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) 
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 
2OJN°C206, 13.8.1992, p 12 
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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 
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 
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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 301 Sodium ascorbate 
unprocessed vegetables E 302 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 
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10. The 9th row of Annex II concerning sterilised and UHT cream is replaced by 
Sterilised and UHT 
cream, k>w-calorie 
cream and 
pasteurised low-fat 
cream 
• E 270 Lactic acid 
E 322 Lecithin 
E 325 Sodium lactate 
E 326 Potassium lactate 
E 327 Calcium lactate 
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 quantum satis 
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 
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13. For additive E385 Ethylene diamine tetra acetate in Annex IV replace the table 
with the following: 
E 385 Calcium 
disodium 
ethylene 
diamine tetra­
acetate Emulsified 
sauces 
Canned and 
bottled white 
vegetables and 
pulses, legumes, 
mushrooms and 
artichokes 
Canned and 
bottled 
crustaceans 
Canned and 
bottled fish 
Minarine 75 mg/kg 
250 mg/kg 
250 mg/kg 
75 mg/kg 
100 mg/kg 
14. For additive E407 Carrageenan add the following line to the list of foodstuffs and 
maximum levels: 
Low-calorie and 
reduced fat emulsions 10g/kg 
15 To annex IV add a new line to the table: 
E444 Sucrose acetate 
isobutyrate non-alcoholic 
aromatised water based 
drinks 300mg/l 
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" 
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