Communication from the Commission on foods and food ingredients authorised for treatment with ionising radiation in the Community (Text with EEA relevance)
Date: 2001-08-29
Institutions: European Commission
Subjects: food inspection, foodstuff, ionising radiation, irradiation, perishable goods, public health

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

(2001/C 241/03)

(Text with EEA relevance)

Summary

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.

Only a single food category is listed on the EU wide positive list for irradiation treatment: (cid:145)dried aromatic
herbs, spices and vegetable seasonings(cid:146). 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.

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:

Before submitting a proposal for a Community positive list to
the Council and the European Parliament,
the Commission
services launched an open discussion with consumer organi-
sations, 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.

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

During the discussions leading to the adoption of the above-
mentioned Directives, the Council and the Eurpean Parliament
agreed only on a single food category to be authorised EU wide
(cid:145)dried aromatic herbs, spices and
for irradiation treatment:
vegetable seasonings(cid:146). 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.

2. LEGAL BACKGROUND

Irradiated foods are regulated by:

(cid:151) 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
authorising food
irradiation.

and conditions

for

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and Council on the

(cid:151) the implementing Directive 1993/3/EC of the European
Parliament
a
Community list of food and food ingredients authorised
for treatment with ionising radiation. So far, this positive
(cid:145)dried aromatic
list contains only a single food category:
herbs, spices and vegetable seasonings(cid:146).

establishment of

The framework Directive requires or provides specifically
that:

1. the treatment of a specific food item may only be authorised

if

(cid:151) there is a reasonable technological need,

(cid:151) it presents no health hazard,

(cid:151) it is of benefit to the consumers,

(cid:151) it is not used as a substitute for hygiene and health
for good manufacturing or agricultural

practices or
practice;

2. any food irradiated as such or containing irradiated food

ingredients has to be labelled;

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

4. the Commission shall forward a proposal by 31 December
foodstuffs

2000 to complete the Community positive list of
authorised for irradiation;

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

6. until a completed positive list enters into force, Member
irradiated

States may also maintain restrictions or bans of
foods, in compliance with the Treaty;

7. Member States shall ensure that the analytical methods used

to detect irradiated foods are validated or standardised;

8. foodstuffs, including those imported from third countries,

may only be irradiated in approved irradiation facilities.

3. SCIENTIFIC BACKGROUND

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

In fact, WHO
dose of 10 kGy is considered to be safe.
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
(fruit, vegetables,
cereals, starchy tubers, spices and condiments, fish, shellfish,
frog legs,
fresh meats, poultry, camembert
flakes, rice
gum arabic, casein/caseinates, egg white, cereal
flour, blood products). The SCF
food
irradiation must not be used to cover negligence in handling
foodstuffs or to mask their unsuitability for use as food.

emphasised that

from raw milk,

foodstuffs

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 tech-
nological 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 Standard-
isation (CEN) or
in the process of standardisation. Thus,
analytical control of whether irradiated foods are correctly
labelled is possible in most cases. In the remaining cases, docu-
mentary 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.

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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
further heat
treatment, and may give rise to cross-contamination.

ingested without

5. EXISTING COMMUNITY MEASURES TO ENSURE HYGIENE

BY MEANS OTHER THAN FOOD IRRADIATION

international

to ensure safe food, also at

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
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
to the
production process, may present a residual microbiological
risk. In these circumstances, there may be no other option
than to allow reduction of
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.

the microbial

inherent

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 auth-
orised for irradiation treatment in the European Community.
The paper was also placed on the web site of this Direc-
torate-General
the pos-
sibility
(http://europa.eu.int/comm/food/fs/sfp/
fi_index_en.html). The paper proposed a strategy for drawing

interested parties

to give other

to comment

up the Community-wide positive list and can be summarised as
follows:

(cid:151) 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;

(cid:151) the framework Directive requires that

there must be a
It was argued that some
reasonable technological need.
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;

(cid:151) the framework Directive requires that irradiation should not
be used to substitute good hygiene practices. It was argued
that 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.

The paper indicated that
included in the positive list when applying this strategy:

the following products could be

(cid:151) deep frozen aromatic herbs, dried fruit, cereal flakes and
germs. These
are mainly used in
compound foodstuffs, such as milk-based products, which
are not heated during processing;

food ingredients

(cid:151) 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;

(cid:151) 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 decontami-
nation 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:

(cid:151) 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 insuf-
ficient technogical need;

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(cid:151) fresh red meat and poultry meat (1).

to
discourage good hygiene practices, priority should be
given to measures which improve the hygiene conditions
during the production of
than the
subsequent decontamination of the foods by irradiation.

these foods rather

In order not

7. RESULTS OF THE CONSULTATION

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

the US Government,

Food

on

7.1. Opinions of consumer organisations

that a product
in one Member State. There is

The consumer organisations expressed very critical views. They
argue that food irradiation is not necessary if good hygiene
practices are applied. A (cid:145)reasonable technological need(cid:146) is not
is already irradiated in
defined by the fact
substantial amounts
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 United States
the global activities of
Government
associations/institutes
some
expressed similar opinions.

food irradiation,
research

and

(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
(OJ L 84, 23.3.2001, p. 59).

consumer

food irradiation is
protection

safe and contributes
destroying
by

The main arguments are that according to the scientific
to
community,
increasing
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,
is
sound science and proper
acknowledged that improvement of hygiene should have first
priority, the failure of hygiene measures to avoid the presence
of harmful micro-organisms, especially in red meat and
chicken, is stressed. Many countries have 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 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 (cid:145)no technological need(cid:146) since social, environmental and
economic factors have an overwhelming power over tech-
nological need, scientific endorsement and consumer benefit.

risk analysis. Although it

Comments against food irradiation

to inhibit

in favour of

The food producing industry, in particular the producers and
traders of meat products, dried fruit/vegetables, potatoes, milk
the
flakes and tea are not
products, cereal
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
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

for

conditions

laid down in the
authorisation as
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 inter-
preted in both ways either in favour of the inclusion of certain
products or against.

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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
United States Government and some research associations/
institutes, claims that there is no scientific justification not to
include all
for which the SCF expressed a
favourable opinion.

the products

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
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 auth-
orities. Only some specific sectors are in favour of authorising
irradiation of their products,
like shrimps, frog legs, crayfish
and blood products.

the use of

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
(cid:145)no technological need(cid:146). The only
can be interpreted as
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

interest

from all parts of

society
Food irradiation arises
although the actual application of
this technique is rather
limited. Even in countries (cid:151) inside and outside the European
Community (cid:151) 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 food irradiation is safe for the
health of the consumers if it is applied under good manufac-
turing practice. The Community legislation requires labelling of
irradiated foods, even those which contain only a small
all
irradiated products. Enough reliable detection
portion of
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
conditions, had suggested a compromise
nature of
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
revealed that any proposal on a
exist. The
Community positive list would be susceptible to criticism
from one or the other side, and most probably from both.

comments

the

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 Article 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)

Authorised at the given maximum dose [kGy]

BE

0,15

0,15

0,15

0,15

FR

10

0,075

0,075

0,075

Product

Deep frozen aromatic herbs

Potatoes

Yams

Onions

Garlic

Shallots

Vegetables, including pulses

Pulses

Fruit (including 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

Offal of chicken

Frozen frog legs

Dehydrated blood, plasma, coagulates

Fish and shellfish (including eels, crustaceans and
molluscs)

Frozen peeled or decapitated shrimps

5

5

Shrimps

Egg white

Casein, caseinates

1

10

4

3

5

5

5

5

10

5

3

6

IT

NL

UK

0,15

0,15

0,15

0,2

0,2

0,2

0,2

0,2

1

2

1

7

3

1

1

1

3

7

5

3

3