# Official Journal C 311E/2006

| | ISSN 1725-2423 |
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| Official Journal
  of the European Union | C 311E |
| | |
| English edition | Information and Notices | Volume 4919 December 2006 |

ISSN 1725-2423

Official Journal

of the European Union

C 311E

English edition

Information and Notices

Volume 4919 December 2006

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| Notice No | Contents | page |
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| | I   Information |
| | Council |
| 2006/C 311E/1 | Common Position (EC) No 32/2006 of 23 November 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies | 1 |
| 2006/C 311E/2 | Common Position (EC) No 33/2006 of 23 November 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on the assessment and management of flood risks | 10 |
| 2006/C 311E/3 | Common Position (EC) No 34/2006 of 4 December 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC | 21 |

Notice No

Contents

page

I   Information

Council

2006/C 311E/1

Common Position (EC) No 32/2006 of 23 November 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to the adoption of a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

1

2006/C 311E/2

Common Position (EC) No 33/2006 of 23 November 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council on the assessment and management of flood risks

10

2006/C 311E/3

Common Position (EC) No 34/2006 of 4 December 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC

21

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EN

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I Information

Council

| 19.12.2006 | EN | Official Journal of the European Union | CE 311/1 |
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19.12.2006

EN

Official Journal of the European Union

CE 311/1

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COMMON POSITION (EC) No 32/2006

adopted by the Council on 23 November 2006

with a view to the adoption of Regulation (EC) No .../2006 of the European Parliament and of the Council of ... amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

(Text with EEA relevance)

(2006/C 311 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee (1),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (3) is intended to provide a single legal framework for transmissible spongiform encephalopathies (TSEs) in the Community. |
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(1)

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (3) is intended to provide a single legal framework for transmissible spongiform encephalopathies (TSEs) in the Community.

| (2) | Regulation (EC) No 932/2005 of the European Parliament and of the Council of 8 June 2005 amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies as regards the extension of the period for transitional measures (4) prolonged the period of application of the transitional measures provided for in Regulation (EC) No 999/2001 until 1 July 2007 at the latest. |
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(2)

Regulation (EC) No 932/2005 of the European Parliament and of the Council of 8 June 2005 amending Regulation (EC) No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies as regards the extension of the period for transitional measures (4) prolonged the period of application of the transitional measures provided for in Regulation (EC) No 999/2001 until 1 July 2007 at the latest.

| (3) | During the General Session of the World Organisation for Animal Health in May 2003, a Resolution was adopted to simplify the current international criteria for the classification of countries according to their Bovine Spongiform Encephalopathy (BSE) risk. A proposal was adopted at the General Session in May 2005. The Articles of Regulation (EC) No 999/2001 should be adapted to reflect the new internationally agreed categorisation system. |
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(3)

During the General Session of the World Organisation for Animal Health in May 2003, a Resolution was adopted to simplify the current international criteria for the classification of countries according to their Bovine Spongiform Encephalopathy (BSE) risk. A proposal was adopted at the General Session in May 2005. The Articles of Regulation (EC) No 999/2001 should be adapted to reflect the new internationally agreed categorisation system.

| (4) | New developments concerning sampling and analysis will require comprehensive amendments to Annex X to Regulation (EC) No 999/2001. It is therefore necessary to make certain technical amendments to the existing definition of ‘rapid tests’ in Regulation (EC) No 999/2001 in order to facilitate amendment of the structure of that Annex at a later stage. |
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(4)

New developments concerning sampling and analysis will require comprehensive amendments to Annex X to Regulation (EC) No 999/2001. It is therefore necessary to make certain technical amendments to the existing definition of ‘rapid tests’ in Regulation (EC) No 999/2001 in order to facilitate amendment of the structure of that Annex at a later stage.

| (5) | In the interests of clarity of Community legislation, it is appropriate to clarify that the definition of ‘mechanically separated meat’ provided for in other Community legislation on food safety should be applicable in Regulation (EC) No 999/2001 in the context of TSE eradication measures. |
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(5)

In the interests of clarity of Community legislation, it is appropriate to clarify that the definition of ‘mechanically separated meat’ provided for in other Community legislation on food safety should be applicable in Regulation (EC) No 999/2001 in the context of TSE eradication measures.

| (6) | Regulation (EC) No 999/2001 establishes a monitoring programme for BSE and scrapie. In its opinion of 6-7 March 2003, the Scientific Steering Committee recommended the introduction of a monitoring programme for TSEs in cervids. Therefore the monitoring system provided for in that Regulation should be extended to other TSEs, with the possibility to adopt further measures to implement that system at a later stage. |
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(6)

Regulation (EC) No 999/2001 establishes a monitoring programme for BSE and scrapie. In its opinion of 6-7 March 2003, the Scientific Steering Committee recommended the introduction of a monitoring programme for TSEs in cervids. Therefore the monitoring system provided for in that Regulation should be extended to other TSEs, with the possibility to adopt further measures to implement that system at a later stage.

| (7) | A harmonised breeding programme to select for resistance to TSEs in ovine animals has been put in place as a transitional measure by Commission Decision 2003/100/EC of 13 February 2003 laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep (5). Regulation (EC) No 999/2001 should be amended to provide a permanent legal basis for that programme, as well as the possibility of amending such programmes to take account of the evaluated scientific results and overall consequences of their implementation. |
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(7)

A harmonised breeding programme to select for resistance to TSEs in ovine animals has been put in place as a transitional measure by Commission Decision 2003/100/EC of 13 February 2003 laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep (5). Regulation (EC) No 999/2001 should be amended to provide a permanent legal basis for that programme, as well as the possibility of amending such programmes to take account of the evaluated scientific results and overall consequences of their implementation.

| (8) | Regulation (EC) No 999/2001 prohibits the feeding of certain processed animal proteins to certain animals, with the possibility to provide for derogations. New developments concerning prohibitions on animal feeding may require amendments to be made to Annex IV to that Regulation. It is necessary to make certain technical amendments to the existing wording of the corresponding Article in order to facilitate amendment of the structure of that Annex at a later stage. |
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(8)

Regulation (EC) No 999/2001 prohibits the feeding of certain processed animal proteins to certain animals, with the possibility to provide for derogations. New developments concerning prohibitions on animal feeding may require amendments to be made to Annex IV to that Regulation. It is necessary to make certain technical amendments to the existing wording of the corresponding Article in order to facilitate amendment of the structure of that Annex at a later stage.

| (9) | Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (6) establishes rules for the disposal of specified risk materials and animals infected by TSEs. Rules on transit through the Community of products of animal origin have now been adopted. Accordingly, in the interests of consistency of Community legislation, the existing rules in Regulation (EC) No 999/2001 on the disposal of such materials and animals should be replaced by a reference to Regulation (EC) No 1774/2002, and the reference to rules on transit in Regulation (EC) No 999/2001 should be deleted. |
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(9)

Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (6) establishes rules for the disposal of specified risk materials and animals infected by TSEs. Rules on transit through the Community of products of animal origin have now been adopted. Accordingly, in the interests of consistency of Community legislation, the existing rules in Regulation (EC) No 999/2001 on the disposal of such materials and animals should be replaced by a reference to Regulation (EC) No 1774/2002, and the reference to rules on transit in Regulation (EC) No 999/2001 should be deleted.

| (10) | New developments concerning specified risk materials will also require comprehensive amendments to Annex V to Regulation (EC) No 999/2001. It is necessary to make certain technical amendments to the existing wording of the corresponding provisions of that Regulation in order to facilitate amendment of the structure of that Annex at a later stage. |
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(10)

New developments concerning specified risk materials will also require comprehensive amendments to Annex V to Regulation (EC) No 999/2001. It is necessary to make certain technical amendments to the existing wording of the corresponding provisions of that Regulation in order to facilitate amendment of the structure of that Annex at a later stage.

| (11) | Although stunning by injection of gas in the cranial cavity is prohibited within the Community, injection of gas may also occur after stunning. It is therefore necessary to amend the relevant provisions on slaughter methods in Regulation (EC) No 999/2001 with a view to prohibiting gas injection into the cranial cavity after stunning. |
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(11)

Although stunning by injection of gas in the cranial cavity is prohibited within the Community, injection of gas may also occur after stunning. It is therefore necessary to amend the relevant provisions on slaughter methods in Regulation (EC) No 999/2001 with a view to prohibiting gas injection into the cranial cavity after stunning.

| (12) | Commission Regulation (EC) No 1915/2003 of 30 October 2003 amending Annexes VII, VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the trade and import of ovine and caprine animals and the measures following the confirmation of transmissible spongiform encephalopathies in bovine, ovine and caprine animals (7) sets out new provisions on eradication of scrapie in ovine and caprine animals. Accordingly, it is necessary to prohibit the movement of ovine and caprine animals from holdings where scrapie is officially suspected. |
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(12)

Commission Regulation (EC) No 1915/2003 of 30 October 2003 amending Annexes VII, VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the trade and import of ovine and caprine animals and the measures following the confirmation of transmissible spongiform encephalopathies in bovine, ovine and caprine animals (7) sets out new provisions on eradication of scrapie in ovine and caprine animals. Accordingly, it is necessary to prohibit the movement of ovine and caprine animals from holdings where scrapie is officially suspected.

| (13) | Based on evolving scientific knowledge, Regulation (EC) No 999/2001 should allow the extension to other species of the scope of the rules concerning the placing on the market and export of bovine, ovine and caprine animals, their semen, embryos and ova. |
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(13)

Based on evolving scientific knowledge, Regulation (EC) No 999/2001 should allow the extension to other species of the scope of the rules concerning the placing on the market and export of bovine, ovine and caprine animals, their semen, embryos and ova.

| (14) | The opinion of the Scientific Steering Committee of 26 June 1998 indicates that certain restrictions regarding sourcing of raw material for the manufacture of di-calcium phosphate should be observed. Accordingly, di-calcium phosphate should be removed from the list of products which are not subject to restrictions on placing on the market under Regulation (EC) No 999/2001. The absence of restrictions applicable to milk and dairy products should be clarified. |
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(14)

The opinion of the Scientific Steering Committee of 26 June 1998 indicates that certain restrictions regarding sourcing of raw material for the manufacture of di-calcium phosphate should be observed. Accordingly, di-calcium phosphate should be removed from the list of products which are not subject to restrictions on placing on the market under Regulation (EC) No 999/2001. The absence of restrictions applicable to milk and dairy products should be clarified.

| (15) | Based on evolving scientific knowledge and risk classification, and notwithstanding the possibility to adopt safeguard measures, Regulation (EC) No 999/2001 should permit the adoption in accordance with the comitology procedure of more specific requirements for the placing on the market and export of products of animal origin originating from Member States or third countries with a controlled or undetermined risk of TSE. |
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(15)

Based on evolving scientific knowledge and risk classification, and notwithstanding the possibility to adopt safeguard measures, Regulation (EC) No 999/2001 should permit the adoption in accordance with the comitology procedure of more specific requirements for the placing on the market and export of products of animal origin originating from Member States or third countries with a controlled or undetermined risk of TSE.

| (16) | The measures necessary for the implementation of Regulation (EC) No 999/2001 should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8). |
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(16)

The measures necessary for the implementation of Regulation (EC) No 999/2001 should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8).

| (17) | In particular, the Commission should be empowered to adopt decisions approving the rapid tests, adapting the age of the animals, introducing the tolerance level, allowing feeding of young animals of ruminant species with proteins derived from fish and extending certain provisions to other animal species; to establish rules providing for exemptions to remove and destroy specific risk material; to establish criteria to demonstrate improvement of the epidemiological situation and criteria for granting exemptions from certain restrictions as well as production processes. Since those measures are of general scope and are designed to amend non-essential elements of that Regulation and or to supplement that Regulation by the addition of new non-essential elements, those measures should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. |
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(17)

In particular, the Commission should be empowered to adopt decisions approving the rapid tests, adapting the age of the animals, introducing the tolerance level, allowing feeding of young animals of ruminant species with proteins derived from fish and extending certain provisions to other animal species; to establish rules providing for exemptions to remove and destroy specific risk material; to establish criteria to demonstrate improvement of the epidemiological situation and criteria for granting exemptions from certain restrictions as well as production processes. Since those measures are of general scope and are designed to amend non-essential elements of that Regulation and or to supplement that Regulation by the addition of new non-essential elements, those measures should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

| (18) | Regulation (EC) No 999/2001 should therefore be amended accordingly, |
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(18)

Regulation (EC) No 999/2001 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 999/2001 is hereby amended as follows:

| 1) | the following recital shall be inserted:






  ‘(8a) | The feeding to non-ruminants of certain processed animal proteins originating from non-ruminants should be allowed taking into account the prohibition on intra-species recycling as laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (9) and the control aspects in particular linked to the differentiation of processed animal proteins specific to certain species as laid down in the Communication on the TSE Road map adopted by the Commission on 15 July 2005. |
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1)

the following recital shall be inserted:

‘(8a)

The feeding to non-ruminants of certain processed animal proteins originating from non-ruminants should be allowed taking into account the prohibition on intra-species recycling as laid down in Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (9) and the control aspects in particular linked to the differentiation of processed animal proteins specific to certain species as laid down in the Communication on the TSE Road map adopted by the Commission on 15 July 2005.

| 2) | the following recitals shall be inserted:






  ‘(11a) | In its resolution of 28 October 2004 (10), the European Parliament expressed concerns about feeding animal proteins to ruminants as they do not form part of the natural nutrition of adult cattle. In the wake of the BSE crisis and the foot-and-mouth disease crisis it has increasingly become accepted that the best way to ensure human and animal health is to keep and nourish animals in a way that respects the particularities of each species. Pursuant to the precautionary principle and in keeping with the natural diet and living conditions of ruminants, it is therefore necessary to maintain the prohibition on the feeding of animal proteins to ruminants in forms not normally constituting part of their natural diet. |
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2)

the following recitals shall be inserted:

‘(11a)

In its resolution of 28 October 2004 (10), the European Parliament expressed concerns about feeding animal proteins to ruminants as they do not form part of the natural nutrition of adult cattle. In the wake of the BSE crisis and the foot-and-mouth disease crisis it has increasingly become accepted that the best way to ensure human and animal health is to keep and nourish animals in a way that respects the particularities of each species. Pursuant to the precautionary principle and in keeping with the natural diet and living conditions of ruminants, it is therefore necessary to maintain the prohibition on the feeding of animal proteins to ruminants in forms not normally constituting part of their natural diet.

| (11b) | Mechanically separated meat is obtained by removing meat from bones in such a way that the muscle fibre structure is destroyed or modified. It can contain parts of the bones and the periosteum (bone skin). Thus, mechanically separated meat is not comparable with regular meat. Consequently its use for human consumption should be reviewed. |
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(11b)

Mechanically separated meat is obtained by removing meat from bones in such a way that the muscle fibre structure is destroyed or modified. It can contain parts of the bones and the periosteum (bone skin). Thus, mechanically separated meat is not comparable with regular meat. Consequently its use for human consumption should be reviewed.

| 3) | in Article 3, paragraph 1 shall be amended as follows:






  (a) | point (l) shall be replaced by the following:






  ‘(l) | rapid tests: the screening methods listed in Annex X, for which the results are known within 24 hours;’; |
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3)

in Article 3, paragraph 1 shall be amended as follows:

(a)

point (l) shall be replaced by the following:

‘(l)

rapid tests: the screening methods listed in Annex X, for which the results are known within 24 hours;’;

| (b) | the following points shall be added:






  ‘(n) | mechanically separated meat or “MSM”: the product obtained by removing meat from flesh-bearing bones after boning, using mechanical means resulting in the loss or modification of the muscle fibre structure; |
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(b)

the following points shall be added:

‘(n)

mechanically separated meat or “MSM”: the product obtained by removing meat from flesh-bearing bones after boning, using mechanical means resulting in the loss or modification of the muscle fibre structure;

| (o) | passive surveillance: the reporting of all animals suspected of being infected by a TSE and, where TSE cannot be excluded by clinical investigation, the laboratory testing of such animals; |
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(o)

passive surveillance: the reporting of all animals suspected of being infected by a TSE and, where TSE cannot be excluded by clinical investigation, the laboratory testing of such animals;

| (p) | active surveillance: the testing of animals not reported as suspected of being infected by a TSE, such as emergency slaughtered animals, animals with observations at ante mortem inspection, fallen stock, healthy slaughtered animals and animals culled in connection with a TSE case, in particular in order to determine the evolution and prevalence of TSE in a country or region thereof.’; |
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(p)

active surveillance: the testing of animals not reported as suspected of being infected by a TSE, such as emergency slaughtered animals, animals with observations at ante mortem inspection, fallen stock, healthy slaughtered animals and animals culled in connection with a TSE case, in particular in order to determine the evolution and prevalence of TSE in a country or region thereof.’;

| 4) | Article 5 is hereby amended as follows:






  (a) | paragraph 1 shall be replaced by the following:
  ‘1.   The BSE status of Member States or third countries or regions thereof (hereinafter referred to as “countries or regions”) shall be determined by classification into one of the following three categories:






  — | negligible BSE risk as defined in Annex II, |
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4)

Article 5 is hereby amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1.   The BSE status of Member States or third countries or regions thereof (hereinafter referred to as “countries or regions”) shall be determined by classification into one of the following three categories:

—

negligible BSE risk as defined in Annex II,

| — | controlled BSE risk as defined in Annex II, |
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—

controlled BSE risk as defined in Annex II,

| — | undetermined BSE risk as defined in Annex II. |
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—

undetermined BSE risk as defined in Annex II.

The BSE status of countries or regions may be determined only on the basis of the criteria set out in Annex II, Chapter A. These criteria shall include the outcome of a risk analysis on the basis of all the potential factors for the appearance of bovine spongiform encephalopathy as defined in Annex II, Chapter B, and their development over time, as well as comprehensive active and passive surveillance measures taking into account the risk category of the country or region.

Member States, and third countries wishing to be retained on the list of third countries approved for the export to the Community of the live animals or of the products covered by this Regulation, shall submit to the Commission an application for their BSE status to be determined, accompanied by the relevant information on the criteria set out in Annex II, Chapter A, and on the potential risk factors specified in Annex II, Chapter B, and their development over time.’;

| (b) | paragraph 4 shall be replaced by the following:
  ‘4.   Member States and third countries which have not submitted an application in accordance with the third subparagraph of paragraph 1 shall, with respect to the dispatch from their territory of live animals and products of animal origin, comply with the import requirements applicable to countries with an undetermined BSE risk, until they have submitted such an application and a final decision has been taken on their BSE status.’; |
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(b)

paragraph 4 shall be replaced by the following:

‘4.   Member States and third countries which have not submitted an application in accordance with the third subparagraph of paragraph 1 shall, with respect to the dispatch from their territory of live animals and products of animal origin, comply with the import requirements applicable to countries with an undetermined BSE risk, until they have submitted such an application and a final decision has been taken on their BSE status.’;

| 5) | Article 6 is hereby amended as follows:






  (a) | paragraph 1 shall be replaced by the following:
  ‘1.   Each Member State shall carry out an annual monitoring programme for TSEs based on active and passive surveillance in accordance with Annex III. If available for the animal species, that programme shall include a screening procedure using rapid tests.
  Rapid tests shall be approved for that purpose in accordance with the procedure referred to in Article 24(3) and listed in Annex X.’; |
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5)

Article 6 is hereby amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1.   Each Member State shall carry out an annual monitoring programme for TSEs based on active and passive surveillance in accordance with Annex III. If available for the animal species, that programme shall include a screening procedure using rapid tests.

Rapid tests shall be approved for that purpose in accordance with the procedure referred to in Article 24(3) and listed in Annex X.’;

| (b) | the following paragraphs shall be inserted:
  ‘1a.   The annual monitoring programme referred to in paragraph 1 shall cover as a minimum the following subpopulations:






  (a) | all bovine animals above 24 months of age sent for emergency slaughter or with observations at ante mortem inspections; |
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(b)

the following paragraphs shall be inserted:

‘1a.   The annual monitoring programme referred to in paragraph 1 shall cover as a minimum the following subpopulations:

(a)

all bovine animals above 24 months of age sent for emergency slaughter or with observations at ante mortem inspections;

| (b) | all bovine animals above 30 months of age slaughtered normally for human consumption; |
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(b)

all bovine animals above 30 months of age slaughtered normally for human consumption;

| (c) | all bovine animals above 24 months of age not slaughtered for human consumption, which have died or been killed on the farm, during transport or in an abattoir (fallen stock). |
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(c)

all bovine animals above 24 months of age not slaughtered for human consumption, which have died or been killed on the farm, during transport or in an abattoir (fallen stock).

Member States may decide to derogate from the provision under point (c) in remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this possibility shall inform the Commission and submit a list of the areas concerned together with a justification for the derogation. The derogation shall not cover more than 10 % of the bovine population in a Member State.

1b.   After consultation of the appropriate scientific committee, the age laid down in paragraph 1a(a) and (c) may be adapted according to scientific progress in accordance with the procedure referred to in Article 24(3).

At the request of a Member State which can demonstrate the improvement of the epidemiological situation of the country, according to certain criteria to be laid down in accordance with the procedure referred to in Article 24(3), the annual monitoring programmes for that particular Member State may be revised.

The Member State concerned shall provide proof of its capability to determine the effectiveness of the measures in place and ensure protection of human and animal health based on a comprehensive risk analysis. In particular, the Member State shall demonstrate:

| (a) | a clearly declining or consistently low BSE prevalence, based on up-to-date testing results; |
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(a)

a clearly declining or consistently low BSE prevalence, based on up-to-date testing results;

| (b) | that it has implemented and enforced for at least six years a full BSE testing scheme (Community legislation on traceability and identification of live animals and BSE surveillance); |
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(b)

that it has implemented and enforced for at least six years a full BSE testing scheme (Community legislation on traceability and identification of live animals and BSE surveillance);

| (c) | that it has implemented and enforced for at least six years Community legislation on total feed ban for farmed animals.’; |
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(c)

that it has implemented and enforced for at least six years Community legislation on total feed ban for farmed animals.’;

| (c) | the following paragraph shall be added:
  ‘5.   Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).’; |
| --- | --- |

(c)

the following paragraph shall be added:

‘5.   Rules for the implementation of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).’;

| 6) | the following Article shall be inserted:
  ‘Article 6a
  Breeding programmes
  1.   Member States may introduce breeding programmes to select for resistance to TSEs in their ovine populations. Those programmes shall include a framework to recognise the TSE-resistant status of certain flocks and may be extended to include other animal species based on scientific evidence corroborating the resistance to TSE of particular genotypes of those species.
  2.   Specific rules for the programmes provided for in paragraph 1 of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).
  3.   Member States which introduce breeding programmes shall submit regular reports to the Commission in order to enable the programmes to be scientifically evaluated, in particular with regard to their impact on the incidence of TSEs but also on genetic diversity and variability and on the maintenance of old or rare ovine breeds or of those that are well-adapted to a particular region. The scientific results and overall consequences of the breeding programmes shall be evaluated regularly, and where necessary, those programmes shall be amended accordingly.’; |
| --- | --- |

6)

the following Article shall be inserted:

‘Article 6a

Breeding programmes

1.   Member States may introduce breeding programmes to select for resistance to TSEs in their ovine populations. Those programmes shall include a framework to recognise the TSE-resistant status of certain flocks and may be extended to include other animal species based on scientific evidence corroborating the resistance to TSE of particular genotypes of those species.

2.   Specific rules for the programmes provided for in paragraph 1 of this Article shall be adopted in accordance with the procedure referred to in Article 24(2).

3.   Member States which introduce breeding programmes shall submit regular reports to the Commission in order to enable the programmes to be scientifically evaluated, in particular with regard to their impact on the incidence of TSEs but also on genetic diversity and variability and on the maintenance of old or rare ovine breeds or of those that are well-adapted to a particular region. The scientific results and overall consequences of the breeding programmes shall be evaluated regularly, and where necessary, those programmes shall be amended accordingly.’;

| 7) | Article 7 is hereby amended as follows:






  (a) | paragraphs 1 to 4 shall be replaced by the following:
  ‘1.   The feeding to ruminants of protein derived from animals shall be prohibited.
  2.   The prohibition provided for in paragraph 1 shall be extended to animals other than ruminants and restricted, as regards the feeding of those animals with products of animal origin, in accordance with Annex IV.
  3.   Paragraphs 1 and 2 shall apply without prejudice to the provisions laid down in Annex IV setting out the derogations from the prohibition contained in those paragraphs.
  The Commission may decide in accordance with the procedure referred to in Article 24(3), based on a scientific assessment of the dietary needs of young ruminants and subject to the rules adopted for the implementation of this Article provided for in paragraph 5 of this Article, and following an assessment of the control aspects of this derogation, to allow the feeding of young animals of ruminant species with proteins derived from fish.
  4.   Member States, or regions thereof, with an undetermined BSE risk shall not be permitted to export or store feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals.
  Third countries, or regions thereof, with an undetermined BSE risk shall not be permitted to export to the Community feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals.
  At the request of a Member State or third country a decision in accordance with the procedure referred to in Article 24(2) may be taken, following detailed criteria to be laid down in accordance with the procedure referred to in Article 24(3), to grant individual exemptions from the restrictions in this paragraph. Any exemption shall take account of the provisions provided for in paragraph 3 of this Article.’; |
| --- | --- | --- |

7)

Article 7 is hereby amended as follows:

(a)

paragraphs 1 to 4 shall be replaced by the following:

‘1.   The feeding to ruminants of protein derived from animals shall be prohibited.

2.   The prohibition provided for in paragraph 1 shall be extended to animals other than ruminants and restricted, as regards the feeding of those animals with products of animal origin, in accordance with Annex IV.

3.   Paragraphs 1 and 2 shall apply without prejudice to the provisions laid down in Annex IV setting out the derogations from the prohibition contained in those paragraphs.

The Commission may decide in accordance with the procedure referred to in Article 24(3), based on a scientific assessment of the dietary needs of young ruminants and subject to the rules adopted for the implementation of this Article provided for in paragraph 5 of this Article, and following an assessment of the control aspects of this derogation, to allow the feeding of young animals of ruminant species with proteins derived from fish.

4.   Member States, or regions thereof, with an undetermined BSE risk shall not be permitted to export or store feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals.

Third countries, or regions thereof, with an undetermined BSE risk shall not be permitted to export to the Community feed intended for farmed animals which contains protein derived from mammals or feed intended for mammals, except feed for dogs, cats and fur animals, which contains processed protein derived from mammals.

At the request of a Member State or third country a decision in accordance with the procedure referred to in Article 24(2) may be taken, following detailed criteria to be laid down in accordance with the procedure referred to in Article 24(3), to grant individual exemptions from the restrictions in this paragraph. Any exemption shall take account of the provisions provided for in paragraph 3 of this Article.’;

| (b) | the following paragraph shall be inserted:
  ‘4a.   Based on a favourable risk assessment taking into account at least the amount and possible source of contamination and the final destination of the consignment, a decision may be taken in accordance with the procedure referred to in Article 24(3) to introduce a tolerance level for insignificant amounts of animal proteins in feedingstuffs caused through adventitious and technically unavoidable contamination.’; |
| --- | --- |

(b)

the following paragraph shall be inserted:

‘4a.   Based on a favourable risk assessment taking into account at least the amount and possible source of contamination and the final destination of the consignment, a decision may be taken in accordance with the procedure referred to in Article 24(3) to introduce a tolerance level for insignificant amounts of animal proteins in feedingstuffs caused through adventitious and technically unavoidable contamination.’;

| (c) | paragraph 5 shall be replaced by the following:
  ‘5.   Rules for the implementation of this Article, in particular rules on the prevention of cross-contamination and on the methods of sampling and analysis required to check compliance with this Article, shall be adopted in accordance with the procedure referred to in Article 24(2). Those rules shall be based on a report of the Commission covering sourcing, processing, control and traceability of feedingstuffs of animal origin.’; |
| --- | --- |

(c)

paragraph 5 shall be replaced by the following:

‘5.   Rules for the implementation of this Article, in particular rules on the prevention of cross-contamination and on the methods of sampling and analysis required to check compliance with this Article, shall be adopted in accordance with the procedure referred to in Article 24(2). Those rules shall be based on a report of the Commission covering sourcing, processing, control and traceability of feedingstuffs of animal origin.’;

| 8) | in Article 8, paragraphs 1 to 5 shall be replaced by the following:
  ‘1.   The specified risk material shall be removed and disposed of in accordance with Annex V to this Regulation and with Regulation (EC) No 1774/2002. It shall not be imported into the Community. The list of specified risk material referred to in Annex V shall include at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months and the vertebral column of bovine animals above an age to be determined in accordance with the procedure referred to in Article 24(3). Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b), the list of specified risk material in Annex V shall be amended accordingly.
  2.   Paragraph 1 of this Article shall not apply to tissues from animals which have undergone an alternative test approved for that distinct purpose in accordance with the procedure referred to in Article 24(3) provided that this test is listed in Annex X, is applied under the conditions provided for in Annex V and the test results are negative.
  The Member States which authorise the use of an alternative test pursuant to this paragraph shall inform the other Member States and the Commission.
  3.   In Member States, or regions thereof, with a controlled or undetermined BSE risk, the laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity in connection with stunning, shall not be used on bovine, ovine or caprine animals whose meat is intended for human or animal consumption.
  4.   The data relating to age set out in Annex V may be adjusted. Such adjustments shall be based on the latest proven scientific findings concerning the statistical probability of the occurrence of a TSE in the relevant age groups of the Community's bovine, ovine and caprine population.
  5.   Rules providing for exemptions from paragraphs 1 to 4 of this Article may be adopted in accordance with the procedure referred to in Article 24(3), with regard to the date of the effective enforcement of the feeding prohibition provided for in Article 7(1) or, as appropriate for third countries or regions thereof with a controlled BSE risk, with regard to the date of the effective enforcement of the ban of mammalian protein in feed for ruminants with a view to limiting the requirements to remove and destroy specified risk material to animals born before that date in the countries or regions concerned.’; |
| --- | --- |

8)

in Article 8, paragraphs 1 to 5 shall be replaced by the following:

‘1.   The specified risk material shall be removed and disposed of in accordance with Annex V to this Regulation and with Regulation (EC) No 1774/2002. It shall not be imported into the Community. The list of specified risk material referred to in Annex V shall include at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months and the vertebral column of bovine animals above an age to be determined in accordance with the procedure referred to in Article 24(3). Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b), the list of specified risk material in Annex V shall be amended accordingly.

2.   Paragraph 1 of this Article shall not apply to tissues from animals which have undergone an alternative test approved for that distinct purpose in accordance with the procedure referred to in Article 24(3) provided that this test is listed in Annex X, is applied under the conditions provided for in Annex V and the test results are negative.

The Member States which authorise the use of an alternative test pursuant to this paragraph shall inform the other Member States and the Commission.

3.   In Member States, or regions thereof, with a controlled or undetermined BSE risk, the laceration, after stunning, of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injection into the cranial cavity in connection with stunning, shall not be used on bovine, ovine or caprine animals whose meat is intended for human or animal consumption.

4.   The data relating to age set out in Annex V may be adjusted. Such adjustments shall be based on the latest proven scientific findings concerning the statistical probability of the occurrence of a TSE in the relevant age groups of the Community's bovine, ovine and caprine population.

5.   Rules providing for exemptions from paragraphs 1 to 4 of this Article may be adopted in accordance with the procedure referred to in Article 24(3), with regard to the date of the effective enforcement of the feeding prohibition provided for in Article 7(1) or, as appropriate for third countries or regions thereof with a controlled BSE risk, with regard to the date of the effective enforcement of the ban of mammalian protein in feed for ruminants with a view to limiting the requirements to remove and destroy specified risk material to animals born before that date in the countries or regions concerned.’;

| 9) | in Article 9, paragraphs 1 and 2 shall be replaced by the following:
  ‘1.   The products of animal origin listed in Annex VI shall be produced using production processes approved in accordance with the procedure referred to in Article 24(3).
  2.   Bones of bovine, ovine and caprine animals from countries or regions with a controlled or undetermined BSE risk shall not be used for the production of mechanically separated meat (MSM). Before 1 July 2008, the Member States shall submit a report to the Commission on the use and the production method of MSM in their territory. This report shall include a statement as to whether the Member State intends to continue with the production of MSM.
  The Commission shall thereupon present a communication to the European Parliament and the Council on the future necessity and use of MSM in the Community, including the information policy towards consumers.’; |
| --- | --- |

9)

in Article 9, paragraphs 1 and 2 shall be replaced by the following:

‘1.   The products of animal origin listed in Annex VI shall be produced using production processes approved in accordance with the procedure referred to in Article 24(3).

2.   Bones of bovine, ovine and caprine animals from countries or regions with a controlled or undetermined BSE risk shall not be used for the production of mechanically separated meat (MSM). Before 1 July 2008, the Member States shall submit a report to the Commission on the use and the production method of MSM in their territory. This report shall include a statement as to whether the Member State intends to continue with the production of MSM.

The Commission shall thereupon present a communication to the European Parliament and the Council on the future necessity and use of MSM in the Community, including the information policy towards consumers.’;

| 10) | Article 12 is hereby amended as follows:






  (a) | paragraph 1 shall be replaced by the following:
  ‘1.   Any animal suspected of being infected by a TSE shall be either placed under an official movement restriction until the results of a clinical and epidemiological examination carried out by the competent authority are known, or killed for laboratory examination under official control.
  If a TSE is officially suspected in a bovine animal at a holding in a Member State, all other bovine animals at that holding shall be placed under an official movement restriction until the results of the examination are available. If a TSE is officially suspected in an ovine or caprine animal at a holding in a Member State, all other ovine and caprine animals at that holding shall be placed under an official movement restriction until the results are available.
  However, if there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the competent authority may decide that only the animal suspected of being infected shall be placed under an official movement restriction.
  If considered necessary, the competent authority may also decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.
  In accordance with the procedure referred to in Article 24(2) and by way of derogation from the official movement restrictions provided for in this paragraph, a Member State may be exempted from implementing such restrictions if it applies measures offering equivalent safeguards based on an appropriate assessment of the possible risks for human and animal health.’; |
| --- | --- | --- |

10)

Article 12 is hereby amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1.   Any animal suspected of being infected by a TSE shall be either placed under an official movement restriction until the results of a clinical and epidemiological examination carried out by the competent authority are known, or killed for laboratory examination under official control.

If a TSE is officially suspected in a bovine animal at a holding in a Member State, all other bovine animals at that holding shall be placed under an official movement restriction until the results of the examination are available. If a TSE is officially suspected in an ovine or caprine animal at a holding in a Member State, all other ovine and caprine animals at that holding shall be placed under an official movement restriction until the results are available.

However, if there is evidence that the holding where the animal was present when the TSE was suspected is unlikely to be the holding where the animal could have been exposed to the TSE, the competent authority may decide that only the animal suspected of being infected shall be placed under an official movement restriction.

If considered necessary, the competent authority may also decide that other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available.

In accordance with the procedure referred to in Article 24(2) and by way of derogation from the official movement restrictions provided for in this paragraph, a Member State may be exempted from implementing such restrictions if it applies measures offering equivalent safeguards based on an appropriate assessment of the possible risks for human and animal health.’;

| (b) | paragraph 3 shall be replaced by the following:
  ‘3.   All parts of the body of the suspect animal shall be either retained under official control until a negative diagnosis has been made, or disposed of in accordance with Regulation (EC) No 1774/2002.’; |
| --- | --- |

(b)

paragraph 3 shall be replaced by the following:

‘3.   All parts of the body of the suspect animal shall be either retained under official control until a negative diagnosis has been made, or disposed of in accordance with Regulation (EC) No 1774/2002.’;

| 11) | in Article 13, paragraph 1 is hereby amended as follows:






  (a) | point (a) of the first subparagraph shall be replaced by the following:






  ‘(a) | all parts of the body of the animal shall be disposed of in accordance with Regulation (EC) No 1774/2002 except for material retained for records in accordance with Annex III, Chapter B, of this Regulation.’; |
| --- | --- | --- | --- |

11)

in Article 13, paragraph 1 is hereby amended as follows:

(a)

point (a) of the first subparagraph shall be replaced by the following:

‘(a)

all parts of the body of the animal shall be disposed of in accordance with Regulation (EC) No 1774/2002 except for material retained for records in accordance with Annex III, Chapter B, of this Regulation.’;

| (b) | point (c) of the first subparagraph shall be replaced by the following:






  ‘(c) | all animals and products thereof at risk, as listed in Annex VII, point 2, of this Regulation, identified by the inquiry referred to in point (b) of this paragraph shall be killed and disposed of in accordance with Regulation (EC) No 1774/2002.’; |
| --- | --- | --- |

(b)

point (c) of the first subparagraph shall be replaced by the following:

‘(c)

all animals and products thereof at risk, as listed in Annex VII, point 2, of this Regulation, identified by the inquiry referred to in point (b) of this paragraph shall be killed and disposed of in accordance with Regulation (EC) No 1774/2002.’;

| (c) | after the first subparagraph, the following subparagraph shall be inserted:
  ‘At the request of a Member State and based on a favourable risk assessment taking particularly into account the control measures in that Member State, a decision may be taken in accordance with the procedure referred to in Article 24(2) to allow the use of bovine animals referred to in this paragraph until the end of their productive lives.’; |
| --- | --- |

(c)

after the first subparagraph, the following subparagraph shall be inserted:

‘At the request of a Member State and based on a favourable risk assessment taking particularly into account the control measures in that Member State, a decision may be taken in accordance with the procedure referred to in Article 24(2) to allow the use of bovine animals referred to in this paragraph until the end of their productive lives.’;

| 12) | in Article 15, paragraph 3 shall be replaced by the following:
  ‘3.   In accordance with the procedure referred to in Article 24(3), the provisions of paragraphs 1 and 2 may be extended to other animal species.
  4.   Rules for implementing this Article may be adopted in accordance with the procedure referred to in Article 24(2).’; |
| --- | --- |

12)

in Article 15, paragraph 3 shall be replaced by the following:

‘3.   In accordance with the procedure referred to in Article 24(3), the provisions of paragraphs 1 and 2 may be extended to other animal species.

4.   Rules for implementing this Article may be adopted in accordance with the procedure referred to in Article 24(2).’;

| 13) | Article 16 is hereby amended as follows:






  (a) | in paragraph 1, point (b) shall be replaced by the following:






  ‘(b) | milk and dairy products, hides and skins, and gelatine and collagen derived from hides and skins.’; |
| --- | --- | --- | --- |

13)

Article 16 is hereby amended as follows:

(a)

in paragraph 1, point (b) shall be replaced by the following:

‘(b)

milk and dairy products, hides and skins, and gelatine and collagen derived from hides and skins.’;

| (b) | paragraphs 2 and 3 shall be replaced by the following:
  ‘2.   Products of animal origin imported from a third country with a controlled or undetermined BSE risk shall come from healthy bovine, ovine and caprine animals which have not been subjected to a laceration of the central nervous tissue or gas injection into the cranial cavity as referred to in Article 8(3).
  3.   Food products of animal origin containing material obtained from bovine animals originating in a country or region with an undetermined BSE risk shall not be placed on the market unless they come from animals which:






  (a) | were born eight years after the date from which the prohibition on the feeding to ruminants of animal protein derived from mammals was effectively enforced; and |
| --- | --- | --- |

(b)

paragraphs 2 and 3 shall be replaced by the following:

‘2.   Products of animal origin imported from a third country with a controlled or undetermined BSE risk shall come from healthy bovine, ovine and caprine animals which have not been subjected to a laceration of the central nervous tissue or gas injection into the cranial cavity as referred to in Article 8(3).

3.   Food products of animal origin containing material obtained from bovine animals originating in a country or region with an undetermined BSE risk shall not be placed on the market unless they come from animals which:

(a)

were born eight years after the date from which the prohibition on the feeding to ruminants of animal protein derived from mammals was effectively enforced; and

| (b) | were born, raised and have stayed in herds with a certified history of freedom from BSE for at least seven years. |
| --- | --- |

(b)

were born, raised and have stayed in herds with a certified history of freedom from BSE for at least seven years.

Furthermore, food products of ruminant origin shall not be dispatched from a Member State or a region thereof with an undetermined BSE risk to another Member State or be imported from a third country with an undetermined BSE risk.

This prohibition shall not apply to products of animal origin listed in Annex VIII, Chapter C, and fulfilling the requirements of Annex VIII, Chapter C.

They must be accompanied by an animal health certificate issued by an official veterinarian certifying that they have been produced in conformity with this Regulation.’;

| 14) | the following Article shall be inserted:
  ‘Article 23a
  The following measures for implementation of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3):






  (a) | approval of the rapid tests referred to in Article 6(1) and Article 8(2), |
| --- | --- | --- |

14)

the following Article shall be inserted:

‘Article 23a

The following measures for implementation of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3):

(a)

approval of the rapid tests referred to in Article 6(1) and Article 8(2),

| (b) | adaptation of the age referred to in Article 6(1b), |
| --- | --- |

(b)

adaptation of the age referred to in Article 6(1b),

| (c) | criteria to demonstrate improvement of the epidemiological situation referred to in Article 6(1b), |
| --- | --- |

(c)

criteria to demonstrate improvement of the epidemiological situation referred to in Article 6(1b),

| (d) | decision to allow feeding of young animals of ruminant species with proteins derived from fish as referred to in Article 7(3), |
| --- | --- |

(d)

decision to allow feeding of young animals of ruminant species with proteins derived from fish as referred to in Article 7(3),

| (e) | criteria for granting exemptions from the restrictions referred to in Article 7(4), |
| --- | --- |

(e)

criteria for granting exemptions from the restrictions referred to in Article 7(4),

| (f) | decision to introduce a tolerance level as referred to in Article 7(4a), |
| --- | --- |

(f)

decision to introduce a tolerance level as referred to in Article 7(4a),

| (g) | decision on age as referred to in Article 8(1), |
| --- | --- |

(g)

decision on age as referred to in Article 8(1),

| (h) | rules providing for exemptions to remove and destroy specified risk material as referred to in Article 8(5), |
| --- | --- |

(h)

rules providing for exemptions to remove and destroy specified risk material as referred to in Article 8(5),

| (i) | production processes referred to in Article 9(1), |
| --- | --- |

(i)

production processes referred to in Article 9(1),

| (j) | decision to extend certain provisions to other animal species as referred to in Article 15(3). |
| --- | --- |

(j)

decision to extend certain provisions to other animal species as referred to in Article 15(3).

These measures shall be annexed to this Regulation.’;

| 15) | Article 24 shall be replaced by the following:
  ‘Article 24
  Committees
  1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. However, the Standing Committee on Zootechnics shall also be consulted by the Commission with regard to Article 6a.
  2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
  The time-limits referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days.
  3.   Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’; |
| --- | --- |

15)

Article 24 shall be replaced by the following:

‘Article 24

Committees

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health. However, the Standing Committee on Zootechnics shall also be consulted by the Commission with regard to Article 6a.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The time-limits referred to in Article 5(6) of that Decision shall be three months and, in the case of safeguard measures referred to in Article 4(2) of this Regulation, 15 days.

3.   Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

| 16) | the following Article shall be inserted:
  ‘Article 24a
  Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Community.’. |
| --- | --- |

16)

the following Article shall be inserted:

‘Article 24a

Decisions to be adopted in accordance with one of the procedures referred to in Article 24 shall be based on an appropriate assessment of the possible risks for human and animal health and shall, taking into account existing scientific evidence, maintain, or if scientifically justified increase, the level of protection of human and animal health ensured in the Community.’.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ...

For the European Parliament

The President

...

For the Council

The President

...

---

(1)  OJ C 234, 22.9.2005, p. 26.

1

(2)  Opinion of the European Parliament of 17 May 2006 (not yet published in the Official Journal), Council common position of 23 November 2006 and Position of the European Parliament of ... (not yet published in the Official Journal).

2

(3)  OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1041/2006 (OJ L 187, 8.7.2006, p. 10).

3

(4)  OJ L 163, 23.6.2005, p. 1.

4

(5)  OJ L 41, 14.2.2003, p. 41.

5

(6)  OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p. 25).

6

(7)  OJ L 283, 31.10.2003, p. 29.

7

(8)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11.)

8

(9)  OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 208/2006 (OJ L 36, 8.2.2006, p. 25).’;

9

(10)  OJ C 174 E, 14.7.2005, p. 178.’;

10

---

STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

| 1. | The Commission forwarded to the Council on 7 December 2004 a proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001.The proposal is based on Article 152 of the Treaty. |
| --- | --- |

1.

The Commission forwarded to the Council on 7 December 2004 a proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001.The proposal is based on Article 152 of the Treaty.

| 2. | The European Parliament adopted its opinion at first reading on 17 May 2006. The Economic and Social Committee gave its opinion on 9 March 2005. |
| --- | --- |

2.

The European Parliament adopted its opinion at first reading on 17 May 2006. The Economic and Social Committee gave its opinion on 9 March 2005.

| 3. | On 23 November 2006, the Council adopted its Common Position in accordance with Article 251 of the Treaty. |
| --- | --- |

3.

On 23 November 2006, the Council adopted its Common Position in accordance with Article 251 of the Treaty.

II.   OBJECTIVES

The proposed Regulation intends to address Member States' concerns, particularly regarding:

| — | Categorisation of countries with regard to BSE risk |
| --- | --- |

—

Categorisation of countries with regard to BSE risk

| — | Definition of passive and active surveillance measures |
| --- | --- |

—

Definition of passive and active surveillance measures

| — | and above all, the possibility of adapting the current monitoring system to improvements in the epidemiological situation of the Member State concerned. |
| --- | --- |

—

and above all, the possibility of adapting the current monitoring system to improvements in the epidemiological situation of the Member State concerned.

III.   ANALYSIS OF THE COMMON POSITION

1.   General context

An agreement at first reading was reached on this dossier in May 2006.

The revision of the draft Regulation by lawyer-linguists of both institutions was carried out on 19 September 2006 (PE-CONS 3618/06).

In the meanwhile, the Council adopted Decision 2006/512/EC introducing a new procedure named ‘regulatory procedure with scrutiny’ into Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (Article 5a).

The new Committee procedure has to be followed to adopt measures of general scope which seek to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia by deleting some of those elements or by supplementing the instrument by the addition of new nonessential elements.

2.   Adaptations introduced by the Council

Regulation (EC) No 999/2001 always refers to the Committee regulatory procedure when implementing powers are conferred to the Commission and therefore has to be adapted, when appropriate, to the new Committee regulatory procedure with scrutiny.

Due to the urgency of the matter (1), it will be necessary that the adoption of this Regulation by the Parliament and the Council take place by December 2006.

The Commission has accepted the common position agreed by the Council.

---

(1)  Several implementing measures are blocked at Commission level.

---

| 19.12.2006 | EN | Official Journal of the European Union | CE 311/10 |
| --- | --- | --- | --- |

19.12.2006

EN

Official Journal of the European Union

CE 311/10

---

COMMON POSITION (EC) No 33/2006

adopted by the Council on 23 November 2006

with a view to adopting Directive 2006/.../EC of the European Parliament and of the Council of ... on the assessment and management of flood risks

(2006/C 311 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | Floods have the potential to cause fatalities, displacement of people and damage to the environment, to severely compromise economic development and to undermine the economic activities of the Community. |
| --- | --- |

(1)

Floods have the potential to cause fatalities, displacement of people and damage to the environment, to severely compromise economic development and to undermine the economic activities of the Community.

| (2) | Floods are natural phenomena which cannot be prevented. However, some human activities and climate change contribute to an increase in the likelihood and adverse impacts of flood events. |
| --- | --- |

(2)

Floods are natural phenomena which cannot be prevented. However, some human activities and climate change contribute to an increase in the likelihood and adverse impacts of flood events.

| (3) | It is feasible and desirable to reduce the risk of adverse consequences, especially for human health and life, the environment, cultural heritage, economic activity and infrastructure associated with floods. However, measures to reduce these risks should, as far as possible, be coordinated throughout a river basin if they are to be effective. |
| --- | --- |

(3)

It is feasible and desirable to reduce the risk of adverse consequences, especially for human health and life, the environment, cultural heritage, economic activity and infrastructure associated with floods. However, measures to reduce these risks should, as far as possible, be coordinated throughout a river basin if they are to be effective.

| (4) | Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (3) requires river basin management plans to be developed for each river basin district in order to achieve good ecological and chemical status, and it will contribute to mitigating the effects of floods. However, reducing the risk of floods is not one of the principal objectives of that Directive, nor does it take into account future risks of flooding caused by climate change. |
| --- | --- |

(4)

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (3) requires river basin management plans to be developed for each river basin district in order to achieve good ecological and chemical status, and it will contribute to mitigating the effects of floods. However, reducing the risk of floods is not one of the principal objectives of that Directive, nor does it take into account future risks of flooding caused by climate change.

| (5) | The Commission Communication of 12 July 2004 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Flood risk management — Flood prevention, protection and mitigation’ sets out its analysis and approach to managing flood risks at Community level, and states that concerted and coordinated action at Community level would bring considerable added value and improve the overall level of flood protection. |
| --- | --- |

(5)

The Commission Communication of 12 July 2004 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Flood risk management — Flood prevention, protection and mitigation’ sets out its analysis and approach to managing flood risks at Community level, and states that concerted and coordinated action at Community level would bring considerable added value and improve the overall level of flood protection.

| (6) | Effective flood prevention and mitigation requires, in addition to coordination between Member States, cooperation with third countries. This is in line with Directive 2000/60/EC and international principles of flood risk management as developed notably under the United Nations Convention on the protection and use of transboundary water courses and international lakes, approved by Council Decision 95/308/EC (4), and any succeeding agreements on its application. |
| --- | --- |

(6)

Effective flood prevention and mitigation requires, in addition to coordination between Member States, cooperation with third countries. This is in line with Directive 2000/60/EC and international principles of flood risk management as developed notably under the United Nations Convention on the protection and use of transboundary water courses and international lakes, approved by Council Decision 95/308/EC (4), and any succeeding agreements on its application.

| (7) | Council Decision 2001/792/EC, Euratom of 23 October 2001 establishing a Community mechanism to facilitate reinforced cooperation in civil protection assistance interventions (5) mobilises support and assistance from Member States in the event of major emergencies, including floods. Civil protection can provide adequate response to affected populations and improve preparedness and resilience. |
| --- | --- |

(7)

Council Decision 2001/792/EC, Euratom of 23 October 2001 establishing a Community mechanism to facilitate reinforced cooperation in civil protection assistance interventions (5) mobilises support and assistance from Member States in the event of major emergencies, including floods. Civil protection can provide adequate response to affected populations and improve preparedness and resilience.

| (8) | Under Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (6) it is possible to grant rapid financial assistance in the event of a major disaster to help the people, natural zones, regions and countries concerned to return to conditions that are as normal as possible, but the Fund may only intervene for emergency operations, and not for the phases preceding an emergency. |
| --- | --- |

(8)

Under Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (6) it is possible to grant rapid financial assistance in the event of a major disaster to help the people, natural zones, regions and countries concerned to return to conditions that are as normal as possible, but the Fund may only intervene for emergency operations, and not for the phases preceding an emergency.

| (9) | Throughout the Community different types of floods occur, such as river floods, flash floods, urban floods and floods from the sea in coastal areas. The damage caused by flood events may also vary across the countries and regions of the Community. Hence, objectives regarding the management of flood risks should be determined by the Member States themselves and should be based on local and regional circumstances. |
| --- | --- |

(9)

Throughout the Community different types of floods occur, such as river floods, flash floods, urban floods and floods from the sea in coastal areas. The damage caused by flood events may also vary across the countries and regions of the Community. Hence, objectives regarding the management of flood risks should be determined by the Member States themselves and should be based on local and regional circumstances.

| (10) | Flood risks in certain areas within the Community could be considered not to be significant, for example in thinly populated or unpopulated areas or in areas with limited economic assets or ecological value. In each river basin district or unit of management the flood risks and need for further action should be assessed. |
| --- | --- |

(10)

Flood risks in certain areas within the Community could be considered not to be significant, for example in thinly populated or unpopulated areas or in areas with limited economic assets or ecological value. In each river basin district or unit of management the flood risks and need for further action should be assessed.

| (11) | In order to have available an effective tool for information, as well as a valuable basis for priority setting and further technical, financial and political decisions regarding flood risk management it is necessary to provide for the establishing of flood hazard maps and flood risk maps showing the potential adverse consequences associated with different flood scenarios. |
| --- | --- |

(11)

In order to have available an effective tool for information, as well as a valuable basis for priority setting and further technical, financial and political decisions regarding flood risk management it is necessary to provide for the establishing of flood hazard maps and flood risk maps showing the potential adverse consequences associated with different flood scenarios.

| (12) | With a view to avoiding and reducing the negative impacts of floods in the area concerned it is appropriate to provide for flood risk management plans. The causes and consequences of flood events vary across the countries and regions of the Community. Flood risk management plans should therefore take into account the particular characteristics of the areas they cover and provide for tailored solutions according to the needs and priorities of those areas, whilst ensuring relevant coordination within river basin districts. |
| --- | --- |

(12)

With a view to avoiding and reducing the negative impacts of floods in the area concerned it is appropriate to provide for flood risk management plans. The causes and consequences of flood events vary across the countries and regions of the Community. Flood risk management plans should therefore take into account the particular characteristics of the areas they cover and provide for tailored solutions according to the needs and priorities of those areas, whilst ensuring relevant coordination within river basin districts.

| (13) | Flood risk management plans should focus on prevention, protection and preparedness. The elements of flood risk management plans should be periodically reviewed and if necessary updated, taking into account the likely effects of climate change on the occurrence of floods. |
| --- | --- |

(13)

Flood risk management plans should focus on prevention, protection and preparedness. The elements of flood risk management plans should be periodically reviewed and if necessary updated, taking into account the likely effects of climate change on the occurrence of floods.

| (14) | The solidarity principle is very important in the context of flood risk management. In the light of it Member States should be encouraged to seek a fair sharing of responsibilities, when measures are jointly decided for the common benefit, as regards flood risk management along water courses. |
| --- | --- |

(14)

The solidarity principle is very important in the context of flood risk management. In the light of it Member States should be encouraged to seek a fair sharing of responsibilities, when measures are jointly decided for the common benefit, as regards flood risk management along water courses.

| (15) | To prevent duplication of work, Member States should be entitled to use existing preliminary flood risk assessments, flood hazard and risk maps and flood risk management plans for the purposes of achieving the objectives and satisfying the requirements of this Directive. |
| --- | --- |

(15)

To prevent duplication of work, Member States should be entitled to use existing preliminary flood risk assessments, flood hazard and risk maps and flood risk management plans for the purposes of achieving the objectives and satisfying the requirements of this Directive.

| (16) | Development of river basin management plans under Directive 2000/60/EC and of flood risk management plans under this Directive are elements of integrated river basin management. The two processes should therefore use the mutual potential for common synergies and benefits, having regard to the environmental objectives of Directive 2000/60/EC, ensuring efficiency and wise use of resources while recognising that the competent authorities and management units might be different under this Directive and Directive 2000/60/EC. |
| --- | --- |

(16)

Development of river basin management plans under Directive 2000/60/EC and of flood risk management plans under this Directive are elements of integrated river basin management. The two processes should therefore use the mutual potential for common synergies and benefits, having regard to the environmental objectives of Directive 2000/60/EC, ensuring efficiency and wise use of resources while recognising that the competent authorities and management units might be different under this Directive and Directive 2000/60/EC.

| (17) | In cases of multi-purpose use of bodies of water for different forms of sustainable human activities (e.g. flood risk management, ecology, inland navigation or hydropower) and the impacts of such use on the bodies of water, Directive 2000/60/EC provides for a clear and transparent process for addressing such uses and impacts, including possible exemptions from the objectives of ‘good status’ or of ‘non-deterioration’ in Article 4 thereof. |
| --- | --- |

(17)

In cases of multi-purpose use of bodies of water for different forms of sustainable human activities (e.g. flood risk management, ecology, inland navigation or hydropower) and the impacts of such use on the bodies of water, Directive 2000/60/EC provides for a clear and transparent process for addressing such uses and impacts, including possible exemptions from the objectives of ‘good status’ or of ‘non-deterioration’ in Article 4 thereof.

| (18) | The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7). |
| --- | --- |

(18)

The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (7).

| (19) | This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, it seeks to promote the integration into Community policies of a high level of environmental protection in accordance with the principle of sustainable development as laid down in Article 37 of the Charter of Fundamental Rights of the European Union. |
| --- | --- |

(19)

This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, it seeks to promote the integration into Community policies of a high level of environmental protection in accordance with the principle of sustainable development as laid down in Article 37 of the Charter of Fundamental Rights of the European Union.

| (20) | Since the objective of this Directive, namely the establishment of a framework for measures to reduce the risks of flood damage, cannot be sufficiently achieved by the Member States and can by reason of scale and effects of actions be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. |
| --- | --- |

(20)

Since the objective of this Directive, namely the establishment of a framework for measures to reduce the risks of flood damage, cannot be sufficiently achieved by the Member States and can by reason of scale and effects of actions be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

| (21) | In accordance with the principles of proportionality and subsidiarity and the Protocol on the application of the principles of subsidiarity and proportionality attached to the Treaty, and in view of existing capabilities of Member States, considerable flexibility should be left to the local and regional levels, in particular as regards organisation and responsibility of authorities. |
| --- | --- |

(21)

In accordance with the principles of proportionality and subsidiarity and the Protocol on the application of the principles of subsidiarity and proportionality attached to the Treaty, and in view of existing capabilities of Member States, considerable flexibility should be left to the local and regional levels, in particular as regards organisation and responsibility of authorities.

| (22) | In accordance with point 34 of the Interinstitutional Agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public, |
| --- | --- |

(22)

In accordance with point 34 of the Interinstitutional Agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interest of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

The purpose of this Directive is to establish a framework for the assessment and management of flood risks, aiming at the reduction of the adverse consequences for human health, the environment, cultural heritage and economic activity associated with floods in the Community.

Article 2

For the purpose of this Directive, in addition to the definitions of ‘river’, ‘river basin’, ‘sub-basin’ and ‘river basin district’ as set out in Article 2 of Directive 2000/60/EC, the following definitions shall apply:

| 1) | ‘flood’ means the temporary covering by water of land not normally covered by water. This shall include floods from rivers, mountain torrents, Mediterranean ephemeral water courses, and floods from the sea in coastal areas, and may exclude floods from sewerage systems; |
| --- | --- |

1)

‘flood’ means the temporary covering by water of land not normally covered by water. This shall include floods from rivers, mountain torrents, Mediterranean ephemeral water courses, and floods from the sea in coastal areas, and may exclude floods from sewerage systems;

| 2) | ‘flood risk’ means the combination of the probability of a flood event and of the potential adverse consequences for human health, the environment, cultural heritage and economic activity associated with a flood event. |
| --- | --- |

2)

‘flood risk’ means the combination of the probability of a flood event and of the potential adverse consequences for human health, the environment, cultural heritage and economic activity associated with a flood event.

Article 3

1.   For the purposes of this Directive Member States shall make use of the arrangements made under Article 3(1), (2), (3), (5) and (6) of Directive 2000/60/EC.

2.   However, for the implementation of this Directive, Member States may:

| (a) | appoint competent authorities different from those identified pursuant to Article 3(2) of Directive 2000/60/EC; |
| --- | --- |

(a)

appoint competent authorities different from those identified pursuant to Article 3(2) of Directive 2000/60/EC;

| (b) | identify certain coastal areas or individual river basins and assign them to a unit of management different from those assigned pursuant to Article 3(1) of Directive 2000/60/EC. |
| --- | --- |

(b)

identify certain coastal areas or individual river basins and assign them to a unit of management different from those assigned pursuant to Article 3(1) of Directive 2000/60/EC.

In these cases, Member States shall, by... (9), communicate to the Commission the information referred to in Annex I to Directive 2000/60/EC. For this purpose, any reference to competent authorities and river basin districts shall be taken as references to the competent authorities and unit of management referred to in this Article. Member States shall inform the Commission of any changes in the information provided pursuant to this paragraph within three months of the change coming into effect.

CHAPTER II

PRELIMINARY FLOOD RISK ASSESSMENT

Article 4

1.   Member States shall, for each river basin district or unit of management referred to in Article 3(2)(b) or the portion of an international river basin district lying within their territory, undertake a preliminary flood risk assessment in accordance with paragraph 2 of this Article.

2.   A preliminary flood risk assessment shall be undertaken to provide an assessment of potential risks based on available or readily derivable information, such as records. The assessment shall include at least the following:

| (a) | maps of the river basin district at the appropriate scale including the borders of the river basins, sub-basins and where appropriate coastal areas, showing topography and land use; |
| --- | --- |

(a)

maps of the river basin district at the appropriate scale including the borders of the river basins, sub-basins and where appropriate coastal areas, showing topography and land use;

| (b) | a description of the floods which have occurred in the past and which had significant adverse impacts on human health, the environment, cultural heritage and economic activity and for which the likelihood of similar future events is still relevant, including their flood extent and conveyance routes and an assessment of the adverse impacts they have entailed; |
| --- | --- |

(b)

a description of the floods which have occurred in the past and which had significant adverse impacts on human health, the environment, cultural heritage and economic activity and for which the likelihood of similar future events is still relevant, including their flood extent and conveyance routes and an assessment of the adverse impacts they have entailed;

| (c) | a description of the significant floods which have occurred in the past, where significant adverse consequences of similar future events might be envisaged; |
| --- | --- |

(c)

a description of the significant floods which have occurred in the past, where significant adverse consequences of similar future events might be envisaged;

and, where appropriate, it shall include:

| (d) | an assessment of the potential adverse consequences of future floods for human health, the environment, cultural heritage and economic activity, taking into account as far as possible issues such as the topography, the position of watercourses and their general hydrological and geo-morphological characteristics, the position of populated areas, areas of economic activity and long-term developments including impacts of climate change on the occurrence of floods. |
| --- | --- |

(d)

an assessment of the potential adverse consequences of future floods for human health, the environment, cultural heritage and economic activity, taking into account as far as possible issues such as the topography, the position of watercourses and their general hydrological and geo-morphological characteristics, the position of populated areas, areas of economic activity and long-term developments including impacts of climate change on the occurrence of floods.

3.   In the case of international river basin districts, or units of management referred to in Article 3(2)(b) which are shared with other Member States, Member States shall ensure that exchange of relevant information takes place between the competent authorities concerned.

4.   Member States shall complete the preliminary flood risk assessment by 22 December 2012.

Article 5

1.   On the basis of a preliminary flood risk assessment as referred to in Article 4, Member States shall, for each river basin district, or unit of management referred to in Article 3(2)(b), or portion of an international river basin district lying within their territory, identify those areas for which they conclude that potential significant flood risks exist or might reasonably be considered likely to occur.

2.   The identification under paragraph 1 of areas belonging to an international river basin district, or to a unit of management referred to in Article 3(2)(b) shared with another Member State, shall be coordinated between the Member States concerned.

CHAPTER III

FLOOD HAZARD MAPS AND FLOOD RISK MAPS

Article 6

1.   Member States shall, at the level of the river basin district or unit of management referred to in Article 3(2)(b), prepare flood hazard maps and flood risk maps, at the most appropriate scale for the areas identified under Article 5(1).

2.   The preparation of flood hazard maps and flood risk maps for areas identified under Article 5 which are shared with other Member States shall be subject to prior exchange of information between the Member States concerned.

3.   Flood hazard maps shall cover the geographical areas which could be flooded according to the following scenarios:

| (a) | floods with a low probability, or extreme events scenarios; |
| --- | --- |

(a)

floods with a low probability, or extreme events scenarios;

| (b) | floods with a medium probability (likely return period ≥ 100 years); |
| --- | --- |

(b)

floods with a medium probability (likely return period ≥ 100 years);

| (c) | floods with a high probability, where appropriate. |
| --- | --- |

(c)

floods with a high probability, where appropriate.

4.   For each scenario referred to in paragraph 3 the following elements shall be shown:

| (a) | the flood extent; |
| --- | --- |

(a)

the flood extent;

| (b) | water depths or water level, as appropriate; |
| --- | --- |

(b)

water depths or water level, as appropriate;

| (c) | where appropriate, the flow velocity or the relevant water flow. |
| --- | --- |

(c)

where appropriate, the flow velocity or the relevant water flow.

5.   Flood risk maps shall show the potential adverse consequences associated with flood scenarios referred to in paragraph 3 and expressed in terms of the following:

| (a) | the indicative number of inhabitants potentially affected; |
| --- | --- |

(a)

the indicative number of inhabitants potentially affected;

| (b) | type of economic activity of the area potentially affected; |
| --- | --- |

(b)

type of economic activity of the area potentially affected;

| (c) | installations as referred to in Annex I to Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (10) which might cause accidental pollution in case of flooding and potentially affected protected areas identified in Annex IV(1)(i), (iii) and (v) to Directive 2000/60/EC; |
| --- | --- |

(c)

installations as referred to in Annex I to Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (10) which might cause accidental pollution in case of flooding and potentially affected protected areas identified in Annex IV(1)(i), (iii) and (v) to Directive 2000/60/EC;

| (d) | other information which the Member State considers useful such as the indication of areas where floods with a high content of transported sediments and debris floods can occur. |
| --- | --- |

(d)

other information which the Member State considers useful such as the indication of areas where floods with a high content of transported sediments and debris floods can occur.

6.   Member States may decide that, for coastal areas where an adequate level of protection is in place, the preparation of flood hazard maps shall be limited to the scenario referred to in paragraph 3(a).

7.   Member States may decide that, for areas where flooding is from groundwater sources, the preparation of flood hazard maps shall be limited to the scenario referred to in paragraph 3(a).

8.   Member States shall ensure that the flood hazard maps and flood risk maps are completed by 22 December 2013.

CHAPTER IV

FLOOD RISK MANAGEMENT PLANS

Article 7

1.   On the basis of the maps referred to in Article 6, Member States shall establish flood risk management plans coordinated at the level of the river basin district or unit of management referred to in Article 3(2)(b) for the areas identified under Article 5(1) and the areas covered by Article 13(1)(b) in accordance with paragraphs 2 and 3 of this Article.

2.   Member States shall establish appropriate objectives for the management of flood risks for the areas identified under Article 5(1) and the areas covered by Article 13(1)(b), focusing on the reduction of potential adverse consequences of flooding for human health, the environment, cultural heritage and economic activity, and, if considered appropriate, on non-structural initiatives and/or on the reduction of the likelihood of flooding.

3.   Flood risk management plans shall include measures that aim at achieving the objectives established in accordance with paragraph 2 and shall include the components set out in Part A of the Annex.

Flood risk management plans shall take into account relevant aspects such as costs and benefits, flood extent and flood conveyance routes and areas which have the potential to retain flood water, the environmental objectives of Article 4 of Directive 2000/60/EC, soil and water management, spatial planning, land use, nature conservation, navigation and port infrastructure.

Flood risk management plans shall address all aspects of flood risk management focusing on prevention, protection, preparedness, including flood forecasts and early warning systems and taking into account the characteristics of the particular river basin or sub-basin. Flood risk management plans may also include the controlled flooding of certain areas in the case of a flood event.

4.   Flood risk management plans established in one Member State shall not include measures which, by their extent and impact, significantly increase flood risks upstream or downstream of other countries in the same river basin or sub-basin, unless these measures have been coordinated and an agreed solution has been found among the Member States concerned in the framework of Article 8.

5.   Member States shall ensure that flood risk management plans are completed and published by 22 December 2015.

Article 8

1.   For river basin districts or units of management referred to in Article 3(2)(b) which fall entirely within their territory, Member States shall ensure that one single flood risk management plan, or a set of flood risk management plans coordinated at the level of the river basin district, is produced.

2.   Where an international river basin district or unit of management referred to in Article 3(2)(b) falls entirely within the Community, Member States shall ensure coordination with the aim of producing one single international flood risk management plan, or a set of flood risk management plans coordinated at the level of the international river basin district. Where such plans are not produced, Member States shall produce flood risk management plans covering at least the parts of the international river basin district falling within their territory, as far as possible coordinated at the level of the international river basin district.

3.   Where an international river basin district or unit of management referred to in Article 3(2)(b) extends beyond the boundaries of the Community, Member States shall endeavour to produce one single international flood risk management plan or a set of flood risk management plans coordinated at the level of the international river basin district; where this is not possible, paragraph 2 shall apply for the parts of the international river basin falling within their territory.

4.   The flood risk management plans referred to in paragraphs 2 and 3 shall be supplemented, where considered appropriate by countries sharing a sub-basin, by more detailed flood risk management plans coordinated at the level of the international sub-basins.

5.   Where a Member State identifies an issue which has an impact on the management of flood risks of its water and that issue cannot be resolved by that Member State, it may report the issue to the Commission and any other Member State concerned and may make recommendations as to how the issue should be resolved.

The Commission shall respond to any report or recommendations from Member States within a period of six months.

CHAPTER V

COORDINATION WITH DIRECTIVE 2000/60/EC, PUBLIC INFORMATION AND CONSULTATION

Article 9

Member States shall take appropriate steps to coordinate the application of this Directive and that of Directive 2000/60/EC focusing on opportunities for improving efficiency, information exchange and for achieving common synergies and benefits having regard to the environmental objectives laid down in Article 4 of Directive 2000/60/EC. In particular:

| 1) | the development of the first flood hazard maps and flood risk maps and their subsequent reviews as referred to in Articles 6 and 14 of this Directive shall be carried out in such a way that the information they contain is consistent with relevant information presented according to Directive 2000/60/EC. They may, if considered appropriate, be further coordinated with, and integrated into, the reviews provided for in Article 5(2) of Directive 2000/60/EC; |
| --- | --- |

1)

the development of the first flood hazard maps and flood risk maps and their subsequent reviews as referred to in Articles 6 and 14 of this Directive shall be carried out in such a way that the information they contain is consistent with relevant information presented according to Directive 2000/60/EC. They may, if considered appropriate, be further coordinated with, and integrated into, the reviews provided for in Article 5(2) of Directive 2000/60/EC;

| 2) | the development of the first flood risk management plans and their subsequent reviews as referred to in Articles 7 and 14 of this Directive shall be carried out, if considered appropriate, in coordination with, and may be integrated into, the reviews of the river basin management plans provided for in Article 13(7) of Directive 2000/60/EC; |
| --- | --- |

2)

the development of the first flood risk management plans and their subsequent reviews as referred to in Articles 7 and 14 of this Directive shall be carried out, if considered appropriate, in coordination with, and may be integrated into, the reviews of the river basin management plans provided for in Article 13(7) of Directive 2000/60/EC;

| 3) | the active involvement of all interested parties under Article 10 of this Directive shall be coordinated, as appropriate, with the active involvement of interested parties under Article 14 of Directive 2000/60/EC. |
| --- | --- |

3)

the active involvement of all interested parties under Article 10 of this Directive shall be coordinated, as appropriate, with the active involvement of interested parties under Article 14 of Directive 2000/60/EC.

Article 10

1.   In accordance with applicable Community legislation, Member States shall make available to the public the preliminary flood risk assessment, the flood hazard maps, the flood risk maps and the flood risk management plans.

2.   Member States shall encourage active involvement of interested parties in the production, review and updating of the flood risk management plans referred to in Chapter IV.

CHAPTER VI

IMPLEMENTING MEASURES AND AMENDMENTS

Article 11

1.   The Commission may, in accordance with the procedure referred to in Article 12(2), adopt technical formats for the purpose of processing and transmission of data, including statistical and cartographic data, to the Commission. The technical formats should be adopted at least two years before the dates indicated respectively in Articles 4(4), 6(8) and 7(5), taking into account existing standards as well as formats developed under relevant Community acts.

2.   The Commission may, taking into account the periods for review and updating and in accordance with the procedure referred to in Article 12(2), adapt the Annex to scientific and technical progress.

Article 12

1.   The Commission shall be assisted by the committee established under Article 21 of Directive 2000/60/EC (hereinafter referred to as ‘the Committee’).

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   The Committee shall adopt its rules of procedure.

CHAPTER VII

TRANSITIONAL MEASURES

Article 13

1.   Member States may decide not to undertake the preliminary flood risk assessment referred to in Article 4 for those river basins, sub-basins or coastal areas where they have either:

| (a) | already undertaken a risk assessment to conclude, before 22 December 2010, that a potential significant flood risk exists or might be reasonably considered likely to occur leading to the identification of the area among those referred to in Article 5(1) or |
| --- | --- |

(a)

already undertaken a risk assessment to conclude, before 22 December 2010, that a potential significant flood risk exists or might be reasonably considered likely to occur leading to the identification of the area among those referred to in Article 5(1) or

| (b) | decided, before 22 December 2010, to prepare flood hazard maps and flood risk maps and to establish flood risk management plans in accordance with the relevant provisions of this Directive. |
| --- | --- |

(b)

decided, before 22 December 2010, to prepare flood hazard maps and flood risk maps and to establish flood risk management plans in accordance with the relevant provisions of this Directive.

2.   Member States may decide to make use of flood hazard maps and flood risk maps finalised before 22 December 2010, if such maps provide a level of information equivalent to the requirements of Article 6.

3.   Member States may decide to make use of flood risk management plans finalised before 22 December 2010, provided the content of these plans is equivalent to the requirements set out in Article 7.

4.   Paragraphs 1, 2 and 3 shall apply without prejudice to Article 14.

CHAPTER VIII

REVIEWS, REPORTS AND FINAL PROVISIONS

Article 14

1.   The preliminary flood risk assessment, or the assessment and decisions referred to in Article 13(1), shall be reviewed, and if necessary updated, by 22 December 2018 and every six years thereafter.

2.   The flood hazard maps and the flood risk maps shall be reviewed and if necessary updated, by 22 December 2019 and every six years thereafter.

3.   The flood risk management plan(s) shall be reviewed, and if necessary updated, including the components set out in part B of the Annex, by 22 December 2021 and every six years thereafter.

4.   The likely impact of climate change on the occurrence of floods shall be taken into account in the reviews referred to in paragraphs 1 and 3.

Article 15

1.   Member States shall make available the preliminary flood risk assessment, the flood hazard maps, the flood risk maps and flood risk management plans referred to in Articles 4, 6 and 7, as well as their review and, where applicable, their updates to the Commission within three months after the dates indicated respectively in Articles 4(4), 6(8), 7(5) and 14.

2.   Member States shall inform the Commission of the decisions taken in accordance with Article 13(1), (2) and (3) and make available the relevant information thereon by the dates indicated respectively in Articles 4(4), 6(8) and 7(5).

Article 16

The Commission shall, by 22 December 2018, and every six years thereafter, submit to the European Parliament and to the Council a report on the implementation of this Directive.

Article 17

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before ... (11). They shall forthwith inform the Commission thereof.

When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 18

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 19

This Directive is addressed to the Member States.

Done at,

For the European Parliament

The President

...

For the Council

The President

...

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(1)  Opinion of 17 May 2006 (not yet published in the Official Journal).

1

(2)  Opinion of the European Parliament of 13 June 2006 (not yet published in the Official Journal) and Council Decision of ... (not yet published in the Official Journal).

2

(3)  OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

3

(4)  OJ L 186, 5.8.1995, p. 42.

4

(5)  OJ L 297, 15.11.2001, p. 7.

5

(6)  OJ L 311, 14.11.2002, p. 3.

6

(7)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

7

(8)  OJ C 321, 31.12.2003, p. 1.

8

(9)  Two years and a half after the date of entry into force of this Directive.

9

(10)  OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 (OJ L 33, 4.2.2006, p. 1).

10

(11)  Two years after the date of entry into force of this Directive.

11

---

ANNEX

A.   FLOOD RISK MANAGEMENT PLANS

| I. | Components of the first flood risk management plans:






  1) | the conclusions of the preliminary flood risk assessment as required in Chapter II in the form of a summary map of the river basin district or the unit of management referred to in Article 3(2)(b) delineating the areas identified under Article 5(1) which are the subject of this flood risk management plan; |
| --- | --- | --- |

I.

Components of the first flood risk management plans:

1)

the conclusions of the preliminary flood risk assessment as required in Chapter II in the form of a summary map of the river basin district or the unit of management referred to in Article 3(2)(b) delineating the areas identified under Article 5(1) which are the subject of this flood risk management plan;

| 2) | flood hazard maps and flood risk maps as prepared under Chapter III, or already in place in accordance with Article 13, and the conclusions that can be drawn from those maps; |
| --- | --- |

2)

flood hazard maps and flood risk maps as prepared under Chapter III, or already in place in accordance with Article 13, and the conclusions that can be drawn from those maps;

| 3) | a description of the appropriate objectives of flood risk management, established in accordance with Article 7(2); |
| --- | --- |

3)

a description of the appropriate objectives of flood risk management, established in accordance with Article 7(2);

| 4) | a summary of the measures aiming to achieve the appropriate objectives of flood risk management, including the measures taken in accordance with Article 7, and flood related measures taken under other Community acts, including Council Directives 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (1) and 96/82/EC of 9 December 1996 on the control of major accident hazards involving dangerous substances (2), Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (3) and Directive 2000/60/EC; |
| --- | --- |

4)

a summary of the measures aiming to achieve the appropriate objectives of flood risk management, including the measures taken in accordance with Article 7, and flood related measures taken under other Community acts, including Council Directives 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (1) and 96/82/EC of 9 December 1996 on the control of major accident hazards involving dangerous substances (2), Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (3) and Directive 2000/60/EC;

| 5) | when available, for shared river basins or sub-basins, a description of the methodology, defined by the Member States concerned, of cost-benefit analysis used to assess measures with trans-national effects. |
| --- | --- |

5)

when available, for shared river basins or sub-basins, a description of the methodology, defined by the Member States concerned, of cost-benefit analysis used to assess measures with trans-national effects.

| II. | Description of the implementation of the plan:






  1) | a description of the way in which progress in implementing the plan will be monitored; |
| --- | --- | --- |

II.

Description of the implementation of the plan:

1)

a description of the way in which progress in implementing the plan will be monitored;

| 2) | a summary of the public information and consultation measures/actions taken; |
| --- | --- |

2)

a summary of the public information and consultation measures/actions taken;

| 3) | a list of competent authorities and, as appropriate, a description of the coordination process within any international river basin district and of the coordination process with Directive 2000/60/EC. |
| --- | --- |

3)

a list of competent authorities and, as appropriate, a description of the coordination process within any international river basin district and of the coordination process with Directive 2000/60/EC.

B.   COMPONENTS OF THE SUBSEQUENT UPDATE OF FLOOD RISK MANAGEMENT PLANS:

| 1) | any changes or updates since the publication of the previous version of the flood risk management plan, including a summary of the reviews carried out in compliance with Article 14; |
| --- | --- |

1)

any changes or updates since the publication of the previous version of the flood risk management plan, including a summary of the reviews carried out in compliance with Article 14;

| 2) | an assessment of the progress made towards the achievement of the objectives referred to in Article 7(2); |
| --- | --- |

2)

an assessment of the progress made towards the achievement of the objectives referred to in Article 7(2);

| 3) | a description of, and an explanation for, any measures foreseen in the earlier version of the flood risk management plan which were planned to be undertaken and have not been taken forward; |
| --- | --- |

3)

a description of, and an explanation for, any measures foreseen in the earlier version of the flood risk management plan which were planned to be undertaken and have not been taken forward;

| 4) | a description of any additional measures since the publication of the previous version of the flood risk management plan. |
| --- | --- |

4)

a description of any additional measures since the publication of the previous version of the flood risk management plan.

---

(1)  OJ L 175, 5.7.1985, p. 40. Directive as last amended by Directive 2003/35/EC of the European Parliament and of the Council (OJ L 156, 25.6.2003, p. 17).

(2)  OJ L 10, 14.1.1997, p.13. Directive as last amended by Directive 2003/105/EC of the European Parliament and of the Council (OJ L 345, 31.12.2003, p. 97).

(3)  OJ L 197, 21.7.2001, p. 30.

---

STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

The Commission adopted its proposal for a Directive of the European Parliament and of the Council on the assessment and management of floods on 18 January 2006.

The European Parliament adopted its first-reading opinion on 13 June 2006.

The Committee of the Regions has decided not to deliver an opinion.

The Economic and Social Committee adopted its opinion on 17 May 2006.

The Council adopted its common position on 23 November 2006.

II.   OBJECTIVE

The objective of this Directive is to establish a framework for the assessment and management of flood-related risks to human health, the environment, cultural heritage and economic activity. It will ask for a preliminary flood risk assessment, flood mapping in all areas with a significant flood risk, coordination within shared river basins and production of flood risk management plans through a broad participatory process.

Given the diversity across the EU in terms of geography, hydrology and settlement structure, the proposed Directive provides considerable flexibility for Member States to determine the objectives for the management of flood risks, the measures to be taken to achieve these objectives, and the timetables for implementing measures in the flood risk management plans.

The application of the proposed Directive and that of the Water Framework Directive shall be coordinated.

III.   ANALYSIS OF THE COMMON POSITION

1.   General

The common position incorporates a number of the European Parliament's first reading amendments, either verbatim, in part or in spirit. These improve or clarify the text of the proposed Directive.

However, other amendments are not reflected in the common position because the Council agreed that they were unnecessary and/or unacceptable.

2.   General provisions (Title, Chapter I)

The common position is consistent with Amendment 1, which changes the title of the Directive. Since the reference to the attainment of environmental objectives laid down in existing Community legislation is covered by the Directive's legal basis, Amendment 26 was taken in part. The common position is not aligned with Amendment 27 which would limit the application of the Directive to specific causes of floods. The consequences for human health and economic activity are also mentioned in the definition of flood risk. The Council, however, adds a non-exhaustive list of types of flood and the possibility of excluding floods from sewerage systems. Amendments 28 and 29 were taken in part and in full, respectively.

Amendment 30 on the use of other competent authorities was taken in full. In addition, a possibility of using units of management different from those assigned pursuant to Article 3(1) of Directive 2000/60/EC was introduced.

3.   Preliminary flood risk assessment (Chapter II)

Amendments 32 and 33 were taken in full. Article 4 was simplified to reduce the administrative burden of the preliminary flood risk assessments and, consequently, Amendments 34 and 36 were not accepted. However, the assessment of the effectiveness of existing flood protection infrastructure as mentioned in Amendment 36 forms an implicit part of any flood risk assessment. A distinction between past and future floods was also made. In Article 4(2)(d), the Council made the taking into account of future floods optional for Member States.

The Council deleted Article 5 (1)(a) of the original proposal to which Amendment 38 is referring to with the aim of simplifying and streamlining the text. Amendment 39 was accepted in spirit. Amendment 40 was taken over in Article 4.

4.   Flood hazard maps and flood risk maps (Chapter III)

The issue of subsidies is beyond the scope of this Directive and Amendment 85 was therefore not accepted. Amendments 42 and 43 were rejected because they were redundant. Amendments 44, 46 and 48 are covered by Article 6(5)(d), which leaves it up to Member States to decide on other information to include in flood risk maps. Article 7(3) is also consistent with Amendment 48. Amendment 45 is redundant since the wording in the common position has changed. Amendment 47 was rejected since it is not feasible to distinguish between and map specific causes of floods, and Amendment 49 was taken over in part.

Amendments 50 and 51 were not acceptable because they added extra layers to the risk assessment and characterisation process. Amendment 52 was accepted in Article 6(5)(d).

5.   Flood risk management plans (Chapter IV, Annex)

The part of Amendments 35 and 60 which related to cost and benefit considerations was taken over in Article 7(3). Amendment 53 was not taken, since it is not necessary to make an explicit reference to other Directives Member States have to comply with. Article 7(3) is consistent with Amendment 54 as regards flood plain areas and conveyance routes. Amendment 56 was taken up insofar as it related to the solidarity principle and Amendment 57 was partly accepted as regards non-structural measures and as far as flood risk management plans shall not include measures which may increase flood risk upstream or downstream of other countries (Article 7(4)).

Amendment 58 was not acceptable since the Council did not wish to lay stress on the review of flood events. Amendment 59 was taken in principle in the Annex. Amendment 61 was taken in part and principle as regards the principle of solidarity. Amendment 62 was not accepted so as to keep the solidarity principle sufficiently general. Amendment 63 was not accepted since the suggested coordination procedure was not taken on board and certain parts of the amendment were unnecessary.

Amendments 64 and 65 were taken in part and principle with respect to coordination for the whole of the river basin. Amendment 66 was fully taken but with different wording, reproducing the text from the Water Framework Directive. The two separate votes were rejected since the Council wanted to maintain the coordination optional. Amendment 68 was taken in principle in the common position by making a reference to public participation in Article 10(1). Amendment 69 was rejected because involvement of the public was already covered in Article 10. The common position does not include details of preparedness measures and is therefore not consistent with Amendments 69 and 70. Amendment 72 was rejected because it is not appropriate in the context of reporting requirements.

Amendment 74 was rejected. The Council believes that Article 7(3) already provided the link between this Directive and the Water Framework Directive. It is up to Member States to define the measures aimed at reducing the potential adverse consequences of flooding. Amendment 75 was rejected since the terminology is inconsistent with Articles 7(2) and 7(3). Amendment 86 was accepted.

6.   Transitional measures (Chapter VII)

The common position builds on existing work at national and regional levels, namely flood hazard maps, flood risk maps and management plans. Article 13 takes on board, in part and/or in principle, Amendments 31, 37, 41, 55 and 71.

7.   Other

| — | In the preamble, the common position takes in part or principle European Parliament Amendments 2, 12, 16, 17, 24 and 25. The common position is not consistent with Amendment 4 since preliminary flood risk assessment takes into consideration floods which have occurred in the past and the failure of traditional flood risk management strategies. Amendment 5 is out of place in this Directive since it refers to coordination within Member States and to how authorities coordinate internally. Amendment 9 was rejected because it is unnecessary: it expands Recital 19 and reproduces text from Council conclusions. Amendment 23 was also rejected since it is an editorial change to Recital 19. Amendment 13 was rejected as it does not reflect a provision in the articles. Since the notion of preliminary risk assessment was simplified, Amendments 15 and 18 were not acceptable. Amendments 19 and 21 are beyond the scope of this Directive. The common position being based on the principles of subsidiarity and solidarity, Amendment 20 was partly taken on board. Amendment 22 was already covered by Recital 17 and, therefore, rejected. |
| --- | --- |

—

In the preamble, the common position takes in part or principle European Parliament Amendments 2, 12, 16, 17, 24 and 25. The common position is not consistent with Amendment 4 since preliminary flood risk assessment takes into consideration floods which have occurred in the past and the failure of traditional flood risk management strategies. Amendment 5 is out of place in this Directive since it refers to coordination within Member States and to how authorities coordinate internally. Amendment 9 was rejected because it is unnecessary: it expands Recital 19 and reproduces text from Council conclusions. Amendment 23 was also rejected since it is an editorial change to Recital 19. Amendment 13 was rejected as it does not reflect a provision in the articles. Since the notion of preliminary risk assessment was simplified, Amendments 15 and 18 were not acceptable. Amendments 19 and 21 are beyond the scope of this Directive. The common position being based on the principles of subsidiarity and solidarity, Amendment 20 was partly taken on board. Amendment 22 was already covered by Recital 17 and, therefore, rejected.

| — | References to climate change (Amendments 7, 9, 10 and 38 are covered in part by Recitals 2 and 5 and by Article 4(2)(d). The obligation to take into account climate change starts in 2018, so Amendment 73 was unacceptable. |
| --- | --- |

—

References to climate change (Amendments 7, 9, 10 and 38 are covered in part by Recitals 2 and 5 and by Article 4(2)(d). The obligation to take into account climate change starts in 2018, so Amendment 73 was unacceptable.

IV.   CONCLUSION

The Council considers that its common position largely takes into account the opinion of the European Parliament at first reading. It represents a balanced and realistic solution aiming to reduce the consequences of floods in the European Union, while ensuring a close link to the implementation of the Water Framework Directive. The Council looks forward to a constructive discussion with the European Parliament with a view to the early adoption of the Directive.

---

| 19.12.2006 | EN | Official Journal of the European Union | CE 311/21 |
| --- | --- | --- | --- |

19.12.2006

EN

Official Journal of the European Union

CE 311/21

---

COMMON POSITION (EC) No 34/2006

adopted by the Council on 4 December 2006

with a view to adopting Directive 2006/.../EC of the European Parliament and of the Council of ... laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC

(2006/C 311 E/03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | Council Directives 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids (3) and 80/232/EEC of 15 January 1980 on the approximation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products (4) set out nominal quantities for a number of liquid and non-liquid prepacked products, the purpose of which was to ensure the free movement of products complying with the requirements of those Directives. For most products, national nominal quantities are allowed to exist alongside the Community nominal quantities. For some products, however, Community nominal quantities are set to the exclusion of any national nominal quantities. |
| --- | --- |

(1)

Council Directives 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids (3) and 80/232/EEC of 15 January 1980 on the approximation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products (4) set out nominal quantities for a number of liquid and non-liquid prepacked products, the purpose of which was to ensure the free movement of products complying with the requirements of those Directives. For most products, national nominal quantities are allowed to exist alongside the Community nominal quantities. For some products, however, Community nominal quantities are set to the exclusion of any national nominal quantities.

| (2) | Changes in consumer preferences and innovation of prepacking and retailing at Community and national level made it necessary to assess whether the existing legislation is still appropriate. |
| --- | --- |

(2)

Changes in consumer preferences and innovation of prepacking and retailing at Community and national level made it necessary to assess whether the existing legislation is still appropriate.

| (3) | The Court of Justice held in its judgment of 12 October 2000 in Case C-3/99 Cidrerie Ruwet (5) that Member States are precluded from prohibiting the marketing of a prepackage having a nominal volume not included in the Community range, which is lawfully manufactured and marketed in another Member State, unless such a prohibition is designed to meet an overriding requirement relating to consumer protection, applies without distinction to national and imported products alike, is necessary in order to meet the requirement in question and is proportionate to the objective pursued, and that objective cannot be achieved by measures which are less restrictive of intra-Community trade. |
| --- | --- |

(3)

The Court of Justice held in its judgment of 12 October 2000 in Case C-3/99 Cidrerie Ruwet (5) that Member States are precluded from prohibiting the marketing of a prepackage having a nominal volume not included in the Community range, which is lawfully manufactured and marketed in another Member State, unless such a prohibition is designed to meet an overriding requirement relating to consumer protection, applies without distinction to national and imported products alike, is necessary in order to meet the requirement in question and is proportionate to the objective pursued, and that objective cannot be achieved by measures which are less restrictive of intra-Community trade.

| (4) | Consumer protection is facilitated by directives which were adopted after Directives 75/106/EEC and 80/232/EEC, notably Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (6). |
| --- | --- |

(4)

Consumer protection is facilitated by directives which were adopted after Directives 75/106/EEC and 80/232/EEC, notably Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (6).

| (5) | An impact assessment, including a wide consultation of all interested stakeholders, indicated that, in many sectors, free nominal quantities increase the freedom of producers to provide goods according to consumer tastes and enhance competition as regards quality and price on the internal market. In other sectors, however, it is more appropriate, in the interests of consumers and business, to retain mandatory nominal quantities for the time being. |
| --- | --- |

(5)

An impact assessment, including a wide consultation of all interested stakeholders, indicated that, in many sectors, free nominal quantities increase the freedom of producers to provide goods according to consumer tastes and enhance competition as regards quality and price on the internal market. In other sectors, however, it is more appropriate, in the interests of consumers and business, to retain mandatory nominal quantities for the time being.

| (6) | Implementation of this Directive should be accompanied by more information for consumers and industry to enhance understanding of unit pricing. |
| --- | --- |

(6)

Implementation of this Directive should be accompanied by more information for consumers and industry to enhance understanding of unit pricing.

| (7) | Consequently, nominal quantities should generally not be subject to regulation at Community or national level and it should be possible to place prepacked goods on the market in any nominal quantity. |
| --- | --- |

(7)

Consequently, nominal quantities should generally not be subject to regulation at Community or national level and it should be possible to place prepacked goods on the market in any nominal quantity.

| (8) | However, in certain sectors such deregulation could result in disproportionately heavy extra costs, especially for small and medium sized enterprises. For those sectors, therefore, existing Community legislation should be adapted in the light of experience, in particular to ensure that Community nominal quantities are fixed at least in the case of those products most sold to consumers. |
| --- | --- |

(8)

However, in certain sectors such deregulation could result in disproportionately heavy extra costs, especially for small and medium sized enterprises. For those sectors, therefore, existing Community legislation should be adapted in the light of experience, in particular to ensure that Community nominal quantities are fixed at least in the case of those products most sold to consumers.

| (9) | Since the maintenance of mandatory nominal quantities should be regarded as a derogation, it should be periodically reassessed in the light of experience and in order to meet the needs of consumers and producers. For these sectors, existing Community legislation should be adapted, in particular to limit the fixed Community nominal quantities only to those most sold to consumers. |
| --- | --- |

(9)

Since the maintenance of mandatory nominal quantities should be regarded as a derogation, it should be periodically reassessed in the light of experience and in order to meet the needs of consumers and producers. For these sectors, existing Community legislation should be adapted, in particular to limit the fixed Community nominal quantities only to those most sold to consumers.

| (10) | In order to promote transparency, all nominal quantities for prepacked products should be set in a single legislative text, and consequently Directives 75/106/EEC and 80/232/EEC should be repealed. |
| --- | --- |

(10)

In order to promote transparency, all nominal quantities for prepacked products should be set in a single legislative text, and consequently Directives 75/106/EEC and 80/232/EEC should be repealed.

| (11) | In order to increase protection for consumers, in particular vulnerable consumers, such as the disabled and the elderly, proper attention should be paid to weight and volume indications on consumer product labelling being more easily legible and visible on the prepackage in normal conditions of presentation. |
| --- | --- |

(11)

In order to increase protection for consumers, in particular vulnerable consumers, such as the disabled and the elderly, proper attention should be paid to weight and volume indications on consumer product labelling being more easily legible and visible on the prepackage in normal conditions of presentation.

| (12) | For certain liquid products, Directive 75/106/EEC sets out metrological requirements identical to those set out in Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products (7). Directive 76/211/EEC should therefore be amended to include in its scope the products currently covered by Directive 75/106/EEC. |
| --- | --- |

(12)

For certain liquid products, Directive 75/106/EEC sets out metrological requirements identical to those set out in Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products (7). Directive 76/211/EEC should therefore be amended to include in its scope the products currently covered by Directive 75/106/EEC.

| (13) | In accordance with point 34 of the Interinstitutional Agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. |
| --- | --- |

(13)

In accordance with point 34 of the Interinstitutional Agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

| (14) | Since the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore, by reason of repealing Community ranges and ensuring uniform Community nominal quantities where needed, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives, |
| --- | --- |

(14)

Since the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore, by reason of repealing Community ranges and ensuring uniform Community nominal quantities where needed, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

1.   This Directive lays down rules on the nominal quantities for products put up in prepackages. It shall apply to prepacked products and prepackages, as defined in Article 2 of Directive 76/211/EEC.

2.   This Directive shall not apply to the products listed in the Annex which are sold in duty-free shops for consumption outside the European Union.

Article 2

Free movement of goods

1.   Save as otherwise provided for in Articles 3 and 4, Member States may not, on grounds relating to the nominal quantities of the package, refuse, prohibit or restrict the placing on the market of prepacked products.

2.   While respecting the principles stated in the Treaty and, in particular, the free movement of goods, Member States which currently prescribe mandatory nominal quantities for milk, butter, dried pasta and coffee may continue to do so until ... (9).

Member States which currently prescribe mandatory nominal quantities for white sugar may continue to do so until ... (10).

CHAPTER II

SPECIFIC PROVISIONS

Article 3

Placing on the market and free movement of certain products

Member States shall ensure that the products listed in point 2 of the Annex and put up in prepackages in the intervals listed in point 1 of the Annex are placed on the market only if they are prepacked in the nominal quantities listed in point 1 of the Annex.

Article 4

Aerosol dispensers

1.   Aerosol dispensers shall indicate the nominal total capacity of the container. The indication shall be such as not to create confusion with the nominal volume of the contents.

2.   By way of derogation from Article 8(1)(e) of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (11), products which are sold in aerosol dispensers need not be marked with the nominal weight of their contents.

Article 5

Multi-packs and prepackages made up of individual packages which are not intended to be sold individually

1.   For the purposes of Article 3, where two or more individual prepackages make up a multi-pack, the nominal quantities listed in point 1 of the Annex shall apply to each individual prepackage.

2.   Where a prepackage is made up of two or more individual packages which are not intended to be sold individually, the nominal quantities listed in point 1 of the Annex shall apply to the prepackage.

CHAPTER III

REPEALS, AMENDMENT AND FINAL PROVISIONS

Article 6

Repeals

Directives 75/106/EEC and 80/232/EEC shall be repealed.

Article 7

Amendment

In Article 1 of Directive 76/211/EEC, the words ‘with the exception of those referred to in the Council Directive 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids, and’ shall be deleted.

Article 8

Transposition

1.   Before ... (12) Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.

They shall apply those measures from ... (13).

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 9

Reporting, communication of derogations and monitoring

1.   The Commission shall submit a report on the application and effects of this Directive to the European Parliament, the Council and the European Economic and Social Committee by ... (14) at the latest, and every ten years thereafter. Where necessary, the report shall be accompanied by a proposal for revision of this Directive.

2.   The Member States referred to in Article 2, paragraph 2 shall communicate to the Commission before ... (13) the sectors subject to the derogation referred to in that paragraph, the period of such derogation, the range of mandatory nominal quantities applied and the interval concerned.

3.   The Commission shall monitor the application of Article 2(2) based on its own findings and on reports from the Member States concerned.

Article 10

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Articles 2, 6 and 7 shall apply from ... (13).

Article 11

Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament

The President

...

For the Council

The President

...

---

(1)  OJ C 255, 14.10.2005, p. 36.

1

(2)  Opinion of the European Parliament of 2 February 2006 (not yet published in the Official Journal), Council Common Position of 4 December 2006 and Position of the European Parliament of ... (not yet published in the Official Journal)

2

(3)  OJ L 42, 15.2.1975, p. 1. Directive as last amended by the 2003 Act of Accession.

3

(4)  OJ L 51, 25.2.1980, p. 1. Directive as last amended by Directive 87/356/EEC (OJ L 192, 11.7.1987, p. 48).

4

(5)  [2000] ECR I-8749.

5

(6)  OJ L 80, 18.3.1998, p. 27.

6

(7)  OJ L 46, 21.2.1976, p. 1. Directive as amended by Commission Directive 78/891/EEC (OJ L 311, 4.11.1978, p. 21).

7

(8)  OJ C 321, 31.12.2003, p. 1.

8

(9)  60 months after the date of entry into force of this Directive.

9

(10)  72 months after the date of entry into force of this Directive.

10

(11)  OJ L 147, 9.6.1975, p. 40. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

11

(12)  12 months after the date of entry into force of this Directive.

12

(13)  18 months after the date of entry into force of this Directive.

13

(14)  8 years after the date of entry into force of this Directive.

14

---

ANNEX

RANGE OF NOMINAL QUANTITIES OF CONTENTS OF PREPACKAGES

1.   Products sold by volume (quantity in ml)

| Still wine | On the interval from 100 ml to 1 500 ml only the following 8 nominal quantities:
  ml: 100 — 187— 250 — 375 — 500 — 750 — 1 000 — 1 500 |
| --- | --- |
| Yellow wine | On the interval from 100 ml to 1 500 ml only the following nominal quantity:
  ml: 620 |
| Sparkling wine | On the interval from 125 ml to 1 500 ml only the following 5 nominal quantities:
  ml: 125 — 200 — 375 — 750 — 1 500 |
| Liqueur wine | On the interval from 100 ml to 1 500 ml only the following 7 nominal quantities:
  ml: 100— 200 — 375 — 500 — 750 — 1 000 — 1 500 |
| Aromatised wine | On the interval from 100 ml to 1 500 ml only the following 7 nominal quantities:
  ml: 100 — 200 — 375 — 500 — 750 — 1 000 — 1 500 |
| Spirit drinks | On the interval from 100 ml to 2 000 ml only the following 9 nominal quantities:
  ml: 100 — 200 — 350 — 500 — 700 — 1 000 — 1 500 — 1 750 — 2 000 |

Still wine

On the interval from 100 ml to 1 500 ml only the following 8 nominal quantities:

ml: 100 — 187— 250 — 375 — 500 — 750 — 1 000 — 1 500

Yellow wine

On the interval from 100 ml to 1 500 ml only the following nominal quantity:

ml: 620

Sparkling wine

On the interval from 125 ml to 1 500 ml only the following 5 nominal quantities:

ml: 125 — 200 — 375 — 750 — 1 500

Liqueur wine

On the interval from 100 ml to 1 500 ml only the following 7 nominal quantities:

ml: 100— 200 — 375 — 500 — 750 — 1 000 — 1 500

Aromatised wine

On the interval from 100 ml to 1 500 ml only the following 7 nominal quantities:

ml: 100 — 200 — 375 — 500 — 750 — 1 000 — 1 500

Spirit drinks

On the interval from 100 ml to 2 000 ml only the following 9 nominal quantities:

ml: 100 — 200 — 350 — 500 — 700 — 1 000 — 1 500 — 1 750 — 2 000

2.   Product definitions

| Still wine | Wine as defined in Article 1(2)(b) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (1) (Common Customs Tariff (CCT) heading: CN code ex 2204). |
| --- | --- |
| Yellow wine | Wine as defined in Article 1(2)(b) of Regulation (EC) No 1493/1999 (CCT heading: CN code ex 2204) with the designation of origin: ‘Côtes du Jura’, ‘Arbois’, ‘L'Etoile’ and ‘Château-Chalon’ in bottles as defined in Annex I, point 3 of Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products (2) |
| Sparkling wine | Wine as defined in Article 1(2)(b) and in Annex I, points 15, 16, 17 and 18 of Regulation (EC) No 1493/1999 (CCT subheading: 2204 10) |
| Liqueur wine | Wine as defined in Article 1(2)(b) and in Annex I, point 14 of Regulation (EC) No 1493/1999 (CCT subheadings: 2204 21 — 2204 29) |
| Aromatised wine | Aromatised wine as defined in Article 2(1)(a) of Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails (3) (CCT heading: 2205) |
| Spirit drinks | Spirit drinks as defined in Article 1(2) of Council Regulation (EEC) No l576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks (4) (CCT heading: 2208) |

Still wine

Wine as defined in Article 1(2)(b) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (1) (Common Customs Tariff (CCT) heading: CN code ex 2204).

Yellow wine

Wine as defined in Article 1(2)(b) of Regulation (EC) No 1493/1999 (CCT heading: CN code ex 2204) with the designation of origin: ‘Côtes du Jura’, ‘Arbois’, ‘L'Etoile’ and ‘Château-Chalon’ in bottles as defined in Annex I, point 3 of Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products (2)

Sparkling wine

Wine as defined in Article 1(2)(b) and in Annex I, points 15, 16, 17 and 18 of Regulation (EC) No 1493/1999 (CCT subheading: 2204 10)

Liqueur wine

Wine as defined in Article 1(2)(b) and in Annex I, point 14 of Regulation (EC) No 1493/1999 (CCT subheadings: 2204 21 — 2204 29)

Aromatised wine

Aromatised wine as defined in Article 2(1)(a) of Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails (3) (CCT heading: 2205)

Spirit drinks

Spirit drinks as defined in Article 1(2) of Council Regulation (EEC) No l576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks (4) (CCT heading: 2208)

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(1)  OJ L 179, 14.7.1999 p. 1. Regulation as last amended by Regulation (EC) No 2165/2005 (OJ L 345, 28.12.2005, p. 1).

(2)  OJ L 118, 4.5.2002 p. 1. Regulation as last amended by Regulation (EC) No 1507/2006 (OJ L 280, 12.10.2006, p. 9).

(3)  OJ L 149, 14.6.1991 p. 1. Regulation 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).

(4)  OJ L 160, 12.6.1989 p. 1. Regulation as last amended by Regulation (EC) No 1882/2003.

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

On 2 December 2004, the Commission forwarded to the Council and to the European Parliament a proposal (1) for a Directive of the European Parliament and of the Council laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC based on Article 95 of the Treaty.

| 1. | The Economic and Social Committee adopted its opinion on 6 April 2005 (2) |
| --- | --- |

1.

The Economic and Social Committee adopted its opinion on 6 April 2005 (2)

| 2. | The European Parliament's first reading opinion was adopted on 2 February 2006 (3). |
| --- | --- |

2.

The European Parliament's first reading opinion was adopted on 2 February 2006 (3).

| 3. | The Commission adopted its amended proposal on 4 April 2006. |
| --- | --- |

3.

The Commission adopted its amended proposal on 4 April 2006.

| 4. | On 26 April 2006 the Commission presented its amended proposal. (4) |
| --- | --- |

4.

On 26 April 2006 the Commission presented its amended proposal. (4)

| 5. | On 25 September 2006, the Council (Competitiveness) reached a political agreement on a compromise text with a view to adopting its common position. |
| --- | --- |

5.

On 25 September 2006, the Council (Competitiveness) reached a political agreement on a compromise text with a view to adopting its common position.

| 6. | On 4 December 2006, the Council adopted its Common Position, pursuant to Article 251 of the EC Treaty. |
| --- | --- |

6.

On 4 December 2006, the Council adopted its Common Position, pursuant to Article 251 of the EC Treaty.

II.   OBJECTIVES

The proposed Directive aims to repeal Directives 75/106/EEC and 80/232/EEC, to abolish nominal quantities of pack sizes for most sectors, to maintain obligatory nominal quantities for a very limited number of sectors and to include them in a single legislative instrument. The main thrust of the proposed Directive is to deregulate, as a wide consultation of the stakeholders has shown that most arguments are in favour of liberalising nominal quantities.

III.   COMMON POSITION

The common position adopted by the Council reflects partially the opinion of the European Parliament at first reading. Some of Parliament's amendments were already incorporated in the Commission's amended proposal.

A number of Parliament's amendments have been reflected either in full or in part in the common position.

All modifications to the Commission's amended proposal introduced by the Council in its common position have been accepted by the Commission.

Neither the Council nor the Commission could, however, accept the European Parliament amendments to harmonise sizes in sectors where this is currently not the case, namely milk, butter, coffee, pasta, rice and brown sugar.

Detailed analysis of the Common Position

The Council has accepted in full the amendments 1,2, 4, 5, 8, 10 to 12, 14 and in principle the amendments 3, 6, 7, 13, 16, though slightly reworded.

The Council does not consider that the sectors of milk, butter, coffee, pasta, rice and brown sugar, that currently do not have harmonised mandatory sizes, require an EC range of nominal quantities.

The Council has introduced, in Article 2 (2), a transitional period of five years after the entry into force of the Directive, during which time the currently existing national sizes can be maintained for domestic production of milk, butter, coffee, dried pasta and rice as well as a period of six years for white sugar.

IV.   CONCLUSION

The Council considers that its common position is well in line with the original objectives of the proposed Directive.

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