Non-renewal of approval of the active substance thiram

(1)

Commission Directive 2003/81/EC included thiram as an active substance in Annex I to Council Directive 91/414/EEC

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011.

(3)

The approval of the active substance thiram, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2019.

(4)

An application for the renewal of the approval of thiram was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 20 January 2016.

(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 27 January 2017 the Authority communicated to the Commission its conclusion on whether thiram can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified a high acute risk to consumers and to workers from application of thiram by foliar spraying. Furthermore, it identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment. Residue definitions for risk assessment purposes could not be derived from the incomplete information available on metabolite M1, consequently the assessment of consumer risk through dietary intake could not be completed and maximum residue levels could not be established. Furthermore, the formation of N,N-dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in drinking water when surface water and groundwater containing thiram and its metabolite DMCS is subject to water treatment processes could not be excluded by the Authority based on the available information and in addition a high risk to aquatic organisms from exposure to DMCS was concluded by the Authority based on the limited information available. Also, based on the information available the Authority could not conclude on the endocrine disrupting potential of thiram.

(9)

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

(10)

However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

(11)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance thiram in accordance with Article 20(1)(b) of that Regulation.

(12)

On 18 May 2018 the applicant wrote to the Commission to withdraw from the renewal application the representative uses concerning application by foliar spraying.

(13)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(14)

Taking into account the risk identified for birds and wild mammals from treated seeds the placing on the market and the use of seeds treated with plant protection products containing thiram should be prohibited.

(15)

The prohibition of placing on the market and use of treated seeds should apply as of 31 January 2020 in order to allow for a sufficient period of transition for the seed supply chain taking into account the limited availability of seeds that are not treated with products containing thiram.

(16)

Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing thiram.

(17)

For plant protection products containing thiram, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 30 April 2019 for plant protection products used for foliar application and on 30 January 2020 for other plant protection products, including those used for seed treatment.

(18)

Commission Implementing Regulation (EU) 2018/524 extended the expiry date of thiram to 30 April 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

(19)

This Regulation does not prevent the submission of a further application for the approval of thiram in accordance with Article 7 of Regulation (EC) No 1107/2009.

(20)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,