# C_2010007EN.01000101.xml

| 13.1.2010 | EN | Official Journal of the European Union | C 7/1 |
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13.1.2010

EN

Official Journal of the European Union

C 7/1

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Notification pursuant to Article 114, paragraph 4, of the Treaty on the Functioning of the European Union — Authorisation to maintain national measures being more stringent than provisions of an EC harmonisation measure

(Text with EEA relevance)

2010/C 7/01

| 1. | By letter of 20 November 2009, which reached the Commission on 26 November 2009, the Kingdom of Denmark notified the Commission of its intention to continue (1) 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 (2) into Danish law in so far as it relates to the use of nitrites (3) in meat products and instead maintain its existing national legislation in this respect. Order No, 22 of 11.1.2005 on food additives (Bekendtgørelse 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«) include the national provisions Denmark wishes to maintain. |
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1.

By letter of 20 November 2009, which reached the Commission on 26 November 2009, the Kingdom of Denmark notified the Commission of its intention to continue (1) 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 (2) into Danish law in so far as it relates to the use of nitrites (3) in meat products and instead maintain its existing national legislation in this respect. Order No, 22 of 11.1.2005 on food additives (Bekendtgørelse 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«) include the national provisions Denmark wishes to maintain.

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| 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 (now Article 114 of the Treaty on the Functioning of the European Union — TFEU). 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 traditionally produced meat products, where it was not possible to control the in-going amounts because of their traditional manufacturing process. |
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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 (now Article 114 of the Treaty on the Functioning of the European Union — TFEU). 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.

E 249 potassium nitrite

E 250 sodium nitrite

By way of exception, Directive 2006/52/EC contains maximum residual levels for certain specified traditionally 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. |
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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.

E 249 potassium nitrite

E 250 sodium nitrite

| 4. | The Danish provisions are therefore more stringent than Directive 2006/52/EC in relation to the addition of nitrites to meat products. |
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4.

The Danish provisions are therefore more stringent than Directive 2006/52/EC in relation to the addition 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 botulism compared with other Member States, and not a single case caused by meat products has been recorded since before 1980. |
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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 botulism compared with other Member States, and not a single case caused by meat products has been recorded since before 1980.

| 6. | The Commission will process this notification in accordance with Article 114(4) and (6) TFEU. Article 114(4) provides that if, after the adoption of an EU harmonisation measure, a Member State wishes to maintain its more stringent national provisions on grounds of major needs referred to in Article 36 TFEU 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 justified on grounds of major needs referred to in Article 36, 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. |
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6.

The Commission will process this notification in accordance with Article 114(4) and (6) TFEU. Article 114(4) provides that if, after the adoption of an EU harmonisation measure, a Member State wishes to maintain its more stringent national provisions on grounds of major needs referred to in Article 36 TFEU 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 justified on grounds of major needs referred to in Article 36, 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. |
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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 |
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| Directorate-General for Health and Consumers |
| DG SANCO. A.2 — Legal Affairs |
| Ms Elena Savia |
| Tel. +32 22993900 |
| Electronic address: elena.savia@ec.europa.eu |

8.

Further details about the Danish notification can be obtained from:

European Commission

Directorate-General for Health and Consumers

DG SANCO. A.2 — Legal Affairs

Ms Elena Savia

Tel. +32 22993900

Electronic address: elena.savia@ec.europa.eu

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(1)  An authorisation for two years was granted by Commission Decision 2008/448/EC of 23 May 2008 concerning national provisions notified by Denmark on the addition of nitrite to certain meat products (OJ L 157, 17.6.2008).

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

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(3)  The notification relates to E 249 potassium nitrite and E 250 sodium nitrite.

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sodium nitrite

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