REPORT on the proposal for a regulation of the European Parliament and the Council amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed as regards the implementing powers conferred on the Commission

24.9.2007 - (COM(2006)0908 – C6‑0025/2007 – 2006/0294(COD)) - ***I

Committee on the Environment, Public Health and Food Safety
Rapporteur: Robert Sturdy

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and the Council amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed as regards the implementing powers conferred on the Commission

(COM(2006)0908 – C6‑0025/2007 – 2006/0294(COD))

(Codecision procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to the European Parliament and the Council (COM(2006)0908)[1],

–   having regard to Article 251 and Articles 37 and 152 (4) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6‑0025/2007),

–   having regard to Rule 51 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety (A6‑0342/2007),

1.  Approves the Commission proposal as amended;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council and Commission.

Text proposed by the Commission	Amendments by Parliament
Amendment 1 ARTICLE 1, POINT 1 Article 4, paragraph 1 (Regulation (EC) No 396/2005)
1. The products, product groups and/or parts of products referred to in Article 2(1) to which harmonised MRLs shall apply shall be defined in and covered by Annex I. Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).	1. The products, product groups and/or parts of products referred to in Article 2(1) to which harmonised MRLs shall apply shall be defined in and covered by Annex I. Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3). Annex I shall include all products for which MRLs are set, as well as the other products for which it is appropriate to apply harmonised MRLs in particular in view of their relevance in the diet of consumers or in trade. Products shall be grouped in such a way that MRLs may as far as possible be set for a group of similar or related products.
Justification
The original text of the current regulation should be restored in order to clarify the scope of the regulatory procedure with scrutiny.
Amendment 2 ARTICLE 1, POINT 2 Article 5, paragraph 1 (Regulation (EC) No 396/2005)
1. Active substances of plant protection products evaluated under Directive 91/414/EEC for which no MRLs are required shall be defined and listed in Annex IV hereto, taking into account the uses of those active substances and the matters referred to in Article 14(2), (a), (c) and (d) of this Regulation. Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).	1. Active substances of plant protection products evaluated under Directive 91/414/EEC for which no MRLs are required shall be defined and listed in Annex IV hereto, taking into account the uses of those active substances and the matters referred to in Article 14(2), (a), (c) and (d) of this Regulation. Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).
Amendment 3 ARTICLE 1, POINT 4 Article 14, paragraph 1 (Regulation (EC) No 396/2005)
1. Upon receipt of the opinion of the Authority and taking into account that opinion, one of the following shall be prepared by the Commission without delay and at the latest within three months: (a) a Regulation on the setting, modification or deletion of an MRL designed to amend non-essential elements of this Regulation which shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4); on imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 45(5); (b) a Decision rejecting the application which shall be adopted in accordance with the procedure referred to in Article 45(2).	1. Upon receipt of the opinion of the Authority and taking into account that opinion, a Regulation on the setting, modification or deletion of an MRL or a Decision rejecting the application shall be prepared by the Commission without delay and at the latest within three months, and submitted for adoption in accordance with the procedure referred to in Article 45(3).
Justification
Two different procedures for decisions under Article 14 should be avoided. One single regulatory procedure with scrutiny seems to be more appropriate. At the same time, however, curtailing of standard time limits of the regulatory procedure with scrutiny as well as introducing urgency procedures is not acceptable.
Amendment 4 ARTICLE 1, POINT 5 Article 15, paragraph 2, subparagraph 1 (Regulation (EC) No 396/2005)
2. Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from Annex III by a Regulation one year after the date of the inclusion or non inclusion in Annex I to Directive 91/414/EEC of the active substance concerned. That Regulation designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 45(5).	2. Where a temporary MRL is set as provided for in paragraph 1(b), it shall be deleted from Annex III by a Regulation one year after the date of the inclusion or non inclusion in Annex I to Directive 91/414/EEC of the active substance concerned. That Regulation designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3). Introduction of urgency procedures is not acceptable either.
Amendment 5 ARTICLE 1, POINT 6 Article 18, paragraph 1, point (b) (Regulation (EC) No 396/2005)
(b) 0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance while taking into account the routine analytical methods available. Such default values shall be listed in Annex V. Those measures designed to amend nonessential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 45(5).	(b) 0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance while taking into account the routine analytical methods available. Such default values shall be listed in Annex V. Those measures designed to amend nonessential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3). Introduction of urgency procedures is not acceptable either.
Amendment 6 ARTICLE 1, POINT 6 Article 18, paragraph 3, subparagraph 2 (Regulation (EC) No 396/2005)
Measures to define the active substance/product combinations listed in Annex VII which are designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).	Measures to define the active substance/product combinations listed in Annex VII which are designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).
Amendment 7 ARTICLE 1, POINT 6 Article 18, paragraph 4 (Regulation (EC) No 396/2005)
4. In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or in pursuance of obligations in Directive 2000/29/EC, a Member State may authorise the placing on the market and/or the feeding to animals within its territory of treated food or feed not complying with paragraph 1, provided that such food or feed does not constitute an unacceptable risk. Such authorisations shall immediately be notified to the other Member States, the Commission and the Authority, together with an appropriate risk assessment for consideration without undue delay with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4). On imperative grounds of urgency the Commission may use the urgency procedure referred to in Article 45(5).	4. In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or in pursuance of obligations in Directive 2000/29/EC, a Member State may authorise the placing on the market and/or the feeding to animals within its territory of treated food or feed not complying with paragraph 1, provided that such food or feed does not constitute an unacceptable risk. Such authorisations shall immediately be notified to the other Member States, the Commission and the Authority, together with an appropriate risk assessment for consideration without undue delay with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).
Amendment 8 ARTICLE 1, POINT 7 Article 20, paragraph 2 (Regulation (EC) No 396/2005)
2. Specific concentration or dilution factors for certain processing and/or mixing operations or for certain processed and/or composite products may be included in the list in Annex VI. Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).	2. Specific concentration or dilution factors for certain processing and/or mixing operations or for certain processed and/or composite products may be included in the list in Annex VI. Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).
Amendment 9 ARTICLE 1, POINT 8 Article 21, paragraph 1 (Regulation (EC) No 396/2005)
1. MRLs for products covered by Annex I shall be first established and listed in Annex II, incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, taking into account the criteria mentioned in Article 14(2) of this Regulation. Those measures designed to amend nonessential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).	1. MRLs for products covered by Annex I shall be first established and listed in Annex II, incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, taking into account the criteria mentioned in Article 14(2) of this Regulation. Those measures designed to amend nonessential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3)
Amendment 10 ARTICLE 1, POINT 9 Article 22, paragraph 1, subparagraph 2 (Regulation (EC) No 396/2005)
Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).	Those measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).
Amendment 11 ARTICLE 1, POINT 10 Article 27, paragraph 2 (Regulation (EC) No 396/2005)
2. Measures to determine the sampling methods necessary for carrying out such controls of pesticide residues in products other than those provided for in Directive 2002/63/EC which are designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4) of this Regulation.	2. Measures to determine the sampling methods necessary for carrying out such controls of pesticide residues in products other than those provided for in Directive 2002/63/EC which are designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3) of this Regulation.
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).
Amendment 12 Article 1, POINT 10 A (new) Article 28, paragraph 2 (Regulation (EC) No 396/2005)
	(10a) In Article 28, paragraph 2 is replaced by the following:
	"2. Technical guidelines dealing with the specific validation criteria and quality control procedures in relation to methods of analysis for the determination of pesticide residues may be adopted in accordance with the procedure referred to in Article 45(3)."
Justification
Guidelines for analysis and quality control procedures for methods of analysis are of a general nature. Therefore, such guidelines should be adopted according to the regulatory procedure with scrutiny.
Amendment 13 Article 1, POINT 10 B (new) Article 29, paragraph 2 (Regulation (EC) No 396/2005)
	(10b) In Article 29, paragraph 2 is replaced by the following:
	"2. The Community control programme shall be adopted and updated every year in accordance with the procedure referred to in Article 45(3). The draft Community control programme shall be presented to the Committee referred to in Article 45(1) at least six months before the end of each calendar year."
Justification
The Community control programme is a measure of a general nature. Therefore, such a programme should be adopted according to the regulatory procedure with scrutiny.
Amendment 14 ARTICLE 1, POINT 11 Article 45, paragraph 4 (Regulation (EC) No 396/2005)
4. Where reference is made to this paragraph, Article 5a (1) to (4) and (5) (b) and Article 7 of the Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.	deleted
The time limits laid down in Article 5a (3)(c), (4) (b) and (4) (e) of Decision 1999/468/EC shall be two months, one month and two months respectively.
Justification
Since the draft report does not include curtailed time limits and urgency procedures for the regulatory procedures with scrutiny, the references to Article 45 paragraphs 4 and 5 shall be deleted.
Amendment 15 ARTICLE 1, POINT 11 Article 45, paragraph 5 (Regulation (EC) No 396/2005)
5. Where reference is made to this paragraph, Article 5a (1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.	deleted
Justification
Since the draft report does not include curtailed time limits and urgency procedures for the regulatory procedures with scrutiny, the references to Article 45 paragraphs 4 and 5 shall be deleted.
Amendment 16 ARTICLE 1, POINT 13 Article 49, paragraph 1, subparagraph 2 (Regulation (EC) No 396/2005)
However, in order to ensure a high level of consumer protection appropriate measures concerning those products may be taken. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(5).	However, in order to ensure a high level of consumer protection appropriate measures concerning those products may be taken. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
Introduction of the urgency procedure is not acceptable.
Amendment 17 ARTICLE 1, POINT 13 Article 49, paragraph 2 (Regulation (EC) No 396/2005)
2. Where it is necessary in order to allow for the normal marketing, processing and consumption of products, further transitional measures may be laid down for the implementation of certain MRLs provided for in Articles 15, 16, 21, 22, and 25. Those measures which are designed to amend non-essential elements of this Regulation by supplementing it and shall be without prejudice to the obligation to ensure a high level of consumer protection shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(4).	2. Where it is necessary in order to allow for the normal marketing, processing and consumption of products, further transitional measures may be laid down for the implementation of certain MRLs provided for in Articles 15, 16, 21, 22, and 25. Those measures which are designed to amend non-essential elements of this Regulation by supplementing it and shall be without prejudice to the obligation to ensure a high level of consumer protection shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 45(3).
Justification
It is inappropriate to curtail standard time limits of the regulatory procedure with scrutiny. Therefore, the reference to Article 45(4) of this Proposal shall be deleted and replaced by a reference to Article 45(3).

• [1]  OJ C ... / Not yet published in OJ.

EXPLANATORY STATEMENT

The adjustment of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed to the revised Comitology Decision 1999/468/EEC should take fully into account the newly introduced regulatory procedure with scrutiny. This procedure should provide for the adoption of measures of general scope designed to amend non-essential elements of the basic act, inter alia by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.

The references to the regulatory procedure with scrutiny should be clear and not entail any curtailing of time limits compared to the standard time limits of the regulatory procedure with scrutiny.

PROCEDURE

Title	Residue levels of pesticides in or on food and feed (implementing powers conferred on the Commission)
References	COM(2006)0908 - C6-0025/2007 - 2006/0294(COD)
Date submitted to Parliament	22.12.2006
Committee responsible        Date announced in plenary	ENVI 17.1.2007
Rapporteur(s)        Date appointed	Robert Sturdy 27.2.2007
Date adopted	12.9.2007
Result of final vote	+: –: 0:	24 0 0
Members present for the final vote	Adamos Adamou, Georgs Andrejevs, Liam Aylward, Johannes Blokland, John Bowis, Frieda Brepoels, Dorette Corbey, Gyula Hegyi, Jens Holm, Eija-Riitta Korhola, Marios Matsakis, Alexandru-Ioan Morţun, Riitta Myller, Péter Olajos, Miroslav Ouzký, Vittorio Prodi, Daciana Octavia Sârbu, Karin Scheele, Bogusław Sonik, Antonios Trakatellis, Thomas Ulmer, Marcello Vernola, Glenis Willmott
Substitute(s) present for the final vote	Kartika Tamara Liotard, Robert Sturdy