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)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2015/762@2015-05-12/en
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, 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 2014. The Commission presented the review report 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 Council. 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 540/2011 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 calcium hydroxide as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.
Article 2 Amendments to Implementing Regulation (EU) No 540/2011
Part C of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 Entry 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 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 Commission The President Jean-Claude Juncker
ANNEX
ANNEX I
Common Name, Identification Numbers IUPAC Name Purity Date of approval Specific provisions Calcium Hydroxide CAS No 1305-62-0 Calcium Hydroxide 920 g/kg 1 July 2015 Calcium 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.
Food grade
The following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter):
Barium 300 mg/kg
Fluoride 50 mg/kg
Arsenic 3 mg/kg
Lead 2 mg/kg.
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 Date of approval Specific provisions 4 Calcium Hydroxide CAS No 1305-62-0 Calcium Hydroxide 920 g/kg 1 July 2015 Calcium 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.
Food grade
The following impurities are of toxicological concern and must not exceed the levels below (expressed in mg/kg on dry matter):
Barium 300 mg/kg
Fluoride 50 mg/kg
Arsenic 3 mg/kg
Lead 2 mg/kg.
Versions
Cited by
- Commission Regulation (EU) 2016/143 of 18 January 2016 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards COS-OGA, cerevisane, calcium hydroxide, lecithins, Salix spp cortex, vinegar, fructose, Pepino mosaic virus strain CH2 isolate 1906, Verticillium albo-atrum isolate WCS850 and Bacillus amyloliquefaciens subsp. plantarum strain D747 (Text with EEA relevance) Regulation · Grade B
Calcium-hydroxide is approved as basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council. In view of Commission Implementing Regulation (EU) 2015/762, the Commission considers that the inclusion of that substance in Annex IV to Regulation (EC) No 396/2005 is appropriate.