Commission Implementing Regulation (EU) 2018/691

Contents

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^note, 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 23 July 2015 an application from Compo Expert France SAS, for the approval of Talc E553B 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 Talc E553B on 6 June 2016^note. Considering the additional documentation submitted by the applicant to address the comments collated through the consultation with Member States and the Authority and related to operator exposure, the Commission asked the Authority for further scientific assistance to assess the new information submitted. The Authority presented to the Commission a second Technical Report on Talc E553B on 27 July 2017^note.

(3)The Commission presented the draft review report^note on 5 October 2017 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 13 December 2017 and finalised them for the meeting of that Committee on 22 March 2018.

(4)The documentation provided by the applicant shows that Talc E553B 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^note. 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.

(5)It has appeared from the examinations made that Talc E553B 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 Talc E553B as a basic substance.

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

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

(8)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 substance#

The substance Talc E553B is approved as a basic substance as laid down in Annex I.

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

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

Article 3Entry 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.

Annex I

Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Specific provisions
Talc E553BCAS No: 14807-96-6	Magnesium hydrogen metasilicatesilicate mineral	Food grade in conformity with Commission Regulation (EU) No 231/2012^note.< 0,1 % of respirable Crystalline Silica	28 May 2018	Talc E553B shall be used in accordance with the specific conditions included in the conclusions of the review report on Talc E553B (SANTE/11639/2017) and in particular Appendices I and II thereof.

Annex II

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

19 | Talc E553BCAS No: 14807-96-6 | Magnesium hydrogen metasilicatesilicate mineral | Food grade in conformity with Commission Regulation (EU) No 231/2012.< 0,1 % of respirable Crystalline Silica | 28 May 2018 | Talc E553B shall be used in accordance with the specific conditions included in the conclusions of the review report on Talc E553B (SANTE/11639/2017) and in particular Appendices I and II thereof.

Commission Implementing Regulation (EU) 2018/691

Article 1Approval of a basic substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force#

Annex I

Annex II

Connections

Key facts

History · 2 versions

Article 1Approval of a basic substance#

Article 2Amendments to Implementing Regulation (EU) No 540/2011#

Article 3Entry into force#

Annex I

Annex II