Date: 2015-02-04Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2015/165 of 3 February 2015 amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for lactic acid, Lecanicillium muscarium strain Ve6, chitosan hydrochloride and Equisetum arvense L. in or on certain products (Text with EEA relevance)
Executive Summary:
Commission Regulation (EU) 2015/165 amends Annex IV to Regulation (EC) No 396/2005 regarding maximum residue levels (MRLs) of pesticides. It includes lactic acid, Lecanicillium muscarium strain Ve6, chitosan hydrochloride, and Equisetum arvense L. in Annex IV, where previously a default value of 0.01 mg/kg applied. The regulation entered into force on February 23, 2015, twenty days after its publication.
Key Points / Main Content:
* **Amendment of Annex IV:**
* Lactic acid, Lecanicillium muscarium strain Ve6, chitosan hydrochloride, and Equisetum arvense L. are added to Annex IV of Regulation (EC) No 396/2005.
* These substances were previously subject to a default MRL of 0.01 mg/kg.
* **Justification for Inclusion:**
* Chitosan hydrochloride and Equisetum arvense L. are approved as basic substances under Regulation (EC) No 1107/2009.
* Lactic acid is approved as a food additive under Regulation (EC) No 1333/2008.
* The European Food Safety Authority (EFSA) concluded that the inclusion of Lecanicillium muscarium strain Ve6 in Annex IV is appropriate.
* **Regulatory Basis:**
* The modifications to MRLs fulfill the requirements of Article 51 and Article 14 of Regulation (EC) No 396/2005.
* The measures are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.
* **Entry into Force:**
* The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union (February 23, 2015).
Impact Analysis:
* **European Commission:**
* *Impact:* Responsible for implementing and enforcing the amended regulation.
* *Action Required:* Ensure that the changes to Annex IV are correctly applied and monitored across member states.
* **European Food Safety Authority (EFSA):**
* *Impact:* Plays a role in assessing the safety of substances and providing scientific advice.
* *Action Required:* Continue to provide scientific support and risk assessments related to the listed substances as needed.
* **Member States:**
* *Impact:* Required to apply the regulation directly.
* *Action Required:* Incorporate the changes to MRLs into their national regulations and ensure compliance.
* **Food Producers and Operators:**
* *Impact:* Need to comply with the revised MRLs for the specified substances in or on their products.
* *Action Required:* Monitor residue levels of lactic acid, Lecanicillium muscarium strain Ve6, chitosan hydrochloride, and Equisetum arvense L. in their products to ensure compliance with the amended regulation.
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 (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.
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.
Lactic acid: A food additive included in Annex IV to Regulation EC No 396/2005.
Lecanicillium muscarium strain Ve6: A substance included in Annex IV to Regulation EC No 396/2005.
Chitosan hydrochloride: A basic substance included in Annex IV to Regulation EC No 396/2005.
Equisetum arvense L.: A basic substance included in Annex IV to Regulation EC No 396/2005.
4.2.2015 EN Official Journal of the European Union L 28/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) 2015/165
of 3 February 2015
amending Annex IV to Regulation (EC) No 396/2005 of the European Parliament and of the
Council as regards maximum residue levels for lactic acid, Lecanicillium muscarium strain Ve6,
chitosan hydrochloride and Equisetum arvense L. in or on certain products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular Article 5(1) thereof,
Whereas:
(1) For lactic acid, Lecanicillium muscarium strain Ve6, chitosan hydrochloride and Equisetum arvense L., no specific
MRLs were set nor were the substances included in Annex IV to Regulation (EC) No 396/2005, so the default
value of 0,01 mg/kg laid down in Article 18(1)(b) of that Regulation applies.
(2) Chitosan hydrochloride is approved as basic substance in accordance with Regulation (EC) No 1107/2009 of the
European Parliament and of the Council (2). In view of Commission Implementing Regulation (EU)
No 563/2014 (3), the Commission considers that the inclusion of such substance in Annex IV to Regulation (EC)
No 396/2005 is appropriate.
(3) Equisetum arvense L. is approved as basic substance in accordance with Regulation (EC) No 1107/2009. In view of
Commission Implementing Regulation (EU) No 462/2014 (4), the Commission considers that the inclusion of
such substance in Annex IV to Regulation (EC) No 396/2005 is appropriate.
(4) Lactic acid is approved as a food additive in accordance with Regulation (EC) No 1333/2008 of the European
Parliament and of the Council (5). In view of Commission Regulation (EU) No 1129/2011 (6), the Commission
considers that the inclusion of lactic acid in Annex IV to Regulation (EC) No 396/2005 is appropriate.
(1) OJ L 70, 16.3.2005, p. 1.
(2) 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).
(3) Commission Implementing Regulation (EU) No 563/2014 of 23 May 2014 approving the basic substance chitosan hydrochloride, 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 Implementing Regulation (EU) No 540/2011 (OJ L 156, 24.5.2014, p. 5).
(4) Commission Implementing Regulation (EU) No 462/2014 of 5 May 2014 approving the basic substance Equisetum arvense L., 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 Implementing Regulation (EU) No 540/2011 (OJ L 134, 7.5.2014, p. 28).
(5) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354,
31.12.2008, p. 16).
(6) Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the
European Parliament and of the Council by establishing a Union list of food additives (OJ L 295, 12.11.2011, p. 1).L 28/2 EN Official Journal of the European Union 4.2.2015
(5) As regards Lecanicillium muscarium strain Ve6, the European Food Safety Authority (the Authority) concluded (1)
that its inclusion in Annex IV to Regulation (EC) No 396/2005 is appropriate.
(6) Based on the conclusion of the Authority and taking into account the factors relevant to the matter under consid
eration, the appropriate modifications to the MRLs fulfil the relevant requirements of Article 5(1) and
Article 14(2) of Regulation (EC) No 396/2005.
(7) Regulation (EC) No 396/2005 should therefore 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 1
In Annex IV, the entries: ‘lactic acid (2)’, ‘Lecanicillium muscarium strain Ve6’, ‘chitosan hydrochloride’, and ‘Equisetum
arvense L.’ are added, in alphabetical order.
Article 2
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, 3 February 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance Lecanicillium
muscarium strain Ve6, notified as Verticillium lecanii. EFSA Journal 2010; 8(1):1446. [45 pp.]. doi:10.2903/j.efsa.2010.1446.