Date: 2021-06-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2021/1040 of 16 April 2021 amending Delegated Regulation (EU) 2016/128 as regards the requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This document is Commission Delegated Regulation (EU) 2021/1040, amending Delegated Regulation (EU) 2016/128 concerning pesticide requirements in food for special medical purposes designed for infants and young children. It aligns the definition of pesticide residue with Regulation (EC) No 396/2005 and updates Annexes II and III of Delegated Regulation (EU) 2016/128. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Amendment Purpose:**
* Aligns the definition of pesticide residue in Delegated Regulation (EU) 2016/128 with the definition in Article 3(2)(c) of Regulation (EC) No 396/2005 for legal certainty and clarity.
* **Definition of Residue:**
* Replaces the existing definition of "residue" in Article 3(1) of Delegated Regulation (EU) 2016/128 with a reference to the definition in point (c) of Article 3(2) of Regulation (EC) No 396/2005.
* **Updates to Annexes II and III:**
* Amends Annexes II and III to Delegated Regulation (EU) 2016/128 according to the provided annexes in this regulation.
* Annex II is replaced with a list of active substances and their maximum residue levels.
* Annex III is replaced with a list of active substances.
Impact Analysis:
* **Manufacturers of Food for Special Medical Purposes (FSMP) for Infants and Young Children:**
* Impact: Must comply with the revised definitions and residue levels for pesticides in their products.
* Action Required: Review and update manufacturing processes and product testing to ensure compliance with the amended regulations and residue limits specified in Annexes II and III.
* **European Commission:**
* Impact: Responsible for overseeing and enforcing the updated regulations.
* Action Required: Ensure the regulation is properly implemented and monitored across all member states.
* **EU Member States:**
* Impact: Must implement and enforce the updated regulations within their jurisdictions.
* Action Required: Update national regulations and monitoring programs to align with the amended Delegated Regulation (EU) 2021/1040.
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.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of the EU's powers.
Regulation EU No 609/2013: A 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.
Council Directive 92/52/EEC: A council directive related to food intended for infants and young children, later repealed by Regulation EU No 609/2013.
Delegated Regulation EU 2016/128: A Commission Delegated Regulation supplementing Regulation EU No 609/2013 as regards the specific compositional and information requirements for food for special medical purposes.
Regulation EC No 1107/2009: A regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Regulation EC No 396/2005: A 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.
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 225/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION DELEGATED REGULATION (EU) 2021/1040
of 16 April 2021
amending Delegated Regulation (EU) 2016/128 as regards the requirements on pesticides in food for
special medical purposes developed to satisfy the nutritional requirements of infants and young
children
(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) 2016/128(2) lays down, among other issues, specific requirements on
pesticides and the residues thereof, in food for special medical purposes developed to satisfy the nutritional
requirements of infants and young children.
(2) Delegated Regulation (EU) 2016/128 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 a pesticide residue contained in
Delegated Regulation (EU) 2016/128 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 II and III to Delegated Regulation (EU) 2016/128, in view of future amendments to Regulation (EC)
No 396/2005.
(1) OJ L 181, 29.6.2013, p. 35.
(2) Commission Delegated Regulation (EU) 2016/128 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 food for special
medical purposes (OJ L 25, 2.2.2016, p. 30).
(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).L 225/2 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
(6) Delegated Regulation (EU) 2016/128 should therefore be amended accordingly.
HAS ADOPTED THIS REGULATION:
Article 1
Article 3, paragraph 1, of Delegated Regulation (EU) 2016/128 is replaced by the following:
‘1. For the purposes of this Article, ‘residue’ means pesticide residue as referred to in point (c) of Article 3(2) of
Regulation (EC) No 396/2005.’.
Article 2
Annexes II and III to Delegated Regulation (EU) 2016/128 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 LEYEN25.6.2021 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 225/3
ANNEX
Annexes II and III to Delegated Regulation (EU) 2016/128 are amended as follows:
(1) Annex II is replaced by the following:
‘ANNEX II
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(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’
(2) Annex III is replaced by the following:
‘ANNEX III
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(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).