Part B Active substances approved under Regulation (EC) No 1107/2009F1

Bispyribac

CAS No

125401-75-4

CIPAC No

748

PART A

PART B

Profoxydim

CAS No 139001-49-3

CIPAC No 621

PART A

PART B

Azimsulfuron

CAS No 120162-55-2

CIPAC No 584

≥ 980 g/kg

maximum level of the impurity phenol 2 g/kg

PART A

PART B

Azoxystrobin

CAS No 131860-33-8

CIPAC No 571

≥ 930 g/kg

Toluene maximum content 2 g/kg

Z-isomer maximum content 25 g/kg

PART A

PART B

Imazalil

CAS No 35554-44-0

73790-28-0 (replaced)

CIPAC No 335

(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazole

or

allyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether

PART A

PART B

Prohexadione

CAS No 127277-53-6 (prohexadione-calcium)

CIPAC No 567 (prohexadione)

No 567.020 (prohexadione-calcium)

≥ 890 g/kg

(expressed as prohexadione-calcium)

PART A

PART B

Spiroxamine

CAS No 1181134-30-8

CIPAC No 572

≥ 940 g/kg

(diastereomers A and B combined)

PART A

PART B

Kresoxim-methyl

CAS No 143 390-89-0

CIPAC No 568

≥ 910 g/kg

Methanol: max. 5 g/kg

Methyl chloride: max. 1 g/kg

Toluene: max. 1 g/kg

PART A

PART B

Fluroxypyr

CAS No 69377-81-7

CIPAC No 431

F28≥ 950 g/kg (fluroxypyr-meptyl)

The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:

N-methyl-2-pyrrolidone (NMP): < 3 g/kg

PART A

PART B

Tefluthrin

CAS No: 79538-32-2

CIPAC No: 451

2,3,5,6-tetrafluoro-4-methylbenzyl (1 RS, 3RS )-3-[( Z )-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

Tefluthrin is a 1:1 mixture of Z -(1 R , 3 R ) and Z -(1 S , 3 S ) enantiomers.

≥ 920 g/kg

Hexachlorobenzene: not more than 1 mg/kg

PART A

PART B

Oxyfluorfen

CAS No 42874-03-3

CIPAC No 538

≥ 970 g/kg

Impurities:

N,N-dimethylnitrosamine: not more than 50 μg/kg

F30PART A

PART B

1-naphthylacetamide

CAS No 86-86-2

CIPAC No 282

PART A

PART B

1-naphthylacetic acid

CAS No 86-87-3

CIPAC No 313

PART A

PART B

Fluquinconazole

CAS No 136426-54-5

CIPAC No 474

PART A

PART B

Fluazifop P

CAS No 83066-88-0 (fluazifop-P)

CIPAC No 467 (fluazifop-P)

≥ 900 g/kg in fluazifop P-butyl

The following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured.

PART A

PART B

Terbuthylazine

CAS No 5915-41-3

CIPAC No 234

≥ 950 g/kg

Impurities:

• Propazine not more than 10 g/kg

• Atrazine not more than 1 g/kg

• Simazine not more than 30 g/kg

PART A

PART B

Triazoxide

CAS No 72459-58-6

CIPAC No 729

≥ 970 g/kg

Impurities:

toluene: not more than 3 g/kg

PART A

PART B

8-hydroxyquinoline

CAS No

148-24-3 (8-hydroxyquinoline)

CIPAC No 677

(8-hydroxyquinoline)

PART A

PART B

Acrinathrin

CAS No 101007-06-1

CIPAC No 678

( S )-α-cyano-3-phenoxybenzyl (Z)-(1 R ,3 S )-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate or

( S )-α-cyano-3-phenoxybenzyl ( Z )-(1 R )- cis -2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate

≥ 970 g/kg

Impurities:

1,3-dicyclohexylurea: not more than 2 g/kg

PART A

PART B

Prochloraz

CAS No 67747-09-5

CIPAC No 407

≥ 970 g/kg

Impurities:

Sum of dioxins and furans (WHO-PCDD/T TEQ)^f9: not more than 0,01 mg/kg

PART A

PART B

Metam

CAS No 144-54-7

CIPAC No 20

≥ 965 g/kg

Expressed as metam-sodium on a dry weight basis

≥ 990 g/kg

Expressed as metam-potassium on a dry weight basis

Relevant impurities:

• methylisothiocyanate (MITC)

  • max. 12 g/kg on dry weight basis (metam-sodium),

  • max. 0,42 g/kg on dry weight basis (metam-potassium).

• N,N’ -dimethylthiourea (DMTU)

  • max. 23 g/kg on a dry weight basis (metam-sodium),

  • max. 6 g/kg on a dry weight basis (metam-potassium).

PART A

PART B

Bifenthrin

CAS No

82657-04-3

CIPAC No 415

2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

or

2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

≥ 930 g/kg

Impurities:

Toluene: not more than 5 g/kg

F42PART A

PART B

Fluxapyroxad

CAS No 907204-31-3

CIPAC No 828

≥ 950 g/kg

The impurity toluene must not exceed 1 g/kg in the technical material

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 fluxapyroxad, 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.

In this overall assessment Member States shall pay particular attention to the risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions.

Conditions of use shall include risk mitigation measures, where appropriate.

The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

Fenpyrazamine

CAS No 473798-59-3

CIPAC No 832

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 fenpyrazamine, 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.

The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

Adoxophyes orana granulovirus

Culture collection No DSM BV-0001

CIPAC No 782

Isopyrazam

CAS No 881685-58-1

(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)

CIPAC No 963

A mixture of 3-(difluoromethyl)-1-methyl- N -[(1 RS ,4 SR ,9 RS )-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide

( syn -isomer – 50:50 mix of two enantiomers)

and

3-(difluoromethyl)-1-methyl- N -[(1 RS ,4 SR ,9 SR )-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide

( anti -isomer– 50:50 mix of two enantiomers)

In a range of 78:15 % to 100:0 % syn to anti .

≥ 920 g/kg

In a range of 78:15 % to 100:0 % syn- to anti-isomers

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 isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to aquatic organisms;

2. (b)

   the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;

3. (c)

   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, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.

The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.

F47The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.

Phosphane

CAS No 7803-51-2

CIPAC No 127

≥ 994 g/kg

The relevant impurity arsane must not exceed 0,023 g/kg in the technical material

Authorisations shall be limited to professional users.

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 phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the protection of operators in and around the treated premises during the treatment as well as during and after the aeration;

• the protection of workers in and around the treated premises during the treatment as well as during and after the aeration;

• the protection of bystanders around the treated premises during the treatment as well as during and after the aeration.

Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, where appropriate.

Trichoderma asperellum (strain T34)

CECT number: 20417

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 Trichoderma asperellum (strain T34), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 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 Trichoderma asperellum (strain T34) is to be considered as a potential sensitiser.

Conditions of use shall include risk mitigation measures where appropriate.

Zucchini Yellow Mosaic Virus — weak strain

ATCC accession number: PV-593

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 Zucchini Yellow Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids.

Conditions of use shall include risk mitigation measures, where appropriate.

Cyflumetofen

CAS No 400882-07-7

CIPAC No 721

F52Plant protection products containing cyflumetofen shall only be authorised for uses where the level of metabolite B3 in groundwater is expected to be below 0,1 μg/L.

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 cyflumetofen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.

In this overall assessment, Member States shall pay particular attention to:

• the protection of operators and workers;

• the protection of groundwater, in particular for metabolite B3, when the substance is applied in regions with vulnerable soils and/or climatic conditions;

• the protection of drinking water;

• the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

Trichoderma atroviride strain I-1237

CNCM number: I-1237

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 Trichoderma atroviride strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, 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 Trichoderma atroviride strain I-1237 is to be considered a potential sensitiser.

Conditions of use shall include risk mitigation measures where appropriate.

Ametoctradin

CAS No 865318-97-4

CIPAC No 818

≥ 980 g/kg

X1The impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 mg/kg and 2 g/kg respectively in the technical material.

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 ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04^f10 to groundwater under vulnerable conditions.

Conditions of use shall include risk mitigation measures, where appropriate.

Mandipropamid

CAS No 374726-62-2

CIPAC No 783

≥ 930 g/kg

The impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material.

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 mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis.

The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015.

Halosulfuron-methyl

CAS No 100785-20-1

CIPAC No 785.201

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 halosulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the risk of leakage to groundwater of the metabolite ‘halosulfuron’ rearrangement (HSR)^f11 under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron,

• the risk to non-target terrestrial plants.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies;

2. (b)

   information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured;

3. (c)

   data to clarify the potential genotoxic properties of chlorosulfonamide acid^f12.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.

Bacillus firmus I-1582

Collection number: CNCMI-1582

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 Bacillus firmus I-1582, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 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 Bacillus firmus I-158

2 is to be considered as a potential sensitiser.

Conditions of use shall include risk mitigation measures, where appropriate.

Candida oleophila strain O

Collection number: MUCL40654

Nominal content: 3 × 10 ¹⁰ CFU/g dried product

Range: 6 × 10 ⁹ – 1 × 10 ¹¹ CFU/g dried product

Helicoverpa armigera nucleopolyhedrovirus

DSMZ number: BV-0003

Paecilomyces fumosoroseus strain FE 9901

Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490

Minimum 1,0 × 10 ⁹ CFU/g

Maximum 3,0 × 10 ⁹ CFU/g

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 Paecilomyces fumosoroseus strain FE 9901, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, 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 Paecilomyces fumosoroseus strain FE 9901 is to be considered as a potential sensitiser.

Conditions of use shall include risk mitigation measures, where appropriate.

Potassium phosphonates (no ISO name)

CAS No

13977-65-6 for potassium hydrogen phosphonate

13492-26-7 for dipotassium phosphonate

Mixture: none

CIPAC No 756 (for potassium phosphonates)

Potassium hydrogen phosphonate,

Dipotassium phosphonate

31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions)

17,8 to 20,0 % potassium

≥ 990 g/kg on dry weight basis

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 potassium phosphonates, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the risk to birds and mammals,

• the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.

Spiromesifen

CAS No 283594-90-1

CIPAC No 747

≥ 965 g/kg (racemic)

The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.

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 spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the long-term risk to aquatic invertebrates,

• the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,

• the protection of workers and operators.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.

Spodoptera littoralis nucleopolyhedrovirus

DSMZ number: BV-0005

Bixafen

CAS No 581809-46-3

CIPAC No 819

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 bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the residues of bixafen and of its metabolites in rotational crops;

2. (b)

   the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

3. (c)

   the risk to aquatic organisms;

4. (d)

   the risk to soil and sediment-dwelling organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

Maltodextrin

CAS No 9050-36-6

CIPAC No 801

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 maltodextrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the potential increased growth of fungi and possible presence of mycotoxins on the surface of treated fruits;

2. (b)

   the potential risk to honeybees and non-target arthropods.

Conditions of use shall include risk mitigation measures, where appropriate.

Eugenol CAS No 97-53-0

CIPAC No 967

≥ 990 g/kg

Relevant impurity: methyl eugenol maximum 0,1 % of the technical material

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 eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate,

• the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,

• the risk to aquatic organisms,

• the risk to insectivorous birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   the storage stability (2 years) at ambient temperature on the formulated product;

2. (b)

   data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms;

3. (c)

   the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.

Geraniol CAS No 106-24-1

CIPAC No 968

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 geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to

• the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

• the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

• the risk to aquatic organisms;

• the risk to birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards

1. (a)

   data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;

2. (b)

   the groundwater exposure.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.

Thymol

CAS No

89-83-8

CIPAC No

969

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 thymol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to

• the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

• the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

• the risk to aquatic organisms;

• the risk to birds and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards

1. (a)

   data comparing natural background exposure situations of thymol in relation to exposure from the use of thymol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;

2. (b)

   the long-term and reproductive toxicity, in a form of a full report (in English) of the Combined Test of Repeated Oral-Administration Toxicity and Reproductive Toxicity of Thymol;

3. (c)

   the groundwater exposure.

The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.

Sedaxane

CAS No 874967-67-6

(trans isomer: 599197-38-3/cis isomer: 599194-51-1)

CIPAC No 833

≥ 960 g/kg Sedaxane

(range 820-890 g/kg for the 2 trans-isomers 50:50 mixture of enantiomers and range 100-150 g/kg for the 2 cis-isomers 50:50 mixture of enantiomers)

PART A

PART B

Emamectin

CAS No

• emamectin: 119791-41-2

  (formerly 137335-79-6) and 123997-28-4

• emamectin benzoate: 155569-91-8

  (formerly 137512-74-4 and 179607-18-2)

• emamectin B1a benzoate: 138511-97-4

• emamectin B1b benzoate: 138511-98-5

CIPAC No

• emamectin: 791

• emamectin benzoate: 791.412

• Emamectin B1a:

  (10 E ,14 E ,16 E )-(1 R ,4S,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-6′-[( S )- sec -butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 ^4,8 .0 ^20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L- lyxo -hexapyranosyl)-α-L- arabino -hexapyranoside

• Emamectin B1b:

  (10 E ,14 E ,16 E )-(1 R ,4 S ,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 ^4,8 .0 ^20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L-l yxo -hexapyranosyl)-α-L- arabino -hexapyranoside

• Emamectin B1a benzoate:

  (10 E ,14 E ,16 E )-(1 R ,4S,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-6′-[( S )- sec -butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 ^4,8 .0 ^20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L- lyxo -hexapyranosyl)-α-L- arabino -hexapyranoside benzoate

• Emamectin B1b benzoate:

  (10 E ,14 E ,16 E )-(1 R ,4 S ,5′ S ,6 S ,6′ R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1 ^4,8 .0 ^20,24 ]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′ H -pyran)-12-yl 2,6-dideoxy-3- O -methyl-4- O -(2,4,6-trideoxy-3- O -methyl-4-methylamino-α-L-l yxo -hexapyranosyl)-α-L- arabino -hexapyranoside benzoate

≥ 950 g/kg

as emamectin benzoate anhydrous

(a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate)

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 emamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the risk to non-target invertebrates;

• the protection of workers and operators.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the risk of enantio-selective metabolisation or degradation.

The applicant shall submit to the Commission, Member States and the Authority the relevant information two years after adoption of the pertinent guidance document on evaluation of isomer mixtures.

Pseudomonas sp. strain DSMZ 13134

Collection number: DSMZ 13134

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 Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 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 Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.

The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.

Fluopyram

CAS No 658066-35-4

CIPAC No 807

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 fluopyram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the long-term risk to insectivorous birds;

2. (2)

   the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.

The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.

Aureobasidium pullulans (strains DSM 14940 and DSM 14941)

Collection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941

Minimum 5,0 × 10 ⁹ CFU/g for each strain;

Maximum 5,0 × 10 ¹⁰ CFU/g for each strain

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 Aureobasidium pullulans (strains DSM 14940 and DSM 14941), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 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 Aureobasidium pullulans (strains DSM 14940 and DSM 14941) is to be considered as a potential sensitizer.

Conditions of use shall include risk mitigation measures, where appropriate.

Pyriofenone:

CAS No 688046-61-9

CIPAC No 827

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 pyriofenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards

1. (a)

   the identity of two impurities to fully support the provisional specification;

2. (b)

   the toxicological relevance of the impurities present in the proposed technical specification except for the one impurity for which an acute oral study and an Ames test were provided.

The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.

Disodium phosphonate

CAS No 13708-85-5

CIPAC No 808

281-337 g/kg (TK)

≥ 917 g/kg (TC)

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 disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards

1. (a)

   the chronic risk to fish;

2. (b)

   the long term risk to earthworms and soil macro-organisms.

The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.

Penflufen

CAS No 494793-67-8

CIPAC No 826

≥ 950 g/kg

1:1 (R:S) ratio of enantiomers

F75PART A

PART B

Orange oil

CAS No 8028-48-6 (Orange extract)

5989-27-5 (D-limonene)

CIPAC No 902

≥ 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)

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:

1. (a)

   the protection of operators and workers;

2. (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.

Penthiopyrad

CAS No 183675-82-3

CIPAC No 824

≥ 980 g/kg

(50:50 racemic mixture)

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:

1. (a)

   the protection of operators and workers;

2. (b)

   the risk to aquatic and soil organisms;

3. (c)

   the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

4. (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. (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. (2)

   the toxicological profile and the reference values of the metabolite PAM;

3. (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.

Benalaxyl-M

CAS No 98243-83-5

CIPAC No 766

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.

Tembotrione

CAS No 335104-84-2

CIPAC No 790

≥ 945 g/kg

The following relevant impurities must not exceed a certain threshold in the technical material:

Toluene: ≤ 10 g/kg

HCN: ≤ 1 g/kg

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 tembotrione, 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:

1. (a)

   the protection of operators and workers;

2. (b)

   the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

Spirotetramat

CAS No 203313-25-1

CIPAC No 795

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 spirotetramat, 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 risk to insectivorous birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the potential for endocrine disruptor effects in birds and fish to the Commission, the Member States and the Authority within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

Pyroxsulam

CAS No 422556-08-9

CIPAC No 793

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 pyroxsulam, 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:

1. (a)

   the risk to groundwater, when the active substance is applied in regions with vulnerable soil or climatic conditions;

2. (b)

   the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the toxicological relevance of impurity number 3 (as referred to in the review report);

2. (2)

   the acute toxicity of the metabolite PSA;

3. (3)

   the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742.

The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.

Chlorantraniliprole

CAS No 500008-45-7

CIPAC No 794

≥ 950 g/kg

The following relevant impurities must not exceed a certain threshold in the technical material:

• Acetonitrile: ≤ 3 g/kg

• 3-picoline: ≤ 3 g/kg

• Methanesulfonic acid: ≤ 2 g/kg

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 chlorantraniliprole, 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 risk to aquatic organisms and to soil macroorganisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxamide);

2. (2)

   the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one).

The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.

Sodium silver thiosulfate

CAS No not allocated

CIPAC No 762

≥ 10,0 g Ag/kg

Expressed as silver (Ag)

PART A

PART B

Pyridalyl

CAS No 179101-81-6

CIPAC No 792

PART A

PART B

S-abscisic acid

CAS No

21293-29-8

CIPAC No

Not allocated

(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acid

or

(7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid

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 S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

L-ascorbic acid

CAS No 50-81-7

CIPAC No 774

≥ 990 g/kg

The following relevant impurities shall not exceed:

Methanol: ≤ 3 g/kg

Heavy Metals: ≤ 10 mg/kg (expressed as Pb)

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 L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to aquatic and soil organisms;

2. (b)

   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.

The applicant shall submit confirmatory information as regards:

1. (1)

   the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms;

2. (2)

   the risk to contaminate groundwater.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.

Spinetoram

CAS No 935545-74-7

CIPAC No 802

• XDE-175-J (Major factor)

  (2 R ,3a R ,5a R ,5b S ,9 S ,13 S ,14 R ,16a S , 16b R )-2-(6-deoxy-3- O -ethyl-2,4-di- O -methyl-α-L-mannopyranosyloxy)-13-[(2 R ,5 S ,6 R )-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1 H - as -indaceno[3,2- d ]oxacyclododecine-7,15-dione

• XDE_175-L (Minor factor)

  (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione

≥ 830 g/kg

50-90 % XDE-175-J;

and

50-10 % XDE-175-L

Tolerance limits (g/kg):

XDE-175-J = 581-810

XDE-175-L = 83-270

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 spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to aquatic and soil organisms;

2. (b)

   the risk to non-target arthropods in-field;

3. (c)

   the risk to bees during the application (overspray) and subsequently.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information X2within 6 months after the adoption of pertinent guidance on the assessment of isomers.

1,4-dimethylnaphthalene

CAS No 571-58-4

CIPAC No 822

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 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the protection of operators and of workers at re-entry and during inspection of the warehouse;

2. (b)

   the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the residue definition for the active substance.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.

Amisulbrom

CAS No 348635-87-0

CIPAC No 789

≥ 985 g/kg

The following relevant impurity must not exceed a certain threshold in the technical material:

3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg

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 amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1 H -1,2,4-triazol-3-ylsulfonyl)-1 H -indole and 1-(dimethylsulfamoyl)-1 H -1,2,4-triazole-3-sulfonic acid to contaminate groundwater;

2. (2)

   the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1 H -1,2,4-triazole-3-sulfonic acid, 1 H -1,2,4-triazole-3-sulfonic acid, 1 H -1,2,4-triazole, N , N -dimethyl-1 H -1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3 H -indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff;

3. (3)

   depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water;

4. (4)

   the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1 H -1,2,4-triazol-3-ylsulfonyl)-1 H -indole;

5. (5)

   the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1 H -1,2,4-triazol-3-ylsulfonyl)-1 H -indole.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption.

Valifenalate

CAS No 283159-90-0

CIPAC No 857

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 valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 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 the potential of metabolite S5 to contaminate groundwater.

The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.

Thiencarbazone

CAS No 317815-83-1

CIPAC No 797

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 thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to

1. (a)

   the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions;

2. (b)

   the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts.

That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018.

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 acequinocyl, 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 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

• the protection of workers and operators;

• the risk to birds, mammals and aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   an analytical method for residues in body fluids and tissues;

2. (b)

   the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards;

3. (c)

   the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals.

The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.

Ipconazole

CAS No

125225-28-7 (mixture of diastereoisomers)

115850-69-6 (ipconazole cc, cis isomer)

115937-89-8 (ipconazole ct, trans isomer)

CIPAC No 798

≥ 955 g/kg

Ipconazole cc: 875 – 930 g/kg

Ipconazole ct: 65 – 95 g/kg

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 ipconazole, 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 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. 1..

   the risk to granivorous birds;

2. 2..

   the protection of workers and operators;

3. 3..

   the risk to fish.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   the acceptability of the long-term risk to granivorous birds;

2. (b)

   the acceptability of the risk to soil macro-organisms;

3. (c)

   the risk of enantio-selective metabolisation or degradation;

4. (d)

   the potential endocrine disrupting properties of ipconazole for birds and fish.

The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level.

Flubendiamide

CAS No 272451-65-7

CIPAC No 788

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 flubendiamide, 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 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to aquatic invertebrates;

2. (b)

   the potential presence of residues in rotational crops.

Conditions of use shall include risk mitigation measures, where appropriate.

Bacillus pumilus QST 2808

USDA Agricultural Research Service (NRRL) Patent culture collection in Peoria Illinois, USA under the reference number B-30087

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 Bacillus pumilus QST 2808, 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 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 Bacillus pumilus QST 2808 is to be considered as a potential sensitizer.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   the identification of the aminosugar produced by Bacillus pumilus QST 2808;

2. (b)

   analytical data for the content of that aminosugar in the production batches.

The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.

Metobromuron

CAS No 3060-89-7

CIPAC No 168

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 metobromuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the protection of workers and operators;

2. (b)

   the risk to birds, mammals, aquatic organisms and terrestrial non-target plants.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline;

2. (b)

   the acceptability of the long-term risk to birds and mammals.

The applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016.

Aminopyralid

CAS No 150114-71-9

CIPAC No 771

≥ 920 g/kg

The following relevant impurity shall not exceed a certain threshold:

Picloram ≤ 40 g/kg

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 aminopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;

2. (b)

   the risk to aquatic macrophytes and terrestrial non-target plants;

3. (c)

   chronic risk to fish.

Conditions of use shall include risk mitigation measures, where appropriate.

Metaflumizone

CAS No 139968-49-3

CIPAC No 779

≥ 945 g/kg

(90-100 % E-isomer

10-0 % Z-isomer)

The following relevant impurities shall not exceed a certain threshold:

• Hydrazine ≤ 1 mg/kg

• 4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kg

• Toluene ≤ 2 g/kg

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 metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to fish and sediment dwelling organisms;

2. (b)

   the risk to snail- or earthworm-eating birds.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;

2. (2)

   information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.

Streptomyces lydicus strain WYEC 108

Collection number: American Type Culture Collection (USDA)

ATCC 55445

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 Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to aquatic organisms;

2. (b)

   the risk to soil dwelling organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

Meptyldinocap

CAS No 6119-92-2

CIPAC No 811

≥ 900 g/kg (mixture of trans- and cis- isomers with a defined ratio range of 25:1 to 20:1)

Relevant impurity:

2,6-dinitro-4-[(4 RS )-octan-4-yl]phenyl (2 E/Z )-but-2-enoate

max content 0,4 g/kg

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 meptyldinocap, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 May 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to operators;

2. (b)

   the risk to aquatic invertebrates.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   the groundwater exposure assessment for metabolites (3 RS )-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2 RS )-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709);

2. (b)

   the possible impact of any preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (a) by 31 March 2017 and the information set out in point (b) two years after the adoption of specific guidance by the Commission.

Chromafenozide

CAS No 143807-66-3

CIPAC No 775

≥ 935 g/kg

The following relevant impurity must not exceed a certain threshold in the technical material:

Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg

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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;

2. (b)

   the risk to non-target Lepidoptera in off-crop areas;

3. (c)

   the risk to sediment-dwelling organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;

2. (2)

   the assessment of the risk to sediment dwelling organisms from metabolite M-010;

3. (3)

   the leaching potential of metabolites M-006 and M-023 to groundwater.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.

Gamma-cyhalothrin

CAS No 76703-62-3

CIPAC No 768

( S )-α-cyano-3-phenoxybenzyl (1 R ,3 R )-3-[( Z )-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or

( S )-α-cyano-3-phenoxybenzyl (1 R )- cis -3-[( Z )-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate

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 gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the safety of operators and workers;

2. (b)

   the risk to aquatic organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;

2. (2)

   the toxicity profile of the metabolites CPCA, PBA and PBA(OH);

3. (3)

   the long-term risk to wild mammals;

4. (4)

   the potential for biomagnification in terrestrial and aquatic food chains.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.

Bacillus amyloliquefaciens subsp. plantarum strain D747

Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405

Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234.

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 Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 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 Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.

Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.

Terpenoid blend QRD 460

CIPAC No: 982

Terpenoid blend QRD 460 is a blend of three components:

• α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;

• p -cymene: 1-isopropyl-4-methylbenzene;

• d -limonene: ( R )-4-isopropenyl-1-methylcyclohexene.

The nominal concentration of each component in the active substance as manufactured should be as follows:

• α-terpinene: 59,7 %;

• p -cymene: 22,4 %;

• d -limonene: 17,9 %.

Each component should have a minimum purity as follows:

• α-terpinene: 89 %;

• p -cymene: 97 %;

• d -limonene: 93 %.

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 terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the stability of formulations on storage;

2. (b)

   the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

3. (c)

   the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

4. (d)

   the protection of surface water and aquatic organisms;

5. (e)

   the protection of bees and non-target arthropods.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (1)

   the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material;

2. (2)

   the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.

The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.

Fenhexamid

CAS No: 126833-17-8

CIPAC No: 603

≥ 975 g/kg

The following relevant impurity must not exceed a certain threshold in the technical material:

• toluene: max. 1 g/kg,

• 4-amino-2,3-dichlorophenol: max. 3 g/kg.

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 fenhexamid, 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 operators during field crop handheld operations,

• the protection of workers re-entering indoor-treated crops,

• the risk to aquatic organisms,

• the long-term risk to mammals for field uses.

Conditions of use shall include risk mitigation measures, where appropriate.

Halauxifen-methyl

CAS No:943831-98-9

CIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen)

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 halauxifen-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 risk to aquatic and non-target terrestrial plants.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

• The technical specification of the active substance as manufactured (based on commercial scale production). The relevance of impurities present in the technical material should be confirmed,

• The compliance of the toxicity batches with the technical specification.

The applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016.

Pyridate

CAS No: 55512-33-9

CIPAC No: 447

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 pyridate, 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, non-target terrestrial plants, and herbivorous mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

Sulfoxaflor

CAS No: 946578-00-3

CIPAC No: 820

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 sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

1. (a)

   the risk to bees and other non-target arthropods;

2. (b)

   the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

1. (a)

   the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust;

2. (b)

   risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds;

3. (c)

   the risk to pollinators other than honey bees;

4. (d)

   the risk to bee brood.