(Ordinary legislative procedure - first reading)

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 establishing the European Atomic Energy Community, 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 Article 294(3) and Articles 168(4) (b) and 114 of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 25 March 2014(1),

–  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.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to alter its proposal accordingly, pursuant to Article 293(2) of the Treaty on the Functioning of the European Union;

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

(1) OJ C 226, 16.7.2014, p. 68.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing on the Functioning of the European Atomic Energy Community Union, and in particular Articles 31 Article 168(4)(b) and 32 Article 114 thereof, [Am. 2]

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(1),

Having regard to the opinion of the European Economic and Social Committee(2),

Having regard to the opinion of the European Parliament(3), Acting in accordance with the ordinary legislative procedure(4), [Am. 3]

Whereas:

(1)  Council Directive 96/29/Euratom 2013/59/Euratom(5) lays down basic safety standards for the protection of the health of workers and the general public against the dangers arising from exposure to ionising radiation. [Am. 4]

(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. [Am. 5]

(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 significant from the 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 are were only introduced into the Union according to the common arrangements which in order to safeguard the health of the population while maintaining the unified nature of the market and avoiding deflections of trade. [Am. 6]

(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. [Am. 7]

(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. [Am. 8]

(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. [Am. 9]

(3)  Council Regulation (Euratom) No 3954/87(6), as amended by Council Regulation (Euratom) No 2218/89(7), 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 International 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. [Am. 10]

(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 threshold levels in food 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. [Am. 11]

(5)  There is a need to set up a system allowing the European Atomic Energy Community 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 protect the population ensure a high level of public health protection. [Am. 12]

(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. [Am. 13]

(7)  The Commission is to be informed of a nuclear accident or of unusually high levels of radioactivity according to Council Decision 87/600/Euratom(8), or under the IAEA Convention on early notification of a nuclear accident of 26 September 1986.

(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. Lower maximum permitted levels for foods should be applied to pregnant and breastfeeding women. [Am. 14]

(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 and technical progress at international level, the Commission should include the consultation of the Group of Experts referred to in Article 31 of the Treaty present to the European Parliament and the Council a new proposal to adapt the maximum permitted levels. [Am. 15]

(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. [Am. 16]

(9b)  The group of experts should also estimate the cumulative effect of radioactive contamination. [Am. 17]

(9c)  The maximum permitted levels should be made public and should be regularly revised to take due account of the latest scientific advances and advice as currently 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. [Am. 18]

(10)  In order to ensure that food and feed exceeding the maximum permitted levels are not placed on the market of the EU Union, compliance with these levels should be the subject of appropriate thorough checks by the Member States and the Commission. Penalties for non-compliance should be applied and the public should be informed accordingly. [Am. 19]

(10a)  The rules for verifying compliance with measures designed to prevent, eliminate or reduce to acceptable levels contamination risks to humans or animals, are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council(9). [Am. 20]

(11)  In order to ensure uniform conditions for the implementation of this Regulation as regards rendering applicable the pre-established maximum permitted levels, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(10).

(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 those 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. [Am. 21]

(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(11). The Member States should ensure that their representatives on the committee have sufficient knowledge of radiological protection. [Am. 22]

(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. The public should be informed immediately of the measure and of the maximum levels. [Am. 23]

(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. [Am. 24]

(13b)  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. [Am. 25]

(13c)  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. [Am. 26]

(13d)  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. [Am. 27]

(13e)  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, [Am. 28]

HAS HAVE ADOPTED THIS REGULATION:

Article 1

This Regulation lays down the maximum permitted levels of radioactive contamination of food as set out in Annex I, 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. [Am. 54]

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: as defined in Article 2 of Regulation (EC) No 178/2002;

(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(12);

(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(13);

(f)  tobacco and tobacco products within the meaning of Directive 2001/37/EC of the European Parliament and of the Council(14);

(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. [Am. 29]

(2)  "minor food" means food of minor dietary importance which makes only a marginal contribution to food consumption by the population; [Am. 55]

(3)  "feed" means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals as defined in Article 3 of Regulation (EC) No 178/2002; [Am. 30]

(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. an operation as defined in Article 3 of Regulation (EC) No 178/2002; [Am. 31]

(4a)  "food/feed contact materials" means packages and other materials intended to be in contact with food; [Am. 32]

(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. [Am. 33]

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 the rules laid down in this Regulation, shall not be authorised. [Am. 34]

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, that contaminate food and feed, it shall adopt, if the circumstances so require, in the shortest time possible, an implementing Regulation rendering applicable act laying down maximum permitted levels of radioactivity that may not exceed those maximum permitted levels 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). [Am. 35]

1a.  The maximum permitted levels shall be made public and regularly revised to take due account of the latest scientific advances and advice as available at the relevant time 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. [Am. 36]

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 act in accordance with the procedure referred to in Article 5(3). [Am. 37]

3.  When preparing the draft implementing act acts referred to in paragraphs 1 and 2 of this Article 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 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 into account, particularly of the most vulnerable segments of society. In drawing up those acts, 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 (“group of experts”). The Commission shall make public the composition of the group of experts and its members' declarations of interests. [Am. 38]

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. [Am. 39]

Article 4

1.  As soon as the Commission adopts an implementing Regulation act rendering applicable maximum permitted levels, food, or feed not in compliance with those maximum permitted levels shall not be placed on the market. [Am. 40]

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. That regime shall provide for appropriate compensation in case of nuclear accidents. [Am. 41]

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 it undergoes a customs procedure other than a transit procedure. [Am. 42]

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. [Am. 43]

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.:

(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 communicate provide such 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.

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. [Am. 44]

3.  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. [Am. 45]

4.  The maximum permitted levels laid down in the annexes to this Regulation 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. [Am. 46]

5.  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. [Am. 47]

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 out 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 to this Regulation. 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. [Am. 48]

Article 5

1.  The Commission shall be assisted by the Standing Committee on the Plants, Animals, Food Chain and Animal Health and Feed established by Article 58(1) of Regulation (EC) No 178/2002 of the European Parliament and of the Council(15). That committee shall be considered as a committee within the meaning of Regulation (EU) No 182/2011. [Am. 49]

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 the Annexes I, II and III to this Regulation take account of any new or additional important data becoming available, in particular with regard to the latest scientific knowledge, adaptations to those Annexes shall be proposed by the Commission shall submit to the Parliament and the Council 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 31 of the Treaty establishing the European Atomic Energy Community 3(3). [Am. 50]

Article 6a

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). [Am. 51]

Article 7

Regulation (Euratom) No 3954/87, as amended by Regulation (Euratom) No 2218/1989, and Commission Regulations (Euratom) No 944/89(16) and No 770/90(17) 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 …,

For the European Parliament For the Council

The President 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:

ANNEX II

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF MINOR FOOD

1.  List of minor food

2.  The maximum permitted levels to be applied to the minor food as listed in paragraph 1, shall be the following

[Am. 57]

ANNEX III

Maximum permitted levels of radiactive contamination of feed

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

ANNEX IV

Repealed Regulations

ANNEX V

Correlation Table

(1) OJ C..p.. (2) OJ C , , p. . (3) OJ C , , p. . (4) Position of the European Parliament of 9 July 2015 (not yet published on the Official Journal) and position of the Council of ... . (5) Council Directive 96/29/Euratom 2013/59/Euratom of 13 May 1996 5 December 2013 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (OJ L 159, 29.6.1996, p. 1.), 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). (6) 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 (OJ L 371, 30.12.1987, p. 11). (7) Council Regulation (Euratom) No 2218/89 of 18 July 1989 amending 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 (OJ L 211, 22.7.1989, p. 1). (8) Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of radiological emergency (OJ L 371, 30.12.1987, p. 76). (9) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). (10) 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). (11) 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). (12) 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). (13) 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). (14) 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). (15) 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). (16) 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 (OJ L 101, 13.4.1989, p. 17). (17) 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 (OJ L 83, 30.3.1990, p. 78). (18) 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. (19) 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. (20) 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). (21) Minor food and the corresponding levels to be applied to them are set out in Annex II. (22) 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. (23) Carbon 14, tritium and potassium 40 are not included in this group. (24) Carbon 14, tritium and potassium 40 are not included in this group. (25) 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. (26) These levels apply to feed as ready for consumption.