CELEX: 51992PC0324
Language: en
Date: 1992-07-31
Title: Proposal for a COUNCIL REGULATION (EEC) on feedingstuffs intended for particular nutritional purposes

No C 231 /6                           Official Journal of the European Communities                                     9. 9 . 92
                                                               II
                                                       (Preparatory Acts)
                                                 COMMISSION
              Proposal for a Council Regulation (EEC) on feedingstuffs intended for particular nutritional
                                                            purposes
                                                        (92 /C 231 /09)
                                                      COM(92) 324 final
                                     (Submitted by the Commission on 12 August 1992)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           are in a particular physiological condition for a limited
                                                                   time, such as gestation, lactation, moult, suckling or
                                                                   weaning, or have a temporarily or irreversibly impaired
Having regard to the Treaty establishing the European              process of assimilation, absorption or metabolism ;
Economic Community, and in particular Article 43
thereof,
                                                                   Whereas, when rules are being laid down for the
Having regard to the proposal from the Commission,                 marketing of feedingstuffs intended for particular nu­
                                                                   tritional purposes, care should be taken to ensure that
                                                                   such feedingstuffs have a beneficial effect on the animals
Having regard to the opinion of the European                       which ingest them ; whereas feedingstuffs must therefore
Parliament,                                                        always be of merchantable quality; whereas they must
                                                                   neither present a hazard for animal or human health nor
                                                                   be marketed in a manner liable to mislead ;
Having regard to the opinion of the Economic and
Social Committee,
                                                                   Whereas this Regulation applies without prejudice to
Whereas feedingstuffs intended for particular nutritional          other Community provisions on feedingstuffs, and
purposes are playing an increasing role in the diet of pet         particularly the rules applicable to compound feeding­
animals ; whereas such products are also used in the               stuffs ; whereas, however, in the interests of clarity, this
rearing of productive livestock;                                   Regulation lays down rules on the labelling and sealing
                                                                   of packaging containing feedingstuffs intended for
                                                                   particular nutritional purposes ;
Whereas in some Member States feedingstuffs covered
by this Regulation are already marketed in such a way as
to draw the attention of users to their particular compo­          Whereas the user of feedingstuffs intended for particular
sition ;                                                           nutritional purposes needs to be provided with accurate
                                                                   and meaningful information ;
Whereas a common definition should be laid down for
the products concerned ; whereas the definition must
provide that products presented as intended to meet                Whereas in order to distinguish between the feeding­
certain specific nutritional needs must have a specific            stuffs meeting the criteria laid down in this Regulation
composition and/or be manufactured using special                   and other feedingstuffs, a single qualifying expression,
methods ; whereas it is essential to establish the principle       'dietetic', must accompany the descriptions 'straight
that such feedingstuffs must be clearly distinguished, in          feedingstuff',     'complementary      feedingstuff'     and
their characteristics and purpose, from both ordinary              'complete feedingstuff', as appropriate ;
feedingstuffs and medicated feedingstuffs ;
                                                                   Whereas, as in the case of ordinary feedingstuffs, at least
Whereas the composition and preparation of feeding­                the levels of analytical constituents having a direct effect
stuffs intended for particular nutritional purposes must           on the quality or the feedingstuff should be declared ;
be specially designed to meet the particular nutritional           whereas provision should be made for the declaration of
needs of the categories of animals for which they are              certain additional analytical constituents which give the
intended ; whereas these categories include animals which          feedingstuff its dietetic properties ;
 ---pagebreak---  9. 9 . 92                             Official Journal of the European Communities                              No C 231 / 7
 Whereas all producers of feedingstuffs intended for              Whereas application of this Regulation should be
 particular nutritional purposes must have the option of          delayed for one year in order that rules necessary for its
 indicating on the label certain particulars useful to the        applicability can be laid down ;
 user; whereas such particulars may, in exceptional cases,
 refer to diseases ;
                                                                 Whereas effective inspection of feedingstuffs intended
                                                                  for particular nutritional purposes must be ensured ;
 Whereas, given that feedingstuffs intended for particular       whereas in certain circumstances the usual means at the
 nutritional purposes contain no medicinal substances, it         disposal of the inspection services may be insufficient to
 is not necessary for the supply of such products to be           allow verification that a feedingstuff actually possesses
 subject to presentation of a veterinary prescription ;          the particular nutritional properties attributed to it;
 whereas, however, in cases where feedingstuffs are to be        whereas it should therefore be provided that, where
 administered to animals with irreversibly impaired              necessary, the person responsible for marketing the
 processes of assimilation , absorption or metabolism or         product should assist the inspection service in its duties,
 for a prolonged period to animals not suffering from
 problems associated with old age, the user should be
warned that consulation of a veterinarian, in the case of
                                                                 HAS ADOPTED THIS REGULATION :
 pets, or an expert in animal nutrition, in the case of
 productive livestock, is recommended so that any unde­
 sirable effects can be averted ;
                                                                                            Article 1
Whereas, in order to provide users with sufficient                1 . This Regulation concerns feedingstuffs intended for
guarantees, feedingstuffs intended for particular nu­            particular nutritional purposes .
tritional purposes should normally be marketed in sealed
containers or packages ; whereas, however, provision
must be made for derogations in special cases to be              2.     For the purposes of this Regulation :
defined at Community level ;
                                                                 (a) feedingstuffs means products of vegetable or animal
                                                                      origin, in the natural state, fresh or preserved, and
Whereas a procedure should be provided for drawing up                 products derived from the industrial processing
a list of intended uses for products covered by this Regu­            thereof, and organic or inorganic substances, used
lation, for verifying that the feedingstuffs concerned                singly or in mixtures, whether or not containing
conform to the qualifying expression 'dietetic', for deter­           additives, for oral animal feeding ;
mining the declarations which must appear on labels and
for laying down methods for calculating the energy value
of such feedingstuffs ;                                          (b) feedingstuffs intended for particular nutritional
                                                                      purposes means feedingstuffs which, by virtue of their
                                                                      particular composition or method of manufacture,
Whereas the marketing of feedingstuffs intended for                   can be clearly distinguished from both ordinary feed­
particular nutritional purposes which satisfy the                     ingstuffs and the products defined in Council
requirements of this Regulation must not be subject to                Directive 90/ 167/EEC (2) and are presented as
any restriction on grounds of content, methods of manu­               intended to meet specific nutritional requirements ;
facture, presentation or labelling ;
                                                                 (c) particular nutritional purpose means the purpose of
Whereas, in cases where a product presents a hazard to                satisfying the specific nutritional needs of certain
animal or human health or the environment, provision                  pets or productive livestock whose process of
should be made for any Member State to request that                   assimilaton, absorption or metabolism is impaired, or
the Commission take the appropriate measures, on                      which are temporarily in particular physiological
                                                                      conditions and are therefore able to derive benefit
justified grounds ;
                                                                      from controlled ingestion of feedingstuffs appro­
                                                                      priate to their condition.
Whereas, for cases where the Council empowers the
Commission to apply the rules laid down in respect of
feedingstuffs intended for particular nutritional purposes,                                 Article 2
a procedure should be provided for close cooperation
between the Member States and the Commission in the              Feedingstuffs as referred to in Article 1 ( 1 ) shall be
Standing Committee on Feedingstuffs set up by Council            marketed only if they are wholesome, unadulterated and
Decision 70/ 372/EEC (');                                        of merchantable quality.
(l) OJ No L 170, 3 . 8 . 1970, p. 1 .                            O OJ No L 92, 7 . 4. 1990, p. 42.
 ---pagebreak--- No C 231 / 8                            Official Journal of the European Communities                                    9 . 9 . 92
The nature or composition of these feedingstuffs shall be          (e) the indication of the particular nutritional charac­
such that the products are appropriate for the intended                teristics of the feedingstuff;
particular nutritional purpose while also conforming to
certain dietary principles .
                                                                   (f) for feedingstuffs not intended for pets other than
                                                                       dogs and cats : the ingredients to be declared in
                                                                       accordance with Article 7 ;
These feedingstuffs shall not represent a danger to
animal or human health and shall not be presented or
marketed in a manner liable to mislead .                          (g) the recommended length of time for use of the feed­
                                                                       ingstuff;
                            Article 3                             (h) the declarations required by Article 13 (a) ;
1.     This Regulation is without prejudice to the
Community provisions on :                                         (i) 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 ;
(a) straight feedingstuffs ;
                                                                  (j) the net quantity expressed in units of mass in the
                                                                       case of solid products, and in units of mass or
(b) compound feedingstuffs ;                                           volume in the case of liquid products ;
(c) additives used in feedingstuffs ;                             (k) the storage life to be indicated in accordance with
                                                                       Article 8 ( 1 );
(d) undesirable substances and products in animal
     nutrition ;                                                  (1) the batch number, if the date of manufacture is not
                                                                       given .
(e) certain products used in animal nutrition .
                                                                  2. The storage life, the net quantity and the batch
                                                                  reference number may be marked outside the space
2. However, paragraph 1 (a) and (b) shall not apply               provided for the labelling particulars referred to in
to the provisions relating to the labelling and sealing of        paragraph 1 ; in that case, the relevant particulars shall be
packaging of feedingstuffs as referred to in Article 1 ( 1 ).     accompanied by an indication of where the information
                                                                  appears .
                            Article 4                                                        Article 5
1 . Feedingstuffs as referred to in Article 1 ( 1 ) shall not     In conjunction with the particulars listed in Article 4,
be marketed unless the particulars listed below, which            only the following additional particulars may be put in
shall be clearly visible, legible and indelible and for           the space provided for that purpose :
which the manufacturer, packer, importer, seller or
distributer established within the Community shall be
held responsible, are shown in a space provided for that          (a) the identification mark or trade mark of the person
purpose on the packaging, on the container or on a label               responsible for the labelling particulars ;
attached thereto :
                                                                  (b) the name or business name and the address or
                                                                       registered place of business of the manufacturer, if
(a) the description 'straight feedingstuff, 'comp­                     this is not the person responsible for the labelling
     lementary feedingstuff' or 'complete feedingstuff', as            particulars ;
     applicable, accompanied by the qualifying expression
     'dietetic' ;
                                                                  (c) where appropriate, the batch number ;
(b) the species or category of animal for which the feed­
     ingstuff is intended ;                                       (d) the price of the product;
                                                                  (e) the description or trade name of the product;
(c) the precise use, i.e. the particular nutritional purpose ;
                                                                  (f) for feedingstuffs intended for pets other than dogs
(d) directions for the proper use of the feedingstuff;                 and cats : the ingredients to be declared in
 ---pagebreak--- 9 . 9 . 92                                 Official Journal of the European Communities                                No C 231 / 9
       accordance with Article 7 ;                                   b) feedingstuffs as referred to in Article 1 ( 1 ) intended
                                                                          for pets : ingredients to be listed either indicating the
(g) the date of manufacture to be indicated in                            amount contained or in descending order by weight.
       accordance with Article 8 (2) ;
(h) the official code number enabling the manufacturer               3 . The ingredients shall be described by their specific
       to be identified where the latter is not responsible for      names taking into account, as appropriate, the
       the labelling particulars ;                                   requirements laid down in Commission Directive
                                                                     92/. . ./EEC (*) (the main ingredients normally used for
(i) if appropriate, the declarations allowed pursant to              the preparation of compound feedingstuffs intended for
      Article 13 (a);                                                species other than pets). However, the indication of the
                                                                     specific name of the ingredient may be replaced by the
(j) the descriptions 'complete feedingstuff' or                      name of the category to which the ingredient belongs in
       'complementary feedingstuff' in respect of feeding­           accordance with Commission Directives 91 / 357/EEC (2)
       stuffs intended for pets other than cats and dogs may         and 82 / 475 /EEC (}).
       be replaced by the description 'compound feed­
       ingstuff'. In that case, the declarations required or
       allowed pursuant to this Article shall be those laid          Where one of these two forms of declaration is used, the
       down for complete feedingstuffs ;
                                                                     other shall not be used save where one of the ingredients
                                                                     used belongs to none of the categories which have been
(k) for       compound       feedingstuffs    for    pets,  the      defined ; in such cases, the ingredient, designated by its
       descriptions :                                                specific name, shall be mentioned in order of percentage
                                                                     by weight in relation to the categories .
      — in English, 'compound feedingstuff', 'comp­
           lementary feedingstuff' and 'complete feed­
           ingstuff' may be replaced by the descriptions
           'compound pet food', 'complementary pet food'             4. The labelling of feedingstuffs as referred to in
           and 'complete pet food' respectively;                     Article 1 ( 1 ) for pets may also draw particular attention
                                                                     to the presence, low content or high content of one or
      — in Spanish, 'pienso' may be replaced by the                  more ingredients essential to bestow on the feedingstuff
           description 'alimento',                                   a particular nutritional purpose .
      — in Dutch, 'mengvoeder', 'aanvullend diervoeder'
           and 'volledig diervoeder' may be replaced by the          In such cases, the minimum or maximum content,
           descriptions 'samengesteld voeder', 'aanvullend           expressed in terms of percentage by weight, of the
           samengesteld voeder' and 'volledig samengesteld           ingredient(s) incorporated, must be clearly indicated
           voeder' respectively.                                     either opposite the declaration drawing attention to the
                                                                     ingredient(s) or in the list of ingredients or by
                                                                     mentioning the ingredient(s) and the percentage(s) by
                             Article 6                               weight concerned opposite the corresponding category
                                                                     of ingredients.
The qualifying expression 'dietetic' shall be reserved for
feedingstuffs as referred to in Article 1 ( 1 ).
Qualifying expressions other than 'dietetic' shall be                                           Article 8
prohibited in the labelling and presentation of these feed­
ingstuffs.                                                           1.    The storage life shall be given by the following
                                                                     indications :
                             Article 7
1 . Where a declaration of the ingredients is provided,              — 'use before . . followed by the date (day, month
all the ingredients must be mentioned.                                   and year) in the case of microbiologically highly per­
                                                                         ishable feedingstuffs as referred to in Article 1(1 ),
2.      The listing of ingredients shall be subject to the
following rules :
(a) feedingstuffs as referred to in Article 1 ( 1 ) intended         O OJ No L . . .
      for animals other than pets : ingredients to be listed         O OJ No L 193 , 17 . 7 . 1991 , p . 34 .
      in descending order by weight ;                                0) OJ No L 213 , 21 . 7 . 1982 , p . 27 .
 ---pagebreak---  No C 231 / 10                         Official Journal of the European Communities                                     9 . 9 . 92
— 'best before . . .', followed by the date (month and            animals not suffering from problems associated with old
     year) in the case of other feedingstuffs as referred to      age, should include the words :
     in Article 1 ( 1 ).
                                                                  'The advice of a veterinarian or of an expert in animal
Where other Community rules concerning feedingstuffs             nutrition should be obtained before using'.
as referred to in Article 1 ( 1 ) require the indication of
storage life, only one date shall be indicated, i.e. that
which is the soonest.
                                                                                            Article 12
2.     The date of manufacture shall be shown as follows :        1 . Feedingstuffs as referred to in Article 1 ( 1 ) may be
                                                                 marketed only in packages or containers sealed in such a
                                                                 manner that the seal is damaged on opening and may
'Manufactured ... (x days, months or year(s)) before             not be reused .
the storage life expiry date indicated'.
                                                                 2. Derogations from paragraph 1 , which must be
                                                                 accepted at Community level, shall be adopted by the
                            Article 9                            procedure laid down in Article 16, provided that the
                                                                 identification and quality of the feedingstuffs as referred
The person responsible for the labelling particulars of          to in Article 1 ( 1 ) are guaranteed.
feedingstuffs as referred to in Article 1 ( 1 ) may provide
information in addition to that required pursant to this
Regulation.
                                                                                            Article 13
However, such information :                                      The procedure laid down in Article 16 shall be followed
                                                                 for :
— shall not be designed to indicate the presence or
    content of analytical constituents other than those to       (a) drawing up a list of intended uses reserved for feed­
    be indicated by virtue of Article 4 or 5,                          ingstuffs as referred to in Article 1 ( 1 ) and deter­
                                                                       mining the declarations, whether obligatory or
                                                                       optional, and the general provisions applicable to the
— shall not attribute to the feedingstuff effects or                   marketing of these products (*) ;
    properties that it does not possess or suggest that it
    possesses special characteristics when all feedingstuffs
    possess such characteristics,                                (b) deciding whether feedingstuffs bearing the qualifying
                                                                       expression 'dietetic' are in fact covered by the defi­
                                                                       nition given in Article 1 (2) (c) ;
— shall relate to objective or quantifiable factors which
    can be substantiated,
                                                                 (c) laying down the methods for calculating the energy
                                                                       value of the feedingstuffs.
— shall be clearly separated from all the particulars
    specified in Article 4.
                                                                                            Article 14
                          Article 10                             Trade in feedingstuffs as referred to in Article 1 ( 1 )
                                                                 which comform to this Regulation and any provisions
For the purposes of marketing in other Member States,            adopted to it shall not be prohibited or hindered for
the indications printed on the packaging, container or           reasons relating to their composition, manufacturing
attached label shall be given in at least one of the             characteristics, presentation or labelling.
national or official languages of the country of desti­
nation .
                                                                                            Article 15
                          Article 11
                                                                 1.     Where a Member State establishes that the use of a
                                                                 feedingstuff as referred to in Article 1 ( 1 ) or its use in
The packaging, container, label or instructions for use          the prescribed conditions presentes a hazard for animal
accompanying feedingstuffs as referred to in Article 1 ( 1 )
which are intended for animals whose process of assimi­
lation, absorption or metabolism has been irreversibly           (') These general provisions must be in line with those set out
impaired, or which are to be used for a long period for              in Part A of the Annex to Directive 79/ 373 /EEC .
 ---pagebreak--- 9 . 9 . 92                           Official Journal of the European Communities                                No C 231 / 11
or human health or for the environment, it shall               If the measures envisaged are not in accordance with the
immediately inform the Commission, giving the reasons          opinion of the Committee, or if no opinion is delivered,
for its decision.                                              the Commission shall, without delay, present to the
                                                               Council a proposal relating to the measures to be taken.
                                                               The Council shall act by a qualified majority.
2.      The Commission shall initiate as soon as possible
the procedure laid down in Article 17 with a view to
adopting any appropriate measures.                             If, on the expiry of three months from the date of
                                                               referral to the Council, the Council has not acted, the
                                                               proposed measures shall be adopted by the Commission.
                        Article 16
Where the procedure laid down in this Article is to be                                     Article 18
followed the Commission shall be assisted by the
Standing Committee on Feedingstuffs acting in an               To allow effective official inspection of feedingstuffs as
advisory capacity, hereinafter referred to as 'the             referred to in Article 1 ( 1 ), the following specific
Committee'.                                                    provisions shall apply :
The representative of the Commission shall submit to the        1 . Member States shall take all the measures necessary
Committee a draft of the measures to be taken. The                  to enable their competent authorities to ascertain, by
Committee shall deliver its opinion on the draft, within a          sample checks at all stages of production and
time limit which the chairman may lay down according                marketing of the feedingstuffs as referred to in Article
to the urgency of the matter, if necessary by taking a              1 ( 1 ), that the provisions of this Regualtion are
vote .                                                              complied with ;
The opinion shall be recorded in the minutes ; in addition     2 . where necessary, the competent authority shall be
each Member State shall have the right to ask to have its           empowered to require the person responsible for
position recorded in the minutes.                                   placing the product on the market to produce
                                                                    scientific data establishing the feedingstuffs
The Commission shall take the utmost account of the                 conformity with this Regulation.
opinion delivered by the Committee. It shall inform the
Committee of the manner in which its opinion has been               If such data have been published in readily accessible
taken into account.
                                                                    form, a reference to the publication shall suffice.
                        Article 17
                                                                                           Article 19
Where the procedure laid down in this Article is to be         The following Directives are amended as specified :
followed, the chairman shall refer the matter to the
Standing Committee on Feedingstuffs, hereinafter
referred to as 'the Committee', either on his own
                                                               (a) the following is added to Article 1 (2) of Council
initiative or at the request of the representative of a              Directive 74 /63 / EEC of 17 December 1973 on the
Member State .
                                                                     fixing of maximum permitted levels for undesirable
                                                                     substances and products in feedingstuffs (') :
The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The
Committee shall deliver its opinion on the draft, within a            '(f) feedingstuffs for particular nutritional purposes';
time limit which the chairman may lay down according
to the urgency of the matter. The opinion shall be              (b) the following is added to Article 1 (2) of Council
delivered by the majority laid down in Article 148 (2) of            Directive 77 / 101 / EEC of 23 November 1976 on the
the Treaty for decisions which the Council is required to            marketing of straight feedingstuffs (2) :
adopt on a proposal from the Commission. The votes of
the representatives of the Member States within the
Committee shall be weighted as provided in that Article.              '(e) feedingstuffs for particular nutritional purposes';
The chairman shall not vote .
The Commission shall adopt the measures envisaged if
they are in accordance ' with the opinion of the                O OJ No L 38 , 11 . 2. 1974 , p . 31 .
Committee.                                                      (2) OJ No L 32, 3 . 2 . 1977 , p. 1 .
 ---pagebreak--- No C 231 / 12                          Official Journal of the European Communities                                9 . 9 . 92
(c) the following is added to Article 1 (2) of Council                                    Article 20
    Directive 79/373/EEC of 2 April 1979 on the
    marketing of compound feedingstuffs (1) :                    This Regulation shall enter into force on the seventh day
                                                                 following its publication in the Official Journal of the
    '(h) feedingstuffs for particular nutritional purposes';     European Communities.
(d) the following is added to Article 1 (2) of Council           It shall take effect one year after the date of its entry
    Directive 82/471 /EEC of 30 June 1982 concerning             into force .
    certain products used in animal nutrition (2) :
                                                                 This Regulation shall be binding in its entirety and
    '(f) feedingstuffs for particular nutritional purposes'.     directly applicable in all Member States .
O OJ No L 86, 6. 4. 1979, p. 30.
O OJ No L 213 , 21 . 7 . 1982 , p. 8 .