No C 194/14 Official Journal of the European Communities 31.7.89 
3.18. Annex 5 
The heading is incorrect; the provisions of the Annex 
are actually designed to govern the 'vaccines' used and 
not the 'vaccination conditions'. Moreover, the contents 
of the Annex will no longer be relevant after the adop­
tion of the proposed Directive on the establishment 
of additional provisions for immunological veterinary medicinal products (COM(88) 779 final—SYN 190), 
implementing Directive 81/851/EEC. Work on this is 
currently in progress, and it is hoped that the Directive 
will soon be finalized. 
For this reason, it is recommended that this Annex 
be deleted, together with any references to it in the 
Regulation proper. 
Done at Brussels, 31 May 1989. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
Opinion on the proposal for a Council Directive on the approximation of the laws of the 
Member States concerning food ingredients treated with ionizing radiation 
(89/C 194/06) 
On 26 December 1988, the Council decided to consult the Economic and Social Committee, 
under Article 100A of the Treaty establishing the European Economic Community, on the 
abovementioned proposal. 
The Section for Industry, Commerce, Crafts and Services, which was responsible for preparing 
the Committee's work on the subject, adopted its Opinion on 3 May 1989. The rapporteur 
was Mr Gardner. 
At its 266th plenary session (meeting of 31 May 1989), the Economic and Social Committee 
adopted the following Opinion by 85 votes to 43 with 16 abstentions (vote recorded). 
1. Introduction 
1.1. Ionization of food(1) is used to kill dangerous 
bacteria and larger pathogens, as well as infesting 
insects. It is also used to increase the shelf life of some 
foods. For this purpose, the food is exposed to ionizing 
radiation, either from electric machines or from isotope 
sources, in each case under carefully controlled con­
ditions. The process is technologically complex and 
expensive, so its application will be limited to specific 
cases. 
Six Member States, Belgium (± 10 foods), Denmark (2), 
Spain (2), France (± 9), Italy (3), Netherlands (± 40), permit 
food irradiation to different degrees (different products). Ire­
land, Greece and Portugal have no legislation either prohibit­
ing or permitting ionization of food. The position in Luxem­
bourg is unclear. The UK prohibits ionization. Germany in 
principle prohibits ionization but administrative permission 
can be given for individual foods (e.g. spices). 1.2. Many ordinary people have considerable con­
cerns about the consumer acceptability of food ioniz­
ation and about worker protection associated with the 
ionization facilities. This applies in particular to (a) the 
acceptability on health grounds and the technological 
need for this preservation technique, (b) the danger of 
the ionization procedure and of disregard for hygiene 
standards, (c) the rise in the number of jobs exposed 
to radiation and (d) the nutritional-physiological 
aspects of any reduction in the nutritional value of food 
as a result of ionization. 
1.3. The food ionization technique up to 10 kGy 
has been subjected to very intensive nutritional and 
toxicological tests over the last 30 years, including 
multigeneration ones on animals. Much of these com­
prehensive scientific and technical data were produced 
by an international project funded by 25 governments. 
Consequently the standard of the Food and Agriculture 
Organization of the United Nations (FAO) and the 
World Health Organization (WHO) (CODEX) 'recog-
31. 7. 89 Official Journal of the European Communities No C 194/15 
nizes that the process of food irradiation has been 
established as safe for general application to an overall 
average level of absorbed dose of 10 kGy'. These 
findings were further endorsed by the EEC Scientific 
Committee for Food (SCF). 
Like all safety evaluations, this of course is an assess­
ment of the relative importance of proven and possibly 
unproven risks. 
1.4. The availability of the technique of ionization 
must not lead to unhygienic production or processing 
of food. 
2. Present ionization plants 
2.1. There are currently at least 150 ionization 
plants, operating on a world-wide basis with a number 
of these within the EEC. Other plants are planned 
within Member States of the EEC and elsewhere in the 
world. 
Since ionization cannot be detected in the final food, 
products from all these ionization plants, both EEC 
and others, will continue to be able to move freely 
throughout the Community, unless controls on these 
plants are internationally agreed. 
3. Detection of ionized food 
3.1. Food ionization under controlled conditions, as 
proposed by the Commission and by CODEX, is a very 
mild treatment and generally these changes are not 
significant enough to be detected by current methods. 
Also, present potential detection methods are too indefi­
nite, costly and complex to form a practical basis for 
international control of ionized food. 
3.2. However, as a result of these problems of detect-
ability, various representatives of trade unions, Euro­
pean-level agricultural organizations and consumer 
organizations within the EEC are concerned about the 
international control aspects of ionized food. 
3.3. The Committee recognizes that considerable 
Research and Development (R & D) effort is currently 
being expended within the Member States on solving 
the detection problem. In view of its central importance, 
the Committee strongly urges the Commission to 
increase substantially funding for research in the 
interests of finding a viable and practical method of 
detection very rapidly. The Committee would much 
prefer that the implementation of this draft Directive should be delayed until acceptable tests for the detection 
of irradiation are available. 
4. EC trade 
4.1. Based on current practice, the Commission pro­
poses a system of approval and inspection of plants to 
overcome the present problems associated with the 
detection of ionization in food products. 
4.2. Given that after 1992 there will be free move­
ment of food products throughout the Community, 
there seem to be only two options: 
a) to continue to leave the control of food ionization 
to national legislation, which effectively means free 
movement of ionized food from those countries 
which permit the process; 
b) to initiate a Community framework, such as the 
Commission is proposing. 
4.3. Furthermore, it is particularly important to 
ensure that Member States can only import ionized 
food products from non-EEC countries in line with an 
agreed Community standard (as proposed in Article 8). 
5. General comments 
In the above circumstances, the Committee deems it 
inadvisable to endorse a Community framework for 
food ionization, apart from ionization of spices, until 
such time as the EC Commission has submitted conclus­
ive evidence as to the technical need for and. 
acceptability on health grounds of this preservation 
method. 
The Committee therefore requests the EC Commission 
to draft a report on: 
— assessments of food ionization by certain inter­
national organizations, 
— the development of alternative preservation 
methods, 
— the scope for detecting ionization, 
— international ionization practice, 
— imports of products which are frequently subjected 
to ionization, 
— ascertainment of the capacity of Community plants 
which are suitable for carrying out food ionization, 
and 
— the state of discussions on food ionization in the 
Community Member States, the Commission and 
the Council. 
No C 194/16 Official Journal of the European Communities 31. 7. 89 
6. Detailed comments Article 7 
Article 1.2 (a) 
This should be changed to 10 MeV, only for the devel­
opment of anti-terrorist devices at airports. This covers 
the detection of weapons in food consignments by X-
ray equipment. 
Article 4.1 
This Article, which deals with re-irradiation is less than 
clear. The CODEX version relates to the maximum 
doses and the Committee would prefer this. The Committee would prefer records to be kept for 
20 years or in line with existing practices for such 
documentation. 
Article 8.2 
The Commission should include in this Article a para­
graph recapitulating the statement in the explanatory 
note (page 4) that the Community must reserve the 
right to develop an independent system of inspection 
if the current international cooperation is not fully 
successful. 
Change 'may' to 'should'. 
Article 9 
Article 5 Add: 'In line with the food packaging Directive of 
22 December 1988.' 
This refers to the labelling Directive 79/112/EEC. The 
latter is currently being amended and the reference must 
be changed to the amended version. It is important to 
note that fresh fruit and vegetables do not always 
appear to be covered by the labelling Directive 79/112/ 
EEC, as amended. Clear, categorical marking arrange­
ments are necessary but so far no decision has been 
taken on the amended labelling Directive. 
Article 5.2 Article 11 
The procedure laid down in Article 11 applies to 
changes which may prove necessary in various circum­
stances, particularly those described in Articles 10, 12 
and 13. The Committee considers that the procedure 
currently proposed should include consultation of the 
Economic and Social Committee and that it should be 
laid down that the Council is to decide on the changes 
to be made. The provisions of Article 11 would thus 
have to be amended accordingly. 
While the labelling Directive, as amended, regulates 
descriptions for the final consumer, this Directive deals 
only with labelling for intermediate trade. As it is, 
Article 5.2 (e) should be changed to require the same 
description as the amended Directive 79/112/EEC, so 
that the manufacturer knows what to put on the label 
of the final product. The current version is 'irradiated' 
or 'treated with ionizing radiation'. The international 
logo, which can be used in addition to the declaration, 
may be confusing in some countries. The Committee 
recommends that the Commission consider another 
logo for products moved within the EEC. 
Article 6 
Here the Committee needs to make the important point 
of worker protection. Fortunately, suitable systems of 
worker protection have already been evolved for ioniz­
ation plants used for sterilizing medical equipment 
throughout the Community. The same safeguards must 
apply to food ionization and other future uses. Article 12 
Add: 'Who should take into account the results of any 
FAO/WHO evaluations.' 
Annex 1 
The Committee is concerned that food ionization could 
be used to mask unhygienic food products and therefore 
strongly recommends that the Commission should 
develop EEC-wide microbiological criteria. Annex 1 
should be reviewed critically in line with needs, as 
defined below (Annex 5(1), first indent). 
The list differs in some respects from the evaluation by 
the SCF. We would want the following changes: 
a) The purpose of ionization should be given in each 
case, e.g. reducing bacterial load, disinfestation, etc. 
b) 'Cereal flakes' should be changed to 'cereals', as in 
the SCF report. 
31. 7. 89 Official Journal of the European Communities No C 194/17 
Second indent 
Add: 
in line with SCF evaluation.' 
Annex 5.2 
The introductory phrase should be reworded to read 
as follows: 
'Food irradiation may only serve the following pur­
poses:' 
Last indent 
Change 'disinfect' to 'disinfect and/or disinfest'. 
The Chairman 
of the Economic and Social Committee 
Alberto MASPRONE 
APPENDIX 
to the Opinion of the Economic and Social Committee 
The following members, present or represented, voted in favour of the Opinion: 
Mr/Mrs/Miss: Amato, Aparicio Bravo, Ataide Ferreira, Bazianas, Bento Goncalves, Beretta, Berger, Bleser, 
Boddy, Boisseree, Bos, Breyiannis, Briganti, Broicher, Burnel, Cal, Calvet Chambon, Carroll, Cavazzuti, 
Ceballo Herrero, Christie, Conde, Corell Ayora, Cortois, Dassis, Delia Croce, De Tavernier, Dos Santos, 
Droulin, van Eekert, Elstner, Etty, Eulen, Flum, Forgas, Frandi, Freeman, Gayetot, Germozzi, Geuenich, 
Glesener, Gomez Martinez, Gredal, Haas, Hagen, Hilkens, Horsken, Houthuys, Jaschick, Jenkins, Kirchfeld, 
Lappas, Larsen, Laur, Liverani, Machado von Tschusi, Maddocks, Marvier, Morselli, Mourgues, Muhr, 
Muller, Murphy, Neto Da Silva, Nierhaus, Orsi, Petropoulos, Polyzos, Proenca, Raftopoulos, Rouzier, 
Santillan Cabeza, Schmitz, Schnieders, Silva, Smith L. J., Stadelin, Vallejo Calderon, Vassilaras, Velasco 
Mancebo, Vercellino, Vidal, Wick, Williams, Yverneau. 
The following members, present or represented, voted against the Opinion: 
Mr/Mrs/Miss: Arena, Arets, Bagliano, Beltrami, Berns, Ceyrac, Clavel, Collas, Coyle, van Dam, Dodd, 
Donck, Flather, Gardner, Green, Hancock, Hovgaard Jakobsen, Kaaris, Lustenhouwer, Mainetti, Moreland, 
Noordwal, de Normann, Panizo Arcos, Pardon, Pearson, Pelletier, Perrin-Pelletier, Poeton, Proumens, Ribiere, 
Robinson, Rolao Goncalves, Roseingrave, Schade-Poulsen, Speirs, Storie-Pugh, Tamlin, Telles, Termes 
Carrero, Tukker, Wagner, Whitworth. 
The following members, present or represented, abstained: 
Mr/Mrs/Miss: Aspinall, Bordes-Pages, Bredima-Savopoulou, Campbell, Giacomelli, Kazazis, Kroger, Low, 
Mantovani, Margot, Mayayo, Bello, Muniz Guardado, Quevedo Rojo, Riera Marsa, Serra Caracciolo, Straufi. Annex 3 
See comments on Article 5.2. 
Annex 4 
'Batch' needs to be defined for continuous operation. 
There are precedents for this in other Directives. 
Annex 5.1 
First indent 
Change in line with the food additives Directive to read: 
' 'Need' is defined as a demonstrable technological, 
economic or other advantage of benefit to the con­
sumer.' 
Done at Brussels, 31 May 1989.