Common Position (EC) No 20/2003 of 17 March 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a regulation of the European Parliament and of the Council on additives for use in animal nutrition (Text with EEA relevance)
Date: 2003-03-17
Institutions: Council of the European Union
Subjects: animal nutrition, food additive, labelling, marketing, packaging

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 20/2003

adopted by the Council on 17 March 2003

with a view to adopting Regulation (EC) No . . ./2003 of the European Parliament and of the
Council of . . . on additives for use in animal nutrition

(2003/C 113 E/01)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty establishing the European
Community, and in particular Articles 37 and 152(4)(b)
thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) Livestock production occupies a very important place in
the agriculture of
the Community; satisfactory results
depend to a large extent on the use of safe and good-
quality feedingstuffs.

an essential

(2) The free movement of safe and wholesome food and feed
and
is
contributes significantly to the health and wellbeing of
citizens, and to their social and economic interests.

internal market

aspect of

the

(3) A high level of protection of human life and health should

be assured in the pursuit of Community policies.

(1) OJ C 203 E, 27.8.2002, p. 10.
(2) Opinion delivered on 18 September 2002 (not yet published in the

Official Journal).

(3) Opinion of the European Parliament of 21 November 2002 (not yet
published in the Official Journal), Council Common Position of 17
March 2003 and Decision of the European Parliament of . . . (not
yet published in the Official Journal).

feed additives

In order to protect human health, animal health and the
environment,
should undergo a safety
assessment
through a Community procedure before
being placed on the market, used or processed within
the
the Community. Since pet
human food chain and has no environmental impact on
arable land, specific provisions for additives in pet food are
appropriate.

food is not part of

(5) Action by the Community relating to human health,
animal health and the environment should be based on
the precautionary principle.

(6)

In accordance with Article 153 of
the
Community is to contribute to promoting the right of
consumers to information.

the Treaty,

(7) Experience with the application of Council Directive
70/524/EEC of 23 November 1970 concerning additives
in feedingstuffs (4) has shown that it is necessary to review
all the rules on additives in order to take into account the
need to ensure a greater degree of protection of animal
and human health and of
is also
necessary to take into account the fact that technological
progress and scientific developments have made available
new types of additives, such as those to be used on silage
or in water.

the environment.

It

(8) This Regulation should also cover mixtures of additives
sold to the end-user, and the marketing and use of those
mixtures should comply with the conditions laid down in
the authorisation of each single additive.

(9) Premixtures

should not be regarded as preparations

covered by the definition of additives.

(10) The basic principle in this field should be that only those
additives approved under the procedure provided for in
this Regulation may be placed on the market, used and
processed in animal feeding under conditions set out in
the authorisation.

(4) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regu-

lation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

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(11) Categories of feed additives should be defined in order to
facilitate the assessment procedure with a view to author-
isation. Amino acids, their salts and analogues, and urea
and its derivatives, which are currently covered by Council
Directive 82/471/EEC of 30 June 1982 concerning certain
products used in animal nutrition (1), should be included
as a category of feed additives and therefore transferred
from the scope of that Directive to this Regulation.

(12) Implementing rules concerning applications for author-
isation of
into account
different documentation requirements for food-producing
and other animals.

feed additives

should take

(13) In order to ensure a harmonised scientific assessment of
feed additives, such assessment should be carried out by
the European Food Safety Authority, established by Regu-
lation (EC) No 178/2002 of the European Parliament and
of the Council (2). Applications should be supplemented by
residue studies in order to assess the establishment of
maximum residues limits (MRLs).

feed additives

(14) The Commission should establish guidelines for the auth-
in cooperation with the
orisation of
European Food Safety Authority.
In establishing these
guidelines, attention should be paid to the possibility of
extrapolating the results of
the studies carried out on
major species to minor species.

for

(15) It is also necessary to provide for a simplified author-
isation procedure
additives which have
those
successfully undergone the authorisation procedure for
food use provided for in Council Directive 89/107/EEC
of 21 December 1988 on the approximation of the laws
of the Member States concerning food additives authorised
for use in foodstuffs intended for human consumption (3).

(16) It is recognised that scientific risk assessment alone cannot,
in some cases, provide all the information on which a risk
management decision should be based, and that other
factors relevant to the matter under consideration should
legitimately be taken into account,
including societal,
economic or environmental factors, feasibility of controls

(1) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive

1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(2) Regulation (EC) No 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the general principles
food law, establishing the European Food
and requirements of
Safety Authority and laying down procedures in matters of food
safety (OJ L 31, 1.2.2002, p. 1).

(3) OJ L 40, 11.2.1989, p. 27. Directive amended by Directive
94/34/EC of the European Parliament and of the Council (OJ L
237, 10.9.1994, p. 1).

and the benefit for the animal or for the consumer of
animal products. Therefore,
the authorisation of an
additive should be granted by the Commission.

(17) In order to ensure the necessary level of protection for
animal welfare and consumer safety, applicants should
be
for
encouraged to seek authorisation extensions
minor species by being granted one year's additional
data protection in addition to the 10 year's data protection
for all species for which the additive is authorised.

for

their use

and for maintaining

(18) Competence for authorising feed additives and establishing
conditions
and
publishing a register of authorised feed additives should
be conferred on the Commission in accordance with a
procedure by which close collaboration between Member
States and the Commission is guaranteed in the framework
of the Standing Committee on the Food Chain and Animal
Health.

(19) It is necessary to introduce, where appropriate, an obli-
gation for the holder of the authorisation to implement a
post-market monitoring plan in order to trace and identify
any direct or indirect, immediate, delayed, or unforeseen
effect resulting from the use of feed additives on human or
animal health or the environment using a product tracing
framework similar to that which already exists in other
sectors and in line with the traceability requirements laid
down in food law.

(20) In order to allow technological progress and scientific
development to be taken into account, it is necessary to
revise the authorisations of feed additives regularly. Time-
limited authorisations should allow this review.

(21) A register of authorised feed additives should be estab-
and
should be

lished,
detection methods. Non-confidential data
made available to the public.

product-specific

information

including

their
currently

(22) It is necessary to establish transitional rules to take into
account additives which are already on the market and
which were authorised under Directive 70/524/EEC, and
salts and analogues, urea and its
amino acids,
derivatives,
Directive
82/471/EEC, and silage agents, as well as additives for
In
which the authorisation procedure is in progress.
particular, it is appropriate to provide that such products
can remain on the market only in so far as notification
with a view to their evaluation has been submitted to the
Commission within one year after the entry into force of
this Regulation.

authorised

under

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(23) A number of silage additives are currently marketed and
used in the Community without an authorisation granted
pursuant
is indis-
to Directive 70/524/EEC. While it
pensable to apply the provisions of this Regulation to
it is
such substances in view of their nature and use,
appropriate to apply the same transitional arrangements.
In this way it will be possible to obtain information on all
the substances currently used and to establish a list of
them, which would allow safeguard measures
to be
for those substances that do
taken, where appropriate,
not fulfil the authorisation criteria mentioned in Article
5 of this Regulation.

(24) The Scientific Steering Committee stated in its opinion of
28 May 1999 that: ‘regarding the use of antimicrobials as
growth promoting agents, the use of agents from classes
which are or may be used in human or veterinary
medicine (i.e. where there is a risk of selecting for cross-
resistance to drugs used to treat bacterial
infections)
should be phased out as soon as possible and ultimately
abolished’. The second opinion of the Scientific Steering
Committee on antimicrobial resistance adopted on 10 and
11 May 2001 confirmed the need to provide a sufficient
time
antimicrobials by alternative
products:
‘Thus, the phase-out process must be planned
and coordinated since precipitous actions could have
repercussions for animal health’.

to replace

those

for

time

the antibiotics

the development of

(25) Therefore, it is necessary to set a date after which the use
still authorised for use as growth
of
promoting agents will be forbidden, while allowing
sufficient
alternative
products to replace those antibiotics. Provision should
also be made to forbid the authorisation of any further
antibiotics for use as feed additives. Within the framework
of the phasing out of antibiotics used as growth promoters
and in order to ensure a high level of protection of animal
health, the European Food Safety Authority will be asked
to review the progress achieved in the development of
alternative
of
management, feeding, hygiene, etc. before 2005.

alternative methods

substances

and

(26) Certain substances with coccidiostatic and histomonostatic
effects should be considered as feed additives for the
purposes of this Regulation.

(27) Detailed labelling of the product should be required since
it enables
to make a choice with full
knowledge of the facts, creates fewer obstacles to trade
and facilitates fairness of transactions.

the end-user

the placing on the market of genetically modified food and
feed, including feed additives consisting of, containing or
produced from genetically modified organisms. Since the
objectives of the said Regulation are different from those
of this Regulation, feed additives should undergo an auth-
orisation procedure in addition to the authorisation
procedure provided for by that Regulation before they
are placed on the market.

(29) Articles 53 and 54 of Regulation (EC) No 178/2002
establish procedures for taking emergency measures in
relation to feed of Community origin or imported from
a third country. They allow such measures to be adopted
in situations where feed is likely to constitute a serious risk
to human health, animal health or the environment and
where such risk cannot be contained satisfactorily by
measures taken by the Member State(s) concerned.

(30) The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (1).

(31) Member States

should lay down rules on penalties
applicable to infringements of this Regulation and ensure
that
they are implemented. Those penalties must be
effective, proportionate and dissuasive.

(32) Directive 70/524/EEC should be

repealed. However
labelling provisions applicable to compound feedingstuffs
should be maintained until a
incorporating additives
revision of Council Directive 79/373/EEC of 2 April
1979 on the marketing of compound feedingstuffs (2) is
completed.

for

(33) Guidelines addressed to the Member States for the presen-
tation of an application dossier are contained in Council
Directive 87/153/EEC of 16 February 1987 fixing
guidelines
in animal
nutrition (3). Verification of the conformity of dossiers is
entrusted to the European Food Safety Authority.
It is
therefore necessary to repeal Directive 87/153/EEC.
However,
the Annex should remain in force until
implementing rules are adopted.

the assessment of additives

(28) Regulation (EC) No . . ./2003 of the European Parliament
and of the Council of . . ., on genetically modified food
and feed (*) provides for an authorisation procedure for

(*) See p. 31 of this Official Journal.

(1) OJ L 184, 17.7.1999, p. 23.
(2) OJ L 86, 6.4.1979, p. 30. Directive as last amended by Directive
2002/2/EC of the European Parliament and of the Council (OJ L 63,
6.3.2002, p. 23).

(3) OJ L 64, 7.3.1987, p. 19. Directive as last amended by Commission

Directive 2001/79/EC (OJ L 267, 6.10.2001, p. 1).

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(34) A transitional period is needed to avoid disruptions in the
use of feed additives. Therefore, until the rules of this
Regulation are applicable,
the substances already auth-
orised should be permitted to remain on the market and
be used under the conditions of the current legislation,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SCOPE AND DEFINITIONS

Article 1

Scope

The purpose of

this Regulation is

1.
to establish a
Community procedure for authorising the placing on the
market and use of feed additives and to lay down rules for
the supervision and labelling of feed additives and premixtures
in order to provide the basis for the assurance of a high level
of protection of human health, animal health and welfare,
environment and users' and consumers'
interests in relation
to feed additives, whilst ensuring the effective functioning of
the internal market.

(b)

‘feed materials’ means products as defined in Article 2(a) of
Council Directive 96/25/EC of 29 April 1996 on the
circulation of feed materials (2);

(c)

‘compound feedingstuffs’ means products as defined in
Article 2(b) of Directive 79/373/EEC;

(d)

‘complementary feedingstuffs’ means products as defined
in Article 2(e) of Directive 79/373/EEC;

(e)

(f)

‘premixtures’ means mixtures of feed additives or mixtures
of one or more feed additives with feed materials or water
used as carriers, not intended for direct feeding to animals;

‘daily ration’ means the average total quantity of feed-
ingstuffs, calculated on a moisture content of 12 %,
required daily by an animal of a given species, age
category and yield, to satisfy all its needs;

(g)

‘complete feedingstuffs’ means products as defined in
Article 2(c) of Directive 1999/29/EC;

2.

This Regulation shall not apply to:

(a) processing aids;

(b) veterinary medicinal products as defined in Directive
2001/82/EC (1), with the exception of coccidiostats and
histomonostats used as feed additives.

Article 2

Definitions

(h)

(i)

(j)

‘feedingstuff’,

For the purpose of this Regulation, the definitions of
‘feed business operator’,
laid down in Regu-

1.
‘feed’,
‘placing on the market’ and ‘traceability’
lation (EC) No 178/2002 shall apply.

‘feed business’,

‘processing aids’ means any substance not consumed as a
feedingstuff by itself, intentionally used in the processing
of feedingstuffs or feed materials to fulfil a technological
purpose during treatment or processing which may result
in the unintentional but
technologically unavoidable
presence of residues of the substance or its derivatives in
the final product, provided that these residues do not have
an adverse effect on animal health, human health or the
environment and do not have any technological effects on
the finished feed;

either
‘antimicrobials’ means
synthetically or naturally, used to kill or
the
growth of micro-organisms, including bacteria, viruses or
fungi, or of parasites, in particular protozoa;

substances

produced

inhibit

‘antibiotic’ means antimicrobials produced by, or derived
from, a micro-organism, which destroys or inhibits the
growth of other micro-organisms;

2.

The following definitions shall also apply:

(a)

‘feed additives’ means
substances, micro-organisms or
preparations, other than feed material and premixtures,
which are intentionally added to feed or water in order
to perform,
in particular, one or more of the functions
mentioned in Article 5(3);

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

(k)

‘coccidiostats’
intended to kill or inhibit protozoa;

and ‘histomonostats’ means

substances

(l)

‘maximum residue limit’ means the maximum concen-
tration of residue resulting from the use of an additive
in animal nutrition which may be accepted by the
Community as being legally permitted or recognised as
acceptable in or on a food;

(2) OJ L 125, 23.5.1996, p. 35. Directive as last amended by Directive
2001/46/EC of the European Parliament and of the Council (OJ L
234, 1.9.2001, p. 55).

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(m) ‘micro-organism’ means: colony-forming micro-organisms.

(n)

‘first placing on the market’ means the initial placing on
the market of an additive after its manufacture, the import
of an additive, or, where an additive has been incorporated
into feed without being placed on the market, the first
placing on the market of that feed.

Unless otherwise specified, the mixing of additives to be
4.
sold directly to the end-user shall be allowed, subject
to
compliance with the conditions for use laid down in the auth-
orisation for each single additive. Consequently, the mixing of
authorised additives shall not be subject to specific authoris-
ations other than the requirements laid down in Directive
95/69/EC (1).

it may be determined,

3. Where necessary,
in accordance
with the procedure referred to in Article 21(2), whether a
substance, micro-organism or preparation is a feed additive
within the scope of this Regulation.

5. Where necessary as a result of technological progress or
scientific development, the general conditions set out in Annex
IV may be adapted in accordance with the procedure referred
to in Article 21(2).

CHAPTER II

AUTHORISATION, USE, MONITORING AND TRANSITIONAL
MEASURES APPLICABLE FOR FEED ADDITIVES

Article 3

Placing on the market, processing and use

No person shall place on the market, process or use a

1.
feed additive unless:

(a)

it is covered by an authorisation granted in accordance
with this Regulation;

(b) the conditions for use set out in this Regulation, including
the general conditions
in Annex IV, unless
set out
otherwise provided for in the authorisation, and in the
authorisation of the substance are met; and

(c) the conditions on labelling set out in this Regulation are

met.

the experiments are carried out

2.
For experiments for scientific purposes, Member States
may authorise the use, as additives, of substances which are
not authorised at Community level, with the exception of anti-
biotics, provided that
in
accordance with the principles and conditions laid down in
Directive 87/153/EEC, Directive 83/228/EEC or the guidelines
set out in Article 7(4) of this Regulation and provided that
there is adequate official supervision. The animals concerned
may be used for food production only if
the authorities
establish that
this will have no adverse effect on animal
health, human health or the environment.

3.
In the case of additives belonging to categories (d) and (e)
of Article 6(1) and of those additives falling within the scope of
Community legislation relating to the marketing of products
consisting of, containing or produced from genetically modified
organisms (GMOs), no person other than the holder of the
authorisation named in the authorisation Regulation referred
to in Article 9, his legal successor or successors, or a person
acting under his written authority, shall first place the product
on the market.

Article 4

Authorisation

1.
Any person seeking an authorisation for a feed additive
or for a new use of a feed additive shall submit an application
in accordance with Article 7.

2.
An authorisation shall not be granted, refused, renewed,
modified, suspended or revoked except on the grounds and
under
in
accordance with Articles 53 and 54 of Regulation (EC)
No 178/2002.

in this Regulation, or

the procedures

set out

The applicant for an authorisation or his representative

3.
shall be established in the Community.

Article 5

Conditions for authorisation

1.
No feed additive shall be authorised unless the applicant
for such authorisation has adequately and sufficiently demon-
strated in accordance with the implementing measures referred
to in Article 7 that, when used in accordance with conditions
to be set out in the Regulation authorising the use of the
additive, it satisfies the requirements of paragraph 2, and has
at least one of the characteristics set out in paragraph 3.

2.

The feed additive shall not:

(a) have an adverse effect on animal health, human health or

the environment,

(b) be presented in a manner which may mislead the user,

(1) Council Directive 95/69/EC of 22 December 1995 laying down the
conditions and arrangements for approving and registering certain
feed
establishments and intermediairies operating in the animal
sector
74/63/EEC,
79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15).
Directive as last amended by Council Directive 1999/29/EC (OJ L
115, 4.5.1999, p. 32).

amending Directives

70/524/EEC,

and

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(c) harm the consumer by impairing the distinctive features of
animal products or mislead the consumer with regard to
the distinctive features of animal products.

principal
procedure specified in Articles 7, 8 and 9.

function or

functions,

in accordance with the

3.

The feed additive shall:

(a)

favourably affect the characteristics of feed,

3. Where necessary as a result of technological progress or
scientific development, additional feed additive categories and
functional groups may be established in accordance with the
procedure referred to in Article 21(2).

(b) favourably affect the characteristics of animal products,

(c)

favourably affect the colour of ornamental fish and birds,

Article 7

Application for authorisation

(d) satisfy the nutritional needs of animals,

(e)

favourably affect the environmental consequences of animal
production,

(f)

animal production, performance or
favourably affect
welfare, particularly by affecting the gastro-intestinal flora
or digestibility of feedingstuffs, or

(g) have a coccidiostatic or histomonostatic effect.

Antibiotics, other than coccidiostats or histomonostats,

4.
shall not be authorised as feed additives.

1.
An application for an authorisation as provided for in
Article 4 shall be sent to the Commission. The Commisison
shall without delay inform the Member States and forward the
application to the European Food Safety Authority (hereinafter
referred to as ‘the Authority’).

2.

The Authority shall:

(a) acknowledge receipt of

including the
particulars and documents referred to in paragraph 3, in
writing,
its receipt,
stating the date of receipt;

to the applicant within 15 days of

the application,

(b) make any information supplied by the applicant available

to the Member States and the Commission;

Article 6

Categories of feed additives

(c) make the summary of the dossier mentioned in point (h) of
paragraph 3 available to the public, subject to the confi-
dentiality requirements laid down in Article 17(2).

1.
A feed additive shall be allocated to one or more of the
following categories, depending on its functions and properties,
in accordance with the procedure set out at Articles 7, 8 and 9:

3.
At the time of application, the applicant shall send the
following particulars and documents directly to the Authority:

(a) technological additives: any substance added to feed for a

technological purpose;

(a) his name and address;

(b) sensory additives: any substance, the addition of which to
feed improves or changes the organoleptic properties of the
feed, or the visual characteristics of the food derived from
animals;

(b) the identification of the feed additive, a proposal for its
classification by category and functional group under
Article 6, and its specifications, including, where applicable,
purity criteria;

(c) nutritional additives;

(d) zootechnical

additives:

to affect
favourably the performance of animals in good health or
used to affect favourably the environment;

additive used

any

(c) a description of the method of production, manufacturing
and intended uses of the feed additive, of the method of
analysis of the additive in feed according to its intended use
and, where appropriate, of the method of analysis for the
determination of the level of residues of the feed additive,
or its metabolites, in food;

(e) coccidiostats and histomonostats.

2. Within the categories referred to in paragraph 1, feed
additives shall further be allocated within one or more of the
functional groups mentioned in Annex I, according to their

(d) a copy of the studies which have been carried out and any
other material which is available to demonstrate that the
feed additive satisfies the criteria laid down in Article 5(2)
and (3);

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(e) proposed conditions for placing the feed additive on the
market, including labelling requirements and, where appro-
priate, specific conditions for use and handling (including
known incompatibilities), use levels in complementary feed-
ingstuffs and animal species and categories for which the
feed additive is intended;

which allow for simplified procedures for the authorisation of
additives which have been authorised for use in food.

The Authority shall publish detailed guidance to assist the
its
in the preparation and the presentation of

6.
applicant
application.

(f) a written statement that three samples of the feed additive
have been sent by the applicant directly to the Community
reference laboratory referred to in Article 20, in accordance
with the requirements set out in Annex II;

(g) for additives which, according to the proposal under point
(b), do not belong to either category (a) or category (b)
referred to in Article 6(1), and for additives falling within
scope of Community legislation relating to the
the
marketing of products
containing or
produced from GMOs, a proposal for post-market moni-
toring;

consisting of,

(h) a summary containing the information provided under

points (a) to (g);

Article 8

Opinion of the Authority

The Authority shall give an opinion within six months of
1.
receipt of a valid application. This time-limit shall be extended
whenever the Authority seeks supplementary information from
the applicant under paragraph 2.

The Authority may, where appropriate,

the
2.
applicant
the particulars accompanying the
application within a time-limit specified by the Authority
after consultation with the applicant.

to supplement

request

3.

In order to prepare its opinion, the Authority:

(i)

for additives falling within the scope of Community legis-
lation relating to the marketing of products consisting of,
containing or produced from GMOs, details of any author-
isation granted in accordance with the applicable legis-
lation.

(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 7 and
undertake an assessment in order to determine whether
the feed additive complies with the conditions laid down
in Article 5;

The Commission, having first consulted the Authority,
in accordance with the procedure laid down
implementing rules for the application of
including rules concerning the preparation and

4.
shall establish,
in Article 21(2),
this Article,
the presentation of the application.

(b) shall verify the report of

the Community Reference

Laboratory.

In the event of an opinion in favour of authorising the
the opinion shall also include the following

4.
feed additive,
elements:

Until such implementing rules are adopted, the application
shall be made in accordance with the Annex to Directive
87/153/EEC.

(a) the name and address of the applicant;

After

the Authority has been consulted,

5.
specific
guidelines for the authorisation of additives shall be established,
where necessary for each category of additive referred to in
Article 6(1) in accordance with the procedure laid down in
Article 21(2). These guidelines shall take account of the possi-
bility of extrapolating the results of the studies carried out on
major species to minor species.

this Article may be

After the Authority has been consulted, further rules for the
established in
implementation of
accordance with the procedure referred to in Article 21(2).
These rules should, where appropriate, differentiate between
requirements for feed additives in respect of food-producing
animals and requirements in respect of other animals,
in
particular pets. The implementing rules shall include provisions

(b) the designation of the feed additive including its categori-
sation and allocation within functional groups provided for
in Article 6, its specification, including, where applicable,
purity criteria and method of analysis;

(c) depending on the outcome of

the assessment, specific
conditions or restrictions in relation to handling, post-
market monitoring
including
requirements
animal species and categories of animal species for which
the additive is to be used;

and use,

(d) specific additional requirements for the labelling of the feed
additive necessary as a result of conditions and restrictions
imposed under (c);

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(e) a proposal

for the establishment of maximum residues
limits (MRLs) in the relevant foodstuffs of animal origin,
unless the opinion of the Authority concludes that the
establishment of MRLs is not necessary for the protection
of consumers or MRLs have already been established in
Annex I or III to Council Regulation (EEC) No 2377/90
of 26 June 1990 laying down a Community procedure for
the establishment of maximum residue limits of veterinary
medicinal products in foodstuffs of animal origin (1).

The Authority shall without delay forward its opinion to
the Member States and the applicant,
the feed

5.
the Commission,
including a report describing its assessment of
additive and stating the reasons for its conclusion.

The Authority shall make its opinion public, after
in

6.
deletion of any information identified as confidential
accordance with Article 17(2).

Article 9

Authorisation by the Community

1. Within three months of receipt of the opinion of the
Authority, the Commission shall prepare a draft Regulation
to grant authorisation or to deny authorisation. This draft
shall take into account the requirements of Article 5(2) and
(3), Community law and other legitimate factors relevant to the
matter under consideration and in particular benefits
for
animal health and welfare and for the consumer of animal
products.

Where the draft is not in accordance with the opinion of the
Authority, it shall provide an explanation of the reasons for the
differences.

A Regulation granting the authorisation shall include the
5.
elements mentioned in Article 8(4)(b), (c), (d) and (e) and an
identification number.

and, where

authorisation for

A Regulation granting

6.
additives
belonging to categories (d) and (e) referred to in Article 6(1)
and also for additives consisting of, containing or produced
from GMOs, shall include the name of the holder of the auth-
orisation,
identifier
appropriate,
attributed to the GMO as referred to in Regulation (EC)
No . . ./2003 . . . of
the
the European Parliament and of
Council of
concerning traceability and labelling of
genetically modified organisms and traceability of food and
feed products produced from genetically modified organisms
and amending Directive 2001/18/EC (2).

the unique

. . .

7. Where the levels of residues of an additive in food from
animals fed with that additive might have a detrimental effect
on human health, the Regulation shall include MRLs for the
active substance or for its metabolites in the relevant foodstuffs
In this case the active substance shall be
of animal origin.
considered for the purposes of Council Directive 96/23/EC as
falling under Annex I to that Directive. Where an MRL for the
substance
in
Community rules, that MRL shall also apply to residues of
the active substance or its metabolites originating from the
use of the substance as a feed additive.

established

concerned

already

been

has

authorisation granted in accordance with the
8.
The
laid down in this Regulation shall be valid
procedure
throughout
the Community for 10 years and shall be
renewable in accordance with Article 14. The authorised feed
additive shall be entered in the Register referred to in Article
16 (hereinafter referred to as ‘the Register’). Each entry in the
Register shall state the date of authorisation and shall include
the particulars referred to in paragraphs 5, 6 and 7.

In exceptionally complex cases, the three-month deadline may
be extended.

9.
The granting of authorisation shall be without prejudice
to the general civil and criminal liability of any feed operator in
respect of the feed additive concerned.

The draft

2.
procedure referred to in Article 21(2).

shall be adopted in accordance with the

Rules for the implementation of

3.
this Article and in
particular concerning an identification number for authorised
additives may be established in accordance with the procedure
referred to in Article 21(2).

The Commission shall without delay inform the applicant

4.
of the Regulation adopted in accordance with paragraph 2.

(1) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by
Commission Regulation (EC) No 61/2003 (OJ L 11, 16.1.2003,
p. 12).

Article 10

Status of existing products

1.
By way of derogation from Article 3, a feed additive
which has been placed on the market pursuant to Directive
70/524/EEC and urea and derivatives, an amino acid, salt of an
amino acid or analoguous substance, which was listed in points
2.1, 3 and 4 of the Annex to Directive 82/471/EEC, may be
placed on the market and used in accordance with the
conditions specified in Directives 70/524/EEC or 82/471/EEC
including in particular
and their
specific labelling provisions concerning compound feed and
feed materials, provided that the following conditions are met:

implementing measures,

(2) See p. 21 of this Official Journal.

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(a) within one year of the entry into force of this Regulation,
persons first placing the feed additive on the market or any
other
to the
Commission. At the same time, the particulars mentioned
in Article 7(3)(a), (b) and (c) shall be directly sent to the
Authority;

interested parties

shall notify this

fact

(b) within one year of the notification mentioned under (a), the
Authority shall, after verification that all the information
required has been submitted, notify the Commission that it
has received the information required under this Article.
The products concerned shall be entered in the Register.
Each entry in the Register shall mention the date on which
the product concerned was first entered in the Register and,
where applicable, the expiry date of the existing author-
isation.

An application shall be submitted in accordance with
2.
Article 7, at the latest one year before the expiry date of the
authorisation given pursuant
to Directive 70/524/EEC for
additives with a limited authorisation period, and within a
maximum of seven years after the entry into force of this
Regulation for additives authorised without a time limit or
pursuant to Directive 82/471/EEC. For substances belonging
to the category of coccidiostats and histomonostats, an
application shall be submitted within a maximum of
four
years after the entry into force of
this Regulation. Before
1 January 2008, the Commission shall submit a report on
the use of these substances as feed additives together, where
appropriate, with a legislative proposal concerning further use.

3.
Products entered in the Register shall be subject to the
provisions of this Regulation, in particular Articles 8, 9, 12, 13,
14 and 15, which without prejudice to specific conditions
concerning the labelling, placing on the market and use of
each substance pursuant to paragraph 1, shall apply to such
products as if they had been authorised pursuant to Article 9.

In the case of authorisations not issued to a specific
4.
holder,
the
any person who imports or manufactures
products referred to in this Article or any other interested
party may
referred to in
paragraph 1 or the application as referred to in paragraph 2
to the Commission.

information as

submit

the

5. Where the notification and accompanying particulars
referred to in paragraph 1(a) are not supplied within the
period specified or are found to be incorrect, or where an
application is not submitted as required by paragraph 2
within the period specified, a Regulation shall be adopted, in
accordance with the procedure referred to in Article 21(2),
requiring the additives concerned to be withdrawn from the

market. Such a measure may provide for a limited period of
time within which existing stocks of the product may be used
up.

6. Where, for reasons beyond the control of the applicant,
no decision is taken on the renewal of an authorisation before
its expiry date, the period of authorisation of the product shall
the Commission takes a
automatically be extended until
decision. The Commission shall
inform the applicant of this
extension of the authorisation.

7.
By way of derogation from Article 3, substances, micro-
organisms and preparations used in the Community as silage
additives at the date referred to in Article 25(2), may be placed
on the market and used provided that points (a) and (b) of
paragraph 1 and paragraph 2 are complied with. Paragraphs 3
and 4 shall apply accordingly. For
the
deadline for application as referred to in paragraph 2 shall
be seven years after the entry into force of this Regulation.

these substances,

Article 11

Phasing out

By way of derogation from Article 10 and without prejudice to
Article 13, antibiotics, other than coccidiostats and histo-
monostats, may be marketed and used as feed additives only
until 31 December 2005; as from 1 January 2006,
those
substances shall be deleted from the Register.

Article 12

Supervision

1.
After an additive has been authorised in accordance with
this Regulation, any person using or placing on the market that
into which it has been incor-
substance, or a feedingstuff
porated, or any other interested party shall ensure that any
conditions or restrictions which have been imposed on the
placing on the market, use and handling of the additive or
feedingstuffs containing it are respected.

2. Where monitoring requirements, as referred to in Article
8(4)(c), have been imposed, the holder of the authorisation
shall ensure that monitoring is carried out and shall submit
reports to the Commission in accordance with the author-
isation. The holder of
forthwith
communicate to the Commission any new information that
influence the evaluation of the safety in use of the
might
feed additive,
specific
in particular health sensitivities of
categories of consumers. The holder of
the authorisation
shall forthwith inform the Commission of any prohibition or
restriction imposed by the competent authority of any third
country in which the feed additive is placed on the market.

the authorisation shall

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Article 13

Modification, suspension and revocation of authorisations

(b) a report on the results of the post-market monitoring, if
such monitoring requirements are included in the author-
isation;

On its own initiative or following a request

1.
from a
Member State or from the Commission, the Authority shall
issue an opinion on whether an authorisation still meets the
shall
conditions
forthwith
transmit
to the Member
States and, where applicable, to the holder of the authorisation.

set out by this Regulation.
It
this opinion to the Commission,

2.
the
The Commission shall examine the opinion of
Authority without delay. Any appropriate measures shall be
taken in accordance with Articles 53 and 54 of Regulation
(EC) No 178/2002. A decision on the modification, suspension
or revocation of an authorisation shall be taken in accordance
with the procedure referred to in Article 21(2) of this Regu-
lation.

3.
If the holder of the authorisation proposes changing the
terms of the authorisation by submitting an application to the
Commission, accompanied by the relevant data supporting the
request for the change, the Authority shall transmit its opinion
on the proposal to the Commission and the Member States.
The Commission shall examine the opinion of the Authority
without delay and decide in accordance with the procedure
referred to in Article 21(2).

4.
The Commission shall without delay inform the applicant
of the decision taken. The Register shall be amended where
appropriate.

(c) any other new information which has become available
with regard to the evaluation of the safety in use and the
efficacy of
the feed
the feed additive and the risks of
additive to animals, humans or the environment;

(d) where appropriate, a proposal for amending or supple-
menting the conditions of the original authorisation, inter
alia the conditions concerning future monitoring.

Articles 7(1),

3.
accordingly.

(2),

(4) and (5), 8 and 9 shall apply

4. Where, for reasons beyond the control of the applicant,
no decision is taken on the renewal of an authorisation before
its expiry date, the period of authorisation of the product shall
automatically be extended until
the Commission takes a
decision. Information on this extension of the authorisation
shall be made available to the public in the Register referred
to in Article 16.

CHAPTER III

LABELLING AND PACKAGING

Article 15

5.

Articles 7(1) and (2), 8 and 9 shall apply accordingly.

Labelling and packaging of feed additives and premixtures

Article 14

Renewal of authorisations

1.
Authorisations under this Regulation shall be renewable
for 10-year periods. An application for renewal shall be sent to
the Commission at the latest one year before the expiry date of
the authorisation.

In the case of authorisations not issued to a specific holder, any
person who first places the additive on the market or any other
interested party may submit the application to the Commission
and shall be considered as the applicant.

In the case of authorisations issued to a specific holder, the
holder of the authorisation or his legal successor or successors
may submit the application to the Commission and shall be
deemed to be the applicant.

At the time of application, the applicant shall send the
2.
following particulars and documents directly to the Authority:

(a) a copy of the authorisation for placing the feed additive on

the market;

the

seller

No person shall place on the market a feed additive or a
1.
premixture of additives unless its packaging or container is
responsibility of a producer, packer,
labelled under
the
importer,
in a
Community and bears
in at least
conspicuous, clearly legible and indelible manner,
language or languages of the Member State in
the national
which it is marketed,
in relation to each additive contained
in the material:

following information,

established within

distributor

the

or

(a) the specific name given to the additives upon authorisation,
functional group as

the

preceded by the name of
mentioned in the authorisation;

(b) the name or business name and the address or registered
the

the person responsible for

place of business of
particulars referred to in this Article;

(c)

the net weight or,
premixtures, either the net volume or the net weight;

in the case of

liquid additives and

(d) where appropriate, the approval number assigned to the
establishment or the intermediary pursuant to Article 5
registration number
of Directive 95/69/EC or
assigned
intermediary
to the
pursuant to Article 10 of that Directive;

establishment or

the

the

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(e) directions

for use,

and any safety recommendations
the specific
regarding the use and, where applicable,
requirements mentioned in the authorisation,
including
animal species and categories for which the additive or
premixture of additives is intended;

(f)

the identification number;

(g) the batch reference number and date of manufacture.

2.
In addition to the information specified in paragraph 1,
the packaging or container of an additive belonging to a func-
tional group specified in Annex III must bear the information,
presented in a conspicuous, clearly legible and indelible
manner, indicated in that Annex.

3. Moreover,
‘Premixture’
label, and the carrier substance must be declared.

the word
letters) must appear clearly on the

case of premixtures,

(in capital

in the

(a) name and composition of the feed additive and, where

appropriate, indication of the production strain;

(b) physico-chemical and biological characteristics of the feed

additive;

(c)

the conclusions of the study results on effects of the feed
additive on human and animal health and on the
environment;

(d) the conclusions of the study results on effects of the feed
additive on the characteristics of animal products and its
nutritional properties;

(e) methods

the feed
for detection and identification of
additive and, where applicable, monitoring requirements
and a summary of the results of the monitoring.

Additives and premixtures shall be marketed only in
4.
closed packages or closed containers which must be closed
in such a way that the fastener is damaged on opening and
cannot be re-used.

Notwithstanding paragraph 2,

the Authority shall, on
4.
request, supply the Commission and Member States with all
information in its possession, including any identified as confi-
dential pursuant to paragraph 2.

Amendments to Annex III to take technological progress
5.
and scientific development into account may be adopted in
accordance with the procedure referred to in Article 21(2).

CHAPTER IV

GENERAL AND FINAL PROVISIONS

Article 16

Community Register of Feed Additives

The Commission shall establish and keep up to date a

1.
Community Register of Feed Additives.

2.

The Register shall be made available to the public.

Article 17

Confidentiality

1.
The applicant may indicate which information submitted
under this Regulation he wishes to be treated as confidential on
the ground that its disclosure might significantly harm his
competitive position. Verifiable reasons must be given in
such cases.

2.
The Commission shall determine, after consultation with
the applicant, which information other than that specified in
paragraph 3 should be kept confidential and shall inform the
applicant of its decision.

5.
The Authority shall apply the principles of Regulation
(EC) No 1049/2001 of the European Parliament and of the
Council of 30 May 2001 regarding public
to
European Parliament, Council and Commission documents (1)
when handling applications for access to documents held by
the Authority.

access

6.
The Member States, the Commission and the Authority
shall keep confidential all the information identified as confi-
dential under paragraph 2 except where it is appropriate for
such information to be made public in order to protect human
health, animal health or the environment. Member States shall
handle applications for access to documents received under this
Regulation in accordance with Article 5 of Regulation (EC)
No 1049/2001.

the Member States,

an applicant withdraws or has withdrawn an
If
7.
application,
the Commission and the
Authority shall respect the confidentiality of commercial and
industrial
including research and development
information, as well as information on which the Commission
and the applicant disagree as to its confidentiality.

information,

Article 18

Administrative review

Any decision taken under, or failure to exercise, the powers
vested in the Authority by this Regulation may be reviewed by
the Commission on its own initiative or in response to a
request
from a Member State or from any person directly
and individually concerned.

The following information shall not be considered confi-

3.
dential:

(1) OJ L 145, 31.5.2001, p. 43.

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that purpose, a request

shall be submitted to the
For
Commission within two months after the day on which the
party concerned became aware of
the act or omission in
question.

Detailed rules for implementing Annex II and any amendments
to that Annex shall be adopted in accordance with the
procedure referred to in Article 21(2).

take a decision within two months
The Commission shall
requiring,
the Authority to withdraw its
decision or to remedy its failure to act within a set time-limit.

if appropriate,

Article 19

Data protection

The

and other

scientific data

1.
information in the
application dossier required under Article 7 may not be used
for the benefit of another applicant for a period of 10 years
from the date of authorisation, unless the other applicant has
agreed with the previous applicant
such data and
information may be used.

that

2.
In order to stimulate efforts to obtain authorisations for
minor species for additives whose use is authorised for other
species, the 10-year data protection period shall be extended by
one year for each minor species for which a use extension
authorisation is granted.

3.
The applicant and the previous applicant shall take all
necessary steps to reach agreement on sharing the use of
information, in order not to repeat toxicological tests on verte-
brates. If, however, no such agreement is reached on sharing
the Commission may decide to disclose
the information,
information necessary to avoid repeating toxicological
tests
on vertebrates, while ensuring a reasonable balance between
the interests of the parties concerned.

Article 21

Committee

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health established
by Article 58 of Regulation EC No 178/2002 (hereinafter
referred to as the Committee).

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3.

The Committee shall adopt its rules of procedure.

Article 22

Repeals

1.
Directive 70/524/EEC shall be repealed with effect from
the date of application of this Regulation. However, Article 16
of Directive 70/524/EEC shall remain in force until Directive
79/373/EEC has been revised to include rules concerning the
labelling of feedingstuffs incorporating additives.

Points 2.1, 3 and 4 of

2.
82/471/EEC shall be deleted with effect
application of this Regulation.

the Annex to Directive
from the date of

4.
On the expiry of the 10-year period, the findings of all or
part of the evaluation conducted on the basis of the scientific
data and information contained in the application dossier may
be used by the Authority for the benefit of another applicant.

Directive 87/153/EEC shall be repealed with effect from
3.
the date of application of this Regulation. However, the Annex
to that Directive shall remain in force until the implementing
rules provided for
this Regulation are
in Article 7(4) of
adopted.

Article 20

Reference laboratories

References to Directive 70/524/EEC shall be construed as

4.
references to this Regulation.

The Community Reference Laboratory and its duties and tasks
shall be those laid down in the Annex II.

Article 23

Penalties

Applicants for the authorisation of additives shall contribute to
supporting the cost of the tasks of the Community Reference
Laboratory and the consortium of National Reference Labora-
tories mentioned in Annex II.

Member States shall lay down the rules on penalties applicable
to infringements of this Regulation and shall take all measures
necessary to ensure that they are implemented. The penalties
provided for must be effective, proportionate and dissuasive.

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Member States shall notify those rules and measures to the
Commission at the latest 12 months after the date of publi-
cation of this Regulation and shall notify it without delay of
any subsequent amendment affecting them.

Article 24

Transitional measures

Applications

1.
submitted under Article 4 of Directive
70/524/EEC before the date of application of this Regulation
shall be treated as applications under Article 7 of this Regu-
lation where the initial comments provided for under Article
4(4) of Directive 70/524/EEC have not yet been forwarded to
the Commission. Any Member State selected as rapporteur in
respect of any such application shall immediately forward the
dossier
that application to the
Commission. Notwithstanding Article 22(1), such applications
shall continue to be treated in accordance with Article 4 of
Directive 70/524/EEC where the initial comments provided for

submitted in support of

under Article 4(4) of Directive 70/524/EEC have already been
forwarded to the Commission.

2.
The labelling requirements laid down in Chapter III shall
not apply to products which have been lawfully manufactured
and labelled in the Community or which have been lawfully
imported into the Community and put into circulation, before
the date of application of this Regulation.

Article 25

Entry into force

This Regulation shall enter into force on the 20th day
1.
following that of its publication in the Official Journal of the
European Union.

It shall apply from 12 months after the date of publi-

2.
cation of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, . . .

For the European Parliament

The President

For the Council

The President

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ANNEX I

ADDITIVE GROUPS

1. In the category ‘technological additives’, the following functional groups are included:

(a) preservatives: substances or, when applicable, micro-organisms which protect feed against deterioration caused by

micro-organisms or their metabolites;

(b) antioxidants: substances prolonging the storage life of feedingstuffs and feed materials by protecting them against

deterioration caused by oxidation;

(c) emulsifiers: substances that make it possible to form or maintain a homogeneous mixture of two or more

immiscible phases in feedingstuffs;

(d) stabilisers: substances which make it possible to maintain the physico-chemical state of feedingstuffs;

(e) thickeners: substances which increase the viscosity of feedingstuffs;

(f) gelling agents: substances which give a feedingstuff texture through the formation of a gel;

(g) binders: substances which increase the tendency of particles of feedingstuffs to adhere;

(h) substances for control of radionucleide contamination: substances that suppress absorption of radionucleides or

promote their excretion;

(i) anticaking agents: substances that reduce the tendency of individual particles of a feedingstuff to adhere;

(j) acidity regulators: substances which adjust the pH of feedingstuffs;

(k) silage additives: substances, including enzymes or micro-organisms, intended to be incorporated into feed to

improve the production of silage;

(l) denaturants: substances which, when used for the manufacture of processed feedingstuffs, allow the identification

of the origin of specific food or feed materials.

2. In the category ‘sensory additives’, the following functional groups are included:

(a) colorants:

(i) substances that add or restore colour in feedingstuffs;

(ii) substances which, when fed to animals, add colours to food of animal origin;

(iii) substances which favourably affect the colour of ornamental fish or birds;

(b) flavouring compounds: substances the inclusion of which in feedingstuffs increases feed smell or palatability.

3. In the category ‘nutritional additives’, the following functional groups are included:

(a) vitamins, pro-vitamins and chemically well-defined substances having similar effect;

(b) compounds of trace elements;

(c) amino acids, their salts and analogues;

(d) urea and its derivatives.

4. In the category ‘zootechnical additives’, the following functional groups are included:

(a) digestibility enhancers: substances which, when fed to animals, increase the digestibility of the diet, through

action on target feed materials;

(b) gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a

positive effect on the gut flora;

(c) substances which favourably affect the environment;

(d) other zootechnical additives.

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DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

ANNEX II

1. The Community reference laboratory referred to in Article 20 is the Joint Research Centre of the Commission (JRC).

2. For the tasks outlined in this Annex, the JRC may be assisted by a consortium of national reference laboratories.

The JRC shall be notably responsible for:

— the reception, preparation, storage and maintenance of the reference samples;

— the testing and evaluation or validation of the method for detection;

— evaluating the data provided by the applicant for authorisation to place the feed additive on the market, for the

purpose of testing and evaluation or validation of the method for detection;

— submitting full evaluation reports to the Authority.

3. The Community reference laboratory shall play a role in dispute settlements between Member States concerning the

results of the tasks outlined in this Annex.

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SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN FEED ADDITIVES AND FOR PREMIXTURES

ANNEX III

(a) Zootechnical additives, coccidiostats and histomonostats:

— the expiry date of the guarantee or the storage life from the date of manufacture,

— the directions for use, and

— the concentration.

(b) Enzymes, in addition to the abovementioned indications:

— the specific name of the active component or components in accordance with their enzyme activities,

in

conformity with the authorisation given,

— the International Union of Biochemistry identification number, and

— instead of concentration: units of activity (units of activity per gram or units of activity per millilitre).

(c) Micro-organisms:

— the expiry date of the guarantee or the storage life from the date of manufacture,

— the directions for use,

— the strain identification number, and

— the number of colony-forming units per gram.

(d) Nutritional additives:

— the active-substance level, and

— the expiry date of the guarantee of that level or storage life from the date of manufacture.

(e) Technological and sensory additives:

— the active-substance level.

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ANNEX IV

GENERAL CONDITIONS OF USE

1. The quantity of additives that also exists in the natural state in certain feed materials shall be calculated so that the
total of the elements added and the elements present naturally does not exeed the maximum level provided for in the
authorisation Regulation.

2. Mixing of additives shall be permitted only in premixtures and feedingstuffs where there is physico-chemical and

biological compatibility between the components of the mixture in relation to the effects desired.

3. Supplementary feedingstuffs, diluted as specified, may not contain levels of the additives which exceed those fixed for

complete feedingstuffs.

4. In the case of premixtures containing silage additives the words ‘of silage additives’ must clearly be added on the label

after ‘Premixture’.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

On 22 March 2002 the Commission presented a proposal for a Regulation of the European Parliament
and of the Council, based on Articles 37 and 152(4)(b) of the Treaty, on additives for use in animal
nutrition.

The European Parliament delivered its opinion at first reading on 21 November 2002. The Economic
and Social Committee delivered its opinions on 18 September 2002.

The Council adopted its common position on 17 March 2003, in accordance with the procedure laid
down in Article 251 of the Treaty.

II. OBJECTIVES

The proposal is intended to:

1. simplify the existing rules regarding the authorisation procedure of additives in feedingstuffs,

2. distinguish clearly between the risk evaluation (European Food Safety Authority (EFSA)) and the risk

management (Commission and Member States),

3.

lay down provisions for the phasing out of antibiotics used as growth promoters,

4. maintain the use of coccidiostats as feed additives and to consolidate EU provisions on additives for

use in animal nutrition.

III. ANALYSIS OF THE COMMON POSITION

A. General observations

The Council's common position broadly accords with the positions taken by the Commission and
the Parliament, inasmuch as it:

— confirms the objectives and most of the arrangements proposed by the Commission and

supported by the European Parliament,

— includes a large number of the amendments passed at first reading by the European Parliament.

In particular, the Council has retained the legal form of a Regulation with a view to consolidating
existing provisions on the regulation of additives for use in animal nutrition which stem from a
variety of Directives. The basic legislation (Directive 70/524/EEC) which it is intended to replace has
undergone five major amendments and numerous modifications of
the annexes, making its
application increasingly difficult for operators and authorities.

The Council also felt that it was appropriate to introduce a number of amendments, many of them
at the suggestion of the Parliament, either to define the scope of some provisions, or to make the
wording of the Regulation more explicit and guarantee legal certainty, or to increase its consistency
with other Community instruments and the transparency of some of the arrangements for its
operation.

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B. Specific comments

1. Main amendments to the Commission proposal

(a) Status of coccidiostats — Inclusion of histomonostats — Report of use of coccidiostats and histo-

monostats

At the suggestion of the Parliament, the Council
included histomonostats in the same
category of feed additives as coccidiostats, as listed in Article 6(1), thus maintaining these
two groups within the framework of the feed additives legislation. While not prejudging the
future use of these substances at the present time, the Council also followed Parliament in
asking the Commission to present a report on the use of coccidiostats and histomonostats as
feed additives before 1 January 2008, where appropriate together with a legislative proposal
concerning further use.

(b) Authorisation procedure

Following a series of Parliament amendments, several provisions were adapted to clarify the
in particular concerning the
Commission proposal regarding the authorisation procedure,
steps and delays to be followed by the applicant, the Commission and the EFSA (Articles 1,
2, 3, 5, 7, 10, 11, 12, 13 and 14). Part of these modifications aims at ensuring a strict
separation of risk evaluation and risk management.

Further, a new paragraph in Article 20 specifies that applicants for authorisation of additives
shall contribute to support the implied cost of the the tasks carried out by the Community
reference laboratory and the consortium of national reference laboratories.

(c) Improvement of transparency and traceability — Administrative review

At the suggestion of Parliament, amendments were made to a few provisions in order to
improve the traceability of additives and facilitate communication during the authorisation
procedure and the availability of information to the public, in particular through modifi-
cation of Article 15 on labelling and packaging and Article 17 on confidentiality.

In the interest of animal welfare, a new paragraph was included in Article 19 on data
protection, providing rules for the sharing of information in order to avoid repeating toxi-
cological tests on vertebrates.

Further, a new Article 18 was added regarding the administrative review of decisions or
failures to act by the EFSA.

(d) Minor species — Animal categories

In line with several Parliament amendments, more flexibility in the authorisation procedure
in particular regarding minor species and the extension to further
was provided for,
categories of animals (Article 7(5) and Recitals 14, 15 and 17). Specific conditions
suggested by Parliament were added to Article 19 regarding data protection when
applying for authorisations for minor species.

The Council also followed Parliament suggestions in allowing for specific guidelines for each
category of additive, where necessary (Article 7(5)).

(e) Specific requirements for pets

At the suggestion of Parliament, Article 7(5) and corresponding Recital 4 indicate that
specific provisions for additives in pet food are appropriate. Taking into account that pets
do not enter the human food chain, such exclusive rules may be adopted for pets.

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(f) Definitions and general conditions

The Council considered it appropriate in the interest of legal clarity to include several
additional definitions in Article 2,
‘feed additives’, and to render
others more precise, as
suggested by Parliament. Various clarifications proposed by
Parliament regarding mixtures of additives have been included in Articles 1, 2 and 3 as
well as in Recital 8. Likewise, the additive groups in Annex I have been completed, taking
into account a series of Parliament amendments. A new Annex IV gives room for establishing
general conditions of use.

in particular one of

(g) Silage agents

Following a suggestion by Parliament, an extension for silage agents was added in Article 10.
for silage agents which are
This extension, accompanied by a transitional arrangement
to
currently marketed and used in the Community without an authorisation pursuant
Directive 70/524/EEC, was considered necessary because the scope of said Directive is
vague and therefore there is no uniform application in the Member States concerning
silage agents.

(h) Phasing out of antibiotics used as growth promoters

At the suggestion of Parliament, Article 11 clarifies that any antibiotic, other than cocci-
diostats and histomonostats, shall be deleted from the Register as from the phase-out date
specified in that Article. In setting this date at the 1 January 2006, the Council followed the
Commission proposal.

2. Council's position on the European Parliament's amendments

The Council has incorporated the following amendments in its common position:

— 1, 4, 6, 8, 16, 17, 18, 19, 21, 24, 25, 28, 29, 30, 34, 43 and 45;

and incorporated part of, or retained the principle of amendments

— 3, 5, 12, 13, 20, 26, 31, 32, 33, 36, 38, 40, 41, 44 and 47.

The Council followed the Commission and did not incorporate amendments

— 2, 7, 9, 10, 15, 22, 27, 35 (partially), 37, 42, 46 and 48.