Commission Delegated Regulation (EU) 2021/1041 of 16 April 2021 amending Delegated Regulation (EU) 2016/127 as regards the requirements on pesticides in infant formula and follow-on formula (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2021/1041@2021-04-16/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009, and in particular Article 11(2) thereof,
Whereas:
(1) Commission Delegated Regulation (EU) 2016/127 lays down, among other issues, specific requirements on pesticides and the residues thereof in infant formula and in follow-on formula.
(2) Delegated Regulation (EU) 2016/127 defines residue of pesticides by using the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
(3) However, Article 3(2)(c) of Regulation (EC) No 396/2005 of the European Parliament and of the Council provides for a more precise definition of pesticide residues.
(4) For reasons of legal certainty and clarity, it is necessary to align the definition of pesticide residue contained in Delegated Regulation (EU) 2016/127 with the definition contained in Article 3(2)(c) of Regulation (EC) No 396/2005.
(5) Taking into account that the residue definitions for active substances should apply as defined in Regulation (EC) No 396/2005, it is appropriate to include only the parent compounds of the active substances in the lists set out in Annexes IV and V to Delegated Regulation (EU) 2016/127 in view of future amendments to Regulation (EC) No 396/2005.
(6) Delegated Regulation (EU) 2016/127 should therefore be amended accordingly.
HAS ADOPTED THIS REGULATION:
Article 1
Article 4, paragraph 1 of Delegated Regulation (EU) 2016/127 is replaced by the following: 1. For the purposes of this Article, residue means pesticide residue as referred to in point (c) Article 3(2) of Regulation (EC) No 396/2005.
Article 2
Annexes IV and V to Delegated Regulation (EU) 2016/127 are amended in accordance with the Annex to this Regulation.
Article 3
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, 16 April 2021. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX
Annexes IV and V to Delegated Regulation (EU) 2016/127 are amended as follows:
(1) Annex IV is replaced by the following:
(2) Annex V is replaced by the following:
ANNEX IV ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(3)
Chemical name of the parent compound of the substance Maximum residue level (mg/kg) Cadusafos 0,006 Demeton-S-methyl Demeton-S-methyl sulfone Oxydemeton-methyl 0,006 Ethoprophos 0,008 Fipronil 0,004 Propineb 0,006
ANNEX V ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(4)
Chemical name of the parent compound of the substance Aldrin Dieldrin Disulfoton Endrin Fensulfothion Fentin Haloxyfop Heptachlor Hexachlorobenzene Nitrofen Omethoate Terbufos.