CELEX: 51973PC0797
Language: en
Date: 1973-05-23
Title: PROPOSAL FOR A COUNCIL DIRECTIVE on a ninth amendment to the Directive on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (73) 797
Vol. 1973/0151
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 ---pagebreak---                      OF THE EUROPEAN COMMUNITIES
                                                         COM(73)797 final
                                                         Brussels , 23 May 1973
                                 PROPOSAL FOR A
                               COUNCIL  DIRECTIVE
            on a ninth amendment to the   Directive on the
            approximation of the laws of the Member States
            concerning the preservatives authorized for use
            in foodstuffs intended for human consumption
              ( submitted to the Council by the Commission)
COKC73) 797 final
 ---pagebreak---                                     EXFLM'ATOPY MjTOPASPrjM
                                               I.
1, Article 5(a)        "the Council Directive of 5 November 1963^     on the ap­
     proximation of the laws of the Member States concerning the preservatives
     authorized for use in foo&tuffs intended for human consumption empowers
     the Member States to maintain for a certain period their national laws
     relating to the use of formic acid and its salts , boric acid and its
     salts , organo-borated compounds and hexamethylene-tetramine . Under the
     second sentence of Article 11 of that Directive , as amended by the Council
     Directives of 20 December 1968          and 20 December 1971^* "the ban on
     the use of these substances will take effect on 1 January 1973 »
     The resulting arrangements were nevertheless temporary , for their purpose
     was to permit the acquisition of certain scientific and technological
     knowledge regarding the various preservatives in question with a view to
     the possible authorization of their generai use throughout the Community .
 2 , The Commission is now able to propose that the Council insert , definitively ,
     formic aoid and certain of its salts and he xame thy lene -tetracaine in the
     Annex to the Directive of 5 November 1963 , and should determine the con­
     ditions for their use ,
     In addition , the Commission proposes that the treatment of caviar by boric
     acid and borax should be authorized subject to a review clause .
                                        II .
 The factors on which this proposal from the Commission is based can be summa­
 rized as follows :
                                                                           ♦ •«/• • •
 1 ) OJ N0 12 , 97 January 1964 , P« l6l/o4»
 2 ) OJ IT0 L 309 , 24 December 1968 , p. 25
 3 ) OJ 1° L 2,4 January 1972 , p. 22
 ---pagebreak---                                                                               \
                                         - 2 -
1 . Fommio acid and its salts
    ( a) Formic aoid was examined "by the Joint FAO/WHO Committee of Experts *
          on Food Additives in 1961 and 1964 , and a conditional acceptable daily
          intake (ADl ) of 5 mg/kg "by weight was attributed to it ( WHO Teoh Rep
         Ser 1962 , 228 awl WHO Tech Rep Ser I965 , 309 ).
         The scientific concept of the conditional accept since of an additive means
         that its use may "be authorized without risk to public health , particu­
         larly in developed countries having the legislative and administrative means
          of assessing and verifying the quantities actually involved in the use
         of the additive in question in foodstuffs .
         The Scientific Committee on Foodstuffs , which was consulted on this
         matter in August 1967 and January 1972 , approved the insertion of formic
         acid and its salts on the conditions laid down in this proposal ,
      (b)From the technological point of view , the use of formic acid and its salts
         is necessary in certain semi-preserved fishery produots and vegetables
         in vinegar , for which none of the preservatives already listed in the
         Annex to the ,. Directive of 5 November 1963 can give adequate protection
         against microbial deterioration .                              .  .. .
       , Moreover , the use of formio acid and    foiwfces in place of sulphur dioxide
         and its derivatives is of particular interest for the preservation of certain
         basio preparations intended for the production of non-alcoholic beverages
         in which the SO^ content (free or combined) must be reduced in view of the
         large quantities consumede by children.
         The quantities provided for in this proposal represent only a very low
         proportion of the ADI of formio acid .
                                                                              • • •/ • • •
 ---pagebreak---  Hexamethylene-tetramme
 a) At its 15th session in 197l » "the Joint FAD/WHO Committee of Experts
      on Pood Additives fixed a provisional ADI of 5 mg/kg "by weight of this
      substance#
      The Scientific Committee en Foodstuffs y which was consulted in January
      1972 f approved its use on the conditions laid down in this proposal#
      It was reluctant at that time to reject certain more recent studies
      suggesting an ADI of only 0.15 mg/kg "by weigth , but which it is difficult
     to regard as conclusive#
"b ) The use of hexamethylene-tetranine is essential in the production of
      "Provolone " and " Grana padano " cheeses prepared from the milk of cows
     fed on silage fodder# Here in fact a phenomenon consisting of the swelling
     of the cheese is observed , known as " tympanites " f caused "by the action
     of a olostridium and making the cheese unmarketable . The use of hexane-
     thylene-tetramine can prevent such deterioration#
     Moreover , following certain recent tests , it seems possible to use hexameil
     lene-tetramine for preserving caviar ( and other fish eggs ) which are still
     commonly treated with boric acid and borax in producer countries . These
     tests should be encouraged by authorizing the sale of caviar containing
     hexamethylene-tetramine .
     The residual doses specified in this proposal are a very low percentage of
     the ADI ,. even if the ADI is taken as 0.15 mg .
Boric acid and its salts
Since the Directive of 5 November 1963 was adopted research has been carried
out in several countries on the development of a preservation process for
caviar not using boric acid , but nothing conclusive has yet been found a
 ---pagebreak---   The Scientific Committee , to which the matter was referred in December 1967
  and January 1972 , raised no objections to the temporary authorization of the
  use of "boric acid in "genuine " caviar . Indeed caviar is a luxury product consumed
  only in small quantities at irregular intervals# The quantity absorbed ty caviar
  consummers can be assumed to be 200 g/o^llsj11111and children do no eat caviar on
  the whole# The maximum dose from use of boric acid beiri* 0.4% , the total annual
  intake is less than 1 g. The harmful effects of boric acid lie principally in its
  cumulative effect , which is no cause for concern in this case#
  It should however be stressed that boric acid is being allowed only temporarily ,
  so that those concerned will be encouraged to oontinue research into a rempla-
s cement product such as hexamethylene-tetramine associated with benzoic acid .
  ThS Commission therefore proposes that a review clause be inserted in the
  Directive .
                                         III .
  When the new preservatives are inoluded in the. Annex to the Directive of 5 Novembo
  1963 , the conditions for their use should also be laid down. In fact their use
  reflects a definite technical requirement and , moreover , we cannot put forward a
  solution which may create new barriers to intra-Community trade resulting from
  the introduction of dissimilar national conditions of use .
  The national laws at present governing the use of the three groups of preserva­
  tives oovered by this proposal for a Directive authorize certain uses which the
  Commission at the moment does not find it necessary to propose for the whole
  Community.
 ---pagebreak---                                         - 5 -
In fact , pursuant to
- German legislation , formic acid and its salts may also "be used for preserving
   fruit juices - even it intended for the production of syrups ;
- Dutch legislation ,
   • hexarnethylene-tetramine is permitted for the traetment of semi-pre served
      fishery products ;
   w "boric acid may "be used in egg products .
   The Commission proposes the retention of these uses for three years at national
   level for the following reasons :
a ) Formic acid
    Within the Community the use of this preservative in fruit juices is tech­
    nologically no longer necessary owing to the introduction of deep-freeze
    techniques . It must however be recognized that these techniques are not yet
    in general use in certain third countries exporting fruit juices . T6 allow
    trade flows with these countries to he maintained , the Member State in question
    should be authorized to permit the marketing in its territory of juices
    treated xfith formic acid and its salts during a certain period until the
    countries of Origin have converted their industrial processes .
b) Ke xane thylene -tetrsmne
    This preservative has now been given a provisional ADI which may be expected
    to be converted into a definitive ADI , This may lead the Community to accept
    hexamethylene-tetramine on less stringent conditions than those now proposed ,
    and it would hardly be reasonable , in the meantime to prohibit the continued
    acceptance of these conditions by a Member State in its territory .
c) Boric acid
    The addition of boric acid to egg products serves to prevent salmonella con­
    tamination.
                                                                           # ••/• • *
 ---pagebreak---                                   - 6 -
Industrial practice in "the Member State in question is not yet such that
this traetment can be abandoned and replaced by other processes such as
deep-freezing or pasteurization, A transitional period is therefore necessary.
 ---pagebreak---  Proposal for a Council Directive on a ninth amendment to the Directive
 on the approximation of the laws of the ' Member States concerning the
 preservatives authorized for use in foodstuffs intended for human con­
 sumption
 TIIE COUIJCIL OF THE EUROPEAN COMMUNITIES ,              ..
Having regard to the Treaty establishing the European Economic Community ,
 and in particular Article . 100 thereof ,
Having regard to the Opinion 6f the European Parliament ;               -
Having regard to the Opinion of the Economic and Social Committee ;
Whereas the Council Directive of 5 November 1963^" on the approximation of the
laws of the Member States concerning the preservatives authorized for use
in foodstuffs intended for human .consumption « as last amended by the Coun- .
                                     ( 2)
oil Directive of 20 December 1971 » fixed in particular the list of preser­
vatives authorized for the protection of foodstuffs intended for human
consumption against deterioration caused hy micro-organisme ;
Whereas the use of formic acid and of sodium salts and calcium salts
proves to be necessary for the preservation of certain semi–preserved '
fishery products or vegetables in vinegar and whereas , moreover , these ■ ' ■
substances can be used in place of sulphur dioxide . and its derivatives for
preparations of fruit juices and aromatice substances intended for the pro­
duction of non-alcoholic beverages ;
Whereas such uses represent only a small proportion of the daily intake
of formic acid and its salts and therefore constitute no risk to the
health of . consumers ;
Whereas the use of small quantities of hexamethylene–tetramine in the pro­
duction of "Provolone " and " Grano padano" cheeses makes it possible to
prevent tympanites and whereas ., moreover , hexamethylene-tetramine is technically
a good means of preserving fish eggs , and whereas current tests should be
                                                                          /0 • «
( 1) OJ N0 12 , 27 January I964 , p« I6I/64
( 2 ) OJ F L 2 , 4 January If72 , p« 22»
 ---pagebreak--- encouraged "by authorizing its use in these products ;
Whereas the acceptable daily intake of hexanethylene-tetramine is considerably
higher than the quantities whioh would result from these two uses , and whereas
health protection is thus ensured ;
Whereas boric acid and borax have traditionally been used for "preserving genuine
caviar ( sturgeon eggs ) in producer countries and whereas research into substitute
products has not reached firm conclusions ;
Whereas the total annual boric acid intake from caviar is less than 1 g; whereas
this quantity is negligible from the health point of view and may therefore be
permitted in the Community ;
Whereas the situation must be reviewed after a certain time in the light of current
tests on the products which may be substituted for boric acid and borax; \
Whereas the laws of certain Member States still authorize the use of formic acid
arxi of its salts and of boric acid on terms other than those pf this Directive ;
whereas such laws are based on particular circumstances which will no longer
obtain after a certain time , and a transitional period should be provided for
so that the necessary adjustments may be made ;
Whereas the recent results of toxicological research show that hexamethylene­
tetramine could be used to a greater extent than at present provided for , and other
uses Which are already permitted under national legislation may therefore be
maintained ;
HAS ADOPTED THIS DIRECTIVE :
 ---pagebreak---                                        - 3 -
                      "             Artikel i
The Council   Directive of 5 November 1963 on the approximation of the laws
of the Member States concerning preservatives authorized for use in foodstuffs
intended for human consumption , as l^sb amended "by the Council Directive of
20 December 1971 1 I s amended as follows :
1 , The following Article is inserted after Article 1 :
                                  " Artfole 1 a
After 1 July 1976 and following a review "by the Commission , the Council , acting
in accordance with Article 100 of fae -Treaty , may decide to delete tiie pro­
ducts specified in the Annex under Nos E 240 and E 241 or to make ary o';her
amendment to the provisions governing them ."
2 . Article 5 is aoended to read as follows :
                                  " Ar^icje 5
By way or derogation from Article 2 ( l), the Mealier States may until 30 June
1976 maintain in force the provisions of their national laws relating to the use :
k) of formic acid and its salts in fruit juices intended for the production of
    syrups ;
b) of hexamethylene -tetracaine in semi-preserved fishery products ;
c ) of boric acid in egg products * 11
3 . The following preservatives are added in Section I of the Annex :
 ---pagebreak---                             - 4
                                                                                  ■H
; ESC
I B° ÎTame                                Conditions or use
  E 236 Pormio acid          ( a) Solely in
  E 237 Sodium formate              ( i ) Semi-pre served
         ( sodium salts of                - se a salmonj
         formic acid)                     - Prooessed fish
  E 238 Calcium formata                   • marinated ;
                                          • salted or sweetened
         ( calcium salts of
         formic acid)                     - fish eggs , not smoked
                                          - shrimps }
                                          - vegetables in vinegar ;
                                  ( ii ) Preparations based on fruit juices ,
                                          whither or not concentrated , and on
                               • •        aromatic substances , intended for
                                          the production of non-alcoholic be­
                                          verages , the use of these preserva­
                                          tives together with substances under
                                          E 220-E 227 being prohibited .
                             ( b) When the product is marketed , the content
                                    in these substances , expressed in formic acid,i
                                    must not exceed
                                    ( i) 1 g/kg for
                                        . -processed fish ,
                                            salted or sweetened ;                   '
                                          -fish eggs ;
                                          -vegetables in vinegar ;
                                  ( ii ) 0.3 g/lcg for other semi -pre served
                                          produots ;                           -
                                ( iii ) 10 mg/l for beverages obtained
                                          from the preparations specified
                                          under ( a) ( ii ).
 ---pagebreak---                                         -5-
    EEC                             !
    N°              Name            I                 Conditions of use
                                             ·    _
    E 239 Hexamethylene-tetramme     I  I   ( a ) Solely in
                                     I
I
l
i
                                                   ( i) cheeses of the types
                                 '·
                                      i                  - Provolone ;
                                                         - Grana padano :
                                                 ( ii ) Caviar and other fish
                                                         eggs , not smoked , the use
                                                         of this preservative
                                                         together          substances
                                                         11° EÎ1C6 , E 2 J 7 ? "5 23 », E 240
                                                         and E 24I being prohibited .
                                            (b) When the product is marketed ,
                                                   the content in these substances
                                                   must not exceed
                                                   ( i ) 25 mg/kg for Provolone ;
                                                 ( ii ) 5 rng/kg ( expressed as forer-
                                                         aldehyde ) for Grana padano ;
                                               ( iii ) 1 g/kg for caviar and other
                                                         fish eggs .
  j E 240  Boric acid                       ( a) Solely in caviar ,
  ; E 241  Sodium tetraborate               (b) When the product is marketed , the
  !        ("borax)                                content in these substances ,
                                                   expressed as boric acid , must
                                                   exceed 4 g/kg of caviar.
                                                                                      • ••/
 ---pagebreak---                                   - β -
                                 Article 2
The Member States shall put into force not later than 1 January 1974 the
measures necessary to comply with this Directive and shall forthwith inform
the Dommission thereof .
                                 Article 3
This Direotive is addressed to the Member States .
Done at Brussels ,                                  Por the Council
                                                    The President