# EUR-Lex - 52013PC0576 - EN

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# 52013PC0576

**Draft proposal for a COUNCIL REGULATION laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency Draft presented under Article 31 of the Euratom Treaty for opinion of the European Economic and Social Committee /* COM/2013/0576 final - 2013/ () */**

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EXPLANATORY
MEMORANDUM

1.           On 1 April 1987 the
Commission decided[1]
to instruct its services that all 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 their provisions are clear and
readily understandable.

2.           The codification[2] 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 was initiated by the Commission, and a relevant proposal was
submitted to the legislative authority[3].
The new Regulation was to supersede the various acts incorporated in it[4].

3.           In its opinion of
27.9.2007 the Consultative Working Party of the legal services set up under the
Interinstitutional Agreement of 20 December 1994 on an accelerated working
method for official codification of legislative texts[5] stated that the proposal
referred to in point 2 confined itself to straightforward codification, without
any substantive changes to the acts covered by it.

4.           In the course of the
legislative procedure relating to that initial codification proposal, it was
acknowledged that a provision appearing in the draft codified text provided for
a reservation of implementing powers by the Council which
was not justified in the recitals of Regulation (Euratom) No 3954/87.
In the light of the judgment of the Court of Justice of 6 May 2008 in
Case C-133/06, it was considered necessary to insert a new recital in the new
act replacing and repealing that Regulation in order to justify that reservation
of implementing powers. Since the insertion
of such a recital
would have implied a substantive change, and would have therefore gone beyond
straightforward codification, it was considered necessary that point 8[6] of the Interinstitutional Agreement of 20 December 1994 -
Accelerated working method for official codification of legislative texts - be
applied, in the light of the Joint Declaration on that point[7].

5.           In the light thereof,
codification of Regulation (Euratom) No 3954/87, Regulation (Euratom)
No 944/89 and Regulation (Euratom) No 770/90 was transformed into a recast
in order to incorporate the said amendment, and a relevant proposal was
submitted to the legislative authority[8].

6.           In its opinion of 4.6.2010
the Consultative Working Party of the legal services, acting in accordance with
point 9 of the Interinstitutional Agreement of 28 November 2001 on a more structured
use of the recasting technique for legal acts[9],
stated that the proposal referred to in point 5 did not comprise any
substantive amendments other than those identified as such, and that, as
regards the codification of the unchanged provisions of the earlier acts with
those substantive amendments, the proposal contained a straightforward
codification of the existing texts, without any change in their substance.

7.           In the course of the
legislative procedure relating to that recast proposal, it became apparent that
certain existing provisions contained in Regulation (Euratom)
No 3954/87 have now become incompatible with the new
"Comitology" system laid down in Regulation (EU) No 182/2011 of
the European Parliament and of the Council of 16 February 2011 laying down
the rules and general principles concerning mechanisms for control by Member
States of the Commission’s exercise of implementing powers. It has therefore
been decided to withdraw the recast proposal and to draft a revised proposal of
Regulation (Euratom) No 3954/87, which includes its consolidation and the
implementation of the new "Comitology" system.

8.           On the basis of the
experience gained from the nuclear accidents in Chernobyl and in particular in
Fukushima, the revised proposal provides that the Commission is assisted by a
section of the Standing Committee on the Food Chain and Animal Health -
Toxicological Safety of the Food Chain dealing with radioactive contamination
of food and feed referred to in Article 58 (1) of Regulation (EC) No 178/2002
of the European Parliament and of the Council of 28
January 2002 laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in
matters of food safety[10].

9.           Taking
into consideration the evolution of the primary and secondary law during the
last decades, in particular with regard to food safety under the TFEU, and in
order to ensure legal certainty and coherence of all EU legislative measures
with regard to the conditions governing imports of food and feed from third
countries affected by a nuclear accident or a radiological emergency, the
measures that were established in the post-Chernobyl context will need to be
aligned with the regime of implementing powers and procedures defined in the
present regulation. This might also imply, where necessary, a change of the
legal basis.

10.         It should be noted that the
Group of Experts referred to in Article 31 of the Euratom Treaty,
confirmed in their Opinion dated 21 November 2012 their
conclusion in 1998 (Publication Radiation Protection
105), that the maximum permitted levels pre-established for future accidents in
Regulation 3954/87 are still valid. However, as soon as new scientific
knowledge on doses and risks would be published by ICRP, they considered that
it should be checked whether there is a need for a review of these levels.
Therefore, the Commission has not changed these maximum permitted levels in its
revised proposal [11].

11.         According to the two-stage
procedure laid down in Article 31 of the Euratom Treaty, the Commission shall
first obtain the opinion of the European Economic and Social Committee on the
present draft before submitting a proposal to the Council.

Draft proposal for a 
COUNCIL REGULATION

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

Draft presented under Article 31 of
the Euratom Treaty for opinion of the European Economic and Social Committee

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[12],

Having regard to the opinion of the
European Parliament[13],

Having regard to the opinion of the
European Economic and Social Committee[14],

Whereas:

(1) 
Article 31 of the Euratom Treaty establishes a
two-stage procedure whereby the Commission shall first obtain the opinion of
the European Economic and Social Committee on the present draft before
submitting a proposal to the Council.

(2) 
Council Directive 96/29/Euratom
of 13 May 1996 lays down basic safety standards for the protection of
the health of workers and the general public against the dangers arising from
ionizing radiation[15].

(3) 
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. Measures were adopted[16] to ensure that certain
agricultural products are only introduced into the Union 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.

(4) 
Council Regulation (Euratom) No 3954/87[17] 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.

(5) 
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 may constitute a threat to
public and animal health in the Union and therefore measures were adopted
imposing special conditions governing the import of feed and food originating
in or consigned from Japan, in accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health.

(6) 
There is a need to set up a system allowing
the European Atomic Energy 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 in order to protect the
population.

(7) 
Maximum permitted levels of radioactive
contamination should apply to food and feed originating in the Union or imported from third countries according to the location and circumstances of the
nuclear accident or the radiological emergency.

(8) 
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[18],
or under the IAEA Convention on early notification of a nuclear
accident of 26 September 1986.

(9) 
In order to ensure uniform conditions for the
implementation of this Regulation, 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 Council of 16
February 2011 laying down the rules and general principles concerning
mechanisms for control by the Member States of the Commission's exercise of
implementing powers[19].

(10) 
The examination procedure should be used for the
adoption of acts rendering applicable the pre-established maximum permitted
levels of radioactive contamination of food and feed.

(11) 
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.

(12) 
In order to take into account that diets of
infants during the first six months period of life may vary significantly, and
to allow for uncertainties in the metabolism of infants during the second six
months period of life, there is a benefit in extending the application of lower
maximum permitted levels for foods for infants, to the whole first 12 months of
age.

(13) 
In order to facilitate the adaptation of maximum
permitted levels, in particular with regard to scientific knowledge, procedures
for establishing the maximum permitted levels should include the consultation
of the Group of Experts referred to in Article 31 of the Treaty,

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

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation lays down the maximum
permitted levels of radioactive contamination of food as set out in Annex I
and the maximum permitted levels of minor food as set out in Annex II, and the
maximum permitted levels of radioactive contamination of 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, and the
procedures to render these maximum permitted levels applicable.

Article 2

Definitions

For the purposes of this Regulation, the
following definitions shall 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, including
drink, chewing gum and any substance, including water, 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 Article
1(2) of Directive 2001/83/EC of the European Parliament and of the Council[20] ;

(e) 
cosmetic products within the meaning of Article
2(1)(a) of Regulation (EC) No 1223/2009 of the European Parliament and of the
Council[21];

(f) 
tobacco and tobacco products within the meaning of Directive
2001/37/EC of the European Parliament and of the Council[22] ;

(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.

2.           "minor food" as
listed in Annex II, means food of minor dietary
importance which make 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.

Article 3

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 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 food, minor food or feed are likely
to be reached or have been reached, it shall adopt, if the
circumstances so require, an implementing Regulation rendering applicable those
maximum permitted levels. That implementing act shall be adopted in
accordance with the examination procedure referred to in Article 5(2).

2.           On duly justified imperative
grounds of urgency relating to the circumstances of the nuclear accident or
the radiological emergency, the Commission shall adopt an immediately
applicable implementing Regulation in accordance with the procedure referred to
in Article 5(3).

3.           When preparing the draft
implementing act referred to paragraphs 1 and 2 and discussing it with the
committee referred to in Article 5, 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
protection of the health of the general public and economic and societal
factors into account.

Article 4

1.           As soon as the Commision
adopts an implementing Regulation rendering applicable maximum permitted
levels, food or feed not in compliance with these maximum permitted levels shall
not be placed on the market.

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 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.

Article 5

1.           The Commission shall be
assisted by the Standing Committee on the Food Chain and Animal Health established
by Article 58 (1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council[23]. That
committee shall be considered as 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.

Article 6

In order to ensure that the maximum permitted levels laid down in
Annexes I, II and III take account of any new or additional important data
becoming available, in particular with regard to scientific
knowledge, adaptations to those Annexes shall be proposed by the
Commission after consultation of the Group of Experts referred to in
Article 31 of the Treaty establishing the European Atomic Energy Community
.

Article 7

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.

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.

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

Done at Brussels,

For
the Council

The
President

[...]

ANNEX I

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE
CONTAMINATION OF FOOD

The maximum
permitted levels to be applied to food shall be the following:

|| Food (Bq/kg)[24]

Infant food[25] || Dairy produce[26] || Other food except minor food[27] || Liquid food[28]

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[29] || 400 || 1 000 || 1 250 || 1 000

_____________

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 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, meal and powder of sago or of 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 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 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; 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
paragraph 1, shall be the following

|| (Bq/kg)

Isotopes of strontium, notably Sr-90 || 7500

Isotopes of iodine, notably I-131 || 20000

Alpha-emitting isotopes of plutonium and transplutonium elements, notably Pu-239, Am-241 || 800

All other nuclides of half-life greater than 10 days, notably Cs-134, Cs-137[30] || 12500

ANNEX III

Maximum permitted levels of radiactive contamination of
feed

The maximum
permitted levels for caesium‑134 and caesium-137 shall be the following:

Animal || Bq/kg[31], [32]

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

Article 1(1) || || || Article 1

|| Article 1 || || Article 1

Article 1(2) || || || Article 2

Article 2(1) || || || Article 3(1) and 3(2)

Article 2(2) || || || -

Article 3(1) || || || -

Article 3(2) || || || Article 3(3)

Article 3(3) and (4) || || || -

Article 4 || || || -

Article 5(1) || || || Article 6

Article 5(2) || || || -

Article 6(1) || || || Article 4(1)

Article 6(2) || || || Article 4(2)

|| Article 2 || || Annex II(2)

--- || --- || Article 1 --- || Annex III Article 5

Article 7 || || || -

--- || --- || --- || Article 7

Article 8 || || || Article 8

Annex || || || Annex I

|| Annex || || Annex II(1)

|| || Annex || Annex III

--- || --- || --- || Annex IV

--- || --- || --- || Annex V

[1]               COM(87) 868 PV.

[2]               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.

[3]               COM(2007) 302 final.

[4]               See Annex IV to this proposal.

[5]               OJ C 102, 4.4.1996, p. 2.

[6]               "Should it prove
necessary during the legislative process to go beyond straightforward
codification and make substantive changes, it will be the Commission's
responsibility to submit any proposal(s), where appropriate".

[7]               "The European
Parliament, the Council and the Commission note that if it should appear
necessary to go beyond straightforward codification and make substantive
changes, the Commission will be able to choose, case by case, whether to recast
its proposal or whether to submit a separate proposal for amendment, leaving
its codification proposal on the table, and then, once the substantive change
has been adopted, incorporate it into the proposal for codification".

[8]               COM(2010) 184 final.

[9]               OJ C 77, 28.3.2002, p. 1.

[10]             OJ L 31, 1.2.2002, p.1.

[11]             http://ec.europa.eu/energy/nuclear/radiation_protection/article_31_en.htm

[12]             OJ C..p..

[13]             OJ C , , p. .

[14]             OJ C , , p. .

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

[16]             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).

[17]             OJ L 371, 30.12.1987, p. 11.

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

[19]             OJ L 55, 28.2.2011, p. 13.

[20]             OJ L 311, 28.11.2001, p. 67.

[21]             OJ L 342, 22.12.2009, p. 59.

[22]             OJ L 194, 18.7.2001, p. 26.

[23]             OJ L 31, 1.2.2002, p. 1.

[24]             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.

[25]             Infant food is defined
as those foodstuffs intended for the feeding of infants during the first twelve
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 under one of the following names: “infant formula”,
“follow-on formula” “infant milk” and “follow-on milk”, in accordance with
articles 11 and 12 of Commission Directive 2006/141/EC.

[26]             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).

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

[28]             Liquid food 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.

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

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

[31]             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.

[32]             These levels apply to feed as
ready for consumption.