Amended proposal for a COUNCIL DIRECTIVE on food additives other than colours and sweeteners
Date: 1993-06-22
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, human nutrition

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 
definition  of 
89/107/EEC 

the 
the  framework  directive 

food  additives  as  mentioned 

in 

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 
technological  need 

for  which  E385  is  permitted  because  there  is  a 

-  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 

-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 

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 
(including  UHT  sterilisation)  milk  and  cream 
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 
Commission  shall  review  the conditions of  use  mentioned  in  this Directive,  and 
propose  modifications  where  necessary." 

the  adoption  of 

this  Directive, 

(i) 

<2>OJN*C206,  13.8.1992, p. 12 

- 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 
! 
Frozen  and  deep-frozen 
unprocessed 
and fruit 

I E 300 Ascorbic acid 

I 

E  3 01  S o d i um  a s c o r b a te 

vegetables  E  3 02  Calcium  ascorbate 
., 
.,  V1M  .,..  . 
h  330 Citric acid 
E 331 Sodium  citrates 

quantum satis 

(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 
E  472a  Acetic  acid  esters  of 
mono and  diglycerides of fatty 
acid 

quantum satis 

- 6-

10. The 9th row of Annex II concerning sterilised and UHT cream is replaced by 

quantum satis 

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 

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 

-  I  -

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 

75 mg/kg 

250 mg/kg 

Emulsified 
sauces 

Canned and 
bottled  white 
vegetables and 
pulses, legumes, 
mushrooms and 
artichokes 

Canned and 
bottled 
crustaceans 
Canned and 
bottled  fish 
Minarine 

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 

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