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
Date: 2006-12-22
Institutions: European Commission
Subjects: EU law, European standard, animal nutrition, animal product, crop production, food safety, foodstuff, foodstuffs legislation, operation of the Institutions, pesticide, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2006 
COM(2006) 908 final 

2006/0294 (COD) 

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  

(presented by the Commission) 

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2006/0294 (COD) 

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  

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Articles 
37 and 152 (4) (b) thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4 

Whereas: 

(1) 

(2) 

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2 
3 
4 
5 

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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/EEC5  provides  that 
certain measures are to be adopted in accordance with Council Decision 1999/468/EC 
of 28 June 1999 laying down the procedures for the exercise of implementing powers 
conferred on the Commission6. 

Decision 1999/468/EC has been amended by Decision 2006/512/EC, which introduced 
a regulatory procedure with scrutiny for measures of general scope designed to amend 
non-essential elements of a basic instrument adopted in accordance with the procedure 
referred to in Article 251 of the Treaty, including by deleting some of those elements 
or by supplementing the instrument by the addition of new non-essential elements. 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
… 
OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission Regulation (EC) No 178/2006 (OJ L 
29, 2.2.2006, p. 3). 
OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 
11). 

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(3) 

(4) 

(5) 

In accordance with the joint statement of the European Parliament, the Council and the 
Commission7 on Decision 2006/512/EC, instruments which are already in force must 
be  adjusted  in  accordance  with  the  applicable  procedures.  The  aforesaid  statement 
indicates a list of instruments that should be adjusted as a matter of urgency, including 
Regulation (EC) No 396/2005.  

In particular power should be conferred on the Commission to define the scope of that 
Regulation and the criteria necessary for the establishment of certain maximum levels 
of  pesticide  residues  in  or  on  food  and  feed  of  plant  and  animal  origin  listed  in  the 
relevant  Annexes  to  that  Regulation.  Since  those  measures  are  of  general  scope  and 
are  designed  to  amend  or  delete  non-essential  elements  of  that  Regulation,  or 
supplement that Regulation by the addition of new non-essential elements, they should 
be adopted in accordance with the regulatory procedure with scrutiny provided for in 
Article 5a of Decision 1999/468/EC. 

In  order  to  guarantee  economic  operators  a  rapid  decision-making  process,  whilst 
ensuring a high level of consumer protection, it should be possible to curtail the time-
limits  foreseen  by  the  new  procedure  on  grounds  of  efficiency.  On  grounds  of 
efficiency, the normal time-limits for the regulatory procedure with scrutiny should be 
curtailed for the setting, inclusion, implementation, modification or deletion of MRLs 
and for the establishment of a list of active substances for which no MRLs are required 
as well as a list of active substance/product combinations where the active substances 
are  used  as  fumigant  for  post-harvest  treatment.  Where  on  imperative  grounds  of 
urgency,  in  particular  where  a  risk  to  human  or  animal  health  exists,  and  the  time 
limits  for  the  regulatory  procedure  with  scrutiny  cannot  be  complied  with,  the 
Commission should be authorised to apply for the setting, inclusion, implementation, 
modification or deletion of MRLs the urgency procedure provided for in Article 5a (6) 
of Decision 1999/468/EC. 

(6) 

Regulation (EC) No 396/2005 should therefore be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Regulation (EC) No 396/2005 is amended as follows: 

(1) 

In Article 4, paragraph 1 is replaced by the following: 

"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). " 

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OJ C 255, 21.10.2006, p.1 

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(2) 

In Article 5, paragraph 1 is replaced by the following: 

"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)." 

(3) 

In Article 8, paragraph 2 is replaced by the following: 

"2.  Applications  shall  be  evaluated  in  accordance  with  the  relevant  provisions  of 
the Uniform Principles for the Evaluation and Authorisation of Plant Protection 
Products  set  out  in  Annex  VI  to  Directive  91/414/EEC  or  specific  evaluation 
principles  to  be  laid  down  in  a  Commission  Regulation.  That  Regulation 
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)." 

(4) 

In Article 14, paragraph 1 is replaced by the following: 

"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)."  

(5) 

In Article 15, paragraph 2 is replaced by the following: 

"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). 

However,  where  one  or  more  Member  States  so  request,  the  temporary  MRL 
may  be  maintained  for  an  additional  year  pending  confirmation  that  any 
scientific  studies  necessary  for  supporting  an  application  for  setting  a  MRL 
have  been  undertaken.  In  cases  where  such  confirmation  is  provided,  the 
temporary MRL shall be maintained for a further two years, provided that no 
unacceptable safety concerns for the consumer have been identified." 

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(6) 

Article 18 is replaced by the following: 

"1.  The  products  covered  by  Annex  I  shall  not  contain,  from  the  time  they  are 
placed on the market as food or feed, or fed to animals, any pesticide residue 
exceeding: 

(a) 

the MRLs for those products set out in Annexes II and III;  

(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  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.  Member  States  may  not  prohibit  or  impede  the  placing  on  the  market  or  the 
feeding  to  food-producing  animals  within  their  territories  of  the  products 
covered  by  Annex  I  on  the  grounds  that  they  contain  pesticide  residues 
provided that:  

(a) 

such products comply with paragraph 1 and Article 20; or 

(b) 

the active substance is listed in Annex IV. 

3. 

By way of derogation from paragraph 1, Member States may authorise, further 
to  a  post-harvest  treatment  with  a  fumigant  on  their  own  territory,  residue 
levels for an active substance which exceed the limits specified in Annexes II 
and  III  for  a  product  covered  by  Annex  I  where  the  active  substance/product 
combinations are listed in Annex VII provided that: 

(a) 

such products are not intended for immediate consumption; 

(b) 

appropriate  controls  are  in  place  to  ensure  that  such  products  cannot  be 
made available to the end user or consumer, if they are supplied directly 
to  the  latter,  until  the  residues  no  longer  exceed  the  maximum  levels 
specified in Annexes II or III; 

(c) 

the other Member States and the Commission have been informed of the 
measures taken. 

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). 

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 

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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)." 

(7) 

In Article 20, paragraph 2 is replaced by the following: 

"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). " 

(8) 

In Article 21, paragraph 1 is replaced by the following: 

"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  non-
essential  elements  of  this  Regulation  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 45(4)." 

(9) 

In Article 22, paragraph 1 is replaced by the following: 

"1.  Temporary  MRLs  for  active  substances  for  which  a  decision  on  inclusion  or 
non-inclusion in Annex I to Directive 91/414/EEC has not yet been taken shall 
be  first  established  and  listed  in  Annex  III  to  this  Regulation,  unless  already 
listed in Annex II hereto, taking into account the information provided by the 
Member States, where relevant the reasoned opinion mentioned in Article 24, 
the factors referred to in Article 14(2) and the following MRLs: 

(a) 

remaining MRLs in the Annex to Directive 76/895/EEC; and 

(b)  hitherto unharmonised national MRLs. 

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)." 

(10) 

In Article 27, paragraph 2 is replaced by the following: 

"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 

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regulatory  procedure  with  scrutiny  referred  to  in  Article  45(4)  of  this 
Regulation.". 

(11) 

Article 45 is replaced by the following: 

"Article 45 

Committee procedure 

1. 

The  Commission  shall  be  assisted  by  the  Standing  Committee  on  the  Food 
Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002 
(hereinafter referred to as the Committee). 

2.  Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 
three months. 

3.  Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 
thereof. 

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. 

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. 

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." 

(12) 

Article 46 is replaced by the following: 

"1. 

Implementing  measures  to  ensure  the  uniform  application  of  this  Regulation; 
shall  be  established  or  may  be  amended  in  accordance  with  the  procedure 
referred  to  in  Article  45(2)  and,  where  appropriate,  taking  into  account  the 
opinion of the Authority. 

2.  Measures  to  establish  or  amend  the  dates  in  Article  23,  Article  29(2),  Article 
30(2),  Article  31(1)  and  Article  32(5)  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)." 

(13) 

Article 49 is replaced by the following: 

"1.  The requirements of Chapter III shall not apply to products lawfully produced 
or  imported  into  the  Community  before  the  date  referred  to  in  the  second 
paragraph of Article 50. 

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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). 

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)." 

This  Regulation  shall  enter  into  force  on  the    day  following  that  of  its  publication  in  the 
Official Journal of the European Union. 

Article [2] 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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