# C_2012143EN.01011001.xml

| 22.5.2012 | EN | Official Journal of the European Union | C 143/110 |
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22.5.2012

EN

Official Journal of the European Union

C 143/110

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Opinion of the European Economic and Social Committee on the ‘Proposal for a Council Regulation establishing a Community system for registration of carriers of radioactive materials’

COM(2011) 518 final

2012/C 143/21

Rapporteur: Mr JÍROVEC

Mr JÍROVEC

On 30 August 2011 the European Commission decided to consult the European Economic and Social Committee, under Article 31 of the Treaty on the European Atomic Energy Community, on the

Proposal for a Council regulation establishing a Community system for registration of carriers of radioactive materials

Proposal for a Council regulation establishing a Community system for registration of carriers of radioactive materials

COM(2011) 518 final.

The Section for Transport, Energy, Infrastructure and the Information Society, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 3 February 2012.

At its 478th plenary session, held on 22 and 23 February 2012 (meeting of 22 February 2012), the European Economic and Social Committee adopted the following opinion by 117 votes to 3 with 2 abstentions.

1.   Conclusions and recommendations

Conclusions and recommendations

| 1.1 | The Committee recommends adoption of the proposed regulation. The Committee agrees with the need to assess the regulation's impact two years after its implementation. It will also be useful to revisit the issue in five years to monitor what barriers may still exist to the smooth and safe operation of the transport of radioactive materials in the European Union. |
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1.1

The Committee recommends adoption of the proposed regulation. The Committee agrees with the need to assess the regulation's impact two years after its implementation. It will also be useful to revisit the issue in five years to monitor what barriers may still exist to the smooth and safe operation of the transport of radioactive materials in the European Union.

| 1.2 | The Committee favours the second option proposed in the Impact Assessment Report, namely: Regulation with harmonised rules and a more efficient role for the Competent Authorities. |
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1.2

The Committee favours the second option proposed in the Impact Assessment Report, namely: Regulation with harmonised rules and a more efficient role for the Competent Authorities.

| 1.3 | Member States should ensure that the criteria for granting registration are harmonised. |
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1.3

Member States should ensure that the criteria for granting registration are harmonised.

| 1.4 | The web-based registration system must be in place, tested and functional when this regulation enters into force. |
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1.4

The web-based registration system must be in place, tested and functional when this regulation enters into force.

| 1.5 | The Committee thinks that setting up a new agency – as considered under Option 3 – would increase red tape for businesses and dilute the effect of the regulation as a whole. |
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1.5

The Committee thinks that setting up a new agency – as considered under Option 3 – would increase red tape for businesses and dilute the effect of the regulation as a whole.

| 1.6 | The Committee notes that the insurance cover required for carriers varies from Member State to Member State. While such insurance cover cannot be covered in the registration procedure due to the legal base, the Committee invites the Member States to reach a harmonisation of the insurance schemes needed. |
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1.6

The Committee notes that the insurance cover required for carriers varies from Member State to Member State. While such insurance cover cannot be covered in the registration procedure due to the legal base, the Committee invites the Member States to reach a harmonisation of the insurance schemes needed.

| 1.7 | Definitions as stated in the Regulation should be consistent, as far as possible, with the IAEA Glossary, specially the definition of "carriers" while taking into account that the definitions must be in line with Euratom legislation, in particular Directive 96/29/Euratom. |
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1.7

Definitions as stated in the Regulation should be consistent, as far as possible, with the IAEA Glossary, specially the definition of "carriers" while taking into account that the definitions must be in line with Euratom legislation, in particular Directive 96/29/Euratom.

| 1.8 | The applicant should be given the possibility to correct or complement information in its application instead of being rejected without further examination (Art. 5.7 and 5.10). |
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1.8

The applicant should be given the possibility to correct or complement information in its application instead of being rejected without further examination (Art. 5.7 and 5.10).

2.   Introduction and gist of the proposed regulation

Introduction and gist of the proposed regulation

| 2.1 | The aim of the proposal is to replace the national reporting and authorisation procedures with a unique registration system for carriers of radioactive materials which will help simplify the procedure, reduce red tape and do away with barriers to entry, while maintaining the high radiation protection levels that have been achieved to date. |
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2.1

The aim of the proposal is to replace the national reporting and authorisation procedures with a unique registration system for carriers of radioactive materials which will help simplify the procedure, reduce red tape and do away with barriers to entry, while maintaining the high radiation protection levels that have been achieved to date.

| 2.2 | At European level, carriers of radioactive materials are covered by transport legislation under the Treaty on the Functioning of the European Union (TFEU) and by legislation on radiation-specific aspects, including health protection of workers and the general public, under the Treaty establishing the European Atomic Energy Community (Euratom). |
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2.2

At European level, carriers of radioactive materials are covered by transport legislation under the Treaty on the Functioning of the European Union (TFEU) and by legislation on radiation-specific aspects, including health protection of workers and the general public, under the Treaty establishing the European Atomic Energy Community (Euratom).

| 2.3 | TFEU legislation has been simplified by Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods, which covers all inland transport modes. |
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2.3

TFEU legislation has been simplified by Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods, which covers all inland transport modes.

| 2.4 | Council Directive 96/29/Euratom of 13 May 1996 lays down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation. According to Article 30 of the Treaty, these basic standards are:






  — | maximum permissible doses compatible with adequate safety; |
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2.4

Council Directive 96/29/Euratom of 13 May 1996 lays down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation. According to Article 30 of the Treaty, these basic standards are:

—

maximum permissible doses compatible with adequate safety;

| — | maximum permissible levels of exposure and contamination; |
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—

maximum permissible levels of exposure and contamination;

| — | the fundamental principles governing the health surveillance of workers. |
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—

the fundamental principles governing the health surveillance of workers.

Article 33 requires Member States to lay down appropriate provisions to ensure compliance with the basic standards.

| 2.5 | In order to protect the health of workers and the general public and to better focus their work, Member State authorities need to know which persons, organisations or undertakings to check on. To that effect, Article 3 and Article 4 of the directive require Member States to submit certain practices involving a hazard from ionising radiation to a system of reporting (notification) and prior authorisation or prohibition of certain practices.
  Directive 96/29/Euratom applies to all practices which involve a risk from ionising radiation emanating from an artificial source or from a natural radiation source, including transport. |
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2.5

In order to protect the health of workers and the general public and to better focus their work, Member State authorities need to know which persons, organisations or undertakings to check on. To that effect, Article 3 and Article 4 of the directive require Member States to submit certain practices involving a hazard from ionising radiation to a system of reporting (notification) and prior authorisation or prohibition of certain practices.

Directive 96/29/Euratom applies to all practices which involve a risk from ionising radiation emanating from an artificial source or from a natural radiation source, including transport.

| 2.6 | Given the frequent cross-border nature of transport operations, a carrier may have to follow these reporting and authorisation procedures in all Member States concerned. Moreover, Member States have implemented these procedures in differing systems, thereby adding to the complexity of transport operations as such and of the authorisation procedures. |
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2.6

Given the frequent cross-border nature of transport operations, a carrier may have to follow these reporting and authorisation procedures in all Member States concerned. Moreover, Member States have implemented these procedures in differing systems, thereby adding to the complexity of transport operations as such and of the authorisation procedures.

| 2.7 | This regulation replaces the reporting and authorisation systems in the Member States established under Council Directive 96/29/Euratom with a single registration through a European System for Carrier Registration. Carriers should apply through a central web interface. These applications will be screened by the respective national competent authority, which issues the registration if the applicant fulfils the basic safety standards. At the same time, the system gives the competent authorities a better overview of the carriers operating in their country. |
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2.7

This regulation replaces the reporting and authorisation systems in the Member States established under Council Directive 96/29/Euratom with a single registration through a European System for Carrier Registration. Carriers should apply through a central web interface. These applications will be screened by the respective national competent authority, which issues the registration if the applicant fulfils the basic safety standards. At the same time, the system gives the competent authorities a better overview of the carriers operating in their country.

| 2.8 | The regulation adopts a differentiated ("graded") approach by excluding from the registration procedure carriers who transport exclusively "excepted packages". On the other hand, it leaves it up to the Member States to add additional registration requirements for carriers of fissile and highly radioactive materials. |
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2.8

The regulation adopts a differentiated ("graded") approach by excluding from the registration procedure carriers who transport exclusively "excepted packages". On the other hand, it leaves it up to the Member States to add additional registration requirements for carriers of fissile and highly radioactive materials.

| 2.9 | Other EU and national law as well as international rules regarding physical protection, safeguards, and third-party liability continue to apply, especially Directive 2008/68/EC. |
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2.9

Other EU and national law as well as international rules regarding physical protection, safeguards, and third-party liability continue to apply, especially Directive 2008/68/EC.

| 2.10 | The regulation would free up resources in competent authorities currently involved in these administrative procedures as a registration would be screened by only one competent authority. |
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2.10

The regulation would free up resources in competent authorities currently involved in these administrative procedures as a registration would be screened by only one competent authority.

3.   General comments

General comments

| 3.1 | The Committee favours the second option proposed in the Impact Assessment Report, namely: Regulation with harmonised rules and a more efficient role for the Competent Authorities. |
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3.1

The Committee favours the second option proposed in the Impact Assessment Report, namely: Regulation with harmonised rules and a more efficient role for the Competent Authorities.

| 3.2 | A regulation would go one step further than a recommendation – by a) proposing directly applicable harmonised rules such as a common registration system for carriers which does away with the different systems used in the Member States for reporting and authorisation, and b) giving carriers access to the EU27 transport market in one "slimmed-down" procedure, while adopting a differentiated approach. The Commission would set up a secure online registration system to enable the necessary exchange of data. |
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3.2

A regulation would go one step further than a recommendation – by a) proposing directly applicable harmonised rules such as a common registration system for carriers which does away with the different systems used in the Member States for reporting and authorisation, and b) giving carriers access to the EU27 transport market in one "slimmed-down" procedure, while adopting a differentiated approach. The Commission would set up a secure online registration system to enable the necessary exchange of data.

| 3.3 | Although the options analysed by ECORYS – the independent experts who carried out a supporting study for the Commission – seem to have a rather modest impact from a global viewpoint, this impact does matter to such a small sector. The impacts are categorised in five groups, namely: Public sector expenses and fees, Regulatory effects, Transport, Safety and environment, and Social impacts. |
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3.3

Although the options analysed by ECORYS – the independent experts who carried out a supporting study for the Commission – seem to have a rather modest impact from a global viewpoint, this impact does matter to such a small sector. The impacts are categorised in five groups, namely: Public sector expenses and fees, Regulatory effects, Transport, Safety and environment, and Social impacts.

| 3.4 | Small and medium-sized companies are expected to benefit in proportion to the total savings achieved under these options: the higher the savings in total, the higher the savings for these enterprises, which are, due to complexity and high costs, often blocked out of the market at present. |
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3.4

Small and medium-sized companies are expected to benefit in proportion to the total savings achieved under these options: the higher the savings in total, the higher the savings for these enterprises, which are, due to complexity and high costs, often blocked out of the market at present.

| 3.5 | A regulation would lead to savings of EUR 13,6 million per year over the baseline scenario by providing for, among other things, the mutual recognition of licences for carriers. Such an approach would reduce red tape for carriers, users and producers, while freeing up resources in authorities. These could then be used, at least partially, for compliance checks, the lack of which is one of the problems mentioned above. |
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3.5

A regulation would lead to savings of EUR 13,6 million per year over the baseline scenario by providing for, among other things, the mutual recognition of licences for carriers. Such an approach would reduce red tape for carriers, users and producers, while freeing up resources in authorities. These could then be used, at least partially, for compliance checks, the lack of which is one of the problems mentioned above.

| 3.6 | Because a regulation is binding, this option will be effective in helping to attain the objectives – i.e. to simplify the system, introduce transparency and eliminate barriers to a functioning internal market, while maintaining a high level of safety. |
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3.6

Because a regulation is binding, this option will be effective in helping to attain the objectives – i.e. to simplify the system, introduce transparency and eliminate barriers to a functioning internal market, while maintaining a high level of safety.

| 3.7 | The Committee thinks that setting up a new agency – as considered under Option 3 – would increase red tape for businesses and dilute the effect of the regulation as a whole. |
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3.7

The Committee thinks that setting up a new agency – as considered under Option 3 – would increase red tape for businesses and dilute the effect of the regulation as a whole.

4.   Specific comments

Specific comments

| 4.1 | Definitions as stated in the Regulation should be consistent, as far as possible, with the IAEA Glossary, specially the definition of "carriers" while taking into account that the definitions must be in line with Euratom legislation, in particular Directive 96/29/Euratom. |
| --- | --- |

4.1

Definitions as stated in the Regulation should be consistent, as far as possible, with the IAEA Glossary, specially the definition of "carriers" while taking into account that the definitions must be in line with Euratom legislation, in particular Directive 96/29/Euratom.

| 4.2 | The Committee agrees with the need to assess the regulation's impact two years after its implementation. It will also be useful to revisit the issue in five years to monitor what barriers may still exist to the smooth and safe operation of the transport of radioactive materials in the European Union. |
| --- | --- |

4.2

The Committee agrees with the need to assess the regulation's impact two years after its implementation. It will also be useful to revisit the issue in five years to monitor what barriers may still exist to the smooth and safe operation of the transport of radioactive materials in the European Union.

| 4.3 | A common and uniform system for registration of carriers for radioactive materials in the EU will be achieved with the current draft proposal. Article 3 paragraph 3 will allow a carrier to transport radioactive materials without additional registration under this Regulation if the carrier holds already a registration for use or handling and transport of that material. The Committee invites the Commission to study with stakeholders the possibility of transitional arrangements for holders of transport registrations. |
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4.3

A common and uniform system for registration of carriers for radioactive materials in the EU will be achieved with the current draft proposal. Article 3 paragraph 3 will allow a carrier to transport radioactive materials without additional registration under this Regulation if the carrier holds already a registration for use or handling and transport of that material. The Committee invites the Commission to study with stakeholders the possibility of transitional arrangements for holders of transport registrations.

| 4.4 | Article 3(4) allows for additional registration requirements for materials representing a particular health hazard. The Committee would like this list of materials to include those materials transported under multilateral approvals. |
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4.4

Article 3(4) allows for additional registration requirements for materials representing a particular health hazard. The Committee would like this list of materials to include those materials transported under multilateral approvals.

| 4.5 | The Committee notes that the insurance cover required for carriers varies from Member State to Member State. While such insurance cover cannot be covered in the registration procedure due to the legal base, the Committee invites the Member States to reach a harmonisation of the insurance schemes needed. |
| --- | --- |

4.5

The Committee notes that the insurance cover required for carriers varies from Member State to Member State. While such insurance cover cannot be covered in the registration procedure due to the legal base, the Committee invites the Member States to reach a harmonisation of the insurance schemes needed.

| 4.6 | The web-based registration system for carriers must be available in advance, tested and functional. This would give reassurance to operators and competent authorities, as would an extension of the transition period prior to entry into force depending on the concrete transitional arrangements pursuant to 4.3. |
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4.6

The web-based registration system for carriers must be available in advance, tested and functional. This would give reassurance to operators and competent authorities, as would an extension of the transition period prior to entry into force depending on the concrete transitional arrangements pursuant to 4.3.

| 4.7 | The applicant should be given the possibility to correct or complement information in its application instead of being rejected without further examination (Art. 5.7 and 5.10). |
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4.7

The applicant should be given the possibility to correct or complement information in its application instead of being rejected without further examination (Art. 5.7 and 5.10).

| 4.8 | Member States should ensure that the criteria for granting registration are harmonised. |
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4.8

Member States should ensure that the criteria for granting registration are harmonised.

Brussels, 22 February 2012.

The President of the European Economic and Social Committee

Staffan NILSSON

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