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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
100 versions
· 2011-05-25
2026-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-11-16
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
Changes on 2025-11-16
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| 107 | MCPA CAS No 94-74-6 CIPAC No 2 | 4-chloro-o-tolyloxyacetic acid | ≥ 930 g/kg | 1 May 2006 | 15 August 2026 | PART A Only uses as herbicide may be authorised PART B 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 MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
| 108 | MCPB CAS No 94-81-5 CIPAC No 50 | 4-(4-chloro-o-tolyloxy)butyric acid | ≥ 920 g/kg | 1 May 2006 | 15 August 2026 | PART A Only uses as herbicide may be authorised PART B 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 MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones |
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| 110 | 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,22Z)-(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[15.6.1.14,8.020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one M.A4: (10E,14E,16E,22Z)-(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. 14,8020,24] pentacosa-10,14,16,22-tetraene-6-spiro-2′-tetrahydropyran-2-one | ≥ 950 g/kg | 1 December 2005 | 31 May 2026 | PART A Only uses as acaricide or insecticide may be authorised. PART B 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 milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Risk mitigation measures should be applied where appropriate. |
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| 241 | Plant oils/clove oil CAS No 84961-50-2 (clove oil) 97-53-0 (Eugenol — main component) CIPAC No 906 | Clove Oil is a complex mixture of chemical substances. The main component is eugenol. | ≥ 800 g/kg Relevant impurity: methyl eugenol maximum 0,1 % of the technical material | 1 September 2009 | 31 January 2026 | PART A Only indoor uses as post-harvest fungicide and bactericide may be authorised. PART B 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 clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 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, where appropriate. The notifier shall submit confirmatory information as regards (a) the technical specification; (b) data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product. This data shall cover human exposure. The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016. |
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| 242 | Plant oils/rape seed oil CAS No: 8002-13-9 CIPAC No: not allocated | Rape seed oil | Rape seed oil is a complex mixture of fatty acids Relevant impurity: Maximum 2 % of erucic acid | 1 September 2009 | 31 March 2026 | PART A Only uses as insecticide and acaricide may be authorised. PART B 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 rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 243 | Plant oils/spear mint oil CAS No 8008-79-5 CIPAC No 908 | Spearmint oil | ≥ 550 g/kg as (R)-Carvone | 1 September 2009 | 31 January 2026 | PART A Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised. Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 56 | Orange oil CAS No 8028-48-6 (Orange extract) 5989-27-5 (D-limonene) CIPAC No 902 | (*R*)-4-isopropenyl-1-methylcyclohexene or *p*-mentha-1,8-diene | ≥ 945 g/kg (of D-limonene) The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (*Aurantii dulcis aetheroleum*) and ISO 3140:2011(E) | 1 May 2014 | 31 December 2026 | 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 orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to birds and mammals. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment. The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016. |
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| 57 | Penthiopyrad CAS No 183675-82-3 CIPAC No 824 | *(RS*)-*N*-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide | ≥ 980 g/kg (50:50 racemic mixture) | 1 May 2014 | 31 October 2027 | 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 penthiopyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to aquatic and soil organisms; (c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (d) the level of residues in rotational crops following consecutive application of the active substance over several years. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid) for groundwater with the exception of evidence related to the risk of carcinogenicity, which is dependent on the classificationof the parent and specified separately at (3) below; (2) the toxicological profile and the reference values of the metabolite PAM; (3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxylic acid) and their risk to contaminate groundwater, if penthiopyrad is classified under Regulation (EC) No 1272/2008 as carcinogenic cat. 2. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) and (2) by 30 April 2016 and the information set out in point (3) within six months from the notification of the classification decision concerning penthiopyrad. |
| 57 | Penthiopyrad CAS No 183675-82-3 CIPAC No 824 | *(RS*)-*N*-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide | ≥ 980 g/kg (50:50 racemic mixture) | 1 May 2014 | 31 October 2025 | 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 penthiopyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the protection of operators and workers; (b) the risk to aquatic and soil organisms; (c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; (d) the level of residues in rotational crops following consecutive application of the active substance over several years. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid) for groundwater with the exception of evidence related to the risk of carcinogenicity, which is dependent on the classificationof the parent and specified separately at (3) below; (2) the toxicological profile and the reference values of the metabolite PAM; (3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxylic acid) and their risk to contaminate groundwater, if penthiopyrad is classified under Regulation (EC) No 1272/2008 as carcinogenic cat. 2. The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) and (2) by 30 April 2016 and the information set out in point (3) within six months from the notification of the classification decision concerning penthiopyrad. |
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| 58 | Benalaxyl-M CAS No 98243-83-5 CIPAC No 766 | Methyl *N*-(phenylacetyl)-*N*-(2,6-xylyl)-D-alaninate | ≥ 950 g/kg | 1 May 2014 | 30 September 2027 | 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 benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of workers at re-entry, — the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. |
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| 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 (<sup>33</sup>). Conditions of use shall include risk mitigation measures, where appropriate. |
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| 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. |
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| 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<sup>4,8</sup>.0<sup>20,24</sup>] 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<sup>4,8</sup>.0<sup>20,24</sup>] 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<sup>-1</sup> x cm<sup>-1</sup>; 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. |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) 2-hydroxy-4,6-dimethoxypyrimidine. (<sup>3</sup>) 2,4-dihydroxy-6-methoxypyrimidine. (<sup>4</sup>) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate. (<sup>5</sup>) 5-(trifluoromethyl)-2(1H)-pyridinone. (<sup>6</sup>) 4-{[5-(trifluoromethyl)-2-pyridinyl]oxy}phenol. (<sup>7</sup>) M03: [(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]ethyl(propyl)amine oxide. (<sup>8</sup>) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-[(methoxymethyl)amino]phenol. (<sup>9</sup>) 3-chloro-4-[3-(ethenyloxy)-4-hydroxyphenoxy]benzoic acid. (<sup>10</sup>) 2-chloro-1-(3-methoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene. (<sup>11</sup>) 4-(3-ethoxy-4-hydroxyphenoxy)benzoic acid. (<sup>12</sup>) 3-phenoxybenzaldehyde. (<sup>13</sup>) 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)). (<sup>14</sup>) 7-amino-5-ethyl[1,2,4]triazolo[1,5-a]pyrimidine-6-carboxylic acid. (<sup>15</sup>) 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl-1*H*-pyrazole-4-carboxylic acid. (<sup>16</sup>) 3-chloro-1-methyl-5-sulfamoyl-1*H*-pyrazole-4-carboxylic acid. (<sup>17</sup>) *p*-methyl-phenethylamine. (<sup>18</sup>) OJ L 353, 31.12.2008, p. 1. (<sup>19</sup>) 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). (<sup>20</sup>) 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). (<sup>21</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>22</sup>) 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. (<sup>23</sup>) 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 (<sup>24</sup>) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0605&from=EN (<sup>25</sup>) 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). (<sup>26</sup>) 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. (<sup>27</sup>) 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. (<sup>28</sup>) pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (europa.eu). (<sup>29</sup>) 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). (<sup>30</sup>) 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). (<sup>31</sup>) 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). (<sup>32</sup>) 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). (<sup>33</sup>) 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
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| 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. |
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| 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 (<sup>8</sup>), — 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. |
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| 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. |
| (<sup>1</sup>) Further details on identity and specification of active substance are provided in the review report. (<sup>2</sup>) https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>3</sup>) 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). (<sup>4</sup>) 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. (<sup>5</sup>) https://ec.europa.eu/food/system/files/2016-10/pesticides_ppp_app-proc_guide_phys-chem-ana_microbial-contaminant-limits.pdf (<sup>6</sup>) 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). (<sup>7</sup>) Expressed in World Health Organisation (WHO) toxic equivalents. (<sup>8</sup>) 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. (<sup>9</sup>) Organisation for Economic Cooperation and Development (OECD): https://doi.org/10.1787/9789264221642-en. | | | | | | |
### PART E
2025-07-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-05-28
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-05-15
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2025-03-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-12-02
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-11-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-09-29
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-09-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-07-31
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2024-05-23
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2024-05-01
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2020-12-12
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2020-11-26
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2020-10-20
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2020-10-06
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2020-09-01
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2020-08-03
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2020-08-01
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2020-06-03
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2020-04-09
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2020-02-03
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2019-12-29
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2019-11-01
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2019-08-01
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2019-05-30
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2019-04-14
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2019-02-20
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2019-01-01
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2018-12-01
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2018-10-17
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2018-08-14
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2018-07-01
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2018-06-01
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2018-03-22
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2018-01-23
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2017-12-16
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2017-12-05
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2017-11-01
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2017-09-28
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2017-06-08
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2017-04-03
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2016-12-12
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2016-11-01
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2016-09-16
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2016-08-22
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2016-07-06
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2016-05-13
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2016-05-02
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2016-04-01
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2016-01-01
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2015-12-09
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2015-11-10
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2015-09-03
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2015-08-18
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2015-07-30
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2015-07-01
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2015-04-02
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2015-04-01
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2015-01-01
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2014-09-15
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2014-09-01
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2014-02-01
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2013-08-01
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2013-06-01
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2013-04-01
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2013-02-01
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2012-11-01
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2012-07-23
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2012-07-01
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2012-05-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
2012-01-01
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 impl
original version
Text at this date