(OJ No L270, 14.12.1970)
1. This Directive shall apply to additives in feedingstuffs.
2. This Directive shall not apply to processing aids used
deliberately as substances in the processing of feed materials or of
feedingstuffs in order to achieve a certain technological objective
during treatment or processing which may result in the unintentional
but technically unavoidable presence of residues of the substances or
their derivatives in the final product, provided that these residues
do not present any health risk and do not have any technological
effect on the finished product.
3. Provided they are not products specially enriched with substances corresponding to additives, substances present in their natural state in feed materials which are part of the normal composition of feedingstuffs and which correspond to a substance authorized under this Directive shall not be regarded as additives.
For the purposes of this Directive the following definitions shall
apply:
(a) additives: substances or preparations used in animal nutrition
in order to:
- affect favourably the characteristics of feed materials or of
compound feedingstuffs or of animal products; or
- satisfy the nutritional needs of animals or improve animal
production, in particular by affecting the gastro-intestinal flora or
the digestibility of feedingstuffs; or
- introduce intro nutrition elements conducive to attaining
particular nutritional objectives or to meeting the specific
nutritional needs of animals at a particular time; or
- prevent or reduce the harmful effects caused by animal excretions
or improve the animal environment;
(aa) "micro-organisms": forming colonies; micro-organisms
(aaa) additives subject to authorization linked to the person
responsible for putting them into circulation the additives listed in
Part I of Annex C;
(aaaa) other additives: additives not subject to authorization
linked to the person responsible for putting them into circulation
and referred to in Part II of Annex
C;]1
[(b) Feedingstuffs: products of vegetable or animal
origin in their natural state, fresh or preserved, and products
derived from the industrial processing thereof, and organic or
inorganic substances, used singly or in mixtures, whether or not
containing additives, for oral animal feeding;
(c) Daily ration: the average total quantity of
feedingstuffs, calculated on a moisture content of 12 %, required
daily by an animal of a given species, age category and yield, to
satisfy all its needs;
(d) Complete feedingstuffs: mixtures of feedingstuffs
which, by reason of their composition, are sufficient for a daily
ration;
(e) Supplementary feedingstuffs: mixtures of feedingstuffs
which have a high content of certain substances and which, by reason
of their composition, are sufficient for a daily ration only if they
are used in combination with other
feedingstuffs;]2
[(f) feed materials: various products of vegetable or animal
origin, in their natural state, fresh or preserved, and products
derived from the industrial processing thereof, and organic or
inorganic substances, whether or not containing additives, which are
intended for use in oral animal feeding either directly as such or
after processing, in the preparation of compound feedingstuffs or as
carriers of premixtures, hereinafter referred to as "feed
materials";]1
[(g) Compound feedingstuffs: mixtures of products of vegetable
or animal origin in their natural state, fresh or preserved, or
products derived from the industrial processing thereof, or organic
or inorganic substances, whether or not containing additives, for
oral animal feeding in the form of complete feedingstuffs or
supplementary feedingstuffs;
(h) Premixtures: mixtures of additives or mixtures of one or more
additives with substances used as carriers, intended for the
manufacture of feedingstuffs;
(i) Animals: animals belonging to species normally
nourished and kept or consumed by man;
(j) Pet animals: animals belonging to species normally nourished
and kept, but not consumed, by man, except animals bred for
fur;]2
[(k) "putting into circulation" or "circulation": the holding
of products for the purposes of sale, including offering for sale, or
any other form of transfer, whether free or not, to third parties,
and the sale and other forms of transfer themselves;
(l) person responsible for putting into circulation: the natural or legal person who has responsibility for the conformity of the additive which has been granted Community authorization and for putting it into circulation.
Member States shall require that no additive may be put into circulation unless a Community authorization has been granted. This authorization shall be granted under a Commission regulation in accordance with the procedure laid down in Article 4.
Community authorization of an additive shall be given only if:
(a) when used in animal nutrition it has one of the effects
referred to in Article 2 (a);
(b) taking account of the conditions of use, it does not adversely
affect human or animal health or the environment, nor harm the
consumer by impairing the characteristics of animal products,
(c) its presence can be monitored:
- as an additive per se,
- in premixtures,
- in feedingstuffs or, where appropriate, in feed materials;
(d) at the level permitted, treatment or prevention of animal
disease is excluded; this condition shall not apply to additives
belonging to the group of coccidiostats and other medicinal
substances;
(e) for serious reasons concerning human or animal health its use must nor be restricted to medical or veterinary purposes.
1. In order to obtain the Community authorization for a substance
or a preparation as an additive or for a new use in the case of an
already authorized additive, the applicant for authorization shall
select a Member State to act as rapporteur during the scrutiny
procedure on the dossier he has compiled in accordance with the
provisions of Council Directive 87/153/EEC of 16 February 1987 fixing
guidelines for the assessment of additives in animal nutrition (OJ No
L 64, 7. 3. 1987, p. 19. Directive as last amended by Directive
95/11/EC (OJ No L 106, 11. 5: 1995, p. 23)). Where the applicant is
established in a third country, he must have a representative in the
Community.
2. The Member State acting as rapporteur shall check that:
(a) the dossier has been compiled in accordance with Directive
87/153/EEC;
(b) the substance or preparation, according to the information
given, appears to meet the conditions laid down in Article 3a.
3. The applicant for Community authorizarion shall dispatch to the
Commission, via the Member State acting as rapporteur, an application
accompanied by the dossier, sending copies to the other Member
States, which shall acknowledge receipt at the earliest opportunity.
That dispatch shall be affected no later than one year after the date
of submission of the applicant's dossier in the Member State acting
as rapporteur, unless the latter is rejected or postponed. The Member
State acting as rapporteur shall inform the applicant, the other
Member States and the Commission of the reasons for rejection or
postponement of the dossier.
4. Member States shall have a period of sixty days from the date
on which the dossier was dispatched to them in which to check whether
the dossier has been compiled in accordance with Directive 87/153/EEC
and, where appropriate, to submit their comments in writing to the
Commission and the other Member States.
If, on expiry of the period referred to in the first paragraph, no
objection has been made, the representative of the Commission shall
have a period of thirty days in which to include the authorization
application on the agenda for the Standing Committee for
Feedingstuffs.
5. If, after consultation of the Standing Committee for
Feedingstuffs, it is deemed that the rules on presentation of
dossiers have not been complied with, a representative of the
Commission shall so notify the applicant for authorization to put
into circulation and the Member State acting as rapporteur; where
necessary, a new application must be submitted in accordance with the
above provisions.
6. The Commission shall ensure that a decision is taken, in
accordance with the procedure laid down in Article 23 on the
application for Community authorization within 320 days following its
inclusion on the agenda for the Standing Committee for Feedingstuffs
in accordance with the second subparagraph of paragraph 4. However,
this time limit shall be interrupted where a request is made for
additional information by a Member State in the Standing Committee
for Feedingstuffs, or at the request of the Scientific Committee for
Animal Nutrition.
Where an application for Community authorization to put an additive into circulation is rejected or the decision on it is postponed, a representative of the Commission shall inform the applicant for authorization and the Member State acting as rapporteur of the reasons for the rejection or postponement of the decision
Article 5
Amendments to Directive 87/153/EEC:
- which arise from developments in scientific and technical
knowledge and
- rake account of the provisions of Article 9b (1), Article 9c (3),
Article 9o and Article 9q (5)
shall be adopted in accordance with the procedure laid down in Article 23.
Article 6
1. A fee may be charged, according to the additive groups and the
nature of the Community authorization requested, by the Member State
acting as rapporteur for the examination of dossiers arising from the
obligations laid down in Articles 4 (2), 9b (l), 9c (3) and 9g (4).
This fee shall be paid at the time of submission of the
dossier.]1
[2. Before l October 1999, the Council, acting by a qualified majority on a proposal from the Commission, shall adopt rules for the calculation of the level of the fee referred to in paragraph 1.]3
[Article 7
1. Member States and the Commission shall ensure that any
information which, if disseminated, could affect industrial and
commercial property rights is kept confidential.
2. Confidentiality shall not apply to:
- the name and composition of the additive,
- the physico-chemical and biological characteristics of the
additive,
- the interpretation of the pharmacological, toxicological and
ecotoxicological data relating to the additive,
- the analytical methods for monitoring the additive itself and
the additive in premixtures, in the feedingstuffs and, where
appropriate, in feed materials,
- the methods for testing for residues of the additive or metabolites
thereof in animal products.
Article 7a
If an additive contains or consists of genetically modified
organisms within the meaning of Article 2 (1) and (2) of Council
Dircctive 90/220/EEC of 23 April 1990 on the deliberate release into
the environment of genetically modified organisms (OJ No L 117, 8. 5.
1990, p. 15. Directive as last amended by Directive 94/15/EC (OJ No L
103, 22. 4. 1994, p. 20)), a specific environmental risk assessment
similar to that laid down in the abovementioned Directive shall be
carried out; for this purpose, the following documents shall be
included in the dossier submitted pursuant to Article 4 of this
Directive in order to ensure compliance with the principles set our
in Article 3a:
- a copy of any written consent or consents of the competent
authorities to the deliberate release into the environment of
genetically modified organisms for research and development purposes
pursuant to Article 6 (4) of Directive 90/220/EEC and the result of
the release(s) with respect to the risk in each case to human health
and the environment,
- the complete technical dossier supplying the information
requested in Annexes II and III to Directive 90/220/EEC and the
environmental risk assessment resulting from this information; the
results of any investigations performed for the purposes of research
or development.
Articles 11 to 18 of Directive 90/220/EEC shall not apply to additives consisting of or containing generically modified organisms.
Article 8
1. The Scientific Committee for Animal Nutrition established by
Commission Decision 76/791/EEC (OJ No L 279, 9. 10. 1976, p. 35.
Decision as amended by Decision 86/lO5/EEC (OJ No L 93, 8. 4. 1986,
p. 14)) shall he responsible for assisting the Commission, at the
latter's request, on all scientific questions relating to the use of
additives in animal nutrition.
2. At the request of the Commission, the Member State acting as rapporteur shall ensure that all or part of the dossier referred to in Article 4 is officially forwarded to the members of the Committee referred to in paragraph 1.
Additives as referred to in Article 2 (aaa) which meet the conditions laid down in Article 3a shall be authorized and included in Chapter I of the list referred to in Article 9t (b).
1. In the case of the additives referred to in Article 2 (aaa),
provisional authorization may be given at Community level for the use
of a new additive or a new use of an additive already authorized,
provided that the conditions laid down in Article 3a (b), (c), (d)
and (e) are met and it is reasonable to assume, in view of the
available results, that the other condition laid down in Article 3a
(a) is also met. These additives shall be included in Chapter II of
the list referred to in Article 9t (b).
2. Provisional authorization as referred to in paragraph 1 may not exceed four years from the date on which it rakes effect
1. Community authorization of additives referred to in Article 2
(aaa) shall be valid for 10 years from the date on which final
authorization takes effect and shall be renewable for 10-year
periods. In the event of renewal, the authorization holder shall send
to the Commission, via the Member State acting as rapporteur, an
application accompanied by a dossier complying with the provisions to
be laid down for the renewal of authorizations for additives in
Directive 87/133/EEC. The application and the dossier shall be sent,
at least one year before the date of expiry of the authorization, to
the Commission, which shall acknowledge receipt thereof at the
earliest opportunity. A copy of the renewal application, together
with the dossier, shall be officially forwarded by the authorization
holder via the Member State acting as rapporteur to the other Member
States, which shall acknowledge receipt thereof at the earliest
opportunity.
2. Articles 3, 3a, 4, 7, and 7a shall apply mutatis mutandis
to applications for renewal.
3. Where, for reasons beyond the control of the authorization holder, no decision may be taken on the renewal application before the expiry date of the authorization, the period of authorization of the additive shall be automatically extended until the Commission takes a decision.
1. In the case of the additives referred to in Article 2 (aaa),
the scientific data and other information in the initial dossier
submitted for the purpose of the first authorization may not be used
for the benefit of other applicants for a period of 10 years:
(a) from the date on which the first authorization by means of
regulation takes effect for the additives referred to in Article 9g
(I ), Article 9h (1) and Article 9i (1), or
(b) for other additives from the data on which the first
authorization by means of regulation takes effect or counting from 1
October 1999 if the latter date of taking effect is earlier,
unless the applicant has agreed with the authorization holder that
such data and information may be used.
During this period, however, authorizations for putting into
circulation may be granted to persons other than the person
responsible for first putting the additive into circulation provided
that the conditions in Articles 3a and 4 are met.
2. Where additional information is supplied on an additive which
has been provisionally authorized under Article 9a, for the purpose
of obtaining authorization of the additive under Article 3a, that
information shall be considered as an integral part of the initial
dossier and shall consequently cease to be protected at the same rime
as the information in the initial dossier.
3. On expiry of the 10-year period referred to in paragraph 1, the
findings of all or part of the evaluation conducted on the basis of
the scientific data and information in the dossier which led to
authorization of the additive may be used by the Commission or by a
Member Stare for the benefit of another applicant for authorization
to put an additive which has already been authorized into
circulation.
In such a case, an application accompanied by a dossier in
accordance with the provisions to be laid down for this purpose in
Directive 87/153/EEC shall be addressed by the new applicant, via a
Member State acting as rapporteur, to the Commission, which shall
acknowledge receipt thereof as quickly as possible. A copy of the
application, together with the dossier, shall be officially forwarded
by the new applicant, via a Member State acting as rapporteur, to the
other Member Stares, which shall acknowledge receipt thereof at the
earliest opportunity.
The provisions of Articles 3, 3a, 4, 7 and 7a shall apply
mutatis mutandis.
4. The provisions of paragraph 3 shall also apply to the use of
data from a dossier concerning an additive which has been the subject
of withdrawal of authorization at the request of the holder of that
authorization.
5. The additional scientific data and information required for
modificarion of the conditions for listing an additive or for renewal
of the authorization in accordance with Article 9b (1) or any new
scientific data or information provided during the period of
authorization of the additive may not be used by the Commission or by
a Member State for the benefit of another applicant for a period of
five years from the date on which the authorization of a new use, the
renewal or the submission of new scientific data or information rakes
effect.
Where the data-protection period granted for modification of the
conditions for listing an additive expires before the end of the
period provided for in paragraph 1, the five-year period shall be
extended so that both periods expire simultaneously.
6. Without prejudice to paragraph 1, an applicant for an
authorization for an additive referred to in Article 2 (3) (aaa)
shall, before beginning toxicological tests on vertebrates, check
whether his product or its active substance has not already been
authorized. If necessary, he shall find out from a Member State's
competent authorities whether the product or active substance
concerned is the same as that already authorized.
If the product or active substance concerned has already been
authorized, the applicant and the holder(s) of earlier authorizations
shall take all necessary steps to reach agreement on sharing; the use
of information, in order not to repeat the toxicological tests on
vertebrates.
If, however, the applicant and the holder(s) of previous authorizations for the same product do not reach agreement on sharing the information, the Member States may take national measures to oblige the applicant and the holder(s) of previous authorizations established within their territories to share the information, in order to avoid repeating toxicological tests on vertebrates undertaken on their territory and may lay down conditions for the use of the information while ensuring a reasonable balance between the interests of the parties concerned.
1. Additives as referred to in Article 2 (aaaa) which meet the
conditions laid down in Article 3a shall be authorized and included
in Chapter III of the list referred to in Article 9t (b).
2. Additives as referred to in Article 2 (aaaa) included in Annex I before 1 April 1998 shall be authorized and included in Chapter III of the list referred to in Article 9t (b).
Provisional authorization for a maximum of four or five years
1. In the case of the additives referred to in Article 2 (aaaa),
provisional authorization may be given at Community level for the use
of a new additive or a new use of an additive already authorized,
provided that the conditions laid down in Article 3a (b), (c), (d)
and (e) are met and it is reasonable to assume that the condition
laid down in Article 3a (a) is also met. These additives shall be
included in Chapter IV of the list referred to in Article 9t (b).
2. Provisional authorization as referred to in paragraph 1 may nor
exceed four years from the date on which it takes effect.
3. Additives as referred to in Article 2 (aaa), included in Annex II before 1 April 1998, may continue to be the subject of national provisional authorizations; they shall be included in Chapter IV of the list referred to in Article 9t (b). The period of provisional authorization of these additives may not exceed five years taking account of the period of inclusion in Annex II referred to above.
Notwithstanding Article 3, Member States shall permit the additives listed in Annex B to be put into circulation.
1. Additives as referred to in Article 2 (aaaa) included in Annex
I before 1 January 1988 shall be provisionally authorized as from 1
April 1998 and transferred to Chapter I of Annex B with a view to
their re-evaluation as additives linked to a person responsible for
putting them into circulation.
2. With a view to their re-evaluation, the additives as referred
to in paragraph 1 must, before 1 October 1998, be the subject of new
applications for authorization; such applications, accompanied by the
monographs and the identification notes provided for in Articles 9n
and 9o respectively, shall be addressed by the person responsible for
the dossier on the basis of which the former authorization was
granted or by his successor or successors, via the Member State
acting as rapporteur, to the Commission, sending copies to the other
Member States which shall acknowledge receipt thereof.
3. In accordance with the procedure laid down in Article 23,
provisional authorization of the additives shall be withdrawn through
the adoption of a Regulation and they shall be deleted from the list
in Chapter I of Annex B before 1 October 1999:
(a) if the documents prescribed in paragraph 2 are not submitted
within the time allowed or
(b) if, after scrutiny of the documents, it is established that the
monographs and identification notes are not in accordance with the
data in the dossier on the basis of which the original authorization
was given.
4. Member States shall ensure that the person responsible for
putting an additive as referred to in paragraph 1 into circulation
submits, as provided for in Article 4 and not later than 30 September
2000, the dossier referred to in Article 4 with a view to re-
evaluation. Where he fails to do so, the authorization of the
additive in question shall be withdrawn through the adoption of a
regulation in accordance with the procedure laid down in Article 23
and it shall be deleted from the list in Chapter I of Annex B.
5. The Commission shall take all necessary measures to ensure that
re-evaluation of the dossiers referred to in paragraph 4 is completed
no later than three years after the dossier is submitted.
In accordance with the procedure laid down in Article 23,
authorizations of the additives referred to in Article 1:
(a) shall he withdrawn and they shall be deleted from the list in
Chapter I of Annex B through the adoption of a regulation, or
(b) shall be replaced by authorizations linked to the person
responsible for putting them into circulation for a period of 10
years through the adoption of a regulation taking effect no later
than 1 October 2003 and included in Chapter I of the list referred to
in Article 9t (b).
6. The provisions of Article 9b (3) shall apply mutatis mutandis
1. Additives as referred to in Article 2 (aaa) included in Annex I
after 31 December 1987 shall be authorized provisionally as from 1
April 1998 and transferred to Chapter II of Annex B with a view to
their authorization for a period of 10 years as additives linked to a
person responsible for putting them into circulation in accordance
with paragraphs 2 and 3.
2. The additives referred to in paragraph 1 must, before 1 October
1998, be the subject of new applications for authorization; such
applications, accompanied by the monographs and the identification
notes provided for in Articles 9n and 9o respectively, shall be
addressed by the person responsible for the dossier on the basis of
which the former authorizarion was given or by his successor or
successors, via the Member State acting as rapporteur, to the
Commission, sending copies to the other Member States, which shall
acknowledge receipt thereof.
3. In accordance with the procedure laid down in Article 23,
provisional authorizations of the additives referred to in paragraph
1:
(a) shall he withdrawn and they shall he deleted from the list in
Chapter II of Annex B. through the adoption of a regulation, if the
documents prescribed in paragraph 2 are not submitted within the time
allowed or if after scrutiny of the documents, it is established that
the monographs or the identification notes are not in accordance with
the data in the dossier on the basis of which the original
authorization was given, or
(b) shall he replaced by authorizations linked to the person
responsible for putting them into circulation, which shall he given
for a period of ten years through the adoption of a regulation taking
effect no later than 1 October 1999 and included in Chapter I of the
list referred to in Article 9t (b).
4. The provisions of Article 9b (3) shall apply mutatis mutandis.
1. Additives as referred to in Article 2 (aaa) included in Annex
II before 1 April 1998 may continue to be the subject of national
provisional authorizations; they shall he authorized and transferred
to Chapter III of Annex B with a view to their authorization as
additives linked to a person responsible for putting them into
circulation; the period of provisional authorization of these
additives may not exceed five years taking account of the period of
inclusion in Annex II referred to above.
2. The additives as referred to in paragraph 1 must, before 1
October 1998, be the subject of new applications for authorization;
such applications, accompanied by the monographs and identification
notes provided for in Articles 9n and 9o respectively, shall he
addressed by the person responsible for the dossier on the basis of
which the former authorization was given or by his successor or
successors, via the Member State acting as rapporteur, to the
Commission, sending copies to the other Member States, which shall
acknowledge receipt thereof.
3. In accordance with the procedure laid down in Article 23,
provisional authorizations of the additives referred to in paragraph
1:
(a) shall be withdrawn and they shall be deleted from the list in
Chapter III of Annex B through the adoption of a regulation if the
documents prescribed in paragraph 2 are not submitted within the time
allowed or if, after scrutiny of the documents, it is established
that the monographs and identification notes are not in accordance
with the data in the dossier on the basis of which the original
authorization was given, or
(b) shall be replaced by provisional authorizations as referred to in
paragraph 1 linked to the person responsible for putting them into
circulation through the adoption of a regulation taking effect no
later than 1 October 1999 and the additives shall be included in
Chapter II of the list referred to in Article 9t (b).
The provisions provided for in Article 9b (3) shall apply mutatis mutandis.
Article 9j
Applications for authorization to put into circulation suhmitted between 1 April 1998 and 30 September 1999 in respect of which the Commission has not yet given a ruling at that date shall be examined in accordance with Articles 3, 3a, 7, 7a, Y. 9a, 9b, 9c, 9d, 9e, 9n and 9o, as appropriate.
1. Member Stares shall ensure that in the field of animal
nutrition only additives authorized in accordance with this Directive
may be put into circulation and that they may be used only if
incorporated in feedingstuffs under the conditions set out in the
authorization regulation.
2. Notwithstanding paragraph 1, additives belonging to groups
other than "antibiotics", "coccidiostats and other medicinal
substances", and growth promoters may be used if administered by a
method other than incorporation in feedingstuffs, on condition that
that method is provided for in the authorization regulation.
3. Member States shall, in particular, ensure that additives are added to feed materials and to straight feedingstuffs only where their use is expressly provided for in the authorization regulation.
1. Where additives as referred to in Article 2 (aaa) are
authorized, the person(s) responsible for putting them into
circulation shall be given a registration number and the additive
shall he given a Community registration number.
2. Authorized additives as referred to in Article 2 (aaaa) shall be given a Community registration number.
A regulation shall be adopted to withdraw the authorization of an
additive:
- at the request of the person responsible for putting the
additive into circulation, if the additive is one of those referred
to in Article 2 (aaa),
-if any of the conditions for the authorization of the additive
referred to in Article 3a are no longer met,
- if a standard sample of the additive is not supplied to the
official authorities which have requested it or if an additive put
into circulation does not correspond to the standared sample of the
authorized additive,
- if a reference sample of the active substance is not supplied to
the official authorities which have requested it,
- if the person responsible for putting the additive into circulation
does not provide, within a given period of time, the information
requested by a person responsible at the Commission.
However, such additives may continue to he authorized in order to use up stocks for a period of no longer than one year if at least the conditions laid down in Article 3a (b) and (e) continue to be met.
1. In accordance with Directive 87/153/EEC, Member States shall
ensure that applicants present a monograph for additives as referred
to in Article 2 (aaa).
2. During the authorization procedure for additives as referred to
in Article 2 (aaa), the Standing Committee for Feedingstuffs shall
give an opinion, if appropriate after having made the necessary
amendments, on the monograph of the additive presented in the dossier
provided for in Article 4.
The Commission shall approve opinion given by the Standing
Committee for Feedingstuffs on the monograph and its amendments in
accordance with the procedure laid down in Article 23.
3. Monographs may also be approved for additives other than those
referred to in paragraph 1 in accordance with the procedure laid down
in paragraph 2.
4. The competent authorities of the Member States shall have
recourse to the monograph:
(a) to determine whether an additive for which authorization to
put into circulation has been requested constitutes an innovation or
should he considered as a copy;
(b) to ascertain whether the additive put into circulation actually
corresponds to the additive described in the dossier on the basis of
which the Community authorization was granted.
5. Subsequent amendments to be made to monographs on account of developments in scientific and technical knowledge shall be suhmitted to the Standing Committee for Feedingstuffs for its opinion in accordance with the procedure laid down in Article 23.
1. In accordance with Directive 87/153/EEC, Member States shall
ensure that the applicant presents an identification note summarising
the characteristics and properties of the additive. In the case of
the additives referred to in Article 2 (aaa), or should Article 9n
(3) be applied, the identification note shall contain a summary of
the most important characteristics and properties given in the
monograph referred to in Article 9n.
2. The following shall be adopted in accordance with the procedure laid down in Article 23:
- the identification note,
- subsequent amendments to the identification note as a result of
developments in scientific and technical knowledge.
3. In order to facilitate identification of the additives referred to in paragraph 1 during official checks, the identification note provided for in that paragraph shall be published in the Official Journal of the European Communities.
1. For the additives referred to in Article 2 (aaa) a standard
sample having the characteristics and properties described in the
monograph referred to in Article 9n together with a reference sample
of the active substance shall be made available, upon request, to the
national inspection authorities of the Member States by the
person responsible for putting them into circulation.
2. If the characteristics or properties of the additive are
modified, a new standard sample corresponding to the new monograph
shall he provided.
3. Detailed rules concerning the provision and maintenance of standard samples shall be adopted in accordance with the procedure laid down in Article 23.
1. The maximum and minimum levels set for certain additives shall
refer to complete feedingstuffs with a moisture content of 12 %
insofar as no special provisions are laid down in the authorization
regulation.
If the substance permitted as an additive also exists in the
natural state in certain feed materials, the amount of additive to he
incorporated shall he calculated so that the total of the elements
added and the elements present naturally does not exceed the maximum
level provided for in the authorization regulation.
2. The mixing of additives shall be permitted in premixtures and
feedingstuffs only where there is physico-chemical and biological
compatibility between the components of the mixture in relation to
the effects desired.
3. Unless the mixture concerned is the subject of a specific
authorization as an additive, Member States shall require that:
(a) antibiotics and growth promoters may not be mixed together,
either with substances from their own group or with substances from
the other group;
(b) coccidiostats and other medicinal substances may not be mixed
with antibiotics and growth promoters where coccidiostats also act,
for the same category of animal, as an antibiotic or as a growth
promoter;
(c) coccidiostats and other medicinal substances may not be mixed
together if their effects are similar.
4. Mixing antibiotics, growth promoters, coccidiostats and other
medicinal substances with micro-organisms shall be prohibited unless
such a mixture is authorized by the regulation authorising the
micro-organisms.
5. By way of derogation from Article 3 and paragraphs 2 and 3 of
this Article, Member States may authorize, but only for practical
tests conducted for scientific purposes and for non-commercial ends,
the use as additives of products which are not authorized at
Community level or the use of additives under conditions other than
those laid down in the authorization regulation, provided that:
- the tests are carried out in accordance with the principles and
conditions to he laid down in Directive 87/153/EEC, and
- an adequate official inspection has been performed.
Amendments to be made to the Annexes shall be adopted in accordance with the procedure laid down in Article 23.
Member State shall ensure that the persons responsible for putting the additives referred to in Article 2 (aaa) into circulation forward to the Commission as quickly as possible the name or corporate name and the address or registered office of the producers to whom they have granted the right to manufacture the additive and, if the producers are established in a third country, also the name or corporate name and the address or registered office of their representatives in the Community.
The Commission shall publish in the Official Journal of the
European Communities, "C" Series, nor later than 30 November each
year:
(a) the list of persons responsible for putting additives into
circulation as referred to in Article 9s, the names of the producers
to whom they have granted the right to manufacture the additives and
their representatives in the Community if such producers are
established in a third country;
(b) the list of authorized additives subdivided as follows:
- Chapter I: list of additives linked to a person responsible for
putting them into circulation and authorized for a period of 10
years,
- Chapter II: list of additives linked to a person responsible for
putting them into circulation and authorized on a provisional basis
for no longer than four years or five years in the case of additives
which have been the subject of provisional authorization before 1
April 1998,
- Chapter III: list of other additives authorized for an unlimited
period,
- Chapter IV: list of other additives authorized on a provisional
basis for no longer than four years or five years in the case of
additives which have been the subject of provisional authorization
before 1 April 1998.
Member States shall require that additives and premixtures may be marketed only in closed packages or closed containers. Member States shall require that packages or containers must be closed in such a way that the fastener is damaged on opening and cannot be re-used.]2
1. Where a Member State, as a result of new information or of a
reassessment of existing information made since the provisions in
question were adopted, has detailed grounds for establishing that the
use of one of the additives]2
[authorized]1 [or its
use in conditions which may be specified constitutes a danger to
animal or human health or the environment although it complies with
the provisions of this Directive, that Member State may temporarily
suspend or restrict application of the provisions in question in its
territory. It shall immediately inform the other Member States and
the Commission thereof, giving reasons for its decision.
2. The Commission shall, as soon as possible, examine the grounds
cited by the Member State concerned and consult the Member States
within the Standing Committee for Feedingstuffs; it shall then
deliver its opinion without delay and take the appropriate
measures.
3. Should the Commission consider that amendments to the Directive are necessary in order to mitigate the difficulties mentioned in paragraph 1 and to ensure the protection of human or animal health or the environment, it shall initiate the procedure laid down in Article 24 with a view to adopting these amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force.]2
1. Member States shall require that supplementary feedingstuffs,
diluted as specified, may not contain levels of the additives named
in this Directive which exceed those fixed for complete
feedingstuffs.
2. Member States may require that the levels of antibiotics,
coccidiostats and other medicinal substances, growth promoters, D
vitamins and antioxidants in supplementary feedingstuffs may exceed
the maximum levels fixed for complete feedingstuffs in the case
of:
(a) supplementary which a Member State has authorized to be made
available to all users, provided that their level of antibiotics, D
vitamins or growth promoters does not exceed five times the fixed
maximum level;
(b) supplementary feedingstuffs which are intended for certain
species of animal and which a Member State is permitted to authorize
to be made available within its territory to all users because of
special feeding systems, provided that their level does not
exceed:
- for antibiotics and growth promoters, 1 000 mg/kg and, provided
that the use of these substances is permitted, 2 000 mg/kg in the
case of cattle for fattening;
- for antioxidants, coccidiostats and other medicinal substances,
five times the fixed maximum level;
- for D vitamins, 200 000 IU/kg.
Member States shall prescribe that if, in the manufacture of
supplementary feedingstuffs, recourse is had to the possibility
referred to in (a), the possibility referred to in (b) may not be
made use of at the same time.
3. Where paragraph 2 is invoked, Member States shall require that the feedingstuff has one or more compositional characteristics (as regards, for example, proteins or minerals) which in practice ensure that the level of additives fixed for complete feedingstuffs is not exceeded and that the feedingstuff is not used for other species of animal.]2
1. Member States shall require that certain additives covered by
this Directive, premixtures prepared from those additives with a view
to their being incorporated in compound feedingstuffs and compound
feedingstuffs containing those premixtures may be put into
circulation or used only by the establishments or intermediaries
which meet the conditions laid down, as appropriate, in Council
Directive 95/69/EC of 22 December 1995 laying down the conditions and
arrangements for approving and registering certain establishments and
intermediaries operating in the animal feed sector (OJ No L 332, 30.
12. 1995, p.15).
2. Member States shall require that:
(a) additives referred to in Part A of Annex A may be supplied
only by approved establishments:
(i) to intermediaries or establishments which manufacture premixtures
and which have been approved in accordance with the provisions laid
down in Article 3 ( l ) or Article 2 (2) (b) respectively of
Directive 95/69/EC, and
(ii) in the form of premixtures, only to intermediaries or
establishments which manufacture compound feedingstuffs with a view
to putting them into circulation or for the exclusive requirements of
their holding and which have been approved in accordance with the
provisions laid down in Article 3 (1) or Article 2 (2) (c) or (e)
respectively of the above Directive;
(b) additives listed in Part B of Annex A may be supplied only by
approved establishments:
(i) to intermediaries or establishments which manufacture premixtures
and which have been approved in accordance with the provisions laid
down in Article 3 (1) or Article 2 (2) (b) respectively of the above
Directive, and
(ii) in the form of premixtures, only to:
- intermediaries which have been approved in accordance with the
provisions laid down in Article 3 of the above Directive, or
- establishments which manufacture compound feedingstuffs with a view
to putting them into circulation or for the exclusive requirements of
their holding and which have been registered in accordance with the
provisions laid down in Article 7 (2) (c) or (d) respectively of the
said Directive or, as appropriate, approved in accordance with the
provisions laid down in Article 2 (2) (c) or (e) of this
Directive.
3. Member States shall require that additives referred to in Annex
A (a) and (B) may be incorporated in compound feedingstuffs only if
then have been prepared beforehand in the form of premixtures
containing a carrier substance by establishments which meet the
conditions laid down in Article 2 (2) (b) of Directive 95/69/EC. Such
premixtures may be incorporated in compound feedingstuffs only in a
proportion of at least 0,2% by weight.
By way of derogation from the first subparagraph, Member States
may allow premixtures to he incorporated in compound feedingstuffs in
a proportion as low as 0,05 % by weight, provided that the
quantitative and qualitative composition of the premixture so permits
and that they have first estahlished that the establishments satisfy
the conditions set out in Chapter 1.2 (b) of the Annex, with a view
to achieving homogeneous distribution of premixtures and observing
the additive levels set for the whole feedingstuff.
These manufacturers as referred to in the second paragraph shall
be entered on the national list under a special heading as follows:
"Manufacturers of compound feedingstuffs authorized to use a minimum
proportion of 0,05 % by weight of premixtures ".
4. By way of derogation from paragraph 2, Member States shall
require that:
(a) additives referred to in Annex A (B) may be supplied to
approved intermediaries or registered establishments which
manufacture compound feedingstuffs for pets and fulfil the conditions
laid down, as appropriate, in Article 3 (1 ) or
Article]1
[7]8 [(2) (c) or (d) of
Directive 95/69/EC;
(b) additives referred to in Annex A (A) or (B) may he delivered at
the last stage of circulation to establishments which manufacture
compound feedingstuffs, provided that:
- the Community regulation authorizing the additive provides, in the
case of a specific preparation of the addirive, for direct addition
to feedingstuffs, and
- the manufacturer of compound feedingstuffs is approved in
accordance with Article 2 (2) (c) of the above Directive for the
additives referred to in Annex A (A) or is registered in accordance
with Article 7 (2) (c) of the above Directive for the additives
referred to in Annex A (B), and
- it has been checked on the spot that the manufacturer is in
possession of the appropriate technology defined in Chapter I (3) (b)
or Chapter II (c) of the Annex to the above Directive in order to add
the preparation in question directly to the compound
feedingstuff.
Such manufacturers shall appear on the national list under a special
heading as follows: Manufacturers of compound feedingstuffs referred
to in point (b) authorized to add antibiotics, cocciodiostats and
other medicinal substances, and growth promoters directly to compound
feedingstuffs" or "Manufacturers of compound feedingstuffs authorized
to add copper, selenium and vitamins A and D directly to compound
feedingstuffs".
5. By way of derogation from Article 7 of Directive 95/69/EC and
paragraphs 1 and 2 of this Article, Finland and, as regards that part
of its territory situated to the north of latitude 60°, Sweden
shall be authorized, in view of the special feeding conditions on
their farms, to allow premixtures of vitamins, provitamins and
chemically well-defined substances having similar effect to be
supplied to stock farmers for direct addition to feed materials of
vegetable origin, provided that:
- the directions for use state precisely the dosage to he complied
with according to the species or category of animals and the type of
fodder used, and
- special measures are taken by Finland and Sweden to monitor use
such premixtures.]1
[6. Paragraphs 1 to 3 shall apply without prejudice to article 4(2) and article 9(2) of Directive 95/69/EC.]7
Article 14
1. Member States shall require that authorized additives may be
put into circulation for use in feedingstuffs only if the following
particulars, which must be clearly visible, readily legible and
indelible and must place responsibility on the producer, packer,
importer, seller or distributor established within the Community, are
given on the package, the container or a label affixed thereto:
A. for all additives, with the exception of enzymes and
micro-organisms:
(a) the specific name given to the additive upon authorization,
the EC registration number of the additive and, in the case of an
additive within the meaning of Article 2 (aaa), the trade name and
the registration number given to the person responsible for putting
it into circulation;
(b) the name or business name and the address or registered place of
business of the person responsible for the particulars referred to in
this paragraph;
(c) the net weight and, in the case of liquid additives, either the
net volume or the net weight;
(d) as applicable, 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 the above Directive.
B. In addition, with regard to:
(a) antibiotics, growth promoters, coccidiostats and other
medicinal substances: the name or business name and the address or
registered place of business of the manufacturer, if he is not
responsible for the particulars in the label, the active-substance
level, the expiry dare 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 use in the case of additives which are the
subject of special provisions upon authorization;
(b) vitamin E: the alpha-tocopherol level and the expiry date of the
guarantee of that level or storage life from the date of
manufacture;
(c) vitamins, other than vitamin E, provitamins and substances having
a similar effect: the active-substance level and the expiry date of
the guarantee of that level or storage life from the date of
manufacture;
(d) trace elements, colourants including pigments, preserving agents
and other additives, with the exception of those belonging to the
enzyme and microorganism groups: the active-substance level.
C. For additives belonging to the groups:
(a) of enzymes: the specific name of the active component or
components in accordance with their enzyme activities, in conformity
with the authorization given, the International Union of Biochemistry
identification number, units of activity (units of activity expressed
in micromoles of product released per minute, per gram of enzyme
preparation) (units of activity per gram or units of activity per
millilitre), the EC registration number of the additive, the name or
business name and the address or registered place of business of the
person responsible for the particulars on the label, the name or
business name and the address or registered place of business of the
manufacturer, if he is not responsible for the particulars on the
label, the approval number assigned to the establishment or the
intermediary pursuant to Article 5 of Directive 95/69/EC 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 specifying in particular the recommended dose,
in the form of a range if appropriate, in accordance with the
percentage(s) by weight of target feed material(s) per kilogram of
the whole feedingstuff in accordance with the requirements laid down
on a case-by-case basis in the authorization for the additive and,
where applicable, safety recommendations as provided for hi the
authorization for the additive, the net weight and, in the case of
liquid additives, either the net volume or the net v. eight, where
appropriate indication of special significant characteristics due to
the manufacturing process, in accordance with the provisions
concerning labelling in the authorization for the additive;
(b) of micro-organisms: identification of the strain(s) in accordance
with the authorization granted, the file number of the strain(s), the
number of colony-forming units (CFU per gram), the EC registration
number of the additive, the name or business name and the address or
registered place of business of the person responsible for the
particulars on the label, the or business name and the address or
registered place of business of the manufacturer, if he is not
responsible for the particulars on the label, the approval number
assigned to the establishment or the intermediary pursuant to Article
5 of Directive 95/69/EC, 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
applicable, safety recommendations as provided for in the
authorization for the additive, the net weight and, in the case of
liquid additives, either the net volume or the net weight, where
appropriate an indication of special significant characteristics due
to the manufacturing process, in accordance with the provisions
concerning labelling in the authorization of the additive.
2. Member States shall require that the specific name of the
additive may be accompanied, in cases where the indications are not
required by virtue of paragraph 1:
(a) by the trade name;
(b) by the name or business name and the address or registered place
of business of the manufacturer, if he is not responsible for the
particulars on the label, the directions for use and, where
appropriate, a safety recommendation regarding use.
3. Member States shall require that information other than that required or authorized pursuant to paragraphs 1 and 2 may appear on packages, containers or labels, provided that they are clearly separated from the abovementioned marking particulars.
Article 15
1. Member States shall require that premixtures may he marketed
only if the following particulars, which must be clearly visible,
readily legible and indelible and must place responsibility on the
producer, packer, importer, seller or distributor established within
the Community, are given on the package, the container or a label
affixed thereto:
A. For all premixtures:
(a) the description "premixture";
(b) directions for use, and any safety recommendations regarding the
use of the premixtures;
(c) the animal species or category of animals for which the
premixture is intended;
(d) the name or business name and the address or registered place of
business of the person responsible for the particulars referred to in
this paragraph;
(e) the net weight and, in the case of liquids, either the volume or
net weight;
(f) as applicable, 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 the above Directive.
B. In addition, for the premixtures incorporating the additives
listed below:
(a) antibiotics, growth promoters, coccidiostats and other medicinal
substances: the name or business name and the address or registered
place of business of the manufacturer if he is not responsible for
the details on the label, specific name given to the additive upon
authorization, active substance level and expiry date of the
guarantee of that level, or storage life from the date of
manufacture;
(b) substances having antioxidant effects: specific name given to the
additive upon authorization, and active substance level, provided
that a maximum level is fixed for complete feedingstuffs on
authorization of the additive;
(c) colourants, including pigments: specific name given to the
additive upon authorization, and active substance level, provided
that a maximum level is fixed for complete feedingstuffs upon
authorization of the additive;
(d) vitamin E: specific name given to the additive upon
authorization, alphatoeopherol level and expiry date of the guarantee
of that level or storage life from the date of manufacture;
(e) vitamins other than vitamin E, provitamins and substances having
a similar effect: speeifie name given to the additive upon
authorization, active substance level and expiry dare of the
guarantee of that level or storage life from the date of
manufacture;
(f) trace elements: specific name given to the additive upon
authorization, and level of the various elements insofar as a maximum
level is fixed for complete feedingstuffs upon authorization of the
additive;
(g) preserving agents: specific name given to the additive upon
authorization, and active substance level, provided that a maximum
level is fixed for complete feedingstuffs upon authorization of the
additive;
(h) enzymes: the specific name of the active component(s) according
to its (their) enzymatic activity(ies) in accordance with the
authorization given, the identification number according to the
International Union of Biochemistry, the activity units (activity
units per g or activity units per ml), the additive's EC registration
number, the name or business name and the address or registered place
of business of the manufacturer if he is not responsible for the
particulars on the label, the expiry date of the guarantee or the
storage life from the dare of manufacture, the hatch reference number
and the date of manufacture, the directions for use specifying in
particular the recommended dose, in the form of a range if
appropriate, in accordance with the percentage(s) by weight of target
feed material(s) per kilogram of the whole feedingstuff in accordance
with the requirements laid down on a case-by-case basis in the
authorization for the additive and, where applicable, indication of
any particular significant characteristics due to the manufacture
process, in accordance with the provisions concerning labelling in
the authorization of the additive;
(i) micro-organisms: the identification of the strain(s) in
accordance with the authorization given, the file number of the
strain(s) in accordance with the authorization given, the file number
of the strain(s), the number of colony-forming units (CFU/g), the
additive's EC registration number, the name or business name and the
address or registered place of business of the manufacturer if he is
not responsible for the particulars on the label, the expiry date of
the guarantee of the storage life from the date of manufacture and,
where applicable, indication of any particular significant
characteristics due to the manufacturing process, in accordance with
the provisions concerning labelling in the authorization of the
additive;
(j) other additives belonging to the groups referred to in (b) or (i)
for which no maximum level is laid down and additives belonging to
other groups authorized: specific name given to the additive upon
authorization and active substance level, provided that these
additives fulfil a function in the feedingstuff as such and the
amounts present can be determined by official methods of analysis or,
failing this, by valid scientific methods.
2. Member States shall require that:
(a) the specific name of additives may be accompanied by the
tradename;
(b) the name of the producer of the additives referred to in
paragraph 1 (B) (a) may be indicated in the labelling of premixtures.
However, they may stipulate that this indication shall be
compulsory;
(c) the specific name of the additives authorized may be accompanied
by the additive's EC registration number.
3. Where, pursuant to paragraph I, the expiry date of the
guarantee or storage life from the date of manufacture of several
additives belonging to the same group or different groups has to be
stated, Member States shall require that a single date of guarantee
or a single reference to the storage life may be indicated for all
the additives, namely the deadline which will be reached first.
4. Member States shall require that information other than that required or authorized pursuant to paragraphs 1 to 3 may appear on packages, containers or labels, provided that they are clearly separated from the abovementioned marking particulars.
1. Member States shall require that feedingstuffs incorporating
the additives belonging to the groups listed below may be put into
circulation only if the following particulars, which must be clearly
visible, readily legible and indelible and must place responsibility
on the producer, packer, importer, seller or distributor established
within the Community, are given on the package, the container or a
label affixed thereto:
(a) for antibiotics, coccidiostats and other medicinal substances
and growth promoters: the specific name given to the additive upon
authorization, the active substance level and the expiry date of the
guarantee of that level or storage life from the date of manufacture,
the approval number assigned to the establishment in accordance with
Article 5 of Directive 95/69/EC;
(b) for substances having antioxidant effects:
- in the case of pet foods: use of the words "with antioxidant"
followed by the specific name given to the additive upon
authorization,
- in the case of compound feedingstuffs other than pet foods: the
specific name given to the additive upon authorization;
(c) for colourants, including pigments that these are used for the
colouration of feedingstuffs or animal products:
- in the case of pet foods: use of the words "colourant" or "coloured
with" followed by the specific name given to the additive upon
authorization,
- in the case of compound feedingstuffs other than pet foods: the
specific name given to the additive upon authorization;
(d) for vitamin E: the specific name given to the additive upon
authorization, the alphatocopherol level and the expire date of the
guarantee of that level or storage life from the date of
manufacture;
(e) for vitamins A and D: the specific name given to the additive
upon authorization, the active substance level and the expiry date of
the guarantee of that level or storage life from the date of
manufacture,
(f) for copper: the specific name given to the additive upon
authorization and the level expressed in Cu;
(g) for preserving agents:
- in the case of pet foods: use of the words "preservative" or
"preserved with" followed by the specific name given to the additive
upon authorization,
- in the case of compound feedingstuffs other than pet foods: the
specific name given to the additive upon authorization;
(h) for enzymes: the specific name of the active constituent(s)
according to its (their) enzymatic activity(ies) in accordance with
the authorization given, the identification number according to the
International Union of Biochemistry, the activity units (activity
units per kilogram or activity unit per litre), the EC registration
number of the additive, the expiry date of the guarantee or the
storage life from the date of manufacture and, where applicable,
indication of any particular significant characteristic due to the
manufacturing process, in accordance with the provisions concerning
labelling in the authorization of the additive;
(i) for micro-organisms: the identification of the strain(s) in
accordance with the authorization given the file number of the
strain(s), the number of colony-forming units (CFU/kg), the EC
registration number of the additive, the expiry date of the guarantee
or the storage life from the date of manufacture and, where
applicable, indication of any particular significant characteristic
due to the manufacturing process, in accordance with the provisions
concerning labelling in the authorization of the additive.
2. In addition to the particulars provided for by paragraph 1,
particulars concerning the proper use of the feedingstuffs may be
laid down in the authorization of the additive in accordance with the
procedure provided for in Article 23.
Member States shall require that these particulars must appear on
the package or the container or on a label affixed thereto.
3. The presence of trace elements other than copper and of
vitamins other than vitamins A, D and E, provitamins and additives
having a similar effect may be indicated if the amounts of these
substances can be determined by official methods of analysis or,
failing this, by valid scientific methods of analysis. In such cases
the following details shall be given:
(a) for trace elements other than copper: the specific name of the
additive in accordance with the authorization given and level of the
various elements;
(b) for vitamins other than vitamins A, D and E, provitamins and
substances having a similar chemical effect: the specific name of the
additive in accordance with the authorization given, the active
substance level and the expiry date of the guarantee of that level or
storage life from the date of manufacture;
4. Member States shall require that:
(a) the details provided for in paragraphs 1 to 3 shall be printed
close to the particulars which have to appear on the package,
container or the label affixed thereto in accordance with Community
rules on feedingstuffs;
(b) where a level or a quantity is stated pursuant to paragraphs 1 to
3, such statement shall refer to the amount of additive incorporated
in the feedingstuff;
(c) the details of additives may be accompanied by the EC
registration number of the additive or the trade name where those
particulars are not required by virtue of paragraph 1.
5. Where, pursuant to paragraph 1, the expiry date of the
guarantee or storage life from the date of manufacture of several
additives belonging to the same group or different groups has to be
stated, Member States shall require that a single date of guarantee
or a single reference to the storage life from the date of
manufacture may he indicated for all the additives, namely the
deadline which will be reached first.
6. In the of feedingstuffs distributed by road tankers or similar
vehicles or in bulk, the details provided for in paragraphs 1 to 3
shall be given in the accompanying document.
Where small quantities intended for the end-user are involved, it
shall be sufficient for such details to be conveyed to the purchaser
by a suitable notice.
7. Member States shall require that, in the case of pet foods
containing colourants, preservatives or substances having antioxidant
effects and put up in packages having a net weight of not more than
10 kilograms, it shall be sufficient for the package to bear the
words "coloured with", or '"preserved with", or the words with
antioxidant" as appropriate, followed by the words "EC additives-,
provided that:
(a) the package, container or label bears a reference number by
means of which the feedingstuff may be identified, and
(b) the manufacturer gives, on request, the specific name, or names,
of the additive or additives used.
8. Any reference to additives other than in the form provided for in this Directive shall be prohibited.]1
Articles 14 to 16 referring to the approval and registration numbers provided for in Directive 95/69/EC shall apply from 1 April 2001.]7
[Article 17
1. Without prejudice to the provisions of Directive 79/373/EEC
(3), Member States shall require that supplementary feedingstuffs
which contain additives in excess of the maximum levels fixed for
complete feedingstuffs may be placed on the market only if the
directions for use state, according to the species and age of the
animal, the maximum quantity in grams or kilograms of supplementary
feedingstuff to be given per animal per
day.]2
[This information must be in accordance with the conditions of
use prescribed upon authorisation of the
additive.]1
[This provision shall not apply to products delivered to
manufacturers of compound feedingstuffs or to their suppliers.
2. The declaration referred to in paragraph 1 shall be so formulated that, when it is correctly followed, the proportion of additives does not exceed the maximum level fixed for complete feedingstuffs.
Where feedingstuffs are marketed in other Member States the details referred to in Articles 14 to 17 shall be given in at least one of the official languages of the country of destination.
Member States shall ensure that additives, premixtures and feedingstuffs which conform to this Directive are subject only to the marketing restrictions provided for in this Directive.
Member States shall ensure that livestock products are not subject to any marketing restriction as a result of the application of this Directive.]2
1. Member States shall in particular take all necessary measures
to ensure that additives, premixtures and feedingstuffs put on the
market are officially checked, at least by random sampling, in
respect of the identity of the additives used and to verify that the
other conditions laid down in this Directive are satisfied.
To this end, they shall require in particular that undertakings
which intend to manufacture additives or to put them on the market
must first inform the competent authorities thereof.
2. Under the procedure provided for in Article 23, margins of tolerance may be fixed, to be allowed where there is a discrepancy between the result of the official check and the stated content of the additive in the compound feedingstuff.]2
Where there is found to be unforeseen undesirable interaction between additives referred to in Article 2 (aaa) and other additives or veterinary medicines, Member States shall require that the person responsible for putting the additive into circulation, or his representative within the Community where additives originate in third countries, gathers all the relevant information and forwards it to the competent authorities.
This Directive shall not apply to additives, premixtures and feedingstuffs which are shown, at least by an appropriate indication, to be for export to third countries.]2
[Article 23
1. Where the procedure laid down in this Article is to be
followed, matters shall be referred without delay be (SIC! by) the
chairman, either on his own initiative or at the request of a Member
State, to the Standing Committee for Feedingstuffs, hereinafter
called "the Committee".
2. The votes of the Member States within the Committee shall be
weighted as provided for in Article 148 (2) of the Treaty. The
chairman shall not vote.
3. The representative of the Commission shall submit a draft of
the measures to he adopted. The Committee shall deliver its opinion
on such measures within a time limit set by the chairman according to
the urgency of the matters. Opinions shall be delivered by a majority
of]2
[fifty-four]4
[votes.
4. The Commission shall adopt the measures and implement them
forthwith where they are in accordance with the opinion of the
Committee. Where they are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall
without delay propose to the Council the measures to be adopted. The
Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within three months of the proposal being submitted it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.
1. Where the procedure laid down in this Article is to be
followed, matters shall be referred to the Committee without delay by
the chairman, either on his own initiative or at the request of a
Member State.
2. The votes of the Member States within the Committee shall be
weighted as provided for in Article 148 (2) of the Treaty. The
chairman shall not vote.
3. The representative of the Commission shall submit a draft of
the measures to be adopted. The Committee shall deliver its opinion
on such measures within two days. Opinions shall be delivered by a
majority of]2
[54]4 [votes.
4. The Commission shall adopt the measures and implement them
forthwith where they are in accordance with the opinion of the
Committee. Where they are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall
without delay propose to the Council the measures to be adopted. The
Council shall adopt the measures by a qualified majority.
If the Council has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.]2
[Article 25
A decision on the transfer of antibiotics, coccidiostats and other medicinal substances, together with preparations based on these products, to Directive 81/851/EEC and to future rules on medicinal feedingstuffs shall be adopted by the Council acting unanimously on a proposal from the Commission once the degree of harmonization with regard to the free movement of products in the sector of veterinary medicinal products and medicated feedingstuffs has reached a level comparable to that obtaining with regard to additives.]2
Member States shall, within two years following notification
thereof, bring into force the laws, regulations, or administrative
provisions necessary to comply with this Directive. They shall
forthwith inform the Commission
thereof.]5
[However, in the case of the territory of the former German
Democratic Republic, the Federal Republic of Germany may:
- maintain the provisions applicable prior to unification under
which the use of the following additives in feedingstuffs is
authorized:
- Olaquindox,
- Nourseothricine,
- Ergambur.
This derogation shall expire on the date of the Decision to be taken,
in accordance with Article 7, on the authorization or prohibition of
the use of the additives listed above, and by 31 December 1992 at the
latest. The Federal Republic of Germany shall ensure that those
additives and any feedingstuffs into which they are incorporated are
not dispatched to other parts of the Community;
- derogate, until 31 December 1991, from the labelling provisions in
Articles 14, 15 and 16 for the additives, additive pre-mixtures and
compound feedingstuffs to which additives have been added, produced
in the territory in
question.]6
This Directive is addressed to the Member States.]5
1. Council Directive 96/51/EC of 23 July 1996 (OJ
N° L 235, 17.9.1996)
2. Council Directive 84/587/EEC of 29 November 1984 (OJ N° L
319, 8.12.1984)
3. Council Directive 98/92/EC of 14 December 1998 (OJ N° L 346,
22.12.1998)
4. Council Regulation (EEC) N°3768/85 of 20 December 1985 (OJ
N° L 362, 31.12.1985)
5. Council Directive 70/524/EEC of 23 November 1970 (OJ N° L
270, 14.12.1970)
6. Council Directive 90/654/EEC of 4 December 1990 (OJ N° L 353,
17.12.1990)
7. Council Directive 1999/20/EC of 22 March 1999 (OJ N° L 80,
25.3.1999)
8. Corrigendum to Council Directive 96/51/EC of 23 July 1996 (OJ
N° L 235, 17.9.1996), (OJ N° L115, 16.5.2000)