Proposal for a COUNCIL DIRECTIVE amending Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables, Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals, Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin, and Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables
Date: 1995-06-19
Institutions: European Commission
Subjects: foodstuff, foodstuffs legislation, fruit, meat product, pesticide residue, vegetable

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels,  19.06.1995 
COM(95)  272  final 

95/0154  (CNS) 

Proposal  for  a 
COUNCIL  DIRECTIVE 

amending  Council  Directive  76/895/EEC  of  23  November  1976 
relating  to  the  fixing  of  maximum  levels  for  pesticide  residues 
in  and  on  fruit  and  vegetables, 

Council  Directive  86/362/EEC  of  24  July  1986 
on  the  fixing  of  maximum  levels  for 
pesticide  residues  in  and  on  cereals, 

Council  Directive  86/363/EEC  of  24  July  1986 
on  the  fixing  of  maximum  levels  for  pesticide  residues 
in  and  on  foodstuffs  of  animal  origin,  and 

Council  Directive  90/642/EEC  of  27 November  1990 
on  the  fixing  of  maximum  levels  for  pesticide  residues 
in  and  on  certain  products  of  plant  origin, 
including  fruit  and  vegetables 

(presented  by  the  Commission) 

EXPLANATORY  MEMORANDUM 

1. 

2. 

The use of pesticides  in modern agriculture  is considered 
essential to minimize crop losses resulting  from pest and 
disease attacks.  Their use has contributed  significantly 
to improvements  in agricultural productivity  and also in 
produce quality.  However, it must be realised  that 
pesticides may be dangerous and accordingly  their 
residues should  only be present  in amounts that are 
absolutely  necessary  for optimum pesticidal  effect and 
then only  if toxicologically  acceptable. 

The necessity to regulate pesticide residues was  formally 
recognised  by the Council  in its resolution  of 22 July 
19741 relating to veterinary, phytosanitary  and  animal 
nutrition  sectors, and  subsequently  by the adoption  in 
1976 of Council Directive  76/895/EEC relating  to the 
fixing of maximum  levels for pesticide residues  in and on 
fruit and vegetables2. 

The scope of Community  coverage of maximum  levels for 
pesticide residues was significantly enlarged  in 1986 by 
adoption  of Council Directives  86/362/EEC  and 86/363/EEC3 
covering  cereals and products of animal  origin 
respectively,  and  in 1990 by adoption  of  Council 
Directive  90/642/EEC4 on the fixing  of maximum  levels  for 
pesticide residues  in and on certain products  of plant 
origin,  including  fruit and vegetables.  Since the 
adoption of Directive  90/642/EEC the Community  regime 
covers  in principle most  important  components  of the 
diet, which allows a more systematic  approach  being 
taken  for establishing  Community maximum  residue  limits 
than was previously possible. 

The Commission never considered  Directive  76/895/EEC 
entirely  satisfactory  due to the fact that Member  States 
are not required  to adopt for their national trade the 
maximum  levels  laid down  in the Directive. 

By adopting  Directive  90/642/EEC  - where the  levels  fixed 
are binding  for all trade -the Council  created a 
framework  for  improving the system  applicable  to  fruit 
and vegetables  and allowed the progressive  transferral  of 
existing maximum  levels  in Directive  76/895/EEC  to 

1 

2 

3 

4 

OJ N°  C92 of 6.8.1974, p.2 

OJ N°  L340 of 9.12.1976,  p.26 

OJ N°  L221 of 7.8.1986, p.37 

OJ N° L350 of  14.12.1990, p.71 

2 

Directive  90/642/EEC.  This transferrai already  started 
with the adoption of Council Directives  93/58/EC5 and 
94/30/EC6.  Further transfers  in the future will  finally 
result  in the regime of Directive  76/895/EEC  being 
completely replaced  by the one provided  for  in Directive 
90/642/EEC. 

In this way, the  increased degree of  harmonisation 
already achieved  by Directives  86/362/EEC  for cereals and 
86/363/EEC  for foodstuffs of animal origin, providing  for 
maximum  levels to be applied  in all Member  States, will 
gradually  be extended  to all other agricultural  products 
by setting maximum  residue  levels  in the framework  of 
Directive  90/642/EEC.  In this context the Council  has 
already  adopted  several directives  (93/57/EC7 and 
94/29/EC)8. 

Moreover  in 1991, the Council adopted  Directive 
91/414/EEC9 concerning  the placing  of plant  protection 
products on the market which provided  in its Article 4 
(1)(f) for a formal  link between the  authorization  of a 
plant protection product by a Member  State and the 
establishment  of corresponding maximum  residue  levels in 
the agricultural products.  The Directive provides  for 
the establishment  of provisional  Community  maximum 
residue  levels  following notification  by a Member State. 
Whilst this system  should be efficient and  practicable 
for new active substance as their Good  Agricultural 
Practices gradually  evolve  in Member  States,  it would  be 
clearly  impracticable  for existing  active substances with 
their already  existing wide spectrum  of uses.  In such 
cases,  it could  involve reexamining  single pesticide/ 
product  combination many times over  a relatively  short 
period  of time, notwithstanding  the  fact that most Good 
Agricultural  Practices  in Member  States will have been 
known at the time of the examination  of an active 
substance  for  inclusion  in Annex  I to  Directive 
91/414/EEC.  The Commission  is of the opinion that  it 
would  be preferable to systematically  fix maximum 
residues  levels, where possible, at the time of  inclusion 
of an active  substance  in Annex  I to  Directive 
91/414/EEC. 

Indeed  it is foreseen that the present 

OJ N° L211 of 23.8.93, p.6 

OJ N°  L189 of  23.7.94, p.70 

OJ N° L211 of 23.8.93, p.l 

OJ N° L189  of 23.7.94, p.67 

OJ N°  L230 Of  19.8.91, p.l 

3 

successful approach used to establish MRLs since the 
adoption of Directive 90/642/EEC  should continue, 
although at significantly increased rate than was 
previously possible.  This approach should  allow the 
application of the most appropriate mechanism  for new and 
existing active substances, thereby  allowing  the 
Community to expeditiously  and systematically  approach 
the establishment  of MRLs, ensuring  a high  level of 
consumer protection and contributing to the  efficient 
functioning of the Single Market. 

The Commission  is of opinion that the current  framework 
for maximum residue  level setting established  in the 
Directives 76/895/EEC, 86/362/EEC, 86/363/EEC  and 
90/642/EEC needs to be improved  in order to permit the 
Community to react more adequately  to the  increased  tasks 
it will be confronted with  in future.  The  current 
proposal has provided  for the amendments the  Commission 
feels necessary  to be introduced  in the current 
legislation. 

(a)  Extension of the scope of the Directives to dried 
and/or processed  individual agricultural  products 
and to composite processed products. 

Article  3(1) of Directive 90/642/EEC  already 
provides, only for dried products of plant  origin 
covered  by that Directive, that the maximum  residue 
level applied must be the level  laid down for the 
raw product, taking  into account the residue 
concentration  caused by the drying process. 
Problems of human health protection  and  adequate 
functioning  of the single market can however  also 
arise for other dried products, or for products 
having undergone other types of processing  or for 
products having been incorporated  into  composite 
products.  In line with the principle  established  in 
Article  3(1) of Directive 90/642/EEC, the  Commission 
proposes  in the present proposal the  levels  applied 
by Member  States to such products being based  on 
maximum  residue  levels set in the Annexes  II to 
Directives  86/362/EEC, 86/363/EEC  and  90/642/EEC 
taking  into account the dilution  or concentration  of 
the pesticide residue  in the agricultural  products 
resulting  from processing  and/or, where relevant, 
incorporation  in a composite  food.  It is also 
proposed  that the dilution or concentration  factors 
related  to certain drying or processing  operations 
may be harmonised  at Community  level, if this would 
appear necessary. 

(b)  Introduction  of an adequate  framework  for  setting 
provisional maximum residue  levels throughout  the 
Community  according to the provisions  of Article 4 

(1)(f) of Directive 91/414/EEC. 

According  to these provisions, provisional  maximum 
residue  levels will have to be set by the  Commission 
- within  3 months  from notification  by a Member 
State - on the basis of the good  agricultural 
practice  in only one or few Member  States and of the 
toxicological  data made available  for the  evaluation 
of the active substance  in view of  its inclusion  in 
Annex I to Directive  91/414/EEC.  In order to avoid 
maximum residue  levels being dispersed  over  several 
legal instruments, the Commission proposes that the 
provisional maximum residue  levels be  incorporated 
in the annexes II of Directives 86/362/EEC, 
86/363/EEC  and  90/642/EEC with a specific  reference 
to the procedure  of Article 4  (1)(f).  Such a 
procedure  seems justified given that  provisional 
maximum  residue  levels only differ  from  final 
maximum residue  levels in the fact that an 
adaptation  is more  likely due to the  ongoing 
evolution  of good agricultural practice  in Member 
States,  in particular  in those which did not yet 
grant an authorization  at the time the proposal  for 
a maximum  residue  level was  first notified  to the 
Commission. 

(c)  Introduction  of procedures  for situations  where 

barriers to  intra community  trade may be expected  or 
have appeared  as the result of the absence of 
harmonised maximum  residue  levels  for certain 
pesticide/product combinations. 

Despite the increased progress  in fixing new maximum 
residue  levels since the adoption of Directive 
9 0/642/EEC and the impetus which may be expected  in 
the forthcoming years  in the setting  of maximum 
residue  levels throughout the Community,  it is 
evident that for many pesticide/product  combinations 
common maximum  residue  levels will only be set after 
several years, where already  now  it is required  that 
the single market can operate adequately.  The 
current provisions of Directives  86/3 62/EEC, 
86/363/EEC  and  90/642/EEC do not provide  for a 
conflict resolving procedure  in cases where, in the 
absence of harmonised maximum  residue levels, 
barriers may be expected  to appear  or have  appeared 
for products  satisfying the maximum  residue  levels 
applied  in the producing Member  State but not those 
applied  by the  importing Member State. 

To ensure the best possible  functioning  of the 
single market  in these situations the  following 
procedures  are proposed. 

1) 

In cases where prohibitions  or restrictions  to 
trade are expected  by a producing Member State. 

The proposal provides that every Member  State 
shall provide for a system  enabling  the 
establishment  of  "import tolerances" in those 
cases where no Community harmonization  has yet 
been adopted. When establishing  such maximum 
residue  levels Member  States have to take  into 
account the good agricultural practice  in the 
producing Member State. This system would 
enable a producing Member  State, who  is 
expecting trade problems, to provide all 
necessary data, including  its good  agricultural 
practice, to enable the importing Member  State 
to establish  such an "import tolerance". This 
system  is already  in place  in some of the 
Member States. 

2) 

In cases where prohibitions  or  restrictions 
have effectively taken place, a two step 
conciliation procedure has been provided. 

2.1. a bilateral discussion phase between the 2 

Member  States concerned with the aim to remove, 
if possible, the barrier taking  into account 
the Member  States' rights and obligations  under 
the provisions of Articles  3 0 and  3 6 of the 
Treaty; a report of this discussion  is 
submitted  to the Commission, which  shall then 
submit the report to the Standing  Committee  for 
examination; 

2.2. as a result of this examination, the  Commission 
will open a procedure which may  lead to  setting 
a maximum  residue  level applicable  throughout 
the Community.  Such action would  be 
appropriate when the bilateral discussion  phase 
would not have  led to an adequate solution or 
when the case would  seem to exceed  the 
interests of the two Member  States  concerned. 
Such action would however  only be possible as 
far as the toxicological data necessary  to 
ensure that the levels set satisfy the human 
health  safety requirements  are available. 
Moreover the common maximum  residue  level would 
only be set for a limited  time period  if it 
would  appear that at the time the  conflict 
arises not sufficient data  from  supervised 
trials  in crops are available to establish  with 
sufficient precision the residue  level 
resulting  from the good  agricultural  practice 
in the producing Member  State, while at the 
same time this Member  State has undertaken  that 

these data will be submitted within the set 
time limit which may not exceed  4 years.  For 
the same reasons of clarity mentioned  under 
(b),  it is proposed that these temporary 
maximum residue levels also are incorporated  in 
the annexes II of Directives 86/362/EEC, 
86/363/EEC and 90/642/EEC, together with the 
specified  time limit. 

(d)  Increased harmonisation  of the measures with regard 

to monitoring. 

Check sampling and monitoring  of pesticide  residues 
in and on cereals, foodstuffs of animal origin and 
products of plant origin, including  fruit and 
vegetables, is essential to ensure compliance with 
maximum  levels specified  in Community  legislation. 
In particular, effective and systematic  monitoring 
of pesticide residues  in food will  increase the 
confidence of consumers  in the  levels of  protection 
of human health provided  by the Community  system of 
maximum residue  levels. 
monitoring  and check sampling  contained  in 
Directives 86/362/EEC and 90/642/EEC  are 
inconsistent and  incomplete: the proposed 
replacement provisions would harmonise the 
requirements  on pesticide monitoring  for the 
foodstuffs concerned  and would  in particular: 

The current provisions  on 

establish a clear and  logical time-table  for 
the reporting of  intended  future monitoring 
programmes and the results of previous 
monitoring programmes by Member  State and  for 
the establishment  of annual  co-ordinated 
monitoring programmes, and 

set out clearly the minimum  content and  basic 
objectives of the various monitoring 
programmes. 

This amendment  is not proposed  for  Directive 
86/363/EEC, as monitoring  of pesticide residues  in 
animal products  is addressed, together  with 
monitoring  of other contaminants  or undesirable 
substances  in animal products, in the context of the 
veterinary  legislation. 

(e)  Updating of certain provisions of  Directives 
76/895/EEC. 86/362/EEC and 86/363/EEC to the 
equivalent provisions  in Directive  90/642/EEC. 

In order to ensure coherent  implementation  of the 
three main Directives, the following provisions  are 
proposed  for being updated: 

- 

the provisions concerning  exemptions and 
concerning  exports to third countries; 

the safeguard  clauses provided  for in 
Directives  86/362/EEC and 86/363/EEC; 
the provisions concerning  the Regulatory 
Committee procedure. 

(f)  Introduction  of a Regulatory  Committee  decision 

procedure, in particular  for the following measures: 

adoption of the necessary  amendments  in the 
annexes as a result of developments  in 
scientific and technical knowledge, i.e. the 
necessary  amendments with regard  to the 
description  of the agricultural  products 
concerned  as well as the amendments with  regard 
to establishment  of maximum  residue  levels 
based  on submitted data on good  agricultural 
practices  in the Community  and  corresponding 
supervised  trial data as well as on  submitted 
toxicological data; 

- 

adoption of the temporary maximum  residue 
levels  in the framework  of the  conciliation 
procedure; 
adoption of the dilution  or  concentration 
factors related to certain drying  or processing 
operations. 

The Commission  is of opinion that  for these matters 
a Council decision  is not justified  given that the 
measures concerned  are technical measures based  on 
examination  of technical data  submitted  by Member 
States and/or operators which can be handled  more 
swiftly by a Commission decision  according  to the 
Regulatory  Committee procedure.  Moreover  such 
procedure brings the decision making  procedure  in 
coherence with the following matters  for which a 
Regulatory  Committee procedure has already  been 
provided  for: 

in Directive  91/414/EEC with regard  to the 
inclusion of active substances  in Annex  I to 
that Directive and with regard to the 
establishment  of provisional maximum  residue 
levels,  (Article 4  (l)(f)); 
in Directive  90/642/EEC with regard  to 
amendments to the annexes to this  Directive 
resulting  from the  implementation  of the 
safeguard clause; 
in Regulation  (EEC) n°2377/90 with  regard  to 
the establishment  of maximum  residue  levels 
resulting  from veterinary medicines. 

8 

The Commission  is of opinion that for an  effective 
and streamlined  operation of the provisions of 
Directive  91/414/EEC and the above mentioned 
provisions  in the Directives  76/895/EEC, 86/362/EEC, 
86/363/EEC and  90/642/EEC  similar decision making 
procedures are required.  Moreover, as already 
mentioned under point  (b), the provisional  maximum 
residue  levels of Directive  91/414/EEC  are based  on 
notifications from one or two Member  States who 
granted  the first authorization; they  are only to be 
adapted  afterwards to take  into account the good 
agricultural practice which may  later on have been 
developed  and notified  by other Member States. 

(g)  Measures ensuring rapid transposai  of the  amendments 
introduced  in the annexes by the Member States. 

Proper  functioning  of the single market  implies that 
the decisions, once they have been taken at 
Community  level are swiftly applied  in the Member 
States. 

In 1989 the Commission proposed  a Regulation with 
regard to the fixing of maximum  residue  levels in 
and on certain products of plant origin, which would 
have permitted  to operate a system  of  directly 
applicable  levels throughout the Community.  This 
approach was not accepted  by the Council when  it 
adopted  Directive  90/642/EEC.  The  Commission 
therefore now proposes that Member  States take, if 
necessary, a general  legal or administrative  measure 
permitting  them to transpose rapidly  any  amendments 
to the annexes of the 4 directives  concerned. 

4. 

Coherence of the proposed  action with Article  3b of the 
Treaty  establishing  the European Community  (subsidiarity) 

From the foregoing points  it results that the proposed 
legislative action, which envisages to  improve and update 
the currently  applicable  legislation  on pesticide 
residues,  is in line with the objectives of The  Common 
agricultural policy  and the establishment  of a single 
market taking  into account the necessity  of preserving a 
high  level of protection of human health, and  is already 
covered under exclusive  competence of the Community.  The 
proposed  legislative action  is necessary  to ensure  that 
the above mentioned  objectives are realised  in a more 
effective way than the current provisions permit. 

Proposal  for  a 
COUNCIL  DIRECTIVE 

amending  Council  Directive  76/895/EEC  of  23  November  1976 
relating  to  the  fixing  of  maximum  levels  for  pesticide  residues 
in  and  on  fruit  and  vegetables, 

Council  Directive  86/362/EEC  of  24  July  1986 
on  the  fixing  of  maximum  levels  for 
pesticide  residues  in  and  on  cereals, 

Council  Directive  86/363/EEC  of  24  July  1986 
on  the  fixing  of  maximum  levels  for  pesticide  residues 
in  and  on  foodstuffs  of  animal  origin,  and 

Council  Directive  90/642/EEC  of  27  November  1990 
on  the  fixing  of  maximum  levels  for  pesticide  residues 
in  and  on  certain  products  of  plant  origin, 
including  fruit  and  vegetables 

THE  COUNCIL  OF THE  EUROPEAN  UNION 

Having  regard  to the Treaty  establishing  the  European 
Community,  and  in particular  Article  4 3 thereof, 

Having  regard  to the proposal  from  the  Commission, 

Having  regard  to the  opinion  of the  European  Parliament, 

Having  regard  to the  opinion  of the  Economic  and  Social 
Committee, 

Whereas  Council  Directives  86/362/EEC  of  24 July  1986  on  the 
fixing  of maximum  levels  for pesticide  residues  in and  on 
cereals10;  86/363/EEC  of  24 July  1986  on the  fixing  of  maximum 
levels  for pesticide  residues  in and  on  foodstuffs  of  animal 
origin11; and  90/642/EEC  of  27 November  1990 relating  to  the 
fixing  of maximum  levels  for pesticide  residues  in and  on 
certain  products  of plant  origin,  including  fruit  and 
vegetables12 have  established  a common  regime providing  for 
mandatory  residue  levels  applicable  throughout  the  European 
Community; 

Whereas  this regime provides  for  a gradual  transfer  of  the 
maximum  residue  levels  established  under  Directive  76/895/EEC 
to  Directive  90/642/EEC  after  technical  consideration;  whereas 
such  transfer  has  already  been  realised  for  certain  levels  and 
is  still  in preparation  for others; 

Whereas  Directive  91/414/EEC13 concerning  the placing  of  plant 
protection  products  on the market  has provided  for  a mechanism 
linking  the  authorization  of  a plant  protection  product 
containing  an  active  substance  included  in Annex  I of  that 
Directive  to the  obligation  for  the Member  State  having 
granted  the  authorization  to  establish  a provisional  maximum 
residue  level  of the  active  substance  concerned  in the  treated 
crops; whereas  this mechanism  also provides  for  a mandate  to 

10 

OJ N° L221, 7.8.1986, p. 37. Directive as last amended 
by Directive  94/29/EC  (OJ N°  L189, 23.7.1994, p.67) 

OJ N° L221, 7.8.1986, p.43.  Directive as last amended 
by  94/29/EC  (OJ N°  L189, 23.7.1994, p.67) 

OJ  N°  L350,  14.12.1990,  p.71. 
Directive  as  last 
amended  by  Directive  94/30/EC  (OJ  N°  L189,  23.7.94, 
p.70) 

13 

OJ  N°L230,  19.8.1991  p.l.  Directive  as  last  amended 
by Directive  94/79/EC  (OJ N°  L354,  31.12.1994,  p.16). 

AG 

the Commission to establish, on the basis of the provisional 
maximum residue  level set by a Member  State, provisional 
maximum  residue  levels applicable throughout the Community; 
whereas for reasons of clarity, the provisional  maximum 
residue  levels set according to this mechanism,  should  be 
integrated  in an appropriate way  in the annexes to  Directives 
86/362/EEC, 86/363/EEC  and 90/642/EEC; 

Whereas rules have to be set concerning  the maximum  residue 
levels which are acceptable  in dried  and/or processed  single 
agricultural products and  in composite  foodstuffs  in order to 
ensure proper human health protection  as well as proper 
functioning  of the single market with regard to such products; 

Whereas Member  States should provide  for the possibility  to 
establish maximum  residue  levels for  imported products  in 
order to prevent as much as possible trade problems due to the 
absence of harmonised maximum  residue  levels for  certain 
residue/product  combinations; 

Whereas a conciliation procedure  is necessary  in cases where 
in practice barriers to  intracommmunity  trade have  appeared 
due to the absence of harmonised maximum  residue  levels  for 
certain residue/product  combinations; 

Whereas effective monitoring  of pesticide residues  should  be 
systematically  organised  at both national and Community  stages 
in order to ensure compliance with the mandatory  levels set 
and to contribute to the highest degree of consumer  confidence 
in the degree of protection  of human health  achieved. 

Whereas  it is necessary  to update certain provisions of 
Directives  76/895/EEC  relating to the fixing  of maximum  levels 
for pesticide residues  in and on fruit and vegetables14, 
86/362/EEC  and  86/363/EEC to the similar provisions  in 
Directive  90/642/EEC to ensure coherence  in the  implementation 
of the whole regime concerning maximum  residue levels; 

Whereas the introduction  of amendments  in the annexes as a 
result of developments  in scientific  and technical knowledge, 
as well as the setting  of temporary maximum  residue  levels and 
the establishment  of dilution or concentration  factors related 
to certain drying  or processing  operations  are  technical 
measures; whereas a Regulatory  Committee decision  procedure 
seems appropriate  for the adoption of such measures  in order 
to ensure an effective and streamlined  operation  of the 
implementation measures under Directives  76/895/EEC, 
86/362/EEC, 86/363/EEC  and 90/642/EEC  and the  implementation 
measures under Directive  91/414/EEC  and other  relevant 

14 

OJ  N°  L340,  9.12.1976,  p.26. 
Directive  as  last 
amended  by  Directive  93/58/EEC  (OJ N°  L211, 23.8.93, 
p.6) 

11 

Directives; 

Whereas an adequate protection  of human health and a proper 
functioning  of the single market requires that the  amendments 
introduced  in the Annexes are swiftly applied  by all the 
Member  States, 

HAS ADOPTED THIS DIRECTIVE 

Article 1 

Council Directive 76/895/EEC  of 23 November  1976 relating  to 
the fixing of maximum  levels for pesticide residues  in and on 
fruit and vegetables  is hereby amended  as follows: 

1. 

The first sentence of article 5 is replaced  by the 
following : 

"Without prejudice to Article 4, any amendments to be 
made to the Annexes shall be adopted  in accordance with 
the procedure  laid down  in Article  7." 

Paragraphs  2, 3 and 4 of Article  7 are replaced  by the 
following : 

"2.  The representative  of the Commission  shall submit to 

the Committee a draft of the measures to be taken. 
The Committee  shall deliver  its opinion on the draft 
within a time  limit which the chairman may  lay down 
according to the urgency  of the matter.  The opinion 
shall be delivered  by the majority  laid down in 
Article  148  (2) of the Treaty  in the case of 
decisions which the Council  is called upon to adopt 
on a proposal  from the Commission. The votes of the 
representatives  of the Member  States within the 
Committee  shall be weighted  in the manner  set out in 
that Article.  The chairman  shall not vote. 

3. The Commission  shall adopt the measures envisaged  if 

they are in accordance with the opinion  of the 
Committee. 

4. If the measures are not in accordance with  the 

opinion of the Committee, or  if no opinion  is 
delivered, the Commission  shall without delay  submit 
to the Council a proposal relating  to the measures 
to be taken. The Council  shall act by a qualified 
majority. 

5. If, within three months following the date on which 

12 

the matter was referred to the Council, the Council 
has not acted, the proposed measures shall be 
adopted by the Commission." 

3. 

Paragraphs 2,3  and 4 of Article 8 are replaced by the 
following : 

"2.  The representative of the Commission  shall submit to 

the Committee a draft of the measures to be taken. 
The Committee shall deliver  its opinion on the draft 
within a time limit which the chairman may  lay down 
according to the urgency of the matter.  The opinion 
shall be delivered  by the majority  laid down in 
Article  148  (2) of the Treaty  in the case of 
decisions which the Council  is called upon to adopt 
on a proposal  from the Commission. The votes of the 
representatives  of the Member  States within the 
Committee shall be weighted  in the manner  set out in 
that Article.  The chairman shall not vote. 

3.  The Commission  shall adopt the measures envisaged  if 

they are in accordance with the opinion of the 
Committee. 

4.  If the measures are not in accordance with the 

opinion of the Committee, or if no opinion  is 
delivered, the Commission shall without delay  submit 
to the Council a proposal relating to the measures 
to be taken.  The Council shall act by a qualified 
majority. 

5.  If, within  15 days following the date on which the 

matter was referred to the Council, the Council  has 
not acted, the proposed measures shall be adopted  by 
the Commission." 

4. 

The text of Article  9 is replaced  by the  following: 

"1.  This Directive  shall apply to products referred  to 

in Article  1 intended  for export to third countries, 
However, maximum pesticide residue  levels set in 
accordance with this Directive  shall not apply  in 
the case of products treated  before export where it 
can be satisfactorily  proved that: 

(a)  the third  country of destination requires that 

particular treatment  in order to prevent the 
introduction of harmful organisms  into its 
territory; or 

(b)  the treatment  is necessary  in order to protect 

the products against harmful organisms  during 

13 

transport to the third  country  of  destination 
and  storage there. 

2.  This Directive shall not apply to the products 

referred to in Article  1 where  it can be  established 
by appropriate evidence that they are intended  for: 

(a)  the manufacture of products other than 

foodstuffs and animal feed; or 

(b)  sowing or planting." 

5. 

After Article  10, the following Article  is  inserted: 

"Article  10a 

The Member  States shall bring  into force  laws, 
regulations and administrative provisions necessary  to 
ensure that the amendments referred  to  in Article  5 can 
be implemented  in their territory within a period  of 
maximum  4 months  from their adoption, and within a 
shorter  implementation period when this  is required  for 
reasons of human health protection." 

14 

Article 2 

Council Directive 86/362/EEC of 24 July  1986 on the fixing of 
maximum  levels for pesticide residues  in and on cereals, is 
amended  as follows: 

1. 

Article  1 is replaced by the following: 

"Article 1 

1. 

This Directive shall apply to the cereal  products 
listed  in Annex I in so far as these products may 
contain certain pesticide residues. 

The directive shall also apply to the same products 
after drying or processing  or after  inclusion  in a 
composite food  in so far as they may contain  certain 
pesticide residues. 

2. 

This Directive shall apply without prejudice to: 

(a)  the provisions of Council Directive  74/63/EEC15 

of  17 December  1973 on the fixing of maximum 
permitted  levels for undesirable  substances and 
products  in feedingstuffs; 

(b)  the provisions of Council Directive  76/895/EEC 

of 23 November  1976 relating  to the fixing of 
maximum  levels for pesticide residues  in and on 
fruit and vegetables; 

(c)  the provisions of Council Directive  90/642/EEC 

of 27 November  1990 on the fixing of maximum 
levels for pesticide residues  in and on certain 
products of plant origin, including  fruit and 
vegetables. 

3. 

This Directive shall also apply to products referred 
to in paragraph  1 intended  for export to third 
countries.  However, maximum pesticide  residue 
levels set in accordance with this Directive  shall 
not apply  in the case of products treated  before 
export where  it can be satisfactorily  proved that: 

(a)  the third  country of destination  requires that 

particular  treatment  in order to prevent  the 
introduction of harmful organisms  into  its 
territory; or 

15 

OJ N° L38, 11.2.1974, p.31.  Directive as last amended 
by Directive  94/16/EC  (OJ N° L104, 23.4.94, p.32) 

15 

(b)  the treatment  is necessary  in order to protect 

the products against harmful organisms  during 
transport to the third  country  of  destination 
and storage there. 

4. 

This Directive shall not apply to the products 
referred to in paragraph  1 where  it can be 
established  by appropriate  evidence that they  are 
intended for: 

(a)  the manufacture  of products other than 

foodstuffs and animal feed; or 

(b) sowing or planting." 

2. 

In Article  2(1) the words  "listed  in Annex  II" are 
deleted. 

3. 

Article  4 is replaced  by the  following 

"Article 

4 

1. 

Notwithstanding  the provisions of Article  6, the 
products referred  to in Article  1 shall not contain, 
from the time they are put  into circulation, 
pesticide residue  levels higher than those  specified 
in the  list referred  to  in Annex  II. 

The list of pesticide residues concerned  and their 
maximum  levels shall be established  in Annex  II in 
accordance with the procedure  laid down  in Article 
12 having regard to current scientific  and  technical 
knowledge. 

2. 

In the case of dried  and processed  products  for 
which maximum  levels are not explicitly  fixed  in 
Annex  II, the maximum residue  level applicable  shall 
be that  laid down  in Annex  II, taking  into  account 
respectively  the concentration  caused  by the drying 
process or the concentration  or dilution  caused by 
processing.  In accordance with the procedure  laid 
down  in Article  12 a concentration  or dilution 
factor covering the concentration  and/or  dilution 
caused by certain drying or processing  operations 
may be determined  for certain dried  or processed 
products. 

3. 

In the case of composite  foods containing  a mixture 
of  ingredients and  for which maximum  residue  levels 
are not fixed, the maximum  residue  levels  applied 
may not exceed the levels  laid down  in Annex II, 

16 

taking  into account the relative concentrations of 
the ingredients  in the mixture and also the 
provisions  laid down  in paragraph  2. 

Member  states shall ensure, at least by monitoring 
and check  sampling, compliance with the maximum 
levels referred  to  in paragraph  1.  The  necessary 
inspections and control measures  shall be carried 
16 
out in accordance with Council Directive  89/397/EEC 
of 14 June 1989 on the official  control of 
foodstuffs, and  in particular  Article  4 thereof, 
and Directive  93/99/EEC17 on the subject of 
additional measures concerning  the official  control 
of foodstuffs". 

4. 

Article  5 is replaced  by the following two  articles 

"Article 5 

Where  for a product belonging to a group  specified  in Annex  I, 
a provisional maximum  residue  level throughout  the  Community 
is set by the Commission  in accordance with the provisions of 
Article  4(1)(f) of Directive  91/414/EEC  concerning  the placing 
of plant protection products on the market, this  level will be 
listed  in Annex  II with a reference to that procedure. 

Article 5a 

1. 

For the purposes of this article a  Member  State of 
origin  is defined  as the Member  State on which  territory 
a product  specified  in Article  1  (1), 1st subparagraph  is 
legally produced  or commercialised  and a destination 
Member  State  is defined  as the Member  State  into which 
territory  such product  is introduced  and put  into 
circulation  for operations other than transit to another 
Member  State or third  country. 

Member  States shall provide  for a regime to enable the 
establishment  of maximum  residue  levels for products 
referred  to  in Article  1(1), first  subparagraph, 
introduced  into their territories  from a  Member  State of 
origin, and taking  into account the good  agricultural 
practice  in the  Member  State of origin,  in cases where 
no maximum  residue  levels have been established  for these 

16 

17 

OJ N° L186, 30.6.89, P.23 

OJ N°  L290,  24.11.1993, p.14 

17 

products  in accordance with the provisions of Article 
4(1) or 5. 

3.  Moreover  in cases where no maximum residue  levels have 

been established  in accordance with the provisions of 
Article  4(1) or 5 the following  shall apply. 

1.  Where a product  specified  in Article  1  (1), 1st 

subparagraph  satisfying the maximum  residue  levels 
applied by  its Member  State of origin, has been 
submitted  in the destination Member  State to 
measures with the effect to prohibit or submit to 
special restrictions the putting  into circulation  of 
the product concerned  on the grounds that  such 
product contains pesticide residue  levels  exceeding 
the maximum  residue  level accepted  in the 
destination Member  State, the destination  Member 
State shall  inform thereof the other Member  State 
concerned  and the Commission.  In the  communication 
the cases on which the information  is based,  shall 
be documented. 

On basis of the communication  referred  to in 
subparagraph  1, the two Member  States  concerned 
shall open without delay a discussion  in order to 
remove, whenever possible, the prohibitive  or 
restrictive  effect of the measures applied  by the 
destination Member  State by means of measures  agreed 
between the Member  States and they  shall, within a 
period  of  3 months  from the communication,  notify  to 
the Commission  and the other Member  States the 
result of this discussion, and  in particular  the 
agreed measures  if any, including  the maximum 
residue  level the destination Member  State  intends 
to set in the framework  of the regime referred  to in 
paragraph  2. 

The Member  States shall submit to each other all 
required  information; in particular  the producing 
Member  State shall  indicate the data, including  its 
toxicological  assessment and estimation  of an ADI, 
its good agricultural practice  and  corresponding 
trial data  it relied upon to establish  its own 
maximum  residue  level; the destination Member  State 
shall  indicate the reasons  justifying  the measures 
it applies. 

The Commission  shall refer the matter to the 
Standing Committee on Plant Health.  A  temporary 
maximum  level may be established  in Annex  II for a 
limited period  of time  in accordance with  the 
procedure  laid down  in Article  12. For the 
establishment  of this temporary maximum  level, the 

18 

Commission takes  into account the state of the 
technical  and scientific knowledge. 

Moreover the Member State of origin and/or other 
interested Member  States shall give, where relevant, 
a  satisfactory  undertaking that the necessary  trial 
data will be submitted within a time  limit set in 
accordance with Article  12; this time  limit will not 
exceed  4 years. 

4. 

5. 

Any measure provided  for in paragraphs  2 or 3  shall be 
taken by a Member  State in due respect of  its  obligations 
under the Treaty and  in particular  the Articles  3 0 to 3 6 
thereof. 

The provisions of Council Directive  83/189/EEC18 of 28 
March  1983  laying down a procedure  for the provision  of 
information  in the field  of technical  standards and 
regulations do not apply to the measures  applied  and 
notified  by Member  States  in accordance with  the 
provisons of paragraph  3 of this Article. 

6. 

Detailed measures  for the implementation  of the procedure 
set out in this article may be adopted  in accordance with 
the procedure  laid down  in Article  12." 

5. 

Article  7 is replaced  by the following: 

"Article 

7 

1.  Member  States shall designate an authority  to ensure 

that the monitoring  specified  in Article  4  (4) is 
carried  out; the designated  authority  may be the 
same as the single  liaison body designated  under 
Article  6 of Directive 93/99/EEC. 

2. 

(a)  By  30 June each year, the Member  States  shall 

send to the Commission their  intended  national 
monitoring programmes  for the following  calender 
year.  These forward programmes  shall  specify  at 
least: 

- 

the products to be inspected  and the number 
of  inspections to be carried out, 

OJ N° L109, 26.4.1983, p.8.  Directive as last amended 
by Directive  94/10/EEC  (OJ N°  L100, 19.04.94, p.30) 

19 

the pesticide residues to be inspected  for, 

the criteria applied  in drawing up these 
programmes. 

(b)  By 30 September  each year, the Commission  shall 
refer a draft Decision  setting out a coordinated 
monitoring programme to the Standing  Committee 
on Plant Health. The Decision will be adopted  in 
accordance with the procedure  laid down  in 
Article  13.  The basic objective  of the 
coordinated monitoring programme will be to 
maximise the check  sampling  of cereals  included 
in the groups  listed  in Annex  I, produced  in the 
Community  and  imported  into  it, in order to 
ensure compliance with the maximum  levels for 
pesticide  residues set out  in annex  II.  This 
co-ordinated monitoring programme  may be 
subsequently  adjusted  as required  during  its 
implementation. 

(c)  By 28 February  each year the Member  States  shall 

send to the Commission reports on the 
implementation  in the preceding  calendar year of 
their national monitoring programmes  and of the 
co-ordinated monitoring programme  communicated 
by the Commission  in accordance with sub 
paragraph  (b).  These reports  shall  include at 
least the following  information: 

the products  inspected  and  the number of 
inspections carried out, 

the pesticide residues analyzed  for or to be 
analyzed  for. 

By 31 August each year, the Member  States  shall  send 
to the Commission the results of the analyses  of the 
check  samples taken during the previous year under 
their national monitoring programmes  and under the 
co-ordinated monitoring programme.  The  Commission 
shall collate and combine this  information  and  shall 
communicate  it to the Member  States  in the  framework 
of the Standing Committee on Plant Health  together 
with any recommendations  for consequent  action.  In 
particular, the recommendations  should cover: 

any action to be taken  in the case of reported 
infringements of the maximum  levels, 

the desirability  of publication  of the  collated 
and combined  information, 

specific conclusions as to modifications which 

20 

might be made to national monitoring programmes. 

4. 

In accordance with the procedure  laid down in 
Article  12 the following may be adopted: 

(a)  amendments to paragraphs  (2) and  (3) of this 

Article as far as these amendments concern the 
dates for communication; 

(b)  detailed  implementation rules necessary  for 
proper functioning  of the provisions of 
paragraphs  (2) and (3). 

5. 

Not  later than 31 December  1999 the Commission  shall 
forward to the Council a report on the  application 
of this Article, accompanied,  if necessary, by any 
appropriate proposals." 

6. 

Article  9 is replaced  by the following: 

"Article  9 

Where a Member  State, as a result of new  information 
or of a reassessment of existing  information 
considers that a maximum  level fixed  in Annex  II 
endangers human or animal health, and  therefore 
requires swift action to be taken, that Member  State 
may temporarily  reduce the  level  in its own 
territory.  In that case, it shall  immediately 
notify the other Member  States and the Commission of 
the measures, attaching a statement of the reasons 
therefore. 

The Commission  shall quickly  examine the grounds 
given by the Member State referred  to in the first 
subparagraph  and shall consult the Member  States 
within the Standing Committee on Plant Health, 
hereinafter referred to as  'the Committee'; it shall 
then deliver  its opinion forthwith  and take the 
appropriate measures.  The Commission  shall 
immediately  notify the Council and the Member  States 
of any measures taken.  Any Member  State may  refer 
the Commission's measures to the Council within  15 
days of such notification.  The Council  acting  by a 
qualified majority may take a different  decision 
within  15 days of the date on which the matter was 
referred  to it. 

If the Commission considers that the maximum  levels 
laid down in the list referred to  in Article 1 
should be amended to resolve the  difficulties 
mentioned  in paragraph  1 and to ensure the 

21 

protection  of human health,  it shall  initiate the 
procedure  laid down  in Article  13, with a view to 
adopting those amendments.  In this case, the Member 
State which has taken measures under paragraph  1 may 
in that event maintain them until the Council or the 
Commission has taken a decision  in accordance with 
the said procedure." 

7. 

Article  10 is replaced  by the following: 

"Article 10 

Without prejudice to Article 9, amendments to the  annexes 
shall be adopted  in accordance with the procedure  laid 
down in article  12, having regard to current  scientific 
and technical knowledge." 

8. 

The provisions of Article  11 are deleted. 

9. 

Paragraphs  2, 3 and 4 of Article  12 are replaced  by the 
following: 

"2.  The representative  of the Commission  shall submit to 

the Committee a draft of the measures to be taken. 
The Committee shall deliver  its opinion on the draft 
within a time limit which the chairman may  lay down 
according to the urgency  of the matter.  The  opinion 
shall be delivered  by the majority  laid down  in 
Article  148  (2) of the Treaty  in the case of 
decisions which the Council  is called upon to adopt 
on a proposal  from the Commission. The votes of the 
representatives  of the Member  States within the 
Committee  shall be weighted  in the manner  set out  in 
that Article.  The chairman shall not vote. 

3. 

4. 

The Commission  shall adopt the measures envisaged  if 
they are in accordance with the opinion of the 
Committee. 

If the measures are not  in accordance with the 
opinion of the Committee, or if no opinion  is 
delivered, the Commission  shall without delay  submit 
to the Council a proposal relating to the measures 
to be taken.  The Council shall act by a qualified 
majority. 

5. 

If, within three months following the date on which 
the matter was referred to the Council, the  Council 
has not acted, the proposed measures  shall be 
adopted  by the Commission". 

22 

10.  Paragraphs 2, 3 and 4 of Article 13 are replaced by the 

following: 

"2.  The representative of the Commission shall submit to 

the Committee a draft of the measures to be taken. 
The Committee shall deliver its opinion on the draft 
within a time limit which the chairman may lay down 
according to the urgency of the matter.  The opinion 
shall be delivered by the majority laid down in 
Article 148 (2) of the Treaty in case of decisions 
which the Council is called upon to adopt on a 
proposal from the Commission. The votes of the 
representatives of the Member States within the 
Committee shall be weighted in the manner set out in 
that Article.  The chairman shall not vote. 

3.  The Commission shall adopt the measures envisaged if 
they are in accordance with the opinion of the 
Committee. 

4.  If the measures are not in accordance with the 

opinion of the Committee, or if no opinion is 
delivered, the Commission shall without delay submit 
to the Council a proposal relating to the measures 
to be taken. The Council shall act by a qualified 
majority. 

5.  If, within  15 days  following  the  date  on which  the 
matter was referred  to the Council, the Council has 
not acted, the proposed measures shall be adopted by 
the Commission." 

11.  Article 14 is replaced by the following: 

"Article 14 

The Member States shall bring into force laws, regulations 
and administrative provisions necessary to ensure that the 
amendments in Annex II resulting from decisions referred to 
in Articles  4(1) and  (2), 5, 5a (3),  9(3) and  10 can be 
implemented  in their territory within a period of maximum 
4  months  from  their  adoption,  and  within  a  shorter 
implementation period when this was prescribed for reasons 
of human health protection." 

23 

Article 3 

Council  Directive  86/363/EEC  of  24  July  1986  on  the  fixing  of 
maximum  levels  for  pesticide  residues  in  foodstuffs  of  animal 
origin,  is amended  as follows: 

1. 

The text of Article  1, is replaced  by the  following: 

"1.  This Directive shall apply to the foodstuffs of animal 
origin  listed  in Annex  I in so far  as these  products 
may of a contain certain pesticide residues. 

The  directive  shall  also  apply  to  the  same  products 
after  drying  or  processing  or  after  inclusion  in  a 
composite  food  in so far as they may  contain  certain 
pesticide residues. 

2. 

3. 

4. 

This  Directive  shall  apply  without  prejudice  to  the 
provisions  of  Council  Directive  74/63/EEC  of  17 
December  1973  on  the  fixing  of  maximum  permitted 
levels  for  undesirable  substances  and  products  in 
Directive 
feedingstuffs, 
87/519/EEC. 

amended 

last 

as 

by 

This  Directive  shall  also  apply  to products  referred 
to  in  paragraph  1  intended  for  export  to  third 
countries. 

This  Directive  shall  not  apply  to  the  products 
referred to in paragraph 1 where it can be established 
by appropriate evidence that they are intended for the 
manufacture  of  products  other  than  foodstuffs  and 
animal  feed." 

2. 

In Article 2(1) the words "listed in Annex II" are deleted. 

3. 

Article  4 is replaced  by the following : 

"Article 

4 

1. 

The  products  referred  to  in  Article  1  shall  not 
contain, from the time they are put into circulation, 
pesticide  residue  levels higher  than  those  specified 
in the list referred  to  in Annex  II. 

The  list  of  pesticide  residues  concerned  and  their 

24 

maximum  levels  shall  be  established  in  Annex  II  in 
accordance with the procedure  laid down in Article 12 
having  regard  to  current  scientific  and  technical 
knowledge. 

In the case of dried and processed products for which 
maximum  levels  are not  explicitly  fixed  in Annex II, 
the  maximum  residue  level  applicable  shall  be  that 
laid  down  in  Annex  II,  taking  into  account 
respectively  the  concentration  caused  by  the  drying 
process  or  the  concentration  or  dilution  caused  by 
In  accordance  with  the  procedure  laid 
processing. 
down in Article  12 a concentration or dilution  factor 
covering  the  concentration  and/or  dilution  caused  by 
certain  drying  or  processing  operations  may  be 
determined  for certain dried or processed products. 

In the case of composite foods containing a mixture of 
ingredients  and  for which maximum  residue  levels  are 
not fixed, the maximum residue  limits applied may not 
exceed  the  levels  laid  down  in Annex  II, taking  into 
account the relative concentrations of the ingredients 
in  the  mixture  and  also  the  provisions  laid  down  in 
paragraph  2. 

Member states shall ensure, at least by monitoring and 
check  sampling,  compliance  with  the  maximum  levels 
referred to in paragraph 1.  The necessary  inspections 
and  control  measures  shall  be  carried  out  in 
accordance  with  Directive  89/397/EEC,  and  in 
particular  Article 4 thereof, and Directive 93/99/EEC 
on the  subject  of  additional  measures  concerning  the 
official  control  of  foodstuffs  and  other  relevant 
legislation  concerning  monitoring  of  residues  in 
foodstuffs of animal origin". 

4. 

Article  5 is replaced  by the following two  articles 

"Article 5 

Where  for a product belonging to a group  specified  in Annex  I, 
a provisional maximum  residue  level throughout  the  Community 
is set by the Commission  in accordance with the provisions of 
Article  4(1)(f) of Directive  91/414/EEC  concerning  the placing 
of plant protection products on the market, this  level will be 
listed  in Annex  II with a reference to that procedure. 

25 

Article 5a 

For the purposes of this article a  Member  State of 
origin  is defined  as the Member State on which  territory 
a product specified  in Article  1  (1), 1st subparagraph  is 
legally produced  or commercialised  and a destination 
Member  State is defined  as the Member  State into which 
territory  such product  is introduced  and put  into 
circulation  for operations other than transit to another 
Member  State or third  country. 

Member  States shall provide for a regime to enable the 
establishment  of maximum residue  levels for products 
referred to in Article  1(1), first  subparagraph, 
introduced  into their territories  from a  Member  State of 
origin, and taking  into account the good  agricultural 
practice  in the  Member  State of origin,  in cases where 
no maximum  residue  levels have been established  for these 
products  in accordance with the provisions  of Article 
4(1) or 5. 

Moreover  in cases where no maximum  residue  levels have 
been established  in accordance with the provisions of 
Article  4(1) or 5 the following  shall apply. 

1.  Where a product  specified  in Article  1  (1), 1st 

subparagraph  satisfying the maximum  residue  levels 
applied by  its Member State of origin, has been 
submitted  in the destination Member  State to 
measures with the effect to prohibit or submit to 
special restrictions  the putting  into circulation  of 
the product concerned  on the grounds that  such 
product contains pesticide residue  levels  exceeding 
the maximum  residue  level accepted  in the 
destination Member  State, the destination  Member 
State shall  inform thereof the other Member  State 
concerned  and the Commission.  In the  communication 
the cases on which the  information  is based,  shall 
be documented. 

On basis of the communication  referred  to in 
subparagraph  1, the two Member  States  concerned 
shall open without delay  a discussion  in order to 
remove, whenever possible, the prohibitive  or 
restrictive effect of the measures applied  by the 
destination Member  State by means of measures  agreed 
between the Member  States and they  shall, within a 
period  of 3 months  from the communication, notify to 
the Commission and the other Member  States the 
result of this discussion, and  in particular  the 

26 

agreed measures  if any, including the maximum 
residue  level the destination Member  State  intends 
to set in the framework of the regime referred  to in 
paragraph  2. 

The Member  States shall submit to each other all 
required  information; in particular the producing 
Member State shall indicate the data, including  its 
toxicological  assessment and estimation  of an ADI, 
its good agricultural practice and  corresponding 
trial data  it relied upon to establish  its own 
maximum residue  level; the destination Member  State 
shall  indicate the reasons justifying  the measures 
it applies. 

The Commission  shall refer the matter to the 
Standing  Committee on Plant Health.  A  temporary 
maximum  level may be established  in Annex  II for a 
limited period  of time in accordance with the 
procedure  laid down  in Article  12. For the 
establishment  of this temporary maximum  level, the 
Commission takes  into account the state of the 
technical  and scientific knowledge. 

Moreover the Member  State of origin and/or other 
interested Member  States shall give, where relevant, 
a  satisfactory  undertaking  that the necessary  trial 
data will be submitted within a time  limit set in 
accordance with Article  12; this time  limit will not 
exceed  4 years. 

4. 

5. 

Any measure provided  for in paragraphs  2 or 3  shall be 
taken by a Member  State  in due respect of  its  obligations 
under the Treaty  and  in particular  the Articles  3 0 to  3 6 
thereof. 

The provisions  of Council Directive  83/189/EEC of 28 
March  1983  laying down a procedure  for the provision of 
information  in the field of technical  standards and 
regulations do not apply to the measures applied  and 
notified by Member  States  in accordance with the 
provisons of paragraph  3 of this Article. 

6. 

Detailed measures for the  implementation  of the procedure 
set out  in this article may be adopted  in accordance with 
the procedure  laid down  in Article  12." 

5. 

Article 9 is replaced  by the following: 

27 

"Article 

9 

1.  Where a Member  State, as a result of new  information 

or of a reassessment of existing  information 
considers that a maximum  level fixed  in Annex  II 
endangers human or animal health, and  therefore 
requires swift action to be taken, that Member  State 
may temporarily  reduce the  level  in its own 
territory.  In that case, it shall  immediately 
notify the other Member  States and the Commission of 
the measures, attaching a statement of the reasons 
therefore. 

2. 

3. 

The Commission  shall quickly examine the grounds 
given by the Member State referred to  in the  first 
subparagraph  and shall consult the Member  States 
within the Standing Committee on Plant Health, 
hereinafter referred to as  'the Committee'; it shall 
then deliver  it$ opinion  forthwith and take the 
appropriate measures.  The Commission  shall 
immediately  notify the Council and the Member  States 
of any measures taken.  Any Member  State may  refer 
the Commission's measures to the Council within  15 
days of such notification.  The Council  acting  by a 
qualified majority may take a different  decision 
within  15 days of the date on which the matter  was 
referred  to it. 

If the Commission considers that the maximum  levels 
laid down  in the list referred  to in Article 1 
should  be amended to resolve the  difficulties 
mentioned  in paragraph  1 and to ensure the 
protection  of human health, it shall  initiate the 
procedure  laid down  in Article  13, with a view to 
adopting those amendments.  In this case, the Member 
State which has taken measures under paragraph  1 may 
in that event maintain them until the Council  or the 
Commission has taken a decision  in accordance with 
the said procedure." 

6. 

Article  10 is replaced  by the following: 

"Article  10 

Without prejudice to Article  9, amendments to the  annexes 
shall be adopted  in accordance with the procedure  laid 
down  in article  12, having regard  to current  scientific 
and technical knowledge." 

7. 

The provisions of Article  11 are deleted. 

28 

8. 

Paragraphs  2,  3 and 4 of Article  12 are replaced  by the 
following : 
"2.  The representative  of the Commission  shall  submit to 

the Committee a draft of the measures to be taken. 
The Committee  shall deliver  its opinion on the draft 
within a time  limit which the chairman may  lay down 
according to the urgency  of the matter.  The  opinion 
shall be delivered  by the majority  laid down in 
Article  148  (2) of the Treaty  in the case of 
decisions which the Council  is called upon to adopt 
on a proposal  from the Commission. The votes of the 
representatives  of the Member  States within the 
Committee shall be weighted  in the manner  set out in 
that Article.  The chairman shall not vote. 

3. 

4. 

The Commission  shall adopt the measures envisaged  if 
they are in accordance with the opinion of the 
Committee. 

If the measures are not  in accordance with the 
opinion of the Committee, or if no opinion  is 
delivered, the Commission  shall without delay  submit 
to the Council a proposal relating  to the measures 
to be taken.  The Council  shall act by a qualified 
majority. 

5. 

If, within three months  following  the date on which 
the matter was referred  to the Council, the  Council 
has not acted, the proposed measures  shall be 
adopted  by the Commission". 

9. 

Paragraphs  2, 3 and  4 of Article  13 are replaced  by the 
following: 

"2.  The representative  of the Commission  shall submit to 

the Committee a draft of the measures to be taken. 
The Committee shall deliver  its opinion on the draft 
within a time limit which the chairman may  lay down 
according to the urgency  of the matter.  The  opinion 
shall be delivered  by the majority  laid down in 
Article  148  (2) of the Treaty  in case of  decisions 
which the Council  is called upon to adopt on a 
proposal  from the Commission. The votes of the 
representatives  of the Member  States within  the 
Committee  shall be weighted  in the manner  set out in 
that Article.  The chairman  shall not vote. 

3. 

The Commission  shall adopt the measures  envisaged  if 
they are in accordance with the opinion  of the 
Committee. 

4. 

If the measures are not  in accordance with  the 
opinion of the Committee, or  if no opinion  is 

29 

delivered,  the Commission shall without delay  submit 
to the Council a proposal relating to the measures 
to be taken. The Council  shall act by a qualified 
majority. 

5. 

If,  within  15  days  following  the  date  on  which  the 
matter  was  referred  to  the  Council,  the  Council  has 
not acted,  the proposed  measures  shall  be adopted  by 
the Commission." 

10.  Article  14 is replaced by the following: 

"Article 14 

The Member States shall bring into force  laws, regulations 
and administrative provisions necessary to ensure that the 
amendments in Annex II resulting from decisions referred to 
in Articles  4(1)  and  (2), 5,  5a  (3),9  (3) and  10 can  be 
implemented  in their territory  within  a period  of  maximum 
4  months  from  their  adoption,  and  within  a  shorter 
implementation period when this was prescribed  for reasons 
of human health protection." 

Article 4 

Council Directive  90/642/EEC of 27 November  1990 on the  fixing 
of maximum  levels for pesticide residues  in and on certain 
products of plant origin, including  fruit and vegetables, is 
amended  as follows : 

1. 

Article  1(1), is replaced by the  following: 

"1.  This Directive  shall apply to products within the 
groups specified  in column  1 of the Annex I, 
examples of which are given  in column  2,  in so far 
as products  in these groups, or the parts of product 
described  in column  3, may contain certain  pesticide 
residues. 

The directive shall also apply to the same products 
after drying or processing  or after  inclusion  in a 
composite  food  in so far as they may  contain  certain 
pesticide residues." 

2. 

Article  2  (a) is replaced  by the  following: 

30 

"(a)  'pesticide residues' shall mean residues of the 

pesticides and of their metabolites, and  breakdown 
or reaction products, which are present  in or on the 
products referred to in Article  1;" 

3. 

Article  3 is replaced  by the following: 

"Article 

3 

The products  in the groups or, as the case may be, 
the parts of products referred  to  in Article  1 shall 
not contain, from the time they  are put  into 
circulation, pesticide residue  levels higher  than 
those specified  in the  list referred  to  in Annex II. 

The  list of pesticide residues concerned  and their 
maximum  levels shall be established  in Annex  II in 
accordance with the procedure  laid down  in Article 9 
having regard to current scientific  and  technical 
knowledge.  A pesticide residue  shall not be 
included  on the list for as long as a maximum  level 
is fixed  for it by Directive 76/895/EEC. 

In the case of dried  and processed  products  for 
which maximum  levels are not explicitly  fixed  in 
Annex  II, the maximum  residue  level applicable  shall 
be that  laid down  in Annex  II, taking  into  account 
respectively  the concentration  caused  by the drying 
process or the concentration  or dilution  caused by 
processing.  According  to the procedure  laid down  in 
Article  9 the concentration  or dilution  factor 
covering the concentration  and/or  the dilution 
caused  by certain drying  or processing  operations 
may be determined with regard  to certain dried  or 
processed products. 

In the case of composite foods containing  a mixture 
of  ingredients and  for which maximum  residue  levels 
are not fixed, the maximum  residue  levels  applied 
may not exceed the levels  laid down  in Annex II, 
taking  into account the relative concentrations  of 
the ingredients  in the mixture and also the 
provisions  laid down  in paragraph 2. 

Member  States shall ensure, at least by monitoring 
and check  sampling  compliance with the maximum 
levels referred  to in paragraph  1.  The  necessary 
inspections and control measures  shall be carried 
out in accordance with Directive  89/397/EEC, and  in 
particular Article  4 thereof, and  Directive 
93/99/EEC  on the subject of additional  measures 
concerning  the official control  of  foodstuffs". 

31 

4. 

Article 4 is replaced  by the following: 

"Article 

4 

1.  Member  States shall designate an authority  to ensure 

that the monitoring  specified  in Article  3  (4) is 
carried  out; the designated  authority may be the 
same as the single  liaison body designated  under 
Article  6 of Directive 93/99/EEC. 

2. 

(a)  By 30 June each year, the Member  States  shall 

send to the Commission their  intended  national 
monitoring programmes  for the following  calender 
year.  These forward programmes  shall specify  at 
least: 

the products to be inspected  and the 
number of  inspections to be carried out, 
the pesticide residues to be  inspected 
for, 
the criteria applied  in drawing up these 
programmes. 

(b)  By 30 September  each year, the  Commission 
shall refer a draft Decision  setting  out a 
coordination monitoring programme to the 
Standing Committee on Plant Health. The 
Decision will be adopted  in accordance with the 
procedure  laid down in Article  10.  The basic 
objective of the coordinated  monitoring 
programme will be to maximise the check 
sampling of products of plant origin  included 
in the groups listed  in Annex  I, produced  in 
the Community  and  imported  into it, in order to 
ensure compliance with the maximum  levels for 
pesticide  residues set out  in Annex  II.  This 
co-ordinated monitoring programme  may be 
subsequently  adjusted  as required  during  its 
implementation. 

(c)  By 28 February  each year the Member  States 

shall send to the Commission reports on the 
implementation  in the preceding  calendar  year 
of their national monitoring  programmes  and of 
the co-ordinated  monitoring  programme 
communicated  by the Commission  in accordance 
with sub-paragraph  (b). These reports  shall 
include at least the following  information: 

- 

the products  inspected  and the number of 
inspections carried out, 

32 

the pesticide residues analyzed  for or to 
be analyzed for. 

3. 

By  31 August each year, the Member  States shall send 
to the Commission the results of the analyses of the 
check samples taken during the previous year under 
their national monitoring programmes and under the 
co-ordinated monitoring programme.  The  Commission 
shall collate and combine this  information  and  shall 
communicate  it to the Member States  in the  framework 
of the Standing Committee on Plant Health  together 
with any appropriate recommendations  for  consequent 
action, if necessary. 

4. 

In accordance with the procedure  laid down in 
Article  9 the following may be adopted: 

(a)  amendments to paragraphs  (2) and  (3) of this 

Article as far as these amendments  concern  the 
dates for communication; 

(b)  detailed  implementation  rules necessary  for 
proper  functioning  of the provisions of 
paragraphs  (2) and (3). 

5. 

Not  later than 31 December  1999 the Commission  shall 
forward to the Council a report on the  application 
of this Article, accompanied,  if necessary, by any 
appropriate proposals." 

5. 

After Article  5, the following articles are  inserted 

"Article 5a 

Where for a product belonging to a group specified  in Annex  I, 
a provisional maximum residue  level throughout the  Community 
is set by the Commission  in accordance with the provisions of 
Article  4(1)(f) of Directive  91/414/EEC concerning  the placing 
of plant protection products on the market, this  level will be 
listed  in Annex  II with a reference to that procedure. 

Article  5b 

For the purposes of this article a  Member  State of 
origin  is defined  as the Member  State on which  territory 
a product specified  in Article  1  (1), 1st subparagraph  is 
legally produced  or commercialised  and a destination 
Member  State  is defined  as the Member  State  into which 
territory  such product  is introduced  and put  into 

33 

circulation  for operations other than transit to another 
Member  State or third country. 

Member  States shall provide  for a regime to enable the 
establishment  of maximum residue  levels for products 
referred to in Article  1(1), first  subparagraph, 
introduced  into their territories  from a  Member  State of 
origin, and taking  into account the good  agricultural 
practice  in the  Member  State of origin, in cases where 
no maximum residue levels have been established  for these 
products  in accordance with the provisions of Article 
3(1) or 5a. 

Moreover  in cases where no maximum residue  levels have 
been established  in accordance with the provisions of 
Article  3(1) or 5a the following  shall apply. 

1.  Where a product  specified  in Article  1  (1), 1st 

subparagraph  satisfying the maximum  residue  levels 
applied by  its Member State of origin, has been 
submitted  in the destination Member  State to 
measures with the effect to prohibit or submit to 
special restrictions the putting  into circulation  of 
the product concerned  on the grounds that  such 
product contains pesticide residue  levels  exceeding 
the maximum  residue  level accepted  in the 
destination Member  State, the destination  Member 
State shall  inform thereof the other Member  State 
concerned  and the Commission.  In the  communication 
the cases on which the  information  is based,  shall 
be documented. 

On basis of the communication  referred  to in 
subparagraph  1, the two Member  States  concerned 
shall open without delay a discussion  in order to 
remove, whenever possible, the prohibitive  or 
restrictive effect of the measures applied  by the 
destination Member  State by means of measures  agreed 
between the Member  States and they  shall, within a 
period  of  3 months  from the communication, notify  to 
the Commission and the other Member  States the 
result of this discussion, and  in particular  the 
agreed measures  if any, including the maximum 
residue  level the destination Member  State  intends 
to set in the framework  of the regime referred  to in 
paragraph  2. 

The Member  States shall submit to each other  all 
required  information; in particular  the  producing 
Member  State shall  indicate the data, including  its 
toxicological  assessment  and estimation  of an ADI, 

34 

its good agricultural practice and corresponding 
trial data it relied upon to establish its own 
maximum residue level; the destination Member State 
shall indicate the reasons justifying the measures 
it applies. 

3.  The Commission shall refer the matter to the 

Standing Committee on Plant Health.  A temporary 
maximum level may be established in Annex II for a 
limited period of time in accordance with the 
procedure laid down in Article 9. For the 
establishment of this temporary maximum level, the 
Commission takes into account the state of the 
technical and scientific knowledge. 

Moreover the Member State of origin and/or other 
interested Member States shall give, where relevant, 
a satisfactory undertaking that the necessary trial 
data will be submitted within a time limit set in 
accordance with Article 9; this time limit will not 
exceed 4 years. 

4.  Any measure provided for in paragraphs 2 or 3  shall be 

taken by a Member State in due respect of its obligations 
under the Treaty and  in particular the Articles 3 0 to 3 6 
thereof. 

5.  The provisions of Council Directive 83/189/EEC of 28 

March 1983 laying down a procedure for the provision of 
information in the field of technical standards and 
regulations do not apply to the measures applied and 
notified by Member States in accordance with the 
provisons of paragraph 3 of this Article. 

6.  Detailed measures for the implementation of the procedure 
set out in this article may be adopted in accordance with 
the procedure laid down in Article 9." 

The text of Article 7 is replaced by the following : 

"Amendments to Annexes  I and II as a result of 
developments in scientific or technical knowledge shall 
be adopted in accordance with the procedure laid down in 
Article 9." 

35 

7.  After article 10, the following article is inserted 

"Article 10a 

The Member States shall bring into force laws, 
regulations and administrative provisions necessary to 
ensure that the amendments to Annex II resulting from 
decisions referred to in Articles 3(1) and  (2), 5a, 5b, 
and 8(3) can be implemented in their territory within a 
period of maximum 4 months from their adoption, and 
within a shorter implementation period when this is 
prescribed for reasons of human health protection." 

36 

Article 5 

Member  States  shall  bring  into  force  laws,  regulations  and 
administrative provisions necessary to comply with this Directive 
not later than 31 December 1996. 

When Member States adopt these measures, they  shall contain a 
reference  to  this  Directive  or  shall  be  accompanied  by  such 
reference on the occasion of their official publication.  The 
methods  of making  such  a reference  shall  be  laid  down  by the 
Member States. 

This Directive is addressed to the Member States. 

Article 6 

37 

ISSN 0254-1475 

COM(95) 272 final 

DOCUMENTS 

EN 

03 

Catalogue number  : CB-CO-95-295-EN-C 

ISBN 92-77-90558-1 

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