Commission Implementing Regulation (EU) No 355/2013
of 18 April 2013
approving the active substance maltodextrin, 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:
In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 8 October 2008 an application from Biological Crop Protection Ltd for the inclusion of the active substance maltodextrin in Annex I to Directive 91/414/EEC. Decision 2008/20/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant (now Certis Europe B.V.). The designated rapporteur Member State submitted a draft assessment report on 29 November 2011.
It has appeared from the various examinations made that plant protection products containing maltodextrin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve maltodextrin.
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.
A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.
Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing maltodextrin. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.
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 maltodextrin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2Re-evaluation of plant protection products
1.
Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing maltodextrin as an active substance by 31 March 2014.
By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
2.
By way of derogation from paragraph 1, for each authorised plant protection product containing maltodextrin as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 September 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
(a)
in the case of a product containing maltodextrin as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or
(b)
in the case of a product containing maltodextrin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
Article 3Amendments 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 4Entry into force and date of application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 April 2013.
For the Commission
The President
José Manuel Barroso
ANNEX I
Common Name, Identification Numbers | IUPAC Name | Purity7 | Date of approval | Expiration of approval | Specific provisions |
|---|---|---|---|---|---|
Maltodextrin CAS No 9050-36-6 CIPAC No 801 | None allocated | ≥ 910 g/kg | 1 October 2013 | 30 September 2023 | 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 maltodextrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to:
Conditions of use shall include risk mitigation measures, where appropriate. |
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number
Common Name, Identification Numbers
IUPAC Name
Date of approval
Expiration of approval
Specific provisions
‘44
Maltodextrin
CAS No 9050-36-6
CIPAC No 801
None allocated
≥ 910 g/kg
1 October 2013
30 September 2023
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 maltodextrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
- (a)
the potential increased growth of fungi and possible presence of mycotoxins on the surface of treated fruits;
- (b)
the potential risk to honeybees and non-target arthropods.
Conditions of use shall include risk mitigation measures, where appropriate.’