ANNEX IISupplementary provisions
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 ( 1 ) Date of approval Expiration of approval Specific provisions ‘49 Emamectin CAS No emamectin: 119791-41-2 (formerly 137335-79-6) and 123997-28-4 emamectin benzoate: 155569-91-8 (formerly 137512-74-4 and 179607-18-2) emamectin B1a benzoate: 138511-97-4 emamectin B1b benzoate: 138511-98-5 CIPAC No emamectin: 791 emamectin benzoate: 791.412 Emamectin B1a: (10 E ,14 E ,16 E )-(1 R ,4S,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-6′-[( S )- sec -butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L- lyxo -hexapyranosyl)-α-L- arabino -hexapyranoside Emamectin B1b: (10 E ,14 E ,16 E )-(1 R ,4 S ,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L-l yxo -hexapyranosyl)-α-L- arabino -hexapyranoside Emamectin B1a benzoate: (10 E ,14 E ,16 E )-(1 R ,4S,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-6′-[( S )- sec -butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L- lyxo -hexapyranosyl)-α-L- arabino -hexapyranoside benzoate Emamectin B1b benzoate: (10 E ,14 E ,16 E )-(1 R ,4 S ,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L-l yxo -hexapyranosyl)-α-L- arabino -hexapyranoside benzoate ≥ 950 g/kg as emamectin benzoate anhydrous (a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate) 1 May 2014 30 April 2024 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 emamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to non-target invertebrates; — the protection of workers and operators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the risk of enantio-selective metabolisation or degradation. The applicant shall submit to the Commission, Member States and the Authority the relevant information two years after adoption of the pertinent guidance document on evaluation of isomer mixtures.’ ( 1 ) Further details on identity and specification of active substance are provided in the review report.