Approval of the active substance
Article 1
The active substance Bacillus amyloliquefaciens strain IT-45, as specified in Annex I, is approved
Commission Implementing Regulation (EU) 2022/159 of 4 February 2022 approving the low-risk active substance Bacillus amyloliquefaciens strain IT-45 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)
Commission Implementing Regulation (EU) 2022/159 of 4 February 2022 approving the low-risk active substance Bacillus amyloliquefaciens strain IT-45 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)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Amendments to Implementing Regulation (EU) No 540/2011
Article 2
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Entry into force
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I Common Name, Identification Numbers IUPAC Name Purity ( 1 ) Date of approval Expiration of approval Specific provisions Bacillus amyloliquefaciens IT-45 n.a. The nominal content of Bacillus amyloliquefaciens IT-45 in the technical product and formulation is: minimum: 2 x 10 13 CFU/kg, maximum: 6 x 10 14 CFU/kg. No relevant impurities 27 February 2022 27 February 2037 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 IT-45 shall be taken into account. ( 1 ) Further details on the identity and the specification of the active substance are provided in the review report.
ANNEX IISupplementary provisions
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 ( 1 ) Date of approval Expiration of approval Specific provisions ‘ 35 Bacillus amyloliquefaciens IT-45 n.a. The nominal content of Bacillus amyloliquefaciens IT-45 in the technical product and formulation is: minimum: 2 x 10 13 CFU/kg, maximum: 6 x 10 14 CFU/kg. No relevant impurities 27 February 2022 27 February 2037 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 IT-45 shall be taken into account. ( 1 ) Further details on the identity and the specification of the active substance are provided in the review report.’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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