CELEX: 51976PC0573
Language: en
Date: 1976-11-04
Title: Proposal for a Council Directive laying down the specific criteria of purity for antioxidants that may be used in foodstuffs intended for human consumption (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (76) 573
Vol. 1976/0177
 ---pagebreak--- Disclaimer
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                 COM(76)573 final.
                                                 Brussels . 4 November 197 6.
                                Proposal
 for a Council Directive laying down the specific criteria
 of purity for antioxidants that may be used in foodstuffs
                       intended for human consumption
              ( submitted to the Council by the Commission)
    COM (7 6) 573 final
 ---pagebreak---                              EXPLANATORY MEIORANDUii
 Article 5 (l ) of the Council Directive of 13 July 1970 ( 70/ 357/EEC)
 on the approximation of the laws of the Member States con corning
 the antioxidants authorised for use in foodstuffs intended for
 human consumption ^ states that the Council shall acting unani­
 mously on a proposal from the Commission , lay down by directive
 the specific criteria of purity for the substances listed in Parts I
 to III and IV ( ) to ( 7 ) of the Annex .
 The purpose of this proposal is to lay down these criteria .
 The Commission has established these criteria in close co-operation
 with Government experts and the economic and social interests con­
 cerned .
OJ N° . L 157 , 18/7/1970 , .p. 31
 ---pagebreak---                                            - II -
 Proposal for a Council Directive layinq down the specific criteria of
purity for antioxidants that may be used in foodstuffs intended for hunan
 consunpticn
THE COUNCIL OF THF. EUROPEAN CO^'iUNITIES ,
Having regard to the Treaty establishing the European Econonic Cornunity ,
Hrvinq regard to the Council directive 70 / 357/ EGC of 13 July 1970 on the
approximation - of the laws of .the - Mercher States concerning the antioxidants
authorised for use in foodstuffs intended for huran consumption ( 1 ), and
 in particular Article 5 . ( i ) thereof ,
Urvinci regard to the proposal from the Corcni ssion ,
whereas pursuant to Article 5 . thereof antioxidants must
 comply with the specific criteria of purity if any , laid down in accordance
with Article 5       ( l ) thereof ;
Whereas Directive 65 / 66/ ^0 of 2 6 January 65 ( 2 ),      as last amended by
Directive 76/ 463 / EEC (?), laid down specific criteria of ourity for the
preservatives authorized for use in foodstuffs intended for hur.an consumption .
Whereas specific criteria of ourity should be laid down for all the
antioxidants listed in Parts I to III and points 4 to 7 of part IV of the Annex to
Directive of 13 July 1970 excluding those for which specific criteria of
purity have already been laid down in the Directive 65/ 66/ EEC ;
• fhereas meanwhile           ■ sorbitol and glycerol points 5 and 6 of part IV - of the
Annex to the Directive 70 / 357/ EEC ) have been included in the list of autho­
 rized substances in the Council Directive 74 / 329 / EEC of 18 June 1974 on the
aporoximation of the laws of the Henber States relating to emulsif iers ,.
 stabilizers , thickeners and gelling anents for use in foodstuffs < 4 ) bearing
 the nurbers F 420 and E 4 ?.? respectively ; whereas the specific criteria
 of purity for both these products will therefore be fixed in accordance with
 the Directive laying down the specific criteria of purity for enulsifiers ,
 stabilizers , thickeners and gelling agents for use in foodstuffs ,
   (1 OJ :T° L    157 , 18/7/1970, p. 30
   ( 21 OT If®     22 , 9/2/1963 » p. 373/65
   ( 3 / CXJ 3° L 126 , 14/5/1376% p. 3.3
   ( 4 ) OJ N* L  189 ? 1.2/7/1974 , p « l
 ---pagebreak---                                         - III -
   MAS ADOPTED T W IS DIRECTIVE :
                                       Article 1
   The specific criteria of purity referred to in Article 5 ( l ) of
   Directive 70 / 357/ FFC nre set out in the Annex hereto .
                                       Article ?.
Within eighteen months ofreceipt of notification of this Directive , Member
   Strtes shall put into effect thn regulations and administrative measures
   nc cessnry to comply with the provisions of this Directive and shall inform
   th ? Comnission thereof without delay .
                                       Article 3
   This Directive is addressed to the Member states .
   Done at Brussels ,                          For the Council /
                                               The President
 ---pagebreak---                               Specific priority criteria
                                   General comments
( a) Except where otherwise stated , the quantities and percentage values shall
      be calculated "by weight for the anhydrous form of the substance •
(b) Where the substance in question does not exist from the outset in anhydrous
      form and where "volatile substances " are involved , the water of crystal­
      lization and water due to moisture shall be included in these substances .
( o ) Where the drying temperature and time are not stated , tha letter shall be
      understood to mean "to constant weight " and the former shall be 105° C.
( d) Where the interpretation of the criteria set out below requires that certain
      technical data such as "vacuum" date' be defined , the methods of analysis
      established pursuant to Article 5 § 2 of the Directive concerning substances
      having antioxidant activity shall be referred to .    ,
( e ) Where the concentration is mentioned, this shall be taJcen to mean ,
      weight/volume , except where otherwise stated.
( f) Temperatures shall always be stated in degrees centigrade ( Celsius ).
( g) For substances E 220 to E 224 inclusive , E 226 and E 270 , the specific
      priority criteria have been established by the Directive establishing
      specific priority criteria for preserving agents .
 ---pagebreak---                                                              ANNEX
                           E 300 - L-Ascorbic acid ( l )
APPEAHENCE                          White or pale yellow crystalline powder
MELTING POINT RANGE                 189° - 193° with slight decomposition
CONTENT                            Not less than 99 % ^6^8^6            ^ drying
                                   in a desiccator with sulphuric acid or
                                   phosphorus pentoxide
                                          20
SPECIFIC OPTICAL ROTATORY POWER            - + 20.5° to 21.5® (C « 10 % aqueous )
VOLATILE SUBSTANCES DETERMINED     Not more than 0.4 %
OVER A 24 H PERIOD IN A
DESICCATOR WITH SULPHURIC ACID
OR PHOSPHORUS PENTOXIDE
SULPHATED ASH                      Not more than 0.1%
PH                                 2.4 to 2*8 in 2 % aqueous solution
(1)     subsiancs concerned is !,-.{+} -AsoorWo acid
 ---pagebreak---                                       - 3 -
                                                             ANNEX
                           E 301 ~ Sodium L-ascorbate ( l )
                       ' ( Sodium salt of L -Ascorbic acid)
APPEARANCE                          White or pale yellow crystalline powder
CONTENT                             Not' less than 99 % C6H7°6 Na       24 h
           ,                        drying in a desiccator with sulphuric acid
                                    or phosphorus pentoxide
                                           20
SPECIFIC OPTICAL ROTATORY POWER PoQ - + 103° to + 106° (C = 5 % aqueous )
                                         D
VOLATILE SUBSTANCES DETERMINED      Not more than 0.3 %
OVER 24 H PERIOD IN A
DESICCATOR WITH SULPHURIC ACID
OR PHOSPHORUS PENTOXIDE
PK                                  6.8 to 8.0 in 10 % aqueous solution
( l ) The substance concerned is a derivate of L-(i-) -Ascorbic acid
 ---pagebreak---                                                                ANNEX.
                     >   E 302 - Calcium L-ascorbate ( 1 )
                       ( Calcium sali of L-Ascorbio acid)
APFEARANCE               '           White or very pale grey crystalline powder
CONTENT                              Not less than 99 $ Ca (CgH^O^) 2. 2H20 after
                                     24 h drying in a desiccator with sulphuric
                                     acid or phosphorus pentoxide
SPECIFIC OPTICAL ROTATORY POWER               + 95° + 97° (C - 5 f aqueous )
VOLATILE SUBSTANCES DETERMINED       Not moro than 0.3 $ ( 2 )
OVER A 24 H PERIOD IN A
DESICCATOR WITH SULPHURIC ACID
OR PHOSPHORUS PENTOXIDE
pH                                   6.0 to 7*5 in 10 % aqueous solution
( 1 ) The substance concerned is a derivate of L-(+)-Ascorbio acid
( 2 ) This percentage value does not relate to ths water of crystallisation
      but to the atmospheric water vapour ( moisture in the substance ) deter­
      mined under these conditions .
 ---pagebreak---                                                                   ANNEX
                   .E 303 - 5 1 6-Diaretyl-L-Ascorbi c acid ( 1 )
                                (Aaco ^tyl diacetate )-
APPEARANCE                             White or pale yellow crystalline powder
MELTING POINT RANGE                    155° - 158°
CONTENT                                Not loss than 99 % C^H^Og
SPECIFIC OPTICAL ROTATORY POWER                 - 77° to - 79" (C = 2 $ in methanol )
VOLATILE SUBSTANCES DETERMINED         Not more than 1 %
OVER A 24 H PERIOD IN A
DESICCATOR WITH SULPHURIC ACID
OR PHOSPHORUS PENTOXIDE
SULPHATED ASH                          Not more than 0» 1 #
                            Ν
( l ) The substance concerned is a derivate of L~(+)~Ascorbio acid
 ---pagebreak---                                                               ANNEX
                    E 304 - 6-Palmityl -L-ascorbic acid ( 1 )
                             (Ascoityl ' pàlmitate )
APPEARANCE                        Impalpable white or yellowish-white powder
                                  or yellowish-white crystals
MELTING POINT RANGE               111° - 113° ( changes to viscous state without
                                  completely melting)
CONTENT                           Not less than 98 f C^H^ QO^
SPECIFIC OPTICAL ROTATORY POWER £b*Q'^°=i + 21° to 24° (C - 5 % in methanol)
VOLATILE SUBSTANCES DETERMINED    Not more than 1 £               "J..
OVER A 24 H PERIOD IN A
DESICCATOR WITH SULPHURIC ACID
OR PHOSPHORUS PENTOXIDE
SULPHATED ASH                     Not more than 0.2 4>
v' ) The substance concerned is a derivate of L-(+) -Ascorbic acid
 ---pagebreak---                                                           ΛΝΙΙΕΧ;
                 E 306 – Tocopherol-ri oh extracts of natural origin
APPEARANCE                      Clear , viscous , red to brownish-red oil
CONTENT                         Not less than 34 $ total tocopherols
                  90
SPECIFIC GRACITT d^             Not less than 0.928 and not more than 0.951
FREE FATTY ACIDS                Neutralization of the free fatty acids in
                                10 g E 306 in the presence of phenolphthalein,
                                must not require more than 10 ml 0.1 N sodium
                                hydroxido or 0.1 N potassium hydroxide
 ---pagebreak---                                                               ANNEX
                    E 307 - Svrvthotic Alpha-tocophcrol ( 1 )
APPEARANCE                         Clear , viscous , yellowish oil which darkens
                                   on exposure to air or light
 JQNTENT                           Not less than 96 Jc
                    20
REFR&CTIVE INDES
                   "D              Not less than 1.503 and not more than 1.507
                    20
SPECIFIC GRAVITY" d                Not less than 0.947 and not more than 0.95°
SPECIFIC ABSORPTION E
                       1 %         At the absorption maximum of 292 nm t
                       1 cm
IN ETHANOL
                                   E1cm ( 292      S 72 ~ 76
                                   At the absorption minimum of 255 nm 1
                                   eJ " (255 nm) î 6.0 - 8.0
                                     1 cm
SULPHATED ASH                      Not more than 0.1%
( 1 ) The substance concerned in synthetic DL-Alpha-to cophero 1
 ---pagebreak---                                                             Airaix
                      E 308 - Synthetic Gamma-tocopherol
 APPEARANCE                       Clear , viscous , pale yellow oil which darkens
                                  on exposure to air or light
  CONTENT
                                  Not less than 97 % C28H48°2
                   20
 REFRACTIVE INDEX n£              Not less than 1 o 503 and not more than 1.507
*
 SPECIFIC GRAVITY d|°             Not less than 0.948 and not more than 0,959
                      1
 SPECIFIC ABSORPTION E ' /-       At the absorption maximum of 298 nm
                      1 cm
 IN ETHANOL   „
                                  E1cm (^98 nm) : 91 - 97
                                  At the absorption minimum of 257 nm
                                  Ej £M( 257 nm) Î 5.0 - 8.0
 SULPHATED ASH                    Not more than 0.1%
 ---pagebreak---                                     - 10 -
                                                              ANNEX
                       E 309 - Synthetic De lt a-to conhcro 1
APPEARANCE                       Clear , viscous pale yellowish or orange
                                 oil whioh darkens on exposure to air or light
CONTENT                          Not less than 97 %
REFRACTIVE INDEX ru              Not loss than 1.500 and not more than 1.504
                  20
SPECIFIC INDEX d .               Not " less - than        «Jtid not more than O.962
                     *  07                                '
SPECIFIC ABSORPTION E1           At the absorption maximum of 297 nm - 298 nm
IN ETHANOL      '    1 cm          . a
                                 E1 cm ( 297 " 298        : 89 " 95
                                 At the absorption minimum of 257 nm :
                                 EÎ      ( 257 nm) : 3.0 - 6.0
SULPHATED ASH                    Not more than 0«1 %
 ---pagebreak---                                       11
                                                         ANNEX
                           E 311 - Octyl vallate
APPEARANCE                      White or very pale yellowish crystalline
                                powder
MELTING POINT RANGE             99 - 102.5° after 6 h drying at 9°°
CONTENT                         Not less than 98«5 % ^ 15^22^5 a^er 4 ^
                                drying at 60°
SPECIFIC ABSORPTION E 1 fc      At the absorption maximum of 275 nm :
                      1 cm
IN ETHANOL
                                E1 cm (275 nm^ * 375 " 390
                                At the absorption minimum of 218 nm :
                                 E ] ^ (218 nm) : 935– 960
                                    I  cm
VOLATILE SUBSTANCES DETERMINED   Not more than 0»5 1°
OVER A 4 H PERIOD AT 60° IN A
DESICCATCR
SULPHATED ASH                    Not more than 0.05 %
FREE ACIDS                       Not more than 0.5    expressed as gallic
                                 acid (9.407 mg gallic acid corresponding
                                 to 1 ml 0.05 N-sodium hydroxide ).
 ---pagebreak---                                    t     12 -
                                                           ANÎÏÏ3C
                           E 312 - Dodocvl callate
APPEARANCE                        White or pale cream crystalline powder
MELTING POINT RANGE               96° - 98® after 4 h drying at 60°
CONTENT
                                  Wot less than 9^*5 a ^ 15^30^5 a^or 4 0.
                                  drying at 60°
SPECIFIC ABSORPTION E
                      1 %         At the absorption maximum of 2f5 nm s
                      1 cm
IN ETHANOL                          1 4.
                                  E1 Sm * 275 nm^ : 300 ~ 325
VOLATILE SUBSTANCES DETERMINED    Not more than 0.5 %
0V2R A 4 H PERIOD AT 60° IN A
DESICCATOR
SULPH4TED ASH                     Not more than 0.05
FUSE ACISS                        Not more than 0.5 7- expressed as gallic
                                  aoid (9»407 mg gallic acid corresponding
                                  to 1 ml 0.05 N-eodium hydroxide )«
 ---pagebreak---                                                              ΛΗΚΞΧ
                    E 320 - Butylated hydroxyanisole (BHA ) ( 1 )
APPEARANCE                         White or pale yellowish powder or large
                                   crystals with wasy appearance and slight
                                   aromatio smell
CONTENT                             Not less than 98*5 % ^ 11^16^2 an(^ n°^ "''es3
                                   than 85 $ of the 3-tert. -Butyl-4-hydrox5r-
                                    anisole isomer
SPECIFIC ABSORPTION E  E1 *        At the absorption maximum of 290 nm :
                        1 cm
IN ETHANOL
                                   e]1 ^cm ( 290 nm) : 190 - 210
                                    At the absorption minimum of 228 nm :
                                    E1 ^ (228 nm) s 326 - 345
4-HYDROXYANISOLE CONTENT            Not more than 0.5 %
SULPHATED ASH                       Not more than 0»05 %
( 1 ) All these criteria apply to the substance as it stands®
 ---pagebreak---                                        - 14 -
                                                               ANNEX
                                Butylated hydrosorto luene (BHT;
■APEaaBAHCE                         White crystalline or powdory crystalline
                                    substance
 CONTENT
                                    Not less than 99 % ^15^24^
 MELTING POINT RANGE                690 - 70® ( 1 )
                        1 "■
 SPECIFIC ABSORPTION EJ h           At " the absorption maximum of 278 nm \
                        1 cm
 IN ETHANOL
                                    E1cm ( 278 nm) : 81 ~ 88 ( 1 )
 SULPHAT3SD ASH                     Not' more than 0.005 %
 ( 1 ) The data hers relate to the anhydrous substance (without anticoagulant )
 ---pagebreak---                                                                         ANNE5C
                                     E 322 - Lecithins
 APPEARANCE          " "             - • - Browtt licruid or viscous semi-liquid or powder
 DESCRIPTION             ;   .     -        Lecithins are mixtures of phosphatides obtained
                                             oy sieans of physical procedure from animal or
                                            vegetable foodstuffs ? this extraction trior proceed
                 ' .                     - as far as the stage of fractionation of the
              .            .                 lecithin complex into its various components ,,
                     -           -           The lecithins may be slightly bleached in
                                           " aqueous medium by mean3 of hydrogen peroxide .
                                             This oxidation must not chemical ly modify tho
                                             ledithin phosphatides®
' C';F j;'ENT                                Kot loss than 60 X substance insoluble in acetone
  VOLATILE' SUBSTANCES DETERMINED            Hot more  than 2 $
  BY 1 H DRYING AT 105° C      ...     ...
  SUBSTANCES INSOLUBLE IN.BENZEJE            Not mors  than Q«3 $
  SUBSTANCES INSOLUBLE IN ACETONE?           Hot lees  than-50 f
  ACID NUMBER EXPRESSED AS KILLI -           Not mora ihan 35
  GRAMS POTASSIUM HYDROXIDE
  KEEIED TO NEUTRALIZE THE FREE
  ACIDS PRESENT 121 A 1 G SAMPLE
  FEROXIDE JJUMBEE EXPRESSES AS              Ecrual to or lass t'lwjs 10 »
  MI LLÏSQUIVALENTS PER KO
 ---pagebreak---                                     16 -
                                                         ANNEX
                      E 325 - Sodium lactate
                    ( Sodiura salt of laotic acid )
APPEARANCE                     White hygroscopic mass . Solutions are prac­
                               tically colourless and odourless
DESCRIPTION               '    The substance is usually available commer­
                               cially in the form of an aqueous solution
                             . containing 50 "to GO % of anhydrous sodium
                               lactate ,
CONTENT                        Not less than 98 % Na C^H^O^ after drying
ACIDITT                        Neutralization of a 1 g sample after drying
                               shall not require more than 0,5 ml 0.1 N
                               sodium hydroxide solution in the presence of
                               phono lphtalein*
REDUCING SUBSTANCES            No reduction of Pehling 's solution
 ---pagebreak---                                    - 17 -
                                                           ANNEX
                         E 326 - Potassium lactate
                     ( Potassium salt of lactic acid)
APPEARANCE                       Slightly syrupy , almost odourless , clear
                                 liquid
DESCRIPTION                      The substance is usually available commer­
                                 cially in the form of sin aqueous solution
                                 containing 60 # anhydrous potassium lactate
CONTENT                          Not less than 57 % K
ACIDITÏ                          Neutralization of a 1 g sample shall not
                                 require more than a 0.22 ml 0.1 N sodium
                                 hydroxide solution in the presence of
                                 phe no lpht ale in .
                                 The data given here refer to a 57     aqueous
                                 solution . For other concentrated solutions ,
                                 the values corresponding to their potassium
                                 lactate content must be calculated .
REDUCING SUBSTANCES'             No reduction of Fehling 's solution
 ---pagebreak---                                                                ANNEX
                           E 327 - Calcium laotate ( l )
                          ( Calciura salt of lactio acid )
APPEARANCE                            Almost odourless , white crystalline powder
                                      or granules
CONTENT                               Mot less than 98 $ Ca            after 4 h
                                      drying at 120°
VOLATILE SUBSTANCES DETERIIINED       Not more than 3 $
BY 4 H DOTING AT 120°
                                      The substance is available commercially in
                                      forms other than the anhydrous form , the
                                      most common being :
                                      - calcium lactate with one molecule of water
                                        of crystallization containing not wor ? than
                                        8 $ volatile substances .
                                      - calcium lactate with three molecules of
                                        water of crystallization containing not
                                        more than 20 % volatile substances
                                      - calcium lactate with five molecules of
                                        water of crystallization containing not
                                        more them 30 i- volatile substances#
ACIDITT                               Neutralization of a 1 g sample shall not
                                      require more than 0.5 rol 0*1 N-sodium
                                      hydroxide solution in the presence of phenol-
                                      phtalein.
                                      For aqueous solutions the values corresponding
                                      to their calcium lactate content must be
                                      calculated.
FLU0KIKE                              Not more than 30 mg/kg
REDUCING SUBSTANCES                   No reduction of Pehling 's solution
( 1 ) The data g?-ven here refer to the anhydrous substance .
 ---pagebreak---                                  19 -
                                                       ANNEX
                        E 330 - Citric acid
APPEARANCE                   Colourless or translucent crystalline solid
                             or whito crystalline povrder
CONTENT                      Not less than 99*5 i- CgHgOy
VOLATILE SUBSTANCES   '      Not more than 0.5 1
                -            The substance may "be obtained commercially
                             in forms other than the anhydrous form . One
                             of the most common of these is citric acid
                             with one molecule of water of crystallization
                             containing not more than 8,8 $ volatile
                             substances ,
G&iLATES                 ' ' Not more than 0»05 ^ oxalic acid
SULPHATED ASH       :        Not more than 0,05
                                            -1
SULPHURIC ACID TEST          1 g sample dissolved in 10 ml 95 ^ sulphuric
                             acid and heated for 60 min . at 90° shall not
                             show a darker colouration than a solution
                             containing 0#5 parts of a CoC1^<,6K^0 solution
                             (59*5 mg/ml) and 4,5 parts of a FeCl^.fiHgO
                             solution (45*0 mg/ml)
 ---pagebreak---                                      - 20
                                                           ANIIEX.
                           E 331 - Sodium citrates
                       ( Sodium salts of oitrio acid)
APPEARANCE                        Crystalline white powder or colourless
                                  crystals ,
CONTENT                           Not less than 99 % sodium citrate expressed
                                  as trisodium citrate Na^ C^H^Oy after drying
                                  at 180°
VOLATILE SUBSTANCES DETERMINED    Not more than 1 %
BY DnriflG AT 180°
                                  The substance is available commercially in
                                  forms other than the anhydrous form, the
                                  most common being :
                                  •* sodium citrate with two molecules of water
                                     of crystallization containing not more than
                                     13 ^ volatile substances
                                  - sodium citrate with 5»5 molecules of water
                                     of crystallization containing not more than
                                     30 % volatile substances .
0XALATES                          Not moro than 0*05 % exalio acid
 ---pagebreak---                                                                 Aîwnx.
                        B 332 - Potassium citrates ( l )
                       ( Potassium salte of citric acid)
APPEARANCE                           White , hygroscopic , granular powder or
                                   • transparent crystals .
CONTENT                              Not loss than 99 % potassium citrate express <
                                     as tripotassium citrate CgK^O^K^ after 4 h
                                     drying at 1G0°
VOLATILE SUBSTANCES DETERMINED       Not more than 6 f
DY 4 H DRYING AT 180° •
OXALATES                             Not more than 0.05 % oxalic aoid
( 1 ) The substance is available commercially in tV. for-n of potassium citrate
      with one molecule of water of crystallizati on * The data here refer to Ur
      substance with one molecule of water of cry r4 _ ii:Usatione     ^
 ---pagebreak---                                        - 22 -
                                                              ANflEX
                           E 333 •» Calcium citrates ( ij
                          ( Calcium salta of citrio acid)
APPEARANCE                           Fine white powder
CONTENT                              Not less than 97*5 a> caloium citrate expressed
                                     as tricalcium citrato Ca. ( C^IL-O-)- after
                                  »                            3   o 5 7 Z
                                     drying at 180°
VOLATILE SUBSTANCES DETERMINED       Not more than 13 f>
BY DRYING AT 180°                             - ;    •
CARBONATES                           Dissolving of 1 g calcium citrate in 10 ml
                                     dilute hydrochlorio acid ( 2) must not liberate
                                     more than a few isolated bubbles .
0XALATES                             Not more than 0.05 % oxalio acid
FLUORINE                             Not more than 30 mg/kg
( 1 ) The substance is available commercially in the form of calcium citrate
      with four molecules of water of crystallization containing not more than
      13 ft volatile substances .
( 2) Mix 260 ml hydrochlorio acid ( 25 f' v/v HCl) and a little water, then make
      up to 1 000 ml ( approximately 2 N)«
 ---pagebreak---                                    - 23 -
                                                         ANNEX
                          E 334 - Tartaric acid'(l )
APPEARANCE                       Colourless or translucent crystalline solid ,
                                 or vhite crystalline powder
CONTENT
                                 Not less than 99 • 5 a  6 6 after
                                 at 105 8
VOLATILE SUBSTANCES DETERMINED   Not more than 0.5 %
AFTER DIETING AT 105°
SULPHATED ASH                    Not more than 0 . 1 %
0XALATES                         Not more than 0.05 % oxalic acid
(0 The substance concerned is L-(+)-Tart e.rio ac? d           . . r..T
 ---pagebreak---                                           24 -
                                                               ANIiEX:
                            E 33 5 - Sodium tartrates ( 1 )
                          ( Sodium salts of tartaric ecid)
APPEARANCE                            Transparent t colourless orystals
CONTENT
                                      Not less than 99 ft Nag C^H^Og after 3 h
                                      drying at 150°
VOLATILE SUBSTANCES DETERMINED        Not more than 17 $
BY 3 H DRYING AT 150°
0XALATES                              Not more them 0.05 % oxalio acid
                                                                             Ν  %
( l ) Tha substances concerned are derivates of L-(+) -Tart aria acid.'.Thio
      substance is available commercially in the form of sodium tartrate with
      two molecules of t-rater of crystallization containing not less than 14 %
      and not more than 17# of volatile substances#
 ---pagebreak---                                                                  AHNEK
                          E 336 - Potassium tartrates ( j )
                     »   ( Potassium salts of tartario acid)
APPEARANCE                             Khita crystalline or granulated powder
CONTENT                                Not lees than 99 $ K^C - K - Og after drying at
                                       160°
VOLATILE SUBSTANCES DETERMINED         Not less than 4 %
BY DRYING AT 160°                       ;                   • ■. .     ' ;  ,"r .
OXALATES                               Not more than 0.05 % oxalic acid
( 1 ) The substance concerned is a derivate of L-(+ )-Tartcric acid#
       The 'substance is available commercially in the form of potassium tart ra/t
     ■ with half a molecule . of yrater of crystallization containing not more tha
       4 7- volatile substances . •               . .. .
 ---pagebreak---                                       - 26 -
                                                              ANT1EX
                      E 337 - Sodium potassium tartrate ( 1 )
APPEARANCE                          Colourless crystals or white crystalline
                                    powder
CONTENT                             Not less than 99 % Na K C^Og after 3 h
                                    drying at 150°
VOLATILE SUBSTANCES DETERMINED      Not more than 26 1
BY 3 H DRYINO AT 150®
                                                                     \
OXALATES                            Not more than 0»05 5t oxalic aoid .
( 1 ) The Bubstance ooncerned is a derivate of L-(+) -Tart'&ri q acid . The substance
      is available commercially in the form of sodium potassium tartrate with
      four molecules of water of crystallization containing not loss than 21 J?
      and not more than 26 aL volatile substances4
 ---pagebreak---                                         - 27 -
                                                                ANNEX  •
                            E 338 - Orthophosphoric acid ( l )
APPEARANCE                           Clear , colourless , viscous liquid
CONTENT
                                     Not less than 85 % ^3^4
                             .. .
CHLORIDES                            Not more than 0.02 % expressed as chlorine
NITRATES                             Not more than 0.0005 % expressed at NaNO .
SULPHATES                            Not more than 0 . 15 X expressed as CaSO .
FLUORINE                             Not more than 10 mg/kg expressed as fluorine
VOLATILE ACIDS                       Not more than 0.001 % expressed as acetic acid
( l ) All the data here refer to a substance composed cf not , less than 85
      HLPO . and not more than '15 ^ watery "                            ; • •
 ---pagebreak---                                        - 28 -
                                                                ANNEX
                      E 339 A - Monosodium orthophosphate ( 1 )
                       ( Sodium salts of orthophosphoric acid)
APPEARANCE                            Slightly deliquescent ) white povrdeiy
                                      crystals or granules
CONTENT
                                      Not less than 97 1- Na H^PO^ after 1 h drying
                                      at 60° and then 4 h drying at 1056
VOLATILE SUBSTANCES DETERMINED ■ Not more than 2 f
BY 1 H DRYING AT 60° THEN 4 H
DRYING AT 105°
WATER INSOLUBLE SUBSTANCES            Hot more than 0.2 f
FLUORINE                              Not more than 10 mg/kg expressed as fluorine#
( l ) The forms of the substance available commercially other than the anhydrous
      form are :                                                      '   ' *  "
      Ho no sodium orthophosphate with one molecule of water of crystallization
      containing not more than 15 %
      Monosodium orthophosphate with two molecules of water of crystallization
      containing not more than 25
 ---pagebreak---                                         - 29 -
                                                                 ANNEX
                       E 339 B - Disodium orthophosphate ( l )
                       ( Sodium salts of orthophosphoric acid)
APPEARANCE                            Anhydrous form : white hygroscopic powder
                                      With tvo molecules water : white crystalline
                                      solid
                                      With seven molecules water : white granular
                                      powder of effluorescent crystals
                                      With twelve molecules water : white powder
                                      or effluorescent crystals
CONTENT
                                      Mot less than $8 % Nag H PO^ after 1 h drying
                                      at 60° ' and then 4 h drying at 105°
VOLATILE SUBSTANCES DETERMINED        Not less than 5 $
BY 1 H DRYING AT 60° AND 4 H
DRYING AT 105°
WATER INSOLUBLE SUBSTANCES            Not more than 0.2
FLUORINE                              Not more than 10 mg/kg expressed as fluorine
( l ) The product is available commercially in forms other than the anhydrous
        form such as :
      - Disodium orthophosphate with two molecules of water of crystallisation
         containing not more than 21 ^ of volatile substances
      - Disodium orthophosphate with seven mole cules of water of crystallization
       ' containing not more than 50 % of volatile substances       .          - •
      - Disodium orthophosphate ivith tvelve molecules of water crystallization
         containing not more than 61 % of volatile Babstonces *
 ---pagebreak---                                          - 30 -
                                                                   ANNEX
                         E 339 C – Trisodium orthophosphate ( l )
                         ( Sodium salts of orthophosphorio aoid)
  APPEARANCE                            White powder , crystals or granules
  CONTENT                               Not less than 97 $ Na^ PO^ after 30 min
                                        calcining at 800°
  VOLATILE SUBSTANCES DETERMINED        Not more than 2 f
  BY 30 MIN CALCINATION AT 800°              '
  VJATER INSOLUBLE SUBSTANCES           Not more than 0.2
  FLUORINE                              Not more than 10 mg/kg expressed as fluorine *
" ( l ) The substance • is available commercially in the following forms other than
         the anhydrous form :
         ~ Trisodium orthophosphate with one molecule of water of crystallization
           containing not more than 9 % of volatile substanoes
       " ~ Trisodium orthophospha-te with twelve molecules o f wat er of crystallization
           containing not more than            volatile sut>stances «
 ---pagebreak---                                                             AN1JEX
                   E 340 A - Monopotassium o rtho phosphate
                  ( Potassium salt g of orthopliosphoric acid )
APPEARANCE                         Colourless crystals   or white granular or
                                   Cï*ystalline powder
CONTENT                            Not less than 98 % KH2P04 after 4 h drying
               "                   at 105°                           •' • '
VOLATILE SUBSTANCES DETERMINED     Not more than 2 %
BY 4 H DRYING AT 105 a                                 .  .
WATER INSOLUBLE SUBSTANCES        Not more than 0.2 £
FLUORINE                          Not more than 10 rng/kg expressed as fluorine
 ---pagebreak---                                     - 32 -
                                                          ANNBC
                     E 340 B - Dipotassium orthophoBphate
                  ( Potassium salts of orthophosphoric acid)
ÀPFEARANCE                        ColourleBS or white granular déliquescent
                                  substance
CONTENT                           Not less than 98 % Kg H P0^ after 4 h drying
                                  at 105°
WOLATILE SUBSTANCES DETERMINED    Not more than 2%
BY 4 H DETING AT 105°
WATER INSOLUBLE SUBSTANCES        Not more than 0.2 %
FLUORINE                          Not more than 10 mg/kg expressed as fluorine *
 ---pagebreak---                                                                 AilNEC
                    E 340 C - Tripotassium orthophosphate ( l )
                     ( Potassium salts of orthophosphoric acid)
APPEARANCE                            White hygroscopic crystals or granules
CONTENT                               Not less than 97 % K J, F04. after 30 min
                                 -■-- calcination at 800°
VOLATILE SUBSTANCES DETERMINED        Not more than 3 fc
BY 30 MIN CALCINATION AT 800®                  '
WATER INSOLUBLE SUBSTANCES            Not more than 0„2 p
FLUORINE                        " " . Hot more than 10 mg/kg expressed as fluorine#
( l ) The substance is available commercially in forms other than the anhydrous
      form, the most common "being :
      Tripotassium orthophosphate w ith one molecule of vrater of crystnl ligation
      containing not more than 20 ?T~of volatile substances#
 ---pagebreak---                                           34 ""
                                                              ΛΙ-ΠΤΕΧ;
                       E 341 A - Mono calcium orthopho sphate
                      (Calcium salts of orihophosphorio acid)
 APFEAFANCF
                                     white , déliquescent granular powder ,
                                     crystals or granules
 CALCIUM CONTENT                     Anhydrous form : not less than 23 % and not
                                     more than 25 % expressed as CaO
                                     With one molecule of water : not less than
                                     22.2 % and not more than 24.7 % expressed
                                     as CaO,
VOLATILS SUBSTANCES                 Anhydrous) form : not less than 14 f and not
                                    more than 15*5 * determined by less during
                                    30 min heating at 800°
                                    With one molecule of vater : not more than
                                    0.6 $ ( l)j determined ly 3 h drying at 60°
FLUORINE
                                    Not more than 30 mg/kg expressed as fluorine .
( 1 ) 0.6 $ does not refer. tP K&ter of crystallization but at moisture lost
      under these conditions .                                  •   •
 ---pagebreak---                                          35 -
                                                              AN1CTC
                     E 34 1. B - Pi calcium orthonhosphate .
                  ( Calcium salts of orthophosphoric acid)
APPEARANCE                           Impalpable white powder
CALCIUM CONTENT                   ' Anhydrous form s not less than 39 % and not
                                     more than 42 f; expressed as CaO
                                     With two, molecules of vrater : not less than
                                     31.9 % and not more than 33«5 % expressed
                                     as CaO
VOLATILE SUBSTANCES DETERMINED       Anhydrous form : not less than 7     aiid not
BY CALCINATION BETWEEN 300 AND                      *
825° TO CONSTANT WEIGHT              more than      /-
                                     With trro molecules of vater : not less than
                                     24.5 ii and not more than 26,5 #
FLUORINE                             Not more than 50 mg/kg expressed as fluorine .
 ---pagebreak---                                            36
                                                              ANNEX
                      E 341 C ~ Tri.calcium ortho phosphate
                   ( Calcium salts . of orthophosphoric acid)
APPEARANCE                            Impalpable white powder
                                , (
CALCIUM CONTEJIT                      Wot less than 90 % Ca. (PO. ) ^ after calcin&tion
                                     ■between 800 and 825° to constant weight
VOLATILE SUBSTANCES DETERMINE!)      Not more than 10 £
BY CALCINATION BETWEEN 800 AND
825° TO CONSTANT WEIGHT
FLUORINE                            Not more than 50 mg/kg expressed as fluorine
 ---pagebreak---                                       - 37 -
                  \
                                                                  ΑΙΓ.ΊΓΧ
                        Propylene glycol . ( 1 , 2-pro-oanediol )
APPEAMNCE                           Clear , colourless , odourless , viscous ,
                                    hygroscopic liquid with a slightly sharp
                                    flavour
CONTENT                             Not les3 than 97»5 a hy weight 1,2 propane­
                                    diol and not more than 0.2 ^ water ; the
                                    remaining 0.8 f. being composed of a poly-
                                    propyleneglycol compound which f in tho case
                                    of the substance containing no water , may
                                    reach 1 $
DISTILLATION RANGE
DISTILLATI0N                        Not less than 185° and not more than 189°
SPECIFIC
SPECIFIC GRAVITY
         GRAVITY d|°
                     PO
                    dj              Not less than 1.035 and not more than 1.037
REFRACTIVE
REFRACTIVE INDEX
            INDEX n^°
                     ?0
                    n£              Not less than 1.431 and not more than 1.433
CALCINATION RESIDUES
CALCINATION  RESIDUES   .           Not more than 0,07   -  1