Proposal for a Regulation of the European Parliament and of the Council on additives for use in animal nutrition
Date: 2002-03-22
Institutions: European Commission
Subjects: animal nutrition, food additive, food chemistry, labelling, product designation

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Proposal for a Regulation of the European Parliament and of the Council on additives for use in
animal nutrition

(2002/C 203 E/03)

COM(2002) 153 final — 2002/0073(COD)

(Submitted by the Commission on 22 March 2002)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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,

Having regard to the opinion of the Economic and Social
Committee,

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,

Whereas:

an essential

(1) The free movement of safe and wholesome food and feed
internal market and
is
contributes significantly to the health and well being of
citizens, and to their social and economic interests.

aspect of

the

(2) A high level of protection of human life and health
should be assured in the pursuit of Community policies.

(3) In order to protect human health, animal health and the
should undergo a safety
environment,
through a Community procedure before
assessment
being placed on the market, used or processed within
the Community.

feed additives

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

(5) In accordance with Article 153 of

the
Community is to contribute to promoting the right of
consumers to information.

the Treaty,

(6) Experience with the application of Council Directive
70/524/EEC of 23 November 1970 concerning additives
in feedingstuffs (1) has shown that it is necessary to review
all the rules on additives to take into account the need to
ensure a greater degree of protection of animal and
human health and of
is also
the
necessary to take into account the fact that technological
progress has made available new types of additives, such
as those to be used on silage or in drinking water.

environment.

It

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

(8) Categories of feed additives should be defined in order to
facilitate the assessment procedure in view of the author-
isation. Amino acids which are currently covered by
Council Directive 82/471/EEC of 30 June 1982
concerning certain products used in animal nutrition (2)
should be included as a category of feed additives, and
therefore transferred from the scope of that Directive to
this Regulation.

(9) In order to ensure a harmonised scientific assessment of
feed additives such assessment should be carried out by
the European Food Safety Authority. The applications
should be supplemented by residue studies in order to
assess the establishment of Maximum Residues Limits
(MRLs).

(10) It

factors

relevant

recognised that

scientific risk assessment alone
is
cannot,
in some cases, provide all the information on
which a risk management decision should be based, and
that other
to the matter under
consideration should legitimately be taken into account,
including societal, economic or environmental
factors,
feasibility of controls and the benefit for the animal or
for the consumer of animal products. Therefore, the auth-
orisation of an additive should be granted by the
Commission.

(11) Competence for authorising feed additives and estab-
lishing conditions for their use and for maintaining and
publishing a register of authorised feed additives should
be conferred on the Commission according to the
collaboration between
procedure by which a
Member States and the Commission is guaranteed in the
framework of the Standing Committee on the Food Chain
and Animal Health.

close

(12) It is necessary to introduce, where appropriate, an obli-
gation to implement a post-market monitoring plan in
order
indirect,
immediate, delayed, or unforeseen effect resulting from
the use of feed additives on human or animal health or
the environment.

to trace and identify any direct or

(1) OJ L 270, 14.12.1970, p. 1.

(2) OJ L 213, 21.7.1982, p. 8.

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(13) In order to allow technical and scientific progress to be
taken into account it is necessary to revise regularly the
authorisations of feed additives. Time limited authoris-
ations will allow this review.

knowledge of the facts and creates fewest obstacles to
trade and facilitates fairness of transactions.

(14) A register of authorised feed additives should be estab-
lished,
information and
sampling and detection methods. Non-confidential data
should be made available to the public.

including product

specific

(15) It is necessary to establish rules to take into account
additives which are already on the market and which
were authorised under Directive 70/524/EEC, and amino
acids currently authorised under Directive 82/471/EEC, as
authorisation
additives
for
well
procedure is in progress.

for which the

as

(16) 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
adopted on
Committee on anti-microbial
10-11 May 2001 confirmed the need to provide a
sufficient time to replace those antimicrobials by alter-
native products:
‘Thus, the phase-out process must be
planned and coordinated since precipitous actions could
is
have repercussions for animal health’. Therefore,
necessary to set a date after which the use of the anti-
biotics still authorised for use as growth promoting agents
will be forbidden, while allowing sufficient time for the
development of alternative products to replace those anti-
biotics. Provision should also be made to forbid the auth-
orisation of any further antibiotics
feed
additives.

for use as

resistance

it

(17) Certain substances with coccidiostatic effects should be
considered as feed additives for the purpose of this Regu-
lation.

(18) 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 in
the development of alternative substances and alternative
rearing methods before 2005.

(19) Detailed labelling of the product should be required since
to make a choice in full

the final user

it enables

(20) Regulation (EC) No . . . of the European Parliament and of
the Council on genetically modified food and feed
provides for an authorisation procedure for 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 Regulation (EC) No . . . of the European
Parliament and of the Council on genetically modified
food and feed are different from those of this Regulation,
feed additives should undergo an authorisation procedure
in addition to the authorisation procedure provided for by
this Regulation prior to their placing on the market.

(21) Fees could be charged for the consideration of dossiers by
the European Food Safety Authority,
to the
outcome of the report provided for in Article 45 of Regu-
lation (EC) No 178/2002 of the European Parliament and
of the Council of 28 January laying down the general
principles and requirements of food law, establishing the
European Food Safety Authority,
and laying down
procedures in matters of food safety (1).

subject

(22) Articles 53 and 54 of Regulation 178/2002 establish
procedures for taking emergency measures in relation to
feed of Community origin or imported from a third
country. They allow the Commission to adopt such
measures 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.

(23) Technological progress and scientific developments should
be taken into account when implementing this Regu-
lation.

(24) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (2),
they should be adopted by use of
regulatory
procedure provided for in Article 5 of that Decision.

the

(25) The Member States should lay down rules on penalties
applicable to infringements of the provisions of this Regu-
they are implemented. Those
lation and ensure that
penalties must be effective, proportionate and dissuasive.

(1) OJ L 31, 28.1.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.

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(26) Directive 70/524/EEC should be

repealed. However
labelling provisions applicable to compound feedingstuffs
incorporating additives should be maintained until a
revision of Council Directive 79/373/EEC of 2 April
1979 on the marketing of compound feedingstuffs (1)
the Annex of
will be completed. Points 3 and 4 of
Directive 82/471/EEC should be deleted in order
to
enable the transfer of amino acids and their salts to this
Regulation.

(27) Guidelines addressed to the Member States for the pres-
entation of an application dossier are contained in
Directive 87/153/EEC. The verification of the conformity
of dossiers is conferred to the European Food Safety
Authority.
It is therefore necessary to repeal Directive
87/153/EEC, maintaining however the Annex in place
until implementing rules have been adopted.

(28) 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 legis-
lation,

HAVE ADOPTED THIS REGULATION:

(b) veterinary medicinal products as defined in Directive

2001/82/EC (2).

it may be determined,

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

Article 3

Definitions

‘feed business’,

‘feed business operator’,

For the purpose of this Regulation, the definitions of ‘feed’ or
‘feedingstuff’,
‘placing
on the market’ and ‘traceability’ laid down in Regulation (EC)
No 178/2002 of the European Parliament and of the Council
laying down the general principles and requirements of food
law, establishing the European Food Safety Authority, and
laying down procedures in matters of food safety shall apply.

The following definitions shall also apply:

(a)

‘feed materials’ means products as defined in Article 2(a) of
Council Directive 96/25/EC (3);

(b) ‘complementary feedingstuffs’ means products as defined in

Article 2(e) of Directive 79/373/EEC;

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

(c)

Article 1

Subject matter

The purpose of this Regulation is to establish a Community
procedure for authorisation and supervision of feed additives
and to lay down rules to ensure labelling of feed additives 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' interests in relation to feed additives,
whilst ensuring the effective functioning of the internal market.

Article 2

Scope

This Regulation shall

1.
apply to chemically defined
substances or micro-organisms not normally used as feed
materials which are intentionally added to feedingstuffs or
drinking water, hereinafter referred to as ‘feed additives’.

2.

This Regulation shall not apply to:

feed additives’ means mixtures of

‘premixtures of
feed
additives or mixtures of one or more feed additives with
feed materials used as carriers, not
intended to direct
feeding of animals but intended for distribution to estab-
lishments registered or approved according to Council
Directive 95/69/EC (4);

(d)

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

(e)

(f)

‘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;

‘processing aids’ means any substances 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 and which do
not remain in the final product;

(a) processing aids, nor

to technological but unavoidable

residues of processing aids in the final product;

(1) OJ L 86, 6.4.1979, p. 30.

(2) OJ L 311, 28.11.2001, p. 1.
(3) OJ L 125, 13.5.1996, 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).

(4) OJ L 332, 30.12.1995, p. 15. Directive as last amended by

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

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(g)

‘antimicrobial agents’ means substances produced either
synthetically or naturally by bacteria,
fungi or plants,
used to kill or inhibit
the growth of micro-organisms
including bacteria, viruses and fungi, and of parasites, in
particular protozoa;

accordance with Articles 53 and 54 of Regulation (EC)
178/2002 of
the Council
the European Parliament and of
laying down the general principles and requirements of food
law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety.

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

The applicant for an authorisation shall be established in

3.
the Community.

(i)

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

accepted

be

(j)

‘growth promoter’ means a chemically defined substance
which, when fed to animals,
improves production
performance parameters.

Article 6

Conditions for authorisation

No feed additive shall be authorised unless the applicant
1.
for such authorisation has adequately and sufficiently demon-
strated 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 must not:

CHAPTER II

(a) present a risk to animal health, human health or the

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

environment,

Article 4

(b) mislead the user,

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;

(c) harm the consumer by impairing the distinctive features of

animal products.

3.

The feed additive must:

(a)

favourably affect the characteristics of feed,

(b) the conditions for use set out in this Regulation and in the

authorisation of the substance are met; and

(b) favourably affect the characteristics of animal products,

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

(c) satisfy the nutritional needs of animals,

met.

2.
In the case of additives belonging to categories (d) and (e)
as provided for in Article 7(1) and of additives consisting of,
containing or produced from genetically modified organisms
(GMOs), no person shall place the product on the market
other than the authorisation holder named in the authorisation
Regulation or a person acting under his written authority.

Article 5

Authorisation

Any person seeking an authorisation for a feed additive

1.
shall submit an application in accordance with Article 8.

2.
An authorisation shall not be granted, refused, renewed,
modified, suspended or revoked except on the grounds and
in
under

in this Regulation, or

the procedures

set out

(d) favourably affect the environmental consequences of animal

production.

4.

Antibiotics shall not be authorised as feed additives.

5.
By derogation of paragraph 4 certain substances with a
coccidiostatic effect and presented for continuous use mixed in
feed or drinking water, referred to hereafter as coccidiostats,
are considered as feed additives for the purpose of this Regu-
lation.

Article 7

Categories of feed additives

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 8 to 10:

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

technological purpose;

(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;

(c) nutritional additives: any substance used for nutritional

purposes;

(d) zootechnical

additives:

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

additive used

any

(e) coccidiostats.

2. Within these 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
principal function, in accordance with the procedure specified
in Articles 8 to 10.

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

Article 8

Application for authorisation

1.
An application for an authorisation as provided for in
Article 5 shall be submitted to the European Food Safety
Authority, hereinafter referred to as ‘the Authority’.

shall

The Authority

2.
the
application, in writing, to the applicant within 15 days of its
receipt. The acknowledgement shall state the date of receipt of
the application.

acknowledge

receipt

of

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

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

(g) for additives proposed in paragraph (b) as not belonging to
category (a) and (b) referred to in Article 7(1), and in the
case of additives consisting of, containing or produced
from GMOs, a proposal for post-market monitoring;

(h) a summary of the dossier;

(i)

for additives consisting of, containing or produced from
GMOs, details of the Community authorisation according
to Regulation (EC) No . . .

After

consultation of

4.
implementation of
accordance with the procedure referred to in Article 21(2).

the Authority,
this Article may be

the
for
rules
established in

Until the adoption of these implementing rules the application
shall be made in accordance with the Annex of Directive
87/153/EEC.

The Authority shall publish detailed guidance concerning
5.
the
the
preparation,
later than one year after the entry into
applications, not
force of this Regulation.

presentation,

validation

and

of

Article 9

Opinion of the Authority

The application shall be accompanied by the following

3.
particulars and documents:

The Authority shall give an opinion within six months of

1.
the receipt of a valid application.

(a)

the name and the address of the applicant;

(b) the designation of the feed additive, including a proposal
for its classification by category and functional group under
Article 7, and its specifications, including purity criteria;

(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 and, where appropriate, of
the analytical method for the determination of residues of
the feed additive in food;

(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 6(2)
and (3);

request

to supplement

The Authority may, where appropriate,

the
2.
applicant
the particulars accompanying the
application within a time limit specified by the Authority.
Where the Authority requests supplementary information, the
time limit laid down in paragraph 1 shall be suspended until
such time that the information has been provided. Likewise,
the applicant may at the request of the Authority, or on his
own initiative prepare oral or written explanations within a
specified time limit.

3.

In order to prepare its opinion, the Authority:

(a) shall verify that the particulars and documents submitted
by the applicant are in accordance with Article 8, and
undertake
to determine
whether the feed additive complies with the criteria laid
down in Article 6(2) and (3);

risk assessment

in order

a

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(b) shall verify the report of

the Community Reference

Laboratory;

The Authority shall make its opinion public, after
in

6.
deletion of any information identified as confidential
accordance with Article 18(2).

(c) shall make

the

information supplied by
Member States and to the Commission;

application and any
the

applicant

supplementary
to

available

(d) shall make the summary of

the dossier mentioned in

Article 8(3)(h) available to the public;

(e) may ask any official scientific body of the Member States
working in the field of animal nutrition to contribute to the
assessment of the feed additive.

Article 10

Authorisation by the Community

1. Within three months of receipt of the opinion of the
Authority, the Commission shall prepare a draft of the Regu-
lation to be adopted in respect of the application, taking into
account the requirements of Article 6(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.

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

4.
feed additive,
elements:

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

(a) the name and address of the applicant;

(b) the designation of the feed additive including its categori-
sation and allocation within functional groups provided for
in Article 7, its specification, including purity criteria and
method of analysis;

(c) depending on the results of the risk assessment, specific
conditions or
restrictions in relation to handling, use
levels, the proportion of incorporation when used in feed
or drinking water, and animal species and categories of
animal species for which the additive is to be used, and
post-market monitoring requirements;

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

(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 the consumers or MRLs have already been established in
Annex I or III of 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).

shall

The Authority

5.
forward its opinion to the
Commission, the Member States and the applicant, including
its assessment of the feed additive and stating the reasons for
its conclusion.

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

2.
In the event of a draft Regulation which envisages the
granting of authorisation, the draft Regulation shall include the
elements mentioned in Article 9(4)(b), (c) and (d).

3.
In the event of a draft Regulation which envisages the
granting of authorisation for additives belonging to categories
(d) and (e) referred to in Article 7(1) and also for additives
consisting of, containing or produced from GMOs, the draft
Regulation shall include the name of the authorisation holder,
and, where appropriate, the unique code attributed to the GMO
as referred to in the Regulation (EC) No . . . [of the European
Parliament and of
the Council 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].

4. Where the Commission considers that levels of residues
of an additive in food from animals fed with that additive
might have a detrimental effect on human health it shall
include in the draft Regulation Maximum Residues Limits
(MRLs) for the active substance or for its metabolites in the
relevant foodstuffs of animal origin.
In this case the active
substance shall be considered for the purposes of Council
Directive 96/23/EC (2) as
to that
Directive. Where an MRL for the substance concerned has
already been established 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 feed additive.

falling under Annex I

(1) OJ L 224, 18.8.1990, p. 1.

(2) OJ L 125, 23.5.1993, p. 10.

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The Regulation concerning the application for author-
5.
isation of a feed additive shall be adopted in accordance with
the procedure referred to in Article 21(2).

listing the priority order for the re-evaluation of the different
classes of additives may be adopted in accordance with the
procedure referred to in Article 21(2).

The Commission shall without delay inform the applicant

6.
of the decision taken.

authorisation granted in accordance with the
The
7.
laid down in this Regulation shall be valid
procedure
throughout
ten years and shall be
the Community for
renewable in accordance with Article 15. The authorised feed
additive shall be entered in the Register referred to in Article
17 (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 2 and 3.

The granting of authorisation shall be without prejudice
8.
to the general civil and criminal liability of any feed operator in
respect of the feed additive concerned.

Article 11

Status of existing products

By way of derogation from Article 4, a feed additive
1.
which has been placed on the market pursuant to Directive
70/524/EEC and an amino acid, salt of an amino acid, and
analogous substance which was listed in points 3 and 4 of
the Annex to Directive 82/471/EEC before the date referred
to in the second paragraph of Article 26 of this Regulation,
may be placed on the market and used in accordance with the
conditions specified in the entries in the annexes to Directives
70/524/EEC or 82/471/EEC relating
substance,
provided that the following conditions are met:

to that

(a) within one year of the entry into force of this Regulation,
each person who places the feed additive on the market
shall notify this fact to the Authority. This notification shall
be accompanied by the particulars mentioned in Article
8(3)(a) to (c);

3.
Products entered in the Register shall be subject to the
provisions of this Regulation, in particular Articles 13, 14, 15
and 16, which shall apply to such products as if they had been
authorised pursuant to Article 10.

4.
In case of authorisations not issued to a specific holder,
any person who imports or manufactures the products referred
the
submit
to in this Article shall
application to the Authority.

the information or

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.

Article 12

Phasing out

By derogation from Article 5 and Article 11, the placing on the
market and use as antibiotic growth promoters of the following
substances mentioned in Annex B under A of Chapters I and II
of Directive 70/524/EEC:
sodium-sali-
nomycin, flavophospholipol and avilamycin, shall be prohibited
from 1 January 2006 and, from that date, those substances
shall be deleted from the Register.

sodium monensin,

Article 13

Supervision

(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 concerned products shall be entered in the Register.
Each entry in the Register shall mention the date on which
the concerned product was first entered in the Register and,
where applicable, the expiry date of the existing author-
isation.

After an additive has been authorised in accordance with
1.
this Regulation, any person using or placing on the market that
substance, or a feedingstuff into which it has been incorporated
shall ensure that any conditions or restrictions which have
been imposed on the placing on the market, use and
the additive or feedingstuffs containing it, are
handling of
respected. Where monitoring requirements, as referred to in
Article 9(4)(c) have been imposed, the authorisation holder
shall ensure that it is carried out and shall submit reports to
the Authority in accordance with the authorisation.

2.
An application shall be submitted in accordance with
Article 8, at the latest one year before the expiry date of the
authorisation given pursuant with 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. For
the substances belonging to the category of coccidiostats, an
application shall be submitted within a maximum of four years
after the entry into force of this Regulation. A detailed calendar

2.
The authorisation holder shall forthwith communicate to
the Authority any new information that might influence the
evaluation of the safety in use of the feed additive, in particular
health sensitivities of specific categories of consumers. The
authorisation holder shall forthwith inform the Authority of
any prohibition or
restriction imposed by the competent
authority of any third country in which the feed additive is
placed on the market.

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Article 14

Modification, suspension and revocation of authorisations

1. Where, on its own initiative or following a request from a
the Authority
Member State or
concludes that an authorisation granted in accordance with
this Regulation should be modified, suspended or revoked, it
shall forthwith transmit this opinion to the Commission.

from the Commission,

2.
If the authorisation holder proposes to modify the terms
of the authorisation, he shall submit an application to the
Authority, which includes the relevant data supporting the
request for the change. The Authority shall give an opinion
on the proposal.

the feed additive and the risks of
efficacy of
additive to animals, humans or the environment;

the feed

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

The applicant shall also send to the Commission at the
3.
same time as he submits an application to the Authority the
particulars and documents referred to in paragraph 2.

The procedure set out in Articles 9 and 10 shall apply in

4.
a like manner.

3.
the
The Commission shall examine the opinion of
Authority without delay, and a final decision on the modifi-
cation, suspension or revocation of an authorisation shall be
adopted in accordance with the procedure referred to in Article
21(2).

5. 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.

4.
The Commission shall without delay inform the applicant
of the decision taken. The Register shall be amended as appro-
priate.

The implementing rules for the application of this Article
in

6.
shall be established after consultation of
the Authority,
accordance with the procedure referred to in Article 21(2).

Article 15

Renewal of authorisations

The Authority shall publish detailed guidance concerning

7.
the preparation and the presentation of the application.

1.
Authorisations under this Regulation shall be renewable
for ten-year periods, on application to the Authority by the
applicant at the latest one year before the expiry date of the
authorisation.

In case of authorisations not issued to a specific holder, any
person who imports or produces the products referred to in
this Article may submit the information or the application to
the Authority and shall be considered as the applicant.

The Authority shall acknowledge receipt of the application, in
writing, to the applicant within 15 days of its receipt. The
acknowledgement
the
application.

state the date of

receipt of

shall

The application shall be accompanied by the following

2.
particulars and documents:

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

the market;

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

(c) any other new information which has become available
with regard to the evaluation of the safety in use and the

CHAPTER III

LABELLING

Article 16

Labelling of feed additives

1.
No person shall place on the market a feed additive, a
mixture of feed additives or a premixture of additives, unless its
packaging or container bears the following information, in a
conspicuous, clearly legible and indelible manner, in relation to
each additive contained in the material:

(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 paragraph;

(c)

the net weight, or in the case of liquid additives, either the
net volume or the net weight;

(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,

regarding the use and, where applicable,
requirements mentioned in the authorisation,
animal
additive mixture or premixture of additives is intended.

and any safety recommendations
the specific
including
for which the additive,

species and categories

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.

In the case of premixtures, the word ‘PREMIXTURE’ must

3.
clearly appear on the label.

4.
Amendments to Annex III to take technical and scientific
development into account may be adopted in accordance with
the procedure referred to in Article 21(2).

CHAPTER IV

GENERAL PROVISIONS

Article 17

Community Register of Feed additives

1.
The Commission shall
Community Register of Feed additives.

establish and maintain a

2.

3.

The Register shall be made available to the public.

The Register shall be consolidated at least once a year.

Article 18

Confidentiality

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

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

Information relating to the following shall not be

3.
considered confidential:

(a) name and composition of the feed additive and, where
appropriate, indication of the substrate and the production
strain;

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

additive;

(d) effects of the feed additive on the characteristics of animal

products and its nutritional properties;

(e) methods for sampling, detection and identification of the
feed
applicable, monitoring
requirements and a summary of the results of the moni-
toring;

and, where

additive

(f)

information on waste treatment and emergency response.

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.

5.
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.

If

6.
an applicant withdraws or has withdrawn an
application, the Authority, the Commission and the Member
the confidentiality of commercial and
States shall
industrial
including research and development
information as well as information on which the Authority
and the applicant disagree as to its confidentiality.

respect
information,

Article 19

Data protection

The scientific data and other information in the application
dossier required under Article 8 may not be used for the
benefit of another applicant for a period of ten years from
the date of authorisation, unless the other applicant has
agreed with the previous applicant
such data and
information may be used. On expiry of the ten-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.

that

Article 20

Reference laboratories

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

National
accordance with the procedure referred to in Article 21(2).

laboratories may

established

reference

be

in

(c) effects of the feed additive on human and animal health

and on the environment;

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).

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Article 21

Committee

and shall take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective,
proportionate and dissuasive.

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health, established
by Regulation EC No 178/2002 of the European Parliament
laying down general principles and
and of
requirements of
food law, establishing the European Food
Safety Authority, and laying down procedures in matter of
food safety.

the Council

2. When reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be three months.

Article 22

Repeals

1.
Directive 70/524/EEC is 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 compound feedingstuffs incorporating additives.

Points 3 and 4 of the Annex of Directive 82/471/EEC are
2.
deleted with effect from the date of application of this Regu-
lation.

Directive 87/153/EEC is repealed with effect from the
3.
date of application of this Regulation. However, the Annex
to that Directive shall remain in force until the adoption of
the implementing rules provided for in Article 8(4) of this
Regulation.

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

4.
references to this Regulation.

Article 23

Penalties

The Member States shall notify those rules and measures to the
Commission at the latest six 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

submitted under Article 4 of Directive
1.
70/524/EEC before the entry into force of
this Regulation
shall be treated as applications under Article 8 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 States selected as rapporteur in
respect of such an application shall immediately transmit the
dossier submitted pursuant to that application to the Authority.

2.
The labelling requirements laid down in Chapter III of
this Regulation 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 free circulation, before the date of application of this
Regulation.

Article 25

Entry into force

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

It shall apply from [1 year after the date of publication of this
Regulation].

The Member States shall
lay down the rules on penalties
applicable to infringements of the provisions of this Regulation

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

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ANNEX I

ADDITIVE GROUPS

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

(a) preservatives: substances, including silage agents or, when applicable, micro-organisms which prolong the storage
life of feedingstuffs and feed materials by protecting them against deterioration caused by micro-organisms;

(b) antioxidants: substances which prolong 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) anticaking agents: substances that reduce the tendency of individual particles of a feedingstuff to adhere to one

another;

(h) acidity regulators: substances which adjust the pH of feedingstuffs.

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

(a) colorants:

(i) substances that add or restore colour in feedingstuffs, including natural constituents of feed materials and

natural sources which are normally not consumed as feed materials;

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

(iii) denaturants: substances which, when used for the manufacture of processed feedingstuffs, allow the identi-

fication of the origin of specific food or feed materials;

(b) flavouring and appetising compounds: natural products obtained by appropriate physical, chemical, enzymatic or
microbiological processes from materials of vegetable or animal origin, or chemically defined substances, the
inclusion of which in feedingstuffs increases feed palatability.

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

(a) vitamins;

(b) trace elements;

(c) amino acids.

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 improvers: micro-organisms forming colonies or other chemically defined substances, which, when fed

to animals, have a positive effect on the gut flora;

(c) growth promoters: chemically defined substances which, when fed to animals, improve production performance

parameters.

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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 Commission's Joint Research Centre shall be assisted by a consortium of

national reference laboratories.

The JRC shall be notably responsible for:

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

— testing and validation of the method for sampling and detection;

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

the purpose of testing and validation of the method for sampling and 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.

ANNEX III

SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN FEED ADDITIVES AND FOR PREMIXTURES

(a) Zootechnical additives: the expiry date of the guarantee or the storage life from the date of manufacture, the batch
reference number and the date of manufacture, the directions for use and, where appropriate, a safety recommen-
dation regarding the use in the case of additives which are the subject of special provisions upon authorisation.

(b) Enzymes, in addition of 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 (IUB number).

(c) Micro-organisms, in addition to the abovementioned indications: the strain identification number of colony forming

units (CFU 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.