CELEX: 51981PC0005
Language: en
Date: 1981-01-19
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (81) 5
Vol. 1981/0002
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983
concernant l'ouverture au public des archives historiques de la Communauté économique
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983,
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003
(JO L 243 du 27.9.2003, p. 1), ce dossier est ouvert au public. Le cas échéant, les documents
classifiés présents dans ce dossier ont été déclassifiés conformément à l'article 5 dudit
règlement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243,
27.9.2003, p. 1), this file is open to the public. Where necessary, classified documents in this
file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
Februar 1983 über die Freigabe der historischen Archive der Europäischen
Wirtschaftsgemeinschaft und der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983,
S. 1), geändert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003
(ABI. L 243 vom 27.9.2003, S. 1), ist diese Datei der Öffentlichkeit zugänglich. Soweit
erforderlich, wurden die Verschlusssachen in dieser Datei in Übereinstimmung mit Artikel 5
der genannten Verordnung freigegeben.
 ---pagebreak---  COMMISSION CF THE EUROPEAN COMMUNITIES
                                                          COM(81)5 final
                                                ) T>v     Brussels , 19 January 1981
                            Α-' *
                            A- •         t"'J          \ iA
                           I::J
                          r --t             . „
                                                    -A Y-.3
                                                  \/J \J*\
                          l -d      '> ;j " u *          Ir^T
                           V?.
                            VI­
                                  ■ν..·ν τ'π'ΤΓ\ν .\>
                                    Proposal for a
                                 COUNCIL DIRECTIVE
 on the approximation of the laws of the Member States relating to materials and
 articles made of regenerated cellulose film intended to come into contact with
                                      foodstuffs
                 ( submitted to the Council by the Commission )
C0MC81 ) 5 final
 ---pagebreak---                           EXPLANATORY MEMORANDUM
I. INTRODUCTION
1 . Under certain conditions , packaging materials used for foodstuffs are
    known to transfer the substances used in their manufacture to the
    foodstuffs themselves .   Such substances , if toxic , represent a risk
    for the consumer .   Accordingly , most of the Member States of the
    European Community have' drawn up regulations ( in the form of laws ,
    recommendations , codes of practice ) designed to avoid , or reduce to
    the lowest achievable level , risks connected with the use of
    packaging materials .   Regenerated cellulose film is one of the materials
    used for foodstuffs packaging and , as such , is covered by specific
    regulations in Italy , Belgium and the Federal Republic ,of Germany.    It
    is' also covered by general rules in France , the Netherlands , the
    United Kingdom and Denmark .
2 . Althou^i they have the same aim , to protect the consumer , the various
    regulations propose different methods* of achieving that protection and
    hence represent a technical barrier 1to Community trade .    In its
    Resolution of 13 December 1973 * "the Council included the harmonization
    ccf laws , regulations and administrative provisions on materials and
    articles intended to come into contact with foodstuffs in its programme
    ccf action on the removal of technical t}jfkriers to trade and gave it
    priority rating.          .
3 . In this context the Council adopted a Directive on 23 November 1976
    relating to materials and articles intended to come into contact with
    foodstuffs .    This Directive laid down the general principles , criteria
    and procedures for drawing up specific directives relating to certain
    groups of materials ( e.g. ceramics , plastics , paper and paperboard).
 Directive 76/893/2EC , OJ No L 34Û , 9-12.1976 , p. 19
 ---pagebreak---                              o
                                        - 2 -
      Three specific directives have already been submitted to the Council .
                                            2
      The first involves ceramic articles , the second materials and articles
                                          3    ,    ^ ,  ,  ,  , .       , . , 4
      containing vinyl chloride monomer     and the third plastics materials .
      The present proposal for a directive is thus the fourth specific
      directive .
 4. The Commission points out that Parliament , in its opinion on the
     above-mentioned framework directive , asked the Commission to submit
     the specific directives in question at the earliest possible juncture .
 5. The Advisory Committee on Foodstuffs ,, which comprises industrial ,
     consumer , agricultural , trade and worker representatives , has delivered
     an opinion in favour of the adoption of this proposal for a directive .
     The European professional organization for the producers of regenerated
     cellulose film ( CIPCEL ) has asked th^ Commission on several occasions ,
     to draw up a proposal for a directive in this sector .        For their
     part , the European consumer organizations have confirmed the need to
     pay particular attention to materials? intended to case into contact
     with foodstuffs where the health and safety of the consumer are
     concerned .
II . CONTENTS ' ON THE DRAFT DIRECTIVE
 1 . The regulations in question on regenerated cellulose film originate
     from the current provisions in force in Belgium , Italy and the Federal
     Republic of Germany .    They are "based largely on the definition of an
     " approved list ", i.e. a list of substances authorized to he used in
     the manufacture of regenerated cellulose film .      Maximum quantities
     are laid down concerning the use of such substances , especially
     additives which are likely to "migrate", in order to limit to the
     technologically indispensable minimus* their presence in the finished
      product .   This reduces the risk of food contamination.
  20J No C 46 , 27.2.1975
   Directive 78/142/ESC , OJ No L 44, 15.2*1978
  40J No C 141 , 16.6.1978
 ---pagebreak---    2 . She drafting of the approved list required the toxicological evaluation
         of all substances used "by European industries on the part of the
        Scientific Committee for, Food"*.   Thiis has entailed a considerable
        amount of work in terms of collecting scientific data f not only at
        European , "but also at world level .   The ad hoc working party of the
        Scientific Committee has spent two yoars assessing all the substances
        on the list propiosed "by the CIPCEL aj,id which had the "backing of the
        Member States , which were consulted :[.n advance . It was not always
        possible to obtain all the 'data required for a serious assessment of
        the harmfulness of the substances , aijd in such cases , these substances
        were removed from the list with the agreement of CIPCEL and the
        Member States .   In contrast , where it was possible to establish a daily
        permissible dose for substances , a comparison was made between such
        quantities - and the estimated absorbed dose on the basis of migration
        data or on the basis of the assumption that all the substance present
        or transferable has actually migrated to the! foodstuff .     Given these
        conditions , it can be reasonably argued that observation of the present
        regulations more than protects the health of the consumer without
        putting undue strain on the European industry .
   3 . An approved list was not drawn up foy dyes , since it was felt
        sufficient to apply the principle of non-mi grat ability , which has to
        be confirmed by highly sensitive method . .           -   -
        Until there is a Community directive national standards currently in
      - force regarding purity criteria will continue to apply to dyes , as to
        other substances included in the list .    ■
        Finally, regenerated cellulose film coated with more than 50 mg/dia"
        lacquer is not covered by this directive on account of the faot that ,
        it should be included in the directive on plastic materials ^,
^The Scientific Committee for Food is made up of highly qualified independent
" personalities connected with medicine , putrition, toxicology , biology,
• 'Chemistry or similar fi^ds
^Eeport of the Scientific 6'couaittea for Food, Sixth series , 1978
 ---pagebreak--- CONSULTATION OP THE EUROPEAN PARLIAMENT AND OP THE ECONOMIC AND SOCIAL
COIZIITTZE
This proposal is for a " specific directive" within the meaning of
Article 3 of Directive 76/893/EEC of 23 November 197^ and should
therefore "be adopted in accordance with the procedure laid down lay
Article 100 of the Treaty .  Pursuant to the second paragraph of
that Article ! consultation of the European Parliament and of the
Economic and Social Committee is necessary.   Implementation of the
provisions of a directive will , for all member States , mean making
amendments to their legal provisions .
 ---pagebreak---       Proposal for a Council Directive on the approximation of the laws of
      the Member States relating to materials and articles made of regenerated
      cellulose film intended to come into contact with foodstuffs
  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
  Having regard to the Treaty establishing the European Economic Community ,
  and in particular Article 100 thereof ,
  Having regard to Directive 76/893 /EEC of 23 November 1976     "the -
  approximation of the laws of the Member Staies relating to materials and
. articles intended to come into contact with foodstuffs    and in particular
  Article 3 thereof ,
  Having regard to the proposal from the Commission ,
  Having regard to the Opinion of the European Parliament ,                   '
                                ■  . 1       •          '
  Having regard to the Opinion of the Economic and Social Committee ,
  Whereas Article 2 of Directive 76/893/EEC lays down that materials and
  articles must not transfer their constituents to foodstuffs in quantities
  which could endanger human health or bring about an unacceptable change
  in the composition of the foodstuffs ;
  Whereas, in order to achieve this objective in the case of regenerated
  cellulose film , a suitable instrument is a specific Directive within the
  meaning of Article 3 of Directive 76/893/EEC , the general provisions of which
  are also applicable to the case in question ;
  Whereas synthetic casings of Regenerated cellulose should be subject to
  specific provisions;'
  Whereas the method for determining the absence of migration of colouring
                                  .1
  matters should be established at a later stage :
   X0J No L 340 , 9.12.1976 . P. 19
 ---pagebreak--- Whereas,until criteria of purity and methods of analysis have been drawn up ,
national provisions will remain in force ;
Whereas the establishment of a list of approved substances , accompanied ■
by maximum percentage levels of the quantities to be used , will be
sufficient in this specific case to achieve the objective laid down
in Article 2 of Directive 76/893/EEC ;
Whereas , to protect the health of the consumer , direct contact between
foodstuffs and the printed surfaces of regenerated cellulose film should
be avoided ;
Whereas fixing the procedure for the determination of possible migration in
or on foodstuffs of colouring matters used in the manufacture of regenerated
cellulose film is an implementing measure of a technical nature and therefore ,
in order to simplify and accelerate the procedure, thi s should be the
responsibility of the Commission ;
Whereas, in all cases in which the Council confers on the Commission
authority to implement the rules relating to materials and articles
intended to come into contact with foodstuffs , a procedure should be laid down
establishing close cooperation between Member States and the Commission
within the Standing Committee for Foodstuffs set up tinder Council Decision
69/414/EEC2,                                          '
HAS ADOPTED THIS DIRECTIVE :
 OJ No L 291 , 19.11.1969 , p. 9 .
 ---pagebreak---                                    Article 1
                                             »             '
1 . This Directive is a specific Directive within t hie meaning of Article 3
    of Directive 76 / 893 / EEC .
2 . This Directive applies to regenerated cellulose film which complies with
    the description given in Annex I and which , in the finished state , is intended
    to / or does , come into contact with foodstuffs , according
    to its purpose . It is hereinafter called "regenerated cellulose film".
3 . This directive does not apply to' :        -
    – regenerated cellulose film which , on the side intended to come into contact
      with foodstuffs , has a coating exceeding 50 mg / dm2
    - synthetic casings of regenerated cellulose
                                   Article 2
1 . Only those substances or groups of substances listed in Annex II to this
    Directive may be . used for the manufacture of regenerated 'cellulose film and
    only under the conditions laid down therein .
2 . In derogation from paragraph 1 , substances other than those listed in Annex II-
    may be used when these substances are employed as colouripg matter ( dyes- and
    pigments ), provided that there is no migration of the substance into or onto
    foodstuffs , detectable by a method which shall be determined in accordance with
    the procedure laid down in Article 10 of Directive          76 / 893 /EEC ..
                                   Article 3
Printed surfaces of regenerated cellulose film shall         not come into direct
contact with the foodstuff .
                                                    V'
                                   Article 4                                    . '
Both sides must comply with the rules laid down in this Directive unless there is
an indication of the side not intended to come into contact with the foodstuff ..
                                   Article 5
 Without prejudice to the application of Article 4 of Directive 76 / 893 / EEC ,
amendments to Annex II of this Directive requi red in order to take account of progress
in scientific and technical knowledge shall be adopted,where appropriate follovir.:
c6fis\il Cation of the Scientific Committee for Food, in accordance with the procedure-
 laid down in Article 10 of Directive      76 / 893 / !EEC .
 ---pagebreak---                                  Article 6
This Directive shall not affect national legislation concerning :
– the purity standards of the substances Listed in Annex II and of the colouring ,
   matters referred to in Article 2 ( 2 );
– the methods of analysis .
                                 Article 7
                           £.
1 . Member States shall - make such amendments to their laws as may "be
                                  • I
    necessary in order to comply with the provisions of this Directive and shall
     forthwith inform the Commission thereof . The laws so amended shall be
    applied in such manner that :
    – the marketing of regenerated cellulose film complying with the
       provisions of this Directive is authorized with effect from 1 January 1984
       at the latest ;
    – the marketing of regenerated cellulose film not complying with the
       provisions of this Directive is prohibited with effect from 1 January 1985 .
                                                                '1
                                                                4
2 . Paragraph 1 shall not prevent Member States from prohibiting the
    manufacture of regenerated cellulose film not complying with the
    provisions of this Directive , as from 1 January 1984*
                                 Article 8
This Directive is addressed "to the Member States.'
Done at Brussels ,                                   For the Council
 ---pagebreak---                                                              A'.mex I
Description of regenerated cellulose film
Regenerated cellulose 'film is a thin sheet material produced by chemically "
dissolving a derivate of highly refined cellulose obtained from wood or
cotton that have hot been recycled , and subsequently regenerating the pure cellulose
by chemical precipitation . To meet technical requirements , suitable additives are
incorporated , either in the mass or on the surface . Regenerated cellulose film
can be coated on one or both sides .   '
 \
 ---pagebreak---                                                   ANÎJEX II
        List of substances authorised, for the fabrication of
                    regenerated cellulose film
IT»B . – The percentages in the present annex q.re expressed in
         weight/weight (w/w) and are calculated in regard to
         anhydrous regenerated cellulose :
  /
       – The denominations of the suo stances or group cf SLID stances
         are according to the IUPAC ("International Union of Pure
         and Applied Chemistry") rules . Between square brackets
         f~ J, the usual technical denominations are given*,.
 ---pagebreak--- First Part :                                  UN COATED REGENERATED CELLULOSE FILM
                                      DENOMINATIONS                                                      RESTRICTIONS
             Regenerated cellulose                                                £ 72 %
             Softeners :                                                          £ 27 % au total
             - Bis (2 hydroxyethyl ) ether ^ Diethyleneglycol ]                    The total amount of bis (2 hydroxyethyl ) ether and
             - Ethanediol [Moncethyleneglycol ]                                    ethanediol may not exceed 20 % and only for films to
                                                                                   be coated afterwards , and only for packaging of
                                                                                   non moist foodstuffs , this means those which do not
                                                                                   contain , physically free water at the surface x
               1 ,3 Butane diol
               Glycerol
               1,2 Propanediol [ 1,2 Propylenediol ]
               Polyethylene oxyde [ Polyethyleneglycol ] . .... .                  Average molecular weight "between „i00 and 1200
               1,2 Polypropylene oxyde [ 1,2 Polypropyleneglycol ]                 Average molecular weight £ 400 and 1,3 propanediol
                                                                                   content < 1 % ( w/w )
               Sorbitol
               Triethylene glycol
               Urea
             Additives :
                                                                                     1 % in total
             1st class :                                                           The total quantity of individual substances or 3roups
                                                                                   of substances '    should not exceed 2 mg/ dm2
               Acetic acid and its Mfy , Ca , Mg , K and Na salts
               Ascorbic acid and its NH1», Ca , Mg , K and Na salts
               Benzoic acid and sodium benzoate
               Formic acid and its NH^, Ca , Mg , K and Na salts
               Linear fatty acids , saturated or unsaturated , with an even
               number of carbon atoms from 8 to 20 inclusive and also behenL c
               acid and ricinoleic acids and "the NHL , Ca , Mg , K , Na, Al , I
               salts of these acids       /               4          ,
               Citric , d-1 lactic , nialeic , 1-tartaric acids and their
               Na , K salts     -   1
               Sorbic acid and its NHh , Ca , Mg , K and Na salts
 ---pagebreak---                                                        - .3 -
                          DENOMINATIONS                                                 RESTRICTIONS
Amides of linear fatty acids saturated or unsaturated , with
an even number of carbon atoms from 8 to 20 inclusive and als
■the amides of "behenic and ricinoleic acids
Natural edible starches     and flours
Edible starches and flours modified by chemical treatment       ( according to SCF Report of the 27th February 1 976-
                                                                  second series - Dec . 1976 )
Amylose                                                       '
Calcium and magnesium carbonates      and chloride
                                                    /
Esters of glycerol with 'linear fatty acids , saturated or
unsaturated , with an even number of carbon atoms from 8 to
20 inclusive and/ or - with adipic , citric , 12 hydroxystearic
( Oxystearin ) , ricinoleic acids
Esters of polyoxyethylene ( 8-1 b oxyethylene groups ) with
linear fatty acids , saturated or unsaturated , with an even
number of carbon atoms from 8 to 20 inclusive
Esters of sorbitol with linear fatty acids , saturated or
unsaturated with an even number of carbon atoms from 8 to
20 inclusive
                            \
Mono and/or di esters of stearic acid with ethanediol and/or
bis(2-hydroxyethyl ) ether and/ or triethylene glycol
Oxides and hydroxides of Aluminium., Calcium , Magnesium and
Silicium and silicates and hydrated silicates of Aluminium ,
Calcium , Magnesium and' Potassium
Polyethylene oxide [ Polyethylene glycol ]                        Average molecular weight "between 1200 and 4000
Sodaum Propionate
 ---pagebreak---                                                              -k­
                   , '          DENOMINATIONS    -  ;                                           RESTRICTIONS
  Additives_2nd class :         ... . ..... . . ... .             . . £ 1 mg/ dm2 in total and, unless otherwise indicated , the
                                                                        total quantity of each substance or group of substanc
                                                                        should not exceed 0,2 mg/ dm2
- Sodium alkyl ( Cß-Ciß ) benzenesulphonate
- Sodium isopropyl napht alene sulphonate
- Sodium alkyl . (C 0- C 1 q ) sulphate
   Sodium alkyl ( C q- C ^) sulphonate
- Sodium dioctylsulphosuccinate
- Distearate of di-hydroxyethyl di-ethylene tr-iarnine mono-           £ 0.05 mg/dm in total on the side in contact with
   acetate     •                                                            foodstuffs
- Ammonium , magnesium , potassium and lauryl sulphates
- N - N' distearoyl , diaminoethane .
   LNN 1 < distearoyl ethylene di amine ]  and
  N - N      dipalmitoyl diaminoethane .
   LNN' dipalmitoyl ethylene di amine]' and
  N - N' dioleoyl diaminoethane
  [ NN' dioleoyl ethylenediamine ]
  2 heptadecyl - 4 , U bis (methylenestearate ) oxazoline
■ Polyethylene amino steararaide ethylsulphate                          ^ 0,1 mg/ dm2 in total on the side in contact with
                                                                          , foodstuffs
  M^i^il®|_3rd_class - Anchoring agents               . . . i . . . .   ^ 1 mg/dm2 in total
- Condense d^melamine-formaldehyde , modified "or unmodified :          Free formaldehyde content on side in contact with
  Condensation product of melamine-formaldehyde , modified with          foodstuffs ^ 0,5 mg/ dm2
  one or more of the following products : butanol , diethylene-         Free melamine content on side in contact with food­
 t etrami ne t ethanol , triethylenetetramiìie, tetraethylenepenta-     stuffs ^ 0,3 mg/ dm2
  mine , tri- ( 2-hydroxyethyl ) amine , 3-3 diaminodipropylamine ,
  h-4 diaminodibutylamine
 ---pagebreak---                                                          - 5
                              DENOMINATIONS
                                                                                                RESTRICTIONS
- Cross-linked cationic polyalkyleneammes :
    ( a ) poly ami de-epichlorhydrin resin based on di ami nop ropy1-
           methylamine and epichlorhydrin
    ( b ) polyaraide-epichlorhydrin resin based on epichlorhydrin ,
            adipic acid , caprolactam , diethylene triamine and/ or
            ethylene di amine
    ( c ) potyamide-epichlo.rhydrin resin based on adipic acid ,
            diethylenetriamine and epichlorhydrin , or a mixture of
           epichlorhydrin and ammonia
   ( d ) polyamide-polyamine -epichlorhydrin resin based on epi-
         . chlorhydrin , dimethyl adipate and diethylenetriamine
   ( e ) polyamide-polyamine -epi chlorhydrin resin based on api-
           chlorhydrin , adipand.de and diaminopropylmethylamine
- Polyethyleneamines and polyethyleneimines                              ^ 0,75 mg / dni2 in total
- Condensed urea formaldehyde , modified or not                          tree formaldehyde content on side in contact with
                                                                         foodstuffs ^ 0,5 mg/ dm2
   ( a ) Ureaformaldehyde
   ( b ) Ureaformaldehyde modified vith aminone thylsulphonic acid ,
          butanol , diaminobutane , diaminodiethylamine , 3–3 ' diamino-
           dipropylamine , diaminopropane , diethylenetriamine , ethanal
           guanidine , methanol , I^SOg , sulphanilic acid ,
           triethylenetetramine , tetraethyleneDentamine
                       Class       . .                                   ^ 0,01 mg/ dm2 in total
 – Products resulting from the reaction of the amines of
     edible oils with polyethylene oxide
 - Monoethanolamine lauryl sulphate
 ---pagebreak--- Second Part                                       COATESrBSfîiSLÊM'l^E^CElJiUEiiCBE' RI LM
                                     DEIIOMINATIONS                                                                           RESTRICTIONS
             Regenerated Cellulose                                                                   see 1st part
             Softeners                                                                               see 1st part
             Anchoring agents                       . ■                                              see 1st part
             Coating :                                                                               ^ 50 irg/ dm2 on the side in contact with foodstuffs
              Polymers :                                                                             <: 50 rag/ dm^ in total on the side in contact with food-
                                                                                                     stuffs
            - Ethyl ,   hydroxyethyl ,     hydroxypropyl       and methyl : ethers
              of cellulose
            - Cellulose nitrate                                                                      < 20 mg/ dm2 on the side in contact with foodstuffs ;
                                                              »
                                                                                                     nitrogen content between 10,8 % and 12,2 %
            - Polymers , copolymers and their mixtures made with the                                 In accordance with national le^i*3labion oan-'Iin.?'· ths
              following monomers :     ·········.#· ...,.,,                                          adoption of Community previsione!
            • Vinyl acetals derived from saturated aldehydes ( Cj to_Cg)·                                                       >
              Vinylacetate
              Alkyl C·] to C^ vinylethers
              Acrylic , crotonic , itaconic , maleic , nethacrylic acids
              and their esters
              Butadiene
              Styrene                     ,     .                                                         .
                                                                        ...ν                '''--J
              Methylstyrene
              Vinylchloride                             ,                                             according the VCM directive 78/ 1H2/3EC O.J. LU-'v '
                                                                                                       15.2.1978 , p.15
              Vinyli denechloride
              Acrylpnitrile
              Methacrylonitrile
              Ethylene , propylene , butylene 1 et 2
                                                                                                   s
                                                                             .. -< · Λ:-' "
                                                                                                                                                       I
 ---pagebreak---                             DENOMINATIONS                                                 RESTRICTIONS                1
Resins                                                            ^ 12,5 mg/ dm2 in total on the side in contact with
                                                                   foodstuffs
 - Casein
- Colophony and/or its products of polymerisation , hydroge­
   nation , or disproportionation and their esters of methyl ,
   ethyl or C2 - Cg polyvalent alcohols , or mixtures of these
   alcohols
- Colophony and/or its products of polymerisation , hydrogena­
   tion , or disproportionation condensed with acrylic , maleic ,
   citric , fumaric and/ or phthalic acid and/or bisphenol for­
   maldehyde and esterified with methyl , ethyl or C2 - C$
   polyvalent alcohols or mixtures of these .alcohols
- Esters derived from bis ( 2-hydroxyethyl ) ether with addition
   products of p-pinene and/or dipentene and/or diterpene and
   maleic anhydride
- Edible gelatine
- Castor oil . and its products of dehydration or hydrogenation
   and its condensation products with polyglycerol , adipic ,
   citric , maleic , phthalic and sebacic acid
- Damar    Gum
- Poly-p-pinene ( terpenic resins )
- Modified Urea resins ( see anchoring agents )
               •   ****••••••••••••••••••»                        ^ 12,5 mg/ dm2 in total on the side in contact with
                                                                  foodstuffs
- Acetyl tributyl citrate
-  Acetyl tri(2-ethylhexyl ) citrate
-  Di-ethylhexyl adipate [ Dioctyladipate ]
-  Di-isobutyl and di.n . butyl adipate
-  Di.n.hexyl azelate
 ---pagebreak---                                                  -8-
                            DEÏJ OMI ÎJATI OîJS                                    . RESTRICTIONS
- Butylbenzylphthalate
  Butyl-methylcarboxybutylphthalate [ Butylphthalybutylglyco-
                                                        late ]
- Di . η . butyl and di-isobutyl phthalate.
- Dicyclohexyl phthalate
- Di ( 2-ethyl-hexyl ) phthalate                                                                                        I
- Di ( methyl-cyxlohexyl ) phthalate and its isomers
  t Sextolphthalate ]                                                 -    ·               -   .
- 2-Ethylhexyl diphenyl phosphate                                2,5 mg/ dm2 on the side in contact with . foodstuffs
- Glycerine mono-acetate         [ Monoacetine ]
- Glycerine di-acetate           [ Diacetine ]           .
- Glycerine tri-acetate          [ Triacetine ]
- Methyl-methylcarboxyethyl phthalate
  [ Methylphthalyethyl-glycolate ]                                            •
- Di-butyl      sebacate                                       ,
- Di ( 2~ethylhexyl ) sebacate                                                                                        ,
  [ Dioctylsebacate ]
- Di -, η -butyl tartrate and di-iso-imtyl tartrate
                                                                                                                        1
                           9
                                                                                          4           ,                 t
                                                                                                                        i
                                                                                                                        1
                                                                                                                        1
                                                                                                    '
 ---pagebreak---                                                           9-
                                    DENOMINATIONS
                                                                                                  RESTRICTIONS
 Other additives :                                  - . ■              ^ 6 mg/dm2 in total on the side in contact vith
                                                                       foodstuffs
  ( a ) Additives listed in the fi£3t_gart                             Same particular restrictions of the first part ( auar.ti
                                                                       ties in 1r.g/ dn2 refer however to the side in contact
                                                                       with the foodstuffs )
                                                                                          individual
 ( b ) Sgeci fic_coating additives                            , . .    Total quantity of v substances or group of substance
                                                                       may not exceed 2 mg/ dm2 on the side in co'nt-ast with-
                                                                       foodstuffs
 - 1 hexadecanol and 1 octadecanol
 - Esters of linear fatty acids , saturated or unsaturated ,
     with an even number of carbon atoms from 8 to -20 inclusive
     and of ricinoleic acid with ethyl , butyl , > amyl and oleoyl
     linear alcohols
- Mont an waxes , comprising purified montanic ( Cgg to C32 )
     acids and/ or their esters with ethanediol and/ or 1-3 butane­
     diol and/ or their calcium and potassium salts
- Carnauba wax
- Beeswax
- Esparto wax
- Candellila wax
- Dimethylpolysiloxane                            •                        1 mg/ dm2 on the side in contact with foodstuffs
- Epoxidised soya-bean oil ( oxirane content 6 - 8 % )
- Refined paraffin and microcrystalline waxes
- Pentaerythritol tetrastearate
- Mono and bis ( octadecyl-di ( ethyleneoxide ) phosphates . . . .     -^■ 0,2 rr.g/ in2 on the side in contact wi th - foods tuffs-
- Aliphatic acids ( C3-C20 ) esterified with mono or di
     (2 hydroxyethyl ) amine
- 2- and 3- tert . butyl- It hydroxyanisol                         . . ^ 0,0b mg/dm2 on the side in contact with foodstuffs
    [ ΒγΓίνίνιγά.ΓοχΛτηηι' <-, η1 _ ΒΚΑΐ
 ---pagebreak---                            DENOMINATIONS                              RESTRICTIONS
 - 2,6-di -tert. butyl- l» inethy] Dhenol      ^ 0,06 ag/dn2 on the side in contact vith foodstuffs
   ^Butylhydroxytoluene - BHT^
 - Di-.n-octyltin-bis ( 2-ethylhexyl ) maleate ^ 0,06 mg/dr2 on the Side in contact vith foodstuffs
 Solvents :   ........
                                               Total quantity of all substances or group of substan­
                                               ces may not exceed 0,6 mg/ dm2 on the side in contact
                                               with foodstuffs
 - Butyl acetate                . ,                                        •       :       –
 - Ethyl acetate
 - Isobutyl acetate
 - Isopropyl acetate .
-  Propyl acetate
- Acetone
-  Butyl alcohol
-  Ethyl alcohol
-  Isobutyl alcohol                                             . . /
-  Isopropyl alcohol
~  Pr6pyl alcohol
<- Cyclohexanç
- Ethyleneglycol nionobutylether
-  Ethyieneglycol  monobutylether acetate
-  Ethyieneglycol  monoethylether
-  Ethyieneglycol  monoethylether acetate
~  Ethyieneglycol  nonomethylether
-  Ethyieneglycol  ir.onorr.ethylether acetate
- Methylethyl ketone
- Kethylisobutyl ketone
- Tetrahydrofurane
- Toluene
                                                                                                     I
                                                                                                     I
                                                                                                     I