Commission Implementing Regulation (EU) No 807/2011
of 10 August 2011
approving the active substance triazoxide, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the application of the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Regulation (EC) No 33/2008 laying down detailed rules for the application of Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I.
The application was submitted to the United Kingdom, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as those that were the subject of Decision 2009/860/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.
The United Kingdom evaluated the new information and data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 June 2010.
The additional report by the rapporteur Member State and the new conclusion by the Authority concentrate on the concerns that led to the non-inclusion. Those concerns were in particular that it was not possible to perform a reliable consumer risk assessment as data were missing to determine the nature of residues in plant commodities and the possible transfer of residues in animal products.
The new information submitted by the applicant shows that the exposure of consumers may be considered as acceptable.
Consequently, the additional information provided by the applicant permit to eliminate the specific concerns that led to the non-inclusion. No other open scientific questions have arisen.
It has appeared from the various examinations made that plant protection products containing triazoxide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve triazoxide in accordance with Regulation (EC) No 1107/2009.
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.
Without prejudice to the conclusion that triazoxide should be approved, it is, in particular, appropriate to require further confirmatory information.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1Approval of active substance
The active substance triazoxide, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3Entry into force and date of application
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 October 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 August 2011.
For the Commission
The President
José Manuel Barroso
ANNEX I
Common Name, Identification Numbers | IUPAC Name | Purity9 | Date of approval | Expiration of approval | Specific provisions |
---|---|---|---|---|---|
Triazoxide CAS No 72459-58-6 CIPAC No 729 | 7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide | ≥ 970 g/kg Impurities: toluene: not more than 3 g/kg | 1 October 2011 | 30 September 2021 | PART AOnly uses as fungicide for seed treatment may be authorised. PART BFor 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:
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. |
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
No
Common Name, Identification Numbers
IUPAC Name
Purity10Date of approval
Expiration of approval
Specific provisions
‘17
Triazoxide
CAS No 72459-58-6
CIPAC No 729
7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide
≥ 970 g/kg
Impurities:
toluene: not more than 3 g/kg
1 October 2011
30 September 2021
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:
- (a)
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;
- (b)
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.’