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L 137/16 EN Official Journal of the European Union 25.5.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/1021
of 24 May 2023
renewing the approval of the active substance Bacillus thuringiensis subsp. kurstaki PB 54 in
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and
amending Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
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(1), and in particular Article 20(1) thereof,
Whereas:
(1) Commission Directive 2008/113/EC(2)included a reference to the approval of Bacillus thuringiensis subsp. kurstaki PB
54 as an active substance in Annex I to Council Directive 91/414/EEC(3).
(2) According to Article 78(3) of Regulation (EC) No 1107/2009, 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(4).
(3) The approval of the active substance Bacillus thuringiensis subsp. kurstaki PB 54, as set out in Part A of the Annex to
Implementing Regulation (EU) No 540/2011 expires on 15 August 2024.
(4) On 30 April 2016, an application for the renewal of the approval of the active substance Bacillus thuringiensis subsp.
kurstaki PB 54 was submitted to Denmark, the rapporteur Member State, and the Netherlands, the co-rapporteur
Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012(5) and
within the time period provided for in that Article.
(5) The applicant also submitted the supplementary dossiers required by Article 6 of Implementing Regulation (EU)
No 844/2012 to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European
Food Safety Authority (‘the Authority’). The application was found to be admissible by the rapporteur Member State.
(1) OJ L 309, 24.11.2009, p. 1.
(2) Commission Directive 2008/113/EC of 8 December 2008 amending Council Directive 91/414/EEC to include several micro-
organisms as active substances (OJ L 330, 9.12.2008, p. 6).
(3) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1).
(4) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the
European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
(5) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the
implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European
Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26). This
Regulation was replaced by Commission Implementing Regulation (EU) 2020/1740 (OJ L 392, 23.11.2020, p. 20), however,
according to Article 17 of that Regulation, it continues to apply to the procedure for the renewal of the approval of active substances:
(1) whose approval period ends before 27 March 2024; (2) for which a Regulation, adopted in accordance with Article 17 of
Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later date.25.5.2023 EN Official Journal of the European Union L 137/17
(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur
Member State and submitted it to the Authority and the Commission on 28 June 2019. In its draft renewal
assessment report the rapporteur Member State proposes to renew the approval of Bacillus thuringiensis subsp.
kurstaki PB 54.
(7) The Authority communicated the draft renewal assessment report to the applicant and to the Member States for
comments, launched a public consultation, and forwarded the comments received to the Commission. The
Authority also made the supplementary summary dossier available to the public.
(8) On 2 March 2021, the Authority communicated to the Commission its conclusion(6), which indicates that Bacillus
thuringiensis subsp. kurstaki PB 54 can be expected to meet the approval criteria provided for in Article 4 of
Regulation (EC) No 1107/2009.
(9) The Commission presented a renewal report regarding Bacillus thuringiensis subsp. kurstaki PB 54 and a draft of this
Regulation to the Standing Committee on Plants, Animals, Food and Feed on 14 October 2022and on 25 January
2023, respectively.
(10) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in
accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal
report. The applicant submitted its comments, which have been carefully examined and taken into consideration.
(11) It has been established with respect to one or more representative uses of at least one plant protection product
containing the active substance Bacillus thuringiensis subsp. kurstaki PB 54 that the approval criteria provided for in
Article 4 of Regulation (EC) No 1107/2009 are satisfied.
(12) It is therefore appropriate to renew the approval of Bacillus thuringiensis subsp. kurstaki PB 54.
(13) It is, however, necessary to provide for certain conditions pursuant to Article 14(1), read in conjuction with
Article 6, of Regulation (EC) No 1107/2009. It is, in particular, appropriate as a precautionary approach for
consumer dietary protection to include a minimum time period between the application of plant protection
products containing Bacillus thuringiensis subsp. kurstaki PB 54 and the harvest of edible crops used for fresh
consumption, unless residues data show levels of Bacillus thuringiensis subsp. kurstaki PB 54 below 105 CFU/g at
harvest.
(14) In addition, in order to increase the confidence in the conclusion that Bacillus thuringiensis subsp. kurstaki PB 54 does
not affect human health, the applicant should provide further data regarding the density decline of viable spores of
Bacillus thuringiensis subsp. kurstaki PB 54 on edible plant parts from the time of application of a plant protection
product containing this active substance until the time of harvest or until levels found are below 105 CFU/g.
(15) Furthermore, it is appropriate to require that Member States, when assessing applications for authorisations of plant
protection products containing Bacillus thuringiensis subsp. kurstaki PB 54, pay particular attention to the protection
of operators and workers.
(16) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(6) EFSA Journal. DOI: https://doi.org/10.2903/j.efsa.2021.6496. Available online: www.efsa.europa.eu.L 137/18 EN Official Journal of the European Union 25.5.2023
(17) Commission Implementing Regulation (EU) 2023/689(7) extended the approval of Bacillus thuringiensis subsp.
kurstaki PB 54 until 15 August 2024in order to allow the renewal process to be completed before the expiry of the
approval period of that active substance. However, given that a decision on renewal has been taken ahead of that
extended expiry date, this Regulation should apply earlier than that date.
(18) 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
Renewal of the approval of the active substance
The approval of the active substance Bacillus thuringiensis subsp. kurstaki PB 54, as specified in Annex I, is renewed, 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 and 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 July 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 May 2023.
For the Commission
The President
Ursula VON DER LEYEN
(7) Commission Implementing Regulation (EU) 2023/689 of 20 March 2023 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis
subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus
thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA,
clodinafop, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, malathion, mepanipyrim,
metconazole, metrafenone, pirimicarb, pyridaben, pyrimethanil, rimsulfuron, spinosad, Trichoderma asperellum (formerly T. harzianum)
strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain T11, Trichoderma gamsii (formerly T. viride) strain
ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (OJ L 91, 29.3.2023, p. 1).ANNEX I
Common Name, Identification IUPAC Expiration of
Purity(1) Date of approval Specific provisions
Numbers Name approval
Bacillus thuringiensis subsp. n.a. No relevant 1 July 2023 30 June 2038 The implementation of the uniform principles, as provided for in Article 29(6) of
kurstaki PB 54 impurities Regulation (EC) No 1107/2009, requires that the conclusions of the review report on
Bacillus thuringiensis subsp. kurstaki PB 54 and in particular Appendices I and II thereto,
are taken into account.
In this overall assessment, the Member States shall pay particular attention to:
— the protection of operators and workers, taking into account that micro-organisms
are per se considered as potential sensitisers, ensuring that adequate personal protec
tive equipment is included as a condition of use;
— the assurance by the producer of strict maintenance of environmental conditions
and quality control analysis during the manufacturing process, in order to ensure
the fulfilment of the limits on microbiological contamination as referred to in the
Working Document SANCO/12116/2012(2).
Conditions of use shall include the following risk mitigation measures:
— a minimum time period of 2 days shall be kept between the application of plant pro
tection products containing Bacillus thuringiensis subsp. kurstaki PB 54 and the har
vest of edible crops used for fresh consumption, unless available measured or esti
mated residues data show levels of Bacillus thuringiensis subsp. kurstaki PB 54 below
105 CFU/g at harvest.
The applicant shall submit to the Commission, the Member States and the Authority
additional information as regards:
— data in at least one representative edible crop (i.e. on stone fruits and tomatoes)
regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki
PB 54 on edible plant parts from the time of application of a plant protection pro
duct containing this active substance until the time of harvest or until levels found
are below 105 CFU/g, including storage stability data of the micro-organisms
between the sampling and the spore counting analysis. The relevant methods and
protocols to be employed shall be agreed between the applicant and the Rapporteur
Member State by 14 December 2025.
(1) Further details on the identity and the specification of the active substance are provided in the renewal report.
(2) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).
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137/19ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in part A, entry 195 is deleted,
(2) in Part B, the following entry is added:
Common Name, IUPAC Expiration of
No. Purity(1) Date of approval Specific provisions
Identification Numbers Name approval
‘164 Bacillus thuringiensis n.a. No relevant 1 July 2023 30 June 2038 The implementation of the uniform principles, as provided for in Article 29(6) of
subsp. kurstaki PB 54 impurities Regulation (EC) No 1107/2009, requires that the conclusions of the review report on
Bacillus thuringiensis subsp. kurstaki PB 54 and in particular Appendices I and II thereto,
are taken into account.
In this overall assessment, the Member States shall pay particular attention to:
— the protection of operators and workers, taking into account that micro-organisms
are per se considered as potential sensitisers, ensuring that adequate personal protec
tive equipment is included as a condition of use;
— the assurance by the producer of strict maintenance of environmental conditions and
quality control analysis during the manufacturing process, in order to ensure the ful
filment of the limits on microbiological contamination as referred to in the Working
Document SANCO/12116/2012(2).
Conditions of use shall include the following risk mitigation measures:
— a minimum time period of 2 days shall be kept between the application of plant pro
tection products containing Bacillus thuringiensis subsp. kurstaki PB 54 and the harvest
of edible crops used for fresh consumption, unless available measured or estimated
residues data show levels of Bacillus thuringiensis subsp. kurstaki PB 54 below 105
CFU/g as recommended by EFSA.
The applicant shall submit to the Commission, the Member States and the Authority
additional information as regards:
— data in at least one representative edible crop (i.e. on stone fruits and tomatoes)
regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki
PB 54 on edible plant parts from the time of application of a plant protection product
containing this active substance until the time of harvest or until levels found are
below 105 CFU/g, including storage stability data of the micro-organisms between
the sampling and the spore counting analysis. The relevant methods and protocols
to be employed shall be agreed between the applicant and the Rapporteur Member
State by 14 December 2025.
(1) Further details on the identity and the specification of the active substance are provided in the renewal report.
(2) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).’
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