Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and the Council on additives for use in animal nutrition" (COM(2002) 153 final — 2002/0073 (COD))
Date: 2002-09-18
Institutions: European Economic and Social Committee
Subjects: animal nutrition, antibiotic, food additive, food chemistry, foodstuffs legislation, labelling, veterinary drug

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sustainable energy goals unless other preconditions are met:
Member State commitment; selective legislative support; econ-
omic instruments; successful research and development out-
comes. The case for a full EU strategic energy initiative still

needs to be answered. Nevertheless, the Committee believes
that the programme proposed by the Commission is valuable.
It needs to be put in place by the end of 2002, so this decision
should be made forthwith.

Brussels, 18 September 2002.

The President

of the Economic and Social Committee

Göke FRERICHS

Opinion of the Economic and Social Committee on the ‘Proposal for a Regulation of the European
Parliament and the Council on additives for use in animal nutrition’

(COM(2002) 153 final — 2002/0073 (COD))

(2003/C 61/08)

On 10 April 2002, the Council of the European Union decided to consult the Economic and Social
Committee, under Articles 37 and 152(4)(b) of the Treaty establishing the European Community on the
above-mentioned proposal.

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 29 August 2002. The rapporteur
was Mr Scully.

At its 393rd Plenary Session on 18 and 19 September 2002 (meeting of 18 September) the Economic
and Social Committee adopted the following opinion by 129 votes to one, with five abstentions.

1. Background

nationally and then, with the adoption of Council Directive
70/524/EEC (1) and 96/51/EC (2), on an EU-wide basis.

1.1.
Anti-microbials have been used as growth promoters,
especially in pig and poultry farming for more than four
decades. The use of growth promoters leads to 4 — 5 % more
body weight for animals receiving them. Much larger amounts
of antibiotics are used in this manner than in medical
applications: in Denmark in 1994, 24 kg of the glycopeptide
vancomycin were used for human therapy, whereas 24 000 kg
of a similar glycopeptide avoparcin were used in animal feed.

In 1999,

1.2.
the Scientific Steering Committee (SSC)
expressed great concern about increasing health threats due to
anti-microbial resistance and recommended immediately to
reduce the inappropriate use of anti-microbials. The core
strategy of reducing anti-microbial use should apply equally
the areas of human medicine, veterinary
across each of
medicine, animal production and plant protection.

1.3.
Emergence of anti-microbial resistance is a multifactor-
al problem and thus requires a multifaceted solution and it has

1.1.1.
The use of antibiotics, in various states of purity, as
feed additives has increasingly come under regulation, first

(1) OJ L 270, 14.12.1970, p. 1-17.
(2) OJ L 235, 17.9.1996, p. 39-58.

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therefore been subject of debate at various national and
international bodies such as the World Health Organisation (1),
the
the World Organisation for Animal Health (OIE),
‘Copenhagen’ conference (2), the EU Consumer Committee (3)
etc. The Economic and Social Committee produced an own
initiative opinion (4), that was explicitly welcomed by the June
1999 EU Health Council Resolution, that followed most of its
recommendations.

In addition,

Since the 1970s the European Commission has banned
1.4.
the use of more than 20 antibiotics for use in animal
husbandry.
the Council of Ministers by its
Regulation (EC) 2821/98 (5) of 17 December 1998 accepted
the European Commission’s proposal to ban four antibiotics
used as animal growth-promoters (bacitracin zinc, virginiam-
icyn, thylosine phosphate and spiramycin) entering into force
since 1 July 1999.

1.5.
In June 2001, the European Commission published
a Communication on a Community Strategy against anti-
microbial resistance (6). The strategy details priority actions in
four key areas: surveillance, prevention, research and product
development, and international cooperation. It also included a
recommendation on the prudent use of antibiotics in human
medicine, which has been adopted by the EU Health Council
on 15 November 2001.

The Commission has now proposed to phase out by
1.6.
January 2006 the four
remaining antibiotics (monensin
sodium, salinomycin sodium, avilamycin and flavophospholi-
pol) currently authorised for use as growth-promoters in
feed. The proposal (7) represents a major streamlining and
simplification of the existing rules on the safety evaluation

( 1) WHO Global Principles for the Containment of Anti-microbial
Resistance, Report of a WHO consultation with the participation
of the Food and Agriculture Organization of the United Nations
and the Office International des Epizooties Geneva, Switzerland,
5-9 June 2000.

( 2) The Copenhagen Recommendations. Report from the Invitational
EU Conference on The Microbial Threat. Copenhagen Denmark,
9-10 September 1998, http://www.sum.dk/publika/micro98/
ws–2.htm

( 3) Opinion of the Consumer Committee adopted on 1 March 1999
on ‘Resistance to antibiotics — a threat to public health’ http://
europa.eu.int/comm/consumers/policy/committee/cc08–en.html
( 4) Resistance to antibiotics as a threat to public health CES 1118/
98, OJ C 407, 28.12.1998 and Council Resolution, OJ C 195,
13.7.1999, p. 1-3.

( 5) Council Regulation (EC) No 2821/98, OJ L 351, 29.12.1998,

p. 4-8.

( 6) COM(2001) 333 final.
( 7) Proposal for a Regulation of the European Parliament and the
Council on additives for use in animal nutrition COM(2002) 153
final.

and marketing authorisation of feed additives. The proposal
concerns additives intended for use in feedingstuffs and in
drinking water for animals.

1.7.
The Commission proposes in the draft regulation on
additives for use in animal nutrition the following improve-
ments of the status quo:

— new authorisations for feed additives to be granted for a

ten-year period only;

— the re-evaluation of

feed additives authorised under

existing legislation within the next seven years;

— an obligation on companies to demonstrate the efficiency
of the product and the absence of a risk for human
health, animal health and the environment;

— evaluations by the European Food Safety Authority;

— maximum residue limits for some feed additives, to be

controlled through a post-monitoring system;

— a clear and transparent authorisation procedure;

— stricter measures in the case of coccidiostats, if they were
of antibiotic origin; a new dossier for re-evaluation to be
presented by the applicant within a four-year period.

2. General comments

The debate whether animal husbandry can do without
2.1.
antibacterial growth promoters continues. Sweden has demon-
strated that procedural modifications can decrease the use of
antibiotics as feed additives; the antibacterials are prohibited
as growth promoters since 1986 (8). Learning from the Swedish
experience, agricultural science should define conditions for
animal rearing without use of antibacterial growth promoters
and without sacrificing productivity.

2.2.
The Committee welcomed the White Paper on Food
Safety (9) aims in respect of upgrading food safety in Europe
(applying the farm to fork approach), consequently recognising

(8) Weirup M. 1998. Preventive methods replace antibiotic growth

promoters: ten years experience from Sweden.
APUA Newsletter 16(2):1-4.

(9) COM(1999) 719 final.

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the importance of feedingstuffs for the safety of food and any
possible threat to human health linked to food consumption.

2.2.1.
In this respect, the Committee particularly welcomes
that the European Commission has chosen in this occasion as
legal instrument a regulation (instead of a directive), which has
clear enforcement advantages.

2.3.
The EESC supports the Commission proposal aiming
to streamline the authorisation procedure for feed additives
and to phase out the remaining four antibiotics used for
growth promotion. While for some Member States the delay
in phasing out the remaining antibiotics for growth promotion
might not be acceptable, for other countries this might be of
major concern since comparable, effective alternatives might
not be available or not developed yet. The Committee thinks
that the European Commission offers an acceptable compro-
mise.
In no case, however, would any further delay be
acceptable.

2.4.
The Committee particularly welcomes the safeguard
clause foreseen in the legislation with respect to the renewal of
authorisation.

2.5.
The current procedure for authorising new additives
or new uses of additives is upon request of the applicant
company or, if the applicant is located in a third country, of a
selected Member State acting as rapporteur. This evaluation
will now be transferred to the EFSA. The EESC is in favour of
a centralised procedure and supports indeed the linkage
food safety and human health as
between feedingstuffs,
expressed in the EESC opinion on the White Paper on Food
Safety (1). The Commission proposal correctly centralises the
authorisation procedure.

2.6.
In addition to the measures proposed, the Committee
suggests the introduction of symbols/logos to clarify the target
use of such substances either as feed additives or as medicinal
products.

Use and licensing of animal additives or veterinary
2.7.
medicines varies tremendously worldwide.
In developing
countries, which are responsible for about 25 % of the
world-meat production, policies regulating veterinary use of
antibiotics are poorly developed or absent. In Southeast Asia,

( 1) Opinion CES 585/2000, OJ C 204, 18.7.2000.

use of anti-microbials in shrimp farming is hardly regulated.
The problems caused by inappropriate use of antibiotics reach
beyond the country of origin. Meat products are traded
worldwide, and bacterial populations evolve independently of
geographical boundaries.

2.7.1.
The EESC is therefore concerned that this proposal
does not sufficiently identify the obligations of applicants from
third countries and not least multinational companies acting
from outside Europe but of EU origin. The EESC suggests to
include more precise provisions in this proposal covering such
areas of ambiguity.

2.8.
The EESC agrees that action by the Community relating
to human health, animal health and the environment should
be based on the ’precautionary principle’. The Committee
assumes that the authorisation procedure is strictly following
this principle already and consequently any subsequent action
should be based on new emerging evidence on risks to human
or animal health or the environment. The Committee would
prefer further detailed consideration in this draft legislation
with regard to the application of the precautionary principle,
in order to avoid improper use.

2.9.
The general objectives of this draft regulation set out
that the European Food Safety Authority (EFSA) will have the
competence and responsibility to provide a single address for
dossier evaluation for all
feed additives, bringing clarity,
efficiency and transparency to the process. The adoption of an
assessment report and a public consultation process have been
mentioned. It is also recognised that scientific risk assessment
alone cannot, in some cases, provide all the information on
which a risk management decision would be based, and that
other factors relevant to the matter under consideration should
legitimately be taken into account, such as ethical factors,
feasibility of controls and the benefits for the animals or for
the consumer of animal products. It is therefore suggested,
that the authorisation of an additive should be granted by the
European Commission.

2.9.1.
The EESC is concerned that the text provides no
information how this scheme should function in practice. The
process of public consultation, which might actually bring
other legitimate factors to the attention of the stakeholders
and politicians involved, has not been further considered. The
European Commission should therefore further explain the
actual implementation process of this draft regulation.

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2.10.
Veterinary medicinal products as defined in Directive
2001/82/EC (1) could be considered to include coccidiostats.
The latter are in-feed agents administered throughout the life
of a broiler chicken, for example, to prevent the disease of
coccidiosis. The Directive defines a Veterinary Medicinal
Product as:
‘Any substance or combination of substances
presented for treating or preventing disease in animals.’

2.10.1.
The Committee considers that all agents used for
disease treatment and/or prevention should be licensed as
veterinary medicines in accordance with the definitions pro-
vided in Directive 2001/82/EC. The Committee is aware
that several widely used coccidiostats, none of which have
application in human medicine, are produced wholly by
fermentation processes and are considered of non-human
pharmaceutical quality (so called ‘feed grade’).

The Committee recognises that as a consequence of
2.10.2.
the latter,
the classification of coccidiostats as veterinary
medicines may at present pose bureaucratic difficulties in the
EU. Nevertheless, the Committee wishes to encourage the
European Commission to look again into this subject and to
propose any necessary changes required, in the EU Veterinary
Medicines legislation and/or in Pharmacopoeia, which would
be necessary to accommodate the coccidiostats,
including
those based on feed grade antibiotics.

2.10.3.
The Committee also favours the approach of dealing
with the coccidiostats within the scope of Directive 2001/82/
EC in agreement with the Federation of European veterinarians
(FVE) which believes that these products must be maintained
on the market but it would recommend subjecting their use to
a veterinary control through a veterinary prescription. This
would follow the recommendations from many international
bodies such as the OIE or the WHO and would offer additional
guarantees for a rational and prudent use of these substances,
along the lines of the principles developed by the FVE in its
guidelines on ‘The prudent use of antibiotics in veterinary
medicine’ communicated in 1999.

The Committee thinks however that alternative sub-
2.11.
stances to replace cocciodiostats should be considered and
dealt with in this proposal; in particular, emphasis should be
granted on research on the irreversibility of resistance among
protozoa. The Committee endorses the FVE recommendation
to the European Commission to give priority to research
projects into alternatives to coccidiostats (through its 5th and
6th Research Programme), as coordinated efforts between
European scientists could be decisive for a long-term solution
to this problem.

2.12.
Additives that are either genetically modified or
produced from a GMO should first comply with the require-
ments of and be evaluated according to the Regulation on
genetically modified food and feed, prior to undergoing
the authorisation procedure under this proposed Regulation.
GMOs, which contain genes expressing resistance to antibiotics
in use for medical or veterinary treatment, should not be
released into the environment. This position is affirmed in the
past by the EESC: ‘As a precautionary measure to protect the
environment and health, the ESC is of the view that no
antibiotic-resistant marker genes should be used when geneti-
cally modified organisms are deliberately released into the
environment’ (2).

2.13.
The Commission acknowledges that detailed labelling
of the product should be required since it enables the final user
to make a choice in full knowledge of the facts. Particular rules
for the labelling of feed additives are laid down in this draft
legislation. The Committee is concerned that no explicit links
are made to other important labelling requirements, such as
for the labelling of additives consisting or being produced
from GMOs.

The EESC finds it important that based on meaning-
2.13.1.
ful feed additive information, properly indicated, the farmers
would be able to perform their duties as regards to the
appropriate use of such substances in order to avoid inducing
any harmful effects to public health. The latter requires
adequate labelling measures.

2.14.
For certain categories of additives the proposal fore-
sees a post-marketing monitoring program. It is not clear who
is going to decide whether such monitoring will be necessary.
The EESC supports full transparency regarding any monitoring
requirements. The results of monitoring should be made
available to the public.

2.14.1.
The Committee, in agreement with FEDESA (Euro-
pean Federation of Animal Health), believes that a post-
marketing surveillance system, as laid down in the relevant EU
legislation, should be used for in-use monitoring of any adverse
effects of these products after the marketing authorisation has
been granted.

( 1) OJ L 311, 28.11.2001, p. 1.

28.12.1998.

(2) See point 2.8.1 of

the Opinion CES 1117/98, OJ C 407,

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2.15.
A proposal for the establishment of MRLs in the
relevant foodstuffs of animal origin is foreseen as part of the
authorisation procedure. The Committee strongly believes that
the risk assessor, the EFSA, should not decide whether or not
to establish an MRL. This should be a decision to be made by
the risk manager,
in this case the European Commission,
reacting on the advice of the risk assessor.

There are indications that the therapeutic usage of
2.16.
antibiotics has increased recently, since the ban on the use
of some antibiotics as growth-promoters. Some of these
antibiotics, such as amoxicillin, are also used in human
medicine. At a WHO meeting with experts in this field, in
October 1997, the group of experts considered that attention
must be given to the risks associated with the widespread use
of fluoroquinolones as medicines for animals, especially as
these drugs are an important group of antibiotics in human
medicine.

2.16.1.
In this respect, the EESC demands that the monitor-
ing of anti-microbial consumption should not be limited to
human medicine but extended to veterinary medicine and
agricultural use together with strict control of the therapeutic
use of antibiotics. This is in order to ensure that existing
legislation is
strictly respected and not undermined by
increased and uncontrolled use of antibiotics that should only
be used to cure sick animals.

2.16.2.
The Committee finds it important to keep a close
link to the monitoring and control of zoonoses and zoonotic
agents with regard to the recognition of antibiotic resistance.

2.17.
Proper enforcement of the legislation is crucial. The
Member States should lay down rules on penalties applicable
to infringements of the provisions of this Regulation and
they are fully implemented. These penalties
ensure that
should be harmonised and laid down in the appropriate EU
Regulation. The EESC wishes to stress the importance of
controls carried out by qualified inspectors and strongly
believes that the strict application of penalties in case of non-
compliance is the key for effective implementation of the
legislation. The EESC wishes to have a strong link made with
the legislation proposed by the European Commission on
‘Official Food and Feed veterinary controls’ (1).

( 1) COM(2002) 377 final.

2.18.
The EESC expresses its concerns regarding the rising
costs of livestock production due to this European Commission
proposal, tackling compensation measures if necessary, as EU
livestock production would become less competitive on the
world market.

2.19.
The provisions on imported meat from animals must
fully comply with EU-rules in order to avoid distortion of
competition and assure the EU consumers’ protection. The EU
should make a serious effort to get the latter endorsed by the
this point relates also to animal welfare
WTO.
conditions and the use of growth hormones and additives in
general.

In fact

2.20.
The EESC would like to note that in addition to
coccidiostats other medicinal substances authorised today as
feed additives should be moved under the EU legislation
covering veterinary medicinal products.

2.21.
The EESC wishes to ask the European Commission to
anticipate the phasing out date (2006) foreseen in Article 12
of this proposal, serving so the interest of all parties involved.

3. Specific comments

The proposal defines various technical

3.1.
expressions used in the text.

terms or

3.1.1.
to define coccidiostats.

The Committee is concerned that the proposal fails

3.2.
As the MBMs’ ban is temporary, the EESC believes that
this proposal should clearly indicate the risk involved by
the use of additives of animal origin and should foresee
comprehensive policy measures.

3.3.
The EESC misses more detailed information on how to
guarantee transparency of the authorisation procedure as the
Committee considers it insufficient just to publish the opinion
of the EFSA. The process of establishing the opinion is crucial
with regard to the transparency of the system and therefore at
least the summary of a dossier (after deletion of any infor-
mation identified as confidential) should be available to the
public for a defined period of time to allow for comments.

The establishment of MRLs should be an integral part
3.4.
of the authorisation procedure. The suggestion of the EFSA for
the non-application of MRLs should not prevent the European

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Commission from requesting further research into the area
with the aim to establish MRLs. In any case the MRLs should
be fixed before an authorisation is granted.

3.7.1.
The Committee therefore suggests properly defined
assignment of duties undertaken by the national Control
authorities.

3.5.
The risk assessment procedure will be carried out by
the EFSA. The Committee finds it important that the risk
assessment procedure should follow a codified modus
operandi, which should be publicly accessible.

3.6.
The status of existing products needs to be checked
and therefore notification and accompanying particulars as
explained in this proposal need to be supplied to the EFSA.
The proposal refers to a Regulation that needs to be applied in
case of non-notification or incorrect submission of particulars
to the EFSA. The Committee is concerned that no further
details are given as to the content and timeframe for adoption
of such legislation.

3.6.1. Moreover the Committee is concerned that the
timeframe for the withdrawal of products, not notified in time
or for which the dossier was considered deficient, has not been
defined.

3.7.2.
The Committee is also in favour of the establishment
of a clear reporting procedure from the MS to the European
Commission referring to incidents of non-compliance.

This draft legislation explains the tasks of the Com-
3.8.
munity reference laboratories. The Committee
it
important to spell out the need for the establishment and
publication of validated test methods in order to perform
necessary substances testing as it is a precondition for any
efficient controls.

finds

The Committee regrets that

3.9.
fails to
include special labelling requirements resulting from special
legislation dealing with GMOs and asks for appropriate
amendment of the proposal.

the proposal

3.7.
For carrying out controls on the authorisation of
animal feedingstuffs the draft legislation makes certain pro-
visions. The EESC believes that these provisions are insufficient
to carry out effectively such controls.

3.10.
The Committee urges the EU Commission to seek for
an agreement on internationally accepted rules, regarding the
application of the precautionary principle, under the umbrella
of Codex Alimentarius.

Brussels, 18 September 2002.

The President

of the Economic and Social Committee

Göke FRERICHS