2. Introduction
Assessment of additives safety
Regulation Food additives
Example of banned food additives
3.
4. The overall consumption of food additives is
139 lbs/year/person (63 kg/person/year).
If the common additives like spices, sugars,
salt, honey, pepper, mustard, dextrose etc.
are excluded, the consumption decreases to
5 lbs/year (2.3 kg/person/year).
The food additives generally can be divided
into six categories.
5.
6.
7. "All things are poisons; nothing is without
poison; only the dose determines whether
there is a harmful effect".
Paracelsus (16th Century Philosopher)
8. To put it another way, eating a high amount
(or dose) of anything will be harmful but at a
lower level it can be safe
9. Even "natural" additives may be harmful in
certain quantities (table salt, for example) or
because of allergic reactions in certain
individuals.
Safrole was used to flavor root beer until it
was shown to be carcinogenic.
Due to the application of the Delaney
clause, it may not be added to foods, even
though it occurs naturally in sassafras and
sweet basil.
10. Tests assess how the additive reacts in the
body and also look for any toxic effects at the
levels the additive is to be used in foods.
This includes testing to see if there is any
chance of genetic damage or cancers being
caused by the long-term use of the additive.
11. In general, food additives must be subjected
to a wide range of tests before they are
allowed in food.
12. For food additives, a safety evaluation is
obtained generally from experimental data
derived from investigations in laboratory
animals.
Although it may be possible to use human
data derived from medical use, occupational
epidemiology or from volunteers, the
obtained data would be limited.
13. At the end of the toxicological studies data
derived from animal studies can be used to
extrapolate to give information on human
exposure.
Therefore, defining the Acceptable
Daily Intake (ADI), described as the dose level
at which the additive causes effects on the
health of the animals, is important.
14. The highest level at which no adverse effect on
the health of the animals is observed is called
the NOAEL (No-Observed-Adverse-Effect-
Level).
An ADI is derived by dividing the NOAEL
obtained from these studies, by an appropriate
‘uncertainty’ factor,
which is intended to take account of
differences between the animals on which the
additive was tested and humans, in order to
reduce further possibility of risk to humans.
15. This uncertainty factor is
commonly 100 (assuming that human beings are 10
times more sensitive than test animals and that the
different levels of sensitivity within the human
population is in a 10 fold range),
but may be as much as 1,000 (if, for example, the toxic
effect in animals is found to be particularly severe)
or as low as 10 (where it has been found
that humans are less likely than animals to be
affected,
based on actual data on the additive
in humans) (Food Safety Authority of Ireland, 2011).
16. For example, an additive that has no
observable effect in tests at a level of 5 g in a
kilogram of food would only be allowed up to
a level of 50 mg per kilogram.
17.
18. Prohibits use of additives that cause cancer in any
animal at any concentration
FDA has defined acceptable risk from chemical
consumption as up to one additional case per
million cases, when consumed over a lifetime
Repealed in respect to pesticides in 1996
19.
20. JECFA is the scientific advisory body to the
Food and Agriculture Organization (FAO) and
theWorld HealthOrganization (WHO).
It also advises the Codex Alimentarius
Commission, which has international
responsibility for assessing food safety.
21. They make regular safety evaluations of
additives in use, and establishAcceptable
Daily Intake levels (ADI's) for each additive
Their findings are made public and individual
additive assessments can be viewed at
www.inchem.org
22. EFSA is the body responsible for all food
safety matters in the EU.
The EFSA evaluations for individual additives
are published on their respective websites.
23. EU law states that food additives are allowed
only if:
1. they present no hazard to health at the level
used in foods
2. a reasonable need for the additive can be
demonstrated (e.g. in the processing or
preservation of food)
3. they do not mislead the consumer
24. Each food additive is assigned a unique E
number, which have been assessed for use
within the European Union (EU) to inform
consumers.
E numbers for European countries are all
prefixed by “E”; on the other hand non-
European countries do not use this prefix.
E letter stands for the approval of the food
additive in Europe.
25. The United States Food and Drug
Administration listed these items as
“generally recognized as safe” or GRAS.
As an example, additive E 341 (Tricalcium
phosphate) is approved by US so has an “E”
prefix and 341 numbering which stands for
340-349 subset known as “phosphates”
under Antioxidants andAcidity Regulators
group
26.
27. From start to finish, it can take 10 years or
more to obtain approval for a new food
additive in the EU.
Five years to carry out safety testing,
followed by two years for evaluation by the
European Food SafetyAuthority and at least
another three years before the additive
receives an EU-wide approval for use in every
country in the European Union.
28.
29. 1. The safety of the antioxidant BHA has been
questioned in the light of the fact that its
consumption leads to cancer in rodents.
2. Sensitive asthmatics have been reported to develop
allergic responses to the food color tartrazine.
3. Allergies have been reported to cause even fatal
shock.
4. Nitrites can form cancer-causing nitrosamines in
foods in which they are added as preservatives.
30. 5. MSG intake of 1.5g or more can result in
acute illness characterized by burning or
tingling sensation on face, neck and head,
tightness, stiffness or pressure in chest
and facial muscles.
This is the ―Chinese Restaurant Syndrome‖
because these symptoms have been seen in
people who had consumed Chinese food.
31. 4. High levels of
erythrosine intake
have been
associated with
thyroid tumors.
32. Ponceau 4R,Tartrazine and SunsetYellow
FCF have provoked allergic reactions in
several individuals even at low levels of
intake.
The allergic responses vary rashes to
swelling and worsening of the condition of
patients with asthma.
33.
34. boric acid was widely used as a food
preservative from the 1870s to the 1920s,
but was banned afterWorldWar I due to its
toxicity, as demonstrated in animal and
human studies.
During World War II the urgent need for
cheap, available food preservatives led to it
being used again, but it was finally banned in
the 1950s..