EUROPEAN COMMISSION Brussels, 4.8.2021 SWD(2021) 225 final COMMISSION STAFF WORKING DOCUMENT



EVALUATION

of the















EU legal framework on food irradiation (Directives 1999/2/EC and 1999/3/EC) {SWD(2021) 226 final}



Table of contents 1Introduction 1.1. Definition of food irradiation 1.2. Purpose and scope of the evaluation 2Background to the intervention 2.1 Description of the intervention and its objectives 2.2 Legislation before the adoption of the Directives 3Implementation / state of Play 3.1 Main legal provisions 3.2 Use of irradiation by the EU food industry 3.3 Import of irradiated foodstuffs in the EU 3.4 Results of official controls 3.4.1 Notifications through the EU report on food irradiation 3.4.2 Notifications to the rapid alert system for food and feed (RASFF) 4Method 4.1 Evaluation process 4.2 Methodology of the study supporting the evaluation 4.3 Limitations and robustness of findings 5Analysis and answers to the evaluation questions

5.1 Relevance 5.1.1 Relevance of food irradiation for public health 5.1.2 Relevance of food irradiation for plant health 5.1.3 Relevance of food irradiation for reducing pesticide use 5.1.4 Relevance of the Directives’ objectives 5.1.5 Relevance of the Directives’ requirements 5.1.6 Consumer opinion on the relevance of food irradiation 5.2 Coherence 5.2.1 Internal coherence 5.2.2 Coherence with the EU food legislation 5.2.3 Coherence with other EU acts 5.2.4 Coherence with international standards 5.3 Effectiveness 5.3.1 Overview of the provisions’ effectiveness 5.3.2 Requirements for the sources of irradiation 5.3.3 Limits of absorbed doses 5.3.4 Listing of foodstuffs authorised for irradiation 5.3.5 Labelling of irradiated foodstuffs 5.3.6 Approval of irradiation facilities 5.3.7 Provisions on intra EU trade of irradiated foodstuffs

5.3.8 Provisions on import of irradiated foodstuffs 5.3.9 Enforcement 5.3.10 Reporting 5.4 Efficiency 5.4.1 Costs and benefits for consumers 5.4.2 Costs and benefits for the environment 5.4.3 Costs and benefits for national competent authorities 5.4.4 Costs and benefits for irradiation industry and food business operators 5.4.5 Competition between EU and non EU businesses 5.4.6 Main reasons for the decline of food irradiation in the EU 5.5 EU added-value 5.5.1 Harmonisation of regulatory approaches within the EU 5.5.2 Existence and effectiveness of additional rules at national level 5.5.3 Interest of stakeholders in maintaining an intervention at EU level 5.5.4 Potential consequences of a phasing out of the EU rules 6Conclusions Annex 1: Procedural information Annex 2: Stakeholder consultation – Synopsis report Annex 3: Methods and analytical models Annex 3: List of evaluation questions

Glossary Term or acronym Meaning or definition 2-ACBs 2-Alkylcyclobutanones EFSA European Food Safety Authority FAO The Food and Agriculture Organization of the United Nations HACCP Hazard analysis and critical control points MEP Member of the EU Parliament NGO Non-governmental organisation RASFF Rapid Alert System for Food and Feed UV Ultra Violet 1Introduction 1.1.Definition of food irradiation According to the Codex Alimentarius, food irradiation is the processing of food products by ionizing radiation, specifically gamma rays, X-rays or accelerated electrons in order to, among other things, control foodborne pathogens, reduce microbial load and insect infestation, inhibit the germination of root crops, and extend the durable life of perishable produce. 1.2.Purpose and scope of the evaluation The present evaluation is carried out on the EU legislative framework for the treatment of food with ionising radiation (hereafter “food irradiation”), which consists of Directives 1999/2/EC and 1999/3/EC (hereafter “the Directives”). The evaluation was deemed necessary since the Directives had not been evaluated since their entry in force, despite significant scientific and technological developments, and despite the adoption of the General Food Law in 2002 (Regulation (EC) No 178/2002), which provided a new legal framework for EU interventions on food safety. The purpose of this evaluation is to assess whether the Directives are still fit for purpose, considering five different criteria: relevance, effectiveness, efficiency, EU-added value and coherence. The evaluation covers the implementation of the Directives from the date of their entry into force until the present day, in all EU Member States. In addition to assessing whether the intended objectives of the legislation have been achieved and whether the objectives are still relevant, the evaluation assesses the main provisions of the Directives: requirements on sources of irradiation and limits for absorbed doses, listing of foodstuffs authorised for irradiation, labelling of irradiated foodstuffs, approval of irradiation facilities by competent authorities, rules for import and intra EU trade of irradiated foodstuffs, enforcement of official controls and reporting obligations. The evaluation is expected to provide evidence that will be used to identify any need for changes in the EU legislation on food irradiation. 2Background to the intervention 2.1Description of the intervention and its objectives The intervention logic, presented in Figure 1, indicates the drivers, objectives, intended actions and outputs of the intervention. However, part of what is captured in the intervention logic has not occurred because some processes defined by the Directives have not progressed as intended. Namely, the “progressive additions to the list of foods and food ingredients treated with ionising radiation” mentioned in “Actions/inputs” did not occur, and the measures meant to be transitional, as stated in “Outputs” have remained in place. One of the initial drivers of the development of EU food irradiation legislation was the differences in national approaches to regulate the technology. These were perceived to disrupt the free movement of goods and meant that EU food businesses were not on an equal footing with each other or with food businesses in third countries importing into the EU. The variation may also have had significant resource impacts on enforcement and control authorities and hampered access to markets for innovative products and processes. A lack of information for consumers contributed to consumer distrust and concern regarding the potential health impact of food irradiation. The need to protect human health led to the need to consider the various positive and negative impacts irradiation may have on food safety and human health. The general objectives of the Directives were set to address these problems. The disruption to free movement and the lack of a level playing field for EU food businesses was addressed through the harmonisation of legislation on irradiation, ensuring free movement and fair competition. Ensuring the enforcement of the Directives and a harmonised approach was meant to help address concerns surrounding the resource use by Member State enforcement and control authorities. Ensuring enforcement, alongside providing information to consumers, would also help to address consumer distrust. Preserving high levels of protection for the health of consumers and requiring that irradiation is not used in place of proper hygiene or good agricultural practices addressed the potential impacts of irradiation to human and environmental health. Through establishing favourable conditions for innovation, the Directives also aimed to reduce the burdens associated with market access for innovative products and processes.

To attain these general objectives, several operational objectives needed to be met. Harmonisation required the establishment of transitional measures to maintain existing Member States authorisations until a single EU-level list of products authorised for irradiation came into force. It also required the establishment of conditions for the approval of facilities, sources of irradiation and limits for absorbed doses. Ensuring fair competition and enforcement requires the same rules to be applied on imported foodstuffs and to products irradiated in the EU, and adequate control and monitoring systems. Ensuring that irradiated foodstuffs are labelled as such helps to provide information to consumers and to ensure that only authorised foodstuffs are placed on the market. Ensuring that risk assessments are undertaken contributes to preserving a high level of protection of consumer health, and helps to ensure that irradiation is not used to mask poor hygiene or agricultural practices. Which operational objectives were intended to establish favourable conditions for innovation, and how they have translated into actions and outputs, is unclear. The Directives include a number of actions and inputs to address these objectives. A procedure for the establishment of lists of products authorised by Member States was included as a transitional measure in Directive 1999/2/EC. This Directive includes the definition of general and technical aspects, along with a definition of EU and non-EU facility approvals, to ensure that the same conditions are applied to all irradiated foodstuffs marketed within the EU market, whether from EU or non-EU countries. Definition of the labelling requirements in Directive 1999/2/EC was intended to ensure that products are consistently and appropriately labelled. Establishing procedures for the monitoring and control by Member States was intended to ensure that only authorised food enters the market and that an adequate control and monitoring system is in place. No EU-level monitoring or control procedures were specifically established for imports, however. The inclusion of a procedure for the establishment of an EU list and progressive additions to the list was intended to ensure that the same conditions are applied across Member States and to third country imports. The procedure for adding foods to the positive list also stipulated that this only happens with a favourable opinion of the Scientific Committee on food, so risk assessment is part of the approval process. These actions and inputs lead to the key outputs that are meant to meet the Directives’ objectives. Transitional measures have been established and these, along with the list of authorisations of foodstuffs in Member States and the establishment of the sources, doses and labelling rules are meant to contribute to the transparent use of irradiation within Member States, and to provide legal certainty for food business operators on the use of irradiation. The list of approved facilities, the annual reports and the standards for the detection of irradiation in food samples have been established to contribute to the transparent management of food irradiation. Requiring a favourable opinion of the Scientific Committee on Food (which has now been replaced by the European food authority agency, EFSA) before the addition of foodstuffs to the initial positive list means that Scientific Committee on Food opinions guide the use of irradiation and that there is consequently a better alignment of the approval of irradiation for certain foodstuffs with scientific opinion and that relevant information is available for stakeholders. The intervention logic mentions how the outputs of the Directives were expected to lead to impacts, namely: improving the competitiveness of Member States with third countries, improving the function of the single market, maintaining the level of health protection for workers and consumers, improving consumer choice and welfare through the availability of safe food, fair competition and access within the internal market and the protection of consumer health while ensuring innovation and market access. 2.2Legislation before the adoption of the Directives Before the Directives entered into force in 1999, EU Member State policies toward irradiation differed greatly. France, the Netherlands and Belgium were at the forefront of using food irradiation, while Germany was making extensive efforts to prevent irradiated foods from entering the market. These differences were the subject of discussions at the EU level in the 1980s and 1990s. Some countries, including Belgium, France, the Netherlands and the UK, promoted the development of a directive that would have authorised the irradiation of several product categories, while others and the European Parliament supported the development of a directive that would have limited the authorisation of food irradiation to herbs and spices. The first positive list proposed at EU level included nine different foods. Over the course of ten years of debate, this was reduced to just dried aromatic herbs, spices and vegetable seasonings. The broader regulatory context in the EU was characterised by the rejection of irradiation for imported fresh meat, as per Directive 72/462/EEC. Labelling of irradiated foods was already required on foodstuffs intended for sale to the ultimate consumer by Council Directive 89/395/EEC amending Directive 79/112/EEC. Before then, various rules applied in the Member States. Belgium and the Netherlands had no labelling requirements in place, while France did. It was suggested in the late 1980s and early 1990s that the differences in labelling regulations within the single market led unlabelled irradiated products to be sold in countries that required labelling, although it is not clear whether this was actually the case. News reports indicate also that there was an issue with the import of herbs, spices and soft fruit that had been irradiated without being labelled as such. Studies by the Trading Standards Office in the UK determined that around 1 in 10 samples may have been irradiated without stating as such. There was also an instance where regulators in the UK and Germany uncovered the illegal irradiation of liquid whole eggs. In some Member States, such as Poland and the Czech Republic, pre-existing legislation was in force until their EU accession, at a time where EU legislation on food irradiation was already in force. In the Czech Republic, national legislation required the labelling (with both the Radura symbol and specific words) of irradiated foods, but only for ingredients that made up more than 2% of a product by weight. This meant that processed products containing irradiated herbs and spices would generally not need to be labelled as such.



3Implementation / state of Play 3.1Main legal provisions With the exception of the provisions regarding the exercise of implementing powers conferred on the Commission, the provisions of the Directives have not been amended since their entry into force. Requirements on sources of irradiation Directive 1999/2/EC provides that only gamma rays, X-rays and electron beams may be used as sources of ionising radiation, but does not include definitions for “ionising radiation” or “irradiation” (a term also used several times in the act). As a result, Member States have interpreted the scope of the Directive and implemented it in different ways (See Section 5.3.2 “ Requirements for the sources of irradiation ”). Directive 1999/2/EC does not provide specific requirements regarding recently developed irradiation technologies for surface treatment (the traditional technologies affect the food “through and through”), such as low energy electron beam. Listing of foodstuffs authorised for irradiation The EU list of foodstuffs authorised for irradiation to the exclusion of all others (“the EU positive list”) to be established before 31 December 2000 in accordance with the second subparagraph of Article 4(3) of Directive 1999/2/EC has not been established. This has two consequences. First, the initial EU list established by the Directive 1999/3/EC is still in force. This list only contains one product category: “dried aromatic herbs, spices and vegetable seasoning”, which is therefore the only irradiated food whose marketing cannot be prohibited, restricted or hindered by the Member States. Second, the provisions of Article 4 (5) to (7) of Directive 1999/2/EC, which were meant to be transitional, still apply. They provide that Member States may: -maintain existing national authorisations (a Member State may add to its national list of authorised products those the authorisation of which has been maintained in another Member State) ; -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 EU list established by Directive 1999/3/EC.

So far, six Member States (BE, CZ, FR, IT, NL, PL) maintained a national list of authorisations concerning the treatment of foodstuffs with ionising radiation. Labelling of irradiated foodstuffs Directive 1999/2/EC provides that the words ‘irradiated’ or ‘treated with ionising radiation’ must appear on the label of irradiated foodstuffs, or, in case irradiated products are used as ingredients, the same words must accompany their designation in the list of ingredients. This provision is implemented by Member States, which regularly identify through their official controls a small proportion of non-compliances relating to non-labelling or labelling issues (See Section 3.4 “ Results of official controls ”). Approval of irradiation facilities All approved facilities as well as facilities wishing to engage in food irradiation in the European Union are subject to controls carried out by the relevant Member State competent authorities. A list of EU-approved facilities is maintained up to date by the Commission. Between 2003 and 2019, seven facilities have been added to the list due to the accession of new Member States (in Bulgaria (2), Cyprus (1), Estonia (1), Croatia (1), Hungary (1), and Romania (1)), three facilities have been added in Member States already present (in Germany (1), Spain (1) and France (1)), and three facilities were removed (in Denmark (1) and France (2)). The list was last updated in 2019 with the removal of two entries. Non-EU facilities are subject to the same requirements as EU facilities. The Commission instructs experts to carry out, under its authority, evaluations and inspections of irradiation facilities in third countries for their inclusion on the list of approved non-EU facilities. The last audit carried out by the Commission in a non-EU country took place in China in 2009. Prior to this audit, audits for the approval of irradiation facilities took place in 2008 (India), 2005 (Thailand), 2003 (Switzerland and Turkey) and 2001 (South Africa). Reports of these audits are published online. Rules for intra EU trade of irradiated foodstuffs Since the provisions of Article 4(7) of Directive 1999/2/EC still apply (see above), Member States may restrict or ban irradiated foodstuffs, which are not included in the initial EU list established by the Directive 1999/3/EC, from entering their market, whether these products come from other Member States or from third countries. The Directive does not require Member States to notify to the Commission the national restrictions or bans on trade that they apply (see Section 5.3.7 “ Provisions on intra EU trade of irradiated foodstuffs ”). Rules for import of irradiated foodstuffs in the EU Directive 1999/2/EC provides that a foodstuff treated with ionising radiation may not be imported from a third country unless it complies with the conditions which apply to that foodstuff, and was treated in a facility approved and listed by the Commission. The Commission carries out audits in non-EU countries and Member States carry out controls at point of entry into the EU to check the implementation of these rules. Official controls and reporting obligations The Directive 1999/2/EC provides that national competent authorities must forward every year to the Commission 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, and the results of checks carried out at the product marketing stage. The Directive 1999/2/EC does not provide for specific requirements on the checks to be carried out, only that Member States must ensure that the methods used to detect treatment with ionising radiation comply with the Directive 85/591/EEC and are standardised or validated. In accordance with Article 7(4) of Directive 1999/2/EC, the Commission publishes a report to the European Parliament and the Council based on information provided by Member States, which contains the results of checks carried out by Member States in irradiation facilities and at marketing stage. The report was annual until 2015 and is biennial since then. 3.2Use of irradiation by the EU food industry The EU irradiated on average 6,100 tonnes of food annually in the last ten years, which is less than 1% of the volume irradiated worldwide. In contrast to the quickly growing world trend (especially due to USA and China), food irradiation in the EU decreased by more than 50% since 2010 (see Figure 2 ). Among the three authorised sources of ionising radiation, the most common in EU is the high energy gamma rays emitted by a radioactive substance, usually cobalt 60. Streams of high energy electrons generated by an electron gun are also used, whereas EU facilities or approved importers do not currently use X-ray technology.

The radiation dose used varies depending on the product in question, the maximum doses stipulated by Member State regulations, and the intended outcome – the effects of irradiation change as the dose is modified. Lower dosages (e.g. below 1 kGy) are used for treatments with plant health purposes, higher doses (e.g. up to 10 kGy, the legal maximum in the EU) are used for microbial decontamination of food. On 31 December 2019, there were 24 approved irradiation facilities in the EU, which were located in 14 Member States: France (5), Germany (4), Bulgaria (2), the Netherlands (2), Spain (2), Belgium (1), Czech Republic (1), Croatia (1), Estonia (1), Italy (1), Hungary (1), Poland (1), Romania (1), and United Kingdom (1). Of those 14 Member States equipped with irradiation facilities, four did not irradiate any foodstuffs in 2018-2019: Bulgaria, Italy, Romania and the United Kingdom. A total quantity of 7,832 tonnes of products were treated with ionising irradiation in Member States during the years 2018 and 2019. Most food irradiation in the EU occurred in a single facility in Belgium, which treated 81.4% of the irradiated food of the EU. The Netherlands also accounts for a substantial percentage, and there is some activity in France, Spain and Germany. Together, these five countries account for 96% of the food irradiation that occurs in the EU. Irradiation is also concentrated on a few select products. The three main commodities irradiated in the EU are frog legs (65.1%), poultry (20.6%) and dried aromatic herbs, spices and vegetables seasoning (14.0%). 3.3Import of irradiated foodstuffs in the EU Currently, ten irradiation facilities are approved in non-EU countries to process products for export to the EU: three in South Africa, three in India, two in Thailand, one in Switzerland and one in Turkey. The application of one non-EU country (China) was rejected in 2009 after the on-the-spot audit yielded an unfavourable result. Since these facilities are not subject to reporting obligations, there is no data on the quantities of irradiated foodstuffs which enters the EU from third countries. 3.4Results of official controls 3.4.1Notifications through the EU report on food irradiation For the period 2018-2019, 25 Member States notified having carried out analyses for the detection of irradiated foodstuffs at marketing stage. 9 808 samples were analysed, i.e. overall 12.1% less in average than in 2016-2017. Germany accounted for more than 50% of the samples analysed ( Figure 3 ). Three Member States and Norway did not perform any analytical checks at product marketing stage in 2018-2019 due to budgetary restrictions (Denmark and Norway), lack of laboratory capacity (Cyprus) or other control priorities (Sweden). The majority of the products analysed were 'herbs and spices' (39%) and 'cereals, seed, vegetables, fruit and their products' (24%). Under category 'other' (foods supplements and soup and sauces) the percentage was 20%. From the total of 9,808 samples, 83 gave not compliant results (1%) and 88 (1%) gave inconclusive results. The types of non-compliance observed were mainly incorrect labelling and forbidden irradiation. The percentage of non compliance (1%) was slightly higher than in the previous report (0.8%). Over the past several years, the regular sampling carried out by Member States and reported to the European Commission indicate a consistent and small percentage of non-compliant foodstuffs (between 0.8%-2.4%) among those tested. 3.4.2Notifications to the rapid alert system for food and feed (RASFF) Created in 1979, the Rapid Alert System for Food and Feed (RASFF) enables information to be shared rapidly between EU Member State national food safety authorities, the Commission and EFSA when risks to public health are detected. Information exchanged through RASFF on the non-compliances detected can lead national competent authorities to apply control measures, e.g. products being recalled from the market. Between 1999 and 2019, out of about 50,000 notifications recorded in the RASFF database, 358 notifications related to irradiation. As shown in Figure 4 , the most frequent countries of origin for products subject to RASFF notifications were China, the United States, Russia and Vietnam, none of them having EU approved irradiation facilities.

Of these 358 notifications, 87 (approximately 24%) related to unlabelled irradiation. A further 270 (approximately 75%) relate to “unauthorised irradiation”. It is not clear whether this refers to the irradiation of unauthorised foodstuffs, irradiation in a not approved facility or unlabelled irradiation, or some combination of the three. Non-compliances were not identified in relation to the maximum permitted dose. Of these 358 notifications, risk assessments had been made for 108 and these risk assessments indicated that serious non-compliance incidents were rare, with 98% labelled ‘not serious’. In 2020, 6 RASFF notifications related to irradiation were registered: 2 from China, and 1 each from USA, India, Vietnam and Belgium. The six notifications related to “unauthorised irradiation”, the risk assessment for all of them led to “non-serious risk” classifications.



4Method 4.1Evaluation process The Commission has set up an inter-service steering group (ISG) to supervise this evaluation, which includes representatives from SG, GROW, ΤRADE, RTD, SANTE, AGRI and JRC. After validation of the roadmap in September 2017, the company ICF won the call for tenders for carrying out a support study, on which the evaluation is mainly based (hereafter, “the support study”). The support study was launched in 2018 and ended in 2020 (see timeline Figure 5 ). 4.2Methodology of the study supporting the evaluation The study supporting the evaluation applied a mixed-methods approach to address the evaluation questions, and consisted in five phases: Inception, Desk research, Implementation of the consultation strategy for the study, Analysis of the data collected, and Conclusions and recommendations. During these phases, the following analytical methods were employed: desk research, interviews and surveys, case studies. Phase 1: Inception The inception phase involved preliminary desk research on the legal situation in Member States and key trends in production and trade of irradiated foods, as well as seven exploratory interviews intended to provide an overview of stakeholder perspectives, assess potential data gaps, and identify sources of evidence and key contacts. Various actors were consulted, including national competent authorities, federations of food business operators, the International Atomic Energy Agency (IAEA). NGOs were solicited but declined the requests for interview. ICF also liaised with DG SANTE officials and ICF’s external experts to further develop the intervention logic, and identify scientific, academic and legal sources of information. Phase 2: Desk research The purpose of the desk research phase was to extract qualitative and quantitative information relevant to the evaluation questions from published sources. The scope of the desk research includes relevant legislation, statistics, complaints, case law and infringements (including notifications from the RASFF, and audits on third country irradiation facilities), studies, reports, research and materials issued or endorsed by the EU institutions, European or national stakeholders’ associations, individual stakeholders, as well as Member States’ authorities. A data collection template was used to structure the research and directly compare information collected on the same questions from different sources. Literature and data were retrieved online. The research covered international and EU documentation, and included both academic studies and grey literature. Phase 3: Implementation of the consultation strategy for the study Five case studies have been completed, on the following topics: labelling requirements in herbs and spices in France (1) and in Poland (2), advantages and disadvantages of irradiation and other available treatments for herbs and spices in the EU (3), use of irradiation to address plant health risks (4) and use of irradiation to prevent sprouting, extend shelf life and reduce food waste (5). The case studies involved interviews with industry, national competent authorities and experts from various EU countries and the United States, as well as desk research. Three online surveys, respectively addressed to national competent authorities, the irradiation industry and food business operators, were conducted to validate the findings of the desk research and the case studies. A total of 56 responses were received, corresponding to 31 national competent authorities in 22 Member States, 20 irradiation industry representatives from seven Member States and six non-EU countries, and five food business operators’ representatives. Since they refused to participate at the inception phase of the project, consumer organisations were not included in the surveys. A follow-up survey was issued to national competent authorities to address some remaining gaps in the data collection. This survey received 17 responses from national competent authorities in 14 Member States.

In addition, 16 interviews have been conducted with representatives from the national competent authorities (2), the irradiation industry (5), an expert from DG SANTE (1), and food industry representatives (8). The survey for the Web-based Public Consultation was launched from 3 March 2020 to 6 July 2020, and received a total of 72 responses from academics/research institutions (5), business and business associations (16), national competent authorities of Member States (2) and third countries (2), NGOs (3), international organisation (1), EU citizens (39) and non EU citizens (4). Of the academics, business associations and businesses who responded, the majority appeared to be associated with the irradiation industry. Contributions were made from ten different Member States and six third countries. Phases 4 & 5: Analysis of the data collected & Conclusions and recommendations Data collected were brought together in consideration of judgment criteria agreed between the contractor and DG SANTE. The results of this analysis were presented in the interim report. Gaps in the data were identified based on this analysis and further targeted interviews, desk research and a survey were undertaken to address them. The results of the additional research and the public consultation were then further triangulated with the analysis from the interim report. Conclusions were developed based on a consideration of the analyses presented for each judgment criterion. The ‘coherence’ criterion was not included in the terms of reference of the support study, which only cover the four other criteria. SANTE assessed the ‘coherence’ criteria itself, based on the outputs of the public consultation, and feedbacks collected from other Units in SANTE and from other DGs (through the ISG). 4.3Limitations and robustness of findings The main issue encountered was the lack of information and knowledge regarding irradiation in the EU food industry. This reflects the marginal nature of the practice and its absence from the agenda of stakeholder groups - consumer organisations, NGOs, and in much of the EU food industry. Based on discussions with various stakeholders, it appears that many non-responses or refusals to take part were linked to the nature of food irradiation itself, which is perceived as controversial. In other words, the risk of seeing one’s name associated with the term ‘food irradiation’ could discourage participation in consultations of this nature. This has meant that securing participation and gathering meaningful feedback from several stakeholder groups, including food business operators, has been particularly difficult. This is reflected in the responses received to the surveys: only six of the 68 food business operators invitees responded. The study team tried to contact food business operators using food irradiation, since those may have more opinions and knowledge than the sector’s representatives. But this initiative had only limited success since information on which companies are using irradiation is not publicly available. This means that the majority of the data collected through consultations for this project came directly from the irradiation industry or from national competent authorities. Securing the participation of relevant persons exporting or importing irradiated food to or from the EU was a further challenge. While there was some success with the United States, no feedback was received from experts contacted in China and Turkey. Responses to the public consultation from other non-EU countries (including Australia and Israel) have helped to address this gap. Another major data gap related to consumer views on food irradiation. Despite a strong belief among food business operators’ organisations and others that food irradiation would not be accepted by EU consumers, few recent studies have sampled the EU consumer population and are relevant to this aspect of the evaluation. The methodology undertaken for this study was not able to fill in this gap. Further attempts were made to contact consumer organisations, in particular those who had previously written about the topic, but none agreed to participate in an interview. There were a small number of responses to the public consultation from the general public, but these did not provide any generalisable evidence. This has meant that gaps remain in the evidence base and that there is a bias to the responses received. This has been addressed as much as possible in the text by acknowledging this bias wherever conclusions rely heavily on the consultations and by avoiding making strong conclusions based on the evidence provided by the irradiation and food industry alone.



5Analysis and answers to the evaluation questions The list of evaluation questions is available in Annex 4. All these questions are answered in the following sections, which have been revised in comparison to those of the study report, for the sake of clarity and to avoid repetitions. 5.1Relevance This section assesses the relevance of the food irradiation technology for food safety, plant health and environmental health, as well as the relevance of the Directives’ objectives and requirements considering the evolution of societal needs, and scientific and technological developments. Main findings Although its use has decreased in the EU, food irradiation is a technology that remains relevant to addressing food safety concerns in certain products. Irradiation is an established food decontamination technique, and an EFSA scientific opinion published in 2011 has confirmed that it is effective and safe in ensuring the microbiological safety of foods. Food irradiation has the potential to contribute to protecting the EU from certain plant health risks, although there has been no use of irradiation for this purpose in the EU thus far and stakeholders have not expressed interest in this application of the technology. Food irradiation is not likely to significantly reduce consumer exposure to pesticides. Indeed, irradiation is not used commercially as fungicide or herbicide, and therefore cannot serve as alternative for pesticides used on fruits and vegetables for these purposes. Moreover, EU stakeholders prefer other strategies than irradiation for controlling insect infestations (such as choice of low-risk sourcing locations, inspections and other physical treatments e.g. hot or cold treatments).

All of the stated objectives of the directives are still relevant considering the evolution of societal needs and scientific and technological developments. However the directives do not address the strong drive at consumer, policy and, more recently, industry level, to reduce and manage the environmental impacts of food production. While most of the requirements of the Directives are still relevant, some requirements are no longer relevant given the progress of science and technology. The Directives requirements are notably not relevant for the so called “low energy electron beam technology”, which has been recently developed to enable surface treatment of dry food products. Considering the low public awareness of the technology and consumer wariness when presented with labelling, it is difficult to characterise the current state of public opinion on the relevance of food irradiation. Consumer groups that opposed the technology in the early 2000s no longer have this topic on their agenda. But it is unclear whether this means that opposition to the technology has dissipated or whether it is simply no longer considered a topic of concern given the very marginal use of irradiation in the food industry in the EU. 5.1.1Relevance of food irradiation for public health Biological safety of irradiated foodstuffs Irradiation is an established food decontamination technique and the 2011 EFSA scientific opinion on the efficacy and microbiological safety of irradiation of food has confirmed that it is effective and safe in ensuring the microbiological safety of certain foods: “When integrated into an overall food safety management program that includes Good Agricultural, Manufacturing and Hygienic Practices and HACCP, and depending on the dose applied, food irradiation can contribute to improved consumer safety by reducing food-borne pathogens in all the food categories and food commodities addressed by the present Opinion.” Where irradiation is used in the EU, it is generally well-integrated in the supply chain. There are certain cases and supply chains where irradiation is the preferred option for decontamination in the EU, notably frog legs. It is also the preferred option for certain herbs and spices in certain supply chains. Consumer associations and the European Parliament have raised concerns that food irradiation may be misused by food business operators to mask poor hygiene in production processes, see Section 5.3.4 “ Listing of foodstuffs authorised for irradiation ”. Such practice would be in contradiction with the Food Hygiene Regulations (EC) No 852/2004 and (EC) No 853/2004. Toxicological safety of irradiated foodstuffs The 2011 EFSA scientific opinion on the toxicological safety of irradiated foods concluded that most of the substances formed in food by irradiation are also formed during other types of food processing, with levels comparable to those arising, for instance, from the heat treatment of foods. However it also indicates some outstanding concerns relating to the formation of 2-Alkylcyclobutanones (2-ACBs) in irradiated foods that contain fat and to the development of leukoencephalomyelopathy in cats fed highly irradiated feed. On 2-ACBs, the 2011 EFSA opinion concluded that : “the available data indicate that at least some 2-ACBs may be genotoxic in vitro. The toxicological relevance of these findings, i.e. whether 2-ACBs may represent a genotoxic hazard for humans, is not elucidated due to the absence of proper in vivo studies. However, several arguments support the hypothesis that the genotoxic hazard associated with 2-ACBs intake is minimal, if any.” Since 2011, new studies were carried out, which confirmed that the ingestion of 2-ACBs through irradiated foods is unlikely to affect the human health, but suggesting that the determination of chronic toxicity by long-term exposure to low concentrations of 2-ACBs has to be evaluated more clearly to determine if these compounds are safe to human. On leukoencephalomyelopathy in cats, the 2011 EFSA’s opinion suggests that “information on the cause and pathogenesis in cats should be collected, including data on the relationship between irradiation dose, composition of feed, the amount of consumed irradiated feed and the elicitation of the leukoencephalomyelopathy. In absence of this understanding, the relevance for humans cannot be ruled out. Considering that only a very limited quantity of food is irradiated in Europe currently, the Panel is of the view that there is not an immediate cause for concern. However, the relevance of the cats studies for human health should be clarified.” A concern was also raised by one national competent authority about possible migration of elements from packaging and into food in the context of food irradiation. It is described in the scientific literature that for pre-packaged foods undergoing irradiation, packaging made from polymers are susceptible to radiation effects. The extent of these effects differs depending on the polymer. This is not a new issue, and under the EU Directives, packaging materials used for foods undergoing irradiation “must be suitable for the purpose”. However, as new packaging materials are developed, they should be tested before use in the irradiation process. In a resolution of the 17 December 2002 against the establishment of an extended EU positive list of foodstuffs approved for irradiation, the European Parliament expressed concerns considering the lack of evidence regarding the long-term safety of eating a diet based largely on irradiated foods (See Section 5.3.4 “ Listing of foodstuffs authorised for irradiation ”). Nutritional quality of irradiated foodstuffs

The irradiation-induced changes in food components are generally small and not significantly different from those reported in other conventional preservation processes, especially those based on thermal treatment. The changes in some components that are sensitive to irradiation, like some vitamins, may be minimised by using proper treatment conditions. Moreover, this impact is generally minimal, as most foods that are irradiated are not significant enough to dietary requirements to play a nutritional substantial role. 5.1.2Relevance of food irradiation for plant health The increased globalisation of trade has increased the likelihood of invasive species being introduced to new countries and climate change has increased the likelihood that invasive species will survive in these new environments. Irradiation can prevent the reproduction of adult insects and their larvae, and can as such be an effective tool to address plant health risks. Irradiation is however not suitable for on the spot treatments when infestations are discovered, due to the specific infrastructure and packaging required to carry out irradiation. There is a number of fruit irradiation treatments approved as international standards for phytosanitary measures (ISPM) under the International Plant Protection Convention (ISPM 28, ISPM 18). Irradiation has been approved for plant health purposes in some third countries, including the US, Australia and New Zealand. There, it can be used on a variety of fruit and vegetables, to address almost all pests. It is most frequently used for tropical fruit imported in the US from Asia, Mexico and Southern America and for trade between Australia and New Zealand. According to DG SANTE, several non-EU countries (India, Australia, the US, Uganda, Jamaica and Israel) have expressed interest in using irradiation as a post-harvest treatment for products exported to the EU. However, the EU stakeholders consulted (one industry organisation and one food business) indicated that the current industry preference is to use strategic sourcing, systems approaches and inspections to address plant health risk. Irradiation for plant health purpose can be allowed under Plant Health Regulation 2016/2031 as post-harvest treatment for certain products, but industry stakeholders indicated that they would be wary of using irradiation for this purpose due to the labelling requirements and expected consumer concerns associated with the use of irradiation. Therefore, while irradiation could, from a technical perspective, be used as a tool for plant health protection, commercial interest in using the technique is low due largely to perceived consumer concerns. 5.1.3Relevance of food irradiation for reducing pesticide use Despite its potential for addressing certain plant health risks, food irradiation is unlikely to have a significant effect on pesticide use whether in the EU or in third countries exporting food in the EU. Indeed, irradiation cannot serve as alternative for pesticides used on fruits and vegetables as fungicide or herbicide (such as imazalil and prochloraz), since it would be effective at higher doses than what would be suitable for fruit and vegetables (fruit and vegetables tend to lose firmness and quality when subjected to higher doses of irradiation). Thanks to its effects on insects, post-harvest irradiation could theoretically serve as an alternative to certain insecticides. However, insecticides treatments, whether by fumigation or other means, are currently either prohibited or not the preferred post-harvest treatment methods for fruits and vegetables produced or imported in the EU. In particular, food irradiation is unlikely to have an effect on the use of methyl bromide, a substance which has a detrimental effects for the environment and contributes to the deletion of the ozone layer, and for which irradiation is often cited as alternative. Indeed, the use of methyl bromide is already prohibited in the EU, and while the import of food treated in non-EU countries with methyl bromide is theoretically possible (as long as residue levels are kept below the maximum authorised by the EU legislation), the import of food treated with methyl bromide is believed to be marginal: interviews with EU fruit importers showed that they prefer other strategies, such as choice of low-risk sourcing locations, inspections, systems approaches and physical treatments (e.g. hot or cold treatments) to control risks related to insects, see support study, Section 5.2.1. 5.1.4Relevance of the Directives’ objectives All of the stated objectives of the Directives are still relevant considering the evolution of societal needs and scientific and technological developments. These are: -Harmonise legislation on irradiation across the EU; -Ensure free movement of irradiated foodstuffs within the single market; -Ensure fair competition with regards to irradiated foodstuffs in EU and with non-EU countries; -Ensure enforcement of irradiation legislation; -Provide information to consumers/citizens to ensure choice and welfare;

-Preserve high level of protection of the health of consumers; -Irradiation should not be used in place of proper hygiene and good agricultural practices; and -Establish favourable conditions for innovation. The Directives do not address the strong drive at consumer, policy and, more recently, industry level, to reduce and manage the environmental impacts of food production. Concerns about climate change and other environmental issues have led to calls from various stakeholders, policy-makers, and elected officials to produce food in a more sustainable way, including reduction of the sector’s carbon and water footprint. There was not the same emphasis on sustainable food production at the time the directives were passed. Consideration of the environmental impacts of irradiation and alternative technologies is not reflected in the Directives. 5.1.5Relevance of the Directives’ requirements Most of the requirements of the Directives are still relevant. The main three sources of irradiation in use at the time the Directives were adopted (Cobalt-60, electron beam and x-ray) are still in use. There have been some developments in detection techniques since the introduction of the Directives, which have helped to improve the accuracy of detection for certain foods. But since detection methods are not stipulated by the Directives, these developments do not have any implications for the relevance of the Directives. Some of the requirements associated with the directives are no longer relevant given the progress of science and technology, notably: -Assigning maximum doses to food classes, which does not take into account differences in processing or preparation (e.g. if a food is frozen or not); and -The use of overall average absorbed dose, rather than minimum and maximum dose. The use of overall average absorbed dose, and the setting of a maximal value for the “maximum/minimum dose” ratio is not relevant for the so called “low energy electron beam technology”, which has been recently developed to enable surface treatment of dry food products. However this technology is not yet used in the EU or in third countries in commercial conditions, based on information provided by the manufacturer of that technology. 5.1.6Consumer opinion on the relevance of food irradiation A survey of British consumers conducted by a non-governmental organisation (NGO) in 1987, when irradiation was still banned in the UK, indicated that 85% of consumers would not buy irradiated food even if the government removed the ban. No further information was identified regarding consumer acceptance of irradiated foods in Europe prior to the Directives. In a consultation undertaken immediately after the implementation of the Directives, consumer organisations were highly critical towards the technology and cited the following concerns, which they summarised with the slogan ‘good food does not need irradiation’: - Irradiation could be used to mask poor hygiene in production processes; - Irradiated foods could be subject to re-contamination if not handled properly and re-introduced pathogens may multiply faster in a sterile environment; - Irradiation may significantly reduce the nutritional quality of certain foods, and - Prolonging the shelf life of foods may not always be desirable, as nutritional quality degrades over time. The Food and You Survey conducted by the UK Food Standards Agency in 2012 found that 34% of respondents were aware of food irradiation and that of those aware, 51% reported feeling uneasy about the technology. Awareness differed significantly by age: 19% and 54 % among people aged 16-24 and 55-64 respectively, were aware of the technology. Studies conducted beyond Europe, in countries where irradiation is used more widely, gave similar results: research has indicated that awareness in Australia and New Zealand is low and that consumers would generally pay a premium for foods that have not been irradiated. A recent study involving German, Finnish and Spanish consumers explored the effect of the labelling of low-energy electron beams on consumer acceptance, considering the impact of labelling products both as “treated with irradiation” and “surface treated with electrons” with differing amounts of additional information. Results showed that the lack of understanding of irradiation contributed to reduced willingness to purchase irradiated products. Although using labelling with no reference to irradiation had the highest level of consumer acceptance, consumer acceptance was greater where labelling indicating “surface treated with electrons” included additional information on its potential benefits and purpose. Possible influencing factors on consumer acceptance include personal preference and consumer knowledge of irradiation, with those that are more informed about irradiation being more likely to purchase irradiated products. Part of consumers’ concerns relates to nuclear technologies. For example, a 2014 study showed that Italian consumers had a low acceptance to food irradiation because they associated radiation with the accident at the Chernobyl Nuclear Power Plant in 1986.

Considering the low public awareness of the technology and consumer wariness when presented with labelling, it is difficult to characterise the current state of public opinion on this subject. Within Europe, many of the consumer groups that opposed the technology in the early 2000s no longer have this topic on their agenda. But it is unclear whether this means that opposition to the technology has dissipated or whether it is simply no longer considered a topic of concern given the very marginal use of irradiation in the food industry in the EU.



5.2Coherence This Section assesses the internal coherence of the Directives, their coherence with the EU food legislation, with other EU legislation and with international standards. Main findings Internal coherence The provisions of the Directives co-act as intended. However, because the establishment of a EU list of foodstuffs authorised for irradiation to the exclusion of all others, as planned by the Directives, did not take place, some transitional measures are still in force more than 20 years after their adoption. Coherence with EU food legislation The Directives were adopted before the entry in force of the so-called “general food law” and “hygiene package”, a set of legislative acts which form the basis of current EU legislation on food hygiene. However, no major inconsistencies between the Directives and these acts have been identified. Coherence with other EU legislation There are very few other pieces of EU legislation interacting with the Directives. Directive 2013/59/EURATOM lays down a clear definition of “ionising radiation”, which excludes some technologies, such as UV radiation with wavelength above 100 nanometres. This definition would help clarify the scope of the Directives, if applied to food irradiation. Regulation (EU) 2018/848 provides that food irradiation is incompatible with organic production, whose main objective is to protect the environment and the climate. The irradiation industry is on the contrary of the opinion that food irradiation could help protect the environment by reducing the use of pesticides as post-harvest treatment and food waste. Available information is insufficient to assess this aspect. The EU legislation on plant heath protection includes irradiation as a potential treatment to address plant health risks. This legislation and the Directives both apply when food of non-animal origin are subject to irradiation for plant health purpose. Coherence with international standards The Directives do not take into account the latest updates of the standards of the Codex Alimentarius, notably as regards the concept of absorbed doses. Experts from the irradiation industry called for the EU legislation to be updated and aligned with the current Codex Alimentarius recommendations, considering that this could help to resolve conflicts or grey areas in relation to international trade. 5.2.1Internal coherence The review by DG SANTE of the provisions of the Directives as regards the requirements for the sources of irradiation and limits for absorbed doses, the labelling of irradiated foodstuffs, the listing of foodstuffs authorised for irradiation, the import and intra EU trade of irradiated foodstuffs, and the official controls and reporting obligations, has not led to identify contradictions between them. During the interviews and workshops carried out within the frame of the evaluation, stakeholders did not raised any issue regarding potential contradictions between the provisions of the Directives. The feedbacks gathered through the public consultation also did not mention any issue regarding the internal coherence of the Directives.

5.2.2Coherence with the EU food legislation Coherence of the Directives’ objectives with EU Food Safety objectives The desk research and the consultations carried out within DG SANTE showed that the objectives of the Directives are largely aligned with the EU food safety objectives, as shown in the Table 1 . Objectives of the Directives EU food safety objectives -ensure enforcement of irradiation legislation; -preserve high level of protection of the health of consumers; -provide information to consumers/citizens to ensure choice and welfare. -guarantee a high level of protection of human life and health and the protection of consumers’ interests. -guarantee fair practices in food trade, taking into account animal health and welfare, plant health and the environment. -Harmonise irradiation legislation in the EU; -ensure free movement of irradiated foodstuffs within the single market; -ensure free movement of food and feed manufactured and marketed in the Union, in accordance with the General Food Law Regulation. -irradiation should not be used in place of proper hygiene and good agricultural practices; -ensure that relevant hygiene requirements are applied at all stages of production, processing and distribution of food -ensure enforcement of irradiation legislation -ensure the application of food law through on official controls and other official activities (Official controls regulation) -ensure fair competition with regards to irradiated foodstuffs in EU and with third countries -facilitate global trade of safe feed and safe, wholesome food by taking into account international standards and agreements when developing Union legislation, except where this might undermine the high level of consumer protection pursued by the Union. However, the Directives currently do not take into account the potential environmental impacts of food irradiation technology as compared to alternative technologies used for the same purpose, nor do they incorporate a provision to measure or regulate them. As such, their contribution to the objectives of the EU Farm to Fork strategy, which seeks to ensure that the EU food system is ‘fair, healthy, and environmentally friendly’ and that all food produced and consumed is economically and environmentally sustainable, could not be evaluated due to lack of information on this aspect. General principles of the food law and hygiene package The Directives were adopted in 1999, before the adoption of the general food law (Regulation (EC) No 178/2002) and the so called “hygiene package” (Regulations (EC) 852/2004, 853/2004, and 882/2004, the latter repealed and replaced by Regulation (EU) 2017/625), which together constitute the foundation of current EU food legislation. These acts apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene, such as the ones provided by the Directives. As the following analysis of the legislation shows, there is no major inconsistencies between the Directives and the general principles of the food law and hygiene package (hereafter, “the EU food legislation”). In the EU food legislation, food decontamination techniques are one of the tools available to food business operators to ensure the safety of their products and is, as such, allowed under the EU food legislation. Food business operators who include food decontamination in their food safety management programmes have the responsibility to ensure that the techniques they use comply with the general and specific provisions laid down by the EU food legislation. In most cases, the EU food legislation do not set specific requirements or restrictions on the use of food decontamination techniques, but rather targets or conditions to be met. Since decontamination is a critical control point under the principles of hazard analysis and critical control points (HACCP), the competent authority responsible for a food establishment using decontamination techniques must check whether the food business operator has carried out proper validation of the process, and whether this validation has given favourable results. But in certain cases, the EU food legislation does set specific requirements (e.g. pasteurisation and ultra-high temperature treatment of dairy products) or subject the decontamination process to authorisation (e.g. the substances used to remove surface contamination from products of animal origin are to be authorised under Article 3(2) of Regulation (EC) 853/2004). Thus, the approach provided by the Directives, which lay down specific requirements for food irradiation, and subject the process to authorisation, is coherent with the general approach towards food decontamination provided by the EU food legislation. Some stakeholders questioned the coherence of the initiative with EU food legislation, as the latter prompts food business operators to ensure food safety by applying good hygiene practices at each stage of the production process, rather than relying on a final decontamination step. The risk that irradiation could be used to mask poor hygiene in production processes was notably mentioned as a concern by the consumer associations consulted before the adoption of the Directives (see section 3.5), and by the European Parliament in its 2002 a resolution, which stopped the process for adding new categories to the EU list of foodstuffs authorised for irradiation (see section 5.3.4, Listing of foodstuffs authorised for irradiation ). One stakeholder interviewed during the evaluation has suggested that irradiation may sometimes be used to compensate poor hygiene or agricultural practice elsewhere in the supply chain, but there was no evidence available to either substantiate or disprove this. The Directives explicitly provide that irradiation should not be used in place of proper hygiene and good agricultural practices, but do not provide specific provisions on how to achieve this objective. Approval of irradiation facilities The desk research and the consultations carried out within DG SANTE did not lead to identify incoherence as regards the approval of irradiation facilities in the EU and in third countries, in comparison to the general framework for registration and approval of food establishments under the EU food legislation. The registration and approval regimes provided by Regulation (EC) 852/2004 and Regulation (EC) 853/2004 apply to irradiation facilities when appropriate, in addition to their specific approval procedure laid down by the Directives. The approach applied so far for the approval of food irradiation establishments in third countries is based on on-the-spot inspections carried out by the Commission in each facility applying for EU-approval. This approach differs from the one that the Commission applies to most other types of food-processing establishments in third countries, the so called ‘pre-listing’ approach.

The pre-listing approach means that the Commission relies on the competent authorities of exporting countries to draw up and keep up to date the list of approved establishments. To be eligible for pre-listing, a non-EU country must provide adequate guarantees with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures. It must notably demonstrate that the listed establishments are under the official oversight of a competent authority, which carried out regular official controls and other activities to ensure that the establishments and their operations comply with applicable EU requirements. The Directive 1999/2/EC does not lay down specific provisions on the approach to be applied for the approval of irradiation facilities in third countries, but only retains the right of the Commission to carry out on-the-spot inspections to verify that the facilities to be approved meet the applicable EU requirements. Therefore, the Directive 1999/2/EC does not prevent the application of the “pre-listing” approach to the approval of irradiation facilities in third countries. Specific hygiene rules for food of animal origin The audits carried out by the Commission have shown that the control of the temperature of refrigerate or frozen food in irradiation facilities is challenging during the food irradiation process, especially in irradiation facilities that predominately irradiate products other than foodstuffs. Two stakeholders (from France and the Netherlands) interviewed within the framework of the support study mentioned notably that the maximum storage temperature set by Regulation (EC) 853/2004 for frozen mechanically separated chicken (-18 degrees Celsius throughout the process) contributed to the decline of the irradiation of this product. Both explained that they stopped the irradiation of mechanically separated chicken, because maintaining that temperature throughout the irradiation process proved challenging. Therefore, there is a certain incoherence in authorising certain foods to be irradiated, when these foods cannot (or only hardly can) be irradiated under conditions that would meet the specific hygiene rules under Regulation (EC) No 853/2004. Microbiological criteria The desk research and the consultations carried out within DG SANTE showed that the Directives are coherent with Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs, which takes into account the possible use of decontamination to eliminate the microorganisms of concern from food. Indeed, the criteria laid down by Regulation (EC) No 2073/2005 apply to irradiated foodstuffs, except where a derogation is granted for food which has undergone a treatment effective to eliminate the microorganisms of concern. Conversely, the Regulation lays down certain criteria that specifically apply to food that have undergone a treatment, in order to check on the efficiency of the treatment and prevent recontamination. Novel food legislation The desk research and the consultations carried out within DG SANTE did not identify incoherence between Regulation (EU) 2015/2283 (‘the novel food regulation’) and the Directives. According to Regulation (EU) 2015/2283 (‘the novel food regulation’), food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food affecting its nutritional value, metabolism or level of undesirable substances is considered a novel food. According to Article 4 of the same regulation, food business operators shall verify whether or not the food which they intend to place on the market within the Union falls within the scope of this Regulation. If after considering all the information available food business operators are still unsure about a food as novel, they should consult the competent authorities of the Member State where they first intend to place the food on the market, according to the procedure described in Commission Implementing Regulation (EU) 2018/456. Although significant technological progresses have been achieved in the area of ionising radiation in the recent years (e.g. development of low energy electron beam), it is unlikely, but cannot be a priori excluded, that foodstuffs resulting from that technology might be considered as novel food as changes in composition or structure of food induced by such irradiation techniques are minor. However, as indicated above, it is responsibility of food business operators to verify whether or not the food which they intend to place on the market within the Union falls within the scope of the novel food regulation and a case by case analysis is necessary. If foodstuffs resulting from a new irradiation technology would be considered as novel food, their irradiation would be possible once they are authorised under the Directives and under the novel food Regulation. Labelling requirements The desk research and the consultations carried out within DG SANTE did not identify incoherence between the labelling requirements laid down by the Directives, and those laid down by Regulation (EU) No 1169/2011 on the provision of the food information to consumers. Directive 1999/2/EC refers in its Article 6 to Directive 79/112/EEC, which has been repealed by Directive 2000/13/EC, itself repealed by Regulation (EU) No 1169/2011. Regulation (EU) No 1169/2011 applies without prejudice to labelling requirements provided for in specific Union provisions applicable to particular foods (see Article 1(4) of Regulation (EU) No 1169/2011), i.e. without prejudice to Article 6 of Directive 1999/2/EC. Regulation (EU) No 1169/2011 echoes the labelling requirements for irradiated foodstuffs laid down by the Directive 1999/2/EC, by providing in its article 17 paragraph 5 and Annex VI, Part A, point 3, that the particulars ‘irradiated’ or ‘treated with ionising radiation’ shall accompany the name of the food and by specifying in article 18(2) that “ingredients shall be designated by their specific name, where applicable, in accordance with the rules laid down in article 17 and in Annex VI”. The same rules apply therefore for foods and ingredients: the particulars ‘irradiated’ or ‘treated with ionising irradiation’ shall accompany the name.

In addition to labelling rules in Regulation (EU) No 1169/2011, Directive 1999/2/EC provides that the irradiation facility’s identity or reference number should be indicated in the case of products not intended for the ultimate consumer and mass caterers (Article 6.2.b of Directive 1999/2/EC), and provides that the indication of the treatment shall in all cases be given on the documents which accompany or refer to irradiated foodstuffs (Article 6.3 of Directive 1999/2/EC). Official controls and reporting obligations Regulation (EU) 2017/625 (the Official Controls Regulation) establishes common rules for EU official controls carried out by national competent authorities to verify compliance with agri-food chain rules, including on food and feed safety, integrity and wholesomeness throughout production, processing and distribution and labelling. The regulation also covers imports of certain animals and goods from outside the EU which are subject to checks at EU border control posts. Official controls concerning irradiated foodstuffs and irradiation facilities are not specifically addressed in this Regulation, but they are mentioned in Commission Implementing Regulation (EU) 2019/627, Article 45 of which lays down the measures in cases of non-compliance with requirements for fresh meat, and provides that the official veterinarian shall declare fresh meat unfit for human consumption if the meat “(l) has been treated illegally with ionising radiation, including UV-radiation”. The inclusion of UV-radiation under the term “ionising radiation” in this Article differs from the definition of ionising radiation under Council Directive 2013/59/EURATOM (see below). Even if they are not specifically addressed in the Official Controls Regulation, official controls of irradiated foodstuffs and irradiation facilities falls within the scope of this Regulation and should therefore be carried out in accordance with its provisions. The data collected through the evaluation suggest that the controls carried out by Member States are not harmonised, neither by their frequency (Germany represents more than 50% of the samples taken in the EU) nor by the approach adopted. In particular, some Member States appear to carry out random sampling, while the Regulation sets out a risk-based control system, so that national enforcement authorities carry out official controls where they are most needed. This suggests that the organisation of the controls to check compliance with the Directives may not be carried out in line with the general provisions laid down by the Official Controls Regulation. Directive 1999/2/EC provides that the methods used during official controls to detect treatment with ionising radiation shall comply with paragraphs 1 and 2 of the Annex to Directive 85/591/EEC. This Directive has been repealed by Regulation (EC) No 882/2004, itself repealed by Regulation (EU) 2017/625. However, paragraphs 1 and 2 of the Annex to Directive 85/591/EEC laid down general requirements for analysis methods, which all methods currently used under Regulation (EU) 2017/625 for official controls fulfil. As the Directives do not set specific provisions regarding the monitoring of imports, no incoherence with the legal provisions applying to the control of imported foodstuffs in the EU have been identified. 5.2.3Coherence with other EU acts Plant health legislation No incoherence has been identified between the Directives and the EU legislation on plant health. Irradiation can be an effective tool to address plant health risks (see Section 5.1.2 “ Relevance of food irradiation for plant health ”), and is therefore addressed in the EU legislation on plant health. Regulation (EU) 2019/2072 provides notably requirements for the import of plants (whether edible plant or non-edible plant) and plant products in the EU, which can include the use of post-harvest treatment by fumigation with plant protection products or irradiation (Annex VII and Annex IX). Regulation (EU) 2019/2072 provides that, in certain cases, third countries have to communicate in advance to the Commission if they plan to make use of post-harvest treatments on plants or plant products to be exported in the EU. Exporting countries must declare in the certificate accompanying consignments of plant if a post-harvest treatment (whether chemical or physical) has been applied. To date, the use of irradiation to fulfil phytosanitary import requirement is explicitly recognized as an available option in only two cases, namely for import of certain wood species and of wood packaging material. However, these are not commercially used, and they do not concern consumable plant products. The scope of the Directives is not limited to the use of the technique for hygiene purpose, but also includes its uses for plant health purposes. Indeed Annex I of Directive 1999/2/EC provides that food irradiation may be used “to rid foodstuffs of organisms harmful to plant or plant products”. Therefore, when irradiation is used on food of non-animal origin for plant health purposes, both the Directives and the EU legislation on plant health apply. This means for example that import of food of non-animal origin irradiated for plant health purpose can only occur: -from facilities authorised under the Directives, and -if the efficacy of the treatment for plant health purpose has been demonstrated under the EU legislation on plant health (based on international standards or on a dossier submitted to the Commission). Member States that do not authorise irradiation of certain food products on their territory may forbid the import of food of non-animal origin irradiated for plant health purpose, based on the provisions of the Directive 1999/2/EC. Council Directive 2013/59/EURATOM The Directives regulate use of ionising radiation for treatment of foods but do not define this expression, nor “food irradiation”, which created uncertainty among stakeholders (see following Sections).

‘Ionising radiation’ is on the other hand defined in Council Directive 2013/59/EURATOM as ‘energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 x 1015 hertz or more) capable of producing ions directly or indirectly’. Applying this definition also for the purposes of the Directives would help clarify the scope of the Directives, since this definition clearly excludes certain technologies such as cold plasma and UV treatment with wavelength above 100 nanometres. Such technologies have begun to be used in commercial conditions in the years after the Directives came into force, but only in limited ways and for particular products (e.g. UV for water treatment). The definition would however not exclude the ‘low energy electron beam’ technology, which has been recently developed to enable surface treatment of dry food products but is not yet used in the EU or in third countries in commercial conditions (based on information provided by the manufacturer of that technology, see support study, Section 3.5.1.1.). Regulation (EU) 2018/848 on organic production Regulation (EU) 2018/848 on organic production and labelling of organic products prohibits the use of ionising radiation (i.e. irradiation) in the treatment of organic food or feed, and in the treatment of raw materials used in organic food or feed, considering that the use of ionising radiation is incompatible with the concept of organic production and consumers’ perception of organic products. Regulation (EU) 2016/425 on personal protective equipment The desk research and the consultations carried out within the Commission did not identify any incoherence between the provisions of the Directives and the Regulation (EU) 2016/425 as regards occupational safety in food irradiation facilities. 5.2.4Coherence with international standards There is potential to revise the Directives to better align with the most recent update to the Codex Alimentarius General standards. The Codex Alimentarius has developed a code of practice for radiation processing of food and a general standard for irradiated foods, and has published a list of methods for the detection of irradiated foods. These documents provide guidelines for governments to effectively apply the irradiation technology to improve food safety, together with guidance on the labelling of irradiated foods. However, it is left to governments to determine their own approach to the use of food irradiation. Currently, there is a single reference to the Codex Alimentarius in Directive 1999/2/EC, article 7(2) of which provides that irradiation facilities must meet the “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)” in order to be granted approval. Since the code of practice referred to has now been replaced by the code of practice for radiation processing of food, CAC/RCP 19-1979, there is some ambiguity as to whether the Directives require compliance with this latest code of practice. Further, the general standard for irradiated foods, updated in 2003, uses a concept of “maximum absorbed dose” which is considered a more appropriate than the one used in the Directives, i.e. the concept of “maximum overall average absorbed dose”. Experts from the irradiation industry called for the EU legislation to be updated and aligned with the current Codex Alimentarius recommendations, in particular as regards the concept of absorbed doses, considering that this could help to resolve conflicts or grey areas in relation to international trade, see Section 5.4.5 “ Competition between EU and non EU businesses ”. In addition to the recommendations provided by the Codex Alimentarius, Member States can rely on other international standard when enforcing the Directiveson. A standard ISO 14470:2011 on “food irradiation: requirements for the development, validation and routine control of the ionizing radiation process used for the treatment of food”, was notably developed and published for the first time in 2011.



5.3Effectiveness Main findings The Directives have not fully met their objectives. The harmonisation of the legislation on irradiation across the EU has been only achieved to a limited extent. Requirements on sources of irradiation, absorbed doses, labelling of irradiated foodstuffs and irradiated ingredients, approval of irradiation facilities, and on reporting have been fully harmonised. However, national lists of foodstuffs authorised for irradiation remained, as well as national bans or restrictions on the trade of irradiated foodstuffs. As a consequence, free movement of irradiated foodstuffs within the single market has been ensured only for the sole food category included in the current EU list of foodstuffs authorised for irradiation: “Dried aromatic herbs, spices and vegetable seasonings”. The Directives did not achieve their objective to establish a fair competition in the EU and with third countries, especially for products other than herbs and spices, since the harmonisation of the legislation has only be been limited. Moreover, while the Directives provide that irradiated foodstuffs entering the EU should comply with the EU requirements applicable to those foods, representatives of the EU food industry expressed concerns that irradiated products were being imported without meeting EU requirements, thus undermining competition with third countries.

The enforcement of irradiation legislation has been partially achieved. The controls applied by Member States are considered mostly effective, but the level of enforcement differs greatly between Member States, one Member State being responsible for more than 50% of the official controls in the EU. Almost all non-compliances identified relate to foodstuffs imported from third countries, which fuels the hypothesis that there may be gaps in the enforcement of EU requirements on import of irradiated foodstuffs, although the extent of this issue is difficult to evaluate. It is difficult to conclude on the effectiveness of the Directives to provide information to consumers/citizens to ensure choice and welfare, in absence of direct data on consumer perceptions and understanding of the labels. Labelling requirements are harmonised and enforced, but available evidence suggest that consumers’ awareness of irradiation has decreased since the implementation of the Directives, and that they frequently misunderstand irradiation labelling, interpreting them as a warning. Finally, since they do not include specific provisions to establish favourable conditions for innovation, the Directives as such did not play a significant role for the achievement of these objectives. The requirements on sources of irradiation created confusion on the scope of the Directives, which may even have hampered innovation. 5.3.1Overview of the provisions’ effectiveness The degree of achievement of the objectives were assessed for the following main provisions: requirements on sources of irradiation and limits for absorbed doses, listing of foodstuffs authorised for irradiation, labelling of irradiated foodstuffs, approval of irradiation facilities by competent authorities, rules for import and intra EU trade of irradiated foodstuffs, enforcement of official controls and reporting obligations. A summary of the conclusions drawn from the answers provided during the support study, and detailed hereafter, is given in Table 2 . Provisions of the Directives Objectives have been met most effectively / less effectively / not at all Requirements on sources of irradiation and limits for absorbed doses Less effectively The requirements for the use of food irradiation are harmonised but there are different national interpretation as regards the use of recently developed technologies Listing of foodstuffs authorised for irradiation Not at all The planned replacement of the initial EU list, which includes only one food, and of the national lists by an extended EU list has not taken place. As a consequence, Member States may maintain national lists of foodstuffs authorised for irradiation, and national bans or restrictions on the trade in irradiated foodstuffs. Labelling of irradiated foodstuffs Less effectively Where labelling requirement is followed and consumers understand the labelling, the Directives enables consumer’s choice and welfare. However, consumers’ awareness of irradiation is low and they may frequently misunderstand irradiation labelling. Approval of irradiation facilities by competent authorities Most effectively The process for approval is harmonized and applies to both EU and non EU facilities. Lists of approved facilities are published by the Commission Rules for intra EU trade of irradiated foodstuffs Not at all The provisions on intra EU trade of irradiated foodstuffs did not meet their objective of harmonising legislation on irradiation across the EU and ensuring free movement of irradiated foodstuffs within the single market. Rules for import of irradiated foodstuffs into the EU Less effectively / Most effectively Requirements applying to imported irradiated foodstuffs are considered adequate but stakeholders have concerns regarding compliance of imported products with EU requirements. Enforcement of official controls Less effectively Official controls applied by Member States are mostly effective, but their frequency differs among Member States and controls of food irradiated with low level doses are not possible with current standardised methods. Reporting obligations Most effectively The Commission published every two years a report presenting the quantities of foodstuffs irradiated in the EU and the results of checks carried out by Member States. 5.3.2Requirements for the sources of irradiation The technical provisions of the Directives have only partially met their objective of providing a unified legal status for irradiated food products in the EU. In particular, the absence of definition of “ionising radiation” in the Directives (see Section 3.1) created uncertainty about the scope of the Directives as regards some novel decontamination technologies such as low energy electron beam, cold plasma or ultraviolet (UV) treatment. This uncertainty led to some discrepancies in the implementation of Directive 1999/2/EC in the EU: some Member States considered that these new technologies are not listed in the Directive because their use is forbidden, while others considered that these technologies are authorised but not listed because they do not fall under the definition of ionising radiation, and therefore within the scope of the Directive. These differences between Member States’ legal approaches towards novel technologies may have contributed to confusion in businesses. Moreover, this issue may have posed problems for the development of innovative products and processes. Very few patents related to food irradiation have been filed in the EU since the Directives entered into force (none of which were granted). This suggests that the Directives have not been effective in allowing for the entry in the EU market of innovative products or processes. However, no evidence has been identified on the types of innovation that were prevented and in what ways. Moreover, no evidence showed that the lack of innovation has been caused by the confusion on the scope of the Directives, rather by the low interest of EU operators in such technologies because of the possible negative perception of consumers (See Section 5.4.6 “ Main reasons for the decline of food irradiation in the EU ”). 5.3.3Limits of absorbed doses The requirements concerning the limits of absorbed doses are harmonised within the EU, but some issues in their implementation have been reported. First, the Directives base dose requirements on a measurement of “overall average absorbed dose”, a concept that is not directly measurable and must be estimated. This approach is not the one used in many non-EU countries and recommended by the Codex Alimentarius since 2003, which relies on minimum and maximum dose (See Section 5.2.4 “ Coherence with international standards ”). Stakeholders involved with the irradiation industry mentioned that the legislation’s focus on “overall average absorbed doses” obscures the importance of ensuring a minimum dose is applied – particularly when irradiation is used to ensure food safety, a concept which is also reflected in the Codex Alimentarius General Standard for Irradiated Foods. However, the purpose of the Directive is in the first place to ensure food safety, not the efficiency of a treatment. It is primary to the irradiation establishment to demonstrate that the cost of such treatment has a benefit. Second, the 2011 EFSA’s opinion on the efficacy and microbiological safety of irradiation of food also noted that the way doses are currently assigned (to general food classes) does not consider other important factors (such as whether food is fresh or frozen, differentiations in composition between products within the same class and new and diverse types of products now available to consumers). Finally, the requirements of the Directives for the limits for absorbed doses are not relevant for the recently developed ‘low energy electron beam’ technology, which enables surface treatment of dry food products, but this does not affect the effectiveness of the Directive, since this technology has not yet entered the market. 5.3.4Listing of foodstuffs authorised for irradiation The objective to replace the initial EU list and national lists of foodstuffs which may be treated with ionising radiation by an EU list of foodstuffs which may be treated with ionising radiation to the exclusion of all others has not been met. The process for the replacement of the initial EU list, which included only one foodstuff category (‘dried aromatic herbs, spices and vegetable seasonings’), was launched in 2000. The Commission addressed a Communication to the European Parliament and the Council on Foods and food ingredients authorised for treatment with ionising radiation in the Community offering three options:

-Option 1 was the inclusion of the only two foods for which a clear technological need had been identified through the consultation carried out at the time: “peeled shrimps” and “frog legs”; -Option 2 was, a list based on an opinion from the EU’s Scientific Committee for Food and including the “ deep frozen aromatic herbs”, “dried fruit”, “flakes and germs of cereals”, “mechanically recovered chicken meat”, “offal of chicken”, “egg white”, “gum Arabic”, “frog legs” and “peeled shrimps”; -Option 3 was to consider the current list as complete, having regard to the divergence of views resulting from the consultation process. The consultation showed that there were strong, polarised views on the matter, a lack of support for the proposals from a number of representative organisations for the food industry, consumer organisations and NGOs. The Communication of the Commission indicated that most of the food production and trade sectors were against the inclusion of their products into the EU positive list, mainly because they expected negative consumer reactions. Only some specific sectors were in favour of authorising irradiation of their products, like shrimps, frog legs, crayfish and blood products. By a vote on 17 December 2002, the European Parliament adopted a resolution in favour of Option 3, which stopped the process for adding new products to the EU positive list of products. The rapporteur of the resolution stated that the current EU list should not be extended at this stage and should be regarded as complete. The European Parliament expressed several concerns around the establishment an extended EU list of foodstuffs authorised for irradiation, including that: -there was evidence that the existing legislation was not being appropriately enforced; -there was a lack of evidence regarding the long-term safety of eating a diet based largely on irradiated foods; -there was a lack of evidence on how worker health and safety may be impacted by gamma irradiation; and -there were concerns that irradiation could be used to mask poor hygiene standards in certain industries. A persistent and fundamental disagreement between Member States on the potential role and acceptability of irradiation was pointed out as an obstacle. A broader debate was announced by the Commission, but never took place. The 2011 EFSA opinions on the biological and toxicological safety of food irradiation addressed the concerns on food safety expressed in the European Parliament resolution, but this did not reopen the discussion on a possible extension of the EU list of foodstuffs authorised for irradiation. 5.3.5Labelling of irradiated foodstuffs The Directives harmonised the labelling requirements within the EU but this is difficult to conclude directly whether these labelling requirements are effective in informing consumers in order to ensure consumer choice and welfare. The Directives ensure that consumers are provided with information that enables choice and consumer welfare, only where 1) the labelling requirement is followed, and 2) consumers understand the labelling. Non-compliances on labelling requirements have been identified through the official controls carried out by Member States but their extent seems limited (see Section 3.4 “ Results of official controls ”). There is no direct data on consumer perceptions and understanding of the mandatory particulars ‘irradiated' and ‘treated with ionising radiation', but based on the evidence available, it appears possible that they contributed to consumer confusion and misperceptions, and led consumers to interpret the irradiation labelling as a warning. The overall consumers’ awareness of irradiation is low. In the current context, most EU consumers would almost never encounter an irradiated product since food irradiation has become such a narrow share of the EU food production system. As an example, more than 300,000 tons of herbs and spices are consumed yearly in the EU while only 600 tons are being irradiated in EU facilities. Within the EU, frog legs are the only regularly sold irradiated product, and these are mostly consumed in France and Belgium. Some studies, showed that the lack of consumer acceptance stems from misconceptions about the technology, and when presented with more information, consumers are more likely to accept it. Representatives of the irradiation industry were concerned that the labelling requirements provided by the Directives, acted as a main factor in the decline of food irradiation in the EU (See Section 5.4.6 “ Main reasons for the decline of food irradiation in the EU ”). 5.3.6Approval of irradiation facilities The provisions on theapproval and monitoring of irradiation facilities within the EU and in non-EU countries are effectively applied, and ensure that manufacturing of irradiated foodstuffs is implemented in line with the Directives. This was confirmed in the survey of national competent authorities (see support study, Section 4.1.9). No non-compliance incidents related to irradiation facilities have been identified.

All facilities in the EU have been approved in line with the Directives. So far, the approval of irradiation facilities in non-EU countries occurred after an audit of the Commission in these premises. The Commission rejects applications for facility approval if there is no confidence that competent authorities in non-EU countries will be able to provide official supervision to guarantee that the requirements of the Directives are upheld. This was the case, for example, following the results of an audit on facilities in China in 2009. They are no active controls of the use of irradiation in non-EU countries by the Commission after the initial approval of the facilities. After approval, the Commission relies on the competent authorities of third countries to ensure that facilities keep complying with the Directives. The approval of facilities in third countries is granted for all food and food ingredients, whereas only one product is included in the current EU list. As a consequence, it is often unclear to food business operators and competent authorities which foods they are authorised to irradiate and export to the EU, and in which Member State. The Directives do not subject approved facilities in third countries to the same reporting requirements as those to which approved facilities in the EU are subject (annual reporting of the quantities and type of food irradiated). Certain national competent authorities considered this information could be useful to improve the control carried out at import to identify irradiated foodstuffs not labelled as such. There have been some limited instances of products which have been irradiated in unapproved facilities finding their way on to the EU market (see Section 3.4 “ Results of official controls ”). 5.3.7Provisions on intra EU trade of irradiated foodstuffs The provisions on intra EU trade of irradiated foodstuffs did not meet at all their objective of harmonising legislation on irradiation across the EU and ensuring free movement of irradiated foodstuffs within the single market. Indeed, since the process provided by Directive 1999/2/EC to adopt a EU list of foodstuffs that may be treated with ionising radiation to the exclusion of all others did not take place (see Section 5.3.4 “ Listing of foodstuffs authorised for irradiation ”), the provisions to maintain the existing national authorisations of the Member States are still in force, whereas they were supposed to be transitional, and the rules applying to import and intra EU trade of irradiated foodstuffs have not been harmonised. The maintaining of only one category of irradiated foodstuff listed at EU level and of several categories at the national level in six Member States prevented a consistent regime for irradiated foodstuffs and their free movement within the EU market to be established. Currently, free movement within the single market is only ensured for the one category of foodstuffs included in the initial EU list (‘aromatic herbs, spices and vegetable seasoning’). The rules applying to other foodstuffs are defined at national level by Member States, which may, in accordance with Directive 1999/2/EC, continue to apply existing national restrictions or bans on ionising radiation of foodstuffs and on trade in irradiated foodstuffs. Whereas the national lists of foodstuffs authorised for irradiation are notified to the Commission and published in Official Journal of the European Union, this reporting obligation does not exist as regards the national rules applied to the trade of foodstuffs irradiated in other Member States or in third countries. This creates confusion among stakeholders and national competent authorities, who do not know exactly which irradiated foods are accepted by which Member State. According to the survey carried out on national competent authorities (See support study), only Germany laid down rules to ban or require specific approval for products not on the EU list (in particular, for the entry on its market of irradiated frog legs). The lack of an EU positive list of foodstuffs authorised for irradiation to the exclusion of all others, and the persistence of different authorisations at the national level in several Member States created uncertainty for businesses interested in using irradiation, both within the EU and for third countries looking to import to the EU. Evidence from the consultations suggests that the difference between the EU and national lists may contribute, in part, to food business operators’ decisions not to irradiate. However, it is difficult to assess the extent t