Reform history

Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances Text with EEA relevance

100 versions · 2011-05-25
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Changes on 2014-09-15

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| 130 | Cyprodinil CAS No 121522-61-2 CIPAC No 511 | (4-cyclopropyl-6-methyl-pyrimidin-2-yl)-phenyl-amine | ≥ 980 g/kg | 1 May 2007 | 30 April 2018 | PART AOnly uses as fungicide may be authorised.PART BFor 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 cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States:— must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones.The concerned Member States shall request the submission of further studies to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA 304075 in food of animal origin. They shall ensure that the notifiers at whose request cyprodinil has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 131 | Fosetyl CAS No 15845-66-6 CIPAC No 384 | Ethyl hydrogen phosphonate | ≥ 960 g/kg (expressed as fosetyl-Al) | 1 May 2007 | 30 April 2018 | PART AOnly uses as fungicide may be authorised.PART BFor 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 fosetyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States:— must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target arthropods.Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.The concerned Member States shall request the submission of further studies to confirm the risk assessment for non-target arthropods, in particular with regard to in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at whose request fosetyl has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 132 | Trinexapac CAS No 104273-73-6 CIPAC No 732 | 4-(cyclopropyl-hydroxymethylene)-3,5-dioxo- cyclohexanecarboxylic acid | ≥ 940 g/kg (expressed as trinexapac-ethyl) | 1 May 2007 | 30 April 2018 | PART AOnly uses as plant growth regulator may be authorised.PART BFor 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 trinexapac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.In this overall assessment Member States:— must pay particular attention to the protection of birds and mammals.Conditions of authorisation should include risk mitigation measures, where appropriate. |
| 133 | Dichlorprop-P CAS No 15165-67-0 CIPAC No 476 | (R)-2-(2,4-dichlorophenoxy) propanoic acid | ≥ 900 g/kg | 1 June 2007 | 31 May 2017 | PART AOnly uses as herbicide may be authorised.As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.Use on grassland shall not be authorised.PART BFor 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 dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 134 | Metconazole CAS No 125116-23-6 (unstated stereo-chemistry) CIPAC No 706 | (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol | ≥ 940 g/kg (sum of cis-and trans-isomers) | 1 June 2007 | 31 May 2017 | PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor 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 metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment:— Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. |
| 133 | Dichlorprop-P CAS No 15165-67-0 CIPAC No 476 | (R)-2-(2,4-dichlorophenoxy) propanoic acid | ≥ 900 g/kg | 1 June 2007 | 30 April 2018 | PART AOnly uses as herbicide may be authorised.As regards cereals, only application in spring may be authorised, at rates not exceeding 800 g active substance per hectare per application.Use on grassland shall not be authorised.PART BFor 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 dichlorprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants.Conditions of authorisation shall include risk mitigation measures, where appropriate. |
| 134 | Metconazole CAS No 125116-23-6 (unstated stereo-chemistry) CIPAC No 706 | (1RS,5RS:1RS,5SR)-5-(4-chlorobenzyl)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol | ≥ 940 g/kg (sum of cis-and trans-isomers) | 1 June 2007 | 30 April 2018 | PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor 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 metconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment:— Member States must pay particular attention to the protection of aquatic organisms, birds and mammals. Conditions of authorisation should include risk mitigation measures, where appropriate, — Member States must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate. |
| 135 | Pyrimethanil CAS No 53112-28-0 CIPAC No not allocated | N-(4,6-dimethylpyrimidin-2-yl) aniline | ≥ 975 g/kg (the manufacturing impurity cyanamide is considered to be of toxicological concern and must not exceed 0,5 g/kg in the technical material) | 1 June 2007 | 30 April 2018 | PART AOnly uses as fungicide may be authorised.PART BFor 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 pyrimethanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States:— must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones, — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment.The Member States concerned shall request the submission of further studies to confirm the risk assessment to fish. They shall ensure that the notifiers at whose request pyrimethanil has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 136 | Triclopyr CAS No 055335-06-3 CIPAC No 376 | 3,5,6-trichloro-2-pyridyloxyacetic acid | ≥ 960 g/kg (as Triclopyr butoxyethyl ester) | 1 June 2007 | 31 May 2017 | PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing triclopyr for uses other than spring applications in pasture and grassland, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.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 triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States:— must pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate, — must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation should include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further studies to confirm the acute and long-term risk assessment for birds and mammals and the risk to aquatic organisms from exposure to the metabolite 6-chloro-2-pyridinol. They shall ensure that the notifiers at whose request triclopyr has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 136 | Triclopyr CAS No 055335-06-3 CIPAC No 376 | 3,5,6-trichloro-2-pyridyloxyacetic acid | ≥ 960 g/kg (as Triclopyr butoxyethyl ester) | 1 June 2007 | 30 April 2018 | PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing triclopyr for uses other than spring applications in pasture and grassland, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.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 triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.In this overall assessment Member States:— must pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated in vulnerable zones, where appropriate, — must pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — must pay particular attention to the protection of birds, mammals, aquatic organisms and non-target plants. Conditions of authorisation should include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further studies to confirm the acute and long-term risk assessment for birds and mammals and the risk to aquatic organisms from exposure to the metabolite 6-chloro-2-pyridinol. They shall ensure that the notifiers at whose request triclopyr has been included in this Annex provide such studies to the Commission within two years from the approval. |
| 137 | Metrafenone CAS No 220899-03-6 CIPAC No 752 | 3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone | ≥ 940 g/kg | 1 February 2007 | 30 April 2018 | PART AOnly uses as fungicide may be authorised.PART BFor 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 metrafenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.The Member States 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. |
| 138 | Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713 Culture collection No: NRRL B -21661 CIPAC No not allocated | Not applicable | | 1 February 2007 | 30 April 2018 | PART AOnly uses as fungicide may be authorised.PART BFor 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 subtilis, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. |
| 139 | Spinosad CAS No 131929-60-7 (Spinosyn A) 131929-63-0 (Spinosyn D) CIPAC No 636 | Spinosyn A: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosyn D: (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-ß-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]as-indacene-7,15-dione Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D | ≥ 850 g/kg | 1 February 2007 | 30 April 2018 | PART AOnly uses as insecticide may be authorised.PART BFor 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 spinosad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.In this overall assessment Member States— must pay particular attention to the protection of aquatic organisms; — must pay particular attention to the risk to earthworms when the substance is used in glasshouses.Conditions of use shall include risk mitigation measures, where appropriate. |
@@ -261,7 +261,7 @@
| 195 | Bacillus thuringiensis subsp. kurstaki STRAIN: ABTS 351 Culture collection: No ATCC SD-1275 STRAIN: PB 54 Culture collection: No CECT 7209 STRAIN: SA 11 Culture collection: No NRRL B-30790 STRAIN: SA 12 Culture collection: No NRRL B-30791 STRAIN: EG 2348 Culture collection: No NRRL B-18208 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide may be authorised.PART BFor 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 thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54 (SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 196 | Bacillus thuringiensis subsp. Tenebrionis STRAIN: NB 176 (TM 141) Culture collection: No SD-5428 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide may be authorised.PART BFor 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 thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 197 | Beauveria bassiana STRAIN: ATCC 74040 Culture collection: No ATCC 74040 STRAIN: GHA Culture collection: No ATCC 74250 | Not applicable | Max level of beauvericin: 5 mg/kg | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide may be authorised.PART BFor 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 Beauveria bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 198 | Cydia pomonella Granulovirus (CpGV) | Not applicable | Contaminating micro-organisms (Bacillus cereus) < 1 × 106 CFU/g | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide may be authorised.PART BFor 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 Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 198 | Cydia pomonella Granulovirus (CpGV) | Not applicable | Minimum concentration: 1 × 10<sup>13</sup> OB/l (occlusion bodies/l) and Contaminating microorganisms (*Bacillus cereus*) in the formulated product < 1 × 10<sup>7</sup> CFU/g | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide may be authorised.PART BFor 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 Cydia pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 199 | Lecanicillium muscarium (formerly Verticilium lecanii) STRAIN: Ve 6 Culture collection: No CABI (=IMI) 268317, CBS 102071, ARSEF 5128 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide may be authorised.PART BFor 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 Lecanicillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 200 | Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) STRAIN: BIPESCO 5/F52 Culture collection: No M.a. 43; No 275-86 (acronyms V275 or KVL 275); No KVL 99-112 (Ma 275 or V 275); No DSM 3884; No ATCC 90448; No ARSEF 1095 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART AOnly uses as insecticide and acaricide may be authorised.PART BFor 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 Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5 and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| 201 | Phlebiopsis gigantea STRAIN: VRA 1835 Culture collection: No ATCC 90304 STRAIN: VRA 1984 Culture collection: No DSM16201 STRAIN: VRA 1985 Culture collection: No DSM 16202 STRAIN: VRA 1986 Culture collection: No DSM 16203 STRAIN: FOC PG B20/5 Culture collection: No IMI 390096 STRAIN: FOC PG SP log 6 Culture collection: No IMI 390097 STRAIN: FOC PG SP log 5 Culture collection: No IMI 390098 STRAIN: FOC PG BU 3 Culture collection: No IMI 390099 STRAIN: FOC PG BU 4 Culture collection: No IMI 390100 STRAIN: FOC PG 410.3 Culture collection: No IMI 390101 STRAIN: FOC PG97/1062/116/1.1 Culture collection: No IMI 390102 STRAIN: FOC PG B22/SP1287/3.1 Culture collection: No IMI 390103 STRAIN: FOC PG SH 1 Culture collection: No IMI 390104 STRAIN: FOC PG B22/SP1190/3.2 Culture collection: No IMI 390105 | Not applicable | No relevant impurities | 1 May 2009 | 30 April 2019 | PART AOnly uses as fungicide may be authorised.PART BFor 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 Phlebiopsis gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
@@ -349,53 +349,8 @@
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| 254 | Sodium hypochlorite CAS No: 7681-52-9 CIPAC: 848 | Sodium hypochlorite | Sodium hypochlorite: 105 g/kg-126 g/kg (122 g/L-151 g/L) technical concentrate 10-12 % (w/w) expressed as chlorine | 1 September 2009 | 31 August 2019 | PART AOnly indoor uses as disinfectant may be authorised.PART BFor 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 sodium hypochlorite (SANCO/2988/2008) 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.In this overall assessment Member States shall pay particular attention to:(a) the risk to operator and workers; (b) the exposure of soil to sodium hypochlorite and its reaction products through spreading of treated compost on organic land shall be avoided.Conditions of use shall include risk mitigation measures, where appropriate. |
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| 255 | Straight Chain Lepidopteran Pheromones | Acetate group: | Review report (SANCO/2633/2008) | 1 September 2009 | 31 August 2019 | PART AOnly uses as attractants may be authorised.PART BFor 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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
| (E)-5-decen-1-yl acetate CAS No 38421-90-8 CIPAC No not allocated | (E)-5-decen-1-yl acetate | | | | | |
| (E)-8-dodecen-1-yl acetate CAS No 38363-29-0 CIPAC No not allocated | (E)-8-dodecen-1-yl acetate | | | | | |
| (E/Z)-8-dodecen-1-yl acetate CAS No not available CIPAC No not avaiable | (E/Z)-8-dodecen-1-yl acetate as individual isomers | | | | | |
| (Z)-8-dodecen-1-yl acetate CAS No 28079-04-1 CIPAC No not allocated | (Z)-8-dodecen-1-yl acetate | | | | | |
| (Z)-9-dodecen-1-yl acetate CAS No 16974-11-1 CIPAC No 422 | (Z)-9-dodecen-1-yl acetate | | | | | |
| (E,Z)-7,9-dodecadien-1-yl acetate CAS No 54364-62-4 CIPAC No not allocated | (E,Z)-7,9-dodecadien-1-yl acetate | | | | | |
| (E)-11-tetradecen-1-yl acetate CAS No 33189-72-9 CIPAC No not allocated | (E)-11-tetradecen-1-yl acetate | | | | | |
| (Z)-9-tetradecen-1-yl acetate CAS No 16725-53-4 CIPAC No not allocated | (Z)-9-tetradecen-1-yl acetate | | | | | |
| (Z)-11-tetradecen-1-yl acetate CAS No 20711-10-8 CIPAC No not allocated | (Z)-11-tetradecen-1-yl acetate | | | | | |
| (Z, E)-9, 12-tetradecadien-1-yl acetate CAS No 31654-77-0 CIPAC No not allocated | (Z, E)-9, 12-tetradecadien-1-yl acetate | | | | | |
| Z-11-hexadecen-1-yl acetate CAS No 34010-21-4 CIPAC No not allocated | Z-11-hexadecen-1-yl acetate | | | | | |
| (Z, E)-7, 11-hexadecadien-1-yl acetate CAS No 51606-94-4 CIPAC No not allocated | Z, E)-7, 11-hexadecadien-1-yl acetate | | | | | |
| (E, Z)-2, 13-octadecadien-1-yl acetate. CAS No 86252-65-5 CIPAC No not allocated | (E, Z)-2, 13-octadecadien-1-yl acetate. | | | | | |
| Alcohol group: | Alcohol group: | | | | | |
| (E)-5-decen-1-ol CAS No 56578-18-8 CIPAC No not allocated | (E)-5-decen-1-ol | | | | | |
| (Z)-8-dodecen-1-ol CAS No 40642-40-8 CIPAC No not allocated | (Z)-8-dodecen-1-ol | | | | | |
| (E,E)-8,10-dodecadien-1-ol CAS No 33956-49-9 CIPAC No not allocated | (E,E)-8,10-dodecadien-1-ol | | | | | |
| tetradecan-1-ol CAS No 112-72-1 CIPAC No not allocated | tetradecan-1-ol | | | | | |
| (Z)-11-hexadecen-1-ol CAS No 56683-54-6 CIPAC No not allocated | (Z)-11-hexadecen-1-ol | | | | | |
| Aldehyde group: | Aldehyde group: | | | | | |
| (Z)-7-tetradecenal CAS No 65128-96-3 CIPAC No not allocated | (Z)-7-tetradecenal | | | | | |
| (Z)-9-hexadecenal CAS No 56219-04-6 CIPAC No not allocated | (Z)-9-hexadecenal | | | | | |
| (Z)-11-hexadecenal CAS No 53939-28-9 CIPAC No not allocated | (Z)-11-hexadecenal | | | | | |
| (Z)-13-octadecenal CAS No 58594-45-9 CIPAC No not allocated | (Z)-13-octadecenal | | | | | |
| Blends acetates: | Blends acetates: | | | | | |
| (i) (Z)-8-dodecen-1-yl acetate CAS No 28079-04-1 CIPAC No not allocated and | (i) (Z)-8-dodecen-1-yl acetate and | | | | | |
| (ii) Dodecyl acetate CAS No 112-66-3 CIPAC No not allocated; | (ii) Dodecyl acetate; | | | | | |
| (i) (Z)-9-dodecen-1-yl acetate CAS No 16974-11-1 CIPAC No 422 and | (i) (Z)-9-dodecen-1-yl acetate and | | | | | |
| (ii) Dodecyl acetate CAS No 112-66-3 CIPAC No 422; | (ii) Dodecyl acetate; | | | | | |
| (i) (E,Z)-7,9-dodecadien-1-yl acetate CAS No 55774-32-8 CIPAC No not allocated and | (i) (E,Z)-7,9-dodecadien-1-yl acetate, and | | | | | |
| (ii) (E,E)-7,9-dodecadien-1-yl acetate CAS No 54364-63-5 CIPAC No not allocated; | (ii) (E,E)-7,9-dodecadien-1-yl acetate; | | | | | |
| (i) (Z,Z)-7,11-hexadecadien-1-yl acetate and | (i) (Z,Z)-7,11-hexadecadien-1-yl acetate and | | | | | |
| (ii) (Z,E)-7,11-hexadecadien-1-yl acetate CAS No i) & ii) 53042-79-8 CAS No i) 52207-99-5 CAS No ii) 51606-94-4 CIPAC No not allocated; | (ii) (Z,E)-7,11-hexadecadien-1-yl acetate; | | | | | |
| Blends aldehydes: | Blends aldehydes: | | | | | |
| (i) (Z)-9-hexadecenal CAS No 56219-04-6 CIPAC No not allocated and | (i) (Z)-9-hexadecenal and | | | | | |
| (ii) (Z)-11-hexadecenal CAS No 53939-28-9 CIPAC: not allocated and | (ii) (Z)-11-hexadecenal and | | | | | |
| (iii) (Z)-13-octadecenal CAS No 58594-45-9 CIPAC No not allocated; | (iii) (Z)-13-octadecenal; | | | | | |
| Blends mixtures: | Blends mixtures: | | | | | |
| (i) (E)-5-decen-1-yl acetate CAS No 38421-90-8 CIPAC No not allocated and | (i) (E)-5-decen-1-yl acetate and | | | | | |
| (ii) (E)-5-decen-1-ol CAS No 56578-18-8 CIPAC No not allocated; | (ii) (E)-5-decen-1-ol; | | | | | |
| (i) (E/Z)-8-dodecen-1-yl acetate CAS No as individual isomers CIPAC No not allocated; and | (i) (E/Z)-8-dodecen-1-yl acetate and | | | | | |
| (i) (E)-8-dodecen-1-yl acetate CAS No (E) 38363-29-0 CIPAC No not allocated and | (i) (E)-8-dodecen-1-yl acetate and | | | | | |
| (i) (Z)-8-dodecen-1-yl acetate CAS No (Z) 28079-04-1 CIPAC No not allocated and | (i) (Z)-8-dodecen-1-yl acetate and | | | | | |
| (ii) (Z)-8-dodecen-1-ol CAS No ii) 40642-40-8 CIPAC No not allocated; | (ii) (Z)-8-dodecen-1-ol; | | | | | |
| (i) (Z)-11-hexadecenal CAS No 53939-28-9 CIPAC No not allocated and | (i) (Z)-11-hexadecenal and | | | | | |
| (ii) (Z)-11-hexadecen-1-yl acetate CAS No 34010-21-4 CIPAC No not allocated | (ii) (Z)-11-hexadecen-1-yl acetate | | | | | |
| 255 | Straight Chain Lepidopteran Pheromones | Review report (SANCO/2633/2008) | Review report (SANCO/2633/2008) | 1 September 2009 | 31 August 2019 | PART AOnly uses as attractants may be authorised.PART BFor 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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards:(1) the genotoxic profile of aldehyde group compounds; (2) exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016. |
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| 256 | Trimethylamine hydrochloride CAS No 593-81-7 CIPAC No not allocated | Trimethylamine hydrochloride | ≥ 988 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly uses as attractant may be authorised.PART BFor 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 trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures. |
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| 257 | Urea CAS No 57-13-6 CIPAC No 913 | Urea | ≥ 98 % w/w | 1 September 2009 | 31 August 2019 | PART AOnly uses as attractant and fungicide may be authorised.PART BFor 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 urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.The notifier shall submit confirmatory information as regards:(a) the analysis method for urea and for the impurity biuret; (b) the risk for operators, workers and bystanders.The information set out in point (a) and in point (b) shall be submitted to the Member States, the Commission and the Authority respectively by 1 May 2013 and 1 January 2016. |
@@ -410,7 +365,7 @@
| 265 | 2,5-Dichlorobenzoic acid methylester CAS No 2905-69-3 CIPAC No 686 | methyl-2,5-dichlorobenzoate | ≥ 995 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.PART BFor 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 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. |
| 266 | Metamitron CAS No 41394-05-2 CIPAC No 381 | 4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one | ≥ 960 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly uses as herbicide may be authorised.PART BIn assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.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 metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:— the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate; — the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; — the risk to birds and mammals, and non-target terrestrial plants.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 267 | Sulcotrione CAS No 99105-77-8 CIPAC No 723 | 2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione | ≥ 950 g/kg Impurities: — hydrogen cyanide: not more than 80 mg/kg — toluene: not more than 4 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly uses as herbicide may be authorised.PART BFor 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 sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; — the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. |
| 268 | Tebuconazole CAS No 107534-96-3 CIPAC No 494 | (RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol | ≥ 905 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly uses as fungicide may be authorised.PART BFor 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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers to the tebuconazole (triazole) metabolites; — the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.The Member States concerned shall request the submission of further information to confirm the risk assessment for birds and mammals. They shall ensure that the notifier at whose request tebuconazole has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 268 | Tebuconazole CAS No 107534-96-3 CIPAC No 494 | (RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol | ≥ 905 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly uses as fungicide and plant growth regulator may be authorised.PART BFor 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 tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to:— the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — the dietary exposure of consumers to the tebuconazole (triazole) metabolites; — the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil or climatic conditions, in particular as regards the occurrence in groundwater of the metabolite 1,2,4-triazole; — the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 269 | Triadimenol CAS No 55219-65-3 CIPAC No 398 | (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol | ≥ 920 g/kg isomer A (1RS,2SR), isomer B (1RS,2RS) Diastereomer A, RS + SR, range: 70 to 85 % Diastereomer B, RR + SS, range: 15 to 30 % | 1 September 2009 | 31 August 2019 | PART AOnly uses as fungicide may be authorised.PART BFor 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 triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to:— the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure; — the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate.The Member States concerned shall ensure that the notifier submits to the Commission:— further information on the specification; — information to further address the risk assessment for birds and mammals. — information to further address the risk of endocrine disrupting effects on fish.They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines. |
| 270 | Methomyl CAS No 16752-77-50 CIPAC No 264 | S-methyl (EZ)-N-(methylcarbamoyloxy)thioacetimidate | ≥ 980 g/kg | 1 September 2009 | 31 August 2019 | PART AOnly uses as insecticide on vegetables may be authorised at rates not exceeding 0,25 kg active substance per hectare per application and for a maximum of 2 applications per season.Authorisations shall be limited to professional users.PART BFor 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 methomyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.In this overall assessment Member States shall pay particular attention to:— the operator safety: conditions of use shall prescribe the use of adequate personal protective equipment. Special attention shall be paid to the exposure of operators using knapsacks or other hand-held application equipment, — the protection of birds, — the protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as buffer zones, reduction of run-off and drift reduction nozzles, — the protection of non-target arthropods, in particular bees: risk mitigation measures to avoid all contact with bees shall be applied.Member States shall ensure that methomyl-based formulations contain effective repelling and/or emetic agents.Where appropriate, conditions of authorisation shall include further risk mitigation measures. |
| 271 | Bensulfuron CAS No 83055-99-6 CIPAC No 502.201 | α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluic acid (bensulfuron) methyl α-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-o-toluate (bensulfuron-methyl) | ≥ 975 g/kg | 1 November 2009 | 31 October 2019 | PART AOnly uses as a herbicide may be authorised.PART BFor 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 bensulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 8 December 2008 shall be taken into account.In this overall assessment Member States must pay particular attention to the following:— the protection of aquatic organisms; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate, — the protection of the groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions.The Member States concerned shall ensure that the notifier submits to the Commission:— further studies on the specification, — information to further address the route and rate of degradation of bensulfuron-methyl under aerobic flooded soil conditions, — information to address the relevance of metabolites for the consumer risk assessment.They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011. |
@@ -685,6 +640,8 @@
| 1 | *Equisetum arvense* L. CAS No: not allocated CIPAC No: not allocated | Not applicable | European Pharmacopeia | 1 July 2014 | *Equisetum arvense* L. may be used in accordance with the specific conditions included in the conclusions of the review report on *Equisetum arvense* L. (SANCO/12386/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014. |
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| 2 | Chitosan hydrochloride CAS no: 9012-76-4 | Not applicable | European Pharmacopeia Max content of heavy metals: 40 ppm | 1 July 2014 | Chitosan hydrochloride shall comply with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011. Chitosan hydrochloride may be used in accordance with specific conditions included in the conclusions of the review report on Chitosan hydrochloride (SANCO/12388/2013) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014. |
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| 3 | Sucrose CAS no: 57-50-1 | α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside | Food grade | 1 January 2015 | Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved. Sucrose shall be used in accordance with the specific conditions included in the conclusions of the review report on sucrose (SANCO/11406/2014) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014. |
| (<sup>1</sup>)Further details on identity, specification and manner of use of basic substance are provided in the review report. | | | | | |
(<sup>1</sup>) OJ L 309, 24.11.2009, p. 1.
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