Food Additives- The Canadian SituationFood Additives- The Canadian Situation

Presented to: Guelph Food Safety Seminar

May 11th, 2005

Guelph, Ontario

Presented by: Doug Morrison

Canadian Food Inspection Agency

(416) 973 - 4226

Email: “morrisondc@Inspection.gc.ca”

Food Safety Issues are sure keeping everyone busy!

Thanks for the invite!

Challenge Challenge (Today):(Today):

How much information to provide and explain to you within 45 minutes?

Chemicals and Foods

Ingredient [HC - optional review]

Processing Aid[HC - optional review]

Food Additive(FDR/ colours…)

Agricultural Chemicals[PMRA] - (Pest Control Product Act eg. alachlor, captan …)

Fertilizers[CFIA]

Vitamins &Minerals(FDR/ Vitamin A)

Veterinary Drugs(FDR/neomycin )

Contaminants(heavy metals, mycotoxins …)

Packaging Material(FDR/ Octylin, acrylonitrile …)

Chemical Risk EvaluationChemical Risk EvaluationAll Substances are Chemical in All Substances are Chemical in

NatureNatureCommon foods themselves are chemicalsNon intentional presence of a contaminant

is evaluated to be tolerated– heavy metals, mycotoxins, industrial contaminants ...

Intentional additions are evaluated to be safe before allowed for use– food additives, ag chemicals, packaging material

components ...

Chemicals NaturallyChemicals NaturallyEggsEggs

Ovalbumin Conlbumin Ovomucoid Mucin Globulins Amino Acids Lipovitellin Livetin Cholesterol

Lecithin Lipids (fats) Fatty Acids Butyric Acid Acetic Acid Sodium Chloride Lutein Zeaxanthine Vitamin A

Chemicals NaturallyChemicals NaturallyCoffeeCoffee

Acetone Methyl Acetate Furan Diacetyl Butanol Methylfuran Isoprene Methylbutanol

Caffeine Essential Oils Methanol Acetaldehyde Methyl Formate Ethanol Dimethyl Sulfide Propionaldehyde

Chemicals NaturallyChemicals NaturallyMelonMelon

Starches Sugars Cellulose Pectin Malic Acid Citric Acid Succinic Acid

Anisyl Propionate Amyl Acetate Ascorbic Acid Vitamin A Riboflavin Thiame

Chemicals NaturallyChemicals NaturallyAppleApple

Fructose Sucrose Glucose Pectin Hemicellulose Celluose Formic Acid Acetic Acid

Malic Acid Potassium Calcium Phosphorus Carotene Caprylic Ester Ascorbic Acid Acetaldehyde

Important TermsImportant Terms

Food:Food:

Any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever

Food Additives Food Additives Part B /Foods/ Division 1Part B /Foods/ Division 1

Any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but … (do not include)

Food Additives Food Additives do not include:do not include:

Nutritive food ingredients such as salt, sugar, starch, glucose, casein...

vitamins, minerals, amino acidsspices, seasonings, flavouring

preparationsagricultural chemicalsveterinary drugsfood packaging materials

Why? Covered separately by the FDR

Processing AidProcessing Aid(An Administrative Definition)(An Administrative Definition)

Understood to be a substance added during food processing and determined necessary to actually manufacture/ process an end food product, with no residue detectable in the end food

No technological effect in the final foodReview/acceptance by Health Canada

is not necessary, but recommended

Vegetable Washes Vegetable Washes Not regulated under the Food and

Drugs Act and RegulationsConsidered to be a processing aid

situation and not a food additive situation

General FDA safety requirements expected

HC does offer letter of opinion when asked

Fruit & Vegetable CoatingsFruit & Vegetable Coatings

Not regulated under the Food and Drugs Act and Regulations (except mineral oil, paraffin & petroleum)

General FDA safety requirements expected

HC does offer letter of opinion when asked

AppreciateAppreciateThe Regulations Now !The Regulations Now !

FDA FDR

B.01.003(Ingredient label) B.01.008

(Ingredient declarationand exemptions)

B.01.042(Standardized Foods)

Division 16(Additive Tables)

B.01043(Non standardized foods)

B.01.045(Food Chemical CodexSpecification) B.25.062

(Infant foods)

Food AdditiveRegulations (FDAR)

B.01.009(component exemptions)

B.01.010(Ingredient commonname)

FDRDivision 16(Food Additives)

B.16.001(Food Additives require quantitative statement,or directions for use for end food additive level compliance)

B.16.002(Additive table amendmentprocess)

B.16.003(Minister to respondwithin 90 days)

B.16.006(B.01.042(c) & B.01.043(a) do not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives

B.16.007(sale of food prohibitedunless additive use coveredby B.01.042&43/B.25.062)

B.16.100(Food additivesale prohibitedunless listed in tables)

B.16.002 - Submission B.16.002 - Submission RequirementsRequirements

description, chemical name, method of manufacture, and specifications

purpose, area of use and proposed level of use

analytical methodefficacy dataresidue datasample of additive and active ingredients

Other Considerations:Other Considerations:Must not lead to deceptionMust result in an advantage to consumers

by improving, or maintaining the nutritive value, quantity, quality or acceptability of the food

Good Manufacturing PracticeGood Manufacturing Practice(Section B.01.044)(Section B.01.044)

Where a limit is prescribed for a food additive in a Table to section B.16.100 is stated to be GMP the amount of the additive added… shall not exceed the amount required to accomplish the purpose for which the additive is permitted to be added to that food

The Additive Challenge - The Additive Challenge - Finding a Recognizable NameFinding a Recognizable Name

What about the following and do they each have permitted use?– Sodium Phosphate Monobasic*– Sodium Biphosphate– Sodium Dihydgrogen Phosphate– Monosodium Orthophosphate– Primary Sodium Phosphate– Acid Sodium Phosphate

References to ConsiderReferences to ConsiderIn Finding a Recognizable NameIn Finding a Recognizable Name

Google Search (simply type in the name and see what comes up)

Food Chemical CodexMerck Index, eleventh editionHandbook of Food AdditivesCFIA policies - Intranet and Internet“Your” Program Specialist

Units of MeasureUnits of Measureppm - parts per million (a weight to weight ratio)

– 10 to the minus six– one ounce of salt in 31 tons of potato chips

ppb - parts per billion– 10 to the minus nine– one ounce of salt in 31000 tons of potato chips

Percentage - value divided by 100– 0.1 % is equivalent to 1000 ppm– 200 ppm is equal to 0.02%

A Frequently Asked Question:A Frequently Asked Question:Preservatives I - IVPreservatives I - IV

Classes of preservatives refer to groups of compounds having similar micro or chem spectrums of activity– Class I : Curing preservatives in Meats/Cheeses– Class II : Antimicrobials– Class III: Antifungal Agents– Class IV: Antioxidants and antioxidant

synergists

Units of WeightUnits of Weight

1 kg = 1000 g 1 mg - 1000 L 1 oz (imp) = 28.4 g

1 g = 1000 mg 1 kg = 2.2 lbs (imperial)

1 gram = 1 ppm

Units of Volume Units of Volume (liquid)(liquid)

1 oz (imp) = 0.028 L 1 oz (USA) = 0.02957 L

1 pint (imp) = 19.02 oz 1 pint (US) = 16 oz

Temporary Marketing Authorization Temporary Marketing Authorization Letter Letter (B.01.054)(B.01.054)

Letter issued by HC to authorize the sale of a currently non compliant product

To assist in generating information in support of a regulation amendment

Period of time and designated area of sale is stated

Safety data for the additive is completed and accepted by HC

Interim Marketing Authorization Interim Marketing Authorization (B.01.056)(B.01.056)

Provided by HC to a firm in situations where the firm has requested an amendment to either the Division 16 Food Additive Tables I - XV, or the Tables II, or III of Division 15

The IMA has to be published in Canada Gazette I (public notice of HC’s intent to amend the regulations)

Information provided by a firm is adequate and amendment to the Regulations is expected

Summary - Summary - For Compliant Additive For Compliant Additive UseUse

The Additive must be listed in the Tables to Section B.16.100

Added to the foods listedUsed for the purpose stated (fifteen tables)Within the limits prescribed by the listingMeet, or exceed Food Chemical Codex

Specs

EEC - Numbering System EEC - Numbering System (Tab 6)

EEC - European Economic Community– a system which has been successfully used in

Europe to label food additive use– the system is not accepted in Canada or the

USA

INS Numbering SystemINS Numbering System INS - International Numbering System for Food

Additives– a Codex sponsored numbering system– set out in three columns providing

• Identification Number• The name of the additive• The Technological Function of the Additive

For Tartrazine: (colour 102)/colour(tartrazine) For Sodium Carboxymethyl Cellulose

• (thickener 466) / thickener (sodium carboxymethyl cellulose)

How am I doing?

Assessing Food Assessing Food Additive SafetyAdditive Safety

Important TermsImportant Terms

No Observed Effect LevelNo Observed Effect Level(NOEL)(NOEL)

Estimated to be the no observed effect level in animals, divided by a 100 (sometimes a 1000) safety factor

Acceptable Daily IntakeAcceptable Daily Intake(ADI)(ADI)

Estimated to be the no observed effect level in animals, divided by a 100

Sometimes a 1000 safety factor depending on the nature of toxic effects noted and quality of available toxicity data

The dietary intake of an additive which can be safely ingested over a lifetime without appreciable risk from the known information

For Example:For Example:It is determined that a 1 kg rat could

consume without effect 300,000 mg daily, the no effect level expressed per unit of body weight would be 3000 mg/kg/day

– the ADI (using a 100 safety factor) would be 30 mg/kg/day

Estimating the P.D.I.Estimating the P.D.I.(Probable Daily Intake)(Probable Daily Intake)

Obtained by adding up likely sources and exposures elsewhere in the diet– necessary to determine if the proposed additive

amendment will continue to result in consumer exposure within the ADI established for the additive

The RDIThe RDI (Reasonable Daily Intake)(Reasonable Daily Intake)

Where to find these values:– on the product label (serving size)– Part D, Schedule K of FDR (pg. 537)– in absence of the above, USA/FDA ….?

Classification of Toxicological Testing

Acute Oral ToxicityStudies

28- day Oral ToxicityStudy

90- day Oral ToxicityStudy

One - year Oral ToxicityStudy

GenotoxicityTests

TeratogenicityStudies (Oral)

Reproduction Studies(Oral)

PharmacokineticStudies

Sensitization Studies

Classification of Toxicological TestsClassification of Toxicological Tests

Another Term for Evaluating Another Term for Evaluating Chemical Toxicity Chemical Toxicity (eg. pesticides)(eg. pesticides)

LD 50 test– this is a test for the dose of the additive which is

level (deadly) to 50% of the animals when given only once

– several animal species are tested– the lower the LD 50, the higher the toxicity

Assessing Food Assessing Food AdditiveAdditiveControlControl

Taking the Barometer Reading for Food Additive Control

PotentialFor Food Additive Problems

Taking the Barometer Reading for Food Additive Control

PotentialFor Food Additive Problems

Do additives meet Food ChemicalCodex Specifications Are certificates of analysis obtained

from suppliers for each additive lot

Are verification checksof additive qualityconducted

Are written recipes usedfor addition of food additives

Does plant managementroutinely verify and updatethe procedures for addingfood additives

Are all food additivesproperly declared on labels of finished products

Are food additives correctlylabelled and stored properly

Does the firm keepadditives which are notpermitted in their products

Does the firm have additivetraining and use trainedstaff

Does firm haveadditive measuring equipment

Key ProceduresKey Procedures (to be Assessed)(to be Assessed)

Purchase specifications (meeting FCC)Knowledge of FDAR Written formulationsTrained staffAccurate measurement procedure and

equipmentLabel controlProper storage practices

What about colours?What about colours?

Division 6Colour Classes

Synthetic Colours

Inorganic Colours

Natural Colours

Division 6Synthetic Colours

B.06.002Synthetic Colours & maximum limits B.06.003

Arsenic, lead, andheavy metal limitsfor synthetic colours

B.06.004Labelling &Certification of synthetic colours

B.06.005Importation of Synthetic colours& Certification

B.06.006Colour mixtures requirea lot number & words ‘Food Colour’

B.06.007Colour Preparations

B.06.008Certified coloursonly inmixtures & preparations

Synthetic Colours

DyesDyes

LakesLakes

Lake DispersionsLake Dispersions

Food Colour DyesFood Colour DyesFood colour dyes are synthetic organic

compoundsEach batch is to be certified and registered

with HCEight primary colours are permitted in

CanadaDyes are usually the most economical form

of food colouring

Permitted Synthetic ColoursPermitted Synthetic Colours

Allura Red FD & C Red # 40 129 Amaranth FD & C Red # 2 123 Erythrosine FD & C Red # 3 127 Ponceau SX FD & C Red # 4 125 Citrus Red No. 2 Citrus Red # 2 121 Tartrazine FD & C Yellow # 5 102 Sunset Yellow FCF FD & C Yellow # 6 110 Fast Green FCF FD & C Green # 3 143 Brilliant Blue FCF FD & C Blue # 1 133 Indigotine FD & C Blue # 2 132

CANADA UNITED STATES EUROPEAN

Food Colour LakesFood Colour LakesMade by precipitating soluble dyes onto an

aluminum hydroxide substrate which is dried and ground to a very fine particle size

Lakes function as pigments and are effective colourants without being dissolved

Effective in colouring low moisture foodsEach batch is to be certifiedGenerally more stable to heat, light & ph

change

Lake DispersionsLake DispersionsRequire high-shear mixing into a liquid for

optimum tinting power and uniform colouringForms of lake dispersions:

– sucrose based (sugar coated candy)– glycerine based (chewing gum & other confections)– oil based (cookie fillings & cream type confections)– propylene glycol (certain low-moisture applications)– water based (film coating of pharmaceutical tablets)

Possible Synthetic Colour Possible Synthetic Colour Defects Defects

Precipitation (solubility exceeded, chem rx, low temp, pH)

Dulling effects (excessive colour, high temp, product type)

Speckling and spotting (bakery & confectionary)

Fading– light, metals, micro-organisms, excessive heat, oxidizing

and reducing agents, strong acids & alkalis, retorting with protein material

Poor shelf life - canned carbonated beverages

Natural / Inorganic ColoursNatural / Inorganic Colours(Exempt from Certification)(Exempt from Certification)

Tumeric Titanium dioxide Charcoal black Annatto Beta Carotene Caramel Paprika Oleoresin

Carimine/Cochineal Red Cabbage Red Beet Red Fruit Juice Grape skin extract Passiflora

Note: use limits are GMP levels

Synthetic Colour CertificationSynthetic Colour Certification Colours are unique as they are the only additive

requiring certification by HC Manufacturers may apply for self certification status

by submitting to HC: methodology, analytical data on three samples provided by HC

Colour shipments before entry must be certified and only manufacturers with status may apply– required to submit 100 g sample of dye, certificate of analysis &

analytical data

If accepted, HC issues a Certification Number (CN) to the Cdn Importer to be presented to Customs

Certificates issued by FDA are also acceptable Colour lakes are issued an Identification Number (IN)

Product TestingProduct Testing

Challenges - Too ManyChallenges - Too Many

Thousands of permitted food additives listed in the Food and Drug Regulations

Just as many possible food additives not permitted in Canada

The number of different methods required is in the hundreds

Division 16 - GroupsDivision 16 - Groups

Although additives are divided by groups in Division 16, testing of each within each group are not all similar

– Additives within each group may be mineral, carbohydrate, protein, lipid, hydrocarbons or combinations of them

– Each type is tested differently

Testing EquipmentTesting EquipmentDifferent additive types, require different

types of instruments, or perhaps can not be instrumentally analyzed at all

– HPLC, GC, Atomic Absorption, UV/Vis Spectrometer, Infrared Spectrometer, etc.

– Not all labs have the instruments or apparatus needed

MethodologyMethodology

Although a wide variety of methods are published, some additives do not have specific methods

Labs require some expertise with the additive, or method before offering testing services

Thankyou!