The Canadian Situation
Presented to: Guelph Food Safety Seminar
May 11 th , 2005
Guelph, Ontario
Presented by: Doug Morrison
Canadian Food Inspection Agency
(416) 973 - 4226
Email: “morrisondc@Inspection.gc.ca”

Thanks for the invite!

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

Contaminants
(heavy metals, mycotoxins …)
Packaging Material
(FDR/ Octylin, acrylonitrile …)
Ingredient
[HC - optional review]
Veterinary
Drugs
(FDR/neomycin )
Vitamins &
Minerals
(FDR/ Vitamin A)
Chemicals
Fertilizers
[CFIA] and
Foods
Processing Aid
[HC - optional review]
Food Additive
(FDR/ colours…)
Agricultural Chemicals
[PMRA] - (Pest Control Product Act eg. alachlor, captan …)

 Common foods themselves are chemicals
 Non 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 ...

 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

 Acetone
 Methyl Acetate
 Furan
 Diacetyl
 Butanol
 Methylfuran
 Isoprene
 Methylbutanol
 Caffeine
 Essential Oils
 Methanol
 Acetaldehyde
 Methyl Formate
 Ethanol
 Dimethyl Sulfide
 Propionaldehyde

 Starches
 Sugars
 Cellulose
 Pectin
 Malic Acid
 Citric Acid
 Succinic Acid
 Anisyl Propionate
 Amyl Acetate
 Ascorbic Acid
 Vitamin A
 Riboflavin
 Thiame

 Fructose
 Sucrose
 Glucose
 Pectin
 Hemicellulose
 Celluose
 Formic Acid
 Acetic Acid
 Malic Acid
 Potassium
 Calcium
 Phosphorus
 Carotene
 Caprylic Ester
 Ascorbic Acid
 Acetaldehyde

 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

Part 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)

do not include:
 Nutritive food ingredients such as salt, sugar, starch, glucose, casein...
 vitamins, minerals, amino acids
 spices, seasonings, flavouring preparations
 agricultural chemicals
 veterinary drugs
 food packaging materials
Why?
Covered separately by the FDR

(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 food
 Review/acceptance by Health Canada is not necessary, but recommended

 Not regulated under the Food and
Drugs Act and Regulations
 Considered 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

 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

FDA FDR

B.01.042
(Standardized Foods)
B.01.003
(Ingredient label)
B.01043
(Non standardized foods)
Food Additive
Regulations
(FDAR)
B.01.045
(Food Chemical Codex
Specification)
Division 16
(Additive Tables)
B.01.008
(Ingredient declaration and exemptions)
B.01.009
(component exemptions)
B.01.010
(Ingredient common name)
B.25.062
(Infant foods)

B.16.100
B.16.001
(Food Additives require quantitative statement, or directions for use for end food additive level compliance)
B.16.002
(Food additive sale prohibited unless listed in tables)
FDR
(Additive table amendment process)
Division 16
(Food Additives)
B.16.003
(Minister to respond within 90 days)
B.16.007
(sale of food prohibited unless additive use covered by B.01.042&43/B.25.062)
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

 description, chemical name, method of manufacture, and specifications
 purpose, area of use and proposed level of use
 analytical method
 efficacy data
 residue data
 sample of additive and active ingredients

 Must not lead to deception
 Must result in an advantage to consumers by improving, or maintaining the nutritive value, quantity, quality or acceptability of the food

(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

 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

 Google Search (simply type in the name and see what comes up)
 Food Chemical Codex
 Merck Index, eleventh edition
 Handbook of Food Additives
 CFIA policies - Intranet and Internet
 “Your” Program Specialist

 ppm - 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%

Preservatives 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



1 kg = 1000 g
1 mg - 1000 F L
 1 oz
( imp)
= 28.4 g
 1 g = 1000 mg


1 kg = 2.2 lbs
(imperial)
1 F gram = 1 ppm

(liquid)
 1 oz
(imp)
= 0.028 L
 1 oz
(USA)
= 0.02957 L
 1 pint
(imp)
= 19.02 oz
 1 pint
(US)
= 16 oz

(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

(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

 The Additive must be listed in the Tables to
Section B.16.100
 Added to the foods listed
 Used for the purpose stated (fifteen tables)
 Within the limits prescribed by the listing
 Meet, or exceed Food Chemical Codex
Specs

(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 - 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)

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

 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

 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

 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

(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 Tests
Pharmacokinetic
Studies
Sensitization Studies
Acute Oral Toxicity
Studies
Reproduction Studies
(Oral)
Teratogenicity
Studies (Oral)
Genotoxicity
Tests
28- day Oral Toxicity
Study
Classification of
Toxicological
Testing
One - year Oral Toxicity
Study
90- day Oral Toxicity
Study

(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

Taking the Barometer Reading for Food Additive Control
Potential
For Food
Additive
Problems

Taking the Barometer Reading for Food Additive Control
Do additives meet Food Chemical
Codex Specifications Are certificates of analysis obtained from suppliers for each additive lot
Does the firm have additive training and use trained staff
Does the firm keep additives which are not permitted in their products
Potential
For Food
Additive
Problems
Are verification checks of additive quality conducted
Are written recipes used for addition of food additives
Are food additives correctly labelled and stored properly
Are all food additives properly declared on labels of finished products
Does firm have additive measuring equipment
Does plant management routinely verify and update the procedures for adding food additives

(to be Assessed)
 Purchase specifications (meeting FCC)
 Knowledge of FDAR
 Written formulations
 Trained staff
 Accurate measurement procedure and equipment
 Label control
 Proper storage practices

Synthetic Colours
Natural Colours
Division 6
Colour Classes
Inorganic Colours

B.06.007
Colour Preparations
B.06.006
Colour mixtures require a lot number & words ‘Food Colour’
B.06.008
Certified colours only in mixtures & preparations
Division 6
Synthetic Colours
B.06.002
Synthetic Colours & maximum limits
B.06.005
Importation of
Synthetic colours
& Certification
B.06.004
Labelling &
Certification of
B.06.003
synthetic colours
Arsenic, lead, and heavy metal limits for synthetic colours

Lake Dispersions
Synthetic
Colours
Dyes
Lakes

 Food colour dyes are synthetic organic compounds
 Each batch is to be certified and registered with HC
 Eight primary colours are permitted in
Canada
 Dyes are usually the most economical form of food colouring

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

 Made 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 foods
 Each batch is to be certified
 Generally more stable to heat, light & ph change

 Require high-shear mixing into a liquid for optimum tinting power and uniform colouring
 Forms 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)

 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

(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

 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)

 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

 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

 Different 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

 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