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PRODUCT LABELLING AND PACKAGING > Foodstuffs treated with ionising radiation The use of ionisation, a method of food preservation, is harmonised in the European Union (EU) on the basis of treatment conditions and a list of foodstuffs which may be ionised. The labelling of ionised foodstuffs must state that they have been treated by this method. ACT 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 (framework Directive) [Official Journal L 66 of 13.03.1999] 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 (implementing Directive) [Official Journal L 66 of 13.03.1999] SUMMARY Directive 1999/2/EC Scope This Directive applies to the manufacture, marketing and importation of foods and food ingredients treated with ionising radiation. It does not apply to foodstuffs exposed to ionising radiation generated by measuring or inspection devices within certain specified limits nor to foodstuffs which are prepared for patients requiring sterile diets under medical supervision. Ionising radiation is used to reduce the number of pathogenic micro-organisms in food ingredients in order to increase the storage life of the end product and/or to reduce the health risks for consumers. Conditions for application Irradiated foodstuffs may be placed on the market only if they comply with the Directive. To this end, Annexes I, II and III lay down provisions on: the conditions for authorising food irradiation (technological need, benefit to the consumer, etc.) and permissible purposes (to reduce the incidence of disease, to rid foodstuffs of harmful organisms, etc.) in addition to the general requirement that foodstuffs must be in a wholesome state and the obligation not to replace hygiene measures. Irradiation may be combined with other chemical treatment, but only if the chemical treatment is for different purposes; sources of ionising radiation (gamma rays, X rays and electrons of certain characteristics); dosimetry (determination of the overall average absorbed dose and procedures for measuring it). The Directive also specifies that the maximum radiation dose for foodstuffs may be given in partial doses. Provision is made for adapting these requirements to scientific and technical progress. Products covered. Both treatment and placing on the market must comply with the Directive and the dose limits recommended by the Standing Committee on the Food Chain and Animal Health and therefore the list of Member States' authorisations and the list of approved facilities for the treatment of foods and food ingredients with ionising radiation (see "Related acts" below). Labelling and packaging The words "irradiated" or "treated with ionising radiation" must appear on the label or packaging, which must be suitable in every case, and on the documents which accompany irradiated foodstuffs or foodstuffs containing irradiated ingredients. In the case of products intended for sale to the ultimate consumer, the information requirements laid down in Council Directive 79/112/EEC on the labelling, presentation and advertising of foodstuffs must be complied with. Products not intended for sale to the ultimate consumer must be marked to indicate that they have been irradiated and the name and address of the facility where this was carried out. Submission of information The Member States are required to forward the following information to the Commission: the names of the competent national regulatory authorities (responsible for prior approval of irradiation facilities and allocation of a reference number to them) and for inspection of irradiation of foodstuffs, the references of the irradiation facilities approved and the results of checks carried out in the ionising irradiation facilities and at the product marketing stage. Registration obligations Irradiation facilities must keep a record for each source of ionising radiation showing the information specified (nature and quantity of foodstuffs irradiated, data for control of the irradiation process, etc.). These records must be kept for five years. Detailed rules on keeping of the register will be adopted by the Commission, assisted by the Standing Committee on the food chain and animal health. Import arrangements Foodstuffs may be imported from a third country provided they comply with the conditions laid down in the framework Directive and are accompanied by documents showing the name and address of an irradiation facility approved by the Community plus the necessary records. Confirmation must be given that the irradiation was carried out under official supervision guaranteeing compliance with the requirements of the Directive. The Commission may conclude technical arrangements with third countries on the approval and inspection of irradiation facilities in those countries. Protection of health After consulting the Standing Committee on the Food Chain and Animal Health, the Commission will adopt any appropriate measures should a Member State consider that the irradiation of certain foodstuffs endangers human health, even though it complies with the provisions of the Directive. Directive 1999/3/EC The annex to this Directive contains an initial Community list of foods and food ingredients authorised for irradiation treatment in accordance with the rules laid down in the framework Directive, namely dried aromatic herbs, spices and vegetable seasonings, and sets a maximum overall average absorbed radiation dose of 10 kGy for this purpose. Member States may not hinder the marketing of foodstuffs irradiated in accordance with these two Directives. REFERENCES Entry into force Deadline for transposition in the Member States Official Journal Directive 1999/2/EC 20.03.1999 - OJ L 66 of 13.03.1999 Directive 1999/3/EC 10.03.1999 20.09.2000 OJ L 66 of 13.03.1999 Entry into force Deadline for transposition in the Member States Official Journal 20.11.2003 - OJ L 284 of 31.10.2003 Act Amending act(s) Regulation (EC) No 1882/2003 [adoption : codecision COD/2001/0314] RELATED ACTS List of Member States' authorisations of food and food ingredients which may be treated with ionising radiation [Official Journal C 56 of 11.03.2003] Includes 28 types of product which may be subjected to this treatment. List of approved facilities for the treatment of foods and food ingredients with ionising radiation in the Member States [Official Journal C 187 of 7.08.2003] Commission Decision of 23 October 2002 adopting the list of approved facilities in third countries for the irradiation of foods [Official Journal L 287 of 25.10.2002]. Amended by Decision 2004/691/EC [Official Journal L 314 of 13.10.2004] Commission report on food irradiation for the year 2002 [COM (2004) 69 final - Not published in the Official Journal] Two types of check were carried out: to establish (i) whether irradiated products had been properly labelled and (ii) whether any products had been irradiated which should not have been. Market checks on labelling were carried out by only eight Member States: Austria, Finland, France, Germany, Ireland, Netherlands, Sweden and United Kingdom (same as in the previous period). These checks found that about 1.4 % of products (without dietary supplements) on the market had been irradiated but not labelled. The products involved were mainly dietary supplements and herbs and spices or compound foods containing herbs and spices. Other products irradiated but not labelled were frogs' legs, aquatic animal products, mushrooms, fresh fruits, tea, coffee, sauces and similar products. In 2002 the United Kingdom, Ireland, Germany and the Netherlands also performed irradiation checks on dietary supplements, which are not allowed to be irradiated, and found that 29.4 % of the products checked had in fact been irradiated. Commission report on food irradiation for the period September 2000 to December 2001 [COM (2002) 549 - Not published in the Official Journal] In the period covered by the report, six Member States approved facilities for the irradiation of foods on their territory. The individual reports of the Member States indicate that all the units concerned meet most of the provisions of the Directive. Eight Member States carried out checks on the foodstuffs placed on the market. The results showed that, overall, only a few products were marketed without a label to indicate that they had been "irradiated" (approximately 0.5%). These were culinary herbs, spices or foodstuffs containing culinary herbs or spices, common prawns, large prawns and vegetables. However, in the United Kingdom, the authorities discovered that 42% of certain food supplements on the market were irradiated. Since most food supplements cannot be treated with ionising radiation in the EU, the Commission asked the other Member States to check this sector very carefully. The Commission concluded that the provisions of Directive 1999/2/EC were complied with overall. Communication from the Commission on foods and food ingredients authorised for treatment with ionising radiation in the Community [Official Journal C 241 of 29.08.2001] Before submitting a proposal to the Council and the European Parliament on a positive Community list of products that may be treated with ionising radiation, the Commission launched, in the autumn of 2000, an open discussion with consumers' organisations, sectoral organisations and other interested parties on the strategy for drawing up the positive list. According to the proposals made in the consultation document, the following products could be included in the positive list: aromatic herbs, dry fruits, flakes and germs of cereals, offal of chicken, egg white, gum arabic, frogs' legs and peeled shrimps. The following products could be excluded from the positive list: fresh fruits and vegetables, cereals, starchy tubers (potatoes), fish, camembert from raw milk, casein, rice flour and blood products. Widely differing views were expressed on this proposal: the ionising radiation and research sectors were in favour of ionising radiation, consumers' organisations were opposed to it, and most producers and distributors of foodstuffs were opposed to the inclusion of their product in the positive list for fear of a negative reaction from consumers. Given the difficulty of reconciling these positions, there were three possible options: include only peeled shrimps and frogs' legs; include frozen aromatic herbs, dry fruits, flakes and germs of cereals, offal of chicken, egg white, gum arabic, frogs' legs and peeled shrimps; consider the current list to be exhaustive. For more information, please consult the website of the Directorate-General for Health and Consumer Protection .