# CE2007109EN.01000101.xml

| 15.5.2007 | EN | Official Journal of the European Union | CE 109/1 |
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15.5.2007

EN

Official Journal of the European Union

CE 109/1

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COMMON POSITION (EC) No 7/2007

COMMON POSITION

adopted by the Council on 19 April 2007

with a view to adopting Directive 2007/.../EC of the European Parliament and of the Council of ... amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury

(Text with EEA relevance)

(2007/C 109 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 95 thereof,

Having regard to the proposal from the Commission,

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

1

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

2

Whereas:

| (1) | The Commission communication of 28 January 2005 on the Community strategy concerning mercury, which considered all uses of mercury, concluded that it would be appropriate to introduce Community-level marketing restrictions on certain non-electrical or non-electronic measuring and control equipment containing mercury, which is the main mercury product group not covered by Community action so far. |
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(1)

The Commission communication of 28 January 2005 on the Community strategy concerning mercury, which considered all uses of mercury, concluded that it would be appropriate to introduce Community-level marketing restrictions on certain non-electrical or non-electronic measuring and control equipment containing mercury, which is the main mercury product group not covered by Community action so far.

| (2) | There would be benefits for the environment, and in the long term, for human health, through preventing mercury from entering the waste stream, if restrictions on the marketing of measuring devices containing mercury were introduced. |
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(2)

There would be benefits for the environment, and in the long term, for human health, through preventing mercury from entering the waste stream, if restrictions on the marketing of measuring devices containing mercury were introduced.

| (3) | Taking into account technical and economic feasibility, the available evidence concerning measuring and control devices indicates that immediate restrictive measures should cover only those measuring devices that are intended for sale to the general public and, in particular, all fever thermometers. |
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(3)

Taking into account technical and economic feasibility, the available evidence concerning measuring and control devices indicates that immediate restrictive measures should cover only those measuring devices that are intended for sale to the general public and, in particular, all fever thermometers.

| (4) | The import of mercury-containing measuring devices that are more than fifty years old concerns either antiques, or cultural goods as defined in Council Regulation (EEC) No 3911/92 of 9 December 1992 on the export of cultural goods (3). Such trade is limited in extent and seems to pose no risk to human health or the environment and should therefore not be restricted. |
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(4)

The import of mercury-containing measuring devices that are more than fifty years old concerns either antiques, or cultural goods as defined in Council Regulation (EEC) No 3911/92 of 9 December 1992 on the export of cultural goods (3). Such trade is limited in extent and seems to pose no risk to human health or the environment and should therefore not be restricted.

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| (5) | At present, mercury barometers are manufactured by only a few small specialist enterprises, and they are sold to the general public mainly as decorative items. An additional phasing-out period should be provided for the placing on the market of such barometers so as to allow the manufacturers to adapt their business in line with the restrictions and move over to the production of mercury-free barometers. |
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(5)

At present, mercury barometers are manufactured by only a few small specialist enterprises, and they are sold to the general public mainly as decorative items. An additional phasing-out period should be provided for the placing on the market of such barometers so as to allow the manufacturers to adapt their business in line with the restrictions and move over to the production of mercury-free barometers.

| (6) | With the aim of minimising the release of mercury into the environment and in order to ensure the phasing-out of the remaining measuring devices containing mercury in professional and industrial use, especially sphygmomanometers in healthcare, the Commission should carry out a review of the availability of reliable safer alternatives that are technically and economically feasible. In the case of sphygmomanometers in healthcare, medical experts should be consulted to ensure that the needs, in terms of diagnosis and treatment, of specific medical conditions are adequately addressed. |
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(6)

With the aim of minimising the release of mercury into the environment and in order to ensure the phasing-out of the remaining measuring devices containing mercury in professional and industrial use, especially sphygmomanometers in healthcare, the Commission should carry out a review of the availability of reliable safer alternatives that are technically and economically feasible. In the case of sphygmomanometers in healthcare, medical experts should be consulted to ensure that the needs, in terms of diagnosis and treatment, of specific medical conditions are adequately addressed.

| (7) | In accordance with this Directive only the placing on the market of new measuring devices should be restricted. This restriction should therefore not apply to devices that are already in use or sold second hand. |
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(7)

In accordance with this Directive only the placing on the market of new measuring devices should be restricted. This restriction should therefore not apply to devices that are already in use or sold second hand.

| (8) | The disparities between the laws or administrative measures adopted by Member States as regards restriction on mercury in various measuring and control devices could create barriers to trade, distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market. It therefore appears necessary to approximate the laws of Member States in the field of measuring and control devices by introducing harmonised provisions with regard to those products containing mercury, thus preserving the internal market whilst ensuring a high level of protection for human health and the environment. |
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(8)

The disparities between the laws or administrative measures adopted by Member States as regards restriction on mercury in various measuring and control devices could create barriers to trade, distort competition in the Community and may thereby have a direct impact on the establishment and functioning of the internal market. It therefore appears necessary to approximate the laws of Member States in the field of measuring and control devices by introducing harmonised provisions with regard to those products containing mercury, thus preserving the internal market whilst ensuring a high level of protection for human health and the environment.

| (9) | Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (4) should be amended accordingly. |
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(9)

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (4) should be amended accordingly.

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| (10) | This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5) and individual directives based thereon, in particular Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (6). |
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(10)

This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (5) and individual directives based thereon, in particular Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (6).

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| (11) | In accordance with point 34 of the Interinstitutional agreement on better law-making (7), 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, |
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(11)

In accordance with point 34 of the Interinstitutional agreement on better law-making (7), 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,

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HAVE ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex to this Directive.

Article 2

1.   Member States shall adopt and publish, not later than ... (8), the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.

8

They shall apply these measures from ... (9).

9

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a 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 3

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

Official Journal of the European Union

Article 4

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)  OJ C 318, 23.12.2006, p. 115.

1

(2)  Opinion of the European Parliament of 14 November 2006 (not yet published in the Official Journal), Council Common Position of 19 April 2007 and Position of the European Parliament of ... (not yet published in the Official Journal).

2

(3)  OJ L 395, 31.12.1992, p. 1. Regulation as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

3

(4)  OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2006/139/EC (OJ L 384, 29.12.2006, p. 94).

4

(5)  OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

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(6)  OJ L 131, 5.5.1998, p. 11.

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

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(8)  One year after the date of entry into force of this Directive.

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

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ANNEX

The following point is inserted in Annex I to Directive 76/769/EEC:

| ‘19a
  Mercury
  CAS No 7439-97-6 | 1. | May not be placed on the market:






  (a) | in fever thermometers; |
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‘19a

Mercury

CAS No 7439-97-6

1.

May not be placed on the market:

(a)

in fever thermometers;

| (b) | in other measuring devices intended for sale to the general public (e.g. manometers, barometers, sphygmomanometers, thermometers other than fever thermometers). |
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(b)

in other measuring devices intended for sale to the general public (e.g. manometers, barometers, sphygmomanometers, thermometers other than fever thermometers).

| 2. | The restriction in paragraph (1)(b) shall not apply to:






  (a) | measuring devices that are more than fifty years old on ... (1); or |
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2.

The restriction in paragraph (1)(b) shall not apply to:

(a)

measuring devices that are more than fifty years old on ... (1); or

| (b) | barometers (except barometers within point (a)) until ... (2). |
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(b)

barometers (except barometers within point (a)) until ... (2).

| 3. | By ... (2) the Commission shall carry out a review of the availability of reliable safer alternatives that are technically and economically feasible for mercury-containing sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses.
  On the basis of this review or as soon as new information on reliable safer alternatives for sphygmomanometers and other measuring devices containing mercury becomes available, the Commission shall, if appropriate, present a legislative proposal to extend the restrictions in paragraph 1 to sphygmomanometers and other measuring devices in healthcare, and other professional and industrial uses, so that mercury in measuring devices is phased out whenever technically and economically feasible.’ |
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3.

By ... (2) the Commission shall carry out a review of the availability of reliable safer alternatives that are technically and economically feasible for mercury-containing sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses.

On the basis of this review or as soon as new information on reliable safer alternatives for sphygmomanometers and other measuring devices containing mercury becomes available, the Commission shall, if appropriate, present a legislative proposal to extend the restrictions in paragraph 1 to sphygmomanometers and other measuring devices in healthcare, and other professional and industrial uses, so that mercury in measuring devices is phased out whenever technically and economically feasible.’

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(1)  The date of entry into force of this Directive.

1

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

2

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

| 1. | On 21 February 2006 the Commission presented its proposal (1). |
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1.

On 21 February 2006 the Commission presented its proposal (1).

| 2. | The Working Party Technical Harmonisation (Dangerous Substances) has examined at several meetings in 2006 the Commission proposal as well as a number of draft amendments of the European Parliament to the Commission proposal.
  Following informal meetings held between the European Parliament, the Presidency and the Commission, a draft compromise package was prepared, the content of which was acceptable to both the Commission and to the European Parliament. |
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2.

The Working Party Technical Harmonisation (Dangerous Substances) has examined at several meetings in 2006 the Commission proposal as well as a number of draft amendments of the European Parliament to the Commission proposal.

Following informal meetings held between the European Parliament, the Presidency and the Commission, a draft compromise package was prepared, the content of which was acceptable to both the Commission and to the European Parliament.

| 3. | On 31 October 2006 the Permanent Representatives Committee approved the draft compromise package (doc. 14419/06). |
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3.

On 31 October 2006 the Permanent Representatives Committee approved the draft compromise package (doc. 14419/06).

| 4. | The European Parliament adopted on 14 November 2006 its Opinion at first reading (2). This Opinion includes not only the compromise package, but also one amendment granting an unlimited derogation to barometers manufacturers together with licensing mechanisms to be established by Member States, and some additional amendments. The text of the legislative resolution, rather than presenting the amendments one by one, sets out the text of the Commission Proposal, as amended. |
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4.

The European Parliament adopted on 14 November 2006 its Opinion at first reading (2). This Opinion includes not only the compromise package, but also one amendment granting an unlimited derogation to barometers manufacturers together with licensing mechanisms to be established by Member States, and some additional amendments. The text of the legislative resolution, rather than presenting the amendments one by one, sets out the text of the Commission Proposal, as amended.

| 5. | On 13 December 2006 the Permanent Representatives Committee approved the same text of the compromise package of 31 October 2006 and agreed to submit it to a forthcoming Council as an A item after legal/linguistic revision of the text, with a view to a Common Position. |
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5.

On 13 December 2006 the Permanent Representatives Committee approved the same text of the compromise package of 31 October 2006 and agreed to submit it to a forthcoming Council as an A item after legal/linguistic revision of the text, with a view to a Common Position.

| 6. | The Council adopted its Common Position (3) in accordance with Article 251 of the EC Treaty on 19 April 2007. |
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6.

The Council adopted its Common Position (3) in accordance with Article 251 of the EC Treaty on 19 April 2007.

II.   OBJECTIVES

The aim of the Commission proposal for a Directive is to restrict the placing on the market of measuring devices containing mercury by amending Directive 76/769/EEC. According to the proposal, metallic mercury shall not be placed on the market in any fever thermometers (for consumer, professional and other uses) nor in all other measuring devices intended for sale to the general public (e.g. barometers, sphygmomanometers and other thermometers than fever thermometers).

A preliminary first reading agreement had been negotiated on the proposal. The Chair of the Permanent Representatives Committee had confirmed the preliminary agreement to the European Parliament on behalf of the Council. The European Parliament added, however, some additional amendments to those that had been negotiated amongst the three Institutions (added a recital on a review to be made, reworded another recital on placing on the market, expanded the ban on sphygmomanometers (except strain gauges) for healthcare use, added a mechanism for granting permanent exemption to barometers, seeking to establish also a special licensing and controlling their placing on the market).

III.   COMMON POSITION

The Common Position adopted by the Council reflects partially the Opinion of the European Parliament at first reading.

It differs mainly from the Opinion as it contains a two-year transition period for barometers, which in the Opinion may instead be unlimited in time.

The Council does not believe that a permanent derogation for mercury barometers is justified taking into account inter alia that they contain a significant amount of mercury and that safer alternatives exist. Also, the Council believes that banning also sphygmomanometers for healthcare use may be premature, because of the current lack of information on reliable safer mercury-free alternatives. The Common Position states therefore that the Commission should carry out a review of the available alternatives.

Analysis of the Common Position as set out in doc. 5665/07

New elements contained in the Common Position as compared with the Commission proposal:

Recitals

| | (3) was slightly reworded. |
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(3) was slightly reworded.

| | (4) on the need not to restrict import of antique and/or cultural goods containing mercury is a new recital. |
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(4) on the need not to restrict import of antique and/or cultural goods containing mercury is a new recital.

| | (5) on the two-year transition period for barometers is a new recital. |
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(5) on the two-year transition period for barometers is a new recital.

| | (6) on the need to review the availability of reliable safer alternative to sphygmomanometers is a new recital. |
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(6) on the need to review the availability of reliable safer alternative to sphygmomanometers is a new recital.

| | (11) is a new recital. It encourages the Member States to draw up their own correlation tables between this Directive and the corresponding measures. |
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(11) is a new recital. It encourages the Member States to draw up their own correlation tables between this Directive and the corresponding measures.

Art. 2

The second sentence of Art. 2 par. 1 was deleted and replaced by the new recital (11).

Annex

The Annex introduces two exemptions from the ban: a permanent one for antique (i.e. more than fifty years old) measuring devices and another one for barometers, until two years after entry into force of the Directive.

IV.   CONCLUSION

The Council considers that its Common Position, which is fully supported by the Commission, is well in line with the objectives of the proposed Directive. Although it could not include all of the European Parliament amendments, it contains one additional necessary exemption, provides a transition period which should allow the SMEs producing barometers to re-convert their production and a review clause to ensure the phasing-out of the remaining measuring instruments containing mercury, especially sphygmomanometers in healthcare, whenever safer alternative solutions become available.

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(1)  Doc. 6693/06 ENT 39 ENV 118 CODEC 179.

(2)  Doc. 15181/06.

(3)  Doc. 5665/07.

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