Address https://gelex.eu/eli/EU/regulation/2014/1316@2014-12-11/en

Contents

1. Preamble
2. 1. Article 1 Approval of active substance
   2. Article 2 Re-evaluation of plant protection products
   3. Article 3 Amendments to Implementing Regulation (EU) No 540/2011
   4. Article 4 Extension of existing provisional authorisations
   5. Article 5 Entry into force and date of application
3. ANNEX
4. ANNEX I
5. ANNEX II

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) and Article 78(2) thereof,

Whereas:

(1) In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Bacillus amyloliquefaciens subsp. plantarum strain D747 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Implementing Decision 2011/253/EU.

(2) In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 21 October 2010 an application from Mitsui AgriScience International SA/NV, for the inclusion of the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747 in Annex I to Directive 91/414/EEC. Implementing Decision 2011/253/EU confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3) For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 14 January 2013.

(4) The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter the Authority). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747 on 27 March 2014. The draft assessment report and the conclusion 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 10 October 2014 in the format of the Commission review report for Bacillus amyloliquefaciens subsp. plantarum strain D747.

(5) It has appeared from the various examinations made that plant protection products containing Bacillus amyloliquefaciens subsp. plantarum strain D747 may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Bacillus amyloliquefaciens subsp. plantarum strain D747.

(6) A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(7) Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing Bacillus amyloliquefaciens subsp. plantarum strain D747. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(8) The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties, it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(9) 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) It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing Bacillus amyloliquefaciens subsp. plantarum strain D747 in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations.

(11) 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 active substance

The active substance Bacillus amyloliquefaciens subsp. plantarum strain D747, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2 Re-evaluation of plant protection products

1. Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing Bacillus amyloliquefaciens subsp. plantarum strain D747 as an active substance by 30 September 2015. By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2. By way of derogation from paragraph 1, for each authorised plant protection product containing Bacillus amyloliquefaciens subsp. plantarum strain D747 as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 March 2015 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009. Following that determination Member States shall:

(a) in the case of a product containing Bacillus amyloliquefaciens subsp. plantarum strain D747 as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or

(b) in the case of a product containing Bacillus amyloliquefaciens subsp. plantarum strain D747 as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

Article 3 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 4 Extension of existing provisional authorisations

Member States may extend existing provisional authorisations for plant protection products containing Bacillus amyloliquefaciens subsp. plantarum strain D747 for a period ending on 30 September 2016 at the latest.

Article 5 Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 April 2015. However, Article 4 shall apply from the date of the entry into force of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 December 2014. 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405 Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234. Not applicable Minimum concentration: 2,0 × 1011 CFU/g 1 April 2015 31 March 2025 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 Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. 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 B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions 83 Bacillus amyloliquefaciens subsp. plantarum strain D747 Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405 Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234. Not applicable Minimum concentration: 2,0 × 1011 CFU/g 1 April 2015 31 March 2025 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 Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. 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

1. 2014-12-11

Cited by

• Commission Regulation (EU) 2016/143 of 18 January 2016 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards COS-OGA, cerevisane, calcium hydroxide, lecithins, Salix spp cortex, vinegar, fructose, Pepino mosaic virus strain CH2 isolate 1906, Verticillium albo-atrum isolate WCS850 and Bacillus amyloliquefaciens subsp. plantarum strain D747 (Text with EEA relevance) Regulation · Grade B

  Commission Implementing Regulation (EU) No 1316/2014 approved the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747. 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 review report for that substance stated that it is not pathogenic to humans and is not expected to produce toxins that are relevant for human health. It is therefore appropriate to include that substance in Annex IV to Regulation (EC) No 396/2005.

• Commission Implementing Regulation (EU) 2025/99 of 21 January 2025 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus amyloliquefaciens subsp. plantarum D747, benalaxyl-M, cyprodinil, dichlorprop-P, formetanate, fosetyl, halosulfuron-methyl, imazamox, milbemectin, phenmedipham, pirimicarb, Pseudomonas sp. strain DSMZ 13134, pyrimethanil, pyriofenone, pyroxsulam, spinosad, sulphur, Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains ICC012, T-25 and TV-1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain ICC080, triticonazole and ziram (Text with EEA relevance) Regulation · Grade B

  Commission Implementing Regulation (EU) No 1316/2014 approved the active substance Bacillus amyloliquefaciens subsp. plantarum strain D747 until 31 March 2025.