Commission Directive 2007/5/EC of 7 February 2007 amending Council Directive 91/414/EEC to include captan, folpet, formetanate and methiocarb as active substances (Text with EEA relevance) (c. 5)

ANNEX U.K.

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

a Further details on identity and specification of active substance are provided in the review report.
No	Common name, identification numbers	IUPAC name	Puritya	Entry into force	Expiration of inclusion	Specific provisions
‘151	Captan CAS No 133-06-02 CIPAC No 40	N-(trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide	≥ 910 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 5 g/kg Folpet: not more than 10 g/kg [F1 Carbon tetrachloride not more than 0,1 g/kg]	1 October 2007	30 September 2017	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(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, 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 entry into force of this Directive.
152	Folpet CAS No 133-07-3 CIPAC No 75	N-(trichloromethylthio)phthalimide	≥ 940 g/kg Impurities: Perchloromethylmercaptan (R005406): not more than 3,5 g/kg Carbon tetrachloride not more than 4 g/kg	1 October 2007	30 September 2017	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(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, 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 entry into force of this Directive.
153	Formetanate CAS No 23422-53-9 CIPAC No 697	3-dimethylaminomethyleneaminophenyl methylcarbamate	≥ 910 g/kg	1 October 2007	30 September 2017	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(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, 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 entry into force of this Directive.
154	Methiocarb CAS No 2032-65-7 CIPAC No 165	4-methylthio-3,5-xylyl methylcarbamate	≥ 980 g/kg	1 October 2007	30 September 2017	PART A Only uses as repellent in seed treatment, insecticide and molluscicide may be authorised. PART B In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methiocarb, 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 and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures; must pay particular attention to the operator and bystander 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, as well as to confirm the toxicological assessment on metabolites potentially present in crops. They shall ensure that the notifier at whose request methiocarb has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.’

Textual Amendments

F1 Substituted by Commission Decision of 7 October 2008 correcting Directive 2007/5/EC amending Council Directive 91/414/EEC to include captan, folpet, formetanate and methiocarb as active substances (notified under document number C(2008) 5583) (Text with EEA relevance) (2008/782/EC).