CELEX: 51987PC0281
Language: en
Date: 1987-06-16
Title: PROPOSAL FOR A COUNCIL REGULATION ( EURATOM ) LAYING DOWN MAXIMUM PERMITTED RADIOACTIVITY LEVELS FOR FOODSTUFFS, FEEDINGSTUFFS AND DRINKING WATER IN THE CASE OF ABNORMAL LEVELS OF RADIOACTIVITY OR OF A NUCLEAR ACCIDENT

No C 174/6                                Official Journal of the European Communities                                    2.7. 87
                                                                 II
                                                         (Preparatory Acts)
                                                   COMMISSION
              Proposal for a Council Regulation laying down maximum permitted radioactivity levels for
              foodstuffs, feedingstuffs and drinking water in the case of abnormal levels of radioactivity or of
                                                        a nuclear accident
                                                        COM(87) 281 final
                                  (Submitted by the Commission to the Council on 16 June 1987)
                                                          (87/C 174/09)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                             common arrangements which safeguard the health of the
                                                                     population while maintaining the unified nature of the
Having regard to the Treaty establishing the European                market and preventing deflections of trade;
Atomic Energy Community, and in particular Article 31
thereof,
                                                                     Whereas the need arises to set up a more permanent
Having regard to the proposal from the Commission,                   system allowing the Community, in cases of nuclear
drawn up after obtaining the opinion of a group of                   accidents or other events leading to a significant radio-
experts appointed by the Scientific and Technical                    active contamination of foodstuffs, feedingstuffs or
Committee,                                                           drinking water, to fix maximum permitted levels of radio-
                                                                     active contamination in order to protect the population;
Having regard to the opinion of the European Par-
liament,
Having regard to the opinion of the Economic and                     Whereas the Commission will be informed of a nuclear
Social Committee,                                                    accident or of unusually high levels of radioactivity
                                                                     according to the Council Decision on a Community
Whereas Article 2(b) of the Treaty requires that the                 system of rapid exchange of information in cases of
Community establish uniform safety standards to protect              abnormal levels of radioactivity or of a nuclear accident
the health of workers and of the general public and                  or under the Convention on Early Notification of a
ensure that they are applied, as further set out in Title            Nuclear Accident of 26 September 1986;
Two, Chapter III of the Treaty;
Whereas, on 2 February 1959, the Council adopted                     Whereas the Commission will, if the circumstances so
Directives (*) laying down basic safety standards, the text          require, adopt a Regulation rendering applicable pre-
of which was replaced by that of Council Directive                   established maximum permitted levels;
80/836/Euratom (2), as amended by Directive 84/467/
Euratom (3), and whereas Article 45 of that Directive
requires Member States to stipulate intervention levels in           Whereas, on the basis of current data available in the
the event of accidents;                                              field of radiation protection, derived reference levels can
                                                                     be established and serve as a basis for the fixing of
Whereas, following the accident at the Chernobyl                     maximum permitted radioactivity levels which can be
nuclear power-station on 26 April 1986, considerable                 applied immediately in the case of such an accident or
quantities of radioactive materials were released into the           other event resulting in significant radioactive contami-
atmosphere, contaminating foodstuffs and feedingstuffs               nation of foodstuffs, feedingstuffs or drinking water;
in several European countries to levels significant from
the health point of view;
                                                                     Whereas such maximum permitted levels have been
Whereas, the Community adopted provisional measures,                 established following an international scientific seminar
and in particular Council Regulation (EEC) No 1707/                  on foodstuff intervention levels after a nuclear accident
86 (4), to ensure that certain agricultural products are             which was organized by the Commission in Luxembourg
only introduced into the Community according to                      on 27 to 30 April 1987;
0)  OJ No  11, 20. 2. 1959, p. 221/59.
O   OJ No  L 246, 17. 9. 1980, p. 1.                                 Whereas these levels take due account of the latest
C)  OJ No  L 265, 5. 10. 1984, p. 4.                                 scientific advice as presently available on an international
(') OJ No  L 146, 31. 5. 1986, p. 88.                                scale whilst reflecting the need for reassuring the public
 ---pagebreak---  2. 7. 87                              Official Journal of the European Communities                              No C 174/7
 and avoiding divergence in international        regulatory        applicable the maximum permitted levels laid down in
 practice;                                                         Annex 1.
Whereas, however, it is necessary to take due account of           2.    The period of validity of any Regulation as referred
 the particular conditions applying and, therefore, to             to in paragraph 1 shall not exceed three months.
 establish a procedure allowing the rapid adaptation of
 these pre-established levels to maximum permitted levels
 appropriate to the circumstances of any particular                                         Article 3
 nuclear accident or other event leading to a significant          1.    The Commission shall immediately upon adopting
radioactive contamination of foodstuffs, feedingstuffs or          a Regulation in accordance with Article 2 obtain the
drinking water;                                                    opinion of the group of experts referred to in Article 31
                                                                   of the Treaty (hereinafter called 'the group of experts')
Whereas the adoption of a Regulation fixing maximum                on any subsequent Regulation required in the circum-
permitted levels would also preserve the unity of the              stances.
common market, prevent deflections of trade within the
Community and preclude any national prohibitions or                2.    When seeking the opinion of the group of experts,
restrictions within the meaning of Article 36 of the EEC          the Commission may set a time limit within which such
Treaty;                                                            opinion shall be given. No vote shall be taken. However,
                                                                   any member of the group of experts may demand that
Whereas, in order to facilitate the adaptation of                 his or her views be set down in the minutes.
maximum permitted levels, procedures should be
provided for allowing on the one hand the consultation                                      Article 4
of the group of experts referred to in Article 31 of the
Treaty and establishing, on the other hand, close                  1.    If the circumstances so require, the Commission
cooperation      between    Member     States    and    the       shall submit to an ad hoc committee for the radioactive
Commission within a management committee;                         contamination of foodstuffs (hereinafter called 'the
                                                                  committee'), a draft Regulation replacing the Regulation
Whereas compliance with the maximum permitted levels              referred to in Article 2 (1) within one month after its
will have to be the subject of appropriate checks;                adoption. The committee shall consist of representatives
                                                                  of the Member States with a representative of the
                                                                  Commission as chairman.
Whereas, in order to supplement, clarify or adjust, as
necessary, the measures provided for by this Regulation,
a simplified procedure should be established,                     2.     The Commission shall, when submitting the draft
                                                                  Regulation referred to in paragraph 1, take into account
                                                                  the basic standards laid down in accordance with Articles
HAS ADOPTED THIS REGULATION:                                      30 and 31 of the Treaty and in particular shall apply the
                                                                  principle that all exposures shall be kept as low as
                                                                  reasonably achievable taking economic and social factors
                          Article 1                               into account.
1.     This Regulation lays down the procedure for
determining the maximum permitted levels of radioactive           3.     The Committee shall deliver its opinion on the
contamination of drinking water, of foodstuffs and of             draft within a time limit which the chairman may lay
feedingstuffs which may be placed on the market or                down according to the urgency of the matter. The
exported following a nuclear accident or any other event          opinion shall be delivered by the majority laid down in
which could lead or has led to significant radioactive            Article 118 (2) of the Treaty in the case of decisions
contamination of foodstuffs, feedingstuffs or drinking            which the Council is required to adopt on a proposal
water.                                                            from the Commission. The votes of the representatives of
                                                                  the Member States within the committee shall be
2.     Foodstuffs within the meaning of this Regulation           weighted in the manner set out in that Article. The
are products which are fit for human consumption either           chairman shall not vote.
immediately or after processing. Feedingstuffs are
products which are fit only for animal nutrition.                 4.     The Commission shall adopt the Regulation which
                                                                  shall apply immediately. However, if the Regulation is
                                                                  not in accordance with the opinion of the committee, it
                          Article 2                               shall forthwith be communicated by the Commission to
1.     Where a nuclear accident or any other event is             the Council. In that event the Commission may defer
notified to the Commission according to the procedure             application of the Regulation which it has decided upon
envisaged by Council Decision N o . . . of . . . (rapid           for not more than 15 days from the date of such
information) or under the Convention on Early                     communication.
Notification of a Nuclear Accident of 26 September
1986, the Commission shall immediately, if the circum-            5.    The Council, acting by a qualified majority, may
stances so require, adopt a Regulation rendering                  take a different decision within 15 days.
 ---pagebreak--- N o C 174/8                                     Official Journal of the European Communities                                               2.7.87
                              Article 5                                           feedingstuffs coming from third countries shall be
                                                                                  considered to be placed on the market when they are, on
The period of validity of any Regulation as referred to in                        the customs territory of the Community, the subject of a
Article 4 shall be limited. It may be revised at the request                      customs procedure other than a transit procedure.
of a Member State or on the initiative of the
Commission in accordance with the procedure laid down                              2.    Each Member State shall provide the Commission
in Articles 3 and 4.                                                              with all information concerning the application of this
                                                                                   Regulation, in particular concerning cases of non-
                              Article 6                                            compliance with the maximum permitted levels. The
1.    In order to ensure that the maximum permitted                                Commission shall communicate such information to the
levels laid down in Annex I take account of any new                                other Member States.
scientific data becoming available, the Commission shall,
from time to time, seek the opinion of the group of                                                               Article 8
experts.
                                                                                   Detailed rules for applying this Regulation and any
2.    At the request of a Member State or the                                      amendments to be made to the list of minor foodstuffs
Commission, the maximum permitted levels laid down in                              contained in Annex II shall be adopted in accordance
Annex I may be revised or supplemented, in accordance                             with the procedure laid down in Article 4.
with the procedure laid down in Article 31 of the Treaty.
                                                                                                                  Article 9
                              Article 7
                                                                                   This Regulation shall enter into force on the third day
1.    Foodstuffs or feedingstuffs not in compliance with                           following its publication in the Official Journal of the
the maximum permitted levels laid down in any Regu-                                European Communities.
lation adopted in accordance with Articles 2 or 4 shall
not be placed on the market or exported. For the                                   This Regulation shall be binding in its entirety and
purposes of applying this Regulation foodstuffs or                                 directly-applicable in all Member States.
      1/
                                                                        ANNEX I
              MAXIMUM PERMITTED LEVELS FOR FOODSTUFFS, FEEDINGSTUFFS AND DRINKING
                                                                         WATER
                                                                    (Bq/kg or Bq/1)
                                                                 Dairy           Other foodstuffs Drinking water and
                                                             produce (')          except minor    liquid foodstuffs (3)   Feedingstuffs
                                                                                  foodstuffs (2)
              Isotopes of iodine and strontium,
              notably 1-131, Sr-90                                500                 3 000               400                -o
              Alpha-emitting isotopes of plu-
              tonium and transplutonium el-
              ements, notably Pu-239, Am-241                        20                   80                 10               —(4)
              All other nuclides of half-life
              greater than 10 days, notably
              Cs-134, Cs-137                                     1000                 1250                800                2 500
              O Dairy produce is defined as milk falling within heading Nos 04.01 and 04.02 of the Common Customs Tariff and
                  those foodstuffs intended for the special feeding of infants during the first four to six months of life, which meet, in
                  themselves, the nutritional requirements of this category of person and are put up for retail sale in packages which are
                  clearly identified and labelled 'food preparation for infants'.
              (') Minor foodstuffs are those foodstuffs listed in Annex II. For these a level of contamination ten times that quoted in
                  this column may be allowed.
              (3) Liquid foodstuffs as defined by Chapter 20 and 22 of the Common Customs Tariff.
              (') No value for immediate application.
 ---pagebreak--- 2. 7. 87                  Official Journal of the European Communities                                    N o C 174/9
                                               ANNEX II
                                       MINOR FOODSTUFFS
           CCT
          heading                                       Description
            No
           07.01   Vegetables, fresh or chilled:
                   O. Capers
           07.03   Vegetables provisionally preserved in brine, in sulphur water or in other preservative
                   solutions but not specially prepared for immediate consumption:
                   B. Capers
         Chapter 9 Coffee, tea, mate and spices
 ---pagebreak--- No C 174/10                              Official Journal of the European Communities                                       2.7.87
           DERIVED REFERENCE LEVELS AS A BASIS FOR THE CONTROL OF FOODSTUFFS
                                              FOLLOWING A NUCLEAR ACCIDENT
           A RECOMMENDATION FROM THE GROUP OF EXPERTS SET UP PURSUANT TO ARTICLE
                                                  31 OF THE EURATOM TREATY
           Introduction
           The previous recommendation of the group of experts, dated 4 September 1986, has been reviewed and
           revised by the group in the light of the Commission's international scientific seminar on foodstuffs
           intervention levels following a nuclear accident held in Luxembourg from 27 to 30 April 1987; the revised
           recommendations are set out below.
           Basic policy
           The radiological control of foodstuffs following an accidental release of radioactive material to the
           environment poses two very different sets of problems. The first, and most urgent, concerns the use of food
           produced, and sometimes consumed, in the area near the accident. Decisions are needed within a day or
           two of the release so that the affected area can be defined and alternative food supplies provided. The
           second set of problems relates to the long-term widespread distribution of food from the local area and
           also from larger, more widely dispersed areas where immediate control is not necessary but where
           measurable contamination exists. In the context of the Community, the emphasis is on this second set of
           problems and on the movement of food between Member States and between the Community and other
           countries.
           On the conventional and prudent assumption that any radiation dose to man causes some increase in the
           risk of long-term consequences, the consumption of food contaminated at any level implies some risk.
          There is thus no way in which decisions about the control of food can be taken solely on consideration of
           risks to health. Although any decision by the competent authorities must be based on a balance between the
           magnitude of these risks and the costs in money resources, and social disruption of any protective action, it
           is fundamental to maintain public confidence in the overall system of radiological protection under which
           the public is legitimately exposed to radiation as a result of the widespread beneficial uses of radiation and
           radioactive materials. This confidence can be strengthened if the reaction to an accident is seen to be
           appropriate.
           Reference levels (RL)
           It is not appropriate to set limits in dealing with emergency situations because an emergency is rarely, if
           ever, susceptible to rigid limitation. It is, however, very useful to establish reference levels which are based
          upon and respect the principles of the basic safety standards and below which action is likely to be inap-
          propriate and above which that intervention ought to be taken, or at least seriously considered. The
          reference level must be related to the severity and complexity at the intervention action — simple actions,
          with few social consequences, are appropriate at low levels of radiation exposure; complex actions require
           high levels of exposure before they can be justified. In this report, the group of experts has considered
           those actions needed to control the distribution and importation of foodstuffs in the Community. This type
           of action is complex and has considerable social and economic implications and needs a significant level of
           exposure for justification.
           In principle, the selected RLs should relate to the lifetime dose likely to be accumulated from the continued
           consumption of a single foodstuff. Only then can the benefit of the reduction in dose achieved by control
           of that foodstuff be compared with the costs and detriments of the control action. At the levels of dose
           likely to be encountered and at the scale of the necessary intervention, which is not likely to cause serious
           food shortages at the national or Community level, it is correct to treat each foodstuff as independent of
           all others.
          In practice, however, there are very many foodstuffs potentially involved and it is desirable to make simple
          and comprehensible rules for deciding on intervention. The group of experts has therefore chosen to
          recommend reference levels of dose for the major components of diet and to choose the corresponding
          derived levels in foodstuffs with some conservatism, so that it is unlikely that the reference level of dose
          will be exceeded by any likely combination of contamination in different foodstuffs at different times after
 ---pagebreak--- 2.7.87                               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 174/11
       an accident. This procedure is more restrictive than that recommended by the International Commission on
       Radiological Protection but less restrictive than that of taking total diet as a single basis for decisions. The
       group has also chosen to use the dose in a year as the basis for reference levels because the dose in the first
       year is larger than the dose accumulated in any single subsequent year.
       The recommendations apply to the situation resulting from an accident irrespective of any pre-existing
       sources of exposure, including any previous accidents. The reference levels can thus be the same for all
       accidents. On that basis, the group of experts recommends the adoption of two reference levels of dose as
       indicated in reference 1 — a lower RL below which action is extremely unlikely to be justified on radio-
       logical protection grounds and an upper RL at which action is almost certain to have been attempted on
       radiological protection grounds.
       For the first year after an accident, the group of experts recommends a lower RL for the committed
       effective dose equivalent to the age of 70 years resulting from the consumption of foodstuffs of 5 mSv. The
       upper RL should be 50 mSv. For the special case of iodine isotopes which deliver almost all their dose to
       the thyroid, an additional lower RL of 50 mSv to the thyroid is recommended, with a corresponding upper
       RL of 500 mSv (reference 2). In all cases, the figures relate to the committed dose resulting from intake of
       food over the year in question. For subsequent years, the levels of contamination will be lower and there
       will have been time to organize effective and economic means of control should these still be necessary.
       Derived reference levels (DRL)
       The practical control of foodstuffs must depend on the measurement or prediction of the concentration of
       radioactive materials in the food; it cannot be achieved by direct estimation of the dose to the consumers.
       It is therefore necessary to derive practical values of concentration from the RLs of dose. The values used
       in the vicinity of an accident for controlling the situation in the first few weeks after an accident have been
       called derived emergency reference levels (DERL). For the long-term control of the trade in foodstuffs the
       term derived reference level (DRL) has been used in this report. It is not in any sense a limit. However, the
       problems of interfering legitimately with international trade may make it necessary to incorporate the
       reference levels into Community regulations. An initial examination of the techniques of optimization of
       protection, formulated by a working group of the W H O and presented at the Luxembourg seminar, shows
       that the levels recommended by the group of experts of Article 31 are close to those reached by the process
       of optimization. The levels recommended are thus sufficient in their own right and no further reduction is
       necessary.
       The estimation of DRLs in foodstuffs poses substantial problems because the different routes by which
       different nuclides reach the food, combined with the different distribution systems for different foodstuffs
       and the differences in diet with age and location, lead to very complex links between the activity in a single
       foodstuff and the total dose to an individual resulting from the consumption of food. If it is intended to
       limit the total dose from all foodstuffs, each foodstuff should have a different DRL for each nuclide and a
       calculation should be carried out on each occasion and for each location, depending on the activity level in
       all the relevant foodstuffs for all the relevant nuclides. This may well be possible in the immediate area of
       an accident where the situation can be closely defined, but it is not feasible as a basis for action at
       Community level.
       The group of experts has therefore established proposals for the major components of diet for three classes
       of radionuclides. The values are shown in the Table. They have been established on the basis of typical
       patterns of diet in the Community. The contamination of foodstuffs after an accident will vary with time
       and with location and it is unrealistic to assume that an individual might consume food all of which is
       contaminated at the DRL for a whole year. The group has assumed, therefore, that, over a whole year, the
       intake would amount to no more than 10 % of that given by continuous consumption of a foodstuff at the
       peak value at any time and any location. Data presented at the Luxembourg seminar and wider consul-
       tations have convinced the group that the 10 % value is appropriate and this value was included in the
       computation of derived reference levels.
 ---pagebreak--- No C 174/12                                Official Journal of the European Communities                                   2.7.87
           However, this value is no longer regarded as conservative enough in all circumstances to cover the addition
           of doses from all foodstuff groups considered. To take account of this, a reduction factor of 5 has been
           applied to each of the values calculated for the individual foodstuffs making up the groups now described
           as milk products, other major foodstuffs (comprising cereals, fruit and vegetables, meat) and drinking
           water (including beverages). Because of the short half-lives of the relevant iodine isotopes there is no need
           to apply this factor for additivity to the values calculated for these nuclides. The figures for the strontium
           isotopes in the nuclide group 'iodine and strontium' do however contain the appropriate reduction factors.
           With regard to the addition of contributions from different radionuclides in the food chain, the following
           points have been taken into account:
           — each nuclide group has been assessed on the basis that the total activity of nuclides in the group is
               compared with the limiting value for the most radiotoxic relevant nuclide in that group applied to the
               most limiting age group,
           — reference levels for iodine isotopes are based on the dose to the thyroid; their contribution to the
               effective dose equivalent is therefore reduced,
           — it is unlikely that, in any accident, nuclides from the three groups will be present together in significant
               amounts in the food chain.
           For these reasons the group concludes that adequate allowance has been made for additivity of the contri-
           bution from different radionuclides both within and between nuclide groups.
           The tablulated values have thus been established on the basis that each food group and each group of
           nuclides can be treated quite separately from all the others; adequate allowance has already been made for
           the existence of several contaminated foodstuffs or of nuclides in more than one group.
           The levels apply to the foodstuffs as ready for consumption. In practice, controls are likely to be exercised
           at an earlier stage, e. g. in the processing and marketing of primary produce. No account has been taken of
           the reduction in activity which is due to food processing and preparation.
                                                                 TABLE
           DERIVED REFERENCE LEVELS (*) AS THE BASIS FOR THE CONTROL OF FOODSTUFFS
                                                    FOLLOWING AN ACCIDENT
                                                                 (Bq/kg)
                                                    Isotopes of iodine and strontium (2)
                                                          Notably 1-131, Sr-90
                  Milk products (J)                     Other major foodstuffs (4)                     Drinking water
                         500                                      3 000/                                     400
                                 Alpha-emitting isotopes ofplutonium and transplutonium elements (2)
                                                        Notably Pu-239, Am-241
                  Milk products (5)                     Other major foodstuffs (4)                     Drinking water
                          20                                        80                                       10
                                          All other nuclides of half-life greater than 10 days (2) (5)
                                                         Notably Cs-134, Cs-137
                  Milk products (J)                     Other major foodstuffs (4)                     Drinking water
                        4 000                                     5 000                                      800
 ---pagebreak--- ^Bm^                                          C^ffici^journ^ofL^Euroo^nC^Omrnuniu^                                                ^ooet^B^
     (^ These derived reference levels are intended for general application; they are based on the lower RL discussed in the
        te^t,namely,acommitted effective equivalent of^m^vinayearandacommitted dose equivalent to the thyroid of ^0
        m^vinayear.Values based on the higher RL would be lOtimes greater.
     (a within each group of nuclides the values relate to the total activity of all the nuclides in the group.^ach group can
        then be treated as completely independent of the other groups.
     (^ milk products include fresh milk and reconstituted milk drinks or foods prepared from dried milk preparations. Cheese
        should be considered as one of the mother ma^or foodstuffs^.
     (a Forminorfoodstuffs,e.g.thosewithanannualconsumptionof less than about 10kg,values of 10 times those for
        ma^or foodstuffs will be appropriate.lt is not to be expected that restrictions will be needed on items such as spices and
        condiments.
     (^ Carbonic and tritium are not included in this group because of their low contribution to the doses for any forseeable
        accident.
     t. Commission of the ^urooean Communities. Radiological orotection criteria for controlling doses to the
        o u b l i c i n t h e e y e n t o f accidental releases of radioactiyematerial.VB^2^0B^2r^l^.Commissionof the
        r^urooean Communities, Luxembourg, 1^2.
     2. MternationalCommissionon Radiological Protection. Publication^O. Protectionof t h e P u b l i c i n t h e
        r^yent of ^a^or Radiation Accidents^ Principles for Planning, annals of t h e I C R P , V o l u m e t 4 ^ C o 2,
        1^4