Table I. Foods, radiation sources, the purpose for radiation and their overall doses.

ANNEX

Proposed Format of New Division toControl Food Irradiation

Division 27

ceeds the 10 kGy value. It should alsobe emphasized that no radioactivitywhatsoever is imparted to a food pro­duct that is irradiated with the sourcesof ionizing radiation mentioned in thedraft regulations.

A.B. Morrison, Ph.D.,Assistant Deputy Minister

0.15 kGy

0.75 kGy

0.15 kGy

Column IVMaximum Overall Average

Absorbed Dose

c) information on the nature of thedosimeter, frequency of the dOSi­metry on the product, and data per­taining to the dosimetry and phan­toms used with a view to assuringthat the dosimetry readings ade­quately reflect the dose absorbed bythe food during exposure;

d) data which would indicate the ef­fects, if any, on the nutritional qucili.ty of the food under the irradiationconditions proposed;

e) data establishing that the irradiatedfood has not been significantly al·tered in chemical or physical char­acteristics to render the material un·fit for human consumption;

f) the recommended conditions ofstorage and/or shipment (time,temperature, packaging, etc.) of thefood subjected to the irradiation pro­cess when compared with a similarfood not irradiated;

g) in the case of an individual food itemproposed to be irradiated above a 10kGy overall average absorbed dose,detailed reports of tests made toestablish the safety of the food underthe conditions of such treatments;and

h) such other data as the Director mayrequire.

B.27.005. (1) A manufacturer whosells a food treated with ionizing radia­tion shall keep on the premises for atleast two years from the time of irradia­tion a record of:a) the food treated;b) the purpose of the treatment;c) the date of the treatment, quantity

treated, and lot numbers of thetreated food;

d) the dose absorbed by the food;e) the type of ionizing radiation source;

andf) an indication whether or not the

product has been irradiated pre­viously and if so, details of suchtreatment.

(2) Any person who imports a foodto be offered for sale in Canada whichhas been treated by ionizing radiationshall keep on his premises a record ofthe information required under Subsec-

Column IIIPurpose ofIrradiationTo inhibitsproutingduring storageTo inhibitsproutingduring storageTo control insectinfestation instored product

Cobalt-60

Cobalt-60

Cobalt-60

Column IIPermitted Sources

of RadiationColumn I

FoodPotatoes(Solanum

tuberosum L.)Onions

(Allium cepa)

Wheat, flour,Whole wheat flour

(Triticum s.p.)

Food IrradiationB.27.001. In this Division, the term

"ionizing radiation" shall refer to radia­tion from the following sources:a) gamma-radiation from a Cobalt-60 or

Cesium-137 source;b) X-rays generated from machine

sources operated at or below anenergy level of 5 MeV: and

c) electrons generated from machinesources operated at or below anenergy level of 10 MeV.

B.27.002. No person shall sell a foodwhich has been subjected to any treat­ment with ionizing radiation, except asprescribed by these regulations.

B.27.003. These regulations do notapply to foods exposed to radiationdoses imparted by measuring in­struments used for purposes of weightdetermination, bulk solids estimation,measurement of total solids in liquidsand other such inspection procedures.

B.27.004. A request that a food beadded to or a change made in the Tableto this Division shall be accompanied bya submission to the Director in a form,manner, and content satisfactory to himand shall include:a) information on the isotopes to be us­

ed, the dosages to be used, the fre­quency of dosage, and the purposefor which the radiation is proposed;

b) experimental data indicating that theradiation dose proposed accom­plishes the intended technical effectand does not exceed the amountreasonably required to accomplishthis technical effect;

RegulatoryProposed Revised Regulations forthe Control of Food IrradiationIn Canada, irradiation of food ispresently regulated under the Food Ad­ditive Tables of Division 16, Food andDrug Regulations. Provision existsunder Table VIII for the use of "gam­ma radiation from Cobalt-60 source" in(1) potatoes and onions as an an­tisprouting agent, the level of use notto exceed 15 000 rads (i.e., 0.15 kGy),and (2) wheat, flour and whole wheatflour for deinfestation purposes, thelevel of use not to exceed 75 000 rads(i.e., 0.75 kGy).

Currently, there is renewed interna­tional interest in this process as outlinedin the recommendations of the 1981Report of the Joint FAO/IAEA/WHO*Expert Committee(l). In addition, as amember of the Codex AlimentariusCommission, Canada has an obligationto consider, with a view to adoption, in­ternational recommendations dealingwith irradiation of food(Z) Therefore,the existing regulatory mechanism forcontrolling food irradiation was re­examined with a view towards assess­ing its adequacy in terms of consumerprotection and harmonization with in­ternational standards. As a result, it isproposed that food irradiation nolonger be controlled under the food ad­ditive provisions in Division 16 of theFood and Drug Regulations. Rather, it isproposed to control irradiation as a foodprocess in new regulations. This changewould also facilitate submissionsrespecting new uses of irradiation forthe purposes of increasing the quality,safety and shelf-life of foods.

The Health Protection Branch intendsto recommend to the Minister that anew Division entitled Food Irradiationbe established under Part B of the Foodand Drug Regulations. This new Divi­sion, tentatively designated as Division27, will contain revised regulatory re­quirements appropriate to the use ofradiation in the treatment of foods. Theproposed new Regulations appear as anAnnex to this letter.

Of particular note is the fact that theJoint FAO/IAEA/WHO Expert Commit­tee stated that toxicological testing offoods irradiated below 10 kGy is nolonger required. All studies carried outto date on a large number of individualfoods have produced no evidence ofadverse effects as a result of irradiationbelow this dosage level. Based on theseconsiderations, the Health ProtectionBranch proposes that the requirementfor tests to establish safety of irradiatedfoods will thus be necessary only whenthe overall average absorbed dose ex-

x / Affaires de l'Institut J. Inst. Can. Sci. Technal. Aliment. Vol. 17, No. I, 1984

Table I. Foods, radiation sources, the purpose for radiation and their overall doses.

ANNEX

Proposed Format of New Division toControl Food Irradiation

Division 27

ceeds the 10 kGy value. It should alsobe emphasized that no radioactivitywhatsoever is imparted to a food pro­duct that is irradiated with the sourcesof ionizing radiation mentioned in thedraft regulations.

A.B. Morrison, Ph.D.,Assistant Deputy Minister

0.15 kGy

0.75 kGy

0.15 kGy

Column IVMaximum Overall Average

Absorbed Dose

c) information on the nature of thedosimeter, frequency of the dosi­metry on the product, and data per­taining to the dosimetry and phan­toms used with a view to assuringthat the dosimetry readings ade­quately reflect the dose absorbed bythe food during exposure;

d) data which would indicate the ef­fects, if any, on the nutritional quali­ty of the food under the irradiationconditions proposed;

e) data establishing that the irradiatedfood has not been significantly al­tered in chemical or physical char­acteristics to render the material un­fit for human consumption;

f) the recommended conditions ofstorage and/or shipment (time,temperature, packaging, etc.) of thefood subjected to the irradiation pro­cess when compared with a similarfood not irradiated;

g) in the case of an individual food itemproposed to be irradiated above a 10kGy overall average absorbed dose,detailed reports of tests made toestablish the safety of the food underthe conditions of such treatments;and

h) such other data as the Director mayrequire.

B.27.005. (1) A manufacturer whosells a food treated with ionizing radia­tion shall keep on the premises for atleast two years from the time of irradia­tion a record of:a) the food treated;b) the purpose of the treatment;c) the date of the treatment, quantity

treated, and lot numbers of thetreated food;

d) the dose absorbed by the food;e) the type of ionizing radiation source;

andf) an indication whether or not the

product has been irradiated pre­viously and if so, details of suchtreatment.

(2) Any person who imports a foodto be offered for sale in Canada whichhas been treated by ionizing radiationshall keep on his premises a record ofthe information required under Subsec-

Column IIIPurpose ofIrradiationTo inhibitsproutingduring storageTo inhibitsproutingduring storageTo control insectinfestation instored product

Cobalt·60

Cobalt·60

Cobalt·60

Column IIPermitted Sources

of RadiationColumn I

FoodPotatoes(Solanum

tuberosum L.)Onions

(Allium cepa)

Wheat, flour,Whole wheat flour

(Triticum s.p.)

Food IrradiationB.27.001. In this Division, the term

"ionizing radiation" shall refer to radia­tion from the following sources:a) gamma-radiation from a Cobalt-60 or

Cesium-137 source;b) X-rays generated from machine

sources operated at or below anenergy level of 5 MeV: and

c) electrons generated from machinesources operated at or below anenergy level of 10 MeV.

B.27.002. No person shall sell a foodwhich has been subjected to any treat­ment with ionizing radiation, except asprescribed by these regulations.

B.27.003. These regulations do notapply to foods exposed to radiationdoses imparted by measuring in­struments used for purposes of weightdetermination, bulk solids estimation,measurement of total solids in liquidsand other such inspection procedures.

B.27.004. A request that a food beadded to or a change made in the Tableto this Division shall be accompanied bya submission to the Director in a form,manner, and content satisfactory to himand shall include:a) information on the isotopes to be us­

ed, the dosages to be used, the fre­quency of dosage, and the purposefor which the radiation is proposed;

b) experimental data indicating that theradiation dose proposed accom­plishes the intended technical effectand does not exceed the amountreasonably required to accomplishthis technical effect;

RegulatoryProposed Revised Regulations forthe Control of Food IrradiationIn Canada, irradiation of food ispresently regulated under the Food Ad­ditive Tables of Division 16, Food andDrug Regulations. Provision existsunder Table VIII for the use of "gam­ma radiation from Cobalt-60 source" in(1) potatoes and onions as an an­tisprouting agent, the level of use notto exceed 15 000 rads (Le., 0.15 kGy),and (2) wheat, flour and whole wheatflour for deinfestation purposes, thelevel of use not to exceed 75 000 rads(i.e., 0.75 kGy).

Currently, there is renewed interna­tional interest in this process as outlinedin the recommendations of the 1981Report of the Joint FAO/IAEA/WHO*Expert Committee(l). In addition, as amember of the Codex AlimentariusCommission, Canada has an obligationto consider, with a view to adoption, in­ternational recommendations dealingwith irradiation of food(2) Therefore,the existing regulatory mechanism forcontrolling food irradiation was re­examined with a view towards assess­ing its adequacy in terms of consumerprotection and harmonization with in­ternational standards. As a result, it isproposed that food irradiation nolonger be controlled under the food ad­ditive provisions in Division 16 of theFood and Drug Regulations. Rather, it isproposed to control irradiation as a foodprocess in new regulations. This changewould also facilitate submissionsrespecting new uses of irradiation forthe purposes of increasing the quality,safety and shelf-life of foods.

The Health Protection Branch intendsto recommend to the Minister that anew Division entitled Food Irradiationbe established under Part B of the Foodand Drug Regulations. This new Divi­sion, tentatively designated as Division27, will contain revised regulatory re­quirements appropriate to the use ofradiation in the treatment of foods. Theproposed new Regulations appear as anAnnex to this letter.

Of particular note is the fact that theJoint FAO/IAEA/WHO Expert Commit­tee stated that toxicological testing offoods irradiated below 10 kGy is nolonger required. All studies carried outto date on a large number of individualfoods have produced no evidence ofadverse effects as a result of irradiationbelow this dosage level. Based on theseconsiderations, the Health ProtectionBranch proposes that the requirementfor tests to establish safety of irradiatedfoods will thus be necessary only whenthe overall average absorbed dose ex-

x / Affaires de l'Institut J. Inst. Can. Sci. Technal. Aliment. Vol. 17, No. I, 1984

tion (1), for at least two years from thedate of import.

B.27.006. Subject to the conditionsprescribed in Columns I, 11, and IV, thefoods named in Column I of the aboveTable may be irradiated:

Labelling of Irradiated FoodsRenewed international and industry

interests in utilizing ionizing radiationas a process in the treatment of foodsrequires that Canada review the presentlabelling requirements and where possi­ble align its position with the proposedinternational recommendations dealingwith the irradiation of foods. Since thelabelling of foods falls withinC.C.A.C.'s mandate, the purpose ofthis communique is to obtain input andguidance on a number of options thatcould be contemplated in establishingregulations for the labelling of irradiatedproducts.

In evaluating the options, considera­tion should be given to the widespreadbelief that consumers will be reluctantto accept foods treated by the ionizingradiation process due to the misconcep­tion that these produc~s may retainsome of the radiation and presenthealth hazards. Every effort should bemade to avoid negative or alarmingdescriptions and to explain and identifythe benefits and advantages of thisprocess.

It has been suggested by the Interna­tional Atomic Energy Agency and theCodex Alimentarius Committee onFood Additives that food irradiationshould be considered as a process andnot as an additive, and that the label­ling of foods treated with ionizing radia­tion may not be essential from a scien­tific point of view. These two groupsfurther suggested that it should not bea requisite to state, on the label of foodsprepared from irradiated ingredients,that the foods were made with ingre­dients which had been irradiated.

Canada's position, as presented at thelast meeting of the Codex AlimentariusCommittee on Food Labelling, sup­P?rted the view that irradiated ingre­dIents need not be identified as havingbeen irradiated on the label of the pro­duct in which they are used and re­served judgement as to the extent ormanner in which irradiated foods re­quire identification.

The Consumers' Association of Can­ada (C.A.C), at their 1982 annualmeeting, proposed that all foods and in­gre~ie.nts of foods treated with ionizing~adlabon be so designated on the labelIn a clearly recognizable manner. TheC.A.C. further proposed that an ap­propriate symbol be used, on the label,to identify any food which has been

Can. Inst. Food Sci. Technol. J. Vol. 17, No. 1, 1984

treated with ionizing radiation or whichcontains, as an ingredient, a product sotreated. The C.A.C. went on to proposethat such a symbol should appear inclose proximity to the name of the food,the name of the ingredient, or on aposter where unlabelled bulk foods aresold to consumers. Symbols arepresently in use in Australia, Belgium,Holland, Israel and South Africa.

Taking the above recommendation,the following labelling options for foodsor ingredients treated with 10 or lesskGy over-all average absorbed dose forthe purpose of maintaining the quali­ty, salubrity or shelf-life of the product,are submitted to you for evaluation:

Option 1a) that all foods treated with ionizing

radiation and all single-ingredientfoods which are prepared from a rawmaterial which has been treated withionizing radiation be described onthe principal display panel as"treated with ionizing energy";

b) that foods containing an ingredienttreated with ionizing radiation not berequired to indicate, in the list of in­gredients, that the ingredient hasbeen so treated or that the food con­tains an ingredient or ingredients sotreated, unless the total mass of suchingredients constitutes more than15% of the total mass of the product.

Option 2Same as option 1 except that thestatement "treated with ionizingenergy" be replaced on the label byan appropriate symbol such as thatsuggested by the C.A.C.

Example of the symbol, a greencolored design used in the above­mentioned countries is shown be­low.

Option 3Combination of options 1 and 2.Labels would carry both the state­ment and a symbol.

Option 4Multi-ingredient and single­ingredient foods or ingredientswhich have been subjected to ioniz­ing radiation would not carry, ontheir labels, any indication, symbolor treatment to the effect that theyhave been "treated with" ionizingradiation.

Although, in the above, foods and in­gredients treated by the irradiation pro­cess have been dealt with in a similarmanner for labelling purposes, con­sideration may be given to various com­binations of these options.

Respondents are being requested toprovide the rationale for their selection,

or proposal, of labelling options.Specific comments and suggestions

relative to the following issues are alsobeing solicited:a) the recommended type size and

positioning on the principal displaypanel of the information, if it isdeemed necessary;

b) the rationale for choosing any otheramount than the 15% content beingproposed as a criterion for identify­ing ingredients which have beensubjected to ionizing radiation;

c) whether or not bulk foods should belabelled with the same information.

Please note that responses to thiscommunique will be subject to the pro­visions of the Access to InformationAct. If you feel that the comments youare providing, in fact, constitute con­fidential information, please add a noteto this effect. Should a request for in­formation regarding the submissions bemade, you will then receive notice ofany intention to disclose these docu­ments and will have an opportunity toprovide reasons which could justifyrefusing disclosure.

Kathleen Francoeur HendricksAssistant Deputy Minister

Bureau of Consumer Affairs

Proposals for Regulatory Change(1) Rum

A national trade association, repre­senting Canadian distilling interests,has formally petitioned for an amend­ment to Section B.02.031 of the Foodand Drug Regulations, to reduce the ag­ing requirements of rum in small wood(maximum 150 gallon capacity) fromtwo years to one year. It is contendedthat such a reduction is supported byconsumer preference for "lightness" inrums in Canada, and that a one yearmaturation process will provide thedesired characteristics normally at­tributed to any type of rum. Additional­ly, it is claimed that such a change willstill provide for sufficient (longer)maturation periods for heavier or darkrums. Finally, a reduced aging time willlower the heavy investment and opera­tional costs related to the maturationprocess and will help eliminate costlyevaporation losses in warehouses dur­ing the aging process.

The questions to be addressed hereare first of all whether a one yearmaturation period is considered ade­quate for rum, and secondly, if so, whatwould be a suitable aging period for the"flavouring" component added pur­suant to regulations made under the Ex­cise Act.(2) Brandy

An independent Canadian distillerhas made the following requests of the

Institute Affairs / xi