CELEX: 51984PC0726
Language: en
Date: 1984-12-18
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO MODIFIED STARCHES INTENDED FOR HUMAN CONSUMPTION

N o C 31/6                            Official Journal of the European Communities                                1.2.85
                                                             II
                                                     (Preparatory Acts)
                                               COMMISSION
               Proposal for a Council Directive on the approximation of the laws of the Member States
                             relating to modified starches intended for human consumption
                                                    COM(84) 726 final
                            (Submitted by the Commission to the Council on 3 January 1985)
                                                       (85/C 31/09)
THE COUNCIL OF THE EUROPEAN                                      protective measures without delay; whereas, however,
COMMUNITIES,                                                     such action should be followed by a Community
                                                                 Decision;
Having regard to the Treaty establishing the
European Economic Community, and in particular
Article 100 thereof,                                             Whereas it is necessary to define labelling
                                                                 requirements in respect of modified starches in order
Having regard to the proposal from the Commission,               to facilitate trade and to enable the manufacturers of
                                                                 such products to provide a more precise indication of
Having regard to the opinion of the              European        their intended use, by adopting the designations listed
Parliament,                                                      in Annex 1;
Having regard to the opinion of the Economic and                 Whereas, however,         since foodstuffs     intended
Social Committee,                                                specifically for infants and young children constitute
                                                                 the principal source of infant nutrition in many cases,
Whereas any laws concerning modified starches                    the use of certain starches should be limited to 5 %
which may be used in foodstuffs intended for human               and the use of propylene oxide-modified starches
consumption must take account firstly of the need to             should be prohibited;
protect human health, secondly of the need to protect
the consumer from adulterated products and thirdly
of the economic and technological necessities within             Whereas the list of authorized modified starches
the     limits    imposed     by     health     protection       should be adapted in line with scientific and technical
considerations;                                                  developments; whereas, however, it is advisable in
                                                                 such cases to entrust the Member States with the task
Whereas differences between national laws relating to            of contributing, through the adoption of temporary
these substances, in so far as they impede the free              national measures, to the search for a Community
movement of foodstuffs           intended for human              solution;
consumption, can lead to unequal conditions of
competition and thus directly affect the establishment
                                                                 Whereas any changes, based on advances in scientific
or proper functioning of the common market;
                                                                 and technical knowledge, to the conditions of use and
                                                                 the upper residue limits set out in Annex 1 as well as
Whereas the approximation of these laws is necessary             the definition of sampling and analysis methods for
to ensure the free movement of foodstuffs intended               the purpose of checking the listed substances and
for human consumption;                                           their purity constitute technical          implementing
                                                                 measures; whereas, for the purpose of simplifying and
Whereas for this purpose it is appropriate to draw up            accelerating their adoption and facilitating their
a single list of relevant substances, use of which in            implementation, steps should be taken to ensure close
foodstuffs intended for human consumption does not,              cooperation between the Member States and the
according to the present state of scientific knowledge,          Commission within the framework of the Standing
pose a threat to human health; whereas this list                 Committee on Foodstuffs set up pursuant to Council
should be supplemented by the definition of purity               Decision 69/414/EEC (*),
criteria which these substances must satisfy;
Whereas, in the event of a subsequent threat to public
health, the Member States should be able to take                 0) OJ No L 291, 19. 11. 1969, p. 9.
 ---pagebreak--- 1.2.85                                Official Journal of the European Communities                            N o C 31/7
HAS ADOPTED THIS DIRECTIVE:                                      (c) all foodstuffs manufactured therewith shall bear a
                                                                      special indication to be laid down in the author-
                                                                      ization.
                          Article 1
                                                                 2.     The Member States shall communicate to the
For the purposes of this Directive, the term 'modified           other Member States and to the Commission the text
starches' means the products obtained by one or more             of any authorization decision adopted pursuant to the
chemical treatments of edible starches, which may                provisions of paragraph 1, within two months after
have previously undergone a physical or enzymatic                the date on which the decision takes effect.
treatment.
                                                                 3.     Before the three-year period stipulated in
                                                                 paragraph 1 has expired the Member State may
                         Article 2                               request the Commission to include in Annex 1 the
                                                                 modified starch which had been the subject of
1.     Subject to the provisions of Article 3, and               national authorization pursuant to the provisions of
notwithstanding Community or national requirements               paragraph 1. At the same time, the Member State
governing the composition of certain foodstuffs which            shall provide the evidence which, in its view, supports
are justified on grounds of the prevention of fraud,             such inclusion and shall indicate how the modified
Member States shall authorize the marketing and use              starch is to be used.
as foodstuffs ingredients of the modified starches               Within 18 months from the date of submission of the
listed in Annex 1 under the conditions laid down                 request, a decision shall be taken, on the basis of data
therein.                                                         relating to public health and after consulting the
                                                                 Scientific Committee for Food in accordance with the
2.     The Member States shall prohibit the marketing            procedure laid down in Article 9, as to whether the
and use of all other modified starches.                          modified starch in question can be included in Annex
                                                                 1 or whether the authorization given by the Member
                                                                 State should be revoked. If provisions additional to
                         Article 3                               those set out in Annex 2 are found to be necessary,
                                                                 they shall be adopted using the same procedure. By
Without prejudice to Community provisions relating               way of derogation from paragraph 1 (a), an author-
to infant formulae and follow-up milk, use as an                 ization granted by a Member State shall remain in
ingredient of foodstuffs intended specifically for               force until a decision has been taken on the request
infants and young children:                                      for inclusion.
                                                                 If, in accordance with the provisions of the second
(a) shall be prohibited in the case of the modified
                                                                 subparagraph, it is decided that the authorization
     starches listed in Annex 1 under the letters K
                                                                 granted by a Member State must be revoked, this
     and R;
                                                                 decision shall apply simultaneously to any author-
                                                                 ization of the same modified starch granted by any
(b) shall be limited to 5 % m/m in the case of the               other Member State.
     modified starches listed in Annex 1 under jhe
     letters D, F, G, H , I, J and N.                                                     Article 6
                                                                 1.     If, as a result either of the submission of a
                          Article 4                              detailed assessment based on new data or the re-
                                                                 evaluation of existing data since the adoption of this
Modified starches shall satisfy the general purity               Directive, a Member State ascertains that the use as a
criteria set out in Annex 2.                                     foodstuffs ingredient of one of the modified starches
                                                                 listed in Annex 1 or its content in one or more of the
                                                                 substances referred to in Annexes 1 and 2 constitutes
                          Article 5
                                                                 a hazard for public health, notwithstanding its
1.     In order to take account of scientific or                 compliance with the provisions of this Directive, that
technical developments which have occurred since the             Member State may provisionally suspend or restrict
adoption of this Directive, a Member State may                   the application of the relevant provisions within its
authorize the marketing and use within its territory of          territory. It shall immediately inform the other
a modified starch not listed in Annex 1, provided that           Member States and the Commission of such action
the following conditions are satisfied:                          and of the reasons therefor.
                                                                 2.     As soon as possible thereafter, the Commission
(a) the authorization shall be limited to a maximum              shall examine the reasons cited by the Member State
     period of three years;                                      concerned and shall consult the Member States within
                                                                 the framework of the Standing Committee on
(b) the Member States must ensure that foodstuffs                Foodstuffs. It shall then deliver its opinion without
     containing any modified starch it has authorized            delay and proceed to the adoption of the appropriate
     are officially monitored;                                   measures.
 ---pagebreak--- N o C 31/8                          Official Journal of the European Communities                                 1.2.85
3.     If the Commission is of the opinion that                manufacturing characteristics of the modified starches
amendments to the Directive are necessary to mitigate          shall be adopted in accordance with the procedure
the difficulties referred to in paragraph 1 and to             laid down in Article 9.
ensure the protection of public health, it shall initiate
the procedure laid down in Article 9 with a view to                                       Article 9
the adoption of those amendments; in that case, the
Member State which originally adopted the protective           1. If the procedure laid down in this Article is
measure shall be permitted to maintain them until              invoked, the matter shall be referred to the Standing
those amendments enter into force.                             Committee on Foodstuffs, hereinafter referred to as
                                                               the 'Committee', by its chairman, acting either on his
                         Article 7                             own initiative or at the request of a representative of
                                                               a Member State.
 1.    The labelling of modified starches shall consist
solely of the following mandatory wording:                     2.     The Commission representative shall submit to
                                                               the Committee a draft of the measures to be taken.
(a) the denomination under which the product is                The Committee shall deliver its opinion on the draft
     sold, consisting                                          within a time limit to be set by the chairman in the
     — either of the term 'modified starch' followed           light of the urgency of the matter. Opinions shall be
          by the reference letter of the product               delivered by a qualified majority, the votes of the
          indicated in Annex 1,                                Member States being weighted as provided for in
                                                               Article 148 (2) of the Treaty. The chairman shall not
     — or of the name of the modified starch as given
                                                               vote.
          in Annex 1,
     the constituents of a mixture being designated            3. (a) The Commission shall adopt the measures in
     individually;                                                      question if they accord with the opinion of the
                                                                        Committee.
 (b) the words 'for human consumption' or an
                                                                    (b) If the measures do not accord with the opinion
     indication of the specific intended use of the
                                                                        of the Committee or if it is not able to deliver
     modified starch;
                                                                        an opinion, the Commission shall immediately
 (c) the net quantity, except in the case of products                   submit to the Council a proposal relating to
     put up in bulk;                                                    the measures to be taken. The Council shall
                                                                        act by a qualified majority.
 (d) the date of manufacture, or identification of the
     production batch;                                              (c) If the Council does not act within three
                                                                        months following the date on which the
 (e) the name or business name and address of the                       proposal is submitted, the proposed measures
      manufacturer or packer, or of a vendor                            shall be adopted by the Commission.
      established within the Community.
                                                                                         Article 10
 2.    The information referred to in paragraph 1 (a)
 and (d) shall appear on the package or on a label              Member States shall take the measures necessary to
 attached thereto.                                              comply with this Directive. They shall forthwith
 The information referred to in paragraph 1 (b) and             inform the Commission thereof.
 (c) shall appear:
                                                                Those measures shall be applied in such a way as to:
 — either on the package or on a label attached                 — permit products complying with this Directive to
     thereto;                                                        be marketed as from 1 July 1986 at the latest (');
 — or on the commercial documents relating to the               — prohibit products not complying with this
     modified starch in question.                                    Directive from being marketed with effect from
                                                                     1 November 1987 (2).
 3.     The provisions of this Article shall be without
 prejudice to more specific or more comprehensive                                        Article 11
 Community provisions relating to metrology.
                                                                This Directive is addressed to the Member States.
                          Article 8
 The rules relating to sampling and the methods of              (') 18 months after notification.
 analysis necessary for checking the composition and            (2) Three years after notification.
 ---pagebreak--- 1.2. 85                                Official Journal of the European Communities                                      N o C 31/9
                                                            ANNEX 1
                                               LIST OF MODIFIED STARCHES
Notes
1. The raw materials used may be dry, moist or in an aqueous suspension.
2. The percentages given relate to the dry material (m/m).
   Reference           Denomination                           Treatment                    Specification of the finished product
     letter
       A        White or yellow dextrin,     Dry heat treatment in the presence of     Final p H of 2,5 to 7,0
                roasted or dextrinated       not more than 0,15 % hydrochloric
                starch                       acid or not more than 0,17 % ortho-
                                             phosphoric acid (E 338)
       B        Starch modified by acid      Treatment with not more than 7 %          Final p H of 4,8 to 7,0
                treatment                    hydrochloric acid or not more than
                                             2 % sulphuric acid or not more than
                                             7 % orthophosphoric acid (E 338)
       C        Starch modified by alkali    Treatment with not more than 1 %          Final pH of 5,0 to 7,5
                treatment                    sodium      hydroxide      or  potassium
                                             hydroxide
       D        Oxidized starch              Treatment with not more than 5,5 %        Not more than 1 % of carboxyl groups
                                             sodium hypochlorite, expressed as         and not more than 0,5 % of sodium
                                             chlorine                                  chloride
       E        Bleached starch              Treatment with peracetic acid and/or      Not more than 0,1 % of added carboxyl
                                             hydrogen peroxide containing not          groups
                                             more than 0,45 % active oxygen, "or
                                             with sodium hypochlorite containing
                                             not more than 0,82 %            available
                                             chlorine, or with 0,5 % sodium            N o reagent residues
                                             chlorite; or with sulphur dioxide
                                             (E 220) or other permitted forms of
                                             sulphites (E221-E227)
                                             With not more than 0,2 % potassium        Not more than 50 mg/kg of residual
                                             permanganate, or with not more than       manganese
                                             0,075 % ammonium persulphate
       F        Monostarch phosphate         Esterification with orthophosphoric       Not     more       than      0,5 %     residual
                                             acid (E 338), sodium (E 339) or potas-    phosphate, calculated as phosphorus in
                                             sium     (E 340)    orthophosphate     or the case of potato starch or wheat
                                             sodium tripolyphosphate (E 450b)          starch, or not more than 0,4 % in the
                                                                                       case of other starches
       G        Acetylated starch            Esterification with not more than 10 %    Not more than 2,5 % acetyl groups
                                             acetic anhydride
                                             Esterification with not more than         Not more than 2,5 % acetyl groups
                                             7,5 % vinyl acetate
       H        Acetylated distarch          Esterification with not more than         Not more than 2,5 % acetyl groups
                adipate                      0,10 % acetic anhydrides and not more
                                             than 0,12 % adipic anhydrides
        I       Distarch phosphate           Esterification   with   sodium   trimeta- Not     more      than     0,14 %      residual
                                             phosphate                                 phosphate, calculated as phosphorus in
                                                                                       the case of potato starch and wheat
                                                                                       starch, or not more than 0,04 % in the
                                                                                       case of other starches
                                             Esterification with not more         than Not     more      than     0,14 %      residual
                                             0,1 % phosphorus oxychloride              phosphate, calculated as phosphorus in
                                                                                       the case of potato starch and wheat
                                                                                       starch, or not more than 0,04 % in the
                                                                                       case of other starches
 ---pagebreak--- N o C 31/10                           Official Journal of the European Communities                                            1. 2. 85
   Reference         Denomination                            Treatment                      Specification of the finished product
     letter
       J       Distarch phosphate            Esterification with not more than         Not more than 2,5 % acetyl groups and
                                             0,1 % sodium trimetaphosphate or          not     more       than     0,14 %      residual
                                             phosphorus oxychloride combined with      phosphate, calculated as phosphorus in
                                             esterification with not more than 10 %    the case of potato starch and wheat
                                             acetic anhydride or not more than         starch, or not more than 0,04 % in the
                                             7,5 % vinyl acetate                       case of other starches
       K       Hydroxypropyl starch          Esterification with not more than 10 %    Not more than 0,1 mg/kg (0,1 ppm)
                                             propylene oxide                           propylene chlorhydrins
       N       Phosphated distarch           Combination of the treatment under F      Not      more       than      0,5 %     residual
               phosphate                     and I                                     phosphate, calculated as phosphorus in
                                                                                       the case of potato and wheat starch, or
                                                                                       not more than 0,4 % in the case of other
                                                                                       starches
       R       Hydroxypropyl     distarch    Esterification with sodium trimeta-       Not more than 0,1 mg/kg (0,1 ppm)
               phosphate                     phosphate or phosphorus oxychloride,      propylene chlorhydrin, and not more
                                             combined with etherification with not     than 0,14 % residual phosphate, calcu-
                                             more than 10 % propylene oxide            lated as phosphorus in the case of potato
                                                                                       starch and wheat starch, or not more
                                                                                       than 0,04 % in the case of other starches
                                                            ANNEX 2
                       GENERAL PURITY CRITERIA APPLICABLE TO MODIFIED STARCHES
             1. Modified starches shall not:
                — contain any substances in quantities that are liable to endanger public health;
                — contain moulds, insects, remains of insects or other impurities of an animal nature or origin;
                — have an abnormal flavour or odour.
             2. The maximum contents set out below shall not be exceeded:
                NB: Where the amounts refer to one or more vegetable species, these amounts only refer to the
                      products derived from a single species. In the case of mixtures, it is necessary to calculate
                      the permissible amounts proportionately to the percentages of the various constituents.
                                        Substance                                   Maximum content
                — Arsenic                                                                1 mg/kg
                — Lead                                                                   1 mg/kg
                — Cadmium                                                              0,1 mg/kg
                — Mercury                                                             0,05 mg/kg
                — Sulphur dioxide                                                       50 mg/kg
                Moisture
                — Modified starches made from cereals                                  15 % m / m
                — Modified starches made from potatoes                                 21 % m / m
                — Modified starches of other origins                                   18 % m / m
                Proteins
                — Starches in general                                                     0,5 %
                — Amylase-rich starches                                                   1,0%