Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending European Parliament and Council Directive 95/2/EC on food additives other than colours and sweeteners
Date: 1996-09-04
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation

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1  COMMISSION OF THE EUROPEAN COMMUNITIES 
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Brussels,  04.09.1996 
COM(96) 303 final 

96/0166  (COD) 

Proposal  for a 

EUROPEAN  PARLIAMENT AND COUNCIL DIRECTIVE 

amending European Pariiament and Council Directive 95/2/EC 

on food additives other than colours and sweeteners. 

(presented  by the  Commission) 

EXPLANATORY  MEMORANDUM 

1. 

SUBSIDIARITY  IMPACT STATEMENT 

1.  What are the objectives of the proposed measure with regard to the Community's obligations? 

Directive  89/107/EEC provides  for  the adoption  of  specific  directives to harmonise the use of 
different  categories  of additives  in foodstuffs.  The Directive 95/2/EC on food  additives  other 
than colours and sweeteners  was adopted  on 20 February  1995.  It now needs to be adapted in 
the  light  of  recent  technical  and  scientific  developments. 

2.  Does competence  for the proposed  measure  lie solely  with the Community  or is it shared with 

the  Member States? 

Competence  for  the  proposed  measure  lies  solely  with  the  Community. 

3.  To  what extent  is  this  a problem  on  a Community  scale? 

Harmonisation  of the use of additives at Community  level was a priority  for completion  of the 
internal  market.  It  was  also  a  difficult  subject.  The  framework  Directive  89/107/EEC  on 
additives was adopted on 21 December  1988 and the three specific Directives in 1994 and 1995. 
Since  then, the  instruments  relating  to the  use  of  additives  have  been  the  same  in the  fifteen 
Member States.  This structure guarantees the free  movement of foodstuffs,  ensures a high level 
of  consumer  protection  and  offers  the consumer  greater  freedom  of  choice  between  different 
foodstuffs. 

Like the two other specific  Directives, Directive 95/2/EC on food  additives other than colours 
and sweeteners is based on the principle of the positive list.  A list of authorised food  additives 
is  set out in the different  Annexes  to the  Directive  with  a list of the foodstuffs  in  which  they 
may  be  used  and  the  conditions  of  use.  All  food  additives  not  included  in  the  list  are 
prohibited. 

Since the  legal  basis  of  the  Directive  is  Article  100A  of  the  EC Treaty,  the proposal  for  the 
amendment  has to follow  the same procedure, implying  the participation  of Parliament  in the 
decision  making  process. 

4.  What is the most effective  solution taking into account the means available to the Community 

and the Member States? 

Once the period for transposing the aforementioned  Directives has expired, Member States will 
not be able to use new additives (except for a limited period of 2 years for new food  additives 
not  included  in  the  positive  lists)  or  amend  the  rules  governing  use  on  their  own  initiative. 
Action  must therefore  be taken  at Community  level. 

5.  What practical  additional  benefit  will  the proposed  measure  provide  and  what would  be the  cost 

of  failure  to  take  action? 

The  Commission  proposals  will  establish  effective  legislation  at  Community  level,  attuned  to 
If  the  amendment  is  not  adopted  the 
new  developments  in  industry  and  consumer  needs. 
legislation  will become ineffective,  if not obsolete, and this could disrupt the proper  functioning 
of  the  internal  market  in  foodstuffs. 

6.  What  forms  of  action  are  open  to  the  Community? 

A  new  Directive  adopted  by  Parliament  and  the  Council  on  the  basis  of  Article  100a  is  needed 
to  amend  Directive  95/2/EC. 

7. 

Is  it  absolutely  necessary  to  adopt  uniform  rules  or  would  a  Directive  establishing  general 
principles  and  leaving  implementation  to  the  Member  States  be  sufficient? 

The  Commission  proposal  is  based  on  the  principle  of  complete  harmonisation  at  Community 
level,  as  prescribed  by  the  framework  directive  on  food  additives.  Uniform  rules  are  needed 
since additives concern  public health.  There  needs to be a large degree of transparency  between 
the Member  States  in order to establish  a reasonable  level of safety  in trade in foodstuffs  within 
the  Community. 

SPECIFIC  REMARKS 

This  amendment  to Directive  95/2/EC  merely  allows  already  authorised  food  additives  to be  used  in 
certain  new categories of food  which  are not included  in the directive. These products are  effectively 
on  the  market  since  several  years  and  the  entering  in  force  of  the  directive  will  effectively  prohibit 
its  marketing. 

Furthermore  the  proposal  for  amendment  takes  into  account  certain  foodstuffs  manufactured  in  the 
new  Member  States  not  covered  by  the  Directive  and  in  which  certain  additives  are  used. 

Some new  food  additives, which  are currently  forbidden,  and which  have recently  been evaluated  by 
the Scientific  Committee  for Food and found  acceptable  for  human consumption,  are included  in this 
proposal. 

No  further  changes  can  be  made  to the conditions  of  use  laid  down  in  the  Directive  until  the  results 
of  the  consumer  surveys  required  by  Article  7  of  the  Directive  are  available. 

Proposal  for a 
European Parliament and Council  Directive 
amending  European Parliament and Council  Directive  95/2/EC 
on food additives other than colours  and sweeteners. 

THE EUROPEAN  PARLIAMENT AND  THE COUNCIL OF THE EUROPEAN  UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article  100a thereof, 

Having  regard  to the  proposal  from  the Commission,1 

Having  regard  to the  opinion  of  the  Economic  and  Social  Committee,2 

Acting  in  accordance  with  the  procedure  referred  to  in  Article  189b of  the  Treaty,3 

Having  regard  to Council  Directive  89/107/EEC  of  21 December  1988 on  the approximation  of  the laws 
of  the  Member  States  concerning  food  additives  authorised  for  use  in  foodstuffs  intended  for  human 
consumption,4  as  last  amended  by  Directive  94/34/EC,5 and  in  particular  Article  3(2) thereof; 

Whereas  since the adoption  of Directive 95/2/EC6 there have been  technical  developments  in the field of 
food  additives; 

Whereas  the  Directive  should  be  adapted  to take account  of  these  developments; 

Whereas the Scientific Committee for Food was consulted before the adoption of provisions liable to have 
an effect  on  public  health, 

HAVE ADOPTED  THIS DIRECTIVE: 

• OJ 

2OJ 

3OJ 
4  O J N ° L 4 0,  11.2.89,  p.27. 
5  OJN°L237,  10.9.94,  p. 1. 
6  OJ N°  L 61,  20.2.1995  p.l. 

Article  1 

Directive  95/2/EC  is hereby  amended  as  follows: 

1. Article  2(3) (a) 3rd  indent  is replaced  by : 

"- non-emulsified  oils and fats  of animal  or vegetable  origin  (except oils and  fats  for cooking  and 
frying  purposes)." 

2. Article  2(3)  (a)  11th indent  is replaced  by : 

"- dry  pasta excluding  gluten-free  pasta" 

3.  Article  2(3) (a)  5th  indent  is replaced  by : 

"pasteurized and sterilized (including UHT) milk (including plain, skimmed and semi-skimmed") and 
plain  pasteurized  cream" 

4. 

The tables of the Annexes are modified  in accordance  with the dispositions contained  in the Annex 
to this  Directive. 

Article 2 

Member States shall, where necessary, amend their laws, regulations and administrative provisions in order 
to : 

authorise  trade  in products  conforming  to this  Directive, by  31  December  1997 at  the  latest; 

prohibit  trade  in  products  not  conforming  to  this  Directive  from  30 June  1998.  However, 
products  placed  on  the  market  or  labelled  before  that  date  which  do  not  comply  with  the 
Directive  may  be  marketed  until  stocks are  exhausted. 

They  shall  forthwith  inform  the Commission  thereof. 

When  Member  States  adopt  these  measures,  they  shall  contain  a reference  to this  Directive  or  shall  be 
accompanied by such reference on the occasion of their official  publication.  The methods of making such 
reference  shall be  laid down  by the  Member  States. 

This Directive shall enter into force on the seventh day following  its publication  in the Official  Journal of 
the European  Communities. 

Article  3 

This  Directive  is addressed  to the Member States. 

Article  4 

Done  at Brussels, 

For the  European  Parliament 
The  President 

For the Council 
The  President 

1.  The following additives are added to Annex I: 

ANNEX 

E468 
E469 
E1103 
E1451 

Cross linked sodium carboxymethylcellulose 
Enzymatically hydrolysed carboxymethylcellulose 
Invertase 
Acetylated oxidised starch 

2.  The list of  additives and the maximum level  permitted for "jams, jellies  and marmalades as 
defined  in  Directive  79/693/EEC  and  other  similar  fruit  spreads  including  low-calorie 
products" mentioned  in Annex  II is completed  as follows: 

E471  Mono and diglycerides  of  fatty  acids 

I quantum  satis 

3.  The designation of "sterilised pasteurized and UHT cream, low-calorie cream and pasteurised 

low-fat  cream" mentioned in Annex  II is modified  as follows: 

"Plain pasteurized cream" 

4.  The designation of  "Frozen and deep-frozen  unprocessed fruit and vegetables" mentioned in 

Annex II is modified  as follows: 

"Frozen  and  deep-frozen  unprocessed  fruit  and  vegetables;  prepacked,  refrigerated 
unprocessed  fruit and vegetables  ready for consumption " 

5.  The designation of "Non-emulsified  oils and fats of animal or vegetable origin (except virgin 

oils  and olive oils)" mentioned  in Annex II is  modified  as follows: 

"Non-emulsified  oils and fats of animal or vegetable origin (except virgin oils, olive oils, 
oils  and fats for cooking  and frying purposes)" 

6.  The following  table is added to Annex II: 

Sliced  and  grated  ripened 
cheese 

Soured-cream  butter 

El70  Calcium  carbonate 
E504 Magnesium  carbonates 
E509 Calcium  chloride 
E575 Glucono-delta-lactone 
E460  Cellulose 
E500 Sodium  carbonates 

quantum satis 

quantum satis 

7.  The  list  of  additives  and  the  maximum  level  permitted  for  "canned  and  bottled  fruit  and 

vegetables" mentioned  in Annex  II is completed  as follows: 

Canned  and  bottled  fruit  and 
vegetables 

E296 Malic  acid 

quantum satis 

8.  The  list  of  additives  and  the  maximum  level  permitted  for  "Mozzarella and  whey  cheese" 

mentioned  in  Annex  II  is completed  as  follows: 

Mozzarella and  whey  cheese 

E260 Acetic  acid 
E507  Hydrochloric  acid 

quantum satis 

9.  The  list of  additives  and  the maximum  level  permitted  for  "Gehakt" mentioned  in Annex  II 

is completed  as  follows: 

Gehakt 

E300 Ascorbic  Acid 
E301  Sodium  ascorbate 
E302 Calcium  ascorbate 

quantum satis 

10.  The following  foodstuffs  and  the corresponding  maximum  levels: 
"Emulsified  sauces  with  a fat  content  of 60  % or more" 
"Emulsified  sauces  with  a fat  content  of  less than  60 %" 
mentioned  in  Annex  III  part  A are  deleted. 

11.  The following  foodstuffs  and  maximum  levels  mentioned  in  Annex  III part  A are  added: 

Foodstuff 

...Mehu and Makeutettu ... Mehu 
Analogues  of  meat,  fish, 
crustacean,  cephalopods  and 
cheese, based  on  vegetable-
cereal  or mycoprotein 

I Dulce de membrillo 

Marmalada 

Ostkaka 

Pasha 
Cheese  and cheese  analogues 
(surface  treatment  only) 
Cooked  red beet 
Emulsified  sauces  with  a fat 
content  less than  60 % 

Emulsified  sauces  with  a  fat 
content of  60  % or  more 

12.  The designation  "Non-heat-treated  dairy-based  desserts"  in  Annex  III  part  A, in the 

foodstuffs  collumn  is  replaced  by  "Non-sterilised  (including  UHT)  dairy-based  desserts". 

13.  The following  foodstuffs  and maximum  levels  are added to Annex  III part B: 

Foodstuff 

Maximum  level  (mg/kg  ormg/l  as  appropriate) 
Expressed  as  S02 

Cooked  crustaceans  and 
cephalopods 
Marinated  nuts 
Dehydrated  apples  and  pears  with a 
moisture  content  of  more  than  12% 
not  sold  to  the end  consumer 
Analogues  of  meat,  fish,  crustacean, 
cephalopods  and cheese,  based  on 
mycoprotein 

50 mg/kg7 

50  mg/kg 

1500 mg/kg 

200 

14.  The following  foodstuffs  and maximum  levels  are added to the table concerning  food 

additives  E251  and E252  mentioned  in Annex  III part C : 

E251 
E252 

Sodium  nitrate 
Potassium  nitrate 

Foie gras, foie  gras  entier, 
blocs de foie gras 

50 

(4) 

15.  The following  foodstuffs  and maximum  levels  are added to the table concerning  food 

additives E280, E281, E282 and E283  mentioned  in Annex  III part C : 

E280 
E281 
E282 
E283 

Propionic  acid 
Sodium  propionate 
Calcium  propionate 
Potassium  propionate 

Prepacked p0lsebr0d, 
boiler and  flutes 

2000  mg/kg 
expressed  as  propionic 
acid 

16.  The designation  concerning  "dehydrated granulated  potatoes" mentioned  in table of  Annex 

in  part D  in the foodstuffs  collumn is replaced  by  "dehydrated potatoes" 

17.  The designation  "instant tea  powder" contained  in the table of  Annex  IV concerning  E297 
Fumaric acid  is replaced  by  "flavoured  tea and herbal  infusions,  and their instant products" 

in edible parts. 

18.  The table concerning  E 338  to E452  mentioned  in Annex  IV  is  replaced  by  the  following 

table : 

"In  the following  applications  the indicated  maximum  levels  of  phosphoric  acid  and  the  phosphates 
E  338, E 339, E 340, E 341, E343, E 450, E 451  and  E 452  may  be added  individually  or in 
combination  (expressed  as P2Os) 

E338 

Phosphoric  acid 

1  H  339 

Sodium  phosphates 
(i)  Monosodium  phosphate 
(ii)  Disodium  phosphate 
(iii)  Trisodium  phosphate 

E340 

E34I 

E343 

E450 

E451 

E452 

Potassium  phosphates 
(i)  Monopotassium  phosphate 
(ii)  Oipotassium  phosphate 
(iii)  Tripotassium  phosphate 

Calcium  phosphates 
(i)  Monocalcium  phosphate 
(ii)  Dicalcium  phosphate 
(iii)  Tricalcium  phosphate 

Magnesium  phosphates 
(i)  Monomagnesium  phosphate 
(ii)  Dimagnesium  phosphate 

Diphosphates 
(i)  Disodium  diphosphate 
(ii)  Trisodium  diphosphate 
(iii)  Tetrasodium  diphosphate 
(v)  Tetrapotassium  diphosphate 
(vi)  Dicalcium  diphosphate 
(vii)  Calcium  dihydrogen 

diphosphate 

Triphosphates 
(i) 
(ii)  Pentapotassium  triphosphate 

Pentasodium  triphosphate 

Sodium  polyphosphate 

Polyphosphates 
(i) 
(ii)  Potassium  polyphosphate 
(iii)  Sodium  calcium  polyphosphate 
(iv)  Calcium  polyphosphates 

Non-alcoholic flavoured drinks 
Sterilised  and  UHT milk 
Partly  dehydrated  milk  with  less than  28% solids 
Partly  dehydrated  milk  with  more  than  28% solids 
Dried  milk  and  dried  skimmed  milk 
Pasteurised,  sterilised  and  UHT creams 
Whipped  cream  and  vegelable  fat  analogues 
Unripened  cheese  (except  MOZZARELLA  ) 
Processed  cheese  and  processed  cheese  analogues 
Meat  products 
Sport  drinks and  prepared  table  waters 
Dietary  supplements 
Salt  and  its  substitutes 
Vegetable  protein  drinks 
Beverage  whiteners 
Beverage  whiteners  for  vending  machines 
Edible  ices 
Desserts 
Dry  powdered  dessert  mixes 
Fine  bakery  wares 
Flour 
Flour,  self  raising 
SODA  BREAD 
Liquid  egg (white, yolk  or  whole  egg) 
Sauces 
Soups  and  broths 
Tea and  herbal  infusions 
Cider  and  perry 
Chewing  gum 
Dried  powdered  foodstuffs 
Chocolate  and  malt  dairy-based  drinks 
Alcoholic  drinks  (excluding  wine  and  beer) 
Breakfast  cereals 
Snacks 
Surimi 
Fish  and crustacean  paste 
Toppings  (syrups  for  pancakes,  flavoured  syrups  for  milkshakes 
and  ice cream;  similar  products) 
Special  formulae  for  particular  nutritional  uses 
Glazings  for  meat  and  vegetable  products 
Sugar  confectionery 
Icing  sugar 
Noodles 
Batters 
Fillets  of  unprocessed  fish,  frozen  and  deep-frozen 
Frozen  and  deep-frozen  crustacean,  cephalopod  and  mollusc 
products 
Processed  potato  products(including  frozen,  deep-frozen,  chilled  and 
dried  processed  products)  and  pre-fried  frozen  and  deep-frozen 
potatoes 
Spreadable  fats  excluding  butter 
Soured-cream  butter 

700 mg/I 
1  g/1 
1 g/kg 
15  g/kg 
2.5  g/kg 
5  g/kg 
5  g/kg 
2  g/kg 
20  g/kg 
5  g/kg 
0.5  g/1 

quantum  satis 
10 g/kg 
20 g/1 
30  g/kg 
50  g/kg 
1 g/kg 
3  g/kg 
7  g/kg 
20  g/kg 

2.5  g/kg 

20  g/kg 
20  g/kg 
10 g/kg 
5  g/kg 
3  g/kg 
2  g/1 
2 g/ 

quantum  satis 
10g/kg 
2 g/1 
1 g/1 
5  g/kg 
5  g/kg 
1  g/kg 
5  g/kg 

3  g/kg 
5  g/kg 
4  g/kg 
5  g/kg 
10 g/kg 
2  g/kg 
12 g/kg 
5  g/kg 

5  g/kg 

5  g/kg 
5  g/kg 
2  g/kg 

10 

19.  The entry concerning "Minarine" in the table concerning E385 mentioned in Annex 

IV is modified  as follows: 

100 mg/kg 

Spreadable fats as 
defined  in Annex B and 
C of Regulation No 
2991/94(8) having a fat 
content of 41  % or less 

20.  The following  foodstuffs  and maximum levels are added to the table concerning 

E473 and E474 mentioned in Annex IV: 
Sucrose esters of fatty  acids 
Sucroglycerides 

E473 
E474 

Milk and cream 
analogues 
Sterilised cream and 
reduced  fat cream 
Water based  flavoured 
drinks 

5  g/kg 

5  g/kg 

200mg/l 

21.  The entry concerning "Low and very low fat spreads and dressings " in the table 

concerning E476 mentioned in Annex IV is modified  as follows: 

E476 

Polyglycerol  polyricinoleate  Spreadable fats as 

4 g/kg 

defined  in Annex A, B 
and C of Regulation No 
2991/94 having a fat 
content of 41  % or less 
Spreadable fats  with a 
very  low fat content of 
less than  10 % fat 
Dressings 

4  g/kg 

4  g/kg 

22.  The following  foodstuffs  and maximum levels mentioned in the table concerning 

E551 to E559 of Annex IV are added: 

Fats and oils for  frying 
purposes 
Seasonings 
Confectionery  (surface 
treatment only) 

30 g/kg 

30 g/kg 
quantum satis 

23.  The entry concerning "sliced hard cheese and sliced processed cheese" mentioned in 

the table concerning E551 to E559 of Annex IV is modified  as follows: 

10g/kg 

Sliced or grated  hard, 
semi-hard  and processed 
cheese 
Sliced or grated cheese 
analogues and processed 
cheese  analogues 

<8>OJ. L 316 of 09.12.94 p.2 

- 11 

24.  The  following  foodstuff  and  maximum  level  is  added  to  the  table  concerning  E405  mention  in 

Annex  IV: 

E405 

|  Propane-1,2-diol  alginate 

|  cider  (excluding  cidre bouché) 

I  100 mg/1 

25.  The  following  foodstuff  and  maximum  levels  is added  to the table concerning  E900  mention  in 

Annex  IV  are  added: 

E900 

jDimethyl  polysiloxane 

[cider  (excluding  cidre bouché) 

I  10 mg/1 

26.  The  following  foodstuff  and  maximum  level  is added  to the table concerning  E912 and E914 

mentioned  in Annex  IV: 

E912 
E914 

Montanic  acid  esters 
Oxidised  polyethylene  wax 

Fresh  melon,  mango, papaya and 
avocado, surface  treatment  only 

quantum  satis 

27.  The entries  concerning  "Margarine,  Minarine"  mentioned  in the table concerning  E959 of  Annex 

IV  are  modified  as  follows: 

E959 

Neohesperidine  DC 

Spreadable  fats  as defined  in  Annex  B 
and C  of  regulation  No  2991/94 

5  mg/kg 

28.  The  following  foodstuff  and  maximum  levels  is added  to the table concerning  E999  mention  in 

Annex  IV  are  added: 

E999 

Quillaia  extract 

cider  (excluding  cidre bouché) 

200 mg/kg  calculated 
as  anhydrous  extract 

12 

29.  The  following  table  is added  to Annex  IV: 

E905  Microcristalline  wax 

El518  I  Triacetin 

Surface  treatment of 
glazed  rice 

-  confectionery  excluding  chocolate 
- 
-  melons, papaya,  mango and 

chewing  gum 

avocado 

Chewing  gum 

quantum satis 

140 mg/kg 

quantum satis 

30.  The following  entry  is  added  to the table contained  in  annex  V: 

• 

• 

E1451 
E468 

E469 

Acetylated  oxidised  starch 
Cross  linked  sodium 
carboxymethylcellulose 

Enzymatically  hydrolysed  carboxy 
methyl  cellulose 

31.  The  following  entry  is  added  to the  table contained  in  annex  VI part 3: 

El 451 

[Acetylated  oxidised  starch 

|  Weaning  foods 

|  50 g/kg 

32.  The  following  sentence  is added  to Annex  VI part 4: 

"E1450 Starch  sodium  octenyl  succinate  (E1450)  may  be added  up 20 g/kg  to infant  formulae 
for  infants  for  special  medical  purposes  and  for  follow-on  formulae  for  infants  for  special 
medical  purposes." 

13 

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