Notification pursuant to Article 95, paragraph 4 of the EC Treaty — Authorisation to maintain national measures being more stringent than provisions of an EC harmonisation measure (Text with EEA relevance )
Date: 2008-02-02
Institutions: European Commission
Subjects: Denmark, EU law - national law, approximation of laws, exchange of information, food additive, market approval

2.2.2008

EN

Official Journal of the European Union

C 30/5

Notification pursuant to Article 95, paragraph 4 of the EC Treaty — Authorisation to maintain
national measures being more stringent than provisions of an EC harmonisation measure

(Text with EEA relevance)

(2008/C 30/02)

1.
By letter of 14 August 2007, the Kingdom of Denmark informed the Commission about its intention
not to transpose Directive 2006/52/EC 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) into Danish law in so far as it
relates to the use of nitrites in meat products and instead maintain its existing national legislation in this
respect. By letter of 21 November 2007, which reached the Commission on 23 November 2007, Denmark
notified the Commission of Order No 22 of 11 January 2005 on food additives (Bekendtgørelse nr. 22 af
11.
januar 2005 om tilsætningsstoffer til fødevarer) and the Danish positive list of permitted food additives
(Liste over tilladte tilsætningsstoffer til fødevarer, ‘Positivlisten’) as the national provisions it wishes to maintain.

2.
Directive 2006/52/EC, which was adopted by the European Parliament and the Council on 5 July
2006, is based on Article 95 of the EC Treaty. With regard to the use of nitrates and nitrites in meat
products it aims to strike a balance between the risk of the formation of carcinogenic nitrosamines through
the presence of nitrites in meat products and the protective effects of nitrites against the multiplication of
the bacteria responsible for life threatening botulism,
in line with scientific advice received from the
European Food Safety Authority (EFSA) and the Scientific Committee for Food (SCF).

Directive 95/2/EC as it was adopted originally laid down maximum residual levels for nitrites and nitrates in
various meat products. By contrast, Directive 2006/52/EC introduces the principle, recommended in an
EFSA opinion from 2003, that the control of nitrites should be regulated in the form of maximum amounts
that may be added during the manufacture of meat products for E 249 (potassium nitrite) and E 250
(sodium nitrite). The amount is 150 mg/kg for meat products in general and 100 mg/kg for sterilised meat
products.

By way of exception, Directive 2006/52/EC contains maximum residual levels for certain specified tradition-
ally produced meat products, where it was not possible to control the in-going amounts because of their
traditional manufacturing process.

3.
The Danish Order No 22 allows the addition of E 249 (potassium nitrite) and E 250 (sodium nitrite)
to meat products only in so far as specific added amounts are not exceeded. Depending on the products in
question these maximum amounts are 0, 60, 100 or 150 mg/kg. Unlike Directive 2006/52/EC, the Danish
provisions do not contain any exceptions to the principle of fixing maximum added amounts for nitrites,
thereby not permitting the placing on the market of certain traditionally manufactured meat products from
other Member States. In so far as the 0 and the 60 mg/kg limits apply, the Danish legislation, in addition,
contains lower limits for added amounts of nitrites than the Directive for a number of meat products.

The Danish provisions are therefore more stringent than Directive 2006/52/EC in relation to the addi-

4.
tion of nitrites to meat products.

5.
The Kingdom of Denmark considers that, unlike Directive 2006/52/EC, the current Danish provisions
are fully consistent with the scientific recommendations for the SCF and of EFSA in that they contain no
exception to the regulation of ‘added amounts’ as opposed to residual levels.

Denmark also points out that, through the lower maximum added amounts, the Danish provisions further
minimise the risk posed by nitrosamines.

Denmark emphasises that, despite the fact that its rules providing for lower levels of nitrites which may be
added to meat products have been in place for many years, they have never given rise to problems with
preservation of the products concerned and that Denmark has a very low rate of food poisoning cases
caused by sausages compared with other Member States.

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

C 30/6

EN

Official Journal of the European Union

2.2.2008

6.
the
The Commission will process this notification in accordance with Article 95(4) and (6) of
EC Treaty. Article 95(4) of the EC Treaty provides that if, after the adoption of a Community harmonisation
measure, a Member State wishes to maintain its more stringent national provisions on grounds of major
needs referred to in Article 30 of the EC Treaty or relating to the protection of the environment or the
working environment, it shall notify them to the Commission indicating the reasons for maintaining them.
Following the notification of the Danish provisions the Commission has six months to approve or reject
them. In this period the Commission shall verify whether the maintenance of the Danish provisions is justi-
fied on grounds of major needs referred to in Article 30, or relating to the protection of the environment,
and that they do not constitute a means of arbitrary discrimination or a disguised restriction on trade and
that they do not create an unnecessary and disproportionate obstacle to the functioning of the internal
market.

7.
Any party who wishes to provide comments on this notification must send them to the Commission
within 30 days from the publication of this notice. Any comment submitted after this period will not be
taken into account.

8.

Further details about the Danish notification can be obtained from:

European Commission
General Directorate Health and Consumer Protection
DG SANCO A.2 — Legal Affairs
Mr Robert Mathiak
Tel. (32-2) 296 93 57
E-mail: robert.mathiak@ec.europa.eu