REPORT on the 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

2.6.2015 - (COM(2013)0943 – C7‑0045/2014 – 2013/0451(NLE)) - *

Committee on the Environment, Public Health and Food Safety
Rapporteur: Esther Herranz García

Procedure : 2013/0451(NLE)

Document stages in plenary

Document selected :

A8-0176/2015

Texts tabled :

A8-0176/2015

Debates :

PV 09/07/2015 - 9
CRE 09/07/2015 - 9

Votes :

PV 09/07/2015 - 12.2
CRE 09/07/2015 - 12.2
Explanations of votes

Texts adopted :

P8_TA(2015)0267

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
EXPLANATORY STATEMENT
OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS
RESULT OF FINAL VOTE IN COMMITTEE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the 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

(COM(2013)0943 – C7‑0045/2014 – 2013/0451(NLE))

(Consultation)

The European Parliament,

– having regard to the Commission proposal to the Council (COM(2013)0943),

– having regard to Articles 31 and 32 of the Treaty on European Union, pursuant to which the Council consulted Parliament (C7‑0045/2014),

– having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

– having regard to Rules 59 and 39 of its Rules of Procedure,

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A8-0176/2015),

1. Approves the Commission proposal as amended;

2. Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union and Article 106a of the Euratom Treaty;

3. Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4. Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal;

5. Instructs its President to forward its position to the Council and the Commission.

Amendment 1 Proposal for a regulation Title
Text proposed by the Commission	Amendment
Proposal for a	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	regulation of the European Parliament and of the Council laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency
	(This amendment applies throughout the text.)
<Amend>Amendment <NumAm>2</NumAm> Proposal for a regulation</DocAmend> <Article>Citation 1</Article>
Proposal for a regulation	Amendment
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof,	Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(4)(b) and Article 114 thereof,

</Amend>

Amendment 3

Proposal for a regulation

Citation 3


Text proposed by the Commission	Amendment
Having regard to the opinion of the European Parliament¹⁴,	Acting in accordance with the ordinary legislative procedure,
____________________
¹⁴ OJ C …, …, p. ….

(This amendment is linked to amendment 2.)

Justification

Brings the text into line with the change of legal basis.

Amendment 4

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) Council Directive 96/29/Euratom¹⁶ lays down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation.

(1) Council Directive 2013/59/Euratom¹⁶lays down basic safety standards for protection against the dangers arising from exposure to ionising radiation.

__________________

¹⁶ 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 (OJ L 159, 29.6.1996, p. 1.)

¹⁶ Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for the protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom(OJ L 13, 17.1.2014, p. 1.)

Amendment 5

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1a) In accordance with Article 168 of the Treaty on the Functioning of the European Union (TFEU), a high level of human health protection should be ensured in the definition and implementation of all Union policies and activities.

Amendment 6

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(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 foodstuffs and feedingstuffs in several European countries to levels significant from the health point of view. Measures were adopted 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.

(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 foodstuffs and feedingstuffs in several European countries to significant levels from a health point of view, causing life-threatening illnesses and health conditions. A high level of radioactive contamination still persists today. Given that the radioactive material released has contaminated air, water, soil and vegetation, measures were adopted to ensure that certain agricultural products were only introduced into the Union according to the common arrangements in order to safeguard the health of the population while maintaining the unified nature of the market and avoiding deflections of trade.

Amendment 7

Proposal for a regulation

Recital 2 a (new)


Text proposed by the Commission	Amendment
	(2a) Member States are responsible for monitoring compliance with the levels laid down in this Regulation, in particular by supervising safety standards for food and feed. Point (b) of Article 168(4) TFEU provides for the adoption of common measures in the veterinary field which have as a direct objective the protection of human health. In addition, Article 114 TFEU provides for an appropriate level of harmonisation to ensure that the internal market can run smoothly.

Justification

Article 168 provides the legal basis for codecision with regard to feed, and Article 114 covers matters relating to food for human consumption.

Amendment 8

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission

Amendment

(2b) It is a proven fact that higher doses of radiation have a harmful and destructive effect on the body's cells and can give rise to cancers.

Amendment 9

Proposal for a regulation

Recital 2 c (new)

Text proposed by the Commission

Amendment

(2c) It is important to set low thresholds for maximum permitted levels of radioactive contamination in food, in order to take into account the higher cumulative dose caused by contaminated food that is eaten over an extended period of time.

Amendment 10

Proposal for a regulation

Recital 3


Text proposed by the Commission	Amendment
(3) Council Regulation (Euratom) No 3954/87¹⁷ 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.	(3) Council Regulation (Euratom) No 3954/87¹⁷ 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 and should be periodically reviewed and updated to take into account new scientific evidence. The maximum permitted levels listed in Annexes I to III have been revised and are set out in the Commission’s Radiological Protection Publication 105. Specifically, they are based on a reference level of 1 mSv per year in addition to the individual dose as ingested, and suppose that 10 % of the food consumed annually is contaminated.
____________________	____________________
¹⁷Council 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 (OJ L 371, 30.12.1987, p. 11).	¹⁷Council 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 (OJ L 371, 30.12.1987, p. 11).

(Commissions's Radiological Protection Publication 105 = Commission's publication Radiation Protection 105 on EU Food Restriction Criteria for Application after an Accident, see http://ec.europa.eu/energy/en/radiation-protection-publications.)

Justification

The purpose of this amendment is to clarify the Commission text by referring to the parameters used to determine the maximum permitted levels laid down in the annexes. The EU has extensive radioactivity protection where food is concerned, with levels far below those permitted internationally.

Amendment 11

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(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 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.

(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 threshold levels applicable in Japan for food. 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. Measures should also be put in place to monitor and minimise the risk of consumption of food products from other countries affected by the radioactive fallout from a nuclear accident in another country.

Amendment 12

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) 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.

(5) There is a need to set up a system allowing the Union, following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to a significant radioactive contamination of food and feed, to establish maximum permitted levels of radioactive contamination in order to ensure a high level of public health protection.

Amendment 13

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) 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, taking into account the effect of natural and cumulative radiation as it moves up the food chain. Periodic revisions of these levels should be in place.

Amendment 14

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) 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.

Amendment 15

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) 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.

(9) In order to facilitate the adaptation of maximum permitted levels, in particular with regard to scientific knowledge and technical progress at international level, the Commission should present to the European Parliament and the Council a new proposal to adapt the maximum permitted levels. .

Amendment 16

Proposal for a regulation

Recital 9 a (new)

Text proposed by the Commission

Amendment

(9a) In order to facilitate the adaptation of maximum permitted levels, procedures should be introduced to allow the regular consultation of experts. A group of experts should be established by the Commission on the basis of scientific and ethical criteria. The Commission should make public the group’s composition and its members’ declarations of interests. In adapting the maximum permitted levels, the Commission should also consult experts from international bodies in the field of radiation protection.

Justification

There is currently no transparent information on the composition of the Group of Experts referred to in Article 31 of the Euratom Treaty. The group’s composition must be determined in a clear and transparent manner under the responsibility of the Commission, as is the case for other scientific committees, particularly in the field of health and consumer protection.

Amendment 17

Proposal for a regulation

Recital 9 b (new)

Text proposed by the Commission

Amendment

(9b) The Group of Experts should also estimate the cumulative effect of radioactive contamination.

Justification

Perhaps the doses are not reached by any food, but if one person consumes different foods with radioactive contamination a bit below these limits could acquire a considerable level of radiation.

Amendment 18

Proposal for a regulation

Recital 9 b (new)

Text proposed by the Commission

Amendment

(9b) The maximum permitted levels should be made public and regularly revised to take due account of the latest scientific advances and advice as presently available internationally, to reflect the need to reassure the public and to provide it with a high level of protection, and to avoid divergences in international regulatory practice.

Justification

Les niveaux maximaux admissibles sont des limites dérivées de la limite de dose qui sert de référence. La limite de dose (en mSv) indique le niveau de risque jugé acceptable. La US FDA a choisi 5 mSv pour la limite de dose efficace (corps entier) et 50 mSv pour la limite de dose à l’organe, le niveau de risque acceptable est un mort par cancer pour 4400 personnes consommant 30% d’aliments contaminés aux niveaux maximaux qu’elle a choisis. C’est un niveau de risque élevé. Pour la totalité de la population européenne, cela représenterait près de 114 000 décès imputables à la consommation des aliments « légalement » contaminés, sans compter les cancers non mortels, maladies génétiques et autres problèmes.

Amendment 19

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

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

(10) In order to ensure that food and feed exceeding the maximum permitted levels are not placed on the market of the Union, compliance with these levels should be the subject of thorough checks by the Member States and the Commission; penalties for non-compliance should be applied and the public should be informed accordingly.

Amendment 20

Proposal for a regulation

Recital 10 a (new)


Text proposed by the Commission	Amendment
	(10a) The rules for verifying compliance with measures designed to prevent, eliminate or reduce to acceptable levels the contamination risks to humans or animals are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004^1a.
	____________________
	^1a OJ L 191, 28.5.2004, p. 1.

Justification

Regulation (EC) No 882/2004 lays down the official controls to be performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

Amendment 21

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) 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.

(12) 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. In the event of a nuclear accident or any other radiological emergency, it is nevertheless necessary to take due account of the particular circumstances and conditions applying to each accident, and, therefore, to establish a procedure allowing the rapid lowering of these pre-established maximum permitted levels, and, if necessary, the introduction of maximum permitted levels for other radionuclides (in particular tritium) involved in the accident, with a view to ensuring the highest possible level of public protection. The public should be informed immediately of the measure and of the maximum levels.

Justification

Les accidents nucléaires ou les urgences radiologiques pouvant être de nature différente et concerner des radionucléides différents, il faut prévoir un mécanisme de révision rapide. La flexibilité pour répondre aux cas spécifiques de chaque accident est aussi l’approche prévue par la US FDA qui recommande l’évaluation immédiate après un accident pour s’assurer que les niveaux en place soient appropriés à la situation. Les normes préétablies ne doivent pas être définies par rapport à une configuration optimiste mais par rapport à une configuration pénalisante. De cette façon, on part d’un niveau de protection a priori adéquat et on peut assouplir le dispositif une fois connu l’intensité, la composition et l’étendue des retombées radioactives.

Amendment 22

Proposal for a regulation

Recital 12 a (new)


Text proposed by the Commission	Amendment
	(12a) The Commission should be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002^1a. The Member States should ensure that their representatives on the committee have sufficient knowledge of radiological protection.
	____________________
	^1a OJ L 31, 1.2.2002, p. 1.

Justification

Under the new comitology procedure, the Commission is to be assisted by the committee in dealing with implementing acts.

Amendment 23

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) 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.

Amendment 24

Proposal for a regulation

Recital 13 a (new)

Text proposed by the Commission

Amendment

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

Justification

This is also the approach applied by the US FDA, which, in 1998, after studying the derived levels for various age groups, recommended adopting the strictest level by age group and by radionuclide, guaranteeing a high level of protection for the entire population on the basis of protection for the most vulnerable, and thereby simplifying the implementation of recommendations (i.e. same diet for all family members).

Amendment 25

Proposal for a regulation

Recital 13 a (new)


Text proposed by the Commission	Amendment
	(13a) When food or feed originating in the Union or imported from third countries poses a serious risk to human or animal health or to the environment, the Commission should, by means of implementing acts, adopt additional measures in line with Regulation (EC) No 178/2002 to ensure a high level of human and animal health protection. If possible, the maximum applicable permitted limits and the additional emergency measures should be laid down in a single implementing regulation.

Justification

The regulation in question lays down, where necessary, trade-restrictive measures to ensure food safety. These additional measures need to be referred to in this legislation.

Amendment 26

Proposal for a regulation

Recital 13 b (new)


Text proposed by the Commission	Amendment
	(13b) When drawing up or reviewing implementing acts, the Commission should take account primarily of the following circumstances: the location, nature and scope of the nuclear accident or of any other cause of a radiological emergency; the nature and scope of radiological substances released into the air, water or soil, as well as in food and feed, whether inside or outside the Union; the risks of actual or potential radiological contamination of food and feed and the resulting doses of radiation; the type and quantity of contaminated food and feed that can reach the Union market, and the maximum permitted levels for contaminated food and feed in third countries;

Amendment 27

Proposal for a regulation

Recital 13 b (new)

Text proposed by the Commission

Amendment

(13b) In the event of a nuclear accident or radiological emergency which requires the maximum permitted levels to be applied, the public should be informed of the levels in force, both by the Commission and by each Member State. Furthermore, the public should also be provided with information about food and feed liable to accumulate stronger concentrations of radioactivity.

Justification

The obligation to provide information is not contained in the regulation, but is essential for its implementation.

Amendment 28

Proposal for a regulation

Recital 13 c (new)

Text proposed by the Commission

Amendment

(13c) Compliance with the maximum permitted levels should be the subject of appropriate checks, and penalties should be introduced for the deliberate export, import or sale of foodstuffs exceeding the maximum permitted contamination levels.

Justification

For obvious ethical reasons, it is not acceptable to export food with levels of contamination that exceed permitted European levels. Furthermore, it is the EU’s duty to protect its citizens and officials wherever they are – whether they are living or travelling within or outside the EU.

Amendment 29

Proposal for a regulation

Article 2 - paragraph 1


Text proposed by the Commission	Amendment
(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:	(1) ‘food’ means any substance or product as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council;
(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 Council²⁰;
(e) cosmetic products within the meaning of Article 2(1)(a) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council²¹;
(f) tobacco and tobacco products within the meaning of Directive 2001/37/EC of the European Parliament and of the Council²²;
(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.
____________________
²⁰ Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
²¹ Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
²² Directive 2001/37/EC of the European Parliament and of the Council of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (OJ L 194, 18.7.2001, p. 26).

Justification

Regulation (EC) No 178/2002 needs to be mentioned here to avoid any future discrepancy with the definition provided by the Commission in its proposal.

Amendment 30

Proposal for a regulation

Article 2 – paragraph 3


Text proposed by the Commission	Amendment
(3) ‘feed’ means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;	(3) ‘feed’ means any substance or product as defined in Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council;

Justification

Regulation (EC) No 178/2002 needs to be mentioned here to avoid any future discrepancy with the definition provided by the Commission in its proposal.

Amendment 31

Proposal for a regulation

Article 2 - paragraph 4


Text proposed by the Commission	Amendment
(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.	(4) ‘placing on the market’ means an operation as defined in Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council;

Justification

Regulation (EC) No 178/2002 needs to be mentioned here to avoid any future discrepancy with the definition provided by the Commission in its proposal.

Amendment 32

Proposal for a regulation

Article 2 – point 4 a (new)

Text proposed by the Commission

Amendment

4a) "food/feed contact materials" means packages and other materials intended to be in contact with food;

Justification

It is necessary to consider the possible contamination of packages, so, if food does not come from a contaminated area but the package has been produced in a contaminated area, the final food could have radiation. It is necessary to consider these aspect, not only the food origin but also the package origin to decide which foods to control.

Amendment 33

Proposal for a regulation

Article 2 – point 4 b (new)

Text proposed by the Commission

Amendment

4b)"radiological emergency" situation means an unusual event that involves a radiation source and requires immediate intervention to mitigate any serious health or safety threats, or any adverse consequences to the quality of life, to property or to the environment, or represents a danger that could lead to such adverse consequences.

Amendment 34

Proposal for a regulation

Article 2 a (new)

Text proposed by the Commission

Amendment

Article 2a

Practices which consist of blending foodstuffs containing concentrations above those permitted by the rules on maximum permitted levels of radioactive contamination in food and feed with uncontaminated or mildly contaminated foodstuffs, so as to obtain a product that complies with these rules, shall not be authorised.

Amendment 35

Proposal for a regulation

Article 3 – paragraph 1

Proposal for a regulation

Amendment

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).

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 that contaminates food and feed, it shall adopt, in the shortest time possible, an implementing Regulation laying down maximum permitted levels of radioactivity that may not exceed those laid down in the Annexes to this Regulation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 5(2).

Amendment 36

Proposal for a regulation

Article 3 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. The maximum permitted levels shall be made public and regularly revised to take due account of the latest scientific advances and advice as presently available internationally, to reflect the need to reassure the public and to provide them with a high level of protection, and to avoid divergences with international regulatory practices which provide higher levels of protection.

Amendment 37

Proposal for a regulation

Article 3 – paragraph 2


Text proposed by the Commission	Amendment
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).	2. On 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).

Justification

The purpose of the implementing act will be to apply the levels laid down in this Regulation, or, if the circumstances permit, lower levels. When action needs to be taken very quickly, in Article 8(2) of Regulation (EU) No 182/2011 the Commission has provided for an emergency procedure involving an implementing act that is applicable with immediate effect.

Amendment 38

Proposal for a regulation

Article 3 – paragraph 3

Proposal for a regulation

Amendment

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.

3. When preparing the draft implementing act referred to in 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 Council Directive 2013/59/Euratom, including the principle that all exposures shall be kept as low as reasonably achievable, taking into account, as a priority, the protection of the health of the general public and considering economic and societal factors, particularly of the most vulnerable segments of society. In drawing up that act, the Commission shall be assisted by an independent group of public health experts chosen on the basis of their knowledge and expertise in radiological protection and food safety. The Commission shall make public the composition of the committee of experts and its members' declarations of interests.

Amendment 39

Proposal for a regulation

Article 3 – paragraph 3 a (new)

Proposal for a regulation

Amendment

3a. The implementing acts referred to in paragraphs 1 and 2 shall be adopted in line with the nature and scope of the radiation and shall be reviewed as many times as is necessary with regard to the manner in which the contamination develops. The Commission shall undertake to carry out the first review within one month at the latest following a nuclear accident or radiological emergency in order to modify, if necessary, the maximum permitted levels of radioactivity and the list of radionuclides.

Amendment 40

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

1. As soon as 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.

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

Amendment 41

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall put in place a nuclear liability regime that is to address the concerns of all the Member States which might be affected by a nuclear accident; this system shall provide for appropriate compensation in case of nuclear accidents.

Amendment 42

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

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, they undergo a customs procedure other than a transit procedure.

For the purposes of applying this Regulation, food, minor 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 undergoes a customs procedure other than a transit procedure.

Amendment 43

Proposal for a regulation

Article 4 – paragraph 1 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

Member States shall monitor compliance with the maximum permitted levels of radioactive contamination within their territories. For that purpose Member States shall maintain a system of official controls for foodstuffs and feedingstuffs, and undertake other activities as appropriate in the circumstances, including public communication on food and feed safety and risks, in accordance with Article 17 of Regulation (EC) No 178/2002.

Amendment 44

Proposal for a regulation

Article 4 – paragraph 2 and 2 a (new)

Proposal for a regulation

Amendment

2. Each Member State shall provide the Commission with all information concerning the application of this Regulation, in particular concerning:

a) the regular scheduling of checks on the maximum permitted levels on its national territory;

b) cases of non-compliance with the maximum permitted levels;

c) the identification of the national competent services in charge of the controls.

The Commission shall provide this information to the other Member States in the shortest time possible.

Cases of non-compliance with the maximum permitted levels shall be notified via the rapid alert system referred to in Regulation (EC) No 178/2002 of the European Parliament and of the Council.

2 a. Member States shall provide information to the public, mainly by means of an online service, about the maximum permitted levels, emergency situations and cases of non-compliance with the maximum permitted levels. The public shall also be notified about foodstuffs that could accumulate higher concentrations of radioactivity, and, in particular, about the product type, brand, origin and date of analysis.

Amendment 45

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. Each Member State shall provide the Commission with all information concerning the application of this Regulation, in particular concerning cases of non-compliance with the maximum permitted levels. The Commission shall communicate such information to the other Member States. The Commission shall impose penalties on Member States which themselves fail to impose penalties for the placing on the market or exportation of feed exceeding the maximum permitted levels of contamination.

Amendment 46

Proposal for a regulation

Article 4 – paragraph 2 – subparagraph 1 b (new)

Text proposed by the Commission

Amendment

The Annexes shall take into account the effect of the partial decay of radioactive isotopes during the shelf life of preserved foodstuffs. Depending on the type of contamination, for example contamination with iodine isotopes, the radioactivity of preserved foodstuffs shall be constantly monitored.

Amendment 47

Proposal for a regulation

Article 4 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Commission shall submit to the European Parliament and the Council, by 31 March 2017, a report on the appropriateness of a mechanism for compensating farmers whose foodstuffs have been contaminated beyond the maximum permitted levels of radioactive contamination and therefore cannot be placed on the market. Such a mechanism is to be based on the polluter-pays principle. The report shall, if appropriate, be accompanied by a legislative proposal setting up such a mechanism.

Amendment 48

Proposal for a regulation

Article 4 a (new)

Text proposed by the Commission

Amendment

Article 4a

1. The Commission shall submit to the European Parliament and the Council, by 31 March 2017, a report on the pertinence of the maximum permitted levels of radioactive contamination set in the Annexes.

2. The report shall enable verification of whether the maximum permitted levels of radioactive contamination ensure that the limit on the effective dose for public exposure of 1 mSv/year is respected and result in thyroid doses sufficiently below the 10 mGy reference level recommended by the WHO for the administration of stable iodine to especially vulnerable groups.

3. The report shall consider the possibility of reviewing the radionuclide classification and including tritium and carbon 14 in the Annexes. In assessing those maximum permitted levels, the report shall focus on the protection of the most vulnerable population groups, in particular children, and examine whether it would be appropriate to set maximum permitted levels for all categories of the population on that basis.

Amendment 49

Proposal for a regulation

Article 5 – paragraph 1


Text proposed by the Commission	Amendment
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 Council²³. That committee shall be considered as a committee within the meaning of Regulation (EU) No 182/2011.	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 of the European Parliament and of the Council²³. That committee shall be considered as a committee within the meaning of Regulation (EU) No 182/2011.
____________________	____________________
²³Regulation (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 (OJ L 31, 1.2.2002, p. 1).	²³ 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 (OJ L 31, 1.2.2002, p. 1).

Justification

The committee’s name has been changed.

Amendment 50

Proposal for a regulation

Article 6

Proposal for a regulation

Amendment

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.

In order to ensure that the maximum permitted levels laid down in the Annexes to this Regulation take account of any new or additional important data becoming available, in particular with regard to the latest scientific knowledge, the Commission shall submit to the Council and Parliament a report accompanied, where necessary, by a proposal to adapt those annexes and revise, if necessary, the list of radionuclides, after consultation of the Group of Experts referred to in Article 3(3).

Amendment 51

Proposal for a regulation

Article 6 a (new)


Text proposed by the Commission	Amendment
	Article 6a
	Reports
	In the event of a nuclear accident or other cause of a radiological emergency leading to contamination of food and feed, the Commission shall submit a report to the European Parliament and the Council giving details of the measures taken in accordance with this Regulation and the information notified pursuant to Article 4(2).

EXPLANATORY STATEMENT

The European Union needs up-to-date legal instruments that include flexible, situation-specific decision-making procedures to address situations like those that occurred in the wake of the accidents at Chernobyl and Fukushima.

In April 2010, the Commission brought forward a proposal for a recast of Council Regulation (Euratom) No 3954/87 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 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 legal basis of the proposal required that the European Parliament be merely consulted. In February 2011, in line with the opinion of its Committee on Legal Affairs, the European Parliament adopted a legislative resolution on the matter, replacing the legal basis of Articles 31 and 32 of the Euratom Treaty with Article 168(4)(b) of the Treaty on the Functioning of the European Union, meaning that that ordinary legislative procedure would apply.

However, as the proposal moved through the circuit it became clear that the provisions of Regulation (Euratom) No 3954/87 were not compatible with the new comitology rules introduced following the entry into force of the Lisbon Treaty. The Commission therefore decided to withdraw its draft and submit a new one.

The new proposal that is the subject of this report introduces a number of new elements that establish a clearer link with EU legislation on food safety. In its explanatory memorandum, the Commission points out that, taking into account developments in primary EU law with regard to food safety, and the need to ensure coherence of all legislative measures on conditions governing imports of food and feed from third countries affected by a nuclear accident or a radiological emergency, it is vital to align the ‘measures that were established in the post-Chernobyl context […] 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.’ This could be interpreted as a sign that the Commission is perhaps ready to accept a change to the legal basis it has pursued until now.

The annexes to the proposal lay down the maximum permitted levels that apply in the event of a radiological accident or emergency. These were confirmed in 2012 by the group of experts set up pursuant to Article 31 of the Euratom Treaty. The levels are listed in the Commission’s Radiological Protection Publication 105.

In the event of a radiological accident or emergency, the Commission will adopt an implementing act so as to apply the maximum permitted levels of radioactivity in food. The Commission will have a lot of room for manoeuvre with regard to adapting the limits laid down in the annexes, if necessary under the circumstances.

Under the new comitology rules, the Commission will for the first time have to be assisted by the section of the Standing Committee on Plants, Animals, Food and Feed responsible for 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.

The rapporteur’s views

In line with the position adopted by the European Parliament in 2010, the rapporteur proposes that the legal basis of the regulation should be changed so as to give Parliament the power of codecision. Food safety is the ultimate objective of the Commission proposal, and the regulation has to reflect developments in EU law since the adoption of the Maastricht Treaty in 1992, which included an article on public health (Article 168) that must be taken into account when amending legislation adopted prior to that. This is particularly relevant and something to which close attention needs to be paid in weighing up the European Parliament’s decision-making powers. The rapporteur proposes that the legal bases should be Article 168(4)(b) and Article 114 of the Treaty on the Functioning of the European Union, which grant Parliament the power of codecision with regard to both food and feed.

The rapporteur takes the view that implementing acts are the best way of ensuring that action can be taken quickly to address critical situations in the wake of a nuclear accident or other radiological emergency. The Commission actually provides for a specific emergency procedure involving the adoption of an implementing act without prior consideration when immediate action is vital in order to guarantee consumer safety. Parliament would nevertheless reserve the right for codecision to apply in amending the limits laid down in the annexes to the regulation should this be necessary in the light of new scientific findings. The draft report also includes an obligation on the Commission to submit a report to Parliament and the Council on the measures taken in the event of a nuclear accident or other radiological emergency.

With regard to implementing acts adopted in the event of a nuclear accident or other radiological emergency, the draft report makes it possible for such acts to be reviewed as many times as is necessary in order to take account of the way in which the contamination develops.

In the recitals, the draft report points out which parameters were used to establish the maximum permitted levels laid down in the annexes to the regulation.

The Commission proposal needs to be fleshed out by including references to the procedures provided for in Regulation (EC) No 178/2002 laying down the general principles of food law, which includes a ‘rapid alert system’ making it possible for information to be exchanged quickly. The relevant legislative references also need to be included with regard to the definitions of ‘food’, ‘feed’ and ‘placing on the market’ set out in the regulation. The inclusion of such references would ensure that any amendments to those definitions apply automatically. If this were not done, discrepancies might crop up between Regulation (EC) No 178/2002 and this regulation.

OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS

Mr Giovanni La Via

Chair

Committee on the Environment, Public Health and Food Safety

BRUSSELS

Subject: Opinion on the legal basis of the 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 (COM(2013)0943 – 2013/0451(NLE))

Dear Mr Chair,

By letter of 5 February 2015 you asked the Committee on Legal Affairs pursuant to Rule 39(2) to consider whether the legal basis of the above Commission proposal was appropriate.

The legal basis proposed by the Commission is Articles 31 and 32 of the Treaty establishing the European Atomic Energy Community (Euratom Treaty).

Amendments tabled in the Committee on the Environment, Public Health and Food Safety aim at changing the legal basis to Articles 168(4)(b) and 114 of the Treaty of the Functioning of the European Union (TFEU).

The Committee on Legal Affairs considered the above question at its meeting on 24 March 2015.

I - Background

The proposed Council regulation aims at replacing Council Regulation (Euratom) No 3954/87, Commission Regulation (Euratom) No 944/89 and Commission Regulation (Euratom) No 770/90, which all relate to permitted levels of radioactive contamination of food and feed.

This proposal constitutes a modification of an earlier proposal for a recast of these acts made in 2010, which did however not align provisions to Article 291 TFEU on the conferral of implementing powers and the 2011 Implementing Acts Regulation[1]. In 2011, Parliament adopted a legislative resolution on the 2010 recast proposal in which it changed the legal basis from Articles 31 and 32 of the Euratom Treaty to Article 168(4)(b) TFEU[2].

The modified proposal, which is the object of this opinion, did however maintain Articles 31 and 32 of the Euratom Treaty as its legal basis.

The draft report on the proposal in the Committee on the Environment, Public Health and Food Safety includes an amendment which aims at changing the legal basis to Articles 168(4)(b) and 114 TFEU, with the following justification:

[AM 2] The regulation needs to take account of developments in the EU Treaties, and especially the inclusion in the Maastricht Treaty (1992) of Article 168 on public health, which post-dates the adoption of the Euratom regulations that are still in force. Article 168(4)(b) covers harmonisation measures for feed, and Article 114 on the internal market guarantees harmonisation of the maximum residue limits for food.

The following amendments tabled to the draft report also aim at changing the legal basis, with the following justifications:

[AM 24] To ensure a high level of health protection for EU citizens in the event of radioactive contamination and to give democratic legitimacy to the adoption of this Regulation, the legal basis should be changed to Article 168(4) of the Treaty on the Functioning of the European Union, to give the Parliament a decision-making role on a regulation potentially affecting public health.

[AM 28] To ensure a high level of health protection for EU citizens in the event of radioactive contamination and to give democratic legitimacy to the adoption of this regulation, the legal basis should be changed under the new Lisbon Treaty to give the European Parliament a decision-making role on a regulation potentially affecting public health. The proposal is to consider public health (Article 168) and consumer protection (Article 169(1)).

II - Relevant Treaty Articles

The following Articles of the Euratom Treaty, under Chapter 3 entitled "Health and safety" are presented as the legal basis in the Commission proposal (emphasis added):

Article 31

The basic standards shall be worked out by the Commission after it has obtained the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts, and in particular public health experts, in the Member States. The Commission shall obtain the opinion of the Economic and Social Commttee on these basic standards.

After consulting the European Parliament the Council shall, on a proposal from the Commission, which shall forward to it the opinions obtained from these Committees, establish the basic standards; the Council shall act by a qualified majority.

Article 32

At the request of the Commission or of a Member State, the basic standards may be revised or supplemented in accordance with the procedure laid down in Article 31.

The Commission shall examine any request made by a Member State.

The expression "basic standards" is defined in Article 30 of the Euratom Treaty (emphasis added):

Article 30

Basic standards shall be laid down within the Community for the protection of the health of workers and the general public against the dangers arising from ionizing radiations.

The expression 'basic standards" means:

(a) maximum permissible doses compatible with adequate safety;

(b) maximum permissible levels of exposure and contamination;

The following Articles of the TFEU are proposed by the Committee on the Environment, Public Health and Food Safety to form the legal basis (emphasis added).

Article 168

(ex Article 152 TEC)

[...]

4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:

(a) [...]

(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;

[...]

Article 114

(ex Article 95 TEC)

1. Save where otherwise provided in the Treaties, the following provisions shall apply for the achievement of the objectives set out in Article 26. The European Parliament and the Council shall, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.

2. [...]

3.The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

[...]

8. When a Member State raises a specific problem on public health in a field which has been the subject of prior harmonisation measures, it shall bring it to the attention of the Commission which shall immediately examine whether to propose appropriate measures to the Council.

III - The proposed legal basis

Article 31 of the Euratom Treaty provides the legal basis for the adoption of basic standards for the protection of the health of workers and the general public against radiation, whereas Article 32 of the Euratom Treaty provides the legal basis for the revision of the basic standards and the provisions supplementing them. The Council acts unanimously and the Parliament is consulted.

Article 168(4)(b)TFEU provides the legal basis for the adoption of measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health. These measures are adopted in accordance with the ordinary legislative procedure.

Article 114 TFEU provides the legal basis for the establishment and the functioning of the internal market by the adoption of measures for the approximation of provisions in this respect. Such measures are adopted in accordance with the ordinary legislative procedure.

IV - Case-law and previous opinions on legal basis

It is settled case law of the Court of Justice that "the choice of legal basis for a Community measure must rest on objective factors amenable to judicial review, which include in particular the aim and content of the measure"[3]. The choice of an incorrect legal basis may therefore justify the annulment of the act at stake.

The Legal Service of Parliament has pointed the Committee's attention to the fact that the Court has recently ruled[4] on the question of the correct legal basis for a legislative act[5] which raises the same questions as concerning the proposal in question. The Court stated the following in relevant parts (emphasis added):

35. However, the Court has repeatedly held that the provisions of Chapter 3 of Title II of the EAEC Treaty are to be interpreted broadly in order to give them practical effect [...]. Those provisions, which include Articles 30 EA and 31 EA, accordingly are intended to ensure the consistent and effective protection of the health of the general public against the dangers arising from ionising radiations, whatever their source and whatever the categories of persons exposed to such radiations [...].

36. In addition, if the Treaties contain a more specific provision that is capable of constituting the legal basis for the measure in question, the measure must be founded on that provision [...].

37. Article 31 EA constitutes a more specific legal basis for protecting the health of populations against radioactive substances in water intended for human consumption than the general legal basis resulting from Article 192(1) TFEU. The EAEC Treaty contains a set of rules relating precisely to the protection of populations and the environment against ionising radiations [...].

38. In any event, if the mere finding that a measure relating to radioactive substances is to protect human health within the meaning of Article 191(1) TFEU were sufficient for Article 192(1) TFEU to be accepted as the appropriate legal basis for that measure, Article 31 EA could no longer serve as the legal basis for Community action since the basic standards within the meaning of Article 30 EA have, by their nature, the protection of human health as their objective. The Parliament’s argument accordingly misconstrues not only the practical effect of Article 31 EA, which constitutes a more specific legal basis than Article 192(1) TFEU, but also the principle enshrined in Article 106a(3) EA, according to which the provisions of the TFEU are not to derogate from the provisions of the EAEC Treaty.

The Court has therefore unambiguously determined that the procedure in Article 31 of the Euratom Treaty takes precedence over more general provisions in the TFEU when it comes to Union measures aimed at the protection of the health of the general public against radiation and radioactive contamination.

In its opinion of 17 September 2013 to the Committee on the Environment, Public Health and Food Safety on the legal basis of the proposal for a legislative act on safety standards against the dangers of radiation[6], the Committee on Legal Affairs recommended that the appropriate legal basis should be Articles 31 and 32 rather than Article 192(1) TFEU.

V - Aim and content of the proposed regulation

The aim of the proposal is to consolidate existing Euratom legislation in order to establish basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure against the dangers arising from radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency for the purpose of their uniform implementation by Member States.

The proposal and its annexes lay down the maximum permitted levels of radioactive contamination of food, the maximum permitted levels of minor food, and the maximum permitted levels of radioactive contamination of feed, which may be placed on the market 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, and the procedures to render these maximum permitted levels applicable.

VI - Determination of the appropriate legal basis

The acts being repealed by the proposal were all based on Article 31 of the Euratom Treaty, and the same maximum permitted levels pre-established for future accidents are maintained in the proposed regulation. Taking into consideration the development of scientific knowledge on doses and the risks of the radioactive contamination, the basic standards will possibly have to be revised or supplemented in the future. Article 32 of the Euratom Treaty has therefore also been included as a legal basis for the proposal.

In order to establish whether this choice of legal basis is appropriate, as the principles derived from the jurisprudence of the Court indicate, the aim and content of the proposed measure constitute the decisive factors.

The predominant aim of the proposal is to establish basic safety standards against the dangers arising from radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency under the Euratom system. The proposal therefore contains the maximum levels of radiation for food and feed, and the procedure for updating them.

Against the background of the Court's case-law and the Committee's previous practice, in particular the above-cited judgment in Case C-48/14 and the opinion on the legal basis of the 2013 ionising radiation directive, Articles 31 and 32 of the Euratom Treaty must therefore constitute the legal basis for the proposal. The use of any suggested alternative legal bases from the TFEU which are of a more general nature when it comes to public health, the environment or consumer protection, including Articles 168(4)(b) and 114 TFEU, would most likely lead to the annulment of the act if challenged at the Court.

VII - Conclusion

Articles 31 and 32 of the Euratom Treaty constitute the appropriate legal basis for the proposal.

VIII - Recommendation

At its meeting of 24 March 2015 the Committee on Legal Affairs accordingly decided, by 21 votes in favour and 2 against, with 2 abstentions

[7]

, to recommend to the Committee on the Environment, Public Health and Food Safety to not alter the legal basis of Articles 31 and 32 of the Euratm Treaty as proposed by the Commission, unless substantive provisions of the regulation are amended so as to make possible to add additional legal bases.

Yours sincerely,

Pavel Svoboda

[1] 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 (OJ L 55, 28.2.2011, p. 13).
[2] See the opinion of the Committee on Legal Affairs of 22 November 2010.
[3] Case C-45/86, Commission v. Council (Generalised Tariff Preferences) [1987] ECR 1439, para. 5; Case C-440/05 Commission v. Council [2007] E.C.R. I-9097; Case C-411/06 Commission v. Parliament and Council (8 September 2009) (OJ C 267 of 07.11.2009. p.8).
[4] Case C-48/14, Parliament v. Council.
[5] Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12).
[6] Council Directive 2013/59/EURATOM of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
[7] The following were present for the final vote: Pavel Svoboda (Chair), Jean-Marie Cavada, Mady Delvaux, Lidia Joanna Geringer de Oedenberg, Axel Voss (Vice-Chairs), Heidi Hautala (rapporteur), Joëlle Bergeron, Marie-Christine Boutonnet, Daniel Buda, Kostas Chrysogonos, Therese Comodini Cachia, Andrzej Duda, Pascal Durand, Angel Dzhambazki, Rosa Estaràs Ferragut, Laura Ferrara, Enrico Gasbarra, Jytte Guteland,
Mary Honeyball, Dietmar Köster, Gilles Lebreton, António Marinho e Pinto, Jiří Maštálka, Victor Negrescu, Emil Radev, Julia Reda, Evelyn Regner, Tadeusz Zwiefka.

RESULT OF FINAL VOTE IN COMMITTEE

Date adopted	26.5.2015
Result of final vote	+: –: 0:	42 21 2
Members present for the final vote	Marco Affronte, Margrete Auken, Pilar Ayuso, Ivo Belet, Simona Bonafè, Biljana Borzan, Lynn Boylan, Cristian-Silviu Buşoi, Nessa Childers, Birgit Collin-Langen, Mireille D’Ornano, Miriam Dalli, Seb Dance, Angélique Delahaye, Jørn Dohrmann, Ian Duncan, Bas Eickhout, Eleonora Evi, Karl-Heinz Florenz, Francesc Gambús, Iratxe García Pérez, Elisabetta Gardini, Gerben-Jan Gerbrandy, Jens Gieseke, Sylvie Goddyn, Matthias Groote, Françoise Grossetête, Andrzej Grzyb, Jytte Guteland, György Hölvényi, Anneli Jäätteenmäki, Kateřina Konečná, Giovanni La Via, Peter Liese, Susanne Melior, Gilles Pargneaux, Piernicola Pedicini, Marcus Pretzell, Frédérique Ries, Daciana Octavia Sârbu, Annie Schreijer-Pierik, Davor Škrlec, Dubravka Šuica, Tibor Szanyi, Claudiu Ciprian Tănăsescu, Nils Torvalds, Glenis Willmott, Jadwiga Wiśniewska, Damiano Zoffoli
Substitutes present for the final vote	Renata Briano, Soledad Cabezón Ruiz, Mark Demesmaeker, Esther Herranz García, Jan Huitema, Merja Kyllönen, Gesine Meissner, József Nagy, James Nicholson, Younous Omarjee, Sirpa Pietikäinen, Christel Schaldemose, Bart Staes, Keith Taylor
Substitutes under Rule 200(2) present for the final vote	Fredrick Federley, Jiří Maštálka

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