Commission Implementing Regulation (EU) 2017/409 of 8 March 2017 approving the basic substance hydrogen peroxide 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. )
Date: 2017-03-08
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: market approval, oxide, plant health control, plant health product




L_2017063EN.01009501.xml










9.3.2017   


EN


Official Journal of the European Union


L 63/95








            COMMISSION IMPLEMENTING REGULATION (EU) 2017/409
of 8 March 2017
         
approving the basic substance hydrogen peroxide 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,


Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 23(5) in conjunction with Article 13(2) thereof,

Whereas:







(1)


In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 9 December 2015 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of hydrogen peroxide as a basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).












(2)


The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 13 September 2016 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2016 and finalised them for the meeting of that Committee on 24 January 2017.












(3)


The documentation provided by the applicant shows that hydrogen peroxide is approved for use as an active substance in biocidal products for human hygiene by Commission Implementing Regulation (EU) 2015/1730 (4). It is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.












(4)


It has appeared from the examinations made that hydrogen peroxide may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve hydrogen peroxide as a basic substance.












(5)


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 for the approval which are detailed in Annex I to this Regulation.












(6)


In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly.












(7)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Approval of a basic substance

The substance hydrogen peroxide as specified in Annex I is approved as a basic substance subject to the conditions laid down in that Annex.


Article 2

Amendments to Implementing Regulation (EU) No 540/2011

Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.


Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 March 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 309, 24.11.2009, p. 1.

(2)  European Food Safety Authority, 2016; Outcome of the consultation with Member States and EFSA on the basic substance application for hydrogen peroxide for use in plant protection as fungicide and bactericide in seed treatment and for disinfecting cutting tools. EFSA supporting publication 2016:EN-1091. 39 pp.

(3)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

(4)  Commission Implementing Regulation (EU) 2015/1730 of 28 September 2015 approving hydrogen peroxide as an existing active substance for use in biocidal products for product types 1, 2, 3, 4, 5 and 6. (OJ L 252, 29.9.2015, p. 27).

(5)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).




ANNEX I









Common Name, Identification Numbers


IUPAC Name


Purity (1)



Date of approval


Specific provisions




Hydrogen peroxide
CAS No 7722-84-1


Hydrogen peroxide


Solution in water (< 5 %)
The hydrogen peroxide used to manufacture the solution shall have a purity according to the FAO JECFA specifications.


29 March 2017


Hydrogen peroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on hydrogen peroxide (SANTE/11900/2016) and in particular Appendices I and II thereof.






(1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.





ANNEX II
In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:











Number


Common Name, Identification Numbers


IUPAC Name


Purity (*1)



Date of approval


Specific provisions




‘15


Hydrogen peroxide
CAS No 7722-84-1


Hydrogen peroxide


Solution in water (< 5 %)
The hydrogen peroxide used to manufacture the solution shall have a purity according to the FAO JECFA specifications.


29 March 2017


Hydrogen peroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on hydrogen peroxide (SANTE/11900/2016) and in particular Appendices I and II thereof.’







(*1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.