1999/830/EC: Commission Decision of 26 October 1999 on the national provisions notified by the Kingdom of Denmark concerning the use of sulphites, nitrites and nitrates in foodstuffs (notified under document number C(1999) 3416) (Text with EEA relevance) (Only the Danish text is authentic
Date: 1999-10-26
Institutions: European Commission
Subjects: Denmark, chemical salt, foodstuff, foodstuffs legislation, national law, public health

22.12.1999

EN

Official Journal of the European Communities

L 329/1

II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 26 October 1999

on the national provisions notified by the Kingdom of Denmark concerning the use of sulphites,
nitrites and nitrates in foodstuffs

(notified under document number C(1999) 3416)

(Only the Danish text is authentic)

(Text with EEA relevance)

(1999/830/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community, and in particular Article 95(6) thereof,

Whereas:

THE FACTS

1. Community legislation

(1) Council Directive 89/107/EEC on the approximation of
the laws of the Member States concerning food additives
authorised for use in foodstuffs intended for human
consumption was adopted on 21 December 1988 (1).
Article 3(2) of this Directive provides that the Council
shall, acting on a proposal from the Commission under
the procedure laid down in former Article 100a of the
EC Treaty, adopt a list of additives the use of which is
authorised to the exclusion of all others and the list of
foodstuffs to which these additives may be added, the
conditions under which they may be added and, where
appropriate, a limit on the technological purpose of their
use.

(2) Pursuant

to the

the Commission
above provision,
presented three proposals for specific directives, the first
on sweeteners, the second on colours and the third on

(1) OJ L 40, 11.2.1989, p. 27. Directive 89/107/EEC as last amended

by Directive 94/34/EC (OJ L 237, 10.9.1994, p. 1).

than colours and sweeteners. These
additives other
proposals were prepared
in accordance with the
requirements of Article 6 of Directive 89/107/EEC after
consultation with the Scientific Committee for Food (SCF)
which had been asked earlier by the Commission to
evaluate the safety of additives. The opinions of the SCF,
on which the Commission based its proposals
for
constantly taken into consideration
directives, were
throughout
the discussions on these proposals in the
European Parliament and the Council, right up to the
themselves. Three specific
adoption of
directives
comprehensive
directive referred to in Article 3 of Directive 89/107/EEC
were thus adopted (2). Only the third of
these three
Directives is concerned with this Decision, i.e. European
Parliament and Council Directive 95/2/EC of 20 February
1995 on food additives other
and
sweeteners.

the directives
constituting stages

than colours

in the

2. National provisions

(3) Before the entry into force of Directive 95/2/EC,

the
Danish legislation consisted of a positive list drawn up in
October 1988 determining the conditions of use in
including nitrates, nitrites and
foodstuffs of additives,
sulphites, and Order No 242 of 17 April 1991. Member
States were required to bring into force the laws,
regulations and administrative provisions necessary to

(2) Directive 94/35/EC on sweeteners (OJ L 237, 10.9.1994, p. 3).
Directive 94/35/EC as last amended by Directive 96/83/EC (OJ L
48, 19.2.1997, p. 16). Directive 94/36/EC on colours (OJ L 237,
10.9.1994, p. 13). Directive 95/2/EC (OJ L 61, 18.3.1995, p. 1).
Directive 95/2/EC as last amended by Directive 98/72/EC (OJ L
295, 4.11.1998, p. 18).

L 329/2

EN

Official Journal of the European Communities

22.12.1999

conditions of use of additives

comply with the directive before 25 September 1996.
Directive 95/2/EC was transposed in Denmark by Order
No 1055 of 18 December 1995 (3). This Order of 18
December 1995 was supplemented by a positive list (4)
determining the
in
the Danish
foodstuffs. By letter of 15 July 1996,
Government
forwarded to the Commission a copy of
these national measures transposing Directive 95/2/EC,
these measures did not
pointing out, however,
that
concern sulphites, nitrites and nitrates and that
it
intended, with regard to those additives, to enact national
provisions
95/2/EC in
accordance with Article 100a(4) of the EC Treaty. On 23
September 1996, namely two days before the time limit
for transposing Directive 95/2/EC, Order No 834 was
adopted, supplementing the previous Order No 1055 and
the positive list as concerned specifically sulphites,
nitrites and nitrates (5).

from Directive

derogating

3. Sulphites

caused

deterioration

them against

additives belonging

(4) Directive 95/2/EC on food additives other than colours
and sweeteners determines the conditions of use of a
to several
certain number of
categories such as preservatives and antioxidants. Article
1(3) of Directive 95/2/EC defines preservatives
as
(cid:145)substances which prolong the shelf-life of foodstuffs by
protecting
by
micro-organisms(cid:146) and antioxidants as (cid:145)substances which
prolong the shelf-life of foodstuffs by protecting them
against deterioration caused by oxidation, such as fat
rancidity and colour changes(cid:146). For
this category of
additive, Article 2(1) of the Directive provides that only
substances listed in Annex III may be used in foodstuffs
for the purposes mentioned in Article 1(3). Article 2(4)
provides that the additives listed in Annex III may only
be used in the foodstuffs referred to in that Annex and
under the conditions specified therein. Annex III, Part B
specifies,
in the form of a table, the conditions of use
for sulphur dioxide (E 220) and sulphites (6): sodium
sulphite (E 221),
sodium hydrogen sulphite (E 222),
sodium metabisulphite (E 223), potassium metabisulphite
(E 224), calcium sulphite (E 226), calcium hydrogen
sulphite
and potassium hydrogen sulphite
(E 228) (7):

(E 227),

(3) Sundhedsministeriets bekendtgłrelse nr. 1055 af 18 December
1995 om tils(cid:230)tningsstoffrer til
j.nr.
95-3400-24. Levnedsmiddelstyrelsen, j.nr. 100-0066. Lovtidende A
h(cid:230)fte 198 udgivet den 30 December 1995 s. 5571. GBEK.

levnedsmidler. Sundhedsmin.,

(4) Fortegnelse over

levnedsmidler-Positivlisten
(Levnedsmiddelstyrelsen Sundhedsministeriet). Publikation nr. 231,
December 1995.

tils(cid:230)tningsstoffer

til

(5) Lovtidende A 1996 h(cid:230)fte 145 udgivet den 23 September 1996 s.

5089. GBEK.

(6) The term (cid:145)sulphite agents(cid:146) comprises both sulphur dioxide and
sulphites. In the present Decision, the term (cid:145)sulphites(cid:146) will be used
to describe (cid:145)sulphite agents(cid:146).

(7) These extracts from the Directive are reproduced for information
purposes. They do not create any right or obligation other than
those deriving from the text of the Directive as published in its
entirety in the Official Journal of the European Communities. Only the
latter text is authentic.

Foodstuff

Maximum level in
relation to the
quantity available
(mg/kg or mg/l, as
appropriate)
expressed as SO2

Burger meat with a minimum vegetable
and/or cereal content of 4 %

Breakfast sausages

Longaniza fresca and butifarra fresca

Dried salted fish of the Gadidae species

Crustaceans and cephalopods:

(cid:151) fresh, frozen and deep-frozen

Crustaceans, penaeidae solencerides, Aristeidae
family:

(cid:151) up to 80 units

(cid:151) between 80 and 120 units

(cid:151) over 120 units

(cid:151) cooked

Dry biscuits

Starches (excluding starches for weaning
foods, follow-on formulae and infant
formulae)

Sago

Pearl barley

Dehydrated granulated potatoes

Cereal- and potato-based snacks

Peeled potatoes

Processed potatoes (including frozen and
deep-frozen potatoes)

Potato dough

White vegetables, dried

White vegetables, processed (including
frozen and deep-frozen white vegetables)

Dried ginger

Dried tomatoes

450

450

450

200

150

200

300

50

50

50

30

30

400

50

50

100

100

400

50

150

200

22.12.1999

EN

Official Journal of the European Communities

L 329/3

Foodstuff

Maximum level in
relation to the
quantity available
(mg/kg or mg/l, as
appropriate)
expressed as SO2

Foodstuff

Maximum level in
relation to the
quantity available
(mg/kg or mg/l, as
appropriate)
expressed as SO2

Horseradish pulp

Onion, garlic and shallot pulp

Vegetables and fruits in vinegar, oil or
brine (except olives and golden peppers in
brine)

Golden peppers in brine

Processed mushrooms (including frozen
mushrooms)

Dried mushrooms

Dried fruits

(cid:151) apricots, peaches, grapes, plums and

figs

(cid:151) bananas

(cid:151) apples and pears

(cid:151) other (including nuts in shell)

Dried coconut

Candied, crystallised or Glico fruit,
vegetables, angelica and citrus peel

Jam, jelly and marmalade as defined in
Directive 79/693/EEC (except extra jam
and extra jelly) and other similar fruit
spreads including low-calorie products

Jams, jellies and marmalades made with
sulphated fruit

Fruit-based pie fillings

Citrus-juice based seasonings

Concentrated grape juice for home
wine-making

Mostarda di frutta

Jellying fruit extract, liquid pectin for sale
to the final consumer

Bottled whiteheart cherries, rehydrated
dried fruit and lychees

800

300

100

500

50

100

2 000

1 000

600

500

50

100

50

100

100

200

2 000

100

800

100

Bottled, sliced lemon

250

Sugars as defined in directive 73/437/EEC,
except glucose syrup, whether or not
dehydrated

Glucose syrup, whether or not dehydrated

Treacle and molasses

Other sugars

Toppings (syrups for pancakes, flavoured
syrups for milkshakes and ice cream;
similar products)

Orange, grapefruit, apple and pineapple
juice for bulk dispensing in catering
establishments

Lime and lemon juice

Concentrates based on fruit juice and
containing not less than 2,5 % barley
(barley water)

Other concentrates based on fruit juice or
comminuted fruit; capilØ groselha

15

20

70

40

40

50

350

350

250

Non-alcoholic flavoured drinks containing
fruit juice

20 (carry-over
from concen-
trates only)

Non-alcoholic flavoured drinks containing
at least 235 g/l glucose syrup

Grape juice, unfermented, for sacramental
use

Glucose-syrup-based confectionery

Beer, including low-alcohol and
alcohol-free beer

Beer, with a second fermentation in the
cask

50

70

50 (carry-over
from the
glucose syrup
only)

20

50

L 329/4

EN

Official Journal of the European Communities

22.12.1999

Foodstuff

Wine

Maximum level in
relation to the
quantity available
(mg/kg or mg/l, as
appropriate)
expressed as SO2

In accordance
with Council
Regulations (EEC)
No 822/87, (EEC)
No 4252/88,
(EEC) No
2332/92 and
(EEC) No
1873/84 and
their implement-
ing Regulations.

Alcohol-free wine

Made wine

Cider, perry, fruit wine, sparkling fruit
wine (including alcohol-free products)

Mead

Fermentation vinegar

Mustard, excluding Dijon mustard

Dijon mustard

Gelatin

Vegetable- and cereal-protein-based meat,
fish and crustacean analogues

200

260

200

200

170

250

500

50

200

(5) The Danish Order of 23 September 1996 introduces an
Annex, Annex No 9,
into the Order of 18 December
1995, specifying in the form of a table the conditions of
use of sulphites other than those covered by Community
Regulations on wine (8):

Foodstuff

Garlic pulp

Horseradish pulp

Apricots

Maximum quantity
added
(mg/kg or mg/l, as
appropriate)
expressed as SO2

300

600

1 000

(8) These extracts from the Danish legislation are reproduced for
information purposes. They do not create any right or obligation
other than those deriving from legal texts that have been adopted
in law and published in the official Danish publications. Only the
latter texts are authentic.

Foodstuff

Maximum quan-
tity added
(mg/kg or mg/l, as
appropriate)
expressed as SO2

Granulated potatoes

Jams, jellies, marmalades and chestnut
puree (covered by Directive 79/693/EEC)

Other jams

Glucose-syrup-based confectionery

Dry biscuits

Deep-water fresh lobster

Frozen crustaceans

Cooked crustaceans

Sugar products (covered by Directive
73/437/EEC)

Glucose syrup

Vinegar with an acid content of 8 %

Lime juice

Lemon juice

Flavoured drinks based on concentrated
fruit juice

Beer

Cider and perry

Fruit wine

100

50

50

50

150

30

30

30

15

20

100

100

300

20

20

50

300

4. Nitrites and nitrates

(6) Article 1(3) of Directive 95/2/EC on food additives other
than colours and sweeteners provides a definition of
preservatives and antioxidants (9). For this category of
additives, Article 2(1) provides that only substances listed
in Annex III may be used in foodstuffs for the purposes

(9) See recital 4 of this Decision.

22.12.1999

EN

Official Journal of the European Communities

L 329/5

Potassium nitrite (E 249) and sodium nitrite (E 250)

Foodstuff

Quantity added
(mg/kg)

mentioned in Article 1(3). Article 2(4) provides that the
additives listed in Annex III may only be used in the
foodstuffs referred to in that Annex and under
the
conditions specified therein. Annex III, Part C specifies, in
the form of a table, the conditions of use for potassium
nitrite (E 249), sodium nitrite (E 250), sodium nitrate (E
251) and potassium nitrate (E 252) (10):

Potassium nitrite (E 249) and sodium nitrite (E 250)

Foodstuff

Indicative
ingoing
amount
(mg/kg)

Residual
amount
(mg/kg)

Non-heat-treated, cured, dried meat
products

150

50

Other cured meat products and canned
meat products

150

100

Foie gras, foie gras entier, blocs de foie
gras

Cured bacon

175

Non-heat-treated meat-based products
derived from whole pieces of meat,
including slices of products

Bacon of the Wiltshire type and related
cuts, including saltcured ham

Heat-treated meat-based products derived
from whole pieces of meat, including
slices of products

Rullepłlse (rolled meat sausage)

Entirely preserved or semi-preserved
heat-treated meat-based products derived
from whole pieces of meat, including
slices of products

Bacon and related cuts of the Wiltshire
type, including saltcured ham

Sodium nitrate (E 251) and potassium nitrate (E 252)

Non-heat-treated meat-based products
derived from minced meat

Foodstuff

Indicative
ingoing
amount
(mg/kg)

Residual
amount
(mg/kg)

Cured meat products

300

250

Canned meat products

Hard, semi-hard and semi-soft cheese

Dairy-based cheese analogue

Pickled herring and sprats

50

200

Fermented Danish salami

Entirely preserved or semi-preserved
non-heat-treated meat-based products
derived from minced meat

Heat-treated meat-based products derived
from minced meat

Meatballs or liver patØ

Entirely preserved or semi-preserved
heat-treated meat-based products derived
from minced meat

60

150

60

100

150

150

60

100

150

60

150

150

(7) The conditions of use for nitrates and nitrites

in
foodstuffs other
feature in the
than meat products
positive list (11), to which the Order of 18 December
1995 refers in its paragraph 11. The Commission has
they
examined these provisions and has decided that
comply with the corresponding provisions of Directive
95/2/EC. The Danish Order of 23 September 1996
introduces an Annex 8 into the Order of 18 December
1995, specifying, in the form of a table, the conditions of
use of nitrites and nitrates in meat products (12):

(10) See footnote 7 of this Decision.
(11) See footnote 4 of this Decision.
(12) See footnote 8 of this Decision.

Sodium nitrate (E 251) and potassium nitrate (E 252)

Foodstuff

Quantity added
(mg/kg)

Bacon of the Wiltshire type and related
cuts, including saltcured ham

Bacon of the Wiltshire type and related
cuts, including saltcured ham

300

300

L 329/6

EN

Official Journal of the European Communities

22.12.1999

THE PROCEDURE

soon as
notification.

they had received the

complete, official

(8) When the Council adopted Directive 95/2/EC on 15
December 1994 as an A item, the Danish delegation
(cid:145)The
asked to make a voting declaration, as follows:
Danish delegation votes against
the
the adoption of
European Parliament and Council Directive on food
additives other than colours and sweeteners. With regard
to the use of nitrites/nitrates,
sulphites and sodium
aluminium phosphates, the Directive does not respond
satisfactorily to health requirements, to which the Danish
importance in provisions
delegation ascribes a crucial
regulating food additives. [(cid:133)] In addition, the Danish
Government remains firmly convinced that the Scientific
Committee for Food ought,
in accordance with the
declarations put forward by the Commission, to deliver
an opinion on nitrites/nitrates and sulphites as soon as
possible. The Government will welcome the conclusions
of
to
the Scientific Committee and reserves the right
maintain national provisions needed to safeguard human
life and health in accordance with Article 100a(4) of the
Treaty(cid:146). Directive 95/2/EC was signed by the Presidents of
the European Parliament and of
the Council on 20
February 1995. The Directive provides that Member
States are required to bring into force national measures
implementing the Directive by 25 September 1996.

a

to

letter

Union

concerning
intends

(9) The Permanent Representation of Denmark to the
European
the
addressed
Secretariat-General of the Commission on 15 July 1996.
By means of this letter, the Danish authorities forwarded
to the Commission a copy of their national measures to
implement Directive 95/2/EC (13). The Danish authorities
pointed out, however, that (cid:145)Denmark has not transposed
the provisions in Directive 95/2/EC concerning nitrates
and nitrites in meat products and concerning sulphites
(see comparative table). Reference should be made to the
voting declaration made by Denmark when the Directive
was adopted. Pursuant to former Article 100a(4) of the
these
Treaty,
the Danish
to apply its national measures,
Government
which are justified by the major needs referred to in
Article 36. Please
enclosed scientific
report(cid:146) (14). Given the incomplete character of the file at
this stage, the Commission departments did not consider
this letter was a formal notification within the
that
meaning of Article 100a(4).
In parallel with this
communication, correspondence was exchanged between
the competent Danish Minister and the competent
Member of
the European Commission. The Minister
confirmed the Danish position as expressed in the voting
declaration. The Commission Member
took note of
Denmark’s intention to ask for a derogation from the
Directive under Article 100a(4),
the
Commission departments would examine this request as

substances,

to the

adding

refer

that

contacts,

the Order which was the subject of

(10) The Commission departments were made aware of Order
No 834 of 23 September 1996 through a complaint
introduced in November 1996.
In a letter requesting
information addressed to the Danish authorities on 20
January 1997 to follow up this complaint, Commission
officials considered that the intention expressed by the
Danish authorities
in July 1996 to derogate from
Directive 95/2/EC had been followed by the later
the
adoption of
complaint. Following informal
the Danish
authorities provided a detailed reply on 20 May 1997 to
the Commission letter asking for more information. An
examination of all the various items of correspondence
led Commission officials to regard the letter dated 15
July 1996 from the Danish authorities, when read
together with their detailed letter of 20 May 1997, as
being equivalent to notifying their legislation on nitrites,
nitrates and sulphites, pursuant to Article 100a(4) of the
the same time, other complaints were
EC Treaty. At
reaching the Commission denouncing obstacles to the
marketing in Denmark of foodstuffs containing sulphites
and meat products containing nitrites and/or nitrates.
Further informal talks were held between Commission
officials and the Danish authorities in order to discuss the
scientific and technical aspects of
this dossier. These
contacts did not make it possible to reach a common
position. The only agreement
the
Danish authorities would forward further information to
the Commission to bolster the justifications needed to
support their request for a derogation. This additional
information was addressed to the Commission on 14 July
1998.

reached was

that

(11) The notification file,

comprising the memorandum
attached to the letter of 15 July 1996 and the additional
information last forwarded by the Danish authorities, was
then forwarded to the other Member States for their
from
opinions. The Commission received opinions
Germany, France,
the Netherlands, Portugal, Finland,
Sweden and the United Kingdom.

(cid:151) Germany points out that the conditions of use of
sulphites, nitrites and nitrates
in foodstuffs were
determined taking account of the evaluations of the
it would be
SCF. Germany nevertheless feels that
useful
the
documentation forwarded by the Danish authorities,

examine

invite

SCF

the

to

to

(13) See recital 3 of this Decision.
(14)

(cid:145)Memorandum(cid:146) on the evaluation of safety and of other aspects of
using nitrates and sulphites in (cid:145)foodstuffs(cid:146), hereinafter referred to
as (cid:145)the memorandum(cid:146)

(cid:151) France thinks

the Danish
that, on some points,
legislation appears discriminatory. France recognises
that it would be useful to re-examine at Community
level the conditions of use of sulphites, nitrites and

22.12.1999

EN

Official Journal of the European Communities

L 329/7

nitrates, and believes that it would be preferable to
await the results of studies on the consumption of
food additives carried out by the Member States
before undertaking this re-examination,

LEGAL ASSESSMENT

1. Applicable rules

support

(cid:151) The Netherlands does not

the Danish
derogation request, since it thinks that the Danish
authorities
their
are particularly justified on
restrictive measures
the Danish
account of
population,

eating habits of

demonstrated

have

that

not

the

(cid:151) Portugal

recalls that

the reasons invoked by the
Danish authorities in their request for a derogation
had already been put forward during the discussions
preceding the adoption of Directive 95/2/EC, but had
not
Portugal
recommends waiting for the results of the studies on
the consumption of food additives to see whether the
conditions of use of additives as provided for in the
Directive should be changed,

the Council.

accepted

been

by

(cid:151) Finland understands

the concern of

the Danish
authorities to see the conditions of use of nitrites,
nitrates and sulphites in foodstuffs tightened up.
Finland points out that Directive 95/2/EC ought to be
reviewed on these points,
depending on the
assessments of the levels of consumption of additives
in the Member States, which should be available at
the end of 1999,

(cid:151) Sweden believes that it has no reason to oppose the
Danish rules, considering that it will be necessary to
the additives in
review the conditions of use of
question in the Community, and stating that
the
application of the Danish rules does not appear to
hamper trade,

(cid:151) The United Kingdom affirms

the Danish
authorities have not supplied proof that the risk is
greater for Danish consumers than for those in the
other Member States.

that

(13) The Treaty of Amsterdam does not contain any specific
transitional provisions concerning the rules applicable to
notifications made before the date of entry into force of
this Treaty, such as the Danish notification which is the
specific
this Decision.
subject of
In the absence of
former
extending
provisions
the
provisions of Article 100a(4) of
the EC Treaty are
considered abrogated from the day of the entry into force
of the new provisions (1 May 1999).

application,

their

submitted under

the notification which it

the new provisions of
the form of

(14) The Commission has informed the Kingdom of Denmark
that
the
provisions of the former Article 100a(4) of the EC Treaty
has been regarded as maintained within the framework
a
of
comparison of
the provisions of Article
100a(4) of
the EC Treaty and the new provisions of
Article 95(4) and (6) of the said Treaty, reveals that these
are
identical. These new
provisions of the Treaty, which have replaced the old
provisions of Article 100a(4) since 1 May 1999, thus
constitute the law which is applicable when examining
this notification.

comparable, where not

this Treaty.

Indeed,

2. Consideration of admissibility

(15) The notification presented by the Danish authorities
seeks to obtain authorisation to maintain certain national
provisions which are
incompatible with Directive
95/2/EC, which constitutes a harmonisation measure
adopted on the basis of the former Article 100a (which
has since become Article 95) of the EC Treaty. Indeed,
although the letters dated 15 July 1996 and 20 May
1997 from the Danish authorities
to national
provisions which postdate the adoption of Directive
95/2/EC, it is necessary to note, as indicated in recital 3,
substantially reproduce
that
national rules which existed before its adoption. It must
therefore be considered that,
in the case in point, the
condition provided for in Article 95(4) of the Treaty has
been fulfilled, according to which rules notified under
this provision are those which a Member State wishes to
(cid:145)maintain(cid:146)
following the adoption of a harmonisation
measure.

the national provisions

refer

(16)

substantially

of Amsterdam amended

(12) On 1 May 1999, the Treaty of Amsterdam amending the
Treaty on European Union, the Treaties establishing the
European Communities and certain related acts, signed at
Amsterdam on 2 October 1997, entered into force. The
Treaty
the
provisions of Article 100a of the Treaty establishing the
European Community, replacing paragraphs 3, 4 and 5
of this Article by eight new paragraphs, numbered from
3 to 10. The Article amended in this way became, due to
the new numbering of the Articles, Article 95 of the
Treaty establishing the European Community. By letter
dated 29 July 1999,
the
Commission informed the Danish authorities that their
notification on the use of sulphites, nitrites and nitrates
in foodstuffs had been taken into account within the
framework of the new provisions of the Treaty.

the Secretariat-General of

its

authorities

the Danish

the Commission was

informed by the
In addition,
intention to maintain
Kingdom of Denmark of
national measures which were
incompatible with
Directive 95/2/EC before the date on which this Directive
was to be implemented. Indeed, with their letter of 15
July 1996,
the
Commission of their intention to maintain their national
provisions derogating from Directive 95/2/EC. This initial
supplemented by later communications which
letter,
a
clarified its
description of the derogating national provisions. In the
case in point, therefore, the Commission was aware of
the Danish derogation measures as from July 1996,
which is before the time limit for the implementation of
measures to transpose the Directive.

exact meaning, did indeed include

informed

L 329/8

EN

Official Journal of the European Communities

22.12.1999

(17)

In the light of the above considerations, the Commission
believes that the notification made by the Kingdom of
Denmark is admissible under Article 95(4) of
the EC
Treaty.

3. Assessment of the merits

(18)

(19)

therefore verify whether

In accordance with the key provisions of Article 95(4) of
the EC Treaty, the Commission must ascertain that the
national provisions notified are justified by the major
needs referred to in Article 30 of the EC Treaty (formerly
Article 36 of the Treaty) or which concern the protection
of the environment or the working environment. In their
letter of notification, the Danish authorities invoke the
objective of safeguarding public health. The Commission
are
must
necessary and proportionate to the objective pursued.
When the Commission has concluded that the national
notified provisions are justified,
then verify,
pursuant to Article 95(6) EC, whether these measures
constitute or not a means of arbitrary discrimination or a
disguised restriction on trade between Member States and
whether or not
they constitute an obstacle to the
functioning of the internal market. In addition, it should
be pointed out that, from now on, Article 95(4) of the
Treaty expressly compels Member States to prove that
these conditions are fulfilled in order for a derogation to
be authorised.

these measures

it must

(a) Justification with regard to the major need to

protect public health

(i) Sulphites

on

Directive

framework

to justify their

In their memorandum, the Danish authorities base their
89/107/EEC
argument
concerning additives
for a
derogation. Annex II of this Directive sets out general
criteria for
food additives. The Danish
authorities criticise the Community legislators for not
having followed these criteria to establish the conditions
of use of sulphites in foodstuffs when Directive 95/2/EC
was adopted.

the use of

request

(20) However,

the elements put

forward by the Danish
authorities with regard to two of the criteria defining the
conditions of use of additives, namely technological need
and the risk of misleading consumers, have nothing to
do with the objective of public health protection as
mentioned in Article 30 of the EC Treaty, neither do they
refer to the other objectives listed in Article 95(4) of this
Treaty. These elements are not in any case pertinent,
therefore, if they are compared with the limited cases for
justification that have been listed in the abovementioned
Article 95(4), and the Commission believes, moreover,
that the arguments put forward are not founded.

(21) As far as the technological need is concerned, the Danish
authorities insist on the need for a strict framework for
the conditions of use of sulphites in foodstuffs and stress
the fact that, since the introduction in 1988 in Denmark
of a restrictive legislation regarding the use of
these
additives, several of the foodstuffs mentioned in Directive
95/2/EC have been marketed in Denmark without the
addition of sulphites and with no problem for food
safety. The Danish authorities quote the example of
peeled potatoes, mustard, dried fruits and canned fruits
and vegetables. The Commission affirms that Community
legislation took proper account of the need for a strict
framework for the conditions of use of sulphites in
foodstuffs.
are
authorised as preservatives and/or antioxidants (15) by
Directive 95/2/EC, and that these additives thus perform
a
a
technological need which cannot be satisfied by other
economically and technologically usable methods. The
this argument
Commission believes, moreover,
cannot be invoked for the purposes of public health
protection, since it is up to the Danish authorities to
establish that the presence of sulphites constitutes a risk
to public health.

specifies, however,

technological

correspond

sulphites

function

that

that

and

to

It

be

are

regarded

(22) Turning to the risk of misleading consumers, the Danish
authorities question once again the justification for using
sulphites established by Directive 95/2/EC, believing that
these additives have a bleaching effect on fruit and
vegetables, which could possibly
as
that
misleading consumers. The Commission recalls
sulphites
authorised by Directive 95/2/EC as
preservatives and/or antioxidants, but not as bleaching
agents. The function of antioxidants
to (cid:145)protect
[foodstuffs] against deterioration caused by oxidation,
changes(cid:146) (16). The Commission
such as
believes that a function of
lead a
this kind cannot
consumer to be misled as to the nature of the product,
given that the product labelling mentions the presence of
the additive in question. What is more, this argument
could not constitute a justification with regard to the
objective of public health protection.

colour

[(cid:133)]

is

(23) The specific community directives on additives were
adopted on the basis of a rigorous safety assessment of
all the additives carried out by the SCF so that only those
additives whose use in foods was judged risk-free would
feature in the specific directives and could hence be used
in the Community. Annex II to Directive 89/107/EEC
provides that (cid:145)to assess the possible harmful effects of a
food additive or derivatives thereof, it must be subjected
to appropriate toxicological testing and evaluation. The
evaluation should also take into account, for example,
any cumulative, synergistic or potentiating effect of its
use and the phenomenon of human intolerance to
substances foreign to the body(cid:146). On several occasions the
SCF has been called on to carry out a toxicological
the last being in an opinion
evaluation of sulphites,

(15) See the definitions of preservatives and antioxidants in recital 4.
(16) Article 1(3)(b) of Directive 95/2/EC.

22.12.1999

EN

Official Journal of the European Communities

L 329/9

delivered on 25 February 1994 (17). The Danish
authorities are using this opinion as a basis for their
argument
exceeding the
acceptable daily intake (ADI) and the risks of allergies
connected with the consumption of sulphites.

to condemn the

risks of

(24) The evaluation of the safety of an additive may highlight
the need to establish an ADI to safeguard public health.
This ADI represents the quantity which can be safely
ingested on average every day throughout a lifetime. The
ADI, which comprises a habitual safety factor of 100,
which may be as high as 500, is expressed in milligrams
per kilogram of body weight (mg/kg bw). The approval
of any food additive and the determination of
its
conditions of use must therefore take into account the
technological need for this additive (the quantity needed
to reach the desired effect) while simultaneously taking
account of the probable daily intake of the additive in all
food products, in order to check that the authorised use
does not
that has been
established for the additive in question being exceeded.

risk leading to the ADI

(25)

In its opinion of 25 February 1994, the SCF established
an ADI of 0,7 mg/kg bw per day for sulphites (18),
corresponding to 49 mg/day for an adult (0,7 mg/kg (cid:215)
70 kg) and 21 mg/day for a child (0,7 mg/kg (cid:215) 30 kg).
This value is based on a quantity which has no effect on
the gastrointestinal system. The conditions of use of
sulphites defined in Directive 95/2/EC may, according to
the Danish authorities, lead to the ADI being exceeded.
The Danish authorities quote the example of wine,
in
which sulphites are authorised up to 160 mg/l (19). The
consumption of two glasses of wine represents an intake
of 40 mg of sulphites (25 cl (cid:215) 160 mg/l) which is not far
from the daily admissible intake for an adult. The Danish
authorities believe that any additional authorisation of
sulphite use will lead to the ADI being exceeded or will
increase the risk of its being exceeded.

(26) The Danish authorities are not however

seeking to
tighten up the conditions of the use of sulphites in wine,
but their conditions of use in other foodstuffs, such as
those defined in Directive 95/2/EC. To tighten up the
conditions of use of sulphites,
the Danish authorities
have reduced the number of foodstuffs in which sulphites

(17) Reports of the SCF, 35th series.
(18) In its previous opinion on sulphites delivered in 1981, the SCF

considered that it was not necessary to set an ADI.

(19) Directive 95/2/EC in fact refers back to Council Regulation (EEC)
No 822/87 of 16 March 1987 on the common organisation of
the market in wine (OJ L 84, 27.3.1987, p. 1), last modified by
Council Regulation (EC) No 1627/98 of 20 July 1998 (OJ L 210,
28.7.1998, p. 8). In its Article 65, this Regulation provides that
the total sulphur dioxide content of still wines (cid:145)may not exceed
[(cid:133)] 160 mg/litre for red wine, 210 mg/litre for white and rosØ
wine(cid:146).

may be used. Thus, the Danish Order of 23 September
1996 retains only 16 categories of foodstuffs in which
sulphites may be used out of the 61 categories which are
included in Directive 95/2/EC.

having

in mustard, without

in the eating habits of

(27) The Commission notes that the Danish authorities have
not
justified the choice which they have made. This
choice may appear arbitrary to the extent that the Danish
authorities have not indicated how technological need
has been demonstrated in some cases and not in others.
For example, the Danish authorities prohibit the use of
provided
sulphites
information on the levels of consumption of mustard in
Denmark, which would show the importance of
this
foodstuff
the population and
hence the need to outlaw the use of sulphites in this
product in order to reduce the sulphite intake in the diet
as a whole. To tighten up the conditions of use of
sulphites in some foodstuffs the Danish authorities have
lowered the levels of use of sulphites (20). The Danish
Order of 23 September 1996 determines the added
quantity, which is the opposite of Directive 95/2/EC,
which determines the maximum quantity available in the
finished product (21). For example, the use of sulphites in
dehydrated potato granules is authorised up to a level of
100 mg/kg in Denmark, while Directive 95/2/EC
authorises a total available quantity of 400 mg/kg of
sulphites. The Danish authorities have not justified this
measure and, more specifically, have not taken account
of the fact that the use of sulphites is authorised by
foodstuffs,
Directive 95/2/EC in a certain number of
including dehydrated potato granules, which can only be
consumed after cooking or reconstitution. It is precisely
these treatments which reduce substantially the sulphite
content
in foodstuffs when they are consumed. The
Commission is therefore inclined to question the choice
made by the Danish authorities of
the foodstuffs in
which sulphites may be used.

(28) The Commission points out

that

the Community
provisions on sulphites are still likely to be the subject of
a review. The safeguard clause provided for in Article 4
of Directive 89/107/EEC may lead to the changing of the
positive list. Article 7 of Directive 95/2/EC, which
imposes on the Member States and on the Commission
the tasks of monitoring additive consumption trends,
should permit a re-examination of the conditions of use
of the additives provided for in the Directive and lead to
its adaptation.

(20) It is not feasible to lower generally the levels of use of sulphites in
foodstuffs. The levels of use which feature in the Directive were
calculated to produce
intrinsic
technological function of these additives; below such levels, the
desired effects are not produced.

effects which are

the

the

(21) See the first footnote of Annex III, Part B, to Directive 95/2/EC.
For dry biscuits, for instance, the quantity allowed in the Danish
Order is as a result higher than that which features in Directive
95/2/EC. Nevertheless, the Danish authorities do not specify that
the maximum level in the finished product is not higher than that
set by the Community text.

L 329/10

EN

Official Journal of the European Communities

22.12.1999

(29) Apart

from the question of exceeding the ADI,

the
Danish authorities stressed the risk of allergic reactions
caused by sulphites which may occur
in certain
predisposed individuals at low levels of exposure. The
Danish authorities refer here directly to the opinion of
the SCF of 25 February 1994 to insist on the need to
limit
the use of sulphites to as small a number of
products as possible and to provide information for
consumers on the presence of sulphites in foodstuffs.

(30) The Commission acknowledges

that

allergic

to the

risks of

sulphites,

food allergies

in so far as it

like a
certain number of other additives, may provoke allergic
reactions in certain individuals and points out that these
risks of allergies have been taken into account in the
Community legislation. The Commission believes that the
Community legislation provides an appropriate response
to the problem of
in general. The
Community legislator admits that it is perfectly legitimate
is possible, subjecting such
to avoid,
reactions. The
individuals
Community legislator did not nevertheless deem it
necessary to outlaw generally the use of these allergenic
such a sulphites
ingredients, among which additives
feature. The solution opted for at Community level
is
individuals who suffer
based on informing consumers:
from an allergy attributable to certain ingredients should
have the possibility of choosing to consume foodstuffs
which do not contain these ingredients. Council Directive
79/112/EEC of 18 December 1978 on the labelling of
foodstuffs (22) offers them this possibility since it provides
for the compulsory listing of ingredients on the labelling
to Article 6 of
of
Directive 79/112/EEC,
a
technological function must of necessity be mentioned
on the labelling. Thus sulphites appear in the list of
ingredients. The Commission believes,
that
existing Community legislation gives consumers or, when
such consumers are children, gives
their parents or
members of their entourage, such as officials in schools,
a guarantee of sufficiently clear and detailed information
as regards the presence of sulphites in foodstuffs.

In particular, pursuant
all

additives which serve

foodstuffs.

therefore,

(32)

(31) The Commission acknowledges that the labelling does
not always indicate the presence of sulphites in certain
circumstances. This is the case of sulphites which, having
remain
been used in the preparation of
present
that stage
serving any technological function (23). This is also the
case of sulphites which are present in a large number of

in the finished product without at

foodstuffs,

such as

foodstuffs without having been voluntarily added (24).
These two examples correspond to very low levels of
sulphites which may nevertheless cause allergies in some
individuals. The Commission notes that the regulation
applicable in Denmark does not solve this problem of a
lack of labelling of sulphites with such low content levels.
Work is in progress at community level
to make it
systematically compulsory to label allergenic ingredients
such as the sulphites quoted in the examples above.
Information for consumers on the presence of sulphites
could also be incomplete as regards foodstuffs offered for
sale which have not been prepackaged. The Commission
would point out that Article 12 of Directive 79/112/EEC
to decide on the manner of
allows Member States
labelling such foodstuffs,
the obligation of
affixing descriptions to accompany products sold loose
(without prepackaging) and containing certain particulars
regarding these products.
to inform all
consumers fully about the content of some foodstuffs,
Member States may thus oblige restaurant owners to
record on the menu the list of ingredients of the dishes
that they offer. The Danish authorities also evoke the
case of alcoholic beverages, in whose labelling the list of
ingredients does not necessarily appear. The Commission
would stress that, pursuant to Article 6(3) of Directive
79/112/EEC,
for a European
Parliament and Council Directive amending Directive
79/112/EEC, aimed at making the labelling of ingredients
in alcoholic drinks (25) compulsory. This proposal for a
formulated by the
Directive follows other proposals
Commission in the past but which led to no tangible
result. That is why the Commission did not propose the
adoption by some Member States of national legislations
making the indication of ingredients compulsory in the
labelling of certain alcoholic beverages.

it presented a proposal

In order

specifically, of

In the light of the information supplied by Denmark, the
Commission also examined whether sulphites constituted
a particular health problem for the Danish population as
compared with the populations of
the other Member
States. In their memorandum, the Danish authorities did
not refer to any epidemiological study, did not offer any
data on the prevalence of food allergies nor of allergies
to additives nor, more
to
sulphites which would have made it possible to make
comparisons with the averages for the European or world
population with a view to establishing whether
the
Danish population is in a specific situation with regard to
the prevalence of allergies to sulphites. The Commission
has no knowledge of any such studies concerning
Denmark or any other Member State or any third
country. The Commission also tried to analyse the
situation in greater detail by referring to a report issued
by the SCF on 22 September 1995 concerning adverse
of
reactions

ingredients

foodstuffs

allergies

and

the

to

(22) OJ L 33, 8.2.1979, p. 1. Directive as last amended by Directive

97/4/EC of 27 January 1997 (OJ L 43, 14.2.1997, p. 2).

(23) Article 6(4)(c)(ii) of Directive 79/112/EEC. Apart

from the
foodstuffs to which the provisions of Directive 95/2/EC are
applicable with respect
to sulphites, sulphites may legally be
transferred to a certain number of other foodstuffs in accordance
with Article 3(1) of this Directive through the application of the
carryover principle.

(24) The second footnote of Annex III, Part B to Directive 95/2/EC
specifies for this reason that sulphites whose content does not
exceed 10 mg/kg are not considered to be present in the finished
product.

(25) Proposal for a Directive published in OJ C 106, 4.4.1997, p. 5.

22.12.1999

EN

Official Journal of the European Communities

L 329/11

present

allergens

In this report,

regions where

foodstuffs (26).
the SCF indicates that,
according to the available studies carried out throughout
the world,
(cid:145)the prevalence of food allergy is clearly less
than 1 % in the adult population and may be slightly
higher in the case of children(cid:146). The SCF mentions several
studies which reveal that this prevalence when related
more specifically to food additives is less than 0,1 % for
the population. But it mentions a further crucial element
in its report, namely that genetic and environmental
factors as well as eating habits may increase the
prevalence of food allergies. The SCF quotes the example
of
the
are
It also quotes the case of regions where
environment.
allergens are widely consumed. Consequently,
the SCF
concludes that (cid:145)the prevalence of food allergy depends
greatly on the geographical region(cid:146). The Commission
therefore felt bound to check whether
the Danish
authorities had actually supplied proof of the existence
and importance of such factors,
linked to genetics, the
environment or eating habits. The Commission has not
detected anything in the memorandum which throws the
existence of any of these factors into relief. Consequently,
the information available to the Commission has not
made it possible to conclude that the Danish population
is in a specific situation compared with the populations
of
immediate
neighbours, as regards this question of allergies related to
sulphites.

other Member

notably

States,

its

in

(33) What is more, the Commission finds that the Danish
measures as notified are inconsistent with the declared
objective of protecting public health.
the
restrictive measures refer only to sulphites. Sulphites,
however, are not the only additives which present allergy
risks. We may also quote the example, based on the
already quoted report by the SCF of 22 September 1995,
of benzoates and certain colourings such as azo dyes.
The Commission observes that these various sources of
allergies have not been subject
to the same sort of
restrictions as those applicable to sulphites in Denmark.

Indeed,

(34)

the Commission is led to
In the light of these facts,
conclude that
though based on
public health considerations, are still not justified by the
need to protect public health.

the Danish measures,

(ii) Nitrites and nitrates

(35) The Danish authorities want to maintain their restrictive
provisions regarding the use of nitrites and nitrates in
meat products. The conditions of use for these additives
in cheese and in fish as laid down in Directive 95/2/EC
have not been questioned. The Danish Order of 23
September 1996 authorises the use of nitrites in the meat
products referred to in Directive 95/2/EC within limits
lower, on average, than half those provided for by the
Directive, except for bacon of the Wiltshire type and

(26) SCF reports, 37th series.

rolled meat sausage (rullepłlse), in which levels of nitrites
used may be comparable to those provided for by the
Directive. The use of nitrates is not authorised by the
Order of 23 September 1996 in any of the products
referred to in the Directive, except
the
Wiltshire type, at levels close to those provided for in the
Directive. The Danish authorities are keen to apply their
restrictive measures since they believe that the use of
nitrites and nitrates in meat products in the conditions
set out in Directive 95/2/EC is not necessary from the
technological viewpoint and that these additives present a
danger to health (27).

in bacon of

that nitrites

to inhibit or halt
such

(36) Nitrites and nitrates are used in meat products as
preservatives (28)
the growth of
Clostridium
as
undesirable micro-organisms
botulinum,
the bacterium responsible for botulism, or
Staphylococcus aureus. The Danish authorities do not
and nitrates perform such a
contest
technological function, but consider that the levels of use
of these additives set out in Directive 95/2/EC exceed
what is required to satisfy this technological need. It is all
the more important to limit the conditions of use of
nitrites and nitrates to what is strictly necessary given
that there are particular health risks which are connected
with these additives (29). The Danish authorities refer to
reports by the Danish National Food Agency showing
that restrictive conditions of use of nitrites and nitrates in
force in Denmark since the adoption of Directive
95/2/EC have not led to cases of botulism among the
population. Experiments carried out in Denmark during
the production phase and based,
in particular, on the
application of the HACCP (30) system regarding hygiene
the levels of nitrites and nitrates in meat
show that
products provided for
in the Danish regulation are
sufficient from the technological standpoint.

(37) The Commission does not share the Danish authorities’
view and considers that the conditions of use of nitrites
in meat products defined in Directive
and nitrates
95/2/EC correspond to what
required from the
technological viewpoint in order to achieve the desired
effects. The Commission observes that the Danish Order
of 23 September 1996 authorises the use of nitrites and
nitrates in conditions comparable to those of Directive
95/2/EC in two types of meat product: bacon of the

is

(27) This would mean that

the three cumulative
conditions for the authorisation of additives set out in Directive
89/107/EEC would not be fulfilled.

the first

two of

in

(28) The technological function of these additives is to extend the shelf
life of foodstuffs by protecting them from deterioration due to
micro-organisms,
of
accordance with
preservatives given in Article 1(3)(a) of Directive 95/2/EC. The use
of nitrites and nitrates also has direct consequences on the
determination of the final date for the consumption of a product
in that they make it possible to retain the water which the meat
product contains naturally in order to preserve its organoleptic
qualities, particularly its aromas, colour and texture.

definition

the

(29) These risks are described in recitals 35 et seq. of this Decision.
(30) HACCP denotes the (cid:145)Hazard analysis and critical control points(cid:146)
system. See Article 3 of Council Directive 93/43/EEC on the
hygiene of foodstuffs (OJ L 175, 19.7.1993, p. 1). The Directive
does not however deal with meat products during the stages
preceding their sale to the final consumer.

L 329/12

EN

Official Journal of the European Communities

22.12.1999

explained why

Wiltshire type and rolled meat sausage (rullepłlse). The
these
Danish authorities have not
products, which are, moreover,
traditional Danish
products, require higher levels of nitrites and nitrates
than other meat products. The Commission does not see
that there are any substantial differences between these
categories of products which could justify discriminatory
treatment of this kind.

cells and tumours

substance,
there is no threshold below which the
can be
formation of cancerous
excluded. It is therefore vital to reduce the exposure to
preformed nitrosamines present in foodstuffs by using
appropriate technological methods
the
minimum needed to obtain the desired preservative effect
and to guarantee microbiological safety.

to arrive at

for

such

these

required

additives

Clostridium

levels of nitrites

(38) The Commission confirms that the conditions of use of
nitrites and nitrates in meat products do not exceed what
to perform their
is
technological function. Nitrites and nitrates used in meat
products tend to inhibit or halt the growth of undesirable
micro-organisms
botulinum.
as
Contamination of meat products by this bacterium is
likely to occur throughout the food production process,
particularly at
the carcasse-cutting stage, during the
production process, up to and including the consumption
stage (31). The
and nitrates must
therefore be calculated so that these additives fulfil their
role as preservatives right up to the last stage of the food
production and consumption process. But
from the
moment
they have been incorporated into meat
products, the quantities of nitrites and nitrates diminish
time and transform
considerably over a period of
themselves
is why Directive
95/2/EC determines both the indicative ingoing amount
and the residual amount. The Danish Order of 23
than Directive
September 1996 is more
95/2/EC: it determines only the quantities of nitrites and
nitrates added and these quantities are generally lower
than the indicative ingoing amounts defined in the
Directive. The Order does not therefore guarantee that
the presence of additives in products at the end of the
food production process is sufficient to perform their
technological
the
microbiological safety of products.

into nitrosamines. That

function, which is

to guarantee

restrictive

that

(39) The Danish authorities base their arguments on the
opinions of the SCF of 19 October 1990 (32) and 22
September 1995 (33) to denounce the serious health risks
connected with nitrites
and nitrates. The Danish
authorities refer in particular to the latter opinion of the
SCF which, having been formulated after the adoption of
Directive 95/2/EC, might have contained new elements
capable of bringing certain aspects of this Directive into
question. In this opinion of 22 September 1995, having
recalled that, after their addition to a meat product,
into nitrites and these
nitrates
nitrites lead to the formation of nitrosamines, the SCF
specified that (cid:145)there is an obvious correlation between the
addition of nitrites for the curing of meat and the
formation of volatile nitrosamines(cid:146). Nitrosamines are
type of
genotoxic, carcinogenic substances. For

transform themselves

this

(31) Infection caused by a consumer when handling the product.
(32) Reports of the SCF, 26th series.
(33) Reports of the SCF, 38th series.

(40) The Danish authorities are of

the opinion that

legislation does not meet

the
this health
Community
protection objective in that
it uses an inappropriate
methodology. The Danish authorities point out that there
is no relation between the quantity of nitrites and nitrates
added and the residues which may be detected in the
food product ready for consumption, but that there is an
(cid:145)obvious correlation(cid:146) between the quantity added and the
formation of nitrosamines. According to the Danish
authorities, legislation justified by health reasons ought to
be based on limiting the quantity added, and not on
limiting the residual amount. But Directive 95/2/EC in
fact determines the ingoing amounts only indicatively. If
there is a need to establish a limit
for the residual
amount, there is a simultaneous need to establish a limit
for the added quantity. The Danish authorities consider
that, quite apart
the
figures for the maximum levels of nitrites and nitrates
given in the Directive are too high compared with the
minimum needed to obtain the desired preservative effect
and to guarantee microbiological
safety. The Danish
authorities are therefore led to evoke the possibility that
the ADI is being exceeded. They do not however give
any details, but quote the SCF, which, in its opinion of
22 September 1995, stated that (cid:145)if the levels of nitrite
residues were as high as those authorised by Directive
95/2/EC, the ADI could be exceeded(cid:146).

from the methodology followed,

(41) The Commission notes in the first place that the Danish
measures do not appear consistent with the declared
objective of health protection in that they do not in any
way prevent nitrosamines from forming in products
which are widely consumed in Denmark, such as bacon
of the Wiltshire type, rolled meat sausage and fermented
Danish salami, since the use of nitrites and nitrates is
authorised in these products by the Danish Order of 23
September 1996 in conditions which are comparable
with those provided for in the Community legislation.

by

raised

fundamental

(42) The Commission then examined with particular attention
the
the Danish
questions
authorities. In its opinion of 1990, the SCF had already
evoked the connection between nitrites and nitrosamines
and had recommended reducing the levels of nitrites and
nitrates in foodstuffs as much as possible in order to
limit exposure by consumers to preformed nitrosamines.
The SCF reported a lack of scientific data concerning the
regards
formation

nitrosamines,

especially

of

as

22.12.1999

EN

Official Journal of the European Communities

L 329/13

regard

risk management.

endogenous nitrosamines, the main source of which is
the nitrites naturally present in saliva. Directive 95/2/EC
was adopted taking into account all
these questions
raised by the SCF. In its opinion of 1995, the SCF upheld
its opinion of 1990. If the memorandum of the Danish
authorities had contained new elements which would
help evaluations to progress, the SCF would have been
informed at once of the dossier. But the Commission is
forced to acknowledge that such is not the case of the
information communicated by the Danish authorities.
The Commission wishes to insist on the responsibility
incumbent on a legislator, whether Community or
national, with
The
to
Community legislator did fix the levels of nitrites and
nitrates in meat products, precisely in order to achieve
the desired technological aim and at the same time to
attain the objective of public health protection. Since
nitrites and nitrates greatly inhibit the proliferation of
they do effectively contribute to
Clostridium botulinum,
technological need,
avoiding cases of botulism. This
which the Danish authorities are not questioning for
some meat products, such as bacon of the Wiltshire type,
is,
from the health
point of view. The levels of use of these additives have
been calculated in order to attain this health objective. It
is not however excluded that, in the future, these levels
of use could be lowered in Community regulations to
take account of possible developments in the HACCP
approach with respect
to the hygiene of meat
products (34).

in the Commission’s view, crucial

(43) As regards the exceeding of the ADI, the Commission
would point out that the SCF has established an ADI of
5 mg/kg bw, expressed as sodium nitrate, for nitrites and
an ADI of 0,1 mg/kg bw, expressed as sodium nitrite, for
nitrites. The daily admissible intake for an adult
is
350 mg (5 mg/kg x 70 kg) in the first case and 7 mg
(0,1 mg/kg x 70 kg) in the other. To reach the level of
this admissible daily intake,
it would be necessary to
consume approximately 1 400 g of prepared meat
products (350 mg/kg/250 mg/kg) every day in the first
in the
case and 40 g of bacon (7 mg/kg/175 mg/kg)
other. The figures for the nitrates exclude a priori any
risk of exceeding the ADI (35). As far as nitrites are
concerned, the Danish authorities put forward no data on
the levels of consumption of meat products containing
nitrites in Denmark. Such data might have justified the
restrictive measures and even led to the adaptation of
Community legislation on this point. But
the Danish
authorities have not mentioned any study in their
memorandum enabling them to make comparisons with
European or world
average
population, with a view to determining whether the
Danish population is in a specific situation with regard to
the danger which the use of nitrites and nitrates could
represent. In this context the Commission would point
the review of Directive 95/2/EC could be
out

concerning

data

that

the

of

permit

additives

trends
to

the Commission to monitor
ought

initiated in several ways. The safeguard clause provided
for in Article 4 of Directive 89/107/EEC might lead to
the amendment of the positive list. Article 7 of Directive
95/2/EC, which makes it compulsory for Member States
in the
and
a
consumption
reexamination of the conditions of use of the additives
provided for in the Directive. Directive 95/2/EC could be
reviewed as a result of any new information provided,
such as a precise study on the levels of consumption of
foodstuffs likely to contain nitrites and nitrates and on
the possible need to impose further restrictions on the
conditions of use of nitrites in order for consumers not
to exceed the ADI. This is not however the case of the
information communicated by Denmark to support its
request for a derogation. What is more, so far no other
Member State has forwarded any such new information
to the Commission.

(44) The Commission therefore considers

that, while the
Danish measures are aimed at protecting public health,
they are excessive in relation to this aim.

(b) Absence of arbitrary discrimination

(45) Since the measures in question are not justified by the
need to protect public health, the Commission does not
have to verify whether this condition is satisfied.

(c) Absence of a disguised restriction on trade between

Member States

(46) Since the measures in question are not justified by the
need to protect public health, the Commission does not
have to verify whether this condition is satisfied.

(d) Absence of an obstacle to the functioning of the

internal market

(47) Since the measures in question are not justified by the
need to protect public health, the Commission does not
have to verify whether this condition is satisfied.

(34) See note 33 of this Decision. Work is in progress at Community
level
to examine the possibility of developing the HACCP
approach with regard to foodstuffs of animal origin which are not
covered by Directive 93/43/EEC.

(35) The conditions of use of nitrates were determined taking account
of the fact that their use as additives in foodstuffs contributes only
a small proportion of the total intake, most of which comes from
vegetables and water.

CONCLUSION

(48)

In the light of the above considerations, the Commission
concludes that the national provisions notified by the
Kingdom of Denmark pursuant
to the former Article
100a(4) of the EC Treaty, concerning the conditions of

L 329/14

EN

Official Journal of the European Communities

22.12.1999

use of sulphites, nitrites and nitrates in foodstuffs, though
pursuing the objective of protecting public health, which
is one of the major needs referred to in Article 30 of the
EC Treaty (formerly Article 36 of the Treaty), are not
justified since they are not strictly necessary for achieving
that objective. The Commission therefore has reason to
consider that the national provisions notified cannot be
approved,

HAS ADOPTED THIS DECISION:

Article 1

The Danish national provisions derogating from Directive
95/2/EC notified pursuant to the former Article 100a(4) of the

EC Treaty and examined by the Commission pursuant
Article 95(4) and (6) are not approved.

to

Article 2

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 26 October 1999.

For the Commission

Erkki LIIKANEN

Member of the Commission