Opinion of the Economic and Social Committee on:the Proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs,the Proposal for a Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin,the Proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption,the Proposal for a Council Regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption, andthe Proposal for a Directive of the European Parliament and of the Council repealing certain Directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Directives 89/662/EEC and 91/67/EEC
Date: 2001-03-28
Institutions: European Economic and Social Committee
Subjects: animal product, food inspection, foodstuff, health legislation, human nutrition

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Opinion of the Economic and Social Committee on:

— the ‘Proposal for a Regulation of the European Parliament and of the Council on the hygiene

of foodstuffs’,

— the ‘Proposal for a Regulation of the European Parliament and of the Council laying down

specific hygiene rules for food of animal origin’,

— the ‘Proposal for a Regulation of the European Parliament and of the Council laying down
detailed rules for the organisation of official controls on products of animal origin intended
for human consumption’,

— the ‘Proposal for a Council Regulation laying down the animal-health rules governing the
production, placing on the market and importation of products of animal origin intended
for human consumption’, and

— the ‘Proposal for a Directive of the European Parliament and of the Council repealing certain
Directives on the hygiene of foodstuffs and the health conditions for the production and
placing on the market of certain products of animal origin intended for human consumption,
and amending Directives 89/662/EEC and 91/67/EEC’

(2001/C 155/09)

On 17 July 2000 the Council decided to consult the Economic and Social Committee, under Articles 37,
95 and 152(4)(b) of the Treaty establishing the European Community, on the above-mentioned proposals.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 8 March 2001. The rapporteur
was Mr Verhaeghe.

At its 380th plenary session of 28 and 29 March 2001 (meeting of 28 March) the Economic and Social
Committee adopted the following opinion by 78 votes to one, with ten abstentions.

1.

Introduction

1.1. Overall summary

1.1.1.
munity legislation on

The present proposals result from a recast of Com-

— food hygiene as contained in Directive 93/43/EEC on the
hygiene of foodstuffs and in a number of directives
governing the production and placing on the market of
products of animal origin,

— animal-health rules related to the placing on the market
of products of animal origin, as contained in a number of
directives,

— official controls on products of animal origin contained

in the current directives.

high level of consumer protection. The large number of
directives involved, the intermingling of different disciplines
(hygiene, animal health, official controls) and the existence of
different hygiene regimes for products of animal origin and
other food have led to a complex situation. This situation can
be improved by recasting the legislation and separating the
food hygiene aspects from the animal-health and official
control issues.

1.1.3.
The Commission proposals respond to a number of
actions announced in the annex to the White Paper on Food
Safety (1). The recast of existing legislation makes for a
comprehensive and integrated approach, covering all food
from the farm to the point of sale to the consumer. This leads
to better coherence and transparency of food legislation. In
addition, the role of the various stakeholders in the food chain
is better defined.

1.1.4.
The leitmotif throughout the recast of the hygiene
rules is that food operators bear full responsibility for the
safety of the food they produce. The observance of basic
hygiene rules (GHP) (2) and — for operators in fields other

These directives (seventeen in total) have been gradu-
1.1.2.
ally developed since 1964 in response to the needs of the
internal market, but also with due regard to the need for a

(1) COM(1999) 719 final.
(2) GHP: Good hygiene practice, as set out in the annex to Directive
93/43/EEC and the Codex Alimentarius international code of
practice.

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than primary production — the implementation of
the
principles of the HACCP system (1) must ensure this safety.
This is in line with the approach advocated at international
level by the Codex Alimentarius.

made it possible to identify a set of rules common to all food,
thus avoiding the repetitions, overlaps and inconsistencies in
the current directives. Some specific rules have been retained,
however, for the various classes of foodstuffs.

The recasting exercise has resulted in the drafting of
1.1.5.
four proposals for regulations on (i) overall food hygiene,
(ii) specific hygiene rules for food of animal origin, (iii) official
controls and (iv) animal-health rules governing the production,
placing on the market and importation of products of animal
origin intended for human consumption. A directive is also
attached repealing existing legislation in the above-mentioned
fields.

The regulation is divided into sections as follows:
1.3.2.
scope (retail sale and product definition), approval of establish-
ments, health marking, detailed requirements, microbiological
criteria, temperatures for storage and transport, small pro-
duction units, imports from non-member countries, quality
and labelling and the exclusion of certain materials from the
manufacture of products.

1.1.6.
The Commission believes that Community law in
the form of regulations presents a number of advantages, such
as the guarantee of uniform application throughout the single
market, better transparency and the possibility for rapid
updating to take account of technical and scientific develop-
ments.

1.2.

Integrated approach

The overall hygiene rules currently found in Directive
1.2.1.
93/43/EEC are to be applied to all
including
products of animal origin which at present fall outside its
scope.

foodstuffs,

1.2.2.
At the same time, these rules have been revised in
order to take account of recent developments in food hygiene.
From now on, the revised rules are to apply to the entire food
chain ‘from farm to table’. Under these rules, the seven
principles of the HACCP system have to be applied as set out
in the Codex Alimentarius. They also require the traceability
of food and their ingredients, and they refer to the concept of
food safety objectives (FSOs) (2).

1.3. Food of animal origin

1.3.1.
The present hygiene rules for food of animal origin
are being simplified by recasting fourteen directives. This has

(1) HACCP: Hazard Analysis Critical Control Points.
(2) FSO: Food Safety Objective in line with Article 6(2) of the new

proposed Regulation on the hygiene of foodstuffs.

1.4. Animal-health requirements

1.4.1.
The animal-health rules are designed to prevent the
spread of animal diseases not considered transmissible to
humans through products of animal origin. Since these
diseases have no direct impact on consumer health, it made
sense to address them separately from hygiene rules as such.

1.4.2.
A high level of protection is also required in this
field. The proposed regulation indicates — among other things
— which animal diseases may be transmitted via products of
animal origin, and how to eliminate transmission risk.

1.5. Official controls

1.5.1.
In accordance with the Commission’s intentions
announced in the White Paper, a proposal covering official
food and feed control is expected to be available shortly. The
current proposal for a regulation covers only the control of
products of animal origin intended for human consumption.
It establishes in particular the responsibilities of the official
services in the Member States, the action to be taken in the
case of risk to the consumer, the training of control officials,
the application of contingency plans, controls on imported
products,
inspections by the Commission and safeguard
measures.

1.5.2.
It must be remembered that, because of their specific
nature, some products such as meat require particular rules.
Intensive discussions are under way at the moment on the
revision of current inspection procedures so as to address the
hazards that are linked to modern methods of food production.
So that the Commission can react promptly at the end of these
discussions, the separate proposal that has been drawn up sets
out the inspection procedures in detail. Pending the outcome
of the scientific assessment, the present rules are to continue
to apply.

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1.6. The external dimension

With the globalisation of the food market, growing concerns
are emerging about food safety. Countries are particularly
sensitive to risks relating to microbiological or chemical
contaminants which have to be eliminated during foodstuff
production and transport. This is reflected in international
obligations and agreements, and in the enhanced role of
international organisations such as the Codex Alimentarius
and the International Office of Epizootics. The Commission
proposals seek to respond to this challenge by introducing
requirements with regard to the hygienic quality of imported
food taking account of international standards and guidelines.

1.7. Ongoing development

It is likely that in the coming years there will be a need to
adapt legislation again depending on the outcome of the self-
checking regimes run by operators, the establishment of codes
of good hygiene practice, Member States’ implementation of
inspections and audits and all new technical developments.

2. General comments

The new Commission food hygiene proposals largely
2.1.
reflect earlier Committee opinions. On the whole,
these
proposals represent a major step forward, for which the
Commission is to be commended.

2.2.

The Committee endorses in particular:

— the principles underlying the new proposals (recitals 3
and 12 of draft Regulation (EC) No 2000/0178),
including:

— the primary responsibility of food operators for food
product safety. Each operator is to be responsible
for the safety of products under his or her control
from primary production to delivery to the con-
sumer;

— the choice of regulations rather than directives, because
by restricting Member States’ scope for interpretation,
these make for better consumer protection and fairer
competition between companies (section IX of
the
explanatory memorandum).

3.

Specific comments

3.1. Hygiene of foodstuffs

3.1.1. S c o p e

The Committee is pleased that the new regulations are to apply
to all stages of food production and distribution. In particular
— and in contrast to current legislation — they are to apply
henceforth to the primary sector, i.e. to products of the soil, of
stock farming, of hunting and fisheries. The Committee feels,
however, that the scope should broadly cover the production
of all food ingredients, including products of mineral origin
and products that are the result of chemical synthesis. Article 2
of draft Regulation (EC) No 2000/0178 should be reworded
accordingly.

3.1.2. D e f i n i t i o n s

( A r t i c l e 2 o f d r a f t R e g u -

l a t i o n ( E C ) N o 2 0 0 0 / 0 1 7 8 )

3.1.2.1.
Pending a definition of ‘food safety objective’, the
list of definitions should be expanded to include, among
others, definitions of ‘food’, ‘objective’, ‘performance standard’
and the English term ‘requirements’ which has been translated
in different ways — in French, for example, as dispositions
(‘provisions’) or conditions (‘conditions’).

3.1.2.2. With a view to simplification and also to avoid
confusion, the definitions should be brought into line with the
Codex Alimentarius definitions that have been drawn up or
revised recently, e.g. food hygiene and food safety.

3.1.3. R e s p o n s i b i l i t y o f

f o o d b u s i n e s s o p e r -

a t o r s

— the ‘farm to table’ approach;

— the obligation to apply HACCP (in the sectors

concerned) and traceability;

— compatibility with international trade agreements;

The wording of the first indent of recital 12 of
3.1.3.1.
draft Regulation (EC) No 2000/0178 should be amended to
state that responsibility for food safety rests with all food
business operators for the section of the food chain covered
by their operations, in line with the wording of Article 3 —
General obligation — of the proposal for a regulation on the
overall hygiene of foodstuffs.

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3.1.3.2.
In particular, the text (Annex I of draft Regulation
(EC) No 2000/0178) should stress the responsibility of the
various partners in the primary production chain which, from
now on, is to be covered by food hygiene law. These partners
— whether the agrochemical industry, seed producers, feed
manufacturers, the developers, vendors and carriers of such
products or farmers themselves — must see to it — each in
his or her respective field — that agricultural produce placed
on the market does not contain unacceptable levels of
biological or chemical residues. While maintaining a high level
of health protection, the administrative burden borne by small
firms and the craft sector should be kept to a minimum.

3.1.4. R e g i o n a l a s p e c t s ( A r t i c l e 4 ( 4 ) o f d r a f t
R e g u l a t i o n ( E C ) N o 2 0 0 0 / 0 1 7 8 )

To avoid penalising typical European products, the Committee
emphasises the need to adapt hygiene rules to their traditional
production methods, and to the production of small quantities
without in any way compromising food safety. Moreover, the
Committee feels that the requisite adjustments must be laid
down and supervised at Community level in order to ensure
optimum protection of consumers’ health and fair competitive
conditions. The future European food authority could play a
scientific assessment role here.

3.1.5. R e t a i l

t r a d e

d r a f t
( A r t i c l e
R e g u l a t i o n ( E C ) N o 2 0 0 0 / 0 1 7 8 a n d
A n n e x I I , p o i n t 2 o f d r a f t R e g u l a t i o n
( E C ) N o 2 0 0 0 / 0 1 7 9 )

9 ( 2 )

o f

The Committee feels that the exclusion of the retail trade from
the scope of the new regulations is wholly unwarranted in the
case of major distribution establishments (supermarkets and
hypermarkets) with rooms in which large quantities of animal
products are prepared (e.g. meat cutting rooms). Such estab-
lishments must meet the appropriate specific hygiene rules.

3.1.6. H A C C P / H y g i e n e

c o d e s
( A r t i c l e s 5 a n d 7 o f d r a f t R e g u l a t i o n
( E C ) N o 2 0 0 0 / 0 1 7 8 )

g u i d e s

a n d

3.1.6.2.
In this respect, the Committee stresses the import-
ance of training that is commensurate with the work of staff,
since product safety requires the involvement of all players —
each at his or her respective level (Annex II, Chapter XII of
draft Regulation (EC) No 2000/0178).

3.1.6.3.
The Committee feels that the Member States should
be encouraged to assess their own working and employment
conditions in the light of the HACCP system, paying particular
attention to the consultation of sectoral representatives, work-
ers and consumers.

3.1.6.4.
The Committee feels that the adoption of food
safety objectives (FSO) should make for the more uniform
application of food hygiene law.

After a reasonable adjustment period, renewed
3.1.6.5.
consideration should be given to the retention of all the
hygiene rules set out in draft Regulation (EC) No 2000/0178
for animal products alongside the requirement that HACCP
principles must be applied.

3.1.6.6.
In the interests of uniformity, the hygiene guides
provided for under Article 7 of draft Regulation (EC)
No 2000/0178 — whether compendiums of good hygiene
practice or guides for using HACCP — should be based on the
Codex Alimentarius models. Where these relate to industrial
products marketed and/or manufactured across the European
Union, they should be drawn up from the start at European
level.

The purpose of

3.1.6.7.
these guides is to help food
operators comply with the legal requirements concerning food
hygiene and safety. For example, the codes of good practice
provided for in Chapter II of Annex I of draft Regulation (EC)
No 2000/0178 describe the measures to be taken for good
stock-farming and animal-health management, and especially
for the proper use of veterinary medicinal products (1). In this
respect, the Committee thinks that the Regulation should
specify the framework within which these codes must be
developed in order to ensure that the requisite zootechnical
and veterinary skills are catered for. This must be done in
consultation with all interested parties.

3.1.6.1.
The obligation placed on food operators to apply
the seven principles of the HACCP system as defined by the
Codex Alimentarius is a welcome move, but greater stress
must be put on the prior need to comply with good hygiene
practice.

(1) See appendix, point 1.

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3.1.7. M i c r o b i o l o g i c a l c r i t e r i a / s t o r a g e t e m -
p e r a t u r e s ( A r t i c l e 6 , d r a f t R e g u l a t i o n
( E C ) N o 2 0 0 0 / 0 1 7 8 ) — p r o d u c t q u a l i t y
p r o v i s i o n s
2 ( j ) ;
e x p l a n a t o r y m e m o r a n d u m )

( s e c t i o n

p o i n t

I I ,

3.1.7.1.
The Committee is pleased that the microbiological
criteria and storage temperatures laid down in the current
vertical directives are to be reviewed and, where required,
substantiated scientifically, as the Committee itself was calling
for. This procedure will make it possible to bring European
legislation into line with the WTO Agreement on the Appli-
cation of Sanitary and Phytosanitary Measures [better known
as the SPS Agreement (1)].

factor in traceability. For processed products, it is an additional
tool alongside the indication of the manufacturing batch.

In theory, approval of an establishment

3.1.8.4.
is an
assurance of compliance with good hygiene practice. The
Committee supports the retention of the approval system as
the rule for establishments which manufacture or handle
microbiologically sensitive products, particularly products of
animal origin. However, in order to secure both a uniform
level of safety and fair competition, it is essential that the
Commission draw up unambiguous criteria on which to base
the decision to approve or simply register an establishment.

3.1.7.2. Moreover, the Committee takes due note of the
Commission’s undertaking to remove non-health-related qual-
ity provisions from hygiene documents as quickly as possible.

3.1.9. H e a l t h m a r k ( A n n e x I I , p o i n t 4 o f d r a f t

R e g u l a t i o n ( E C ) N o 2 0 0 0 / 0 1 7 9 )

3.1.8. T r a c e a b i l i t y
a p p r o v a l o f
9 a n d 1 0 o f
N o 2 0 0 0 / 0 1 7 8 )

—

R e g i s t r a t i o n

o r
f o o d b u s i n e s s e s ( A r t i c l e s
d r a f t R e g u l a t i o n ( E C )

3.1.8.1.
The Committee feels that, where required, it must
be possible to quickly determine the origin of foodstuffs placed
on the market, or even to establish their full history. To do
that, all food operators must be able to retrace the origin of
the ingredients or products for which they are responsible.
Traceability of foodstuffs is thus secured at every stage — or
in successive stages — from primary production to final
consumer.

The Committee therefore endorses the fact that the
3.1.8.2.
rules are to oblige all operators to ensure the traceability of
their products. It feels that the rules must confine themselves
to the principles involved and leave it to the operators,
especially small firms, to choose how to ensure the traceability
of their products. This approach is necessary to respond to
conditions which sometimes vary widely depending on the
sectors and products involved.

3.1.8.3.
The Committee feels that registering all businesses
in the food chain is an enormous administrative task which
may be carried out at local, regional or even national level,
depending on circumstances. Registering businesses is a key

(1) SPS Agreement: WTO Agreement on the Application of Sanitary

and Phytosanitary Measures.

3.1.9.1.
As its name implies, this mark affirms that the
products to which it is affixed are deemed to be safe. For
example, the health mark on meat or shellfish guarantees
consumers that the products have been subject to an official
inspection covering both their origin and state. The Committee
feels that, nowadays, this official guarantee is indispensable.

3.1.9.2
There is a different rationale behind the health
marking of processed products, such as prepared meats and
milk products. In this case, the health mark guarantees that
approval has been granted to the production plant concerned
— i.e. that it meets the requisite hygiene rules. For the
company, therefore, the health mark is a certificate of conform-
ity (such as those issued by certifying bodies) but does not
mean that the products themselves have been subject to
inspection. Accordingly, the Committee feels that,
in the
case of processed products, the health mark need not be
administered by the public authorities. The Committee would
like to see further consideration given to this issue in order to
establish cases where the health mark could be administered
by recognised private bodies.

3.1.10. C o m p o s i t e

I ,
p r o d u c t s
p o i n t 8 . 1 o f d r a f t R e g u l a t i o n ( E C )
N o 2 0 0 0 / 0 1 7 9 )

( A n n e x

The Committee is pleased that composite products no longer
fall under the hygiene rules specifically designed for animal
products. However, there is still room for improving the
current draft since,
in some cases, specific rules should
nonetheless apply to composite products (e.g. breaded fish
fillets which warrant a priori the same hygiene precautions as
non-breaded fillets).

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3.1.11. E x p o r t

t o

c o u n t r i e s
n o n - m e m b e r
( A r t i c l e 1 2 o f d r a f t R e g u l a t i o n ( E C )
N o 2 0 0 0 / 0 1 7 8 )

least

The Committee recognises the need to raise the profile of
in
European foodstuffs on external markets, not
developing countries. However, this must not damage the
competitiveness of European companies. Hence, the Com-
mittee feels that
that exported products
conform to European legislation must be adapted to take
account of specific circumstances in the importing countries.
For instance, specific local conditions in the importing country
may warrant the use of preservatives banned in products
marketed in Europe.

the requirement

3.1.12. C o m m i t t e e p r o c e d u r e s ( A r t i c l e 1 5 o f
d r a f t R e g u l a t i o n ( E C ) N o 2 0 0 0 / 0 1 7 8
a n d A r t i c l e 6 o f d r a f t R e g u l a t i o n ( E C )
N o 2 0 0 0 / 0 1 7 9 ) — e n t r y i n t o f o r c e o f
t h e n e w r e g u l a t i o n s
( A r t i c l e 1 7 o f
d r a f t R e g u l a t i o n ( E C ) N o 2 0 0 0 / 0 1 7 8
a n d A r t i c l e 7 o f d r a f t R e g u l a t i o n ( E C )
N o 2 0 0 0 / 0 1 7 9 )

3.1.12.1.
Although not stipulated in the current draft, the
Committee welcomes the fusion in due course of the Standing
Committee for Foodstuffs and the Standing Veterinary Com-
mittee. This fusion should make for simpler, more coherent
administration.

3.1.12.2. Moreover, the Committee considers that it would
be more reasonable to provide for a brief adjustment period
starting on the date on which the new regulations enter into
force, not least to give the primary sector time to draw up
codes of good hygiene practice correctly.

3.2. Official controls on food products of animal origin (draft

Regulation (EC) No 2000/0180)

The Committee feels that the respective responsibilit-
3.2.1.
ies of
the Member States and the Commission are not
sufficiently clear from the text. The Committee opinion on the
White Paper on Food Safety (1) has already stressed the
importance of effective Commission supervision of enforce-
ment of Community rules.

3.2.2. Moreover, there are still too many texts (2) relating to
veterinary checks and general and specific rules for official
controls. It would be clearer and more practical to consolidate
all these texts.

The Committee notes that official controls on farms
3.2.3.
[Annex I, point 1(a)] cover not only compliance with hygiene
rules, but also compliance with animal welfare rules and
legislation on animal
feed and residues. On the issue of
controls on animal feed, the Committee feels that controls on
manufactured products should be carried out at the production
stage before such products reach the farm.

3.2.4. Meat inspection rules (Annex II) have been revised,
not least to give more importance to ante-mortem inspection.
In this connection, it should be made clear that ante-mortem
inspection must take account of the stock-farming data which
farmers are required to collect (Annex I, Chapter II, point 2 of
draft Regulation (EC) No 2000/0178).

The Committee feels that the text should include a
3.2.5.
reference to harmonised legislation on animal products deem-
ed during the veterinary inspection to be unfit for human
consumption.

3.3. Animal-health rules relating to trade in food products of
animal origin (draft Regulation (EC) No 2000/0181)

3.3.1.
The purpose of this Regulation is to prevent the
spread of animal diseases via food products of animal origin
in intra-Community or international trade.

The proposal also includes provisions for official
3.3.2.
controls. The Committee notes furthermore that,
in this
area, the Commission’s supervisory role is clearly stipulated
(Article 6).

3.3.3.
The animal-health rules for imports from non-
member countries overlap with the hygiene rules set out in the
proposed Regulation relating specifically to the hygiene of
food products of animal origin; this generates confusion. In
particular, the text stipulates that a list of approved third
countries is to be compiled in the light of animal-health criteria
[Article 8(1)], while the specific hygiene Regulation also
provides for a list to be drawn up — this time on the basis of
hygiene criteria (Annex III, point 1 of draft Regulation (EC)
No 2000/0179).

(1) OJ C 204, 18.7.2000.

(2) See appendix, point 2.

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3.3.3.1.
All these provisions should be consolidated so that
there is just one set of rules covering both the public health
(hygiene) and animal health aspects.

The Committee notes that

3.3.4.
the annexes to this
Regulation contain some very interesting information. This is
particularly true of the table Treatments in order to eliminate
animal health risks from meat and the point entitled Treatment to
eliminate animal health risks from milk.

Endorsement of

these health measures at

3.3.5.
inter-
national level would greatly assist international trade in food
products of animal origin. The Committee thus strongly
encourages the Commission to endorse and promote these
measures.

4. Conclusions

In conclusion, the Committee would make the following food
hygiene recommendations.

4.1.
The same hygiene rules and the same control methods
must apply at all stages in the food chain — from primary
production to delivery to the final consumer.

4.2.
All raw materials and ingredients used in food pro-
duction, including minerals and substances that are the result
of chemical synthesis, must be covered by these hygiene
regulations.

4.3.
The obligation placed on food operators to apply the
seven principles of the HACCP system is essential, but, equally,

Brussels, 28 March 2001.

the prior need to comply with good hygiene practice must
also be underlined.

Each operator at each stage in the food chain remains

4.4.
fully responsible for the safety of his or her products.

Traceability must be secured at every stage or in
4.5.
successive stages throughout the food chain, though the type
and size of the enterprises should be borne in mind.

Certain key definitions are missing from the drafts (e.g.
4.6.
the definition of food). These definitions should be established
under general food law, which is also under discussion and to
which hygiene documents will have to refer.

4.7.
Basic safety standards will have to apply to ‘regional’
and/or ‘traditional’ foodstuffs since these will circulate freely
within the single market.

4.8.
Retail outlets in which large quantities of food of
animal origin are prepared and/or cut must meet the specific
hygiene rules applicable to these food products.

4.9.
European foodstuffs intended for export outside the
EU must meet the appropriate standards laid down in the
legislation of the importing country and/or the Codex Ali-
mentarius. In the absence of such standards, it is perfectly
justified to require that these foodstuffs comply with European
legislation.

The President

of the Economic and Social Committee

Göke FRERICHS

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APPENDIX I

to the Opinion of the Economic and Social Committee

Point 1

Definition of ‘veterinary medicinal product’ under Article 1 of Directive 65/65/EEC of 26 January 1965 on the
approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal
products, and Article 1 of Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the
Member States relating to veterinary medicinal products, which includes hormones: (‘any substance or combination
of substances which may be administered to ... animals with a view to ... modifying physiological functions’).

Point 2

— Directive 89/397/EEC of 14 June 1989 (official control of foodstuffs) and Directive 93/99/EEC of 29 October

1993 (additional measures concerning the official control of foodstuffs),

— Directive 89/662/EEC of 11 December 1989 (veterinary checks in intra-Community trade with a view to the

completion of the internal market) and,

— Directive 90/675/EEC of 10 December 1990 as last amended by Directive 97/78/EEC of 18 December 1997
(principles governing the organisation of veterinary checks on products entering the Community from third
countries).

APPENDIX II

to the Opinion of the Economic and Social Committee

Defeated amendment

The following amendment, which received at least one quarter of the votes cast, was defeated during the discussion:

Point 3.1.2.3.

Add a new point (3.1.2.3.), to read:

‘Without wishing to compromise on the objectives of the proposal to amend a number of hygiene directives, closer
examination of certain definitions and how they are applied in practice is necessary in order to avoid unworkable
situations.’

Reason

If the proposal is finalised in its present form, primary producers and small-scale traditional farms in particular will
face serious problems as a result of numerous general definitions and implementation decisions that are not
consistent with practice.

Result of the vote

For: 24, against: 46, abstentions: 12.