1993L0074 — EN — 12.06.1996 — 001.001 — 1
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►B COUNCILDIRECTIVE93/74/EEC
of13September1993
onfeedingstuffsintendedforparticular nutritionalpurposes
(OJ L 237, 22.9.1993, p. 23)
Amended by:
Official Journal
No page date
►M1►M2Council Directive 96/25/EC of 29 April 1996 ◄ L 125 35 23.5.1996
►M2 amended by Directive 2000/16/EC of the European Parliament and the
Council of 10 April 2000L 105 36 3.5.2000
▼B
COUNCILDIRECTIVE93/74/EEC
of13September1993
onfeedingstuffsintendedforparticularnutritionalpurposes
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
Whereas feedingstuffs intended for particular nutritional purposes are
playing an increasing role in the diet of pet animals; whereas suchproducts are also used in the rearing of productive livestock;
Whereas, in some Member States, feedingstuffs covered by this Direc-
tive are already marketed in such a way as to draw the attention of
users to their particular composition;
Whereasa common definition s hould be laid down for the products
concerned; whereas that definition must provide that products presentedas intended to meet certain specific nutritional needs must have a
specific composition and/or be manufactured using special methods;
whereas it is essential to establish the principle that such feedingstuffsmust be clearly distinguished, in their characteristics and purpose, fromboth ordinary feedingstufffs and medicated feedingstuffs;
Whereas the composition and preparation of feedingsuffs intended for
particular nutritional purposes must be specially designed to meet theparticular nutritional needsof categoriesof petsor productive lives tockwhose process of assimilation, absorption or metabolism could brieflybe impaired or istemporarily or irrevers ibly impaired;
Whereas, when rules are being laid down for the marketing of feeding-
stuffs intended for particular nutritional purposes, care should be takento ensure that such feedingstuffs have a beneficial effect on the animalswhich ingest them; whereas feedingstuffs must therefore always be ofmerchantable quality; whereas they must neither present a hazard foranimal or human health or for the environment nor be marketed in a
manner liable to mislead;
WhereasthisDirective applieswithout prejudice to other Community
provisions on feedingstuffs, and particularly the rules applicable tocompound feedingstuffs;
Whereas the user of feedingstuffs intended for particular nutritional
purposes needs to be provided with accurate and meaningful informa-tion;
Whereas in order to distinguish between the feedingstuffs meeting the
criteria laid down in this Directive and other feedingstuffs, a single
qualifying expression, ‘dietetic’, must accompany the description of
the feedingstuff;
Whereas, as in the case of ordinary feedingstuffs, at least the levels of
analytical constituents having a direct effect on the quality of thefeedingstuff should be declared; whereas provision should be made for
the declaration of certain additional analytical constituents which give
the feedingstuff its dietetic properties;
Whereasall producersof feedings tuffsintended for particular nutri-
tional purposes must have the option of indicating on the label certainparticulars useful to the user;1993L0074 — EN — 12.06.1996 — 001.001 — 2
(1) OJ No C 231, 9. 9. 1992, p. 6.
(2) OJ No C 21, 25. 1. 1993, p. 73.
(3) OJ No C 73, 15. 3. 1993, p. 25.
▼B
Whereas it is not necessary for the supply of feedingstuffs intended for
particular nutritional purposes to be subject to presentation of a veter-inary prescription since these products contain no medicinal substances
within the meaning of Council Directive 65/65/EEC of 26 January
1965 on the approximation of provisions laid down by law, regulationor administrative action relating to proprietary medicinal products(
1),
but, to ensure the appropriate use of feedingstuffs with a very specificcharacter, the user should be warned that it is desirable to seek a
specialist's opinion before using them;
Whereas, however, for feedingstuffs designed to satisfy the nutritional
requirements of animals with irreversibly impaired processes of assim-ilation, absorption or metabolism or which are in a pathological staterequiring medical supervision, the possibility should be provided oflaying down additional labelling ruleswhich provide that a recommen-
dation shall be given to the user to request the prior opinion of a
veterinarian instead of the general recommendation to consult a specia-list;
Whereas a positive list should also be drawn up at Community level of
the intended uses of animal feedingstuffs for particular nutritional
purposes, indicating their precise use, essential nutritional characteris-
tics, compulsory or optional declarations and special labellingrequirements; whereas, bearing in mind the importance of this list forthe implementation of this Directive, such list should be adopted ingood time;
Whereasthe marketing of feedings tuffsintended for particular nutri-
tional purposes which satisfy the requirements of this Directive must
not be subject to any restriction on grounds of content, methods ofmanufacture, presentation or labelling;
Whereas, in cases where a product presents a hazard to animal or
human health or the environment, provision should be made for any
Member State to request that the Commission take the appropriate
measures, on justified grounds;
Whereas, for cases where the Council empowers the Commission to
apply the rules laid down in respect of feedingstuffs intended for parti-cular nutritional purposes, a procedure should be provided for closecooperation between the Member States and the Commission in the
Standing Committee on Feedingstuffs set up by Council Decision 70/
372/EEC(
2);
Whereas effective inspection of feedingstuffs intended for particular
nutritional purposes must be ensured; whereas in certain circumstancesthe usual means at the disposal of the inspection services amy be insuf-
ficient to allow verification that a feedingstuff actually possesses the
particular nutritional propertiesattributed to it; whereasit s hould there-fore be provided that, where necessary, the person responsible formarketing the product should assist the inspection service in its duties,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. ThisDirective concernsfeedings tuffsintended for particular
nutritional purposes.
2. Member Statets shall prescribe that feedingstuffs intended for
particular nutritional purposes may be marketed only if they:
— fulfil the conditionsreferred to in Article 3,
— are labelled in accordance with the provisions laid down in Article
5,
— their intended uses are included in the list drawn up pursuant to
Article 6 and they fulfil the other provisions laid down in that list.1993L0074 — EN — 12.06.1996 — 001.001 — 3
(1) OJ No 22, 9. 2. 1965, p. 369/65.
(2) OJ No L 170, 3. 8. 1970, p. 1.
▼B
Article 2
For the purposes of this Directive, the following definitions shall apply:
(a) ‘feedingstuffs’ shall mean products of vegetable or animal origin in
their natural state, fresh or preserved, and products derived from
the industrial processing thereof, and organic or inorganicsubstances, used singly or in mixtures, whether or not containingadditives, for oral animal feeding;
(b) ‘compound feedingstuffs’ mixtures of feed materials, whether or
not containing additives, which are intended for oral animal feedingas complete or complementary feedingstuffs;
(c) ‘feedingstuffs intended for particular nutritional purposes’ shall
mean compound feedingstuffs which, by virtue of their particular
composition or method of manufacture, can be clearly distin-guished from both ordinary feedingstuffs and the products definedin Council Directive 90/167/EEC of 26 March 1990 laying downthe conditionsgoverning the preparation, placing on the marketand use of medicated feedingstuffs in the Community(
1), and are
presented as intended to meet specific nutritional requirements;
(d) ‘particular nutritional purpose’ shall mean the purpose of satisfying
the specific nutritional needs of certain pets or productive livestock
whose process of assimilation, absorption or metabolism could be
temporarily impaired or istemporarily or irrevers ibly impairedand are therefore able to derive benefit from ingestion of feeding-stuffs appropriate to their condition.
Article 3
The Member States shall require that the nature of composition of the
feedingstuffs referred to in Article 1 (1) shall be such that the products
are appropriate for their intended particular nutritional purpose.
Article 4
This Directive shall apply, subject to the specific provisions laid down
therein, without prejudice to the Community provisions on:
(a) compound feedingstuffs;
(b) additives used in feedingstuffs;
(c) undesirable substances and products in animal nutrition;
(d) certain productsus ed in animal nutrition.
Article 5
In addition to the labelling provisions in Article 5 of Directive 79/373/
EEC of 2 April 1979 on the marketing of compound feedingstuffs(
2)
the Member Statess hall require that:
1. the following additional indicationsappear in the s pace provided for
the purpose on the packaging, on the container or on the label of thefeedingstuffs referred to in Article 1 (1):
(a) the qualifying expression ‘dietetic’ together with the description
of the feedingstuff;
(b) the precise use, i.e. the particular nutritional purpose;
(c) the indication of the essential nutritional characteristics of the
feedingstuffs;
(d) the declarationspres cribed in column 4 in the Annex concerning
the particular nutritional purpose;
(e) the recommended length of time for use of the feedingstuff.1993L0074 — EN — 12.06.1996 — 001.001 — 4
(1) OJ No L 92, 7. 4. 1990, p. 42.
(2) OJ No L 86, 6. 4. 1979, p. 30.▼M1
▼B
▼B
The indicationsreferred to in points(a) to (e) mus t comply with the
content of the list of intended uses in the Annex and the generalprovisions to be laid down in accordance with Article 6 (b);
2. indicationsother than thos e referred to in paragraph 1 may be
supplied in the space provided for the purpose, in so far as they arecovered by Article 6 (a);
3. without prejudice to Article 5e of Directive 79/373/EEC, the label-
ling of feedingstuffs as referred to in Article 1 (1) may makereference to a specific pathological condition in so far as that condi-
tion corresponds to the nutritional purpose laid down in the list of
uses drawn up in accordance with Article 6 (a);
4. the label or the directions for use of the feedingstuffs referred to in
Article 1 (1) must bear the indication ‘It is recommended that a
specialist's opinion be sought before use.’
It may, however, be provided in the list of intended uses in the
Annex that this declaration shall be replaced for specific dietetic
feedingstuffs with a recommendation to request the prior opinion ofa veterinarian;
5. the provisions of Article 5c (5) of Directive 79/373/EEC shall also
apply to the feedingstuffs referred to in Article 1 (1) and intendedfor animalsother than pets ;
6. the labelling of the feedingstuffs referred to in Article 1 (1) may
also highlight the presence or the low level of one or more analy-tical constituents which are essential for the description of thefeedingstuff. In such cases, the minimum or maximum level of theanalytical constituents expressed as percentage weight of the
feedingstuff must be clearly indicated in the list of declared analy-
tical constituents;
7. the qualifying expression ‘dietitic’ shall be reserved solely for
feedingstuffs as referred to in Article 1 (1).
Qualifying expressions other than ‘dietitic’ shall be prohibited in the
labelling and presentation of these feedingstuffs;
8. Notwithstanding the provisions of Article 5c (3) of Directive 79/
373/EEC, the declaration of ►
M1feed materials ◄may be made
in the form of categoriesgrouping s everal ►M1feed materials ◄,
even where the declaration of certain ►M1feed materials ◄by
their specific name is required to justify the nutritional characteris-ticsof the feedings tuff.
Article 6
Pursuant to the procedure laid down in Article 9:
(a) a list of intended uses shall be established in accordance with the
Annex not later than 30 June 1994. That list shall contain:
— the indicationsreferred to in Article 5 (1) (b), (c), (d) and (e),
and
— where appropriate, the indicationsreferred to in Article 5 (2)
and Article 5 (4), second subparagraph;
(b) general provisions regarding the application of the indications
referred to in (a), including applicable tolerances, may be estab-
lished;
(c) the measures adopted in accordance with (a) and (b) may be modi-
fied, following developmentsin s cientific and technical knowledge.
Article 7
The Member States shall ensure that feedingstuffs as referred to in
Article 1 (1) are not, for reasons concerning the provisions of thisDirective, subject to marketing restrictions other than those providedfor in thisDirective.1993L0074 — EN — 12.06.1996 — 001.001 — 5
▼B
Article 8
1. Where a Member State establishes that the use of a feedingstuff
as referred to in Article 1 (1) or its use in the prescribed conditions
presents a hazard for animal or human health or for the environment,it shall immediately inform the Commission, giving the reasons for itsdecision.
2. The Commission shall initiate as soon as possible the procedure
laid down in Article 9 with a view to adopting any appropriate
measures.
Article 9
1. Where the procedure laid down in thisArticle isto be followed,
the chairman shall refer the matter to the Standing Committee onFeedingstuffs, hereinafter referred to as ‘the Committee’, either on hisown initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shalldeliver itsopinion on the draft, within a time limit which the chairmanmay lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148 (2) of theTreaty for decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the representatives of the
Member Stateswithin the Committee s hall be weighted asprovided inthat Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall,without delay, present to the Council a proposal relating to themeasures to be taken. The Council shall act by a qualified majority.
If, on the expiry of three monthsfrom the date of referral to the
Council, the Council has not acted, the proposed measures shall be
adopted by the Commission unless the Council has decided against
those measures by a simple majority.
Article 10
To allow effective official inspection of feedingstuffs as referred to in
Article 1 (1), the following specific provisions shall apply:
1. Member States shall make all necessary arrangements for official
inspection during manufacture or marketing, at least by sampling,
in order to ensure compliance with the requirements of this Direc-tive;
2. where appropriate, the competent authority shall be empowered to
require the person responsible for placing the product on the marketto produce data and information establishing the feedingstuff'sconformity with thisDirective.
If such data have been published in readily accessible form, a refer-
ence to the publication shall suffice.
Article 11
The following Directivesare hereby amended ass pecified:1. the following shall be added to Article 1 (2) of Council Directive
74/63/EEC of 17 December 1973 on the fixing of maximum
permitted levels for undesirable substances and products in feeding-
stuffs(
1):
‘(f) feedingstuffs for particular nutritional purposes’;1993L0074 — EN — 12.06.1996 — 001.001 — 6
(1) OJ No L 38, 11. 2. 1974, p. 31.
▼B
2. in Directive 79/373/EEC:
(a) the following shall be added to Article 1 (2):
‘(h) feedingstuffs for particular nutritional purposes’;
(b) the first indent of the second subparagraph of Article 5e shall be
replaced by the following:
‘— may not be designed to indicate the presence or content of
analytical constituents other than those the declaration ofwhich isprovided for in Article 5 of thisDirective orArticle 5 (2) of Council Directive 93/74/EEC of 13September 1993 on feedingstuffs intended for particularnutritional purposes (*);
(*) OJ No L 237, 22. 9. 1993, p. 23.’;
3. the following shall be added to Article 1 (2) of Council Directive
82/471/EEC of 30 June 1982 concerning certain productsus ed in
animal nutrition(
1):
‘(f) feedingstuffs for particular nutritional purposes;’.
Article 12
The Member States shall bring into force the laws, regulations and
administrative provisions necessary for them to comply with this Direc-tive no later than 30 June 1995. They shall forthwith inform theCommission thereof.
When Member States adopt those provisions, they shall include refer-
ences to this Directive or shall accompany them with such references
on their official publication. The Member Statess hall lay down themanner in which such references shall be made.
Article 13
This Directive is addressed to the Member States.1993L0074 — EN — 12.06.1996 — 001.001 — 7
(1) OJ No L 213, 21. 7. 1982, p. 8.
▼B
ANNEX
1993L0074 — EN — 12.06.1996 — 001.001 — 8