Date: 2021-06-25Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Delegated Regulation (EU) 2021/1041 amends Delegated Regulation (EU) 2016/127 regarding pesticide requirements in infant and follow-on formula. This update aligns the definition of pesticide residue with Regulation (EC) No 396/2005 for legal certainty. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Definition of Pesticide Residue:**
* Article 4, paragraph 1 of Delegated Regulation (EU) 2016/127 is updated to define "residue" as pesticide residue as referred to in point (c) of Article 3(2) of Regulation (EC) No 396/2005.
* **Amendments to Annexes IV and V:**
* Annexes IV and V to Delegated Regulation (EU) 2016/127 are amended according to the Annex of this regulation.
* Annex IV lists active substances referred to in Article 4(3) with maximum residue levels, including parent compounds such as Cadusafos, Demeton-S-methyl, Ethoprophos, Fipronil and Propineb.
* Annex V lists active substances referred to in Article 4(4), including parent compounds such as Aldrin, Dieldrin, Disulfoton, Endrin, Fensulfothion, Fentin, Haloxyfop, Heptachlor, Hexachlorobenzene, Nitrofen, Omethoate and Terbufos.
* The most updated residue definition applies as set out in the relevant Annexes II, III, IV or V to Regulation (EC) No 396/2005.
Impact Analysis:
* **Manufacturers of Infant and Follow-on Formula:**
* Impact: Must ensure their products comply with the updated definitions and maximum residue levels for pesticides as outlined in the amended Annexes IV and V of Delegated Regulation (EU) 2016/127.
* Action Required: Review and adjust production processes and testing protocols to adhere to the new residue definitions and limits specified in the regulation.
* **European Commission:**
* Impact: Responsible for overseeing the implementation and enforcement of the updated regulations across all Member States.
* Action Required: Ensure that Member States are aware of the changes and are taking appropriate measures to comply.
* **Member States:**
* Impact: Must incorporate the changes into their national regulations and monitor compliance.
* Action Required: Update national regulations, conduct inspections, and enforce the new rules.
* **Consumers (Infants and Young Children):**
* Impact: Benefit from increased clarity and safety standards regarding pesticide residues in infant and follow-on formula.
* Action Required: No direct action is required, but can expect a higher level of safety and compliance in infant formula products.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation (EU) No 609/2013: Regulation of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control.
Commission Delegated Regulation (EU) 2016/127: Commission Delegated Regulation supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for infant formulae and follow-on formulae.
Regulation (EC) No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Regulation (EC) No 396/2005: Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: City in Belgium. Location where the regulation was adopted.
L 225/4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 25.6.2021
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)
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 2013on 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(1), and in particular Article 11(2) thereof,
Whereas:
(1) Commission Delegated Regulation (EU) 2016/127(2) 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).
(3) However, Article 3(2)(c) of Regulation (EC) No 396/2005 of the European Parliament and of the Council(4)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.
(1) OJ L 181, 29.6.2013, p. 35.
(2) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the
European Parliament and of the Council as regards the specific compositional and information requirements for infant formulae and
follow-on formulae and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1).
(3) 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 (OJ L 309, 24.11.2009, p. 1).
(4) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of
pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).25.6.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 225/5
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 LEYENL 225/6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 25.6.2021
ANNEX
Annexes IV and V to Delegated Regulation (EU) 2016/127 are amended as follows:
(1) Annex IV is replaced by the following:
‘ANNEX IV
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(3)
Chemical name of the parent compound of the substance(1) Maximum residue level (mg/kg)
Cadusafos 0,006
Demeton-S-methyl
Demeton-S-methyl sulfone 0,006
Oxydemeton-methyl
Ethoprophos 0,008
Fipronil 0,004
Propineb 0,006’
(1) The most updated residue definition applies as set out in the relevant Annexes II, III, IV or V to Regulation (EC) No 396/2005 (the
residue definition is mentioned in brackets behind the parent compound of the substance).
(2) Annex V is replaced by the following:
‘ANNEX V
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 4(4)
Chemical name of the parent compound of the substance(1)
Aldrin
Dieldrin
Disulfoton
Endrin
Fensulfothion
Fentin
Haloxyfop
Heptachlor
Hexachlorobenzene
Nitrofen
Omethoate
Terbufos.’
(1) The most updated residue definition applies as set out in the relevant Annexes II, III, IV or V to Regulation (EC) No 396/2005 (the
residue definition is mentioned in brackets behind the parent compound of the substance).