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Food Safety

Safety of Food Products Food irradiation

Consultation Paper
Subject: Irradiated food and food ingredients - Commission proposal for completion of the positive list of foodstuffs authorised for treatment with ionising radiation

The food irradiation Directives 1999/2/EC and 1999/3/EC became applicable on 20 September 2000. However, a major question remains still open:

Which foodstuffs should be allowed to be treated by ionising radiation?

During the discussions leading to the adoption of the above-mentioned Directives, Member States and the European Parliament only agreed on a single food category to be authorised EU wide for irradiation treatment: " dried aromatic herbs, spices and vegetable seasonings". A requirement was introduced in the 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. Until this positive list is completed, Member States can maintain existing national authorisations for irradiation of certain foodstuffs and can continue to apply existing national restrictions or bans. This situation is confusing for consumers and detrimental to the functioning of the internal market. It should be of common interest to agree on a Community list as soon as possible.

Before submitting a Commission proposal for a Community positive list to the Council and the European Parliament, DG Health and Consumer Protection would like to have an open discussion with consumer organisations, stakeholders and other interested parties on the strategy for drawing up the positive list. This paper describes a possible strategy on which we invite comments before 31 October 2000.

Legal Background

1. 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 Directives became applicable on 20 September 2000. The marketing of any product not complying with the Directive is prohibited by 20 March 2001.

2. The framework Directive requires or provides specifically that

- Food irradiation may only be authorised if

  • There is a reasonable technological need
  • It presents no health hazard and is carried out under the conditions proposed
  • It is of benefit to the consumer
  • 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 food on the positive list .

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

- Until the 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

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.

4. 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.

5. 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.

6. 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 CEN standardisation. Thus, analytical control of whether irradiated foods are correctly labelled is possible in most cases even at the level of the final products. In the few remaining cases, documentary control is an alternative.


7. Although existing authorisations in certain Member States allow the irradiation of a number of foods and food ingredients, only few of them are actually irradiated in practice. The total amount of a particular food which is treated by ionising radiation is in most cases small in comparison to the untreated amounts.

8. The main application of irradiation is the reduction 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 flakes of cereals 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.

9. Certain foodstuffs intended for the direct use of the consumer may be contaminated with Salmonella, Listeria or other harmful micro-organisms which can affect the health of the consumers (e.g. chicken and red meat, eggs, cheese from raw milk). Some of these products, especially frog legs and shrimps, are often insufficiently heated during preparation to destroy these harmful micro-organisms or even ingested without further heat treatment. Health hazards may also arise from cross-infection of utensils and other foodstuffs at the place of culinary preparation. Since irradiation is a suitable method for decontamination, these products are often treated by ionising radiation in countries in which this is authorised.

Proposed strategy to draw up the positive list

10. The following strategy is proposed for drawing up the positive list:

- As required by the framework Directive, there must be a benefit for the consumer. A benefit for the consumer can be assumed if possible health hazards are reduced and the shelf life of the products is prolonged. The latter, besides being more convenient, has also the potential to decrease the price of the products.

- As required by the framework Directive, there must be a reasonable technological need. The fact that some products are irradiated in substantial amounts in at least one Member State is an indicator of technological need.

- As required by the framework Directive, irradiation should not be used to substitute good hygienic practices. This can be achieved by restricting the authorisations to those products for which an unacceptable risk for the health of consumers is associated with the untreated products and for which suitable alternatives are missing.

11. Consequently, the main focus would be on products used in the food industry as food ingredients. Products intended for the direct use of the final consumer would be restricted to a few cases. By applying this strategy the following products could be included in the positive list:

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

- Mechanically recovered chicken meat, offal of chicken, egg white 1 and gum arabic (additive). These food ingredients may be unavoidably contaminated and need to be decontaminated to reduce health hazards and to extend the shelf life.

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

12. Products for which the SCF gave a favourable opinion but which would not be included in the positive list are the following:

- 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, when ever this is allowed. This can be interpreted as demonstrating insufficient technological need.

- Fresh red meats and poultry meat. In order not to discourage good hygienic practices, first priority should be given to measures able to improve the hygienic conditions during the production of these foodstuffs rather than the decontamination of the foods afterwards by ionising radiation.


1 No or insufficient detection method available; however given the microbiological risk associated with these products, they are included in the list, in line with the global strategy on food hygiene.


Safety of Food Products   Food irradiation