CELEX: 51973PC0330
Language: en
Date: 1973-03-05
Title: Proposal of a COUNCIL DIRECTIVE (EEC) relating to the harmonization of the laws of Member States concerning natural yeasts and yeast residues (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (73) 330
Vol. 1973/0052
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                 COM(73)330 final
                                                 Brussels , 5 March 1973
                                   Proposal of a
                              COUNCIL DIRECTIVE (EEC )
                   relating to the harmonization of the laws of
                   Member States concerning natural yeasts and
                                  yeast residues
                   ( submitted to the Council by the Commission)
   COM(73) 330 final
 ---pagebreak---          Natural yeasts are microscopic unicellular fungi that proli­
ferate by way of cell-division . Without air they make sugars ferment , '
while producing carbonitt acid gas and alcohol , for which they have
been used since centuries for the production of fermented drinks and
for making bread . Exposed ts the air yeasts reproduce on a sugar
medium without producing alcohol , the sugar being used ifor the creation
of new cells | this is important because these organisms are extremely
rich in proteins,' up to 50% and in vitamins .
         The iast mentioned characteristic has made use since long dead
yeasts for animal feeding purposes . So the Commission recently submitted
to the Council of Ministers' a Proposal of Regulation concerning the
commercialization of forage '(i )^ in which yeasts are represented as
focds as such . However , - it appeared to be impossible to comprise living
or dead' yeasts into one definition to which the different reglementa-
tions concerning these products could refer . Another problem was
h«w to facilitate to the consumer to distinguish between natural yeasts
on the one hand j and on the other hand purely chemical products as
are the baking powders incorrectly called "artificial yeasts ".
         The 'present directive - gives answers to these questions . Of course
this is net the only reason fer establishing the proposed reglementa-
tion . Yeasts are indeed very widely used in foods for their fermenta­
tion power . But above all the essential characteristic ©f dead yeast
is quite evidently that it Can be a rich source of proteins in a world
where - the' greatest part of its rapidly growing population suffers
from an alarming malnutrition } additional supplies of protein's in a
most efficient way should bring help here .                          1  :
  ■ - ■ '^'Specific legislations on" yeasts' of the Kember States , if they
exist , are very succint , and mostly these products1 are treated by very
general provisions ; therefore it is appropriate to provide for a
( 1 ) O.J. n° C 3H- of 14.^.1971
 ---pagebreak--- commun ruling, which establishes in view of health protection minimum
requirements with which yeast for human, consumption . should at least
comply , but . which at the same time leaves room for scientific progress
in the field of yeast production*       The Recommendation . of . the Economic
and Social Council of . the United Nations, of 196? has been taken into
account concerning an, international action aiming at eliminating
the menace of e protein crisis and which concerns especially.. a ati- .
mulation and intensification of reseach en . proteins obtained, from,
unioellular organisms for animal and human foods . ..
      For the products under consideration a general definition is given
by the Directive elaborated with the           of, scientists of authority .,
and which comprise^ a listing0 yea^t, varieties of which it., has.. >een
proven that . certain steinsare harmless to the health . .The directive
is not applicable on forage yeast, w^th the exception that thi,s; defini­
tion and those , of dead yeasts and yeast residues do apply- to > products
destined for animal consumption .                    ( ...
      The ruling provides . for special requirements concerning the
composition of, baker 's yeasts which represent the geeatept part ;in
living yeast production * It establishes also relatively severe
provisions in the bacteriological field (here the government experts
admitted that for the application ,ef the requirement that yeast, be ,
free, of pathogenic, bacteria and taxins , research, for salmonella
and staphylococcus should be made on respectively 20 grams, and 1 gram
cf the, matter as such ) afid .in the; toxicological field., theae provisions
having been stiffened still where they concern human foods . Whe pro-,
duction of yeasts on alcanes ( saturated hydrocarbons ) may seem to : „ . .
open highly interesting perspectives for the development of the pro­
duction of yeasts , but it seemed wise to prohibit for the time being
the use of thorn for - human consumption until it has >een proyen .that
they, are .Jiaormless *     .......                                      -■
 ---pagebreak---                                - 3 -
     Finally it is appropriate to mention that three articles
provide for information of the consumer ; such information should
be layal and as precise and complete as possible .
     This Directive has been elaborated taking into account the
remarks made by the Acceding Countries whese opinion - was solli-
cited .
 ---pagebreak---                                      PFtOPOi/ L
                                         . i' ,"–
                 OP A COUCNIL DIRECTIVE ( ESC ) RELVritTG
                 TO THE HARMONIZATION OF THE LAWS OP MEMBER STATES
                 CONCERNING NATURAL YEASTS AND YEAST RESIDUES .
THE COUNCIL OP THE EUROPEAN COMMUNITIES ,
HAVING REGARD to the Treaty establishing the European Economic Community
and in particular to Article 100 thereof ,
HAVING REGARD to the proposal of the Commission ,
HAVING REGARD to the opinion of the European Parliament ,
                                                                                i
HAVING REGARD to the opinion of the Economic and Social Committee ,
WHEREAS , the legal and administrative provisions in force in certain Member
States define the composition and production characteristics of natural yeasts
as well as the provisions on labelling which must be observed when yeasts
axe marketed j
WHEREAS , the differences between laws create unequal conditions of competi~
tion between yeast producers and between users ; constitute a barrier to
the free movement of the products concerned and for this reason directly
affect the establishment and functioning of the Common Market ;
WHEREAS , it is , consequently , necessary to determine at Community level what
kinds of natural yeasts may be used and the rules to be observed in' respect
of their production , packaging and labelling ; there are good reasons for
defining particular- designations applicable to certain natural yeasts , for
the information of the consumer and with a view to ensuring conditions of
equal competition between producers ;
 ---pagebreak--- WHEREAS , live natural yeasts are organisms which mry be or become pathogenic
 following a genetic change whether or not it is induced ; it is necessary to
ensure that yeasts intended for human consumption correspond to precise
"bacteriological requirements , in particular with regard to yeasts consumed as
yeast .
WHEREAS , dead natural yeasts constitute , inter alia , a considerable source
of proteins , and yeasts are cultivated to that and on various media ; it is
necessary to have regard to the state of the progress of research in this
 sphere and to prohibit for the time being the use in food for human consumption ,
of yeasts grown on allcanes ( saturated hydrocarbons );
WHEREAS , without prejudice to the adoption of Community Rules it is necessary
to prevent National provisions concerning in particular food hygiene on
the subject of materials which may come into contact with foodstuffs , and
labelling regulations creating barriers to the free movement of natural yeasts ;
until tho implementation of such Community Rules .
WHEREAS , the determination of the sampling and analysis methods necessary
for testing the production and composition characteristics of yeasts as
well as any amendments or additions to be made , on the basis of tho results
of scientific and technicr,l research , to the list of kinds of natural yeasts
and permitted media as well as of substances the use of which is authorised
for reasons inherent in the technique of producing yeasts , are measures requiring
technical implementation and the Commission should be made responsible for
their adoption , in order to simplify and accelerate the procedure ;
WHEREAS , in all cases for which the Council has given the Commission
competence for the enforcement of the rules established in the sphere of
 foodstuffs , a procedure should be provided establishing close co-operation
between the Member States and the Commission in the Permanent Committoe on
 foodstuffs set up by Council Decision N° 69/414/EEC of 13 November 1969 ?
 ---pagebreak---                                         -3-
HAS ADOPTED THIS DIRECTIVE :
                                    Article 1
1.      In this Directive natural yeasts and yeast residues mean the products
defined in the Appendix .
2.      Subject to the provisions of paragraph 3 this Directive applies
to the products defined in paragraph 1 which are intended for use in food
for human consumption or for use in industry .
3.      The provisions of this Directive other then Appendix Chapter I A and
C and Chapter II do not apply to yeasts defined in Regulation (EEJC ) N°
made by the Council which concerns trade in animal feeding stuffs .
                                    Article 2
        The Member States shall make all the neoessary provisions to ensure
that the products referred to in Article 1 ( 2 ) may be delivered on sale only
if they satisfy the provisions of this Directive and of the appendix thereto .
                                    Article 3
1.      The water used in the production of the products defined in
Article 1 ( 2 ) shall be recognized as drinking ivater .
2.      The natural yeasts intended for use in foodstuffs for human consumption
must not have been subjected to any qualitative or quantitative modification to
their natural composition , and must not contain any preservative pH corrector,
colouring matter or other additive .
 ---pagebreak---                                           -4-
3.      Notwithstanding the provisions of paragraph 2 the following axe
permitted :
        ( a) in yeasts defined in the Appendix Chapter I B ( l ) and ( 2 ) the
              presence of substances exclusively intended to ensure the
              feeding and growth of the yeasts and to maintain their
              characteristics , "but only in quantities absolutely necessary
              to achieve these objectives .
        ( b) in yeasts defined in the Appendix Chapter I ( 3 ) the presence of
              traces of starchy substances and/or fats or oils whose use is
              inherent in the technical processes of manufacturing yeast .
        ( c ) in yeasts defined in the Appendix Chapter I B ( 3 ) ( a) the presence
              of emulsifiers exclusively intended to ensure the rehydration of
              yeasts but only in quantities absolutely neoessary to achieve this
              objective#
4* '    Notwithstanding the provisions of paragraph 2 Member States mr,y permit
trade in yeasts defined in the Appendix Chapter IB ( 3 ) in which substances
intended to improve and maintain the characteristics of these yeasts have
been incorporated in such quantities , or within such limits as the presence
of these substances is permitted in bread products in whose manufacture the yeast
in question is used .
                                      Article 4
l.'1    The products referred to in Article 1 ( 2 ) intended for use in food
for human consumption must meet the requirements shown below :
                                                                      • • •I• » •
 ---pagebreak---                                 -5~
( a) They must not come from strains of pathogenic yeasts for any
      reason whatsoever .
      These strains are particularly the following:
      – Species in which the strains are generally pathogenic such
         as Candida Albicana .
      – Pathogenic strains of certain species such as Candida Tropicalis
        Candida pseudo Tropicalis , Torulopsis Candida ( Torulopsis
        famata ) and Trichosporum Capitalum .
(b) They must be free from pathogenic bacteria and toxins .
( c ) They must not contain the elements set out in this subsection
      in a proportion greater than the proportion indicated against
      each of them ,                               :        • »
      Sélénium                   1 p.p.m .
      Arsenic                    2 p.p.m .
      Mercury                    0,1 p.p.m .
      Lead                       5 p.p.m .
      Zinc                      50 p.p.m .
      Copper                   120 p.p.m .
( d) They must not show any deterioration in their hygenic organoleptic
      and biological characteristics due inter alia to any residual'
      traces of the components of the medium used which is likely to be
      harmful to health .
 ---pagebreak---                                          - 6 -
            The products mentioned in the Appendix, Chapter I B. ( 2)and(3)shall "be
  kept at a temperature not exceeding 4°C , from the moment of production until
  delivered, and with the purchaser until the products are used.
   2.       The products defined in Appendix Chapter I B ( 3 ) must not oontain
  more than 100 rapy "bread "bacilli per gram calculated on the dry matter .
  3.        Besides compliance with the provisions of paragraph 1 the products
  referred to in the Appendix Chapter I ( o ) and Chapter II may not be used in
( food for . human consuption unless they correspond to the following
  "bacteriological characteristics : .
  - Escherichia coli             • '         Absence in 0,1 g calculated on the
                                             product as it stands .
  - Total content in revivable               les3 than 10,000 in 1 g calculated
      "bacteria                              on the dry matter .
  - Total, content in revivable               less than 50 in 1 S calculated
      moulds                                 on the dry matter .
                                        Article 5
            Yeasts cultivated on alkanes ( saturated hydrocarbons ) as well as
  yeast residues obtained from the acid yeasts may not be marketed as products
  which may be used in food for human consumption .
                                        Article 6
            The packaging materials used for packing the products referred to
   in Article 1 ( 2 ), intended for food for human consumption, must not be such
   as to affect their biological , organoleptic , baateriological or. chemical
  qualities.'                '
                                                               • • •/ *«•
 ---pagebreak---                                            -7-
                                    Ariicle 7
        The products referred to in the Appendix, Chapter I B 3 (b) may be
marketed only in net weights when packed of 500 g or multiplies of 500 g
when the weight is more than 450 g.
                                    stiele 8
        The names:
        "  baker 's yeast " or n bread-caking yeast n
        "  active dried yeast     " fresh yeast n
        n  food ysasts "
        ** yeast residues n
shall be reserved for the products listed in the Appendix to which they
refer and must be used in trade to describe thee:. .
                                    4 Y*"*"" f* 1 P O
1.      The packaging or labels , under which the products referred to in
Article 1 (2) are marketed must5 bear the following easily visible , clearly
legible and indelible details:
        (a) for products referred to in Article 8 , the name which is reserved
             for thee ;
        (t) for products other than those referred to in (a) the nane " yeast
        (c) for products which do not correspond to the requirements of
             Articles 3 and 4      the products defined in Article 5.        words
             " prohibited in food for human consumption
                                                                 • • •/• • •
 ---pagebreak---                                        - 8 -
 (d) for products listed in the Appendix Chapter I B paragraph 3 (b),
         the nett weight when packed in kilograms or in grama and,
         for other products , the nett weight in kilograms or in grams ;
 ( e) for products listed in the Appendix Chapter I B paragraph 3 ( c),
         the weight of dry matter ;
 ( f) where appropriate , for products listed in the Appendix Chapter I B
         paragraphs 1 and 2 mention of the substances referred to in
         Article 3 paragraph 3 ( a)j
 ( g) for products listed in the Appendix Chapter I B ( 3) ( a) and in
         cases covered by Article 3 ( 3 ) ( c) the words "with emulsifying
         agents " together with a statement of the weight of the products
         concerned in the agents ;
 ( h) where appropriate for products defined in the Appendix Chapter I
         B ( 3 ) mention of the substances defined in Article 3 ( 4) as well
         as the weight of the products concerned within these substances ;
( i) for products listed in the Appendix, Chapter I B ( 2 ) and ( 3 ) the
         words "keep cool ";
 ( j ) for products listed in the Appendix Chapter I 3 (4) ( a) mention
         of the medium upon which they are grown, and for products listed
'        there under (b ) mention of -their origin, . such as "beer yeast"
         or "distillery yeast ";
 (k) for products referred to in the Appendix Chapter I ( 6 ) their ,
         respective contents by weight , in proteins (minimum content ) and
         in water (maximum content) and an indication of the medium upon
         which they were grown ;
 ( l ) for products referred to in the Appendix Chapter II their
         respective contents , by weight in proteins (minimum content ),
 . . . water' ( maximum content ) , oils and fats and an indication of the
         medium on which the. original yeast was grown;
     * m *• ^+ » *
                                                                      • • •j• m •
 ---pagebreak---                                           -9-
          ( m) "the name or style and address or registered offices of
               the producer or packer or of a vendor established in the
               Community j
          ( n) for products imported from third couitries , in addition to the
               details listed under ( a) to (m) an indication of the country
               of origin .
2.        When the products referred to in Article 1 ( 2 ) are packed in containers
or packages with a nett weight of more, than 100 kg and are not intended to
be offered in unaltered state for retail sale , the details referred to in
paragraph 1 may be given on the invoices and accompanying documents .
                                      Article 10
          In the labelling and presentation for sale of the products referred
to in Article 1 and in the publicity concerning them , fanciful names , symbals ,
pictures and other signs figurative or otherwise , suggesting a characteristic
 vrhich tho products in question do not possess and which aight for that reason
 be likely to mislead the consumer , shall be prohibited in any form whatsoever .
                                     Article 11
1.       The Member States may not , for reasons concerning composition , pro­
duction characteristics , packaging and labelling , prohibit or hinder trade
in the products referred to in Article 1 ( 2 ) if they satisfy the provisions of
this Directive and its Appendix .
2.        Notwithstanding the provisions of paragraph 1 : : '
 ---pagebreak---                                         - 10-
        ( a) The Member States may request that the details listed in.
             Article 9 under (a) to (a.) be written in their own national
             languages ;
        (b) The Member States who do not make use of the option provided for
             in Article 3 pairgraph 4       prohibit the marketing of bread-making
             yeasts containing substances foreign to their natural composition ,
             other than those referred to in Article 3 paragraph 3 »
                                   Article 12
        The following shall be determined according to the procedure laid
down in Article 13 :
        ( a) the characteristics of the active dried yeast referred to in
             the Appendix Chapter 1 B paragraph 3 » especially its fermentation
             performances1;
        (b) the methods for talcing samples of the products referred to in
             Article 1 ( 2 );        '1
        (c) the analysis methods necessary for testing their characteri sties
             regulated by this Directive *
                                   Article 13
1.      If reference is made to the procedure defined in this Article the
matter shall be laid before the Permanent Committee, on Foodstuffs ,/
( hereinafter oalled " the Committee •' ) by its Chairman , either on the ini­
tiative of the latter, or at the request of the pepresentative of a. Member
State .
 ---pagebreak---                                          -11-
2.       The Commission representative shall submit a draft of th.3 measures
to be taken to the Committee . The Committee sftall give its opinion on that
draft within a period of time which the chairman may fix according to the urgency
                                                     forty-one
of the question concerned. It shall decide by the      /     vote majority , the
votes of the Member States being weighted in accordance qith Article 148 ;
paragraph 2 of the Treaty the chairman shall not take part in the votingg.
3.       ( a) The Commission shall adopt the measures envisaged when they are in
              conformity with the opinion of the Committee ;
         (b) When the measures envisaged are not in conformity with the
              opinion of the Committee , or if there is no opinion , the
              Commission shaxl immediately submit to the Council a proposal
              relating to the measures to be taken . The Council shall act by a
              qualified majority vote ;
         (c) If at the end of a three month period as from the time the matter
              was laid before the Council , the latter has not acted , the
              proposed measures shall be adopted by the Commission .
                                     Article 14
         This Directive shall not apply to products referred to in Article 1 ( 2)
which are exported to third countries , provided that the labelling of such
products does not mention that the said products conform to the provisions
of this Directive .
                                     Article 15
1.       Within oneyear from the notification of this Directive the Member
States shall bring their legislations into line with the above provisions and
they shall inform the Commission immediately thereof .
                                                                     • ••/ • • •
 ---pagebreak---                                         ■12-
2.     ' After a supplementary period of two years the thus modified legis­
lation shall apply to the products produced in or imported into the Community ,
3*    • As   soon as this Directive is notified the Member States shall also
see that they inform the Commission , in sufficient time for it to submit
its observations ! of any subsequent legal or administrative draft provisions which
they contemplate adopting in the sector governed by this Directive .
                         '          Article 16
         This Directive shall be addressed to the Member States .
                                                    Brusselsj
                                                    By. the Council ,
                                                    The President
 ---pagebreak---                                          APPENDIX
                                       EECTITIOIIS
                                 CHAPTER I - NATURAL YEASTS
A. General definitions
            " Natural Yeasts 11 shall "be und<>stood to mean the whole cells
    of one strain of yeast or of a mixture of several strains belonging ,
    acoording to 11 The Yeasts , a taxonomic Study " "by J. Lodder ( l)
    to the following genera:
      D Debaryomyces
    ( 2)  Dekkora
    ( 3)  Endomycopsis
    ( 4)  Hanseniaspora
    (5 )  Hansenula
      6 ) K luyve romyc e s
    (7 ) Lipornyces
      8) Piohia
    (9 Saccharomycode 3
    10    Saccharomyc e s
    Π     Schi zo saccharomyc e s
    12) RhoELdsporidium
    13    Bre 1 1 anomyc e s
    H)    Candi da
    15 )  Kloeckera
    16 )  Rhodotorula
    17    Torulopsis
    18 Trichosporon
           Natural yeasts are obtained either as special cultures or as
lay–products of fermentation processes .
           These products include " live natural yeasts " and " dead natural yeasts "»
( l) Edition North Holland Publishing Co - Amsterdam-London 1970»
 ---pagebreak--- Live Katurr.l Eeasts
Definition :
                                                                .. . .         ■
       " Live natural yeasts " shall be understood to mean yeasts capable
of reproducing themselves and of proliferating . .      •
      A distinction i $ made between these yeasts : .
1*     11 Pure culture yeasts " are yeasts specially cultivated in the
laboratory on appropriate media in order to maintain specifio characte­
ristics of the initial strain and of its subsequent daughter cultures .
2.     " Yeasts for reproduction " more commonly oalled " mother yeasts "
are obtained from successive generations of 11 pure culture yeasts " and , are
used as fermentation agents , especially in brewing , distilling or
wine-making or are used in the production of bread-making yeastsi food yeasts
for industrial use .
3 . " " Baker 's yeast " or " bread-making yeasts " are suitable for
fermenting dough . Yeasts characterized by a fermenting power which in
relation to their dry matter and determined by an appropriate method , have
a value equal to or more than 5Qfo of that of an active dried yeast of
reference are considered to be in this category .
      Bread-Snaking yeasts shall be clear cream or ivory coloured and must
not give off any smell alien to their own specific smell#
      They comprise :
        ( a) " active dried yeasts " the water content of which is reduced
             by controlled dehydration , to a proportion of 10$ by weight at
      ,      the most . • They @3nerally come in the form of granules , powder
             or spherules ;
 ---pagebreak---                                               -3-
           (b) " fresh yeasts         the water content of which is 6jfo or more
                  by weight but not more than 75/° * They generally come in the
                . form of blocks ;
           (c ) yeasts which ., because of their water content , do not fall
                  within categories ( a) or (b) above and which are sold by the
                  weight of the dry matter .
4.         Yeasts , intended for the production of dead yeasts , which are divided
as follows :
( a)       ( i ) yeasts which , with a view to their direct production , are grown on
                  the following media of agricultural origin , specially prepared ,
                  for that purpose or which are the by–products or water residues
                  of industry :
                  – Syrups and molasses of beet or cane sugar j ■
                  – wastes from distilling and yeast–producing operations ,
                  – lactosérum ,
                  – cereal grams and products processed from them ,
                  – liquors ficto hydrolysis of cellulose products#
         ( ii ) yeasts grown on elkanes ( saturated hydrocarbons ) with a vies
                  to their direct production ;
(b )    yeasts recovered at the end of their fermentation action in the
         production of alcohol , such as beer yeasts or distillery yeasts .
C. Dead mrtural yeasts
     Definition :
           " Dead natural yeasts " shall be undcastood to mean the yeasts referred
to in B the cells of which have been killed by bursting and dehydration generally
by means of the Hatmaker or Sprcy processes , with the effect that they lose
their power to proliferate and cause fermentation .
                                                                            • • •/ • • •
 ---pagebreak---          Subject to the provisions of Article 5 "the descriptions " Pood yeast '•
and 11 Fbrrag<3 yeast " shall he taken to mean dead natural yeasts used in
food for human and animal consumption respectively , because of the available
nutrients they contain which sire essentially proteins end vitamins , and
which contain the substances listed below in the following minimum quantities
                             \
calculated on the - product 'itself', by weight :
          ( a) Minimum protein content ( N"x 6,25 )               ■ 35%
          ( b) Maximum water content                                10%
          (c ) Maximum total ash content                     " '    10%
          ( d) Maximum content of ash which is insoluble in HC1
               ( euclusively for yeasts with a maximum protein
               content of 42$> *?y weight )                          Vfo
                                       CHAPTER II
                                     YEAST RESIDUES
          11 Yeast residues " shall be understood to mean natural yeasts from
which any one or more of their constituent parts have been extracted. After
extraction these products must retain the cellular walls of the yeasts from
which they are descended.                         .   .