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 (presented by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 654
Vol. 1988/0217
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                           COM(88 ) 654 final SYN 169
                                           Brussels , 2 December 1988
                                Proposai for a
                              COUNCIL DIRECTIVE
  on the approximation of the laws of the Member States concerning foods
           and food ingredients treated with ionizing radiation
                       ( presented by the Commission )
                                                   V .A
                                                  ,?     I
                                                     / /
                                                 ' /:..■/
 ---pagebreak---                                           - 2 -
                                     Explanatory Note
BACKGROUND
Food irradiation is a physical method of processing food which is comparable
to methods such as heat treatment or freezing .
Like other methods of food processing , irradiation presents no danger to the
consumer as long as it is carried out under properly controlled conditions ;
indeed , it is already permitted by a number of Member States .
There are pressing arguments for Community legislation in this area .
There is no satisfactory and universally reliable method available at the
moment to establish whether a food has been irradiated .             Registration of
irradiation facilities and the marking of the food with lot and plant
identification is the only effective alternative to allow public controls to
be carried out so that the interests of the consumer can be protected .
The Commission considers that , given the consensus of scientific opinion that
foodstuffs irradiated under controlled conditions are wholesome, national
  legislation could not obstruct the free circulation of correctly labelled
foodstuffs legally irradiated and placed on the market in a Member State .
However, to remove the uncertainties and confusion that could arise from
litigation , it is necessary to establish common rules .
A.Completion
     Commissionof proposal    was therefore envisagedj in the White Paper for the
                  the Internal Market in Foodstuffs in order to guarantee a high
level    of protection      to the consumer    and ensure   the free  circulation of
irradiated foods .
In    proposing this directive,
Resolution of the European
                                       the Comit^'ssion has taken into account the
                                     Parliament    particularly in respect of the
  limitation of the process,      the necessity for stringent controls and in making
provisions for imports from third countries .
THE PR0CESS
The technology of food irradiation was first investigated and developed in the
late 1940s .      The food is exposed in specialized facilities for a short period
to x-rays or electron beams generated by appropriate machines or gamma-rays
emitted by the radionuclides Cobalt-60 or less frequently Caesium-137 .          The
process of irradiation does not make the food radioactive .
The Commission has noted and agrees with the statements by the World Health
Organisation      ( WHO ) that the two main benefits of the process to the health
and wellbeing of man are :
1 C0M(85)603 final .
^PE 112.802, Tuesday, 10 March 1987 .
3" In Point of Fact " No 40/ 1987 .
 ---pagebreak---                                          - 3 -
  (i )   the destruction of certain food borne pathogenic organisms , thus making
         the food safer , and
 ( ii ) the prolongation of the shelf-life of food by killing pests and spoilage
         organisms and delaying the deterioration process , thus increasing the
         food supply .
 Food irradiation should not be used as a substitute for good hygiene nor is it
 suitable for the treatment of all kinds of foods .        In this respect , it does
not differ from other physical processes such as canning , pasteurization ,
 freezing and so on , nor the chemical treatments which it might replace .
 For these reasons , whilst recognizing that when carried out within the limits
mentioned in the report of the Scientific Committee for Food, the process
presents no danger , the Commission is proposing that irradiation should only
be allowed for a relatively restricted list of foods , where the process offers
clear advantages to the consumer .
SAFETY OF THE PROCESS
 To address the concerns about safety ,     a large number of lengthy and sometimes
 repetitive animal studies have been carried out in a number of countries .
Some information is also available on humans .
At     the international level , the task of coordinating the work was undertaken
by     the International Project in the Field of Food Irradiation , set up in 1971 ,
as     a result of an agreement between many countries under the joint sponsorship
of     the International Atomic Energy Agency ( IAEA ) and the Food and Agriculture
Organization ( FAO ).
Data generated by this Project were reviewed by Joint            FAO / IAEA / WHO expert
committees who, finally, concluded in 1980 that irradiation of food up to an
overall average dose of 10 kGy          presented no toxicological hazard .           The
committees also considered that irradiation of food up to this                      level
introduced no special nutritional or microbiological problems .
Nevertheless      critisisms  of  the  opinions  of   the Joint    FAO / IAEA / WHO have
continued and the Commission decided that        the EEC Scientific Committee for
Food should reevaluate the data .          The Committee was given access to the
considerable amount of data in the archives of the International project in
Karlsruhe .
The Committee concluded that on the basis of all the available evidence ,             and
in the context of an overall assessment of the wholesomeness of irradiated
foods , only those specific irradiation doses and food classes should be
endorsed that are indicated as appropriate ,             not only from a strict
toxicological point of view , but also from a chemical , microbiological ,
nutritional and technological standpoint .       The Report lists the food classes
and radiation doses submitted to the Committee and considered by it to be
acceptable from a public health standpoint .        The Committee believes that the
health significance of any changes which may take place in the listed foods at
the indicated radiation doses is not different from the health significance of
the changes which are induced by heat treatment .
1
   The absorbed dose is expressed in terms of the gray ( Gy );    k stands for kilo
   (x 1000 ).
 ---pagebreak---                                           - 4 -
The Commission has reconsidered the information on the technological need of
the process with Government experts and economic interests and has concluded
that even though irradiation presents no health risk , there is no need to
permit the irradiation of fresh meat .
IDENTIFICATION OF IRRADIATED FOODS
The Commission has already made proposals to the Directive on the labelling of
food to the final consumer , which impose ^a clear statement on foods that they
or their ingredients have been irradiated .          The text in question is still
before the Council .
The Commission also believes that food circulating between Traders should be
identified as having been irradiated to ensure that the end product is
correctly labelled .
Because the changes induced in the food are so slight , there is at present no
satisfactory method available to detect whether foods have been irradiated ,
which is valid for all foods .          In some cases irradiation can be detected
qualitatively when the rate of deterioration of irradiated food is much slower
than that of non-i rradiated food but this is not an adequate substitute for an
objective control test .       Additionally there are some tests which have limited
applicability to some foods .
The absence of a satisfactory detection method renders the registration of
irradiation installations and the application of common rules and rigourous
control of the process even more imperative .
The    Commission    therefore    proposes   that  rules   for  the   operation  of
installations are laid down on the basis of the FAO / WHO Code of Practice for
the operation of irradiation facilities .
It is particularly important that products imported from Third Countries will
have been submitted to the same rigorous conditions as those applied by
operators in the Community .
In the light of experience gained with the FAO / WHO Code of Practice and
international cooperation , the Commission will decide whether further changes
to the system of inspection should be introduced in due course .
IAEA , WHO and FAO are developing a harmonized international system of official
registration of installations and staff training . The Commission is therefore
cooperating with the IAEA on those aspects .          However, the Community must
reserve the right to develop an independent system of inspection if this
international cooperation is not fully successful .
 - C0M(86 ) 89 final : Proposal for a Council Directive , amending
    Directive 79 / 112 / EEC .
 - C0MC87 ) 242 final : Proposal for a Council Directive , amending
    Directive 79 / 112 / EEC .
 ---pagebreak---                                         - 5 -
Additionally the Commission 's multi-annual action programme " FLAIR" , in its
headings on New Technologies and Processing innovations which enhance food
quality , safety and nutritive value , may include suggestions for studies on
food irradiation , which contribute to these objectives .
The Commission also intends to encourage cooperation between designated
authorities of the Member States relating to technical and administrative
matters on approval and operation of irradiation units and on the exchange of
information on the training of inspectors .
CONTENT OF THE PROPOSAL
Article 1 designates the field of application of the Directive .          The use of
tow doses of ionizing radiation for inspection devices and hospital diets for
certain medical complaints which have been sterilised by this technology are
excluded from the scope of the directive .
Article 2 provides        that foods  irradiated correctly under the conditions
specified in the Directive must be able to circulate throughout the Community .
Article 3 provides the foodstuffs and radiation sources ,        that might be used
for this technique .
Article 4 prohibits reirradiation of food .
Article 5 provides details of the          indications which must appear on the
packets / containers of foods that have been irradiated .
For products not for sale to the final consumer provision has been made for
the optional use of the logo described in Annex III in conjunction with the
statement that food has been irradiated .       The use of the logo without further
explanation could be misleading because in Europe information on its meaning
has not yet been fully disseminated .      The use of the logo could be reexamined
when experience has determined if its application at Community level without a
written statement would be beneficial .
Articles 6,     7 and 8 contain provisions for the approval of installations by
the designated authority in Member States ,       and the publication of a list of
approved units in the Official Journal of the Community ( Article 6 ). Approved
installations are obliged to keep records for a period of five years
( Article 7).        Third country installations are required to comply with
comparable criteria that can be subject to official supervision in such
countries if necessary by the Community ( Article 8 ).
Article 9 introduces the concept that packaging materials shall be appropriate
Tor the purpose .         This subject will be developed in the context of the
Community rules on packaging materials .
Articles 10,     11 , 12 describe simplified procedures by which the Directive may
bi modified to take account of technical progress by the Commission after
consulting the Member States and ,     where appropriate , the Scientific Committee
    C0M(88)351 final : Proposal for a Council Decision to adopt a multi-annual
    Research and Development Programme in Food Science and Technology
    ( 1989-1993 ).
 ---pagebreak---                                        - 6 -
for Food .   The Advisory Committee procedure is proposed by the Commission in
line with the declaration on the powers of implementation of the Commission
annexed to the Single European Act .
Article 13 is a standard inclusion in Directives .      The provisions describe a
machinery for rapid action by the Community should new information , or a
reassessment of existing information give rise to fears that the provisions of
the agreed text are not sufficiently protecting consumers against potential
health risks .
Annex I contains the list of authorized foodstuffs .
Annex II lists the sources of ionizing radiation .
Annex III describes the logo referred to in Article 5 .
Annex IV relates to the technical methodology of calculating the overall
average absorbed dose .
Annex V describes the criteria by which the suitability of the process for
particular food items will be assessed .
OPINION OF THE ADVISORY COMMITTEE FOR FOODSTUFFS
The Advisory Committee for Foodstuffs discussed the matter at its meeting on
the 26th of May 1987 .     Despite the diverging views even within the economic
groups , and consumers , represented in the Committee , with the exception of the
representative of the Workers , there was a net majority of the Committee and
its groups to endorse the principle , that a Directive adopted by the Community
would clarify the legal situation .     The Committee broadly supported contents
of the text presented to it .    However , there were several comments about the
desirability of restricting the process to specific foods .      Some groups felt
that a list was unnecessary and that a maximum of 10 kGy in food was adequate .
On the other hand many speakers regretted the absence of methods of detection
and some went so far as to reject , in principle , a Directive that could not be
enforced by usual enforcement methods and which for its application had to
rely on inspection and accreditation of installations .
ARTICLE 100A
The Commission has studied the question of the high level of health , safety
and consumer protection required by the terms of Article 100A , paragraph 3 .
It has done so after seeking the advice of the Scientific Committee for Food .
It has also consulted the industrial and social partners concerned, in the
light of an analysis of the risks inherent in this area and of the current
technical capabilities of European industry .    The proposal takes full account
of these considerations in the light of the overall objectives of this
provision of the Treaty .
 ---pagebreak---                                              - 7 -
                                    Proposai for a
                                  COUNCIL DIRECTIVE
  on the approximation of the laws of the Member States concerning foods
               and food ingredients treated with ionizing radiation
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 December
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 ;
                                                    4
Whereas Council        Directive 80 / 836 / Euratom ,    as amended by Directive
84 / 467 / Euratom ,    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 FA0 / WH0 Code of
Practice on the operation of irradiation facilities used for the
1
2
3
40J No L 246, 17.9.1980, p . 1 .
50J No L 265, 5.10.1984, p.p . 44 ..
 ---pagebreak---                                      - 8 -
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^, as last amended by Directive      /
/ EEC , on the approximation 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 ;
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 :
60J No L 33, 8.2.1979, p. 1
70J No L
 ---pagebreak---                                        _ 9 -
                                   Artide 1
1 . This Directive applies to the processing and marketing of foods and
    food ingredients, hereinafter called " foodstuff s ", 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.
                                   Artide 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 :
 ---pagebreak---                                              - 10 -
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 ;
    Cb) 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 ;
    ( 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-ir radiated foodstuff contains ingredients 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    FA0 / WH0    Codex   Alimentarius   Commission      Recommended
    International Code          of Practice    for the operation of       irradiation
    facilities used for the treatment of foods ( ref .          FA0 / WH0 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 .
 ---pagebreak---                                     Article ?
1 . Irradiation units approved in asc-ordtttcs viih tht previsions cf
    Article 6 must, for each source of ioitiziii>j i ;H?icVf i«;n used , keep a
    record showing for each lot of foodstuff
    ( a ) the nature and quantity cf foodstuffs irr'ri>>t«?d;
    ( b) the let number ;
    ( c ) the consignée ;
    Cd ) the date of irradiation ;
    ( e ) the type of packaging used during treatment ;
    Cf ) 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 ;
    Ch ) 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 5 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 .
 ---pagebreak---                                         12 -
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 .
                                  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 information 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 temporarily
    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 .
 ---pagebreak---                                        - 13 -
3 . If the Commission considers that      amendments to this Directive are
    necessary in order to resolve          the difficulties 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 1 *
   Member States shall amend their laws ,     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 .
   Done at                                    For the Council ,
                                               The President
 ---pagebreak---                                                          Annex I
      Foodstuffs authorized for irradiation treatment and
                      maximum radiation doses
  FOODSTUFFS                MAXIMUM OVERALL AVERAGE RADIATION DOSE
                                                 ( kGy )
  1 . Strawberries , papayas , mangoes                     2
  2 . Dried fruits                                         1
  3 . Puises ( 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 . Frog legs                                             5
1 1 . Arabie gum                                          10
 ---pagebreak---                                                              ANNEX II
                        Sources of ionizing radiation
   Foodstuffs may be treated only by the following sources of ionizing
   radiation :
a ) Gamma rays from radionuclides ^Co or ^^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 .
 ---pagebreak---                                ■il,
                                                    Annex III
Logo for foodstuffs not intended for the ultimate consumer
              treated with ionizing radiation
 ---pagebreak---                                                                     Annex IV
1.     DOSIMETRY
The over all 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 = – J* 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
         overall average dose       Dmax + Dmin
 The ratio of Dmax should not exceed 3 .
                 Dmin
 * £ = integrate .
 ---pagebreak---                                        AS
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. 3-5 ) 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 mimimum 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 .
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 accelator facilities , the parameters include product
       transport speed and the energy level , electron current and scanner
       width of the facility .
 ---pagebreak---                                                               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
   organ i sms ;
- 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
   sprout i ng ;
- to disinfect foodstuffs of organisms harmful to plant or plant products .