# 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), Part E: Candidates for substitution

Extent: E+W+S+N.I.

Further details on identity and specification of active substance are provided in the review report.
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).
Common Name, Identification Numbers
IUPAC Name
Purity
Date of approval
Expiration of approval
Specific provisions
1
Flumetralin
CAS No 62924-70-3
CIPAC No 971
N -(2-chloro-6-fluorobenzyl)- N -ethyl-α,α,α-trifluoro-2,6-dinitro- p -toluidine
980 g/kg
The impurity Nitrosamine (calculated as nitroso-dimethylamine) shall not exceed 0,001 g/kg in the technical material.
11 December 2015
11 December 2022
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 flumetralin, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
(a)the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;
(b)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;
(c)the risk to herbivorous mammals;
(d)the risk to aquatic organisms.
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);
2..the compliance of the toxicity batches with the confirmed technical specification.
The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 11 June 2016.
2
Esfenvalerate
CAS No: 66230-04-4
CIPAC No: 481
(αS)-α-cyano-3-phenoxybenzyl (2S)-2-(4-chlorophenyl)-3-methylbutyrate
830 g/kg
The impurity toluene shall not exceed 10 g/kg in the technical material.
1 January 2016
31 December 2022
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 esfenvalerate, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
the risk from esfenvalerate and the 2SαR-isomer of fenvalerate to aquatic organisms including the risk for bio-accumulation through the food chain,
the risk to honeybees and non-target arthropods,
the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.
Conditions of use shall include risk mitigation measures, where appropriate.
3
Metsulfuron-methyl
CAS No 74223-64-6
CIPAC No 441.201
Methyl 2-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)benzoate
967 g/kg
1 April 2016
31 March 2023
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 metsulfuron-methyl, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
the protection of consumers,
the protection of groundwater,
the protection of non-target terrestrial plants.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit to the Commission, the Member States and the Authority by 30 September 2016 confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (IN-A4098) to confirm that this metabolite is not genotoxic and not relevant for risk assessment.
4
Benzovindiflupyr
CAS No: 1072957-71-1
CIPAC No: not available
N -[(1 RS ,4 SR )-9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide
960 g/kg (50/50) racemate
2.3.2016
2.3.2023
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 benzovindiflupyr, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.
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) including the relevance of impurities;
(2)the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;
(3)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 requested under points (1) and (2) by 2 September 2016 and the information requested under point (3) within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
5
Lambda-Cyhalothrin
CAS No 91465-08-6
CIPAC No 463
A 1:1 mixture of:
(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or of (R)-α-cyano-3-phenoxybenzyl (1S)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate
900 g/kg
1 April 2016
31 March 2023
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 lambda-cyhalothrin, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to the:
(a)protection of operators, workers and bystanders;
(b)metabolites potentially formed in processed commodities;
(c)risk to aquatic organisms, mammals and non-target arthropods.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicants shall submit confirmatory information as regards:
1..a systematic review to assess the evidence available as regards potential sperm effects linked to exposure to lambda-cyhalothrin using guidance available (e.g. EFSA GD on Systematic Review methodology, 2010);
2..toxicological information to assess the toxicological profile of the metabolites V (PBA) and XXIII (PBA(OH)).
The applicants shall submit those information to the Commission, the Member States and the Authority by 1 April 2018.
6
Prosulfuron
CAS No 94125-34-5
CIPAC No 579
1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3- trifluoropropyl)-phenylsulfonyl]-urea
950 g/kg
The impurity 2-(3,3,3-trifluoro-propyl)-benzene sulphonamide shall not exceed 10 g/kg in the technical material.
1 May 2017
30 April 2024
PART A
Use shall be limited to one application every three years on the same field at a maximum dose of 20 g active substance per hectare.
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 prosulfuron, and in particular Appendices I and II thereof, shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;
the risk to non-target terrestrial and aquatic plants.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit confirmatory information as regards the genotoxic potential of the metabolite triazine-amine (CGA150829) to confirm that this metabolite is not genotoxic and not relevant for risk assessment.
The applicant shall submit that information to the Commission, the Member States and the Authority by 31 October 2017.
7
Pendimethalin
CAS No 40487-42-1
CIPAC No 357
N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene
900 g/kg
1,2-dichloroethane
≤ 1 g/kg
Total N-Nitroso compounds: max 100 ppm, of which N-Nitroso-pendimethalin: < 45 ppm.
1 September 2017
31 August 2024
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 pendimethalin, 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 the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material,
the protection of operators,
the protection of birds, mammals and aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator.
The applicant shall submit confirmatory information to the Commission, the Member States and the Authority as regards:
1..the potential for bioaccumulation, in particular a reliable BCF value for bluegill sunfish ( Lepomis macrochirus );
2..the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.
The applicant shall submit the confirmatory information requested under point 1 by 31 December 2018. The applicant shall submit the confirmatory information requested under point 2 within a period of two years of the publication by the Commission of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
8
Imazamox
CAS No 114311-32-9
CIPAC No 619
2-[(RS)-4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl]-5-methoxymethylnicotinic acid
≥ 950 g/kg
The impurity cyanide ion (CN – ) shall not exceed 5 mg/kg in the technical material.
1 November 2017
31 October 2024
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 imazamox, 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 consumers;
the protection of aquatic plants and of non-target terrestrial plants;
the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include risk mitigation measures and monitoring programs shall be initiated to verify potential groundwater contamination from imazamox and metabolites CL 312622 and CL 354825 in vulnerable zones, where appropriate.
9
Propyzamide
CAS No 23950-58-5
CIPAC No 315
3,5-dichloro- N -(1,1-dimethylprop-2-ynyl) benzamide
920 g/kg
1 July 2018
30 June 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 propyzamide 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 protection of operators,
the protection of groundwater in vulnerable areas,
the protection of birds, mammals, non-target plants, soil and aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
In particular, personal protective equipment such as gloves, coverall and sturdy footwear has to be worn to ensure that the AOEL is not exceeded for the operator.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:
1..the completion of assessment of toxicological profile of metabolites identified in significant concentration in primary and rotational crops;
2..the soil degradation of major metabolite RH- 24580;
3..the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.
The applicant shall submit the information mentioned under point (1) by 31 October 2018 and the information mentioned under point (2) by 30 April 2019. The applicant shall submit the confirmatory information mentioned in point (3) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater be made public by the Commission.
10
Copper compounds:
1 January 2019
31 December 2025
Only uses resulting in a total application of maximum 28 kg of copper per hectare over a period of 7 years shall be authorised.
For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council, the conclusions of the review report on copper compounds and in particular Appendices I and II thereto, shall be taken into account.
In their overall assessment Member States shall pay particular attention to:
the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment and other mitigation measures as appropriate;
the protection of water and non-target organisms. In relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate;
the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, do not exceed the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site, and, where the information is available, copper input from other sources. Member States may in particular decide to set a maximum annual application rate not exceeding 4 kg/ha of copper.
Copper hydroxide CAS No 20427-59-2 CIPAC No 44.305
Copper (II) hydroxide
≥ 573 g/kg
Copper oxychloride CAS No 1332-65-6 or 1332-40-7 CIPAC No 44.602
Dicopper chloride trihydroxide
≥ 550 g/kg
Copper oxide CAS No 1317-39-1 CIPAC No 44.603
Copper oxide
≥ 820 g/kg
Bordeaux mixture CAS No 8011-63-0 CIPAC No 44.604
Not allocated
≥ 245 g/kg
Tribasic copper sulphate CAS No 12527-76-3 CIPAC No 44.306
Not allocated
≥ 490 g/kg
The following impurities shall not exceed the following levels:
Arsenic max. 0,1 mg/g Cu
Cadmium max. 0,1 mg/g Cu
Lead max. 0,3 mg/g Cu
Nickel max. 1 mg/g Cu
Cobalt max. 3 mg/kg
Mercury max. 5 mg/kg
Chromium max. 100 mg/kg
Antimony max. 7 mg/kg
11
Methoxyfenozide
CAS No 161050-58-4
CIPAC No 656
N-tert-Butyl-N′-(3-methoxy-o-toluoyl)-3,5-xylohydrazide
≥ 970 g/kg
The following impurities must not exceed the following levels in the technical material:
Tert-butylhydrazine < 0,001 g/kg
RH-116267 < 2 g/kg
1 April 2019
31 March 2026
Only uses in greenhouses shall be authorised.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methoxyfenozide, and in particular Appendices I and II thereto, shall be taken into account.
In their overall assessment Member States shall pay particular attention to:
the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;
the risk of accumulation in soil;
the protection of non-target arthropods, sediment dwelling and aquatic organisms;
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:
1..a comparative in vitro metabolism study on methoxyfenozide, by 1 April 2020;
2..the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water, within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
The applicant shall also provide an updated assessment of the information submitted and, where relevant, further information to confirm the absence of thyroid endocrine activity in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 1 February 2021.
12
alpha-cypermethrin
CAS No 67375-30-8
CIPAC No 454
Racemate comprising:
(R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
or
(R)-α-cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
and (S)-α-cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
≥ 980 g/kg
The manufacturing impurity hexane is considered to be of toxicological concern and must not exceed 1 g/kg in the technical material
1 November 2019
31 October 2026
For the implementation of the uniform principles, as referred to in Article 9(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on alpha-cypermethrin, 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 the conditions of use prescribe the application of adequate personal protective equipment;
the consumer risk assessment;
the protection of aquatic organisms, bees and non-target arthropods.
Conditions of use shall include risk mitigation measures, where appropriate.
The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:
1..the toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety;
2..the potential relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR);
3..the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water;
4..Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605.
The applicant shall submit the information referred to in point 1 by 30 October 2020; the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of isomer mixtures; and the information referred to in point 3 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
As regards Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity shall be submitted by 30 October 2021.

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Source: https://www.legislation.gov.uk/eur/2011/540/annex/1/part/E (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-540/annex-1/part-E
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.