Commission Implementing Regulation (EU) 2021/1455 of 6 September 2021 approving the low-risk active substance Bacillus amyloliquefaciens strain AH2 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2021/1455@2021-09-06/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 13(2) in conjunction with Article 22(1) thereof,
Whereas:
(1) In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Probelte S.A. submitted to the Netherlands, on 1 June 2015, an application for the approval of the active substance Bacillus amyloliquefaciens strain AH2.
(2) In accordance with Article 9(3) of that Regulation, the Netherlands, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (the Authority) on 25 October 2015 of the admissibility of the application.
(3) On 21 December 2017, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to 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.
(4) 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 the applicant to supply additional information to the Member States, the Commission and the Authority. The rapporteur Member State submitted its assessment of the additional information to the Authority in an updated draft assessment report in December 2018.
(5) On 26 May 2020, the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance Bacillus amyloliquefaciens strain AH2 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.
(6) On 22 October 2020, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed a review report and a draft Regulation regarding Bacillus amyloliquefaciens strain AH2.
(7) The applicant was given the possibility to submit comments on the review report.
(8) It has been established, with respect to one representative use of at least one plant protection product containing the active substance, examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(9) The Commission further considers that Bacillus amyloliquefaciens strain AH2 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Bacillus amyloliquefaciens strain AH2 is a microorganism, which fulfils the conditions set in point 5.2. of Annex II to Regulation (EC) No 1107/2009. No critical area of concerns were identified for humans, animals and the environment.
(10) It is therefore appropriate to approve Bacillus amyloliquefaciens strain AH2 as a low-risk substance.
(11) In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions.
(12) In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(13) 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 the active substance
The active substance Bacillus amyloliquefaciens strain AH2, 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, 6 September 2021. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX I
Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions Bacillus amyloliquefaciens AH2 n.a. The nominal content of Bacillus amyloliquefaciens AH2 in the technical product and formulation is 1,0 × 1011 CFU/L (range 7x1010 – 7x1011). No relevant impurities 27 September 2021 27 September 2036 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Bacillus amyloliquefaciens AH2 and in particular Appendices I and II thereof, shall be taken into account.
ANNEX II
In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: No. Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions 33 Bacillus amyloliquefaciens AH2 n.a. The nominal content of Bacillus amyloliquefaciens AH2 in the technical product and formulation is 1,0 × 1011 CFU/L (range 7x1010 – 7x1011). No relevant impurities 27 September 2021 27 September 2036 For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Bacillus amyloliquefaciens AH2 and in particular Appendices I and II thereof, shall be taken into account.
Versions
Cited by
- Commission Regulation (EU) 2023/1030 of 25 May 2023 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards Bacillus amyloliquefaciens strain AH2, Bacillus amyloliquefaciens strain IT-45 and Purpureocillium lilacinum strain PL11 (Text with EEA relevance) Regulation · Grade B
Commission Implementing Regulation (EU) 2021/1455 approved the low-risk active substance Bacillus amyloliquefaciens strain AH2. During the peer-review of the pesticide risk assessment of the active substance under Regulation (EC) No 1107/2009 of the European Parliament and of the Council, the European Food Safety Authority (Authority) concluded, as regards the dietary risk assessment for consumers, some information was not available and further consideration by risk managers was required. As set out in the review report for that substance in the context of the risk assessment of the active sub