31. 12. 88 Official Journal of the European Communities No C 336/7 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
concerning foods and food ingredients treated with ionizing radiation 
COM(88) 654 final — SYN 169 
(Submitted by the Commission on 9 December 1988) 
(88/C 336/06) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas differences between national laws relating to 
the treatment of foods and food ingredients (hereinafter 
called foodstuffs) by ionizing radiation and its conditions 
of use hinder the free movement of foodstuffs and may 
create conditions of unequal competition, thereby 
directly affecting the establishment or functioning of the 
common market; 
Whereas it is necessary to adopt measures with the aim 
of progressively establishing the internal market over a 
period expiring on 31 Decmeber 1992; whereas the 
internal market comprises an area without internal 
frontiers in which the free movement of goods, persons, 
services and capital is ensured; 
Whereas rules relating to the use of ionizing radiation 
for the treatment of foodstuffs should take account 
primarily of human health requirements but also, within 
the limit required for the protection of health, of 
economic and technical needs; 
Whereas Council Directive 80/836/Euratom (*), as 
amended by Directive 84/467/Euratom (2), on the health protection of the general public and workers against the 
dangers of ionizing radiation (Euratom Safety 
Standards) remain applicable; whereas, however it is also 
appropriate that irradiation units in the Community and 
third countries should be officially approved, specifically 
to take into account the special requirements of food 
irradiation on the basis of the FAO/WHO code of 
practice on the operation of irradiation facilities used for 
the treatment of foods; whereas approved irradiation 
units should be subject to an official control, through an 
inspection system to be created for the needs of this 
Directive; 
Whereas approved units should keep records to ensure 
that the rules of this Directive have been respected; 
Whereas Council Directive 79/112/EEC (3), as last 
amended by Directive .../.. ./EEC, on the approxi­
mation of the laws of the Member States relating to the 
labelling, presentation and advertising of foodstuffs for 
sale to the ultimate consumer has already laid down rules 
concerning the labelling of irradiated foodstuffs for sale 
to the ultimate consumer; 
Whereas appropriate rules must also be laid down for the 
labelling of foodstuffs treated with ionizing radiation not 
intended for the ultimate consumer; 
Whereas the Scientific Committee for Food should be 
consulted before the adoption of provisions likely to 
have an incidence on public health, for example, the 
inclusion of new foodstuffs in the approved list, the 
authorized dosages or their modification; 
0) OJ No L 246, 17. 9. 1980, p. 1. 
(2) OJ No L 265, 5. 10. 1984, p. 4. (3) OJ No L 33, 8. 2. 1979, p. 1. 
No C 336/8 Official Journal of the European Communities 31. 12. 88 
Whereas foodstuffs may only be treated by the action of 
ionizing radiation if there is a food hygiene need, or a 
demonstrable technological or other advantage, or 
benefit to the consumer and if they are wholesome and 
in a proper condition; 
Whereas the process should not be used as a substitute 
for good manufacturing practice, and whereas this 
condition is fulfilled for foodstuffs listed in Annex I; 
Whereas modifications to the list of foodstuffs which 
may be treated with ionizing radiation and their 
conditions of treatment, the elaboration of methods of 
measurement and sampling are technical matters to be 
entrusted to the Commission; 
Whereas, in all cases where the Council empowers the 
Commission to implement rules relating to foodstuffs 
irradiation, provision should be made for a procedure 
instituting close cooperation between Member States and 
the Commission within the Standing Committee for 
Foodstuffs, and, where necessary, the Standing 
Veterinary Committee or the Standing Committee on 
Plant Health; 
Whereas should the use of the process or of a foodstuff 
treated with ionizing radiation authorized on the basis of 
this Directive appear to constitute a health risk, Member 
States should be authorized to suspend or limit such use, 
or to reduce the limits laid down, pending a decision at 
Community level, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive applies to the processing and 
marketing of foods and food ingredients, hereinafter 
called 'foodstuffs', treated by the action of ionizing 
radiation. 
2. This Directive does not apply to: 
(a) foodstuffs exposed to ionizing radiation emitted by 
measuring or inspection devices, providing the dose 
imparted is not greater than 0,5 Gy, at a maximum 
energy level of 5 MeV; 
(b) the irradiation of foodstuffs which are prepared 
under medical supervision for patients requiring 
sterile diets. 
Article 2 
1. Member States shall take all measures necessary to 
ensure that irradiated foodstuffs may be marketed only if 
they comply with the rules laid down in this Directive. 2. Member States may not prohibit, restrict or 
obstruct the marketing of irradiated foodstuffs on 
grounds relating to their treatment by ionizing radiation, 
if the process used complies with the provisions of this 
Directive. 
Article 3 
1. Foodstuffs authorized for irradiation treatment, as 
well as the maximum radiation doses authorized, are 
listed in Annex I. 
2. Only radiation sources listed in Annex II shall be 
used, the requirements of good irradiation practice 
mentioned in Article 6 (3) shall be applied and the 
overall absorbed dose shall be calculated in accordance 
with Annex IV. 
3. Annex I may be amended on the basis of the 
general criteria laid down in Annex V. 
Article 4 
1. Foodstuffs may not be re-irradiated. However, the 
full dose needed for a specific technological function 
may be given as the sum of fractionated doses. 
Irradiation may also be used in conjunction with other 
processes. 
2. Exceptions to the provisions of paragraph 1 shall be 
decided by the procedure laid down in Article 11. 
Article 5 
Member States shall take all necessary measures to 
ensure that foodstuffs irradiated in accordance with the 
provisions of this Directive may be marketed only if their 
packages or containers bear the following information: 
1. For products intended for sale to the ultimate 
consumer, the information required by Directive 
79/112/EEC. 
2. For products not intended for sale to the ultimate 
consumer: 
(a) a statement that the food has been irradiated, of 
the same form as provided for in Directive 
79/112/EEC for products sold to the ultimate 
consumer; 
(b) either the identity and address of the unit which 
has carried out the irradiation, or its reference 
number as provided for in Article 6; 
(c) a lot or batch number; 
31. 12. 88 Official Journal of the European Communities No C 336/9 
(d) the logo depicted in Annex III may be used. In 
this case, the logo shall be placed prominently and 
conspicuously in conjunction with the statement 
provided for in (a); 
(e) where a non-irradiated foodstuff contains ingre­
dients that have been irradiated, a statement of 
the same form as provided for in Directive 
79/112/EEC for products sold to the ultimate 
consumer. This statement is not required if the 
irradiated ingredients are so identified in the list 
of ingredients. 
Article 6 
1. Member States shall designate a competent 
authority or authorities responsible for carrying out the 
requirements of this Directive. 
2. In respect of units for the irradiation of foodstuffs 
competent authorities shall be responsible for: 
— prior approval, 
— the granting of an official reference number, 
— official control and inspection, 
— the withdrawal or modification of an approval. 
3. Approval shall only be given if the plant meets the 
requirements of the Joint FAO/WHO Codex Alimen-
tarius Commission Recommended International Code of 
Practice for the operation of irradiation facilities used 
for the treatment of foods (ref. FAO/WHO CAC/Vol. 
XV Ed. 1), and any supplementary requirements which 
may be adopted in accordance with the procedure laid 
down in Article 11 of this Directive. 
4. Each Member State shall forward to the 
Commission the names, addresses and reference numbers 
of irradiation units it has approved, the text of the act of 
approval, as well as any act suspending or withdrawing 
approval. 
5. The Commission shall publish the details of the 
units referred to in paragraph 4, as well as any changes 
in their status, in the Official Journal of the European 
Communities. 
Article 7 
1. Irradiation units approved in accordance with the 
provisions of Article 6 must, for each source of ionizing, 
radiation used, keep a record showing for each lot of 
foodstuff treated: 
(a) the nature and quantity of foodstuffs irradiated; 
(b) the lot number; 
(c) the consignee; 
(d) the date of irradiation; 
(e) the type of packaging used during treatment; 
(f) the data for control of the irradiation process 
according to Annex IV, the dosimetric checks carried out and the results obtained, with details, in 
particular of the limits, lower and upper, of the dose 
absorbed and the type of ionizing radiation; 
(g) reference to the initial dose validation measurements; 
(h) any supplementary information required by the 
provisions of this Directive. 
2. The records referred to in paragraph 1 must be 
preserved for a period of five years. 
3. Detailed rules for the application of this Article 
shall be adopted in accordance with the procedure laid 
down in Article 11. 
Article 8 
1. Irradiated foodstuffs may not be imported from a 
third country unless: 
— they comply with the provisions of this Directive and 
the documents accompanying any consignment of the 
foodstuffs provide the identity and address of the 
unit which has carried out the irradiation, and the 
details mentioned in Article 7, 
— it has been officially confirmed, for individual units 
carrying out food irradiation, that official supervision 
is exercised in that third country, ensuring that the 
conditions in which irradiation was carried out are 
equivalent to those laid down in Article 6. 
2. The Commission may: 
— enter into arrangements with third countries 
regarding the mutual notification of irradiation 
plants, 
— arrange for Community inspection of irradiation 
plants in third countries. 
3. Rules for the application of paragraph 2 shall be 
determined by the Commission in accordance with the 
procedure laid down in Article 11. 
4. The Commission shall publish details of approved 
units in third countries and Member States in the Official 
Journal of the European Communities. 
Article 9 
Materials used for the packaging of foodstuffs to be 
irradiated shall be appropriate for the purpose. 
No C 336/10 Official Journal of the European Communities 31. 12. 88 
Article 10 
Amendments to the Annexes to take account of scientific 
and technical developments shall be adopted in 
accordance with the procedure laid down in Article 11. 
Article 11 
Where the procedure laid down in this Article is to be 
followed the matter shall be referred to the Standing 
Committee for Foodstuffs by its Chairman. Where 
appropriate, the Standing Veterinary Committee or the 
Standing Committee on Plant Health shall be consulted. 
The Commission representative shall submit to the 
Committee a draft of the measures to be taken. The 
Committee shall deliver its opinion on the draft within a 
time limit which the chairman may lay down according 
to the urgency of the matter, if necessary by taking a 
vote. 
The opinion shall be recorded in the minutes; in addition 
each Member State shall have the right to ask to have its 
position recorded in the minutes. 
The Commission shall take the utmost account of the 
opinion delivered by the Committee. It shall inform the 
Committee of the manner in which its opinion has been 
taken into account. 
Article 12 
Provisions which are likely to have an effect on public 
health shall be adopted after consultation of the 
Scientific Committee for Food. 
Article 13 
1. Where a Member State, as a result of new infor­
mation or of a reassessment of existing information made since this Directive was adopted, has detailed grounds 
for establishing that the irradiation of a foodstuff, 
although it complies with the provisions of this Directive, 
endangers human health, that Member State may tempo­
rarily suspend or restrict application of the provisions in 
question in its territory. It shall immediately inform the 
other Member States and the Commission thereof and 
give reasons for its decision. 
2. The Commission shall examine as soon as possible 
the grounds given by the Member State within the 
Standing Committee for Foodstuffs, shall deliver its 
opinion forthwith and take the appropriate measures. 
3. If the Commission considers that amendments to 
this Directive are necessary in order to resolve the diffi­
culties mentioned in paragraph 1 and to ensure the 
protection of human health, they may be adopted using 
the procedure laid down in Article 11; any Member State 
which has adopted safeguard measures may retain them 
until the amendments enter into force. 
Article 14 
Member States shall amend their lawas, regulations and 
administrative provisions in such a way as to: 
— permit by (18 months after notification) at the latest 
trade in and use of irradiated foodstuffs complying 
with this Directive, 
— prohibit from (three years after notification) trade in 
and use of irradiated foodstuffs not complying with 
this Directive. 
They shall forthwith inform the Commission thereof. 
Article 15 
This Directive is addressed to the Member States. 
31. 12. 88 Official Journal of the European Communities NoC 336/11 
ANNEX I 
Foodstuffs authorized for irradiation treatment and maximum radiation doses 
Foodstuffs 
1. Strawberries, papayas, mangoes 
2. Dried fruits 
3. Pulses (legumes) 
4. Dehydrated vegetables 
5. Cereal flakes 
6. Bulbs and tubers 
7. Aromatic herbs, spices and vegetable seasonings 
8. Shrimps and prawns 
9. Poultrymeat 
10. Frogs' legs 
11. Arabic gum Maximum 
overall average radiation dose 
(kGy) 
2 
1 
1 
10 
1 
0,2 
10 
3 
7 
5 
10 
ANNEX II 
Sources of ionizing radiation 
Foodstuffs may be treated only by the following sources of ionizing radiation: 
(a) gamma rays from radionuclides 60 Co or 137 Cs; 
(b) X-rays generated from machine sources operated at or below an energy level of 5 MeV; 
(c) electrons generated from machine sources operated at or below an energy level of 10 MeV. 
ANNEX III 
Logo for foodstuffs not intended for the ultimate consumer treated with ionizing radiation 
No C 336/12 Official Journal of the European Communities 31. 12. 88 
ANNEX IV 
1. Dosimetry 
The overall average absorbed dose 
It can be assumed for the purpose of the determination of the wholesomeness of food treated with an 
overall average dose of 10 kGy or less that all radiation chemical effects in that particular dose range 
are proportional to dose. 
The overall average dose, D, is defined by the following integral over the total volume of the goods: 
D = ^ | (*) p(x,y,z) d(x,y,z) dV 
where M = the total mass of the treated sample 
p = the local density at the point (x,y,z) 
d = the local absorbed dose at the point (x,y,z) 
dV = dx dy dz, the infinitesimal volume element which in real cases is represented by 
the volume fractions 
The overall average absorbed dose can be determined directly for homogeneous products or for bulk 
goods of homogeneous bulk density by distributing an adequate number of dose meters strategically 
and at random throughout the volume of the goods. From the dose distribution determined in this 
manner an average can be calculated which is the overall average absorbed dose. 
If the shape of the dose distribution curve through the product is well determined, the positions of 
minimum and maximum dose are known. Measurements of the distribution of dose in these two 
positions in a series of samples of the product can be used to give an estimate of the overall average 
dose. In some cases, the mean value of the average values of the minimum (Dmin) and maximum 
(Dmax) dose will be a good estimate of the overall average dose: 
i.e. in these cases 
.. . Dmax + Dmin overall average dose « -
The ratio of ~—— should not exceed 3. Dmin 
2. Procedures 
2.1. Before routine irradiation of a given class of foodstuffs begins at a radiation facility, location of 
minimum and maximum dose are determined by making dose measurements throughout the product 
volume. These validation measurements must be carried out a suitable number of times (e.g. 3 to 5) in 
order to make allowance for variations in product density or geometry. 
2.2. The measurements must be repeated whenever the product, its geometry or the irradiation conditions 
are changed. 
2.3. During the process routine dose measurements are carried out in order to ensure that the dose limits 
are not exceeded. The measurements should be carried out by placing dosimeters at the positions of 
the maximum or minimum dose, or at a reference position. The dose at the reference positions must 
be quantatively linked to the maximum and minimum dose. The reference positions should be located 
at a convenient point in or on the product, where dose variations are low. 
2.4. The routine dose measurements must be carried out in each batch and at suitable intervals during 
production. 
2.5. In cases where flowing, non-packaged goods are irradiated, the locations of minimum and maximum 
dose cannot be determined. Rather random dosimeter sampling may be used to ascertain values of 
these dose extremes. 
(*) J = integrate. 
31. 12. 88 Official Journal of the European Communities No C 336/13 
2.6. The dose measurements should be carried out by using recognized dosimetry systems, and the 
measurements should be traceable to primary standards. 
2.7. During irradiation, relevant facility parameters must be controlled and continuously recorded. For 
radionuclide facilities the parameters include product transport speed or time spent in the radiation 
zone and positive indication for correct position of the source. For accelerator facilities, the 
parameters include product transport speed and the energy level, electron current and scanner width 
of the facility. 
ANNEX V 
Conditions for the approval of the irradiation treatment of foodstuffs 
1. Food irradiation may be approved only if: 
— there is a reasonable technological need, 
— it presents no hazard to the health of the consumer when applied in accordance with the conditions 
proposed, 
— it is of benefit to the consumer, 
— it is not used as a substitute for health rules, or for Good Manufacturing or Agricultural Practice. 
2. Food irradiation may only serve one of the following purposes: 
— to reduce the incidence of foodborne disease by destroying pathogenic organisms, 
— to reduce spoilage of foodstuffs by retarding or arresting decay processes and destroying spoilage 
organisms, 
— to reduce loss of foodstuffs by premature ripening, germination or sprouting, 
— to disinfect foodstuffs of organisms harmful to plant or plant products.