Article 1 
1. This Directive shall apply to the manufacture, marketing and importation of foods and food ingredients, hereinafter called ‘foodstuffs’, treated with ionising radiation. 2. This Directive shall not apply to: (a) foodstuffs exposed to ionising radiation generated by measuring or inspection devices, provided that the dose absorbed is not greater than 0,01 Gy for inspection devices which utilise neutrons and 0,5 Gy in other cases, at a maximum radiation energy level of 10 MeV in the case of X-rays, 14 MeV in the case of neutrons and 5 MeV in other cases; (b) the irradiation of foodstuffs which are prepared for patients requiring sterile diets under medical supervision.
Article 2 
Member States shall take all measures necessary to ensure that irradiated foodstuffs can be placed on the market only if they comply with the provisions of this Directive.
Article 3 
1. The conditions which must be fulfilled for authorisation of the treatment of foodstuffs with ionising radiation are set out in Annex I. At the time of treatment such foodstuffs must be in a suitably wholesome state. 2. Irradiation may be carried out only by means of the sources listed in Annex II and in accordance with the requirements of the Code of Practice referred to in Article 7(2). The overall average absorbed dose shall be calculated in accordance with Annex III.
Article 4 
1. The Community list of foodstuffs which may be treated with ionising radiation to the exclusion of all others and the maximum radiation doses authorised shall be defined in the implementing Directive, which shall be adopted in accordance with the procedure laid down in Article 100a of the Treaty taking account of the authorisation conditions set out in Annex I. 2. This list shall be established in stages. 3. The Commission shall examine the national authorisations in force and, after consulting the Scientific Committee for Food, submit in accordance with the procedure laid down in Article 100a of the Treaty proposals aiming at establishing the list. At the latest 31 December 2000, the Commission shall, in accordance with Article 100a of the Treaty, submit a proposal intended to complete the positive list provided for in paragraph 1. 5. Until entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, any Member State may also authorise the treatment of foodstuffs for which authorisations have been maintained by another Member State in accordance with paragraph 4, where the conditions referred to in paragraph 4 are fulfilled. 6. Member States shall forthwith notify the Commission and the other Member States of authorisations maintained under paragraph 4 or granted under paragraph 5 and of conditions attaching to them. The Commission shall publish these notifications in the Official Journal of the European Communities . 7. Until the entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on ionising radiation of foodstuffs and on trade in irradiated foodstuffs which are not included in the initial positive list established by the implementing Directive.
Article 5 
1. The maximum radiation dose for foodstuffs may be given in partial doses; however, the maximum radiation dose fixed in accordance with Article 4 must not be exceeded. Irradiation treatment may not be used in combination with any chemical treatment having the same purpose as that treatment. 2. Exceptions to paragraph 1 may be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(4).
Article 6 
The labelling of foodstuffs treated with ionising radiation shall be governed by the following provisions: 2. in the case of products not intended for the ultimate consumer and mass caterers: (a) the words provided for in the previous paragraph shall be used to indicate treatment of both the foods and the ingredients contained in a non-irradiated foodstuff; (b) either the identity and address of the facility which carried out the irradiation or its reference number as provided for in Article 7 shall be indicated; 3. the indication of treatment shall in all cases be given on the documents which accompany or refer to irradiated foodstuffs.
Article 7 
1. Member States shall inform the Commission of the competent authority or authorities responsible for: — prior approval of irradiation facilities, — the allocation of an official reference number for approved irradiation facilities, — official control and inspection, — withdrawal or modification of approval. 2. Approval shall be granted only if the facility: — meets the requirements of the joint FAO/WHO Codex Alimentarius Commission Recommended International Code of Practice for the operation of irradiation facilities used for the treatment of foods (reference FAO/WHO/CAC, Vol. XV, edition 1), and any supplementary requirement which may be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(4), — designates a person responsible for compliance with all the conditions necessary for the application of the process. 3. Each Member State shall forward to the Commission: — the names, addresses and reference numbers of the irradiation facilities which it has approved, the text of the approval document, and any decision suspending or withdrawing approval. Furthermore the Member States shall forward to the Commission every year: — the results of checks carried out in the ionising irradiation facilities, in particular regarding the categories and quantities of products treated and the doses administered, — the results of checks carried out at the product marketing stage. Member States shall ensure that the methods used to detect treatment with ionising radiation comply with paragraphs 1 and 2 of the Annex to Directive 85/591/EEC ( 1 ) and are standardised or validated either already or as soon as possible, up to 1 January 2003 at the latest. Member States shall inform the Commission of the methods used and the Commission shall assess the use and development of these methods having regard to an opinion of the Scientific Committee for Food. 4. On the basis of the data supplied in accordance with paragraph 3, the Commission shall publish in the Official Journal of the European Communities : — the details of the facilities as well as any changes in their status, — a report based on the information provided every year by the national supervisory authorities.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’ 1 , the Commission stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a dedicated effort to rationalise and simplify reporting requirements, with the ultimate aim to reduce such requirements by 25%, without undermining the related policy objectives. Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. Streamlining reporting obligations and reducing administrative burden is therefore a priority. In this context, the present proposal aims to simplify initiatives included in headline ambition ‘An Economy that works for the people’, A ‘European Green deal’ and ‘Promoting our European way of life’ in the policy area of the Internal Market, Food safety and Health and impacting respectively the outdoor equipment and the radio equipment industry/sectors as well as sectors related to food treated with ionising radiation and on cross-border healthcare. The proposal aims to rationalise reporting obligations by a combination of measures: – f or Directive 1999/2/EC on foods and food ingredients treated with ionising radiatio n 2 , and for Directive 2000/14/EC on the noise emission of outdoor equipment 3 , this proposal aims to remove reporting obligations that are not necessary; – f or Directive 2014/53/EU on radio equipment 4 , t his proposal aims to reduce the frequency of the reporting obligation of Member States ; – f or Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare 5 , this proposal aims to reduce the frequency of the reporting obligation. With regard to Directive 1999/2/EC, the reporting obligation concerns both Member States and the Commission. Article 7(3) of Directive 1999/2/EC provides that Member States report annually to the Commission the results of official controls they have carried-out in food irradiation facilities and on irradiated food placed on the market. Article 7(4) of that Directive provides that the Commission publishes in the Official Journal of the European Union a report based on the information provided every year by the national supervisory authorities. These reporting obligations have become redundant, as annual reporting obligations for Member States’ competent authorities and the Commission are respectively also laid down in Articles 113 and 114 of Regulation (EU) 2017/625 6 . Those obligations are sufficient to ensure enforcement and facilitate monitoring of the effectiveness of legislation. Therefore, the proposal provides for the deletion of the similar reporting obligations currently laid down in Article 7(3) and (4) of Directive 1999/2/EC. With regard to Directive 2000/14/EC, those reporting requirements concern both companies and public authorities. Indeed, Article 16 of Directive 2000/14/EC provides that manufacturers, or their authorised representatives, shall send to both the authorities of Member States and to the Commission a copy of the EC declaration of conformity for equipment covered by that Directive. The Commission has then the obligation to collect the data and publish the relevant information periodically. According to recital 14 of Directive 2000/14/EC, one of the principal justifications for this reporting obligation was to provide for ‘a basis for informed consumer choice’. However, it appears that this reporting obligation creates an unnecessary administrative burden in this respect, since consumers are already informed of the noise emission level via the mandatory noise marking affixed on all the equipment covered by that Directive. Consumers are also informed on the noise emission of the specific equipment via the instructions for use for machines which are under the scope of both Directive 2006/42/EC 7 on machinery and its successor Regulation (EU) 2023/1230 8 , as those pieces of legislation cover 55 of the 57 equipment categories that fall within the scope of Directive 2000/14/EC. Consequently, it is proposed to delete Article 16 of Directive 2000/14/EC. With regard to Directive 2011/24/EU the reporting obligation concerns the Commission. However, indirectly it also concerns Member States, as the Commission’s reporting relies largely on the Member States’ contributions on how the Directive is being applied at national level. Article 20(1) of Directive 2011/24/EU provides that the Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of the Directive and submit it to the European Parliament and to the Council. The European Reference Networks established under Directive 2011/24/EU are to be evaluated every 5 years in accordance with Article 14(1) of Commission Implementing Decision setting out criteria for establishing and evaluating European Reference Networks 9 . The evaluation of the functioning and operations of all European Reference Networks is a key part of the content of the reports on the operation of Directive 2011/24/EU. Consequently, the current frequency of reporting is disproportionate and does not have added value in the absence of a parallel evaluation of the European Reference Networks. In addition to that, the current reporting period of 3 years is, in practice, insufficient for the Commission and Member States to address all follow-up actions expected. Furthermore, if the two processes (reporting on the operation of the Directive and evaluating the European Reference Networks) were aligned, synergies between the report and the evaluation could be ensured. Therefore, it is proposed to provide for the reporting on the operation of Directive 2011/24/EU to be carried out every 5 years. With regard to Directive 2014/53/EU, the reporting obligation in question concerns Member States. Indeed, Article 47(1) of Directive 2014/53/EU provides that Member States shall submit to the Commission, every two years, a report on the application of the Directive which is to contain a presentation of the market surveillance activities performed by the Member States and whether requirements of that Directive have been attained. The current frequency of that obligation does not match the reporting obligation from the Commission to the European Parliament and to the Council which takes place every five years. In that spirit, it is proposed to reduce the frequency of the reporting obligation of Member States to every five years. 
Revised version (Article 7 ):
1. Member States shall inform the Commission of the competent authority or authorities responsible for: — prior approval of irradiation facilities, — the allocation of an official reference number for approved irradiation facilities, — official control and inspection, — withdrawal or modification of approval. 2. Approval shall be granted only if the facility: — meets the requirements of the joint FAO/WHO Codex Alimentarius Commission Recommended International Code of Practice for the operation of irradiation facilities used for the treatment of foods (reference FAO/WHO/CAC, Vol. XV, edition 1), and any supplementary requirement which may be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(4), — designates a person responsible for compliance with all the conditions necessary for the application of the process. 3. Each Member State shall forward to the Commission the names, addresses and reference numbers of the irradiation facilities which it has approved, the text of the approval document, and any decision suspending or withdrawing approval. 4. On the basis of the data supplied in accordance with paragraph 3, the Commission shall publish in the Official Journal of the European Union the details of the facilities as well as any changes in their status.
Article 8 
2. The records referred to in paragraph 1 must be kept for a period of five years. 3. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 12(2) .
Article 9 
1. A foodstuff treated with ionising radiation may not be imported from a third country unless it: — complies with the conditions which apply to those foodstuffs, — is accompanied by documents showing the name and address of the facility which carried out the irradiation treatment and providing the information referred to in Article 8, — was treated in an irradiation facility approved by the Community and appearing on the list referred to in paragraph 2 of this Article.
Article 10 
Materials used for packaging foodstuffs to be irradiated must be suitable for the purpose.
Article 11 
Amendments to the Annexes to take account of scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 100a of the Treaty.
Article 12 
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 2 ). 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The time limits provided for in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively. 5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 13 
The Scientific Committee for Food shall be consulted on any matter falling within the scope of this Directive likely to have an effect on public health.
Article 14 
1. Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has clear proof that the irradiation of certain foodstuffs endangers human health although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving grounds for its decision. 2. The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee on Foodstuffs; it shall take the appropriate measures in accordance with the procedure laid down in Article 12(2) . The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force. 3. Adaptations of this Directive or of its implementing directive may be made by the Commission only to the extent necessary to ensure the protection of public health and shall in any event be limited to prohibitions or restrictions as compared to the previous legal situation. Those measures, designed to amend non-essential elements of this Directive, inter alia , by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 12(5).
Article 15 
Member States shall bring into force their laws, regulations and administrative provisions to comply with this Directive in such a way as to: — permit the marketing and use of irradiated foodstuffs by 20 September 2000, — prohibit the marketing and use of irradiated foodstuffs not complying with this Directive by 20 March 2001. They shall inform the Commission thereof. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Article 16 
This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities .
Article 17 
This Directive is addressed to the Member States.