Legalize / European Union / Implementing Regulation

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

Type Implementing Regulation

Publication 2011-06-11

Last updated 2026-07-21

State In force

Department European Commission

Source EUR-Lex

articles 2

Reform history JSON API

Article 1

The active substances, as set out in Part A of the Annex, shall be deemed to have been approved under Regulation (EC) No 1107/2009.

The active substances approved under Regulation (EC) No 1107/2009 are as set out in Part B of the Annex to this Regulation. The basic substances approved under Regulation (EC) No 1107/2009 are as set out in Part C of the Annex to this Regulation. The low-risk active substances approved under Regulation (EC) No 1107/2009 are as set out in Part D of the Annex to this Regulation. The candidates for substitution approved under Regulation (EC) No 1107/2009 are as set out in Part E of the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

It shall apply from 14 June 2011.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX ACTIVE SUBSTANCES

PART A

Active substances deemed to have been approved under Regulation (EC) No 1107/2009

General provisions applying to all substances listed in this Part:

— for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;

— Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.

Number	Common name, identification numbers	IUPAC name	Purity ¹	Date of approval	Expiration of approval	Specific provisions
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

40	Deltamethrin CAS No 52918-63-5 CIPAC No 333	(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate	980 g/kg	1 November 2003	30 June 2028	Only uses as insecticide may be authorised For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, — should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, — must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

57	Mecoprop-P CAS No 16484-77-8 CIPAC No 475	(R)-2-(4-chloro-o-tolyloxy)-propionic acid	860 g/kg	1 June 2004	15 October 2027	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

69	Fosthiazate CAS No 98886-44-3 CIPAC No 585	(RS)-S-sec-butyl O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate	930 g/kg	1 January 2004	31 January 2027	Only uses as insecticide or nematicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States — should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions; — should pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season; — should pay particular attention to the protection of non-target soil organisms. Risk mitigation measures should be applied where appropriate. In order to mitigate the potential risk to small birds, product authorisations must require that a very high level of incorporation of granules into soil is achieved. 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.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

74	Ziram CAS No 137-30-4 CIPAC No 31	Zinc bis (dimethyldithiocarbamate)	950 g/kg (FAO-specification) Arsenic: maximum 250 mg/kg Water: maximum 1,5 %	1 August 2004	31 January 2027	Only uses as fungicide or as repellent may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ziram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the protection of non-target arthropods and aquatic organisms. Risk mitigation measures should be applied, where appropriate, — Member States should observe the acute dietary exposure situation of consumers in view of future revisions of Maximum Residue Levels.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

81	Pyraclostrobin CAS No 175013-18-0 CIPAC No 657	methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate	975 g/kg The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.	1 June 2004	15 September 2026	Only uses as fungicide or plant growth regulator may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the protection of aquatic organisms, especially fish, — should pay particular attention to the protection of terrestrial arthropods and earthworms. Risk mitigation measures should be applied where appropriate. 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.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

88	Phenmedipham CAS No 13684-63-4 CIPAC No 77	methyl 3-(3-methylcarbaniloyloxy)carbanilate; 3-methoxycarbonylaminophenyl 3′-methylcarbanilate	Min. 970 g/kg	1 March 2005	30 September 2026	Only uses as herbicide may be authorised. For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phenmedipham, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 February 2004 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

102	Chlorotoluron (unstated stereochemistry) CAS No 15545-48-9 CIPAC No 217	3-(3-chloro-p-tolyl)-1,1-dimethylurea	975 g/kg	1 March 2006	30 June 2028	PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorotoluron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of authorisation should include risk mitigation measures, where appropriate
—————	—————	—————	—————	—————	—————	—————

104	Daminozide CAS No 1596-84-5 CIPAC No 330	N-dimethylaminosuccinamic acid	990 g/kg Impurities: — N-nitrosodimethylamine: not more than 2,0 mg/kg — 1,1-dimethylhydrazide: not more than 30 mg/kg	1 March 2006	15 September 2026	PART A Only uses as growth regulator in non-edible crops may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 February 2005 shall be taken into account. In this overall assessment Member States must pay particular attention to the safety of operators and workers after re-entry. Conditions of authorisation should include protective measures, where appropriate
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

107	MCPA CAS No 94-74-6 CIPAC No 2	4-chloro-o-tolyloxyacetic acid	≥ 930 g/kg	1 May 2006	31 July 2028	PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones
108	MCPB CAS No 94-81-5 CIPAC No 50	4-(4-chloro-o-tolyloxy)butyric acid	≥ 920 g/kg	1 May 2006	31 July 2028	PART A Only uses as herbicide may be authorised PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2005 shall be taken into account Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation should include risk mitigation measures, where appropriate Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

123	Clodinafop CAS No 114420-56-3 CIPAC No 683	(R)-2-[4-(5-chloro-3-fluoro- 2 pyridyloxy)-phenoxy]-propionic acid	≥ 950 g/kg (expressed as clodinafop-propargyl)	1 February 2007	31 July 2027	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clodinafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account.
124	Pirimicarb CAS No 23103-98-2 CIPAC No 231	2-dimethylamino-5,6-dimethylpyrimidin-4-yl dimethylcarbamate	≥ 950 g/kg	1 February 2007	31 October 2026	PART A Only uses as insecticide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pirimicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. 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. Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, such as buffer zones. The concerned Member States shall request the submission of further studies to confirm the long term risk assessment for birds and for potential groundwater contamination, in particular concerning metabolite R35140. They shall ensure that the notifiers at whose request pirimicarb has been included in this Annex provide such studies to the Commission within two years from the approval.
125	Rimsulfuron CAS No 122931-48-0 (rimsulfuron) CIPAC No 716	1-(4-6 dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl) urea	≥ 960 g/kg (expressed as rimsulfuron)	1 February 2007	15 August 2028	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. Member States must pay particular attention to the protection of non target plants and groundwater in vulnerable situations. Conditions of authorisation should include risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————

127	Triticonazole CAS No 131983-72-7 CIPAC No 652	(±)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol	≥ 950 g/kg	1 February 2007	31 January 2027	PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing triticonazole for uses other than seed treatment, 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 triticonazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 January 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety. Conditions of authorisation should include protective measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, in particular from the highly persistent active substance and its metabolite RPA 406341, in vulnerable zones, — must pay particular attention to the protection of granivorous birds (long term risk). Conditions of authorisation should include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of further studies to confirm the risk assessment for granivorous birds. They shall ensure that the notifier at whose request triticonazole has been included in this Annex provide such studies to the Commission within two years from the approval.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

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	31 October 2026	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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	31 October 2026	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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.
—————	—————	—————	—————	—————	—————	—————

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 October 2026	PART A Only 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 B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 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.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

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 March 2027	PART A Only uses as herbicide may be authorised. Only uses with a total application per year of maximum 480 g active substance per hectare shall be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 12 December 2014 shall be taken into account. In this overall assessment Member States: — shall pay particular attention to the protection of groundwater under vulnerable conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated in vulnerable zones, where appropriate, — shall pay particular attention to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment, — 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.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

147	Formetanate CAS No 23422-53-9 CIPAC No 697	3-dimethylaminomethyleneaminophenyl methylcarbamate	≥ 910 g/kg	1 October 2007	30 September 2026	PART A Only uses as insecticide and acaricide may be authorised. PART B In assessing applications to authorise plant protection products containing formetanate for uses other than in field tomatoes and ornamental shrubs 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 formetanate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of birds, mammals, non-target arthropods and bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; — must pay particular attention to the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment; — must pay particular attention to the dietary exposure of consumers in view of future revisions of Maximum Residue Levels. The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and non-target arthropods. They shall ensure that the notifier at whose request formetanate has been included in this Annex provide such studies to the Commission within two years from the approval.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

154	Propamocarb CAS No 24579-73-5 CIPAC No 399	Propyl 3-(dimethylamino) propylcarbamate	≥ 920 g/kg	1 October 2007	31 January 2027	PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing propamocarb for uses other than foliar applications, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards worker exposure 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 propamocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 24 November 2006 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators and workers safety. Conditions of authorisation should include protective measures, where appropriate; — the transfer of soil residues for rotating or succeeding crops; — the protection of surface and groundwater in vulnerable zones; — the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————

156	Pirimiphos-methyl CAS No 29232-93-7 CIPAC No 239	O-2-diethylamino-6-methylpyrimidin-4-yl O,O-dimethylphosphorothioate	> 880 g/kg	1 October 2007	31 January 2027	PART A Only uses as insecticide for post harvest storage can be authorised. Hand-held applications shall not be authorised. PART B In assessing applications to authorise plant protection products containing pirimiphos-methyl for uses other than applications with automated systems in empty cereals storehouses, 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 pirimiphos-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 2007 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment including respiratory protective equipment and risk mitigation measures to reduce the exposure; — the dietary exposure of consumers in view of future revisions of Maximum Residue Levels.
—————	—————	—————	—————	—————	—————	—————

158	Beflubutamid CAS No 113614-08-7 CIPAC No 662	(RS)-N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide	≥ 970 g/kg	1 December 2007	31 October 2026	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on beflubutamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 May 2007 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————

160	Prosulfocarb CAS No 52888-80-9 CIPAC No 539	S-benzyl dipropyl(thiocarbamat)	970 g/kg	1 November 2008	31 January 2027	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prosulfocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 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, — the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no spray buffer zone.
161	Fludioxonil CAS No 131341-86-1 CIPAC No 522	4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile	950 g/kg	1 November 2008	30 September 2026	PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, 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 and: — must pay particular attention to the potential for groundwater contamination, in particular from the soil photolysis metabolites CGA 339833 and CGA 192155, in vulnerable zones, — must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate. 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 fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken into account.
162	Clomazone CAS No 81777-89-1 CIPAC No 509	2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one	960 g/kg	1 November 2008	30 September 2026	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 October 2007 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, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones.
—————	—————	—————	—————	—————	—————	—————

164	Boscalid CAS No 188425-85-6 CIPAC No 673	2-Chloro-N-(4′-chlorobiphenyl-2-yl)nicotinamide	≥ 960 g/kg	1 August 2008	31 March 2028	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention — to the operator safety, — to the long term risk to birds and soil organisms, — to the risk of accumulation in soil if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include adequate risk mitigation measures, where appropriate.
—————	—————	—————	—————	—————	—————	—————

166	Fluoxastrobin CAS No 361377-29-9 CIPAC No 746	(E)-{2-[6-(2-chlorophenoxy)-5-fluoropyrimidin-4-yloxy]phenyl}(5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime	≥ 940 g/kg	1 August 2008	31 January 2027	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluoxastrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety, in particular when handling the undiluted concentrate. Conditions of use shall include adequate protective measures, such as wearing a face shield, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the levels of residues of the metabolites of fluoxastrobin, when straw from treated areas is used as animal feeding stuff. Conditions of use shall include restrictions for feeding to animals, where appropriate, — the risk of accumulation in the soil surface, if the substance is used in perennial crops or in succeeding crops in crop rotation. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — data to allow a comprehensive aquatic risk assessment to be made taking into account spray drift, run-off, drainage and the effectiveness of potential risk mitigation measures, — data on toxicity of non-rat metabolites if straw from treated areas is to be used as feedstuff. They shall ensure that the notifier at whose request fluoxastrobin has been included in this Annex provide such studies to the Commission within two years from the approval.
—————	—————	—————	—————	—————	—————	—————

168	Prothioconazole CAS No 178928-70-6 CIPAC No 745	(RS)-2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-1,2,4-triazole-3-thione	≥ 970 g/kg The following manufacturing impurities are of toxicological concern and each of them must not exceed a certain amount in the technical material: — Toluene: < 5 g/kg — Prothioconazole-desthio (2-(1-chlorocyclopropyl)1-(2-chlorophenyl)-3-(1,2,4-triazol-1-yl)-propan-2-ol): < 0,5 g/kg (LOD)	1 August 2008	31 March 2027	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prothioconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the operator safety in spray applications. Conditions of use shall include adequate protective measures, — the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate, — the protection of birds and small mammals. Risk mitigation measures shall be applied, where appropriate. Conditions of use shall include risk mitigation measures, where appropriate. The concerned Member States shall request the submission of: — information to allow the assessment of consumer exposure to triazole metabolite derivatives in primary crops, rotational crops, and products of animal origin, — a comparison of the mode of action of prothioconazole and the triazole metabolite derivatives to allow the assessment of the toxicity resulting from the combined exposure to these compounds, — information to further address the long-term risk to granivorous birds and mammals arising from the use of prothioconazole as a seed treatment. They shall ensure that the notifier at whose request prothioconazole has been included in this Annex provide such studies to the Commission within two years from the approval.
169	Amidosulfuron CAS No 120923-37-7 CIPAC No 515	3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea or 1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea	≥ 970 g/kg	1 January 2009	30 November 2026	PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, 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 amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, — the protection of aquatic plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.
170	Nicosulfuron CAS No 111991-09-4 CIPAC No 709	2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide or 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea	≥ 910 g/kg	1 January 2009	31 March 2027	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account. In this overall assessment Member States must pay particular attention to: — the potential exposure of the aquatic environment to metabolite DUDN when is applied in regions with vulnerable soil conditions, — the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, — the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, — the protection of groundwater and surface water under vulnerable soil and climatic conditions.
—————	—————	—————	—————	—————	—————	—————

172	Dicamba CAS No 1918-00-9 CIPAC No 85	3,6-dichloro-2-methoxybenzoic acid	≥ 850 g/kg	1 January 2009	31 March 2027	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on dicamba, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the protection of non-target plants. Conditions of use shall include adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the identification and quantification of a group of soil transformation products formed in a soil incubation study; (b) the potential for long range transport through the atmosphere. The notifier shall submit this information to the Member States, the Commission and the Authority by 30 November 2013.
173	Difenoconazole CAS No 119446-68-3 CIPAC No 687	3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether	≥ 940g/kg Toluene maximum content: 5 g/kg	1 January 2009	31 January 2028	PART A Only uses as fungicide may be authorised. PART B For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011 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 adequate risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) further data on the specification of the technical material; (b) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin; (c) the potential for endocrine disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 ¹⁶; (d) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment. The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by 31 May 2012, the information set out in points (b) and (c) by 30 November 2013 and the information set out in point (d) within 2 years from the adoption of specific guidance.
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————
—————	—————	—————	—————	—————	—————	—————

178	Picloram CAS No 1918-02-1 CIPAC No 174	4-amino-3,5,6-trichloropyridine-2-carboxylic acid	≥ 920 g/kg	1 January 2009	15 February 2028	PART A Only uses as herbicide may be authorised. PART B For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picloram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken into account. In the overall assessment Member States must pay particular attention to: — the potential for ground water contamination where picloram is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate; The Member States concerned shall ensure that the notifier submits to the Commission: — further information to confirm that the monitoring analytical method applied in residue trials correctly quantifies the residues of picloram and its conjugates; — a soil photolysis study to confirm the evaluation of picloram degradation. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.
—————	—————	—————	—————	—————	—————	—————

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.