Food irradiation regulations

The international regulations on food irradiation are included in the Codex Alimentarius⁽¹⁾: the Codex General Standard for Irradiated Foods and the Recommended International Code of Practice for Radiation Processing of Food.
Since its foundation in 1963, the Codex system has evolved in an open, transparent and inclusive way to meet emerging challenges. Currently the Codex Alimentarius Commission has 189 Codex Members made up of 188 Member Countries and 1 Member Organization (The European Union). Its purpose is to propose harmonized international food standards, at the basis of trade agreements.
Codex standards are based on sound science provided by independent international risk assessment bodies or ad-hoc consultations organized by FAO and WHO.
Figure 1 graphically describes the process for developing a standard.

Figure 1 - Process for developing a standard, from fao.org

Food irradiation could help producers to meet increasingly rigorous quarantine requirements against invasive pests and thus to open the way to

new markets. The codex does not name specific foods that can or can’t be irradiated: all food may be irradiated to the maximum approved absorbed dose. However, very few countries adopted a regulation in compliance with the Codex Standard, such as Brazil and Singapore. Brazil, as an example, provided that the food tolerates the treatment, it does not impose any limit to the category of food, the absorbed dose or the purpose. Each country has adopted its own unique approach to the introduction, approval, and regulation of the technology for food production and this result in the approval of food irradiation on a case-by-case basis.
Regulations concern the plant, radioactive materials, sources or process; radiation safety, environmental security, and general health and safety during plant operation; the safe disposal of any hazardous materials at the end of the operation. Although there is an agreement among international experts that food is safe and wholesome for consumption after irradiation up to a dose of 10 kGy, most of the countries do not approve irradiation of all foods up to this limit.
Europe was a leader in food irradiation until late 1990’s, since the European Directives 1999/2/EC and 1999/3/EC entered into force. The complexities of the EU Directives along with the different approach across the EU are in contrast to the situation of radiation sterilization of non-food commodities. Sterilization by ionizing radiation is well accepted in EU and the relative legislation has not been a barrier towards its development. This process is trusted to increase the safety of medical devices, drugs, pharmaceuticals and

cosmetic ingredients, packaging, pet toys. Despite the proven safety of irradiated food, assured by reputable national and international organizations (WHO, FAO, IAEA, …), the EU Directives are much more restrictive than the Codex Alimentarius General Standard for Irradiated Foods, used as model in several countries. The list of food products that can be irradiated is “Dried aromatic herbs, spices and vegetable seasonings” up to 10 kGy. This list has never been extended in 19 years and in some Member States even older national authorizations are still in force. This limits the trade of irradiated food: a food that is legally irradiated in one country may be banned in another one. The European regulations limit especially the trade of food outside EU and thus had a negative effect on the expansion of such technology. Also innovative technology, such as e-beam or X-ray are limited. The limited use of this technology deprive Europeans of its benefits: microbiological safety, disinfestation, reduced spoilage and reduced use of pesticides. This is highlighted by the several recalls of meat, eggs, and food poisoning outbreaks that could be easily limited by adopting this technique. The overall limit of 10 kGy was conservatively suggested in 1980 by the Joint WHO-FAO-IAEA Committee on the Safety of Irradiated Food, adopted by European Directives in 1999, but no longer mentioned in the revised Codex Alimentarius General Standard for Irradiated Foods in 2003. Recently, the International Irradiation Association⁽²⁾ requests to reconsider EU regulations in conformity with the Codex Alimentarius General Standard.