1. Food Additives- The Canadian Situation
Presented to: Guelph Food Safety Seminar
May 11th, 2005
Guelph, Ontario
Presented by: Doug Morrison
Canadian Food Inspection Agency
(416)

2. Food Safety Issues are sure keeping everyone busy!
Thanks for the invite!

3. Challenge (Today):
How much information to provide and explain to you within 45 minutes?

4. Chemicals and Foods Contaminants Packaging Material Ingredient
(heavy metals, mycotoxins …)
Packaging Material
(FDR/ Octylin, acrylonitrile …)
Ingredient
[HC - optional review]
Processing Aid
[HC - optional review]
Veterinary Drugs
(FDR/neomycin )
Chemicals
and
Foods
Food Additive
(FDR/ colours…)
Vitamins &
Minerals
(FDR/ Vitamin A)
Processing Aid - not regulated under the FDAR (no mention). Should someone be adding something as a processing aid, ideally they should as HC for review and comment. If they do not onus of proof that the situation does not contravene any provisions of the FDAR falls to the regulator.
Ingredients - Under the FDAR the user is responsible for ensuring the product use is safe. If the user fails to do so and the regulator is concerned the burden of proof that the use violates the FDAR falls to the regulator.
Agricultural Chemicals
[PMRA] - (Pest Control Product Act
eg. alachlor, captan …)
Fertilizers
[CFIA]

5. Chemical Risk Evaluation All Substances are Chemical in Nature
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 ...

6. Chemicals Naturally Eggs
Lecithin
Lipids (fats)
Fatty Acids
Butyric Acid
Acetic Acid
Sodium Chloride
Lutein
Zeaxanthine
Vitamin A
Ovalbumin
Conlbumin
Ovomucoid
Mucin
Globulins
Amino Acids
Lipovitellin
Livetin
Cholesterol

7. Chemicals Naturally Coffee
Acetone
Methyl Acetate
Furan
Diacetyl
Butanol
Methylfuran
Isoprene
Methylbutanol
Caffeine
Essential Oils
Methanol
Acetaldehyde
Methyl Formate
Ethanol
Dimethyl Sulfide
Propionaldehyde

8. Chemicals Naturally Melon
Starches
Sugars
Cellulose
Pectin
Malic Acid
Citric Acid
Succinic Acid
Anisyl Propionate
Amyl Acetate
Ascorbic Acid
Vitamin A
Riboflavin
Thiame

9. Chemicals Naturally Apple
Fructose
Sucrose
Glucose
Pectin
Hemicellulose
Celluose
Formic Acid
Acetic Acid
Malic Acid
Potassium
Calcium
Phosphorus
Carotene
Caprylic Ester
Ascorbic Acid
Acetaldehyde

10. Important Terms

11. 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
- before showing the definition ask the class to provide their understanding for the definition of a food
- taken from Page 1, under interpretation section

12. Food Additives 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)
- Part B / Foods / Division 1 / General / B defines “Food Additives”
as 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 does not include
a) any nutritive material that is used, recognized, or commonly sold as an article or ingredient of food,
b) vitamins, mineral nutrients and amino acids, other than, those listed in the tables to Division 16,
c) spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives,
d) agricultural chemicals, other than those listed in listed in the tables to Division 16,
e) food packaging materials and components thereof, and
f) drugs recommended for administration to animals that may be consumed as food

13. Food Additives 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
- Part B / Foods / Division 1 / General / B defines “Food Additives”
as 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 does not include
a) any nutritive material that is used, recognized, or commonly sold as an article or ingredient of food,
b) vitamins, mineral nutrients and amino acids, other than, those listed in the tables to Division 16,
c) spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives,
d) agricultural chemicals, other than those listed in listed in the tables to Division 16,
e) food packaging materials and components thereof, and
f) drugs recommended for administration to animals that may be consumed as food
Why? Covered separately by the FDR

14. Processing Aid (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
- the term processing aid is not mentioned or defined in the FDAR
- processing aid is a term defined and acknowledged by CODEX
- if a firm were adding something to a food process and the regulator objected, the regulator would be required if possible to find and use a currant section of the FDAR with the courts in the end having the final say one way or the other

15. Vegetable Washes
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
- the term processing aid is not mentioned or defined in the FDAR
- processing aid is a term defined and acknowledged by CODEX
- if a firm were adding something to a food process and the regulator objected, the regulator would be required if possible to find and use a currant section of the FDAR with the courts in the end having the final say one way or the other

16. Fruit & 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
- the term processing aid is not mentioned or defined in the FDAR
- processing aid is a term defined and acknowledged by CODEX
- if a firm were adding something to a food process and the regulator objected, the regulator would be required if possible to find and use a currant section of the FDAR with the courts in the end having the final say one way or the other

17. Appreciate The Regulations Now !
FDA
FDR

18. B
(Ingredient label) B
(Ingredient declaration
and exemptions) B
(Standardized Foods) B
(component exemptions)
B.01043
(Non standardized
foods)
Food Additive
Regulations
(FDAR) B
(Ingredient common
name) B
(Food Chemical Codex
Specification) B
(Infant foods)
Division 16
(Additive Tables)

19. B
(Food Additives require quantitative statement,
or directions for use for end food additive level compliance) B
(Additive table amendment
process) B
(Food additive
sale prohibited
unless listed in tables)
FDR
Division 16
(Food Additives) B
(Minister to respond
within 90 days) B
(sale of food prohibited
unless additive use covered
by B &43/B ) B
(B (c) & B (a) do not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives

20. B.16.002 - Submission Requirements
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

21. Other Considerations:
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

22. Good Manufacturing Practice (Section B.01.044)
Where a limit is prescribed for a food additive in a Table to section B 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

23. The Additive Challenge - Finding 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

24. References to Consider In Finding a Recognizable Name
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
- explain that after a reasonable search for a recognizable name, the onus of providing such a name rests with the legal agent for the product under review
- if we can not find such a name, and the legal agent does not provide one, the additive in question would be considered to be non listed and thus not permitted

25. Units of Measure 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 tons of potato chips
Percentage - value divided by 100
0.1 % is equivalent to 1000 ppm
200 ppm is equal to 0.02%

26. A Frequently Asked Question: 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
- explain that after a reasonable search for a recognizable name, the onus of providing such a name rests with the legal agent for the product under review
- if we can not find such a name, and the legal agent does not provide one, the additive in question would be considered to be non listed and thus not permitted

27. Units of Weight 1 kg = 1000 g 1 mg - 1000 FL 1 oz (imp) = 28.4 g
1 kg = 2.2 lbs (imperial)
1 Fgram = 1 ppm

28. Units of Volume (liquid)
1 oz (imp) = L
1 oz (USA) = L
1 pint (imp) = oz
1 pint (US) = 16 oz

29. Temporary Marketing Authorization Letter (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

30. Interim Marketing Authorization (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

31. Summary - For Compliant Additive Use
The Additive must be listed in the Tables to Section B
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
Fifteen tables include:
I) Food Additives that may be used as anticaking agents
II) Food Additives that may be used as bleaching, maturing and dough conditioning agents
III) Food Additives that may be used as colouring agents
IV) Food Additives that may be used as emulsifing, gelling, stabilizing, and thickening agents
V) Food Additives that may be used as food enzymes
VI) Food Additives that may be used as firming agents
VII) Food Additives that may be used as glazing and polishing agents
VIII) Miscellaneous Food Additives
IX) Food Additives that may be used as sweeteners
X) Food Additives that may be used as pH adjusting agents, acid reacting materials and water correcting agents
XI)I) Food Additives that may be used as class I preservatives
II) Food Additives that may be used as class II preservatives
III) Food Additives that may be used as class III preservatives
IV) Food Additives that may be used as class IV preservatives
XII) Food Additives may be used as sequestering agents
XIII) Food Additives that may used as starch modifying agents
XIV) Food Additives that may used as yeast foods
XV) Food Additives that may be used as carrier or extraction solvents

32. 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

33. INS 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)

34. How am I doing?

35. Assessing Food Additive Safety

36. Important Terms

37. No Observed Effect Level (NOEL)
Estimated to be the no observed effect level in animals, divided by a 100 (sometimes a 1000) safety factor
- ask the class when a safety factor of 1000 would be considered in determining the NOEL

38. Acceptable Daily Intake (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

39. 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

40. Estimating the P.D.I. (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

41. The RDI (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 ….?

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

43. Another Term for Evaluating Chemical Toxicity (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

44. Assessing Food Additive Control

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

46. 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
Are verification checks
of additive quality
conducted
Potential
For Food Additive Problems
Does the firm keep
additives which are not
permitted in their products
Are written recipes used
for addition of food additives
Does firm have
additive measuring equipment
Are food additives correctly
labelled and stored properly
Are all food additives
properly declared on
labels of finished products
Does plant management
routinely verify and update
the procedures for adding
food additives

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

48. What about colours?

49. Synthetic Colours Natural Colours Inorganic Colours Division 6
Colour Classes
Inorganic Colours

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

51. Dyes
Lake Dispersions
Synthetic
Colours
Lakes

52. Food Colour Dyes 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

53. Permitted Synthetic Colours
CANADA
UNITED STATES
EUROPEAN
Allura Red FD & C Red #
Amaranth FD & C Red #
Erythrosine FD & C Red #
Ponceau SX FD & C Red #
Citrus Red No. 2 Citrus Red #
Tartrazine FD & C Yellow #
Sunset Yellow FCF FD & C Yellow #
Fast Green FCF FD & C Green #
Brilliant Blue FCF FD & C Blue #
Indigotine FD & C Blue #

54. Food Colour Lakes
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

55. Lake Dispersions
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)

56. Possible Synthetic Colour 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

57. Natural / Inorganic Colours (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

58. Synthetic 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)
- mention the handout summary provided by HC

59. Product Testing

60. Challenges - 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

61. Division 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

62. Testing Equipment
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

63. Methodology
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

64. Thankyou!