COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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

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   EUROPEAN COMMISSION  Brussels, 4.8.2021  SWD(2021) 226 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE EVALUATION  of the           EU legal framework on food irradiation (Directives 1999/2/EC and 1999/3/EC)            {SWD(2021) 225 final}  
 
 
This  staff  working  document  presents  the  results  of  the  retrospective  evaluation  of 
legislation  related  to  the  irradiation  of  food  and  food  ingredients,  as  codified  in 
Directives  1999/2/EC,  and  1999/3/EC  (hereinafter  ‘the  Directives’).  The  evaluation  is 
mainly based on an external support study commissioned by the European Commission’s 
Directorate General for Health and Food Safety (DG SANTE) and carried out by ICF.  

Purpose and scope  

The Directives were adopted more than 20 years ago. They have not been significantly 
amended since, despite technological progress in 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 their objectives and provisions are 
still  fit  for  purpose.  Gathering  relevant  feedback  was  difficult  because  the  EU  food 
industry and NGOs either lacked knowledge about food irradiation, or were unwilling to 
participate for fear of being involved in what they perceived as a controversial issue. 

Main findings 

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 their 
requirements  are  no  longer  relevant,  notably  as  regards  recently  developed  irradiation 
technologies.  Due  to  the  lack  of  data  on  food  irradiation  and  its  alternatives,  the 
evaluation could not conclude to what extent the Directives were relevant to preserve a 
high  level  of  consumer  health  and  plant  health,  and  to  achieve  the  objectives  of  the 
Farm to Fork strategy in term of environmental protection. 

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

Effectiveness 

The assessment of the effectiveness criteria showed that the provisions of the Directives 
did  not  achieve  all  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.  

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 

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remaining  differences  between  Member  States  legislations  creates  confusion  in 
stakeholders and there is no equivalence between the EU regulatory framework and the 
ones used in third countries.  

The direct costs for businesses and competent authorities of implementing 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. 
It  is  difficult  to  conclude  on  the  effectiveness  of  the  labelling  requirements  to  provide 
information  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. 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.  

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.  

Lesson learned 

It remains unclear, in which cases food irradiation would be considered the most suitable 
treatment with regard to consumer health, plant health and environmental health, because 
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.  

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 European 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 the main factor causing the decline of  food irradiation  in 
the EU is not regulatory. 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. 

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