Amended 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 (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2003-10-09
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuff, foodstuffs legislation, human nutrition

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 9.10.2003
COM(2003) 583 final

2002/0274 (COD)

Amended 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

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

EXPLANATORY MEMORANDUM

1.

PROCEDURE

On  29  November  2002,  the  Commission  adopted  a  proposal  for  a  Directive  of  the
European  Parliament  and  Council  amending  Directive  95/2/EC  on  food  additives
other  than  colours  and  sweetenersA.  The  proposal  was  sent  to  the  European
Parliament  and  the  Council  on  the  same  day.  The  European  Economic  and  Social
Committee issued its opinion supporting the Commission proposal on 14 May 2003.

On 25 June 2003, Coreper agreed unanimously on a revised text.

On 3 July 2003, the European Parliament voted in favour of amendments in line with
the revised text resulting from Coreper.

As  there  is  agreement  between  the  European  Parliament  and  the  Council,  it  is  the
intention  of  the  Council  to  adopt  the  proposal  as  an  A  point  during  the  Italian
presidency.

2.

OBJECTIVE OF THE COMMISSION PROPOSAL

The Commission proposed to amend Directive 95/2/EC as follows:

– 

– 

– 

– 

– 

To authorise a new food additive

To withdraw the authorisation for the use of some food additives

To extend the authorisations for use of some already authorised food additives

To clarify the scope of the functional class “stabilisers”

To harmonise the use of food additives in flavourings at Community level.

3.

COMMISSION  OPINION  ON  THE  AMENDMENTS  ADOPTED  BY  THE  EUROPEAN
PARLIAMENT

The  Commission  can  accept  all  the  amendments  adopted  by  the  European
Parliament.

4.

CONCLUSION

Having  regard  to  Article  250  paragraph  2  of  the  EC  Treaty,  the  Commission
modifies its proposal as follows:

A

COM(2002) 662 final - 2002/0274 (COD)

2

                                                
2002/0274 (COD)

Amended 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

(Text with EEA relevance)

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 Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty3,

Whereas:

(1)

(2)

(3)

(4)

1

2

3

4

5

6

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 consumption4.

Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995
on food additives other than colours and sweeteners5 lays down a list of food additives
that may be used in the Community and the conditions for their use.

There  have  been  technical  developments  in  the  field  of  food  additives  since  the
adoption  of  Directive  95/2/EC.  That  Directive  should  be  adapted  to  take  account  of
those developments.

Council Directive 88/388/EEC of  22  June 1988 on the approximation of the  laws  of
the Member States relating to flavourings for use in foodstuffs and to source materials
for their production6 provides for the adoption of a list of additives necessary for the
storage and use of flavourings, and the adoption of any special conditions for the use
of  such  additives  that  may  be  necessary  for  the  protection  of  public  health  and  to
ensure fair trade.

COM(2002) 662 final - 2002/0274 (COD)OJ C , , p. .
NAT/173 – CESE 581/2003OJ C , , p. .
[…]
OJ L 40, 11.2.1989, p. 27. Directive as amended by Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).
OJ L 61, 18.3.1995, p. 1. Directive as last amended by Directive 2001/5/EC (OJ L 55, 24.2.2001, p. 59).
OJ  L  184,  15.7.1988,  p.  61.  Directive  as  amended  by  Commission  Directive  91/71/EEC  (OJ  L  47,
15.2.1991, p. 25).

3

                                                
(5)

It  is  desirable  to  incorporate  into  Directive  95/2/EC  those  measures  on  additives
necessary for the storage and use of flavourings, in order to contribute to transparency
and  consistency  of  Community  legislation,  and  to  facilitate  compliance  with
Community legislation on  food additives by food  manufacturers,  especially  by  small
and medium size enterprises. In addition, according to Regulation (EC) No 178/2002
of  the  European  Parliament  and  of  the  Council  of  28  January  2002  laying  down  the
general  principles  and  requirements  of  food  law,  establishing  the  European  Food
Safety  Authority  and laying  down  procedures  in  matters  of  food  safety7,  flavourings
fall within the definition of ‘food’.

(6) While  the  use  of  additives  which  are  necessary  to  ensure  the  safety  and  quality  of
flavourings  and  to  facilitate  their  storage  and  use  should  be  authorised,  the  levels  of
additives present in such flavourings should be the minimum required to achieve the
intended  purpose.  In  addition,  consumers  should  be  guaranteed  correct,  adequate
and non-misleading information not be misled on the use of additives.

(7)

(8)

(9)

The presence of an additive in a foodstuff, due to the use of a flavouring, is generally
low and the additive does not have a technological function in the foodstuff. However,
if under  certain circumstances the  additive  does have  a  technological  function  in  the
compound foodstuff, it should be considered as an additive of the compound foodstuff
and not as an additive of the flavouring, and the relevant rules relating to the additive
in  the  particular  foodstuff  should  apply,  including  the  labelling  rules  laid  down  in
Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  of  20  March
2000 on the approximation of the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs8.

Food  manufacturers  should  be  informed  about  the  concentrations  of  all  additives  in
flavourings in order to enable them to comply with Community legislation. This is in
accordance with Directive 88/388/EEC, which requires quantitative  labelling of each
component  subject  to  a  quantitative  limitation  in  a  foodstuff.  A  quantitative
limitation is expressed either numerically or by the "quantum satis" principle.

In accordance with the principle of proportionality, it is necessary and appropriate for
the  achievement  of  the  basic  objective  of  ensuring  market  unity  and  a  high  level  of
consumer  protection  to  lay  down  rules  on  the  use  of  additives  in  flavourings.  This
Directive confines itself to what is necessary in order to achieve the objectives pursued
in accordance with the third paragraph of Article 5 of the Treaty.

(10)

In  accordance  with  a  request  from  a  Member  State  and  the  opinion  of  the  Scientific
Committee  on  Food,  established  under  Commission  Decision  97/579/EC9,
hydrogenated  poly-1-decene,  which  was  authorised  at  national  level  under  Directive
89/107/EEC, should be approved at Community level.

(11) Biphenyl (E 230), orthophenyl phenol (E 231) and sodium orthophenyl phenol (E 232)
are listed as preservatives in and on citrus fruits in Directive 95/2/EC. However, they
fall under the definition of plant protection products in Council Directive 91/414/EEC

7

8

9

OJ L 31, 1.2.2002, p. 1.
OJ  L  109,  6.5.2000,  p. 29.  Directive  as  amended  by  Commission  Directive  2001/101/EC  (OJ  L  310,
28.11.2001, p.19).
OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision 2000/443/EC (OJ L 179, 18.7.2000, p.
13).

4

                                                
of 15 July 1991 concerning the placing of plant  protection products on the  market10.
Therefore,  they  should  no  longer  come  within  the  scope  of  Directive  95/2/EC.  The
Member States and the Commission should take all possible steps to ensure that
there is no legal vacuum with regard to these substances. Authorisation for these
substances  as  plant  protection  products  should  be  dealt  with  as  swiftly  as
possible.

(12)      On  4  April  2003,  the  Scientific  Committee  on  Food  stated  that  the  temporary
acceptable daily intake for E 214 to E 219 p-hydroxybenzoic acid alkyl esters and
their  sodium  salts  should  be  withdrawn  if  no  further  data  are  submitted  in
respect to intake and toxicity.

(13) Directive 95/2/EC should therefore be amended accordingly.

(14) Council  Directive  67/427/EEC11  lays  down  the  control  measures  on  preservatives  in
and on citrus fruits. Since those preservatives are no longer authorised for use in citrus
fruits by Directive 95/2/EC, it is necessary to repeal that Directive.

(15)

The Scientific Committee  on Food has been consulted on the  adoption of  provisions
liable  to  have  an  effect  on  public  health,  pursuant  to  Article  6  of  Directive
89/107/EEC,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 95/2/EC is amended as follows:

(1)

In Article 1(3), point (v) is replaced by the following:

“(v)  ‘stabilisers’  are  substances  which  make  it  possible  to  maintain  the  physico-
chemical  state  of  a  foodstuff;  stabilisers  include  substances  which  enable  the
maintenance of a homogenous dispersion of two or more immiscible substances in a
foodstuff,  substances  which  stabilise,  retain  or  intensify  an  existing  colour  of  a
foodstuff and substances which increase the binding capacity of the food, including
the  formation  of  cross-links  between  proteins  enabling  the  binding  of  food  pieces
into re-constituted food.”

(2)          The following paragraphs are inserted after Article 2 (8):

“9. For E 231 orthophenyl phenol and E 232 sodium orthophenyl phenol, point
(4)(a)  of  the  Annex  shall  enter  into  force  as  soon  as  requirements  for  the
labelling of food treated with these substance(s) become applicable by virtue of
Community legislation on maximum residue limits for pesticides.

10.  Before  1  July  2004,  the  Commission  and  the  European  Food  Safety
Authority shall review the conditions for the use of the additives E 214 to E 219.

10

11

OJ  L  230,  19.8.1991,  p.  1.  Directive  as  last  amended  by  Commission  Directive  2002/64/EC  (L  189,
18.7.2002, p. 27).
OJ L 148, 11.7.1967, p. 1.

5

                                                
11. Within 2 years after entry into force of this Directive, the Commission shall
submit to the European Parliament and the Council a report on the progress of
the  re-evaluation  of  additives.  This  re-evaluation  shall  in  particular  focus  on
E 432  to  E 436  (polysorbates)  as  well  as  E 251  and  E 252  (nitrates)  and  E 249
and E 250 (nitrites)."

(3)(2) Article 3(1) is replaced by the following:

“1. The presence of a food additive in a foodstuff is permissible:

(a)

(b)

in a compound foodstuff other than one mentioned in Article 2 (3) to the
extent that the food additive is permitted in one of the ingredients of the
compound foodstuff;

in  a  foodstuff  where  a  flavouring  has  been  added  to  the  extent  that  the
food  additive  is  permitted  in  the  flavouring  in  compliance  with  this
Directive  and  has  been  carried  over  to  the  foodstuff  via  the  flavouring,
provided  the  food  additive  has  no  technological  function  in  the  final
foodstuff; or

(c)

if  the  foodstuff  is  destined  to  be  used  solely  in  the  preparation  of  a
compound foodstuff  and  to  an  extent  such  that  the  compound  foodstuff
conforms to the provisions of this Directive.”

(4)          The following paragraph is inserted after Article 3 (2):

“3. As regards additives in flavourings, the level of additives shall be limited to
the minimum necessary to guarantee the safety and quality of flavourings and
to facilitate their storage. Furthermore, the presence of additives in flavourings
must not mislead the consumer and shall not present a hazard to the health of
consumers. If the presence of an additive in a food, as a consequence of adding
flavourings, has a technological function in the food, it shall be considered as an
additive of the food and not as an additive of the flavouring.”

(5)(3)

The Annexes are amended as set out in the Annex to this Directive.

Directive 67/427/EEC is repealed.

Article 2

Article 3

Member States shall bring into forceadopt and publish, before […], the laws, regulations
and  administrative  provisions  necessary  to  comply  with  this  Directive  in  order  to:.  They
shall forthwith inform the Commission thereof.

They shall apply those provisions in such a way that:

– 

authorise  trade  in  and  use  of  products  conforming  with  this  Directive  by  [18
months after entry into force] at the latest,

6

(a)          trade  in  and  use  of  products  which  comply  with  this  Directive  are  permitted

from [18 months after entry into force];

– 

prohibit trade in and use of products not conforming with this Directive by [24
months  after  entry  into  force]  at  the  latest;  however,  products  placed  on  the
market or labelled before that date which do not comply with this Directive may
be marketed until stocks are exhausted.

(b)          trade  in  and  use  of  products  which  do  not  comply  with  this  Directive  are

prohibited from [24 months after entry into force].

However, products put on the market or labelled before the date specified  in point  (b)
and  which  do  not  comply  with  this  Directive  may  be  marketed  until  stocks  of  such
products are exhausted.

They shall inform the Commission thereof.

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.

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

Article 4

Article 5

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

7

ANNEX

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

(1)

In Annex I:

(a) Note 2 is replaced by the following:

‘2.  The  substances  listed  under  numbers  E  407,  E  407a  and  E  440  may  be
standardised  with  sugars,  on  condition  that  this  is  stated  in  addition  to  the  number
and designation.’

(b)  in  the  list  of  additives,  the  entry  for  E  170  is  replaced  by  “E  170  Calcium
carbonate”. the following is deleted: ‘(ii) Calcium hydrogen carbonate’

(c) in the list of additives, for E 466 the name  “Cellulose gum”  is added and for E
469 the name “Enzymatically hydrolysed cellulose gum” is added.

(2)

In Annex II:

(a) the following is added to the list of additives and the maximum levels concerning
‘Cocoa and chocolate products as defined in Directive 2000/36/EC73/241/EEC’:

‘E  472c  Citric  acid  esters  of
mono-  and  diglycerides  of
fatty acids

Quantum satis’

(b)  the  following  is  inserted  in  the  list  of  additives  and  the  maximum  level  for
‘Frozen  and  deep-frozen  unprocessed  fruit  and  vegetables;  prepacked,  refrigerated
unprocessed fruit and vegetables ready for consumption and prepacked, unprocessed
and peeled potatoes’:

‘ E 296 Malic acid

Quantum 
satis 
peeled potatoes)’

(only 

for

(c) the following is added to the list of  additives  and the  maximum level for ‘Fruit
compote’:

‘ E 440 Pectin

E 509 Calcium chloride

quantum  satis  (only  for  fruit
compote other than apple)’

(d)  the  following  is  inserted  in  the  list  of  additives  and  the  maximum  level  for
‘Mozzarella and whey cheese’:

‘ E 460ii Powdered cellulose

quantum 
for
satis 
grated  and  sliced  cheese
Mozzarella)’

(only 

8

(e) the following rows are added at the end of the Annex:

‘UHT goat milk

E 331 Sodium citrates

4 g/l

Chestnuts in liquid

E 410 Locust bean gum

Quantum satis’

E 412 Guar gum

E 415 Xanthane gum

(f)  the  entries  “  E 170  Calcium  carbonates”  shall  be  read  “E 170  Calcium
carbonate”.

(3)

In Part A of Annex III:

(a) the designation ‘Partially baked, pre-packed bakery wares intended for retail sale’
is replaced by the following: ‘Partially baked, pre-packed bakery wares intended for
retail sale and energy-reduced bread intended for retail sale’

(b) at the end of this Part, the following rows are added:

2000

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

‘Flavourings

Dairy or fat based
spreads with added
foodstuffs

1500’

(4)

In Part C of Annex III:

1500’

(a) the following rows are deleted:

‘E 230

Biphenyl, diphenyl

Surface treatment of citrus fruit

70 mg/kg

E 231

Orthophenyl phenol

Surface treatment of citrus fruit

E 232

Sodium  orthophenyl
phenol

12 mg/kg
individually or in
combination
expressed as
orthophenyl phenol’

9

(b) the following foodstuff is added to E 1105:

‘E 1105

Lysozyme

in 

Wine 
accordance  with
Regulation  (EC)  No  1493/199912
and  its  implementing  Regulation
(EC) No 1622/200013

Pro memoria’

(5)

In Part D of Annex III:

(a) the following foodstuffs and maximum levels are added to E 310, E 311, E 312
and E 320:

‘E 310

Propyl gallate

Essential oils

E 311

Octyl gallate

E 312

Dodecyl gallate

E 320

Butylated
hydroxyanisole
(BHA)

Flavourings other than essential
oils

1000 mg/kg (gallates
and BHA,
individually or in
combination)

100 mg/kg (gallates,
individually or in
combination) or
200 mg/kg (BHA)’

(b)  in  the  list  of  foodstuffs  concerning  E  315  and  E  316,  the  designation  ‘Semi-
preserved  and  preserved  meat  products’  is  replaced  by  the  following:  ‘Cured  meat
products and preserved canned meat products’

(6)

In Annex IV:

(a) the following foodstuff and maximum level concerning E 338 to E 452 are added:

‘Flavourings

4050 g/kg’

(b)  the  following  foodstuff  and  maximum  level  concerning  E  338  to  E  452  are
deleted:

‘Cider and perry

2 g/l’

(c) the following foodstuff and maximum level are added to E 416:

‘E 416

Karaya gum

Flavourings

50 g/kg’

(d)  the  following  foodstuffs  and  maximum  levels  concerning  E  432  to  E  436  are
added:

‘Flavourings,  except  liquid  smoke
flavourings  and  flavourings  based

10 g / kg

12

13

OJ L 179, 14.4.1999, p.1.
OJ L 194, 31.7.2000, p.1.

10

                                                
on spice oleoresins*

Foods  containing  Lliquid  smoke
flavourings  and  flavourings  based
on spice oleoresins

175 g/kg’

* Spice oleoresins are defined as extracts of spices from which the extraction solvent
has been evaporated leaving a mixture of the volatile oil and resinous material from
the spice’

(e) the following foodstuffs and maximum levels concerning E 444 are added:in
the  list  of  foodstuffs  concerning  E  541,  the  designation  ‘Fine  bakery  wares
(scones  and  sponge  wares  only)’  is  replaced  by  the  following:  ‘Fine  bakery
wares’

‘Flavoured cloudy spirit drinks
containing less than 15 %
alcohol by volume

300 mg/l

(f) the following foodstuff and maximum level concerning E 551 to E 559 are added:

‘Flavourings

50 g / kg (only E
551)’

(g) the following foodstuff and maximum level are added to E 900:

‘E 900

Dimethyl
polysiloxane

Flavourings

10 mg/kg’

(h) in the list for foodstuffs and maximum levels for E 903, the maximum levels are
replaced by the following:

‘E 903

Carnauba wax

As glazing agents only:

- confectionery (including
chocolate)

.

500 mg/kg

1200 mg/kg (only for
chewing gum)

- small products of fine bakery
wares coated with chocolate

200 mg/kg

200 mg/kg

200 mg/kg

200 mg/kg

200 mg/kg

200 mg/kg’

- snacks

- nuts

- coffee beans

- dietary food supplements

- fresh citrus fruits, melons,
apples, pears, peaches and
pineapples (surface treatment

11

only)

(i) the following foodstuffs and maximum levels are added to E 459:

‘E 459

Beta-cyclodextrin

Encapsulated flavourings in

-  flavoured  teas  and  flavoured
powdered instant drinks

500 mg/l0,5 g/kg

- flavoured snacks

1 g/kg

in foodstuffs as
consumed or as
reconstituted
according to the
instructions of the
manufacturer’

2 g/kg

2 g/kg

3 g/kg from all
sources in foodstuffs
as consumed or as
reconstituted
according to the
instructions of the
manufacturer;
individually or in
combination. In the
case of beverages,
the maximum level
of E 1520 shall be
1g/l.

(j) the following row is added at the end of the Annex:

‘E 907

Hydrogenated  poly-
1-decene

As glazing agent for

- sugar confectionery

- dried fruits

E 1505

Triethyl citrate

Flavourings

E 1517

Diacetin

E 1518

.

E 1520

Glyceryl 
(triacetin)

triacetate

Propan-1,2-diol
(propylene glycol)

E 1519

Benzyl alcohol

Flavourings for

- non-alcoholic flavoured drinks

50 mg/kg

- liqueurs, aromatised wines,
aromatised wine-based drinks and
aromatised wine-products
cocktails

100 mg/lkg

- confectionery including
chocolate and fine bakery wares

250 mg/kg

from all sources in

12

foodstuffs as
consumed or as
reconstituted
according to
instruction of the
manufacturer.’

(7)

In Annex V:

(a) the following row is added:

‘E 555

Potassium aluminium silicate

In  E  171  titanium  dioxide  and  E  172  iron
oxides and hydroxides (max 90% relative to
the pigment)’

(b) for E 468 the name “Cross-linked cellulose gum” is added.

(8) In Annex VI:

(a)  in  the  introductory  note,  the  following  subparagraph  is  inserted  after  the  first
subparagraph:

‘Formulae  and  weaning  foods  for  infants  and  young  children  may  contain  E  1450
starch sodium octenyl succinate  resulting  from  the addition  of  vitamin preparations
or polyunsaturated fatty acid preparations. The carry over of E  1450 in  the  product
ready for consumption is not to be more than 100 mg/kg from vitamin preparations
and 1000 mg/kg from polyunsaturated fatty acid preparations.’

(b)in Part 4, the title is replaced by the following:

‘Food additives permitted in dietary foods for infants and young children for special
medical purposes as defined in Commission Directive 1999/21/EC’**

** Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special
medical purposes, (OJ L 91, 7.4.1999, p. 29).’

(c) in Part 4, the following is added to the table:

E 472c

Citric acid esters of mono-
and  diglycerides  of  fatty
acids

g/l 

7,5 
powder

sold 

as

From birth onwards’

9 g/l sold as liquid

13