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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)
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Food Safety Issues are sure keeping everyone busy!
Thanks for the invite!
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Challenge (Today): How much information to provide and explain to you within 45 minutes?
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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]
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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 ...
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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
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Chemicals Naturally Coffee
Acetone Methyl Acetate Furan Diacetyl Butanol Methylfuran Isoprene Methylbutanol Caffeine Essential Oils Methanol Acetaldehyde Methyl Formate Ethanol Dimethyl Sulfide Propionaldehyde
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Chemicals Naturally Melon
Starches Sugars Cellulose Pectin Malic Acid Citric Acid Succinic Acid Anisyl Propionate Amyl Acetate Ascorbic Acid Vitamin A Riboflavin Thiame
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Chemicals Naturally Apple
Fructose Sucrose Glucose Pectin Hemicellulose Celluose Formic Acid Acetic Acid Malic Acid Potassium Calcium Phosphorus Carotene Caprylic Ester Ascorbic Acid Acetaldehyde
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Important Terms
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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
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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
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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
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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
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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
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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
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Appreciate The Regulations Now !
FDA FDR
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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)
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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
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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
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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
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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
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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
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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
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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%
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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
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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
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Units of Volume (liquid)
1 oz (imp) = L 1 oz (USA) = L 1 pint (imp) = oz 1 pint (US) = 16 oz
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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
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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
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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
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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
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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)
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How am I doing?
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Assessing Food Additive Safety
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Important Terms
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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
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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
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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
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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
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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 ….?
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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
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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
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Assessing Food Additive Control
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Taking the Barometer Reading for Food Additive Control
Potential For Food Additive Problems
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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
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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
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What about colours?
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Synthetic Colours Natural Colours Inorganic Colours Division 6
Colour Classes Inorganic Colours
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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
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Dyes Lake Dispersions Synthetic Colours Lakes
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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
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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 #
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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
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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)
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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
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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
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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
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Product Testing
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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
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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
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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
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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
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Thankyou!
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