CELEX: 51988PC0654
Language: en
Date: 1988-12-02
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING FOODS AND FOOD INGREDIENTS TREATED WITH IONIZING RADIATION

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,                          protection of the general public and workers against the
                                                                  dangers of ionizing radiation (Euratom                Safety
                                                                  Standards) remain applicable; whereas, however it is also
Having regard to the Treaty establishing the European             appropriate that irradiation units in the Community and
Economic Community, and in particular Article 100a                third countries should be officially approved, specifically
thereof,                                                          to take into account the special requirements of food
                                                                  irradiation on the basis of the F A O / W H O code of
                                                                  practice on the operation of irradiation facilities used for
Having regard to the proposal from the Commission,
                                                                  the treatment of foods; whereas approved irradiation
                                                                  units should be subject to an official control, through an
In cooperation with the European Parliament,                      inspection system to be created for the needs of this
                                                                  Directive;
Having regard to the opinion of the Economic and
Social Committee,
                                                                  Whereas approved units should keep records to ensure
Whereas differences between national laws relating to             that the rules of this Directive have been respected;
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                 Whereas Council Directive 79/112/EEC (3), as last
directly affecting the establishment or functioning of the        amended by Directive . . . / . . ./EEC, on the approxi-
common market;                                                    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
Whereas it is necessary to adopt measures with the aim
                                                                  concerning the labelling of irradiated foodstuffs for sale
of progressively establishing the internal market over a
                                                                  to the ultimate consumer;
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 appropriate rules must also be laid down for the
                                                                  labelling of foodstuffs treated with ionizing radiation not
Whereas rules relating to the use of ionizing radiation           intended for the ultimate consumer;
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 the Scientific Committee for Food should be
                                                                  consulted before the adoption of provisions likely to
Whereas Council Directive 80/836/Euratom (*), as                  have an incidence on public health, for example, the
amended by Directive 84/467/Euratom (2), on the health            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.
 ---pagebreak--- No C 336/8                             Official Journal of the European Communities                                31. 12. 88
Whereas foodstuffs may only be treated by the action of           2.     Member States may not prohibit, restrict or
ionizing radiation if there is a food hygiene need, or a          obstruct the marketing of irradiated foodstuffs on
demonstrable technological or other advantage, or                 grounds relating to their treatment by ionizing radiation,
benefit to the consumer and if they are wholesome and             if the process used complies with the provisions of this
in a proper condition;                                            Directive.
Whereas the process should not be used as a substitute                                      Article 3
for good manufacturing practice, and whereas this
condition is fulfilled for foodstuffs listed in Annex I;          1.     Foodstuffs authorized for irradiation treatment, as
                                                                  well as the maximum radiation doses authorized, are
                                                                  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            2.     Only radiation sources listed in Annex II shall be
measurement and sampling are technical matters to be              used, the requirements of good irradiation practice
entrusted to the Commission;                                      mentioned in Article 6 (3) shall be applied and the
                                                                  overall absorbed dose shall be calculated in accordance
                                                                  with Annex IV.
Whereas, in all cases where the Council empowers the
Commission to implement rules relating to foodstuffs
irradiation, provision should be made for a procedure             3.    Annex I may be amended on the basis of the
instituting close cooperation between Member States and           general criteria laid down in Annex V.
the Commission within the Standing Committee for
Foodstuffs, and, where necessary, the Standing
Veterinary Committee or the Standing Committee on                                           Article 4
Plant Health;
                                                                  1.     Foodstuffs may not be re-irradiated. However, the
                                                                  full dose needed for a specific technological function
Whereas should the use of the process or of a foodstuff           may be given as the sum of fractionated doses.
treated with ionizing radiation authorized on the basis of        Irradiation may also be used in conjunction with other
this Directive appear to constitute a health risk, Member         processes.
States should be authorized to suspend or limit such use,
or to reduce the limits laid down, pending a decision at
Community level,                                                  2.     Exceptions to the provisions of paragraph 1 shall be
                                                                  decided by the procedure laid down in Article 11.
HAS ADOPTED THIS DIRECTIVE:
                                                                                            Article 5
                                                                  Member States shall take all necessary measures to
                          Article 1
                                                                  ensure that foodstuffs irradiated in accordance with the
 1.    This Directive applies to the processing and               provisions of this Directive may be marketed only if their
marketing of foods and food ingredients, hereinafter              packages or containers bear the following information:
called 'foodstuffs', treated by the action of ionizing
radiation.
                                                                   1. For products intended for sale to the ultimate
                                                                      consumer, the information required by Directive
2.     This Directive does not apply to:                              79/112/EEC.
(a) foodstuffs exposed to ionizing radiation emitted by
                                                                  2. For products not intended for sale to the ultimate
     measuring or inspection devices, providing the dose
                                                                      consumer:
     imparted is not greater than 0,5 Gy, at a maximum
     energy level of 5 MeV;
                                                                      (a) a statement that the food has been irradiated, of
                                                                          the same form as provided for in Directive
(b) the irradiation of foodstuffs which are prepared
                                                                          79/112/EEC for products sold to the ultimate
     under medical supervision for patients requiring
                                                                          consumer;
     sterile diets.
                                                                      (b) either the identity and address of the unit which
                          Article 2                                       has carried out the irradiation, or its reference
                                                                          number as provided for in Article 6;
 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.               (c) a lot or batch number;
 ---pagebreak---  31. 12. 88                              Official Journal of the European Communities                               No C 336/9
    (d) the logo depicted in Annex III may be used. In                   carried out and the results obtained, with details, in
         this case, the logo shall be placed prominently and             particular of the limits, lower and upper, of the dose
         conspicuously in conjunction with the statement                 absorbed and the type of ionizing radiation;
         provided for in (a);
    (e) where a non-irradiated foodstuff contains ingre-            (g) reference to the initial dose validation measurements;
         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               (h) any supplementary information         required  by the
         consumer. This statement is not required if the                 provisions of this Directive.
         irradiated ingredients are so identified in the list
         of ingredients.
                                                                    2.    The records referred to in paragraph 1 must be
                                                                    preserved for a period of five years.
                            Article 6
 1.    Member States shall designate a competent
authority or authorities responsible for carrying out the           3.    Detailed rules for the application of this Article
requirements of this Directive.                                     shall be adopted in accordance with the procedure laid
                                                                    down in Article 11.
2.     In respect of units for the irradiation of foodstuffs
competent authorities shall be responsible for:
                                                                                              Article 8
— prior approval,
                                                                    1.    Irradiated foodstuffs may not be imported from a
— the granting of an official reference number,                     third country unless:
— official control and inspection,
— the withdrawal or modification of an approval.                   — they comply with the provisions of this Directive and
                                                                        the documents accompanying any consignment of the
3.    Approval shall only be given if the plant meets the               foodstuffs provide the identity and address of the
requirements of the Joint F A O / W H O Codex Alimen-                   unit which has carried out the irradiation, and the
tarius Commission Recommended International Code of                     details mentioned in Article 7,
Practice for the operation of irradiation facilities used
for the treatment of foods (ref. F A O / W H O CAC/Vol.
                                                                   — it has been officially confirmed, for individual units
XV Ed. 1), and any supplementary requirements which
                                                                        carrying out food irradiation, that official supervision
may be adopted in accordance with the procedure laid
                                                                        is exercised in that third country, ensuring that the
down in Article 11 of this Directive.
                                                                        conditions in which irradiation was carried out are
4.     Each Member State shall forward to the                           equivalent to those laid down in Article 6.
Commission the names, addresses and reference numbers
of irradiation units it has approved, the text of the act of
                                                                    2.    The Commission may:
approval, as well as any act suspending or withdrawing
approval.
                                                                   — enter into arrangements with third countries
5.    The Commission shall publish the details of the                   regarding the mutual notification of irradiation
units referred to in paragraph 4, as well as any changes                plants,
in their status, in the Official Journal of the European
 Communities.
                                                                   — arrange for Community inspection of irradiation
                            Article 7                                   plants in third countries.
1.     Irradiation units approved in accordance with the
provisions of Article 6 must, for each source of ionizing,          3.    Rules for the application of paragraph 2 shall be
radiation used, keep a record showing for each lot of              determined by the Commission in accordance with the
foodstuff treated:                                                 procedure laid down in Article 11.
(a) the nature and quantity of foodstuffs irradiated;
(b) the lot number;                                                4.     The Commission shall publish details of approved
                                                                   units in third countries and Member States in the Official
(c) the consignee;                                                 Journal of the European Communities.
(d) the date of irradiation;
(e) the type of packaging used during treatment;                                              Article 9
(f) the data for control of the irradiation process                Materials used for the packaging of foodstuffs to be
     according to Annex IV, the dosimetric checks                  irradiated shall be appropriate for the purpose.
 ---pagebreak---  No C 336/10                          Official Journal of the European Communities                                31. 12. 88
                        Article 10                               since this Directive was adopted, has detailed grounds
                                                                 for establishing that the irradiation of a foodstuff,
Amendments to the Annexes to take account of scientific          although it complies with the provisions of this Directive,
 and technical developments shall be adopted in                  endangers human health, that Member State may tempo-
accordance with the procedure laid down in Article 11.           rarily suspend or restrict application of the provisions in
                                                                 question in its territory. It shall immediately inform the
                        Article 11                               other Member States and the Commission thereof and
Where the procedure laid down in this Article is to be          give reasons for its decision.
followed the matter shall be referred to the Standing
                                                                 2.    The Commission shall examine as soon as possible
Committee for Foodstuffs by its Chairman. Where
                                                                the grounds given by the Member State within the
appropriate, the Standing Veterinary Committee or the
                                                                 Standing Committee for Foodstuffs, shall deliver its
Standing Committee on Plant Health shall be consulted.
                                                                opinion forthwith and take the appropriate measures.
The Commission representative shall submit to the
Committee a draft of the measures to be taken. The              3.     If the Commission considers that amendments to
Committee shall deliver its opinion on the draft within a       this Directive are necessary in order to resolve the diffi-
time limit which the chairman may lay down according            culties mentioned in paragraph 1 and to ensure the
to the urgency of the matter, if necessary by taking a          protection of human health, they may be adopted using
vote.                                                           the procedure laid down in Article 11; any Member State
                                                                which has adopted safeguard measures may retain them
The opinion shall be recorded in the minutes; in addition       until the amendments enter into force.
each Member State shall have the right to ask to have its
position recorded in the minutes.                                                         Article 14
The Commission shall take the utmost account of the             Member States shall amend their lawas, regulations and
opinion delivered by the Committee. It shall inform the         administrative provisions in such a way as to:
Committee of the manner in which its opinion has been
taken into account.                                             — permit by (18 months after notification) at the latest
                                                                     trade in and use of irradiated foodstuffs complying
                        Article 12                                   with this Directive,
                                                                — prohibit from (three years after notification) trade in
Provisions which are likely to have an effect on public
                                                                     and use of irradiated foodstuffs not complying with
health shall be adopted after consultation of the
                                                                     this Directive.
Scientific Committee for Food.
                                                                They shall forthwith inform the Commission thereof.
                        Article 13
                                                                                          Article 15
1.    Where a Member State, as a result of new infor-
mation or of a reassessment of existing information made        This Directive is addressed to the Member States.
 ---pagebreak--- 3 1 . 12. 88                             Official J o u r n a l of the E u r o p e a n Communities                           N o C 336/11
                                                                  ANNEX       I
                            Foodstuffs authorized for irradiation treatment and maximum radiation doses
                                                                                                        Maximum
                                            Foodstuffs                                        overall average radiation dose
                                                                                                           (kGy)
               1. Strawberries, papayas, mangoes                                                             2
              2.  Dried fruits                                                                               1
               3. Pulses (legumes)                                                                           1
              4.  Dehydrated vegetables                                                                     10
               5. Cereal flakes                                                                              1
              6.  Bulbs and tubers                                                                           0,2
              7.  Aromatic herbs, spices and vegetable seasonings                                           10
               8. Shrimps and prawns                                                                         3
              9.  Poultrymeat                                                                                7
             10.  Frogs' legs                                                                                5
             11.  Arabic gum                                                                                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
 ---pagebreak--- N o C 336/12                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s             3 1 . 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.
 ---pagebreak--- 3 1 . 12. 88                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s          N o 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.