
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) Commission Implementing Regulation (EU) No 820/2011 provides for the approval of the active substance terbuthylazine and the resulting insertion of terbuthylazine in the Annex to Commission Implementing Regulation (EU) No 540/2011 .
(2) Implementing Regulation (EU) No 820/2011 also provides for the submission of further confirmatory information on the specification of the technical material, as commercially manufactured including information on the relevance of the impurities, the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies and the groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6.
(3) In addition, Implementing Regulation (EU) No 820/2011 required the applicant to submit confirmatory information as regards the relevance of the metabolites MT1 MT13, MT14 and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine was classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council as ‘suspected of causing cancer’.
(4) The applicant submitted additional information within the periods provided for in Implementing Regulation (EU) No 820/2011. With regard to the relevance of specified metabolites of terbuthylazine if terbuthylazine was classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’, the Risk Assessment Committee of the European Chemicals Agency adopted on 5 June 2015 an opinion confirming that terbuthylazine is not to be classified as ‘suspected of causing cancer’, rendering the corresponding confirmatory information unnecessary.
(5) The rapporteur Member State, the United Kingdom, assessed the additional information submitted by the applicant. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission, and the European Food Safety Authority (‘the Authority’) on 6 August 2015.
(6) The rapporteur Member State consulted the other Member States, the applicant and the Authority and asked them to provide comments on the addendum to the draft assessment report. The Authority published a technical report summarising the outcome of this consultation for terbuthylazine on 20 January 2016.
(7) Taking into account the assessment of the rapporteur Member State and the technical report the Commission considers that the requirement to submit confirmatory information on the specification of the technical material, as commercially manufactured, including information on the relevance of the impurities, and on the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies can be considered addressed, provided the currently established maximum levels for the relevant impurities propazine and simazine in the technical material as manufactured are lowered.
(8) The Commission further consulted the Authority in relation to the exposure of groundwater to metabolites of terbuthylazine. The Authority published its updated conclusions on the assessment of the additional information on 29 June 2017 and 19 September 2019 . The Authority identified a risk to infants and toddlers under some conditions of use from exposure to metabolites of terbuthylazine through food and drinking water, according to the additional information provided by the applicant and based on the use of terbuthylazine at a rate of 850 g/ha each year on the same field. Furthermore, where terbuthylazine is applied every year at a maximum rate of 850 g/ha, two metabolites of terbuthylazine, LM3 and LM6, are predicted to occur in groundwater above 0.75 µg/L in all scenarios, triggering the need for a consumer risk assessment which, however, could not be carried out since health-based reference values could not be derived based on the available data.
(9) The draft assessment report, the addendum to the draft assessment report and the conclusions of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 24 March 2021 in the format of the updated review report for terbuthylazine.
(10) The applicant was given the possibility to submit comments on the updated review report.
(11) The Commission has concluded that the additional information provided by the applicant is not sufficient to exclude a risk to consumers from exposure to metabolites of terbuthylazine where it is applied every year in the same field at a maximum rate of 850 g/ha.
(12) Therefore, it is necessary and appropriate to restrict the approval of terbuthylazine to use only every third year on the same field at a maximum rate of 850 g/ha. It is also necessary to amend the maximum levels of the relevant impurities propazine and simazine that are permitted in the technical material as commercially manufactured.
(13) Implementing Regulations (EU) No 820/2011 and (EU) No 540/2011 should therefore be amended accordingly.
(14) Member States should be provided with time to withdraw or amend authorisations for plant protection products containing terbuthylazine which do not comply with the restricted conditions of approval.
(15) For plant protection products containing terbuthylazine, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should expire at the latest 12 months after the entry into force of this Regulation.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
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