COMMISSION STAFF WORKING DOCUMENT EVALUATION of the EU legal framework on food irradiation (Directives 1999/2/EC and 1999/3/EC)
Date: 2021-08-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: consumer protection, food inspection, food safety, foodstuff, health control, ionising radiation, irradiated product, irradiation, labelling, marketing standard

EN 

  EN 

   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 

1 

INTRODUCTION ................................................................................................................. 4 

1.1.  Definition of food irradiation .......................................................................................... 4 

1.2. 

Purpose and scope of the evaluation ............................................................................... 4 

2 

BACKGROUND TO THE INTERVENTION ................................................................... 5 

2.1 

2.2 

Description of the intervention and its objectives ........................................................... 5 

Legislation before the adoption of the Directives ........................................................... 7 

3 

IMPLEMENTATION / STATE OF PLAY ........................................................................ 9 

3.1  Main legal provisions ...................................................................................................... 9 

3.2 

3.3 

3.4 

Use of irradiation by the EU food industry ................................................................... 11 

Import of irradiated foodstuffs in the EU ...................................................................... 12 

Results of official controls ............................................................................................ 12 

3.4.1  Notifications through the EU report on food irradiation ......................................................... 12 

3.4.2  Notifications to the rapid alert system for food and feed (RASFF) ........................................ 13 

4  METHOD ............................................................................................................................. 15 

4.1 

Evaluation process ......................................................................................................... 15 

4.2  Methodology of the study supporting the evaluation .................................................... 15 

4.3 

Limitations and robustness of findings ......................................................................... 17 

5 

ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS ........................ 19 

5.1 

Relevance ...................................................................................................................... 19 

5.1.1  Relevance of food irradiation for public health ...................................................................... 20 

5.1.2  Relevance of food irradiation for plant health ........................................................................ 21 

5.1.3  Relevance of food irradiation for reducing pesticide use ........................................................ 22 

5.1.4  Relevance of the Directives’ objectives .................................................................................. 23 

5.1.5  Relevance of the Directives’ requirements ............................................................................. 23 

5.1.6  Consumer opinion on the relevance of food irradiation .......................................................... 24 

5.2 

Coherence ...................................................................................................................... 26 

5.2.1 

Internal coherence ................................................................................................................... 27 

5.2.2  Coherence with the EU food legislation ................................................................................. 27 

5.2.3  Coherence with other EU acts ................................................................................................. 33 

5.2.4  Coherence with international standards .................................................................................. 35 

5.3 

Effectiveness ................................................................................................................. 36 

5.3.1  Overview of the provisions’ effectiveness .............................................................................. 36 

5.3.2  Requirements for the sources of irradiation ............................................................................ 37 

5.3.3  Limits of absorbed doses ........................................................................................................ 38 

5.3.4  Listing of foodstuffs authorised for irradiation ....................................................................... 39 

5.3.5  Labelling of irradiated foodstuffs ........................................................................................... 40 

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5.3.6  Approval of irradiation facilities ............................................................................................. 41 

5.3.7  Provisions on intra EU trade of irradiated foodstuffs ............................................................. 41 

5.3.8  Provisions on import of irradiated foodstuffs ......................................................................... 42 

5.3.9  Enforcement ............................................................................................................................ 43 

5.3.10 

Reporting ............................................................................................................................ 45 

5.4 

Efficiency ...................................................................................................................... 46 

5.4.1  Costs and benefits for consumers ............................................................................................ 47 

5.4.2  Costs and benefits for the environment ................................................................................... 47 

5.4.3  Costs and benefits for national competent authorities ............................................................ 48 

5.4.4  Costs and benefits for irradiation industry and food business operators ................................. 49 

5.4.5  Competition between EU and non EU businesses .................................................................. 50 

5.4.6  Main reasons for the decline of food irradiation in the EU ..................................................... 51 

5.5 

EU added-value ............................................................................................................. 53 

5.5.1  Harmonisation of regulatory approaches within the EU ......................................................... 53 

5.5.2  Existence and effectiveness of additional rules at national level ............................................ 54 

5.5.3 

Interest of stakeholders in maintaining an intervention at EU level ....................................... 54 

5.5.4  Potential consequences of a phasing out of the EU rules ........................................................ 55 

6 

CONCLUSIONS .................................................................................................................. 57 

ANNEX 1: PROCEDURAL INFORMATION ......................................................................... 60 

ANNEX 2: STAKEHOLDER CONSULTATION – SYNOPSIS REPORT ........................... 62 

ANNEX 3: METHODS AND ANALYTICAL MODELS ........................................................ 73 

ANNEX 3: LIST OF EVALUATION QUESTIONS ................................................................ 75 

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Glossary 

Term or acronym 

Meaning or definition 

2-ACBs 

EFSA 

FAO 

HACCP 

MEP 

NGO 

RASFF 

UV 

2-Alkylcyclobutanones 

European Food Safety Authority 

The Food and Agriculture Organization of the United Nations 

Hazard analysis and critical control points 

Member of the EU Parliament 

Non-governmental organisation 

Rapid Alert System for Food and Feed 

Ultra Violet 

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1 

INTRODUCTION 

1.1.  Definition of food irradiation 

According  to  the  Codex  Alimentarius1,  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/EC2 and 1999/3/EC3 (hereafter “the Directives”).  

their  entry 

The evaluation  was deemed necessary since the Directives had not  been evaluated 
technological 
since 
developments,  and  despite  the  adoption  of  the  General  Food  Law  in  2002 
(Regulation  (EC)  No  178/20024),  which  provided  a  new  legal  framework  for  EU 
interventions on food safety.  

in  force,  despite  significant  scientific  and 

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. 

1  CAC/RCP 19-1979, Code of practice for radiation processing of food 
2  Directive  1999/2/EC  of  the  European  Parliament  and  of  the  Council  of  22  February  1999  on  the 
approximation of  the laws of the  Member States concerning  foods and  food ingredients treated  with 
ionising radiation, OJ L 066 13.3.1999, p. 16. 

3  Directive  1999/3/EC  of  the  European  Parliament  and  of  the  Council  of  22  February  1999  on  the 
establishment of a Community list of foods and food ingredients treated with ionising radiation, OJ L 
66, 13.3.1999, p. 24–25. 

4  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28  January  2002 
laying  down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food 
Safety Authority and laying down procedures in matters of food safety, OJ L 031 1.2.2002, p. 1. 

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2  BACKGROUND TO THE INTERVENTION 

2.1  Description 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.  

Figure 1 : Intervention logic 

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. 

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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 

6 

 
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. 

2.2 

Legislation 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/EEC5. 

Labelling of irradiated foods was already required on foodstuffs intended for sale to 
the  ultimate  consumer  by  Council  Directive  89/395/EEC 6  amending  Directive 
79/112/EEC7. 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 

5   Council  Directive  72/462/EEC  on  health  and  veterinary  inspection  problems  upon  importation  of 

bovine animals and swine andfresh meat from third countries (OJ L 302, 31.12.1972, p. 28). 

6   Council Directive 89/395/EEC 89/395/EEC amending Directive 79/112/EEC on the approximation of 
the laws of the Member States relating to labelling, presentation and advertising of foodstuffs for sale 
to the ultimate consumer (OJ L 186, 30.6.1989, p. 17). 

7   Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member 
States  relating  to  the  labelling,  presentation  and  advertising  of  foodstuffs  for  sale  to  the  ultimate 
consumer (OJ L 33, 8.2.1979, p. 1). 

7 

 
                                                           
by the Trading Standards Office in the UK8 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.  

8   Kilcast,  D.  (1995)  Food  Irradiation:  Current  Problems  and  Future  Potential.  International 

Biodeterioration & Biodegradation: 279-296. 

8 

 
 
 
                                                           
3 

IMPLEMENTATION / STATE OF PLAY 

3.1  Main 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 beam9. 

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 radiation10.  

9  Contrary  to  high  energy  electrons,  which  can  effectively  penetrate  food  products  up  to  several 
centimeters,  the  penetration  depth  of  low  energy  electron  beam  (i.e.  with  energies  of  300  keV  or 
lower) is limited to the micrometer scale, resulting in an high efficiency for surface decontamination. 
https://www.sciencedirect.com/science/article/pii/S092422441730657X?via%3Dihub 
An advantage of this technology, in addition to lower effect on food ingredients, is that low energy e-
beam  machines  do  not  require  thick  shields  and  can  be  applied  for  in-line  irradiation.  This  can 
eliminate the necessity of transportation of a large amount of spices to irradiation facility.   

10  List of Member States’ authorisations of food and food ingredients which may be treated with ionising 
radiation  (According  to  Article  4(6)  of  Directive  1999/2/EC  of  the  European  Parliament  and  of  the 

9 

 
                                                           
 
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 Commission11.  

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 facilities12. 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 online13. 

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 

Council on the approximation of the laws of the Member States concerning foods and food ingredients 
treated with ionising radiation) OJ C 283, 24.11.2009, p. 5.  

11  List of approved facilities for the treatment of foods and food ingredients with ionising radiation in the 
Member States (According to Article 7(4) of Directive 1999/2/EC of the European Parliament and of 
the  Council  on  the  approximation  of  the  laws  of  the  Member  States  concerning  foods  and  food 
ingredients treated with ionising radiation) (OJ C 37, 30.1.2019, p. 6).  

12   Commission Decision 2002/840/EC of 23 October 2002 adopting the list of approved facilities in third countries 

for the irradiation of foods (OJ L 287, 25.10.2002, p.40). 

13   https://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm  

10 

 
                                                                                                                                                                            
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/EEC14 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  States15,  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. 

3.2  Use 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).  

Figure 2 Quantities of foodstuffs treated by ionising radiation in approved irradiation establishments within the 
European Union since 2010 (in tons) 

14   Council  Directive  85/591/EEC  of  20  December  1985  concerning  the  introduction  of  Community 
methods of sampling and analysis  for the  monitoring of  foodstuffs intended for  human  consumption 
(OJ L 372, 31.12.1985, p. 50–52) 

15  https://ec.europa.eu/food/safety/biosafety/irradiation/reports_en  

11 

 
 
                                                           
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 kGy16) 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%).  

3.3 

Import of irradiated foodstuffs in the EU 

Currently,  ten  irradiation  facilities  are  approved  in  non-EU  countries  to  process 
products  for  export  to  the  EU 17 :  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. 

3.4  Results of official controls 

3.4.1  Notifications 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 

16  A gray is defined as the absorption of one joule of radiation energy per kilogram of matter 
17  https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02002D0840-

20120524&qid=1607098954360  

12 

 
                                                           
marketing stage in 2018-2019 due to budgetary restrictions (Denmark and Norway), 
lack of laboratory capacity (Cyprus) or other control priorities (Sweden).  

Figure 3 Samples analysed at product marketing stage within each Member State in 2018-2019 

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.  

3.4.2  Notifications 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. 

13 

 
 
Figure 4: RASFF notifications related to irradiation by country of origin (top 10) 

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. 

14 

 
 
 
 
4  METHOD 

4.1 

Evaluation 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  study18,  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). 

Figure 5 Time of the evaluation process 

4.2  Methodology 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 
legal  sources  of 
information. 

identify  scientific,  academic  and 

logic,  and 

18   Final report of the study to support the retrospective evaluation of legislation related to the irradiation 
of  food  and  food  ingredients,  2021,  ICF,  Luxembourg:  Publications  Office  of  the  European  Union, 
DOI 10.2875/460710, ISBN 978-92-76-37808-2 

15 

 
 
                                                           
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 

16 

 
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). 

4.3 

Limitations 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.  

17 

 
 
 
5  ANALYSIS 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. 

5.1  Relevance 

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. 

18 

 
 
5.1.1  Relevance 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 food19 
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 852/200420 and (EC) No 853/200421. 

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 studies22 were carried out, which confirmed that the ingestion of 2-
ACBs through irradiated foods is unlikely to affect the human health, but suggesting 

19   Scientific  Opinion  on  the  efficacy  and  microbiological  safety  of  irradiation  of  food,  EFSA  Journal 

2011;9(4):2103, DOI: https://doi.org/10.2903/j.efsa.2011.2103  

20   Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 

down specific hygiene rules for food of animal origin (OJ L 139 30.4.2004, p. 55)  

21   Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 

down specific hygiene rules for food of animal origin (OJ L 139 30.4.2004, p. 55)  

22   Song,  B.S.  (2014)  A  critical  review  on  toxicological  safety  of  2-alkylcyclobutanones.  Radiation 

Physics and Chemistry: 188-193 

19 

 
                                                           
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  irradiation23,  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.  

5.1.2  Relevance 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. 

23   European  Parliament  resolution  on  Commission  communication  on  foods  and  food  ingredients 
authorised for treatment with ionising radiation in the Community (COM(2001) 472 – C5-0010/2002 – 
2002/2008(COS)) 

20 

 
                                                           
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 
2016/203124 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. 

5.1.3  Relevance 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 

24   Regulation  (EU)  2016/2031  of  the  European  Parliament  of  the  Council  of  26  October  2016  on 
protective  measures  against  pests  of  plants,  amending  Regulations  (EU)  No  228/2013,  (EU)  No 
652/2014  and  (EU)  No  1143/2014  of  the  European  Parliament  and  of  the  Council  and  repealing 
Council  Directives  69/464/EEC,  74/647/EEC,  93/85/EEC,  98/57/EC,  2000/29/EC,  2006/91/EC  and 
2007/33/EC (OJ L 317, 23.11.2016, p. 4). 

21 

 
                                                           
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. 

5.1.4  Relevance 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.  

5.1.5  Relevance 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 

22 

 
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. 

5.1.6  Consumer opinion on the relevance of food irradiation 

A  survey 25 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  Directives26,  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 Survey27 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 Europe28, 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  consumers29 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 

25   Webb, T. and Lang, T. (1990) Food Irradiation: the myth and the reality. Thorsons: London. 
26   Communication from the Commission to the European Parliament and the Council on foods and food 
ingredients  authorised  for  treatment  with  ionising  radiation  in  the  community,  COM(2001)  472, 
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52001DC0472&from=lv  

Food 

2012. 

27   Prior et al. (2013) Exploring food attitudes and behaviours in the UK: Findings from the Food and You 
at: 

Survey 
https://www.food.gov.uk/sites/default/files/media/document/food-and-you-2012-main-report.pdf 
28   Food  Standards  Australia  New  Zealand  (FSANZ)  (2017)  Labelling  Review  Recommendation  34: 
Review  of  mandatory  labelling  of  irradiated  food.  Supporting  Document  5.  Available  at: 
http://www.foodstandards.gov.au/consumer/labelling/review/Pages/Labelling-review-
recommendation-34irradiation-labelling.aspx 

Standards 

Available 

Agency 

UK. 

29   Balatsas-Lekkas,  A.,  Arvola,  A.,  Kotilainen  H.M.,  Meneses  N.  &  Pennanen,  K.(2020).  Effect  of 
labelling  fresh  cultivated  blueberry  products  with  information  about  irradiation  technologies  and 
related  benefits  on  Finnish,  German,  and  Spanish  consumers’  product  acceptance.  Food  Control, 
107387. 

23 

 
                                                           
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  study30 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. 

30   Parlato, A., Giacomarra, M., Galati, A., Crescimanno, M., 2014. ISO 14470:2011 and EU legislative 
background  on  food  irradiation  technology:  The  Italian  attitude.  Trends  in  Food  Science  and 
Technology 38, 60–74. https://doi.org/10.1016/j.tifs.2014.04.001 

24 

 
 
 
                                                           
5.2  Coherence 

This Section assesses the internal coherence of the Directives, their coherence with 
the EU food legislation, with other EU legislation and with international standards. 

Internal coherence 

Main findings 

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/EURATOM31 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 32  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. 

31   Directive 2013/59/EURATOM laying down basic safety  standards for protection against the  dangers 

arising from exposure to ionising radiation (OJ L 13, 17.1.2014, p. 1–73) 

32   Regulation  (EU)  2018/848  on  organic  production  and  labelling  of  organic  products  (OJ  L  150, 

14.6.2018, p. 1–92) 

25 

 
 
                                                           
5.2.1  Internal 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.  

5.2.2  Coherence 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. 

Table 1 : Alignment of the EU food safety objectives and the Directives’ objectives 

- 
- 

- 

Objectives of the Directives 
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. 

-  Harmonise irradiation legislation in the EU; 
- 

ensure free movement of irradiated 
foodstuffs within the single market; 
irradiation should not be used in place of 
proper hygiene and good agricultural 
practices; 

- 

- 

ensure enforcement of irradiation legislation 

- 

ensure fair competition with regards to 
irradiated foodstuffs in EU and with third 
countries 

- 

- 

- 

- 

- 

- 

EU food safety objectives 

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. 
ensure free movement of food and feed manufactured 
and marketed in the Union, in accordance with the 
General Food Law Regulation. 
ensure that relevant hygiene requirements are applied 
at all stages of production, processing and 
distribution of food 
ensure the application of food law through on official 
controls and other official activities (Official controls 
regulation) 
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  strategy33,  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.  

33   https://ec.europa.eu/food/farm2fork_en 

26 

 
 
                                                           
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 34 ,  the  latter  repealed  and  replaced  by 
Regulation  (EU)  2017/62535),  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 

34   Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on 
official  controls  performed  to  ensure  the  verification  of  compliance  with  feed  and  food  law,  animal 
health and animal welfare rules (OJ L 165 30.4.2004, p. 1) 

35   Regulation  (EU)  2017/625  of  the  European  Parliament  and  of  the  Council  of  15  March  2017  on 
official controls and other official activities performed to ensure the application of food and feed law, 
rules on animal health and welfare, plant health and plant protection products (OJ L 095 7.4.2017, p. 
1) 

27 

 
                                                           
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 

28 

 
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 36 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 37  (‘the  novel  food 
regulation’) and the Directives. 

According  to  Regulation  (EU)  2015/2283 38  (‘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 

36   Commission  Regulation  (EC)  No  2073/2005  of  15  November  2005  on  microbiological  criteria  for 

foodstuffs (OJ L 338 22.12.2005, p. 1) 

37   Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
and  repealing  Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  and 
Commission Regulation (EC) No 1852/2001. OJ L 327, 11.12.2015, p. 1 

38   Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
and  repealing  Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  and 
Commission Regulation (EC) No 1852/2001. OJ L 327, 11.12.2015, p. 1 

29 

 
                                                           
place the food on the market, according to the procedure described in Commission 
Implementing Regulation (EU) 2018/45639. 

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 40  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 41 , 
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 

39   Commission  Implementing  Regulation  (EU)  2018/456  of  19  March  2018  on  the  procedural  steps  of 
the  consultation  process  for  determination  of  novel  food  status  in  accordance  with  Regulation  (EU) 
2015/2283 of the European Parliament and of the Council on novel foods. OJ L 77, 20.3.2018, p. 6 
40   Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 

the provision of food information to consumers (OJ L 304, 22.11.2011, p. 18). 

41   Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  of  20  March  2000  on  the 
approximation of the laws of the Member States relating to the labelling, presentation and advertising 
of foodstuffs (OJ L 109, 6.5.2000, p. 29). 

30 

 
                                                           
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 42,  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. 

42   Commission  Implementing  Regulation  (EU)  2019/627  of  15  March  2019  laying  down  uniform 
practical arrangements for the performance of official controls on products of animal origin intended 
for human consumption in accordance with Regulation (EU) 2017/625 (OJ L 131, 17.5.2019, p. 51). 

31 

 
                                                           
5.2.3  Coherence 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) 2019/207243 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  EU44.  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). 

43   Commission  Implementing  Regulation  (EU)  2019/2072  of  28  November  2019  establishing  uniform 
conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the 
Council, as regards protective measures against pests of plants (OJ L 319, 10.12.2019, p. 1). 

44   https://ec.europa.eu/food/plant/plant_health_biosecurity/non_eu_trade/declarations_en   

32 

 
                                                           
is  on 

in  Council  Directive 
‘Ionising  radiation’ 
form  of  particles  or 
transferred 
2013/59/EURATOM  as  ‘energy 
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’. 

the  other  hand  defined 
the 

in 

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 45  as  regards  occupational  safety  in  food  irradiation 
facilities. 

5.2.4  Coherence 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  food46 and  a  general  standard  for  irradiated  foods47,  and  has  published  a  list  of 
methods for the detection of irradiated foods48. 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 

45   Regulation  (EU)  2016/425  of  the  European  Parliament  and  of  the  Council  of  9  March  2016  on 
personal  protective  equipment  and  repealing  Council  Directive  89/686/EEC  (OJ  L  81,  31.3.2016,  p. 
51–98) 

46   CAC/RCP 19-1979, Code of practice for radiation processing of food 
47   CXS 106-1983, Rev.1-2003, General standard for Irradiated Foods 
48   CXS 231-2001, General methods for the detection of irradiated foods 

33 

 
                                                           
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. 

34 

 
 
 
5.3  Effectiveness 

The Directives have not fully met their objectives. 

Main findings 

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. 

5.3.1  Overview 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 

35 

 
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. 

Table 2 : Summarized conclusions for the main provisions of the Directives 

Provisions of the Directives 

Requirements on sources of 
irradiation and limits for 
absorbed doses 

Objectives have been met most effectively / less 
effectively / not at all 
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 

Labelling of irradiated 
foodstuffs 

Approval of irradiation 
facilities by competent 
authorities 

Rules for intra EU trade of 
irradiated foodstuffs 

Rules for import of irradiated 
foodstuffs into the EU 

Enforcement of official 
controls  

Reporting obligations 

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. 

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. 

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 

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. 

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.  

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.  

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. 

5.3.2  Requirements 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 

36 

 
 
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”). 

5.3.3  Limits 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. 

5.3.4  Listing 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.  

37 

 
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 Community49 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 resolution50 
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 51 .  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.  

49   Communication from the Commission to the European Parliament and the Council on Foods and food 
ingredients  authorised  for  treatment  with  ionising  radiation  in  the  Community,    COM/2001/0472, 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52001DC0472&qid=1615977065383  

50   European  Parliament  resolution  on  Commission  communication  on  foods  and  food  ingredients 
authorised for treatment with ionising radiation in the Community (COM(2001) 472 – C5-0010/2002 – 
2002/2008(COS)) 
 European 

17-12-2002 

Parliament 

Notebook, 

Daily 

51

https://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+PRESS+DN-20021217-
1+0+DOC+XML+V0//EN#SECTION5  

38 

 
                                                           
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. 

5.3.5  Labelling 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 52 , 53  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”).  

5.3.6  Approval 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 

52   Lima Filho, T., Della Lucia, S. M., Lima, R. M., Scolforo, C. Z., Carneiro, J. C. S., Pinheiro, C. J. G., 
&  Passamai  Jr,  J.  L.  (2014).  Irradiation  of  strawberries:  Influence  of  information  regarding 
preservation  technology  on  consumer  sensory  acceptance.  Innovative  Food  Science  &  Emerging 
Technologies, 26, 242-247 

53   Junqueira-Gonçalves,  M.  P.,  Galotto,  M.  J.,  Valenzuela,  X.,  Dinten,  C.  M.,  Aguirre,  P.,  &  Miltz,  J. 
(2011).  Perception  and  view  of  consumers  on  food  irradiation  and  the  Radura  symbol.  Radiation 
Physics and Chemistry, 80(1), 119-122. 

39 

 
                                                           
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”). 

5.3.7  Provisions 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.  

40 

 
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  to  which  this  has  an  impact, 
considering  the  business  reluctance  to  irradiate  for  other  reasons  (such  as 
perceptions of consumer acceptance and cost), see Section 5.4.6 “Main reasons for 
the decline of food irradiation in the EU”. 

5.3.8  Provisions on import of irradiated foodstuffs 

The  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 those foodstuffs, and was treated in a facility approved and listed by 
the Commission. 

Industry  stakeholders  consulted  expressed  concerns  as  regards  a  potential  lack  of 
monitoring at import to check these requirements, which would result in irradiated 
products being imported from third countries without being properly controlled for 
or  labelled.  They  perceived  a  lack  of  compliance  among  some  international 
competitors  to  the  Directives,  which  they  believe  creates  an  unfair  competition 
between  the  EU  and  non-EU  country  producers  (See  Section  5.4.5  “Competition 
between  EU  and  non  EU  businesses”).  Industry  representatives  involved  in  dried 
vegetables, herbs and spices have notably  mentioned that irradiated products  from 
non-EU  countries  might  be  entering  the  EU  without  labels,  some  products  having 
also been irradiated in non-approved facilities. 

Whereas  several  cases  of  mislabelled  or  non-labelled  imported  irradiated  products 
have been found by national competent authorities (see Section 3.4.2 “Notifications 
to  the  rapid  alert  system  for  food  and  feed  (RASFF)”),  there  is  no  evidence  of  a 
broader issue. Industry monitoring does take place in the EU (retailers often perform 
their own checks on suppliers, which mean that they are aware when suppliers have 
used irradiation), but there are no associated reporting obligations.  

Of  surveyed  national  competent  authorities,  17  out  of  24  reported  that  they  had 
established  initiatives  to  monitor  imports  from  non-EU  countries  through  random 
sampling (See support study, Section 5.10.4). These mostly involved sampling plans 
for  a  range  of  different  imported  product  types.  One  national  competent  authority 
also stated that they used RASFF data as a source of information for their checks, to 
support  risk-based  sampling.  One  national  competent  authority  considered  it 
possible  that  many  unlabelled  irradiated  products  enter  the  market,  in  particular 

41 

 
from non-EU countries, as only a small number of checks are carried out to verify 
the irradiation of unlabelled products.  

The  same  proportion  of  national  competent  authorities  agreed  that  it  would  be 
valuable  to  more  actively  monitor  imports  from  non-EU  countries  for  irradiation 
(e.g.  to  collect  data  on  the  quantities  and  types  of  imported  irradiated  foodstuffs): 
this would enable checks for correct labelling to be made on products that were on 
the  market  and  information  on  tests  and  their  findings  could  be  shared  between 
Member States or at EU-level.  

5.3.9  Enforcement 

The  Directives  have  only  partially  ensured  the  enforcement  of  rules  on  the 
irradiation of foodstuffs.  

Identification of non-compliances 

The  enforcement  measures  led  to  identify  non-compliances,  which  were  notified 
through the EU report on food irradiation, and also, when appropriate, to the RASFF 
(See Section 3.4).  

Although the overall percentage of non-compliances detected in the EU is low and 
most  of  the  non-compliances  identified  are  not  serious,  it  is  difficult  to  draw 
conclusion  on  the  real  situation  because  the  number  of  controls  carried  out  within 
the EU is small, and because the approach applied by Member States for sampling 
(risk-oriented or random controls) is not known and not harmonized, and therefore 
not representative of the overall situation in the EU. However, 16 out of 17 national 
competent  authorities  that  answered  the  evaluation  survey  indicated  that  they  did 
not  have  any  information  to  suggest  that  the  problems  were  more  widespread  or 
serious  than  what  the  RASFF  notifications  indicate  (See  support  study,  Section 
4.5.3). Non-compliances were observed on imported irradiated products, which led 
certain stakeholders to express concerns as regards a potential lack of monitoring at 
import (see Section 5.3.8 “Provisions on import of irradiated foodstuffs”). 

The Directives do not include any specific provisions related to the enforcement of 
non-compliances but most Member States reported putting enforcement measures in 
place to deal with samples that tested positive for irradiation. These included formal 
notices and warnings, fines, seizure of products or returning them to the country of 
origin,  and withdrawal of products  from the market.  However, national  competent 
authorities  also  indicated  that  in  many  cases,  these  enforcement  actions  have  not 
been applied as there have been no instances of non-compliance identified.  

Variance in level of enforcement of official controls at marketing stage 

Most  Member  States  carry  out  checks  at  the  product  marketing  level,  which 
involves  testing  a  sample  of  products—generally  a  risk-based  sample—for 
unauthorised irradiation. This sample would include both products originating from 
the EU and from third countries. 

Member State authorities and other stakeholders have indicated through the survey 
and  through  the  public  consultation  (See  Annex  2)  that  enforcement  measures  are 
effective.  However,  there  is  significant  variance  between  enforcement  practices  in 
different Member States, notably in the levels of sampling and controls undertaken 
by Member States. As shown by Figure 6, several Member States carry out very few 
or no controls on irradiation, while one Member State carries more than 50% of the 
tests  at  EU-level.  There  does  not  appear  to  be  a  correlation  between  the  level  of 

42 

 
controls within Member States and the volume of products irradiated. The country 
where the greatest number of controls takes place (Germany) is not responsible for 
significant irradiation in the EU. 

Figure 6 : Samples analysed at product marketing stage within each Member State in 2018-2019 

Analytical methods for official checks 

Some  concerns  were  raised  regarding  the  methods  for  the  detection  of  irradiated 
food. 

The  Directives  do  not  list  the  analytical  methods  authorised  to  carry  out  official 
controls,  but  only  set  general  requirements,  in  particular  that  the  methods  used 
should be standardised or validated. A list of validated methods for the detection of 
irradiated  foods  (CXS  231-2001),  which  Member  States  can  use  for  official 
controls, is published by the Codex Alimentarius. 

Validated detection methods now exist for all the food types for which irradiation is 
permitted, apart from not plant-based food supplements (which is a growing area). 
However, the available methods are only suitable for the detection of irradiation, not 
to estimate with accuracy the irradiation dose, which they can only approximate. In 
the current situation, the dose used for irradiating a foodstuff can therefore only be 
certified by the facilities that proceeded to the irradiation.  

The  control  system  is  not  effective  for  the  detection  of  low-level  irradiated  food, 
since  the  available  methods  are  not  currently  suitable  for  detecting  low  levels  of 
irradiation below 1 kGy, such as would be used as a plant health measure. 

Some  recent  developments  in  analytical  techniques  are  discussed  in  the  literature 
and  mentioned  by  experts  as  potentially  promising  for  the  detection  of  irradiated 
foods, e.g. Nuclear Magnetic Resonance and Near Infrared Spectroscopy. These are 
not  yet  validated  and  because  there  is  only  a  small  market  for  the  detection  of 
irradiated foods, there is little funding for the validation of new techniques. 

Besides  detection  methods,  concerns  were  also  raised  on  the  absence  of  an  EU 
reference laboratory and of an EU network of official laboratories for the detection 
of  irradiated  foods.  As  a  result  no  inter-laboratory  comparisons  (proficiency  tests) 
are organized for these methods across the EU. This makes interpreting the results 
of controls at EU-level challenging, since procedures for the detection of irradiated 
food may vary between Member States. 

43 

 
 
5.3.10  Reporting 

The reporting requirements of the Directives met their objective. The Commission 
published  yearly  or  every  two  years  a  report  on  food  and  food  ingredients  treated 
with ionising radiation, which are accessible online54. National competent authorities 
considered the reporting obligations to be comprehensive, efficient and accurate.  

The Directives largely allow for efficient policy monitoring, particularly within the 
EU. Eighteen out of 19 national competent authorities surveyed have indicated that 
the annual reporting requirement does not impose undue burden (See support study, 
Section  5.10).  Four  national  competent  authorities  considered  however  that  the 
reporting  arrangements  set  in  the  Directives  were  not  sufficient  to  identify  issues 
associated  with  the  manner  controls  were  carried  out,and  provided  the  following 
context for their opinions:  

-  The legislation needs to include new methods and foods for sampling; 

-  TRACES-NT would be a useful tool to carrying out and reporting controls;  

- 

Information on the quantities of irradiated products would be helpful;  

-  The  inclusion  of  the  country-of-origin  of  non-compliances  would  be  helpful 
and would assist Member States in more efficient and risk-based sampling. 

54   https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2019:0454:FIN  

44 

 
 
 
 
                                                           
5.4  Efficiency 

Main findings 

The direct costs for businesses associated with the implementation of the Directives 
appear  to  be  low  and  do  not  affect  their  ability  to  use  food  irradiation.  The  main 
determinants  of  the  cost  of  irradiation  of  foodstuffs  are  the  cost  of  setting  up  and 
running facilities and the cost of transportation of the food products.  

The  benefit  for  consumers’  safety  associated  with  the  implementation  of  the 
Directives  cannot  be  evaluated,  notably  because  a  multitude  of  factors,  which 
cannot  all  be  documented  and  controlled  for,  contribute  to  food  safety  within  the 
EU, and because irradiated foodstuffs represented a very small proportion of the EU 
consumers’ diet.  

The  environmental  impact  of  the  implementation  Directives  is  also  difficult  to 
determine, due to a lack of comparable information on the environmental impacts of 
irradiation and its alternatives.  

Surveyed  national  competent  authorities  indicated  that  the  overall  costs  of 
implementing  the  Directives are in their view justified and proportionate and not 
overly burdensome.  

The principal reason for the decline in the use of irradiation in the EU appears to 
be the concern of the food industry that consumers will react negatively to a label 
indicating that a food or one of its ingredients has been irradiated. In this sense, the 
Directives have affected businesses’ ability to use irradiation as a decontamination 
technique. However, no evidence demonstrated the negative reaction of consumers 
anticipated by businesses. 

The  Directives  have  been  mostly  inefficient  at  ensuring  a  level  playing  field 
between EU Member States and third countries. 

As  regards  the  EU  market,  a  level  playing  field  between  EU  businesses  and  their 
international  competitors  is  ensured  as  long  as  the  products  entering  the  EU  fulfil 
the requirements of the Directives. But stakeholders from the EU industry expressed 
concerns  that  irradiated  products  may  be  imported  from  third  countries  without 
being properly controlled for or labelled, due to insufficient monitoring at import. 
Most national competent authorities considered it would be valuable to improve the 
monitoring at import, e.g. in carrying out more risk-oriented checks.  

As regards the international market, the Directives do not permit EU manufacturers 
and traders to compete on such a level playing field with international competitors, 
since  there  is  no  equivalence  between  the  EU  regulatory  framework  and  the 
regulatory  frameworks  used  in  third  countries.  Some  stakeholders  claimed  that  a 
closer alignment to the Codex Alimentarius General Standard on irradiation could 
help could resolve grey areas in relation to international trade, but such an alignment 
is unlikely to affect the level playing field, since the Codex Alimentarius set neither 
a  list  of  foodstuffs  that  should  be  authorised  for  irradiation,  nor  the  values  to  be 
applied for minimum and maximum absorbed doses. 

5.4.1 

  Costs and benefits for consumers 

The Directives include provisions, which contribute to the objective of preserving a 
high  level  of  protection  of  consumer  health  (notably  the  requirements  concerning 
the  authorised  sources  and  absorbed  doses,  as  well  as  the  approval  procedures  for 

45 

 
foodstuffs  and  facilities).  However, 
the 
implementation of the Directives has contributed to better food hygiene and reduced 
foodborne outbreaks for the following reasons:  

it  cannot  be  ascertained  whether 

 - a multitude of factors contribute to food hygiene and foodborne outbreaks within 
the  EU,  which  cannot  all  be  documented  and  controlled  for,  particularly  over  the 
period that preceded the entry into force of the Directives and afterwards.  

- the data are lacking to separate the effect of the Directives from that of many other 
steps  taken  to  improve  food  hygiene  or  reduce  foodborne  outbreaks  in  the  EU  (at 
business, sector, country or EU level).  

-  irradiation  has  become  such  a  marginal  practice  that  even  if  it  had  an  effect  on 
food safety, it could concern a very small proportion of the food diet, and therefore 
very difficult to identify and measure. 

-  changes  in  the  prevalence  of  the  most  reported  foodborne  diseases  in  the  EU 
(Campylobacteriosis and Salmonellosis) have been linked to food products that are 
not or marginally irradiated in the EU (in particular meat, egg and milk products). 

Whether  the  labelling  requirements  of  the  Directives  have  led  to  benefits  for 
consumer  information  appears  unlikely  and  it  is  possible  that  they  have  instead 
contributed to consumer confusion and misperceptions (see Section 5.3.5 “Labelling 
of irradiated foodstuffs”). 

5.4.2  Costs and benefits for the environment 

The  extent  to  which  environmental  impacts  differ  between  irradiation  and  its 
alternatives  is  largely  unknown.  No  evidence  on  the  quantitative  environmental 
costs  of  irradiation  in  comparison  to  alternatives  was  identified.  Searches  on  the 
environmental  impacts  of  irradiation  (including  energy  use  and  impacts  related  to 
the source of irradiation) yielded no quantitative data.  

The  use  of  food  irradiation  is  often  cited  as  a  potential  alternative  to  chemical 
treatment  of  food,  such  as  methyl  bromide,  but  as  discussed  in  Section  5.1.3 
“Relevance  of  food  irradiation  for  reducing  pesticide  use”,  the  use  of  food 
irradiation is unlikely to reduce the use of pesticides on food produced or imported 
in the EU.  

Qualitatively,  the  use  of  irradiation  likely  requires  increased  transportation  as 
compared to alternative in-house treatment options. The evidence collected through 
interviews,  case  studies  and  surveys  (see  support  study,  Section  3.6)  consistently 
point  to  the  logistical  challenges  of  irradiating  food  in  dedicated  irradiation 
facilities,  which  involves  transporting  food  to  the  facilities,  sometimes  over 
significant  distances.  Moreover,  the  European  Parliament  wrote  in  its  explanatory 
statement  accompanying  the  motion  for  a  resolution  voted  in  2002  (See  Section 
5.3.4  “Listing  of  foodstuffs  authorised  for  irradiation”),  that  food  irradiation 
undermines  the  objective  of  sustainable  development  by  supporting  the  trend 
towards  centralised  mass  production  and  distribution  of  foods  world-wide,  since 
extending  shelf  life  to  allow  transportation  of  foods  over  greater  distances 
contributes, among others, to increased fuel consumption, greenhouse gas emissions 
and air pollution. This statement was however not supported by quantitative data. 

Certain  technologies  used  for  food  irradiation  produce  radioactive  waste  which 
needs to be properly disposed. A radioactive source, Cobalt-60, is notably necessary 
for  gamma  irradiation.  The  source  is  shielded  by  water  when  not  in  use,  and 

46 

 
becomes hazardous waste once its radioactivity levels become too low to be useful 
for  application  of  treatment.  Radioactive  waste  is  also  produced  by  electron  beam 
irradiation. This is an environmental disadvantage for these irradiation types, but in 
general  the  problem  of  radioactive  waste  related  to  Cobalt-60  is  minimal  as 
compared  to  other  radioactive  sources  and  there  are  established  procedures  for 
disposal.  

Emerging technologies that offer producers treatment solutions allowing for on-site 
integration and with reduced energy and water usage, would appear to be the most 
efficient  options.  These  technologies  do  not  penetrate  the  product  as  deeply  as 
gamma  rays  and  are  therefore  only  suitable  as  surface  treatments.  However,  these 
technologies are not specifically addressed by the Directives. 

5.4.3  Costs and benefits for national competent authorities 

The  views  of  national  competent  authorities  collected  through  an  online  survey 
suggest  that  the  majority  of  them  see  the  costs  incurred  for  implementing  the 
irradiation  Directives  as  justified  and  proportionate  (See  support  study,  Section 
5.5.1).  They  see  the  overall  level  of  controls  as  proportionate  considering  the  low 
use of the technique in Europe.  

These  results  are  illustrated  in  Figure  9.  Only  one  national  competent  authority 
surveyed  indicated  that  costs  were  high  in  comparison  to  the  benefits,  citing  the 
annual reporting of data to the Commission and their publication in annual reports 
as disproportionately costly considering the low risks to consumers.  

Figure 7 :  

National competent authorities’ views on proportionality of costs 

5.4.4  Costs and benefits for irradiation industry and food business operators 

Costs of the technology 

The key drivers for the costs involved in food irradiation are the capital costs in 
setting  up  facilities  (estimated  between  EUR  2.5  and  10  million  for  a  Cobalt-60 
irradiation facility) and running them (which depend on the facility capacity: costs 
are  reduced  where  facilities  can  operate  at  a  higher  throughput).  Transport  to  and 

47 

 
 
from  the  irradiation  facilities  is  also  an  important  factor  in  the  overall  cost  of 
irradiation  treatment  in  the  EU.  In  the  case  of  some  products  (such  as  potatoes), 
transport prior to treatment risks damaging foods, such that product loss adds to the 
overall  costs  of  using  the  technology.  Evidence  collected  through  the  targeted 
survey  of  stakeholders  for  the  support  study  has  also  indicated  that  the  cost  of 
irradiation does differ between countries.  

There  are  benefits  and  costs  associated  with  all  sources  of  ionising  radiation. 
The  most  efficient  technology  ultimately  depends  on  the  product  undergoing 
irradiation. The three types of irradiation differ in their level of penetration of food. 
Gamma  radiation  and  X-rays  can  penetrate  the  deepest  into  products  (more  than 
60cm). The limit  of electron beams  penetration is  around 3.5cm.  Electron beam  is 
therefore  less  suitable  for  those  food  products,  such  as  frog  legs,  that  require  full 
penetration  to  address  microbiological  risks.  The  penetration  achieved  by  gamma 
and X-ray irradiation  means that these treatments can be used on shipping pallets, 
increasing  processing  efficiency.  The  limited  penetration  of  electron  beam 
irradiation  means  it  can  be  used  only  to  treat  the  surface  of  foods  before  they  are 
packed for shipping. 

Gamma irradiation occurs through the natural radioactive decay of Cobalt 60, while 
electron  beam  and  X-ray  irradiation  are  machine  generated.  Gamma  irradiation  is 
the  least  expensive  option  at  low  capacity,  but  at  a  certain  quantity  of  product, 
electron beams become more economical. Unlike electron beam and X-ray, gamma 
irradiation  cannot  be  turned  off  and  therefore  its  efficiency  falls  if  not  in  constant 
use.  X-ray  irradiation  is  the  most  expensive  process  as  there  is  significant  energy 
loss during the process of converting electron beams to photons to generate the X-
rays. 

Costs for implementing the irradiation Directives 

The  costs  for  implementing  the  irradiation  Directives  for  the  irradiation  industry 
(corresponding to the procedure for the approval of the facilities and the reporting 
requirements)  and  for  the  food  business  operators  (corresponding  to  labelling)  are 
not well documented but are perceived to be low.  

Given  pre-existing  labelling  provisions  from  Council  Directive  89/395/EEC,  the 
cost  impact  of  the  new  labelling  requirements  introduced  by  the  Directives 
applied  only  to  certain  products  in  those  countries  already  members  of  the  EU  in 
1999    As  reported  in  a  study  to  inform  an  impact  assessment  of  general  food 
labelling issues55, the costs of relabelling for a single product ranged from EUR 225 
(small  change)  to  EUR  7,000-9,000  (extensive  redesign).  Furthermore,  the 
aforementioned  study  also  indicated  that  companies  would  normally  change  their 
labels  of  their  own  accord  regularly,  and  that  63%  would  do  so  within  2  years, 
which  was  the  phase-in  period  for  businesses  to  become  compliant  with  the 
Directives  (as  stated  in  article  15  of  Directive  1999/2/EC).  As  such,  the  costs 
associated with adherence to the Directives do not affect businesses’ ability to use 
irradiation  as  a  decontamination  technique.  According  to  the  information  received 
from  food businesses and the irradiation  industry, businesses were not  deterred by 

55   European Commission (2008) Commission Staff Working Document accompanying the Proposal for a 
Regulation Of The European Parliament And Of The Council on the provision of food information to 
consumers - Impact Assessment Report On General Food Labelling Issues {COM(2008) 40 final} 

48 

 
                                                           
the  cost  of  labelling,  but  rather  by  the  negative  reaction  they  anticipated  from 
consumers to foods labelled as irradiated.  

The  decrease  in  demand  for  irradiated  products  induced  by  the  labelling 
requirements of the Directives (See Section 5.4.6 “Main reasons for the decline of 
food  irradiation  in  the  EU”)  could  be  considered  as  a  significant  indirect  cost  for 
businesses resulting from the Directive. The decrease in demand may in particular 
have  led  certain  irradiation  facilities  to  stop  irradiating  food  (but  most  irradiation 
facilities in the EU obtain their main revenue from the irradiation of products other 
than food, and notably medical devices). In this sense, the Directives have affected 
businesses’ ability to  use irradiation as a decontamination technique. However, no 
evidence  demonstrated 
the  negative  reaction  of  consumers  anticipated  by 
businesses.  

5.4.5  Competition between EU and non EU businesses 

The principle of a ‘level playing field’ is that competition is open and fair between 
manufacturing and trading partners. This relies on two main factors: firstly, whether 
the  regulatory  frameworks  are  similar  or  equivalent  across  markets,  and  secondly 
whether they are implemented similarly or uniformly across partners.  

As regards import into the EU, a level playing field between EU businesses and 
their  international  competitors  is  ensured  as  long  as  the  products  entering  the  EU 
fulfil  the  requirements  of  the  Directives.  Some  industry  representatives  expressed 
claims of unfair competition between the EU and third country producers, due to a 
lack of monitoring at import (see Section 5.3.8 “Provisions on import of irradiated 
foodstuffs”).  

As  regards  export  to  non-EU  countries,  the  Directives  do  not  permit  EU 
manufacturers  and  traders  to  compete  on  such  a  level  playing  field  with 
international competitors, since there is no equivalence between the EU regulatory 
framework  and  the  regulatory  frameworks  used  in  third  countries.  EU  irradiation 
facilities must meet the EU requirements, in particular with regard to the absorbed 
dose  and  the  list  of  foodstuffs  authorised  for  irradiation,  even  when  the  products 
they  process  are  intended  to  be  exported  in  countries  with  less  restrictive 
requirements (e.g. authorising higher doses and/or additional foodstuffs).  

For  example,  the  maximum  dosage  specified  for  the  EU  in  Directives  1999/2/EC 
and 1999/3/EC (10 kGy for dried vegetable seasonings, spices and aromatic herbs, 
with a dose uniformity ratio of less than three) differs from the maximum dosage set 
for herbs and spices in the US and Australia/New Zealand, which allow doses up to 
30 kGy. 

Some stakeholders claimed that a closer alignment to the most recent version of the 
Codex Alimentarius General Standard on irradiation could help could resolve grey 
areas  in  relation  to  international  trade  (See  Section  5.2.4,  “Coherence  with 
international  standards”),  but  such  an  alignment  is  unlikely  to  affect  the  level 
playing  field,  since  the  Codex  Alimentarius  sets  neither  a  list  of  foodstuffs  that 
should be authorised for irradiation, nor the values to be applied for minimum and 
maximum absorbed doses for these foodstuffs (the Codex Alimentarius only sets the 
cumulative  maximum  absorbed  dose  to  10  kGy,  and  tolerates  higher  doses  in 
exceptional cases). It also does not provide specific recommendations regarding the 
labelling of irradiated ingredients in composite products.   

49 

 
Despite  the  fact  that  EU  businesses  are  subject  to  stricter  regulation  than  third 
country  businesses,  no  evidence  could  be  found  of  market  opportunities  that  have 
not  materialised  because  the  Directives  have  prevented  European  producers  from 
exporting irradiated products to third countries. 

5.4.6  Main reasons for the decline of food irradiation in the EU 

The  decline  of  food  irradiation  in  the  EU  has  not  been  continuous.  The  most 
significant  decline  occurred  in  most  Member  States  in  the  years  immediately 
following the implementation of the Directives.  

The  decline  of  irradiated  foodstuffs  on  the  EU  market  can  be  attributed  largely  to 
the  requirement  to  label  irradiated  ingredients,  and  the  associated  belief  shared 
widely  among  businesses  that  consumers  would  not  accept  foods  labelled  as 
irradiated,  as  shown  by  the  survey  results  presented  in  Figure  8.  The  relevance  of 
the  labelling  requirements  has  been  contested  by  some  stakeholders  (notably  food 
business  operators  and  the  irradiation  industry),  many  of  whom  feel  that  the 
requirement  to  label  irradiated  ingredients  within  processed  products  is  overly 
burdensome. No consumer organisations or other NGOs responded on this point. 

Other  factors  that  may  have  contributed  to  the  decline  and  continued  low  use  of 
irradiation include: 

- 

the cost of irradiation as compared to alternative treatments and the cost of 
irradiation as compared to the value of foods undergoing this process;  

- 

a general lack of knowledge of irradiation among food businesses; 

-  uncertainty  among  food  business  operators  around  the  differences  between 

EU and national approved lists of irradiated foodstuff; and 

- 

some  additional  regulatory  requirements  related 
to  required  storage 
temperatures  may  have  also  contributed  to  the  decline  in  irradiated 
mechanically separated meat, See paragraph “Specific hygiene rules for food 
of animal origin” in Section 5.2.3 “Coherence with other EU legislations”.  

The EU market has not made use of irradiation for plant health purposes while this 
has been the main area of growth for food irradiation in third countries. 

50 

 
Figure 8 : Reasons for the decline in irradiated herbs and spices 

All  Member States had to  transpose EU  rules on the labelling of  food products  in 
the  early  1990s,  which  included  a  requirement  to  label  irradiated  foods  (Council 
Directive  89/395/EEC),  well  before  Directives  1999/2/EC  and  1999/3/EC  were 
implemented. However, these labelling requirements were more general than those 
provided  by  the  Directives,  stipulating  simply  that  “any  foodstuff  which  has  been 
treated  with  ionizing  radiation”  must  bear  a  label,  and  they  were  generally 
interpreted  in  a  way  that  the  products  containing  small  amount  of  irradiated 
ingredient had not be labelled. This had presented a problem in particular for herbs 
and  spices,  which  are  one  of  the  most  commonly  irradiated  foods  and  which  are 
generally used as ingredients in other products in small quantities. 

Several stakeholders expressed grievance that consumers do not get a complete and 
balanced  information  on  the  treatment  applied  to  their  food,  since  the  labelling 
obligation  established  in  the  Directives  is  asymmetric,  in  that  the  food  chain  is 
required  to  label  for  certain  treatments,  such  as  irradiation,  but  not  necessarily  for 
others, such as steam treatment or chemical treatments.  

51 

 
 
 
5.5  EU added-value 

Main findings 

The legislative framework at EU level has added limited value to the irradiation of 
foodstuffs, since different national approaches remain, notably as regards the list of 
foodstuffs authorised for irradiation and their circulation in the single market, and as 
regards  the  official  controls,  on  which  the  emphasis  of  Member  States  varies 
greatly. 

It has provided some level of harmonisation of regulatory approach within the EU, 
notably  on  the  authorised  sources  of  irradiation  and  doses  absorbed,  for  labelling 
irradiated  foodstuffs  and  in  particular  irradiated  ingredients,  approving  irradiation 
facilities,  importing  irradiated  foodstuffs  and  monitoring  the  use  of  irradiation  on 
foodstuffs 

Stakeholders  expressed  continued  support  for  EU 
intervention  on  food 
irradiation,  considering  it  benefits  the  internal  market  and  provides  greater  legal 
certainty (although much uncertainty remains). 

If  EU  rules  were  to  be  phased  out,  historical  differences  in  Member  State 
legislation  and  approaches  to  irradiation  would  remain  and  could  widen.  Existing 
gaps  in  enforcement  would  likely  be  exacerbated,  which  may  affect  consumers 
negatively (in terms of choice and welfare). 

5.5.1  Harmonisation of regulatory approaches within the EU 

The  legislative  framework  at  EU  level  harmonised  provisions  on  the  authorised 
sources  of  irradiation  and  doses  absorbed,  for  labelling  irradiated  foodstuffs, 
approving  irradiation  facilities,  importing  irradiated  foodstuffs  and  monitoring  the 
use of irradiation on foodstuffs. The establishment of the initial EU list of foodstuffs 
authorised for irradiation ensured the free movement for the sole product  category 
listed  (“Dried  aromatic  herbs,  spices  and  vegetable  seasonings”)  within  the  EU 
market.  In  this  way,  the  EU  legislative  framework  has  provided  greater  legal 
certainty as compared to the situation prior to the implementation of the Directives. 

Surveyed national competent authorities were asked about the measures introduced 
in  their  Member  State  when  the  Directives  entered  into  force  (See  support  study, 
Section 4.5.1).  

For  some,  changes  related  to  the  implementation  of  the  Directives  were  minor, 
either  because  there  were  no  in-country  irradiation  facilities  and/or  a  lack  of 
evidence  to  indicate  that  irradiated  foods  were  being  imported  (e.g.  Cyprus),  or 
because regulating measures were already in place (e.g. Belgium).  

For others (e.g. France, Italy,  Ireland), in particular where production or import of 
irradiated  foods  was  more  common,  more  work  was  carried  out  to  implement  the 
Directives.  For  example,  irradiation  facilities  were  indexed  and  inspected,  as  were 
food business operators that were known to handle irradiated foods. Sampling plans 
and  procedures  were  introduced  to  detect  food  that  had  been  irradiated,  including 
establishing  a  minimum  number  of  samples,  setting  out  methods  for  testing  and 
confirmatory  analysis  and  disseminating  application  notes  for  correct  sampling. 
Most  national  competent  authorities  also  reported  that  national  sampling  plans 
encompassed  initiatives  to  control  food  products  from  non-EU  countries  to  ensure 
compliance  with  the  Directives.  Additionally,  a  national  competent  authority  also 

52 

 
described validating new laboratory methods for testing and setting up a process for 
approving irradiation facilities.  

The  survey  investigated  whether  the  EU  legislation  had  the  added  value  of 
achieving  economies  of  scale.  Surveyed  national  competent  authorities  (n=17) 
indicated that they did not know whether economies of scale been achieved thanks 
to  the  Directives  (e.g.  if  the  burden  of  national  controls  has  been  reduced),  see 
support  study,  Section  6.1.2.  This  is  likely  a  reflection  of  the  fact  that  significant 
time has passed since the introduction of the Directives. Of those who were able to 
respond, four indicated that costs had neither increased nor decreased, two indicated 
that  costs  have  increased  slightly  and  two  indicated  that  costs  have  increased 
significantly. One national competent authority indicated that this increase was due 
to increased staffing and laboratory costs.   

5.5.2  Existence and effectiveness of additional rules at national level  

In  the  absence  of  a  positive  EU  list  of  foodstuffs  authorised  for  irradiation  to  the 
exclusion  of  all  others,  the  transition  measures  are  still  in  force  and  the  scope  of 
harmonisation  achieved  is  less  than  what  was  projected  when  the  Directives  came 
into  force.  Member  States’  national  legislations  set  the  rules  for  the  circulation  of 
irradiated foods, beyond herbs and spices, in the single market. National legislations 
have  also  been  responsible  for  the  implementation  of  official  control  plans,  with 
varying emphasis. 

When  surveyed,  the  majority  of  national  competent  authorities  (15  out  of  17) 
indicated  that  they  did  not  have  any  additional  national  rules  that  were  more 
effective than EU rules, see support study, Section 6.1.2. The Member States which 
answered positively were: 

- 

Italy,  which  indicated  the  existence  of  an  official  control  plan  at  national 
level, stipulating both the number of samples to be taken in each region, as 
well  as  the  number  of  samples  for  Border  Control  Points.  However,  it  is 
likely that other Member States have similarly implemented official control 
plans,  but  as  indicated  by  the  absence  of  controls  reported  to  the 
Commission in several Member States, some do not.  

-  Germany,  which  referred  to  its  additional  legislation  on  ultraviolet 

treatments. 

There is no evidence to suggest that national rules have been more effective than EU 
rules,  but  they  have  provided  additional  rules  to  those  implemented  by  the 
Directives, specifically permissions for the irradiation of foods not included on the 
current EU list, techniques not addressed by EU legislation (such as UV treatment), 
rules for enforcement and official controls.  

5.5.3  Interest of stakeholders in maintaining an intervention at EU level 

As far as stakeholders are concerned, those who contributed to consultations (which 
reflect  a  limited  sample  of  all  potentially  interested  parties  as  far  as  the  food 
industry  and  civil  society  are  concerned,  as  discussed  in  section  4.3)  expressed 
continued  support  for  EU  intervention  in  this  area.  Both  national  competent 
authorities and industry have indicated the importance of harmonisation in relation 
to  irradiation  rules.  Many  of  the  criticisms  of  the  Directives  relate  to  areas  where 
harmonisation  has  not  been  fully  achieved  (e.g.  through  the  absence  of  the  EU 
positive  list  of  authorised  foodstuffs  to  the  exclusion  of  all  others).  Where 

53 

 
harmonisation  has  been  achieved  (such  as  the  common  process  for  authorising 
irradiation  facilities),  it  has  been  generally  welcome  by  stakeholders,  considering 
that it benefits the internal market and provides greater legal certainty.  

Although  some  food  business  operators  and  some  sector  organisations  have 
expressed  interest  in  the  potential  benefits  of  food  irradiation,  in  general  there 
appears to be low awareness or low interest in the technology within the EU’s food 
industry. The lack of interest appears to be largely due to the fact that producers and 
retailers believe that consumers will not purchase irradiated foods (even if there is 
no  publicly  available  information  on  the  current  perceptions  of  food  irradiation 
among food business operators in the EU). 

Despite  the  lack  of  interest,  several  food  business  operators  (e.g.  from  the  fruit 
importing and red meat sectors) have indicated in interviews that even if they would 
not foresee using it in the near future, if irradiation is considered a safe and effective 
treatment, they would like to see it approved as a treatment option for their products. 

5.5.4  Potential consequences of a phasing out of the EU rules 

If EU rules were phased out, historical differences in Member State legislation and 
approaches to irradiation (as described in Section 2.2), some of which have endured 
through  national  lists  and  national  legislation,  would  remain.  They  could  widen  if 
Member  State  authorities  applied  different  labelling  regimes  regarding  irradiated 
ingredients (as was the case before the Directives came into force) although none of 
the  evidence  collected  and  reviewed  in  the  study  hints  at  the  current  state  of 
preferences on that matter regard at Member State level.  

Regulation (EU) No 1169/2011 refers to Directive 1999/2/EC and echoes certain of 
its provisions (see Section 5.2.2 “Coherence with the EU food legislation”). Should 
the  irradiation  Directives  be  repealed,  the  obligation  to  label  irradiated  foodstuffs 
and ingredients would remain, but the reference to Directive 1999/2/EC included in 
Regulation  (EU)  No  1169/2011  would  need  to  be  amended,  and  the  specific  rules 
applying  in  the  case  of  irradiated  products  not  intended  for  the  ultimate  consumer 
and mass caterers (Article 6.2.b and 6.3 of Directive 1999/2/EC) would be repealed.  

Since most irradiated food is currently processed in Belgium and France one could 
speculate that both  countries could  legislate  further in  that space.  In  Germany, the 
very high proportion of controls it has been carrying out signals also the importance 
given  to  continued  control  over  the  practice  of  food  irradiation.  However,  the 
overall very low volumes of food irradiated in the rest of the EU and lack of interest 
or engagement from the food industry and civil society on the topic suggests that it 
is unlikely to be at the forefront of policymakers’ agenda in most Member States in 
the foreseeable future. This could change if there was a renewed interest in food and 
feed irradiation,  either because of plant health risks  becoming a  greater issue with 
climate  change  (as  some  experts  anticipate),  or  to  accommodate  new  technologies 
that  would  respond  to  business  needs  for  more  sustainable,  effective  or  cheaper 
decontamination solutions. 

If  EU  rules  were  to  be  phased  out  and  different  levels  of  control  were  set  on  the 
irradiation  of  foodstuffs  in  different  Member  States  (beyond  the  differences  that 
already  exist),  it  is  likely  that  existing  differences  in  enforcement  (in  particular 
difference  between  the  levels  of  sampling  and  controls  undertaken  by  Member 
States)  would  be  exacerbated.  If  the  requirement  to  label  irradiated  ingredients 
would be phased out, Member States would likely take different approaches to this 

54 

 
requirement, which  could undermine the provision of information  to  consumers to 
ensure choice and welfare. 

55 

 
 
6  CONCLUSIONS 

The Directives on food irradiation were adopted more than 20 years ago. They have 
not been significantly amended since, despite technological progress in the area of 
ionising radiation, the adoption in 2002 of a new and comprehensive EU legislative 
framework for food safety, and other significant  evolutions, such as the increasing 
globalisation of food trade and growing environmental concerns.  

The purpose of the evaluation was to assess whether the objectives and provisions 
of the Directives are still fit for purpose. Gathering relevant feedback was difficult 
because  the  EU  food  industry  and  NGOs  either  lacked  knowledge  about  food 
irradiation, which is currently only marginally used in the EU, or were unwilling to 
participate for fear of being involved in what they perceived as a controversial issue. 

Relevance 

While all of the stated objectives of the Directives are still relevant considering the 
evolution of societal needs and scientific and technological developments, some of 
the requirements they laid down are no longer relevant, notably as regards recently 
developed  technologies,  such  as  the  “low  energy  electron  beam”  technology.  The 
evaluation  could  not  conclude  to  what  extent  the  Directives  were  relevant  to 
preserve a high level of consumer health. Indeed, while irradiation is considered to 
be an effective and safe treatment by EFSA, the evaluation of the overall impact of 
the  Directives  on  consumers’  health  was  made  impossible  by  the  multitude  of 
factors  involved  and  the  marginal  share  of  irradiated  food  in  the  EU  consumers’ 
diet. 

Similarly, the relevance of the Directives for plant  health could not be evaluated. 
Irradiation  can  be  an  effective  tool  to  manage  plant  health  risks,  but  so  far  food 
irradiation for plant health purposes has not been used in the EU or on food plants 
imported  into  the  EU.  Despite  the  great  interest  expressed  by  some  non-EU 
countries  exporting  fruits  into  the  EU,  EU  stakeholders  favour  other  approach  to 
control  for  plant  pests  (including  strategic  sourcing,  systems  approaches  and 
inspections).    Under  these  circumstances,  food  irradiation  applied  for  plant  health 
purpose is not likely to reduce consumer exposure to pesticides in the EU. 

The Directives do not include objectives or provisions related to the environmental 
impact of irradiation, and as such their relevance to achieve the objectives of the 
Farm  to  Fork  strategy  are  difficult  to  evaluate.  There  was  no  comparable 
information on the environmental impacts of food irradiation and its alternatives. No 
evidence  confirmed  the  claim  of  some  stakeholders  that  food  irradiation  is  more 
sustainable  than  its  alternative  treatments  The  potential  contribution  of  food 
irradiation  in  protecting  the  environment  is  challenged  by  the  fact  that  certain 
irradiation  technologies  generate  radioactive  waste  and/or  are  associated  with 
increased  transportation  as  compared  to  in-house  treatment,  and  that  food  with 
extended life are likely to be transported on longer distance,. 

Coherence 

The  provisions  of  the  Directives  appeared  to  be  coherent  with  each  other.  Even  if 
the Directives were adopted before the entry in force of the basic acts forming the 
current general framework for the EU legislation on food hygiene (the “general food 
law” and the “hygiene package”), no major inconsistencies between the Directives 
and these acts have been identified.  

56 

 
Further, no incoherence have been identified between the Directives and other EU 
legislation.  However,  the  Directives  are  not  aligned  to  the  latest  updates  of  the 
standards  of  the  Codex  Alimentarius,  notably  as  regards  the  concept  of  absorbed 
doses.  

Effectiveness 

The  assessment  of  the  effectiveness  criteria  showed  that  the  provisions  of  the 
Directives  did not  all achieve their objectives.  In particular, the  Directives did  not 
achieved  the  harmonisation  of  the  legislation  on  irradiation  across  the  EU  as  to 
ensure  the  free  movement  of  all  irradiated  foodstuffs  within  the  single  market. 
Member  States  may  continue  to  apply  national  authorisations  and  bans  on  other 
irradiated  foodstuffs  than  “herbs  and  spices”,  because  the  initial  EU  list  and  the 
national  lists  of  foodstuffs  authorised  for  irradiation  have  not  been  replaced  by  an 
extended  EU  list  of  foodstuffs  authorised  for  irradiation  to  the  exclusion  of  all 
others,  as  planned  by  the  Directives.  The  process  was  launched  in  2000  but  was 
opposed by a number of food business and consumer organisations, and was finally 
stopped  by  a  motion  adopted  by  the  European  Parliament  in  2002.  Among  other 
concerns,  MEPs  mentioned  the  lack  of  evidence  regarding  the  long-term  safety  of 
eating  a  diet  based  largely  on  irradiated  foods,  and  the  risk  that  food  irradiation 
could  be  used  to  mask  poor  hygiene  practices  in  production  processes.  The  2011 
EFSA  opinions  on  the  biological  and  toxicological  safety  of  food  irradiation 
addressed the concerns  on food safety expressed in  the resolution, but this  did  not 
reopen the discussion on a possible extension of the list. 

Efficiency 

The Directives have been mostly inefficient at ensuring a level playing field in the 
EU,  and  between  EU  food  business  operators  and  their  international  competitors. 
The  remaining  differences  between  Member  States  legislations  hinder  the  free 
movements  of  irradiated  foodstuffs  other  than  herbs  and  spices  within  the  single 
market and  creates confusion in food business operators and competent  authorities 
of Member States  and of third countries. There is no equivalence between the EU 
regulatory  framework  and  the  regulatory  frameworks  used  in  third  countries.  EU 
irradiation  facilities  must  meet  the  EU  requirements  even  when  the  products  they 
process are intended for export in third countries with less restrictive requirements 
(e.g.  authorising  higher  doses  and/or  additional  foodstuffs).  It  is  unlikely  that  the 
level playing field could be improved by a closer alignment of the EU legislation on 
the Codex Alimentarius standard, since the latter sets neither a list of foodstuffs that 
should be authorised for irradiation, nor the values to be applied for minimum and 
maximum  absorbed  doses.  It  also  does  not  provide  specific  recommendations 
regarding the labelling of irradiated ingredients.  

The  direct  costs  for  businesses  and  national  competent  authorities  associated  with 
the  implementation  of  the  Directives,  which  were  considered  to  be  low  and 
proportionate,  seem  not  to  have  played  a  significant  role  in  the  decline  of  food 
irradiation  in  the  EU.  The  principal  reason  for  this  decline  appears  to  be  the 
concern of the food industry that consumers would refuse to buy foodstuffs labelled 
as irradiated, although this concern has not been demonstrated. The requirement to 
label  irradiated  ingredients  within  processed  products  was  considered  overly 
burdensome by some representatives of the food and irradiation industries, whereas 
no  consumer  organisations  or  NGOs  responded  on  this  point.  It  is  difficult  to 
conclude on the effectiveness  of the labelling requirements to  provide information 

57 

 
to  consumers to  ensure  choice and  welfare, in  absence of direct  data on consumer 
perceptions and understanding of the labels. 

The  enforcement  of  irradiation  legislation  has  been  only  partially  achieved. 
Member  States  competent  authorities  carry  out  official  checks  but  the  control 
intensity  differs  greatly  among  them,  one  being  responsible  for  more  than  50%  of 
the  samples  analysed  in  the  EU.  Almost  all  non-compliances  identified  relate  to 
imported  foodstuffs,  suggesting  potential  gaps  in  the  enforcement  of  irradiation 
legislation at import, although the extent of this issue is difficult to evaluate. Several 
stakeholders  expressed  concerns  that  these  gaps  create  an  unfair  competition 
between  EU  producers  and  their  international  competitors.  Most  of  national 
competent authorities considered it would be valuable to improve the monitoring at 
import, e.g. in carrying out more risk-oriented checks. 

EU-added value 

Despite  all  the  issues  identified,  the  legislative  framework  at  EU  level  has  added 
value  to  the  irradiation  of  foodstuffs  in  that  it  has  provided  some  level  of 
harmonisation of regulatory approach within the EU, the most important one being 
the  labelling  of  irradiated  ingredients.  The  stakeholders  who  contributed  to 
consultations (which reflect a limited sample of all potentially interested parties as 
far as the food industry and civil society are concerned) still warrant intervention at 
EU  level  considering  it  benefits  the  internal  market  and  provides  greater  legal 
certainty for food business operators. If EU rules were to be phased out,  historical 
differences in Member State legislation and approaches to irradiation would remain 
and could widen. Existing differences in enforcement would likely be exacerbated, 
which may affect consumers negatively in terms of choice and welfare, e.g. where 
the requirement to label irradiated ingredients would be phased out. 

Lesson learned 

The evaluation showed that, while the objectives of the Directives are still relevant, 
several of them have not been achieved. In particular, the Directives have failed to 
harmonise  the  legislation  on  food  irradiation  throughout  the  EU  in  a  way  that 
ensures the free movement of all irradiated foods, because the EU list of authorised 
foodstuffs for irradiation to the exclusion of all others has not been adopted. 

This  and  other  minor  regulatory  problems  identified  during  the  evaluation  process 
have  certainly  played  a  role  in  the  decline  of  food  irradiation  in  the  EU.  But  the 
main factor explaining the decline of food irradiation in the EU is the concern of the 
food  industry  that  European  consumers  will  refuse  to  buy  food  labelled  as 
irradiated.  Because  they  anticipate  the  negative  reaction  of  consumers,  food 
business operators prefer to seek and use alternative treatments, even for those food 
categories  where  irradiation  is  technologically  relevant  and  where  EU  legislation 
has been harmonised, i.e. herbs and spices.   

The  reluctance  of  the  food  industry  to  have  recourse  to  food  irradiation  can  have 
serious  consequences,  when  no  suitable  alternatives  exist,  as  shown  by  the  recent 
Ethylene oxide (ETO) incident56. In September 2020, residues of ETO, a substance 
banned  in  the  EU  and  dangerous  to  human  health,  were  detected  in  sesame  seeds 
from  India. The seeds had been treated with  this hazardous substance to  eliminate 

56   https://ec.europa.eu/food/sites/food/files/safety/docs/rasff_ethylene-oxide-incident_crisis-

coord_sum.pdf 

58 

 
                                                           
microbiological contamination, while food irradiation could have been used for the 
same purpose. 

It is unclear however, in which cases food irradiation would be considered the most 
suitable  treatment  with  regard  to  consumer  health,  plant  health  and  environmental 
health,  since  the  lack  of  data  did  not  allow  a  comparative  assessment.  Data  are 
especially  missing  on  the  effect  of  food  irradiation  on  the  environment  and 
biodiversity. A deeper knowledge in that regard could contribute to better-informed 
decision-making on food irradiation legislation.  

It is important to note in this respect the emergence of a new technology called "low 
energy electron beam" (only one food operator is being equipped worldwide at the 
time  of  writing).  This  technology,  which  can  be  implemented  in-house,  does  not 
rely on radioactive sources, consumes less water and energy than most alternatives 
and  does  not  penetrate  the  food  while  being  effective  against  the  main  foodborne 
pathogens  (Salmonella,  Campylobacter  and  Escherichia  Coli),  seems  to  have  a 
higher environmental benefit than the traditional food irradiation technologies.  

The findings of the evaluation do not lead to favour or exclude any particular option 
for  the  future  of  the  European  food  irradiation  legislation,  among  the  four  main 
options  identified:  status  quo,  adoption  of  a  EU  list  of  foods  authorised  for 
irradiation to the exclusion of all others, amendment of the Directives, or repeal of 
the Directives.  

Whichever  option  is  chosen,  the  choice  of  food  operators  regarding  the  strategies 
and  treatments  applied  to  ensure  the  safety  of  the  products  they  place  on  the  EU 
market  is  unlikely  to  be  affected,  since,  as  mentioned  before,  the  main  factor 
affecting  the  decline  of  food  irradiation  in  the  EU  is  not  regulatory.  Therefore,  as 
long  as  the  EU  food  industry  and/or  the  EU  consumers  are  reluctant  towards 
irradiated  foods,  legislative  initiatives  will  have  a  negligible  impact  on  the  use  of 
this  technology  and,  consequently,  on  its  contribution  to  public,  plant  and 
environmental health. 

59 

 
 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

1. Lead DG, Decide Planning/CWP references 

Lead DG: Directorate General Health and Food Safety (DG SANTE) 

Decide planning: PLAN/2016/506 

2. Organisation and timing 

This  evaluation  was  included  in  the  DG  SANTE  evaluation  plan.  It  followed  the 
Better  Regulation  guidelines  with  regard  to  evaluations.  The  evaluation  work  was 
carried out through an external evaluation study, conducted in conformity with the 
DG SANTE procedure for the organisation and management of policy  evaluations 
carried out by external contractors. The work was supervised under the technical as 
well as the contractual management of SANTE unit G4 with the support of unit A1. 

An Inter-service Steering Group (ISG) was set up by the Commission in 2017, with 
the  mandate  to  provide  information,  prepare  the  terms  of  reference,  monitor  the 
work of the external study team, discuss and give advice on the approval of the final 
report, comment on the draft evaluation SWD. 

The  ISG  was  composed  of  the  Secretariat-General  of  the  Commission  and  DGs 
SANTE,  GROW,  ΤRADE,  RTD,  SANTE,  AGRI  and  JRC.  COMP,  ENER,  ENV 
and JUST  were invited but  did  not nominate a representative. The Steering Group 
started its meetings on 21 March 2018.  

The  evaluation  roadmap  was  published  on  the  05  September  2017.  It  set  out  the 
context, scope and aim of the exercise. The roadmap presented the questions to be 
addressed  under  the  five  criteria  of  effectiveness,  efficiency,  relevance,  coherence 
and EU added value. During the feedback period on the roadmap (05 September – 3 
October 2017), 32 contributions were received. These did not require changing the 
approach  towards  the  evaluation,  but  helped  to  further  enrich  the  Terms  of 
reference. 

The  open  public  consultation 57 ,  which  aim  was  to  gather  the  views  of  public 
authorities,  stakeholders  and  EU  citizens,  was  planned  from  02  March  2020  to  25 
May  2020  but  was  extended  by  6  weeks,  i.e.  until  06  July  2020,  because  of  the 
COVID-19 crisis. 

The support study carried out by the external contractor started in August 2018 and 
finalised  in  December  2020.  The  end  of  the  study,  initially  planned  for  January 
2020, has been rescheduled a first time to May 2020 and a second time to December 
2020  to  compensate  for  unexpected  delays  due  to  COVID-19  in  organising  the 
public  consultation.  This  external  support  study,  together  with  the  outcome  of  the 
public consultation provided the basis for this SWD. 

57

 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1477-Evaluation-of-the-EU-

legal-framework-on-food-irradiation/public-consultation   

60 

 
 
 
                                                           
3. Exceptions to the better regulation guidelines 

As  mentioned  above,  the  open  public  consultation  of  reference  for  this  evaluation 
was extended of 6 weeks due to the COVID-19 crisis, and the end of the study has 
itself been rescheduled from January 2020 to December 2020.  

4. Consultation of the RSB (if applicable) 

The RSB will not scrutinize this evaluation SWD. 

5. Evidence, sources and quality 

The evaluation required gathering of relevant data and information from  European 
Union,  as  well  as  national  and  local  levels,  international  organisations  and  some 
third  countries.  The  overall  approach  therefore  combined  three  main  sources  and 
types of evidence: EU level data and information gathering, review and analysis. In 
addition, 5 case studies have been developed in order to supply additional evidence 
on  subjects  agreed  by  the  ISG.  The  study  findings  have  been  presented  during  a 
stakeholder workshop carried out on 21 October 2020. 

61 

 
 
ANNEX 2: STAKEHOLDER CONSULTATION – SYNOPSIS REPORT 

1. Introduction  

This report presents the synopsis of all stakeholder consultation activities undertaken as 
part  of  the  ‘Study  to  support  the  retrospective  evaluation  of  legislation  related  to  the 
irradiation of food and food ingredients’.  

The  consultative  process  helped  the  study  team  address  questions  concerning  the 
relevance,  effectiveness,  efficiency  and  EU  added  value  of  the  legislation.  Four  main 
forms of consultation were completed: 

-  A  Web-based  Public  Consultation,  targeting  all  four  areas  of  the  evaluation 

criteria; 

-  Two workshops with key stakeholders held at the beginning and end of the study;  
-  Targeted telephone interviews; and 
-  Four targeted surveys. 

The sections below provide an overview of the stakeholders and the activities covered, 
as well as the main results of the consultation activities.  

2. Stakeholder groups covered by the consultation activities  

Input was collected from a wide range of stakeholders. These included EU and Member 
States competent authorities, the irradiation industry, Food Business Operators (FBOs) 
and business associations, experts, third countries competent authorities and individuals 
(including third-country nationals and EU citizens).  

The  table  below  provides  an  overview  of  the  types  of  stakeholders  consulted  and  the 
data collection method used to reach those stakeholders.  

Table 1. 

Overview of conducted stakeholder consultations 

Stakeholder type 

Data collection method 

Competent authorities in 
Member States  

  Public Consultation 

  Targeted survey 

  Interviews 

Experts on food irradiation 

  Public Consultation 

Industry (irradiation 
industry and FBOs) 

Third country competent 
authorities 

  Targeted survey 

  Interviews  

  Public Consultation 

  Targeted survey 

  Interviews 

  Public Consultation 

International organisations  

  Public Consultation 

Non-governmental and civil 

  Public Consultation 

62 

 
 
society organisations  

Wider public  

  Public Consultation 

3. Overview of consultation activities  

3.1 Public consultation 

The survey for the web based public consultation was launched on March 3rd, 2020. It 
remained open until July 6th, 2020.  

The public consultation received a total of 72 responses from:  

-  5 academics/research institutions; 

-  8 business associations; 

-  7 businesses; 

-  2 EU Member State national competent authorities; 

-  2 Third Country Competent Authorities; 

-  1 consumer organisation; 

-  2 NGOs; 

-  1 international organisation;  

-  1 trade union; 

-  39 EU citizens; and 

-  4 non-EU citizens. 

Of  the  academics,  business  associations  and  businesses  who  responded,  the  majority 
appeared to be associated with the irradiation industry.  

The geographic spread ofpublic consultation respondents is indicated in Table 2. 

Table 2. 

Country of origin of Public Consultation respondents 

Country of origin 

Number of respondents 

s
e
t
a
t
S

r
e
b
m
e
M
U
E

Austria 

Belgium 

Finland 

France 

Germany 

Italy 

Latvia 

Netherlands 

Poland 

Portugal 

Spain 

T h i r d

c o u n t r i e s

Australia 

1 

6 

1 

8 

6 

6 

1 

1 

3 

1 

22 

1 

63 

 
 
 
 
 
 
 
Israel 

Switzerland 

Turkey 

Ukraine 

United Kingdom 

United States 

3.2 Workshops 

2 

3 

1 

1 

6 

2 

Two workshops were held as part of the consultation strategy: one at the beginning of 
the study, following the inception phase, and one at the end, following the completion 
of the draft final report. Both workshops included the following participants:  

-  Member States’ authorities;  

- 

Industry actors and representative organisations; 

-  NGOs; 

-  Academics; 

- 

International organisations; 

-  European Commission DG SANTE, the Joint Research Centre (JRC) and the 

European Food Safety Authority (EFSA); and 

- 

ICF. 

The  first  workshop  aimed  to  raise  awareness  of  the  evaluation  among  stakeholders, 
discuss stakeholders’ views about the EU legislative framework for food irradiation, and 
gather  initial  insights  from  participants  to  address  the  evaluation’s  objectives.  The 
workshop was held in person in Brussels.  

The  second  workshop  aimed  to  provide  stakeholders  with  an  overview  of  the  initial 
results of the study in relation to each of the evaluation criteria. It also aimed to gather 
feedback from stakeholders on these findings. This workshop was held as a webinar.  

3.3 Targeted consultations 

Three online surveys were conducted to validate the findings of the desk research and 
the case studies. The surveys were addressed to three categories of stakeholder: 

-  National  Competent  Authorities  in  charge  of  implementing  controls  on 

irradiation facilities and irradiated products (doses, labelling). 

-  The  irradiation  industry,  which  provides  irradiation  services  to  Food 

Business Operators (producers, importers, processors). 

-  Food  Business  Operators  (FBOs)  –  the  potential  or  actual  clients  of  food 

irradiation businesses in Europe. 

A  total  of  56  responses  were  received,  corresponding  to  31  national  competent 
authorities in 22 Member States, 20 irradiation industry representatives from 7 Member 
States and 6 Third Countries, and 5 FBO representatives. 

64 

 
A  second  follow-up  survey  was  held  with  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.   

Responses  were  reviewed  and  follow-up  contacts  made  with  three  stakeholders.  In 
addition,  16  interviews  have  been  conducted  with  representatives  from  the  following 
sectors: 

-  2 national competent authorities 

-  5 members of the irradiation industry 

-  1 expert from DG SANTE; and 

-  8 food industry representatives. 

This  included  interviewees  from  EU-level  associations,  as  well  as  interviewees  from 
Belgium, France, Germany, the Netherlands, Poland, Spain, Sweden and Switzerland. 

Written contributions were also received from 2 further food industry representatives. 

4 Methodology 

4.1 Public consultation 

The  public  consultation  responses  were  analysed  following  the  Commissions’  better 
regulation toolbox . The received data was transferred to a ‘master’ Excel spreadsheet 
containing responses to both ‘closed’ and ‘open’ text questions. 

In a first step, the data was cleaned, removing duplicates and incomplete answers. The 
data was prepared for analysis by dividing the answers across the respondent groups and 
by  separating  out  open-ended  answers.  Although  the  team  had  sight  of  differences 
between respondent categories, these were largely not maintained during analysis due to 
the small sample sizes. 

Furthermore,  as  part  of  the  public  consultation  respondents  had  the  opportunity  to 
provide  open-ended  answers.  These  answers  and  additional  documents  received  were 
analysed separately  using qualitative analysis techniques. 

Of  the  academics,  business  associations  and  businesses  who  responded,  the  majority 
appeared to be associated with the irradiation industry. Because the Public Consultation 
was not targeted and received a relatively low level of responses, it is difficult to make 
conclusions  based  on  the  quantitative  results  of  the  survey.  However,  the  Public 
Consultation also allowed for a number of open comments, many of which have been 
reflected and quoted in the report.  

4.2 Targeted consultations 

The  results  from  the  targeted  consultations,  including  interviews,  workshops,  and 
surveys  were  analysed  following  the  Commission’s  Better  Regulation  guideline  on 
stakeholder consultation. All write-ups, data and documents received as a result of the 
consultation  were  examined  using  qualitative  analysis  techniques.  The  comments  and 
contributions  from  stakeholders  were  assessed  against  the  evaluation  questions. 
Distribution  of  respondents  across  Member  States  and  respondents  by  stakeholder 
categories was taken into account.  

65 

 
4.3 Limitations to the method and use of the results 

The main limitation of the consultation activities has been the lack of information and 
knowledge regarding irradiation in the EU food industry by stakeholders. This reflects 
the  marginal  nature  of  the  practice  and  its  absence  from  the  agenda  of  stakeholder 
groups, including consumer organisations, NGOs, and in much of the EU food industry.  

Consultation activities had many non-responses or refusals to take part. For example, in 
response to  the targeted survey only 6 of the 68 FBO invitees responded. Most of the 
data collected through consultations for this project  came directly from the irradiation 
industry or from national competent authorities.   

Another major data gap related to consumer views on food irradiation. Despite a strong 
belief among FBO 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.  There  were  a  small  number  of  responses  to  the  public 
consultation  from  the  general  public,  but  these  did  not  provide  any  generalisable 
evidence. 

5 The results of the stakeholder consultation  

The sections below include a description of the results of the consultation activities per 
evaluation criteria.  

5.1 Relevance 

Under  this  criterion,  the  aim  is  to  analyse  the  extent  to  which  the  EU  legislation  on 
techniques for ionisation treatments of food, including food irradiation, are still fit-for-
purpose and meeting current regulatory needs.  

5.1.1 Contribution to food safety 

irradiation  experts, 

Where  irradiation  has  been  used  for  food  safety  purposes,  consulted  stakeholders, 
including 
industry  representatives  and  national  competent 
authorities,  were  largely  in  agreement  that  it  is  an  effective  method  for  ensuring 
microbiological  food  safety  and  has  minimal  impact  on  food  quality  for  foods  low  in 
fat.  

Responses to the public consultation indicate some scepticism among EU citizens on the 
safety  of  irradiation,  but  due  to  the  small  sample  size  (39  EU  citizens),  these  are  not 
generalisable.  

In the consultation that took place in 2002, one of the main concerns expressed by food 
businesses and other stakeholders regarding irradiation was the potential for irradiation 
to  replace  good  hygiene  practices,  despite  the  requirement  in  the  directives  that 
irradiation  should  not  be  used  as  a  substitute  for  good  hygiene.  The  various 
consultations  for  this  study  have  not  identified  any  significant  evidence  of  this 
occurring. 

The  only  evidence  identified  to  suggest  that  irradiation  has  been  used  to  replace 
hygiene, health or good  manufacturing or agricultural  practice is  anecdotal and comes 
from the case study on the use of irradiation in Poland. According to a member of the 
spice  industry  there,  a  large  share  of  spices  sold  in  Poland  is  imported,  often  from 
Egypt,  Vietnam,  Turkey  or  India.  The  production  process  in  these  countries  has  been 
modernized  over  last  years  and  new,  higher  hygienic  standards  have  been  introduced, 

66 

 
such  that  there  is  no  longer  a  need  to  irradiate  imported  spices.  According  to  this 
interviewee, there is, however, still a need to irradiate spices produced in Poland due to 
low hygienic standards at the production sites. However, no corroborating evidence has 
been  identified  that  would  confirm  this  as  an  issue  and  in  the  survey  of  national 
competent authorities, representatives from all 14 of the Member States that responded 
indicated  that  they  had  no  evidence  of  potential  uses  of  irradiation  to  replace  hygiene 
good practices. 

Input from stakeholders in the irradiation industry and FBOs indicates that irradiation is 
the preferred food safety treatment for certain products in the EU. It is considered to be 
the  best  or  better  option  for  frog  legs,  as  this  is  an  imported  product  at  high  risk  of 
contamination  and  is  generally  imported  frozen,  making  it  suitable  for  irradiation. 
According  to  one  interviewee  from  the  irradiation  industry,  there  are  no  suitable 
alternatives  for  the  treatment  of  frog  legs.  Stakeholders  from  food  businesses  also 
indicated that it is sometimes a preferred method for herbs and spices, but that heat and 
steam  treatments  are  generally  used  as  an  alternative,  due  to  their  lower  cost  and  the 
absence of labelling requirements.   

Stakeholders  confirmed  that  irradiation  does  not  appear  to  be  used  for  reasons  other 
than  food  safety  in  the  EU.  Some  information  received  through  targeted  interviews 
suggested that  there may be interest  in  using low level  irradiation  (e.g. doses below 1 
kGy  as  used  for  plant  health  protection)  to  help  with  insect  disinfestation  for  grains, 
such  as  rice.  However,  one  European  rice  producer  noted  that,  despite  growing 
problems  with  infestation,  a  lack  of  alternative  treatments,  and  the  likely  benefits  of 
irradiation,  it  would  likely  not  use  irradiation  -  even  if  it  were  approved  -  due  to  the 
need to label and the likely consumer concerns this would trigger.   

5.1.2 Contribution to protecting the EU from plant health risks 

Irradiation  is  not  currently  used  in  the  EU  as  a  plant  health  treatment.  According  to 
industry stakeholders (one FBO and one EU level association), strategies such as choice 
of low-risk sourcing locations, inspections, systems approaches and physical treatments 
(e.g.  hot  or  cold  treatments)  are  currently  preferred  to  chemical  treatments,  such  as 
fumigation.  Industry  stakeholders  also  noted  that  these  would  be  preferred  over 
irradiation, even if irradiation were permitted, because of likely consumer concern about 
products labelled as irradiated.   

In  responses  to  the  public  consultation,  both  a  research  institute  in  Israel  and  the 
Australian  Government  noted  the  comparative  effectiveness  of  irradiation  and  its 
suitability  for  certain  types  of  produce.  The  research  institute  in  Israel  stated  that 
irradiation for plant health purpose is a more effective treatment option for dealing with 
pests  in  traded  products  such  as  mangoes  and  red  peppers  when  exporting  to  nearby 
markets, as compared to the ‘cold treatment alternative’ currently used. Given that the 
EU is  Israel’s main  export market for fruits  and vegetables, the respondent  concluded 
that Israel would consider setting up a facility for commercial plant health irradiation if 
the EU changed its current stance on use of the technology. The representative from the 
Australian Government noted that, given irradiation technology is a proven plant health 
treatment  for  fruit  flies  and  other  pests  of  biosecurity  concern  for  products  such  as 
mangoes,  summer  fruits,  cherries  and  table  grapes,  the  EU  should  ‘streamline 
regulation’ to permit trade of irradiated products from outside Member States. 

67 

 
5.1.3 Extent to which the objectives of the irradiation directives are still 

relevant considering the evolution of societal needs and scientific and 
technological developments 

Although  the  objectives  of  the  directives  remain  relevant,  some  stakeholders  from  the 
irradiation  industry  mentioned  that  certain  requirements  are  no  longer  relevant 
considering scientific and technical developments. These are:  

the  use  of  overall  average  absorbed  dose,  rather  than  minimum  and  maximum 

dose; and 

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).  

Given the appearance of a small set of novel technologies, questions have been raised 
by various stakeholders (legal expert, irradiation expert, manufacturer of food treatment 
technology)  regarding  the  scope  of  the  legislation  and  the  manner  it  is  written,  to 
suggest that it could provide more certainty to businesses and particularly to innovating 
businesses, so as to facilitate technological development in this area.  

5.1.4 New problems emerging related to irradiation of foodstuffs and 

its impact on the human health and environment  

Stakeholders involved with the irradiation industry have mentioned that the legislation’s 
focus  on  maximum  doses  obscures  the  importance  of  ensuring  a  minimum  dose  is 
applied  –  particularly  when  irradiation  is  used  to  ensure  food  safety.  Where  the 
necessary  minimum  dose  is  not  applied,  there  is  a  risk  that  foodstuffs  will  not  be 
properly  decontaminated.  According  to  one  national  competent  authority  interviewed, 
however,  inspections  of  food  irradiation  facilities  also  take  the  minimum  dose  into 
account in practice.  

During the targeted interviews, one stakeholder did mention a potential long-term risk 
of  irradiation  leading  to  development  of  irradiation-resistant  bacteria.  No  evidence  on 
this was identified and existing science on irradiation resistance predates the directives. 
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. This is not 
a  new  issue,  and  under  the  EU  directives,  packaging  materials  used  for  foods 
undergoing irradiation “must be suitable for the purpose”.  

Otherwise, stakeholders did not report any new problems related to irradiation. 

5.2 Effectiveness 

Under the effectiveness criterion, the consultation process focused on assessing whether 
the  objectives  of  the  directives  were  achieved,  the  effects  of  the  directives  on 
stakeholders and what other factors might influence the achievement of the objectives.  

5.2.1 Effectiveness at meeting objectives 

The directives have only partially met their objective of providing a unified legal status 
for  irradiated  food  products  in  the  EU.  The  lack  of  an  EU  positive  list  creates 
uncertainty  for  businesses  interested  in  using  irradiation,  both  within  the  EU  and  for 
third countries looking to export to the EU. This view was expressed by the majority of 
respondents  to  the  public  consultation,  as  well  as  in  interviews  with  the  irradiation 
industry.  

68 

 
 
 
The  directives  have  only  partially  ensured  fair  competition  with  regards  to  irradiated 
foodstuffs  in  the  EU  and  with  third  countries.  A  few  claims  of  unfair  competition 
between EU and third country producers relating to irradiated food products have been 
heard.  Industry  representatives  involved  in  dried  vegetables,  herbs  and  spices  have 
mentioned  that  irradiated  products  from  third  countries  might  be  entering  the  EU 
without labels (some products have also been irradiated in non-approved facilities). An 
interview  with  an  industry  body  involved  in  importing  spices  also  indicated  that 
suppliers  from  third  countries  would  sometimes  try  to  provide  spices  that  had  been 
irradiated, not understanding the EU restrictions and requirements. 

Several stakeholders in interviews have noted that the labelling obligation established in 
the  directives  is  asymmetric.  The  food  chain  is  required  to  label  for  treatment  by 
irradiation but not necessarily for other treatments, such as steam treatment or chemical 
treatments.  

5.2.2 Effectiveness of enforcement and controls 

National  competent  authorities  and  other  stakeholders  have  indicated  through  the 
targeted  surveys  and  through  the  public  consultation  that  enforcement  measures  are 
effective. One potential issue highlighted by national competent authorities in response 
to the targeted survey relates to the monitoring of foods imported from third countries 
for irradiation. The majority of non-compliances identified through RASFF come from 
products originating in third countries, but in general neither Member States nor the EU 
actively  collect  data  on  the  quantities  of  irradiated  products  coming  from  third 
countries.  Seventeen  national  competent  authorities  indicated  that  collecting  this  data 
would help to improve their ability to conduct risk-based controls.  

Stakeholders  from  both  national  competent  authorities  and  the  irradiation  industry 
largely  agreed  that  the  manufacturing  control  mechanisms  in  place  are  sufficient  for 
identifying irradiation in food products and ensuring it complies with the EU directives. 

The majority of surveyed national competent authorities reported being ‘very’ or ‘quite’ 
confident  that  the  effort  expended  on  controls  by  Member  State  authorities  was 
sufficient to ensure that food products irradiated in the EU were treated within required 
dose  limits,  and  that  the  analytical  methods  to  detect  irradiated  food  were  adequate. 
national  competent  authorities  considered  methods  for  detection  of  irradiation  to  be 
validated  and  standardised,  and  irradiation  facilities  themselves  adequately  monitored 
and  controlled.  It  was  also  pointed  out  that  the  results  over  time  had  consistently 
reflected  low  levels  of  irradiation  use.  Experts  responding  to  the  public  consultation, 
including  public  authorities,  business  associations  and  academic/research  institutions, 
expressed similar views. Despite these positive views, some concerns were still raised. 
A  national  competent  authority  said  that  there  were  no  quantitative  methods  for 
analysing  the  delivered  dose  of  irradiation  and  only  the  treatment  plant  could  certify 
this,  so  there  was  a  need  to  validate  and  accredit  quantitative  methods.  A  business 
similarly noted that verification of irradiated status was usually “verified on paper” but 
in  cases  of  doubt  there  was  not  an  EU-level  list  of  laboratories  to  test  this.  A  few 
stakeholders from FBO organisations and national competent authorities also expressed 
distrust  in  products  imported  into  the  EU  and  emphasised  the  need  for  good  control 
mechanisms at points of entry (i.e. import controls, in addition to those currently done at 
product marketing level). 

69 

 
5.3 Efficiency 

The  consultation  activities  targeted  for  the  efficiency  criterion  aimed  to  collect  the 
stakeholders’ perspectives on the cost and benefits associated with the implementation 
of the directives, and the implications of these.   

5.3.1 Costs to businesses and the decline of irradiation 

Stakeholders  from  the  irradiation  industry  perceived  the  direct  costs  for  industry/food 
business operators/consumers associated with the implementation of the Directives to be 
low.  However,  irradiation  industry  and  FBO  stakeholders  indicated  that  there  are 
indirect  costs  associated  with  the  labelling  requirement.  The  labelling  obligation 
imposed by the directives reduced demand, meaning that businesses were no longer able 
to apply the technique. In this sense, the directives have affected businesses’ ability to 
use  irradiation  as  a  decontamination  technique.  The  requirement  to  label  irradiated 
foods  was  mentioned  most  frequently  by  stakeholders  in  the  irradiation  industry  and 
FBOs as  the main factor that contributed to the decline  of irradiated foodstuffs on the 
EU  market  following  the  implementation  of  the  directives.  This  was  evident  in 
stakeholder interviews, as well as in the response to the targeted survey.  

Stakeholders  indicated  other  reasons  for  the  decline  in  the  use  of  irradiation.  One 
stakeholder (an irradiation facility) indicated that one reason the technique is not used 
more  widely  is  due  to  a  lack  of  knowledge  of  the  method  within  the  food  industry. 
Although  this  would  not  have  contributed  to  the  initial  decline  in  irradiation,  it  may 
have  contributed  to  the  continued  low  level  of  use.  To  some  extent,  this  lack  of 
knowledge  was  confirmed  through  many  of  the  consultations  held  with  food  industry 
stakeholders  and  through  the  targeted  survey  results.  The  food  industry  stakeholders 
consulted  frequently  lacked  knowledge  on  food  irradiation,  its  costs  and  benefits. 
Response  rates  from  the  food  industry  were  low,  and  within  interviews,  some 
stakeholders suggested that there could be an interest in the use of irradiation, but not 
enough was known about it in relation to their products and in comparison to existing 
techniques. It is difficult to determine the extent to which this has contributed to the lack 
of use or whether it is a consequence of a lack of interest due to the need to label.  

Two interviewees (one in France and one in the Netherlands) mentioned EU Regulation 
EC/852/2004 as a contributing factor to the decline of the irradiation of frozen chicken, 
as  this  set  a  new  maximum  temperature  for  storage  throughout  the  process  at  -18 
degrees  Celsius.  This  new  maximum  temperature  was  colder  than  before,  and 
maintaining  that  temperature  throughout  the  irradiation  process  proved  challenging.  It 
led to both interviewees stopping the irradiation of mechanically separated chicken.   

Despite the lack of interest, several FBO stakeholders (e.g. from the fruit importing and 
red meat sectors) have indicated in interviews that even if they would not foresee using 
it  in  the  near  future,  if  irradiation  is  considered  a  safe  and  effective  treatment,  they 
would like to see it approved as a treatment option for their products.  

5.3.2 Impact on trade and a level playing field 

In  the  targeted  survey,  stakeholders  were  asked  whether  EU  legislation  on  food 
ionisation has an impact on the sector trading with countries outside of the EU. Five out 
of  18  reported  that  it  did,  whilst  most  did  not  know  (10  respondents).  When  asked  to 
describe  how  trade  is  impacted,  respondents  suggested  that  this  mainly  related  to 
restrictions on imports from countries outside the EU. No evidence has been identified 
of market opportunities that have not materialised because the directives have prevented 

70 

 
European producers from exporting irradiated products to third countries. When public 
consultation  respondents  were  asked  if  the  directives  impose  additional  costs  on 
European  manufacturers  and  traders  that  competitors  in  third  countries  do  not  have,  a 
majority  of  respondents  (13  out  of  20)  disagreed.  However,  all  four  business 
associations  that  responded  agreed,  as  did  two  companies  and  one  international 
organisation.  When  asked  to  provide  reasons  for  additional  costs,  responses  mainly 
related  to  economies  of  scale  in  countries  with  fewer  controls,  which  enabled 
manufacturers to operate with lower costs. By contrast, the restrictions in the EU mean 
that  manufacturers  who  want  to  export  food  and  compete  in  the  international  market 
must  use  alternative  treatments  for  the  same  purpose.  In  some  cases,  such  alternative 
treatments  may  be  more  costly  and/or  less  effective.  An  example  given  by  one 
respondent  from  the UK was the higher processing costs of steam  treatment,  although 
other evidence received from the herbs and spices industry in consultation suggests that 
steam treatment is a cheaper alternative. 

5.3.3 Efficiency of monitoring and controls 

Regarding  monitoring,  the  majority  of  national  competent  authorities  considered  that 
the costs involved in implementing the irradiation directives justified, proportionate and 
affordable  given the benefits  which have been achieved. Only  one national  competent 
authority surveyed indicated that costs were high in  comparison  to  the benefits,  citing 
the annual reporting of data to the European Commission and their publication in annual 
reports as disproportionately costly considering the low risks to consumers.  

Of the national competent authorities surveyed (n=17), only one indicated that aligning 
EU rules with those of the Codex Alimentarius would be undesirable, and the majority 
(12 of 17) indicated that it would be either “desirable” or “very desirable”, with several 
indicating  that  this  would  help  to  avoid  conflicts  and  grey  areas  in  relation  to 
international trade. One expert and one industry association representing the irradiation 
industry  also  called  for  a  better  alignment  between  the  directives  and  the  Codex 
Alimentarius.  

The  majority  of  surveyed  national  competent  authorities  (65%;  n=17)  considered  that 
the  reporting  arrangements  set  in  the  directives  were  sufficient  to  identify  issues 
associated with the manner controls were carried out. Two said they did not know, and 
four disagreed.  

The majority of surveyed national competent authorities (71%; n=17) reported that they 
had  established  initiatives  to  monitor  imports  from  non-EU  countries  through  random 
sampling.  These  mostly  involved  sampling  plans  for  a  range  of  different  imported 
product types. One national competent authority also stated that they used RASFF data 
as a source of information for their checks, to support risk-based sampling.  

The same proportion of national competent authorities (71%; n=17) agreed that it would 
be valuable to more actively monitor imports from non-EU countries for irradiation (e.g. 
to collect data on the quantities and types of imported irradiated foodstuffs): this would 
enable checks for correct labelling to be made on products that were on the market and 
information  on  tests  and  their  findings  could  be  shared  between  Member  States  or  at 
EU-level.   

5.4 EU Added Value 

The EU added value criterion refers to the positive effects and results resulting from the 
implementation of the EU legislation compared to legislation at Member State level.  

71 

 
Stakeholders  consulted  expressed  continued  support  for  EU  intervention  in  this  area. 
Both  national  competent  authorities  and  industry  have  indicated  the  importance  of 
harmonisation in relation to irradiation rules.  

In the survey of national competent authorities (n=17), respondents were asked how the 
costs  of  controls  have  been  impacted  by  the  implementation  of  the  directives.  A 
majority (9) indicated that they did not know. This is likely a reflection of the fact that 
significant time has passed since the introduction of the directives. Of those who were 
able  to  respond,  four  indicated  that  costs  had  neither  increased  nor  decreased,  two 
indicated that costs have increased slightly and two indicated that costs have increased 
significantly. One national  competent  authority indicated that this increase was due to 
increased staffing and laboratory costs.     

When surveyed, the majority of national competent authorities (15 out of 17) indicated 
that  they  did  not  have  any  additional  national  rules  that  were  more  effective  than  EU 
rules. One positive response to this question (from  Italy) indicated the existence of an 
official control plan at national level, stipulating both the number of samples to be taken 
in each region, as well as the number of samples for Border Control Points. It is likely 
that  other  Member  States  have  similarly  implemented  official  control  plans,  but  as 
indicated  by  the  absence  of  controls  reported  to  the  Commission  in  several  Member 
States,  many  do  not.  The  other  positive  response  to  this  question,  from  Germany, 
referred to Germany’s additional legislation on ultraviolet treatments. 

72 

 
 
ANNEX 3: METHODS AND ANALYTICAL MODELS 

1. 

CONSULTATION ACTIVITIES  

Consultation  activities  can  be  divided  between  targeted  consultation  activities  and  the 
online public consultation:  

-  Open  public  consultation  in  23  EU  languages.  This  activity  provided  any 
interested  party,  not  consulted  under  the  other  activities,  the  possibility  to 
contribute  to  the  evaluation.  A  dedicated  webpage  page  was  available  on  the 
Commission’s Better Regulation Portal;  

-  Targeted consultation activities included:  

o  Two  workshops  held  as  part  of  the  consultation  strategy:  one  at  the 
beginning of the study, following the inception phase, and one at the end, 
following  the  completion  of  the  draft  final  report.  Both  workshops 
included  Member  States’  authorities,  Industry  actors  and  representative 
organisations,  NGOs,  Academics,  International  organisations,  contractor 
and Commission’s representatives 

o  Three  online  targeted  surveys  addressed  to  i)  National  Competent 
Authorities  (national  competent  authorities),  ii)  the  irradiation  industry, 
iii) Food Business Operators (FBOs). 

o  16 interviews conducted with representatives from the national competent 
authorities  (2),  the  irradiation  industry  (5),  expert  from  DG  SANTE  (1), 
food industry representatives (8).  

2.  MAIN MEETINGS, EVENTS AND TOOLS USED TO INFORM 
STAKEHOLDERS  

-  Workshops with stakeholders (see above) 

-  Meetings of the Standing Committee on Plants, Animals, Food and Feed (PAFF 

Committee); 

-  Regular consultative committees such as the Advisory Group on the Food Chain 

and Animal and Plant Health; 

-  The EU Platform digital tool, DG SANTE’s website and the Commission Better 
the  most  recent 

Regulation  portal  have  been  regularly  updated  with 
developments all along the evaluation process.  

3. 

EXTENSIVE DESK RESEARCH  

Desk research was conducted to extract qualitative and quantitative information relevant 
to the evaluation questions from published sources. The scope of the desk research task 
includes  relevant  legislation,  statistics,  complaints,  case  law  and  infringements 
(including  RASFF  notifications  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 
73 

 
 
were  retrieved  online.  The  research  covered  international  and  EU  documentation,  and 
included both academic studies and grey literature. 

4. 

CASE STUDIES  

Five  case  studies  have  been  completed,  which  topics  were:  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  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. 

5. 

INTERVENTION LOGIC 

The initially developed intervention logic served  as valuable tool for the  contractor to 
establish  a  clear  link  between  the  evaluation  questions  to  be  addressed  and  the 
corresponding methodology. The intervention logic helped the contractor to understand 
the initial  intention of the Commission  at  the time of the  adoption of the  strategy and 
how the strategy evolved with the time. 

6. 

EVALUATION MATRIX 

The study team developed an extensive evaluation matrix (see annex 1 of the study) that 
articulates evaluation questions to sub-questions, success or judgment criteria, targets or 
indicators, data sources, stakeholders involved, and data analysis methods.  

7. 

TRIANGULATION  

To ensure robustness of findings, triangulation of methods/data/sources was used by the 
study team  in  both  quantitative and qualitative evidence. Triangulation  was done with 
available  statistically  representative  sources,  such  as  official  controls  results,  as  well 
with non-representative sources from a statistical point of view, including surveys and 
interviews. 

74 

 
 
 
ANNEX 3: LIST OF EVALUATION QUESTIONS 

Relevance 

- 

- 

- 

- 

- 

To what extent do the objectives of the irradiation directives still correspond to those of the 
EU on food safety policy? 

To  what  extent  can  irradiation  of  foodstuffs  contribute  to  food  safety?  Are  there  specific 
cases  (both  for  the  competent  authorities  and  for  food  business  operators  (FBOs))  where 
irradiation  appears  as  the  best  or  a  better  option?  To  what  extent  is  the  irradiation  of 
foodstuffs used for other reasons (e.g. to prolong shelf-life, prevent sprouting, reduce food 
waste and losses)? 

To  what  extent  can  the  irradiation  of  foodstuffs  contribute  to  protecting  the  EU  against 
phytosanitary risks? What are the practices in that regard? 

To  what  extent  can  irradiation  serve  as  a  healthier  alternative  for  pesticide  use  as  a 
phytosanitary  import  option  for  plant  produce,  while  avoiding  the  risk  for  pesticide 
residues? 

To what extent are the objectives of the irradiation directives still relevant considering the 
evolution  of  societal  needs  and  scientific  and  technological  developments?  Are  there 
requirements that are no longer relevant, given the progress of science and technology, over 
the last twenty years? 

-  Are there any new problems/issues related to irradiation, its use on foodstuffs and its impact 
on  human  health  and  the  environment  that  are  currently  not  addressed  through  the 
irradiation directives? 

Coherence 

- 

To what extent are the irradiation directives coherent with other EU legislation (i.e.  – with 
other EU food legislation)? 

o  Do provisions co-act as intended? Do they overlap or contradict each other and if 
so,  what are the impacts of these overlaps/contradictions?  (Legislation and policy 
activities to be considered include those concerning food hygiene of animal origin: 
best  practices  in  agriculture,  good  hygiene  and  manufacturing  practices,  HACCP 
principles, chemical and bacteriological decontamination etc.) 

-  What is the impact of the current legislation on trade of irradiated foodstuffs and what are 
the  reasons  for  such  impact  (taking  into  account  the  level  of  coherence  between  EU  and 
international  rules)? What  in  particular  could  be  improved  to  ease  the  export of  irradiated 
foodstuffs from the EU? 

Effectiveness 

- 

To  what  extent  do  the  food  irradiation  directives  meet  their  objectives  and  in  particular: 
Which provisions or parts of the directives have met their objectives (i) most effectively, (ii) 
less effectively or (iii) not at all and why? 

-  What is the impact of having only one category of irradiated foodstuff listed at EU level and 

different categories at the national level in several Member States? 

-  Have any food safety problems or impacts on the nutritional quality of food been reported in 

relation to irradiated foodstuffs? 

-  How effective are the controls in place to ensure that  food products are treated within the 

required dose limits? 

- 

Effectiveness  of  national  implementation  measures:  To  what  extent  are  the  directives 
effectively implemented across Member States (e.g. enforcement or possible restrictions and 
bans)? What are the implementation and enforcement measures that have been put in place? 
Were they adequate? 

75 

 
Efficiency 

-  What  are  the  quantitative  and  qualitative  costs  and  benefits  for  industry/food  business 
operators/consumers  (e.g.  measurable  improvement  in  food  hygiene  or  reduction  in 
foodborne outbreaks) associated with the implementation of the food irradiation directives? 

-  What are the quantitative and qualitative costs and benefits for the environment associated 

with the implementation of the food irradiation directives? 

-  What  are  the  key  drivers  for  the  costs  involved  in  the  irradiation  of  foodstuffs  (facilities, 

equipment, different sources of ionising radiation)? 

-  What  are  the  main  reasons  for  the  continuous  decline  of  irradiated  foodstuffs  on  the  EU 

market? 

- 

To  what  extent  are  costs  involved  in  implementing  the  irradiation  directives  justified, 
proportionate  and affordable given the benefits  which  have been achieved (e.g. irradiation 
facilities  used  for  other  purposes,  extended  shelf  life  of  foodstuffs,  reduced  loss  of 
foodstuffs, reduced incidence of food-borne disease and of organisms harmful to plants or 
plant products)? 

-  What  factors  influence  any  particular  discrepancies  (e.g.  given  that  irradiation  extends  the 
shelf life of foods, would Food Business Operators (FBOs) like to see more foods on the EU 
list, or do they think that potential negative public opinion is more important than extended 
shelf life)? 

-  Which source(s) of ionising radiation (taking into account emerging technologies, consumer 
and  environmental  concerns)  could  be  considered  as  most  efficient  in  the  treatment  of 
foodstuffs? 

-  Do  the  food  irradiation  directives  permit  EU  manufacturers  and  traders  to  compete  on  a 

level playing field with their international competitors? 

- 

- 

Is  there  a  potential/need  to  simplify  and  attain  the  objectives  of  the  food  irradiation 
directives  more  efficiently?  (e.g.  do  the  legislative  requirements  create  any  unnecessary 
administrative  burden  for  Member  States  and  could  EU  rules  be  aligned  with  the  Codex 
Alimentarius General Standard for Irradiated Food?) 

To  what  extent  do  the  directives  allow  for  efficient  policy  monitoring?  Does  the  annual 
reporting  allow  for  collection  of  all  relevant  information  without  imposing  undue 
administrative burden on enterprises and competent authorities? Given that the EU accepts 
the import of irradiated foods from third countries (provided that they are treated in facilities 
approved by the EU) and there is no requirement in the directive to monitor these imports, 
how  successful  is  this  practice  in  Member  States?    Would  it  be  useful  to  monitor  these 
imports (e.g. collect information on the quantity and type of imported irradiated foodstuffs)? 

EU added value 

- 

To what extent has the legislative framework at EU level added value to the irradiation of 
foodstuffs  in  a  manner  that  could  not  have  been  achieved  by  measures  taken  at  national 
level? 

-  Have Member States' national rules on the irradiation of foodstuffs been more effective in 

the sector than EU rules? If yes, to what extent? 

- 

To what extent is intervention at EU level still warranted? 

76