CELEX: 51993PC0290
Language: en
Date: 1993-06-22
Title: Amended proposal for a COUNCIL DIRECTIVE on food additives other than colours and sweeteners

COMMISSION OF THE EUROPEAN COMMUNITIES
                                               C0M(93)   290final - SYN424
                                               Brussels, 22   June 1993
*h -v
                               Amended proposal for a
                 on food additives other than colours and sweeteners
             (presented by the Commission pursuant to Article 149(3)
                                  of the EEC-Treaty)
 ---pagebreak---                                    Explanatory memorandum
In response to the opinion of the European Parliament! delivered on 26 May 1993
on the proposal for a Council Directive on food additives other than colours and
sweeteners* and in accordance with the third paragraph of Article 149 of the Treaty
establishing the European Economic Community, the Commission has decided to
amend the above mentioned proposal.
The Commission accepted amendments concerning:
-   Inclusion of 'quantum satis1 in the legal text because of increase of the clearness
    of the legal act
-   exclusion of non-additives of field of application which follows from the
    definition of food additives as mentioned in the framework directive
    89/107/EEC
-   In order to avoid that foodstuffs not conform with this directive should be
    destroyed, an amendment introducing that foodstuffs not conform with the
    directive may be sold until stocks are exhausted.
-   modification to the titles and texts of the annexes increased clearness of directive
-   addition to the list of foodstuffs for which additives are forbidden
-   survey of consumption of additives which is necessary. This will be needed in
    order to adapt the directive periodically
-   Adaptation of maximum levels of use and addition of certain additives because
    they correspond to the technological need
-   addition of foodstuffs for which E385 is permitted because there is a
    technological need
-   modification of the definition of foodstuffs in which nitrates are used
-   addition of a new food additive because it was newly evaluated by the Scientific
    Committee for Food and has a technological purpose
The Commission did not accept amendments concerning:
-   introduction of recitals and articles which were already covered by the proposal
    or covered in the framework directive 89/107/EEC on which this proposal is
    based
-   requirement of labelling provisions because they belong to the directive
    79/112/EEC on labelling
-   requirement concerning additives specification to be adopted by the Scientific
    Committee for Food and opinion of the Scientific Committee for Food because
    these are requirements covered in the framework directive
-   change of the definition of flavour enhancers. The Commissions proposal
1
2
  OJN°C206, 13.8.1992, p 12
 ---pagebreak---                                        -I-
corresponds to International nomenclature
inclusion/exclusion of certain foodstuffs of field of application because they are
not in line with the definition of food additives
prohibition of use of additives in certain foodstuffs for which a technological
need is shown
change in the definition of certain foodstuffs because they are not in line with
Community legislation
change in the maximum levels of permission because there is a shown
technological necessity
addition of foodstuffs already covered by the proposal
deletion of reference to the wine regulation because this item is also covered
by Regulation 822/87 on wine
permission of use of certain additives only in certain countries because it is
against the principles of the free movement of goods
determination of the list of foodstuffs in which phosphates and carrageenan are
used
permission of use of additives in general and in certain foodstuffs and under
certain conditions because the requirements are already taken into account in
the proposal
request for establishment of product-specific lists of foodstuffs because it would
introduce the principle of recipe law
total prohibition of use of sorbitan esters and prohibition of use of sweeteners
as flavour enhancers because there is a positive opinion of the Scientific
Committee for Food and correspond to a technological purpose
 ---pagebreak--- In response to the opinion of the European Parliament l delivered on 26 May 1993
on the proposal for a Council Directive on food additives other than colours and
sweeteners 2 and in accordance with the third paragraph of Article 149 of the Treaty
establishing the European Economic Community, the Commission has decided to
amend the above mentioned proposal as follows:
1. point (h) is added to Article 1 paragraph 4:
     "(h)caseinates and casein"
2. The word "generally" is deleted from Article 2 paragraph 2.
3. Text of Article 2 paragraph 3 (a) is replaced by:
       "a) unprocessed foodstuffs and honey, virgin oils, butter, pasteurised and
           sterilised (including UHT sterilisation) milk and cream (including
           skimmed, plain and semi-skimmed), mineral waters as mentioned in
           Directive 80/777/EEC (1) coffee, sugars as mentioned in Directive
           73/437/EEC (2) non aromatised tea leaves, natural unflavoured yoghurt
           and natural unflavoured buttermilk, durum wheat pasta, except where
           specially provided for.
           Within the meaning of this directive, unprocessed foodstuffs are foodstuffs
           that have not undergone any treatment resulting in a substantial change of
           the original state of the foodstuffs. However, they may have been, for
           example, divided, parted, severed, bored, skinned, pared, peeled, ground,
           cut, cleaned, trimmed, chilled, frozen, deep-frozen, unpacked or packed
           in the presence or not of packaging gases. "
4. A new paragraph 7 is added to article 2:
     "7. In the Annexes to this Directive 'quantum satis1 means that no maximum
          level is specified. However additives shall be used according to good
          manufacturing practice, at a level not higher than is necessary to achieve
          the intended purpose and provided that they do not mislead the consumer. "
5. The text of article 8 is replaced by the following text:
     "Member States shall, within three years of the adoption of this Directive,
     establish systems to monitor the consumption and use of food additives and
     report their findings to the Commission.
     The Commission shall report to the European Parliament within five years of
     the adoption of the Directive on the changes which have taken place in the food
     additives market, the levels of use and consumption.
     In accordance with the General Criteria of point 4 of Annex II to Directive
     89/107/EEC, within 5 years from the adoption of this Directive, the
     Commission shall review the conditions of use mentioned in this Directive, and
     propose modifications where necessary."
(i)
<2>OJN*C206, 13.8.1992, p. 12
 ---pagebreak---                                              -5-
6. To the second indent of the first paragraph of Article 10 add the following text:
    "However products in circulation or bearing a trademark before this date which
    do not conform with this Directive may be marketed until stocks have been
    used up"
7. The title of Annex I is modified as follows:
                     "Food additives generally permitted for use in foodstuffs
                           not referred to in Article 2(3) and Annex II"
8. The first note to Annex I is modified as follows:
    1. Substances in this list may be added to all foodstuffs with the exception to
         those mentioned in Article 2(3) and Annex II following the 'quantum satis'
         principle. Quantum satis means that no maximum level is specified .
         However, these food additives should be used according to good
         manufacturing practice at a level not higher than is necessary to achieve the
         intended purpose, provided they do not mislead the consumer.
9. Add the following to the end of Annex II:
     "T            ! !      ~      I E 300 Ascorbic acid            I
      Frozen and deep-frozen E 3 0 1 S o d i u m a s c o r b a t e
      unprocessed      vegetables E 3 0 2 Calcium ascorbate           quantum satis
       and fruit                     ., V1M .,.. .    .,
                                     h 330 Citric acid
                                     E 331 Sodium citrates
                                       (i) Monosodium citrate
                                       (ii) Disodium citrate
                                       (iii) Trisodium citrate
                                     E 332 Potassium citrates
                                       (i) Monopotassium citrate
                                       (ii) Tripotassium citrate
                                     E 333 Calcium citrates
                                       (i) Monocalcium citrate
                                       (ii) Dicalcium citrate
                                       (iii) Tricalcium citrate
      Quick cooking rice             E 471 Mono and diglycerides
                                     of fatty acids                   quantum satis
                                     E 472a Acetic acid esters of
                                     mono and diglycerides of fatty
                                     acid
 ---pagebreak---                                            -6-
10. The 9th row of Annex II concerning sterilised and UHT cream is replaced by
    Sterilised and UHT      E 270 Lactic acid
                            E 322 Lecithin                    quantum satis
    cream, k>w-calorie
                            E 325 Sodium lactate
    cream and               E 326 Potassium lactate
    pasteurised low-fat     E 327 Calcium lactate
    cream                   E 330 Citric acid
                            E 331 Sodium citrates
                            (i)Monosodium citrate
                            (ii) Disodium citrate
                            (iii) Trisodium citrate
                            E 332 Potassium citrates
                            (i) Monopotassium citrate
                            (ii) Tripotassium citrate
                            E 333 Calcium citrates
  •
                            (i) Monocalcium citrate
                             (ii) Dicalcium citrate
                             (»i) Tricalcium citrate
                            E 400 Alginic acid
                            E 401 Sodium alginate
                            E 402 Potassium alginate
                            E 403 Ammonium alginate
                            E 404 Calcium alginate
                            E 406 Agar
                            E 410 Locust bean gum
                            E 415 Xanthan gum
                            E 440 Pectins
                                 Modified starches
                            E 508 Potassium chloride
                            E 509 Calcium chloride
11. In Annex III(C) for the E251 Sodium nitrate and E252 Potassium nitrate replace in
the column of foodstuffs "cured meat products" by "meat products"
12. In the 6th row of Annex II concerning Jams, Jellies and marmalades replace the
maximum level for Pectins to 10 g/kg
 ---pagebreak---                                            - I -
13. For additive E385 Ethylene diamine tetra acetate in Annex IV replace the table
with the following:
                                          Emulsified                  75 mg/kg
  E 385         Calcium                   sauces
                disodium
                ethylene                                             250 mg/kg
                diamine tetra-           Canned and
                acetate                  bottled white
                                         vegetables and
                                         pulses, legumes,
                                         mushrooms and
                                          artichokes
                                          Canned and                 250 mg/kg
                                          bottled
                                          crustaceans
                                          Canned and                  75 mg/kg
                                          bottled fish
                                          Minarine                   100 mg/kg
14. For additive E407 Carrageenan add the following line to the list of foodstuffs and
maximum levels:
                                  Low-calorie and          10g/kg
                                  reduced fat emulsions
15 To annex IV add a new line to the table:
       E444         Sucrose acetate       non-alcoholic             300mg/l
                    isobutyrate           aromatised water based
                                          drinks
 16. Replace the general title of Annex VI by:
                      "Food Additives permitted in Foods for Infants
                                   and Young Children"
 17. Replace the tittle section IV of Annex VI by:
                      "Food Additives permitted in Foods for Infants
                    and Young Children for special medical purposes"
 ---pagebreak---                                                  S)
                                                                     ISSN 0254-1475
                                                              COM(93) 290 final
                                                      DOCUMENTS
EN                                                                         0610
                                Catalogue number : CB-CO-93-324-EN-C
                                                             ISBN 92-77-56995-6
Office for Officiai Publications of the European Communities
L-2985 Luxembourg