Amended proposal for a Regulation of the European Parliament and of the Council on additives for use in animal nutrition (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2002-12-18
Institutions: European Commission
Subjects: animal feedingstuffs, animal nutrition, antibiotic, food additive, food safety, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 18.12.2002
COM(2002) 771 final

2002/0073 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

ON ADDITIVES FOR USE IN ANIMAL NUTRITION

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

EXPLANATORY MEMORANDUM

1.

BACKGROUND

–

–

–

Adoption of the proposal by the Commission on 22 March 2002 and
transmission to the Parliament and the Council on 22 March 2002 (COM
(2002) 153 final – 2002/0073(COD)), on the basis of Articles 37, and 152 (4)
(b) of the EC-Treaty.

Opinion of the European Economic and Social Committee adopted on 18
September 2002.

Opinion of the European Parliament at first reading adopted on 21 November
2002.

2.

OBJECTIVE OF THE COMMISSION PROPOSAL

The objectives of this proposal are:

1.

2.

3.

4.

to distinguish clearly between the risk evaluation (EFSA) and the risk
management (Commission and Member States),

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

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

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

3.

COMMISSION POSITION ON THE 57 AMENDMENTS ADOPTED BY THE PARLIAMENT

3.1.

Amendments accepted by the Commission

The Commission can accept 24 amendments entirely 1, 3, 4, 5, 6, 8, 12, 16, 17, 18,
19, 21, 24, 25, 26, 29, 31, 34, 38, 41, 43, 44, 45 and 47, as these amendments
improve or bring more clarification to the Commission’s initial proposal.

•

Status of coccidiostats - Inclusion of histomonostats- Report of use of
coccidiostats

Amendment n° 17 concerning Article 3(2) and 24 on Article 7(1) propose to
treat histomonostats in the same way as of coccidiostats, thus maintaining these
two groups within the framework of the feed additives legislation. The
Commission can accept this amendment. In this case, this inclusion brought
clarification of the concept of coccidiostats. Amendment n° 31 concerning
Article 11(2) asks the Commission to present a report on the use of
coccidiostats and histomonostats before 1 January 2008. The Commission can
accept
this amendment, and the report will contain valuable information,
concerning the use of coccidiostats, in view of a decision on the final fate of

2

these substances as additives or as veterinary drugs. The Commission considers
that this report will be an important element for taking a decision to keep or to
delete the coccidiostats from the register.

•

Flexibility of the authorisation procedure

Some amendments n°4, 5, 8 aim to ensure more flexibility in the authorisation
procedure, in particular the extension to minor species and the extension to
further categories of animals and have been included in the new recitals 9a, 10a
or in recital 15.

Specific conditions for data protection when applying for authorisations for
minor species are included in amendment n° 44 (Article 9(2)).

Amendments 45 and 47 include other additive groups in the technological (45)
and zootechnical (47) categories, these additional groups are acceptable and
have been included in Annex I (points 1 and 4).

Clarification of the authorisation procedure

Several amendments n° 12, 16, 19, 21, 34, 38 aim to clarify the Commission
proposal regarding the authorisation procedure, in particular concerning the
steps and delays to be followed by the applicant, the Commission and the
these amendments. These
EFSA. In general,
amendments have been incorporated respectively in Article 2(1), Article 3f,
Article 4(2b), Article 6(2 b and c), Article 11(5b) and Article 15(2) c.

the Commission can accept

Improvement of transparency and traceability

Amendment n° 29, which is included in Article 9(3 d), amendment 41 in
Article 16 (1b) and amendment 43 in Article 16(1f) improve the traceability of
additives and facilitate communication during the authorisation procedure.

Specific requirements for pets

Amendment n° 1 included in recital 3 and amendment 26 in Article 8 (4) 1st
indent
food are
appropriate. Taking into account that pets do not enter the human food chain,
such exclusive rules may be adopted for pets.

indicates that specific provisions for additives in pet

Mixtures of feedingstuffs to be sold directly to the final user

included in Recital 6a, covers mixtures of nutritional
Amendment n°3,
additives, which can be sold to the end user under the condition that the
marketing and the use of those mixtures follow the requirements laid down in
the authorisation of each single additive. Nutritional additives can be sold to
the end user on condition that
the provisions of use laid down in the
authorisation Regulation allow it.

•

•

•

•

3.2.

Amendments accepted in principle, in part and/or subject to re-wording

The Commission can accept 2 amendments in part only (33 and 35) and 5
amendments subject to re-wording (13, 20, 28, 32 and 36).

3

••••

Extension to other substances

•

•

Amendment n°33, which is incorporated in Article 11(5b) foresees in its first
part, an extension for silage agents. This extension can be accepted because the
scope of Directive 70/524/EEC is vague and therefore there is no uniform
application in the MS concerning silage agents.

Furthermore, amendment n°13 concerning Article 2(1) includes substances of
animal or vegetable origin in the scope of this proposal and clarifies the
Commission’s text.

Phasing out of antibiotics used as growth promoters

Amendment n°35 (1) second part is incorporated in Article 12 and indicates
that the antibiotics used as growth promoters still authorised on the date of
entry into force of the Regulation shall be deleted from the Register from that
date. This amendment is totally in line with the Commission’s strategy of
banning the last remaining antibiotics.

Improvement of transparency

Amendment n° 28 (Article 9(2)) improves the transparency of the procedure. It
is important that the applicant is involved in all decisions concerning his
application and particularly concerning the time frame of the risk assessment
and the provision of new information. The Commission accepted the spirit of
this amendment but prefers a more appropriate wording.

Amendment n° 36 is incorporated in Article 14 (1) and improves also the
communication to the public. The Commission accepted this amendment
taking into account that the confidentiality precautions laid down also apply.

3.3.

Amendments not accepted by the Commission

The Commission cannot accept the following amendments: 2, 7, 9, 10, 11, 15, 22,
27, 30, 35 (1) - first part, 37, 39, 40, 42, 46, 48, 51, 53, 54, 55, 56 and 57.

The Commission considers that many of these amendments would undermine the
aim to sustain the overall Community legislation as more transparent, less complex
and efficient.

4.

TECHNICAL AMENDMENTS

Certain technical changes have been made to the text to ensure its conformity with
the Interinstitutional Agreement of 22 December 1998 on common guidelines for the
quality of drafting of Community legislation (OJ C 73, 17.3.1999, p. 1), drawn up
pursuant to Declaration No 39 annexed to the Final Act of Amsterdam on the quality
of the drafting of Community legislation. In accordance with points (b) and (g) of
that Agreement, the text has been revised to take account of the common guidelines
and the Joint Practical Guide drawn up under point (a) thereof.

4

2002/0073 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

ON ADDITIVES FOR USE IN ANIMAL NUTRITION

(Text with EEA relevance)

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 Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the procedure laid down in Article 251 of the Treaty

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

1

2

3

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

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

In order to protect human health, animal health and the environment, feed additives
should undergo a safety assessment through a Community procedure before being
placed on the market, used or processed within the Community. Since pet food is not
part of the human food chain and has no environmental impact on arable land,
specific provisions for additives in pet food are appropriate

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

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

Experience with the application of Council Directive 70/524/EEC of 23 November
1970 concerning additives in feedingstuffs4 has shown that it is necessary to review all

OJ C [….], […], p. […].
OJ C [….], […], p. […].
OJ C [….], […], p. […].

5

the rules on additives to take into account the need to ensure a greater degree of
protection of animal and human health and of the environment. It is also 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.

(6a)

The measures provided for by this Regulation should also cover mixtures of
nutritional additives sold to the end user and the marketing and use of those
mixtures should comply with the conditions laid down on the authorisation of
each single additive.

(7)

(8)

(9)

(9a)

(10)

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.

Categories of feed additives should be defined in order to facilitate the assessment
procedure in view of the authorisation. Amino acids which are currently covered by
Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in
animal nutrition5 should be included as a category of feed additives, and therefore
transferred from the scope of that Directive to this Regulation.

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 (MRL’s).

The guidelines for the authorisation of feed additives should be established by the
Commission in co-operation with the EFSA. In establishing these guidelines,
attention should be paid to the possibility to extrapolate the results of the studies
carried out on major species to minor species.

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
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.

(10a) The effort required in order to obtain authorisation for an additive is, in certain
cases, so prohibitive as to deter applicants from generating scientific data for
“minor species”. In order to ensure the necessary level of protection for animal
welfare and consumer safety, applicants
should be encouraged to seek
authorisation extensions for minor species by being granted one year’s additional
data protection in addition to the 10 years’ data protection for all species for
which the additive is authorised.

(11) Competence for authorising feed additives and establishing conditions for their use
and for maintaining and publishing a register of authorised feed additives should be
conferred on the Commission according to the procedure by which a close

4

5

OJ L 270, 14.12.1970, p. 1.
OJ L 213, 21.7.1982, p. 8.

6

collaboration between Member States and the Commission is guaranteed in the
framework of Standing Committee on the Food Chain and Animal Health.

(12)

It is necessary to introduce, where appropriate, an obligation 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.

(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
authorisations will allow this review.

(14) A register of authorised feed additives should be established,

including product
specific information and sampling and detection methods. Non-confidential data
should be made available to the public.

(15)

(16)

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 well as for additives for which
the authorisation procedure is in progress. It is also necessary to provide for a
simplified authorisation procedure for those additives, which have 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 consumption6.

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 anti-microbial resistance
adopted on 10-11 May 2001 confirmed the need to provide a sufficient time to replace
those antimicrobials by alternative products: “Thus, the phase-out process must be
planned and co-ordinated since precipitous actions could have repercussions for
animal health”. Therefore, it is necessary to set a date after which the use of the
antibiotics still authorised for use as growth promoting agents will be forbidden, while
allowing sufficient time for the development of alternative products to replace those
antibiotics. Provision should also be made to forbid the authorisation of any further
antibiotics for use as feed additives.

(17) Certain substances with coccidiostatic effects should be considered as feed additives

for the purpose of this Regulation.

(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

6

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

7

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 it enables the final user to
make a choice in full knowledge of the facts and creates fewest obstacles to trade and
facilitates fairness of transactions.

(20) Regulation (EC) No …/… of the European Parliament and of the Council on
genetically modified food and feed7 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, subject
to the outcome of the report provided for in Article 45 of
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28
January 2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority, and laying down procedures in
matters of food safety8.

(22) 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 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 or States concerned.

(23)

(24)

Technological progress and scientific developments should be taken into account
when implementing this Regulation.

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 Commission9, they should be adopted by use of the regulatory
procedure provided for in Article 5 of that Decision.

(25)

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

(26) Council Directive 70/524/EEC of 23 November 1970 concerning additives in
feedingstuffs 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

7

8

9

OJ L […], […], p. […].
OJ L 31, 28.1.2002, p. 1.
OJ L 184, 17.7.1999, p. 23.

8

feedingstuffs10 is completed. Points 3 and 4 of the Annex of Directive 82/471/EEC
should be deleted in order to enable the transfer of amino acids and their salts to this
Regulation.

(27)

Since the task of verification of the conformity of dossiers is conferred to the
European Food Safety Authority,
is necessary to repeal Council Directive
87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in
animal nutrition11. Certain provisions of that Directive should be kept in place, until
implementing rules have been adopted.

it

(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
authorised should be permitted to remain on the market and be used under the
conditions of the current legislation,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT-MATTER, SCOPE AND DEFINITIONS

Article 1
Subject matter

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

Article 2
Scope

This Regulation shall apply to chemically defined or described 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”.

This Regulation shall not apply to:

(a)

processing aids, nor to technological but unavoidable residues of processing
aids in the final product;

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

9

1.

1.

2.

10

11

(b)

veterinary medicinal products as defined in Directive 2001/82/EC of the
European Parliament and of the Council12.

3.

Where necessary, it may be determined, in accordance with the procedure referred to
in Article 21 (2), whether a substance or a microorganism is a feed additive within
the scope of this Regulation.

Article 3
Definitions

For the purpose of this Regulation,
the definitions of “feed” or “feedingstuff”, “feed
business”, ”feed business operator”, “placing on the market” and “traceability” laid down in
Regulation (EC) No 178/2002 shall apply.

The following definitions shall also apply:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

12

13

14

“feed materials” means products as defined in Article 2(a) of Council Directive
96/25/EC13 ;

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

“premixtures of feed additives” means mixtures 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 establishments registered or
approved according to Council Directive 95/69/EC14;

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

“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
feedingstuffs by
themselves, 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; which may result in the unintentional but technically
unavoidable presence of residues of the substances or their derivatives in the
final product, provided that those residues do not present any health risk and
do not have any technological effect on the finished feed;

“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;

OJ L311, 28.11.2001,p. 1.
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).
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).

10

(h)

(i)

(j)

(ja)

“antibiotic” means antimicrobial produced by or derived from a micro-organism,
which destroys or inhibits the growth of other micro-organisms;

“maximum residue limit” means the maximum concentration of residue resulting
from the use of an additive in animal nutrition which may be accepted by the
Community to be legally permitted or recognised as acceptable in or on a food;

“growth promoter” means a chemically defined substance which, when fed to
animals, improves production performance parameters,

‘coccidiostats and histomonostats’ means substances with a coccidiostatic or
histomonal effect.

CHAPTER II

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

Article 4
Placing on the market, processing and use

1.

No person shall place on the market, process or use a feed additive unless:

a)

b)

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

the conditions for use set out in this Regulation and in the authorisation of the
substance are met; and

c)

the conditions on labelling set out in this Regulation are met.

2.

(a) 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 antibiotics, provided the experiments are
carried out in accordance with the principles and conditions laid down in
Directive 87/153/EEC, Council Directive 83/228/EEC15 or the guidelines in
Article 8(4) and provided that there is adequate official supervision. The
animals concerned may only be used for food production if the authorities
establish that no health risk exists.

(b) Unless otherwise specified, the mixing of nutritional additives to be sold
directly to the end user will be allowed, when respecting the conditions for
use laid down in the authorisation for each single additive. Consequently,
the mixing of authorised additives shall not be subject
to specific
authorisations other than the requirements provided under Council
Directive 95/69/EEC16.

15

16

OJ L 126, 13.5.1983, p.23.
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).

11

(c)

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 granting authorisation pursuant to Article 10 of this Regulation, or a
person acting under his written authority.

Article 5
Authorisation

1.

2.

3.

1.

Any person seeking an authorisation for a feed additive shall submit an application in
accordance with Article 8.

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

The applicant for an authorisation shall be established in the Community.

Article 6
Conditions for authorisation

No feed additive shall be authorised unless the applicant for such authorisation has
adequately and sufficiently demonstrated, according to guidelines provided for in
Article 8(4), that, when used in accordance with conditions to be set out in the
it satisfies the requirements of
Regulation authorising the use of the additive,
paragraph 2 of this Article, and has at least one of the characteristics set out in
paragraph 3.

2.

The feed additive must not:

(a)

present a risk to animal health, human health or the environment,

(b)

be presented in a manner which may mislead the user,

(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.

3.

The feed additive must :

(a)

favourably affect the characteristics of feed,

(b)

favourably affect the characteristics of animal products,

(c)

satisfy the nutritional needs of animals,

(d)

favourably affect the environmental consequences of animal production.

4.

Antibiotics shall not be authorised as feed additives.

12

5.

1.

2.

3.

1.

2.

3.

By derogation from paragraph 4, coccidiostats presented for continuous use mixed in
feed or drinking water are considered as feed additives for the purpose of this
Regulation.

Article 7
Categories of feed additives

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:

(a)

(b)

technological additives: any substance added to feed for a technological
purpose;

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

(e)

coccidiostats and histomonostats.

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

Where necessary, as a result of scientific progress or technological 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

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”.

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

in writing,

The application shall be accompanied by the following particulars and documents:

(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, where appropriate;

13

(c)

(d)

(e)

(f)

(g)

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 ;

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);

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

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
in
Article 20 for the purpose of validation of the method of analysis,
accordance with the requirements set out in Annex II;

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 [ …/…].

4.

After consultation of the Authority, specific guidelines for the authorisation of
additives shall be established for each category of additive referred to in Article
7 (1) in accordance with the procedure referred to in Article 21(2). Those
guidelines shall take account of the possibility of extrapolating the results of the
studies carried out on major species to minor species.

After consultation of the Authority, further rules for the implementation of this
Article may be established in accordance with the procedure referred to in Article
21(2).Those implementing rules shall, where appropriate, differentiate between
standards for feed additives in respect of animals for food production and
standards in respect of other animals, in particular pets. The implementing
rules shall include provisions which allow for simplified procedures for the
authorisation of additives which have been authorised for use in food.

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

5.

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

14

Article 9
Opinion of the Authority

1.

2.

The Authority shall give an opinion within six months of the receipt of a valid
application.

The Authority may, where appropriate, request the applicant to supplement
the
particulars accompanying the application within a time limit specified by the
Authority, after consultation with the applicant. Where the Authority requests
supplementary information,
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.

the 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 shall undertake a risk assessment in order to
determine whether the feed additive complies with the criteria laid down in
Article 6(2) and (3);

(b)

shall verify the report of the Community Reference Laboratory.

(c)

(d)

shall make the application and any supplementary information supplied by the
applicant available to Member States and to the Commission;

shall make the summary of the dossier mentioned in Article 8 (3) (h) available
to the public, without prejudice to the confidentiality requirements laid
down in Article 18(2)

(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.

4.

In the event of an opinion in favour of authorising the feed additive, the opinion shall
also include the following elements:

(a)

the name and address of the applicant;

(b)

(c)

(d)

(e)

the designation of the feed additive including its categorisation and allocation
within functional groups provided for in Article 7, its specification, including
purity criteria and method of analysis;

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;

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

a proposal for the establishment of Maximum Residues Limits (MRLs) in the
relevant foodstuffs of animal origin, unless the opinion of the Authority

15

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 to
Council Regulation (EC) No 2377/9017.

The Authority shall 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.

The Authority shall make its opinion public, after deletion of any information
identified as confidential in accordance with Article 18(2).

Article 10
Authorisation by the Community

Within three months of receipt of the opinion of the Authority, the Commission shall
prepare a draft of the Regulation 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.

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.

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

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).

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]18.

Where the Commission considers that levels of residues of an additive in food
obtained 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/EC19 as falling under Annex I 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.

OJ L 224, 18.8.1990, p. 1. Regulation last amended by Commission Regulation (EC) No 1937/2002 (OJ
L 297, 31.10.2002, p. 3).
OJ L …..,
OJ L 125, 23.5.1993. p. 10.

16

5.

6.

1.

2.

3.

4.

17

18

19

5.

6.

7.

8.

1.

2.

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

The Commission shall without delay inform the applicant of the decision taken.

The authorisation granted in accordance with the procedure laid down in this
Regulation shall be valid throughout the Community for ten years and shall be
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 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 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 25 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 to that substance, provided that the following conditions are met:

(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), (b) and (c);

(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
authorisation.

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 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). For the 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.

17

Before 1 January 2008, the Commission shall submit a report on the use of these
substances as feed additives.

For additives authorised without a time limit, a list of those additives which
require re-evaluation and their priority order for re-evaluation shall be adopted
in accordance with the procedure referred to Article 21 (2). The Authority shall
be consulted in drawing up the list.

Products entered in the Register shall be subject to the provisions of this Regulation
in particular Articles 13, 14, 15, 16 and 21, which shall apply to such products as if
they had been authorised pursuant to Article 10.

In case of authorisations not issued to a specific holder, any person who imports or
manufactures the products referred to in this Article shall submit the information
that is to accompany notification pursuant to paragraph 1 or the application
referred to in paragraph 2 to the Authority or the application to the Authority.

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,

Paragraphs 2 to 5 shall also apply to chemically defined substances, enzymes
and micro-organisms used as silage agents. For these substances, the deadline
for application as referred to in paragraph 2 shall be seven years after the entry
into force of this Regulation.

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

shall automatically be extended until

the product

3.

4.

5.

5a

5b

Article 12
Phasing out

By derogation from Article 5 and Article 11, from 1 January 2006 the placing on the market
and use of antibiotic growth promoters of the following substances mentioned in Annex B
under A of Chapters I and II of Directive 70/524/EEC: sodium monensin, sodium-
salinomycin, flavophospholipol and avilamycin, shall be prohibited and any antibiotic
growth promoters which are still authorised when this Regulation enters into force and,
from that date, those substances shall be deleted from the Register.

Article 13
Supervision

1.

After an additive has been authorised in accordance with this Regulation, any person
using or placing on the market that substance, or a feedingstuff into which it has been

18

2.

1.

2.

3.

4.

1.

incorporated 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. 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.

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.

Article 14
Modification, suspension and revocation of authorisations

Where, on its own initiative or following a request from a Member State or from the
Commission, the Authority 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. The Authority shall on its own initiative
or following a request from a Member State or the Commission, deliver an
opinion on compliance with the conditions laid down in this Regulation. It shall
forward this opinion to the Commission, the authorisation holder and the
Member States. The opinion shall be made public, in accordance with the
confidentiality requirements laid down in Article 18(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 Commission shall examine the opinion of the Authority without delay, and a
final decision on the modification, suspension or revocation of an authorisation shall
be adopted in accordance with the procedure referred to in Article 21(2).

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

Article 15
Renewal of authorisations

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.

19

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

in writing,

2.

The application shall be accompanied by the following particulars and documents:

(a)

a copy of the authorisation for placing the feed additive on the market;

(b)

(c)

a report on the results of the post-market monitoring,
requirements are included in the authorisation;

if such monitoring

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

(d) where appropriate, a proposal for amending or complementing the conditions
inter alia the conditions concerning future

of the original authorisation,
monitoring.

The applicant shall also send to the Commission at the 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 a like manner.

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. The
Commission shall inform the applicant of this extension of the authorisation.

The implementing rules for the application of this Article shall be established after
consultation of the Authority, in accordance with the procedure referred to in Article
21 (2).

The Authority shall publish detailed guidance concerning the preparation and the
presentation of the application.

Chapter III

LABELLING

Article 16
Labelling of feed additives

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 preceded, by the
name of the functional group as mentioned in the authorisation ;

20

3.

4.

5.

6.

7.

1.

(b)

the name or business name and the address or registered place of business in
the Community of the person responsible for the 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 of Directive 95/69/EC or the registration
number assigned to the establishment or the intermediary pursuant to Article
10 of that Directive;

(e)

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

(f)

the batch reference number and the date of manufacture.

In addition to the information specified in paragraph 1, the packaging or container of
an additive belonging to a functional 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 clearly appear on the
label.

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

The Commission shall establish and maintain a Community Register of Feed
additives.

The Register shall be made available to the public.

The Register shall be consolidated at least once a year.

2.

3.

4.

1.

2.

3.

21

1.

2.

3.

4.

5.

6.

1.

Article 18
Confidentiality

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 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 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;

(c)

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

(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 additive and,
where applicable, monitoring requirements and a summary of the results of the
monitoring;

(f)

information on waste treatment and emergency response.

Notwithstanding paragraph 2,
supply the
Commission and Member States with all information in its possession, including any
identified as confidential pursuant to paragraph 2.

the Authority shall, on request,

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

the Authority,

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 that 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

22

scientific data and information contained in the application dossier may be used by
the Authority for the benefit of another applicant.

2.

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

In specific cases where urgent approval is needed to ensure the protection of
animal welfare, the Commission may, by special derogation, provisionally
authorise the use of an additive for a maximum period of 5 years, with the
possible extension of authorisation subject to a satisfactory outcome of the post-
approval monitoring programme.

Article 20
Reference laboratories

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

National reference laboratories may be established in accordance with the procedure referred
to in Article 21 (2).

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).

Article 21
Committee

The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal Health, established by Regulation (EC) No 178/2002.

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 1999/468/EC shall be three
months.

Article 22
Repeals

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 deleted with effect from the
date of application of this Regulation.

1.

2.

3.

1.

2.

23

3.

4.

Directive 87/153/EEC is repealed with effect from the 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 references to this
Regulation.

Article 23
Penalties

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

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

Article 24
Transitional measures

1.

2.

Applications submitted under Article 4 of Directive 70/524/EEC before the entry into
force of this Regulation shall be treated as applications under Article 8 of this
Regulation 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.

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]

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

24

ANNEX I

ADDITIVE GROUPS

1.

In the category “technological additives”,
included:

the following functional groups are

a)

b)

c)

d)

e)

f)

g)

h)

i)

j)

substances,

Preservatives:
including silage agents or, when applicable,
microorganisms which prolong the storage life of feedingstuffs and feed
materials by protecting them against deterioration caused by micro-organisms.

Antioxidants: substances which prolong the storage life of feedingstuffs and
feed materials by protecting them against deterioration caused by oxidation.

Emulsifiers:
homogeneous mixture of two or more immiscible phases in feedingstuffs.

substances that make it possible to form or maintain a

Stabilisers: substances which make it possible to maintain the physico-
chemical state of feedingstuffs.

Thickeners: substances which increase the viscosity of feedingstuffs.

Gelling agents: substances which give a feedingstuff texture through the
formation of a gel.

Anticaking agents: substances that reduce the tendency of individual particles
of a feedingstuff to adhere to one another.

Acidity regulators: substances which adjust the pH of feedingstuffs.

Binders:
feedingstuffs to adhere.

substances, which increase the tendency of particles of

Coagulants:
feedingstuffs.

substances, which increase

the

viscosity

of

liquid

2.

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

a)

Colorants:

i)

ii)

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;

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 identification of the origin of specific
food or feed materials;

25

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)

b)

c)

Vitamins;

Trace elements;

Amino acids;

4.

In the category “zootechnical additives”,
included:

the following functional groups are

a)

b)

c)

d)

Digestibility enhancers: substances which, when fed to animals, increase the
digestibility of the diet, through action on target feed materials.

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.

Growth promoters: chemically defined substances which, when fed to animals,
improve production performance parameters.

substances which have a positive effect on the environmental impact of
animal production.

26

ANNEX II

DUTIES AND TASKS OF THE COMMUNITY REFERENCE LABORATORY

1.

2.

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

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.

27

ANNEX III

SPECIFIC LABELLING REQUIREMENTS FOR CERTAIN FEED ADDITIVES AND
FOR PREMIXTURES

a)

b)

c)

d)

e)

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 recommendation regarding the use
in the case of additives which are the subject of special provisions upon
authorisation;

Enzymes, in addition of the above mentioned indications: the specific name of the
in
active component or components in accordance with their enzyme activities,
conformity with the authorisation given, the International Union of Biochemistry
identification number (IUB number);

Micro-organisms,
identification number of colony forming units (CFU per gram);

in addition to the above mentioned indications: the strain

Nutritional additives: the active-substance level and the expiry date of the guarantee
of that level or storage life from the date of manufacture;

Technological and sensory additives: the active-substance level.

28