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)Text with EEA relevance

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

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

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

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

PART A

Only uses as acaricide or insecticide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on milbemectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

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

Risk mitigation measures should be applied where appropriate.

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.

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.

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.

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.

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.

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.

PART A

Only uses as plant growth regulator 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 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.

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.

PART A

Only uses as fungicide and plant growth regulator 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 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.

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 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.

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.

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 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.

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 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.

PART A

Only uses as fungicide on the following crops may be authorised:

• cereals

• rape seed

• sugar and fodder beet

• maize

at rates not exceeding

• 0,25 kg active substance per hectare per application for cereals and rape seed;

• 0,075 kg active substance per hectare per application for sugar and fodder beet

• 0,1 kg active substance per hectare per application for maize.

The following uses must not be authorised:

• air application;

• knapsack and handheld applications neither by amateur nor by professional users;

• home gardening.

Member States shall ensure that all appropriate risk mitigation measures are applied. Particular attention must be paid to the protection of:

• aquatic organisms. Appropriate drift mitigation measures must be applied to minimise the exposure of surface water bodies. This should include keeping a distance between treated areas and surface water bodies alone or in combination with the use of drift-reducing techniques or devices;

• earthworms and other soil macro-organisms. Conditions of authorisation shall include risk mitigation measures, such as the selection of the most appropriate combination of numbers and timing of application, and, if necessary, the degree of concentration of the active substance;

• birds (long term risk). Depending on the results of the risk assessment for specific uses, targeted mitigation measures to minimise the exposure may become necessary;

• operators, who must wear suitable protective clothing, in particular gloves, coveralls, rubber boots and face protection or safety glasses during mixing, loading, application and cleaning of the equipment, unless the exposure to the substance is adequately precluded by the design and construction of the equipment itself or by the mounting of specific protective components on such equipment.

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

The Member States concerned shall request that the applicant provides the following to the Commission:

• by 1 December 2011 at the latest, information as regards the toxicological and ecotoxicological relevance of the impurity AEF037197;

• by 1 June 2012 at the latest, the examination of the studies included in the list in the draft re-assessment report of 16 July 2009 (Volume 1, Level 4 ‘Further information’, pp. 155 – 157);

• by 1 June 2013 at the latest, information on the fate and behaviour (route of aerobic degradation in soil) and the long term risk to birds.

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing captan for uses other than tomatoes 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 captan, 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 operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

• the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

• 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;

• the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the long term risk assessment for birds and mammals, as well as the toxicological assessment on metabolites potentially present in groundwater under vulnerable conditions. They shall ensure that the notifiers at whose request captan has been included in this Annex provide such studies to the Commission within two years from the approval.

PART A

Only uses as fungicide can be authorised.

PART B

In assessing applications to authorise plant protection products containing folpet for uses other than winter wheat 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 folpet, 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:

• operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

• the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

• the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for birds, mammals and earthworms. They shall ensure that the notifiers at whose request folpet has been included in this Annex provide such studies to the Commission within two years from the approval.

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.

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 dimethomorph, 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. Authorised conditions of use must prescribe the application of adequate personal protective equipment;

• to the protection of birds, mammals and aquatic organisms.

Conditions of authorisation should include risk mitigation measures, where appropriate.

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing metribuzin for uses other than in post-emergence selective herbicide in potatoes 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 metribuzin, 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 protection of algae, aquatic plants, non-target plants outside the treated field 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.

The Member States concerned shall request the submission of further data to confirm the risk assessment for groundwater. They shall ensure that the notifiers at whose request metribuzin has been included in this Annex provide such studies to the Commission within two years from the approval.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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:

1. the identification and quantification of a group of soil transformation products formed in a soil incubation study;

2. 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.

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:

1. further data on the specification of the technical material;

2. residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin;

3. 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⁾;

4. 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.

PART A

Only uses as plant growth regulator 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 imazaquin, 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

The notifier shall submit confirmatory information as regards:

1. further data on the specification of the technical material;

2. 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 and the information set out in point (b) within 2 years from the adoption of specific guidance.

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 lenacil, 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 this overall assessment Member States must pay particular attention to:

• the risk to aquatic organisms, especially algae and aquatic plants. Conditions of authorisation shall include risk mitigation measures, such as bufferzones between treated areas and surface water bodies;

• the protection of the groundwater, where the active substance is applied in regions with vulnerable soil or climatic conditions. Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission confirmatory information on the identity and characterisation of soil metabolites Polar B and Polars and metabolites M1, M2 and M3 whichoccurred in lysimeter studies and confirmatory data on rotational crops, including possible phytotoxic effects. They shall ensure that the notifier provides such information to the Commission by 30 June 2012.

If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council⁽³⁾ identifies the need for further information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3, Polar B and Polars, the Member States concerned shall request the submission of such information. They shall ensure that the notifier provides that information to the Commission within six months from the notification of such a classification decision.

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.

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 bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

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

1. the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

2. the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops;

3. the environmental conditions leading to the potential formation of nitrofen.

Member States shall impose restrictions as regards the conditions of use, where appropriate in view of point (c).

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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.

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

• the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

• the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.

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 fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 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,

• the protection of non target plants,

• the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure,

• the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur.

Conditions of authorisation should include risk mitigation measures, where appropriate.

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 fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 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 protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone.

The Member States concerned shall request the submission of:

• information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

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 tritosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

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

• the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

• the protection of aquatic organisms,

• the protection of small mammals.

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

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber 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 flutolanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 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 climatic conditions.

Conditions of authorisation should include risk mitigation measures, where appropriate.

PART A

Only uses as fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing fluazinam for uses other than potatoes, 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 fluazinam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

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

• the protection of the operators’ and workers’ safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

• the residues in food of plant and animal origin and evaluate the dietary exposure of consumers,

• the protection of aquatic organisms. In relation to this identified risk, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies to confirm the risk assessment for aquatic organisms and soil macro-organisms. They shall ensure that the notifiers at whose request fluazinam has been included in this Annex provide such studies to the Commission within two years from the approval.

PART A

Only uses as plant growth regulator may be authorised.

PART B

In assessing applications to authorise plant protection products containing mepiquat for uses other than in barley, 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 mepiquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

The Member States must pay particular attention to the residues in food of plant and animal origin and evaluate the dietary exposure of consumers.

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 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.

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 reports on Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008) and T-11 (SANCO/1841/2008) respectively, 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.

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 reports on Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908 (SANCO/1840/208) respectively 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.

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 reports on Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008) and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1 (SANCO/1868/2008) 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.

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 Trichoderma viride (SANCO/1868/2008), 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.

PART A

Only uses as acaricide may be authorised.

The following uses must not be authorised:

• applications in high crops with a high risk of spray drift, for example tractor mounted air-blast sprayer and hand-held applications.

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 fenpyroximate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 July 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 impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall request the submission of information to further address:

• the risk to aquatic organisms from metabolites containing the benzyl moiety,

• the risk of biomagnification in aquatic food chains.

They shall ensure that the notifiers at whose request fenpyroximate has been included in this Annex provide such information to the Commission within two years from the approval.

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing aclonifen for uses other than sunflower, 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 aclonifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 2008 shall be taken into account.

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

• the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the protection of the operators safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

• the residues in rotational crops and evaluate the dietary exposure of consumers,

• the protection of birds, mammals, aquatic organisms and non-target plants. In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

The Member States concerned shall request the submission of further studies on rotational crops residues and relevant information to confirm the risk assessment for birds, mammals, aquatic organisms and non-target plants.

They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the approval.

PART A

Only uses as herbicide may be authorised. Applications shall be limited to a total dose of not more than 1,0 kg metazachlor/ha in a three-year period on the same field.

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 metazachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 September 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,

• the protection of aquatic organisms,

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

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable zones, where appropriate.

If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information on the relevance of the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 with respect to cancer.

They shall ensure that the notifiers provide that information to the Commission within six months from the notification of such a classification decision.

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 acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.

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

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

The notifier shall submit confirmatory information as regards:

• the acute and long-term risk to birds and mammals,

• the risk to honeybees,

• the risk to non-target arthropods.

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

PART A

Only uses as repellent 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 aluminium ammonium sulphate (SANCO/2985/2008) 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:

1. the impact on the environment of the transformation/dissociation products of aluminium ammonium sulphate;

2. the risk to non-target terrestrial organisms other than vertebrates and aquatic organisms.

This information shall be submitted to the Member States, the Commission and the Authority by 1 January 2016.

PART A

Only uses as repellent 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 aluminium silicate (SANCO/2603/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator safety; conditions of use shall include the application of adequate personal and respiratory protective equipment, where appropriate.

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

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

2. the relevance of the test material used in the toxicity dossier in view of the specification of the technical material.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 1 May 2013.

PART A

Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 10Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1069/2009⁽¹⁷⁾ and Regulation (EU) No 142/2011⁽¹⁸⁾.

PART B

In assessing applications to authorise plant protection products containing blood meal for uses other than with direct application localised on individual plants, 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 authorization 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 amended review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

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

The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.

PART A

Only uses as repellent 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 amended review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

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

PART A

Only uses as repellent 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 amended review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

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

The notifier shall submit confirmatory information as regards:

• further data on the specification of the technical material,

• analytical methods for the determination of calcium carbonate in the representative formulation and of the impurities in the technical material.

These information shall be submitted to the Member States, the Commission and the Authority by 1 March 2013.

PART A

Only uses as a fumigant 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 carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.

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

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, 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 denathonium benzoate (SANCO/2607/2008) 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.

In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.

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

PART A

Only indoor uses as plant growth regulator by professional users 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 ethylene (SANCO/2608/2008) 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:

1. the compliance of ethylene with the required specifications, irrespective of the form in which it is supplied to the user;

2. the protection of operators, workers and bystanders.

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

PART A

Only uses as fungicide in greenhouse 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 extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to

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

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

• the protection of surface water and aquatic organisms;

• the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms.

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

The notifier shall submit confirmatory information as regards:

1. the plant metabolism and consumer exposure;

2. the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol;

3. the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products;

4. the effects on biological methods of sewage treatment.

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

PART A

Only uses as repellent may be authorised. Fat distillation residues of animal origin must be in compliance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council and Commission Regulation (EU) No 142/2011 (OJ L 54, 26.2.2011, p. 1).

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on fat distillation residues (SANCO/2610/2008) 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 the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.

PART A

Only uses as insecticide, acaricide, and herbicide and plant growth regulator 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 fatty acids (SANCO/2610/2008) 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.

PART A

Only uses as plant growth regulator 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 gibberellic acid (SANCO/2613/2008) 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.

PART A

Only uses as plant growth regulator 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 gibberellins (SANCO/2614/2008) 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.

PART A

Only uses as attractant may be authorised. Hydrolysed proteins of animal origin must be in compliance with Regulation (EC) No 1069/2009⁽¹⁷⁾ and Commission Regulation (EU) No 142/2011⁽¹⁸⁾.

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 hydrolysed proteins (SANCO/2615/08) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator and worker safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate.

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

The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

1. the specifications of the technical material, as commercially manufactured, supported by appropriate analytical data;

2. the risk to aquatic organisms.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 May 2013, the information set out in point (b) by 1 November 2013.

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 amended review report on iron sulphate (SANCO/2616/2008) 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.

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

• the risk for operator;

• the risk to children/residents playing on treated turf;

• the risk to surface waters and to aquatic organisms.

Conditions of use shall include, where appropriate, risk mitigation measures and the application of adequate personal protective equipment. The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers.

The Member States concerned shall ensure that the notifier submits to the Commission such information by 1 May 2013.

PART A

Only indoor uses as insecticide and acaricide by professional users 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 kieselgur (diatomaceous earth) (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the safety of operators and workers. Conditions of use shall include the application of adequate personal and respiratory protective equipment. Where necessary, conditions of use shall prohibit the presence of workers after application of the product concerned for a period appropriate in view of the risks caused by that product.

The Member States concerned shall ensure that the notifiers submit, by 25 November 2015, to the Commission, the Member States and the Authority information concerning the inhalation toxicity to confirm the occupational limits of kieselgur (diatomaceous earth).

PART A

Only uses as repellent 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 amended review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

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

PART A

Only uses as repellent 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 methyl nonyl ketone (SANCO/2619/2008) 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. Contact with food and feedcrops shall be avoided.

The notifier shall submit confirmatory information as regards:

1. the specification of the material tested in the mammalian toxicology and ecotoxicology studies;

2. the specification with suporting batch data and validated methods of analysis;

3. an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment;

4. the risk to aquatic and to soil living organisms.

The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (a) and (b) by 30 April 2013 and the information set out in points (c) and (d) by 31 December 2015.

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing pepper dust extraction residue (PDER) for uses other than in home garden area, 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 authorization 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 amended review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012 shall be taken into account.

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

The notifier shall submit to the Member States, the Commission and the Authority, confirmatory information on the specification of the technical material, by 1 March 2013.

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 citronella oil (SANCO/2621/2008) 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.

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

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

• the protection of groundwater, when the substance is applied in regions with vulnerable soil;

• the risk to non-target organisms.

The notifier shall submit confirmatory information as regards:

1. the technical specification;

2. data comparing natural background exposure situations of plant oils/citronella oil and methyl eugenol and methyl isoeugenol in relation to exposure from the use of plant oils/citronella oil as a plant protection product. This data shall cover human exposure as well as exposure of non-target organisms;

3. the groundwater exposure assessment for potential metabolites of plant oils/citronella oil, in particular for methyl eugenol and methyl isoeugenol.

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

PART A

Only indoor uses as post-harvest fungicide and bactericide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.

The notifier shall submit confirmatory information as regards

1. the technical specification;

2. data comparing natural background exposure situations of plant oils/clove oil, eugenol and methyl eugenol in relation to exposure from the use of plant oils/clove oil as a plant protection product. This data shall cover human exposure.

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

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.

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

PART A

Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised.

Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

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

PART A

Only uses as fungicide and 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 potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to honeybees. Conditions of use shall include, where appropriate, risk mitigation measures.

PART A

Only uses as attractant 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 1,4-diaminobutane (putrescine) (SANCO/2626/08) 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.

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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.

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

1. the risk to operators and workers;

2. the risk to non-target organisms.

Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures.

The applicant shall submit confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies;

2. the risk from inhalation;

3. the residue definition;

4. the representativeness of the major component ‘pyrethrin 1’ as regards the fate and behaviour in soil and water.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December 2015.

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing quartz sand for uses other than on trees in forestry, 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 authorization is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) 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.

PART A

Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.

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 fish oil (SANCO/2629/2008) 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 the specification of the technical material and the analysis of the maximum levels of impurities and contaminants of toxicological concern. This information shall be submitted to the Member States, the Commission and the Authority by 1 May 2013.

PART A

Only uses as repellent applied by glove or brush 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 amended review report on repellents by smell of animal or plant origin/tall oil crude (SANCO/2631/2008) 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.

In assessing applications to authorise plant protection products containing Repellents by smell of animal or plant origin/tall oil crude for uses other than as a repellent in forestry, 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 information is provided before such an authorisation is granted.

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

• the protection of operator, worker and bystander;

• the risk to non target species.

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

The Member States concerned shall request the submission of confirmatory information as regards:

1. the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;

2. the toxicological profile of repellents by smell of animal or plant origin/tall oil crude.

The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.

PART A

Only uses as repellent 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 amended review report on repellents by smell of animal or plant origin/tall oil pitch (SANCO/2632/2008) 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.

In assessing applications to authorise plant protection products containing repellents by smell of animal or plant origin/tall oil pitch for uses other than as a repellent in forestry applied by glove or brush, 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 information is provided before such an authorization is granted.

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

• the protection of operator, worker and bystander;

• the risk to non target species.

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

The Member States concerned shall request the submission of confirmatory information as regards:

1. the equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicity dossiers;

2. the toxicological profile of repellents by smell of animal or plant origin/tall oil pitch.

The Member States concerned shall ensure that the notifier submits to the Commission the information set out in point (a) by 1 May 2013 and the information set out in point (b) by 31 May 2014.

PART A

Only indoor uses as disinfectant 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 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:

1. the risk to operator and workers;

2. 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.

PART A

Only uses as attractants 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 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.

PART A

Only uses as attractant and 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 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:

1. the analysis method for urea and for the impurity biuret;

2. 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.

PART A

Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use aluminium phosphide containing products may be authorised.

As rodenticide, talpicide and leporicide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

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 aluminium phosphide, 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 protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

• the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

• the protection of operators and workers during fumigation for indoor uses;

• the protection of workers at re-entry (after fumigation period) for indoor uses;

• the protection of bystanders against leaking of gas for indoor uses;

• the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

• the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

PART A

Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-use magnesium phosphide containing products may be authorised.

As rodenticide, talpicide and leporicide only outdoor uses may be authorised.

Authorisations should be limited to professional users.

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 magnesium phosphide, 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 protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

• the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

• the protection of operators and workers during fumigation for indoor uses;

• the protection of workers at re-entry (after fumigation period) for indoor uses;

• the protection of bystanders against leaking of gas for indoor uses;

• the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

• the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

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

• the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

PART A

Only uses as fungicide on ornamentals in glasshouse 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 dodemorph, 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 where appropriate;

• the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;

• conditions of authorisation should include risk mitigation measures, where appropriate.

PART A

Only indoor uses as plant growth regulator and fungicide for grafting of grapevines 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 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.

PART A

Only uses as herbicide may be authorised.

PART B

In 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.

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 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.

PART A

Only uses as fungicide and plant growth regulator 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 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.

PART A

Only uses as a 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 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.

PART A

Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

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

• the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

• the protection of the groundwater, 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.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

PART A

Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

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

• the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

• the protection of the groundwater, 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.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

PART A

Only use as plant growth regulator 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 sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 2008 shall be taken into account.

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

• the specification of the technical material as commercially manufactured, which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the protection of the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure,

• the protection of the groundwater, 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.

The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 October 2011.

PART A

Only uses as acaricide and insecticide may be authorised.

PART B

In assessing applications to authorise plant protection products containing tebufenpyrad in formulations other than water soluble bags 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 tebufenpyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 December 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 protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

• the protection of insectivorous birds and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the notifier submits to the Commission:

• further information confirming that no relevant impurities are present,

• information to further address the risk to insectivorous birds.

They shall ensure that the notifier provides such information to the Commission by 31 October 2011.

PART A

Only uses as plant growth regulator on cereals and non edible crops may be authorised.

PART B

In assessing applications to authorise plant protection products containing chlormequat for uses other than in rye and triticale, notably as regards the exposure of consumers, 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 chlormequat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 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 birds and mammals.

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

The Member States concerned shall request the submission of further information on the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of the predicted concentrations in groundwater, surface water and sediment), the monitoring methods for determination of the substance in animal products and water, and the risk to aquatic organisms, birds and mammals. They shall ensure that the notifier at whose request chlormequat has been included in this Annex provide such information to the Commission by 30 November 2011 at the latest.

PART A

Only uses as bactericide and fungicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing copper for uses other than on tomatoes in greenhouses, 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 copper compounds, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009, shall be taken into account.

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

• the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

• the protection of water and non-target organisms. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate,

• the amount of active substance applied and ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effects and do not cause any unacceptable effect on the environment taking into account background levels of copper at the application site.

The notifiers shall present to the Commission, the Authority and the Member States a monitoring programme for vulnerable areas where the contamination of the soil and water (including sediments) by copper is a concern or may become one.

That monitoring programme shall be submitted by 31 July 2015. The interim results of such monitoring programme shall be submitted as interim report to the Rapporteur Member State, the Commission and the Authority by 31 December 2016. Final results shall be submitted by 31 December 2017.

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 propaquizafop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

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

• the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

• the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

• the protection of non-target arthropods and ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

The Member States concerned shall ensure that the notifier submits to the Commission:

• further information on the relevant impurity Ro 41-5259,

• information to further address the risk to aquatic organisms and to non-target arthropods.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

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 quizalofop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 January 2009 shall be taken into account.

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

• the specification of the technical material as commercially manufactured which must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material,

• the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

• the protection of non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

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

The Member States concerned shall ensure that the notifier submits to the Commission further information on the risk to non-target arthropods.

They shall ensure that the notifier provides such information to the Commission by 30 November 2011.

PART A

Only uses as herbicide in application max. of 1,0 kg/ha only every third year on the same field 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 dimethachlor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

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

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential groundwater contamination from metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in vulnerable zones, where appropriate.

The Member States concerned shall:

• ensure that the notifier submits to the Commission further studies on the specification by 1 January 2010.

If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008, the Member States concerned shall request the submission of further information on the relevance of the metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier provides that information to the Commission within six months from the notification of the classification decision concerning that substance.

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 etofenprox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 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 bees and non-target arthropods; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate.

The Member States concerned shall:

• ensure that the notifier submits to the Commission further information on the risk to aquatic organisms including the risk to sediment dwellers and biomagnification,

• the submission of further studies on the endocrine disruption potential in aquatic organisms (fish full life cycle study).

They shall ensure that the notifiers provide such studies to the Commission by 31 December 2011.

PART A

Only uses as fungicides 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 penconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 climatic conditions.

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

The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall ensure that the notifier at whose request penconazole has been included in this Annex provide such information to the Commission by 31 December 2011 at the latest.

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 tri-allate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 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 dietary exposure of consumers to residues of tri-allate in treated crops as well as in succeeding rotational crops and in products of animal origin

• the protection of aquatic organisms and non-target plants and ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate,

• the potential for ground water contamination by the degradation products TCPSA when the active substance is applied in regions with vulnerable soil and/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 assess the primary plant metabolism,

• further information on the fate and behaviour of the soil metabolite diisopropylamine,

• further information on the potential for biomagnification in aquatic food chains,

• information to further address the risk to fish-eating mammals and the long-term risk to earthworms.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

PART A

Only uses as fungicide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2009 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 arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier submit to the Commission further information to confirm the risk assessment for birds, mammals, sediment dwelling organisms and non-target arthropods. They shall ensure that the notifier at whose request sulphur has been included in this Annex provide such data to the Commission at latest by 30 June 2011.

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 tetraconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2009 shall be taken into account.

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

• the protection of aquatic organisms and non-target plants; in relation to these identified risks, risk mitigation measures, such as buffer zones, shall be applied where appropriate,

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

The Member States concerned shall request:

• the submission of further information on a refined consumer risk assessment,

• further information on the specification regarding ecotoxicology,

• further information on the fate and behaviour of potential metabolites in all relevant compartments,

• the refined risk assessment of such metabolites to birds, mammals aquatic organisms and non-target arthropods,

• further information on the potential for endocrine disrupting effects to birds, mammals and fish.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

Part A

Only uses as insecticide, acaricide and 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 paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, including its addendum, and in particular Appendices I and II thereof, shall be taken into account.

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

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oil 8042-47-5, and in particular Appendices I and II thereof, shall be taken into account.

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

The Member States concerned shall request:

• The submission of the specification of the technical material as commercially manufactured to verify the compliance with purity criteria of European Pharmacopoeia. 6,0

• They shall ensure that the notifier provides such information to the Commission by 30 June 2010.

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 cyflufenamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 2 October 2009 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 climatic conditions.

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

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 fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.

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

• the protection of aquatic organisms,

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

• to the risk to operators during application,

• the potential for long range transport via air.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.

PART A

Only uses as a post-harvest fungicide for indoor use 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 2-phenylphenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009, as amended in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.

In this overall assessment Member States must pay particular attention:

• to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment,

• to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the drenching and other application systems. Member States permitting the release of wastewater into the sewage system, shall ensure that a local risk assessment is carried out.

The Member States concerned shall ensure that the notifier submits to the Commission:

• further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel,

• further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates.

They shall ensure that the notifier provides such information to the Commission by 31 December 2011.

Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers.

They shall ensure that the notifier provides such information to the Commission by 31 December 2012.

PART A

Only uses as an insecticide in greenhouses with a permanent structure may be authorised. Authorisations shall be limited to professional users.

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 malathion, 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.

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

1. releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic organisms;

2. the protection of pollinator colonies purposely placed in the greenhouse;

3. the protection of operators and workers, so as to ensure that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate;

4. the protection of consumers in the case of processed commodities.

Member States shall ensure that malathion-based formulations are accompanied by the necessary instructions to avoid any risk of formation of isomalathion in excess of the permitted maximum quantities during storage and transport.

Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.

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 penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.

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

• the protection of aquatic organisms,

• the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops,

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

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

The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July 2012.

The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

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 proquinazid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account.

In this overall assessment, Member States must pay particular attention:

• to the long-term risk to earthworm-eating birds for uses in grapevine,

• to the risk to aquatic organisms,

• the dietary exposure of consumers to proquinazid residues in products of animal origin and in succeeding rotational crops,

• to the operator safety.

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

The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.

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 metalaxyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 12 March 2010 shall be taken into account.

Member States must pay particular attention to the potential contamination of groundwater by the active substance or its degradation products CGA 62826 and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied where appropriate.

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 flonicamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010, shall be taken into account.

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

• the risk to operators and re-entry workers,

• the risk to bees.

Conditions of authorisation shall include risk mitigation measures 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.

PART A

Only uses as insecticide/nematicide (fumigant) applied by professional users in sealable structures may be authorised insofar:

1. these structures are empty; or

2. where food or feed commodities are present in a fumigated facility, the users and the food business operators ensure that only the food or feed commodities compliant with the existing maximum residue levels for sulfuryl fluoride and fluoride ion set by Regulation (EC) No 396/2005 of the European Parliament and of the Council⁽¹⁹⁾ may enter the food and feed chain; to this purpose, the users and the food business operators shall fully implement measures equivalent to the HACCP principles as laid down in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council⁽²⁰⁾; in particular, the users shall identify the critical control point at which control is essential to prevent maximum residue levels to be exceeded, and establish and implement effective monitoring procedures at that critical control point.

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 sulfuryl fluoride, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 7 December 2016 shall be taken into account.

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

• the risk posed by inorganic fluoride through contaminated products, such as flour and bran that remained in the mill machinery during fumigation, or grain stored in silos in the mill. Measures are required to ensure that only products complying with the existing MRLs enter the food and feed chain;

• the risk to operators and the risk to workers, such as when re-entering a fumigated structure after aeration. Measures are required to ensure that they wear self-containing breathing apparatus or other appropriate personal protective equipment;

• the risk to bystanders by applying an appropriate exclusion zone around the fumigated structure.

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

The notifier shall submit to the Commission, Member States and the Authority monitoring data on tropospheric concentrations of sulfuryl fluoride every fifth year, starting from 30 June 2017. The limit of detection for the analysis shall be at least 0,5 ppt (equivalent to 2,1 ng sulfuryl fluoride/m³ of tropospheric air).

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 napropamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010, shall be taken into account.

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

• operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,

• protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,

• consumer safety as regards the occurrence in groundwater of the metabolite 2-(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’.

The Member States concerned shall ensure that the applicant presents to the Commission, by 31 December 2012 at the latest, information confirming the surface water exposure assessment as regards the photolysis metabolites and the metabolite NOPA and information for the risk assessment of aquatic plants.

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 quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

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

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

• the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops

• the risk to aquatic organisms and the long term risk for earthworms.

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

The Member States concerned shall request the submission of information as regards:

• the potential of plant metabolism to result in an opening of the quinoline ring;

• residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5.

They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall 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 aquatic organisms and mammals,

• the risk to non target arthropods including honeybees.

Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify the real exposure of honeybees to pyridaben in areas extensively used by such bees for foraging or by beekeepers, where and as appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

• the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,

• the potential long term risk for mammals,

• the assessment of fat soluble residues.

They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.

PART A

Only uses as rodenticide in the form of ready-to-use baits placed in bait stations or target locations 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 zinc phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

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

• the protection of non target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread of baits where only part of the content has been consumed.

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 cycloxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to non-target plants.

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

The Member States concerned shall request the submission of further information concerning the methods for analysis of residues of cycloxydim in plant and animal products.

The Member States concerned shall ensure that the applicant submits such methods of analysis to the Commission by 31 May 2013.

PART A

Only uses as plant growth regulator 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 6-benzyladenine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate.

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 bromuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

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

• operator's safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

• protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones.

The Member States concerned shall ensure that the applicant presents to the Commission:

• further information on residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

• information to further address the long term risk to herbivorous mammals.

They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31 January 2013 at the latest.

The Member States concerned shall ensure that the applicant submits to the Commission further information addressing the potential endocrine disrupting properties of bromuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

PART A

Only uses as insecticide and acaricide on 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 buprofezin, 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.

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

• the operators' and workers' safety and ensure that conditions of use impose the use of adequate personal protective equipment where appropriate,

• the application of an appropriate waiting period for rotational crops in greenhouses,

• the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures, where appropriate.

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

PART A

Only uses as fungicide for seed pelleting of sugar beets in professional seed treatment facilities 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 hymexazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

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

• the operators and workers safety. Conditions of authorisation shall include protective measures, where appropriate,

• the risk to granivorous birds and mammals.

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

The Member States concerned shall request the submission of confirmatory information as regards the nature of residues in root crops and the risk for granivorous birds and mammals.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

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 dodine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 23 November 2010 shall be taken into account.

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

• the potential long-term risk to birds and mammals;

• the risk to aquatic organisms and ensure that conditions of use impose adequate risk mitigation measures;

• the risk to non-target plants in the off-field area and ensure that conditions of use impose adequate risk mitigation measures;

• the monitoring of residue levels in pome fruit.

The Member States concerned shall request the submission of confirmatory information as regards:

• long-term risk assessment for birds and mammals,

• risk assessment in natural surface water systems where major metabolites have potentially formed.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

PART A

Only uses as plant growth regulator in ornamentals 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 indolylbutyric acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operators and workers safety. Conditions of authorisation shall include the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure.

The Member States concerned shall request the submission of further information to confirm:

• the absence of clastogenicity potential of indolylbutyric acid;

• the vapour pressure of indolylbutyric acid and, consequently, an inhalation toxicity study;

• the natural background concentration of indolylbutyric acid in the soil.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tau-fluvalinate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

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

• the risk to aquatic organisms and ensure that conditions of use prescribe the application of adequate risk mitigation measures;

• the risk to non-target arthropods and ensure that conditions of use prescribe the application of adequate risk mitigation measures;

• the test material used in the toxicity dossiers shall be compared and verified against the specification of the technical material commercially manufactured.

The Member States concerned shall request the submission of confirmatory information as regards:

• the risk of bioaccumulation/biomagnification in the aquatic environment;

• the risk to non-target arthropods;

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

The Member States concerned shall ensure that the applicant submits confirmatory information, two years after the adoption of specific guidance, as regards:

• the possible impact on the environment of the potential enantio-selective degradation in environmental matrices.

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 clethodim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 December 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the protection to aquatic organisms, birds and mammals, and shall ensure that conditions of use include the application of adequate risk mitigation measures.

The Member States concerned shall request the submission of confirmatory information, on the basis of most recent scientific knowledge, as regards:

• the soil and groundwater exposure assessments,

• the residue definition for risk assessment.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

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 bupirimate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

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

• the protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate,

• the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigations, where appropriate,

• the in-field risk to non-target arthropods.

The Member States concerned shall request the submission of confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured, by appropriate analytical data; including information on the relevance of the impurities,

2. the equivalence between the specifications of the technical material; as commercially manufactured, and those of the test material used in the toxicity dossiers,

3. the kinetic parameters, the soil degradation and the adsorption and desorption parameter for the major soil metabolite DE-B⁽⁶⁾.

The Member States concerned shall ensure that the applicant submits such confirmatory data and information to the Commission set out in point (1) and (2) by 30 November 2011 and the information set out in point (3) by 31 May 2013.

PART A

Only uses as plant growth regulator 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 1-decanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

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

• the risk to consumers from residues in case of use on food or feed crops;

• the risk for operator and ensure that conditions of use prescribe the application of adequate 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 aquatic organisms;

• the risk to non-target arthropods and bees that may be exposed to the active substance by visiting flowering weeds present in the crop at time of application.

Risk mitigation measures shall be applied, where appropriate.

The Member States concerned shall request the submission of confirmatory information, as regards the risk to aquatic organisms and of information confirming the groundwater, surface water and sediment exposure assessments.

The Member States concerned shall ensure that the applicant submits such confirmatory information to the Commission by 31 May 2013.

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 isoxaben, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, the risk to non-target terrestrial plants and the potential leaching of metabolites to groundwater.

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

The Member States concerned shall request the submission of confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured,

2. the relevance of the impurities;

3. the residues in rotational crops;

4. the potential risk to aquatic organisms.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a) and (b) by 30 November 2011 and the information set out in points (c) and (d) by 31 May 2013.

PART A

Only uses as herbicide on cotton 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 fluometuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

• pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

• pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate;

• pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards:

1. the toxicological properties of the plant metabolite trifluoroacetic acid;

2. the analytical methods for the monitoring of fluometuron in air;

3. the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water;

4. the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.

The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within six months from the notification of the decision classifying fluometuron.

PART A

Only uses as nematicide, fungicide, herbicide and insecticide may be authorised. Only application as soil fumigant may be authorised. Use shall be limited to one application every third year.

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 dazomet, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

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

• the risk to operators, workers and bystanders;

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

• the risk to aquatic organisms.

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

The Member States concerned shall request the submission of confirmatory information as regards:

1. the potential groundwater contamination by methyl isothiocyanate;

2. the assessment of the long range atmospheric transport potential of methyl isothiocyanate and related environmental risks;

3. the acute risk to insectivorous birds;

4. the long term risk to birds and mammals.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.

PART A

Only uses as molluscicide 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 metaldehyde, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

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

• the risk to operators and workers;

• the dietary exposure situation of consumers in view of future revisions of maximum residue levels;

• the acute risk and long term risk to birds and mammals.

Member States shall ensure that authorisations shall contain an effective dog repellent agent.

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

PART A

Only uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption 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 sintofen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain.

The Member States concerned shall request the submission of confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

2. the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide;

3. the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material;

4. the metabolic profile of sintofen in rotational crops.

The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 30 November 2011 and the information set out in point (4) by 31 May 2013.

PART A

Only uses as acaricide in greenhouses 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 fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, and of the addendum to the review report on fenazaquin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 22 March 2018, shall be taken into account.

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

1. the protection of aquatic organisms;

2. the protection of operators, also ensuring that the conditions of the use include the application of adequate personal protective equipment;

3. the protection of bees;

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

5. the risk to consumers, in particular from the residues generated during processing;

6. the conditions of use to avoid exposure to residues of fenazaquin with respect to crops for human and animal consumption.

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

PART A

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 azadirachtin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 and of the addendum to the review report on azadirachtin, and in particular Appendices I and II thereto, as finalised by the Standing Committee on Plants, Animals, Food and Feed on 17 July 2020 shall be taken into account.

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

1. the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

2. the protection of non-target arthropods and aquatic organisms.

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

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 azadirachtin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

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

• the dietary exposure of consumers in view of future revisions of Maximum Residue Levels;

• the protection of non target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

• the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.

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 diclofop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

• pay particular attention to the operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment;

• pay particular attention to the risk to aquatic organisms and non target plants and require risk mitigation measures to be applied.

The Member States concerned shall request the submission of confirmatory information as regards:

1. a metabolism study on cereals;

2. an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest two years after the adoption of a specific guidance document on evaluation of isomers mixtures.

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 lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

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

• operator safety and shall ensure that the conditions of authorisation include appropriate protective measures;

• to the protection of aquatic organisms and non target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate.

PART A

Only indoor uses as post-harvest bactericide for ornamental plants 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 aluminium sulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

The Member States concerned shall request the submission of confirmatory information as regards the specification of the technical material, as commercially manufactured, in the form of appropriate analytical data.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 30 November 2011.

PART A

Only uses as plant growth regulator 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 paclobutrazol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the risk to aquatic plants and ensure that conditions of use include the risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured;

2. the analytical methods in soil and surface water for the metabolite NOA457654;

3. the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

4. the potential endocrine disrupting properties of paclobutrazol;

5. the potential adverse effects of breakdown products of the different optical structures of paclobutrazol and its metabolite CGA 149907 on the environmental compartments soil, water and air.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 30 November 2011, the information set out in points (3) by 31 May 2013, the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption and the information set out in point (5) within two years after the adoption of specific guidance.

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 tebufenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.

In this overall assessment Member States shall:

• pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment;

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

• pay particular attention to the protection of aquatic organism and ensure that conditions of use prescribe adequate mitigation measures;

• pay particular attention to the risk to Lepidoptera non-target insects.

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

The Member States concerned shall request the submission of confirmatory information, as regards:

1. the relevance of metabolites RH-6595, RH-2651, M2;

2. the degradation of tebufenozide in anaerobic soils and soils of alkaline pH.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.

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 dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 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 risk mitigation measures, where appropriate,

• pay particular attention to the operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate,

• pay particular attention to the long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

• the storage stability and the nature of residues in processed products,

• the aquatic and groundwater exposure assessment for phthalic acid,

• the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde and 1,2 benzenedimethanol.

The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 May 2013.

PART A

Only uses as acaricide may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on hexythiazox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 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 risk mitigation measures, where appropriate;

• the operators and workers safety. Conditions of use shall include protective measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

1. the toxicological relevance of the metabolite PT-1-3⁽¹⁴⁾;

2. the potential occurrence of the metabolite PT-1-3 in processed commodities;

3. the potential adverse effects of hexythiazox on bee brood;

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

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (a), (b) and (c) by 31 May 2013 and the information set out in point (d) two years after the adoption of specific guidance.

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 flurochloridone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 February 2011 shall be taken into account.

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

1. the risk for non-target plants and aquatic organisms;

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

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

The Member States concerned shall ensure that the applicant submits to the Commission further confirmatory information as regards:

1. the relevance of impurities other than toluene;

2. the compliance of ecotoxicological test material with the technical specifications;

3. the relevance of the groundwater metabolite R42819⁽¹⁵⁾;

4. the potential endocrine disrupting properties of flurochloridone.

The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 1 December 2011, the information set out in point (3) by 31 May 2013 and the information set out in point (4) within two years after the adoption of the OECD test guidelines on endocrine disruption.

PART A

Only uses as herbicide in rice 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 bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures where appropriate.

The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03⁽²⁾, M04⁽³⁾ and M10⁽⁴⁾.

They shall ensure that the applicant provides such information to the Commission by 31 July 2013.

PART A

Only uses as herbicide in rice 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 profoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

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

• the long-term risk to non-target organisms.

Conditions of authorisation shall include risk mitigation measures where appropriate.

PART A

Only uses as herbicide may be authorised.

Aerial applications may 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 azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

1. the protection of non-target plants;

2. the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions;

3. the protection of aquatic organisms.

Member States shall ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).

The notifier shall submit confirmatory information as regards:

1. the risk assessment on aquatic organisms;

2. the identification of the degradation products in the aqueous photolysis of the substance.

The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

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 azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

1. the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;

2. the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

3. the protection of aquatic organisms.

The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.

The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

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 imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment Member States shall:

1. pay particular attention to the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;

2. pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;

3. pay particular attention to the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;

4. ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out;

5. pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.

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

The notifier shall submit confirmatory information as regards:

1. route of degradation of imazalil in soil and surface water systems;

2. environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;

3. a hydrolysis study to investigate the nature of residues in processed commodities.

The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

PART A

Only uses as plant growth regulator 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 prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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 spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

1. the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

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

3. the risk to aquatic organisms.

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

The notifier shall submit confirmatory information as regards:

1. the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;

2. the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;

3. the groundwater exposure assessment for metabolite M03⁽⁷⁾;

4. the risk to aquatic organisms.

The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.

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 kresoxim-methyl and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.

Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.

The applicant shall submit confirmatory information as regards:

Groundwater exposure risk assessment, and in particular:

• on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L,

• on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L,

• on a groundwater exposure risk assessment for the late application in apples, pears and grapes.

The applicant shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.

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

• the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil or with vulnerable climatic conditions;

• the risk to aquatic organisms.

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

PART A

Only uses as insecticide may be authorised.

The seed coating shall only be performed in professional seed treatment facilities. These facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tefluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

• the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment,

• the risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage,

• ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorisation.

The applicant shall submit confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured;

2. a validated analytical method for water;

3. the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in point (2) by 31 December 2012, and the information set out in point (3) 2 years after the adoption of a specific guidance document on evaluation of isomers mixture.

PART A

Only uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per year.

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 oxyfluorfen, 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.

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

• operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate,

• the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.

Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.

PART A

Only uses as plant growth regulator 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 1-naphthylacetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.

In this overall assessment Member States:

1. shall pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

2. shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

3. shall pay particular attention to the risk to aquatic organisms;

4. shall pay particular attention to the risk to non-target plants;

5. shall pay particular attention to the risk to birds.

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

The applicant shall submit confirmatory information as regards:

1. the risk to non-target plants;

2. the long-term risk to birds.

The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.

PART A

Only uses as plant growth regulator 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 1-naphthylacetic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment Member States:

1. shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

2. shall pay particular attention to the dietary exposure situation of consumers in view of future revisions of maximum residue levels;

3. shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

4. shall pay particular attention to the risk to aquatic organisms;

5. shall pay particular attention to the risk to birds.

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

The applicant shall submit confirmatory information as regards:

1. the route and rate of degradation in soil including an assessment of the potential for photolysis;

2. the long-term risk to birds.

The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.

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 fluquinconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment Member States:

1. shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

2. shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);

3. shall pay particular attention to the risk to birds and mammals.

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

The applicant shall submit confirmatory information as regards:

1. residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

2. the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure;

3. the acute risk to insectivorous mammals;

4. the long-term risk to insectivorous and herbivorous birds and mammals;

5. the risk to earthworm-eating mammals;

6. the endocrine disruption potential in aquatic organisms (fish full life cycle study).

The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.

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 fluazifop-P, 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 consumer safety as regards the occurrence in groundwater of the metabolite compound X⁽⁵⁾;

• pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

• pay particular attention to the protection of surface water and groundwater in vulnerable zones;

• pay particular attention to the risk for non-target plants.

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

The applicant shall submit confirmatory information as regards:

1. the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;

2. the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

3. the potential long-term risk to herbivorous mammals;

4. the fate and behaviour in the environment of the metabolite compounds X⁽⁵⁾ and IV⁽⁶⁾;

5. the potential risk to fish and aquatic invertebrates for the metabolite compound IV⁽⁶⁾.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.

PART A

Only uses as fungicide for use as seed treatment 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 triazoxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.

In this overall assessment Member States:

1. shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

2. shall pay particular attention to the risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures.

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the long-term risk to granivorous mammals by 30 September 2013.

PART A

Only uses as fungicide and bactericide in greenhouses 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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate.

The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards:

1. the method of analysis for air;

2. a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.

The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.

PART A

Only uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acrinathrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.

In this overall assessment Member States:

1. shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

2. shall pay particular attention to the risk to aquatic organisms, in particular fish, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;

3. shall pay particular attention to the risk to non-target arthropods and bees and shall ensure that conditions of authorisation include risk mitigation measures.

The applicant shall submit confirmatory information as regards:

1. the potential risk to groundwater from the metabolite 3-PBAld⁽¹²⁾;

2. the chronic risk to fish;

3. the risk assessment for non-target arthropods;

4. the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 December 2013 and the information set out in point 4 2 years after the adoption of specific guidance.

PART A

Only uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prochloraz, 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:

1. shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;

2. shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;

3. shall pay particular attention to the long-term risk to mammals and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate.

The applicants shall submit confirmatory information as regards:

1. comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;

2. the environmental risk assessment for the metal complexes of prochloraz;

3. the potential endocrine disrupting properties of prochloraz on birds.

The notifier shall submit to the Commission, the Member States and the Authority the information set out in points 1 and 2 by 31 December 2013 and the information set out in point 3 within 2 years after the adoption of the pertinent OECD test guidelines on endocrine disruption.

PART A

Only uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.

The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.

The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.

Authorisations shall be limited to professional users.

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 metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.

In this overall assessment Member States:

1. shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate;

2. shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate;

3. shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers;

4. shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone;

5. shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information on methyl isothiocyanate as regards:

1. the assessment of the long-range atmospheric transport potential and related environmental risks;

2. the potential groundwater contamination.

The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.

PART A

Only uses as insecticide in greenhouses with a permanent structure 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 bifenthrin, 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.

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

1. releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic and other non-target organisms;

2. the protection of pollinator colonies purposely placed in the greenhouse;

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

Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.

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 fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 and the Standing Committee on Plants, Animals, Food and Feed on 18 May 2020 shall be taken into account. The purity given in this entry is based on a commercial plant production.