Article 1 Subject matter
This Regulation lays down the maximum permitted levels of radioactive contamination of: (a) food, as set out in Annex I; (b) minor food, as set out in Annex II; and (c) feed, as set out in Annex III, which may be placed on the market following a nuclear accident or any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed. This Regulation also lays down the procedure to adopt or subsequently amend implementing Regulations laying down the applicable maximum permitted levels.
Article 2 Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘food’ means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance intentionally incorporated into the food during its manufacture, preparation or treatment. ‘Food’ does not include: (a) feed; (b) live animals unless they are prepared for placing on the market for human consumption; (c) plants prior to harvesting; (d) medicinal products within the meaning of point (2) of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council ( 10 ) ; (e) cosmetic products within the meaning of point (a) of Article 2(1) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council ( 11 ) ; (f) tobacco and tobacco products within the meaning of, respectively, points (1) and (4) of Article 2 of Directive 2014/40/EU of the European Parliament and of the Council ( 12 ) ; (g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971; (h) residues and contaminants; (i) water intended for human consumption within the meaning of point (1) of Article 2 of Directive 2013/51/Euratom; (2) ‘minor food’ means food of minor dietary importance which makes only a marginal contribution to food consumption by the population; (3) ‘feed’ means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals; (4) ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves; (5) ‘radiological emergency’ means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, property or the environment, or a hazard that could give rise to such serious adverse consequences.
Article 3 Applicable maximum permitted levels
1. If the Commission receives — in particular either under the Community arrangements for the early exchange of information in the event of a radiological emergency, or under the IAEA Convention on Early Notification of a Nuclear Accident of 26 September 1986 — official information on a nuclear accident or on any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, it shall adopt an implementing Regulation rendering applicable maximum permitted levels to the potentially contaminated food or feed that could be placed on the market. Without prejudice to Article 3(4), the applicable maximum permitted levels set out in such an implementing Regulation shall not exceed those set out in Annexes I, II and III. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 5(2). On duly justified imperative grounds of urgency relating to the circumstances of the nuclear accident or other radiological emergency, the Commission shall adopt an immediately applicable implementing Regulation in accordance with the procedure referred to in Article 5(3). 2. The period of validity of implementing Regulations adopted under paragraph 1 shall be as short as possible. The duration of the first implementing Regulation following a nuclear accident or any other case of radiological emergency shall not exceed 3 months. Implementing Regulations shall be periodically reviewed by the Commission and, if appropriate, amended on the basis of the nature and location of the accident and of the evolution of the level of radioactive contamination effectively measured. 3. When preparing or reviewing implementing Regulations, the Commission shall take into account the basic standards laid down pursuant to Articles 30 and 31 of the Treaty, including the justification principle and the optimisation principle, with the aim of keeping the magnitude of individual doses, the likelihood of exposure and the number of individuals exposed as low as reasonably achievable, taking into account the current state of technical knowledge and economic and societal factors. When reviewing implementing Regulations, the Commission shall consult the group of experts referred to in Article 31 of the Treaty if a nuclear accident or any other case of radiological emergency causes such widespread contamination of food or feed consumed in the Community that the rationale and assumptions underpinning the maximum permitted levels set out in Annexes I, II and III to this Regulation are no longer valid. The Commission may seek the opinion of that group of experts in any other case of contamination of food or feed consumed in the Community. 4. Without prejudice to the health protection objective pursued by this Regulation, the Commission may, by means of implementing Regulations, allow any Member State, at its request and in the light of exceptional circumstances prevailing in that Member State, to derogate temporarily from the maximum permitted levels in respect of specified food or feed consumed on its territory. Those derogations shall be based on scientific evidence and be duly justified by the circumstances, in particular societal factors, prevailing in the Member State concerned.
Article 4 Restrictive measures
1. When the Commission adopts an implementing Regulation rendering applicable maximum permitted levels, food or feed not in compliance with those maximum permitted levels shall not be placed on the market, as from the date specified in that implementing Regulation. For the purposes of applying this Regulation, food or feed imported from third countries shall be considered to be placed on the market if, on the customs territory of the Union, it is placed under a customs procedure other than a transit procedure. 2. Each Member State shall provide the Commission with all information concerning the application of this Regulation. The Commission shall communicate such information to the other Member States. Any case of non-compliance with the applicable maximum permitted levels shall be notified through the Rapid Alert System for Food and Feed (RAFF).
Article 5 Committee procedure
1. The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Article 6 Reporting
In the event of a nuclear accident or any other case of a radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, the Commission shall submit to the European Parliament and to the Council a report. The report shall cover the implementation of the measures undertaken pursuant to this Regulation and notified to the Commission in accordance with Article 4(2).
Article 7 Repeal
Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 ( 13 ) and (Euratom) No 770/90 ( 14 ) are repealed. References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV.
Article 8 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .