Council Regulation (Euratom) 2016/52

of 15 January 2016

laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof,

Having regard to the proposal from the European Commission, drawn up after obtaining the opinion of the group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States,

Having regard to the opinion of the European Parliament1,
Having regard to the opinion of the European Economic and Social Committee2,

Whereas:

(1)
Council Directive 2013/59/Euratom3 lays down basic safety standards for the protection against the dangers arising from exposure to ionising radiation.
(2)

Following the accident at the Chernobyl nuclear power station on 26 April 1986, considerable quantities of radioactive materials were released into the atmosphere, contaminating food and feed in several European countries to levels that were significant from the point of view of health. Measures were adopted to ensure that certain agricultural products are only introduced into the Union in accordance with the common arrangements which safeguard the health of the population while maintaining the unified nature of the market and avoiding deflections of trade.

(3)
Council Regulation (Euratom) No 3954/874 lays down maximum permitted levels of radioactive contamination to be applied following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to significant radioactive contamination of food and feed. Those maximum permitted levels are still in line with the latest scientific advice as presently available internationally. The basis for the establishment of the maximum permitted levels set out in this Regulation has been reviewed and described in the Commission Radiation Protection Publication 105 (EU Food Restriction Criteria for Application after an Accident). In particular, those levels are based on a reference level of 1 mSv per year for the increment in individual effective dose by ingestion and on the assumption that 10 % of food consumed annually is contaminated. However, different assumptions apply to infants under 1 year.
(4)
Following the accident at the Fukushima nuclear power station on 11 March 2011, the Commission was informed that radionuclide levels in certain food products originating in Japan exceeded the action levels in food applicable in Japan. Such contamination could constitute a threat to public and animal health in the Union and therefore measures were adopted imposing special conditions governing the import of food and feed originating in or consigned from Japan, in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, established by Regulation (EC) No 178/2002 of the European Parliament and of the Council5.
(5)

There is a need 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 food and feed, to establish maximum permitted levels of radioactive contamination regarding products to be placed on the market in order to protect the population.

(6)
Like other food, drinking water is ingested directly or indirectly and therefore plays a role in the consumer's overall exposure to radioactive substances. With regard to radioactive substances, quality control of water intended for human consumption is already provided for in Council Directive 2013/51/Euratom6, with the exclusion of mineral waters and waters which are medicinal products. This Regulation should apply to food, minor food and feed which could be placed on the market following a nuclear accident or any other case of radiological emergency, and not to water intended for human consumption for which Directive 2013/51/Euratom applies. However, in the case of a radiological emergency, Member States are free to choose to refer to the maximum levels for liquid food set out in this Regulation in order to manage the use of water intended for human consumption.
(7)

Maximum permitted levels of radioactive contamination should apply to food and feed originating in the Union or imported from third countries on the basis of the location and circumstances of the nuclear accident or other radiological emergency.

(8)
The Commission is to be informed of a nuclear accident or of unusually high levels of radioactivity under Council Decision 87/600/Euratom7 or under the International Atomic Energy Agency (IAEA) Convention on Early Notification of a Nuclear Accident of 26 September 1986.
(9)

In order to take into account that diets of infants during their first 6 months may vary significantly and that there are uncertainties in the metabolism of infants during the second 6-month period as well, it is appropriate to extend the application of lower maximum permitted levels for foods for infants to the first 12 months.

(10)

In order to facilitate the adaptation of applicable maximum permitted levels, in particular with regard to the circumstances of the nuclear accident or other radiological emergency, procedures for reviewing the implementing Regulations should include the consultation by the Commission of the group of experts referred to in Article 31 of the Treaty.

(11)

In order to ensure that food and feed exceeding the applicable maximum permitted levels are not placed on the Community market, compliance with these levels should be the subject of appropriate checks.

(12)
In order to ensure uniform conditions for the implementation of this Regulation as regards rendering applicable maximum permitted levels, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8 which is to apply for the purpose of this Regulation notwithstanding the fact that it does not refer explicitly to Article 106a of the Treaty.
(13)

The Commission should be assisted by the Standing Committee on Plants, Animals, Food and Feed. Member States should ensure that, where draft implementing acts based on this Regulation are discussed by that Committee, their representatives have, or can rely on, adequate expertise in radiological protection.

(14)

The examination procedure should be used for the adoption of acts rendering applicable maximum permitted levels of radioactive contamination of food and feed.

(15)

The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to certain radiological emergencies which are likely to lead or have led to a significant radioactive contamination of food and feed, imperative grounds of urgency so require.

(16)

This Regulation should constitute a lex specialis for the procedure to adopt and subsequently amend implementing Regulations laying down applicable maximum permitted levels of radioactive contamination following a case of radiological emergency. Where it is evident that food or feed originating in the Union or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission is allowed to adopt additional emergency measures pursuant to Regulation (EC) No 178/2002. The Commission should ensure that this Regulation and Regulation (EC) No 178/2002 are implemented in a harmonised way. Where possible, applicable maximum permitted levels and additional emergency measures should be integrated in a single implementing Regulation based on this Regulation and Regulation (EC) No 178/2002.

(17)
Furthermore, general rules for the performance of official controls to verify compliance with rules aiming, inter alia, to prevent, eliminate or reduce to acceptable levels risks to humans and animals are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council9.
(18)

When preparing or reviewing implementing Regulations, the Commission should take into account, inter alia, the following circumstances: location, nature and extent of the nuclear accident or other radiological emergency within or outside the Community; nature, extent and spread of the identified or projected release of radioactive substances in air, water and soil and in food and feed within or outside the Community; radiological risks of the identified or potential radioactive contamination of food and feed and the resulting radiation doses; type and quantity of the contaminated food and feed which might be brought onto the market in the Community; maximum permitted levels for contaminated food and feed set in third countries; importance of this food and feed for providing the population with an adequate food supply; consumer expectations regarding the safety of food and possible changes to consumers' eating habits as a result of a radiological emergency.

(19)

In duly justified cases, any Member State should have the possibility to request to be allowed to derogate temporarily from the maximum permitted levels of radioactive contamination in respect of specified food or feed consumed on its territory. Implementing Regulations should specify the food and feed to which the derogations apply, the types of radionuclides concerned, as well as the geographical scope and duration of the derogations,

HAS ADOPTED THIS REGULATION:

Article 1Subject matter

This Regulation lays down the maximum permitted levels of radioactive contamination of:

  1. (a)

    food, as set out in Annex I;

  2. (b)

    minor food, as set out in Annex II; and

  3. (c)

    feed, as set out in Annex III,

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 food and feed.

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 2Definitions

For the purposes of this Regulation, the following definitions apply:

  1. (1)

    ‘food’ means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

    ‘Food’ includes drink, chewing gum and any substance intentionally incorporated into the food during its manufacture, preparation or treatment.

    ‘Food’ does not include:

    1. (a)

      feed;

    2. (b)

      live animals unless they are prepared for placing on the market for human consumption;

    3. (c)

      plants prior to harvesting;

    4. (d)
      medicinal products within the meaning of point (2) of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council10;
    5. (e)
      cosmetic products within the meaning of point (a) of Article 2(1) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council11;
    6. (f)
      tobacco and tobacco products within the meaning of, respectively, points (1) and (4) of Article 2 of Directive 2014/40/EU of the European Parliament and of the Council12;
    7. (g)

      narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971;

    8. (h)

      residues and contaminants;

    9. (i)

      water intended for human consumption within the meaning of point (1) of Article 2 of Directive 2013/51/Euratom;

  2. (2)

    ‘minor food’ means food of minor dietary importance which makes only a marginal contribution to food consumption by the population;

  3. (3)

    ‘feed’ means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

  4. (4)

    ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves;

  5. (5)

    ‘radiological emergency’ means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, property or the environment, or a hazard that could give rise to such serious adverse consequences.

  6. (6)

    F2“appropriate authority” means—

    1. (a)

      in relation to England, the Secretary of State;

    2. (b)

      in relation to Wales, the Welsh Ministers;

    3. (c)

      in relation to Scotland, the Scottish Ministers;

  7. (7)

    “Food Safety Authority” means—

    1. (i)

      as regards England and Wales, the Food Standards Agency;

    2. (ii)

      as regards Scotland, Food Standards Scotland;

  8. (8)

    “prescribe” means prescribe by regulations.

F3Article 3Applicable maximum permitted levels

 1.

If the appropriate authority receives — in particular under the IAEA Convention on Early Notification of a Nuclear Accident of 26 September 1986 — official information on a nuclear accident or on any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, the appropriate authority must, subject to paragraph 6, prescribe measures which apply the applicable maximum permitted levels to the potentially contaminated food or feed that could be placed on the market.

2.

If the Food Safety Authority receives official information of the kind described in paragraph 1, it must immediately notify the appropriate authority by sharing that official information with the appropriate authority.

3.

The maximum permitted levels applied by the measures prescribed under this Article must not exceed those set out in Annexes 1, 2 and 3.

4.

The period of validity of measures prescribed under this Article must be as short as possible. The duration of the first measures prescribed under this Article following a nuclear accident or any other case of radiological emergency must not exceed 3 months.

5.

The measures prescribed under this Article must be periodically reviewed by the appropriate authority and, if appropriate, amended on the basis of the nature and location of the accident and of the evolution of the level of radioactive contamination effectively measured.

6.

When preparing measures to be prescribed, or reviewing measures prescribed, under this Article, the appropriate authority must take into account the basic standards laid down pursuant to Articles 30 and 31 of the Euratom Treaty, including the justification principle and the optimisation principle, with the aim of keeping the magnitude of individual doses, the likelihood of exposure and the number of individuals exposed as low as reasonably achievable, taking into account the current state of technical knowledge and economic and societal factors.

7.

When reviewing measures prescribed under this Article, the appropriate authority must consider, among other matters, whether the nuclear accident or any other case of radiological emergency has caused such widespread contamination of food or feed consumed in Great Britain that the rationale and assumptions underpinning the maximum permitted levels set out in Annexes 1, 2 and 3 to this Regulation are no longer valid.

F4Article 4Restrictive measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5Article 5Committee procedure

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6Article 5ARegulations and devolved powers

1.

Any power to make regulations under Article 3—

(a)

so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b)

so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;

2.

For regulations made under Article 3 by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

3.

Any power to make regulations under Article 3 includes power—

(a)

to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and

(b)

to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

4.

Any statutory instrument or Scottish statutory instrument containing regulations made under Article 3 is subject to annulment in pursuance of a resolution—

(a)

in the case of England, of either House of Parliament;

(b)

in the case of Wales, of Senedd Cymru;

(c)

in the case of Scotland, of the Scottish Parliament;

5.

In Article 3, any power—

(a)

of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b)

of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c)

of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.

F7Article 6Reporting

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 7Repeal

Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/8913 and (Euratom) No 770/9014 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 IV.

Article 8Entry into force

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

F8...

Done at Brussels, 15 January 2016.

For the Council

The President

J.R.V.A. Dijsselbloem

ANNEX IMAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF FOOD

The maximum permitted levels to be applied to food shall not exceed the following:

Isotope group/Food group

Food (Bq/kg)15
Infant food16
Dairy produce17
Other food except minor food18
Liquid food19

Sum of isotopes of strontium, notably Sr-90

75

125

750

125

Sum of isotopes of iodine, notably I-131

150

500

2 000

500

Sum of alpha-emitting isotopes of plutonium and transplutonium elements, notably Pu-239 and Am-241

1

20

80

20

Sum of all other nuclides of half-life greater than 10 days, notably Cs-134 and Cs-13720

400

1 000

1 250

1 000

15

The level applicable to concentrated or dried products is calculated on the basis of the reconstituted product as ready for consumption. F9The Food Safety Authority may make recommendations concerning the diluting conditions in order to ensure that the maximum permitted levels laid down in this Regulation are observed.

16

Infant food is defined as food intended for the feeding of infants during the first 12 months of life which meets, in itself, the nutritional requirements of this category of persons and is put up for retail sale in packages which are clearly identified and labelled as such.

17

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

18

Minor food and the corresponding levels to be applied to them are set out in Annex II.

19

Liquid food is defined as products falling within heading 2009 and Chapter 22 of the Combined Nomenclature. Values are calculated taking into account consumption of tap-water and the same values could be applied to drinking water supplies at the discretion of competent authorities in Member States.

20

Carbon-14, tritium and potassium-40 are not included in this group.

ANNEX IIMAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF MINOR FOOD

1.List of minor food

CN code

Description

0703 20 00

Garlic (fresh or chilled))

0709 59 50

Truffles (fresh or chilled)

0709 99 40

Capers (fresh or chilled)

0711 90 70

Capers (provisionally preserved, but unsuitable in that state for immediate consumption)

ex 0712 39 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, chilled, frozen 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 or ground fruit 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 cardamoms

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, meal and powder of sago or of roots or tubers of heading 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, except plants or parts of plants used for food production

1301

Lac; natural gums, resins, gum-resins and oleoresins (for example, 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 31 00

Caviar

1604 32 00

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 90 10

Truffles (prepared or preserved otherwise than by vinegar or acetic acid)

2006 00

Vegetables, fruit, nuts, fruit-peel and other parts of plants, preserved by sugar (drained, glacé or crystallised)

2102

Yeasts (active or inactive); other single-cell micro-organisms, dead (but not including vaccines of heading 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; extracted oleoresins; 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

2.The maximum permitted levels to be applied to the minor food as listed in point 1 shall not exceed the following:

Isotope group

Bq/kg

Sum of isotopes of strontium, notably Sr-90

7 500

Sum of isotopes of iodine, notably I-131

20 000

Sum of alpha-emitting isotopes of plutonium and transplutonium elements, notably Pu-239 and Am-241

800

Sum of all other nuclides of half-life greater than 10 days, notably Cs-134 and Cs-13721

12 500

21

Carbon-14, tritium and potassium-40 are not included in this group.

ANNEX IIIMAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF FEED

The maximum permitted levels for the sum of caesium-134 and caesium-137 shall not exceed the following:

Feed for

Bq/kg2223

Pigs

1 250

Poultry, lambs, calves

2 500

Other

5 000

22

These levels are intended to contribute to the observance of the maximum permitted levels for food; 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 feed as ready for consumption.

ANNEX IVCORRELATION TABLE

Regulation (Euratom) No 3954/87

Regulation (Euratom) No 944/89

Regulation (Euratom) No 770/90

This Regulation

Article 1(1)

Article 1

Article 1

Article 1

Article 1(2)

Article 2

Article 2(1)

Article 3(1)

Article 2(2)

Article 3(2)

Article 3(1)

—

Article 3(2)

Article 3(3)

Article 3(3) and (4)

—

Article 4

—

Article 5

—

Article 6(1)

Article 4(1)

Article 6(2)

Article 4(2)

Article 2

Annex II, point 2

—

—

—

Article 5

Article 7

—

—

—

—

Article 7

Article 8

Article 3

Article 2

Article 8

Annex

Annex I

Annex

Annex II, point 1

Annex

Annex III

—

—

—

Annex IV