1999/5/EC: Commission Decision of 21 December 1998 on the national provisions notified by the Kingdom of Sweden concerning the use of certain colours and sweeteners in foodstuffs (notified under document number C(1998) 4193) (Only the Swedish text is authentic) (Text with EEA relevance) (1999/5/EC)
Date: 1998-12-21
Institutions: European Commission
Subjects: Sweden, food colouring, foodstuff, foodstuffs legislation, national implementing measure, sweetener

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II

(Acts whose publication is not obligatory)

COMMISSION

COMMISSION DECISION

of 21 December 1998

on the national provisions notified by the Kingdom of Sweden concerning the
use of certain colours and sweeteners in foodstuffs

(notified under document number C(1998) 4193)

(Only the Swedish text is authentic)

(Text with EEA relevance)

(1999/5/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community, and in particular Article 100a(4) thereof,

foodstuffs to which these additives may be
of
added, the conditions under which they may be
added, and, where appropriate, a limit on the tech-
nological purpose of their use.

Whereas:

(2)

THE FACTS

1. Community legislation

(1)

Council Directive 89/107/EEC on the approxima-
tion of the laws of the Member States concerning
food additives authorised for use in foodstuffs
intended for human consumption (1) was adopted
on 21 December 1988. Article 3(2) of this Directive
shall, acting on a
provides
proposal
the
procedure laid down in 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

that
from the Commission under

the Council

(1) OJ L 40, 11. 2. 1989, p. 27; Directive as last amended by

Directive 94/34/EC,

(OJ L 237, 10. 9. 1994, p. 1).

Pursuant to the above provision, the Commission
presented three proposals for specific Directives,
the first on sweeteners, the second on colours and
the third on various additives. These proposals were
prepared in accordance with the requirements of
Article 6 of Directive 89/107/EEC after consulta-
tion with the Scientific Committee for Food (SCF)
which was asked by the Commission to evaluate
the safety of additives. The opinions of the SCF
which were used as a basis for the Commission’s
proposals for Directives were constantly taken into
consideration throughout the discussions on these
proposals for Directives in the European Parlia-
ment and the Council, right up to the adoption of
the Directives themselves. On 30 June 1994 two (2)
specific Directives (forming part of the compre-
hensive Directive pursuant to Article 3 of Directive
89/107/EEC) were adopted by the European Parlia-
in accordance with the
ment and the Council
procedure laid down in Article 100a, namely Direc-
in
tive 94/35/EC (3) on sweeteners

for use

(2) The third Directive, 95/2/EC,

is not concerned by this De-

cision.

(3) OJ L 237, 10. 9. 1994, p. 3; Directive as last amended by
(OJ L 48, 19. 2. 1997, p. 16; corri-

Directive 96/83/EC,
gendum: OJ L 259, 7. 10. 1994, p. 33).

(3)

(4)

(5)

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foodstuffs and Directive 94/36/EC on colours for
use in foodstuffs (1).

2. The national provisions

their national measures

On 1 December 1995 the Swedish authorities
adopted
transposing
Directives 94/35/EC and 94/36/EC (2). Member
States had been required to bring into force the
laws,
regulations and administrative provisions
necessary to comply with these two Directives by
31 December 1995 at the latest. The Swedish meas-
ures were communicated to the Commission in a
letter dated 30 April 1996. But in a previous letter,
dated 5 December 1995, the Swedish authorities
had informed the Commission of their decision
not
to transpose these two Directives in their
entirety. In this letter of 5 December 1995 the
Swedish Government notified the Commission,
pursuant to Article 100a(4) of the EC Treaty, of its
decision to continue to apply the national provi-
sions concerning the use in foodstuffs of azo dyes
(tartrazine E 102, orange yellow S, E 110, azorubine
E 122, amaranth E 123, ponceau 4R, E 124, red 2G,
E 128, allura red AC, E 129, black PN, E 151,
brown FK, E 154, brown HT, E 155 and litholru-
bine BK, E 180) and cyclamate (cyclamic acid and
its Na and Ca salts E 952) (3) by way of derogation
from Directives 94/35/EC and 94/36/EC.

concerning

Swedish provisions

The
additives
appear in three separate texts: the Foodstuffs Act (4),
the Foodstuffs Decree (5)
and the Foodstuffs
Administrative Order (6). This Order comprises the
positive list of additives authorised in Sweden and
the conditions for their use.

follows from Directive 94/36/EC
Accordingly it
that azo dyes may be used in specific maximum
quantities in certain foodstuffs, namely non-alco-
holic flavoured drinks, confectionery, pastries, ice
cream, desserts, sauces, mustard, soups and certain
fish products, but also in alcoholic drinks, cocktail
cherries and lumpfish roe caviar.

(6)

Order No 33 of 1993 permits azo dyes to be used
only under the following conditions:

— tartrazine E 102: cocktail cherries (maximum
200 mg/kg), alcoholic drinks and extracts for
the manufacture of
similar drinks and of
mixtures of drinks (maximum 500 mg/l),

— orange yellow S, E 110:

lumpfish roe caviar
(maximum 200 mg/kg), alcoholic drinks and
extracts for the manufacture of similar drinks
and of mixtures of drinks (maximum 500 mg/l),

— amaranth E 123: alcoholic drinks and extracts
for the manufacture of similar drinks and of
mixtures of drinks (maximum 100 mg/l),

— ponceau 4R, cochineal red A, E 124: alcoholic
the manufacture of
and of mixtures of drinks

drinks and extracts for
similar drinks
(maximum 100 mg/l),

— brilliant black BN, black PN, E 151: lumpfish

roe caviar (maximum 300 mg/kg),

— use of the colours azorubine E 122, red 2G,
E 128, allura red AC, E 129, brown FK, E 154,
brown HT E 155 and litholrubine BK, E 180 is
prohibited.

3. The case of azo dyes

4. The case of cyclamate

(7)

Directive 94/36/EC on colours provides that only
the substances listed in Annex I thereto may be
used as colours in foodstuffs. The Directive has four
other annexes. Annex II lists the foodstuffs which
may not contain added colours, except where
specifically provided for in Annex III, IV or V.
Annex III lists the foodstuffs to which only certain
permitted colours may be added. Annex IV covers
colours permitted for certain uses only, and Annex
V lists the colours permitted in foodstuffs other
than those mentioned in Annexes II and III.

(1) OJ L 237, 10. 9. 1994, p. 13.
(2) SLV FS 1995: 31.
(3) SLV FS 1993: 33.
(4) 1971: 511.
(5) 1971: 807.
(6) SLV FS 1993: 33 and SLV FS 1995: 31.

Directive 94/35/EC on sweeteners provides that
only sweeteners listed in the annex thereto may be
placed on the market with a view to sale to the
ultimate consumer or use in the manufacture of
foodstuffs. Sweeteners listed in the annex to the
Directive placed on the market with a view to the
manufacture of foodstuffs may only be used in the
manufacture of the foodstuffs listed in the annex
under the conditions specified therein. Accordingly
it follows from Directive 94/35/EC that cyclamate
may be marketed as such and used in specific
maximum doses in certain reduced-energy food-
stuffs or foodstuffs without added sugar, namely
water-based flavoured drinks, desserts,
confec-
tionery, edible ices, jams, and formulae for weight
control.

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(8)

(9)

(10)

Foodstuffs Administration Order No 33 of 1993
provides that foodstuffs containing cyclamate may
be placed on the market only if the Foodstuffs
Administration gives its authorisation. No such
authorisation has been given. The Order provides
only that table-top sweeteners with saccharine or
cyclamate or a mixture of these products as their
sole sweetening agents may be placed on the
market, under certain labelling conditions.

THE PROCEDURE

On 26 July 1994, some weeks after the adoption of
Directives 94/35/EC and 94/36/EC, the Swedish
delegation to the European Communities sub-
mitted a first request for derogation from these
directives to the General Secretariat of the Council,
invoking Article 151(2) of the Act of Accession.
The dossier was passed to the Commission depart-
ments, which then examined it. It was the subject
of in-depth discussions between the representatives
of the Swedish authorities and the Commission
departments
The Commission
departments.
informed the Swedish authorities that a derogation
could not be authorised on the basis of the scien-
tific grounds with which they had justified their
to the General
request. In a further letter sent
Secretariat of the Council on 23 December 1994
the Swedish authorities noted the unfavourable
opinion of the Commission departments, accepted
that the Article 151 procedure had to be terminated
and affirmed that if Sweden had been able to take
part in the vote when the two Directives were
adopted it would have voted against their adoption.

the EC Treaty. In this request

In a letter dated 5 December 1995 the Swedish
Government made a new request for derogation
from these two Directives, invoking Article 100a(4)
of
the Swedish
authorities gave a detailed account of the reasons
why they had decided to keep their national legis-
lation in force. The notification was forwarded to
the other Member States for their opinions. The
Commission received opinions
from Germany,
Greece, Spain, France, Portugal, Finland and the
United Kingdom. None of these Member States is
in favour of Sweden’s request.

— Germany considers that

the arguments put
forward by the Swedish authorities cannot call
into question the opinions of the SCF on the
basis of which the Directives were adopted,

— Greece thinks the demands of

the internal
market make it necessary to find a solution to
the problem at Community level. A system for
monitoring trends in the consumption of addi-
tives has already been set up to this end,

— Spain considers that no toxicological or epid-
emiological study justifies the taking of meas-
ures more restrictive than Community legisla-
tion,

— France thinks the Swedish restrictions do not
seem justified since the Swedish authorities
have not supplied case-by-case proof of
the
public health risk,

— Portugal considers that Sweden has not proved
that the additives in question present health
risks or that the danger is greater for Swedish
consumers,

— Finland considers that the grounds given by
Sweden do not take account of scientific bases
which would make it possible to decide that the
situation of the Swedish population is excep-
tional compared with the other Member States,

— The United Kingdom considers

the
Swedish request does not appear to be based on
factors which would concern only the Swedish
population.

that

LEGAL ASSESSMENT

1. Consideration of admissibility

(11) Directives 94/35/EC and 94/36/EC were adopted
on 31 June 1994. At that time Sweden was not a
the European Community but had
member of
observer status. Sweden had therefore been unable
to take part in the voting on these two Directives
but it had pointed out that had it been able to
participate it would have voted against adoption of
the text. Sweden had therefore declared its inten-
tion to request a derogation from these Directives.
Sweden could not obtain a derogation from these
Directives in the framework of the accession nego-
tiations which had been concluded six months
previously, on 31 December 1993. It could not,
therefore, set in motion the machinery provided for
in Article 151(2) of the Act of Accession. This
provides for the possibility for a Member State to
enjoy a temporary derogation from acts of the insti-
tutions adopted between 1 January and 24 June
1994, the date of signature of the Accession Treaty.
But the Directives in question were adopted after
that date, on 30 June 1994. On 7 December 1995
the Commission received a notification from
Sweden pursuant
the EC
Treaty, the admissibility of which has to be exam-
ined in the light of that Article.

to Article 100a(4) of

(12)

(13)

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In this respect it should be pointed out first of all
that the Commission received Sweden’s notifica-
tion pursuant
to Article 100a(4) before 31
December 1995, the time limit for the transposi-
tion of Directives 94/35/EC and 94/36/EC.

the Commission has concluded that the national
provisions notified were justified, it must also verify
whether these measures do not constitute a means
of arbitrary discrimination or a disguised restriction
of trade between Member States.

The first indent of Article 100a(4) reads as follows:
‘If, after the adoption of a harmonisation measure
by the Council acting by a qualified majority, a
Member State deems it necessary to apply national
provisions on grounds of (. . .) it shall notify the
Commission of these provisions'. The Commission
considers this to mean that the State in question is
a Member State at the time when it notifies the
Commission of its national provisions. The provi-
sion has, moreover, to be interpreted in the light of
what
it seeks to achieve, which is to allow a
Member State to obtain the right to derogate from a
harmonisation measure which it has not agreed to,
since such a mesure may be adopted by a qualified
majority and no longer unanimously as was the
case before the entry into force of the Single Euro-
pean Act which introduced Article 100a(4).

(14)

In the case in point the Commission therefore
considers the Kingdom of Sweden to be entitled to
notify the Commission of a request for derogation
from Directives 94/35/EC and 94/36/EC under
Article 100a(4) of the EC Treaty, since it was not in
a position to agree to the adoption of the Directives
in question and made its notification as a Member
State before the time limit for transposition of the
Directives in question.

2. Assessment of the merits

(a) Justification with regard to the major need to

protect public health

(i) The case of azo dyes

(16)

(17)

In the 1970s the Swedish authorities decided to
limit the use of azo dyes in Sweden. These restric-
tions were justified by the risks of allergies caused
by azo dyes. Azo dyes may cause allergic reactions
in certain individuals, or hypersensitivity reaction
such as urticaria and asthma. The Swedish author-
ities mention in their notification letter a number
of epidemiological studies of the Swedish popula-
tion which they claim indicate the presence of
allergic complaints (1). They also refer to several
studies of children in another Member State, which
show an increase over time in the number of chil-
dren suffering from allergies for reasons connected
with the azo dyes which are permitted there (2). The
Swedish authorities have sent
the Commission
copies of these different studies.

The Commission is not calling into question either
the methods used or the results obtained in these
studies. It considers that
they tally with those
carried out by the SCF on the same issues. These
SCF evaluations, on the basis of which Directive
94/36/EC on colours was adopted, also highlighted
cases of certain individuals’ intolerance to azo dyes.
The SCF’s latest evaluations on these matters are
contained in its ‘Report on adverse reactions to
foodstuffs and their ingredients', published on 22
September 1995. In this report the SCF states that
‘although azo dyes and non-azo colours were
involved in a number of anecdotal hypersensitivity
reactions, it was concluded that their involvement
was rare'. It must therefore be recognised that the

(15)

In accordance with the substance provisions of
Article 100a(4) of the EC Treaty the Commission
has to make sure that the national provisions noti-
fied pursuant
to that Article are justified on
grounds of major needs referred to in Article 36, or
relating to protection of the environment or the
working environment. In their notification letter
the Swedish authorities give as their objective the
protection of public health. The Commission
therefore has to verify whether these measures are
necessary and in proportion to the objective. Once

(1) Settipane G. A., Chafee F. H., Postman I. M., Levine M. I.,
Saker J. H., Barrik R. H., Nicholas S. S., Schwartz H. J.,
Honsinger R. W., Klein D. E., Significance of tartrazine sensi-
tivity in chronic urticaria of unknown etiology. J. Allergy
Clin. Immunl 1976; 57; 541-6.
(cid:143)berg N., H(cid:132)sselmar B., (cid:143)berg B., Eriksson B., 1995. Increase
of asthma, allergic rhinitis and eczema in Swedish school-
children between 1979 and 1991. Clin. and Exp. Allergy, Vol.
25, 815-819.
Slorach S. A. 1981. The problem with intolerance to food
additives and Nordic strategies for dealing with it. Toxicology
Forum Meeting, Gen(cid:138)ve, 6 to 9 April.

(2) Fuglsang G., Madsen C., Saval P., Osterballe O., 1993. Pre-
valence of intolerance to food additives among Danish school
children. Pediatric and Allergy Immunology, 4: 123-129.

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(18)

restrictive measures applied in Sweden with regard
to azo dyes are in fact based on public health
considerations. But it has to be verified whether
these measures are necessary and in proportion to
the objective of protecting public health.

The Swedish authorities point out in their request
that their objective is to protect public health and
that in order to achieve this objective the use of
additives likely to damage the health of consumers
must be reduced as far as possible. The Commis-
sion recognises this principle and recalls that it is
the basis of the Directives on additives. Annex II to
the framework Directive 89/107/EEC on additives
sets the general criteria for the use of food addi-
tives. Accordingly, food additives can be approved
only if (i) there can be shown to be a sufficient
technological need and the objective pursued
cannot be achieved by other economically and
technologically feasible methods, (ii) if they present
no danger to the health of the consumer, in so far
as the scientific data available allow this to be
judged, and (iii) if their use does not mislead the
consumer. The use of a food additive can be envis-
aged only if it is proved that the proposed use of
the additive brings demonstrable benefits for the
consumer. To determine the possible harmful
effects of a food additive or its derivatives, the addi-
tive has to be subjected to appropriate toxicological
testing and evaluation. This evaluation has to take
into account, for example, any cumulative, syner-
gistic or potentiating effect depending on its use, as
well as any intolerance of the foreign substances by
the human body. Directive 94/36/EC was adopted
on the basis of the opinions delivered by the SCF
on colours. Due account has been taken in that
Directive of the opinions of the SCF stating that
azo dyes cause allergies in certain individuals.
Directive 94/36/EC defines the conditions for use
of azo dyes in a restrictive way by setting limits as
to the foodstuffs in which these additives can be
used and by specifying maximum quantities for
their use. But the Swedish authorities want to go
further. They think the use of
these additives
should be restricted even more since their use is
not technically indispensable. Since azo dyes have a
technological function, which consists in colouring
food which does not have a colour of its own so
that it will have a more attractive appearance, the
Swedish authorities take the view that this simple
need for colouring could be satisifed with other
colours which would not present allergy risks.

(19)

The Commission does not share this view. It has
no knowledge of any non-azo colours which can be

(20)

(21)

specific

colouring

chosen for

substituted for each of the azo dyes to give equi-
valent colouring of foodstuffs. The colouring of a
foodstuff meets a technological need. In most cases,
a
commercial
purposes to give a food an attractive appearance can
be obtained only by using a specific colour. In a
number of cases this specific colour has to be used
in a particular food to the exclusion of other
substances for technological reasons to do with its
and stability
(uniform colouring)
effectiveness
(durable colouring) in the finished product. Thus it
may become necessary for both commercial and
technological reasons to use azo dyes in order to
obtain precise colouring of certain foods such as
confectionery or drinks.

The Commission also finds that the Swedish meas-
ures notified are inconsistent with the declared
objective of protecting public health. The restric-
tive measures apply to azo dyes only. But azo dyes
are not the only additivies which present allergy
risks. Thus one might, on the basis of the SCF’s
report of 22 September 1995 referred to above,
mention the example of certain non-azo dyes,
sulphites and benzoates. One might also take as a
basis a study, mentioned by the Swedish authorities
themselves in their notification letter, entitled ‘The
problem of intolerance to food additives and the
Nordic countries’ strategies for dealing with it',
citing cases of allergies to benzoates. The Commis-
sion observes that in Sweden these different sources
of allergies have not been subject to the same sort
of restrictions as those applicable to azo dyes.

reactions

food allergies

the Commission considers

Furthermore,
that
Community legislation provides an appropriate
in
response to the problem of
general. As mentioned in the previous point, it is
recognised that a number of additives can set off
allergic
in certain individuals. The
Community legislator accepts that it is perfectly
legitimate to avoid, as far as possible, exposing
these individuals to risks of allergic reactions. But
the Community legislator did not see fit to place a
general ban on the use of these additives. The
solution adopted by the Community is based on
informing the consumer:
individuals who are
allergic to certain ingredients should be able to
choose foodstuffs which do not contain them.

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(22)

(23)

Directive 79/112/EEC on foodstuff labelling gives
them this possibility by making it compulsory to
indicate the ingredients on the labelling. In partic-
ular, under Article 6 of that Directive all additives
function in the
technological
which fulfil
finished product (such as colours which have the
function of giving the finished product a particular
colouring) have to be mentioned on the labelling.
Accordingly, azo dyes must always appear in the
list of ingredients.

a

In their letter of 5 December 1995 the Swedish
authorities themselves recognise that these label-
ling measures are sufficient to allow consumers
who are allergic to select foodstuffs they wish to
consume. But the Swedish authorities state at the
same time that this opportunity for consumers to
make a choice is not available when they are
for
offered the food without prepackaging, as
example in restaurants and school canteens. In
such circumstances, where there is no labelling, the
consumer cannot know the list of ingredients.

The Commission considers that this does not in
itself justify a total ban of the use of azo dyes in
these non-prepackaged foodstuffs. The Commis-
that measures other than
sion would point out
prohibition can be carried out in conformity with
existing Community legislation to settle this partic-
ular problem of foodstuffs offered for sale to the
consumer without prepackaging. Article 12 of
Directive 79/112/EEC provides that the Member
States decide detailed rules for labelling these food-
stuffs, such as the obligation to affix notices accom-
panying products sold in bulk and containing
certain particulars on these products. Moreover, in
the
order to inform all consumers fully about
content of certain foodstuffs Member States may
require restaurants to include the list of ingredients
on the menu. It is true that most of the time the
consumers concerned are in fact children:
the
products in question are confectionery and non-
alcoholic drinks which children tend to consume
more often and in larger quantities than adults.
Children cannot be considered to be ‘consumers
who are heedful of the composition of a product'
within the meaning of
the Court of Justice
Decision of 26 October 1995 in Case C-51/94 (1).
But the Commission thinks that the case of food-
stuffs containing azo dyes and offered without
prepackaging to children could also be resolved in

letter

school.

authorities’

notification

a positive way instead of via prohibition. From the
Swedish
the
Commission notes that children eat such confec-
tionery at
In the Commission’s view
Swedish schools, like the parents, could take care
not to make available to allergic children products
which are likely to give them allergic reactions. In
school canteens, for instance, posting up the list of
ingredients in food offered to children would allow
an adult to check whether this list tallied with a
list, drawn up by a doctor, of ingredients causing
allergic reactions in the child concerned.

(24)

(25)

The Commission has also checked whether azo
dyes pose a particular health problem for
the
Swedish population compared with the populations
of other Member States. The Swedish authorities
mention several epidemiological studies in their
notification letter. The Commission has taken note
of these studies and examined them in detail to see
whether they contain the proof that the Swedish
population or a subgroup of the population, such as
children, are a special case compared with the
populations of the other Member States with regard
to allergies to azo dyes.

The studies mentioned by the Swedish author-
ities (2) tend to describe the prevalence of allergic
disorders in Sweden in a general way. They show
that the frequency of allergies is higher in children
than in adults and that it is appreciably higher in
the northern regions than in the more southern
regions of Sweden. Another study carried out in
Sweden over several years shows a rise in the
number of allergy cases. These studies underline
the fact that the allergic disorders found have envir-
onmental causes, and in particular the individuals’
quality of life at school or work. These studies do
not highlight cases of allergies connected with the
consumption of
foodstuffs containing additives
such as azo dyes. There cannot in fact be any study
foodstuffs
connected with the consumption of
containing azo dyes in Sweden on account of the
prohibitions and restrictions on the use of these
additives laid down in the relevant national legisla-
tion. But with the study tending to indicate a
predisposition of Swedish children to allergies, one
might be inclined to think that if the children eat
food likely to contain azo dyes (basically con-
fectionery and fizzy drinks) many of
them are
going to suffer allergic reactions. In their notifica-
tion letter
the Swedish authorities have thus
referred to a study of Danish schoolchildren which
reveals allergic disorders connected with additives
including certain azo dyes, putting at 1 to 2 % the
prevalence of allergy to food additives in Danish
children.

(1) European Commission v. Federal Republic of Germany, ECR

1995 p. I-3599.

(2) See paragraph 16.

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(26)

(27)

(28)

there is a causal

The Commission has to check whether all of the
information submitted by the Swedish authorities
link between the
shows that
possible consumption in Sweden of
foodstuffs
containing azo dyes and specific allergic risks in
the
in
Swedish population and particularly
children. This involves several stages.

available

information such as

First of all the Commission has to make sure that it
has the necessary information, and then compare it
with the
that
collected at European or international level. The
Swedish authorities have provided statistical data
on the prevalence of allergy in the Swedish popula-
tion, but not on the prevalence of food allergy or
allergy to additives, and have not therefore been in
a position to evaluate the prevalence of allergy to
azo dyes. It is not possible to estimate the preval-
ence of allergy to azo dyes by referring to existing
data on the prevalence of allergy in general, since
the mechanisms, like the symptoms, of allergies
differ from one allergen to another, an individual
subject to one type of allergy not necessarily being
subject to another. The Commission therefore finds
that
the Swedish authorities have not
supplied it with statistical data on the prevalence of
allergy to azo dyes in the Swedish population, it
cannot make comparisons with average data for the
European population or the world population, in
order to determine whether the Swedish population
is a special case as regards the prevalence of allergy
to azo dyes.

since

The Commission has also endeavoured to study the
situation in greater depth by taking as its basis the
SCF’s report of 22 September 1995 on adverse reac-
tions to food and food ingredients. In this report
the SCF points out that according to the available
studies carried out throughout the world ‘the pre-
valence of food allergy is substantially less than
1 % in the adult population and may be slightly
higher in children'. The SCF mentions several
studies showing that the prevalence in respect of
food additives in particular is less than 0,1 % of the
population. But the SCF adds an important rider in
its report: genetic and environmental factors and
food habits can increase the prevalence of food
allergy. The SCF gives the example of regions
where allergens are present in the environment. It
also mentions the cases of regions where allergens
are widely consumed. The SCF concludes that ‘the
prevalence of food allergy depends very much on
the geographical region'. The Commission has thus
checked whether the Swedish authorities really

have proved (in the studies which they have
communicated to the Commission) the existence
and the importance of such factors, connected with
genetics, environment or food habits. The Finnish
authorities too, in the context of the consultation of
the Member States on the Swedish derogation
request, described a similar situation with regard to
Finnish children. These facts and studies quoted by
the Swedish authorities do not allow one to
conclude that the Swedish population, or Swedish
children in particular, are a special case compared
with the populations of the other Member States, in
particular Sweden’s immediate neighbours, with
regard to this matter of allergies associated with azo
dyes.

(29)

It appears in fact that the measures taken by the
Swedish authorities in the 1970s to restrict the use
of azo dyes were part of a general prevention policy
and not because a specific public health risk had
been found. The preventive nature of these policy
measures has been explicitly confirmed in the
study communicated by the Swedish authorities
entitled ‘The problem of intolerance to food addi-
tives and the Nordic countries’
for
strategies
the Swedish
dealing with it'. The position of
authorities contrasts, moreover, with that taken on
the same problem by the Danish and Finnish
authorities, which did not pursue the same strategy
as the Swedish authorities aimed at restricting the
conditions of use of azo dyes compared with those
provided for in Directive 94/36/EC, but which
judged the labelling measures to be sufficient.

(30)

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

(ii) The case of cyclamate

(31)

In the 1970s the Swedish authorities decided to
limit the use of cyclamate as a food additive. The
conditions of use of cyclamate provided for in
Directive 94/35/EC are less restrictive than those
laid down in Sweden. In the view of the Swedish
authorities there are good public health reasons for
keeping their more restrictive national provisions.
The Swedish authorities refer to studies which
the conditions of use of cyclamate
show that
provided for in Directive 94/35/EC can in certain
consumers lead to the permissible daily dose being
exceeded.

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Official Journal of the European Communities

7. 1. 1999

The specific Community Directives on additives
were adopted on the basis of a thorough safety
evaluation carried out on all additives by the SCF
so that only additives considered safe to use in food
appear in these specific Directives and can there-
fore be used in the Community. The evaluation of
the safety of an additive may reveal the need to fix
an acceptable daily intake (ADI) to protect public
health. This ADI represents the quantity which can
safely be ingested without risk on average each day
throughout a lifetime. The ADI, which itself
includes a safety factor
is
expressed in milligrams per kilogram of body
weight (mg/kg bw). The approval of any food addi-
tive and determination of the conditions for using
it therefore have to take into account the techno-
logical need for the additive in question (dose
needed to achieve the desired effect) and the prob-
able daily supply of the additive in all foodstuffs, so
as to verify that the use authorised will not exceed
the ADI established for the additive in question.

from 100 to 500,

case of a five year-old child who, it would seem,
consumes each day reduced-energy foods or foods
without added sugar, amounting to 600 ml of soft
drinks containing cyclamate in a dose of 400 mg/l,
60 g of sweets containing cyclamate in a dose of
500 mg/kg and 90 g of ice cream containing cycla-
mate in a dose of 250 mg/kg. It would seem that
this diet provides the child with some 292 mg of
cyclamate a day, this being the sum total of the
cyclamate from the drinks (600 ml (cid:253) 400 mg/l =
240 mg) from the sweets (60 g (cid:253) 500 mg/kg = 30
mg) and from the ice cream (90 g (cid:253) 250 mg/kg =
22 mg). This figure of 292 mg should be compared
with the admissible daily intake for this child who
weighs 20 kg. The admissible daily intake is calcu-
lated by multiplying the weight of the consumer by
the ADI. The ADI set by the SCF is 11 mg/kg cw
(value confirmed in a SCF opinion issued on 14
December 1995), and the admissible daily intake
for the child is 220 mg (20 kg (cid:253) 11 mg/kg cw).
This child’s daily intake of cyclamate, apparently
292 mg, is therefore significantly greater than the
admissible intake which is 220 mg.

(32)

(33)

(35)

The Swedish authorities consider that
ingesting
cyclamate in the conditions set out in Directive
94/35/EC while keeping to the precise limits laid
down in it might cause the ADI to be exceeded if
the levels of consumption of the various products
in which cyclamate can be used are taken into
account. The Swedish authorities rely on estimates
made by the Swedish Foodstuffs Administration
showing that there is a risk that the ADI will be
exceeded for those population sub-groups who are
advised to use this type of sweetener, namely
diabetics and people on a diet, especially children.
The figures given by the Swedish authorities there-
fore reflect the high consumption levels that such
people may have. As these figures are not directly
available they have been obtained by extrapolation
of the basis of data on household food consump-
tion (1), by applying a factor of
three to these
average consumption levels.

The Commission has examined in detail all the
information communicated by the Swedish author-
ities. This examination has led it to express reserves
about the methodology chosen in order to estimate
the high levels of consumption of foodstuffs likely
to contain cyclamate. The Commission recognises
the difficulties that
the Member States have in
monitoring consumption of food additives in order
to estimate the high consumption levels that some
population sub-groups may have. These difficulties
have been analysed in detail in a report submitted
to the Commission in January 1998 (2). This report
indicates that in the case of an additive from a
single source (one group of foodstuffs) high levels
may be estimated by extrapolation on the basis of
the average data available using the factor 3.
However, according to this report the same method
is inappropriate for calculating the intake of an
additive from several combined sources (e.g. drinks,
a
It
sweets
consumer with a large consumption of foodstuff
belonging to a particular group of foodstuffs cannot
be considered statistically as consuming in the
same way, i.e. substantially, foodstuffs belonging to

recognised that

and desserts).

is

(34)

The Swedish authorities cite a number of examples
of consumers of different ages and hence different
weights belonging to these population sub-groups
who are liable to consume sweetened foodstuffs in
greater quantities than the average for the popula-
tion as a whole. They mention in particular the

(1)

‘Hush(cid:134)llens
(household food purchases and eating habits).

livsmedelsink(cid:148)p och kostvanor' HULK 1989

(2) Report dated 16 January 1998 submitted to the Commission
including Sweden, entitled
by a number of Member States,
‘Development of methodologies for the monitoring of
food
additive intake across the European Union'. This report was
cooperation
drawn up in the
programme provided for by Council Directive 93/5/EEC of 25
February 1993 on assistance to the Commission and coopera-
tion by the Member States in the scientific examination of
questions relating to food (OJ L 52, 4. 3. 1993, p. 18).

scientific

context

of

a

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Official Journal of the European Communities

L 3/21

(37)

other groups. It is therefore recommended in this
report that an alternative statistical method should
be used which does not run the risk of overesti-
mating actual consumption levels. The Commis-
sion finds that this method was not used by the
Swedish authorities, with the result that it has reser-
vations about the figures submitted to it. However,
above and beyond these considerations about
extrapolation methods, the Commission wonders
whether the figures put forward by the Swedish
authorities are realistic. The statistical method used
shows that there would seem to be a significant
exceeding of the ADI in the case of diabetics and
in particular diabetic children. The Commission is
not convinced that these results, arrived at on the
basis of statistics, are realistic. They do not take
account of the fact that diabetics are a population
sub-group who, more than any other consumers,
attach particular importance to their diet, which in
order to be balanced is in most cases the subject of
medical supervision. Be that as it may, and what-
ever method is used,
the data suplied by the
Swedish authorities do not, in the Commission’s
the Swedish population or
opinion, show that
population sub-groups are in a specific situation
compared with the populations of
the other
Member States with regard to this question of
exceeding the cyclamate ADI.

all, however, these measures do not seem to take
account of the fact that consumers are informed of
the presence of cyclamate in food.

that

considers

Commission

their parents or
for example,

The
existing
Community legislation gives consumers or, in the
the persons
case of children,
responsible for them,
teachers, an
assurance of sufficiently clear and full information
as to whether or not foodstuffs contain cyclamate.
As an additive, cyclamate has to be included in the
list of ingredients, under Articles 3 and 6 of Direc-
tive 79/112/EEC. Also, products containing cycla-
mate must state ‘with sweetener' on their labelling,
to Council Directive 96/21/EC of 29
pursuant
March 1996 amending Commission Directive 94/
54/EC concerning the compulsory indication on
the labelling of certain foodstuffs of particulars
other than those provided for in Directive 79/
112/EEC (1). These labelling rules are mandatory
for products offered for sale to the consumer in
prepackaged form. As regards products containing
cyclamate which are not
the
Commission recalls to mind that under Article 12
of Directive 79/112/EEC the Member States decide
the manner in which these foodstuffs are labelled,
such as the obligation to affix notices accom-
panying products sold in bulk and containing
certain particulars on these products. To sum up,
the Commission finds that
there are labelling
measures in existence which are, moreover, consid-
ered sufficient by the authorities of
the other
Member States, which have not thought it neces-
sary to tighten up the conditions of use of cycla-
mate compared with those provided for in Direc-
tive 94/35/EC.

prepackaged,

(36)

examined whether

The Commission has
the
restrictive measures in force in Sweden are propor-
tionate. In other words, the aim of the Swedish
provisions must not be achievable by means that
are less restrictive of trade within the Community.
The Commission would point out that the Direc-
tive authorises the use of cyclamate in a number of
reduced-energy products or products without added
sugars, namely certain soft drinks, certain fruit-
based or milk-based drinks, desserts, sweets,
ice
cream,
jam and dietary preparations. Foodstuffs
Administrative Order No 33 of 1993 prohibits in
principle the use of cyclamate in foodstuffs. Cycla-
mate is only authorised in Sweden as a table-top
sweetener. In the Commission’s view the Swedish
measures seem to go further than is necessary to
deal with the problem. They appear radical in that
in practice they amount purely and simply to a ban
on the use of cyclamate in foodstuffs. To the
Commission, a less unreasonable way to avoid cases
of exceeding the ADI for cyclamate would seem to
be to tighten up the conditions for using cyclamate
in food, for example, by limiting the foodstuffs in
Above
can
which

cyclamate

used.

be

(38)

The Commission considers that the uses of cycla-
mate currently provided for in Directive 94/35/EC
are sufficiently regulated and unlikely to lead to
risks of exceeding the ADI expressed by the SCF.
The Directive lays down conditions for use of
cyclamate such that there should not be consumers
or groups of consumers with a balanced diet who
regularly exceed the ADI over a substantial period
of time. Moreover, the Commission would point
out that the Community provisions on cyclamate
may be revised. The revision of Directive 94/35/EC
could take place in three possible ways: (i) in the
framework of Article 4 of Directive 89/107/EEC,
which introduces a safeguard clause into the frame-
work legislation on additives; (ii) at the Commis-
sion’s initiative, which might be envisaged as a way
of following up the opinion which the SCF should

(1) OJ L 88, 5. 4. 1996, p. 5.

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7. 1. 1999

deliver in the first half of 1999 with regard to
cyclamate; and (iii) under Article 8 of Directive
94/35/EC, which requires Member States and the
Commission to monitor sweetener consumption.
This revision could take place on the basis of any
new piece of information, such as a detailed study
of the levels of consumption of foodstuffs liable to
contain cyclamate and of the possible need for
additional restrictions on the conditions of use of
cyclamate, so that consumers do not exceed the
ADI. This is not the case with the information
communicated by Sweden in its derogation request.
Moreover, not one Member State has so far sent the
Commission any such information.

The Commission therefore considers that, while
the Swedish measures are aimed at protecting
public health, they are excessive in relation to this
aim.

(b) The absence of arbitrary discrimination

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) The absence of a disguised restriction on trade

between Member States

(39)

(40)

CONCLUSION

(42)

the above considerations

In the light of
the
Commission concludes that the national provisions
notified by the Kingdom of Sweden pursuant to
Article 100a(4) of the EC Treaty, concerning the
conditions of use of azo dyes and cyclamate in
foodstuffs,
though pursuing the objective of
protecting public health, which is one of the major
needs referred to in Article 36 in the Treaty, are not
justified since they are not strictly necessary for
achieving that objective.

(43)

The Commission therefore has reason to consider
the national provisions notified cannot be
that
confirmed,

HAS ADOPTED THIS DECISION:

Article 1

The Swedish national provisions derogating from Direct-
ives 94/35/EC and 94/36/EC notified pursuant to Article
100a(4) of the EC Treaty are not confirmed.

Article 2

This Decision is addressed to the Kingdom of Sweden.

Done at Brussels, 21 December 1998.

(41)

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.

For the Commission

Martin BANGEMANN

Member of the Commission