Opinion of the Advocate General — ECLI:EU:C:1996:480
Date: 1996-12-10
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Agriculture and Fisheries;Veterinary legislation
Procedure: Reference for a preliminary ruling
Origin: Netherlands

Summary
I — Introduction I - 4318
II — The legal framework I - 4319
A — The Community provisions I - 4319
(1) Council Directive 91/493/EEC I - 4319
(2) Council Directive 90/675/EEC I - 4322
(3) Commission Decision 95/119/EEC I - 4323
B — The relevant national legislation I - 4326
C — The Agreement on the application of sanitary and phytosanitary measures ... I - 4326
III — Facts I - 4329
IV — The question submitted by the national court I - 4332
V — Answer to the question submitted I - 4333
Preliminary observations I - 4333
A — The need to supplement the judgment in Zuckerfabrik I - 4334
(1) Admissibility I - 4334
(2) Substance I - 4335
B — Insufficient statement of reasons for the Commission's decision I - 4336
(1) Extent of the Commission's powers under Article 19 of Directive
90/675 I - 4336
(2) Sufficient statement reasons for the contested decision I - 4339
C — Infringement of the principle of proportionality I - 4341
(1) Was the measure adopted appropriate to the objective pursued? I - 4341
(2) Was the measure adopted necessary? I - 4343
* Original language: Greek.
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OPINION OF MR COSMAS — CASE C-183/95
(a) Inspections by sampling I - 4344
(b) Need for the measure adopted I - 4345
(3) Balancing of advantages and disadvantages I - 4347
D — Infringement of the principle of equal treatment I - 4348
E — Infringement of the principle of the protection of legitimate expectations ... I - 4349
F — Breach of the Agreement on the application of sanitary and phytosanitary
measures I - 4350
(1) Admissibility I - 4351
(2) The direct effect of the provisions of the Agreement I - 4351
(3) The incompatibility of Decision 95/119 with Articles 2 and 5 of the
Agreement I - 4357
G — Misuse of powers and abuse of process I - 4360
(1) Misuse of powers I - 4360
(2) Abuse of process I - 4361
VI — Conclusion I - 4361
I — Introduction
1. In connection with an application for
interim measures, the College van Beroep
voor het Bedrijfsleven (Administrative Court
for Trade and Industry) has submitted to the
Court for a preliminary ruling pursuant to
Article 177 of the Treaty a question concern­
ing the validity of Commission Decision
95/119/EC of 7 April 1995 concerning cer­
tain protective measures with regard to fish­
ery products originating in Japan. 1
2. This case concerns a review by the Court
of the validity of measures for the protection
of public health which the Commission
adopts by virtue of its powers under Article
19 of Council Directive 90/675/EEC of 10
December 1990 laying down the principles
governing the organization of veterinary
checks on products entering the Community
from third countries. 2
3. At the same time, this case also gives the
Court the opportunity to rule for the first
time on the question whether the provisions
of the Agreement on the application of sani­
tary and phytosanitary measures (hereinafter
'the Agreement'), 3 which forms part of
1 — OJ 1995 L 80, p. 56.
2 — OJ 1990 L 373, p. 1.
3 — OJ 1994 L 336, p. 40.
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
Annex 1A to the Agreement establishing the
World Trade Organization (hereinafter 'the
WTO'), 4 have direct effect.
II — The legal framework
A — The Community provisions
4. A series of Community provisions form
the framework of substantive and procedural
rules concerning veterinary checks on prod­
ucts imported into the Community, in par­
ticular fishery products.
(1) Council Directive 91/493/EEC
5. Council Directive 91/493/EEC of 22 July
1991 laying down the health conditions for
the production and the placing on the mar­
ket of fishery products, 5 sets out, in Chapter
II, which deals with imports from third
countries, the veterinary conditions which
fishery products entering the Community
from third countries must fulfil and the
checks and inspections which those products
must undergo (Articles 10 to 12).
6. Article 10 sets forth the principle that the
provisions governing the importation of fish­
ery products from third countries must be at
least equivalent to those governing the pro­
duction and placing on the market of Com­
munity products. The provision is worded as
follows:
'Provisions applied to imports of fishery
products from third countries shall be at
least equivalent to those governing the pro­
duction and placing on the market of Com­
munity products.
7. In order to ensure that imported products
satisfy the requirements laid down by the
Community provisions, Article 11 provides
for the possibility of fixing specific import
conditions based on a system of approved
establishments from which fishery products
4 — OJ 1994 L 336, p. 3.
5 — OJ 1991 L 268, p. 15.
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OPINION OF MR COSMAS — CASE C-183/95
may be exported to the Community. Article
11 is worded as follows:
'1 . For each third country or group of third
countries, fishery products must fulfil the
specific import conditions ..., depending on
the health situation in the third country con­
cerned.
2. In order to allow the import conditions to
be fixed, and in order to verify the condi­
tions of production, storage and dispatch of
fishery products for consignment to the
Community, inspections may be carried out
on the spot by experts from the Commission
and the Member States.
3. When fixing the import conditions of
fishery products referred to in paragraph 1,
particular account shall be taken of:
(a) the legislation of the third country;
(b) the organization of the competent auth­
ority of the third country and of its
inspection services, the powers of such
services and the supervision to which
they are subject, as well as their facilities
for effectively verifying the implementa­
tion of their legislation in force;
(c) the actual health conditions during the
production, storage and dispatch of fish­
ery products intended for the Commu­
nity;
(d) the assurances which a third country can
give on the compliance with the stan­
dards laid down in Chapter V of the
Annex.
4. The import conditions referred to in para­
graph 1 shall include:
(a) the procedure for obtaining a health cer­
tificate which must accompany consign­
ments when forwarded to the Commu­
nity;
(b) the placing of a mark identifying the
fishery products, in particular with the
approval number of the establishment of
origin, except in the case of frozen fish­
ery products, landed immediately for
canning and bearing the certificate pro­
vided for under (a);
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
(c) drawing up a list of approved establish­
ments and auction or wholesale markets
registered and approved by the Commis­
sion ... .
For that purpose, one or more lists of such
establishments shall be drawn up on the
basis of a communication from the compe­
tent authorities of the third country to the
Commission. An establishment may not
appear on a list unless it is officially
approved by the competent authority of the
third country exporting to the Community.
Such approval shall be subject to observance
of the following requirements:
— compliance with requirements equivalent
to those laid down in this directive,
— monitoring by an officiai inspection ser­
vice of the third country.
...'. 6
8. Article 11(7) provides that, pending the
fixing of the specific import conditions, the
conditions applied to imports from third
countries must be at least equivalent to those
governing the production and placing on the
market of Community products.
9. In Decision 93/185/EEC of 15 March
1993 laying down certain transitional mea­
sures concerning the certification of fishery
products from third countries in order to
facilitate the switchover to the arrangements
laid down in Council Directive
91/493/EEC, 7 the Commission stipulated
that fishery products imported into the
Community from third countries, for which
no specific import conditions have been
fixed, must be accompanied by health certifi­
cates complying with the model set out in
the Annex.
10. Article 3 of Decision 93/185 provided
that the arrangements contained therein
would apply from 1 July 1993 until 31
December 1994. The period of validity was
extended until 1 March 1995 by Council
Decision 94/941/EC of 14 December 1994. 8
Decision 94/941 maintained until that date
(1 March 1995) the conditions which had
applied until then to imports of fishery
products, as referred to in Article 11(7) of
6 — Chapter V of the Annex, to which reference is made in para­
graph 3(d), concerns the health control and monitoring of
production conditions.
7 — OJ 1993 L 79, p. 80.
8 — OJ 1994 L 366, p. 34.
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OPINION OF MR COSMAS — CASE C-183/95
Directive 91/493. 9 The period of validity
was subsequently extended until 30 June
1995 by Council Decision 95/49/EC 10 of 27
February 1995.
11. Article 12(1) of Directive 91/493 pro­
vides that the procedure and the inspections
to be carried out by the Member States, as
well as the safeguard provisions to be imple­
mented, must be laid down on the basis of
Directive 90/675/EEC, to which express ref­
erence is made.
(2) Counal Directive 90/675/EEC
12. Council Directive 90/675/EEC of 10
December 1990 1 1lays down the principles
governing the organization of veterinary
checks on products entering the Community
from third countries.
13. Chapter II contains specific 'safeguard
provisions' intended to ensure efficient and
timely protection of public health. Article 19
thereof is worded as follows:
'1 . If, in the territory of a third country, a
disease ..., a zoonosis or other disease or
phenomenon liable to present a serious
threat to animal or public health, or if any
other serious animal health or public health
reason so warrants in particular in the light
of the findings of its veterinary experts, the
Commission may, acting on its own initiative
or at the request of a Member State, adopt
one of the following measures without delay
and depending on the gravity of the situa­
tion:
— suspend imports coming from part or all
of the third country concerned, and
where appropriate from the transit third
country,
— set special conditions in respect of
imports coming from part or all of the
third country concerned.
4. Representatives of the Commission may
make an immediate visit to the third country
concerned.
9 — From 1 July 1995, Decision 93/185 was replaced by Com­
mission Decision 95/328/EC of 27 July 1995 establishing
health certification for fishery products from third countries
which arc not yet covered by a specific decision (OJ 1995
L 191, p. 32). The period of validity of that decision was
fixed as two years. Article 1(1) of the decision provides that
consignments of fishery products introduced into the Com­
munity must (a) come from an agreed establishment
inspected by the competent authority of the third country
and (b) be accompanied by a numbered original health cer­
tificate attesting that the health conditions of production,
handling, processing, packaging and identification of the
products arc at least equivalent to those established by
Directive 91/493. The model of the health certificate is laid
down in the Annex.
10 — OJ 1995 L 53, p. 30.
11 — Directive already cited in footnote 2.
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
6. Without delay the Commission shall
review the situation within the Standing Vet­
erinary Committee. ...'
(3) Commission Decision 95/119/EC
14. Between 27 and 31 March 1995, experts
from the Commission conducted an investi­
gation in Japan of the conditions of produc­
tion and processing of fishery products
which were to be exported to the Commu­
nity. Four establishments, which were cho­
sen by the competent Japanese authorities, as
well as the fish market in Tokyo, were vis­
ited. 12
15. Following that visit, a 'preliminary
report concerning a mission in Japan about
the import of scallops and other fishery
products', dated 4 April 1995, was produced.
16. The Community experts concluded that
the establishments for scallops and fishery
products which they had visited did not
comply with the requirements of Directive
91/493 and that some establishments pre­
sented serious public health risks. Moreover,
the checks by the competent authorities were
not strict enough and gave no guarantee
about the absence of fraud concerning the
origin of the products.
17. The report by the Community experts
reads as follows:
'1 . General remarks
These remarks concern both establishments
for scallops and for other fishery products.
1.1 The official authority (Ministry of
Health and Welfare, assisted by the Health
Centres of the Prefectures) does not carry
out a satisfactory check on the establish­
ments; some establishments presenting seri­
ous public health risks were put on the list of
establishments by the Japanese authority and
declared as complying with the requirements
of Directive 91/493/EEC.
12 — In its written observations (point 10), the Commission
points out that, with regard to Japan, the specific conditions
referred to in Article 11(1) of Directive 91/493 for imports
of fishery products have not yet been fixed. On 22 March
1995, the Japanese authorities sent to the Commission a list
of 80 approved establishments. Once the Commission's
inspections, provided for by Article 11(2) of Directive
91/493, of the control system operated by those authorities
had been carried out and that system had been approved,
the specific conditions for imports of the products con­
cerned could be fixed. Until then, the Japanese authorities
issued health certificates only in respect or fishery products
exported to the Community from establishments which
complied with the requirements of Directive 91/493.
The Community's mission of experts was sent out in order
to ascertain what conditions prevailed in the fish-processing
establishments in Japan, so that the specific conditions for
imports of fishery products from that country could subse­
quently be fixed. Following that mission's negative find­
ings, which were set out in the report of 4 April 1995, and
the ensuing adoption of Commission Decision 95/119, the
Japanese authorities suspended the issue of health certifi­
cates as from the beginning of May 1995, and on 7 August
1995 sent to the Commission a new list of two approved
establishments. On 7 September 1995, they notified the
Commission that they had approved another four establish­
ments. Health certificates were again issued but only in
respect of products from those establishments.
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OPINION OF MR COSMAS — CASE C-183/95
1.2 The Japanese legislation, for some points
(health conditions for fishing vessels and for
landing points, microbiological criteria for
drinking water, temperature of frozen prod­
ucts ... is not equivalent to Community leg­
islation.
1.3 The control of the critical points (Haz­
ard Analysis Critical Control Points) is nei­
ther understood nor properly implemented
by the establishments.
1.4 The guarantees for the use of drinking
water in the establishments are clearly insuf­
ficient (deep well water not treated and not
checked, municipal network water not
checked frequently enough).
1.5 Batch identification (raw materials,
products during processing and finished
products) is not carried out most of the time
and does not allow for the trace-back to ori­
gin (establishment and process).
2. Scallop establishments
3. Establishments for other fishery products
The mission visited four establishments,
selected by the competent authority, and the
Tokyo fish market.
3.1 The conditions of structure, equipment
and hygiene in these four establishments,
were not in compliance with the require­
ments of Council Directive 91/493/EEC.
3.2 In two establishments, in particular, in a
cannery, the absence of hygiene and the bad
manufacturing practices presented serious
public health risks.
3.3 The deficiencies of the checks carried out
by the competent authority (procedure to
approve the establishments, regular inspec­
tions, approval of the private laboratories)
and the improper identification of the pro­
duction batches do not give any guarantee
that the exported products meet the require­
ments of Council Directive 91/493/EEC and
come from an approved establishment.
3.4 By letter of 22 March 1995, the Mission
of Japan in Brussels provided the Commis­
sion with a list of 80 establishments which
"meet the conditions laid down by Council
Directive 91/493/EEC". None of the four
establishments, selected by the Japanese
authority, met these conditions, at the time
of the visit.
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
4. Conclusion
The establishments visited for scallops and
fishery products did not comply with Coun­
cil Directive 91/493/EEC. Some presented
serious public health risks.
The checks by the competent authority are
not strict enough and give no guarantee
about the absence of fraud concerning the
origin of the products.' 13
18. The experts also produced individual
reports on visits to seven establishments,
three of which are geared to processing scal­
lops and four to other fishery products.
19. On the basis of that report by its
experts, on 7 April 1995, pursuant to Article
19 of Directive 90/675/EEC, the Commis­
sion adopted Decision 95/119/EC concern­
ing certain protective measures with regard
to fishery products originating in Japan, 14
which provided as follows:
Article 1
'Member States shall prohibit the import of
consignments of fishery products in what­
ever form originating in Japan.' 15
Article 3
'Member States shall amend the measures
that they apply to imports to comply with
this decision. They shall inform the Com­
mission thereof.' 16
13 — Section 2 of the report, which relates to scallop-processing
establishments, reads as follows:
'Thirteen establishments are on the list provided by the
Japanese authority. During the visit, five establishments
were supposed to be in operation, the seven others being
located m arcas where scallop harvesting was not open, due
to weather conditions.
Out of these five establishments, the mission selected three
establishments to be visited, and gave their names on the
day of arrival in Tokyo (27 March). Some hours later, the
mission was informed that one out of the three establish­
ments was closed. Therefore, the mission insisted on carry­
ing out a short visit, which made possible the discovery that
this establishment was not meeting Community require­
ments.
2.1 The biotoxines (DSP and PSP) analytical methods, used
by official and private accredited laboratories, arc not fully
harmonized.
2.2 The official analytical procedures showed that the
matrix to be tested is not the ovary (as indicated in the
Commission Decision of 8 April 1994), but the muscle,
which does not concentrate the biotoxines.
2.3 In two out of three establishments visited, the mission
found cartons of frozen scallop plastic bags (muscle and
ovary) in cold stores, labelled in French "Frozen on 10
April 1990, best before 10 April 1992".
2.4 The identification system for process products cannot
prevent fraud concerning products coming from non-
approved establishments.
2.5 The three establishments visited did not meet the
requirements concerning structure, equipment and hygiene,
as laid down by Council Directive 91/493/EEC. Therefore,
the Mission of Japan in Brussels, by letter of 22 December
1994, declared that the 13 establishments had met the
requirements from that date on. They had received a provi­
sional approval between 8 April 1994 and 31 December
1994, in order to have the opportunity to achieve the
improvements necessary to respect the Community
requirements.'
14 — Decision cited in footnote 1.
15 — That prohibition was subsequently only partly lifted. The
article in question was replaced, in Commission Decision
95/537/EC of 6 December 1995 (OJ 1995 L 304, p. 51), by
the following text:
'Member States shall prohibit the import of bivalve mol­
luscs, echinoderms, tunicates and marine gastropods in
whatever form originating in Japan.'
16 — Article 2 of Decision 95/119 reads as follows:
'Decision 94/206/EC is repealed'.
Decision 94/206 of 8 April 1994 (OJ 1994 L 99, p. 44)
amended for the second time Commission Decision
92/91/EEC of 6 February 1992 on certain protective mea­
sures with respect to scallops originating in Japan (OJ 1992
L 32, p. 37), allowing the resumption of imports into the
Community. Decision 92/91 prohibited the importation of
scallops from Japan. This last decision was amended by
Commission Decision 92/293/EEC (OJ 1992 L 155, p. 39)
which extended the prohibition to all bivalve molluscs and
marine gastropods originating in Japan.
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OPINION OF MR COSMAS — CASE C-183/95
Article 4
'This decision is addressed to the Member
States.'
B — The relevant national legislation
20. In order to implement Commission
Decision 95/119, the Netherlands Secretary
of State for Public Health, Welfare and
Sport, acting on the advice of the Minister of
Agriculture, the Environment and Fisheries,
adopted the Decree of 13 April 1995 17
amending the Warenwetregeling Invoerver­
bod Bepaalde Visserijprodukten uit Japan
(Decree, issued pursuant to the Law on
Foodstuffs, prohibiting the importation of
certain fishery products from Japan, herein­
after 'the Warenwetregeling'). 18
21. The prohibition entered into force in the
Netherlands on 15 April 1995.
22. Article 1 of the decree, as amended, pro­
vides that consignments of fishery products
originating in Japan may not be introduced
into Netherlands territory in any form what­
ever.
C — The Agreement on the application of
sanitary and phytosanitary measures
23. The Community approved the Agree­
ment on the application of sanitary and phy­
tosanitary measures 19 by Council Decision
94/800/EC of 22 December 1994 concerning
the conclusion on behalf of the European
Community, as regards matters within its
competence, of the agreements reached in the
Uruguay Round multilateral negotiations
(1986-1994). 20
24. Paragraphs 2 and 3 of Article 2 of the
Agreement, headed 'Basic Rights and Obli­
gations', read as follows:
'2. Members shall ensure that any sanitary
or phytosanitary measure is applied only to
the extent necessary to protect human, ani­
mal or plant life or health, is based on scien­
tific principles and is notmaintained without
sufficient scientific evidence ...
3. Members shall ensure that their sanitary
and phytosanitary measures do not arbi­
trarily or unjustifiably discriminate between
Members where identical or similar condi­
tions prevail, including between their own
territory and that of other Members. Sani­
tary and phytosanitary measures shall not
17 — Staatscourant 1995, p. 74.
18 — Staatscourant 1994, p. 86.
19 — This agreement has already been cited in footnote 3.
20 — OJ 1994 L 336, p. 1.
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
be applied in a manner which would consti­
tute a disguised restriction on international
trade.' 21
25. Article 3, headed 'Harmonization' pro­
vides as follows:
'1 . To harmonize sanitary and phytosanitary
measures on as wide a basis as possible,
Members shall base their sanitary or phy­
tosanitary measures on international stan­
dards, guidelines or recommendations, where
they exist, except as otherwise provided for
in this Agreement, and in particular in para­
graph 3.
2. ...
3. Members may introduce or maintain sani­
tary or phytosanitary measures which result
in a higher level of sanitary or phytosanitary
protection than would be achieved by mea­
sures based on the relevant international
standards, guidelines or recommendations, if
there is a scientific justification, or as a con­
sequence of the level of sanitary or phy­
tosanitary protection a Member determines
to be appropriate in accordance with the rel­
evant provisions of paragraphs 1 through 8
of Article 5(1).
…'
Footnote (1) to paragraph 3 reads as follows:
Tor the purposes of paragraph 3 of Article
3, there is a scientific justification if, on the
basis of an examination and evaluation of
available scientific information in conformity
with the relevant provisions of this Agree­
ment, a Member determines that the relevant
international standards, guidelines or recom­
mendations are not sufficient to achieve its
appropriate level of sanitary or phytosani­
tary protection.'
26. Article 5, headed 'Assessment of Risk
and Determination of the Appropriate Level
of Sanitary or Phytosanitary Protection',
reads as follows:
'1 . Members shall ensure that their sanitary
or phytosanitary measures are based on an
21 — Article 4 of the Agreement, headed 'Equivalence', reads as
follows:
'1 . Members shall accept the sanitary or phytosanitary mea­
sures of other Members as equivalent, even if these mea­
sures differ from their own or from those used by other
Members trading in the same product, if the exporting
Member objectively demonstrates to the importing Member
that its measures achieve the importing Member's appropri­
ate level of sanitary or phytosanitary protection. For this
purpose, reasonable access shall be given, upon request, to
the importing Member for inspection, testing and other rel­
evant procedures.
2. Members shall, upon request, enter into consultations
with the aim of achieving bilateral and multilateral agree­
ments on recognition of the equivalence of specified sani­
tary or phytosanitary measures.'
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OPINION OF MR COSMAS — CASE C-183/95
assessment, as appropriate to the circum­
stances, of the risks to human, animal or
plant life or health, taking into account risk
assessment techniques developed by the rel­
evant international organizations.
2. In the assessment of risks, Members shall
take into account available scientific evi­
dence; relevant processes and production
methods; relevant inspection, sampling and
testing methods; prevalence of specific dis­
eases or pests; existence of pest-or disease-
free areas; relevant ecological and environ­
mental conditions; and quarantine or other
treatment.
3. In assessing the risk to animal or plant life
or health and determining the measure to be
applied for achieving the appropriate level of
sanitary or phytosanitary protection from
such risk, Members shall take into account as
relevant economic factors: the potential dam­
age in terms of loss of production or sales in
the event of the entry, establishment or
spread of a pest or disease; the costs of con­
trol or eradication in the territory of the
importing Member; and the relative cost-
effectiveness of alternative approaches to
limiting risks.
4. Members should, when determining the
appropriate level of sanitary or phytosani­
tary protection, take into account the objec­
tive of minimizing negative trade effects.
5. ...
6. ... when establishing or maintaining sani­
tary or phytosanitary measures to achieve
the appropriate level of sanitary or phy­
tosanitary protection, Members shall ensure
that such measures are not more trade-
restrictive than required to achieve their
appropriate level of sanitary or phytosani­
tary protection, taking into account technical
and economic feasibility (1).
7. In cases where relevant scientific evidence
is insufficient, a Member may provisionally
adopt sanitary or phytosanitary measures on
the basis of available pertinent information,
including that from the relevant international
organizations as well as from sanitary or
phytosanitary measures applied by other
Members. In such circumstances, Members
shall seek to obtain the additional infor­
mation necessary for a more objective assess­
ment of risk and review the sanitary or phy­
tosanitary measure accordingly within a
reasonable period of time.'
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
The footnote to Article 5(6) reads as follows:
Tor purposes of paragraph 6 of Article 5, a
measure is not more trade-restrictive than
required unless there is another measure, rea­
sonably available taking into account techni­
cal and economic feasibility, that achieves the
appropriate level of sanitary or phytosani-
tary protection and is significantly less
restrictive to trade.'
Ill — Facts
27. Affish BV (hereinafter 'Affish') imports,
mainly from Japan, and distributes deep-
frozen fishery products. Since 1980, it has
maintained for that purpose relations with
the trading house Hanwa Co. Ltd of Osaka
(hereinafter 'Hanwa').
28. Hanwa represents four Japanese factories
which further process 'Sūrimi', semi-
processed fish, into Sūrimi fish products,
known as 'kamaboko', 22 which are placed
on the market in the Community as snacks.
29. Affish sells its products mainly to whole­
salers in the Netherlands, Belgium, Ger­
many, France and Spain.
30. Between 23 January 1995 and 15 March
1995, Affish purchased 11 consignments of
Surimi products from Hanwa.
31. At the end of March 1995, Hanwa
shipped to the Netherlands two of those
consignments of kamaboko, in respect of
which health certificates had been issued by
the competent Japanese authorities.
32. By decision of 2 May 1995, issued on the
basis of Commission Decision 95/119, the
Rijksdienst voor de Keuring van Vee en
Vlees (National Department for the Inspec­
tion of Livestock and Meats, hereinafter 'the
22 — According to the order for reference, the fish caught is
semi-processed at sea into 'Surimi' products which arc
further processed in the Japanese factories; the resultant
product is called 'kamaboko'.
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OPINION OF MR COSMAS — CASE C-183/95
Rijksdienst') refused to allow the importa­
tion of the said consignments into the Neth­
erlands.
33. On 3 May 1995, Affish lodged an objec­
tion against the Rijksdienst's decision.
34. By application of 3 May 1995, Affish
asked the President of the College van
Beroep voor het Bedrijfsleven, by way of
interim relief, to suspend the enforcement of
the Rijksdienst's decision and to declare that
the Rijksdienst is entitled to refuse to allow
the importation of the aforementioned con­
signments of fishery products, and of any
consignments of fishery products which Aff­
ish may import in the future, only on
grounds of the protection of health and life
of humans or animals, and that the Rijksdi­
enst would be entitled to base such refusal
only on a laboratory investigation, con­
ducted or commissioned by the Rijksdienst,
showing that an actual threat to the health
and life of humans or animals would result
from the importation of the consignments in
question.
35. In support of its application to the
national court, Affish claimed that contested
Decision 95/119 was invalid on the following
four grounds: (a) it conflicted with Article 19
of Directive 90/675, (b) it infringed the prin­
ciple of proportionality, (c) it infringed the
principle of equal treatment and (d) it was in
breach of Articles 2, 4 and 5 of the Agree­
ment. In the alternative, Affish claimed that
the Netherlands had infringed the principle
of the protection of legitimate expectations,
enshrined in Community law, by failing to
provide for a transitional arrangement for
consignments which had already been
shipped.
36. Against that, the Rijksdienst argued that
the Netherlands authorities were obliged to
comply fully with the Community decision
and were not competent to consider the
question whether the decision had been law­
fully adopted: that was a matter for the
Court alone. Since the decision did not pro­
vide for a transitional period, the Nether­
lands Government could not provide for one
either.
37. The national court first considered Aff-
ish's claim in the alternative and dismissed it
on the ground that neither contested
Decision 95/119 nor Directive 90/675, nor
Community law in general, contains provi­
sions which would allow the Member States,
in implementing the decision, to provide for
a transitional arrangement. Furthermore,
assuming that the protection of public health
within the meaning of Article 19 of Directive
90/675 was actually at stake, there would be
no room for taking into account the econ­
omic interests of affected traders.
I - 4330
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
38. The national court went on to consider
the extent to which the requirements set out
by the Court in its judgment in the Zucker­
fabrik case 23 had been met in order for the
national court to suspend the operation of a
national administrative act based on an act of
a Community institution (Community regu­
lation). In its view, there were strong reasons
to doubt the validity of the contested
decision.
39. The national court questions the pro­
cedure followed by the Commission in
adopting the decision. It considers that the
aim of the mission of experts was to inspect
the state of the fish-processing establish­
ments in Japan in order subsequently to fix,
in accordance with Article 11 of Directive
91/493, the specific conditions for the impor­
tation of fish products. In the national
court's initial assessment, however, the find­
ings of the mission of experts do not provide
conclusive justification for the decision.
40. The national court goes on to consider
that, of the many dozens of establishments
which exist in Japan, the experts visited only
four in the north-east of the country. The
conclusions in the report do not justify a
general prohibition on the importation of
fishery products from Japan, because it is not
clear that the conditions found at the four
establishments were representative 24 of all
the establishments, or that supervision by the
authorities was also inadequate in the other
regions of Japan, in view of the fact that Aff-
ish obtains its products from establishments
in regions other than those visited by the
experts. No general prohibition on the
importation of fishery products should
therefore have been imposed.
41. The national court further points out
that the prohibition affects a particular mar­
ket, namely, the market in kamaboko prod­
ucts, which, at least in the Netherlands, had
hitherto been free of problems. In addition,
any unreliability of the health certificates
issued for certain types of product can be
offset by checks at the time of importation of
the products concerned into the Community.
Moreover, it observes that the results of the
inspections do not seem to have been dis­
cussed with the persons concerned before
the contested decision was adopted.
42. The national court further considers that
the fact that the Commission was not repre­
sented at the hearing, although it had been
23 — Joined Cases C-143/88 and C-92/89 Zuckerfabrik Süder-
dithmarchen and Zuckerfabrik Soest [1991] ECR I-415,
paragraph 16 et seq. The conditions set out by the Court in
that judgment were clarified in Case C-466/93 Adanta
Fruchthandelsgeselhchaft (II) [1995] ECR I-3799, para­
graph 35 et seq.
24 — At one of the establishments, the conditions were even
assessed as 'satisfactory'.
I-4331
OPINION OF MR COSMAS — CASE C-183/95
invited to attend by the Rijksdienst, in order
to explain the conclusions of the mission of
experts on which it had based its decision,
hindered a proper appreciation of the
report. 25
43. Finally, the national court considers that
the market on which Affish offers the prod­
uct in question for sale will very soon be lost
through competition from other, similar
products from other countries, and that, in
view of the proportion of Affish's total sales
accounted for by the product, it will inevita­
bly become insolvent as a result of the
import prohibition. In those circumstances,
according to the national court, the require­
ment for urgency, as set out by the Court in
the Zuckerfabrik case 26 for granting the
interim relief sought, is satisfied, without any
financial interests of the Community being
involved which would preclude the grant of
relief.
44. Although the national court maintained
its reservations as regards the supervision
and health checks carried out by the compe­
tent Japanese authorities at the establish­
ments in the region from where Affish
imports its products, and thus as regards the
reliability of the health certificates issued,
and therefore held, having regard to the
overriding interest of the protection of pub­
lic health, that the threefold inspection of
imported fishery products provided for in
Directive 91/493 27 was not conclusive, it
granted Affish's application and ordered the
suspension of the contested Commission
decision, instructing the Rijksdienst: (a) to
have the consignments of fishery products
which Affish was prohibited from importing
into the Community investigated as thor­
oughly as possible in accordance with the
present state of the art for possible defects
from the point of view of the protection of
health and life of humans and animals and
(b) to release the said consignments for cir­
culation in the Community only if they were
shown to a sufficient extent by the aforesaid
investigation to have no such defects. At the
same time, it requested the Court to give a
preliminary ruling on the validity of Com­
mission Decision 95/119.
IV — The question submitted by the
national court
45. The College van Beroep voor de Bedrijf­
sleven has referred the following question to
the Court for a preliminary ruling:
'Regard being had to the considerations set
out in this order, is Commission Decision
25 — The Commission was in fact represented at the hearing in a
later case before the same court and between the same par-
tics (concerning a prohibition on the importation of further
consignments of kamaboko, pursuant to Decision 95/119),
in which judgment was given on 24 August 1995.
26 — Already cited in footnote 23.
27 — That is, a documentary check, an identity check and, finally,
a physical check.
I - 4332
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
95/119/EC of 7 April 1995 valid in so far as
it extends to Sūrimi fish products, also
referred to as kamaboko, as imported by the
applicant, which come from regions of Japan
other than those in which the establishments
investigated by a mission of experts from the
Commission were located according to their
report of 4 April 1995, or at least from estab­
lishments other than those investigated, and
in relation to products which, following
appropriate investigation upon their impor­
tation into the Community, showed no sign
of health risks?'
V — Answer to the question submitted
Preliminary observations
46. It should be observed first of all that
Affish applied to the national court for the
suspension of the Rijksdienst's decision.
According to the operative part of the order
for reference, the national court has sus­
pended the enforcement of Commission
Decision 95/119. I am, however, of the opin­
ion that the national court, doubting the
validity of contested Decision 95/119, has in
substance suspended the enforcement of the
administrative act of the competent national
authority 28 prohibiting the importation of
certain consignments of fishery products
from Japan, a decision which was adopted
pursuant to the Warenwetregeling, which
was in turn amended in order to give effect
to the Commission's decision in theNether­
lands. I am thus of the opinion that the
national court has made an error, because it
could not have suspended an act of a Com­
munity institution, namely the contested
Commission decision, since the validity of
such acts can be reviewed and, if necessary,
suspended only by the Court; the national
court suspended only the national act imple­
menting the decision. However, that error
cannot be subject to review by the Court.
47. Having clarified that, I shall first exam­
ine whether it is necessary to supplement the
judgment in Zuckerfabrik 29 with a further
requirement, this time of a procedural
nature, for the grant of interim relief when a
national court questions the validity of a
Community act (A). Next, the grounds
raised against the validity of Commission
Decision 95/119, both by the national court
and by Affish in its observations to the
Court, must be examined. 30 I shall thus
28 — The Italian and the Netherlands Governments point this
out in their observations.
29 — Already cited in footnote 23.
30 — The national court points out that the other grounds relied
upon by Affish in order to contest the validity of the
decision concern the proportionality of the measure at
issue, viewed in the light of the requirements set forth in
Article 19 of Directive 90/675. I am of the opinion that all
of Affish's arguments must be examined in turn, even
though the national court has not taken a view on any par­
ticular argument. The Court's case-law is clear on this
point. In the judgment in Joined Cases 103/77 and 145/77
Scholten-Honig [1978] ECR 2037, paragraphs 16 and 17,
the Court considered the validity of a Community regu­
lation on the basis of the grounds for annulment relied on
by the plaintiff in the main proceedings, since the national
court had asked the Court in general terms for a ruling on
the question whether the regulation in question was valid.
I - 4333
OPINION OF MR COSMAS — CASE C-183/95
consider to what extent the Commission, in
adopting the decision, acted in breach of
Article 19 of Directive 90/675 by not giving
a sufficient statement of reasons for its
decision, in so far as there was no reference
to 'serious reasons' which would justify such
a restrictive measure (B). I shall go on to
examine whether the Commission infringed
the principle of proportionality (C), the
principle of equal treatment (D), the prin­
ciple of the protection of legitimate expecta­
tions (E), the provisions of the Agreement
on the application of sanitary and phytosani-
tary measures (F) and, finally, whether it was
guilty of misuse of powers or abuse of pro­
cess (G).
(A) The need to supplement the judgment in
Zuckerfabrik
(1) Admissibility
48. In its order for reference, the national
court merely observes that the fact that the
Commission was not represented at the hear­
ing, despite being invited to attend by the
President at the request of the Rijksdienst,
hindered the proper assessment of the con­
clusions set forth in the experts' report on
their visit to the establishments concerned,
and consequently also the examination of the
validity of the contested decision.
49. According to the Commission, this case
gives the Court an opportunity to rule for
the first time on the question whether the
requirements set out in the Zuckerfabrik
judgment for suspension by the national
court of a national administrative act based
on an act of a Community institution, the
validity of which is contested, must be
supplemented by the requirement that the
national court give the Community institu­
tion an opportunity to make its point of
view known before suspending the act.
50. I am of the opinion that it is not neces­
sary for the Court to take a view on this
point. My objection is that the national court
has not directly raised this question. 31 It is
true that there have been a number of occa­
sions when the Court has interpreted provi­
sions even though the national court did not
expressly request it to do so. 32 However, on
each occasion when it did so, this was solely
in order to give the national court a helpful
reply which would enable it subsequently to
resolve the dispute pending before it. I am
thus of the opinion that an answer to this
question is neither necessary nor useful for
the purpose of answering the question
referred by the national court for a prelimi­
nary ruling, nor does it have to be answered
31 — The national court did invite the Commission to explain its
point of view at the hearing, even though the Commission
was unable to attend.
As was observed at the hearing, instances can be cited (as in
the United Kingdom, for example) in which the national
court has called on the Community institution to explain
the reasons why it adopted a particular act.
32 — See, for example, Case 70/77 Simmenthal [1978] ECR 1453,
paragraph 57; Case C-114/91 Claeys [1992] ECR I-6559,
paragraph 21 in conjunction with paragraph 10; Case
C-280/91 Viessmann [1993] ECR I-971, paragraph 17, and
the Opinion of Advocate General Jacobs in that case
(point 14).
I - 4334
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
in order to enable the national court to
resolve the dispute before it. 33
(2) Substance
51. With regard to the question of the extent
to which it is necessary to supplement the
Zuckerfabrik judgment and, more specifi­
cally, whether it is necessary for the Court to
lay down procedural rules governing the
manner in which national courts grant
interim relief, 34 I must observe that the
Court is being asked by the Commission to
lay down a procedural rule which would
guarantee the right of the Community insti­
tutions to defend themselves in the event of
the validity of one of their acts being called
into question. In that way, the Community
institution would be able, if it so wished, to
put forward its point of view and provide
the national court with an explanation of the
reasons which prompted it to adopt the con­
tested measure. In other words, it would
then no longer be necessary for the national
court to summon the Community institution
in order to make its point of view known:
the Community institution would be entitled
to do so as of right. 35
52. Although the recognition of such a
requirement is theoretically of interest, I am
not in favour of it. The national court cannot
assess the validity of a Community act, and
it must therefore refer a question for a pre­
liminary ruling whenever it has doubts about
the validity of such an act. The proper forum
for dealing with such a question is the Court.
Apart from that, the Community institution
will not wish to run the risk of having its
decision annulled by the national court. I
believe that the national court would derive
little benefit from the explanation given by
the Community institution, which can in any
case put its point of view to the Court later
on if a reference for a preliminary ruling is
made on the matter. Under the case-law
established by the Zuckerfabrik judgment, 36
the national court can suspend only the
enforcement of a national administrative act
based on an act of a Community institution,
and at the same time refer a question to the
33 — In my opinion, this is the only view which accords with the
purpose of Article 177 of the Treaty and finds support in
the settled case-law of the Court which has repeatedly held
that the duty assigned to it under Article 177 is that of
assisting in the administration of justice in the Member
States (see Case 244/80 Foglia [1981] ECR 3045, paragraph
21; Case C-231/89 Gmurzynska-Bscher [1990] ECR I-4003,
paragraph 20; Case C-346/93 Kleinwort Benson [1995]
ECR 1-615, paragraph 24; and Case C-415/93 Bosman
[1995] ECR 1-4921, paragraph 60), and not that of deliver­
ing advisory opinions on general or hypothetical questions
unconnected with the resolution of the pending dispute; see
Foglia, already cited, paragraphs 18 and 20, and Case
149/82 Robards [1983] ECR 171, paragraph 19. See also
Joined Cases C-422/93, C-423/93 and C-424/93 Zabola
[1995] ECR 1-1567, paragraph 29.
34 — Let me point out that the national court invited the Com­
mission to explain its point of view at the hearing, but that
the Commission was prevented from doing do for reasons
unconnected with the case. It was, however, represented
during the hearing of a later application for similar judicial
relief, brought by Affish before the same court.
35 — In practice, this would mean that the Parliament would
have the right to defend itself whenever any of its acts pro­
duced legal effects or was adopted in accordance with the
co-decision procedure under Article 189b of the Treaty, that
is, jointly with the Council, the Commission and the Euro­
pean Central Bank.
36 — Already cited in footnote 23.
I - 4335
OPINION OF MR COSMAS — CASE C-183/95
Court for a preliminary ruling on the valid­
ity of the Community act, thereby avoiding
lengthy protraction of the proceedings. 37
(B) Insufficient statement of reasons for the
Commission's decision
53. According to Affish, in adopting
Decision 95/119, the Commission infringed
Article 19 of Directive 90/675 in several
respects. In particular, it argues that the
Commission cannot be regarded as the
Community legislature, and that it therefore
does not have a wide discretion under
Article 19. But even if it did have such a dis­
cretion, it would still have to give a proper
statement of the legal and factual reasons
forming the basis of a measure as restrictive
as an import prohibition in respect of fishery
products from Japan, namely the Sūrimi
products imported by Affish, which had
hitherto undergone all veterinary checks
inside and outside the Community without
any problem. 38
(1) Extent of the Commission's powers
under Article 19 of Directive 90/675
54. In the first place, Article 43 of the Treaty
is cited as the legal basis for Directive 90/675
which in turn formed the basis of the con­
tested decision; in terms of its substance,
moreover, the contested decision falls within
the scope of the common agricultural policy,
an area in which the Community institutions
generally have a wide discretion in view of
the tasks which the Treaty assigns to them. 39
55. Article 19 of Directive 90/675 confers
exclusively on the Commission a wide
discretion since, 'depending on the gravity
37 — In addition, the national court can always ask the Commu­
nity institution which adopted the measure for information
in order to obtain a clear picture of the factual context of
the dispute pending before it; see, for example, the order
of 13 July 1990 in Case C-2/88 Imm. Zwartfeld [1990]
ECR 1-3365.
38 — At the hearing, Affish argued that the hypothetical risk
from hygiene deficiencies at the fish-processing establish­
ments was very small because the fish used for Sūrimi is
caught in Alaska and Canada and processed into semi­
finished products at sea.
39 — The Court has ruled on the Commission's powers in this
field in Case 27/85 Vandemoortele [1987] ECR 1129, para­
graph 14. In that judgment, which concerned the scope of
the implementing powers granted in principle to the Com­
mission in regard to the common agricultural policy, the
Court held (paragraph 14) that 'it follows from the context
of the Treaty in which Article 155 must be placed and also
from practical requirements that the concept of implemen­
tation must be given a wide interpretation'. Since 'only the
Commission is in a position to keep track of agricultural
market trends and to act quickly when necessary, the
Council may confer on it wide powers of discretion and
action in that sphere, and when it docs so the limits of those
powers must be determined in the light of the essential gen­
eral aims of the market organization'.
With regard to the Council's powers in the context of the
common agricultural policy, see, for guidance, Case
C-122/94 Commission v Council [1996] ECR 1-881, para­
graph 18, which deals with State aid in the wine sector, and
my Opinion in that case, as well as the earlier judgment
in Case 138/79 Roquette Frères [1980] ECR 3333, para­
graph 25.
I - 4336
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
of the situation', it has to act without delay
if, in the territory of a third country, a
zoonosis or other disease occurs or spreads
which is 'liable to present a serious threat' to
animal or human health, or if such action is
warranted by any other 'serious' animal or
public health reason, in particular 'in the
light of the findings of its veterinary experts'.
56. Article 19 of the directive thus employs a
series of broadly-based legal concepts, such
as 'serious threat to animal or public health',
'serious animal health or public health rea­
son', 'gravity of the situation', to be defined
by the Commission, subject to review by the
Court.
57. To my mind, the question of what facts
or situations ultimately constitute a 'serious
threat', 'serious reasons' or a 'grave situation'
must be assessed from case to case, taking
account of many factors such as, for
example, the nature of the product, its pos­
sible susceptibility to rapid deterioration, or
the possibility of thorough and conclusive
checks at both the production stage and
during transport or on release for consump­
tion. 40
58. In exercising the power conferred on it
by Article 19 of the directive, the Commis­
sion acts as the Community legislature since
in a given situation it can take action to regu­
late a problem by adopting one of the mea­
sures specified in that provision.
59. That wide discretion is given to the
Commission in the framework of a system
of safeguards within the overall organization
of veterinary checks on products entering
the Community from third countries, to be
used in serious and exceptional circum­
stances. 41
40 — However, the Commission's wide discretion does not mean
that there is no supervision of the decisions which it adopts
in exercising its powers. If the indeterminate legal concepts
contained in Article 19(1), whose more precise definition is
left to the Commission's discretion, were excessively wid­
ened, they would cease to be effective. Those concepts can­
not cover every symptom of disease or zoonosis, or any
kind of circumstance, because their meaning would then be
lost and, as indeterminate legal concepts, they would have
merely nominal status without any substantive binding
effect or, ultimately, any practical utility.
41 — The sixth recital in the preamble to Directive 90/675 states
that 'provision must be made for safeguard arrangements; ...
in this context, the Commission must be able to act, par­
ticularly by visiting the places concerned and adopting mea­
sures appropriate to the circumstances'.
I - 4337
OPINION OF MR COSMAS — CASE C-183/95
60. In my opinion, it is clear from Article 19
(1) of Directive 90/675 that discretion is con­
ferred on the Commission in order to enable
it to take preventive action for the protection
of public health by suspending imports from
third countries. More specifically, it has the
power to act on its own initiative or at the
request of a Member State, without delay
and depending on the gravity of the situa­
tion, to order the suspension of imports
from part or all of the territory of the third
country concerned, or else to lay down spe­
cific conditions in respect of products com­
ing from part or all of the territory of the
third country concerned, in particular in the
light of the findings of its veterinary experts.
The Commission can act not only when, in
the territory of a third country, a disease or
zoonosis occurs or spreads, from which a
serious threat to human and animal health is
likely to arise, but also if such action is war­
ranted by other serious animal health or
public health reasons.
61. To my mind, it is clear from Article 19
of Directive 90/675 that the Commission can
prohibit imports of, in this case, fishery
products for as long as it deems it necessary,
not only in the event of an actual threat from
imports of fishery products which appear
harmful to public health (because they have
deteriorated, for example), but also when
veterinary checks in the country of export
are either completely absent or seriously
defective, that is, where the veterinary checks
carried out in that country are seriously
inadequate, regardless of whether or not an
actual threat to public health has arisen. In
other words, the Commission can prohibit
imports in order to prevent consumption,
not only of products which threaten public
health, but also of products insufficiently
checked, once it has serious reasons for
believing that either circumstance applies.
62. The Court has ruled in many cases not
only on the extent of the powers of the
Community institutions pursuant to Treaty
provisions relating to the implementation of
the common agricultural policy, but also on
the limits of its powers of review when those
institutions enjoy a wide discretion and have
to evaluate a complex economic situation.
Thus the Court has taken the view that, in
the case of a common organization of the
market in certain products, 42 'in reviewing
the exercise of such a power the Court must
confine itself to examining whether it con­
tains a manifest error or constitutes a misuse
of power or whether the authority in ques­
tion did not clearly exceed the bounds of its
discretion'. 43
42 — According to the first recital in the preamble to Directive
91/493, the directive was adopted with a view, among other
things, to ensuring 'the smooth operation of the common
organization of the market in fishery products'.
43 — In other words, when the institution adopting the decision
has wide discretion, the Court, which has no power to sub­
stitute its own assessment for that of the institution — in
this case the Commission — adopting the decision, must
establish with a reasonable degree of certainty, on the basis
of the evidence produced by the parties, that the institution
has not exceeded the bounds of its discretion; that there was
no manifest error concerning the facts which could affect
the validity of the decision, that there was no misapplica­
tion of excessively vague legal concepts, that the decision
was not adopted by misuse of powers, that there was no
manifest error in the assessment of the facts, and that the
reasons stated for the decision are valid in law; see Roquette
Frères, cited in footnote 39, paragraph 25; Case 166/78 Italy
v Council [1979] ECR 2575, paragraph 14; and the judg­
ment cited in footnote 39 in Case C-122/94 Commission v
Council [1996], paragraph 18. See also the concluding sen­
tence of point A of de Opinion of Advocate General Gand
in Case 8/65 Acciaierie e Ferriere Pugliesi [1966] ECR 1.
I - 4338
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
63. I shall examine in turn each of the
grounds raised by Affish, in particular to
what extent the circumstances which led the
Commission to adopt Decision 95/119 con­
stitute sufficient justification for legal pur­
poses, in other words whether or not the
statement of reasons is defective.
(2) Sufficient statement reasons for the con­
tested decision
64. It should first be recalled that, under
Article 190 of the Treaty, acts of the Com­
munity institutions must state the reasons on
which they are based. As the Court has con­
sistently held, however, 44 the statement of
reasons required by Article 190 must be
'appropriate to the nature of the measure in
question. It must show clearly and
unequivocally the reasoning of the institu­
tion which enacted the measure so as to
inform the persons concerned of the justifi­
cation for the measure adopted and to enable
the Court to exercise its powers of review. It
has also been held that the statement of rea­
sons for a measure is not required to specify
the matters of fact or of law dealt with, pro­
vided that it falls within the general scheme
of the body of measures of which it forms
part'.
65. In this connection, I should point out
that a statement of reasons for an act is
insufficient if it does not mention the factual
circumstances on the basis of which the
institution concerned reached its assessment,
even though there are reasons which justify
the adoption of the decision, and do not give
a sufficiently clear statement of the objectives
pursued. 45
66. The first recital in the preamble to con­
tested Commission Decision 95/119 reads as
follows: 'Whereas a mission of experts of the
Commission went to Japan to check the con­
ditions of production and processing of fish­
ery products exported to the Community;
whereas according to the observations of
these experts, the official guaranties given by
the Japanese authorities are not adhered to
and the conditions of production and storage
of fishery products show serious defects as
regards hygiene and control which can con­
stitute risks to public health'.
67. The second recital in the preamble reads
as follows: 'Whereas Commission Decision
94/206/EC prohibits the import of consign­
ments of bivalve molluscs and marine gastro­
pods originating in Japan other than scallops
and other Pectinidae, frozen or processed'.
44 — Sec, for example, Case C-353/92 Greece v Council [1994]
ECR I-3411, paragraph 19; Joined Cases C-63/90 and
C-67/90 Portugal and Spain v Council [1992] ECR I-5073,
paragraph 16; Atlanta FruchthandehgeseUschaft II, cited in
footnote 23, paragraph 16; and Commission v Council, cited
in footnote 39, paragraph 29.
45 — See Case C-331/88 Fedesa [1990] ECR I-4023, paragraph
29, and Case 68/86 United Kingdom v Council [1988]
ECR 855, paragraph 28.
I - 4339
OPINION OF MR COSMAS — CASE C-183/95
68. On the basis of the conclusions of the
mission of experts, the Commission found,
as stated in the third recital in the preamble,
that 'it is necessary to suspend the import of
all fishery products originating in Japan
pending improvement of the conditions of
hygiene and control of production'.
69. Examination of the Community experts'
report shows that they directed their obser­
vations (sections 2 and 3 of the report) pri­
marily at the serious shortcomings of the
veterinary checks carried out by the compe­
tent Japanese authorities, at the same time
pointing out the serious public health risks
which existed at the time of the visits (see, in
particular, points 1.4, 2.3 and 3.2 of the
report).
70. The report as a whole, to which the first
recital expressly refers, but especially point 3
therein, sets out the reasons why the condi­
tions at the fish-processing establishments
visited, in particular their structure, equip­
ment and hygiene, the manufacturing prac­
tices and the deficiencies in the veterinary
checks carried out by the competent Japa­
nese authorities, were not only inconsistent
with the provisions of Directive 91/493, but
also presented serious public health risks. In
view of the nature of the fishery products
concerned, which, as the Commission points
out, can only be effectively checked at the
production stage, there were thus serious
reasons for adopting measures for the pro­
tection of public health. I therefore consider
that the statement of reasons for the con­
tested Commission decision, which refers in
general terms to the negative conclusions in
the report, is neither insufficient nor incor­
rect since it can be assumed that the condi­
tions laid down in Article 19 of the directive,
on which the decision is based, had been ful­
filled.
71. I am likewise of the opinion that the
statement of reasons for the contested Com­
mission decision may not be regarded as
insufficient because it is too brief. It is true
that the reasons in question do not include
an exhaustive enumeration of all the factors
in the Commission's reasoning, do not cite
in full the conclusions of the mission of
experts sent out to Japan, and do not explain
why a less restrictive measure would not
have been appropriate. However, as an act
adopted under a discretionary power, the
contested decision does contain, albeit in
summarized form, mention of factual cir­
cumstances which the Commission took into
consideration, and the legal conclusions jus­
tifying its adoption. It is precisely because
the decision is an act based on a discretion­
ary power that a summary statement of
reasons is sufficient, as Advocate General
Lagrange has also pointed out. 46
46 — See his Opinion in Joined Cases 36/59, 37/59, 38/59 and
40/59 Geitling v High Authority [1960] ECR 423.
I - 4340
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
72. The serious defects as regards hygiene
and control by the Japanese authorities are,
in my view, characteristic circumstances
which may constitute 'a serious animal
health reason' or present a threat to 'public
health'.
73. As a whole, therefore, the preamble to
the decision forms a statement of reasons
which must be considered sufficient for the
purposes of Article 190 of the Treaty with
regard not only to its wording but also to
the factual circumstances which led to its
adoption (reference to 'serious defects as
regards hygiene and control') and all the
rules of law governing the matter in ques­
tion. 47
(C) Infringement of the principle of propor­
tionality
74. Affish considers that the contested
decision infringes the principle of propor­
tionality which also governs Article 19 of
Directive 90/675. 48 In particular, it maintains
that the measure selected by the Commission
was neither appropriate nor necessary for
achieving the objective pursued and that the
possibility of adopting a less drastic measure
was not examined. Finally, according to Aff­
ish, the disadvantages of the measure selected
outweigh the advantages.
(1) Was the measure adopted appropriate to
the objective pursued?
75. According to Affish, the fact that the
local authorities in a particular region of
Japan failed to carry out the necessary veteri­
nary checks cannot justify the adoption of
such a restrictive measure by the Commis­
sion.
76. As the national court observes, points
1.3 to 1.5 of the report indicate that insuffi­
cient attention was paid to critical aspects of
the production process, such as water supply,
for example, and verification of every batch.
It also notes that the four establishments
from which Affish obtains its products com­
ply fully with the Community requirements.
It points out that the conclusions of the mis­
sion of experts 49 are not a sufficient basis for
such a restrictive measure since there had
been no actual complaints about particular
products which could justify the adoption
of safeguard measures under Article 19 of
47 — See also, for example, Case 185/83 University of Groningen
[1984] ECR 3623, paragraph 38; Case 203/85 Nicolei
Instrument [1986] ECR 2049, paragraph 10; Case 167/88
Association generale des producteurs de pié et autres céréales
[1989] ECR 1653, paragraph 34; Joined Cases C-121/91
and C-122/91 CT Control and JCT Benelux [1993]
ECR 1-3873, paragraph 31.
48 — According to Affish, Article 19 contains a double propor­
tionality test, because on the one hand the reasons justify­
ing the measures adopted must be stated, and on the other,
the measure selected must be commensurate with the situ­
ation which has arisen.
49 — Neither the national court nor Affish disputes the reliability
of the conclusions of the mission of experts with regard to
the establishments visited.
I - 4341
OPINION OF MR COSMAS — CASE C-183/95
Directive 90/675, as had been the case earlier
with scallops and had ultimately led to their
prohibition.
77. Those arguments cannot be accepted.
78. According to settled case-law, by virtue
of the principle of proportionality, 'measures
imposing financial charges on economic
operators are lawful provided that they are
appropriate and necessary for meeting the
objectives legitimately pursued by the legis­
lation in question. Of course, when there is a
choice between several appropriate measures,
the least onerous measure must be used and
the charges imposed must not be dispropor­
tionate to the aims pursued.' 50
79. With regard to the question of the extent
to which those conditions are amenable to
judicial review, the Court has consistently
held 51 that 'in matters concerning the com­
mon agricultural policy, the Community leg­
islature has a discretionary power which
corresponds to the political responsibilities
imposed by Articles 40 and 43 of the Treaty.
Consequently, the legality of a measure
adopted in that sphere can be affected only if
the measure is manifestly inappropriate hav­
ing regard to the objective which the compe­
tent institution intends to pursue.'
80. I must therefore begin by examining the
objective of the contested decision (95/119)
in order to determine thereafter whether the
measure adopted by the Commission is
appropriate and necessary in order to achieve
that objective, and whether its disadvantages
outweigh its advantages.
81. It is clear from the first recital in the pre­
amble that the objective of the decision is the
protection of public health which would be
put at risk by the consumption of fishery
products from Japan since serious defects as
regards hygiene have been found to exist.
82. In its recent order in the case concerning
bovine spongiform encephalopathy (BSE —
or 'mad cow disease'), 52 the Court, in bal­
ancing the conflicting interests, pointed out
that Article 3(o) of the EC Treaty provides
that the objectives of the Community
50 — Sec, for example, Case 265/87 Schräder [1989] ECR 2237,
paragraph 21; Fedesa, cited in footnote 45, paragraph 12;
Case C-295/94 Hüpeden [1996] ECR 1-3375, paragraph 14;
and Case C-296/94 Pietsch [1996] ECR 1-3409, para­
graph 15.
51 — See, for example, Schräder, cited in footnote 50, para­
graph 22; Case C-331/88 Fedesa, cited in footnote 45, para­
graph 14; and Case C-280/93 Germany v Council [1994]
ECR 1-4973, paragraphs 89 and 90.
52 — Order of 12 July 1996 in Case C-180/96 R United Kingdom
v Commission [1996] ECR 1-3903.
I - 4342
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
include 'a contribution to a high level of
health protection'. The Court went on to
state: 'That objective is reiterated in the first
subparagraph of Article 129(1) of the Treaty,
under which the Community is to contribute
towards ensuring a high level of human
health protection. The third subparagraph of
Article 129(1) further specifies that health
protection requirements are to form a con­
stituent part of the Community's other poli­
cies.' 53 It is significant, moreover, that in
that order the Court considered that 'efforts
to achieve the objectives of the common
agricultural policy cannot disregard require­
ments of public interest, such as the protec­
tion of consumers or of the health and life of
humans and animals, which the Community
institutions must take into account in exer­
cising their powers.' 54
83. In the light of that case-law, I am of the
opinion that the measure adopted by the
Commission, namely the prohibition of
imports of all fishery products from Japan,
was appropriate for the achievement of the
objective pursued, which is undoubtedly of a
higher order, namely the protection of public
health. That is because of the inadequate
standard of the veterinary checks carried out
by the competent Japanese authorities on the
establishments visited by the Community
experts (section 1 and points 3.1 and 3.2 of
the report) and the public health risks pre­
sented by the defects identified. 55
(2) Was the measure adopted necessary?
84. According to Affish, the problem of
defective control arises only in a different
region of Japan from that where Affish
obtains its products, and a general prohibi­
tion on imports from Japan was not a meas­
ure which was necessary to achieve the
objective pursued.
85. The national court points out that the
conclusions of the Community experts can­
not be representative since at one of the
establishments inspected the conditions were
regarded as 'satisfactory'. Moreover, inspec­
tions were carried out at only a very small
number (four) of establishments in a specific
region of Japan, which was not that where
Affish obtains its products.
53 — Paragraph 63.
54 — Paragraph 63; see also Case 68/86 United Kingdom v Coun­
cil, cited in footnote 45, paragraph 12.
55 — As the Commission explained during the hearing, the defi­
ciencies in veterinary control are attributable to the legal
system in force in Japan. While the central authorities lay
down general rules with which all the regional authorities
have to comply, there is nevertheless no central monitoring
of compliance with those rules by the decentralized local
authorities.
I - 4343
OPINION OF MR COSMAS — CASE C-183/95
(a) Inspections by sampling
86. In considering the need for the measure
adopted by the Commission, the question
arises of how far the results of an inspection
by sampling can suffice to justify the general
prohibition on fishery products from Japan
imposed by the Commission. This is all the
more relevant since both Affish and the
national court observe that veterinary
inspection of production in Japan is decen­
tralized and there is no central supervisory
authority: it does not mean, however, that
inspection is also so deficient in other
regions of that country that all importation
must be prohibited.
87. In my opinion, on-the-spot inspections
by sampling were the proper way to verify
conditions at Japanese fish-processing estab­
lishments which, as is clear from the experts'
reports and as pointed out by the Commis­
sion at the hearing, did not comply with
Community requirements. The Commission
was therefore entitled to draw conclusions
about the general conditions prevailing in
those establishments in accordance with the
law of probability, that is, by the broad
method of extrapolation.
88. Support for this view can be found in the
case-law of the Court, which has held that
the Commission may base its action on the
results of an inspection by sampling carried
out in a sufficiently reliable manner, and on
the conclusions of experts, that is, scientists
with specialized knowledge who are able to
make a full assessment of the actual situa­
tion 56 and to produce a report on the basis
of their findings in relation to the whole 57 of
which they have inspected certain parts. 58
89. The Court has also held that, in the
absence of specific rules governing the
56 — See Case C-269/90 Technische Universität München [1991]
ECR 1-5469 concerning exemption from import duty for a
scientific instrument on the ground that there were no
equivalent instruments in the Community. Having stated
that 'the Commission has admitted that it has always fol­
lowed the opinions of the group of experts because it has
no other source of information concerning the apparatus
being considered', the Court went on to hold that 'in those
circumstances, the group of experts cannot properly carry
out its task unless it is composed of persons possessing the
necessary technical knowledge in the various fields in which
the scientific instruments concerned are used or the mem­
bers of that group are advised by experts having that
knowledge' (paragraphs 21 and 22).
57 — See Case C-413/92 Germany v Commission [1994] ECR
I-3781, paragraph 13, which concerned the grant of aid for
processing skimmed milk into casein and cascinates. In that
judgment, the Court held that, in relation to the supervision
to be exercised by the national intervention agency, the
term 'regular supervision' in Article 3(3) of Regulation No
756/70 of the Commission of 24 April 1970 on granting aid
for skimmed milk processed into casein and cascinates (OJ,
English Special Edition (I), p. 201) implies that if it appears
from the official analysis that some of the batches which
satisfied the internal checks carried out by the manufactur­
ing concern do not in fact comply with the requirements of
that regulation and thus cannot be considered eligible for
aid, the national authorities must carry out further checks
in order to ascertain whether the other batches for which an
application for aid has been submitted do in fact comply
with the requirements of the regulation or make the
appropriate extrapolation in accordance with the law of
probability.
58 — In Case C-385/89 Greece v Commission [1992] ECR 1-3225
concerning clearance of the EAGGF accounts, the Court
reviewed the legality of the Commission decision in ques­
tion, which was adopted on the basis of the results of an
inspection by sampling, and held that 'although the Com­
mission must adopt appropriate and reliable methods of
inspection, it is for the applicant Member State ... to adduce
evidence that the methods adopted by the Commission
were not appropriate for the type of inspection to be car­
ried out and that the results obtained were unreliable'
(paragraph 25).
I - 4344
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
conduct of inspection by sampling, the
Commission may apply the methods of
inspection which it considers to be most
appropriate, 59 subject, however, to the gen­
eral requirement that the methods chosen are
reliable. 60
90. In this case, there is no lack of rules con­
cerning the requirements with which fish-
processing establishments must comply, as
the annex to Directive 91/493 shows, but
there are no rules on the number of estab­
lishments to be inspected. Since the Com­
mission cannot in practice stipulate that all
fish-processing establishments in Japan
which export products to the Community
must be inspected, I take the view that it was
entitled to be satisfied with the results of the
inspection by sampling, that is, to base its
action on the findings of the Community
experts after a representative number of
establishments had been inspected, and from
those to draw its conclusions concerning the
general state of the fish-processing industry
in Japan.
91. Since Affish has not shown that all the
establishments from which it obtains its
products comply with Community require­
ments, its argument that the Commission
was not entitled to base its decision on the
conclusions of the mission of experts which
it had sent out to inspect the fish-processing
industry in a third country cannot be
accepted.
(b) Need for the measure adopted
92. According to the Commission, a general
prohibition on imports of fishery products
from Japan was necessary for the effective
protection of public health.
93. As the Commission rightly argues, the
prohibition on imports could not have been
restricted only to one particular region
where the problem was localized by the
inspections, or only to particular establish­
ments, for three reasons:
(a) The fact that the Japanese authorities
themselves had designated the establish­
ments to be inspected 61and thus the
region where inspection would take
place,62 and where the conditions of
59 — See point 34 et seq. of the Opinion of Advocate General
Gulmann in Case C-385/89 Greece v Commission, cited in
footnote 58.
60 — See Joined Cases C-161/90 and C-162/90 Petruzzi and
Longo [1991] ECR I-4845, paragraphs 17 and 18, which
concerned the examination by sampling of certain charac­
teristics of olive oil.
61 — It stands to reason that the establishments which they
selected arc among the average, if not the best.
62 — As stated by the Commission at the hearing, in reply to a
question from the Court on this point.
I - 4345
OPINION OF MR COSMAS — CASE C-183/95
hygiene were subsequently found to be
unsatisfactory, led the Commission to
assume that conditions at establishments
not visited by the Community experts
would be comparable.
(b) As the experts point out in their report
(point 3.3), because of the deficiencies in
the checks carried out by the competent
Japanese regional authorities and the
incorrect identification of batches of fish,
there is no guarantee that the exported
products complied with the require­
ments of Directive 91/493 and came
from an approved establishment. More­
over, as the Commission has pointed out
both in its written observations and at
the hearing, since there is no central
supervisory authority for the whole of
Japan, any restriction of the prohibition
to particular regions would by no means
guarantee that products from an estab­
lishment situated in an 'uncontaminated
region' where all the veterinary require­
ments had been met were not mixed
with products from other regions. 63
(c) According to the Commission and the
Netherlands Government, an import
prohibition is more effective than inspec­
tion on importation because, due to the
nature of fishery products, which are
liable to deteriorate quickly and present
a health risk, veterinary inspection at
source, that is, at the production stage, 64
is more appropriate. Inspection of fish­
ery products is more effective where it is
carried out before packaging, when
products are still in unsorted piles and
relatively easy to inspect in greater quan­
tities. Moreover, inspection at the pro­
duction stage is the rationale underlying
the Community's directives on veteri­
nary health inspections, and in particular
Directive 91/493. 65
94. Inspection of every batch of packaged
fishery products must naturally take place by
way of sampling since inspection of all the
packages would not be feasible financially
and would take so long that the product
could deteriorate. Nevertheless, it could not
guarantee that all the packages in a batch
63 — The Court took a similar view in its order in Case
C-180/96 R United Kingdom v Commission, cited in foot­
note 52. It held that (paragraph 68): 'the reason for the con­
tainment measure's covering the whole of the United King­
dom rather than one or more specific regions is that the
disease, while doubtless localized several years ago, had
spread over the whole country, and that, since not all ani­
mals were adequately identified, it was impossible to deter­
mine where they came from or whether they had at any
time in their life belonged to a herd in which cases of BSE
had been found. In that regard, the United Kingdom stated
at the hearing that only animals infected or suspected of
being infected by BSE were recorded and it did not chal­
lenge the Commission's figure of 11 000 cases of animals
affected by BSE whose herd of origin was not identifiable*.
See also paragraph 75 of that order.
64 — As the Commission states, inspection at the production
stage is the proper way to prevent these problems the world
over. It is also the method used in the Codex Alimentarius
of the Food and Agriculture Organization of the United
Nations (FAO).
65 — The Annex to Directive 91/493 lays down conditions appli­
cable to factory vessels, during and after landing, general
conditions for establishments on land, special conditions
for handling fishery products on shore, arrangements with
regard to health control and monitoring of production con­
ditions, and rules on the packaging, identification, storage
and transport of the products concerned.
I - 4346
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
were free from pathogenic micro-organisms,
even if the batch as a whole were found to
comply with Community standards. 66 For
that reason, inspection at the time of impor­
tation would be incomplete and also less rep­
resentative and therefore less reliable than
inspection at the production and processing
stage.
95. In view of the foregoing considerations,
there was no alternative solution and the
Commission decision, adopted in accordance
with the advice of the Standing Veterinary
Committee, was the only measure which was
appropriate and necessary for the protection
of public health. 67
(3) Balancing of advantages and disadvan­
tages
96. According to Affish, the infringement of
its freedom to pursue a trade, and the huge
attendant damage which it would suffer as a
consequence of the disappearance of the
market for the Sūrimi product which
accounts for 72% of its turnover, are disad­
vantages which are not offset by the advan­
tages in terms of the protection of public
health.
97. In the light of the foregoing analysis, it
seems to me that, having regard to the higher
interest of the objective pursued, namely the
protection of public health, the disadvan­
tages, namely the infringement of, in this
case, Affish's freedom to pursue a trade 68
and the damage which it will suffer as a
result of the prohibition on imports of the
products concerned, regardless of the date on
which those products were shipped from
Japan, that is, before or after 7 April 1995
when Decision 95/119 was adopted, do not
outweigh the advantages. There is therefore
no doubt about the validity of the decision
66 — The importance attached to inspection at the production
stage is also clear from Article 11(2) of Directive 91/493,
under which fishery products imported from third coun­
tries must fulfil specific import conditions. Those condi­
tions are fixed, inter alia, after inspection on the spot of the
conditions of production, storage and dispatch of the fish-
cry products for consignment to the Community.
67 — As the Finnish Government rightly points out in its obser­
vations, this power of the Commission is very important,
particularly for the small countries of the Community,
which do not have the resources needed in order to carry
out the necessary veterinary checks.
68 — In Germany v Council, cited in footnote 51, paragraph 78,
the Court recognized that the freedom to pursue a trade or
business is one of the general principles of Community law,
pointing out that that principle is not absolute, but must be
viewed in relation to its social function. Consequently, the
freedom to pursue a trade or profession may be made sub­
ject to restrictions, particularly in the context of a common
organization of the market, provided that those restrictions
in fact correspond to objectives of general interest pursued
by the Community and do not constitute, with regard to
the aim pursued, a disproportionate and intolerable inter­
ference impairing the very substance of the rights guaran­
teed; see also Schräder, cited in footnote 50, paragraph 15;
Case 5/88 Wachauf [1989] ECR 2609, paragraph 18; and
Case C-177/90 Kühn [1992] ECR I-35, paragraph 16.
I - 4347
OPINION OF MR COSMAS — CASE C-183/95
from the point of view of infringement of
the principle of proportionality. 69
(D) Infringement of the principle of equal
treatment
98. Affish is of the view that the Commis­
sion has infringed the principle of equal
treatment of operators/importers of Sūrimi
products from Japan, on the one hand, and
from Thailand and Korea, on the other, a
principle laid down in Article 40(3) of the
Treaty. Sūrimi products from Japan compete
with similar products from Thailand or
Korea, which, although of inferior quality
(in point of taste, composition and bacterio­
logical hygiene), may be imported without
restriction into the Community. According
to Affish, the Commission should have sent
its mission of experts to those countries as
well, before adopting measures against Japa­
nese kamaboko.
99. The Court has consistently held 70 that,
under the second subparagraph of Article
40(3) of the Treaty, the common organiza­
tion of the agricultural markets is to exclude
any discrimination between producers or
consumers within the Community and that
'prohibition of discrimination is only a spe­
cific expression of the general principle of
equal treatment in Community law, which
means that comparable situations are not to
be treated differently and that different situ­
ations are not to be treated alike unless such
treatment is objectively justified'.
100. In my opinion, the plaintiff's argument
is unsubstantiated since Affish has not
shown that the situation as regards condi­
tions of production and marketing is the
same in Korea and Thailand as it is in Japan,
and that the Commission has therefore
infringed the higher principle of equal treat­
ment.
69 — In its order in Case C-180/96 R, cited in footnote 52, after
balancing the conflicting interests, the Court dismissed the
United Kingdom's application for suspension of the opera­
tion of Commission Decision 96/239/EC of 27 March 1996
on emergency measures to protect against bovine spongi­
form encephalopathy (OJ 1996 L 78, p. 47). To that end it
stated (in paragraphs 91 to 93) that: 'It is true that the fore­
going analysis has shown that damage to commercial and
social interests is likely to result from maintaining the
export ban in force for the time being and that a part of
such damage would not easily be reparable if the main
action were to be upheld. That damage cannot however
outweigh the serious harm to public health which is liable
to be caused by suspension of the contested decision, and
which could not be remedied if the main action were sub­
sequently dismissed'. It concluded as follows: 'Scientists
have as yet only an imperfect knowledge of Creutzfeldt-
Jakob disease and, more particularly, its recently-discovered
variant. ... Since the most likely explanation of this fatal dis­
ease is exposure to BSE, there can be no hesitation. Whilst
acknowledging the economic and social difficulties caused
by the Commission's decision in the United Kingdom, the
Court cannot but recognize the paramount importance to
be accorded to the protection of health' (emphasis added).
70 — Sec, for example, Case C-311/90 Hierl [1992] ECR I-2061,
paragraph 18; Scholten-ffonig, cited in footnote 30, para­
graphs 25 to 27; Case 203/86 Spain v Council [1988] ECR
4563, paragraph 10; Case 84/87 Erpelding [1988] ECR 2647,
paragraph 29; Joined Cases C-267/88 to C-285/88 Wuidart
and Others [1990] ECR I-435, paragraph 13; and Case
C-63/93 Fintan Duff [1996] ECR I-569, paragraph 26.
I - 4348
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
(E) Infringement of the principle of the pro­
tection of legitimate expectations
101. Affish maintains that Article 19 of
Directive 90/675 left some room for the
principle of the protection of legitimate
expectations to be taken into account but
that the Commission disregarded that prin­
ciple when it adopted the contested decision
(95/119). It argues that the decision does not
impose, and could not have imposed, an
immediate ban on imports of fishery prod­
ucts originating in Japan and consequently
an import ban on consignments which had
already been shipped was not necessary since
those consignments could have been sub­
jected to a further inspection on arrival in
the Community.
102. In its observations, the Italian Govern­
ment argues in favour of the validity of the
contested Commission decision and recog­
nizes that in this case the Member States do
not have the same wide margin of discretion
as they have in implementing the measures
necessary to comply with a Community
directive, but points out that Decision
95/119, and in particular Article 3 thereof,
does not expressly set a time-limit within
which Member States must comply there­
with. That points to the fact that it must be
complied with within a strict and uniform
time-limit consistent with the purpose of the
act. The decision did not, however, preclude
the national authorities, in adopting their
implementing measures, from taking into
account the special situation of consignments
which had already been shipped, on the basis
of the principle of legal certainty and the
protection of legitimate expectations, and
thereby fully safeguarding the Community
interest.
103. According to the Rijksdienst, since the
contested Commission decision did not set a
transitional period or expressly provide for
one to be set prior to its entry into force, the
Netherlands Government was not entitled to
lay down any such period. 71
104. As the Court has repeatedly held: 72
'That principle [the protection of legitimate
expectations], which is part of the Commu­
nity legal order, is the corollary of the prin­
ciple of legal certainty, which requires that
legal rules be clear and precise, and aims to
ensure that situations and legal relationships
governed by Community law remain fore­
seeable'. The Court continued: 73 'It is settled
case-law that in the sphere of the common
organizations of the markets, whose purpose
involves constant adjustments to meet
changes in the economic situation, economic
agents cannot legitimately expect that they
will not be subject to restrictions arising out
of future rules of market or structural
policy'. The Court also pointed out that 'the
principle of the protection of legitimate
expectations may be invoked as against
Community rules only to the extent that the
Community itself has previously created a
71 — The contested Commission decision was published on 7
April 1995. The Netherlands Warenwetregeling, which was
adopted in order to implement the decision in the Nether­
lands, is dated 13 April 1995 and entered into force on
15 April 1995.
72 — Sec Fintan Duff, cited in footnote 70, paragraph 20, and
point 23 et seq. of my Opinion in that case. See also Joined
Cases 205/82 to 215/82 Deutsche Milchkontor [1983]
ECR 2633, paragraph 30, and Kühn, cited in footnote 68,
paragraph 13.
73 — Judgment in Fintan Duff, cited in footnote 70, para­
graph 20.
I - 4349
OPINION OF MR COSMAS — CASE C-183/95
situation which can give rise to a legitimate
expectation'. 74
105. In view of the Court's consistent case-
law, I consider Affish's allegation that the
Commission has infringed the principle of
the protection of legitimate expectations to
be unfounded. The provision on the basis of
which Decision 95/119 was adopted imposes
an obligation to achieve a certain result,
namely the protection of public health. From
the time when the Commission found itself
obliged, on account of the serious deficien­
cies identified by the mission of experts in
the veterinary checks carried out, to declare
the prohibition imposed by it immediately
enforceable in order to protect public health,
the Member States were obliged to comply
with it.
106. It is precisely because the objective pur­
sued by the decision was the protection of
public health that it would, in my opinion,
have been injudicious to leave the timing
open in order to accommodate the legitimate
expectations of the individuals affected. Con­
sequently, it was of little relevance whether a
few consignments were shipped from Japan
before or after 7 April 1995.
107. I am therefore of the opinion that the
possible fixing of a transitional period by the
Member States would have jeopardized the
uniform application of Community law and
the effectiveness of the measure adopted. 75 If
a Member State had fixed a transitional
period for consignments already shipped, it
would, in my view, have infringed Article 189
of the Treaty, pursuant to which a decision
is binding in its entirety upon all those
to whom it is addressed. 76
108. On all those grounds, the absence of
transitional measures cannot affect the valid­
ity of Commission Decision 95/119.
(F) Breach of the Agreement on the applica­
tion of sanitary and phytosanitary measures
109. This argument put forward by Affish
concerns the interpretation and direct effect
of the Agreement on the application of sani­
tary and phytosanitary measures. 77 Affish
claims that, by its decision, the Commission
has breached the Agreement, the provisions
of which, according to Affish, may be relied
on by undertakings and private individuals
74 — See, for example, Kühn, cited in footnote 68, paragraph 14.
75 — See Case 112/80 Dürbeck [1981] ECR 1095 which con­
cerned the temporary suspension of the release into free cir­
culation in the Community of apples from Chile, in which
the Court held as follows (paragraph 50): 'in view of the
needs which the temporary suspension of imports met,
transitional measures which exempted contracts already
entered into from the suspension of imports would have
robbed the protective measure of all practical effect by
opening up the Community market in dessert apples to a
volume of imports likely to jeopardize that market'.
76 — Article 191(3) of the Treaty provides, moreover, that deci­
sions are to be notified to those to whom they arc
addressed and are to take effect upon such notification.
77 — Already cited in footnote 3.
I - 4350
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
before the national courts since they contain
clearly worded obligations which are capable
of judicial review. In the proceedings before
the national court, it argued that, even if the
Agreement does not have direct effect, Com­
munity law, and in particular Article 19 of
Directive 90/675, must be interpreted in the
light of the Agreement.
(1) Admissibility
110. The agent of the Netherlands Govern­
ment pointed out at the hearing that the
national court is not asking the Court
directly whether Decision 95/119 is invalid
on account of breach of the Agreement,
although the national court mentions in its
order for reference that Affish did indeed
raise that question. That is why, according to
the Netherlands Government, the examina­
tion by the Court of this aspect of the case
raises the question of admissibility. It is pre­
cisely because the national court has not
raised the question that the Member States
have not made known their point of view on
the matter in accordance with Article 20 of
the Protocol on the Statute of the Court of
Justice of the European Community. 78
111. I am of the opinion that the foregoing
line of argument cannot be accepted. Since
the order for reference from the national
court mentions this point, in that Affish
raised it in its observations before that court,
it is necessary, in order to provide the
national court with a helpful answer, to
examine this point so as to remove any
doubt concerning the validity of the con­
tested decision. 79
(2) The direct effect of the provisions of the
Agreement
112. As the Court has consistently held, in
considering whether the provisions of an
international agreement concluded by the
Community can have direct effect, it is nec­
essary, after first examining the spirit, word­
ing and scheme of the agreement, to examine
to what extent the individual is entitled to
rely on those provisions before the national
courts. In other words, it is necessary to
ascertain whether they are sufficiently precise
and unconditional or require the adoption of
78 — The Court has consistently held that the order for reference
must contain the necessary information on the factual and
legislative context of the case in order to enable the Mem­
ber States and other interested parties to submit observa­
tions pursuant to Article 20 of the Statute of the Court; sec,
for example, the orders in Case C-2/96 Sunino [1996]
ECR 1-1543, paragraph 5, and Case C-458/93 Saddik [1995]
ECR I-511, paragraph 12; and the judgment in Joined
Cases 141/81 to 143/81 Holdijk and Others [1982]
ECR 1299, paragraph 6.
79 — The Court's case-law does not preclude examination of a
plea relied on by a party even though the national court
does not expressly refer to it; sec Scholten-Honig, cited in
footnote 30, paragraphs 16 and 17. Moreover, the Court
has, on a number of occasions, interpreted provisions even
though the national court did not expressly request their
interpretation, and assessed to what extent provisions
whose validity the national court had called in question
were in accordance with provisions which the Court was
interpreting on its own initiative; however, this was always
done in order to provide the national court with a helpful
answer to the questions referred for a preliminary ruling;
sec, for example, Simmenthal, paragraph 57; Claeys, para­
graphs 21 and 10; and Viessmann, paragraph 17, all cited in
footnote 32.
I - 4351
OPINION OF MR COSMAS — CASE C-183/95
more detailed implementing measures. In my
opinion, this question must be examined in
the context of the set of agreements reached
in the Uruguay Round multilateral negotia­
tions (1986-1994). 80
113. Under the General Agreement on Tar­
iffs and Trade (GATT) which was in force at
the time, the Court, when examining the
spirit, scheme or wording of that Agreement,
consistently held 81 that, because of its spe­
cial features, 'an individual may not invoke it
in a court to challenge the lawfulness of a
Community act' and that those features also
preclude 'the Court from taking provisions
of GATT into consideration to assess the
lawfulness of a regulation in an action
brought by a Member State under the first
paragraph of Article 173 of the Treaty'. 82
114. Next, I shall examine to what extent we
can conclude from its spirit, scheme and
wording whether it is possible to rely
directly on the provisions of the recent
Agreement Establishing the World Trade
Organization, 83 to which the Agreement
now under consideration is an annex, in
order to contest before a court the lawful­
ness of a Community act, having regard to
the primacy of international agreements con­
cluded by the Community over provisions
of secondary Community legislation. 84 An
analysis of the Agreement in the light of
both its object and purpose and of its provi­
sions as a whole may help us to answer the
question whether or not it has direct effect.
115. The Court has consistently pointed out
that the effect of an international agreement
in the Community legal order must be deter­
mined having regard to the objectives and
nature of that agreement. The Court has also
made it clear that the said effect cannot be
ascertained without taking into account the
international origin of the provisions of the
agreement in question and that, in confor­
mity with the principles of public interna­
tional law, the contracting parties are free to
agree what effect the provisions of the agree­
ment are to have in their respective internal
legal orders. 85
116. In its examination of the spirit, scheme
and wording of the GATT 1947, the Court
held that that agreement which, according to
its preamble, is based on the principle of
negotiations undertaken 'on the basis of
reciprocal and mutually advantageous
arrangements', 'is characterized by the great
flexibility of its provisions, in particular
those conferring the possibility of deroga­
tion, the measures to be taken when con­
fronted with exceptional difficulties and the
80 — This was acknowledged by the Court, for example, during
its examination of the results of the Agreement on free
trade between the Community and Portugal in Case 104/81
Kupferberg [1982] ECR 3641, paragraph 23. See also Ger­
many v Council, cited in footnote 51, paragraphs 105 to
110; Joined Cases 21/72 to 24/72 International Fruit Com­
pany [1972] ECR 1219, paragraphs 19 to 29; and Case
266/81 SIOT [1983] ECR 731, paragraph 28.
81 — See Germany v Council, cited in footnote 51, paragraph
109. See also the earlier judgments in Joined Cases 21/71 to
24/72 International Fruit Company, cited in footnote 80,
paragraphs 19 to 29; Case 9/73 Schlüter [1973] ECR 1135,
paragraphs 28 to 30; and SIOT, cited in footnote 80, para­
graph 28.
82 — In addition, sec Case C-469/93 Chiquita Italia [1995] ECR
I-4533, paragraphs 26 to 29.
83 — Already cited in footnote 4.
84 — See Case C-61/94 Commission v Germany [1996] ECR
I-3989, paragraph 52.
85 — Kupferberg, cited in footnote 80, paragraph 17.
I - 4352
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
settlement of conflicts between the contract­
ing parties'. 86 The Court analyzed in turn
the features of the former GATT and found
that 'the GATT rules are not unconditional
and that an obligation to recognize them as
rules of international law which are directly
applicable in the domestic legal systems of
the contracting parties cannot be based on
the spirit, general scheme or terms of
GATT', 87
117. The Court found that no obligation
could be inferred from the GATT rules for
the contracting parties to recognize those
rules as rules of international law directly
applicable within their national legal sys­
tems. 88 In the absence of such an obligation
following from GATT itself, the Court left
open the possibility that it could 'review the
lawfulness of the Community act in question
from the point of view of the GATT rules ...
only if the Community intended to imple­
ment a particular obligation entered into
within the framework of GATT, or if the
Community act expressly refers to specific
provisions of GATT'. 89
118. I shall examine whether the provisions
in question, both of the Agreement Estab­
lishing the World Trade Organization and of
the new General Agreement, 90 are capable of
producing direct effect in accordance with
the criteria set out by the Court and, more
particularly, whether individuals can be
regarded as entitled to rely directly on the
provisions of the Agreement.
119. I am of the opinion that the provisions
of both the WTO Agreement and GATT
1994 are still characterized by great flexibil­
ity, which means that they cannot be
regarded as having direct effect and that an
individual is not entitled to rely on them
before the national courts. 91 This applies
with respect to the possibility of derogation
and the measures to be taken when con­
fronted with exceptional difficulties as well
86 — See, in particular, International Fruit Company, cited in
footnote 80, paragraph 21, and Germany v Council, cited in
footnote 51, paragraph 106.
87 — Sec, in particular, Germany v Council, cited in footnote 51,
paragraph 110.
88 — Germany v Council, cited in footnote 51, paragraph 110.
89 — See Germany v Council, cited in footnote 51, paragraph
111, and the earlier judgments in Case 70/87 Fediol [1989]
ECR 1781 and Case C-69/89 Nakajima [1991] ECR I-2069.
90 — OJ 1994 L 336, p. 11.
91 — For more general background on these issues, see, for
example, the articles by Paolo Mengozzi, 'Les droits des
citoyens de l'Union européenne et l'applicabilité directe
des accords de Marrakech' in Revue du Marché Unique
Européen, 1994, part 4, pp. 165 to 174, and C. W. A. Tim­
mermans, 'L'Uruguay Round: sa mise en oeuvre par la
Communauté européenne', in Revue du Marché Unique
Européen, 1994, part 4, pp. 175 to 193.
I - 4353
OPINION OF MR COSMAS — CASE C-183/95
as to the provisions on the settlement of dis­
putes between the contracting parties. 92
120. The Agreement is aimed at the applica­
tion of sanitary and phytosanitary measures
and its provisions must undoubtedly be
interpreted in the light of all the rules result­
ing from GATT 1994. More particularly,
with regard to Articles 2 and 5, I am of the
opinion that they are not so clearly and spe­
cifically worded that the individual may rely
on them before the national courts. 93 As is
92 — It is true that the new GATT 1994 contains a new system
for the settlement of disputes between Members along the
lines of the judicial model, which offers more certainty in
the sphere of application of the recommendations and deci­
sions of the Dispute Settlement Body (hereinafter: 'DSB'),
unlike the old GATT. That system is set out in Annex 2 to
the WTO Agreement, which incorporates the Understand­
ing on Rules and Procedures governing the Settlement of
Disputes (OJ 1994 L 336, p. 234). However, the spirit of
negotiations, which characterized the old GATT, is not
altogether absent from the new GATT.
Thus, the possibility of compensation or the suspension of
concessions or other obligations continues to be available to
Members (Article 22(1) of the Understanding) for the
settlement or prevention of disputes.
Furthermore, the quasi-judicial character of the DSB is
diminished by the fact that Article IX of the WTO Agree­
ment, headed 'Decision-Making', provides, notwithstanding
the practice of decision-making by consensus introduced by
GATT 1947 (paragraph 1), that the Ministerial Conference
and the General Council composed of representatives of all
the Members, that is, political (intergovernmental) bodies,
are to have exclusive authority to adopt interpretations of
the Agreement and of the Multilateral Trade Agreements
(paragraph 2).
Moreover, the possibility for any Member to modify or
withdraw its commitments is maintained (Article XXI of
the General Agreement on Trade in Services (GATTS),
incorporated as Annex 1B to the WTO Agreement) (OJ
1994 L 336, p. 190)). That spirit of flexibility is also exem­
plified by Article XX of the Agreement, under which each
Member may set out in a schedule the specific commit­
ments which it undertakes with regard to market access for
services and service suppliers of another Member.
The new GATT provides that, in the event of a dispute in
which the procedure for dispute settlement laid down in the
Understanding is followed, the Members may conclude
agreements on mutually acceptable compensation (Article
22(2) and (3) of the Understanding).
Article 8(2) of the Agreement on Safeguards (which forms
part of Annex 1A to the WTO Agreement, OJ 1994 L 336,
p. 184) rather limits the scope which a Member has for
adopting safeguard measures in order to prevent very large
volumes of imports or the risk of serious injury to its
domestic industry from like or indirectly competitive prod­
ucts (Article 2), but allows the adoption of such measures
(while offering adequate compensation for the adverse
effects of the measure on the trade of the Members con­
cerned), in particular, reduction of the obligations resulting
from GATT 1994 (Article 8; see also Article 5). More spe­
cifically, there is provision for suspending the application of
concessions or other obligations of a similar nature result­
ing from GATT 1994 to the trade of the Member applying
the safeguard measure. Likewise, the possibility of adopting
provisional measures in exceptional circumstances is main­
tained (Article 6). The application of safeguard measures is
allowed for however long is necessary in order to prevent
the risk of serious damage or to eliminate adverse conse­
quences or facilitate adjustment (Article 7), and in no case
longer than 8 years (Article 7(3)), but that does not alter the
flexible character of GATT 1994.
See also the reservations expressed by C. W. A. Timmer­
mans on this point in his article cited in footnote 91, p. 178
et seq.
93 — In Case 87/75 Bresciani [1976] ECR 129, paragraph 25, the
Court held that Article 2(1) of the Convention of Associa­
tion between the European Economic Community and the
African States and Madagascar associated with the Commu­
nity, signed at Yaoundé on 20 July 1963, which expressly
refers to Article 13 of the EEC Treaty, has direct effect, and
therefore confers, with effect from 1 January 1970, on those
subject to Community law the right, which the national
courts must protect, not to pay to a Member State a charge
having equivalent effect to customs duties, 'since this obli­
gation is specific and not subject to any implied or express
reservation on the part of the Community'.
In Case 17/81 Pabst [1982] ECR 1331, which concerned the
Agreement establishing an Association between the EEC
and Greece, signed in Athens on 9 July 1961 and approved
and confirmed on behalf of the Community by decision of
the Council of 25 September 1961 (OJ, English Special Edi­
tion, Second Series, I External Relations (1), p. 3), the Court
held (in paragraph 27) that it follows from the wording of
Article 53(1) and from the objective and nature of the Asso­
ciation Agreement that 'that provision ... contains a clear
and precise obligation which is not subject, in its imple­
mentation or effects, to the adoption of any subsequent
measures. In those circumstances, Article 53(1) must be
considered as directly applicable ...'. Accordingly, the Court
concluded (paragraph 28), an importer of spirits from other
Member States or from Greece was entitled to rely before a
national court on, inter alia, Article 53(1) of the Association
Agreement with Greece.
Case C-18/90 Kziber [1991] ECR I-199 concerned the
question of the extent to which the Cooperation Agreement
between the European Economic Community and the
Kingdom of Morocco, signed in Rabat on 27 April 1976
and concluded on behalf of the Community by Council
Regulation (EEC) No 2211/78 of 26 September 1978 (OJ
1978 L 264, p. 1), has direct effect. After first examining the
terms of the Agreement (paragraph 16), the Court held that
Article 41(1) was capable of Deing applied directly (para­
graph 23) and could be relied on before the national court,
regard being had, on the one hand, to the nature and pur­
pose of the Agreement, and on the other, to the meaning of
the provision, which defined the persons entitled to certain
benefits and their rights sufficiently precisely and thus had
direct effect (paragraphs 24 to 29).
I - 4354
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
clear from the terms of the Agreement, most
of the provisions of the contested articles (2
and 5) are addressed to the Members of the
World Trade Organization 94 andalthough
they contain obligations to act or to refrain
from acting, 95 they also require supplemen­
tary implementing measures, that is, more
detailed implementing provisions to be
adopted, 96 as the Court has pointed out in
similar cases in which it has reviewed the
direct effect of international agreements. 97
121. The need for more detailed implement­
ing measures becomes apparent on examina­
tion of a series of provisions of the Agree­
ment. For example, Article 2(2) of the
Agreement provides that a sanitary or phy-
tosanitary measure may not be maintained
without 'sufficient scientific evidence'. It is
for the competent authorities to determine
what constitutes 'sufficient' scientific evi­
dence. 98
122. The express references to 'scientific evi­
dence' (Article 5(2) and (3) of the Agree­
ment) and 'relevant economic factors'
(Article 5(3)) cannot, in my opinion, create
any direct obligations for Members. Further,
the adoption of more detailed implementing
94 — The wording used is clear: 'Members shall ensure' (Article
2(2) and (3)), 'Members shall take into account' (Article
5(2), (4) and (6)), 'a Member may provisionally adopt sani­
tary or phytosanitary measures', and 'Members shall seek
to obtain' (Article 5(7)).
95 — We read: 'Members shall ensure', 'Members shall take into
account': in my opinion, the verb form here must be con­
strued as having mandatory force.
96 — In Case C-277/94 Taflan-Met [1996] ECR 1-4085, the
Court did not deny that Decision No 3/80 of the Associa­
tion Council of 19 September 1980 on the application of the
social security schemes of the Member States of the Euro­
pean Communities to Turkish workers and members of
their families (OJ 1983 C 110, p. 60) is binding on the Con­
tracting Parties, but answered the question referred for a
preliminary ruling as follows: 'So long as the supplemen­
tary measures essential for implementing Decision No 3/80
have not been adopted by the Council, Articles 12 and 13
of that decision do not have direct effect in the territory of
the Member States and are therefore not such as to entitle
individuals to rely on them before the national courts'. See
also the earlier judgments in Kziber, cited in footnote 93,
paragraph 15, and Case 12/86 Demirel [1987] ECR 3719,
paragraph 14.
97 — It can be inferred from the Court's case-law that, until the
Community has adopted the necessary implementing mea­
sures for the purpose of fulfilling its obligations under
GATT, it cannot be compelled to do so by judicial means
by the operators concerned. In such circumstances, it will
be entitled to use the remedies made available by GATT
1947 and negotiate a solution with the affected third Mem­
ber. However, if the Commission has fulfilled its obligation,
it has deprived itself of that possibility, and the parties con­
cerned are entitled to rely on the provision concerned
before the courts. For example, in Case 70/87 Fediol, cited
in footnote 89, the Court held (paragraph 20) that the flex­
ibility which is a feature of the provisions of GATT 'does
not, however, prevent the Court from interpreting and
applying the rules of GATT with reference to a given case,
in order to establish whether certain specific commercial
practices should be considered incompatible with those
rules. The GATT provisions have an independent meaning
which, for the purposes of their application in specific
cases, is to be determined by way of interpretation.' That
conclusion, reached by the Commission, can again be found
in Council Regulation (EEC) No 2641/84 of 17 September
1984 on the strengthening of the common commercial
policy with regard in particular to protection against illicit
commercial practices (OJ 1984 L 252, p. 1), which was at
issue in that case: that regulation confers on the operators
concerned the right to rely, in their complaint lodged with
the Commission, on the provisions of GATT in order to
have it established whether the practices by which they
claim to have been injured arc unlawful.
In Case C-69/89 Nakajima v Council, cited in footnote 89,
which concerned the applicability of Council Regulation
(EEC) No 2423/88 of 11 July 1988 on protection against
dumped or subsidized imports from countries not members
of the European Economic Community (OJ 1988 L 209,
p. 1), the Court ruled that the possibility of questioning the
validity of the regulation for breach of the Anti-Dumping
Code adopted in 1979 within the framework of GATT for
the purpose of implementing Article VI thereof does not
presuppose that the Agreement in question has direct effect.
That possibility exists because GATT is binding on the
Community and the contested regulation was adopted in
order to comply with the international obligations of the
Community (see paragraphs 28 to 31).
The Court also followed that approach in Germany v
Council, cited in footnote 51, paragraph 111).
98 — The Commission observes that there is disagreement
between the Community and its commercial partners on
the question whether there is 'sufficient' scientific evidence
in order to prohibit the use of hormones in cattle-breeding,
and the question has now been referred to a special group
of the WTO in Geneva.
I - 4355
OPINION OF MR COSMAS — CASE C-183/95
measures is therefore necessary. The same
problem arises with regard to Article 5(4)
which provides that, when determining their
appropriate level of sanitary or phytosani-
tary protection, 'Members should ... take
into account the objective of minimizing
negative trade effects'.
123. The need for implementing measures is
also apparent from Article 5(6) and (7). Para­
graph 6 refers to measures which Members
adopt with a view to achieving the 'appropri­
ate level' of sanitary or phytosanitary protec­
tion, provided that such measures are not
more trade-restrictive than required to
achieve that level, taking into account techni­
cal and economic feasibility. Finally, para­
graph 7, pursuant to which, in the absence of
scientific evidence, the competent national
authority may provisionally adopt sanitary
or phytosanitary measures, likewise makes it
clear that the definition of such evidence
requires the adoption of further implement­
ing measures.
124. Any assumption that all the provisions
of the Agreement are unconditional is
refuted by the fact that the least-developed
countries may delay application of its provi­
sions for a period of five years following the
date of entry into force of the WTO Agree­
ment, while other developing countries may
delay application for two years (Article 14).
At the same time, there is provision for spe­
cial and differential treatment for those
countries' products (Article 10).
125. Article 13 provides that Members are
fully responsible for the observance of all
obligations set forth in the Agreement.
However, that may be assumed to refer to
the international responsibility of Members,
irrespective of which body (governed by
public or private law) is entrusted with the
enforcement of rules concerning sanitary or
phytosanitary protection. 99
126. It may be inferred from Article 14 of
the Agreement on Agriculture, 100 headed
'Sanitary and Phytosanitary Measures', 101
that the Members considered further imple-
99 — This is clear from Article XXIV: 12 as interpreted by the
Understanding on the Interpretation of Article XXIV
of the General Agreement on Tariffs and Trade 1994
(OJ 1994 L 336, p. 16), which reads as follows:
'Each Member is fully responsible under GATT 1994 for
the observance of all provisions of GATT 1994, and shall
take such reasonable measures as may be available to it to
ensure such observance by regional and local governments
and authorities within its territory.'
100 — OJ 1994 L 336, p. 22.
101 — Article 14 reads as follows:
'Members agree to give effect to the Agreement on the
application of sanitary and phytosanitary measures'.
I - 4356
AFFISH v RIJKSDIENST KEURING VEE EN VLEES
menting measures to be necessary for the
entry into force of the Agreement. 102
127. Finally, I am of the opinion that the
11th recital in the preamble to Council
Decision 94/800 approving the agreements
reached in the Uruguay Round multilateral
negotiations, which states that 'by its nature,
the Agreement establishing the World Trade
Organization, including the Annexes thereto,
is not susceptible to being directly invoked
in Community or Member State courts',
must be read in the light of the foregoing
analysis. In the absence of a corresponding
provision in the text of Decision 94/800, that
recital cannot by itself preclude the direct
effect of the provisions of the Agreement.
That is why an analysis of the wording,
scheme and spirit of the Agreement and, in
general, of the agreements reached in the
Uruguay Round multilateral negotiations,
was necessary. The existence of that
recital 103 merely reflects the fact that the
weighty reasons which led the Court to hold
that no direct effect could be conferred on
GATT 1947 104 have not ceased to apply
with the conclusion of GATT 1994 and the
WTO Agreement, as the Commission has
also pointed out. 105
128. I therefore conclude that while the
Agreement has certainly introduced a new
system which is binding on its members, it
does not have direct effect, that is to say, the
provisions of the Agreement may not be
invoked by individuals before the national
courts.
(3) The incompatibility of Decision 95/119
with Articles 2 and 5 of the Agreement
129. Although I have concluded that the
provisions of the Agreement do not have
direct effect and that individuals may not
102 — Under the fourth recital in the preamble to the Agreement
on Agriculture, cited in footnote 100, the Members are
'committed ... to reaching an agreement on sanitary and
phytosanitary issues'.
103 — Sec the severe criticism levelled at the insertion of that
recital in the preamble to Decision 94/800 by Professor
Paolo Mengozzi in his article cited in footnote 91 (p. 168
et seq.). Mengozzi is also an advocate of direct effect for
the provisions of the new GATT, because otherwise the
primacy of Community law in the national legal systems
could be jeopardized (p. 174).
104 — Sec, for example, Germany v Council, cited in footnote 51,
paragraphs 106 to 108.
105 — Moreover, in explaining the inclusion of this recital in the
preamble to Decision 94/800, the Commission states that
other contracting parties (the United States and Canada)
were of the opinion that GATT 1994 does not have direct
effect. In its view, that is also why, in the absence of reci­
procity, GATT cannot have direct effect in the Commu­
nity. I consider that argument to be irrelevant for the pur­
pose of answering the question whether or not the
Agreement has direct effect, because the Commission does
nor substantiate its assertion and because, as the Court has
stated: 'According to the general rules of international law
there must be bona fide performance of every agreement.
Although each contracting party is responsible for execut­
ing fully the commitments which it has undertaken, it is
nevertheless free to determine the legal means appropriate
for attaining that end in its legal system unless the agree­
ment, interpreted in the light of its subject-matter and pur­
pose, itself specifies those means. Subject to that reserva­
tion, the fact that the courts of one of the parties consider
that certain of the stipulations in the agreement arc of
direct application whereas the courts of the other party
perhaps do not recognize such direct application is not in
itself such as to constitute a lack of reciprocity in the
implementation of the agreement'; sec Kupferberg, cited in
footnote 80, paragraph 18.
I - 4357
OPINION OF MR COSMAS — CASE C-183/95
rely on them before the national courts, nev­
ertheless, should the Court rule otherwise,
and having regard to the Court's settled
case-law under which the primacy of inter­
national agreements concluded by the Com­
munity over secondary Community legisla­
tion means that such legislation 'must, so far
as is possible, be interpreted in a manner that
is consistent with those agreements', 106 I
shall for the sake of completeness examine to
what extent the Commission decision is con­
trary to Articles 2 and 5 of the Agreement.
130. First, Affish maintains that, by basing
its decision solely on the experts' report
without having regard to other available
information, such as, for example, inspection
reports on products which had already been
imported into the Community over a long
period of time, or earlier inspections of fac­
tories from where Affish obtains its prod­
ucts, which showed no evidence of any dan­
ger to public health, the Commission acted
in breach of Article 5(7) of the Agreement.
131. Second, according to Affish, the Com­
mission acted in breach of Article 2(3) of the
Agreement since the measure adopted by it
results in arbitrary or unjustified discrimi­
nation between Members where identical or
similar conditions prevail, as well as between
their own territory and that of other Mem­
bers, and has been applied in such a way as
to constitute a disguised restriction on inter­
national trade.
132. Affish further maintains that the Com­
mission did not comply with the obligations
resulting from Article 5(4) and (6) of the
Agreement, namely to minimize the negative
effects on trade of such measures adopted
and to ensure that such measures were not
more trade-restrictive than required to
achieve an appropriate level of sanitary or
phytosanitary protection.
133. In my view, those arguments put for­
ward by Affish cannot be accepted since they
are not supported by any evidence.
134. The sixth recital in the preamble to the
Agreement refers to the guidelines and
recommendations developed by the Codex
Alimentarius Commission as the basis for
any sanitary and phytosanitary measures
adopted by Members. That is also stipulated
by Article 3(1) of the Agreement. As the
Commission contends, its action is based on
and is in conformity with internationally
106 — See Commission v Germany, cited in footnote 84, para­
graph 52. In Case C-70/94 Werner [1995] ECR I-3189,
paragraph 23, and Case C-83/94 Leifer [1995] ECR
1-3231, paragraphs 23 and 24, the Court interpreted Coun­
cil Regulation (EEC) No 2603/69 of 20 December 1969
establishing common rules for exports (OJ, English Special
Edition (II), p. 590) in the light of the provisions of Article
XI of GATT 'which can be considered to be relevant for
the purposes of interpreting a Community instrument
governing international trade'.
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AFFISH v RIJKSDIENST KEURINGVEE EN VLEES
accepted principles and procedures which are
not inconsistent with the Agreement. 107
135. Under Article 5(2) of the Agreement, in
assessing risks, Members are to take into
account, among other factors, relevant pro­
duction processes and production methods.
136. The Commission points out that the
provisions of Directive 91/493 are based on
findings and principles set out by the Codex
Alimentarius Commission and are in accord­
ance with the latter's recommendations, and
that emphasis has rightly been laid, in par­
ticular, on veterinary checks at the produc­
tion stage, that is, the stage between the
catching and packaging of the fish.
137. Since the mission of experts drew atten­
tion in its report (point 3) to the inadequacy
of the checks carried out by the Japanese
authorities at the establishments visited and
to the serious public health risks resulting
from the conditions of production and pack­
aging of the products concerned, in my view
the Commission was lawfully entitled, in
accordance with Article 2(1) of the Agree­
ment, to adopt the contested decision.
138. In the light of the foregoing analysis,
and in particular of the possible infringement
of the principle of proportionality, the meas­
ure adopted clearly cannot, since it was
directed towards the protection of public
health, be claimed to be 'more trade-
restrictive than required to achieve an appro­
priate level of sanitary or phytosanitary pro­
tection, taking into account technical and
economic feasibility', as stated in Article 5(6)
and the explanatory footnote thereto.
139. To recapitulate, let me reiterate that,
under the Community legislation in force,
the Commission is required to act on the
basis of uniform rules with regard to the
determination of the health conditions which
fishery products, whether or not of Commu­
nity origin, must satisfy; that seems to me to
be shown by the principle of equivalence
contained in Article 10 of Directive 91/493.
Since, moreover, the Commission took as the
basis for its decision reliable information
supplied by experts, I am of the opinion that
Affish's allegation that the Commission drew
an 'arbitrary and unjustified distinction
between Members where identical or similar
conditions prevail' and that the measure
adopted by it constitutes a 'disguised restric­
tion on international trade' within the mean-
107 — The Commission states that the Codex Alimentarius
Commission publishes internationally recommended
codes of practice, in particular in the field of fishery prod­
ucts. The two most important principles in that commis­
sion's recommendations are the identification of possible
public health risks arising at the production stage, and the
control of critical points in the production process.
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OPINION OF MR COSMAS — CASE C-183/95
ing of Article 2(3) of the Agreement must be
rejected for lack of evidence. 108
(G) Misuse of powers and abuse of process
(1) Misuse of powers
140. The national court and Affish raise the
question whether the Commission used its
powers under Article 19 of Directive 90/675
as a means of bringing pressure to bear on
third countries in order to induce the health
authorities in those countries to tighten up
their supervision. In other words, were those
powers used, not for the protection of the
health of the consumer, but as an instrument
of commercial policy, in order to bring about
the adoption in Japan of a harmonized sys­
tem of controls for fish-processing establish­
ments, equivalent to the system which exists
in the Community?
141. The question which thus arises in
substance is whether the contested Commis­
sion decision is invalid on account of misuse
of powers, that is, whether it was adopted
for a purpose other than that for which
Article 19 conferred the relevant power on
the Commission.
142. Affish has not produced the evidence
required to substantiate an allegation of mis­
use of powers and for the Commission's
decision to appear, 'on the basis of objective,
relevant and consistent indications', to have
been adopted for purposes other than those
for which it was intended. 109
143. Moreover, the facts, as set out in the
experts' report and in the first recital in the
preamble to the decision, viewed as a whole,
show that there were serious grounds for
adopting measures for the protection of pub­
lic health, since serious defects as regards
hygiene and control had been identified at
the fish-processing establishments visited.
That is why, in adopting its decision, the
Commission had regard above all to protect­
ing public health, as it is obliged to do pur­
suant to Directive 90/675. 110
144. The Commission therefore did not use
the powers vested in it by Article 19 for a
purpose other than that for which they were
conferred, since it manifestly had in view the
protection of public health. There was thus
no misuse of powers.108 — The Commission points out that Japan has not raised the
question whether Decision 95/119 is in conformity with
the Agreement. Following the negative findings of the
mission of experts and the adoption of the decision by the
Commission, the Japanese authorities even suspended the
issue of health certificates from the beginning of May
1995. On 7 August 1995, they sent to the Commission a
new list of two approved establishments. On 7 September
1995, they announced that four further establishments had
been approved. Thereafter, the issuing of health certificates
was resumed only for products from those establishments.
109 — See, for example, Case C-323/88 Serines [1990] ECR
I-3027, paragraph 33, and Nakajima, cited in footnote 89,
paragraph 134.
110 — Sec the Court's reasoning by analogy in Commission v
United Kingdom, cited in footnote 52, paragraph 62.
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AFFISH v RIJKSDIENST KEURING VEE EN VLEES
(2) Abuse of process
145. Affish maintains that, in sending a mis­
sion of experts to Japan, the Commission
followed the procedure under Article 11 of
Directive 91/943 with a view to adopting the
contested act. However, according to Affish,
the procedure in question is intended to
allow specific import conditions to be fixed
and should not have been used as the basis
for an import prohibition under Article 19 of
Directive 90/675. Hence the question arises
whether there has been an abuse of process
on grounds which could lead the Court to
declare Decision 95/119 void.
146. As a ground for annulment of a meas­
ure adopted by a Community institution,
'abuse of process' constitutes a special sub­
category within the wider concept of 'misuse
of powers'. 11 1It implies that, by circum­
venting the relevant provisions laying down
the procedure to be followed in taking a
decision, the institution in question has
adopted the measure by following another
procedure, prescribed for a different pur­
pose. 112
147. Affish's argument cannot be accepted.
Within the scope of its powers under Article
19 of Directive 90/675, the Commission may
assess whether a serious animal health or
public health reason requires it to act, and to
that end it was entitled to take into account
the disturbing conclusions of the experts sent
out by it.
VI — Conclusion
148. In view of the foregoing considerations, I propose that the Court should
answer the question referred to it by the College van Beroep voor het Bedrijfsleven
for a preliminary ruling as follows:
Consideration of the question raised has disclosed no factor of such a kind as to
affect the validity of Commission Decision 95/119/EC of 7 April 1995 concerning
certain protective measures with regard to fishery products originating in Japan.
111 — Sec, in particular, Case 2/57 Compagnie des Hauts Four­
neaux de Chasse [1958] ECR 199 and Joined Cases 32/87,
52/87 and 57/87 ISA [1988] ECR 3305, paragraph 19. In
Case C-225/91 Matra [1993] ECR 1-3203, paragraph 25,
the Court expressly states that it also examines whether
there has been an abuse of process.
112 — See Fedesa, cited in footnote 45, paragraph 24, and points
68 to 70 of my Opinion in Case C-122/94 Commission v
Council, cited in footnote 39.
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