BETA

169 Amendments of Michèle RIVASI related to 2011/0254(NLE)

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’.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
Amendment 20 #

Recital 8
(8) A new methodology introduced by ICRP to calculate doses based on the latest knowledge on radiation risks should also be taken into account in this Directive.deleted
2013/02/27
Committee: ENVI
Amendment 21 #

Recital 9
(9) The current annual dose limits for occupational and public exposure are maintained. However, there should be no further need for averaging over five years, except in special circumstances specified in national legislation.deleted
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
Amendment 26 #

Recital 17
(17) In the medical area, important technological and scientific developments have led tothere has been a notable increase in the exposure of patients. In this respect, the Directive should emphasise the need for justification of medical exposure, including the exposure of asymptomatic individuals, and should strengthen the requirements concerning information to be provided to patients, the recording and reporting of doses from medical procedures, the use of diagnostic reference levels and the availability of dose-indicating devices.
2013/02/27
Committee: ENVI
Amendment 27 #

Recital 21
(21) There is benefit in having the same activity concentration values both for the exemption of practices from regulatory control and for the clearance of materials from regulated practices. After a comprehensive review, it has been concluded that the values recommended in IAEA document RS-G-1.7 can be used both as default exemption values, replacing the activity concentration values laid down in Annex I to Directive 96/29/Euratom, and as general clearance levels, replacing the values recommended by the Commission in Radiation Protection No 122.deleted
2013/02/27
Committee: ENVI
Amendment 29 #

Recital 22
(22) Member States may grant specific exemption from authorisation for certain practices involving activities above the exemption values.deleted
2013/02/27
Committee: ENVI
Amendment 31 #

Recital 23
(23) Specific clearance levels, above the default values for exemption and clearance, as well as corresponding Community guidance remain important tools for the management of large volumes of materials arising from the dismantling of licensed facilities.deleted
2013/02/27
Committee: ENVI
Amendment 32 #

Recital 25
(25) With regard to the management of emergency exposure situations, the current approach based on intervention levels should be replaccomplemented by a more comprehensive system comprising threat analysis, an overall emergency management system, emergency response plans for identified threats, and pre- planned strategies for the management of each postulated event.
2013/02/27
Committee: ENVI
Amendment 33 #

Recital 26
(26) The introduction of reference levels in emergency and existing exposure situations allows for the protection of the individual as well as consideration of other societal criteria in the same way as dose limits and dose constraints for planned exposure situations.deleted
2013/02/27
Committee: ENVI
Amendment 35 #

Recital 28
(28) The International Atomic Energy Agency together with the World Health Organisation, the Food and Agricultural Organisation, the International Labour Organisation, the Nuclear Energy Agency of the Organisation for Economic Cooperation and Development, and the Pan-American Health Organisation are revising the International Basic Safety Standards in the light of the ICRP’s new Publication 103.deleted
2013/02/27
Committee: ENVI
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 their uniform implementation byguaranteeing a uniform threshold level of protection in the Member States.
2013/02/27
Committee: ENVI
Amendment 46 #

Article 4 – paragraph 1 – point 3
(3) Emergency means a non-routine situation orsituation resulting from an accident, malfunction, malicious act or conflict or from any other non- routine event that necessitates prompt action primarily to mitigate a hazard or adverse consequences for human health and safety, quality of life, property or the environment. This includes nuclear and radiological emergencies;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
Amendment 52 #

Article 4 – paragraph 1 – point 14
(14) Existing natural exposure situation means an exposure situ situation of exposure to natural sources of ionising radiation that already exists when a decision on its control has to be taken and which does not call or no longer calls for urgent measures to be taken;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
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. This includee definition used in ICRP Publication 103 delimits detriment as loss arising from tissue effects, cancer and severe genetic disorder (equivalent to a terminal illness);
2013/02/27
Committee: ENVI
Amendment 61 #

Article 4 – paragraph 1 – point 30
(30) Outside worker means any exposed worker of category A who is not employed by the undertaking responsible for the supervised and controlled areas, but performs activities in these areas, including trainees, apprentices and students;
2013/02/27
Committee: ENVI
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 it is judged inappropriate to allow exposures to occurthe authorities must implement protective or remedial measures, and below which optimisation of protection shouldmust continue to be implementedapply;
2013/02/27
Committee: ENVI
Amendment 64 #

Article 4 – paragraph 1 – point 35
(35) Exposed worker means a person, either self-employed or working under an employer, who is subject to exposure at work carried out within a practice regulated by this Directive and who is liable to receiveliable in the context of his or her work to receive an effective dose greater than 0.2 mSv or an equivalent doses exceeding one or other of the dosf the limits for public exposure;
2013/02/27
Committee: ENVI
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 560 years following intake for adults and up to age 780 for children. The unit for committed effective dose is the sievert.
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
Amendment 72 #

Article 4 – paragraph 1 – point 57
(57) ConsumerExempted product means a device or manufactured item into which radionuclides have deliberately been incorporated or produced by activation, or which generates ionising radiation, and which can be sold or made available to members of the publicinformed professionals without special surveillance or regulatory control after sale;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
Amendment 76 #

Article 4 – paragraph 1 – point 71
(71) RHighly radon-prone area means a geographic area or administrative region defined on the basis of surveys indicating that the percentage of dwellings expected to exceed the national reference level is significantly higher than in other parts of the country;
2013/02/27
Committee: ENVI
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 and, in the latter case, implies a probability rather than a certainty of appearance;
2013/02/27
Committee: ENVI
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;
2013/02/27
Committee: ENVI
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, or where a decision has been taken not to implement any protective measures;
2013/02/27
Committee: ENVI
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 560 years is assumed for adults and up to age 780 for children. The unit for committed equivalent dose is the sievert.;
2013/02/27
Committee: ENVI
Amendment 84 #

Article 4 – paragraph 1 – point 97
(97) Normal exposureExposure in normal situations means exposure expected to occur under the normal operating conditions of a facility or activity (including maintenance, inspection, decommissioning), including possible minor mishaps that can be kept under control, i.e. during normal operation and anticipated operational occurrences;
2013/02/27
Committee: ENVI
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 and, dose limitation and reparation of damage:
2013/02/27
Committee: ENVI
Amendment 88 #

Article 5 – paragraph 1 – point a
(a) justification: decisions introducing or altering a radiation source, an exposure pathway or actual exposureswhich increase individuals’ exposure to ionising radiation shall be justified in the sense that such decisions shall be taken with the intent to ensure that the individual or societal benefit resulting from them offsets the detriment that they may cause;
2013/02/27
Committee: ENVI
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, whereby o. The individuals exposed or their representatives must be involved in assessing what is ‘reasonably achievable’ taking into account economic and societal factors. Optimisation of the protection of individuals undergoing medical exposure shall be commensurate with the medical purpose of the exposure as described in Article 55. This principle shall be applied in terms of effective dose as well as organ doses, as a precautionary measure to allow for uncertainties as to health detriment below the threshold, for deterministic effects; ;
2013/02/27
Committee: ENVI
Amendment 92 #

Article 5 – paragraph 1 – point c
(c) dose limitation: in planned exposure situations, tthe sum of doses received by a member of the public from all regulated radiation sources and all existing anthropic exposure situations must not exceed the dose limits laid down for public exposure. The sum of doses to an individualexposed worker from all regulated radiation sources may not exceed the dose limits laid down for occupational exposure or public exposure. Dose limits shall not apply to medical exposures.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
Amendment 101 #

Article 8 – paragraph 1
1. Reference levels shall be established for emergency and existing exposure situations as a level of effective dose or organ dose above which it is judged inappropriate to allow exposures in emergency or existing exposure situationssituations involving exposure to natural radiation; they shall correspond to a level of effective dose or organ dose above which protective measures must be taken to limit the risk incurred by the persons exposed.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
Amendment 105 #

Article 8 – paragraph 3
3. Optimisation of protection shall give priority to exposures above the refLevels of intervention shall be laid down for the various countermeasures applicable in emergence level. The choices of reference levels shall take into account both radiological protection requirements and societal criteriay exposure situations; they shall correspond to a level of effective dose or organ dose above which protective measures must be taken to limit the risk incurred by the persons exposed.
2013/02/27
Committee: ENVI
Amendment 106 #

Article 8 – paragraph 4
4. The choice of reference levels for the effective dose shall take into account the three bands of reference levels set out in point 1 of Annex Ivalues corresponding to effective dose and equivalent organ dose set by the Member States for the reference and intervention levels shall be communicated to the Commission and published. Member States shall involve stakeholders in the process of setting these values.
2013/02/27
Committee: ENVI
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 206 mSv in any single year. On a transitional basis, for a maximum period of five years from the entry into force of this Directive, Member States may set higher exposure limits, provided that the dose does not exceed 60 mSv in total over the five consecutive years and 15 mSv in any one of the five years. However, in special circumstances or for certain exposure situations specified in national legislation, a higher effectivexternal irradiation dose of up to 520 mSv per year may be authorised in a single year, provided that the average dose over any five consecutive years does not exceed 206 mSv per year.
2013/02/27
Committee: ENVI
Amendment 108 #

Article 10 – paragraph 2 – point a
(a) the limit on the equivalent dose for the lens of the eye shall be 2015 mSv in a year or, where applicable, the same value as specified for the limit on effective dose;
2013/02/27
Committee: ENVI
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 comparable withat least equal to that provided for members of the public. The employment conditions for the pregnant woman shall be such that the equivalent dose to the unborn child is as low as reasonably achievable and unlikely to exceed 1 mSv during at least the remainder of the pregnancypregnant woman shall not therefore be employed in work which involves a risk of intake of radionuclides or of external exposure. At all events, the equivalent dose to the unborn child received as a result of its mother’s occupational exposure between the start of pregnancy and birth must be less than 0.1 mSv.
2013/02/27
Committee: ENVI
Amendment 110 #

Article 11 – paragraph 2
2. As soon as a breastfeeding woman informs the undertaking of her conditionintention to breastfeed, she shall not be employed in work involving a significant risk of intake of radionuclides.
2013/02/27
Committee: ENVI
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 the dose limits for occupational exposureose for category B workers laid down in Article 1038.
2013/02/27
Committee: ENVI
Amendment 112 #

Article 12 – paragraph 2 – subparagraph 1
The limit on the effective dose for apprentices aged between 16 and 18 years and for students aged between 16 andose 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 6 mSv per yearthe same as those for members of the public laid down in Article 13.
2013/02/27
Committee: ENVI
Amendment 113 #

Article 12 – paragraph 2 – subparagraph 2
In addition to limits of effective dose laid down in the first subparagraph, the following limits on equivalent dose shall apply: (a) the limit on the equivalent dose for the lens of the eye shall be 20 mSv in a year; (b) the limit on the equivalent dose for the skin shall be 150 mSv in a year, averaged over any area of 1 cm², regardless of the area exposed; (c) the limit on the equivalent dose for the hands, forearms, feet and ankles shall be 150 mSv in a year.deleted
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
Amendment 120 #

Article 13 – paragraph 2 – point a
(a) the limit on the equivalent dose for the lens of the eye shall be 153 mSv in a year;
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
Amendment 135 #

Article 23 – paragraph 3 a (new)
3a. Member States shall be responsible for researching, developing and implementing alternative technologies.
2013/02/27
Committee: ENVI
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.
2013/02/27
Committee: ENVI
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, except for justified practices involving the following:.
2013/02/27
Committee: ENVI
Amendment 141 #

Article 25 – paragraph 1 – point a
(a) materials containing radioactive substances where the quantities of the activity involved do not exceed in total the exemption values set out in Annex VI or higher values that, for specific applications, are authorised by the competent authorities and satisfy the general exemption and clearance criteria set out in Annex VI; ordeleted
2013/02/27
Committee: ENVI
Amendment 143 #

Article 25 – paragraph 1 – point b
(b) materials containing radioactive substances, provided that the concentrations of activity per unit mass do not exceed the exemption values set out in Table A of Annex VI, or higher values that, for specific applications, are authorised by the competent authorities and satisfy the general exemption and clearance criteria set out in Annex VI; ordeleted
2013/02/27
Committee: ENVI
Amendment 144 #

Article 25 – paragraph 1 – point c
(c) any cathode ray tube intended for the display of visual images, or other electrical apparatus operating at a potential difference not exceeding 30 kV, or any other apparatus or product which is of a type approved by the competent authorities of the Member State, provided that: (i) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSvh– 1 at a distance of 0.1 m from any accessible surface of the apparatus; and (ii) if it contains radioactive substances, these substances are embedded in a capsule or fixed to a solid holder; and (iii) conditions for disposal have been specified by the competent authorities.deleted
2013/02/27
Committee: ENVI
Amendment 145 #

Article 25 – paragraph 1 – point c – point i
(i) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSvh– 1 at a distance of 0.1 m from any accessible surface of the apparatus; etdeleted
2013/02/27
Committee: ENVI
Amendment 146 #

Article 25 – paragraph 1 – point c – point ii
(ii) if it contains radioactive substances, these substances are embedded in a capsule or fixed to a solid holder; andeleted
2013/02/27
Committee: ENVI
Amendment 147 #

Article 25 – paragraph 1 – point c – point iii
(iii) conditions for disposal have been specified by the competent authorities.deleted
2013/02/27
Committee: ENVI
Amendment 149 #

Article 25 – paragraph 2
2. Member States may exempt further types of practices from the notification requirement subject to compliance with the general exemption criteria established in point 3 of Annex VI, or in such cases where an assessmentshall specify the information which the undertaking is required to provide in order to enable the competent authority to assess the levels of exposure of members of the public and workers and the radiological risks, in normal and emergency situations. On that basis, and drawing, where appropriate, ofn the optimisation of protection shows that exemption is the best optionfindings of additional investigations, the competent authority shall determine which administrative arrangements are applicable and what regulatory control resources are required.
2013/02/27
Committee: ENVI
Amendment 152 #

Article 26 – paragraph 2
2. Notified practices may be exempted from authorisation. the requirements of this Directive governing the protection of human beings and the environment by means of a regulatory decision on the basis of the information provided in conjunction with the notification of the practice and in line with general exemption criteria set out in Annex VI. A justified practice using any cathode ray tube intended for the display of visual images, or other electrical apparatus operating at a potential difference not exceeding 30 kV, or any other apparatus or product which is of a type approved by the competent authorities of the Member State may also be exempted, provided that: (i) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSvh–1 at a distance of 0.1 m from any accessible surface of the apparatus; and (ii) if it contains radioactive substances, these substances are embedded in a capsule or fixed to a solid holder; and (iii) conditions for disposal have been specified by the competent authorities; and (iv) in the event of malfunction or accident, no human being is likely to be exposed to a dose exceeding 10 µSv.
2013/03/12
Committee: ENVI
Amendment 154 #

Article 26 – paragraph 3
3. In the case of moderate amounts of material as specified by Member States, the activity concentration values laid down in Annex VI, Table B, column 2, may be used for the purpose of exemption.deleted
2013/03/12
Committee: ENVI
Amendment 156 #

Article 27 – paragraph 2 – point b
(b) the deliberate addition of radioactive substances in the production and manufacture of consumer products or other products, including medicinal products, and the import or export of such products;deleted
2013/03/12
Committee: ENVI
Amendment 157 #

Article 27 – paragraph 2 – point e
(e) practices in which workers are liable to receive an annual effective dose of more than 62 mSv in normal operation and under normal working conditions;
2013/03/12
Committee: ENVI
Amendment 158 #

Article 27 – paragraph 3 – point e
(e) practices in which workers are liable to receive an annual effective dose of more than 10.2 mSv in normal operation and under normal working conditions;
2013/03/12
Committee: ENVI
Amendment 159 #

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 0.3 mSv per year.deleted
2013/03/12
Committee: ENVI
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 0.31 mSv per year.
2013/03/12
Committee: ENVI
Amendment 163 #

Article 29 – title
ReleManagement of radioactive waste from regulatory controlauthorised practices
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 165 #

Article 29 – paragraph 2
2. The materials for disposal, recycling or reuse may be released from the requirements of this Directive provided that the concentrations of activity per unit mass: (a) do not exceed the values set out in Annex VI, Table A, part 1; or (b) comply with specific clearance levels and associated requirements for specific materials or for materials originating from specific types of practices; these specific clearance levels, in addition to the general clearance levels referred to in point (a), shall be established by the national competent authority following the general exemption criteria set out in Annex VI, point 3 and taking into account technical guidance provided by the Community.deleted
2013/03/12
Committee: ENVI
Amendment 166 #

Article 29 – paragraph 3
3. For the clearance of materials containing naturally occurring radionuclides, the values for the concentrations of activity per unit mass shall be those laid down in Annex VI, Table A, part 2. Nevertheless the following requirements shall apply: (a) for practices subject to licensing as specified in Article 27(3)(f), the dose criteria for clearance of naturally occurring radionuclides shall be complied with; (b) for other licensed practices, in particular those forming part of the nuclear fuel cycle, the clearance levels shall comply with the dose criteria for clearance of materials containing artificial radionuclides; (c) for authorised practices subject to notification as specified under Article 25(3), the corresponding requirements for the placing on the market of building materials shall be complied with.deleted
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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 10.2 mSv per year or an equivalent dose of 153 mSv per year for the lens of the eye or 50 mSv per year for the skin and extremities. Such arrangements shall be appropriate to the nature of the installations and sources and to the magnitude and nature of the risks.
2013/03/12
Committee: ENVI
Amendment 170 #

Article 33 – paragraph 2
2. For practices involving naturally occurring radioactive material where the effective dose to workers is liable to exceed 60.2 mSv per year, the requirements set out in this Chapter shall apply. Where the effective dose to workers is less than or equal to 6 mSv per year the competent authorities shall at least require undertakings to keep exposures under review, taking into account the potential for protection to be improved or the potential for doses to increase over time or as a result of changes in the process or the work arrangements.
2013/03/12
Committee: ENVI
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 60.2 mSv per year, the relevant requirements set out in this Chapter shall apply. Where the effective dose to the crew is less than or equal to 6 mSv per year and liable to be above 1 mSv per year, the competent authorities shall at least require undertakings to keep exposures under review, taking into account the potential for doses to change over time or as a result of changes in the work arrangements. The undertakings shall take appropriate measures, in particular:
2013/03/12
Committee: ENVI
Amendment 175 #

Article 38 – paragraph 1 – point a
(a) category A: exposed workers who are liable to receive an effective dose greater than 62 mSv per year or an equivalent dose greater than 15 mSv per year for the lens of the eye or greater than 150 mSv per year for skin and extremities;
2013/03/12
Committee: ENVI
Amendment 176 #

Article 39 – paragraph 1
1. Category AExposed workers shall be systematically monitored based on individual measurements performed by a dosimetry service. In cases where category Aexposed workers are liable to receive significant internal exposure or significant exposure of the lens of the eye or extremities an adequate system for monitoring shall be set up. The competent authority shall give special attention to the identification of such workers.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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 7590 years, but in any case not less than 350 years after termination of the work involving exposure. Member States shall ensure that the information needed to assess the health effects of radiation is collected, recorded and stored. They shall ensure that the anonymity and rights of workers and their dependants are safeguarded.
2013/03/12
Committee: ENVI
Amendment 179 #

Article 43 – paragraph 1
1. Member States shall require that workers to have access at their request toreceive the results of their individual monitoring, including the results of measurements which may have been used in estimating these results, or to the results of the assessment of their doses made as a result of workplace measurements.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 181 #

Article 44 – paragraph 2 – subparagraph 1
The medical surveillance of category Aexposed workers shall be the responsibility of occupational health services.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 183 #

Article 44 – paragraph 3 – subparagraph 2
The state of health of all category Aexposed workers shall be reviewed at least once a year, in order to determine whether they remain fit to perform their duties. The nature of these reviews, which can be performed as many times as the occupational health services consider necessary, shall depend on the type of work and on the individual worker’s state of health.
2013/03/12
Committee: ENVI
Amendment 184 #

Article 46 – title
Prohibition to employ or classify workers who are unfit worker are holders of fixed-term contracts
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 186 #

Article 47 – paragraph 1
1. A medical record shall be opened for each category Aexposed worker and kept up to date so long as the worker remains a worker in that category. Thereafter, it shall be retained until the individual has or would have attained the age of 7590 years, but in any case not less than 350 years after termination of the work involving exposure to ionising radiation.
2013/03/12
Committee: ENVI
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 µSv.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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;
2013/03/12
Committee: ENVI
Amendment 191 #

Article 51 – paragraph 1 – point b
(b) apprentices, students, women who are or may become pregnant women, and, if there is a risk of intake of radionuclides, breastfeeding women shall be excluded from such exposures;
2013/03/12
Committee: ENVI
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 1 0200 Bq m- 3 for workplaces.
2013/03/12
Committee: ENVI
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 radon-pronehigh radon risk areas and in specific types of workplaces as identified in the action plan. Workplaces located on the ground floor or at basement level must be monitored throughout the Member States within 6 years of the publication of this Directive.
2013/03/12
Committee: ENVI
Amendment 200 #

Article 65 – paragraph 1 – subparagraph 1 – introductory part
The operational protection of members of the public in normal circumstances from notified practices subject to licensing shall include all arrangements and surveys for detecting and eliminating factors which, in the course of any operation involving exposure to ionising radiation, are liable to create a risk of exposure for members of the public which cannot be disregarded from the radiation protection point of view. Such protection shall include the following tasks:
2013/03/12
Committee: ENVI
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;
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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;
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 214 #

Chapter 8 – section 3 – title
Existing ANTHROPOGENIC exposure situations
2013/03/12
Committee: ENVI
Amendment 215 #

Article 73 – paragraph 1 – introductory part
1. Strategies for managing contaminated areas shall include, where applicable, the followingFollowing an emergency, and in particular a nuclear accident, Member States shall ensure:
2013/03/12
Committee: ENVI
Amendment 216 #

Article 73 – paragraph 1 – point a
(a) delineation of the affected regions and identification of the affected members of the publicradiological profiling of the contaminated regions and in particular, the production of maps based on soil contamination and dose rates, marking prohibited areas and areas with restricted access;
2013/03/12
Committee: ENVI
Amendment 217 #

Article 73 – paragraph 1 – point b
(b) consideration of the need for and extent of protassessment of effective doses and doses to vital organs recteive measures applied tod during the emergency phase by all those affected regions and members of the publicand particularly by critical groups;
2013/03/12
Committee: ENVI
Amendment 218 #

Article 73 – paragraph 1 – point c
(c) consideration of the need to prevent or control access to the affected regions, or to impose restrictions on living conditions in these regionassessment of provisional residual doses following implementation of protective measures, in particular for people still living in contaminated areas;
2013/03/12
Committee: ENVI
Amendment 219 #

Article 73 – paragraph 1 – point d
(d) assessment of the exposure of different groups in the population and assessment of the means available to individuals for controlling their ownstudy and implementation of protective and remedial measures aimed at reducing people’s levels of residual exposure;
2013/03/12
Committee: ENVI
Amendment 220 #

Article 73 – paragraph 1 – point e
(e) objectimonitoring of contamination levels and long-term goals pursued by the strategy and corresponding reference levelin foodstuffs, eliminating products at risk and provision of uncontaminated food to critical groups.
2013/03/12
Committee: ENVI
Amendment 221 #

Article 73 – paragraph 1 – point e a (new)
(ea) implementation of a medical assistance and health monitoring programme for those affected
2013/03/12
Committee: ENVI
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,
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 224 #

Article 73 – paragraph 2
2. For areas with long-lasting residual contamination in which the Member State has decided to allow habitation and the resumption of social and economic activities, Member States shall ensure, in consultation with stakeholders, that arrangements are in place, as necessary, for the ongoing control of exposure with the aim of establishing living conditions that can be considered as normal, including: (a) establishment of reference levels consistent with day-to-day life; (b) establishment of an infrastructure to support continuing self-help protective measures in the affected areas, such as information provision, advice and monitoring.deleted
2013/03/12
Committee: ENVI
Amendment 226 #

Article 74 – paragraph 1 – point a
(a) 2100 Bq m-3 for new dwellings and new buildings with public access;
2013/03/12
Committee: ENVI
Amendment 227 #

Article 74 – paragraph 1 – point b
(b) 3200 Bq m-3 for existing dwellings;
2013/03/12
Committee: ENVI
Amendment 228 #

Article 74 – paragraph 1 – point c
(c) 3200 Bq m-3 for existing buildings with public access. In specific cases where the occupancy time is low, a reference level of up to 1 0nd there is no alternative solution, a maximum level of activity of 500 Bq m-3 can be set.
2013/03/12
Committee: ENVI
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 level and toand encourage radon- reducing measures in existing dwellings where the reference levels are exceeded; . Member States shall make it compulsory to conduct checks on radon levels and, where necessary, take remedial measures in rental dwellings. Member States shall make it compulsory, in connection with property transactions, to produce results of checks on radon levels;
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 250 #

Article 100 – title
Programmes on existing anthropic exposure situations
2013/03/12
Committee: ENVI
Amendment 251 #

Article 100 – paragraph 1
1. Member States shall ensure that programmes are established to identify and evaluate existing exposure situations and to determine which occupational and public exposures are of concern from a radiation protection point of view.deleted
2013/03/12
Committee: ENVI
Amendment 252 #

Article 100 – paragraph 2 – introductory part
2. The requirements for existing exposure situations shall apply to: Member States shall ensure that programmes are established to identify existing exposure situations attributable to anthropic activities and to assess their dosimetric impact in terms of individual and collective effective dose. This shall cover exposure due to contamination of areas by residual radioactive material from:
2013/03/12
Committee: ENVI
Amendment 253 #

Article 100 – paragraph 2 – point a – introductory part
(a) exposure due to contamination of areasMember States shall ensure that programmes are established to identify existing exposure situations attributable to anthropic activities and to assess their dosimetric impact in terms of individual and collective doses. This shall cover exposure due to contamination of areas and products, in particular foodstuffs, by residual radioactive material from:
2013/03/12
Committee: ENVI
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;
2013/03/12
Committee: ENVI
Amendment 255 #

Article 100 – paragraph 3
3. Member States may decide, having regard to the general principle of justification, that an existing exposure situation warrants no consideration of protective measures.deleted
2013/03/12
Committee: ENVI
Amendment 256 #

Article 101 – paragraph 2 – point a
(a) the objectives pursued by the strategy, in particular in terms of residual dose;
2013/03/12
Committee: ENVI
Amendment 257 #

Article 101 – paragraph 2 – point b
(b) appropriate reference levels, taking into account the bands of reference levels laid down in Annex I.deleted
2013/03/12
Committee: ENVI
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 are still above the reference levelexceed dosimetric targets.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 262 #

Annex 1
1. The optimisation of public exposures in emergency and existing exposure situations shall be based on a reference level to be established within the following bands, expressed in mSv effective dose (acute or annual): (a) greater than 20 and less or equal to 100 (b) greater than 1 and less or equal to 20 (c) 1 or less. The choice of the reference level shall fulfil the conditions set out in points 2-5. 2. Without prejudice to reference levels set for organ doses, reference levels expressed in effective doses shall be set in the range of 1 to 20 mSv per year for existing exposure situations and 20 to 100 mSv for emergency exposure situations. 3. In specific situations, a reference level below ranges referred to in point 1 may be considered, in particular: (a) a reference level below 20 mSv may be set in an emergency exposure situation where appropriate protection can be provided without causing a disproportionate detriment from the corresponding countermeasures or an excessive cost; (b) a reference level below 1 mSv per year may be set, where appropriate, in an existing exposure situation for specific source-related exposures or pathways of exposure. 4. For the transition from an emergency exposure situation to an existing exposure situation, appropriate reference levels shall be set, in particular upon the termination of long-term countermeasures such as relocation. 5. The reference levels set shall take account of the features of prevailing situations as well as societal criteria, which may include the following: – (a) for exposures below 1 mSv or 1 mSv per year, general information on the level of exposure, without specific consideration of individual exposures; – (b) in the range up to 20 mSv or 20 mSv per year, specific information to enable individuals to manage their own exposure, if possible; – (c) in the range up to 100 mSv or 100 mSv per year, assessment of individual doses and specific information on radiation risks and on available actions to reduce exposures.ANNEX I deleted Bands of reference levels for public exposure
2013/03/12
Committee: ENVI
Amendment 263 #

Annex 3 – heading 1
Placing on the market of apparatus or products emitting ionising radiation
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 265 #

Annex 3 – point B – point 3
(3) in the case of a consumer product, whether the product is adequately designed to meet the exemption criteria and does not necessitate specific precautions for disposal when no longer in use;deleted
2013/03/12
Committee: ENVI
Amendment 266 #

Annex 3 – point B – point 5
(5) whether the apparatus or product is appropriately labelled and suitable documentation is provided to the customer with instructions for proper use and disposal.
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 270 #

Annex 6 – point 1 – paragraph 1
PNotified practices may be exempted from requirements of this Directive either directly, on the basis of compliance with numerical exemption criteria (activity values (Bq) or concentration values (Bq g-1)) laid down in Section 2, or through a regulatory decision, on the basis of the information provided in conjunction with the notification of the practice and in line with general exemption criteria set out in Section 3, to exempt the practice from further requirements.
2013/03/12
Committee: ENVI
Amendment 271 #

Annex 6 – point 2
2. Exemption and clearance values The total activity values (Bq) for exemption apply to the total activity involved in a practice and are laid down in column 3 of Table B for artificial radionuclides and for some naturally occurring radionuclides used in consumer products. For other practices involving naturally occurring radionuclides, such values are in general not applicable. The exempt activity concentration values (Bq g-1) for the materials involved in the practice are laid down in Table A, Part 1 for artificial radionuclides and in Table A, Part 2 for naturally occurring radionuclides. The values in Table A1, Part 1 are given for individual radionuclides, where applicable including short-lived radionuclides in equilibrium with the parent nuclide as indicated. The values in Table A, Part 2 apply to all radionuclides in the decay chain of U-238 or Th-232, but for segments of the decay chain which are not in equilibrium with the parent radionuclide higher values may be applied. The concentration values in Table A, Part 1 or in Table A, Part 2 also apply to the clearance of solid materials for re-use, recycling, conventional disposal or incineration. Higher values may be defined for specific materials or specific pathways, taking Community guidance into account, including where appropriate additional requirements in terms of surface activity or monitoring requirements. 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. Where appropriate this condition can be verified on the basis of best estimates of the composition of the radionuclide mix. The values in Table A, Part 2 apply individually to each parent nuclide. Some elements in the decay chain, e.g. Po-210 or Pb-210, may warrant the use of values significantly higher, by up to two orders of magnitude, taking Community guidance into account. The values in Table A, Part 2 may not be used to exempt the incorporation into building materials of residues from industries processing naturally occurring radioactive material. Such recycling of residues from identified industries shall be managed as an authorised practice or be exempted on the basis of the general exemption criteria laid down in Section 3. For this purpose, compliance of the sum of radionuclide concentrations with the appropriate value of the radionuclide index I for building materials as defined in Annex VII shall be verified. The values laid down in Table B, column 3, apply to the total inventory of radioactive substances held by a person or undertaking as part of a specific practice at any point in time. However, the regulatory authority may apply these values to smaller entities or packages, for instance to exempt the transport or storage of exempted consumer products, if the general exemption criteria in Section 3 are satisfied.deleted
2013/03/12
Committee: ENVI
Amendment 273 #

Annex 6 – point 2 – paragraph 5
The values in Table A, Part 2 may not be used to exempt the incorporation into building materials of residues from industries processing naturally occurring radioactive material. Such recycling of residues from identified industries shall be managed as an authorised practice or be exempted on the basis of the general exemption criteria laid down in Section 3. For this purpose, compliance of the sum of radionuclide concentrations with the appropriate value of the radionuclide index I for building materials as defined in Annex VII shall be verified.deleted
2013/03/12
Committee: ENVI
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:
2013/03/12
Committee: ENVI
Amendment 275 #

Annex 6 – point 3 – paragraph 1 – point a
(ai) the radiological risks to individuals caused by the practice or by the release of radioactive substances are sufficiently low as to be of no regulatory concern; and (ii) the radiological risks to the population as a whole caused by the exempted practice or the clearance of radioactive materials are sufficiently low as to be of no regulatory concern; and (iii) the radiological risks to individuals and the population as a whole caused by the aggregate effect of all exemption decisions and clearances are sufficiently low as to be of no regulatory concern; and
2013/03/12
Committee: ENVI
Amendment 276 #

Annex 6 – point 3 – paragraph 2
Practices involving small amounts of radioactive substances or low activity concentrations, comparable to the exemption values laid down in Tables A, Part 1 or B, and in general all practices involving naturally occurring radionuclides are deemed to fulfil criterion (c).deleted
2013/03/12
Committee: ENVI
Amendment 277 #

Annex 6 – point 3 – paragraph 3
Practices involving amounts of radioactive substances or activity concentrations below the exemption values laid down in Table A, Part 1 or Table B automatically comply with criterion (a) without further consideration. This is also the case for the values in Table A, Part 2, with the exception of the recycling of residues in building materials or the case of specific exposure pathways, for instance drinking water.deleted
2013/03/12
Committee: ENVI
Amendment 278 #

Annex 6 – point 3 – paragraph 4 – introductory part
For notified practices not complying with these values, an assessment shall be made of the resulting exposure of individuals. For compliance with the general criterion (a), it shall be demonstrated that the following dose criteria are met in all feasible circumstances:
2013/03/12
Committee: ENVI
Amendment 279 #

Annex 6 – point 3 – paragraph 5 – introductory part
For artificial radionuclides and natural radionuclides used for their fissile, fertile or radioactive properties:
2013/03/12
Committee: ENVI
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 is of the order of 10 µSv or lessor to the clearance of radioactive materials from an authorised practice does not exceed 5 µSv in a year.; and
2013/03/12
Committee: ENVI
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
2013/03/12
Committee: ENVI
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 µSv in a year.
2013/03/12
Committee: ENVI
Amendment 283 #

Annex 6 – point 3 – paragraph 6 – subparagraph 1
Th(i) The effective dose increment, allowing for to the prevailing background radiation from natural radiation sources, which is liable to be incurred by an individual due to the exempted practice is of the order of 300 µSv or less in a year for members of the public and less than 1 mSv for workersor to the clearance of radioactive materials does not exceed 20 µSv in a year; and (ii) the collective dose incurred over a year in which the practice is exercised does not exceed 1 man-sievert; and (iii) no individual is liable to incur - as a result of the aggregate effect of exempted practices and releases of materials from authorised practices - an effective dose which exceeds 100 µSv in a year.
2013/03/12
Committee: ENVI
Amendment 284 #

Annex 6 – point 3 – paragraph 6 – subparagraph 1 a (new)
The results of dosimetric assessments cannot be adjusted for exposure occurrence probability.
2013/03/12
Committee: ENVI
Amendment 285 #

Annex 6 – point 3 – paragraph 6 – subparagraph 2
The assessment of doses to members of the public shall take into account not onlyall pathways of exposure through, not only those caused by airborne or liquid effluent, but also pathways resulting from the disposal or recycling of solid residues.
2013/03/12
Committee: ENVI
Amendment 286 #

Annex 6 – section 1
1. Exemption PNotified practices may be exempted from requirements of this Directive either directly, on the basis of compliance with numerical exemption criteria (activity values (Bq) or concentration values (Bq g- 1)) laid down in Section 2, or through a regulatory decision, on the basis of the information provided in conjunction with the notification of the practice and in line with general exemption criteria set out in Section 3, to exempt the practice from further requirements.
2013/03/12
Committee: ENVI
Amendment 287 #

Annex 6 – section 2
2. Exemption and clearance values The total activity values (Bq) for exemption apply to the total activity involved in a practice and are laid down in column 3 of Table B for artificial radionuclides and for some naturally occurring radionuclides used in consumer products. For other practices involving naturally occurring radionuclides, such values are in general not applicable. The exempt activity concentration values (Bq g-1) for the materials involved in the practice are laid down in Table A, Part 1 for artificial radionuclides and in Table A, Part 2 for naturally occurring radionuclides. The values in Table A1, Part 1 are given for individual radionuclides, where applicable including short-lived radionuclides in equilibrium with the parent nuclide as indicated. The values in Table A, Part 2 apply to all radionuclides in the decay chain of U-238 or Th-232, but for segments of the decay chain which are not in equilibrium with the parent radionuclide higher values may be applied. The concentration values in Table A, Part 1 or in Table A, Part 2 also apply to the clearance of solid materials for re-use, recycling, conventional disposal or incineration. Higher values may be defined for specific materials or specific pathways, taking Community guidance into account, including where appropriate additional requirements in terms of surface activity or monitoring requirements. 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. Where appropriate this condition can be verified on the basis of best estimates of the composition of the radionuclide mix. The values in Table A, Part 2 apply individually to each parent nuclide. Some elements in the decay chain, e.g. Po-210 or Pb-210, may warrant the use of values significantly higher, by up to two orders of magnitude, taking Community guidance into account. The values in Table A, Part 2 may not be used to exempt the incorporation into building materials of residues from industries processing naturally occurring radioactive material. Such recycling of residues from identified industries shall be managed as an authorised practice or be exempted on the basis of the general exemption criteria laid down in Section 3. For this purpose, compliance of the sum of radionuclide concentrations with the appropriate value of the radionuclide index I for building materials as defined in Annex VII shall be verified. The values laid down in Table B, column 3, apply to the total inventory of radioactive substances held by a person or undertaking as part of a specific practice at any point in time. However, the regulatory authority may apply these values to smaller entities or packages, for instance to exempt the transport or storage of exempted consumer products, if the general exemption criteria in Section 3 are satisfied.deleted
2013/03/12
Committee: ENVI
Amendment 288 #

Annex 9 – part B – paragraph 1 – point 1
1. RPredefined reference levels, taking into account the criteria laid down in Annex I and intervention levels expressed in terms of projected and received doses;
2013/03/12
Committee: ENVI
Amendment 289 #

Annex 9 – part B – paragraph 1 – point 3
3. Predefined generic criteria for particularreference levels and intervention levels for the various existing protective measures, expressed in terms of projected and received doses, in particular evacuation, sheltering, confinement, administering of stable iodine, and foodstuff restrictions;
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
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;
2013/03/12
Committee: ENVI
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;
2013/03/12
Committee: ENVI
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.
2013/03/12
Committee: ENVI
Amendment 294 #

Annex 10 – part B – point 1 – point a
(a) information on the type of emergency which has occurred and, where possible, its characteristics (e.g. its origin, extent and probable development);
2013/03/12
Committee: ENVI