Commission Implementing Regulation (EU) 2015/762 of 12 May 2015 approving the basic substance calcium hydroxide 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)
Commission Implementing Regulation (EU) 2015/762of 12 May 2015approving the basic substance calcium hydroxide 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/EECOJ L 309, 24.11.2009, p. 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 19 September 2012 an application from the European group of the International Federation of Organic Agriculture Movements (IFOAM) for the approval of calcium hydroxide as 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 16 September 2014Outcome of the consultation with Member States and EFSA on the basic substance application and its update on calcium hydroxide for use in plant protection against fungal diseases on pome fruit. EFSA supporting publication 2014:EN-655. 63 pp.. The Commission presented the review reporthttp://ec.europa.eu/sanco_pesticides/public/?event=activesubstance.selection&language=EN and the draft of this Regulation on the approval of calcium hydroxide to the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.(3)The documentation provided by the applicant and the results of examinations carried out by the Authority show that calcium hydroxide fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the CouncilRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).. Moreover, 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 calcium hydroxide 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 calcium hydroxide 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 540/2011Commission 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). 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 1Approval of a basic substanceThe substance calcium hydroxide as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.
Article 2Amendments to Implementing Regulation (EU) No 540/2011Part C of 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 applicationThis 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 July 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 12 May 2015.For the CommissionThe PresidentJean-Claude JunckerANNEX I
Further details on identity, specification and manner of use of basic substance are provided in the review report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalSpecific provisions
Calcium HydroxideCAS No 1305-62-0Calcium Hydroxide920 g/kgFood gradeThe following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter):Barium 300 mg/kgFluoride 50 mg/kgArsenic 3 mg/kgLead 2 mg/kg.1 July 2015Calcium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on Calcium Hydroxide (SANCO/10148/2015) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.
ANNEX IIIn Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Further details on identity, specification and manner of use of basic substance are provided in the review report.
NumberCommon Name, Identification NumbersIUPAC NamePurityDate of approvalSpecific provisions
"4Calcium HydroxideCAS No 1305-62-0Calcium Hydroxide920 g/kgFood gradeThe following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter):Barium 300 mg/kgFluoride 50 mg/kgArsenic 3 mg/kgLead 2 mg/kg.1 July 2015Calcium hydroxide shall be used in accordance with the specific conditions included in the conclusions of the review report on Calcium Hydroxide (SANCO/10148/2015) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015."
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Further details on identity, specification and manner of use of basic substance are provided in the review report.