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Commission 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

Type Implementing Regulation

Publication 2011-06-11

Last updated 2026-07-21

State In force

Department European Commission

Source EUR-Lex

articles 2

Reform history JSON API

Number	Common Name, Identification Numbers	IUPAC Name	Purity ²¹	Date of approval	Expiration of approval	Specific provisions
166	Bacillus thuringiensis subsp. kurstaki SA-12	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 SA-12 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 1 day shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki SA-12 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-12 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-12 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.

167	Aluminium ammonium sulfate (dodecahydrate) CAS No: 7784-26-1 CIPAC No: 840	Aluminium ammonium sulfate	— 975 g/kg — Anhydrous - Not less than 510 g/kg — No relevant impurities	1.2.2024	31.1.2039	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Aluminium ammonium sulfate, 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 where relevant, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of aquatic organisms when the substance is applied in regions with acidic or basic soil conditions; — the protection of bees from spray applications during the flowering period of adjacent fields or when flowering weeds are present in the treated field; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions (i.e. situations when soil pH is lower than 5,5, e.g. grassland in upland areas, areas of coniferous forestry and areas of ericaceous ornamental plant growing); — the authorisation, for use on row and combinable crops, as a barrier treatment only on field edges. Conditions of use shall include risk mitigation measures where relevant.

168	Ethephon CAS No: 16672-87-0 CIPAC No: 373	2-chloroethylphosphonic acid	≥ 692 g/kg (TK) ≥ 910 g/kg (TC, theoretical) The following impurities are of toxicological concern and shall not exceed the following levels in the technical material: TK: 1,2-dichloroethane < 0,3 g/kg 2-chloroethanol < 0,3 g/kg TC (theoretical): 1,2-dichloroethane < 0,5 g/kg 2-chloroethanol < 0,3 g/kg	1 February 2024	31 January 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 review report on ethephon, 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 bystanders and residents, ensuring that conditions of use include the use of drift reduction equipment during application. Conditions of use shall include risk mitigation measures, where appropriate.

169	Trinexapac-ethyl CAS No 95266-40-3 CIPAC No 732.202	ethyl (1RS,4EZ)-4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate	≥ 950 g/kg The following impurities shall not exceed the following levels in the technical material: — toluene: 3 g/kg — ethyl (1RS)-3-hydroxy-5-oxocyclohex-3-ene-1-carboxylate (CGA158377): 6 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 trinexapac-ethyl, and in particular Appendices I and II thereof, shall be taken into account. In their overall assessment Member States shall pay particular attention to: — the specification of technical material used in plant protection products, in particular when carrying out assessments of equivalence in accordance with Article 38 of Regulation (EC) No 1107/2009; — the assessment of consumer intake from the diet taking into account the residues of the metabolites of trinexapac-ethyl and the impact of processing; — the levels of residues of the metabolites of trinexapac-ethyl, when straw is used as animal feeding stuff. Conditions of use shall include restrictions for feeding of straw to animals and risk mitigation measures, where appropriate. The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues of trinexapac-ethyl and its metabolites present in surface water, when surface water is abstracted for drinking water, by 1 April 2026.

170	Captan CAS No 133-06-2 CIPAC No 40	N-[(trichloromethyl)thio]cyclohex-4-ene-1,2 -dicarboximide	≥ 930 g/kg perchloromethylmercaptan: ≤ 5 g/kg folpet: ≤ 10 g/kg carbon tetrachloride: ≤ 0,1 g/kg	1 November 2024	31 October 2039	For outdoor uses the following conditions shall apply: — only uses outside flowering of the crop and when no flowering weeds are present in the rows of the treated crops may be authorised, — Member States shall require that applications in orchards (e.g. apples, cherries) are only done with application equipment that increases the precision and accuracy of the application (e.g. emission shields, shielded sprayers, hooded sprayers, tunnel sprayers, sensor-controlled sprayers), and, while maintaining the application rate on the target surfaces, achieves an average reduction of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional application equipment and practice. 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 captan, and in particular Appendices I and II thereto, shall be taken into account. In addition, risk mitigations such as no-spray buffer zones from field margins, shall be required, when appropriate, by the Member States on the basis of their risk assessment to protect bees and aquatic organisms. In this overall assessment Member States shall pay particular attention to: — the compliance with the technical specification of the active substance contained in the plant protection product for which applications for authorisation are submitted, — the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment taking into account the high skin sensitising potential of the active substance, — the protection of bystanders and residents ensuring that conditions of use include adequate risk mitigation measures taking into account the high skin sensitising potential of the active substance. In addition, Member States may set monitoring requirements when granting authorisations, in order to supplement the monitoring under Directives 2000/60/EC ⁵¹ and 2009/128/EC ⁵² of the European Parliament and of the Council. Within two years from 24 September 2024, 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 of captan’s metabolites THPI and THPAM present in ground water, when it is abstracted for drinking water; (2) the relevance of metabolites THPI and THPAM that may occur in groundwater, taking into account the proposal of classification of captan as toxic to reproduction Category 2 and as STOT-RE Category 1 in the Opinion of the Risk Assessment Committee of the European Chemicals Agency of 14 September 2023; (3) the storage stability of captan in high acid content matrices, in compliance with the relevant OECD Test Guideline; and Furthermore, within 18 months from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority: (4) information and exposure data demonstrating that the pesticide application equipment used on orchards increases the precision and accuracy of the application and achieves a reduction of exposure of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional equipment and practices.

171	Metrafenone CAS No: 220899-03-6 CIPAC No: 752	3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone	≥ 980 g/kg The impurity dimethyl sulphate shall not exceed 0,01 g/kg in the technical material.	1 November 2024	31 October 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 metrafenone, 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; — the consumer exposure assessment with regards to residues that may be present in food. Conditions of use shall include risk mitigation measures, where appropriate. 1) An updated assessment for point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to confirm the absence of endocrine activity concerning the T-modality of non-target organisms other than mammals, including where relevant, further information. 2) An updated assessment of the genotoxicity of the metabolites CL 1500834 and CL 3000402. The applicant shall submit the information related to point 1 by 29 March 2026 and the information related to point 2 by 29 December 2024.

172	Folpet CAS No: 133-07-3 CIPAC No: 75	N-[(trichloromethyl)thio]phthalimide	≥ 940 g/kg The following impurities shall not exceed the following levels in the technical material: — (trichloro(chlorosulfanyl) methane) (PCMM): 2 g/kg — carbon tetrachloride: 2 g/kg — captan: 3 g/kg — carbon disulphide: 2,5 g/kg	1 November 2024	31 October 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 folpet, 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, ensuring a minimum of 95 % spray drift reduction next to water bodies such as that provided by a 20 m no spray buffer zone unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift; — the protection of operators (use of PPE for operators during mixing, loading and application) and workers (use of workwear and protective gloves for re-entry activities); and — the protection of bystanders and residents, ensuring that conditions of use include the adequate risk mitigation measures, such as drift reduction equipment, with the aim of minimising exposure. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information to determine the levels of phthalic acid deriving from the use of folpet taking into account the background levels of phthalic acid in wheat and barley during residue field trials for the uses listed in Appendix II of the renewal report only. The applicant shall submit to the Commission, the Member States and the Authority this information by 25 March 2025.

173	Mepiquat chloride CAS No: 24307-26-4 CIPAC No: 440.302	1,1-dimethylpiperidinium chloride	≥ 990 g/kg (theoretical dry technical material, TC) 615-665 g/L (technical concentrate, TK) The impurity N-methylpiperidine shall not exceed 3 g/kg (on theoretical dry weight basis) or 2 g/L (in the technical concentrate, TK).	1 March 2025	29 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 renewal report on mepiquat chloride, 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 include the application of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate.

174	Pythium oligandrum B301	Not applicable	No relevant impurities	11 February 2025	10 February 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 Pythium oligandrum B301, 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 sensitisers, 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 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 ⁵³. Conditions of use shall include risk mitigation measures, where appropriate.

175	Lenacil CAS No: 2164-08-01 CIPAC No: 163	3-cyclohexyl-6,7-dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione or 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione	975 g/kg	1 July 2025	30 June 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 lenacil, and in particular Appendices I and II thereto, shall be taken into account. Conditions of use shall include risk mitigation measures, where appropriate. In this overall assessment Member States shall pay particular attention to the possible need for additional rotational crop field trials and a livestock exposure assessment until the required confirmatory information has been assessed by the rapporteur Member State and evaluated by the Authority. By 25 March 2027, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information on rotational crops field trials, including analysis for known and possible new metabolites. If new metabolites are found, the applicant is requested to perform toxicological studies assessing these metabolites. The applicant is requested to perform an appropriate livestock exposure assessment if necessary.

176	Milbemectin Milbemectin is a mixture of M.A3 and M.A4 CAS No: M.A3: 51596-10-2 M.A4: 51596-11-3 CIPAC No: 660	M.A3: (10E,14E,16E)- (1R,4S,5′S,6R,6′R,8R,13R, 20R,21R,24S)- 21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-(3,7,19-trioxatetracyclo[15.6.1.1^4,8.0^20,24] pentacosa-10,14,16, 22-tetraene)-6-spiro-2′- (tetrahydropyran)-2-one; M.A4: (10E,14E,16E)- (1R,4S,5′S,6R,6′R,8R,13R, 20R,21R,24S)-6′-ethyl-21,24- dihydroxy-5′,11,13,22-tetramethyl-(3,7,19-trioxatetracyclo[15.6.1.1^4,8.0^20,24] pentacosa-10,14,16,22-tetraene)-6- spiro-2′-(tetrahydropyran)-2-one	≥ 950 g/kg	16 November 2025	15 November 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 milbemectin, 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 conditions of use include the application of adequate personal protective equipment; — the protection of bees and pollinators that may be exposed to the active substance by visiting the flowers present in the crop at the time of application; — the protection of aquatic organisms. — Conditions of use shall include risk mitigation measures, in particular to reduce drift to terrestrial and aquatic areas outside the treated field, where appropriate. The applicant shall submit confirmatory information as follows: 1. to confirm that the bone marrow was exposed in the available in vivo micronucleus test or to confirm the absence of the aneugenic potential of milbemectin; 2. an in vitro comparative metabolism study with milbemectin (at least in the pivotal species used to characterise milbemectin’s toxicity and in comparison with human metabolism); 3. an in vitro phototoxicity study with milbemectin, testing the range of wavelengths (between 290 and 700 nm) where the absorption coefficient is > 10 L x mol^-1 x cm^-1; 4. an updated risk assessment for the aquatic sediment organisms in accordance with the EFSA Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters. To allow for proper comparison of the sensitivity with other species, this confirmatory information should include a spiked-sediment test (OECD TG 218) and spiked-water test (OECD TG 219) with Chironomidae exposed to milbemectin, where milbemycin A3/milbemycin A4 is present in the same ratio than in other ecotoxicology studies. The applicant shall submit to the Commission, the Member States and the Authority the information referred to the points above by 5 November 2027.

177	Spinosad CAS No: Spinosad: 168316-95-8 Spinosyn A: 131929-60-7 Spinosyn D: 131929-63-0 CIPAC No: 636	Spinosyn A: (50–95 %) (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione Spinosyn D: (50–5 %) (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione	≥ 850 g/kg with 50–95 % of spinosyn A and 5–50 % of spinosyn D	1 April 2026	1 April 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 on spinosad of 21 January 2026, 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 assessment of the consumer intake, taking into account the residues of the metabolites of spinosad and considering the impact of storage and processing; — the protection of operators, in particular for hand-held applications in low crops; — the protection of wild mammals, aquatic organisms, bees and non-target arthropods. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) an in vitro interspecies comparative metabolism study; (2) an overall assessment of DNT (developmental neurotoxicity) including the submission of data from an in vitro DNT test battery; (3) the toxicity and magnitude of residues in plant and animal matrices of spinosyn B and K, PsA and MET A-Li-4(5b) to confirm the residue definitions for risk assessment; (4) the effect of water treatment processes on the nature of residues present in drinking water; (5) chronic effects on honeybees (adults and larvae). The applicant shall submit the information referred to in point 1, 3, and 4 to the Commission, the Member States and the Authority by 11 March 2028. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 2 within two years after adoption of a guidance document on assessing DNT. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 5 within two years after the adoption of a guidance document with a revised risk assessment methodology for honeybees.

178	Bixlozone CAS No: 81777-95-9 CIPAC No: Not allocated	2-(2,4-dichlorobenzyl)-4,4-dimethylisoxazolidin-3-one	≥ 960 g/kg The impurity TBAB shall not exceed 2 g/kg in the technical material.	21 April 2026	21 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 bixlozone 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 co-formulants present in bixlozone-containing plant protection products, taking into account in particular the criteria for identification of unacceptable co-formulants as set out in Implementing Regulation (EU) 2023/574, — the consumer risk assessment, in particular for residues present in succeeding crops, including the setting of appropriate plant-back intervals, — the protection of aquatic organisms and non-target terrestrial plants. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: 1. the technical specification of the active substance as manufactured (based on commercial scale production), the relevance of one of the impurities and the compliance of the toxicity batches with the confirmed technical specification; 2. the natural occurrence of 2,2-dimethyl-3-OH-propionic acid and dimethylmalonic acid; 3. the genotoxic and general toxicity potential of dimethylmalonic acid (free and conjugated), 2,2-dimethyl-3-OH-propionic acid (free and conjugated), F9600-dimethyl-malonamide, F9600-hydroxy-isobutyramide and F9600-3-OH-propanamide; 4. the relevance of the livestock metabolites dimethylmalonic acid, F9600-dimethyl-malonamide and F9600-3-OH-propanamide; 5. 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. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 to 5 of the fourth subparagraph by 21 April 2028.

179	Pyrimethanil CAS No: 53112-28-0 CIPAC No: 714	N-(4,6-dimethylpyrimidin-2-yl) aniline	≥ 975 g/kg The following impurities shall not exceed the following levels in the technical material: — cyanamide: 0,5 g/kg; — aniline: 4 g/kg; — acetylacetone: 0,1 g/kg.	1 May 2026	30 April 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 on pyrimethanil, 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, ensuring that conditions of use include the application of adequate personal protective equipment; — the protection of bystanders and residents, ensuring that drift reduction measures are applied, where necessary; — the protection of aquatic organisms, bees and other pollinators. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the toxicity of the metabolite M605F004, including its conjugates, and the metabolite M605F007, to confirm the relevant residue definitions for risk assessment; (2) the effect of water treatment processes on the residues of pyrimethanil or its metabolites present in water abstracted for the production of drinking water, in accordance with the EFSA and ECHA Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water; (3) the degradation of pyrimethanil in soil, including where relevant the identification and characterisation of metabolites. If the information indicates the relevance of the metabolite U2, soil, surface water, sediment and groundwater exposure and risk assessment for the metabolite U2 shall be provided. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1.2 and 3 by 11 March 2028.

180	Paraffin oil (Not ISO) Paraffin, light liquid ‘‘Paraffinum Perliquidum’’ (European Pharmacopoeia, EurPharm) CAS No: 8042-47-5 CIPAC No: 898	White mineral oil (petroleum) (Not IUPAC)	1 000 g/kg The impurity Polycyclic Aromatic Hydrocarbons (PAHs) shall not exceed 0,3 mg/kg in the technical material in accordance with the European Pharmacopoeia.	1 July 2026	30 June 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 on paraffin oil (CAS 8042-47-5), 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 consumer risk assessment, in particular to ensure compliance with maximum levels that are set in Union law for total mineral oil aromatic hydrocarbon (MOAH); — the protection of aquatic organisms, non-target arthropods in off field area and bees. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information to: (1) demonstrate the compliance of technical grade paraffin oil with the maximum level of PAH (PAH4- benzo(a)pyrene, benz(a)anthracene, benzo(b) fluoranthene and chrysene and PAH8) in the technical specification (0,3 mg/kg) with validated analytical methods for the determination of those PAHs in the technical paraffin oil and the formulations for the representative uses as proposed by the applicant; (2) complete the consumer risk assessment, where exposure to PAH residues shall be estimated using an approach based on application rate and yield rate for the representative uses as proposed by the applicant. This risk assessment shall be carried out based on that estimated exposure. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 12 May 2027.

(¹)

Further details on identity and specification of active substance are provided in the review report.

(²)

2-hydroxy-4,6-dimethoxypyrimidine.

(³)

2,4-dihydroxy-6-methoxypyrimidine.

(⁴)

sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.

(⁵)

5-(trifluoromethyl)-2(1H)-pyridinone.

(⁶)

4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol.

(⁷)

M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide.

(⁸)

5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol.

(⁹)

3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid.

(¹⁰)

2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene.

(¹¹)

4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid.

(¹²)

3-phenoxybenzaldehyde.

(¹³)

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)).

(¹⁴)

7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid.

(¹⁵)

3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1H-pyrazole-4-carboxylic acid.

(¹⁶)

3-chloro-1-methyl-5-sulfamoyl-1H-pyrazole-4-carboxylic acid.

(¹⁷)

p-methyl-phenethylamine.

(¹⁸)

OJ L 353, 31.12.2008, p. 1.

(¹⁹)

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).

(²⁰)

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).

(²¹)

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf

(²²)

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.

(²³)

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

(²⁴)

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN

(²⁵)

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).

(²⁶)

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.

(²⁷)

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.

(²⁸)

pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu).

(²⁹)

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).

(³⁰)

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).

(³¹)

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).

(³²)

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).

(³³)

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 ⁵⁴	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 ⁵⁵	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 ⁵⁶ Bentonite: Purity required by Implementing Regulation (EU) No 1060/2013 ⁵⁷	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 ⁵⁶. < 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 ⁵⁸	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 ⁵⁹, Regulation (EC) No 396/2005 of the European Parliament and of the Council ⁶⁰, Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006 ⁶¹	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'

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