2008/448/EC: Commission Decision of 23 May 2008 concerning national provisions notified by Denmark on the addition of nitrite to certain meat products (notified under document number C(2008) 2168)
Date: 2008-05-23
Institutions: European Commission
Subjects: Denmark, chemical salt, derogation from EU law, food additive, foodstuffs legislation, meat product

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(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 23 May 2008

concerning national provisions notified by Denmark on the addition of nitrite to certain meat
products

(notified under document number C(2008) 2168)

(Only the Danish text is authentic)

(2008/448/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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

Whereas:

I. FACTS AND PROCEDURE

(1)

(2)

(3)

By letter of 21 November 2007, which reached the Commission on 23 November 2007, the
Permanent Representation of the Kingdom of Denmark to the European Union, notified to the
Commission its national provisions concerning the addition of nitrites to certain meat products,
pursuant to Article 95(4) of the Treaty establishing the European Community. The Kingdom of
Denmark considers it necessary to maintain these provisions in spite of the adoption of Directive
2006/52/EC of the European Parliament and of the Council of 5 July 2006 amending Directive
95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners
for use in foodstuffs (1) and intends not to transpose Directive 2006/52/EC into national law insofar
as it concerns the addition of nitrite to meat products.

1.1. ARTICLE 95(4) AND (6) OF THE EC TREATY

1. COMMUNITY LEGISLATION

Article 95(4) of the EC Treaty provides that ‘If, after the adoption by the Council or by the
Commission of a harmonisation measure, a Member State deems it necessary to maintain national
provisions on grounds of major needs referred to in Article 30, or relating to the protection of the
environment or the working environment, it shall notify the Commission of these provisions as well
as the grounds for maintaining them.’

According to Article 95(6) of the EC Treaty, the Commission shall, within six months of the
notification, approve or reject the national provisions involved after having verified whether or
they are a means of arbitrary discrimination or a disguised restriction on trade between
not
Member States and whether or not they shall constitute an obstacle to the functioning of the
internal market.

(1) OJ L 204, 26.7.2006, p. 10.

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(4)

(5)

(6)

(7)

(8)

(9)

1.2. DIRECTIVE 2006/52/EC

Under the general principles of Council Directive 89/107/EEC of 21 December 1988 on the approxi-
mation of the laws of the Member States concerning food additives authorised for use in foodstuffs
intended for human consumption (1), the approval of a food additive is subject to a reasonable
technological need, its acceptability from a health point of view and its use not being misleading
for the consumer.

in
inter alia, to secure,
Nitrites have been used in meat and meat products for many decades,
in
conjunction with other factors, the preservation and microbiological safety of meat products,
particular cured meat products,
inhibiting, amongst other things, the multiplication of Clostridium
botulinum, the bacteria responsible for life-threatening botulism. At the same time, it is recognised
that the presence of nitrites in meat products can give rise to the formation of nitrosamines, which
have been found to be carcinogenic. Legislation in this field must, therefore, strike a balance between
the risk of the formation of nitrosamines through the presence of nitrites in meat products, on the
one hand, and the protective effects of nitrites against the multiplication of bacteria, in particular
those responsible for botulism.

Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food
additives other than colours and sweeteners (2), as it was adopted originally, laid down maximum
levels of nitrites and nitrates for various meat products as well as ‘indicative ingoing
residual
amounts’. Annex I(3)(c) to Directive 2006/52/EC amends Annex III Part C to Directive 95/2/EC in
relation to E249 (potassium nitrite) and E250 (sodium nitrite).

By contrast, as a general rule, Directive 2006/52/EC contains maximum amounts for E249 potassium
nitrite and E250 sodium nitrite that may be added during manufacture. The maximum added amount
is 150 mg/kg for meat products in general and 100 mg/kg for sterilised meat products. For a few
specified cured meat products made traditionally in specific Member States the maximum amount is
180 mg/kg.

This approach follows opinions from the Scientific Committee for Food (hereinafter SCF) of 1990 (3)
and 1995 (4) as well as from the European Food Safety Authority (hereinafter EFSA) of 26 November
2003 (5), which established that the ingoing amount of nitrite, rather than the residual amount,
contributes to the inhibitory effect against C. botulinum and recommended to replace ‘indicative
ingoing amounts’ with ‘maximum ingoing amounts’. It also takes account of the Court's ruling in
Case C-3/00 Denmark/Commission relating to a previous Danish request under Article 95(4) of the EC
Treaty and in which the Court held that, when rejecting the Danish request in relation to the use of
nitrites in meat products, the Commission did not take sufficient account of the SCF's opinions of
1990 and 1995, which cast doubt on the appropriateness of the amounts of nitrite authorised by
Directive 95/2/EC (6).

By way of exception to the general rule, Directive 2006/52/EC contains maximum residual levels for
certain specified traditional cured meat products, which are produced through traditional manufac-
levels of 50 mg/kg, 100 mg/kg and 175 mg/kg
turing methods. There are maximum residual
applying to different groups of such products, e.g. 175 kg/kg for Wiltshire bacon, dry-cured bacon
and similar products, and 100 mg/kg for Wiltshire ham and similar products. In relation to these
products maximum residual values have been established since it is not possible to control the
ingoing amount of curing salts absorbed by the meat due to the nature of the manufacturing
these specific products is
process associated with these products. The production process of
described in the Directive to enable identification of ‘similar products’ and to make clear what
products are covered by the different maximum levels. The table below contains the maximum
levels established by Directive 2006/52/EC (7).

(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament

and of the Council (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 61, 18.3.1995, p. 1. The Directive was last amended by Directive 2006/52/EC (OJ L 204, 26.7.2006, p. 10).
(3) Opinion on nitrates and nitrites expressed on 19 October 1990, European Commission — Reports of the Scientific

Committee for Food (26th series), p. 21.

(4) Opinion on nitrates and nitrite expressed on 22 September 1995, European Commission — Reports of the Scientific

Committee for Food (38th series), p. 1.

(5) Opinion of the Scientific Panel on Biological Hazards on a request from the Commission related to the effects of

Nitrites/Nitrates on the Microbiological Safety of Meat Products, The EFSA Journal (2003) 14, 1-34.

(6) Judgment of 20 March 2003, in particular points 109-115.
(7) Directive 2006/52/EC as corrected by Corrigendum (OJ L 78, 17.3.2007, p. 32).

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E No

Name

Foodstuff

Potassium nitrite (x) Meat products

E249

E250

Maximum amount
that may be added
during manufacture
(expressed as
NaNO3)

150 mg/kg

Maximum residual
level
(expressed as
NaNO3)

Sodium nitrite (x)

Sterilised meat products (Fo > 3,00) (y)

100 mg/kg

Traditional
products (1):

immersion

cured meat

Wiltshire bacon (1.1);

Entremeada, entrecosto, chispe, orelheira e
cabeça (salgados)

Toucinho fumado (1.2);

and similar products

Wiltshire ham (1.1);

and similar products

Rohschinken, nassgepökelt (1.6);

and similar products

Cured tongue (1.3)

Traditional dry-cured meat products (2):

Dry-cured bacon (2.1);

and similar products

Dry-cured ham (2.1);

Jamón
paleta
curado,
embuchado y cecina (2.2);

curada,

lomo

Presunto, presunto da pá and paio do
lombo (2.3);

and similar products

175 mg/kg

100 mg/kg

50 mg/kg

50 mg/kg

175 mg/kg

100 mg/kg

Rohschinken, trockengepökelt (2.5);

50 mg/kg

and similar products

Other
products (3):

traditionally

cured

meat

180 mg/kg

Vysočina

Selský salám

Turistický trvanlivý salám
Poličan

Herkules

Lovecký salám

Dunajská klobása
Paprikáš (3.5);

and similar products

Rohschinken, trocken-/nassgepökelt (3.1);

50 mg/kg

and similar products

Jellied veal and brisket (3.2)

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referred to in these

(10) As recommended in the relevant opinions of the SCF and
EFSA, Directive 2006/52/EC is based on the estab-
lishment of maximum added amounts and reflects the
scientific opinions by
ranges
are
specifying that up to 100 mg/kg of nitrite
permitted in sterilised meat products and 150 mg/kg in
other meat products. Given the vast variety of (cured)
meat products and manufacturing methods within the
Community, the Community legislator held that it was,
for the moment, not possible to specify the appropriate
level of nitrite for each product.

(15) With regard to the use of nitrites E249 and E250 in
meat and meat products the Danish positive list sets
out
the
following maximum level:

added amounts

and contains

exclusively

Foodstuff

Amount of
nitrites added
(mg/kg)

Non-heat-treated

8.2.1.
meat-based
products derived from whole pieces of
meat,
(in
general)

including slices of products

(11)

The exceptions to the rule of applying maximum added
amounts have a limited character. They apply to specific
products which are traditionally manufactured in certain
Member States and for which it is not possible to control
the ingoing amount of curing salts absorbed by the meat
due to the nature of the manufacturing process associ-
ated with these products. The traditional products to
which they apply are defined,
in particular, through a
description of the production method.

Bacon of the Wiltshire type and related
cuts, including salt cured ham

Heat-treated meat-based products
8.2.2.
derived from whole pieces of meat,
including slices of products (in general)

Rullepølse (rolled-meat sausage)

preserved

Entirely
semi-preserved
products, bacon of the Wiltshire type and
cuts thereof, including salt cured ham

or

Non-heat-treated

8.3.1.
products derived
including slices of products (in general)

meat-based
from minced meat,

Fermented salamis

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

8.3.2.
derived from minced meat

Heat-treated meat-based products

Meatballs and liver paté (kødboller and lever-
postej)

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

(12) Directive 2006/52/EC was due to be transposed by the
Member States by 15 February 2008 in order to permit
trade in and the use of products complying within this
Directive by 15 February 2008 and prohibit trade in and
use of products which are not
in compliance by
15 August 2008.

2. NATIONAL PROVISIONS NOTIFIED

(13)

The national provisions notified by Denmark are Order
No 22 of 11 January 2005 on food additives (Bekendt-
gørelse nr 22 af 11.1.2005 om tilsætningsstoffer til fødevarer)
and the Danish positive list of permitted food additives
(Liste over tilladte tilsætningsstoffer til fødevarer, ‘Positivlisten’).

and with the
It

(14) Order No 22 contains the principle that only additives
contained in a positive list may be used for the foodstuffs
under
specified
specified conditions,
objectives and restrictions (1).
further provides that,
unless otherwise specified, the maximum values set out
in the positive list refer to the maximum amounts of the
additive which may be present in a foodstuff in the form
in which it is sold (2). As a consequence, only foodstuffs
which are in compliance with the requirements of Order
No 22 and the positive list may be sold on the Danish
market. The positive list established by the Danish
Veterinary and Food Administration on the basis of
Order No 22 states which additives may be used for
foodstuffs, and in what amounts. The
the individual
version notified applies with effect
from 29 January
2005.

(16)

that

therefore,

maximum

the limit of 60 mg/kg (3)
It appears,
applies to many types of meat products, whereas the
Directive
corresponding
2006/52/EC are 100 or 150 mg/kg.
certain
sausages the accepted maximum in Denmark is 100
semi-preserved meat
mg/kg. For
including ‘bacon of
products,
the Wiltshire type and
related cuts’, the maximum is 150 mg/kg.

specific entirely or

limits

For

of

(1) See paragraph 13 of Order No 22 ‘Use of additives’.
(2) See paragraph 20 of Order No 22.

(3) For kødboller and leverpostej the use of nitrite is banned in accordance

with Decision 292/97/EC.

60

150

60

100

150

60

100

150

60

0

150

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3. PROCEDURE

it does not

(17) On 17 August 2007 the Commission received a first
communication from the Kingdom of Denmark, dated
14 August 2007, in which Denmark criticised different
aspects of Directive 2006/52/EC and informed the
Commission that
intend to transpose
Directive 2006/52/EC in relation to nitrites in meat
products. However, Denmark did not notify
the
national provisions which it wishes to maintain. By
letter of 13 November 2007 the Commission pointed
this out
to the Danish Government. By letter of
21 November 2007, which reached the Commission
on 23 November 2007, the Permanent Representation
of the Kingdom of Denmark to the European Union,
relevant national
notified to the Commission the
provisions.
of
an
22 November 2007, which was
received by the
Commission on 27 November 2007 and which
contains a report of
the National Food Institute of
30 October 2007, Denmark substantiated its application.

correspondence

additional

In

(18)

By letter of 21 December 2007 the Commission
confirmed that it had received the notification and that
the
examination under
for
Article 95(6) started on 24 November 2007, the day
following the day on which the notification was received.

six-month period

its

(19)

By letter of 31 March 2008 Denmark provided data on
the consumption of meat products in Denmark.

(20)

By letter of 31 January 2008 the Commission informed
the other Member States and the EFTA States on the
notification and gave them the opportunity to submit
comments thereon within 30 days. The Commission
also published a notice regarding the notification in the
Official Journal of the European Union (1) in order to inform
other interested parties of Denmark's national provisions,
as well as the grounds invoked to support the request.
from Estonia,
The Commission received comments
France, Hungary and Norway (2).

— Estonia emphasises that, given the restrictive effect of
the Danish legislation on trade, it is essential that the
restrictions are scientifically justified,

— France stresses that nitrites are a powerful inhibitor
against the proliferation of certain bacteria, including
Clostridium botulinum and, therefore, significant in the
prevention of food poisoning and that there is no

(21)

(1) OJ C 30, 2.2.2008, p. 5.
(2) In addition, the Commission received comments from Ireland on
1 May 2008, i.e. outside the time limit fixed by the Commission.

alternative in relation to meat products. In its view,
Directive 2006/52/EC is based on the EFSA opinion
of 26 November 2003 and limits as much as possible
the concentration of nitrosamines while securing the
microbiological safety. As recommended by EFSA, it
regulates added amounts.
to maximum
residual values only as an exception and only where
it was not possible to lay down maximum added
amounts. A new analysis
should be undertaken
only once the results of studies in the Member
States on the consumption of additives on the basis
of the new rules are available.

refers

It

— Hungary, while

to nitrites

supporting the decrease

in the
exposure
and nitrosamines with all
possibly available means, emphasises the need to
regulate appropriate nitrite levels for the whole EU,
including for traditional cured meat products, which
may differ from the Danish meat products and where
the addition of higher nitrite levels may be justified. It
questions Denmark’s claim that the transposition of
Directive 2006/2052 could lead to a 2,3 to 2,4-fold
increase in nitrite in Denmark, having regard to the
fact that manufacturers are obliged to apply less than
the maximum permitted amount
can
safety.
guarantee
European culture would grow poorer if traditional
cured meat products had to disappear
from the
market.

required microbiological

they

the

if

— Norway considers that the Danish measure is justified
on grounds of major needs referred to in Article 30.
In its view, the measure is intended to ensure a high
level of human health protection based on scientific
advice and is not an arbitrary discrimination or a
disguised restriction on trade.
It contends that the
obstacle to the functioning of the internal market
and proportionate.
created by
Norway agrees with Denmark that,
in relation to
nitrites
in meat products, Directive 2006/52/EC
does not fully reflect scientific advice in that it does
not ensure that the lowest level of nitrites necessary
to achieve the desired effect is applied and the appli-
cation of residual levels in relation to a number of
meat products.

is necessary

it

4. REQUEST TO EFSA

By letter of 10 March 2008 the Directorate-General for
Health and Consumer Protection requested EFSA to
provide a scientific opinion on whether the previous
opinions of the SCF of 1990 and 1995 and EFSA of
2003 are
information
submitted by Denmark. In its reply of 28 March 2008
EFSA concluded that the previous opinions of the SCF
and EFSA are still valid in light of
the information
provided by Denmark.

still valid in light of

the

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(22) With regard to the effects of nitrites/nitrates on the
microbiological safety of meat products EFSA refers to
the opinion of its Scientific Panel on Biological Hazards
of 26 November 2003. In this opinion it was stated that
several factors contribute to the safety of meat products
(cooking process, salt/concentration, water activity etc.
and that the ingoing amount of nitrites is important
for microbiological
ingoing
amounts should be controlled (rather than the residual
amount). EFSA also refers to the fact that its Scientific
Panel on Biological Hazards agreed with the view of the
Scientific Committee for Food (SCF)
that 50-100 mg
added nitrite per kg of meat products may suffice for
many products and in other products, especially those
with a low salt content and having a prolonged shelf
life, addition of between 50-150 mg/kg nitrite
is
necessary to inhibit growth of C. botulinum.

safety, which is why

II. ASSESSMENT

1. ADMISSIBILITY

(27)

(28)

(29)

(23) Under Article 95(4) and (6) of the EC Treaty a Member
State may, after
the adoption of a harmonisation
measure, maintain national provisions on grounds of
major needs referred to in Article 30, or relating to the
protection of the environment or the working environ-
it notifies these national provisions to the
ment,
Commission and if
the
application.

the Commission approves

if

(24)

The Danish notification relates to national provisions
derogating from those of Annex I(3)(c)
to Directive
2006/52/EC amending Annex III Part C to Directive
95/2/EC in relation to E249 and E250. The current
Danish provisions already existed at
the
adoption of Directive 2006/52/EC.

the time of

(30)

(25) Order No 22 and the Danish positive list contain more
stringent provisions in relation to the use of nitrites in
meat and meat products than Directive 2006/52/EC in
that they lay down lower maximum added amounts than
Directive 2006/52/EC for several types of products (in
many cases 60 mg/kg) and insofar as they do not, unlike
Directive 2006/52/EC, allow the placing on the market
of certain traditional meat products on the basis of
maximum residual values.

(26)

In accordance with Article 95(4), the notification was
supplemented by a description of the grounds relating
to one or more of
the major needs referred to in
Article 30 or to the protection of the environment or
the working environment, in this case the protection of
health and life of humans. The Danish position is
explained in more detail
the Danish
Food Institute of 30 October 2007, which was
submitted on 27 November 2007, as well as in the
other documents referred to in points 17 and 19 above.

in a report of

In light of the foregoing, the Commission considers that
the application submitted by Denmark with a view to
obtaining
national
provisions on the use of nitrites in meat and meat
products is admissible under Article 95(4) of the EC
Treaty.

to maintain

authorisation

its

2. ASSESSMENT OF MERITS

In accordance with Article 95(4) and (6), first subpara-
graph, of the EC Treaty, the Commission must ascertain
the conditions enabling a Member State to
that all
maintain its national provisions derogating from a
Community harmonisation measure provided for
in
that Article are fulfilled.

In particular, the Commission has to assess whether or
not the national provisions are justified by the major
the EC Treaty or
needs referred to in Article 30 of
the environment or the
relating to the protection of
working environment and do not exceed what
is
necessary to attain the legitimate objective pursued. In
the
addition, when the Commission considers
national provisions fulfill the above conditions, it must
verify, pursuant
to Article 95(6), whether or not the
national provisions are a means of arbitrary discrimi-
nation or a disguised restriction on trade between
Member States and whether or not they constitute an
obstacle to the functioning of the internal market.

that

the EC Treaty,

It has to be noted that, in the light of the time frame
the
established by Article 95(6) of
Commission, when examining whether
the national
measures notified under Article 95(4) of the EC Treaty
are justified, has to take as a basis ‘the grounds’ put
forward by the notifying Member State. This means
that, according to the provisions of
the
responsibility of proving that the national measures are
justified lies with the requesting Member State which
seeks
procedural
framework established by Article 95 paragraphs 4 and
6 of
including in particular a strict
deadline for a decision to be adopted, the Commission
normally has to limit itself to examining the relevance of
the elements which are submitted by the requesting
Member State, without having to seek itself possible
reasons of justifications.

the EC Treaty,

them. Given

to maintain

the Treaty,

the

(31) However, where the Commission is in the possession of
information in the light of which the Community har-
monisation measure from which the notified national
provisions derogate may need to be reviewed,
it can
take
such information into consideration in the
assessment of the notified national provisions.

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(32)

2.1. THE POSITION OF DENMARK

traditional meat products

than the ones provided for

The Kingdom of Denmark claims that
its legislation
ensures a higher level of protection of health and life
it down lower maximum added
of human in that
amounts of E249 (potassium nitrite) and E250 (sodium
nitrite)
in Directive
2006/52/EC, and does not allow the placing on the
market of
for which no
ingoing amounts can be established. Denmark considers
that the Danish provisions are fully consistent with the
recommendations which the Scientific Committee on
Food (SCF) made in 1990 and 1995, as well as with
the opinion of
the European Food Safety Authority
(EFSA) of 26 November 2003, since they contain no
exceptions to the principle of establishing maximum
‘added amounts’ as opposed to residual
levels and lay
down more differentiated maximum levels related to
particular groups of meat products.

(33) Denmark acknowledges that in certain respects Directive
2006/52/EC complies with the scientific recommen-
dations from the SCF and EFSA,
in particular where,
unlike the original version of Directive 95/2/EC it
provides for ‘maximum added amounts’, as opposed to
residual amounts and ‘indicative added amounts’.
It
criticises, however,
there are exceptions to this
principle, with the consequence that various traditionally
produced meat products are still regulated from the point
of view of residual amounts and considers that this can
be a hazard to human health. It stresses that the concen-
tration of residual nitrite is a very uncertain marker of
added nitrite and refers to studies which have shown that
residual values may even mask extremely high additions
of nitrites, leading to an unpredictably high formation of
N-nitroso compounds.

that

(34) Denmark also emphasises

amounts

that nitrosamines, whose
formation depends on the presence of nitrite in meat
products, are genotoxic and carcinogenic, which is why
the use of nitrites should be allowed only in the amounts
that are absolutely necessary. Denmark considers that the
maximum added
in Directive
2006/52/EC are too high from a health point of view
and that a technological need for these values has not
been documented. It contends that, in light of the advice
given by the Community scientific bodies, the inhibition
of growth of Clostridium botulinum could be achieved by
keeping the limits within the range of 50-150 mg/kg
nitrite and specifying the limits for categories of meat
products depending on the scientifically based needs.

out

set

(35) Given that approximately 90 % of the intake of cured
meat products
to
which a maximum amount of 60 mg/kg of added

in Denmark consists of products

nitrite currently applies in Denmark, Denmark points
out that the transposition of the Directive and the intro-
duction of a general
limit of 150 mg/kg for all cured
meat products could lead to the intake of nitrites in
Denmark rising by a factor of 2,3-2,4, which may
imply a corresponding rise in the intake of preformed
nitrosamines.

(36) Denmark stresses that, despite the fact

that

that

food poisoning cases

its rules
providing for lower levels of nitrites which may be
added have been in place for many years, they have
to prevent botulism. The Danish
proved adequate
these rules have never
Government points out
given rise to problems with the preservation of
the
products concerned and that Denmark has a very low
caused by sausages
rate of
compared with other Member States. It states that there
are fewer cases of botulism than in most other Member
to the European Communicable
States. According
Disease Bulletin, Eurosurveillance, of
January 1999,
issue on botulism in Europe,
which is
botulism is very rare in Denmark. The Danish health
surveillance institution, the Statens Serum Institute, states
on its website that after 1980 there have only occurred
five cases of botulism amongst the Danish population,
none of these being caused by the consumption of meat
products.

special

a

(37) Moreover, Denmark maintains that

its provisions on
nitrite do not act as an obstacle to trade, referring to
imports of meat products from
figures showing that
other Member States have been taking place and have
even been increasing in recent years.

(38)

In sum, Denmark considers it legitimate to reduce the
risk to human health stemming from the exposure to
requirements of Directive
nitrosamines beyond the
its
2006/52/EC through the continued application of
legislation.

2.2. EVALUATION OF THE DANISH POSITION

2.2.1. Justification on grounds of major needs referred

to in Article 30

(39)

The Danish legislation aims to achieve a higher level of
protection of health and life of humans with regard to
exposure to nitrites and the possible formation of nitro-
samines in meat products, by specifying lower maximum
added amounts of nitrite in relation to many meat
products and not allowing the placing on the market
of products for which only maximum residual
levels
can be established.

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(40) When assessing whether the Danish legislation is actually
adequate and necessary for achieving this objective a
In
number of factors need to be taken into account.
particular,
the
two health risks need to be balanced,
one related to the presence of nitrosamines in meat
products, on the one hand, and the microbiological
safety of meat products, on the other hand. The latter
aspect is more than a mere technological need, but a
highly relevant health concern in its own right. While
in meat
recognised that
it
products need to be limited,
lower levels of nitrite in
meat will not automatically lead to a higher protection
of human health. The most appropriate level of nitrite
depends on a number of factors acknowledged in the
the
relevant opinions of
addition of salt, moisture, pH, shelf life of the product,
hygiene, temperature control, etc.

the levels of nitrites

the SCF and EFSA,

e.g.

is

(41)

(9) and (10) before,

In the light of the preceding considerations and those
under points
the Commission
in principle, Directive 2006/52/EC
considers
constitutes an adequate response to the challenge of
reconciling two conflicting health risks in light of the
diversity of meat products across the Community.

that,

(42) On the other hand, the Commission has to evaluate the
specific choices made by the Danish regulator and the
experience made with these rules, which have been in
force for a considerable period of time. Through the
figures it provided on the occurrence of food poisoning
and, in particular, botulism, Denmark has demonstrated
that it has so far achieved satisfactory results with its
legislation. These data show that the maximum levels
specified in the Danish legislation appear to have been
sufficient to ensure the microbiological safety of the meat
products currently made in Denmark and the production
methods currently used in Denmark.

(43)

the Danish legislation is
The Commission notes that
compatible with the relevant scientific opinions of the
Community’s scientific bodies. It is based on a regulation
of maximum added values and respects the ranges of
added amounts of nitrite referred to in these opinions,
i.e. 50-150 mg/kg. At the same time, Denmark has estab-
lished more specific maximum added amounts
for
particular groups of meat products, compared with the
Directive,
in light of the types of meat products and
manufacturing methods prevailing in Denmark.

(44)

it must be considered that, according to
In addition,
information provided by Denmark,
the
meat products consumed by the Danish population,
approximately 90 %, relates to meat products for which
there is currently a limit of 60 mg/kg and which would
have to be replaced with a limit of 100 or 150 mg/kg.

the bulk of

is unlikely that

Since Danish manufacturers, like manufacturers in other
Member States, would not be obliged to raise the
amounts of nitrites currently added to their products to
the maximum levels referred to in Directive 2006/52/EC,
the Danish
it
population to nitrites in meat products would increase
to the extent suggested in the Danish submission, i.e. by
a factor of 2,3-2,4. However, an increase of the actual
exposure of the Danish population to nitrites cannot be
excluded.

the actual exposure of

(45) On the basis of the information available at the moment,
the Commission considers that the request to maintain
more
contained in
Directive 2006/52/EC can be temporarily accepted on
grounds of protection of public health in Denmark.

stringent measures

than those

2.2.2. Absence of any arbitrary discrimination, any
disguised restriction of trade between Member
States or any obstacle to the functioning of the
internal market

2.2.2.1. Absence of arbitrary discrimination

(46) Article 95(6) obliges the Commission to verify that the
envisaged measures are not a means of arbitrary dis-
the
crimination. According to the jurisprudence of
Court of Justice,
in order for there to be no discrimi-
nation, similar situations must not be treated in different
ways and different situations must not be treated in the
same way.

(47)

The Danish national
rules apply to both domestic
products and products made in other Member States.
In the absence of any evidence of the contrary,
it can
be concluded that
the national provisions are not a
means of arbitrary discrimination.

2.2.2.2. Absence of a disguised restriction on trade

extent

insofar

to trade,

(48) National measures which restrict the use of products to a
than a Community Directive would
greater
normally constitute
as
a barrier
products that are legally placed on the market and
used in the rest of the Community are not expected, as
a result of the prohibition on use, to be placed on the
market
concerned. The pre-
conditions laid down in Article 95(6) of the EC Treaty
are intended to prevent restrictions based on the criteria
set out in paragraphs 4 and 5 thereof from being applied
inappropriate reasons, and constituting in effect
for
economic measures
importation of
to impede
products from other Member States, that is to say, a
means of indirectly protecting national production.

in the Member State

the

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17.6.2008

States

(49) Given that the Danish rules impose stricter standards on
to meat products also on
the addition of nitrites
operators based
in an
in other Member
otherwise harmonised area, they are liable to constitute
a disguised restriction of trade or an obstacle to the
functioning of
is recognised,
the internal market.
however, that Article 95(6) of the EC Treaty must be
read in the sense that only national measures constituting
a disproportionate obstacle to the internal market may not
be approved. In this connection, Denmark has submitted
figures which indicate that
imports of meat products
from other Member States have been taking place in
spite of its legislation and have even been increasing in
recent years.

It

(50)

the
In the absence of any evidence suggesting that
in effect, a measure
national provisions constitute,
it can be
intended to protect national production,
concluded that they are not a disguised restriction to
trade between Member States.

(51)

2.2.2.3. Absence of obstacles to the functioning of

the internal market

This condition cannot be interpreted in such a way that
it precludes the approval of any national measure likely
to affect the establishment of the internal market. Indeed,
any national measure derogating from a harmonisation
measure aiming at the establishment and operation of
the internal market constitutes in substance a measure
in
likely to affect
order to preserve the useful character of the procedure
laid down in Article 95 of the EC Treaty, the concept of
obstacle to the functioning of the internal market must,
in the context of Article 95(6) of the EC Treaty, be
understood as a disproportionate effect in relation to
the pursued objective.

the internal market. Consequently,

(52) Given the health benefits

invoked by the Danish
government in relation to the reduction of exposure to
nitrites in meat products and the fact that, on the basis
of currently available figures, trade does appear not to be
the
affected at all or only to a very limited extent,
Commission considers that
the notified Danish rules
may be temporarily maintained on grounds relating to
the protection of health and life of humans having regard
to the fact that they are not disproportionate and do,
therefore, not constitute an obstacle to the functioning
of the internal market in the sense of Article 95(6) of the
EC Treaty.

(53)

In the light of this analysis, the Commission considers
that the condition relating to the absence of obstacles to
the functioning of the internal market is fulfilled.

2.2.3. Limitation in time

(54)

The above conclusions are based on the currently
available information and, in particular, on figures indi-

cating that Denmark has been able to control botulism
despite lower maximum levels of nitrite added to
particular types of meat products, while not disrupting
trade in a disproportionate fashion.

(55) Another important factor is the rate of consumption in
Denmark of meat products in relation to which the
application of Directive 2006/52/EC could lead to an
increase of the exposure of the Danish population to
nitrites and thereby nitrosamines.

(56)

(57)

(58)

Since it cannot be predicted with a sufficient degree of
certainty that these factors will not change significantly
in the course of
the Commission considers it
appropriate to re-examine the situation at the latest in
two years’ time on the basis of updated information.

time,

The two-year period will permit the Danish Government
to introduce a renewed application, in due time, and to
supply further relevant data concerning the fact that the
application of
laid down in Directive
2006/52/EC does not achieve the required level of
protection and would lead to an unacceptable risk to
human health.

levels

the

In order to be able to submit such data Denmark will
have to monitor the situation in particular with regard to
the share of meat products
the control of botulism,
in the overall
covered by
the 60 mg/kg
consumption of meat products in Denmark,
including
typical dietary habits as
any other
relevant, as well as imports of meat products from
other Member States.

risk factor of

limit

(59)

In its renewed application Denmark would also have to
provide a full justification for the continued maintenance
of its legislation.

(60) At the same time, the two-year period will allow the
Commission to check and analyse the transposition of
Directive 2006/52/EC in the Member States, and to re-
examine Directive 2006/52/EC under
the terms of
Article 95(7) of the EC Treaty, including further consul-
tations of the Member States and EFSA.

(61) Against this background, the Commission considers that
the national provisions, to the extent specified above, can
be approved for a limited period. The approval should
extend to the time needed to gather and to carefully
evaluate the necessary information. The Commission
considers that a period of two years from the date of
the present decision is necessary to that effect. The
decision will expire on that date.

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(62) Denmark remains obliged to transpose

the other
provisions of Directive 2006/52/EC into its national law,

III. CONCLUSION

In the light of
the above considerations, and taking
account of comments provided by Member States on
the notification submitted by the Danish authorities,
the Commission is of the opinion that the request by
Denmark, submitted on 23 November 2007, for main-
taining its national provisions on the addition of nitrites,
than those of Directive
which are more stringent
2006/52/EC, can be approved for a period of
two
the present
years
decision, pending the demonstration by the Danish auth-
orities that the levels laid down in Directive 2006/52/EC
would lead to an unacceptable risk,

from the date of

adoption of

on food additives (Bekendtgørelse nr 22 af 11.1.2005 om tilsæt-
ningsstoffer til fødevarer) and the Danish positive list of permitted
food additives (Liste over tilladte tilsætningsstoffer til fødevarer, ‘Posi-
tivlisten’), which the Kingdom of Denmark notified to the
to
Commission by letter of 21 November 2007, pursuant
Article 95(4) of the EC Treaty, are approved.

Article 2

This Decision shall expire on 23 May 2010.

Article 3

This Decision is addressed to the Kingdom of Denmark.

HAS ADOPTED THIS DECISION:

Done at Brussels, 23 May 2008.

Article 1

The national provisions on the addition of nitrites to meat and
meat products contained in Order No 22 of 11 January 2005

For the Commission

Androulla VASSILIOU
Member of the Commission