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"BCOUNCIL DIRECTIVE
of 24 July 1986
on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin
(86/363/EEC)
(OJ L 221, 7.8.1986, p. 43)
Amended by:
Official Journal
No page date
"M1 Council Directive 93/57/EEC of 29 June 1993 L 211 1 23.8.1993
"M2 Council Directive 94/29/EC of 23 June 1994 L 189 67 23.7.1994
Amended by:
"A1 Act of Accession of Austria, Sweden and Finland C 241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.19951986L0363 — EN — 01.01.1995 — 003.001 — 1
COUNCIL DIRECTIVE
of 24 July 1986
on the fixing of maximum levels for pesticide residues in and on
foodstuffs of animal origin
(86/363/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Articles 43 and 100 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas crop and animal production play a very important role in the
Community;
Whereas the yield from that production is continually affected by
harmful organisms and weeds;
Whereas it is absolutely essential to protect plants, plant products and
livestock against these organisms, not only to prevent a reduction in yield
but also to increase agricultural productivity;
Whereas one of the most important methods of protecting plants, plant
products and livestock from the effects of these harmful organisms is the
use of chemical pesticides;
Whereas, however, these pesticides do not have only a favourable effect
on plant and animal production, since they are generally toxic substances
or preparations with dangerous side-effects;
Whereas a large number of these pesticides and of their metabolites or
breakdown products may have harmful effects on consumers of plant and
animal products;
Whereas these pesticides and the contaminants which may accompany
them can present dangers for the environment and indirectly affect
humans through animal products;
Whereas, in order to deal with these dangers, several Member States
have already fixed maximum levels for certain pesticide residues in and
on foodstuffs of animal origin;
Whereas the differences which exist between Member States with regard
to the maximum permissible levels for pesticide residues can help to
create barriers to trade and thus hinder the free movement of goods
within the Community;
Whereas, for this reason, in an initial stage, maximum levels should be
fixed for certain organochlorine compounds in meat and meat products
and milk and milk products, which must be observed when these
products are put into circulation;
Whereas, moreover, observance of the maximum levels will ensure that
the goods can circulate freely and that the health of consumers is
properly protected;
Whereas at the same time the Member States should be enabled to
authorize the monitoring of levels of pesticide residues in foodstuffs of
animal origin produced and consumed in their territory by a monitoring
system and related measures so as to provide safeguards equivalent to
those resulting from the levels laid down;!B
(1) OJ No C 56, 6. 3. 1980, p. 14.
(2) OJ No C 28, 9. 2. 1981, p. 64.
(3) OJ No C 300, 18. 11. 1980, p. 29.1986L0363 — EN — 01.01.1995 — 003.001 — 2
Whereas it is normally sufficient to apply check sampling to fresh milk
or frozen cream at the dairy or when it is put on sale to the final
consumer; whereas, however, Member States should be authorized also
to apply check sampling to fresh milk and fresh cream at an earlier stage;
Whereas it is not necessary to apply this Directive to products intended
for export to third countries;
Whereas Member States should be allowed to reduce temporarily the
levels laid down if they unexpectedly prove to be dangerous to human or
animal health;
Whereas it is appropriate in that case to establish close cooperation
between the Member States and the Commission within the Standing
Committee on Plant Health;
Whereas, in order to guarantee compliance with this Directive when the
foodstuffs in question are put into circulation, the Member States must
provide for suitable control measures;
Whereas Community methods of sampling and analysis should be
established to be used at least as reference methods;
Whereas methods of sampling and analysis are technical and scientific
matters, which should be determined by means of a procedure involving
close cooperation between the Member States and the Commission
within the Standing Committee on Plant Health;
Whereas Council Directive 64/433/EEC of 26 June 1964 on health
problems affecting intra-Community trade in fresh meat (1), as last
amended by Regulation (EEC) No 3768/85 (2), Council Directive
72/462/EEC of 12 December 1972 on health and veterinary problems
upon importation of bovine animals and swine and fresh meat from third
countries (3), as last amended by Regulation (EEC) No 3768/85, and
Council Directive 85/397/EEC of 5 August 1985 on health and
animal-health problems affecting intra-Community trade in heat-treated
milk (4), as amended by Regulation (EEC) No 3768/85, provide for the
fixing of permitted limits for pesticides with regard respectively to fresh
meat sent from one Member State to another, fresh meat imported from
third countries and heat-treated milk sent from one Member State to
another, and for the laying down of the required methods of analysis; and
whereas maximum residue levels laid down in this Directive should also
apply for the purposes of those three Directives;
Whereas it is appropriate that Member States make an annual report to
the Commission on the results of their control measures so as to enable
information concerning levels of pesticide residues to be collected for the
Community as a whole;
Whereas the Council should review this Directive before 30 June 1991
with the aim of attaining a uniform Community system,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive concerns foodstuffs of animal origin listed in Annex I in
so far as those foodstuffs may contain residues of pesticides listed in
Annex II, and without prejudice to Community or national provisions
concerning dietary or children’s food.!B
(1) OJ No 121, 29. 7. 1964, p. 2012/64.
(2) OJ No L 362, 31. 12. 1985, p. 8.
(3) OJ No L 302, 21. 12. 1972, p. 28.
(4) OJ No L 226, 24. 8. 1985, p. 12.1986L0363 — EN — 01.01.1995 — 003.001 — 3
Article 2
1. For the purposes of this Directive, ‘pesticide residues’ means
residues of the pesticides and of their metabolites, and breakdown or
reaction products listed in Annex II, which are present in or on the
products referred to in Article 1.
2. For the purposes of this Directive, ‘putting into circulation’means
any handing over, whether or not for a consideration, of the products
referred to in Article 1.
Article 3
1. Member States shall ensure that the products referred to in Article 1
do not, from the time they are put into circulation, present a danger to
human health as a result of the presence of pesticide residues.
2. Member States may not prohibit or impede the putting into
circulation within their territories of the products referred to in Article
1 on the grounds that they contain pesticide residues if the quantity of
such residues does not exceed the maximum levels specified in Annex II.
Article 4
1. Member States shall prescribe that the products referred to in Article
1 may not contain, from the time they are put into circulation, levels of
pesticide residues greater than those specified in Annex II.
2. Member States shall take all necessary measures to ensure, at least
by check sampling, compliance with the maximum levels laid down in
accordance with paragraph 1.
Article 5
1. In the case of the products referred to in Article 1 other than those
imported from third countries or intended for other Member States,
Member States may, by way of derogation from Article 4, continue to
apply a system of monitoring already in force on their territory for the
presence of pesticide residues together with any other measure in order
to ensure that an effect equivalent to the levels of pesticide residues laid
down in Annex II is obtained and to assess the total dietary exposure of
their population to these residues, whatever their source. Such measures
shall include regular representative surveys of the levels of these
pesticide residues in typical diets.
2. Member States shall inform the other Member States and the
Commission of any implementation of paragraph 1.
Article 6
Notwithstanding the provisions of Article 4, in the case of the products
referred to in Annex I falling within heading No 04.01 of the Common
Customs Tariff, the check sampling provided for shall be carried out at
the dairy or, if they are not delivered to a dairy, at the point of supply to
the consumer. Member States may nevertheless provide also for check
sampling from the time these products are first put into circulation.
Article 7
Member States shall make a report to the Commission, before 1 August
each year, on the results of the official checks, the monitoring carried out
and the other measures taken pursuant to Article 4 and, where
appropriate, Article 5, during the previous year.!B1986L0363 — EN — 01.01.1995 — 003.001 — 4
Article 8
1. The methods of sampling and analysis necessary for carrying out the
checks, monitoring and other measures provided for in Article 4 and,
where appropriate, Article 5, shall be determined in accordance with the
procedure laid down in Article 12. The existence of Community analysis
methods, to be used in cases of dispute, shall not preclude the use by
Member States of other scientifically valid methods capable of achieving
comparable results.
2. Member States shall inform the other Member States and the
Commission of the use of other methods pursuant to paragraph 1.
3. Paragraphs 1 and 2 shall apply without prejudice to Community
veterinary inspection measures for checking pesticide residues in
products referred to in Article 1, in particular those adopted pursuant
to Directives 64/433/EEC, 72/462/EEC and 85/397/EEC.
Article 9
1. Where a Member State considers that a maximum level set in Annex
II endangers human 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 taken, attaching a statement
of the reasons therefor.
2. If the situation envisaged in paragraph 1 arises, it shall be decided in
accordance with the procedure laid down in Article 13 whether the
maximum levels laid down in Annex II should be altered. Until such time
as a decision is taken by the Council or the Commission in accordance
with the abovementioned procedure, the Member State may maintain the
measures which it has implemented.
Article 10
Without prejudice to Article 9, amendments to the maximum levels set in
Annex II as a result of developments in scientific or technical knowledge
shall be adopted by the Council acting by a qualified majority on a
proposal from the Commission.
Article 11
The Council, acting unanimously on a proposal from the Commission,
shall adopt, by means of Directives, any new list of products or any new
list of pesticide residues in and on the products referred to in Article 1,
and their maximum values.
Article 12
1. Where the procedure laid down in this Article is to be followed, the
matters shall be referred without delay to the Standing Committee on
Plant Health, hereinafter referred to as the ‘Committee’, by its chairman,
either on his own initiative or at the request of a Member State.
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 required 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.!B
!A11986L0363 — EN — 01.01.1995 — 003.001 — 5
"A13.3Where the measures are in accordance with the opinion of
the Committee, the Commission shall adopt them and shall implement
them forthwith. If the measures are not in accordance with the opinion of
the Committee or if no opinion is delivered, the Commission shall
immediately submit to the Council a proposal on the measures to be
taken. The Council shall adopt the measures by a qualified majority.
If, within three months following the date on which the matter was
referred to it, the Council has not adopted any measures, the Commission
shall adopt the proposed measures, except where the Council has voted
by a simple majority against the said measures.
Article 13
1. Where the procedure laid down in this Article is to be followed, the
matter shall be referred without delay to the Committee by its chairman,
either on his own initiative or at the request of a Member State.
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 within two days. 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 required 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.
"A13.3Where the measures are in accordance with the opinion of
the Committee, the Commission shall adopt them and shall implement
them forthwith. Where they are not in accordance with the opinion of the
Committee or if no opinion is del ivered, the Commission shall
immediately submit to the Council a proposal on the measures to be
taken. The Council shall adopt the measures by a qualified majority.
If, within 15 days of the date onwhich the matter was referred to it, the
Council has not adopted any measures, the Commission shall adopt the
proposed measures, except where the Council has voted by a single
majority against the said measures.
Article 14
This Directive shall not apply to the products referred to in Article 1
where it can be established at least by appropriate evidence that they are
intended for export to third countries.
Article 15
In order to improve upon the Community system introduced by this
Directive, the Council, on the basis of a Commission report accom-
panied, if appropriate, by suitable proposals, shall re-examine this
Directive by 30 June 1991 at the latest.
Article 16
Member States shall bring into force not later than 30 June 1988 the
laws, regulations and administrative provisions necessary to comply with
this Directive. They shall forthwith inform the Commission thereof.
Member States shall communicate to the Commission the texts of the
main provisions of national law which they adopt in the field governed
by this Directive.
Article 17
This Directive is addressed to the Member States.!B
!A1
!B1986L0363 — EN — 01.01.1995 — 003.001 — 6
ANNEX I
CN code Description
0201 Meat of bovine animals, fresh or chilled
0202 Meat of bovine animals, frozen0203 Meat of swine, fresh, chilled or frozen0204 Meat of sheep or goats, fresh chilled or frozen0205 00 00 Meat of horses, asses, mules or hinnies, fresh, chilled or
frozen
0206 Edible offal of bovine animals, swine, sheep, goats, horses,
asses, mules or hinnies, fresh, chilled or frozen
0207 Meat and edible offal, of the poultry of heading No 0105
(fowls of the species Gallus domesticus , ducks, geese,
turkeys and Guinea fowls), fresh, chilled or frozen
ex 0208 Other meat and edible meat offal, fresh, chilled or frozen
0209 00 Pig fat free of lean meat and poultry fat (not rendered), fresh,
chilled, frozen, salted in brine, diced or smoked
0210 Meat and edible meat offal, salted in brine, dried or smoked;
edible flours and meals of meat or meat offal
0401 Milk and cream, not concentrated nor containing added sugar
or other sweetening mattern
0402 Milk and cream, concentrated or containing added sugar or
other sweetening matter
0405 00 Butter and other fats and oils derived from milk0406 Cheese and curd0407 00 Birds’ eggs, in shell, fresh, preserved or cooked0408 Birds’ eggs, not in shell, and egg yolks, fresh, dried, cooked
by steaming or by boiling in water, moulded, frozen orotherwise preserved, whether or not containing added sugar
or other sweetening matter
1601 00 Sausages and similar products, of meat, meat offal or blood:
food preparations based on these products
1602 Other prepared or preserved meat offal or blood!
B
!M11986L0363 — EN — 01.01.1995 — 003.001 — 7
ANNEX II
PART A
Pesticide residuesMaximum levels in mg/kg (ppm)
of fat, contained in meat,
preparations of meat, offals and
animal fats listed in Annex I
under heading Nos ex 0201,
0202, 0203, 0204, 0205 00 00,
0206, 0207, ex 0208, 0209 00,
0210, 1601 00 and 1602 (1)(4)for cow’ s milk and
whole cream cow’ s
milk listed in Annex I
under heading No
0401: for the other
foodstuffs in heading
Nos 0401, 0402,
0405 00 and 0406 in
accordance with (2)(4)of shelled fresh eggs,
for birds’ eggs and eggyolks listed in Annex I
under heading Nos
0407 00 and
0408 (
3)(4)
1. ALDRINsingly or combined,
expressed as dieldrin
(HEOD)0,2 0,006 0,029
=
; 2. DIELDRIN
(HEOD)
3. CHLORDANE (sum of cis- and trans-
isomers and oxychlordane expressed as
chlordane)0,05 0,002 0,005
4. DDT (sum of p,p ’-DDT, o,p ’-DDT,
p,p’-DDE and p,p ’-TDE (DDD) ex-
pressed as DDT)1 0,04 0,1
5. ENDRIN 0,05 0,0008 0,005
6. HEPTACHLOR (sum of heptachlor and
heptachlor epoxide, expressed as hep-tachlor)0,2 0,004 0,02
7. HEXACHLOROBENZENE (HCB) 0,2 0,01 0,02
8. HEXACHLOROCYCLOHEXANE
(HCH)
8.1. alpha-isomer 0,2 0,004 0,02
8.2. beta-isomer 0,1 0,003 0,01
8.3. gamma-isomer (lindane) 2
ex 0204 sheepmeat
1 other products0,008 0,1
9. CHLORPYRIFOS 0,05 (*)
0207 Poultry meat0,01 (*) 0,01 (*)
10. CHLORPYRIFOS-METHYL 0,05 (*) 0,01 (*) 0,01 (*)
11. CYPERMETHRIN including other mix-
tures of constituent isomers
(sum of isomers)0,05 (*)
0207 Poultry meat
0,2 other products0,02 0,05 (*)
12. DELTAMETHRIN 0,05
0207 Poultry meat0,05 (*)
13. FENV ALERATE including other mix-
tures of constituent isomers
(sum of isomers)(a)
0207 Poultry meat
0,5 other products0,05 (a)
14. PERMETHRIN
(sum of isomers)0,5 0,05 0,05
15. CYFLUTHRIN, including other mixed
isomeric constituents (sum of isomers)0,05 0,02 (*) 0,02 (*)!
B
!M1
!M21986L0363 — EN — 01.01.1995 — 003.001 — 8
Pesticide residuesMaximum levels in mg/kg (ppm)
of fat, contained in meat,
preparations of meat, offals and
animal fats listed in Annex I
under heading Nos ex 0201,
0202, 0203, 0204, 0205 00 00,
0206, 0207, ex 0208, 0209 00,
0210, 1601 00 and 1602 (1)(4)for cow’ s milk and
whole cream cow’ s
milk listed in Annex I
under heading No
0401: for the other
foodstuffs in heading
Nos 0401, 0402,
0405 00 and 0406 in
accordance with (2)(4)of shelled fresh eggs,
for birds’ eggs and eggyolks listed in Annex I
under heading Nos
0407 00 and
0408 (
3)(4)
16. LAMBDA-CYHALOTHRIN, including
other mixed isomeric constituents (sum
of isomers)0,5
(except 0207 poultrymeat)
0,02 (*)
(0207 poultrymeat)0,05 0,02 (*)
"M2 (*) Indicates limit of analytical determination.
(1) In the case of foodstuffs with a fat content of 10 % or less by weight, the residue is related to the total weight of the boned foodstuff.
In such cases, the maximum level is one-tenth of the value related to fat content, but must be no less than 0,01 mg/kg.
(2) In determining the residues in raw cow’ s milk and whole cream cow’ s milk, a fat content of 4 % by weight should be taken as a basis.
For raw milk and whole cream milk of another animal origin the residues are expressed on the basis of the fat.
For the other foodstuffs listed in Annex I under heading Nos 0401, 0402, 0405 00 and 0406:
— with a fat content of less than 2 % by weight, the maximum level is taken as half that set for raw milk and whole cream milk,
— with a fat content of 2 % or more by weight, the maximum level is expressed in mg/kg of fat. In such cases, the maximum level
is 25 times that set for raw milk and whole cream milk.
(3) For egg products with a fat content higher than 10 % the maximum level is expressed in mg/kg fat. In this case the maximum level is
10 times higher than the maximum level for fresh eggs.
(4) Footnotes (1), (2) and (3) do not apply in cases where the limit of analytical determination is indicated. 3
(a) Should levels no be adopted by 1 January 1998, the following maximum level shall apply: 0,05*.!M2
!M11986L0363 — EN — 01.01.1995 — 003.001 — 9
!M1
PART B
Pesticide residuesMaximum levels in mg/kg (ppm)
of meat, including fat,
preparations of meat, offals and
animal fats listed in Annex I
under heading Nos ex 0201,
0202, 0203, 0204, 0205 00 00,
0206, 0207, ex 0208, 0209 00,
0210, 1601 00 and 1602for milk and milk
products listed in
Annex I under
heading Nos 0401,0402, 0405 00 and
0406of shelled fresh
eggs, for birds’ eggs
and egg yolks listed
in Annex I under
heading Nos
0407 00 and 0408
1. ACEPHATE 0,02 (*) 0,02 (*) 0,02 (*)
2. BENOMYL
sum expressed as
carbendazim0,1 (*) 0,1 (*) 0,1 (*)
3. CARBENDAZIM9
>>=
>>; 4. THIOPHONATE
METHYL
5. CHLOROTHALONIL 0,01 (*) 0,01 (*) 0,01 (*)
6. GL YPHOSA TE 0,5
ex 0206 pig kidney
2
ex 0206 cattle, goat and
sheep kidney
0,1 (*) other products0,1 (*) 0,1 (*)
7. IMAZALIL 0,02 (*) 0,02 (*) 0,02 (*)
8. MANCOZEB
sum expressed as
CS20,05 (*) 0,05 (*) 0,05 (*)
9. MANEB10. METIRAM11. PROPINEB9
>>>>>>=
>>>>>>;12. ZINEB
13. METHAMIDOPHOS 0,01 (*) 0,01 (*) 0,01 (*)
14. IPRODIONE (sum of compounds
and all metabolitescontaining the
3,5-dichloroaniline
moiety expressed as3,5 dichloroaniline)0,05 (*) 0,05 (*) 0,05 (*)
15. PROCYMIDONE9
>>>>>=
>>>>>;16. VINCLOZOLIN
17. FENARIMOL Ex 0208 (a)
liver + kidney
0,02 (*) other products0,02 (*) 0,02 (*)
18. METALAXYL 0,5 (*) 0,05 (*) 0,05 (*)
19. BENALAXYL 0,5 (*) 0,05 (*) 0,05 (*)20. DAMINOZIDE
(sum of daminozide and 1,1-dimethylhydra-
zine expressed as daminozide)0,05 0,05 (*) 0,05 (*)
21. ETHEPHON 0,05 (*) 0,05 (*) 0,05 (*)
22. PROPICONAZOLE Ex 0206 0,1 ruminant
liver
0,05 (*) other products0,1 (*) 0,05 (*)
23. CARBOFURAN
(sum of carbofuran and 3-hydroxycarbofuran
expressed as carbofuran)0,1 (*) 0,1 (*) 0,1 (*)
24. CARBOSULFAN 0,5 (*) 0,05 (*) 0,05 (*)
25. BENFURACARB 0,5 (*) 0,05 (*) 0,05 (*)26. FURATHIOCARB 0,5 (*) 0,05 (*) 0,05 (*)
"
M2 (*) Indicates limit of analytical determination. 3
"M2 (a) As from 30 June 1999 and save for adoption of other levels, the following maximum limit shall apply: 0,02. 3!M2
!M11986L0363 — EN — 01.01.1995 — 003.001 — 10