Maximum residue levels for Bacillus amyloliquefaciens strain IT-45
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EU decides active substance Bacillus amyloliquefaciens strain IT-45 does not need MRLs
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
Update
On 26 May 2023, the European Commission published Regulation 2023/1030 deleting the maximum residue levels (MRLs) for Bacillus amyloliquefaciens strain IT-45.
Impacted Products
All products treated with Bacillus amyloliquefaciens strain IT-45
What is changing?
The active substance Bacillus amyloliquefaciens strain IT-45 will no longer have MRLs.
Why?
On 7 February 2022, the Commission approved Bacillus amyloliquefaciens strain IT-45 as a low-risk active substance. At the time, no specific MRLs had been set, so the MRLs were automatically set to the default level of 0.01 mg/kg.
During the peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain IT-45, EFSA (2021) concluded this substance is safe for humans. The strain is not pathogenic to humans and is not expected to produce toxins relevant to human health. The risk to humans through metabolites is negligible. Therefore, there is no need to establish MRLs for Bacillus amyloliquefaciens strain IT-45.
Timeline
This regulation enters into force on 15 June 2023 and is directly applicable.
Background
MRLs are set in accordance with the rules set out in Regulation 396/2005. For information on current MRLs for other substances, please consult the EU Pesticide Residues database.
Resources
EFSA (2021) Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain IT-45. EFSA Journal, 19(5): 6594.
Sources
Commission Regulation (EU) 2023/1030