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
Further details on identity and specification of active substance are provided in the review report.
2-hydroxy-4,6-dimethoxypyrimidine.
2,4-dihydroxy-6-methoxypyrimidine.
sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.
5-(trifluoromethyl)-2(1H)-pyridinone.
4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.
M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.
5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol.
3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid.
2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene.
4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid.
3-phenoxybenzaldehyde.
Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs), expressed as World Health Organisation (WHO) toxic equivalent (TEQ) using the WHO-toxic equivalency factors (WHO-TEFs)).
7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid.
3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid.
3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid.
p-methyl-phenethylamine.
OJ L 353, 31.12.2008, p. 1.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33).
https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf
Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311; ECHA-18-G-01-EN.
Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN
Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (OJ L 227, 1.9.2022, p. 8).
Guidance on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180653_microorganism-metabolites-concern_202011.pdf.
Guidance on the approval and low-risk criteria linked to ‘antimicrobial resistance’ applicable to microorganisms used for plant protection (SANTE/2020/12260): https://food.ec.europa.eu/system/files/2020-11/pesticides_ppp_app-proc_guide_180652_microorganism-amr_202011.pdf.
pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).
Commission Implementing Regulation (EU) 2023/574 of 13 March 2023 setting out detailed rules for the identification of unacceptable coformulants in plant protection products in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ L 75, 14.3.2023, p. 7).
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1, ELI: http://data.europa.eu/eli/dir/2000/60/oj).
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71, ELI: http://data.europa.eu/eli/dir/2009/128/oj).
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.
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 [^E0054] | 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 [^E0055] | 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 [^E0056] Bentonite: Purity required by Implementing Regulation (EU) No 1060/2013 [^E0057] | 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 [^E0056]. < 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 [^E0058] | 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 [^E0059], Regulation (EC) No 396/2005 of the European Parliament and of the Council [^E0060], Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 [^E0061] | 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. |
Further details on identity, specification and manner of use of basic substance are provided in the review report.
Available online: http://www.fao.org/fao-who-codexalimentarius/standards/list-of-standards/en/
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).
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).
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).
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).
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).
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.
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