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Proposal for a Council Regulation (EURATOM) laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (Codified version)

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Proposal for a Council Regulation (EURATOM) laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (Codified version) /* COM/2007/0302 final - CNS 2007/0103 */


[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 5.6.2007

COM(2007) 302 final

2007/0103 (CNS)

Proposal for a

COUNCIL REGULATION (EURATOM)

laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (Codified version)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1 In the context of a people’s Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make it clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the specific rights it gives him.

This aim cannot be achieved so long as numerous provisions that have been amended several times, often quite substantially, remain scattered, so that they must be sought partly in the original instrument and partly in later amending ones. Considerable research work, comparing many different instruments, is thus needed to identify the current rules.

For this reason a codification of rules that have frequently been amended is also essential if Community law is to be clear and transparent.

2. On 1 April 1987 the Commission therefore decided[1] to instruct its staff that all legislative acts should be codified after no more than ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

3. The Conclusions of the Presidency of the Edinburgh European Council (December 1992) confirmed this[2] stressing the importance of codification as it offers certainty as to the law applicable to a given matter at a given time.

Codification must be undertaken in full compliance with the normal Community legislative procedure.

Given that no changes of substance may be made to the instruments affected by codification , the European Parliament, the Council and the Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-track adoption of codification instruments.

4. The purpose of this proposal is to undertake a codification[3] of Council Regulation (Euratom) No 3954/87 of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency, Commission Regulation (Euratom) No 944/89 of 12 April 1989 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency and Commission Regulation (Euratom) No 770/90 of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency. The new Regulation will supersede the various acts incorporated in it[4]; this proposal fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself.

5. The codification proposal was drawn up on the basis of a preliminary consolidation , in all official languages, of Regulation (Euratom) No 3954/87 and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by means of a data-processing system . Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table set out in Annex V to the codified Regulation.

3954/87

2007/0103 (CNS)

Proposal for a

COUNCIL REGULATION (EURATOM)

laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 31 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament[5],

Having regard to the opinion of the European Economic and Social Committee[6],

Whereas:

1. Council Regulation (Euratom) No 3954/87 of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency[7] has been substantially amended[8]. In the interests of clarity and rationality the said Regulation should be codified, together with Commission Regulation (Euratom) No 944/89 of 12 April 1989 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency[9] and Commission Regulation (Euratom) No 770/90 of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency[10].

3954/87 Recital 1 (adapted)

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.

3954/87 Recital 2 (adapted)

3. On 2 February 1959, the Council adopted Directives[11] laying down basic safety standards, the text of which was replaced by that of 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 radiation [12] . Article 50(2) of that Directive requires Member States to stipulate intervention levels in the event of accidents.

3954/87 Recital 3

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.

3954/87 Recital 4 (adapted)

5. The Community adopted measures[13] to ensure that certain agricultural products are only introduced into the Community according to the common arrangements which safeguard the health of the population while maintaining the unified nature of the market and avoiding deflections of trade.

3954/87 Recital 5

6. The need arises to set up a system allowing the Community, 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 population.

3954/87 Recital 6 (adapted)

7. The Commission is to be informed of a nuclear accident or of unusually high levels of radioactivity according to Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of radiological emergency[14], or under the IAEA Convention on early notification of a nuclear accident of 26 September 1986.

3954/87 Recital 7 (adapted)

8. The Commission should , if the circumstances so require, immediately adopt a Regulation rendering applicable pre-established maximum permitted levels.

3954/87 Recital 8 (adapted)

9. On the basis of current data available in the field of radiation protection, derived reference levels have been established and these levels may 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.

3954/87 Recital 9

10. Such maximum permitted levels take due account of the latest scientific advice as presently available on an international scale whilst reflecting the need for reassuring the public and avoiding divergences in international regulatory practice.

3954/87 Recital 10

11. However, it is necessary to take due account of the particular conditions applying and, therefore, to establish a procedure allowing the rapid adaptation 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 feedingstuffs.

3954/87 Recital 11 (adapted)

12. A Regulation rendering applicable maximum permitted levels should also maintain the unity of the Internal Market and avoid deflections of trade within the Community.

3954/87 Recital 12

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 Treaty.

3954/87 Recital 13 (adapted)

14. Compliance with the maximum permitted levels should be the subject of appropriate checks,

3954/87

HAS ADOPTED THIS REGULATION:

Article 1

1. This Regulation lays down the procedure for determining the maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs which may be placed on the market following a nuclear accident or any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of foodstuffs and feedingstuffs.

3954/87 (adapted)

Corrigendum, OJ L 18, 22.1.1988, p. 74

2. For the purposes of this Regulation, the following definitions shall apply:

(a) “foodstuffs” means products which are intended for human consumption either immediately or after processing;

(b) “feedingstuffs” means products which are intended only for animal nutrition.

Article 2

1. In the event of the Commission receiving — in particular according to either the Community arrangements for the early exchange of information in case of a radiological emergency or under the 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 permissible levels laid down in Annex I are likely to be reached or have been reached, it shall immediately adopt, if the circumstances so require, a Regulation rendering applicable those maximum permissible levels.

3954/87

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).

Article 3

3954/87 (adapted)

1. After consultation with experts, which shall include the group of experts referred to in Article 31 of the 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.

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 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.

3954/87

3. The Council shall, acting by a qualified majority, take a decision on the proposal for a Regulation referred to in paragraphs 1 and 2 within the time limit set out in Article 2(2).

4. In the event that the Council does not decide within this time limit, the levels set out in Annex I shall continue to apply until the Council does decide or until the Commission withdraws its proposal because the conditions set out in Article 2(1) no longer apply.

Article 4

The period of validity of any Regulation within the meaning of Article 3 shall be limited. This period may be revised at the request of a Member State or on the initiative of the Commission in accordance with the procedure laid down in Article 3.

Article 5

3954/87 (adapted)

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 experts.

3954/87

2. At the request of a Member State or the Commission, the maximum permitted levels laid down in Annex I 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 Treaty.

Article 6

1. Foodstuffs or feedingstuffs not in compliance with the maximum permitted levels laid down in a Regulation adopted in accordance with Articles 2 or 3 shall not be placed on the market.

For the purposes of applying this Regulation, 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.

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.

944/89 Art. 1 (adapted)

Article 7

1. A list of minor foodstuffs together with the maximum levels of radioactive contamination to be applied thereto is set out in Annex II.

944/89 Art. 2 (adapted)

2. For the minor foodstuffs given in Annex II, the maximum permitted levels to be applied are 10 times those applicable to “other foodstuffs except minor foodstuffs” fixed in Annex I or pursuant to Regulations adopted on the basis of Article 3 .

770/90 Art. 1 and Annex (adapted)

Article 8

Maximum permitted levels of radioactive contamination of feedingstuffs are set out in Annex III.

2218/89 Art. 2 (adapted)

Article 9

Rules for applying this Regulation, the list of minor foodstuffs referred to in Article 7 and the maximum levels for feedingstuffs referred to in Article 8 shall be adopted in accordance with the procedure referred to in Article 42 of Council Regulation (EC) No 1255/1999 [15] , which shall apply by analogy. To this end the Commission shall be assisted by an ad hoc Committee.

Article 10

Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and No 770/90 are repealed.

References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex V.

3954/87 (adapted)

Article 11

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Council

The President

2218/89 Art. 1 and Annex (adapted)

ANNEX I

MAXIMUM PERMITTED LEVELS FOR FOODSTUFFS (Bq/kg)

Foodstuffs[16] |

Ö Infant Õ food[17] | Dairy produce[18] | Other foodstuffs except minor foodstuffs[19] | Liquid foodstuffs[20] |

Isotopes of strontium, notably Sr-90 | 75 | 125 | 750 | 125 |

Isotopes of iodine, notably I-131 | 150 | 500 | 2 000 | 500 |

Alpha-emitting isotopes of plutonium and transplutonium elements, notably Pu-239, Am-241 | 1 | 20 | 80 | 20 |

All other nuclides of half-life greater than 10 days, notably Cs-134, Cs-137[21] | 400 | 1 000 | 1 250 | 1 000 |

_____________

944/89 Art. 1 and Annex (adapted)

ANNEX II

List of minor foodstuffs

CN CODE | DESCRIPTION |

0703 20 00 | Garlic (fresh or chilled)) |

0709 Ö 59 50 Õ | Truffles (fresh or chilled) |

0709 90 40 | Capers (fresh or chilled) |

0711 Ö 90 70 Õ | Capers (provisionally preserved, but unsuitable in that state for immediate consumption) |

0712 30 00 | Truffles (dried, whole, cut, sliced, broken or in powder, but not further prepared) |

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 pith |

0814 00 00 | Peel of citrus fruit or melons (including watermelons), fresh, frozen, dried or provisionally preserved in brine, in sulphur water or in other preservative solutions |

0903 00 00 | Maté |

0904 | Pepper of the genus Piper; dried or crushed of ground fruits of the genus Capsicum or of the genus Pimenta |

0905 00 00 | Vanilla |

0906 | Cinnamon and cinnamon-tree flowers |

0907 00 00 | Cloves (whole fruit, cloves and stems) |

0908 | Nutmeg, mace and cardamons |

0909 | Seeds of anise, badian, fennel, coriander, cumin or caraway; juniper berries |

0910 | Ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices |

1106 20 | Flour and meal of sago, roots or tubers of heading No 0714 |

1108 14 00 | Manioc (cassava) starch |

1210 | Hop cones, fresh or dried, whether or not ground, powdered or in the form of pellets; lupulin |

1211 | Plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh or dried, whether or not cut, crushed or powdered |

1301 | Lac; natural gums, resins, gum-resins and Ö oleoresins (for example, Õ balsams) |

1302 | Vegetable saps and extracts; pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products |

1504 | Fats and oils and their fractions, of fish or marine mammals, whether or not refined, but not chemically modified |

1604 30 | Caviar and caviar substitutes |

1801 00 00 | Cocoa beans, whole or broken, raw or roasted |

1802 00 00 | Cocoa shells, husks, skins and other cocoa waste |

1803 | Cocoa paste, whether or not defatted |

2003 20 00 | Truffles (prepared or preserved otherwise than by vinegar or acetic acid) |

2006 00 | Ö Vegetables, Õ fruit, nuts, fruit-peel and other parts of plants, preserved by sugar (drained, glacé or crystallized) |

2102 | Yeasts (active or inactive); other single-cell micro-organisms, dead (but not including vaccines of heading No 3002); prepared baking powders |

2936 | Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent |

3301 | Essential oils (terpeneless or not), including concretes and absolutes; resinoids; concentrates of essential oils in fats, in fixed oils, in waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils |

_____________

770/90 Art. 1 and Annex

ANNEX III

Maximum permitted levels of ra DIACTIVE CONTAMINATION (CAESIUM-134 AND CAESIUM-137) OF FEEDINGSTUFFS

ANIMAL | BQ/KG[22] [23] |

Pigs | 1 250 |

Poultry, lambs, calves | 2 500 |

Other | 5 000 |

_____________

ANNEX IV

Repealed Regulations

Council Regulation (Euratom) No 3954/87 | (OJ L 371, 30.12.1987, p. 11) |

Council Regulation (Euratom) No 2218/89 | (OJ L 211, 22.7.1989, p. 1) |

Commission Regulation (Euratom) No 944/89 | (OJ L 101, 13.4.1989, p. 17) |

Commission Regulation (Euratom) No 770/90 | (OJ L 83, 30.3.1990, p. 78) |

_____________

ANNEX V

Correlation Table

Regulation (Euratom) No 3954/87 | Regulation (Euratom) No 944/89 | Regulation (Euratom) No 770/90 | This Regulation |

Articles 1 to 5 | Articles 1 to 5 |

Article 6(1) first and second sentence | Article 6(1) first and second subparagraphs |

Article 6(2) | Article 6(2) |

Article 1 | Article 7(1) |

Article 2 | Article 7(2) |

Article 1 | Article 8 |

Article 7 | Article 9 |

- | - | - | Article 10 |

Article 8 | Article 11 |

Annex | Annex I |

Annex | Annex II |

Annex | Annex III |

- | - | - | Annex IV |

- | - | - | Annex V |

_____________

[1] COM(87) 868 PV.

[2] See Annex 3 to Part A of the Conclusions.

[3] Carried out pursuant to the Communication from the Commission to the European Parliament and the Council – Codification of the Acquis Communautaire, COM(2001) 645 final.

[4] See Annex IV to this proposal.

[5] OJ C […], […], p. […].

[6] OJ C […], […], p. […].

[7] OJ L 371, 30.12.1987, p. 11. Regulation as amended by Regulation (Euratom) No 2218/89 (OJ L 211, 22.7.1989, p. 1).

[8] See Annex IV.

[9] OJ L 101, 13.4.1989, p. 17.

[10] OJ L 83, 30.3.1990, p. 78.

[11] OJ 11, 20.2.1959, p. 221/59.

[12] OJ L 159, 29.6.1996, p. 1.

[13] Council Regulations (EEC) No 1707/86 (OJ L 146, 31.5.1986, p. 88), (EEC) No 3020/86 (OJ L 280, 1.10.1986, p. 79), (EEC) No 624/87 (OJ L 58, 28.2.1987, p. 101) and (EEC) No 3955/87 ( OJ L 371, 30.12.1987, p. 14).

[14] OJ L 371, 30.12.1987, p. 76.

[15] OJ L 160, 26.6.1999, p. 48.

[16] The level applicable to concentrated or dried products is calculated on the basis of the reconstituted product as ready for consumption. Member States may make recommendations concerning the diluting conditions in order to ensure that the maximum permitted levels laid down in this Regulation are observed.

[17] Infant food is defined as those foodstuffs intended for the feeding of infants during the first four to six months of life, 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”.

[18] Dairy produce is defined as those products falling within the following CN codes including, where appropriate, any adjustments which might be made to them later: 0401, 0402 (except 0402 29 11).

[19] Minor foodstuffs and the corresponding levels to be applied to them are defined in accordance with Article 9.

[20] Liquid foodstuffs as defined in the heading 2009 and in chapter 22 of the combined nomenclature. Values are calculated taking into account consumption of tap-water and the same values should be applied to drinking water supplies at the discretion of competent authorities in Member States.

[21] Carbon 14, tritium and potassium 40 are not included in this group.

[22] These levels are intended to contribute to the observance of the maximum permitted levels for foodstuffs; they do not alone guarantee such observance in all circumstances and do not lessen the requirement for monitoring contamination levels in animal products destined for human consumption.

[23] These levels apply to feedingstuffs as ready for consumption.

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