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
Date: 2001-08-08
Institutions: European Commission
Subjects: food inspection, food processing, foodstuff, human nutrition, irradiation, marketing, perishable goods

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 8.8.2001
COM(2001) 472 final

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

COMMUNICATION ON FOODS AND FOOD INGREDIENTS AUTHORISED FOR
TREATMENT WITH IONISING RADIATION IN THE COMMUNITY

(Text with EEA relevance)

Executive Summary

food irradiation Directives 1999/2/EC and 1999/3/EC became

The
applicable on
20 September 2000. Since 20 March 2001 all irradiated foods and food ingredients on the
Community market must comply with the provisions of the Directives.

Only a single food category is listed on the EU wide positive list for irradiation treatment:
“dried aromatic herbs, spices and vegetable seasonings”. A requirement was introduced in
Directive 1999/2/EC that the Commission should forward a proposal by 31 December 2000 to
complete this Community positive list of foodstuffs authorised for irradiation, to be adopted
through the co-decision procedure. Meanwhile, Member States can maintain existing national
authorisations for irradiation of certain foodstuffs and can continue to apply existing national
restrictions or bans in compliance with the Treaty.

Before preparing a proposal to the European Parliament and the Council for a Community
positive list,
the Commission services launched an open discussion with consumer
organisations, industry organisations and other interested parties in autumn 2000 on the
strategy for drawing up the positive list. A consultation paper outlining a strategy was
launched, inviting for comments.

The comments revealed strong views, either in favour or against. The conditions for
authorisation as laid down in the Directive, especially technological need, benefit to the
consumers and no substitute for hygiene, are subject to a wide range of interpretations.

Given the complexity of this issue, the Commission considers that a broader debate is
opportune at this stage.

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1.

INTRODUCTION

The food irradiation Directives 1999/2/EC and 1999/3/EC became applicable on 20
September 2000. Since 20 March 2001 all irradiated foods and food ingredients on the
Community market must comply with the provisions of the Directives. However, a major
question still remains open:

Which foodstuffs should be allowed to be treated by ionising radiation
in the whole Community?

the
During the discussions leading to the adoption of the above-mentioned Directives,
Council and the European Parliament agreed only on a single food category to be authorised
EU wide for irradiation treatment: “dried aromatic herbs, spices and vegetable seasonings”.
A requirement was introduced into Directive 1999/2/EC that the Commission should forward
a proposal by 31 December 2000 to complete the Community positive list of foodstuffs
authorised for irradiation, to be adopted through the co-decision procedure. Meanwhile,
Member States can maintain existing national authorisations for irradiation of certain
foodstuffs and can continue to apply existing national restrictions or bans in compliance with
the Treaty.

the Commission services

Before submitting a proposal for a Community positive list to the Council and the European
Parliament,
launched an open discussion with consumer
organisations, industry organisations and other interested parties in autumn 2000 on the
strategy for drawing up the positive list. A consultation paper outlining a strategy was
launched, inviting for comments.

2.

LEGAL BACKGROUND

Irradiated foods are regulated by

• the framework Directive 1999/2/EC of the European Parliament and Council on the
approximation of the laws of Member States concerning foods and food ingredients treated
with ionising radiation, which covers general and technical aspects for carrying out the
process, labelling of irradiated foods and conditions for authorising food irradiation.

• the implementing Directive 1999/3/EC of the European Parliament and Council on the
establishment of a Community list of food and food ingredients authorised for treatment
with ionising radiation. So far, this positive list contains only a single food category: “dried
aromatic herbs, spices and vegetable seasonings”.

The framework Directive requires or provides specifically that

1.

The treatment of a specific food item may only be authorised if

• there is a reasonable technological need,

• it presents no health hazard,

3

• it is of benefit to the consumers,

• it

is not used as a substitute for hygiene and health practices or for good

manufacturing or agricultural practice.

Any food irradiated as such or containing irradiated food ingredients has to be
labelled.

A favourable opinion of the Scientific Committee on Food (SCF) is needed to place a
specific food item on the positive list.

The Commission shall forward a proposal by 31 December 2000 to complete the
Community positive list of foodstuffs authorised for irradiation.

National authorisations of Member States which allow the irradiation of certain
foods can be maintained until the completed positive list enters into force.

Until a completed positive list enters into force, Member States may also maintain
restrictions or bans of irradiated foods, in compliance with the Treaty.

Member States shall ensure that the analytical methods used to detect irradiated
foods are validated or standardised.

Foodstuffs, including those imported from third countries, may only be irradiated in
approved irradiation facilities.

SCIENTIFIC BACKGROUND

2.

3.

4.

5.

6.

7.

8.

3.

On the basis of scientific studies, the Food and Agriculture Organisation, the International
Atomic Energy Agency and the World Health Organisation (FAO/IAEA/WHO) concluded in
1980 that the irradiation of any food up to a maximum dose of 10 kGy is considered to be
safe. In fact, WHO encourages the use of the irradiation process in order to reduce the
incidence of food borne diseases caused by micro-organisms.

Building upon the work of FAO/IAEA/WHO, the Scientific Committee on Food expressed
opinions on irradiated foods in 1986, 1992 and 1998 and gave favourable opinions on
irradiation of a number of foodstuffs (fruit, vegetables, cereals, starchy tubers, spices and
condiments, fish, shellfish, fresh meats, poultry, camembert from raw milk, frog legs, gum
arabic, casein/caseinates, egg white, cereal flakes, rice flour, blood products). The SCF
emphasised that food irradiation must not be used to cover negligence in handling foodstuffs
or to mask their unsuitability for use as food.

The FAO/IAEA/WHO published in 1999 the report of a study group on the wholesomeness of
food irradiated with doses above 10 kGy. This study group concluded that food irradiated
with any dose appropriate to achieve the intended technological objective is both safe to
consume and nutritionally adequate.

Reliable detection methods are available for most of the foods which can be irradiated. These
methods are validated and either already standardised by the European Committee for
Standardisation (CEN) or in the process of standardisation. Thus, analytical control of

4

whether irradiated foods are correctly labelled is possible in most cases. In the remaining
cases, documentary control is an alternative.

4.

APPLICATIONS

Although existing authorisations in certain Member States (Annex) allow the irradiation of a
number of foods and food ingredients, only few are irradiated in practice. The percentage of a
particular food which is treated by ionising radiation is in most cases small.

Irradiation is applied to reduce the number of micro-organisms in food ingredients intended
for the production of industrially produced compound foodstuffs in order to extend the shelf
life of the final products. This is especially the case for ingredients which are added to
products for which the production process does not
involve heating, such as yoghurt
containing cereals flakes or white cheese containing herbs and spices. The same foods/food
ingredients (flakes, dried fruits, etc.) may not need to be irradiated if they are intended as such
directly for the final consumers, since the shelf life necessary for home-made products is
much shorter and the normal microbial load does not induce health hazards as long as the
ingredients are stored and handled by the consumers in a normal and reasonable manner.

Irradiation is also applied to certain foodstuffs which may be contaminated with Salmonella,
Listeria or other harmful micro-organisms (e.g. chicken meat, eggs, cheese from raw milk)
and which are intended for the direct use of the consumer. Some of these products, especially
frog legs and shrimps, are often insufficiently heated during preparation to destroy these
harmful micro-organisms or ingested without further heat treatment, and may give rise to
cross-contamination.

5.

EXISTING COMMUNITY MEASURES TO ENSURE HYGIENE BY MEANS OTHER THAN
FOOD IRRADIATION

Food hygiene rules are laid down in Council Directive 93/43/EEC on hygiene of foodstuffs
and in a number of Council Directives governing the production and placing on the market of
products of animal origin. These legislative requirements set a high level of consumer health
protection for all foods. These requirements are commonly accepted to be essential to ensure
safe food, also at international level through Codex Alimentarius. Experience has shown that
a strict respect of these rules is efficient without there being a need to rely on other steps such
as a final decontamination of food for reasons of food safety. However, experience has also
shown that certain foods, due to limits inherent to the production process, may present a
residual microbiological risk. In these circumstances, there may be no other option than to
allow reduction of the microbial load in the final product or to prohibit the food. This is
recognised in the Commission Proposals on Food Hygiene, where additional decontamination
steps are foreseen for certain foods presenting a particular high risk profile. Where such steps
are applied, it is clearly stated that decontamination is without prejudice to the correct
implementation of all food hygiene requirements and that decontamination can only be
applied in accordance with conditions of use to be defined by the relevant Scientific
Committee. This aims to avoid improper and inappropriate use of decontamination.

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6.

CONSULTATION OF CONSUMER ORGANISATIONS, INDUSTRY ORGANISATIONS AND
OTHER INTERESTED PARTIES ON A STRATEGY TO DRAW UP THE COMMUNITY
WIDE POSITIVE LIST

On 27 September 2000, the Commission services sent a consultation paper on food irradiation
to European consumer organisations and European industry associations, addressing in
particular the question of which foodstuffs should be authorised for irradiation treatment in
the European Community. The paper was also placed on the web site of this Directorate-
comment
General
(http://europa.eu.int/comm/food/fs/sfp/fi_index_en.html). The paper proposed a strategy for
drawing up the Community-wide positive list and can be summarised as follows:

possibility

interested

parties

other

give

the

to

to

• The framework Directive requires that there must be a benefit for the consumer. It was
argued that a benefit for the consumer could be assumed if possible health hazards are
reduced or the shelf life of the products is prolonged. The latter, besides being more
convenient, could also have the potential to decrease the price of products.

• The framework Directive requires that there must be a reasonable technological need. It
was argued that some products are irradiated in substantial amounts in at least one Member
State which could be seen as an indicator of technological need, at least in that Member
State.

• The framework Directive requires that irradiation should not be used to substitute good
hygiene practices.
this could be achieved by restricting the
authorisations for irradiation to those products for which an unacceptable risk for the
health of consumers is associated with the untreated products and for which suitable
alternatives to decontamination may be lacking.

It was argued that

The paper indicated that the following products could be included in the positive list when
applying this strategy:

• Deep frozen aromatic herbs, dried fruit, cereal flakes and germs. These food ingredients
are mainly used in compound foodstuffs, such as milk based products, which are not
heated during processing.

• Offal of chicken, egg white and gum arabic (additive). These food ingredients may be
contaminated and need to be decontaminated to reduce health hazards and to extend shelf
life.

• Frog legs and peeled shrimps may not meet appropriate microbiological standards by
virtue of the methods of collection and preparation. These products are intended for the
direct use of the final consumer and decontamination increases the safety of these products.

Based on the same reasoning, the following products might not be included in the positive list
although the SCF gave a favourable opinion as to their safety:

• Fresh fruits and vegetables, cereals, starchy tubers (potatoes), fish, camembert from raw
milk, casein, rice flour and blood products. These products are not irradiated in Member
States or only in very small amounts, whenever this is allowed. This can be interpreted as
demonstrating insufficient technological need.

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• Fresh red meat and poultry meat1. In order not to discourage good hygiene practices,
priority should be given to measures which improve the hygiene conditions during the
production of these foods rather than the subsequent decontamination of the foods by
irradiation.

7.

RESULTS OF THE CONSULTATION

A total of 33 comments were received from consumer and industry organisations, the US
Government,
the FAO/WHO International Consultative Group on Food Irradiation,
companies and individual persons (http://europa.eu.int/comm/food/fs/sfp/fi_index_en.html).

7.1

Opinions of consumer organisations

The consumer organisations expressed very critical views. They argue that food irradiation is
not necessary if good hygiene practices are applied. A “reasonable technological need” is not
defined by the fact that a product is already irradiated in substantial amounts in one Member
State. There is the danger that food irradiation might be used as a substitute for good hygiene
practices. The benefit of irradiated foods for the consumer has been questioned since extended
shell life of food products would not be in the interest of consumers, but in the interest of
producers. Priority should focus on improving food production at primary level, in storage
and in manufacturing processes.

7.2

Opinions of industry associations and other parties

The views of industry associations and other parties which sent comments are more diverse.

Comments in favour of food irradiation

The irradiation industry is clearly in favour of authorising all products for which the SCF has
expressed a favourable opinion. The FAO/WHO International Consultative Group on Food
Irradiation which has the mandate to evaluate and advise on the global activities of food
irradiation, the US Government and some research associations/institutes expressed similar
opinions.

The main arguments are that according to the scientific community, food irradiation is safe
and contributes to increasing consumer protection by destroying harmful organisms in food
(red meat, poultry, etc.). The technique, if applied using good manufacturing practice, will not
substitute for good hygiene practices. There is no justified reason to prohibit/restrict the
application of food irradiation in the EU. The global trade liberalisation through the WTO
requires that national authorities base their regulations on Codex Standards, sound science
and proper risk analysis. Although it is acknowledged that improvement of hygiene should
the failure of hygiene measures to avoid the presence of harmful
have first priority,
is stressed. Many countries have
microorganisms, especially in red meat and chicken,
authorised irradiation of a number of food products, including red meat and poultry. Also,
food irradiation is the best substitute for fumigation of fruit and vegetable in order to get rid

1

Since the publication of the Consultation paper, mechanically recovered meat from bovine, ovine and
caprine animals has been banned by Commission Decision 2001/233/EC of 14 March 2001 (O.J. L 84
of 23.3.2001, p. 59)

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of pests. Food irradiation has in general the potential to substitute for harmful chemicals. The
current low treatment volumes do not indicate that there is “no technological need” since
social, environmental and economic factors have an overwhelming power over technological
need, scientific endorsement and consumer benefit.

Comments against food irradiation

The food producing industry, in particular the producers and traders of meat products, dried
fruit/vegetables, potatoes, milk products, cereal flakes and tea are not
in favour of the
inclusion of their products into the list. Current procedures to ensure good hygiene are
considered to be sufficient (no technological need). HACCP systems should get first priority
to improve hygiene. The authorisation would affect negatively the image of these products.
The irradiation of fresh fruit and vegetables to inhibit sprouting and delay ripening might
mislead consumers with regard to age and freshness of the products. The Confederation of the
Food and Drink Industries of the EU (CIAA) is of the opinion that it is unlikely that food
manufacturers will make use of food irradiation until consumer confidence in the technology
is secured. CIAA believes that
the negative image of food irradiation will be further
reinforced if all the products for which the SCF expressed a favourable opinion were to be
authorised for irradiation. Food irradiation could be used to substitute good hygiene practices
and could lead to unfair trade practices. Any extension of the list should be accompanied by
an information campaign to reassure consumers about the safety of the technology. The issue
of extending the list should be postponed.

7.3

Summary of the results of the consultation

The conditions for authorisation as laid down in the Community legislation, especially that
irradiation should not be a substitute for hygiene practices, that there must be a technological
need and a benefit to the consumers, are interpreted in both ways either in favour of the
inclusion of certain products or against.

The consumer organisations are either totally against additional authorisations or would like
to see this technique applied as restrictively as possible. On the contrary, the irradiation
industry, backed by the FAO/WHO Consultative Group, the US Government and some
research associations/institutes, claims that there is no scientific justification not to include all
the products for which the SCF expressed a favourable opinion.

Interestingly, most of the food production and trade sectors are against the inclusion of their
products into the positive list, mainly because they expect negative consumer reactions. There
are also indications that the use of irradiated herbs and spices by the food producing industry
is declining due to the strict labelling requirements of the EU legislation and the increased
control of correct labelling by Member State authorities. Only some specific sectors are in
favour of authorising irradiation of their products, like shrimps, frog legs, crayfish and blood
products.

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8.

OPTIONS FOR DRAWING UP THE PROPOSAL FOR A POSITIVE LIST

Option 1

The food producing industry is mainly against the inclusion of the food ingredients proposed
in the consultation paper. This can be interpreted as “no technological need”. The only
products for which a clear need has been identified in the consultation are peeled shrimps and
frog legs, which could be proposed for authorisation. The conditions in subtropical and
tropical countries from which these products are imported are such that a certain microbial
load cannot be avoided.

Option 2

The food producing industry is against the inclusion of food ingredients mostly because they
are concerned about negative consumer reactions. The Commission has the responsibility to
draft
legislation which is scientifically justified and which increases the safety of food
products. There is no doubt that this technology can improve the safety of certain products.
Thus, the Commission could propose the products which are irradiated in some Member
States in substantial amounts, namely deep frozen aromatic herbs, dried fruit, cereal flakes
and germs, chicken offal, egg white, gum arabic (additive), peeled shrimps and frog legs.

Option 3

Having regard to the divergence of views resulting from the consultation process, a third
option might be to regard the current list as complete.

CONCLUSIONS

Food irradiation arises interest from all parts of society although the actual application of this
technique is rather limited. Even in countries – inside and outside the European Community –
which allow the irradiation of a lot of different foodstuffs, the treated volumes are in most
cases very small in comparison to the non-treated ones. An exception are frog legs which are
always irradiated, e.g. in France, and to a certain extent shrimps.

The scientific community, including the Scientific Committee on Food, is of the opinion that
is applied under good
food irradiation is safe for the health of the consumers if it
manufacturing practice. The Community legislation requires labelling of all irradiated foods,
even those which contain only a small portion of irradiated products. Enough reliable
detection methods are available for the food control authorities to enforce correct labelling.

Directive 1999/2/EC lays down the conditions for authorising foods for irradiation. The
conditions are that irradiated foods present no health hazard, that it is not used as a substitute
for hygiene practices, that there is a reasonable technological need and that it is of benefit to
the consumers. The consultation showed that the latter three conditions can be interpreted in
both ways either in favour of the inclusion of certain products or against. The Commission,
being aware of the debatable nature of the conditions, had suggested a compromise solution in
the consultation paper, focussing on the few products which are already irradiated in
substantial amounts in at least one Member State and for which hygiene problems exist. The

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comments revealed that any proposal on a Community positive list would be susceptible to
criticism from one or the other side, and most probably from both.

Given the complexity of this issue, the Commission considers that a broader debate with all,
interested parties is opportune before putting forward the proposal for the completion of the
positive list.

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Annex

LIST OF MEMBER STATES’ AUTHORISATIONS OF FOOD AND FOOD INGREDIENTS WHICH
MAY BE TREATED WITH IONISING RADIATION

(ACCORDING TO ART 4 (6) 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)

Product

Deep frozen aromatic herbs

Authorised
at the given maximum dose [kGy]

BE

FR

10

IT

NL

UK

Potatoes

Yams

Onions

Garlic

Shallots

0,15

0,15

0,15

0,075

0,15

0,15

0,075

0,15

0,15

0,075

Vegetables, incl. pulses

Pulses

Fruit (incl. fungi, tomato, rhubarb)

Dried vegetables and fruits

Cereals

Flakes and germs of cereals for milk products

Flakes from cereals

Rice flour

Gum arabic

Chicken meat

Poultry

Poultry (domestic fowls, geese, ducks, guinea
fowls, pigeons, quails, and turkeys)

Mechanically recovered chicken meat

11

1

10

4

3

5

5

0,2

0,2

0,2

0,2

0,2

1

2

1

7

1

1

1

3

7

Offal of chicken

Frozen frog legs

Dehydrated blood, plasma, coagulates

Fish and shellfish (incl. eels, crustaceans and
molluscs)

Frozen peeled or decapitated shrimps

Shrimps

Egg white

Casein, caseinates

5

5

5

5

10

5

3

6

3

5

3

3

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