Commission Implementing Regulation (EU) 2016/951 of 15 June 2016 approving the low-risk active substance Trichoderma atroviride strain SC1, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2016/951@2016-06-15/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and in particular Article 22(1) in conjunction with Article 13(2) thereof,
Whereas:
(1) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, France received on 6 November 2012 an application from BI-PA NV for the approval of the active substance Trichoderma atroviride strain SC1. In accordance with Article 9(3) of that Regulation, France, as rapporteur Member State, notified the Commission on 5 February 2013 of the admissibility of the application.
(2) On 27 May 2014, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter the Authority), assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(3) The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in February 2015.
(4) On 21 April 2015 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Trichoderma atroviride strain SC1 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.
(5) On 10 December 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for Trichoderma atroviride strain SC1 and a draft Regulation providing that Trichoderma atroviride strain SC1 is approved.
(6) The applicant was given the possibility to submit comments on the review report.
(7) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve Trichoderma atroviride strain SC1.
(8) The Commission further considers that Trichoderma atroviride strain SC1 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Trichoderma atroviride strain SC1 is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. Trichoderma atroviride strain SC1 is a wild-type strain isolated from decaying hazelnut wood in Italy. It is not pathogenic or virulent to humans or animals. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.
(9) It is therefore appropriate to approve Trichoderma atroviride strain SC1 as a low-risk substance for a period of 15 years. In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1 Approval of a low-risk active substance
The active substance Trichoderma atroviride strain SC1, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2 Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 June 2016. For the Commission The President Jean-Claude Juncker
ANNEX
ANNEX I
Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions Trichoderma atroviride strain SC1 Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The Netherland CIPAC No: 988 Not applicable minimum concentration 1 × 1010 CFU/g 6 July 2016 6 July 2031 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain SC1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
ANNEX II
In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions 7 Trichoderma atroviride strain SC1 Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The Netherland CIPAC No: 988 Not applicable minimum concentration 1 × 1010 CFU/g 6 July 2016 6 July 2031 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain SC1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
Versions
Cited by
- Commission Regulation (EU) 2017/171 of 30 January 2017 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, azoxystrobin, cyantraniliprole, cyflufenamid, cyproconazole, diethofencarb, dithiocarbamates, fluazifop-P, fluopyram, haloxyfop, isofetamid, metalaxyl, prohexadione, propaquizafop, pyrimethanil, Trichoderma atroviride strain SC1 and zoxamide in or on certain products (Text with EEA relevance) Regulation · Grade B
The low-risk active substance Trichoderma atroviride strain SC1 was approved by Commission Implementing Regulation (EU) 2016/951. The Authority concluded that as regards the dietary risk assessment for consumers some information was not available and further consideration by risk managers was required. The Standing Committee on Plants, Animals, Food and Feed noted at its meeting on 19 May 2016 that the substance concerned does not produce relevant metabolites of significant toxicity or at levels leading to an exposure higher than negligible. It is therefore appropriate to include that substanc