Proposal for a Directive of the European Parliament and of the Council amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs
Date: 2004-10-11
Institutions: European Commission
Subjects: baby food, dietary product, food additive, food processing, food safety, foodstuffs legislation, human nutrition, preservative, texture agent

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 11.10.2004 
COM(2004) 650 final 

2004/0237 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 95/2/EC on food additives other than colours and sweeteners  
and Directive 94/35/EC on sweeteners for use in foodstuffs 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

AMENDMENT TO DIRECTIVE 95/2/EC 

Directive  95/2/EC  on  food  additives  other  than  colours  and  sweeteners  sets  out  a  list  of 
authorised  food  additives,  the  foodstuffs  in  which  they  may  be  used  and  their  conditions  of 
use. The Directive was adopted in February 1995 and has since been amended five times: in 
1996, 1998, 2000 and twice in 2003.  

It now needs again to be adapted in the light of recent technical and scientific developments. 
The intention of this proposal is to ensure the functioning of the internal market, a high level 
of protection of human health and the protection of consumers’ interests. 

It is proposed to amend the Directive as follows:  

1. Revision of current authorisations 

a) 

Nitrite and nitrate  

Salts of nitrite and nitrate are permitted for use in meat products, cheese and certain 
fish products for preservation. 

Due  to  the  judgement  of  the  Court  of  Justice  in  Case  C-3/00,  Denmark  v. 
Commission,  the  Commission  consulted  the  European  Food  Safety  Authority 
(EFSA) for advice on the current authorisation of nitrite and nitrate in meat products.  

On the basis of the opinion of EFSA, expressed in November 2003, the Commission 
is  now  proposing  changes  to  current  authorisations  in  order  to  keep  the  level  of 
nitrosamines as low as possible by lowering the levels of nitrites and nitrates added 
to food whilst maintaining the microbiological safety of food products.  

EFSA  confirms  that  nitrite  contributes  to  microbiological  safety  and  also  to  the 
flavour, colour and anti-oxidative stability of meat products. Levels up to 100 mg/kg 
of  added  nitrite  might  suffice  for  preservation  of  many  products,  but  some  might 
require up to 150 mg/kg. 

EFSA  notes  that  nitrate  provides  no  direct  protection  against  the  growth  of 
Clostridium  botulinum  in  most  meat  products.  However,  the  use  of  nitrate  as  a 
reservoir  of  nitrite  appears  necessary,  in  particular,  in  traditionally-cured  meat 
products.  

EFSA recommends that the levels of nitrite and nitrate are set down in the legislation 
as  “added  amount”.  EFSA  is  of  the  opinion  that  the  added  amount  of  nitrite  rather 
than the residual amount contributes to the inhibitory activity against C. botulinum. 

Furthermore,  EFSA  is  of  the  opinion  that  monitoring  of  residual  levels  of 
nitrites/nitrates  in  the  final  product  is  of  limited  value.  The  main  reason  is  that  the 
rate of loss of nitrite in a product is dependent on a number of factors including the 
heat process used, the pH of the product, the storage temperature and the addition of 
ascorbic acid or other reducing agents. Consequently, the detection of low levels of 
nitrite  will  give  no  indication  as  to  whether  a  product  was  recently  manufactured 

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with an initial low level of nitrite or was a product that had been stored for several 
months  at  a  low  temperature  with  an  initially  modest  level  of  nitrite,  or  whether  it 
was a product which contained, in addition, ascorbate.  

It is proposed to amend the current provisions in such a way that the maximum levels 
permitted, as mentioned by EFSA, in non-heat-treated or heat-treated meat products, 
in  cheese  and  in  fish  are  set  as  added  amounts.  However,  for  certain  traditionally-
manufactured meat products maximum residual levels should be set.  

b) 

Weaning foods 

Annex  VI  of  Directive  95/2/EC  lays  down  the  provisions  for  the  use  of  food 
additives  in  foods  for  infants  and  young  children.  In  order  to  align  the  wording  on 
foods  for  infants  and  young  children  with  Council  Directive  89/398/EEC  on  the 
approximation of  the  laws of the Member States relating to foodstuffs intended for 
particular  nutritional  uses,  it  is  proposed  that  every  reference  made  to  “weaning 
foods”  shall  be  replaced  by  a  reference  to  “processed  cereal-based  foods  and  baby 
foods”. By this proposal, the Commission has fulfilled its commitment made during 
the adoption of Directive 2003/114/EC amending Directive 95/2/EC. 

c) 

Food supplements and foods for special medical purposes 

The designation of certain food categories in Directive 95/2/EC should be adapted to 
take  into  account  Directive  2002/46/EC  of  the  European  Parliament  and  of  the 
Council  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  food 
supplements  and  Commission  Directive  1999/21/EC  on  dietary  foods  for  special 
medical  purposes.  Therefore,  it  is  proposed  that  every  reference  made  to  “dietary 
food supplements” will be replaced by a reference to “food supplements as defined in 
Directive  2002/46/EC”  and  every  reference  to  “dietetic  foods  intended  for  special 
medical  purposes”  will  be  replaced  by  a  reference  to  “dietary  foods  for  special 
medical purposes as defined in Directive 1999/21/EC”. 

d) 

p-Hydroxybenzoates  

Directive 2003/114 amending Directive 95/2/EC on food additives other than colours 
and sweeteners obliges the Commission and the European Food Safety Authority to 
review  the  conditions  for  the  use  of  E  214  –  219  p-hydroxybenzoates  and  their 
sodium salts before 1 July 2004. 

EFSA  has  assessed  the  information  on  the  safety  of  p-hydroxybenzoates  and 
expressed  its  opinion  on  13  July  2004.  EFSA  established  a  full-group  acceptable 
daily  intake  (ADI)  of  0-10  mg/kg  bw  for  the  sum  of  methyl  and  ethyl  p-
hydroxybenzoic  acid  esters  and  their  sodium  salts.  EFSA  considered  that  propyl 
paraben should not be included in this group ADI because propyl paraben, contrary 
to methyl and ethyl paraben, had effects on sex hormones and the male reproductive 
organs  in  juvenile  rats.  Therefore,  EFSA  was  unable  to  recommend  an  ADI  for 
propyl  paraben  because  of  the  lack  of  clear  no-observed-adverse-effect-level 
(NOAEL).  

It  is  proposed  to  withdraw  E  216  propyl  p-hydroxybenzoate  and  E  217  sodium 
propyl p-hydroxybenzoate from Directive 95/2/EC.  

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In addition, on the basis of the information received, it is proposed to withdraw the 
use of p-hydroxybenzoates in liquid dietary food supplements. 

(e) 

Gelling agents in jelly mini-cups 

In April 2004, the Commission suspended the placing on the market and import of 
jelly  mini-cups  containing  gel-forming  food  additives  derived  from  seaweed  and 
certain gums, due to the risk of choking on these products (Decision 2004/374/EC)1. 
Jelly mini-cups are described as jelly confectionery of a firm consistency, contained 
in semi-rigid mini-cups or mini-capsules, intended to be ingested in a single bite by 
exerting  pressure  on  the  mini-cup  or  mini-capsule  to  project  the  confectionery  into 
the mouth and containing food additives derived from seaweed and or certain gums. 

EFSA has assessed the risk of choking from the presence in jelly mini-cups of gel-
forming additives and expressed its opinion on 12 July 2004. It concludes that “any 
gel-forming  additive  whether derived from seaweed  or  from  non-seaweed origin or 
any other type that gave rise to confectionery product of a similar size, with similar 
physical  and/or  physicochemical  properties  and  that  could  be  ingested  in  the  same 
way as the jelly mini-cups, would give rise to a risk for choking.” 

It  is  proposed  to  withdraw  the  use  of  the  following  gel-forming  food  additives  in 
jelly mini-cups: E 400 alginic acid, E 401 sodium alginate, E 402 potassium alginate, 
E 403 ammonium alginate, E 404 calcium alginate, E 406 agar, E 407 carrageenan, E 
407a processed euchema seaweed, E 410 locust bean gum, E 412 guar gum, E 413 
tragacanth, E 414 acacia gum, E 415 xanthan gum, E 417 tara gum and E 418 gellan 
gum. 

2. Authorisation of new food additives  

a) 

Erythritol 

Erythritol  is  a  four-carbon  sugar  alcohol  (polyol)  that  has  sweetness  approximately 
60-80%  that  of  sucrose.  It  occurs  naturally  in  minor  amounts  in  some  fruits, 
mushrooms, fermented foods and cheese. 

The Scientific Committee on Food (SCF) has assessed the information on the safety 
of erythritol and expressed its opinion on 5 March 2003. The Committee concluded 
that  in  accordance  with  the  Committee’s  earlier  opinion  on  other  polyols  it  is 
considered inappropriate to establish a numerical ADI for erythritol and that the use 
of erythritol as a food additive is acceptable. The Committee also notes that erythritol 
has a laxative effect, but at a higher dose than other polyols. 

Erythritol has many technical non-sweetening properties that are important in a wide 
range of foods, from confectionery to dairy products. These include functions such as 
flavour  enhancer,  carrier,  humectant,  stabiliser,  thickener,  bulking  agent  and 
sequestrant. 

It  is  proposed  to  permit  the  use  of  erythritol  in  the  same  food  applications  as  the 
other currently-permitted polyols. 

1 

OJ L 118, 23.4.2004, p. 70. 

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In  addition,  it  is  proposed  to  amend  Directive  94/35/EC  on  sweeteners  for  use  in 
foodstuffs,  as  erythritol  can  also  be  used  for  sweetening  purposes  like  the  other 
currently-permitted  polyols.  The  fact  that  polyols  have  a  dual  use  was  already 
recognised by the SCF in its evaluation of sweeteners in 1984. 

b) 

4-Hexylresorcinol 

Black spots (melanosis) form on the shell of raw, refrigerated and frozen crustaceans 
within a few hours after harvesting by the action of polyphenol oxidase on naturally-
occurring  colourless  phenols,  resulting  in  coloured  quinones.  These  subsequently 
polymerise  to  insoluble  dark  melanins.  Refrigeration  alone  does  not  prevent  this 
process,  but  only  slows  it  down  as  the  enzyme  remains  active  during  refrigeration, 
ice storage and post-freeze thawing. Sulphites are used to inhibit melanosis. 

The Scientific Committee on Food has assessed the information on the safety of 4-
hexylresorcinol and expressed its opinion in March 2003. The Committee concluded 
that  4-hexylresorcinol  is  toxicologically  acceptable  for  prevention  of  melanosis  in 
crustaceans, provided residues in crustacean meat do not exceed 2 mg/kg. 

It  is  proposed  that  4-hexylresorcinol  can  be  used  as  an  alternative  to  sulphites  for 
preventing browning of crustaceans. France authorised 4-hexylresorcinol temporarily 
for this use under Article 5 of Directive 89/107/EEC. 

c) 

Soybean hemicellulose 

Soybean  hemicellulose  is  refined  water-soluble  polysaccharide  extracted  from  soy 
fibre. Soy fibre is a mixture of cellulosic and non-cellulosic structural components of 
the  internal  cell  wall  of  soybeans.  The  raw  material  from  which  the  soluble 
hemicellulose  is  extracted  is  a  high-fibre-containing  by-product  of  the  soy  oil  and 
soy  protein  production  process.  Soybean  hemicellulose  intended  for  sale  in  the  EU 
will be made from traditional soya, as this is the product which was evaluated by the 
SCF.  

The  Scientific  Committee  on  Food  has  assessed  the  information  on  the  safety  of 
soybean  hemicellulose  and  expressed  its  opinion  in  April  2003.  The  Committee 
concluded that the use of soybean hemicellulose is acceptable in the foods requested 
and  at  the  inclusion  levels  requested.  The  Committee  recommends  that,  in  view  of 
possible  allergenic  potential,  consumers  should  be  informed  that  the  product  is 
derived from soybean. However, as all the products derived from soybean are to be 
labelled  as  laid  down  in  Directive  2003/89/EC  amending  Directive  2000/13/EC  as 
regards  indication  of  the  ingredients  present  in  foodstuffs,  the  Committee’s 
recommendations are already a legal obligation. 

It  is  proposed  to  use  soybean  hemicellulose  as  an  emulsifier  in  sauces,  food 
supplements  and  flavourings,  as  a  thickener  in  bakery  ware  and  in  jelly 
confectionery, as a stabiliser in frozen foods and dairy-based drinks and as an anti-
caking agent in rice and noodles. 

Soybean hemicellulose has the following effects in food. 

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It stabilizes protein particles under acidic conditions. This property together with low 
viscosity is used in the production of acidic dairy beverages, such as yoghurt drinks, 
to obtain good flavour release, smooth feel in the mouth and a light, refreshing taste. 

It  has  strong  emulsifying  and  emulsion-stabilizing  properties.  This  enables 
production of different-flavoured acidic beverages in highly diluted conditions. 

It  is  soluble  in  both  cold  and  hot  water  without  gel  formation  and  has  good  water-
binding capacity. Therefore,  when used  in applications such as baked foods, which 
are  kept  deep-frozen  and  then  heated  by  microwave,  soybean  hemicellulose 
minimizes  damage  caused  by  the  treatment  and  maintains  the  softness  and 
tastefulness  of  the  product,  as  opposed  to  it  becoming  glutinous  and  stiff.  In  non-
fried instant noodles, soybean hemicellulose improves the texture of the dough and 
shortens the cooking time of the noodles. 

It  has  strong  anti-caking  properties.  By  coating  the  surface  of  the  rice  or  noodle 
particle,  soybean  hemicellulose  controls  the  stickiness  of  the  particles  preventing 
them  from  becoming  too  glutinous  and  keeping  their  glossy  appearance,  which 
improves their mixing characteristics with other added ingredients. 

d) 

Ethyl cellulose 

Ethyl cellulose is the ethyl ether of cellulose. It is prepared from wood pulp or cotton 
by  treatment  with  alkali  and  ethylation  of  the  alkali-treated  cellulose  with  ethyl 
chloride.  Ethyl  cellulose  is  already  widely  used  as  a  pharmaceutical  excipient  in 
solid-dosage forms, where it acts as a binder and/or filler substance in tablets. 

The  European  Food  Safety  Authority  has  assessed  the  information  on  the  safety  of 
ethyl cellulose and expressed its opinion in February 2004. The Authority decided to 
include  ethyl  cellulose  in  the  group  ADI  “not  specified”2  for  modified  celluloses 
established by the Scientific Committee on Food. 

The  main  application  of  ethyl  cellulose  is  in  food  supplements  and  encapsulated 
flavourings.  It  is  proposed  that  the  use  of  ethyl  cellulose  would  be  permitted  in  a 
similar way to other celluloses (foodstuffs in general except in those listed in Article 
2(3)) and as a carrier for food additives). 

3. Authorisation for extending the use of authorised food additives 

a) 

Sodium hydrogen carbonate in sour milk cheese 

Sour  milk  cheese  is  ripened  cheese  manufactured  from  sour  milk  quark.  Sour  milk 
quark  is  made  from  pasteurised  low-fat  milk.  During  the  manufacture  of  sour  milk 
cheese, the raw material sour milk quark is first ground in order to obtain a uniform 
mixture.  E  500ii  sodium  hydrogen  carbonate  is  added  to  the  mixture  in  order  to 

2 

ADI  “not  specified”  means  that  on  the  basis  of  the  available  toxicological,  biochemical  and  clinical 
data, the total intake of the substance, arising from its natural occurrence and/or its present use or uses 
in food at the levels necessary to achieve the desired technological effect, will not represent a hazard to 
health. For this reason, the establishment of a numerical limit for the ADI is not considered necessary 
for the substance. 

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buffer  the  lactic  acid  to  a  pH  value  of  around  5,  thereby  creating  the  necessary 
growth conditions for the ripening cultures. It is proposed to allow the use of sodium 
hydrogen carbonate in sour milk cheese. 

b) 

Sorbates and benzoates in crustaceans 

Currently, it is authorised to use a mixture of sorbates (E 200 - 203) and benzoates (E 
210  -  213)  in  cooked  shrimps  for  preservation.  In  addition,  the  use  of  sorbates  is 
allowed  in  cooked  crayfish  tails  and  cooked  pre-packed  marinated  molluscs. 
However,  the  latter  also  requires  the  addition  of  benzoates  for  preservation. 
Therefore, it is proposed to allow the use of a mixture of sorbates and benzoates in 
all cooked crustacean and molluscs, not only in cooked shrimps. 

According to the information contained in the Danish Report on EU Food Additives 
Monitoring (February 2003), the average intake per day of products, such as cooked 
crustaceans and molluscs, is 0.05 g (overestimation). On the basis of the use level of 
1  g  benzoates  per  kilogram,  such  an  intake  would  result  in  0.05  mg  benzoates  per 
day, a negligible contribution to the total consumption of benzoates. 

c) 

Silicon dioxide as a carrier 

E 551 silicon dioxide is permitted as a carrier for food colours at the maximum level 
of 5%. It is proposed to permit the use of silicon dioxide as a carrier for food colours 
E  171  titanium  dioxide  and  E  172  iron  oxides  and  hydroxides  at  the  level  of 
maximum 90% relative to the pigment. This would allow the creation of innovative 
colour  effects  such  as  colour  travel  (colour  changing  by  angle  of  light)  and  colour 
flop  (two  colours  visible  at  the  same  time).  With  this  innovation,  the  number  of 
organic dyes used can be reduced. 

d) 

Additives in traditional Hungarian products 

Directive 95/2/EC limits the use of additives listed in Annex I in traditional French 
bread  “Pain  courant  francais”.  The  same  limited  use  is  proposed  for  similar 
traditional Hungarian bread “Búzakenyér, fehér és félbarna kenyerek.” 

It is also proposed that in Hungarian liver patés (libamáj, libamáj egészben, libamáj 
tömbben) similar to foie gras, ascorbic acid (E 300), sodium ascorbate (E 301) and 
calcium disodium EDTA (E 385) may be used. 

It  is  proposed  to  allow  the  use  of  sorbates  and  benzoates  for  preservation  of 
Hungarian quick-frozen chestnut puree “Gyorsfagyasztott gesztenyepüré”. 

2. 

AMENDMENT TO DIRECTIVE 94/35/EC 

Directive  94/35/EC  on  sweeteners  for  use  in  foodstuffs  sets  out  a  list  of  authorised 
sweeteners,  the  foodstuffs  in  which  they  may  be  used  and  their  conditions  of  use.  The 
Directive was adopted in June 1994 and has been amended twice: in 1996 and 2003.  

It now needs to be adapted in the light of recent technical and scientific developments. The 
intention of this proposal is to ensure the functioning of the internal market, a high level of 
protection of human health and the protection of consumers’ interests. 

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It is proposed to amend the Directive as follows:  

Authorisation of a new food additive erythritol 

Due  to  its  sweetness,  erythritol  may  be  used  for  sweetening  purposes  as  a 
replacement  for  sugar.  It  is  proposed  that  erythritol  may  be  used  in  table  top 
sweeteners and in energy reduced foods and foods with no added sugars. 

In table top sweeteners, erythritol is used at levels where it contributes significantly 
to the sweetness, typically in combinations with intense sweeteners, whereby it also 
serves  as  a  carrier.  The  sensorial  profile-modifying  properties  of  erythritol  are  of 
great  importance  resulting  in  sweetness  synergy,  improved  feel  in  the  mouth  and 
masking  of  unwanted  off-flavours.  In  addition,  erythritol’s  crystalline  structure  and 
density are similar to that of sucrose. 

Permitted  polyols  share  technological  properties  that  have  justified  authorisations 
under  Directive  94/35/EC,  such  as  sweetness,  reduced  caloric  value  and  non-
cariogenicity.  Erythritol  shares  all  these  technical  properties.  In  addition,  it  is  non-
caloric  (0  to  0,2  kcal/g,  other  polyols  2,4  kcal/g)  and  it  has  the  highest  digestive 
tolerance of all polyols. Due to the latter, it is proposed to exempt erythritol from the 
labelling rule regarding labelling of laxative effect in table-top sweeteners containing 
polyols. 

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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. Directive 95/2/EC on food 
additives  other  than  colours  and  sweeteners  was  adopted  on  20  February  1995. 
Directive  94/35/EC  on  sweeteners  for  use  in  foodstuffs  was  adopted  on  30  June 
1994.  They  now  need  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? 

The  use  of  food  additives  in  foodstuffs  is  fully  harmonised  in  the  European 
Community. 

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

Directive 95/2/EC on food additives other than colours and sweeteners and Directive 
94/35/EC  on  sweeteners  for  use  in  foodstuffs  are  based  on  the  principle  of  the 
positive  list.  A  list  of  authorised  food  additives  is  set  out  in  the  Annexes  to  the 
Directives 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 except for the new 
additives  that  are  temporarily  authorised  by  Member  States  for  a  limited  period  of 
two years. 

4. 

What  is  the  most  effective  solution  taking  into  account  the  means  available  to 
the Community and the Member States? 

The use of food additives should be regulated uniformly in the European Community 
to  ensure  a  high  level  of  food  safety  and  free  trade  in  foodstuffs  within  the 
Community. 

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5. 

What practical additional benefit will the proposed measure provide and what 
would be the cost of failure to take action? 

Previously,  the  Scientific  Committee  on  Food  and,  since  July  2003,  the  European 
Food Safety Authority have evaluated the substances to be used as food additives. If 
the  Commission  proposes  the  use  of  these  substances  as  food  additives,  and  the 
European Parliament  and  the  Council adopt the proposal, they can be authorised at 
Community level. If the Commission does not propose the use of these substances, 
they cannot be used in the Community. 

6. 

What form of action is open to the Community? 

A  new  Directive  adopted  by  the  European  Parliament  and  the  Council  under  the 
procedure  laid  down  in  Article  95  is  needed  to  amend  Directive  95/2/EC  and 
Directive 94/35/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. 

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2004/0237 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 95/2/EC on food additives other than colours and sweeteners  
and Directive 94/35/EC on sweeteners for use in foodstuffs 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

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

Having regard to the proposal from the Commission3, 

Having regard to the opinion of the European Economic and Social Committee4, 

After consulting the Scientific Committee on Food and the European Food Safety Authority, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty5, 

Whereas: 

(1) 

(2) 

(3) 

3 
4 
5 
6 

7 

8 

Food additives may be approved for use in foodstuffs only if they comply with Annex 
II 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 consumption6. 

Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 
on food additives other than colours and sweeteners7 lays down a list of food additives 
that may be used in the Community and the conditions for their use. 

Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on 
sweeteners for use in foodstuffs8 lays down a list of sweeteners that may be used in the 
Community and the conditions for their use. 

OJ C […] of […], p. […]. 
OJ C […] of […], p. […]. 
OJ C […] of […], p. […]. 
OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ  L  61,  18.3.1995,  p.  1.  Directive  as  last  amended  by  Directive  2003/114/EC  (OJ  L  24,  29.1.2004, 
p. 58). 
OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive 2003/115/EC (OJ L 24, 29.1.2004, 
p. 65). 

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(4) 

(5) 

(6) 

(7) 

(8) 

There  have  been  technical  developments  in  the  field  of  food  additives  since  the 
adoption of Directives 95/2/EC and 94/35/EC. These Directives should be adapted to 
take account of these developments.  

On  the  basis  of  an  opinion  of  EFSA,  expressed  on  26  November  2003,  changes  are 
made  to  current  authorisations  in  order  to  keep  the  level  of  nitrosamines  as  low  as 
possible  by  lowering  the  levels  of  nitrites  and  nitrates  added  to  food  whilst 
maintaining  the  microbiological  safety of food products. EFSA  recommends that  the 
levels of nitrite and nitrate are set in the legislation as “added amount”. EFSA is of the 
opinion that the added amount of nitrite rather than the residual amount contributes to 
the inhibitory activity against C. botulinum. The current provisions should be amended 
in such a way that the maximum levels permitted, as mentioned by EFSA, in non-heat-
treated or heat-treated meat products, in cheese and in fish are set as added amounts. 
However,  for  certain  traditionally-manufactured  meat  products  maximum  residual 
levels should be set.  

Directive 2003/114 amending Directive 95/2/EC on food additives other than colours 
and  sweeteners  obliges  the  Commission  and  the  European  Food  Safety  Authority  to 
review the conditions for the use of E 214 – 219 p-hydroxybenzoates and their sodium 
salts  before  1  July  2004.  EFSA  has  assessed  the  information  on  the  safety  of  p-
hydroxybenzoates and expressed its opinion on 13 July 2004. EFSA established a full-
group acceptable daily intake (ADI) of 0-10 mg/kg bw for the sum of methyl and ethyl 
p-hydroxybenzoic  acid  esters  and  their  sodium  salts.  EFSA  considered  that  propyl 
paraben should not be included in this group ADI because propyl paraben, contrary to 
methyl  and  ethyl  paraben,  had  effects  on  sex  hormones  and  the  male  reproductive 
organs in juvenile rats. Therefore, EFSA was unable to recommend an ADI for propyl 
paraben because of the lack of clear no-observed-adverse-effect-level (NOAEL). It is 
necessary to withdraw E 216 propyl p-hydroxybenzoate and E 217 sodium propyl p-
hydroxybenzoate from Directive 95/2/EC. In addition, it is necessary to withdraw the 
use of p-hydroxybenzoates in liquid dietary food supplements. 

In  April  2004,  the  Commission  suspended  the  placing  on  the  market  and  import  of 
jelly  mini-cups  containing  gel-forming  food  additives  derived  from  seaweed  and 
certain gums due to risk of choking on these products (Decision 2004/374/EC)9. In the 
light  of  a  review  of  that  Decision  it  is  necessary  to  exclude  the  use  of  certain  gel-
forming food additives in jelly mini-cups. 

The Scientific Committee on Food (SCF) has assessed the information on the safety of 
erythritol and expressed its opinion on 5 March 2003. The Committee concluded the 
use  of  erythritol  as  a  food  additive  is  acceptable.  The  Committee  also  notes  that 
erythritol has a laxative effect, but at a higher dose than other polyols. Erythritol has 
many technical non-sweetening properties that are important in a wide range of foods, 
from  confectionery  to  dairy  products.  These  include  functions  such  as  flavour 
enhancer, carrier, humectant, stabiliser, thickener, bulking agent and sequestrant. It is 
necessary  to  permit  the  use  of  erythritol  in  the  same  food  applications  as  the  other 
currently permitted polyols. In addition, it is necessary to amend Directive 94/35/EC, 
as  erythritol  can  also  be  used  for  sweetening  purposes  like  the  other  currently-

9 

OJ L 118, 23.4.2004, p. 70. 

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permitted  polyols.  It  is  also  necessary  to  exempt  erythritol  from  the  labelling  rule 
regarding labelling of laxative effect in table-top sweeteners containing polyols. 

(9) 

The  Scientific  Committee  on  Food  has  assessed  the  information  on  the  safety  of 
soybean  hemicellulose  and  expressed  its  opinion  on  4  April  2003.  The  Committee 
concluded that the use of soybean hemicellulose is acceptable certain foods requested 
and at certain inclusion levels. It is therefore appropriate to permit such use for certain 
purposes. 

(10)  The  European  Food  Safety  Authority  has  assessed  the  information  on  the  safety  of 
ethyl cellulose and expressed its opinion on 17 February 2004. The Authority decided 
to  include  ethyl  cellulose  in  the  group  ADI  “not  specified”  for  modified  celluloses 
established  by  the  Scientific  Committee  on  Food.  The  main  application  of  ethyl 
cellulose  is  in  food  supplements  and  encapsulated  flavourings.  The  use  of  ethyl 
cellulose should therefore be permitted in a similar way as other celluloses. 

(11)  During  the  manufacture  of  sour  milk  cheese,  E  500ii  sodium  hydrogen  carbonate  is 
added  to  the  pasteurised  milk  in  order  to  buffer  the  lactic  acid  to  an  appropriate  pH 
value, thereby creating the necessary growth conditions for the ripening cultures. It is, 
therefore,  appropriate  to  permit  the  use  of  sodium  hydrogen  carbonate  in  sour  milk 
cheese. 

(12)  Currently, it is authorised to use a mixture of sorbates (E 200 - 203) and benzoates (E 
210  -  213)  in  cooked  shrimps  for  preservation.  It  is  appropriate  to  extend  that 
authorisation to its use in all cooked crustaceans and molluscs. 

(13)  E 551 silicon dioxide is permitted as a carrier for food colours at the maximum level 
of 5%. The use of silicon dioxide as a carrier for food colours E 171 titanium dioxide 
and  E  172  iron  oxides  and  hydroxides  should  also  be  permitted  at  the  level  of 
maximum 90% relative to the pigment.  

(14)  Directive  95/2/EC  limits  the  use  of  additives  listed  in  Annex  I  to  that  Directive  in 
traditional French bread “Pain courant francais”. The same limitattion should apply to 
similar traditional Hungarian bread. It is also appropriate to authorise use of ascorbic 
acid  (E  300),  sodium  ascorbate  (E  301)  and  calcium  disodium  EDTA  (E  385)  in 
Hungarian  liver  patés.  It  is  necessary  to  allow  the  use  of  sorbates  and  benzoates  for 
preservation of Hungarian quick-frozen chestnut puree. 

(15) 

In  accordance  with  a  request  from  a  Member  State  and  the  opinion  of  the  Scientific 
Committee  on  Food  of  5  March  2003,  4-hexylresorcinol,  which  was  authorised  at 
national level under Directive 89/107/EEC, should be authorised at Community level.  

(16)  The  terminology  used  in  Directive  95/2/EC  should  be  adapted  to  take  into  account 
Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the 
Member  States  relating  to  foodstuffs  intended  for  particular  nutritional  uses10, 
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 
on the approximation of the laws of the Member States relating to food supplements11 

10 
11 

OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003. 
OJ L 183, 12.7.2002, p. 51.  

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and Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special 
medical purposes12. 

(17)  Directives 95/2/EC and 94/35/EC should, therefore, be amended accordingly. 

HAVE ADOPTED THIS DIRECTIVE: 

Directive 95/2/EC is amended as follows: 

Article 1 

(1) 

In  paragraph  2  of  Article  3  the  words  ‘weaning  foods’  are  replaced  by  the  words 
‘processed cereal-based foods and baby foods’. 

(2) 

The Annexes are amended in accordance with Annex I to this Directive. 

Directive 94/35/EC is amended as follows: 

Article 2 

(1) 

In Article 5(2) the word “polyols” are replaced by the words “ polyols except E 968 
erythritol”. 

(2) 

The Annex is amended in accordance with Annex II to this Directive. 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive in order to: 

Article 3 

(a)  permit  trade  in  and  the  use  of  products  complying  with  this  Directive  by  [18 
months after entry into force] at the latest, 

prohibit trade in and use of products which do not comply with this Directive 

(b) 
by [24 months after entry into force] at the latest. 

However,  products  placed  on  the  market  or  labelled  before  that  date  referred  to  in 
point (b) which do not comply with this Directive may be marketed until stocks are 
exhausted. 

2. 

When  Member  States  adopt  those  measures,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

12 

OJ L 91, 7.4.1999, p. 29. Directive as amended by the Act of Accession of 2003. 

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Article 4 

1. 

Member States shall adopt and publish, by […] at the latest, the laws, regulations and 
administrative  provisions  necessary  to  comply  with  this  Directive.  They  shall 
forthwith  communicate  to  the  Commission  the  text  of  those  provisions  and  a 
correlation table between those provisions and this Directive. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 5 

Article 6 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I 

The Annexes to Directive 95/2/EC are amended as follows:  

(1) 

Annex I is amended as follows: 

(a) 

In the introductory note, the following note 4 is added: 

“4. 

The substances listed under numbers E 400, E 401, E 402, E 403, E 404, E 406, E 
407, E 407a, E 410, E 412, E 413, E 414, E 415, E 417 may not be used in jelly mini-
cups (*) 

_______________ 
(*) For the purpose of this Directive, jelly mini-cups means jelly confectionery of a 
firm consistence, contained in semi-rigid mini-cups or mini-capsules, intended to be 
ingested  in  a  single  bite  by  exerting  pressure  on  the  mini-cups  or  mini-capsule  to 
project the confectionery into the mouth. 

(b) 

In the table, the following row is inserted: 

“E 462 

(2) 

(a) 

Ethyl cellulose” 

Annex II is amended as follows: 

The row for “ripened cheese” is replaced by the following:  

‘Ripened cheese 

E 170 Calcium carbonate 
E 504 Magnesium carbonates
E 509 Calcium chloride 
E 575 Glucono-delta-lactone 
E 500ii Sodium hydrogen 
carbonate 

quantum satis 

quantum  satis  (only  for  sour 
milk cheese)’ 

(b) 

(c) 

(3) 

(a) 

(i) 

In  the  row  for  ‘Pain  courant  français’  after  the  words  ’Pain  courant  français’  the 
following words are added: ’Búzakenyér, fehér és félbarna kenyerek’. 

In the row for ’Foie gras, foie gras entier, blocs de foie gras‘ after the words ’Foie 
gras, foie gras entier, blocs de foie gras‘ the following words are added: “Libamáj, 
libamáj egészben, libamáj tömbben‘.  

Annex III is amended as follows: 

Part A is amended as follows: 

In  the  table  “Sorbates,  benzoates  and  p-hydroxybenzoates”,  the  rows  for  “E  216 
Propyl  p-hydroxybenzoate”  and  “E  217  Sodium  propyl  p-hydroxybenzote”  are 
deleted. 

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(ii) 

The table for foodstuffs is amended as follows:  

–  The following rows are deleted: 

2000 

‘Shrimps, cooked 

Crayfish 
tails, 
cooked,  and  pre-
packed  marinated 
cooked molluscs 

Liquid dietary food 
supplements 

–  The following rows are added:  

1000 

‘Crustacean 
molluscs, cooked 

and 

Food  supplements 
as 
in 
defined 
Directive 
2002/46/EC 
(*) 
supplied  in  liquid 
form 

Gyorsfagyasztott 
gesztenyepüré 

_______________ 

2000 

2000 

2000 

1000’ 

2000’ 

(*) Directive 2002/46/EC of the European Parliament and of the Council (OJ L 183, 
12.7.2002, p. 51).’ 

(iii) 

The words ‘Dietetic food intended for special medical purposes’ are replaced by the 
words  ‘Dietary  foods  for  special  medical  purposes  as  defined  in  Directive 
1999/21/EC (**) 

_______________ 
(**) Commission Directive 1999/21/EC (OJ L 91, 7.4.1999, p. 29).’ 

(b) 

In  Part  C  the  rows  for  E  249  and  E  250  and  the  rows  for  E  251  and  E  252  are 
replaced by the following:  

‘E No  Name 

Foodstuff 

Maximum  level  that 
may  be  added  during 
the manufacturing 

‘E 249  Potassium nitrite*  Meat products 

150 mg/kg 

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17 

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E 250 

Sodium nitrite* 

Sterilised  meat  products 
3.00)** 

(Fo  > 

100 mg/kg 
expressed as NaNo2 

Wiltshire cured bacon and ham 

Dry cured bacon and ham 

Cured tongue, jellied veal, brisket 

E 251 

Sodium nitrate 

Non-heat-treated meat products 

E 252 

Potassium nitrate 

Wiltshire cured bacon and ham 

Dry cured bacon and ham 

Cured tongue, jellied veal, brisket 

E 251 

Sodium nitrate 

Hard, semi-hard and semi-soft cheese 

E 252 

Potassium nitrate 

Dairy-based cheese analogue 

Pickled herring and sprat 

175  mg/kg 
residue 

as 

a 

175  mg/kg 
residue 

as 

a 

10 mg/kg as a residue 
expressed as NaNo2 

150 mg/kg  
expressed as NaNo3 

250  mg/kg 
residue 

as 

a 

250  mg/kg 
residue 

as 

a 

10 mg/kg as a residue 
expressed as NaNo3 

150 mg/kg in cheese 
milk 

150 mg/kg in cheese 
milk 

500 mg/kg 
expressed as NaNo3’ 

*  When  labelled  “for  food  use”,  nitrite  may  only  be  sold  in  a  mixture  with  salt  or  a  salt 
substitute. 

** Fo-value 3 is equivalent to 3 min heating at 121ºC (reduction of the bacterial load of one 
billion spores in each 1000 cans to one spore in a thousand cans).’ 

(c) 

In Part D the following row is added:  

‘E 586 

4-hexylresorcinol 

Fresh, frozen and deep-frozen 
crustaceans 

2 mg/kg as residues 
in crustacean meat’ 

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(4) 

(a) 

‘E 385 

Annex IV is amended as follows: 

The row for E 385 is replaced by the following: 

Calcium disodium 
ethylene diamine 
tetra-acetate 
(Calcium disodium 
EDTA) 

Emulsified sauces 

75 mg/kg  

Canned and bottled 
pulses, legumes, 
mushrooms and 
artichokes 

Canned and bottled 
crustaceans and 
molluscs 

250 mg/kg 

75 mg/kg 

Canned and bottled 
fish 

75 mg/kg 

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

100 mg/kg 

Frozen and deep- 
frozen crustaceans 

75 mg/kg 

Libamáj, egészben es 
tömbben 

250 mg/kg 

* OJ L 316, 9.12.1994, p. 2.’ 

b) 

The following row is inserted after the row for E 967: 

‘E 968 

Erythritol 

Foodstuffs 
drinks 
referred to in Article 2(3)) 

in  general 
those 

and 

(except 
foodstuffs 

and 

Frozen 
unprocessed 
molluscs and cephalopods 

fish, 

deep-frozen 
crustaceans, 

quantum satis 

quantum satis 

Liqueurs 

quantum satis 

For  purposes  other 
than sweetening 

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(c) 

The following row is added: 

‘E 426 

Soybean 
hemicellulose 

Dairy-based drinks 

5 g/l 

Food  supplements  as  defined  in 
Directive 2002/46/EC 

1,5 g/kg 

Emulsified sauces 

Bakery ware 

Noodles 

Rice 

Processed potato and rice products 
frozen,  deep-frozen, 
(including 
chilled 
processed 
products) 

dried 

and 

30 g/l 

10 g/kg 

10 g/kg 

10 g/kg 

10 g/kg 

Pre-fried  frozen  and  deep-frozen 
potatoes 

10 g/kg 

Dehydrated,  concentrated,  frozen 
and deep-frozen egg products 

10 g/kg 

Jelly  confectionery,  except  jelly 
mini-cups 

10 g/kg 

Flavourings 

1,5 g/kg 

(d) 

(e) 

(f) 

(5) 

(a) 

In row E 468 the words ‘Solid dietary supplements’ are replaced by the words ‘Food 
supplements as defined in Directive 2002/46/EC supplied in solid form’. 

In row E 416, row E 432 to E 436, row E 473 and E 474, row E 475, row E 491 to E 
495, row E 551 to E 559, row E 901 to E 904, and row E 1201 and E 1202 the words 
‘Dietary food supplements’ are replaced by the words ‘Food supplements as defined 
in Directive 2002/46/EC’. 

In row E 405, row E 432 to E 436, row E 473 and E 474, row E 475, row E 477, row 
E 481 and E 482, row E 491 to E 495 the words ‘Dietetic food intended for special 
medical  purposes’  are  replaced  by  the  words  ‘Dietary  foods  for  special  medical 
purposes as defined in Directive 1999/21/EC’. 

Annex V is amended as follows: 

The following row is inserted after the row for E 967: 

‘E 968 

Erythritol’ 

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(b) 

The following row is inserted after the row for E 466: 

‘E 462 

Ethyl cellulose’ 

(c) 

In the third column of the row for E 551 and E 552 the following sentence is added: 

’For E 551, in E 171 titanium dioxide and E 172 iron oxides and hydroxides (max. 
90% relative to the pigment).’ 

(6) 

(a) 

(b) 

Annex VI is amended as follows: 

In the first, second and third paragraph of the introductory note the words ‘weaning 
foods’ are replaced by the words ‘processed cereal-based foods and baby foods’. 

In Part 3, in the title, in row E 170 to 526, row E 500, E 501 and E 503, row E 338, 
row  E  410  to  E  440,  row  E  1404  to  E  1450  and  row  E  1451  the  words  ‘weaning 
foods’ are replaced by the words ‘processed cereal-based foods and baby foods’. 

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The Annex to Directive 94/35/EC is amended as follows: 

ANNEX II 

(a) 

(b) 

In the first column of the row for E 420 to E 967, the word ‘E 968’ is added. 

In the second column of the row for E 420 to E 967, the word “Erythritol” is added. 

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