CELEX: 51982PC0615
Language: en
Date: 1982-10-01
Title: Proposal for a COUNCIL DIRECTIVE on the fixing of guidelines for the assessment of certain products used in animal nutrition (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (82) 615
Vol. 1982/0193
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 ---pagebreak--- COMMItMQN OF THE EUROPEAN COMMUNITIES
                                                  COM(82 ) 615 final
                                                  Brussels , 1 October 1982
                                 Proposal for a
                               COUNCIL DIRECTIVE
 on the fixing of guidelines for the assessment of certain products used
                              in animal nutrition
                 (submitted to the Council by the Commission )
 C0M(S2 > 615 final
 ---pagebreak---                                                    l-h
                          EXPLANATORY MEMORANDUM
On 30 June 1982 , the Council adopted Directive 82 /471 / EEC concerning certain
products used in animal nutrition on account of their protein content .
The purpose of that framework directive was to authorize - under certain
conditions - the production and use of bioproteins for animal feeding .
More particularly , the purpose was to control not only the use of certain
well-known products such as amino acids , non-protein nitrogenous compounds
and certain yeasts , but above all the use of novel proteins obtained from
algae , fungi and the culture of micro-organisms ( bacteria , yeast ) on
substrates of various origins such as petroleum or methanol .
In order to establish every possible guarantee ensuring the safeguard of
human and animal health and protection of the environment , the Council
decided to make protein products obtained from bacteria , yeasts , algae
and inferior fungi subject to a very severe authorization procedure ,
under which the Commission will be required to consult the Scientific
Committee for Animal Nutrition and the Scientific Committee for Food , and
to obtain the opinion of the Standing Committee for Feedingstuf fs .
Furthermore , to ensure compliance with the provisions on human and
animal health in the framework Directive , Article 7 provides that , for
each product , the Member State concerned must send a dossier officially
to all the other Member " States and to the Commission and to the members
of the Scientific Committees .   This dossier must be drawn up in accor­
dance with guidelines which the Council undertook to adopt in time for
them to apply as from the date of application of the basic Directive .
                  i
 ---pagebreak---                               - 2 -
Accordingly , the purposp of the present Directive is to Lay down the said
guidelines for the presentation of the product dossiers referred to in
Article 7 of Directive 82 / 471 / EEC . These guidelines will be used as a
reference for assessing the products concerned in the light of current
scientific knowledge and for ensuring that such products meet the basic
criteria laid down for their authorization .
 ---pagebreak---                                 Proposal for a
                               COUNCIL DIRECTIVE
on the fixing of guidelines for the assessment of certain products used
                               in animal nutrition
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
Having regard to Council Directive 82 /471 / EEC of 30 June 1982 concerning certain
                                      1
products used in animal nutrition       , and in particular Article 7 thereof ,
Having regard to the proposal from the Commission,
Whereas Directive 82 / 471 / EEC provides that the products belonging to certain
groups must be examined on the basis of a dossier forwarded officially to
the Member States and the Commission ;
Whereas such dossiers must make it possible to verify that the products in question
comply with the general principles laid down in the Directive in respect of the
inclusion of new products in the Annex ;
Whereas it has been found necessary to provide for the dossiers to be compiled in
accordance with common guidelines defining , for each principle , the scientific
data which make it possible to identify and characterize the products concerned
and the studies necessary in order to evaluate their nutritional properties
and biological effects ; whereas these guidelines must be applicable on the date
on which Directive 82 /471 / EEC itself enters into force ;
Whereas the guidelines are intended primarily as a general guide ; whereas ,
depending on the nature of the product or its conditions of use , the extent of
the studies necessary in order to evaluate its properties or its effects may
vary ;
Whereas the guidelines have been drawn up on the basis of present scientific and
technical knowledge and they may be adapted if necessary to any developments in
this sphere ,
                                   –                                            ./.
( 1 ) J.O. N° L 213 , 21.7.1982 , p. 8 .
 ---pagebreak--- HAS ADOPTED THIS DIRECTIVE    :
                                Article 1
Member States shall prescribe that the dossiers on the products listed in points
1.1 . and 1.2 . of the Annex to Directive 82 / 471 / EEC are to be compiled in
accordance with the guidelines set out in the Annex hereto .
                                Article 2
Member States shall bring into force on    13 July 1984 the laws , regulations or
administrative provisions necessary in order to comply with this Directive . They
shall forthwith inform the Commission thereof .
                                Article 3
This Directive is addressed to the Member States .
Done at Brussels ,                                         For the Council
 ---pagebreak---                                                                   ANNEX
        GUIDELINES FOR THE ASSESSMENT OF CERTAIN PRODUCTS
                 USED IN ANIMAL NUTRITION
GENERAL ASPECTS
This document is intended as a guide for establishing dossiers on products
Listed in item 1 of the Annex of Council Directive 82 / 471 / EEC of 30 June
1982 concerning certain products used in animal nutrition ( 1 ), which have
been obtained from culturing microorganisms and which are proposed as a
new source of proteins in animal nutrition . These dossiers should enable
an assessment of such products based on the present state of knowledge and
should ensure their compliance with the fundamental principles laid down
for permitting their use , which are the subject of the provisions of Article
6(2 ) of the abovement ioned Directive .
All the studies outlined in this document may be required and , if necessary ,
additional information may be requested . As a general rule , all the informa­
tion necessary to establish the identity of the microorganism and the compo­
sition of the culture medium , and also the manufacturing process , characte­
ristics, presentation , conditions of use , methods of determination and nutri­
tional properties of the product must be provided . The same applies to the
information necessary to assess the tolerance of the product by the target
species and the risks for man and the environment , which could result directly
or indirectly from the use of the product . The toxicological studies required
 for this purpose will depend on the nature of the product , the animal species
 concerned and the metabolism of the product in laboratory animals .
The documentation to be provided should include detailed reports , presented
 in the order and with the numbering proposed in these guidelines and should
 be accompanied by a summary . The omission of any proposed studies should be
 justified . The publications quoted as references should be attached .
 OBSERVATIONS
 The term " product ", as used in these guidelines , refers to any proteinaceous
 product in the state in which it will be presented as feedingstuff or component
 of a feedingstuff .
 Any modification in the manufacturing process or in the conditions of use of
 a product will require notification and, if necessary, additional documentation
 for a new assessment .
 The guidelines will be updated as new scientific knowledge develops .
  ( 1 ) 0J No L 213 , 21 .7.1982 , p. 8
 ---pagebreak--- PRESENTATION OF STUDIES
I.    Microorganism, cultur-s medium and manufacturing process, charac­
      teristics of product , presentation and conditions of use, methods
      of determination .
II .  Studies on the nutritional properties of the product .
III . Studies on the biological consequences of the use of the product in
      animal nutrition .
IV .  Other relevant studies .
SECTION I :      MICROORGANISM, CULTURE MEDIUM AND MANUFACTURING PROCESS ,
                 CHARACTERISTICS OF PRODUCT , PRESENTATION AND CONDITIONS
                 OF USE , METHODS OF DETERMINATION
1.      MICROORGANISM
1.1 .   Classification, morphology , biological properties, any genetic
        manipulation .
1.2 .   Innocuity , possible survival outside the fermenter and environ-
        mental conséquences .
1.3 .   Constancy and purity of strains cultivated . Methods used to check
        these criteria .
2.      CULTURE MEDIUM AND MANUFACTURING PROCESS
2.1 .   Composition of substrate , added substances , etc .
2.2 .   Manufacturing and purification processes . Methods used to check
        the constancy of composition of the culture product and the
        detection of any chemical and biological contamination during
        production .
2.3 .   Technical processes of preparation for use .
3.      CHARACTERISTICS OF PRODUCT
3.1 .   Physical and physico-chemical properties : macro- and micro-
        morphology, particle size , density, specific weight , hygrosco­
        picity , solubility , solution characteristics ( pH, rheological
        characteristics ), electrostatic properties , etc .
3.2 .   Chemical composition :
3.2.1 . Content of moisture, crude protein, crude fat , crude fibre ,
        ash , nitrogen-free extract . Limits of variation .
3.2.2 . Content of total , ammonium, amide , nitrate and nitrite nitrogen,
        true protein . Qualitative and quantitative composition of total
        and free amino acids , nucleic acids (purine and pyrimidine bases ).
 ---pagebreak--- 3.2.3. Qualitative and quantitative composition of total lipids : fatt'y
        acids , non-saponi fiablé matter , lipid soluble pigments, etc .
3.2.4 . Qualitative and quantitative composition of carbohydrates and
         related substances .
3.2.5 . Qualitative and quantitative composition of inorganic components .
3.2.6 . Qualitative and quantitative colposi tion of vitamins .
3.2.7 . Qualitative and quantitative compositon of the other consti­
        tuents : additives , residues of substrate and solvents , conta­
        minants ( in particular , polycyclic aromatic hydrocarbons , nitro­
        samines ), etc .
3.3 .   Contamination by microorganisms during the manufacturing process .
3.4 .   Behaviour and stability of the product , as such and when mixed
        with feedingstuf fs in current use, during storage .
4.      PRESENTATION AND CONDITIONS OF USE
4.1 .   Proposed names for marketing the product .
4.2 .   Proposed formulations for marketing the product .
4.3 .   Intended use of the product in animal nutrition . Proposed con­
        centrations in complete and complementary feedingstuf fs for the
        animal species concerned .
5.      METHODS OF DETERMINATION
        Qualitative and quantitative methods for determination of the
        product in complete and complementary feedingstuf fs .
        N.B. : Description of these methods should be accompanied by in­
                formation as to specificity , sensitivity , limits of de­
                tection , margin of error , possible interferences by other
                substances . Samples of the product in its various proposed
                presentations should be available .
SECTION II : STUDIES ON THE NUTRITIONAL PROPERTIES OF THE PRODUCT
1.      ASSESSMENT OF PROTEIN VALUE
1.1 .   Chemical and/ or microbiological studies .
1.2 .   Studies on laboratory animals (preferably rats ) : digestibility ,
        protein efficiency ratio (PER), biological value of the product
        compared with reference proteins .
2.      S TUDIES ON TARGET SPECIES
        The following studies should be performed on each target species
        in comparison with a control group receiving , under the same con­
        ditions of nutritional balance , a diet in current use containing
        equivalent amounts of protein nitrogen .
 ---pagebreak---  t-.1 . Protein nd energy . up,»let.ieiitdticn value of t;ie product in the
         reticvis i.nc ?r the >.      conditions of use at various physio­
         logical stages of th . animals (growing period, pregnancy, laying,
        etc .) .
2.2 .    Influence of the product under the proposed conditions of use on
        growth ret *, feed conversion rate , morbidity, mortality , etc .
2.3 .   Optimum levels of incorporation of the product in the rations .
2.4 .   Effect of the product under the proposed conditions of use on the
        composition and on nutritive ,, technological and organoleptic
        quality of neat , offal , eggs and milk .
3.      EXPERIMENTAL CONDITIONS IN THE STUDIES ON TARGET SPECIES
        Give a detailed description of the tests performed and provide
        the following data :
3.1 .   Species , breed , age a.id sex of the animals , identification
        procedure .
3.2 .   Number of test and control groups; number of animals in each
        group ( the number should be large enough for statistical analysis
        using suitable statistical parameters ).
3.3 .   Levels of incorporation of the product , qualtitative and quan­
        titative composition of the ration and its analysis .
3.4 .   Location of each experiment , physiological state and animal
        health conditions , rearing conditions ( these should reflect those
        used in practice in the Community ).
3.5 .   Exact duration of testing and date of the analyses performed .
3.6 .   Adverse effects which occured during the experiment and time of
        their appearance .
SECTION III    : STUDIES CONCERNING THE BIOLOGICAL CONSEQUENCES OF THE
                 USE OF THE PRODUCT IN ANIMAL NUTRITION
The studies outlined in this section are intended to permit assessment
of the safety in use of the product in the target species , and of the
risks for man and the environment which could result directly or in­
directly from this use . The toxi cological studies required for this
purpose will depend on the nature of the product , the animal species
concerned and the metabolism of the product in laboratory animals .
1 .     STUDIES ON TARGET SPECIES
        The following studies should be performed on each target species
        in comparison with a control group receiving , under the same con­
        ditions of nutritional balance , a diet in current use containing
        equivalent amounts of protein nitrogen .
 ---pagebreak---                                       –  5 -
 1.1 .   Maximum incorporation rates of the product in the ration without
         producing any adverse effect .
 1.2 .   Effects of ingestion of the product under the proposed conditions
         of use on microorganisms of the flora of the alimentary tract and
         on colonization of pathogens in the alimentary tract .
1.3 .    Investigation under the   proposed conditions of use of possible
         residues of the product   ( substrate , culture medium, solvents,
         contaminants) in animal   products ( meat , milk , eggs , etc .).
1.4 .    Investigation under the   proposed conditions of use of possible
         residues of the product   ( substrate , culture medium, solvents ,
         contaminants ) in excreta .
2-      STUDIES ON LABORATORY ANIMALS
2.1 .   Metabolism
         Fate of the product in the animal : absorption, elimination, etc .
2.2 .   Mutageni city
        Investigations of potential mutagenicity due to contaminants ( in
        particular mycotoxins ) or residues of the product ( substrate ,
        culture, medium, solvents ), including in vitro screening tests
        using metabolic activation systems .
2.3 .   Toxi cologi cal studies
        The following studies should be performed in comparison with
        control groups receiving , under the same conditions of nutriti­
        onal balance , a diet- in current use containing equivalent amounts
        of protein nitrogen . Toxic effects should be investigated to elu­
        cidate their cause and mechanisms and to ascertain that they do
        not result from nutritional imbalance or from an overdosage of
        the product in the diet .
2.3.1 . Subchronic toxicity ( at least 90 days )
        In general , these studies should be carried out on two animal
        species , one of which being a rodent . The product should be
        administered in the daily ration in at least two levels of in­
        corporation . If possible , these should be chosen so as to de­
        termine a no-effect level and a level showing some adverse effect .
        The experimental groups should contain an adequate number of
        animals of each sex . A control group should always be included .
        All relevant biological data should be recorded at appropriate
        intervals , particularly data on growth rate , feed consumption ,
        haematology , urine analysis , biochemical parameters , mortality ,
        organ weights , gross pathology and hi stopathology of major organs
        and tissues . The results should be presented in detail and, as
        far as possible , should include statistical assessment .
 ---pagebreak--- <. 3.2 „ Chronic '(oxvcity
         In general , c . iror.v, fxicity studies should be carried out on two
         animal species , one of which being a rodent . The product should
         be administered in rr ) daily ration in at leart two levels of
         incorporation . Expt ^ :;icnts should extend for ?. mininum of two
         years Ir. th ? rat or oJ weeks in mice . The experimental groups
         should contain an c....;qujte number of animals of ? cch sex . A
         control group shoulci always be included . The experiment , if
         continued beyond the !iinimum period , should be terminated when
         survival in any but the group with the highest level of incorpo­
         ration has fallen to 20 % .
         The biological examinations mentioned under item 2.3.1 . should be
         carried out preferr^ly on a small satellito group of animals at
         appropriate inte'v^is throughout the experiment and on the sui–
         viviny animals at t.se end of the experiment . For assessing
         carcinogenicity , particular attention should be paid to the time
         of appearance, the Vstological types of any observed tumours and
         their incidence . Any effect on the incidence of tumours and / or
         the incidence or progress of diseases should be assessed by
         reference to control iroups , as indicated in paragraph 2.3 . The
         result should be presented in detail and , as far as possible ,
         should include statistical assessment .
2.4 .    Other studies
         Reproduction studies should extend over at least two filial
         generations and may be combined with embryotoxicity including
         teratogenicity studies . Particular attention should be paid to
         fertility , fecundity and observation on post-natal development of
         li tters .
2.5 .    Experimental conditions in the studies on laboratory animals
         Give detailed description of the tests performed and provide the
         following data :
2.5.1 . Species , breed , strain and sex of animals .
2.5.2 . Number of test and control groups , number of animals in each
         group ( the number should be large enough for statistical analysis
         using suitable statistical parameters ).
2.5.3 . Levels of incorporation of the product , qualitative and quanti­
         tative composition of the ration and its analysis .
2.5.4 . General rearing conditions throughout the period of testing .
2.5.5 . Exact duration of testing and date of examinations performed .
2.5.6 . Rate and timing of deaths for the various test groups .
2.5.7 . Pathological incidents which occurred during the experiment and
         time of their appearance .
 ---pagebreak---                                    - 7 –
3.      STUDIES CONCERNING THE ENVIRONMENT
        Depending on the nature of possible residues of the product
        ( substrate , culture medium , solvents , contaminants ) in excreta of
        target species , data on the fate of these residues in manure ,
        soil and water and also their effects on soil biology, plant
        growth and aquatic life may be required .
SECTION   IV : OTHER RELEVANT STUDIES
Depending on the nature and the conditions of use of the product , data
on allergic effects , on irritation of the skin and mucous membranes of
the eye , respiratory or digestive tract may be required to assess pos­
sible risks in handling the product and to prevent them .