Annex

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

Further details on identity and specification of active substance are provided in the review report.
No	Common name, identification numbers	IUPAC name	Purityf1	Entry into force	Expiration of inclusion	Specific provisions
‘347	Sintofen CAS No 130561-48-7 CIPAC No 717	1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid	≥ 980 g/kg Impurities: 2-methoxyethanol, not more than 0,25 g/kg N,N-dimethylformamide, not more than 1,5 g/kg	1 June 2011	31 May 2021	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 of Annex VI, the conclusions of the review report on sintofen, 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 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 1 December 2011 and the information set out in point (4) by 31 May 2013.’