2011/0254(NLE)
Human health and environment protection: basic safety standards for protection against the dangers arising from exposure to ionising radiation
Human health and environment protection: basic safety standards for protection against the dangers arising from exposure to ionising radiation 2011/0254(NLE)
Next event: 2013/07/10 Vote scheduled in committee, 1st reading/single reading
Lead committee dossier: ENVI/7/07306
Legal basis: Euratom Treaty A 031 , Euratom Treaty A 032
Next event: 2013/07/10 Vote scheduled in committee, 1st reading/single reading
| EMPL | ENVI | ITRE | |
| Lead Rapporteur | ULMER Thomas (EPP) | ||
| Opinion Rapporteur(s) |
Legal basis: Euratom Treaty A 031 , Euratom Treaty A 032
Awaiting Parliament 1st reading / single reading / budget 1st stage
2011/0254(NLE) Human health and environment protection: basic safety standards for protection against the dangers arising from exposure to ionising radiation
Next event: Vote scheduled in committee, 1st reading/single reading 2013/07/10 more...
Lead committee dossier: ENVI/7/07306
Legal Basis Euratom Treaty A 031, Euratom Treaty A 032
Next event: Vote scheduled in committee, 1st reading/single reading 2013/07/10 more...
- Indicative plenary sitting date, 1st reading/single reading 2013/09/10
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Opinion | EMPL | ||
| Lead | ENVI | ULMER Thomas (EPP) | TĂNĂSESCU Claudiu Ciprian (S&D), PANAYOTOV Vladko Todorov (ALDE), RIVASI Michèle (Verts/ALE), OUZKÝ Miroslav (ECR), WILS Sabine (GUE/NGL) |
| Opinion | ITRE |
Legal Basis Euratom Treaty A 031, Euratom Treaty A 032
Subjects
- 3.40.07 Building industry
- 3.60.04 Nuclear energy, industry and safety
- 3.70.01 Protection of natural resources: fauna, flora, nature, wildlife, countryside; biodiversity
- 3.70.08 Radioactive pollution
- 4.15.15 Health and safety at work, occupational medicine
- 4.20 Public health
- 4.20.05 Health legislation and policy
Activites
-
2013/09/10
Indicative plenary sitting date, 1st reading/single reading
-
2013/07/10
Vote scheduled in committee, 1st reading/single reading
- 2013/03/12 Amendments tabled in committee
- 2013/02/27 Amendments tabled in committee
- 2012/12/20 Committee draft report
-
2012/11/22
Referral to associated committees announced in Parliament
- 2012/07/03 Committee referral announced in Parliament, 1st reading/single reading
-
2012/05/30
Legislative proposal
-
COM(2012)0242
summary
PURPOSE: to lay down laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation. PROPOSED ACT: Council Directive. BACKGROUND: exposure to ionising radiation results in a health detriment. In normal situations doses are very low so that there is no clinically observable tissue effect, but there still is a possible late effect, cancer in particular. Euratom legislation has always followed the recommendations of the International Commission on Radiological Protection (ICRP). This highly respected scientific organisation has recently issued new guidance on the system of radiation protection (Publication 103, 2007). The problem at EU level can be summarised as follows: (i) scientific progress is not fully reflected in present legislation; (ii) there are inconsistencies between the existing pieces of legislation; (iii) the scope of the present legislation does not fully cover natural radiation sources or the protection of the environment. This translates into four specific objectives: to introduce the necessary subject-matter amendments in order to respond to the latest scientific data and operational experience; to clarify the requirements and to ensure coherence within the body of European legislation; to ensure coherence with the international recommendations; to cover the whole range of exposure situations and categories of exposure. IMPACT ASSESSMENT: several options were analysed: Option 1: Maintaining the status quo of existing legislation Option 2: Revision of Basic Safety Standards and Medical Directive Option 3: Revision and consolidation of Basic Safety Standards and Medical Directive and integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive (non-legislative measures to address natural radiation issues and the protection of non-human species, see Annex XI), Option 4: Revision of the Basic Safety Standards Directive and broadening the scope to cover public exposure to natural radiation Option 5 : Revision of the Basic Safety Standards Directive and broadening the scope to cover protection of non-human species Option 6: Revision and consolidation of the Basic Safety Standards Directive and Medical Directive, integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive and broadening the scope to cover public exposure to natural radiation and protection of non-human species. Option 6, which combines Options 4 and 5, covers all aspects of the objective of broadening the scope of radiation protection legislation. Their combination, in Option 6, together with undertaking an effort for consolidation similar to Option 3, is most effective in achieving all objectives. The analysis of the options in terms of efficiency supports the conclusion that Option 6 should be pursued, as the most effective, efficient and coherent policy option. LEGAL BASIS: Articles 31 and 32 of the Treaty establishing the European Atomic Energy Community. It should be noted that prior to proposing the current text, the Article 31 Group of Experts gave its opinion on the revised Basic safety standards Directive, there was still discussion whether a Directive on radioactive substances in water intended for human consumption should be based on Euratom Treaty or EC Treaty. In these circumstances it was decided to proceed with the proposal for a revised Basic Safety Standards Directive as agreed upon in February 2010 by Article 31 Group of Experts (as presented by the Commission in its summary dated 29 September 2011 - initial legislative proposal published). The current proposal constitutes the definitive text published by the Commission. CONTENT: the recast of five Directives yields a voluminous single Directive, with over 100 articles and numerous annexes. In view of the extent and complexity of the changes, a formal recast procedure is not pursued. A description of the main features of each chapter may be summarised as follows: Subject matter and scope: this chapter defines the scope of the new Directive: the general purpose of the Directive across different categories of exposure and different exposure situations and specific purposes resulting from integration of the requirements for high-activity sealed radioactive sources and for public information, and the exclusion of non-controllable exposures). The scope is broadened to include: the exposure of space crew to cosmic radiation; domestic exposure to radon gas in indoor air; external exposure to gamma radiation from building materials, and the protection of the environment beyond environmental pathways leading to human exposure. System of radiation protection: this title includes the general principles of radiation protection: justification, optimisation and dose limitation. It explains the more prominent role of dose constraints and reference levels in the process of optimisation, with Annex I giving the bands of reference levels proposed by the ICRP for existing and emergency exposure situations. The dose limits are not modified, except for a uniform definition of the annual occupational dose limit (no averaging over 5 years) and a lower organ dose limit for the lens of the eye, as recommended by the ICRP. The new Directive no longer includes the technical measurements entering into the definition of the effective dose and other factors entering into the assessment of doses, but refers to ICRP Publication 103 for this purpose. In addition, the Directive no longer includes the long lists of radionuclide-specific dose coefficients (doses per unit intake by ingestion or inhalation), but will refer to a forthcoming consolidated publication of the ICRP which can be downloaded free of charge. Requirements for radiation protection education, training and information: this chapter brings together the miscellaneous requirements governing education and training in the different Directives and includes provisions for recognition of the 'Radiation Protection Expert' and 'Medical Physics Expert'. Justification and regulatory control of practices: the application of the principle of justification remains a national responsibility. Specific attention is given to the justification of practices involving the deliberate exposure of humans for non-medical imaging (e.g. security screening in airports). The regime for regulatory control is now presented as a three-tier system (notification, registration, licensing), replacing the earlier two-tier system of reporting and 'prior authorisation'. A more detailed list of which types of practice are subject to either registration or licensing is given. Protection of workers, apprentices and students: this title includes, with little amendment, the provisions on occupational exposure in Directive 96/29/Euratom. It also includes the specific requirements in the Outside Workers Directive, and introduces a clear allocation of responsibilities between the employer and the undertaking where the practice is conducted. The data system for individual radiological monitoring of exposed workers and the minimum set of data to be communicated for outside workers has been updated. This chapter now also covers occupational exposure in all exposure situations, which provides more explicit protection for emergency workers as well as for workers exposed to high levels of indoor radon in their workplace. Protection of patients and other individuals subjected to medical exposure: this chapter includes the relevant requirements from the Medical Directive, but strengthens them, in particular with regard to: the application of the justification principle; information to patients on the health risks and benefits; information on doses; diagnostic reference levels; involvement of the Medical Physics Expert; prevention of accidental and unintended medical exposures. Protection of members of the public: this chapter includes the public exposure requirements in Directive 96/29/Euratom, with more explicit consideration of the issuing of discharge authorisations for radioactive effluent The section on emergency exposure situations includes the requirements of the Public Information Directive. The section on existing exposure situations addresses indoor exposure to radon, with a somewhat lower maximum reference level for existing dwellings than in Commission Recommendation 90/143/Euratom, in line with ICRP and WHO recommendations. It also includes requirements for the classification of building materials on the basis of a radioactivity index and a uniform reference level for the annual dose resulting from residence in a building constructed with such materials. Protection of the environment: this chapter, in line with the broader scope of the Directive as in the International Basic Safety Standards, aims to provide a means to demonstrate compliance with environmental criteria. It is up to national authorities to assess the doses to representative animals and plants in terms of protection of the ecosystem. Appropriate technical measures also need to be taken to avoid the environmental consequences of an accidental release and to monitor existing levels of radioactivity in the environment, from the perspectives of both environmental protection and human health. Requirements for regulatory control: this chapter includes all the responsibilities of the regulatory authorities in all exposure situations. The first section on 'institutional infrastructure' calls for a clear definition of the responsibilities of different authorities. The Commission is to receive periodically updated information and publish this in the Official Journal. This section also defines the responsibilities of the 'Radiation Protection Expert', the 'Radiation Protection Officer' (in the current BSS these concepts were merged within the function of 'Qualified Expert') and the 'Medical Physics Expert'. Final provisions: a 2-year transposition deadline is deemed sufficient. Specific new features, such as the protection of the environment, can be transposed later. In line with the Euratom Treaty, the Basic Standards are to be uniformly applied in the Member States, though without prejudice to those requirements for which flexibility is clear from the wording of the text. However, dose limits, default exemption values, the reference level for building materials, etc. are explicitly intended for uniform transposition and application. BUDGETARY IMPLICATIONS: there are no implications for the EU budget.
- SWD(2012)0137
- SWD(2012)0138
- DG {u'url': u'http://ec.europa.eu/dgs/energy/index_en.htm', u'title': u'Energy'}, OETTINGER Günther
-
COM(2012)0242
summary
- 2012/02/22 Economic and Social Committee: opinion, report
-
2011/09/29
Initial legislative proposal
-
COM(2011)0593
summary
PURPOSE : to lay down laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation. PROPOSED ACT : Council Directive. BACKGROUND : exposure to ionising radiation results in a health detriment. In normal situations doses are very low so that there is no clinically observable tissue effect, but there still is a possible late effect, cancer in particular. Euratom legislation has always followed the recommendations of the International Commission on Radiological Protection (ICRP). This highly respected scientific organisation has recently issued new guidance on the system of radiation protection (Publication 103, 2007). The problem at EU level can be summarised as follows: (i) scientific progress is not fully reflected in present legislation; (ii) there are inconsistencies between the existing pieces of legislation; (iii) the scope of the present legislation does not fully cover natural radiation sources or the protection of the environment. This translates into four specific objectives: to introduce the necessary subject-matter amendments in order to respond to the latest scientific data and operational experience; to clarify the requirements and to ensure coherence within the body of European legislation; to ensure coherence with the international recommendations; to cover the whole range of exposure situations and categories of exposure. IMPACT ASSESSMENT : several options were analysed : Option 1: Maintaining the status quo of existing legislation Option 2: Revision of Basic Safety Standards and Medical Directive Option 3: Revision and consolidation of Basic Safety Standards and Medical Directive and integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive (non-legislative measures to address natural radiation issues and the protection of non-human species, see Annex XI), Option 4: Revision of the Basic Safety Standards Directive and broadening the scope to cover public exposure to natural radiation Option 5 : Revision of the Basic Safety Standards Directive and broadening the scope to cover protection of non-human species Option 6: Revision and consolidation of the Basic Safety Standards Directive and Medical Directive, integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive and broadening the scope to cover public exposure to natural radiation and protection of non-human species. Option 6, which combines Options 4 and 5, covers all aspects of the objective of broadening the scope of radiation protection legislation. Their combination, in Option 6, together with undertaking an effort for consolidation similar to Option 3, is most effective in achieving all objectives. The analysis of the options in terms of efficiency supports the conclusion that Option 6 should be pursued, as the most effective, efficient and coherent policy option. LEGAL BASIS : Articles 31 and 32 of the Treaty establishing the European Atomic Energy Community. CONTENT : the recast of five Directives yields a voluminous single Directive, with over 100 articles and numerous annexes. In view of the extent and complexity of the changes, a formal recast procedure is not pursued. A description of the main features of each chapter may be summarised as follows: Subject matter and scope: this chapter defines the scope of the new Directive: the general purpose of the Directive across different categories of exposure and different exposure situations and specific purposes resulting from integration of the requirements for high-activity sealed radioactive sources and for public information, and the exclusion of non-controllable exposures). The scope is broadened to include: the exposure of space crew to cosmic radiation; domestic exposure to radon gas in indoor air; external exposure to gamma radiation from building materials, and the protection of the environment beyond environmental pathways leading to human exposure. System of radiation protection: this title includes the general principles of radiation protection: justification, optimisation and dose limitation. It explains the more prominent role of dose constraints and reference levels in the process of optimisation, with Annex I giving the bands of reference levels proposed by the ICRP for existing and emergency exposure situations. The dose limits are not modified, except for a uniform definition of the annual occupational dose limit (no averaging over 5 years) and a lower organ dose limit for the lens of the eye, as recommended by the ICRP. The new Directive no longer includes the technical measurements entering into the definition of the effective dose and other factors entering into the assessment of doses, but refers to ICRP Publication 103 for this purpose. In addition, the Directive no longer includes the long lists of radionuclide-specific dose coefficients (doses per unit intake by ingestion or inhalation), but will refer to a forthcoming consolidated publication of the ICRP which can be downloaded free of charge. Requirements for radiation protection education, training and information: this chapter brings together the miscellaneous requirements governing education and training in the different Directives and includes provisions for recognition of the 'Radiation Protection Expert' and 'Medical Physics Expert'. Justification and regulatory control of practices: the application of the principle of justification remains a national responsibility. Specific attention is given to the justification of practices involving the deliberate exposure of humans for non-medical imaging (e.g. security screening in airports). The regime for regulatory control is now presented as a three-tier system (notification, registration, licensing), replacing the earlier two-tier system of reporting and 'prior authorisation'. A more detailed list of which types of practice are subject to either registration or licensing is given. Protection of workers, apprentices and students: this title includes, with little amendment, the provisions on occupational exposure in Directive 96/29/Euratom. It also includes the specific requirements in the Outside Workers Directive, and introduces a clear allocation of responsibilities between the employer and the undertaking where the practice is conducted. The data system for individual radiological monitoring of exposed workers and the minimum set of data to be communicated for outside workers has been updated. This chapter now also covers occupational exposure in all exposure situations, which provides more explicit protection for emergency workers as well as for workers exposed to high levels of indoor radon in their workplace. Protection of patients and other individuals subjected to medical exposure: this chapter includes the relevant requirements from the Medical Directive, but strengthens them, in particular with regard to: the application of the justification principle; information to patients on the health risks and benefits; information on doses; diagnostic reference levels; involvement of the Medical Physics Expert; prevention of accidental and unintended medical exposures. Protection of members of the public: this chapter includes the public exposure requirements in Directive 96/29/Euratom, with more explicit consideration of the issuing of discharge authorisations for radioactive effluent The section on emergency exposure situations includes the requirements of the Public Information Directive. The section on existing exposure situations addresses indoor exposure to radon, with a somewhat lower maximum reference level for existing dwellings than in Commission Recommendation 90/143/Euratom, in line with ICRP and WHO recommendations. It also includes requirements for the classification of building materials on the basis of a radioactivity index and a uniform reference level for the annual dose resulting from residence in a building constructed with such materials. Protection of the environment: this chapter, in line with the broader scope of the Directive as in the International Basic Safety Standards, aims to provide a means to demonstrate compliance with environmental criteria. It is up to national authorities to assess the doses to representative animals and plants in terms of protection of the ecosystem. Appropriate technical measures also need to be taken to avoid the environmental consequences of an accidental release and to monitor existing levels of radioactivity in the environment, from the perspectives of both environmental protection and human health. Requirements for regulatory control: this chapter includes all the responsibilities of the regulatory authorities in all exposure situations. The first section on 'institutional infrastructure' calls for a clear definition of the responsibilities of different authorities. The Commission is to receive periodically updated information and publish this in the Official Journal. This section also defines the responsibilities of the 'Radiation Protection Expert', the 'Radiation Protection Officer' (in the current BSS these concepts were merged within the function of 'Qualified Expert') and the 'Medical Physics Expert'. Final provisions: a 2-year transposition deadline is deemed sufficient. Specific new features, such as the protection of the environment, can be transposed later. In line with the Euratom Treaty, the Basic Standards are to be uniformly applied in the Member States, though without prejudice to those requirements for which flexibility is clear from the wording of the text. However, dose limits, default exemption values, the reference level for building materials, etc. are explicitly intended for uniform transposition and application. BUDGETARY IMPLICATIONS : there are no implications for the EU budget.
- SEC(2011)1098
- SEC(2011)1099
- DG {u'url': u'http://ec.europa.eu/dgs/energy/index_en.htm', u'title': u'Energy'}, OETTINGER Günther
-
COM(2011)0593
summary
Documents
- Initial legislative proposal published: COM(2011)0593
- Document attached to the procedure: SEC(2011)1098
- Document attached to the procedure: SEC(2011)1099
- Economic and Social Committee: opinion, report: CES0488/2012
- Legislative proposal published: COM(2012)0242
- Document attached to the procedure: SWD(2012)0137
- Document attached to the procedure: SWD(2012)0138
- Committee draft report: PE501.908
- Amendments tabled in committee: PE506.023
- Amendments tabled in committee: PE506.142
| Amendments | Dossier |
| 323 |
2011/0254(NLE) Human health and environment protection: basic safety standards for protection against the dangers arising from exposure to ionising radiation
2013/01/22
EMPL
40 amendments...
Amendment 13 #
Article 1 – paragraph 2 2. This Directive applies to the protection of the environment as
Amendment 14 #
Article 2 – paragraph 2 – point c – point i i) practices exposing workers to cosmic radiation, including the operation of aircraft and spacecraft as well as frequent flying;
Amendment 15 #
Article 4 – paragraph 1 – point 1 (1) Medical exposure means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health
Amendment 16 #
Article 4 – paragraph 1 – point 24 (24) Occupational exposure means exposure of workers
Amendment 17 #
Article 4 – paragraph 1 – point 35 (35) Exposed worker means a person, either self-employed or working under an employer, including a trainee or volunteer, who is subject to exposure at work carried out within a practice regulated by this Directive and who is liable to receive doses exceeding one or other of the dose limits for public exposure; persons under 18 years of age shall not be assigned to any work which would define them as exposed workers.
Amendment 18 #
Article 4 – paragraph 1 – point 54 (54) Non-medical imaging exposure means any deliberate exposure of humans for imaging purposes where the primary motivation for the exposure is not related to the health
Amendment 19 #
Article 6 – paragraph 1 1. For occupational exposure, the dose constraint shall be established as an operational tool for optimisation by the undertaking
Amendment 20 #
Article 11 – paragraph 1 1. As soon as a pregnant woman informs the undertaking of her condition, in accordance with national legislation or national practice, the protection of the unborn child shall be
Amendment 21 #
Article 11 – paragraph 2 2. As soon as a breastfeeding woman informs the undertaking of her condition, she shall not be e
Amendment 22 #
Article 12 – paragraph 2 – subparagraph 2 – point a (a) the limit on the equivalent dose for the lens of the eye shall be
Amendment 23 #
Article 12 – paragraph 2 – subparagraph 2 – point b (b) the limit on the equivalent dose for the skin shall be
Amendment 24 #
Article 12 – paragraph 2 – subparagraph 2 – point c (c) the limit on the equivalent dose for the hands, forearms, feet and ankles shall be
Amendment 25 #
Article 16 – paragraph 1 – introductory part 1. Member States shall require the undertaking or the employer to inform exposed workers without exception, apprentices and students who are subject to occupational exposure on:
Amendment 26 #
Article 16 – paragraph 1 – point a a (new) (aa) safe working procedures minimizing the risks;
Amendment 27 #
Article 16 – paragraph 1 – point d a (new) (da) the conditions under which workers are entitled to health surveillance;
Amendment 28 #
Article 17 – paragraph 1 – point b (b) advised and trained in the visual detection of sources and their containers as well as in how to report them;
Amendment 29 #
Article 27 – paragraph 1 In cases where a quantifiable dose limit can be established for a practice, a limited risk of exposure does not necessitate the examination of individual cases and the practice is undertaken in accordance with conditions laid down in national legislation, competent authorities may limit regulatory control to registration of the practice and an appropriate frequency of inspections. Licensing shall only be requested where the authorisation is applied to the overall activities of an undertaking.
Amendment 30 #
Article 27 – paragraph 2 – introductory part 2. Member States shall require licensing for undertakings performing the following activities, or, where appropriate in accordance with paragraph 1, registration for the following practices:
Amendment 31 #
Article 27 – paragraph 2 – point e Amendment 32 #
Article 27 – paragraph 3 – point e Amendment 33 #
Article 28 – paragraph 2 – point a a (new) (aa) measures taken due to this directive;
Amendment 34 #
Article 31 – paragraph 1 – point e (e) medical surveillance
Amendment 35 #
Article 33 – paragraph 3 – introductory part 3. For undertakings
Amendment 36 #
Article 33 – paragraph 3 – point a (a) to assess the exposure of the crew or workers concerned;
Amendment 37 #
Article 33 – paragraph 3 – point b (b) to take into account the assessed exposure when organising working schedules with a view to reducing the doses of highly exposed crew or workers subject to work-related frequent flying;
Amendment 38 #
Article 38 – paragraph 1 – point a (a) category A: exposed workers who are liable to receive an effective dose greater than 6 mSv per year or an equivalent dose greater than 15 mSv per year for the lens of the eye or greater than
Amendment 39 #
Article 39 – paragraph 2 2. Monitoring for category B workers shall be at least sufficient to demonstrate that such workers are correctly classified in category B. Member States
Amendment 40 #
Article 41 – paragraph 3 3. The dose record referred to in paragraph 1 shall be submitted to the data system for individual radiological monitoring established by the Member State in accordance with the provisions of Annex VIII. The information referred in paragraph 1 shall be retained during the period of their working life involving exposure to ionising radiation and afterwards until they have or would have attained the age of 75 years, but in any case not less than 30 years after termination of the work involving exposure.
Amendment 41 #
Article 43 – paragraph 1 1. Member States shall require workers to have access at
Amendment 42 #
Article 46 – paragraph 1 No worker may be employed or classified for any period in a specific post as a category A worker if medical surveillance establishes that the worker is unfit for that specific post or fit for limited duties.
Amendment 43 #
Article 47 – paragraph 2 a (new) 2 a. The employee shall have access to his or her personal health file at any time.
Amendment 44 #
Article 49 – paragraph 1 Member States shall lay down the procedure for appeal against the findings and decisions made pursuant to Articles 45, 46 and 48. Consultation and participation of workers and/or their representatives shall be regulated by Article 11 of Council Directive 89/391/EEC.
Amendment 45 #
Article 50 – paragraph 1 1. Member States shall ensure that the system for individual radiological monitoring affords outside workers equivalent protection and medical care to that for workers employed on a permanent basis by the undertaking.
Amendment 46 #
Article 54 – paragraph 1 – subparagraph 1 Medical exposure shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefits it produces, including the direct benefits to health
Amendment 47 #
Article 54 – paragraph 1 a (new) 1 a. Staff shall be trained regularly and compliance with the applicable rules shall be monitored.
Amendment 48 #
Article 70 – paragraph 1 1. Member States shall require the undertaking responsible for a licensed practice to notify the competent authorities immediately of any emergency occurring in its facility or related to its activities and to take all appropriate action to reduce the consequences.
Amendment 49 #
Article 85 – paragraph 2 – point f a (new) (fa) establishing documented procedures used for information and training of exposed workers.
Amendment 50 #
Article 86 – paragraph 2 – point l a (new) (la) establishing documented procedures used for information and training of exposed workers.
Amendment 51 #
Annex 4 – paragraph 1 – point A – point 4 4. Radiological health assessment for other purposes not intended to benefit the health
Amendment 52 #
Annex 8 – paragraph 2 The data system for individual radiological monitoring established by a Member State may be realised either as a centralised national network or as a national dose register. These networks or registers
source: PE-502.218
2013/02/27
ENVI
139 amendments...
Amendment 12 #
Draft legislative resolution Citation 2 – having regard to
Amendment 13 #
Draft legislative resolution Paragraph 2 a (new) 2a. Calls on the Commission to notify the Parliament how amendments from Parliament have been taken into due account in the final text of the directive as amended from the council;
Amendment 14 #
Citation 1 Having regard to the Treaty
Amendment 15 #
Recital 1 (1) Article
Amendment 16 #
Recital 1 (1) Article 2(b) of the Treaty provides for the establishment of uniform safety standards to protect the health of workers and the general public and Article 30 of the Treaty defines ‘basic standards’ for the health protection of workers and the general public against the dangers arising from ionising radiations, and provides that ‘maximum permissible doses’ have to be ‘compatible with adequate safety’.
Amendment 17 #
Recital 1 a (new) (1a) Article 153 TFEU allows for the establishment of safety standards to protect the health of workers and of the general public.
Amendment 18 #
Recital 1 b (new) (1b) Article 168 TFEU allows for the establishment of basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation.
Amendment 19 #
Recital 7 (7) This Directive should follow the situation based approach introduced by ICRP Publication 103 and distinguish between existing, planned and emergency exposure situations. With regard to the application of the standards and requirements, however, it should also draw a distinction between existing exposure situations attributable to natural radiation and existing anthropic exposure situations. Taking into account this new framework the Directive should cover all exposure situations and all categories of exposure, namely occupational, public and medical exposures.
Amendment 20 #
Recital 8 Amendment 21 #
Recital 9 Amendment 22 #
Recital 13 Amendment 23 #
Recital 13 (13) The new requirements on natural radioactivity in building materials should allow for the free circulation of building materials while at the same time improving protection against radiological risks.
Amendment 24 #
Recital 15 (15) The exposure of aircrew to cosmic radiation should be managed as a planned exposure situation. The operation of spacecraft should come under the scope of this Directive and should be managed as a specially authorised exposure. In addition, more attention should be paid to the potential risks of cosmic radiation to frequent air travellers. Like aircrew, who have the option of being registered and receiving health checks focusing on the risks from radiation, there should also be the option of registration for frequent air travellers – for example by calling on firms to register their employees who frequently travel by air.
Amendment 25 #
Recital 16 (16) The
Amendment 26 #
Recital 17 (17) In the medical area,
Amendment 27 #
Recital 21 Amendment 28 #
Recital 22 Amendment 29 #
Recital 22 Amendment 30 #
Recital 23 Amendment 31 #
Recital 23 Amendment 32 #
Recital 25 (25) With regard to the management of emergency exposure situations, the current approach based on intervention levels should be
Amendment 33 #
Recital 26 Amendment 34 #
Recital 27 (27) The efficient management of a nuclear emergency with cross-border consequences calls for enhanced cooperation and transparency between Member States in emergency planning and response.
Amendment 35 #
Recital 28 Amendment 36 #
Recital 30 (30) More precise requirements and appropriate sanctions should be introduced for the issuing discharge authorisations and for the monitoring of discharges. Commission Recommendation 2004/2/Euratom of 18 December 2003 on standardised information on radioactive airborne and liquid discharges into the environment from nuclear power reactors and reprocessing plants in normal operation introduced standardised information for the reporting of data on discharges from nuclear power plants and reprocessing facilities.
Amendment 37 #
Recital 31 (31)
Amendment 38 #
Article 1 – paragraph 1 1. This Directive establishes the basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure as well as the environment against the dangers arising from ionising radiation for the purpose of their
Amendment 39 #
Article 1 – paragraph 1 1. This Directive establishes the basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure against the dangers arising from ionising radiation for the purpose of
Amendment 40 #
Article 1 – paragraph 2 Amendment 41 #
Article 1 – paragraph 3 3. This Directive sets out requirements for the control of the safety and security of radioactive sources and the provisions of
Amendment 42 #
Article 1 – paragraph 4 4. This Directive sets out requirements for the pr
Amendment 43 #
Article 2 – paragraph 1 1. This Directive applies to any planned, existing, accidental or emergency exposure situation which involves a risk from exposure to ionising radiation
Amendment 44 #
Article 2 – paragraph 2 – point a (a) the production, processing, handling, use, storage, holding, transport, shipment, import to, and export from the Community
Amendment 45 #
Article 2 – paragraph 2 – point c – point i (i) practices exposing workers to cosmic radiation, including the operation of aircraft and spacecraft as well as frequent flying;
Amendment 46 #
Article 4 – paragraph 1 – point 3 (3) Emergency means a
Amendment 47 #
Article 4 – paragraph 1 – point 7 (7) Members of the public means individuals, subject to public exposure and constituting the most exposed group in the population;
Amendment 48 #
Article 4 – paragraph 1 – point 8 (8) Radiation source means an entity that
Amendment 49 #
Article 4 – paragraph 1 – point 10 (10) Radioactive material means any material in a liquid, gaseous or solid form incorporating radioactive substances;
Amendment 50 #
Article 4 – paragraph 1 – point 13 (13) Disposal means the emplacement of radioactive waste or spent fuel in an authorised facility
Amendment 51 #
Article 4 – paragraph 1 – point 14 (14) Existing exposure situation means an exposure situation that already exists when a decision on its control has to be
Amendment 52 #
Article 4 – paragraph 1 – point 14 (14) Existing natural exposure situation means a
Amendment 53 #
Article 4 – paragraph 1 – point 14 a (new) (14a) Existing anthropic exposure situation means a situation of exposure to residual contamination attributable to an emergency situation, an unregulated activity or a practice for which there is no longer legal accountability and which cannot be managed as a planned exposure situation;
Amendment 54 #
Article 4 – paragraph 1 – point 16 (16) Planned exposure situation means an exposure situation that arises from the planned operation or introduction of a radiation source or from activities which alter exposure pathways, so as to cause the exposure or potential exposure of people or the environment. Planned exposure situations may include both normal exposures and potential exposures. They include the management of pollution caused by the functioning of installations in non-emergency situations and by clean-up operations, notably in connection with decommissioning;
Amendment 55 #
Article 4 – paragraph 1 – point 17 (17) Potential exposure means exposure that
Amendment 56 #
Article 4 – paragraph 1 – point 18 (18) Radiation protection means the protection of people
Amendment 57 #
Article 4 – paragraph 1 – point 19 (19) Practice means any activity that involves the operation or introduction of radiation sources or which alters exposure pathways and is managed as a
Amendment 58 #
Article 4 – paragraph 1 – point 21 (21) Storage means the holding of radioactive sources or radioactive waste in a facility that provides adequate containment, with the intention o
Amendment 59 #
Article 4 – paragraph 1 – point 22 (22) Optimisation means a forward-looking iterative process to establish adequate protection measures taking into account the prevailing circumstances, the available options, and the nature of the exposure situation, with the aim of keeping the magnitude and likelihood of exposure and the number of people exposed as low as
Amendment 60 #
Article 4 – paragraph 1 – point 25 (25) Health detriment means an estimate of the risk of reduction in length and quality of life occurring in a population following exposure. Th
Amendment 61 #
Article 4 – paragraph 1 – point 30 (30) Outside worker means any exposed worker
Amendment 62 #
Article 4 – paragraph 1 – point 34 (34) Reference level means
Amendment 63 #
Article 4 – paragraph 1 – point 34 (34) Reference level means, in an emergency exposure situation or in an existing natural exposure situation, the level of dose or risk at and above which
Amendment 64 #
Article 4 – paragraph 1 – point 35 (35) Exposed worker means a person, either self-employed or working under an employer, who is
Amendment 65 #
Article 4 – paragraph 1 – point 39 – paragraph 2 In specifying E(τ), τ is given in the number of years over which the integration is made. For the purpose of complying with dose limits specified in this Directive, τ is a period of
Amendment 66 #
Article 4 – paragraph 1 – point 41 (41) Occupational health service means a health professional or body having competence for the medical surveillance of exposed workers, whose status affords a guarantee of independence from the employer of the workers for whom the occupational health service is responsible and whose capacity to act in that respect is recognised by the competent authorities;
Amendment 67 #
Article 4 – paragraph 1 – point 42 a (new) (42a) Competent authority is any authority designated by a Member State.
Amendment 68 #
Article 4 – paragraph 1 – point 44 (44) Emergency response plan means arrangements to plan for
Amendment 69 #
Article 4 – paragraph 1 – point 46 (46) Dosimetry service means a body or an individual having the competence for calibration, reading or interpretation of individual monitoring devices, or for measurement of radioactivity in the human body or in biological samples, or for assessment of doses, whose status affords a guarantee of independence from the employer of the exposed workers and whose capacity to act in this respect is recognised by the competent authorities;
Amendment 70 #
Article 4 – paragraph 1 – point 53 (53) Radioactive substance means any substance in a gaseous, liquid or solid form that contains one or more radionuclides
Amendment 71 #
Article 4 – paragraph 1 – point 53 (53) Radioactive substance means any substance that contains one or more radionuclides, the activity or activity concentration of which cannot be disregarded as far as radiation protection is concerned;
Amendment 72 #
Article 4 – paragraph 1 – point 57 (57)
Amendment 73 #
Article 4 – paragraph 1 – point 62 (62) Radioactive waste means any radioactive material in gaseous, liquid or solid form for which no further use is foreseen.
Amendment 74 #
Article 4 – paragraph 1 – point 65 Amendment 75 #
Article 4 – paragraph 1 – point 65 (65) Clearance levels means values established by the competent authority or in national legislation, and expressed in terms of activity concentrations and of total activity, at or below which materials arising from any practice subject to notification or authorisation may be released from the requirements of this Directive;
Amendment 76 #
Article 4 – paragraph 1 – point 71 (71)
Amendment 77 #
Article 4 – paragraph 1 – point 74 (74) Individual detriment means clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed
Amendment 78 #
Article 4 – paragraph 1 – point 82 (82) Representative person means an individual receiving or liable to receive a dose that is representative of the more highly exposed individuals in the population. Evaluations must take account of scenarios that are worse than the existing conditions unless it is demonstrated that such scenarios are not liable to arise or that their emergence would be identified and would trigger re- evaluation of the dosimetric impact;
Amendment 79 #
Article 4 – paragraph 1 – point 83 (83) Radiation protection officer means an individual who is technically competent in radiation protection matters relevant for a given type of practice and is designated by the undertaking to oversee the implementation of the radiation protection arrangements of the undertaking; their capacity to act is recognised by the competent authorities;
Amendment 80 #
Article 4 – paragraph 1 – point 91 (91) Residual dose means the dose expected to be incurred from all exposure pathways after protective measures have been fully implemented
Amendment 81 #
Article 4 – paragraph 1 – point 92 – introductory part Amendment 82 #
Article 4 – paragraph 1 – point 96 – paragraph 5 In specifying HT(τ), τ is given in years. When τ is not given, a period of
Amendment 83 #
Article 4 – paragraph 1 – point 97 (97) Normal exposure means exposure expected to occur under the normal operating conditions of a facility or activity (including maintenance, inspection, decommissioning)
Amendment 84 #
Article 4 – paragraph 1 – point 97 (97)
Amendment 85 #
Article 5 – paragraph 1 – introductory part Member States shall establish legal requirements and an appropriate regime of regulatory control which, for all exposure situations reflect a system of radiation protection based on the following principles of justification,
Amendment 86 #
Article 5 – paragraph 1 a (new) Information regarding justification and dose limitation should be made available to the general public:
Amendment 87 #
Article 5 – paragraph 1 – introductory part Member States shall establish legal requirements and an appropriate regime of regulatory control which, for all exposure situations reflect a system of radiation protection based on the following principles of justification, optimisation
Amendment 88 #
Article 5 – paragraph 1 – point a (a) justification: decisions
Amendment 89 #
Article 5 – paragraph 1 – point b (b)
Amendment 90 #
Article 5 – paragraph 1 – point b (b) optimisation: in all exposure situations, radiation protection shall be optimised with the aim of keeping the magnitude and likelihood of exposure and the number of individuals exposed as low as reasonably achievable, taking into account economic and societal factors
Amendment 91 #
Article 5 – paragraph 1 – point c (c) dose limitation: in
Amendment 92 #
Article 5 – paragraph 1 – point c (c) dose limitation:
Amendment 93 #
Article 5 – paragraph 1 – point c a (new) (ca) Reparation for damages: before authorising the construction of a nuclear installation or renewing its operating licence, Member States must establish a mechanism which guarantees reparation for all physical damage and personal injury likely to be caused by an emergency at the installation.
Amendment 95 #
Article 6 – paragraph 2 2. For public exposure, the dose constraint shall be set for the individual dose that members of the public receive from the planned operation of a specified radiation source. The competent authorities shall set the constraint so as to ensure the protection of health of the general public and compliance with the dose limit for the sum of doses to the same individual from all authorised practices.
Amendment 96 #
Article 6 – paragraph 2 2. For public exposure, the dose constraint shall be set for the individual dose that members of the public receive from the planned operation of a specified radiation source. The competent authorities shall set the constraint so as to ensure compliance with the dose limit for the sum of doses to the same individual from all authorised practices, as well as from natural sources of radiation.
Amendment 97 #
Article 6 – paragraph 2 2. For public exposure, the dose constraint shall be set for the individual dose that members of the public receive from the planned operation of a specified radiation source or as a result of an existing anthropic exposure situation. The competent authorities shall set the constraint so as to ensure compliance with the dose limit for the sum of doses to the same individual from all authorised practices and residual contamination. The values chosen for the dose constraints shall be published, so that any member of the public can check that he or she has not received, as a result of aggregate planned and existing anthropic exposure situations, a dose in excess of the legal limit.
Amendment 98 #
Article 6 – paragraph 3 3. With regard to potential exposures,
Amendment 99 #
Article 7 – paragraph 2 – subparagraph 1 (new) The doses received by persons not involved in providing support and comfort to patients must be taken into account when assessing the doses received by members of the public and implementing radiation protection measures. This shall apply, in particular, to children forming part of the entourage of patients to whom radioactive substances have been administered for diagnostic or therapeutic purposes and workers performing certain professional activities who are not registered as exposed workers but who are likely to come into frequent contact with patients.
Amendment 100 #
Article 8 – paragraph 1 1. Reference levels shall be established for
Amendment 101 #
Article 8 – paragraph 1 1. Reference levels shall be established for emergency and existing
Amendment 102 #
Article 8 – paragraph 2 2. Optimised protective strategies shall be planned and implemented with the objective of reducing individual doses below the reference levels. The values chosen for reference levels shall
Amendment 103 #
Article 8 – paragraph 2 2. Optimised protective strategies shall be planned and implemented with the objective of reducing individual doses to the lowest level below the reference levels which can reasonably be achieved. The values chosen for reference levels shall depend upon the type of exposure situation, the nature of the risk and the forms of intervention and protective and remedial measures available.
Amendment 104 #
Article 8 – paragraph 3 Amendment 105 #
Article 8 – paragraph 3 3.
Amendment 106 #
Article 8 – paragraph 4 4. The
Amendment 107 #
Article 10 – paragraph 1 – subparagraph 1 The limit on the effective dose for occupational exposure received in the form of external and internal irradiation shall be
Amendment 108 #
Article 10 – paragraph 2 – point a (a) the limit on the equivalent dose for the lens of the eye shall be
Amendment 109 #
Article 11 – paragraph 1 1. As soon as a pregnant woman informs the undertaking of her condition, in accordance with national legislation or national practice, the protection of the unborn child shall be
Amendment 110 #
Article 11 – paragraph 2 2. As soon as a
Amendment 111 #
Article 12 – paragraph 1 1. The dose limits for apprentices aged 18 years or over and students aged 18 years or over who, in the course of their studies, are obliged to work with radiation sources shall be the same as th
Amendment 112 #
Article 12 – paragraph 2 – subparagraph 1 The
Amendment 113 #
Article 12 – paragraph 2 – subparagraph 2 Amendment 114 #
Article 13 – paragraph 1 1. The limit on the effective dose for public exposure shall be 1 mSv in a year. This limit shall be based on the aggregate doses received as a result of internal and external exposure linked to all regulated practices and existing anthropic exposure situations.
Amendment 115 #
Article 13 – paragraph 1 1.
Amendment 116 #
Article 13 – paragraph 1 a (new) 1a. The competent authority or authorities shall ensure public participation according to national legislation in the process leading to set or to amend dose limits for public exposure.
Amendment 117 #
Article 13 – paragraph 1 b (new) 1b. The public participation shall include reasonable time-frames for the different phases, allowing sufficient time for informing the public and for the public to participate effectively during the decision- making.
Amendment 118 #
Article 13 – paragraph 1 c (new) 1c. Each Member State shall ensure that each legal or natural person has access to a comprehensive review procedure before a court. In addition, each Member State shall ensure that each legal or natural person has access to administrative or judicial procedures by means of which to contest the actions and omissions of the competent authority or authorities.
Amendment 119 #
Article 13 – paragraph 1 d (new) 1d. Each Member State shall ensure that in the decision due account is taken of the outcome of public participation.
Amendment 120 #
Article 13 – paragraph 2 – point a (a) the limit on the equivalent dose for the lens of the eye shall be
Amendment 121 #
Article 15 – paragraph 2 2. Member States shall establish continuous education, training and retraining to
Amendment 122 #
Article 18 – paragraph 1 1. Member States shall ensure that emergency workers and any other persons who might be involved in the organisation of emergency assistance in the event of an emergency are
Amendment 123 #
Article 19 – paragraph 5 a (new) 5a. As regards EU citizens, the information requirements laid down in this Directive shall be met in one of the official languages of the European Union in such a way that each citizen understands the information provided.
Amendment 124 #
Article 20 – paragraph 1 1. Member States shall ensure that new types of practices resulting in exposure to ionising radiation are justified and pre- tested before being approved, and are regularly checked during implementation.
Amendment 125 #
Article 20 – paragraph 1 – subparagraph 1 (new) Member States shall ensure that all stakeholders, in particular the persons likely to be affected by the health impact of the practice, whether in normal operating circumstances or in an emergency, are involved in the decision- making process. That involvement must be arranged sufficiently far ahead of the deadline for a decision so that alternative solutions can be properly studied.
Amendment 126 #
Article 20 – paragraph 1 a (new) 1a. New practices aimed at eliminating an immediate or expected danger shall not require any justification under Article 5 (a).
Amendment 127 #
Article 20 – paragraph 3 3. Existing types of practices shall be reviewed as to their justification whenever new and important evidence about their efficacy or potential consequences is acquired and/or where negative results have been registered.
Amendment 128 #
Article 20 – paragraph 3 3. Existing types of practices shall be reviewed as to their justification whenever new and important evidence about their efficacy or potential consequences is acquired. The Commission and the Member States shall lay down procedures for the revision of the justifications for existing practices at European and national level. The arrangements must in particular ensure that groups or individuals exposed to the dangers of ionising radiation as a result of these practices, and in particular members of the public and workers, can put forward proposals and take part in the decision- making process.
Amendment 129 #
Article 21 – paragraph 3 a (new) 3a. In accordance with the provisions of Article 22, these types of apparatus and products shall be intended for use in controlled environments, both professional and other, outside the public domain.
Amendment 130 #
Article 22 – paragraph 1 Member States shall prohibit
Amendment 131 #
Article 22 – paragraph 1 Member States shall prohibit the deliberate addition of radioactive substances in the production of foodstuffs, toys, personal ornaments and cosmetics and, more generally, in consumer goods, and shall prohibit the import or export of such products. Without prejudice to Directive 1999/2/EC of the European Parliament and of the Council, practices involving the activation of material resulting in an increase in activity in the associated products shall be deemed not to be justified.
Amendment 132 #
Article 23 – paragraph 1 1. Member States shall ensure the identification, by means of surveys or by any other appropriate means, of practices involving non-medical imaging exposure, as set out in Annex IV. They shall assess each year the individual and collective doses associated with each of the practices listed, their impact and their development over time.
Amendment 133 #
Article 23 – paragraph 2 – introductory part 2. Member States shall monitor and ensure that special attention is given to the justification of practices involving non- medical imaging exposure, in particular:
Amendment 134 #
Article 23 – paragraph 3 – point f (f) where the exposure is routinely carried out for security purposes the
Amendment 135 #
Article 23 – paragraph 3 a (new) 3a. Member States shall be responsible for researching, developing and implementing alternative technologies.
Amendment 136 #
Article 24 – paragraph 1 Member States shall ensure the identification of practices involving naturally occurring radioactive material and leading to exposure of workers or members of the public
Amendment 137 #
Article 24 – paragraph 1 Member States shall ensure the identification and publication of practices involving naturally occurring radioactive material
Amendment 138 #
Article 24 – paragraph 1 Member States shall ensure the identification of practices involving naturally occurring radioactive material and leading to exposure of workers or members of the public which cannot be disregarded from a radiation protection point of view. Such identification shall be carried out by means of surveys or by any other appropriate means taking into account, in particular, industrial sectors listed in Annex V.
Amendment 139 #
Article 25 – paragraph 1 – introductory part 1. Member States shall require all practices, including practices identified in accordance with Article 24, to be notified
Amendment 140 #
Article 25 – paragraph 1 – point a Amendment 141 #
Article 25 – paragraph 1 – point a Amendment 142 #
Article 25 – paragraph 1 – point b Amendment 143 #
Article 25 – paragraph 1 – point b Amendment 144 #
Article 25 – paragraph 1 – point c Amendment 145 #
Article 25 – paragraph 1 – point c – point i Amendment 146 #
Article 25 – paragraph 1 – point c – point ii Amendment 147 #
Article 25 – paragraph 1 – point c – point iii Amendment 148 #
Article 25 – paragraph 2 Amendment 149 #
Article 25 – paragraph 2 2. Member States
Amendment 150 #
Article 26 – paragraph 1 1. Member States shall require any notified practice to be subject to regulatory control
source: PE-506.023
2013/03/12
ENVI
144 amendments...
Amendment 151 #
Article 26 – paragraph 2 Amendment 152 #
Article 26 – paragraph 2 2. Notified practices may be exempted from
Amendment 153 #
Article 26 – paragraph 3 Amendment 154 #
Article 26 – paragraph 3 Amendment 155 #
Article 26 – paragraph 4 Amendment 156 #
Article 27 – paragraph 2 – point b Amendment 157 #
Article 27 – paragraph 2 – point e (e) practices in which workers are liable to receive an annual effective dose of more than
Amendment 158 #
Article 27 – paragraph 3 – point e (e) practices in which workers are liable to receive an annual effective dose of more than
Amendment 159 #
Article 27 – paragraph 3 – point f Amendment 160 #
Article 27 – paragraph 3 – point f (f) industries involving naturally occurring radioactive material identified by Member States as required in Article 24, and liable to lead to an effective dose to a member of the public equal to or exceeding 0.
Amendment 161 #
Article 28 – paragraph 5 5. Member States shall require the undertaking to promptly notify the occurrence of any significant event resulting in, or liable to result in the exposure of an individual beyond the operational limits or conditions of operation specified in licensing requirements with regard to occupational or public exposure or as defined by the authorities for medical exposure. Random controls by the authorities should be put in place.
Amendment 162 #
Article 29 Amendment 163 #
Article 29 – title Amendment 164 #
Article 29 – paragraph 1 1. The disposal, recycling or reuse, in closely-monitored sectors, of radioactive materials arising from any authorised practice is subject to authorisation. Recycling or reuse of such materials in the public domain is prohibited.
Amendment 165 #
Article 29 – paragraph 2 Amendment 166 #
Article 29 – paragraph 3 Amendment 167 #
Article 29 – paragraph 4 4. The deliberate dilution of radioactive residues, other than the mixing of materials that takes place in normal operation when radioactivity is not a consideration, shall not be permitted. The competent authority may authorise in specific situations the mixing of radioactive residues containing naturally occurring radioactive material with other materials to promote the reuse and recycling of these materials and to reduce public exposure. The stakeholders shall be involved in the decision-making process and the file justifying the decision shall be made public.
Amendment 168 #
Article 32 – paragraph 1 – introductory part Member States shall require the undertaking to consult an independent radiation protection expert on the examination and testing of protective devices and measuring instruments, in particular for:
Amendment 169 #
Article 33 – paragraph 1 1. For the purposes of radiation protection, arrangements shall be made as regards all workplaces where there is a possibility of exposure to ionising radiation in excess of an effective dose of
Amendment 170 #
Article 33 – paragraph 2 2. For practices involving naturally occurring radioactive material where the effective dose to workers is liable to exceed
Amendment 171 #
Article 33 – paragraph 3 – introductory part 3. For undertakings
Amendment 172 #
Article 33 – paragraph 3 – introductory part 3. For undertakings operating aircraft where the effective dose to the crew from cosmic radiation is liable to exceed
Amendment 173 #
Article 33 – paragraph 3 – point a (a) to assess the exposure of the crew or workers concerned;
Amendment 174 #
Article 33 – paragraph 3 – point b (b) to take into account the assessed exposure when organising working schedules with a view to reducing the doses of highly exposed crew or workers subject to work-related frequent flying;
Amendment 175 #
Article 38 – paragraph 1 – point a (a) category A: exposed workers who are liable to receive an effective dose greater than
Amendment 176 #
Article 39 – paragraph 1 1.
Amendment 177 #
Article 39 – paragraph 3 3. In cases where individual measurements are impossible or inadequate, the individual monitoring shall be based on an estimate arrived at either from individual measurements made on other exposed workers or from the results of the surveillance of the working environment provided for in Article 37. The occurrence of such situations must be documented and justified.
Amendment 178 #
Article 41 – paragraph 3 3. The information referred to in paragraph 1 shall be retained during the period of their working life involving exposure to ionising radiation and afterwards until they have or would have attained the age of
Amendment 179 #
Article 43 – paragraph 1 1. Member States shall require that workers
Amendment 180 #
Article 43 – paragraph 2 2. Member States shall facilitate the exchange among competent authorities, occupational health services, radiation protection experts, or dosimetry services within the Union of all relevant information on the doses previously received by a worker in order to perform the medical examination prior to employment or classification as a category A worker pursuant to Article 44 and to control the further exposure of workers. The system put in place must contain guarantees for exposed workers and must not lead to a management system of employment based on absorbed doses.
Amendment 181 #
Article 44 – paragraph 2 – subparagraph 1 The medical surveillance of
Amendment 182 #
Article 44 – paragraph 2 – subparagraph 2 This medical surveillance shall allow for better protection of workers’ health by ensuring the effectiveness of means of protection and the consistency of working conditions, documenting the professional risks to which they are exposed and alerting employers by submitting proposals to them. It shall not be restricted to allowing for the state of health of workers under surveillance to be ascertained as regards their fitness for the tasks assigned to them. To this end, the occupational health services shall have access to any relevant information they require, including the environmental conditions in the working premises.
Amendment 183 #
Article 44 – paragraph 3 – subparagraph 2 The state of health of all
Amendment 184 #
Article 46 – title Prohibition to employ or classify workers who are unfit
Amendment 185 #
Article 46 – paragraph 1 – subparagraph 1 (new) Member States shall ensure that exposed workers are employed under open-ended contracts. They shall prohibit classification of temporary workers or those employed under fixed-term contracts as category A workers.
Amendment 186 #
Article 47 – paragraph 1 1. A medical record shall be opened for each
Amendment 187 #
Article 47 – paragraph 2 2. The medical record shall include information regarding the nature of the employment, the results of the medical examinations prior to employment or classification as a category A worker, the periodic reviews of health and the record of doses required by Article 41. In the case of doses received by external exposure, the record must include all results, in particular: 1/ the results of whole body counts and analyses of biological samples in order to assess the incorporated activities, including details of the activities, uncertainties and detection limits for each of the radionuclides which may be present; 2/ all the hypotheses, models and coefficients used to assess the dose received and the details and results of the calculations. The assessments shall be compulsory if the dose resulting from the contamination is liable to be in excess of 20 Sv.
Amendment 188 #
Article 50 – paragraph 2 2. The undertaking shall be responsible, either directly or through contractual agreements with the employer of outside workers, for the operational aspects of the radiation protection and working conditions of outside workers.
Amendment 189 #
Article 50 – paragraph 3 – point c a (new) (ca) ensure compliance with labour law, in particular as regards the length of working hours, the weekly rest period, use of derogations for urgent work, etc.
Amendment 190 #
Article 51 – paragraph 1 – point a (a) only category A workers employed under open-ended contracts as defined in Article 38 may be subject to such exposures;
Amendment 191 #
Article 51 – paragraph 1 – point b (b) apprentices, students, women who are or may become pregnant
Amendment 192 #
Article 53 – paragraph 1 1. Within the action plan referred to in Article 103, Member States shall establish national reference levels for indoor radon concentrations. Such reference levels shall not exceed an annual average of
Amendment 193 #
Article 53 – paragraph 2 2. Under the national action plan, Member States shall ensure that radon measurements are carried out, not later than 3 years from the publication of this Directive, in workplaces located on the ground floor or at basement level within
Amendment 194 #
Article 55 – paragraph 3 – point b (b) these individuals are given full inform
Amendment 195 #
Article 55 – paragraph 4 4. The optimisation shall include the selection of equipment, the consistent production of adequate diagnostic information or therapeutic outcomes, the practical aspects of medical exposure procedures, quality assurance- including appropriate staff training, and the assessment and evaluation of patient and staff doses or administered activities, taking into account economic and social factors.
Amendment 196 #
Article 55 – paragraph 5 – point b (b) appropriate guidance is established for the exposure of carers and comforters, as well as for the proper use of the equipment;
Amendment 197 #
Article 56 – paragraph 3 3. The practitioner shall ensure that the patient or legal guardian is provided with
Amendment 198 #
Article 59 – paragraph 2 – point a (a) all medical radiological equipment in use is kept under strict surveillance regarding radiation protection and is disposed off in accordance with the appropriate legislation in force;
Amendment 199 #
Article 62 – paragraph 1 – point a (a) all reasonable steps are taken to minimise the probability and magnitude of accidental or unintended exposures of patients from all medical radiological procedures
Amendment 200 #
Article 65 – paragraph 1 – subparagraph 1 – introductory part The operational protection of members of the public in normal circumstances from notified practices
Amendment 201 #
Article 65 – paragraph 2 – introductory part 2. The competent authority shall establish and publish authorised limits for discharging radioactive effluents. These discharge authorisations shall
Amendment 202 #
Article 65 – paragraph 2 – point a (a) take into account the doses received by members of the public due to existing anthropogenic situations and other planned activities and the results of the optimisation of public exposure;
Amendment 203 #
Article 66 – paragraph 1 1. Member States shall, on the basis of the exposure risk involved, establish a system for the estimation of individual and collective doses to members of the public from planned exposure situations. Account shall be taken of the contribution of existing anthropogenic exposure situations when assessing compliance with dose limits.
Amendment 204 #
Article 66 – paragraph 2 2. The competent authorities shall identify practices where a realistic assessment of doses to members of the public shall be carried out. For other practices Member States may require only a screening assessment with generic data. In both cases, Member States shall ensure that the assessments do not underestimate people’s exposure or the number of people exposed.
Amendment 205 #
Article 66 – paragraph 3 – point a (a) ensure that dose estimates for practices as referred to in Article 65 are made as realistic as possible for representative persons without there being a danger of underestimating risk levels if the exposure parameters are changed;
Amendment 206 #
Article 67 – paragraph 2 2. Member States shall require any undertaking responsible for a nuclear power reactor or reprocessing plant to monitor discharges
Amendment 207 #
Article 68 – paragraph 1 – point a (a) achieving and maintaining
Amendment 208 #
Article 69 – paragraph 1 Member States shall ensure that
Amendment 209 #
Article 69 – paragraph 1 Member States shall ensure that an appropriate environmental monitoring programme is in place for estimating the exposure of members of the public as a result of regulated practices and residual contamination.
Amendment 210 #
Article 70 – paragraph 2 a (new) 2 a. Member States should inform each other immediately about any radiation emergency that has occurred on their territory.
Amendment 211 #
Article 70 – paragraph 3 – point c (c) individuals, to reduce exposure
Amendment 212 #
Article 71 – paragraph 1 1. Member States shall ensure that members of the public likely to be affected in the event of an emergency are given information about the health protection measures applicable to them and about the action they should take in the event of such an emergency. This would concern, at the very least, people living within 50km of an installation at risk.
Amendment 213 #
Article 72 a (new) Article 72a Informing the general public As soon as news of an emergency situation is received, the Member States shall ensure that the general public is informed as soon as possible. All information necessary for an assessment of the situation and its development – in particular weather data and forecasts, air movements and ground deposits, ambient dose rates and contamination levels of critical foodstuffs – must be made public. The relevant authorities shall make public forecasts of the effective dose and equivalent dose for the vital organs, planned and completed interventions, and the expected and actual residual doses.
Amendment 215 #
Article 73 – paragraph 1 – introductory part 1.
Amendment 216 #
Article 73 – paragraph 1 – point a (a)
Amendment 217 #
Article 73 – paragraph 1 – point b (b)
Amendment 218 #
Article 73 – paragraph 1 – point c (c)
Amendment 219 #
Article 73 – paragraph 1 – point d (d)
Amendment 220 #
Article 73 – paragraph 1 – point e (e)
Amendment 221 #
Article 73 – paragraph 1 – point e a (new) (ea) implementation of a medical assistance and health monitoring programme for those affected
Amendment 222 #
Article 73 – paragraph 1 – point e b (new) (eb) assessment of damage to property and physical injury and identification and compensation of victims,
Amendment 223 #
Article 73 – paragraph 1 – point e c (new) (ec) rehousing people likely to receive an effective dose in excess of 1 mSv/year (up to 5 mSv over 5 years), as a result of being contaminated and in spite of the implementation of protective measures, who do not wish to remain where they are.
Amendment 224 #
Article 73 – paragraph 2 Amendment 225 #
Article 74 Amendment 226 #
Article 74 – paragraph 1 – point a (a)
Amendment 228 #
Article 74 – paragraph 1 – point c (c)
Amendment 229 #
Article 74 – paragraph 2 – point a (a) ensure that radon measurements are carried out in single-unit dwellings and in multi-unit basement and ground-floor dwellings within five years (for dwellings in radon-prone areas) or within 10 years (for other dwellings). Checks shall be carried out immediately in new buildings. Member States shall identify existing dwellings exceeding the reference
Amendment 230 #
Article 74 – paragraph 2 – point b (b) ensure that radon measurements are carried out in buildings with public access within radon-prone areas within no more than four years and throughout their territory within 10 years.
Amendment 231 #
Article 74 – paragraph 3 3. Member States shall establish specific building codes to prevent radon ingress from the soil and, as specified in the national action plan, from building materials, and require compliance with such building codes, in particular in radon- prone areas, so as to avoid radon concentrations exceeding the reference level for new buildings. Member States shall establish procedures for approving inspection bodies and for professionals carrying out remedial measures.
Amendment 232 #
Article 75 – paragraph 1 – point a (a) building materials which are identified and listed by the relevant competent authority as being of concern from the radiation protection of public health and environmental protection point of view, taking into account the indicative list of materials set out in Annex XI with regard to their emitted
Amendment 233 #
Article 75 – paragraph 2 – introductory part 2. For identified types of building materials, the industries shall be forbidden by law to plac
Amendment 234 #
Article 75 – paragraph 3 3. The competent authority shall ensure that identified types of building materials are classified, as laid down in Annex VII, on the basis of their
Amendment 235 #
Article 75 – paragraph 4 Amendment 236 #
Article 75 – paragraph 5 Amendment 237 #
Article 75 – paragraph 6 6. Information on identified types of building materials, relevant to the implementation of building codes, including their radionuclide concentrations, activity concentration index and corresponding classification, shall be made available
Amendment 238 #
Article 76 – paragraph 1 Member States shall include, in their legal framework for radiation protection and in particular within the overall system of human health protection, provision for the radiation protection of non-human species in the environment. This legal framework shall introduce environmental criteria aiming to protect populations of vulnerable or representative non-human species in the light of their significance as part of the ecosystem. Where appropriate, types of practices shall be identified for which regulatory control is warranted in order to implement the requirements of this legal framework. To this end, Member States should strengthen research in this area and update the legal framework to take account of any new findings accordingly.
Amendment 239 #
Article 78 – paragraph 1 Member States shall require undertakings to take appropriate technical measures to avoid significant environmental damage in the event of an accidental release or to mitigate the extent of such damage. National authorities should provide for random periodic checks of sites or installations, as well as of the practices used by the undertakings, in order to ensure that such measures are being taken or are in place.
Amendment 240 #
Article 79 – paragraph 1 When establishing environmental monitoring programmes, or requiring such programmes to be carried out, Member States' competent authorities shall include representative non-human species
Amendment 241 #
Article 80 – paragraph 1 1. Member States shall designate the competent authority or authorities to carry out t
Amendment 242 #
Article 80 – paragraph 1 a (new) 1 a. Each Member state shall ensure that public participation is enforced according to national legislation by the competent authority of the member states when dose limits are set or amended.
Amendment 243 #
Article 80 – paragraph 1 b (new) 1 b. The public participation procedures shall include reasonable time-frames for the different phases, allowing sufficient time for informing the public and for the public to prepare and participate effectively during the decision making.
Amendment 244 #
Article 80 – paragraph 1 c (new) 1 c. The competent authority shall ensure that in the decision for dose limits due account is taken of the outcome of public participation.
Amendment 245 #
Article 81 – paragraph 1 – subparagraph 1 – point c (c) radiation protection experts
Amendment 246 #
Article 81 – paragraph 1 – subparagraph 2 Member States shall lay down provisions to ensure the continuity of expertise and independence of these services and experts.
Amendment 247 #
Article 91 – paragraph 1 – subparagraph 1 a (new) Member States shall ensure that licence- holders mark containers and document the practices with high-activity sealed sources in a form not subject to weathering. The documentation shall comprise both the chemical, toxic and radiological composition of the inventory and an indication of whether it is solid, liquid or gaseous.
Amendment 248 #
Article 94 – paragraph 1 Member States shall require that a metal scrap recycling installation promptly notifies the competent authority of any melting of an orphan source and shall require that the contaminated metal not be further processed
Amendment 249 #
Article 98 – paragraph 4 a (new) 4a. Member States shall ensure that they have the necessary financial resources to meet the direct and indirect costs of a nuclear accident, manage the emergency phase, carry out the remedial work, provide compensation for all material and non-material damage, and cope with the adverse impact on the economy, in particular within farming and tourism.
Amendment 251 #
Article 100 – paragraph 1 Amendment 252 #
Article 100 – paragraph 2 – introductory part 2.
Amendment 253 #
Article 100 – paragraph 2 – point a – introductory part (a)
Amendment 254 #
Article 100 – paragraph 2 – point a – point iii (iii) residues from past activities for which the undertaking is no longer legally accountable; no member of the public shall be exposed, as a result of planned exposure situations and residual contamination, to an effective dose exceeding 1 mSv per year;
Amendment 255 #
Article 100 – paragraph 3 Amendment 256 #
Article 101 – paragraph 2 – point a (a) the objectives pursued by the strategy, in particular in terms of residual dose;
Amendment 257 #
Article 101 – paragraph 2 – point b Amendment 258 #
Article 102 – paragraph 3 3. The distribution of residual doses that has resulted from the implementation of a strategy shall be assessed. Further efforts shall be considered with the aim of reducing any exposures that
Amendment 259 #
Article 107 – paragraph 1 – subparagraph 1 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [00.00.0000] at the latest. The provisions laid down in Chapter IX with regard to the protection of the environment shall be transposed by [00.00.0000] at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. The Commission shall report on those communications to the European Parliament.
Amendment 260 #
Article 107 – paragraph 1 – subparagraph 2 a (new) Should a Member State plan to adopt standards stricter than those laid down by this Directive, it shall inform the Commission and the other Member States accordingly.
Amendment 261 #
Article 107 – paragraph 2 2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. A summary of those communications shall be drawn up by the Commission, which shall forward it to the European Parliament.
Amendment 262 #
Annex 1 Amendment 263 #
Annex 3 – heading 1 Placing on the market of apparatus or products emitting ionising radiation
Amendment 264 #
Annex 3 – point A – point 5 a (new) (5a) the radiological risks associated with malfunctioning and accidents likely to affect the apparatus or product.
Amendment 265 #
Annex 3 – point B – point 3 Amendment 266 #
Annex 3 – point B – point 5 (5) whether the apparatus or product is appropriately labelled and suitable documentation is provided to the
Amendment 267 #
Annex 3 – point B a (new) Ba. The competent authorities shall give prior and full information to potential users of apparatuses and products and shall ensure that they are involved in the decision-taking process.
Amendment 268 #
Proposal for a directive Annex 5 – paragraph 1 – point 4 a (new)</ (4 a) Exploration and extraction of natural gas from coal seams requiring the depressurisation of coal seams to release coal bed methane, independently of the quantity extracted, .
Amendment 270 #
Annex 6 – point 1 – paragraph 1 Amendment 271 #
Annex 6 – point 2 Amendment 272 #
Annex 6 – point 2 – paragraph 4 For mixtures of artificial radionuclides, the weighted sum of nuclide-specific activities or concentrations (for various radionuclides contained in the same matrix) divided by the corresponding exemption value shall be less than unity.
Amendment 273 #
Annex 6 – point 2 – paragraph 5 Amendment 274 #
Annex 6 – point 3 – paragraph 1 – introductory part The general criteria for the exemption of notified practices or the clearance of radioactive materials from authorised practices are as follows:
Amendment 275 #
Annex 6 – point 3 – paragraph 1 – point a (
Amendment 276 #
Annex 6 – point 3 – paragraph 2 Amendment 277 #
Annex 6 – point 3 – paragraph 3 Amendment 278 #
Annex 6 – point 3 – paragraph 4 – introductory part Amendment 279 #
Annex 6 – point 3 – paragraph 5 – introductory part For artificial radionuclides and natural radionuclides used for their fissile, fertile or radioactive properties:
Amendment 280 #
Annex 6 – point 3 – paragraph 5 – subparagraph 1 The effective dose expected to be incurred by an individual due to the exempted practice
Amendment 281 #
Annex 6 – point 3 – paragraph 5 – subparagraph 1 a (new) the collective effective dose incurred over a year in which the practice is exercised and/or materials are cleared does not exceed 0.5 man-sievert; and
Amendment 282 #
Annex 6 – point 3 – paragraph 5 – subparagraph 1 b (new) no individual is liable to incur - as a result of the aggregate effect, over a year, of all exempted practices and clearances of materials from authorised practices - an effective dose which exceeds 10 Sv in a year.
Amendment 283 #
Annex 6 – point 3 – paragraph 6 – subparagraph 1 Amendment 284 #
Annex 6 – point 3 – paragraph 6 – subparagraph 1 a (new) The results of dosimetric assessments cannot be adjusted for exposure occurrence probability.
Amendment 285 #
Annex 6 – point 3 – paragraph 6 – subparagraph 2 The assessment of doses to members of the public shall take into account
Amendment 286 #
Annex 6 – section 1 1. Exemption
Amendment 287 #
Annex 6 – section 2 Amendment 288 #
Annex 9 – part B – paragraph 1 – point 1 1.
Amendment 289 #
Annex 9 – part B – paragraph 1 – point 3 3. Predefined
Amendment 290 #
Annex 10 – part A – point 4 4. Appropriate information on action to be taken by the public, and on supplies and equipment which must be available to the public, in the event of an emergency.
Amendment 291 #
Annex 10 – part A – point 4 a (new) 4a. Information on the nature and scale of harm liable to be caused by various emergency situations;
Amendment 292 #
Annex 10 – part A – point 4 b (new) 4b. Information on the terms for damages for personal injury and material loss following an emergency;
Amendment 293 #
Annex 10 – part A – point 4 c (new) 4c. Information on how to store and use stable iodine tablets provided by the competent authorities.
Amendment 294 #
Annex 10 – part B – point 1 – point a (a) information on the type of emergency which has occurred and
source: PE-506.142
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History
(these mark the time of scraping, not the official date of the change)
| activities/9/date | changed |
Old
2013-07-02New
2013-09-10 |