Relevant impurities of technical active substances
Background
Active substances often contain impurities which originate from manufacturing. According to the definition of Regulation (EU) No 283/2013, impurities in the technical active substance are considered relevant if they are particularly undesirable because of their toxicological, ecotoxicological or environmental properties. Furthermore, the FAO definition includes impurities which are phytotoxic to treated plants, cause taint in food crops, affect the stability of the active substance or have other adverse effects. These particular characteristics are always assessed in relation to the pure active substance.
Regulation (EU) No 540/2011 sets maximum limits at approval for relevant impurities in certain active substances. Since the Regulation constitutes the law in force, these maximum limits are binding throughout the EU. In addition, the BVL can set maximum limits in exceptional cases for impurities which are not governed by the Regulation. These maximum limits are set when the plant protection product is authorised.
The following table contains relevant impurities in technical active substances which are used for plant protection products in Germany. The maximum limits stated refer to the technical active substance if not stated otherwise.
Table of impurities (July 2023)
| Active substance | BVL- No | Impurity | Maximum limit |
|---|---|---|---|
| Aclonifen | 0656 | Phenol | 5 g/kg |
| Amectoctradin | 1152 | Amitrole o-Xylene | 0.05 g/kg 2 g/kg |
| Aminopyralid | 1055 | Picloram | 40 g/kg |
| Amisulbrom | 1094 | 3-Bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indol | 2 g/kg |
| Azadirachtin | 0943 | Aflatoxin B1, B2, G1 and G2 | 300 μg/kg Azadirachtin A |
| Azoxystrobin | 0902 | Toluene Z-Isomer | 2 g/kg 25 g/kg |
| Benthiavalicarb | 1032 | 6,6'-Difluoro-2,2'-dibenzothiazole Bis(2-amino-5-fluorophenyl)disulfide | 3.5 mg/kg 14 mg/kg |
| Bifenazate | 1027 | Toluene | 0.7 g/kg |
| Bifenox | 0537 | 2,4-Dichloroanisole 2,4-Dichlorophenol | 6 g/kg 3 g/kg |
| Bupirimate | 0418 | Ethirimol Toluene | 2 g/kg 3 g/kg |
| Captan | 0012 | Perchloromethylmercaptan Folpet Carbon tetrachloride | 5 g/kg 10 g/kg 0.1 g/kg |
| Carbon dioxide | 0785 | Phosphane Benzene Carbon monoxide Methanol Hydrogen cyanide | 0.3 ppm v/v 0.02 ppm v/v 10 ppm v/v 10 ppm v/v 0.5 ppm v/v |
| Chlorantraniliprole | 1095 | Acetonitrile 3-Picoline Methanesulfonic acid | 3 g/kg 3 g/kg 2 g/kg |
| Chlormequat chloride | 0388 | 1,2-Dichloroethane Chloroethene | 0.1 g/kg 0.5 mg/kg |
| Clethodim | 0921 | Toluene | 4 g/kg |
| Clonostachys rosea strain J1446 | 9660 | Gliotoxin | 0.05 mg/kg |
| Copper compounds | Lead Cadmium Arsenic Nickel Cobalt Mercury Chromium Antimony | 0.3 mg/g 0.1 mg/g 0.1 mg/g 1 mg/g 3 mg/g 5 mg/g 100 mg/g 7 mg/g | |
| Cyantraniliprole | 1182 | IN-Q6S09 IN-RYA13 Methanesulfonic acid Acetonitrile Heptane 3-Picoline | 1 mg/kg 20 mg/kg 2 g/kg 2 g/kg 7 g/kg 3 g/kg |
| Cypermethrin | 0498 | Hexane | 5 g/kg |
| 2,4-D | 0027 | Free phenols (expressed as 2,4-dichlorophenol) Dioxins and furans (WHO-TCDD TEQ) | 3 g/kg 0.01 mg/kg |
| Daminozide | 0437 | N-Nitrosodimethylamine 1,1-Dimethylhydrazide | 2 mg/kg 30 mg/kg |
| Difenoconazole | 0865 | Toluene | 5 g/kg |
| Dimethachlor | 0413 | 2,6-Dimethylaniline | 0.5 g/kg |
| Dimethenamid-P | 0988 | 1,1,1,2-Tetrachloroethane | 1 g/kg |
| Esfenvalerate | 0767 | Toluene | 10 g/kg |
| Ethephon | 0481 | MEPHA 1,2-Dichloroethane | 20 g/kg 0.5 g/kg |
| Ethofumesate | 0383 | Ethyl methane sulfonate Iso-butyl methane sulfonate | 0.1 mg/kg 0.1 mg/kg |
| Ethylene | 1107 | Ethylene oxide | 1 mg/kg |
| Fenhexamid | 0956 | Toluene 4-Amino-2,3-dichlorophenol | 1 g/kg 3 g/kg |
| Fenpyrazamine | 1157 | Hydrazine | 1 mg/kg |
| Ferric phosphate | 0947 | Lead Mercury Cadmium | 3 mg/kg 0.1 mg/kg 1 mg/kg |
| Ferric pyrophosphate | 1249 | Lead Mercury Cadmium | 3 mg/kg 0.1 mg/kg 1 mg/kg |
| Fish oil | 1133 | Sum of polychlorinated dibenzo-paradioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) Sum of PCDDs, PCDFs and dioxin like polychlorinated biphenyls (PCBs) Mercury Cadmium Lead non-dioxin-like PCBs | 5 ng/kg 20 ng/kg 0.5 mg/kg 2 mg/kg 10 mg/kg 175 µg/kg |
| Flonicamid | 1054 | Toluene | 3 g/kg |
| Florasulam | 0973 | 2,6-Difluoroaniline | 2 g/kg |
| Fluazifop-P | 0833 | 2-Chloro-5-(trifluoromethyl)pyridine | 1.5 g/kg |
| Fluazinam | 0849 | 5-Chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl-α,α,α-trifluoro-4,6-dinitro-o-toluidine | 2 g/kg |
| Fluopicolide | 1058 | Toluene | 3 g/kg |
| Fluroxypyr | 0666 | N-Methyl-2-pyrrolidone | 3 g/kg |
| Fluxapyroxad | 1164 | Toluene | 1 g/kg |
| Folpet | 0091 | Carbon tetrachloride Perchloromethylmercaptane | 4 g/kg 3.5 g/kg |
| Glyphosate | 0405 | N-Nitrosoglyphosate Formaldehyde | < 1 mg/kg < 1 g/kg |
| Imazamox | 0974 | Cyanide | 5 mg/kg |
| Iprovalicarb | 0968 | Toluene | 3 g/kg |
| Iron sulfate | 0229 | Arsenic Cadmium Chromium Lead Mercury | 18 mg/kg 1.8 mg/kg 90 mg/kg 36 mg/kg 1.8 mg/kg |
| Isoxaben | 0674 | Toluene | 3 g/kg |
| Kieselgur | 0923 | Crystalline silica (particle size below 10 μm) | 1 g/kg |
| Kresoxim-methyl | 0904 | Methanol Methylchloride Toluene | 5 g/kg 1 g/kg 1 g/kg |
| Maleic hydrazide (sodium-, potassium- or choline salt) | 0297 | Hydrazine | 0.028 mg/kg |
| Mandestrobin | 1199 | Xylenes (ortho, meta, para) ethyl benzene | 5 g/kg in the technical concentrate |
| Mandipropamid | 1085 | N-{2-[4-(2-Chloro-allyloxy)-3-methoxy-phenyl]ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide | 0.1 g/kg |
| Mefentrifluconazole | 1242 | N,N-Dimethylformamide Toluene 1,2,4-(1H)-Triazole | 0.5 g/kg 1 g/kg 1 g/kg |
| Mesotrione | 0975 | R287431 R287432 1,2-Dichloroethane | 2 mg/kg 2 g/kg 1 g/kg |
| Metalaxyl | 0517 | 2,6-Dimethylaniline | 1 g/kg |
| Metalaxyl-M | 0933 | 2,6-Dimethylphenylamine 4-Methoxy-5-methyl-5H-[1,2]oxathiole-2,2-dioxide 2-[(2,6-Dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester | 0.5 g/kg 1 g/kg 0.18 g/kg |
| Metaldehyde | 0151 | Acetaldehyde | 1.5 g/kg |
| Metazachlor | 0617 | Toluene | 0.5 g/kg |
| 1-Methylcyclopropene | 1039 | 1-Chloro-2-methylpropene 3-Chloro-2-methylpropene | 0.2 g/kg 0.2 g/kg |
| Metiram | 0081 | Ethylene thiourea | 5 g/kg |
| Mild Pepino Mosaic Virus isolate VC1 | 9072 | Nicotine | < 0.1 mg/L |
| Mild Pepino Mosaic Virus isolate VX1 | 9073 | Nicotine | < 0.1 mg/L |
| Napropamide | 0367 | Toluene | 1.4 g/kg |
| Pendimethalin | 0404 | 1,2-Dichloroethane N-Nitroso compounds (total) N-Nitroso-pendimethalin | 1 g/kg 100 mg/kg 45 mg/kg |
| Penoxsulam | 1044 | Bis-CHYMP | 0.1 g/kg |
| Pethoxamid | 1021 | Toluene | 3 g/kg |
| Phosphane | 0013 | Arsane | 23 mg/kg |
| Picloram | 0308 | Hexachlorobenzene | 50 mg/kg |
| Pinoxaden | 1059 | Toluene | 1 g/kg |
| Propaquizafop | 0869 | Toluene | 5 g/kg |
| Prosulfuron | 0917 | 2-(3,3,3-Trifluoropropyl)benzene sulfonamide | 10 g/kg |
| Prothioconazole | 1035 | Toluene Prothioconazole-desthio | 5 g/kg 0.5 g/kg |
| Pseudomonas chlororaphis strain MA 342 | 9380 | DDR | 2 mg/L |
| Pyraclostrobin | 1013 | Dimethylsulfate | 1 mg/kg |
| Pyrimethanil | 0900 | Cyanamide | 0.5 g/kg |
| Quartz sand | 0692 | Crystalline silica (diameter below 50 µm) | 1 g/kg |
| Rape seed oil | 0757 | Erucic acid | 20 g/kg |
| Sintofen | 1075 | 2-Methoxyethanol N,N-Dimethylformamide | 0.25 g/kg 1.5 g/kg |
| Sodium o-nitrophenolate | 1073 | Phenol 2,4-Dinitrophenol 2,6-Dinitrophenol | 0.1 g/kg 0.14 g/kg 0.32 g/kg |
| Sodium p-nitrophenolate | 1077 | Phenol 2,4-Dinitrophenol 2,6-Dinitrophenol | 0.1 g/kg 0.07 g/kg 0.09 g/kg |
| Sulcotrione | 0897 | Hydrogen cyanide Toluene | 80 mg/kg 4 g/kg |
| Sulfosulfuron | 0955 | Phenol | 2 g/kg |
| Tau-Fluvalinate | 0894 | Toluene | 5 g/kg |
| Tebufenozide | 0905 | t-Butylhydrazine | 1 mg/kg |
| Tefluthrin | 0778 | Hexachlorobenzene | 1 mg/kg |
| Tembotrione | 1089 | Toluene Hydrogen cyanide | 10 g/kg 1 g/kg |
| Terbuthylazine | 0316 | Atrazine Propazine Simazine | 1 g/kg 9 g/kg 9 g/kg |
| Tetraconazole | 0941 | Toluene | 13 g/kg |
| Trifloxystrobin | 0972 | AE 1344136 | 4 g/kg |
| Tritosulfuron | 1024 | AMTT | 0.2 g/kg |
Abbreviations
AE 1344136: (E)-[2-(Chloromethyl)phenyl](methoxyimino)acetic acid methyl ester
AMTT: 2-Amino-4-methoxy-6-(trifluoromethyl)-1,3,5-triazine
Bis-CHYMP: 2-Chloro-4-[2-(2-chloro-5-methoxy-4-pyrimidinyl)-hydrazino]-5-methoxypyrimidine
DDR: 2,3-Deepoxy-2,3-didehydrorhizoxzine
IN-Q6S09: 5,6-Dihydro-1,6,10-trimethyl-5-oxoindazolo[2,3-a]chinazoline-3,8-dicarbonitrile
IN-RYA13: 3-Bromo-1-(3-chloro-2-pyridinyl)-N-[4-(formylamino)-2-methyl-6-[(methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide
MEPHA: 2-Chloroethyl phosphonic acid, mono-2-chloroethyl ester
Prothioconazol-desthio: (2-(1-Chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)propan-2-ol)
R287431: 6-Methanesulfonyl-7-nitro-9-oxo-9H-xanthene-1-carbonitrile
R287432: 6-Methanesulfonyl-9-oxo-9H-xanthene-1-carbonitrile