Food Additives- The Canadian Situation

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) 973 - 4226 Email: “morrisondc@Inspection.gc.ca”

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

5. Chemical Risk EvaluationAll 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. 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 NaturallyEggs

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

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

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

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

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)

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 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

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

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

17. AppreciateThe Regulations Now ! FDA FDR

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

19. B.16.001 (Food Additives require quantitative statement, or directions for use for end food additive level compliance) B.16.002 (Additive table amendment process) B.16.100 (Food additive sale prohibited unless listed in tables) FDR 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

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.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

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 ConsiderIn 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

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 31000 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

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

28. 1 oz (imp) = 0.028 L 1 oz (USA) = 0.02957 L 1 pint (imp) = 19.02 oz 1 pint (US) = 16 oz Units of Volume (liquid)

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.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

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

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 28- day Oral Toxicity Study Reproduction Studies (Oral) 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 AdditiveControl

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 Division 6 Colour Classes Inorganic Colours

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