LegalizeCommission 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 Text with EEA relevance
| Number | Common Name, Identification Numbers | IUPAC Name | Purity 21 | Date of approval | Expiration of approval | Specific provisions | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| 136 | 1-methylcyclopropene CAS No 3100-04-7 CIPAC No 767 | 1-methylcyclopropene | ≥ 980 g/kg (technical concentrate) The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate): — 1-chloro-2-methylpropene: maximum of 0,2 g/kg, — 3-chloro-2-methylpropene: maximum of 0,2 g/kg. For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %. | 1 August 2019 | 31 July 2034 | 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 1-methylcyclopropene, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of groundwater, when the substance is applied in regions with vulnerable soil and climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May 2027. | ||||
| 137 | Dimethenamid-P CAS No 163515-14-8 CIPAC No 638 | (S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide | ≥ 930 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: 1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg | 1 September 2019 | 31 August 2034 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of groundwater, in particular regarding the metabolites of dimethenamid-P; — the protection of aquatic organisms and small herbivorous mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water. The applicant shall submit the requested information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. | ||||
| 138 | Tolclofos-methyl CAS No 57018-04-9 CIPAC No 479 | O-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioate O-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate | ≥ 960 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: Methanol max. 1 g/kg | 1 September 2019 | 31 August 2034 | Only for use on ornamentals and on potatoes. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tolclofos-methyl, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to aquatic organisms and mammals, — the risk to consumers, in particular the potential risk from metabolite DM-TM-CH2OH in potatoes, — the risk to operators, workers and bystanders; Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 139 | Florpyrauxifen-benzyl CAS No: 1390661-72-9 CIPAC No: 990.227 | benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate | ≥ 920 g/kg The impurity toluene shall not exceed 3 g/kg in the technical material. | 24 July 2019 | 24 July 2029 | 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 22 March 2019, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of aquatic and terrestrial non-target plants. Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021. | ||||
| 140 | Metalaxyl-M CAS No 70630-17-0 (R) CIPAC No 580 | methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate | 920 g/kg The following relevant impurities shall not exceed a certain threshold: 2,6-dimethylphenylamine: max. content 0,5 g/kg 4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide: max. content 1 g/kg 2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester): max. content 10 g/kg | 1 June 2020 | 31 May 2035 | When used for seed treatment where treated seeds are to be sown outdoors, Member States shall, impose appropriate restrictions concerning the sowing density and require the use of precision drilling equipment. A sowing density above 2 000 000 seeds/ha shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on birds and mammals. 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 metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured, — the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate, — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions, — the protection of non-target arthropods, birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water, by 10 July 2026. | ||||
| 141 | Foramsulfuron CAS No 173159-57-4 CIPAC No 659 | 1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)-5-formamidophenylsulfonyl]urea | ≥ 973 g/kg | 1 June 2020 | 31 May 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on foramsulfuron, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the risk to consumers and operators, — the risk to aquatic organisms and non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water, within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. | ||||
| 142 | Pyriproxyfen. 2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine. CIPAC No: 715. CAS No: 95737-68-1. EC No (Einecs or ELINCS): 429-800-1 | 4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether | ≥ 970 g/kg Max. impurity: Toluene 5 g/Kg | 1 August 2020 | 31 July 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the dietary exposure of consumers to residues of pyriproxyfen, — the protection of sediment-dwelling organisms and aquatic organisms, — the protection of bees. As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms. As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water. The applicant shall submit the requested confirmatory information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. | ||||
| 143 | Kieselgur (Diatomaceous earth) CAS No 61790-53-2 CIPAC No 647 | No IUPAC name exists for kieselgur Other synonyms: Diatomaceous earth, Diatomite | 1 000 g/kg Minimum content of amorphous silica of 800 g/kg The following impurity is of toxicological concern and must not exceed the following level in the technical material: Crystalline silica with particle size below 10 μm – maximum of 1 g/kg | 1 February 2021 | 31 January 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate. Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 144 | Garlic extract Marker components: diallylsulfide (DAS1), diallyldisulfide (DAS 2), diallyltrisulfide (DAS3), diallyltetrasulfide (DAS 4) CAS No 8000-78-0 8008-99-9 CIPAC No 916 | Garlic extract | 1 000 g/kg | 1 March 2021 | 29 February 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on garlic extract, and in particular Appendices I and II thereto, shall be taken into account. On the basis of the proposed and supported uses (as listed in Appendix II), the following issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate: — The risk to aquatic organisms. | ||||
| 145 | Streptomyces strain K61 | Not applicable | No relevant impurities | 1 July 2021 | 30 June 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use. Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination 41. | ||||
| 146 | Cyazofamid CAS No: 120116-88-3 CIPAC No: 653 | 4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide | ≥ 935 g/kg | 01/08/2021 | 31/07/2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the specification of the technical material as commercially manufactured; (b) the impact of processing on the consumer risk assessment; (c) the protection of non-target arthropods and earthworms. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water; 2. points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. As regards point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023 | ||||
| 147 | Clopyralid CAS No 1702-17-6 CIPAC No 455 | 3,6-dichloropyridine-2-carboxylic acid or 3,6dichloropicolinic acid | ≥ 950 g/kg | 1 October 2021 | 30 September 2036 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on clopyralid, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured; — the protection of operators, ensuring that conditions of use for operators include the application of adequate personal protective equipment; — possible presence of clopyralid residues in rotational crops; — the possible transfer of clopyralid residues via compost or manure of animals whose feed originates from treated areas, to avoid damage to susceptible crops; — the protection of groundwater under vulnerable conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water. The applicant shall submit this information within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater. | ||||
| 148 | Purpureocillium lilacinum strain 251 | Not applicable | No relevant impurities | 1 March 2022 | 28 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 Purpureocillium lilacinum strain 251, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 41; (b) the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 149 | Flumioxazin CAS No 103361-09-7 CIPAC No 578 | N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide | ≥ 960 g/kg | 1 March 2022 | 28 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 renewal report on flumioxazin, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material that is authorised for use in plant protection products; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of non-target plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine disrupting properties in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 44 by 1 March 2024. | ||||
| 150 | Carbon dioxide CAS No: 124-38-9 CIPAC No: 844 | Carbon dioxide | 999 g/kg The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: phosphane max. 0,3 ppm v/v benzene max. 0,02 ppm v/v carbon monoxide max. 10 ppm v/v methanol max. 10 ppm v/v hydrogen cyanide max. 0,5 ppm v/vv | 1 May 2022 | 30 April 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 renewal report on carbon dioxide, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — adequate ventilation (e.g. with a ‘certificate of gas clearance’) before humans can re-enter treated and/or surrounding areas (i.e. chambers, buildings and silos). — the need of buffer zones for residents (subjected to revision considering the wind-speeds in the different Member States). Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 151 | Beauveria bassiana strain 203 Accession number at Centraal Bureau voor Schimmelcultures (Fungal Biodiversity Centre, Institute of the Royal Netherlands Academy of Arts and Sciences, Utrecht, Netherlands): CBS 121097 | Not applicable | Max. level of beauvericin: 80 μg/kg in the formulated product. | 19 April 2022 | 18 April 2032 | Only uses on ornamental palm trees shall be authorised. 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 Beauveria bassiana strain 203, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: a) the maximum level of the metabolite beauvericin in the plant protection product; b) the protection of operators and workers, taking into account that the species Beauveria basssiana, irrespective of the strain, is a potential human allergen by both skin and inhalatory exposure, and therefore ensuring that adequate personal protective equipment is included as a condition of use. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012 41. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 152 | Bifenazate 149877-41-8 736 | isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate | 980 g/kg Toluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material. | 1 July 2022 | 30 June 2037 | Only uses on non-edible crops in permanent greenhouses shall be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on bifenazate, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment; — the risk to bees and bumble bees released for pollination in permanent greenhouses. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity. | ||||
| 153 | Straight Chain Lepidopteran Pheromones (aldehydes) | Details are provided in the Review Report SANTE/10828/2021 | Details are provided in the Review Report SANTE/10828/2021 | 1 September 2022 | 30 August 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 renewal report on Straight Chain Lepidopteran Pheromones, and in particular Appendices I and II thereof, shall be taken into account. Member States shall pay particular attention to the efficacy of plant protection products containing either the individual single substances or blends thereof when evaluating applications for authorisation. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 154 | Straight Chain Lepidopteran Pheromones (alcohols) | Review Report SANTE SANTE/10828/2021 | Review Report SANTE SANTE/10828/2021 | 1 September 2022 | 30 August 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 renewal report on Straight Chain Lepidopteran Pheromones, and in particular Appendices I and II thereof, shall be taken into account. Member States shall pay particular attention to the efficacy of plant protection products containing either the individual single substances or blends thereof when evaluating applications for authorisation. Conditions of use shall include risk mitigation measures, where appropriate. | ||||
| 155 | Pythium oligandrum strain M1 Culture collection No ATCC 38472 | Not applicable | No relevant impurities | 1 March 2023 | 28 February 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Pythium oligandrum strain M1, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the specification of the technical material as commercially manufactured, — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers and that physical effects on the respiratory system due to the remnants of culture medium and co-formulants in the Microbial Pest Control Product (MPCP) cannot be excluded. Conditions of use shall include risk mitigation measures, such as: — adequate personal protective and respiratory protective equipment for operators using products containing Pythium oligandrum strain M1. | ||||
| 156 | Pseudomonas chlororaphis strain MA 342 Culture collection: NCIMB, UK: NCIMB 40616 | Not applicable | The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the in the Microbial Pest Control Agent (MPCA) must not exceed the LOQ (2.0 μg/ml). | 1 March 2023 | 28 February 2038 | Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Pseudomonas chlororaphis strain MA 342, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the level of the metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the Microbial Pest Control Agent (MPCA), which must not exceed 2 μg/ml; — the protection of operators and workers, taking into account that Pseudomonas chlororaphis strain MA 342 is to be considered, as any micro-organism, as a potential sensitiser, and paying special attention to exposure through inhalation. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process, shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards: 1. the phylogenetic taxonomic identification of the micro-organism in accordance with point 1.3 (identity, taxonomy and phylogeny) of Annex II, Part B of Commission Regulation (EU) 2022/1439 45; 2. the secondary metabolite DDR in accordance with SANCO/2020/12258 46, in particular on its degradation rate; 3. the potential for gene transfer of antibiotic resistance from Pseudomonas chlororaphis strain MA 342 to other micro-organisms in accordance with SANTE/2020/12260 47. The applicant shall submit the requested information referred to in points 1, 2 and 3 by 23 February 2025. | ||||
| 157 | Abamectin CAS No 71751-41-2 Avermectin B1a CAS No 65195-55-3 Avermectin B1b CAS No 65195-56-4 Abamectin CIPAC No 495 | Avermectin B1a (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside Avermectin B1b (10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside | ≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b | 1 April 2023 | 31 March 2038 | Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses. For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves; — The effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February). | ||||
| 158 | Bacillus amyloliquefaciens strain QST 713 | n.a. | The nominal content of Bacillus amyloliquefaciens strain QST 713 in the technical product and formulation is Minimum: 1 × 1012 CFU/kg Maximum: 3 × 1013 CFU/kg No relevant impurities | 1 July 2023 | 30 June 2038 | When authorising plant protection products containing Bacillus amyloliquefaciens strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall: — only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees; — implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles). For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Bacillus amyloliquefaciens strain QST 713, and in particular Appendices I and II thereof, shall be taken into account. In addition, Member States shall pay particular attention to: — 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 48 — the specification of the technical material as commercially manufactured used in plant protection products; — the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. | ||||
| 159 | Bacillus thuringiensis subsp. aizawai strain ABTS-1857 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. aizawai strain ABTS-1857 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 protective 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 48; — the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate. 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 protection products containing Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. aizawai strain ABTS-1857 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. peppers and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. aizawai strain ABTS-1857 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. The applicant shall submit the requested information by 13 December 2025. | ||||
| 160 | Bacillus thuringiensis subsp. aizawai GC-91 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. aizawai GC-91 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 protective 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 48; — the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate. 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 protection products containing Bacillus thuringiensis subsp aizawai GC-91 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. aizawai GC-91 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. pome fruits, grapes and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. aizawai GC-91 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. The applicant shall submit the requested information by 13 December 2025. | ||||
| 161 | Bacillus thuringiensis subsp. israelensis strain AM65-52 Culture collection No ATCC 1276 | Not applicable | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the renewal report on Bacillus thuringiensis subsp. israelensis strain AM65-52, and in particular Appendices I and II thereof, 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 microorganisms are per se considered as potential sensitizers; — 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 48. — the protection of wild pollinators and of aquatic organisms (e.g. aquatic invertebrates from Diptera taxon in particular) in case of uses in open field. Conditions of use shall include specific risk mitigation measures, where appropriate. Conditions of use shall include risk mitigation measures, such as: — adequate personal protective equipment for operators using products containing Bacillus thuringiensis subsp. israelensis strain AM65-52; — In case of authorisation of uses on edible crops, a minimum time period of 3 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. israelensis AM65-52 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. israelensis AM65-52 below 105 CFU/g at harvest. | ||||
| 162 | Bacillus thuringiensis subsp. kurstaki ABTS-351 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS-351 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 protective 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 48. 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 protection products containing Bacillus thuringiensis subsp. kurstaki ABTS-351 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki ABTS-351 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 cabbage and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki ABTS-351 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 13 December 2025. | ||||
| 163 | Bacillus thuringiensis subsp. kurstaki EG2348 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki EG2348 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 protective 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 48. 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 protection products containing Bacillus thuringiensis subsp kurstaki EG2348 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki EG2348 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 pome fruits and solanaceous vegetables during the fruiting period) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki EG2348 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 13 December 2025. | ||||
| 164 | Bacillus thuringiensis subsp. kurstaki PB 54 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, as provided for in Article 29(6) of 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 protective 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 48. 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 protection 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. | ||||
| 165 | Bacillus thuringiensis subsp. kurstaki SA-11 | n.a. | No relevant impurities | 1 July 2023 | 30 June 2038 | The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki SA-11 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 protective 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 48. 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 protection products containing Bacillus thuringiensis subsp kurstaki SA-11 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-11 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 pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-11 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 13 December 2025. | ||||
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