CELEX: 51993PC0119
Language: en
Date: 1993-03-26
Title: Proposal for a COUNCIL DECISION concerning the use and marketing of enzymes microorganisms and their preparations in animal nutrition

No C 116 / 6                                Official Journal of the European Communities                                      27 . 4 . 93
                                                                     II
                                                             (Preparatory Acts)
                                                       COMMISSION
              Proposal for a Council Decision concerning the use and marketing of enzymes micro-organisms
                                                and their preparations in animal nutrition
                                                              (93 /C 116/07)
                                                            COM(93) 119 final
                                            (Submitted by the Commission on 29 March 1993)
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,                                Whereas it is essential, in the expectation of an
                                                                         amendment to the guidelines and in order to allow the
Having regard to the Treaty establishing the European                    submission of dossiers for these products , to allow
Economic Community, and in particular Article 43                         provisionally the use and marketing of enzymes , micro­
thereof,                                                                 organisms and their preparations at national level ,
                                                                         provided they do not present any danger to human or
                                                                         animal health ;
Having regard to the proposal from the Commission ,
                                                                         Whereas the authorization of these products requires an
Having regard to the opinion of the European                             inventory of them at the level of Member States, and the
Parliament,                                                              transmission to the Commission of certain information
                                                                         justifying their inclusion in national lists ;
Having regard to the opinion of the Economic and
Social Committee ;
                                                                         Whereas Member States may not restrict the marketing
                                                                         of livestock products obtained from feeds containing
Whereas Council Directive 70 / 524 / EEC concerning                      enzymes , micro-organisms or their preparations when
additives in feedingstuffs ('), as last amended by                       these   are  included    on   a  national     list established
Directive 92 / 1 13 / EEC (2) lays down the principles                   according to the provisions of this Decision ;
relating to the authorization and the use of additives ;
Whereas      Council        Directive       87/ 153 /EEC    fixing       Whereas the provisions of this Decision do not apply to
guidelines for the assessment of additives in feeding­                   enzymes, micro-organisms, or to their preparations when
stuffs (}) constitutes a guide for defining the scientific               used as silage agents ;
information necessary to identify and characterize the
products concerned, as well as the studies necessary to                  Whereas this Decision applies without prejudice to
evaluate, in particular, their efficacy and innocuousness                Directive 70 / 524 / EEC subject to the amendments which
for humans , animals and the environment ;                               should still be made to this Directive in order to allow
                                                                         the coexistence of the temporary regime ;
Whereas     advances      in    scientific    and    technological
knowledge permit the use of certain enzymes, micro­
organisms and their preparations in animal nutrition in                  Whereas it is advisable as a consequence to amend
order to improve the digestibility of nutrients, or to                   Directive 87 / 153 /EEC , and quickly, with a view to
stabilize the flora of the digestive system of animals, and              having available the necessary rules for the specific
to reduce the content of certain substances dangerous to                 examination of additives belonging to the new group of
the environment, whereas at the moment no criteria exist                 enzymes and micro-organisms , whereas in the meantime ,
                                                                         the dossiers which will be submitted with a view to
for the examination of requests for authorization for use
as additives of this new generation of products ;                        assessing products included in the national list should be
                                                                         prepared according to the guidelines established for
                                                                         additives in general ;
( 1) OJ No L 270 , 14 . 12 . 1970 , p . 1 .
(2) OJ No L 16 , 25 . 1 . 1993 , p . 2 .                                 Whereas it is advisable that industry is given sufficient
(') OJ No L 64 , 7. 3 . 1987 , p . 19 .                                  time to apply the new provisions provided for enzymes ,
 ---pagebreak---  27 . 4 . 93                             Official Journal of the European Communities                                No C 116 / 7
 micro-organisms and their preparations as well as pre­                                        Article 5
 mixtures and feedingstuffs containing them ,
                                                                    Before 1 January 1988 , a ruling will be given in
                                                                    accordance with the procedure provided by Directive
 HAS ADOPTED THIS DECISION :                                        70/524 /EEC on the dossiers referred to in the second
                                                                    indent of Article 3 concerning the authorization of
                            Article 1                               additives in animal nutrition .
  1 . This Decision shall apply to the use and marketing
 of enzymes , micro-organisms and their preparations in                                        Article 6
 animal nutrition .
                                                                   Where Member States find it impossible to satisfy one of
 2 . This Decison applies without prejudice to the                  the conditions referred to in Article 3 , for an enzyme,
 provisions of Directive 70 / 524 /EEC and particularly to          micro-organism, or a preparation used on their territory,
 the provisions concerning the authorization of enzymes,           they shall take all the necessary measures to ensure that
 micro-organisms and their preparations for use as                  the enzyme, micro-organism or preparation obtained
 additives .                                                        from them is no longer used.
                            Article 2                                                          Article 7
 By way of derogation from Article 3 of Directive                   1 . Enzymes, micro-organisms and their preparations,
 70 / 524 / EEC Member States shall allow the use and              as well as pre-mixtures and compound feedingstuffs in
 marketing of enzymes , micro-organisms and their prepa­           which they have been incorporated, may only be
 rations in feedingstuffs on their territory, provided that,       marketed if the particulars listed below, which should be
 on the basis of the available information , the products do       clearly visible, legible and indelible and for which the
 not present a danger to human or animal health, and               producer, packer, importer, seller or distributor estab­
 that they are included in the list which has been estab­          lished within the Community shall be held responsible
 lished by virtue of Article 3 .                                   are shown on the packaging, container or on a label
                                                                   attached thereto :
                            Article 3
                                                                   A. for enzymes :
 On the basis of the information they receive Member
 States shall forward :                                                (a) the specific name of the active constituent(s)
                                                                            according to their enzymatic activity(ies) and the
— to the Commission before 1 January 1994 a list of                         identification number(s) according to the Interna­
      enzymes and micro-organisms and their preparations                    tional Union of Biochemistry ;
      used on their territories , accompanied by an identifi­
      cation note established for each product according to            (b) the activity units (activity units (') per g or
      the model given in the Annex ,                                        activity units per ml) ;
— to the Commission and to other Member States                         (c) the name or business name and the address or
      before 1 January 1996 , the dossiers justifying these                 registered place of business of the person
      authorizations by the manufacturer(s) having                          responsible for the particulars in this paragraph ;
     requested inclusion of their products in the list                 (d) the name or business name and address or
     referred to in the first indent above .
                                                                            registered place of business of the manufacturer is
                                                                            he is not responsible for the particulars on the
                            Article 4                                       label ;
 1.     The Commission shall communicate to Member
                                                                       (e) the expiry date of the guarantee or the storage
States the lists of enzymes , micro-organisms and their                     life from the date of manufacture ;
preparations, which have been sent to them in
accordance with the provisions of Article 3 .                          (f) the batch reference number and the date of
                                                                            manufacture ;
2 . Where , either an enzyme, micro-organism or a
preparation manufactured from them are included in
                                                                       (g) directions for use and where appropriate, a safety
                                                                            recommendation ;
several national lists , it may be agreed between the
Member States concerned that only one dossier is                       (h) the net weight and for liquid additives either the
presented by one of them .                                                  net volume or the net weight ;
3 . The Commission shall publish in the Official                       (i) the indication 'to be used exclusively for the
Journal of the European Communities, Part C, before 31                      manufacture of feedingstuffs';
March 1996 , on the basis of the dossiers which have
been presented to them in accordance with Article 3 , a
list of enzymes , micro-organisms and their preparations           (') Units of activity expressed as nmole product released per
permitted in different Member States .                                 minute per gram of enzymatic preparation .
 ---pagebreak--- No C 116 / 8                             Official Journal of the European Communities                                    27 . 4 . 93
B. for micro-organisms :                                                 (c) the directions for use and any safety recommen­
     (a) the identification of the strain (s) according to the                dations regarding the use of pre-mixtures ;
          recognized international code of nomenclature                  (d) the animal species or category of animals for
          and the depositing number of the strain(s) ;                        which the pre-mixture is intended ;
     (b) the number of colony-forming units (CFU/g);                     (e) the name or business name and the address or
     (c) the name or business name and address or                             registered place of business of the person
          registered place of business of the person                          responsible for the particulars referred to in this
          responsible for the particulars referred to in this                 paragraph ;
          paragraph ;                                                    (f) the net weight and, in the case of liquids , either
     (d) the name or business name and address or                             the volume or net weight ;
          registered place of business of the manufacturer if            (g) the identification of the strain(s) according to the
          he is not responsible for the particulars on the                    recognized international code of nomenclature
          label ;                                                             and the depositing number of the strain(s) ;
     (e) the expiry date of the guarantee, or the storage                (h) the number of colony-forming units (CFU/g);
          life from the date of manufacturer ;                           (i) the name or business name and address or
     (f) the batch reference number and the date of                           registered place of business of the person
          manufacturer ;                                                      responsible for the particulars referred to in this
     (g) the directions for use and where appropriate, a                     paragraph ;
          safety recommendation ;                                       (j) the name or business name and address or
     (h) the net weight, and for liquid additives either the                 registered place of business of the manufacturer if
          net volume or the net weight ;                                     he is not responsible for the particulars on the
                                                                             label ;
     (i) the indication 'to be used exclusively for the
          manufacture of feedingstuffs';                           E. for compound feeds in which enzymes have been incor­
                                                                        porated:
C. for pre-mixtures containing enzymes :
                                                                        (a) the specific name of the active constituent(s )
     (a) the description 'pre- mixture';
                                                                             according to their enzymatic activity(ies)
    (b) the indication 'to be used exclusively in the                        conforming with Annexes I or II and the identifi­
          manufacture of feedingstuffs';                                     cation number according to the International
    (c) the directions for use and any safety recommen­                      Union of Biochemistry ;
         dations regarding the use of pre-mixtures ;                    (b) the activity units (activity units per g) or activity
    (d) the animal species or category of animals for                        units per ml ;
         which the pre-mixture is intended ;                            (c) the expiry date of the guarantee or the storage
    (e) the name or business name and the address or                         life from the date of manufacture ;
         registered place of business of the person
         responsible for the particulars referred to in this       F. for compoundfeeds in which micro-organisms have been
         paragraph ;                                                    incorporated:
    (f) the net weight and, in the case of liquids, either              (a) the identification of the strain(s) according to the
         the volume or net weight ;                                          recognized international code of nomenclature
    (g) the specific name of the active constituent(s)                       and the depositing number of the strain(s);
         according to their enzymatic activity(ies) and the             (b) the number of colony-forming units (CFU/g);
         identification number(s) according to the Interna­             (c) the expiry, date of the guarantee or the storage
         tional Union of Biochemistry ;                                      life from the date of manufacture .
    (h) the activity units (activity units per g or activity       2.      Information other than that prescribed in paragraph
         units per ml);                                            1 , subparagraphs A, B , C and D such as the commercial
    (i) the expiry date of the guarantee or the storage            name, may be included on the packaging, containers or
         life from the date of manufacturer ;                      on a label attached thereto provided that it is clearly
    (j) the name or business name and address or                   separated from the indications mentioned above.
         registered place of business of the manufacturer if
         he is not responsible for the particulars on the                                      Article 8
         label ;
                                                                   This Decision is applicable from 1 July 1993 . However
D. for pre-mixtures containing micro-organisms:                    Article 7 is only applicable from 1 January 1994.
   (a) the description 'pre-mixture';
                                                                                               Article 9
   (b) the indication 'to be used exclusively in the
         manufacture of feedingstuffs';                            This Decision is addressed to the Member States .
 ---pagebreak--- 27 . 4 . 93                                  Official Journal of the European Communities                                                 No C 116 / 9
                                                                      ANNEX
                                                   MODEL OF IDENTIFICATION NOTE
            1.     Identity of the product
                   — trade name
                  — qualitative and quantitative composition
                      — active substance(s)
                      — other components
                      — impurities
                      — undesirable substances
                   — name or business name and the address or registered place of business of the manufacturer
                   — place of manufacture
                   — name or business name and the address or registered place of business of the manufacturer
            2.     Specifications concerning the active substance
            2.1 . For micro-organisms
                   — name and taxonomic description according to the international codes of nomenclature (')
                   — name and place of culture collection where the strain is registered and deposited and the number
                      of registration and deposit
                   — possible genetic manipulation
                   — the number of colony-forming units (CFU/g) for each species
            2.2 . For enzymes
                   — name according to main enzymatic activities and EC number (2)
                   — biological origin
                   — relevant activities with regard to appropriate types of substrates , chemically pure (expressed in
                       activity units (3) per g)
                    NB : If the active substance is a mixture of active components , all the components must be described
                         separately with an indication of their proportion in the mixture
            3.     Qualities of the product
                   — main sought-after effect
                      — information concerning efficiency
                       — justification for the presence of each component if the substance is a mixture of effective
                           components
                   — other effects
            (') Such as Bergey's ' Manual of Systematic Bacteriology -, ' The Yeasts, a taxonomic study by Lodder and Kreger van Rij ;
                 'Ainsworths and Bishy 's dictionary of the Fungi by Hawksworth ; ' Sutton and Ainsworth on "The genus Aspergillus " ' by
                 Raper and Fennell .
            (') Enzyme Nomenclature, Recommendations ( 1984) of the Nomenclature Committee of the International Union of
                 Biochemistry, Academic Press 1984 .
            (') Activity units expressed as µmole of product released per minute per gram of the enzymatic preparations.
 ---pagebreak--- No C 116 / 10                             Official Journal of the European Communities                                 27 . 4 . 93
            4.     Conditions for the use of product
                   — uses provided for in animal nutrition (species or categories of animal, type of feedingstuffs for
                      animal, period of use, etc.)
                   — proposed dosage in pre-mixes and feedingstuffs (appropriate units of biological activity such as
                      CFU per gram of product for micro-organisms or activity units per gram for enzyme preparations)
                   — other known uses of the active substance or the preparation (in foodstuffs, human or veterinary
                      medicine , industry etc .)
                   — recommendations concerning safety of use of the product in relation to target species , the
                      consumer and the environment
                   — if necessay, measures for the prevention of risks and means of protection during manufacture and
                      handling
            5.     Technological information
                   — stability of product
                      — with regard to atmospheric agents
                      — during the preparation of pre-mixtures and feedingstuffs
                      — in the case of presentation of pre-mixtures and feedingstuffs
                   — detailed description of process of manufacture and methods used concerning the control of the
                      quality of the product during its manufacture
            6.     Control
                   — methods of analysis for the determination of the product
                      — in pre-mixtures
                      — in feedingstuffs
            Where possible information provided in the identification note must be accompanied by existing scientific
            data .