CELEX: 51975PC0252
Language: en
Date: 1975-06-05
Title: PROPOSAL FOR A COUTCIL DIRECTIVE (EEC) amending for the second time Council directive No 65/66/EES en the approximation of the laws of the Member States laying down specific criteria of purity for 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 (75) 252
Vol. 1975/0091
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                                                                 COM( 75 ) 252 final
                                                                 Brussels . 5 June 1975
                       PROPOSAL FOR A COUT CIL DIRECTIVE ( EEC )
          amending for the second "time Council directive Ho 65/ 6 6/ EES
               e the approximation of the laws of the Member States
             laying down specific criteria of purity for preservatives
        authorized for use in foodstuffs intended for human consumption
                    ( submitted to the Council by the Commission)
  C0Î'I(75 )      final
 ---pagebreak---                                                              704A1/75-E
                                    EaPLMATORY TOTE
1 . Council Directive N° 64/54/EEC of 5 November 1963 ( l) established, a single
      list of preservatives in the Community authorized for "tt.se in foodstuffs
      intended for human eonsumption. The Directive also provides for the laying
      down of criteria of purity with which these preservatives must comply *
2 . These criteria of purity were developed and included in Council Directive
      N° 65/66 /EEC of 26 January 1965 ( 2 ) « modified by Council Directive
     N° 67A28/EEC of 27 Juno 1973 < 3 )*" St is - inevitable that any modifi-t-
     ccition to the list of preservatives referred to in paragraph 1 is
     likely to produce a consequential amendment to this Directive#
3 « The present proposal for Directive relates to additives which have already
     been added to the list of preservatives by modifications to the basic Direc­
     tive of 5 November 1963 , namely :
      - calcium sulphite (E 226 ), added by the Council Directive tf° 71/160/EEC of
        30 March 1974(3 )
      - methyl parahydroxybenzoate (E218 ) and calcium bisulphite ( E227 )» added by
        the agreement reached at the entry of the three new Member States into the
        Community (Annex 1 , chapter XI . 2 of the Act of Accession) ( 4)
     - thiabendazole (E233 ) » added "by the Council Directive N°74/394/EEC of
        22 July 1974 ( 5 )
     - formic acid (E236 ) and its sodium (E237 ) and calcium (E238 ) salts and
        hexamethylenetetramine (E239), added by the Council Directive N® 74-/62/EEC
        of 12 December 1973 ( 6 ).
     The aim of this proposal for Directive is the completion of the Directive
     of 26 January 1965 by the addition of the criteria of purity for the above
     mentioned substances .
( 1 ) OJ N0 12 of 27.1.1964 p» I61/64
( 2 ) OJ      22 of 9.2.1965 P.373/65
( 3) OJ NMM O.£ [ti/7/1967 ^ 10
( 4 ) OJ N° L / 87 of &7/V1971 T?V. 12
( 5 ) OJ N° L 73 of 27/3/1972 p. 121
( 6 ) OJ N° -L 208 o-f 30/7/1 97^ P » 25
( 7 ) OJ N° L 38 of 11/2/197^ P - 29
 ---pagebreak---                            \
                                                          {
                                                                     704M/75-E
             Proposal for a Council Directive amending for the second time
             Council Directive IT0 65/06/EEC on the approximation of the
             laws of the Member States laying down specific criteria of
             purity for the preservatives authorized for use in foodstuffs
             intended for human consumption.
THE C0U1TCIL OP THE EUROPEM COMLIUNITIES
Having regard to the Treaty establishing the European Economic Community;
Having regard to the Council Directive N® 64/54/EEC ( l) of 5 November 1963
on the approximation of the laws of the Member States concerning the preserva­
tives authorized for use in foodstuffs intented for human consumption , as last
amended by Council Directive N° 74/394/EEC(2 ) of 22 July 1974 and in particular
Article 8 thereof ;
Having regard to the proposal from the Commission;                        „              .
                                 ( 3) amended by Council Direptive H®1 6?/428/EEC (4)
Whereas the Council Directive K° 65/66/EEC/laid down specific oriteria of purity for
the preservatives listed in the Annex to the Council Directive N° 64/54/EEC ;
whereas that Annex was supplemented by the Council Directive             71/I60/EEC ( 4)
of 30 March 1971 which added calcium sulphite ; by the Act . of Accession ( 5 )
of Denmark , Ireland and the United Kingdom which added methyl p-hydroxybenzoate
and calcium bisulphite ; by the Council Directive IT0 74/62/EEC of 12 December
1973 ( 6 ) which added formic acid , sodium formate , calcium formate and hexame-
thylenetetraaine ; and by Council Directive N® 74/394/EEC of 22 July 1974 ( 7 )
which added thiabendazole to the list of authorized preservatives ;
Whereas it is necessary to lay down speoific criteria of purity for the eight
preservatives mentioned above ;
HAS ADOPTED THIS DIRECTIVE
 CI ) OJ IP 12 , 27.1.1964 , P. 161/64         ( 6) OJ N® L 73 of 27.3.1972 p. 121
( 2 ) OJ N® L 208 , 30.7.1974 , p. 25          ( 7) OJ N® L 38 of 11.2.1974 p. 29
 ( 3 ). OJ N.® 22 , 9.2.1965 , P. 373/65       (.8) OJ N® L 208 of 30.7.1974 p. 25
 ( 4) OJ         148 of Jia/7         p. 10
  ( 5) OJ N® L 87 of 17/V1971
 ---pagebreak---                                        -2-                    704AI/75-E
                                     Article 1
The Annex to the Council Directive N° 65/66 /EEC shall be amended as follows :
1 . The following specification should be inserted between N°s E 2X7 and E 220
    E 218 Methyl p-hydroxybenzoate ( methyl ester of parahydroxybenzoic acid)
    Appearance :             White * almost odourless crystalline powder
    Melting range :          125° - 128° C
    Content :                Not less than 99»0$ calculated as CgHgO^ after
                             drying for 2 hours at 80 °C
    Sulphated ash :          Hot more   than 0.05 $
    Free acidity :       . Not   more   than 0.7$ expressed as p-hydroxybenzoic acid
    Salicylio acid :       : Not more   than 0.1 $ r
    Loss on drying :         Not more   than 0.5$ after drying for 2 hours at 80°C
2 . The following specifications should be inserted between N°s E 225 and E 230
    E 226 Calcium sulphite
    Appearance :             White crystals or crystalline powder
    Content :                Not less than 95$ of CaSO. • 2H 0 and not less than
                              "                         3     2
                     j       39$ of S02
    Sulphate :               Not more than 0,1$
    Chloride :               Not more than 0.0 *4 .
    Iron         :           Not more than O.OOp %
    Selenium J               Not more than 10 mg per kg of the sulphur dioxide
                             content
    E 227 Calcimi bisulphite ( cai cium hydrogen sulphite )
    Appearance :             Clear greenish-yellow aqueous solution having a
                             distinct odour of sulphur dioxide
    Content :                6 to 8$ (w/v) of sulphur dioxide and 2.5 to 3-5 $
                             (w/v) of oalcium oxide corresponding to 10-14$
                             (w/v) of calcium bisulphite /Ca(HS0,) 2_7
    Iron :                   Not more than 30 mg per kg
    Selenium : -             Not more than 10 mg per kg of the sulphur dioxide
             ♦ •   «
           '                 content
 ---pagebreak---                                    -3- 7                       704M/75-E
The following specifications should be inserted between N° E232 and
 E 250 .                  _ »       . .   «
                                             ,
                                             / ■ 1 « ^ 1
                                                           , „
 E 253 2 - ( 4'thiazolyl ) benzimidazole ( thiabendazoley
 Appearance ": white or almost white odourless poweder
 Melting rangea . 296 - 303° C                                     •
 Content .? 98 to 101 % y N S calculated on- the anhydrous product
 Sulphated ash s Not more than 0.2 %
 Moisture 1 Not more than 0.5 % ( Karl - Fischer)
 XPJ Absorption : E 1 % at 302 + 2 m « -about 1230.
 (0-0005 % w/v inE 1 % at .258 + 2 nn = about 200
 0.1NHC1 )         E 1 % at 243 + 2 lira * about 620
                   Ratio of absorption at 24l - 245 nm s 0.47-0.53
                               absorption at 300 – 304 nm
                   Ratio of absorption at 256 - 260 nm_ = 0.14-0 .18
                               absorption at 300 - 304 nm       <•; .
Sélénium = 30 mg/kg
E 236 Forai o acid
Appearance :           Clear colourless highly corrosive liquid with a charac­
                       teristic pungent odour
Content :              Contains not less than 98.0fa of CIL0_.
Aoetic acid î          lïot more than 0.5%
Sulphate :             Not more than <0 mg/kg
Sulphite :             Dilute 25 ml of formic acid with 25 ml of water.
                       Add 0.1 nl Of 0.1 II iodine solution. The solution should
                       retain a distinct yellow colour .
Chloride ::
Chloride               Not more than 50 mg/kg
Specifio gravity :     1.216 - 1.220 ( 20°/20° )
Non volatile matter : Not more than 0.05$
Aldehydes ;            A slightly alkaline jfo solution , on heating must not
                       give off a sharp or burnt smell
Formaldehyde :         Hot more than 0.1% of the formic acid content , estimated
                     . with chromotropic acid
Oxalic acid :          Not more than 0.5% of the formic acid content estimated
                       as calcium oxalate
 ---pagebreak---                                           -4-                    704AI/75-E
E 237 Sodiun foiraate " ( sodium salt of formio acid )
Appearance :                           White crystalline powdefr
Content :                              Not less than 98$ Na CEO - after drying for
                        f .     ■  ' ' 2 hours at 105® C
Volatile matter :                      Not more than 2$ determined "by drying for 2 hours
                                       at 105°' C
Degree of acidity or alkali-           Neutralisation of 1 gram of sodium formate in
       r  v.         .
nity :                       v.        the presence of phenolphthalein must not require
             ' •' * - -   •. ' * ,     more than 0.5 ml of 0.1 N HC1 or 0.1 N NaOH
Aldéhydes :                            A 5$ solution on heating must not give off a
                                       sharp or "burnt smell
Formaldehyde :                         Not more than 0.1$ of the content of sodium
                                       formate estimated with chronotropic acid
Oxalio acid :                          Not more than 0,5 $ of the content of sodium
                                       formate estimated as calcium oxalate
E 238 Calcium ■formate        ( calcium salt of formic acid)
Appearance :                           White crystalline powder
Content :
                                       Not less than 98$ CaCgHgO . after drying for
                                       2 hours at 105° C
Votalile matter Î                      Not more than 2$ determined by drying for
                                       2 hours at 105° C
Water-insoluble matter :               Not more than 0.5$ , *
Degree of acidity or                   Neutralisation of 1 gram of calcium formate
alkalinity :                           in the presence of phenolphthalfeifcn must not
                                       require more than 0.5 ml of O.l/N HC1 or
                                       0.1 N NaOH
Aldéhydes :                            A 5$ solution on heating must no# give off
                                       a sharf> or burnt smell .
Pormaldehyde :                         Note more than 0.1$ of the content of caloium
                                       formate estimated with chronotropic acid
Oxalic acid :                          Not more than 0.3$ of the content of calcium
                                       formate estimated as calcium oxalate
 ---pagebreak---                                      -5-                   704Al/7 §-E
 E 239 Keyanetliylenetetranine
 Appearence :                      Colourless or white crystalline powder
 Content :
                                   Hot less than 99% CgH^N^
 Loss on drying :                  Not more than 0.5$ after drying at 105° C
                                   in vacuum over phosphorus pentoxide for
                                   two hours .
 Sublimation point s               Sublimes at about 260° C without melting
 Sulphated AP*1.:                  not more than 0.05 %
Sulphate :                         Not more than O.OO5 fo
Chloride :
                                  Not more than 0.005 f°
                                  Article 2
Monber States shall , within one year from the notification of this
Directive , amend their laws in - accordance with the preceding provisions
end shall forthwith inform the Commission thereof * The laws thus emended
dltill be implemented at the latest two years after notification of this
DIrectlve -                       Article ^
This Directive is addressed to the Member States.
                                                     For the Council
                                                     The Président