Commission Directive 2008/108/ECShow full title

ANNEX

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
‘193	Flutolanil CAS No 66332-96-5 CIPAC No 524	α,α,α-trifluoro-3′-isopropoxy-o-toluanilide	≥ 975 g/kg	1 March 2009	28 February 2019	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(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 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.
194	Benfluralin CAS No 1861-40-1 CIPAC No 285	N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine	≥ 960 g/kg Impurities: ethyl-butyl-nitrosamine: max. 0,1 mg/kg	1 March 2009	28 February 2019	PART A Only uses as herbicide may be authorised. PART B In assessing applications to authorise plant protection products containing benfluralin for uses other than lettuce and endive, 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 benfluralin, 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' 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 birds, mammals, surface waters and aquatic organisms. 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 metabolism and to confirm the risk assessment for metabolite B12 and for aquatic organisms. They shall ensure that the notifiers at whose request benfluralin has been included in this Annex provide such studies to the Commission within two years from the entry into force of this Directive.
195	Fluazinam CAS No 79622-59-6 CIPAC No 521	3-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-2, 6-dinitro-p-toluidine	≥ 960 g/kg Impurities: 5-chloro-N-(3-chloro-5-trifluoromethyl-2-pyridyl)-α,α,α-trifluoro-4,6-dinitro-o-toluidine not more than 2 g/kg	1 March 2009	28 February 2019	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(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 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 entry into force of this Directive.
196	Fuberidazole CAS No 3878-19-1 CIPAC No 525	2-(2′-furyl)benzimidazole	≥ 970 g/kg	1 March 2009	28 February 2019	PART A Only uses as fungicide may be authorised. PART B In assessing applications to authorise plant protection products containing fuberidazole for uses other than seed dressing, 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 fuberidazole, 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 operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment, long-term risk to mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. In such case the use of adequate equipment ensuring a high degree of incorporation in soil and a minimisation of spillage during application should apply. Conditions of use shall include adequate risk mitigation measures, where appropriate.
197	Mepiquat CAS No 15302-91-7 CIPAC No 440	1,1-dimethylpiperidinium chloride (mepiquat chloride)	≥ 990 g/kg	1 March 2009	28 February 2019	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(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 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.’