Draft Commission Implementing Regulation amending Implementing Regulations (EU) No 540/2011 and 820/2011 as regards the conditions of approval of the active substance terbuthylazine
Title of document
Draft Commission Implementing Regulation amending Implementing Regulations (EU) No 540/2011 and 820/2011 as regards the conditions of approval of the active substance terbuthylazine (5 page(s), in English; 5 page(s), in English)
This draft Commission Implementing Regulation provides that the approval of the active substance terbuthylazine is amended to set revised limits for two toxicologically relevant impurities in the technical material and to introduce a restriction to the rate and frequency of use of the substance. EU Member States shall review authorisations for plant protection products containing terbuthylazine as an active substance. The amendment of the conditions of approval is based on the evaluation of the confirmatory information required in the approval of terbuthylazine for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009.
This decision only concerns the placing on the market of this substance and plant protection products containing it.
Notifying member: European Union
Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment
In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.
Based on the assessment of the confirmatory information related to the specification of the technical material as manufactured, it is concluded that revised maximum levels for propazine and simazine in the technical material as manufactured should be established.
EFSA also 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.
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 (to a maximum of 9 g/kg).
Existing authorisations will need to be adapted accordingly; EU Member States must ensure that the placing on the market of terbuthylazine and the plant protection products containing it are in compliance with the amended conditions of approval as introduced by this draft Commission Implementing Regulation.
- Submission: 21/01/2021
- Reception: 22/01/2021
- Distribution: 22/01/2021
- Final date for comments: 23/03/2021
- Proposed date of adoption: N/A