Transcript Food Additive

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: “[email protected]”
Food Safety Issues are sure
keeping everyone busy!
Thanks for the invite!
Challenge (Today):

How much information to provide and
explain to you within 45 minutes?
Contaminants
(heavy metals, mycotoxins …)
Packaging Material
Ingredient
(FDR/ Octylin, acrylonitrile …)
[HC - optional review]
Processing Aid
Veterinary
Drugs
Chemicals
and
Foods
(FDR/neomycin )
Vitamins &
Minerals
[HC - optional
review]
Food Additive
(FDR/ colours…)
(FDR/ Vitamin A)
Fertilizers
[CFIA]
Agricultural Chemicals
[PMRA] - (Pest Control Product Act
eg. alachlor, captan …)
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 ...
Chemicals Naturally
Eggs
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Ovalbumin
 Conlbumin
 Ovomucoid
 Mucin
 Globulins
 Amino Acids
 Lipovitellin
 Livetin
 Cholesterol
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Lecithin
Lipids (fats)
Fatty Acids
Butyric Acid
Acetic Acid
Sodium Chloride
Lutein
Zeaxanthine
Vitamin A
Chemicals Naturally
Coffee
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Acetone
Methyl Acetate
Furan
Diacetyl
Butanol
Methylfuran
Isoprene
Methylbutanol
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Caffeine
Essential Oils
Methanol
Acetaldehyde
Methyl Formate
Ethanol
Dimethyl Sulfide
Propionaldehyde
Chemicals Naturally
Melon
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Starches
Sugars
Cellulose
Pectin
Malic Acid
Citric Acid
Succinic Acid
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Anisyl Propionate
Amyl Acetate
Ascorbic Acid
Vitamin A
Riboflavin
Thiame
Chemicals Naturally
Apple
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Fructose
Sucrose
Glucose
Pectin
Hemicellulose
Celluose
Formic Acid
Acetic Acid
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Malic Acid
Potassium
Calcium
Phosphorus
Carotene
Caprylic Ester
Ascorbic Acid
Acetaldehyde
Important Terms
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
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)
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
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
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

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

Appreciate
The Regulations Now !
FDA
FDR
B.01.003
B.01.042
(Ingredient label)
B.01.008
(Ingredient declaration
and exemptions)
(Standardized Foods)
B.01.009
B.01043
(Non standardized
foods)
Food Additive
Regulations
(FDAR)
B.01.045
(Food Chemical Codex
Specification)
Division 16
(Additive Tables)
(component exemptions)
B.01.010
(Ingredient common
name)
B.25.062
(Infant foods)
B.16.001
(Food Additives require quantitative statement,
or directions for use for end food additive level
compliance)
B.16.002
B.16.100
(Food additive
sale prohibited
unless listed in tables)
FDR
Division 16
(Food Additives)
(Additive table amendment
process)
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
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

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

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
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
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

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%
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
Units of Weight

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 Volume (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
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

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

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

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 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
Additive Safety
Important Terms
No Observed Effect Level
(NOEL)

Estimated to be the no observed effect
level in animals, divided by a 100
(sometimes a 1000) safety factor
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

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.
(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 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 ….?
Classification of Toxicological Tests
Sensitization Studies
Pharmacokinetic
Studies
Acute Oral Toxicity
Studies
28- day Oral Toxicity
Study
Reproduction Studies
(Oral)
Teratogenicity
Studies (Oral)
Classification of
Toxicological
Testing
90- day Oral Toxicity
Study
Genotoxicity
Tests
One - year Oral Toxicity
Study
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
Assessing Food
Additive
Control
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 food additives correctly
labelled and stored
properly
Are all food additives
properly declared on
labels of finished
products
Are verification checks
of additive quality
conducted
Are written recipes used
for addition of food additives
Does firm have
additive measuring
equipment
Does plant management
routinely verify and update
the procedures for adding
food additives
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

What about colours?
Synthetic Colours
Natural Colours
Division 6
Colour Classes
Inorganic Colours
B.06.007
Colour Preparations
B.06.008
Certified colours
only in
mixtures &
preparations
B.06.006
Colour mixtures require
a lot number & words ‘Food Colour’
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
synthetic colours
B.06.003
Arsenic, lead, and
heavy metal limits
for synthetic colours
Dyes
Lake Dispersions
Synthetic
Colours
Lakes
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

Permitted Synthetic Colours
CANADA
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Allura Red
Amaranth
Erythrosine
Ponceau SX
Citrus Red No. 2
Tartrazine
Sunset Yellow FCF
Fast Green FCF
Brilliant Blue FCF
Indigotine
UNITED STATES
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
EUROPEAN
129
123
127
125
121
102
110
143
133
132
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

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)
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
Natural / Inorganic Colours
(Exempt from Certification)
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Tumeric
Titanium dioxide
Charcoal black
Annatto
Beta Carotene
Caramel
Paprika Oleoresin
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Carimine/Cochineal
Red Cabbage
Red Beet
Red Fruit Juice
Grape skin extract
Passiflora
Note: use limits are GMP levels
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)
Product Testing
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

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
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
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

Thankyou!