2010/0098(CNS) | [ParlTrack]

Proposal for a regulation
Citation 1

Having regard to the Treaty ~~establishing the European Atomic Energy Community~~on the Functioning of the European Union, and in particular Article 3168(4) and Article 169(3) thereof,

Amendment 22 #

Ivo BELET

Proposal for a regulation
Citation 1

Having regard to the Treaty ~~establishing the European Atomic Energy Community~~on the Functioning of the European Union, and in particular Article 3168(4)(b) thereof,

Amendment 23 #

Proposal for a regulation
Recital 2

(2) Article 2(b) of the Treaty requires that the Council establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied, as further set out in Title Two, Chapter III, of the Treaty.deleted

Amendment 24 #

Proposal for a regulation
Recital 2

(2) Article 2(b) of the Euratom Treaty requires that the Council establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied, as further set out in Title Two, Chapter III, of the Euratom Treaty.

Amendment 25 #

Proposal for a regulation
Recital 2 a (new)

(2a) In accordance with Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection should be ensured in the definition and implementation of all EU policies and activities.

Amendment 26 #

Proposal for a regulation
Recital 4

(4) Following the accident at the Chernobyl nuclear power-station on 26 April 1986, considerable quantities of radioactive materials were released into the atmosphere, contaminating foodstuffs and feedingstuffs in several European countries to levels significant from the health point of view; the soil was also contaminated with radioactive fallout, which increased the radioactivity of forest and agricultural foodstuffs obtained in the affected areas.

Amendment 27 #

Proposal for a regulation
Recital 6

(6) The need arises to set up a system allowing the European ~~Atomic Energy Community~~Union, following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to a significant radioactive contamination of foodstuffs and feedingstuffs, to fix maximum permitted levels of radioactive contamination in order to ~~protect the popula~~guarantee a high level of public health protection.

Amendment 28 #

Proposal for a regulation
Recital 6 a (new)

(6a) On the basis of the Treaty establishing the European Atomic Energy Community, and in accordance with Articles 4 and 9 thereof, the Commission shall support research into the dangers of contamination of foodstuffs and feedingstuffs with radioactive isotopes and the effects of ionizing radiation (e.g. gamma rays) used for sterilisation on the quality of these products from the point of view of the chemical and radiological risk.

Amendment 29 #

Proposal for a regulation
Recital 6 b (new)

(6b) The radiological safety of foodstuffs and feedingstuffs cannot be the subject of patents preventing the use of the appropriate safeguard technologies without purchasing licensed rights.

Amendment 30 #

Proposal for a regulation
Recital 8

(8) ~~The Commission should, if the circumstances so require, immediately adopt a Regulation~~In the event of a nuclear accident or radiological emergency, the Commission must immediately render~~ing~~ applicable pre- established maximum permitted levels and communicate them to the public.

Amendment 31 #

Proposal for a regulation
Recital 8 a (new)

(8a) The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in respect of the adaptation to technical progress of the maximum permitted levels of radioactive contamination of foodstuffs and feedingstuffs (Annexes I and III), and of the list of minor foodstuffs (Annex II). It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at EFSA and other experts level.

Amendment 32 #

Proposal for a regulation
Recital 9

(9) On the basis of current data available in the field of radiation protection, derived reference levels have been established and these levels mayust be used as a basis for the fixing of maximum permitted levels of radioactive contamination to be applied immediately following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to significant radioactive contamination of foodstuffs and feedingstuffs.

Amendment 33 #

Proposal for a regulation
Recital 10

(10) ~~Such maximum permitted levels~~The derived reference levels and the maximum permitted levels should be regularly revised to take due account of the latest scientific advances and advice as presently available on an international scale ~~whilst~~, reflect~~ing~~ the need for reassuring the public and ~~avo~~providing them with a high level of protection, and avoid divergences in international regulatory practice.

Amendment 34 #

Proposal for a regulation
Recital 11

(11) ~~However~~In the event of a nuclear accident or any other radiological emergency, it is necessary to take due account of the particular circumstances and conditions applying to each accident, and, therefore, to establish a procedure allowing the rapid ~~adaptation~~lowering of these pre-established levels to maximum permitted levels appropriate to the circumstances of any particular nuclear accident or any other case of radiological emergency which is likely to lead or has led to significant radioactive contamination of foodstuffs and feedingstuffsmaximum permitted levels and if necessary the introduction of maximum permitted levels for other radionuclides (notably tritium) involved in the accident, with a view to ensuring the highest possible level of public protection.

Amendment 35 #

Proposal for a regulation
Recital 12

~~(12) A Regulation rendering applicable maximum permitted levels should also maintain the unity of the Internal Market and avoid deflections of trade within the Union .~~deleted

Amendment 36 #

Proposal for a regulation
Recital 12 a (new)

(12a) The criteria governing the placing on the market of foodstuffs and feedingstuffs should take into account the level of background radiation in the area concerned.

Amendment 37 #

Proposal for a regulation
Recital 13

(13) In order to facilitate the adaptation of maximum permitted levels, procedures should be provided for allowing the regular consultation of experts ~~including~~. A group of experts should be established by the Commission on the basis of scientific and ethical criteria. The Commission should make public the Ggroup ~~of Experts referred to in Article 31 of the Treaty~~’s composition and its members’ declarations of interests. In adapting the maximum permitted levels, the Commission should also consult experts from international bodies working in the field of radiation protection.

Amendment 38 #

Proposal for a regulation
Recital 13

(13) In order to facilitate the adaptation of maximum permitted levels, procedures should be provided for allowing the consultation of experts including the Group of Experts referred to in Article 31 of the Euratom Treaty.

Amendment 39 #

Proposal for a regulation
Recital 13 a (new)

(13a) In the event of a nuclear accident or radioactive incident, consultation procedures should in each case determine whether dilution treatment is permitted, e.g. mixing of contaminated milk with uncontaminated milk.

Amendment 40 #

Proposal for a regulation
Recital 13 a (new)

(13a) The adoption of the maximum permitted levels under this Regulation should be based on the protection requirements for the most critical and vulnerable population groups, in particular children and people in isolated geographic areas or those practising subsistence farming. The maximum permitted levels should be the same for the entire population and should be based on the lowest levels.

Amendment 41 #

Proposal for a regulation
Recital 14

~~(14) The foodstuffs to be considered as minor foodstuffs are those of minor dietary importance which make only a marginal contribution to food consumption by the population.~~deleted

Amendment 42 #

Proposal for a regulation
Recital 15

(15) It is appropriate for the Council to reserve the right to exercise directly the power to adopt a ~~Regulation to timely endors~~Decision to endorse or scale down the measures proposed by the Commission in the first month after a nuclear accident or a radiological emergency. The relevant proposal for the adaptation or confirmation of the provisions laid down in the Regulation adopted by the Commission, in particular the establishment of maximum permitted levels of radioactive contamination and the list of radionuclides, should be based on Article 31s 168 and 169 of the Treaty on the Functioning of the European Union, in view of the health protection of the population. ~~This is without prejudice to the possibility that i~~In the long term, after the accident or the radiological emergency, other le~~gal instruments~~ vels applied should conform to the maximum exposure levels permitted in accor dan~~other legal basis may be used for the purpose of controlling foodstuffs or feedingstuffs being placed on the market.~~ ce with Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation1. __________________ 1 OJ L 314, 4.12.1996, p. 20.

Amendment 43 #

Proposal for a regulation
Recital 15

(15) It is appropriate for the Council to reserve the right to exercise directly the power to adopt a Regulation to timely endorse measures proposed by the Commission in the first month after a nuclear accident or a radiological emergency. The relevant proposal for the adaptation or confirmation of the provisions laid down in the Regulation adopted by the Commission, in particular the establishment of maximum permitted levels of radioactive contamination, should be based on Article 31 of the Euratom Treaty, in view of the health protection of the population. This is without prejudice to the possibility that in the long term after the accident or the radiological emergency other legal instruments or another legal basis may be used for the purpose of controlling foodstuffs or feedingstuffs being placed on the market.

Amendment 44 #

Proposal for a regulation
Recital 15 a (new)

(15a) In the event of a nuclear accident or radiological emergency which requires the maximum permitted levels to be applied, the public should be informed of the levels in force, both by the Commission and by each Member State. Furthermore, the public should also be provided with information about foodstuffs and feedingstuffs liable to accumulate stronger concentrations of radioactivity.

Amendment 45 #

Proposal for a regulation
Recital 16

(16) Compliance with the maximum permitted levels ~~should~~must be the subject of appropriate checks, and sanctions should be introduced for the export or sale of foodstuffs exceeding the maximum permitted contamination levels,

Amendment 46 #

Proposal for a regulation
Article 2 – paragraph 1

1. In the event of the Commission receiving — in particular according to either the European Atomic Energy Community arrangements for the early exchange of information in case of a radiological emergency or under the 1 IAEA Convention of 26 September 1986 on early notification of a nuclear accident — official information on accidents or on any other case of radiological emergency, substantiating that the maximum permitted levels for foodstuffs laid down in Annex I or the maximum permitted levels for feedingstuffs laid down in Annex III are likely to be reached or have been reached, it shall immediately adopt~~, if the circumstances so require, a Regulat~~ a Decision rendering applicable those maximum permitted levels.

Amendment 47 #

Proposal for a regulation
Article 2 – paragraph 2

~~2. The period of validity of any Regulation within the meaning of paragraph 1 shall be as short as possible and shall not exceed three months, subject to the provisions of Article 3(4).~~deleted

Amendment 48 #

Proposal for a regulation
Article 3 – paragraph 1

1. ~~After consultation with experts, which shall include the group of experts referred to in Article 31 of the Treaty~~No later than one month after the nuclear accident or radiological emergency, and after consulting the group of experts established by the Commission, hereinafter “group of experts”, the Commission shall submit to the Council a proposal ~~for a Regulation to adapt or~~to confirm the existing provisions o~~f the Regulation referred to in Article 2(1) of this Regulation with~~r revise the levels and revise the list of radionuclides, depending on~~e month of its adop~~ the specific situation.

Amendment 49 #

Proposal for a regulation
Article 3 – paragraph 1

1. After consultation with experts, which shall include the group of experts referred to in Article 31 of the Euratom Treaty, hereinafter "group of experts' , the Commission shall submit to the Council a proposal for a Regulation to adapt or confirm the provisions of the Regulation referred to in Article 2(1) of this Regulation within one month of its adoption.

Amendment 50 #

Proposal for a regulation
Article 3 – paragraph 2

2. WThe~~n submitting the proposal for a Regulation referred to in paragraph 1 , the Commission shall take into account the basic standards laid down~~ Commission shall, on the basis of the latest medical research and expertise, extend and update Annexes I and III to this Regulation so as to ensure that the maximum level of contamination of foodstuffs and feedingstuffs with radioactive isotopes, in accordance with Articles 30 ~~and 31~~ of the Treaty, including the principle that all exposures shall be kept as low as reasonably achievable, taking the aspect of the protection of the health of the general public and economic and social factors into accoun Establishing the European Atomic Energy Community, complies with the permissible radioactivity measured in becquerels per kilogram of product.

Amendment 51 #

Proposal for a regulation
Article 3 – paragraph 2

2. When submitting the proposal for a ~~Regulat~~Decision referred to in paragraph 1 , the Commission shall take into account the ~~basic standards laid down in accordance with Articles 30 and 31 of the Treaty, including the~~ principle that all exposures shall be kept as low as reasonably achievable, taking the aspect of the protection of the health of the general public ~~and economic and social factors~~, particularly of the most vulnerable sectors of the population, into account.

Amendment 52 #

Proposal for a regulation
Article 3 – paragraph 2

2. When submitting the proposal for a Regulation referred to in paragraph 1, the Commission shall take into account the basic standards laid down in accordance with Articles 30 and 31 of the Euratom Treaty, including the principle that all exposures shall be kept as low as reasonably achievable, taking the aspect of the protection of the health of the general public and economic and social factors into account.

Amendment 53 #

Proposal for a regulation
Article 3 – paragraph 2 a (new)

2a. Given the possibility of isotopes of solid elements escaping into the environment following a nuclear reactor accident, the list of maximum permitted levels of contamination of animal feed should be expanded and supplemented in accordance with Article 32 of the Treaty Establishing the European Atomic Energy Community to include other isotopes in addition to radioactive stable isotopes of caesium, such as transuranium elements and isotopes of strontium and iodine.

Amendment 54 #

Proposal for a regulation
Article 3 – paragraph 3

3. The Council shall, acting by a ~~qualified~~simple majority, take a decision on the proposal for a ~~Regulat~~Decision referred to in paragraphs 1 and 2 within ~~the time limit set out in Article 2(2)~~one month. The Council shall inform the European Parliament of its decision.

Amendment 55 #

Proposal for a regulation
Article 4 – paragraph 1

The period of validity of ~~any Regulat~~the Decision within the meaning of Article 3 shall be limited and, in the long term, shall enable the health protection levels laid down in Directive 96/29/Euratom to be guaranteed. This period may be revised at the request of ~~a Member State~~the Council or the European Parliament or on the initiative of the Commission in accordance with the procedure laid down in Article 3.

Amendment 56 #

Proposal for a regulation
Article 5 – paragraph 1

1. In order to ensure that the maximum permitted levels laid down in Annexes I and III take account of any new scientific data becoming available, the Commission shall~~, from time to time, seek the opinion of experts, which shall include the group of exper~~ be required to consult on a regular basis the group of experts, as well as experts from third countries and international organisations working in this field. The group of experts shall be set up by the Commission on the basis of scientific and ethical criteria. The Commission shall make public the group’s composition and its members’ declarations of interests.

Amendment 57 #

Proposal for a regulation
Article 5 – paragraph 1

Amendment 58 #

Proposal for a regulation
Article 5 – paragraph 1 a (new)

1a. Annexes I, II and III should take into account the effect of the partial decay of radioactive isotopes during the shelf life of preserved foodstuffs; depending on the type of contamination, e.g. with iodine isotopes, the radioactivity of these products should be constantly monitored.

Amendment 59 #

Proposal for a regulation
Article 5 – paragraph 2

2. At the request of ~~a Member State~~the Council, the European Parliament or the Commission, the maximum permitted levels laid down in Annexes I and III may be revised or supplemented, upon the submission of a proposal f~~rom the Commission to the Council in accordance with the procedure laid down in Article 31 of the Treaty~~or the revision of this Regulation from the Commission to the Council and the European Parliament in accordance with the ordinary legislative procedure.

Amendment 60 #

Proposal for a regulation
Article 5 – paragraph 2

2. At the request of a Member State or the Commission, the maximum permitted levels laid down in Annexes I and III may be revised or supplemented, upon the submission of a proposal from the Commission to the Council in accordance with the procedure laid down in Article 31 of the Euratom Treaty.

Amendment 61 #

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2

~~For the purposes of applying this Regulation,~~This Regulation shall also apply to foodstuffs or feedingstuffs imported from third countries ~~shall be considered to be placed on the market if, on the customs territory of the Community, they undergo a customs procedure other than a transit procedure~~, in customs transit or intended for export.

Amendment 62 #

Proposal for a regulation
Article 6 – paragraph 2

2. Each Member State shall provide the Commission with all information concerning the application of this Regulation, in particular concerning cases of non-compliance with the maximum permitted levels. The Commission shall communicate such information to the other Member States. The Commission shall impose sanctions in the event of the sale or export of foodstuffs or feedingstuffs exceeding the maximum permitted contamination levels.

Amendment 63 #

Proposal for a regulation
Article 6 – paragraph 2 a (new)

2a Each Member State and the Commission shall inform the public of the levels in force and provide information about foodstuffs liable to accumulate higher concentrations of radioactivity.

Amendment 64 #

Proposal for a regulation
Article 7 – paragraph 1

~~A list of minor foodstuffs is set out in Annex II.~~deleted

Amendment 65 #

Proposal for a regulation
Article 7 – paragraph 1 a (new)

Annex II should be completely redrafted on the basis of a classification of the intermediate and minor foodstuffs to be found on the EU consumer market; the basic principle of that classification should be consistency with Annex I.

Amendment 66 #

Proposal for a regulation
Article 8

Rules for implementing this Regulation and adaptations to the list of minor foodstuffs , together with the maximum permitted levels of radioactive contamination to be applied thereto, as set out in Annex II, and to the maximum permitted levels for feedingstuffs set out in Annex III shall be adopted in accordance with the procedure referred to in Article 195(2) of Council Regulation (EC) No 1234/200717, which shall apply by analogy. To this end the Commission shall be assisted by an ad hoc Committee.deleted

Amendment 67 #

Proposal for a regulation
Article 9 – paragraph 1

Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and No 770/90 are repealed, as shown in Annex IV.

Amendment 68 #

Proposal for a regulation
Annex I

MAXIMUM PERMITTED LEVELS FOR FOODSTUFFS (Bq/kg) Foodstuffs18 Infant Dairy Other Liquid food19 produce20 foodstuffs foodstuffs22 except minor foodstuffs21 and liquid foodstuffs18 Isotopes of strontium, 75 ~~125 750 125 notably Sr- 90~~notably Sr- 90 Isotopes of iodine, 150 ~~500 2 000 500~~ notably I-131 Alpha- emitting isotopes of plutonium and 1 ~~20 80 20~~ transplutoniu m elements, notably Pu- 239, Am-241 All other nuclides of 400 half-life greater than ~~400 1 000 1 250 1 000~~ 10 days, notably Cs- 134, Cs- 13723

Amendment 69 #

Proposal for a regulation
Annex I – column 4 – title

LTap- and drinking water and liquid foodstuffs

Amendment 70 #

Vicky FORD

Proposal for a regulation
Annex I – footnote 19

19 Infant food is defined as those foodstuffs intended for the feeding of infants during the first four to six months ~~of life~~and formula milk (or equivalent products) intended for infants under the age of twelve months, which meet, in themselves, the nutritional requirements of this category of person and are put up for retail sale in packages which are clearly identified and labelled "food preparation for infants";

Amendment 71 #

Proposal for a regulation
Annex II

This annex is deleted.

Amendment 72 #

Fiona HALL

Proposal for a regulation
Annex II – row 0714

Manioc, arrowroot, salep, Jerusalem artichokes, sweet potatoes and similar roots and tubers with high starch or inulin content, fresh or dried, whether or not sliced or in the form of pellets; sago pithdeleted

Amendment 73 #

Fiona HALL

Proposal for a regulation
Annex II – row 1106 20

~~Flour, meal and powder of sago or of roots or tubers of heading No 0714~~deleted

Amendment 74 #

Fiona HALL

Proposal for a regulation
Annex II – row 1108 14 00

~~Manioc (cassava) starch~~deleted

Amendment 75 #