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
PART C
Basic Substances
General provisions applying to all substances listed in this Part: the Commission shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make them available to them on specific request.
| Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Specific provisions |
|---|---|---|---|---|---|
| 1 | Equisetum arvense L. CAS No: not allocated CIPAC No: not allocated | Not applicable | European Pharmacopeia | 1 July 2014 | Equisetum arvense L. may be used in accordance with the specific conditions included in the conclusions of the review report on Equisetum arvense L. (SANCO/12386/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014. |
| 2 | Chitosan hydrochloride CAS No: 70694-72-3 | Not applicable | European Pharmacopeia Max. content of heavy metals: 40 ppm | 1 July 2014 | Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011. Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014. |
| 3 | Sucrose CAS no: 57-50-1 | α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside | Food grade | 1 January 2015 | Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved. Sucrose shall be used in accordance with the specific conditions included in the conclusions of the review report on sucrose (SANCO/11406/2014) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014. |
| 4 | Calcium Hydroxide CAS No 1305-62-0 | Calcium Hydroxide | 920 g/kg Food grade The following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter): Barium 300 mg/kg Fluoride 50 mg/kg Arsenic 3 mg/kg Lead 2 mg/kg. | 1 July 2015 | Calcium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on Calcium Hydroxide (SANCO/10148/2015) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015. |
| 5 | Vinegar CAS No: 90132-02-8 | Not available | Food grade containing a maximum of 10 % acetic acid. | 1 July 2015 | Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof. |
| 6 | Lecithins CAS No: 8002-43-5 CIPAC No: not allocated Einecs 232-307-2 | Not allocated | As described in the Annex to Regulation (EU) No 231/2012. | 1 July 2015 | Only uses as basic substance being a fungicide are approved. Lecithins shall be used in accordance with the specific conditions included in the conclusions of the review report on lecithins (SANCO/12798/2014) and in particular Appendices I and II thereof. |
| 7 | Salix spp. cortex CAS No: not allocated CIPAC No: not allocated | Not applicable | European Pharmacopeia | 1 July 2015 | Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof. |
| 8 | Fructose CAS No: 57-48-7 | β-D-fructofuranose | Food grade | 1 October 2015 | Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved. Fructose shall be used in accordance with the specific conditions included in the conclusions of the review report on fructose (SANCO/12680/2014) and in particular Appendices I and II thereof. |
| 9 | Sodium hydrogen carbonate CAS no: 144-55-8 | Sodium hydrogen carbonate | Food grade | 8 December 2015 | Sodium hydrogen carbonate shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium hydrogen carbonate (SANTE/10667/2015) and in particular Appendices I and II thereof. |
| 10 | Whey CAS No: 92129-90-3 | Not available | CODEX STAN 289-1995 () | 2 May 2016 | Whey shall be used in accordance with the specific conditions included in the conclusions of the review report on whey (SANTE/12354/2015) and in particular Appendices I and II thereof. |
| 11 | Diammonium phosphate CAS No: 7783-28-0 | Diammonium hydrogen phosphate | Oenological grade | 29 April 2016 | Diammonium phosphate shall be used in accordance with the specific conditions included in the conclusions of the review report on diammonium phosphate (SANTE/12351/2015) and in particular Appendices I and II thereto. |
| 12 | Sunflower oil CAS No: 8001-21-6 | Sunflower oil | Food grade | 2 December 2016 | Sunflower oil shall be used in accordance with the specific conditions included in the conclusions of the review report on sunflower oil (SANTE/10875/2016) and in particular Appendices I and II thereof. |
| 13 | Clayed charcoal CAS No 7440-44-0 231-153-3 (Einecs) (activated charcoal) CAS No 1333-86-4 215-609-9 (Einecs) (carbon black) CAS No 1302-78-9 215-108-5 (Einecs) (bentonite) | Not available. | Charcoal: Purity required by Regulation (EU) No 231/2012 (3) Bentonite: Purity required by Implementing Regulation (EU) No 1060/2013 (4) | 31 March 2017 | Clayed charcoal shall be used in accordance with the specific conditions included in the conclusions of the review report on clayed charcoal (SANTE/11267/2016) and in particular Appendices I and II thereof. |
| 14 | Urtica spp. CAS No 84012-40-8 (Urtica dioica extract) CAS No 90131-83-2 (Urtica urens extract) | Urtica spp. | European Pharmacopeia | 30 March 2017 | Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof. |
| 15 | Hydrogen peroxide CAS No 7722-84-1 | Hydrogen peroxide | Solution in water (< 5 %) The hydrogen peroxide used to manufacture the solution shall have a purity according to the FAO JECFA specifications. | 29 March 2017 | Hydrogen peroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on hydrogen peroxide (SANTE/11900/2016) and in particular Appendices I and II thereof. |
| 16 | Sodium chloride CAS No 7647-14-5 | Sodium chloride | 970 g/kg Food grade | 28 September 2017 | Only uses as basic substance being a fungicide and insecticide are approved. Sodium chloride shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium chloride (SANTE/10383/2017) and in particular Appendices I and II thereof. |
| 17 | Beer CAS No 8029-31-0 | Not applicable | Food grade | 5 December 2017 | Beer shall be used in accordance with the specific conditions included in the conclusions of the review report on beer (SANTE/11038/2017) and in particular Appendices I and II thereto. |
| 18 | Mustard seeds powder | Not applicable | Food grade | 4 December 2017 | Mustard seeds powder shall be used in accordance with the specific conditions included in the conclusions of the review report on mustard seeds powder (SANTE/11309/2017) and in particular Appendices I and II thereof. |
| 19 | Talc E553B CAS No: 14807-96-6 | Magnesium hydrogen metasilicate silicate mineral | Food grade in conformity with Commission Regulation (EU) No 231/2012 (3). < 0,1 % of respirable Crystalline Silica | 28 May 2018 | Talc E553B shall be used in accordance with the specific conditions included in the conclusions of the review report on Talc E553B (SANTE/11639/2017) and in particular Appendices I and II thereof. |
| 20 | Onion oil CAS No: 8002-72-0 | Not applicable | Food grade | 17 October 2018 | Onion oil shall be used in accordance with the specific conditions included in the conclusions of the review report on Onion oil (SANTE/10615/2018) and in particular Appendices I and II thereto. |
| 21 | L-cysteine (E 920) CAS No: 52-89-1 EINECS: 200-157-7 (L-cysteine hydrochloride) CAS No: 7048-04-6 EINECS: 615-117-8 (L-cysteine hydrochloride monohydrate) | L-cysteine hydrochloride (1:1) | Min. 98,0 % L-cysteine hydrochloride (on anhydrous basis) Food grade in conformity with Commission Regulation (EU) No 231/2012. max. 1,5 mg/kg As max. 5 mg/kg Pb | 2.6.2020 | L-cysteine (E 920) shall be used as a mixture with matrix (flour, food grade) at a concentration of maximum 8% (of L-cysteine hydrochloride, on anhydrous basis) in accordance with the specific conditions included in the conclusions of the review report on L-cysteine (SANTE/11056/2019) and in particular Appendices I and II thereto. |
| 22 | Cow Milk CAS No: 8049-98-7 | Not available. | Not applicable | 30.7.2020 | Cow milk shall comply with Regulation (EC) No 1069/2009 and Commission Regulation (EU) No 142/2011. Cow milk shall be used in accordance with the specific conditions included in the conclusions of the review report on cow milk (SANTE/12816/2019), and in particular Appendices I and II thereto. |
| 23 | Allium cepa L. bulb extract CAS No: not allocated CIPAC No: not allocated | Not applicable | The onion bulbs used to prepare the extracts shall be of food grade quality meeting the requirements of WHO monographs on selected medicinal plants (Volume 1, Geneva, 1999) on Bulbus Allii Cepae | 17.2.2021 | Allium cepa L. bulb extract shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium cepa L. bulb extract (SANTE/10842/2020 Rev2) and in particular Appendices I and II thereof. |
| 24 | Chitosan CAS No: 9012-76-4 EC No: 618-480-0 | Chemical name (not IUPAC): poly[4-O-(2-acetamido-2-deoxy-β-D-glucopyranosyl)-2-amino-2-deoxy-β-D-glucopyranose] | ≥ 85 % chitosan heavy metals: max. 20 mg/kg Food grade, meeting the specifications for ‘chitosan extract from fungi’ as set out in Commission Implementing Regulation (EU) 2017/2470 (5) | 11 April 2022 | Chitosan shall be used in accordance with the specific conditions included in the conclusions of the review report on chitosan (SANTE/10594/2021) and in particular Appendices I and II thereto. |
| 25 | magnesium hydroxide E528 CAS No: 1309-42-8 CIPAC No: Not available | magnesium dihydroxide | 95 % Relevant impurities: Lead < 2 mg/kg Arsenic < mg/kg | 2 April 2024 | Magnesium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on magnesium hydroxide (PLAN/2023/2331 RR Rev2) and in particular Appendices I and II thereof. |
| 26 | Onobrychis viciifolia (sainfoin) dried pellets CAS No: Not available CIPAC No: Not available | Not available | 1 000 g/kg Relevant impurities: Arsenic (1 g/kg), Cadmium (0,1 g/kg), Chromium-VI (0,1 g/kg), Mercury (1 g/kg), Nickel (0,1 g/kg), Lead (0,3 g/kg) | 17 July 2024 | Onobrychis viciifolia (sainfoin) dried pellets shall be used in accordance with the specific conditions included in the conclusions of the review report on Onobrychis viciifolia (sainfoin) dried pellets (PLAN/2024/790 RR rev1) and in particular Appendices I and II thereof. |
| 27 | Allium fistulosum, processed CAS No: Not available CIPAC No: Not available | Not available | Food grade compliant with the provisions of Regulation (EC) No 178/2002 of the European Parliament and of the Council (6), Regulation (EC) No 396/2005 of the European Parliament and of the Council (7), Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 (8) | 1 December 2024 | Allium fistulosum, processed, shall be used in accordance with the specific conditions included in the conclusions of the review report on Allium fistulosum, processed, (PLAN/2024/798) and in particular Appendices I and II thereof. |
| 28 | Vitis vinifera L. seed extract (grape seed extract) CAS No: Not available CIPAC No: Not available | Not available | Minimum content of 75 % of Oligomeric proanthocyanidins on the anhydrous basis | 11 February 2025 | Vitis vinifera L. seed extract (grape seed extract) shall be used in accordance with the specific conditions included in the conclusions of the review report on Vitis vinifera L. seed extract (grape seed extract) (PLAN/2024/800 RR rev3) and in particular Appendices I and II thereof. |
| (1) Further details on identity, specification and manner of use of basic substance are provided in the review report. (2) Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/ (3) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1). (4) Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species (OJ L 289, 31.10.2013, p. 33). (5) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72). (6) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj). (7) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/2024-05-11). (8) Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103, ELI: http://data.europa.eu/eli/reg/2023/915/oj). |
PART D
Low-risk active substances'
General provisions applying to all substances listed in this Part: the Commission shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make them available to them on specific request.
| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions | |
|---|---|---|---|---|---|---|
| 1 | Isaria fumosorosea strain Apopka 97 Deposited in the American Type Culture Collection (ATCC) under the name Paecilomyces fumosoroseus Apopka ATCC 20874 | Not applicable | Minimum concentration: 1,0 × 108 CFU/ml Maximum concentration: 2,5 × 109 CFU/ml | 1 January 2016 | 31 December 2030 | 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 Isaria fumosorosea strain Apopka 97, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014, shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Isaria fumosorosea strain Apopka 97 is to be considered as a potential sensitiser. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 2 | COS-OGA CAS No: not allocated CIPAC No: 979 | Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues). | ≥ 915 g/kg — OGA/COS ratio comprised between 1 and 1,6 — Degree of polymerisation of COS comprised between 5 and 10 — Degree of polymerisation of OGA comprised between 9 and 20 — Degree of methylation of OGA < 10 % — Degree of acetylation of COS < 50 % | 22 April 2015 | 22 April 2030 | 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 COS-OGA, and in particular Appendices I and II thereof, shall be taken into account. |
| 3 | Cerevisane (no ISO name adopted) CAS No: not allocated CIPAC No: 980 | Not relevant | ≥ 924 g/kg | 23 April 2015 | 23 April 2030 | 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 cerevisane, and in particular Appendices I and II thereof, shall be taken into account. |
| 4 | Pepino mosaic virus strain CH2 isolate 1906 GenBank, accession number JN835466 CIPAC No: not allocated | Not applicable | minimum concentration 5 × 105 viral genome copies per μL | 7 August 2015 | 7 August 2030 | Only the use in greenhouses 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 review report on Pepino mosaic virus strain CH2 isolate 1906, 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, taking into account that Pepino mosaic virus strain CH2 isolate 1906 is to be considered as a potential sensitiser. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 5 | Ferric phosphate CAS No: 10045-86-0 CIPAC No: 629 | Ferric phosphate | Ferric phosphate 703 g/kg equivalent to 260 g/kg iron and 144 g/kg phosphorus | 1 January 2016 | 31 December 2030 | 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 ferric phosphate, and in particular Appendices I and II thereof, shall be taken into account. |
| 6 | Saccharomyces cerevisae strain LAS02 Accession number in the collection of the ‘Collection Nationale de Cultures de Microorganismes’ (CNCM) of the Pasteur Institute: CNCM I-3936 | Not applicable | Minimum concentration: 1 × 1013 CFU/kg | 6 July 2016 | 6 July 2031 | 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 Saccharomyces cerevisiae strain LAS02, 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, taking into account that Saccharomyces cerevisiae strain LAS02 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 7 | Trichoderma atroviride strain SC1 Accession number CBS 122089 in the collection of the Centraalbureau voor Schimmelcultures (CBS) in Utrecht, The Netherland CIPAC No: 988 | Not applicable | minimum concentration 1 × 1010 CFU/g | 6 July 2016 | 6 July 2031 | 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 Trichoderma atroviride strain SC1, 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, taking into account that microorganisms are considered as potential sensitizers. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 8 | Mild Pepino Mosaic Virus isolate VC1 Reference number DSM 26973 in the German Collection of Micro-organisms and Cell Cultures (DSMZ) | Not applicable | Nicotine < 0,1 mg/L | 29 March 2017 | 29 March 2032 | Only the use in greenhouses 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 review report on Mild Pepino Mosaic Virus isolate VC1, 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, taking into account that Mild Pepino Mosaic Virus isolate VC1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 9 | Mild Pepino Mosaic Virus isolate VX1 Reference number DSM 26974 in the German Collection of Micro-organisms and Cell Cultures (DSMZ) | Not applicable | Nicotine < 0,1 mg/L | 29 March 2017 | 29 March 2032 | Only the use in greenhouses 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 review report on Mild Pepino Mosaic Virus isolate VX1, 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, taking into account that Mild Pepino Mosaic Virus isolate VX1 is to be considered, as any microorganism, a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 10 | Bacillus amyloliquefaciens strain FZB24. Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: 10271 Accession number at the Agricultural Research Service Culture Collection (NRRL), USA: B-50304 | Not applicable | Minimum concentration: 2 × 1014 CFU/kg | 1 June 2017 | 1 June 2032 | 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 strain FZB24, and in particular Appendices I and II thereof, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites; — the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. Conditions of use shall include risk mitigation measures, where appropriate. |
| 11 | Coniothyrium minitans strain CON/M/91-08 Accession number in the culture collection of the ‘Deutsche Sammlung von Mikroorganismen’ (DSM), Germany: DSM 9660 CIPAC No 614 | Not applicable | Minimum content of viable spores: 1,17 × 1012 CFU/kg | 1 August 2017 | 31 July 2032 | 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 Coniothyrium minitans strain CON/M/91-08, 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, taking into account that microorganisms are considered as potential sensitizers. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. Conditions of use shall include risk mitigation measures, where appropriate. |
| 12 | Laminarin CAS No 9008-22-4 CIPAC No 671 | (1→3)-β-D-glucan (according to IUPAC-IUB Joint Commission on Biochemical Nomenclature) | ≥ 860 g/kg on dry matter (TC) | 1 March 2018 | 28 February 2033 | 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 laminarin, and in particular Appendices I and II thereto, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 13 | Pasteuria nishizawae Pn1 Culture collection: ATCC Safe Deposit (SD-5833) CIPAC No Not allocated | Not applicable | minimum concentration 1 × 1011 spores/g | 14 October 2018 | 14 October 2033 | 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 Pasteuria nishizawae Pn1, 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, taking into account that Pasteuria nishizawae Pn 1 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate. Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer. |
| 14 | Ampelomyces quisqualis strain AQ10 | Not applicable | Minimum content of viable spores: 3,0 × 1012 CFU/kg | 1 August 2018 | 1 August 2033 | 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 Ampelomyces quisqualis strain AQ10, 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, taking into account that microorganisms are per se considered as potential sensitizers and 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. Conditions of use shall include risk mitigation measures, where appropriate. |
| 15 | Clonostachys rosea strain J1446 Accession number in the culture collection of the German Collection of Microorganisms and Cell Cultures (DSMZ): DSM 9212 | Not applicable | Not applicable Gliotoxin content: max. 50 μg/kg in the technical grade of the MCPA. | 1 April 2019 | 31 March 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 Clonostachys rosea strain J1446, 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 technical material as commercially manufactured in plant protection products, including full characterisation of potential metabolites of concern; — the protection of operators and workers, taking into account that microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use; — the studies or information from the scientific literature recently made available in relation to antifungal susceptibility of Clonostachys rosea J1446. 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 microbial contamination as referred to in the Working Document SANCO/12116/2012 (2). Conditions of use shall include risk mitigation measures, where appropriate. |
| 16 | ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) | Not Applicable | 1 000 g/kg (active substance) | 20 May 2019 | 20 May 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 ABE-IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) and in particular Appendices I and II thereof, shall be taken into account. |
| 17 | Bacillus subtilis strain IAB/BS03 Accession number in the Spanish Type Culture Collection (CECT), Spain: CECT 7254 Accession number in the German Type Culture Collection (DSMZ), Germany: DSM 24682 | Not applicable | Minimum concentration: 1 × 1013 CFU/kg Maximum concentration: 5 × 1013 CFU/kg | 20 October 2019 | 20 October 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 Bacillus subtilis strain IAB/BS03, and in particular Appendices I and II thereof, 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 used in plant protection products, including full characterisation of relevant secondary metabolites; b) the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, and 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 OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Working Document SANCO/12116/2012 (2). Conditions of use shall include risk mitigation measures, where appropriate. |
| 18 | Verticillium albo-atrum strain WCS850 (culture collection No CBS 276.92) | Not applicable | Minimum concentration: 0,7 × 107 CFU/ml distilled water Maximum concentration: 1,5 × 107 CFU/ml distilled water No relevant impurity | 1 November 2019 | 31 October 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 Verticillium albo-atrum strain WCS850, 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, taking into account that Verticillium albo-atrum strain WCS850 is to be considered as a potential sensitiser. 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 OECD Issue Paper on Microbial Contaminant Limits for Microbial Pest Control Products, contained in the Commission Working Document SANCO/12116/2012 (2). |
| 19 | Lavandulyl senecioate CAS No: 23960-07-8 CIPAC No: n.a. | (RS)-5-methyl-2-(prop-1-en-2-yl)hex-4-en-1-yl 3-methylbut-2-enoate | ≥ 894 g/kg | 3 June 2020 | 3 June 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 review report on Lavandulyl senecioate, and in particular Appendices I and II thereto, shall be taken into account. Member State shall assess any extension of the use pattern beyond passive dispensers, 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 Commission Regulation (EU) No 546/2011 (3). |
| 20 | Ferric pyrophosphate CAS No: 10058-44-3 CIPAC No: — | iron(3+) diphosphate | ≥ 802 g/kg The following impurities are of toxicological and enviromental concern and must not exceed the following levels in the technical material: — Lead: 3 mg/kg — Mercury: 0,1 mg/kg — Cadmium: 1 mg/kg | 3.8.2020 | 3.8.2035 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ferric pyrophosphate, and in particular Appendices I and II thereto, shall be taken into account. |
| 21 | Phlebiopsis gigantea strain VRA 1835 | Not applicable | No relevant impurities | 1 September 2020 | 31 August 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 Phlebiopsis gigantea strain VRA 1835, 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. 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. |
| 22 | Phlebiopsis gigantea strain VRA 1984 | Not applicable | No relevant impurities | 1 September 2020 | 31 August 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 Phlebiopsis gigantea strain VRA 1984, 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. 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. |
| 23 | Phlebiopsis gigantea strain FOC PG 410.3 | Not applicable | No relevant impurities | 1 September 2020 | 31 August 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 Phlebiopsis gigantea strain FOC PG 410.3, 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. 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. |
| 24 | Sodium hydrogen carbonate CAS No: 144-55-8 | Sodium hydrogen carbonate | ≥ 990 g/kg Arsenic ≤ 3 mg/kg Lead ≤ 2 mg/kg Mercury ≤ 1 mg/kg | 1 October 2020 | 1 October 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 review report on sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account. |
| 25 | Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) (4) | Not applicable | No relevant impurities | 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 Akanthomyces muscarius strain Ve6 (formerly Lecanicillium muscarium strain Ve6) 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 per se 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 (2). |
| 26 | Blood meal 90989-74-5 909 | Not applicable | 100 % blood meal haemoglobin content: min 80 %. | 1 April 2021 | 31 March 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 blood meal, and in particular Appendices I and II thereto, shall be taken into account. Member States shall pay particular attention: — to the protection of fish and aquatic invertebrates when less targeted spraying techniques are used, and — on the need of blood meal-containing plant protection products to be swirled before use to wet the product. |
| 27 | 24-epibrassinolide CAS No: 78821-43-9 CIPAC No: Not applicable | (3aS,5R,6S,7aR,7bS,9aS,10R,12aS,12bS)-10((2S,3R,4R,5R)-3,4-dihydroxy-5,6-dimethylheptan-2-yl)5,6-dihydroxy-7a,9a-dimethylhexadecahydro-3Hbenzo[c]indeno[5,4-e]oxepin-3-one | ≥ 900 g/kg | 31 March 2021 | 31 March 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 review report on 4 December 2020, and in particular Appendices I and II thereto, shall be taken into account. |
| 28 | Aqueous extract from the germinated seeds of sweet Lupinus albus CAS No: Not available for the extract BLAD protein: 1219521-95-5 CIPAC No: Not allocated | Not applicable | The minimum purity is not relevant for the extract. BLAD protein content: 195–210 g/kg. The following relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured were identified: Total quinolizidine alkaloids (QA): (lupanine, 13α-OH-lupanine, 13α-angeloyloxylupanine, lupinine, albine, angustofoline, 13α-tigloyloxylupanine, α-isolupanine, tetrahydrorhombifoline, multiflorine, sparteine) Maximum content: set at 0,05 g/kg. Level of lupanine, as a marker compound: set at 0,035 g/kg. | 27 April 2021 | 27 April 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 review report on aqueous extract from the germinated seeds of sweet Lupinus albus, 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 necessary labelling instructions concerning the measures to address foaming and stability of dilutions of the formulation. |
| 29 | Pepino Mosaic Virus, EU strain, mild isolate Abp1 | Not applicable | The impurity nicotine shall not exceed the following values in the technical material: max. 0,005 mg/L in Abp1 TK max. 3,87 x 10-5 mg/kg in MPCP (Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method). | 28 June 2021 | 28 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 review report on Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2, 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 (2). 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 |
| 30 | Pepino Mosaic Virus, CH2 strain, mild isolate Abp2 | Not applicable | The impurity nicotine shall not exceed the following values in the technical material: max. 0,007 mg/L in Abp2 TK max. 3,87 x 10-5 mg/kg in MPCP (Nicotine has been reported to be present in tomato plants, therefore, as the microbial pest control agent (MPCA) is produced in tomato plants, nicotine is present as a consequence of the production method). | 28 June 2021 | 28 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 review report on Pepino Mosaic Virus, EU strain, mild isolate Abp1 and Pepino Mosaic Virus, CH2 strain, mild isolate Abp2, 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 (2). 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 |
| 31 | Calcium carbonate CAS No 471-34-1 CIPAC No 843 Limestone CAS No 1317-65-3 CIPAC No 852 | IUPAC name: Calcium carbonate | 950 g/kg | 1 November 2021 | 31 October 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 calcium carbonate and the review report on limestone, and in particular Appendices I and II thereto, shall be taken into account. |
| 32 | Potassium hydrogen carbonate CAS No 298-14-6 CIPAC No 853 | IUPAC name: Potassium hydrogen carbonate | 990 g/kg | 1 November 2021 | 31 October 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 of potassium hydrogen carbonate, and in particular Appendices I and II thereto, shall be taken into account. |
| 33 | Bacillus amyloliquefaciens AH2 | n.a. | The nominal content of Bacillus amyloliquefaciens AH2 in the technical product and formulation is 1,0 × 1011 CFU/L (range 7x1010 – 7x1011). No relevant impurities | 27 September 2021 | 27 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 Bacillus amyloliquefaciens AH2 and in particular Appendices I and II thereof, shall be taken into account. |
| 34 | Purpureocillium lilacinum strain PL11 | Not applicable | No relevant impurities | 25 January 2022 | 24 January 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 PL11 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 (2); 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. |
| 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 1013 CFU/kg, maximum: 6 x 1014 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. |
| 36 | Metarhizium brunneum strain Ma 43 | Not applicable | No relevant impurities | 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 Metarhizium brunneum strain Ma 43, 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, taking into account that microorganisms are as such considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use. |
| 37 | Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 | Not applicable | The content of the virus in the technical grade active ingredient, produced as an isolated technical material, must be at least 2,0 × 1011 occlusion bodies/g. | 18.4.2022 | 18.4.2037 | 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 Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004, 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 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 (5), — 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. |
| 38 | Straight Chain Lepidopteran Pheromones (acetates) | 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. |
| 39 | Sheep fat CAS No: 98999-15-6 CIPAC No: 919 | Sheep fat | Minimum purity of sheep fat: 100 % No relevant impurity | 1 November 2022 | 30 October 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 sheep fat, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 40 | Heptamaloxyloglucan CAS No: 870721-81-6 CIPAC No: 851 | α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl- (1→2)-α-D-xylopyranosyl-(1→6)-[α-D-xylopyranosyl-(1→6)-β-D-glucopyranosyl-(1→4)]- β-D-glucopyranosyl-(1→4)-D-glucitol | ≥ 780 g/kg The following impurity is of toxicological and enviromental concern and must not exceed the following levels in the technical material: - Patulin, max. 50 μg/kg | 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 review report on heptamaloxyloglucan, and in particular Appendices I and II thereto, shall be taken into account. |
| 41 | Fish oil CAS No: 8016-13-5 CIPAC No: 918 | Not applicable | Minimum purity of the active substance as manufactured: Fish oil 100 % Identity of relevant impurities (of toxicological, ecotoxicological and/or environmental concern) in the active substance as manufactured: Maximum levels according to Commission Directive 2002/32/EC (6) for the following impurities, proportionate to a fish oil with a moisture content of 12 %: 5 ng/kg of sum of polychlorinated dibenzo-paradioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) (7) 20 ng/kg of sum of polychlorinated dibenzo-paradioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and dioxin like polychlorinated biphenyls (PCBs) (7) 0,5 mg/kg of mercury 2 mg/kg of cadmium 10 mg/kg of lead 175 μg/kg of non-dioxin-like PCBs | 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 fish oil, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 42 | Trichoderma atroviride AGR2 | n.a. | The nominal content of Trichoderma atroviride AGR2 in the technical product and formulation is Minimal: 5 x 1011 CFU/kg Nominal: 1 x 1012 CFU/kg Maximal: 1 x 1013 CFU/kg No relevant impurities | 22 February 2023 | 21 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 review report on Trichoderma atroviride AGR2 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 used in plant protection products, including full characterisation of relevant secondary metabolites; — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be recommended to reduce dermal and inhalation exposure. |
| 43 | Trichoderma atroviride AT10 | n.a. | The nominal content of Trichoderma atroviride AT10 in the technical product and formulation is Minimal: 1 x 1011 CFU/kg Nominal: 5 x 1011CFU/kg Maximal: 1 x 1012 CFU/kg No relevant impurities | 20 February 2023 | 20 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 review report on Trichoderma atroviride AT10 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 used in plant protection products, including full characterisation of relevant secondary metabolites; — the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be considered to reduce dermal and inhalation exposure. |
| 44 | Quartz sand (there is no ISO common name) (1) 7631-86-9 (CAS) (2) 14808-60-7 (CAS) 855 (CIPAC) [So far they have been indicated as: CAS No: 14808-60-7 CIPAC No: not allocated] | (1) Silicon dioxide (2) Quartz | 915 g/kg The impurity crystalline silica with a particle diameter ≤ 10 μm is of toxicological concern and shall not exceed a level of 0,1 % of particles in the technical material. | 1 September 2023 | 31 August 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 quartz sand, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 45 | Fat distillation residues CAS No not available 915 (CIPAC No) | Not available | ≥ 400 g/kg of cleaved fatty acids (free/ester bonded) palmitic acid min 19 % of cleaved fatty acids stearic acid min 18 % of cleaved fatty acids oleic acid min 37 % of cleaved fatty acids acid value min 70 mg KOH/g The following impurity is of toxicological concern and shall not exceed the following levels in the technical material: nickel max 0,1 g/kg | 1 November 2023 | 31 October 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 fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 46 | Cydia pomonella granulovirus (CpGV) | Not applicable | Bacillus cereus: < 1 × 107 CFU/g in the formulated products. | 1 November 2023 | 31 October 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 review report on Cydia pomonella granulovirus (CpGV), 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 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 (5), — 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. |
| 47 | Hydrolysed proteins CAS No: Not applicable CIPAC No: 901 | Not available | Hydrolysed proteins. Animal tissues hydrolysate excluding ruminants hides and skins (no ISO common name): — 708 g/kg on a dry weight basis [range in TK (technical concentrate) 400-434 g/kg]. Hydrolysed proteins. Urea enriched beet molasses, hydrolysed (no ISO common name): — 110 g/kg on a dry weight basis [range in TK (technical concentrate) 90-110 g/kg]. Hydrolysed Proteins. Collagen protein Hydrolysate (no ISO common name): — 582 g/kg on a dry weight basis [range in TK (technical concentrate) 249-262 g/kg]. Lead, cadmium, arsenic, mercury and biuret in accordance with Regulation (EU) 2019/1009 on fertilising products. Formaldehyde below 1 g/kg. | 1 May 2024 | 30 April 2039 | 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 hydrolysed proteins, 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 for ‘hydrolysed proteins-urea enriched beet molasses, hydrolysed’ as commercially manufactured on the basis of an analysis of at least five representative batches. Conditions of use shall include risk mitigation measures, where appropriate. |
| 48 | Urea CAS No: 57-13-6 CIPAC No: 913 | Urea | 980 g/kg The following impurities were considered of toxicological concern and a maximum level is established of: Biuret: < 12 g/kg Formaldehyde: < 0,5 g/kg Cadmium: < 1 mg/kg Mercury: < 0,1 mg/kg Lead: < 1 mg/kg Arsenic: < 1 mg/kg | 1 May 2024 | 30 April 2039 | 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 urea, 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 on the basis of an analysis of at least five representative batches. Conditions of use shall include risk mitigation measures, where appropriate. |
| 49 | Betabaculovirus phoperculellae | Not applicable | No relevant impurities | 12 February 2025 | 12 February 2040 | 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 Betabaculovirus phoperculellae, 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, taking into account that all microorganisms are considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use; — the guarantee by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence of the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (8). Conditions of use shall include risk mitigation measures, where appropriate. |
| 50 | Bacillus subtilis RTI477 | Not applicable | No relevant impurities | 12 February 2025 | 12 February 2040 | 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 subtilis RTI477, 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, taking into account that microorganisms per se are considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use, — the strict maintenance by the producer of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (9) Conditions of use shall include risk mitigation measures, where appropriate. |
| 51 | Bacillus velezensis RTI301 | Not applicable | No relevant impurities | 12 February 2025 | 12 February 2040 | 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 velezensis RTI301, 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, 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; — the strict maintenance by the producer of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (9). Conditions of use shall include risk mitigation measures, where appropriate. |
| 52 | Elemental iron CAS No: 7439-89-6 CIPAC No: - | Iron | ≥ 989 g/kg of total iron The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: Arsenic: Max 0,003 g/kg Mercury: Max 0,001 g/kg Lead: Max 0,01 g/kg | 26.5.2025 | 26.5.2040 | 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 elemental iron, and in particular Appendices I and II thereto, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 53 | Lysate of Willaertia magna | Not applicable | No relevant impurities | 7 July 2025 | 7 July 2040 | 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 lysate of Willaertia magna, 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 guarantee by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the adherence of the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65 (8), — the suspensibility of plant protection products containing lysate of Willaertia magna, which may require continuous stirring during their loading and use. — Conditions of use shall include risk mitigation measures, where appropriate. |
| 54 | Rape seed oil CAS No: 8002-13-9 (Rape seed oil) 93165-31-2 (Rape seed oil – low erucic acid) CIPAC No: Not available | Rape seed oil | The purity complies with the European Pharmacopeia 7.0 and Deutscher Arzneimittel-Codex 1986, 6. Erg. 1994 and ph. Eur. 5, 2005. The active substance is a mixture of triglycerides of fatty acids and the mode of action is mechanical rather than chemical: 100 % of the technical active substance is considered as an active substance. The specifications are based on the composition as fatty acids and some physical and chemical parameters. The impurity erucic acid shall not exceed 2 %. | 1 November 2025 | 31 October 2040 | 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 rape seed oil, 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 organisms, honey bees, and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. |
| 55 | Gibberellic acid CAS No: 77-06-5 CIPAC No: 307 | (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid or (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-ethano-3,8b-prop-1-enoperhydroindeno[1,2-b]furan-4-carboxylic acid | ≥ 850 g/kg The impurities Fumonisins B1 and B2; The sum of fumonisin B1 + fumonisin B2 shall not exceed 200 μg/kg in the technical material. | 1 January 2026 | 31 December 2040 | 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 gibberellic acid, 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 non-target terrestrial plants in the off-crop area. Conditions of use shall include risk mitigation measures, where appropriate. |
| 56 | Gibberellins CAS No: GA4: 468-44-0 GA7: 510-75-8 GA4/GA7 mixture: 8030-53-3 CIPAC No: 904 | GA4: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid GA7: (3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid | ≥ 890 g/kg The impurities Fumonisins B1 and B2; The sum of fumonisin B1 + fumonisin B2 shall not exceed 200 μg/kg in the technical material. | 1 January 2026 | 31 December 2040 | 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 gibberellins, and in particular Appendices I and II thereto, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. |
| 57 | Maltodextrin CAS No: 9050-36-6 CIPAC No: 801 | None allocated | ≥ 853 g/kg maltodextrin with chain lengths 3 – 20 monomer units; with dextrose equivalence (DE) 18-20. | 3 March 2026 | 3 March 2041 | 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 of maltodextrin dated 11 December 2025 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 honeybees. Conditions of use shall include risk mitigation measures, where appropriate. |
| (1) Further details on identity and specification of active substance are provided in the review report. (2) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (3) Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127). (4) The concerned active substance was initially approved as Verticillium lecanii, but later, for scientific reasons, its name was changed to Lecanicillium muscarium strain Ve6, which was later changed again to the name under which the approval was renewed, Akanthomyces muscarius strain Ve6. (5) https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (6) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10). (7) Expressed in World Health Organisation (WHO) toxic equivalents. (8) Organisation for Economic Cooperation and Development (2014), OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products, Series on Pesticides and Biocides, No 65, OECD Publishing, Paris, https://doi.org/10.1787/9789264221642-en. (9) Organisation for Economic Cooperation and Development (OECD): https://doi.org/10.1787/9789264221642-en. |
PART E
Candidates for substitution
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