2.1a Clip Food additives
Food additive = substances added intentionally to foodstuffs to perform certain technological
functions (colour, sweeten, preservation, etc.)
in EU all food additives identified by E-number!
Additives used in food:
- Maintain product consistency (thickeners, emulsifiers)
- Improve/maintain nutritional value (vitamin, mineral restauration)
- Maintain palatability and wholesomeness (preservatives, antioxidants)
- Provide leavening or control pH
- Enhance flavour or impact desired colour
Safety of additives is judged upfront, before they are allowed on the market. In EU first there is a
authority that judges the safety (does a risk assessment on the safety: EFSA (European Food Safety
Authority). It evaluates available scientific data and proposes limits (ADI).
The European Commission takes a decision if a food additive can be used and at what levels it can be
used in different food categories. If allowed I gets a E-number.
food additives must be kept under continuous observation and must be re-evaluated if necessary (all
before 2009 has been evaluated again).
In USA; FDA (Food and Drug Administration) both risk assessment and performs regulation
Whole world: JECFA (Joint FAO/WHO Expert Committee on Food Additives) gives judgement
Codex Alimentarius of FAO/WHO set the limits for the whole world. In EU EFSA and
EC dominate.
Industry that wants to use additive has to provide evidence that proposed additive:
- Has a technological need (performs as intended) regulated by itself, not judged
- Will not cause adverse health effects
- The use does not mislead consumer at expected levels of human consumption
Approved? yes then E-number and it can be used.
Food additives risk assessment:
(NOAEL or BMDL) / uncertainty factor of 100 or more = ADI for avoidable chemicals
Uncertainty factors:
1. Interspecies differences: 1/10
2. Interindividual differences: 1/10
3. Other UF’s (quality data, type exposure, etc.)
ADI not applicable for genotoxic carcinogens no safe threshold, no NOAEL. If the genotoxic
compound is avoidable zero tolerance, not approved, not on market!
Additives can be;
- Natural
- Synthetic
- Synthetic but identical to natural ones
, - Prepared using genetically modified organisms (pe enzymes)
Not all additives have an ADI!
4 groups:
1. Additives with ADI defined
2. Additives with temporary ADI (insufficient toxicological info, often extra safety factor used,
so the make ADI a bit lower. Reconsider and make ADI definite when data is available.)
3. Additives with ADI not specified
additive will be used at such a low level, any toxicological level is not reached, so there is no
need to specify an ADI. Margin of safety (MOS) is adequate, and ADI would be so high that all
would be below this level.
4. Additives with no limit due to safe history of use
compounds that are so safe, that you can use them without any limit.
Risk benefit balance:
Use of an additive can be less harmful than elimination of its use. Some additives are considered to
have a lower risk than the risk expected upon absence.
example: Nitrite Added to meat to prevent infection with Clostridium which leads to botulinum
toxin. Nitrosamines may however cause cancer.
There are several lists of E-numbers with misleading information.
Aspartame
EFSA completed full risk assessment and concluded it is safe at current levels of exposure and no
reason to revise ADI. ADI is not applicable to PKU patients (unable to degrade Phe and high plasma
levels Phe result in brain damage).
Additives and carcinogenicity: International Agency for research on Cancer (IARC) classification
- Group 1: carcinogenic to man; should be forbidden
- Group 2A: probably carcinogenic to man; should be forbidden
- Group 2B: possibly carcinogenic for man (results are equivocal, not very clear)
- Group 3: compound cannot be classified because of lack of sufficient data
- Group 4: proven to be non-carcinogenic for man based on scientific arguments and
conservative
Group 2B: carbon black; carcinogenic impurity, BHA; not genotoxic (it gave cancer in forestomach
due to irritation, no gene modification, and humans don’t have a forestomach) and with a NOAEL
and ADI it can be regulated so these can be removed from this category and placed in another
group.
Group 3: BHT; not of concern with respect to genotoxicity, cancer due to toxicity, not genotoxicity.
Saccharin; not yet re-evaluated, but type of cancer probably not relevant for humans.
State of the art: re-evaluation of all food additives in 2006, with food colours as a priority, starting
with the synthetic ones and later the natural ones.
Red 2G (E128): in intestine could be converted to aniline. It can not be excluded that aniline causes
DNA damage and cancer Red 2G banned by EC.
Food additive = substances added intentionally to foodstuffs to perform certain technological
functions (colour, sweeten, preservation, etc.)
in EU all food additives identified by E-number!
Additives used in food:
- Maintain product consistency (thickeners, emulsifiers)
- Improve/maintain nutritional value (vitamin, mineral restauration)
- Maintain palatability and wholesomeness (preservatives, antioxidants)
- Provide leavening or control pH
- Enhance flavour or impact desired colour
Safety of additives is judged upfront, before they are allowed on the market. In EU first there is a
authority that judges the safety (does a risk assessment on the safety: EFSA (European Food Safety
Authority). It evaluates available scientific data and proposes limits (ADI).
The European Commission takes a decision if a food additive can be used and at what levels it can be
used in different food categories. If allowed I gets a E-number.
food additives must be kept under continuous observation and must be re-evaluated if necessary (all
before 2009 has been evaluated again).
In USA; FDA (Food and Drug Administration) both risk assessment and performs regulation
Whole world: JECFA (Joint FAO/WHO Expert Committee on Food Additives) gives judgement
Codex Alimentarius of FAO/WHO set the limits for the whole world. In EU EFSA and
EC dominate.
Industry that wants to use additive has to provide evidence that proposed additive:
- Has a technological need (performs as intended) regulated by itself, not judged
- Will not cause adverse health effects
- The use does not mislead consumer at expected levels of human consumption
Approved? yes then E-number and it can be used.
Food additives risk assessment:
(NOAEL or BMDL) / uncertainty factor of 100 or more = ADI for avoidable chemicals
Uncertainty factors:
1. Interspecies differences: 1/10
2. Interindividual differences: 1/10
3. Other UF’s (quality data, type exposure, etc.)
ADI not applicable for genotoxic carcinogens no safe threshold, no NOAEL. If the genotoxic
compound is avoidable zero tolerance, not approved, not on market!
Additives can be;
- Natural
- Synthetic
- Synthetic but identical to natural ones
, - Prepared using genetically modified organisms (pe enzymes)
Not all additives have an ADI!
4 groups:
1. Additives with ADI defined
2. Additives with temporary ADI (insufficient toxicological info, often extra safety factor used,
so the make ADI a bit lower. Reconsider and make ADI definite when data is available.)
3. Additives with ADI not specified
additive will be used at such a low level, any toxicological level is not reached, so there is no
need to specify an ADI. Margin of safety (MOS) is adequate, and ADI would be so high that all
would be below this level.
4. Additives with no limit due to safe history of use
compounds that are so safe, that you can use them without any limit.
Risk benefit balance:
Use of an additive can be less harmful than elimination of its use. Some additives are considered to
have a lower risk than the risk expected upon absence.
example: Nitrite Added to meat to prevent infection with Clostridium which leads to botulinum
toxin. Nitrosamines may however cause cancer.
There are several lists of E-numbers with misleading information.
Aspartame
EFSA completed full risk assessment and concluded it is safe at current levels of exposure and no
reason to revise ADI. ADI is not applicable to PKU patients (unable to degrade Phe and high plasma
levels Phe result in brain damage).
Additives and carcinogenicity: International Agency for research on Cancer (IARC) classification
- Group 1: carcinogenic to man; should be forbidden
- Group 2A: probably carcinogenic to man; should be forbidden
- Group 2B: possibly carcinogenic for man (results are equivocal, not very clear)
- Group 3: compound cannot be classified because of lack of sufficient data
- Group 4: proven to be non-carcinogenic for man based on scientific arguments and
conservative
Group 2B: carbon black; carcinogenic impurity, BHA; not genotoxic (it gave cancer in forestomach
due to irritation, no gene modification, and humans don’t have a forestomach) and with a NOAEL
and ADI it can be regulated so these can be removed from this category and placed in another
group.
Group 3: BHT; not of concern with respect to genotoxicity, cancer due to toxicity, not genotoxicity.
Saccharin; not yet re-evaluated, but type of cancer probably not relevant for humans.
State of the art: re-evaluation of all food additives in 2006, with food colours as a priority, starting
with the synthetic ones and later the natural ones.
Red 2G (E128): in intestine could be converted to aniline. It can not be excluded that aniline causes
DNA damage and cancer Red 2G banned by EC.
