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

Subject matter

Article 1

This Regulation lays down the maximum permitted levels of radioactive contamination of: (a) food, as set out in Annex I; (b) minor food, as set out in Annex II; and (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. This Regulation also lays down the procedure to adopt or subsequently amend implementing Regulations laying down the applicable maximum permitted levels.

Definitions

Article 2

For the purposes of this Regulation, the following definitions apply: (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: (a) feed; (b) live animals unless they are prepared for placing on the market for human consumption; (c) plants prior to harvesting; (d) medicinal products within the meaning of point (2) of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council  ( 10 ) ; (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 Council  ( 11 ) ; (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 Council  ( 12 ) ; (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; (h) residues and contaminants; (i) water intended for human consumption within the meaning of point (1) of Article 2 of Directive 2013/51/Euratom; (2) ‘minor food’ means food of minor dietary importance which makes only a marginal contribution to food consumption by the population; (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) ‘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) ‘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.

Applicable maximum permitted levels

Article 3

1.   If the Commission receives — in particular either under the Community arrangements for the early exchange of information in the event of a radiological emergency, or 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, it shall adopt an implementing Regulation rendering applicable maximum permitted levels to the potentially contaminated food or feed that could be placed on the market. Without prejudice to Article 3(4), the applicable maximum permitted levels set out in such an implementing Regulation shall not exceed those set out in Annexes I, II and III. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 5(2). On duly justified imperative grounds of urgency relating to the circumstances of the nuclear accident or other radiological emergency, the Commission shall adopt an immediately applicable implementing Regulation in accordance with the procedure referred to in Article 5(3). 2.   The period of validity of implementing Regulations adopted under paragraph 1 shall be as short as possible. The duration of the first implementing Regulation following a nuclear accident or any other case of radiological emergency shall not exceed 3 months. Implementing Regulations shall be periodically reviewed by the Commission 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. 3.   When preparing or reviewing implementing Regulations, the Commission shall take into account the basic standards laid down pursuant to Articles 30 and 31 of the 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. When reviewing implementing Regulations, the Commission shall consult the group of experts referred to in Article 31 of the Treaty if a nuclear accident or any other case of radiological emergency causes such widespread contamination of food or feed consumed in the Community that the rationale and assumptions underpinning the maximum permitted levels set out in Annexes I, II and III to this Regulation are no longer valid. The Commission may seek the opinion of that group of experts in any other case of contamination of food or feed consumed in the Community. 4.   Without prejudice to the health protection objective pursued by this Regulation, the Commission may, by means of implementing Regulations, allow any Member State, at its request and in the light of exceptional circumstances prevailing in that Member State, to derogate temporarily from the maximum permitted levels in respect of specified food or feed consumed on its territory. Those derogations shall be based on scientific evidence and be duly justified by the circumstances, in particular societal factors, prevailing in the Member State concerned.

Restrictive measures

Article 4

1.   When the Commission adopts an implementing Regulation rendering applicable maximum permitted levels, food or feed not in compliance with those maximum permitted levels shall not be placed on the market, as from the date specified in that implementing Regulation. For the purposes of applying this Regulation, food or feed imported from third countries shall be considered to be placed on the market if, on the customs territory of the Union, it is placed under 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. The Commission shall communicate such information to the other Member States. Any case of non-compliance with the applicable maximum permitted levels shall be notified through the Rapid Alert System for Food and Feed (RAFF).

Committee procedure

Article 5

1.   The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Reporting

Article 6

In the event of a nuclear accident or any other case of a radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, the Commission shall submit to the European Parliament and to the Council a report. The report shall cover the implementation of the measures undertaken pursuant to this Regulation and notified to the Commission in accordance with Article 4(2).

Repeal

Article 7

Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89  ( 13 ) and (Euratom) No 770/90  ( 14 ) 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.

Entry into force

Article 8

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

ANNEX ISupplementary provisions

ANNEX I MAXIMUM 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)  ( 1 ) Infant food  ( 2 ) Dairy produce  ( 3 ) Other food except minor food  ( 4 ) Liquid food  ( 5 ) 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-137  ( 6 ) 400 1 000 1 250 1 000 ( 1 )   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. ( 2 )   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. ( 3 )   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). ( 4 )   Minor food and the corresponding levels to be applied to them are set out in Annex II. ( 5 )   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. ( 6 )   Carbon-14, tritium and potassium-40 are not included in this group.

ANNEX IISupplementary provisions

ANNEX II MAXIMUM 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-137  ( 1 ) 12 500 ( 1 )   Carbon-14, tritium and potassium-40 are not included in this group.

ANNEX IIISupplementary provisions

ANNEX III MAXIMUM 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/kg  ( 1 )  ( 2 ) Pigs 1 250 Poultry, lambs, calves 2 500 Other 5 000 ( 1 )   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. ( 2 )   These levels apply to feed as ready for consumption.

ANNEX IVSupplementary provisions

ANNEX IV CORRELATION 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