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Food Toxicology -TOX30306 > Week 3 - Food supplements + flavourings > Flashcards

Week 3 - Food supplements + flavourings Flashcards

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1
Q

True of False : the only supplements regulated are the supplements containing vitamins and minerals, botanical supplements are not regulated

A

true

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2
Q

T or F : when the supplement are considered food like plant food supplements (PFS), it is the manufacturer that is responsible for its safety

A

true, and their regulation and control rather follow incidence

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3
Q

T or F : vitamins and minerals do not go through a safety evaluation

A

false, their safety is evaluated by EFSA and the safe levels of intake are defined by the upper tolerable levels (UL)

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4
Q

T or F : for vitamins and minerals, the RDI is set

A

false, there is some UL which is the tolerable upper intake level

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5
Q

What are the two major categories of supplements in the EU

A
  1. Vitamins and minerals (regulated) 2. Plant food supplements (PFS ; non regulated)
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6
Q

T or F ; there is a growing concern about the risks of PFS

A

true because of the lack of regulation

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7
Q

T or F : nutritional and health claims are regulated only for vitamins and minerals supplements

A

false, also regulated for PFS (since 2012) and thus this leaves important issues for the near future since for PFS the health claims are regulated but not the safety

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8
Q

The list of health claims for supplements is based on :

A

scientific advice provided by EFSA

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9
Q

The directive from 2002, introduces supplements has food defined as ____

A

concentrated sources of nutrients

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10
Q

With regard to vitamins and minerals; food supplements may only contain the vitamins and mineral salts laid down in:

A

Annex 1 and Annex II of the Directive 2002

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11
Q

EC 2002 AD1- Annex I contains information on :

A

the vitamins and minerals that can be used in the manufacture of food supplements. Example calcium.

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12
Q

EC 2002 AD1- Annex II contains information on :

A

information on the vit and min substances that can be used in the manufacture of food supplements (salts forms, combined form). Example calcium-salts. So the source of the supplement if you will.

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13
Q

Annex II - Safety evaluations by EFSA of the nutrient sources focuses on :

A

the source of the nutrient and not on the safety of the nutrient itself

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14
Q

Annex I - The safety evaluation by EFSA of nutrients itself focuses on

A

a tolerable upper intake (UL) since some vitamins and minerals taken at higher doses may results in toxicity.

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15
Q

T or F : new vitamins and minerals may be considered for the inclusion in the Annex I and II following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by EFSA

A

true

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16
Q

What are the characteristics of nutrients which distinguish them from other chemical risk assessment?

A

1- Nutrients are essential for human well-being at a certain range of intake
2- long history of safe consumption
3- for some nutrients there may be experience of widespread chronic consumption at levels significantly above the levels obtained from foods (ex, viamin C)
4- Adverse effects are often available from human studies (reducing the UF)
5- The human body is adapted for the consumption (excretory, metabolic processes, homestatic regulation etc) and this provides a measure of protection
6- Tolerable upper intake level (UL) instead of ADI/TDI or MOE since deficiency can also occur

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17
Q

What is the UL ?

A

it is the tolerable upper intake level (UL) which is the maximum level of total chronic daily intake of a nutrient (from all sources) that will unlikely pose a risk adverse health effect to humans

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18
Q

The default uncertainty value of 100 used in conversion of NOAEL values into ADIs can be applied when defining ULs

A

true and false, depends since the application of UF should not derive the UL to be lower than the RDI and RDA

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19
Q

What was the effect chosen has the critical effect for the establishment of a UL for vitamin A ?

A

the teratogenic potential of vitamin A metabolite (trans-retinoic acid) lead to the establishment of a UL of vitamin A of 3000 µg RE/day

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20
Q

T or F : sometime some claims found on some websites will mislead consumers into thinking more vitamin supplements are better for their health

A

true

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21
Q

What are the concern around PFS

A

1- overconsumptions for particular groups
2- the perception of consumers that natural = safe
3- the availability of PFS on internet from other countries with different regulations
4- no detailed requirements on safety and quality of PFS (no quality control)

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22
Q

What are the various reasons that PFS could be toxic ?

A

1- Naturally present toxic ingredients (ex, pyrrolizidine alkaloids, alkenylbenzen, coumarin, phytoestrogens, kavalactone etc)
2- Replacement of a harmless vriety with a toxic alternative (Ex fangji)
3- Adulteration (ex. viagra to make it work)
4- Contaminants (ex. PAH)

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23
Q

Pyrolizidine alkaloids (PA) is an example of _____ of PFS

A

naturally present toxic ingredient

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24
Q

What are the toxic effect of pyrolizidine alkaloids ?

A

hepatotoxicity, veno-occlusive disease, cancer in animals.

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25
Q

T or F : use of toxic PA-containing plants as food (products) as been restricted

A

true, plant variety like comfrey are not allowed

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26
Q

Alkenylbenzenes are an example of ____ in PFS

A

naturally present toxic ingredient

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27
Q

What are the example of naturally present toxic ingredients seen in PFS seen in this course ?

A
  1. alkenylbenzene
  2. pyrolizidine alkaloids
    3.
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28
Q

In what type of PFS are alkenylbenzenes mostly found ?

A

Essential oils of basil, fennel, nutmeg and some other spices/herbs.

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29
Q

What conditions is associeted the consumption of alkenylbenzenes in rodents

A

tumors are higher levels since these are genotoxic compounds

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30
Q

Anisatin is an example of ___ of PFS

A

replacement of a harmless variety with a toxic alternative

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31
Q

What was the incident that happened around star anise ?

A

in japan and botanist making the tea switched a variatty of the star anise for a toxic variety the anisatin which contains toxic GABA blocker and lead peolple ot the IC units.

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32
Q

Aristolochic acids are an example of ____ of PFS

A

replacement of a harmless variety with a toxic alternative

33
Q

What was the incident regarding aristolochic acids ?

A

in belgiium, the chines herb was used has a weight loss prepation and this lead to cardiovascular damage, kidney damage, cancer of kidneys and urinary tract because the Fang ji Aristolochia fanchi was used instead of the stephania tetranda also called fang ji.

34
Q

t or f : the 1990 incident lead to the phobition of aristolochic acids but the ban didn’t really change the composition of PFS on the market

A

true, some chinese preparation were collected and they still contained aristolochic acids

35
Q

Sibutramine in weight loss preparations is an example of ____ of PFS

A

adulteration

36
Q

What is the problem with the use of sibutramine in weight loss supplements ?

A

increased risk of major adverse cardiovascular events since it is a Rx drug that should only be prescribed under the supervision of a health care practitioner

37
Q

Sildenafil is an example of ___ of PFS

A

adulteration, since it is the active ingredient of viagra

38
Q

What is the problem of the adulteration of PFS with sildenafil ?

A

it is a PDE-5 inhibitor and it can cause problems because it can drop the blood pressure to lethal levels. Also some PFS can contain analogues of PDE-inhibitor / viagra which have never been tested fror their safety

39
Q

The presence of PAH in PFS is an example of ____

A

contaminant

40
Q

How can PAH occur in PFS

A

by the drying of herbs. An example is an incident in 2006 where certain vitaminE supplements contaminated high levels of PAHs due to drying proces of botanicals from which the natural vitaminE was extracted

41
Q

What is the approach used for the evaluation of PFS ?

A

the two tiered approach

42
Q

What is the tier 1 based on for the PFS safety evaluation?

A

Tier 1: based on :

  1. The nature of the botanical
  2. its intended use and the level of use
  3. wether the botanical preparation has a long term history of use showing that the exposure level have no adverse effect on human
43
Q

What is the tier 2 based on for the safety evaluation of PFS

A

only done for compounds lacking a history of food use or use at levels that exceed the histroic intake levels, an assessment of safety may be required (tier 2) based on a known compound in the PFS which ADI or TDI are known or TTC / MOE

44
Q

t or f : MOE approach shows thatsome(thoughnotall) alkenylbenzene-containingPFS are of high priority forrisk management

A

true

45
Q

Why was the safety evaluation of flavour substances was not considered a priority historically ?

A

1- other chemicals were considerd more important
2- perceived as no risk due to low levels

46
Q

What was the first country to take action and regulate the safety of food flavours

A

the US (FDA)

47
Q

Who evaluates the safety of food flavours at the moment in europe ?

A

EFSA (panel on Food Contact materials, enzymes, flavourings and processings aids (CEF panel)

48
Q

When did flavour safety assessment started in europe ?

A

in 1973 with the blue book of permitted flavour substances

49
Q

When did more strict regulations and a list of allowed flavouring sustances entered into force ?

A

in 2012- 2013. The flavouring substances that were not on the list were banned and manufacturing companies were given 18 months phasing out period

50
Q

What are the three different types of flavouring as defined by the EU legislation ?

A

1- Flavouring substances that are chemically identified
2- Flavouring preparations which are mixtures obtained from plant or animal origin (natural flavour complexes)
3- Thermal process flavourngs and smoke flavourings

51
Q

What are the two types of chemically identified flavouring substances

A

1- Natural and nature-identifcal flavourings
2- Artificial flavourings

52
Q

Natural an natural-identical substances are coming from ____ or ____

A

they are chemically known susbtances that either occur naturally in food or formed during the preparation or chemically synthesized

53
Q

T or F : chemically known flavouring substances coming from natural source can’t be chemically synthesized

A

false, most of the time they are chemically synthesized to ensure purity and identity

54
Q

What is the difference between natural/ nature-identical flavouring and artificial flavourings

A

althought both artificial flavourings and natural flavourings can be chemically synthesized, artificial flavourings are not found in nature

55
Q

T or F : artifical flavourings are almost always related structurally to naturally occuring flavouring substances

A

true

56
Q

Diacethyl, isoamyl acetate, benzaldehyde, limonene and methyl anthranilate are all examples of ____ flavours

A

natural and nature identical chemically known flavourings

57
Q

Cinnamyl acetera and butyrate occurs in ___ while cinnamyl proprionate is ___

A

cinnamyl acetetate and butyrate occurs in nature
cinnamyl proprionate : artificial known flavouring chemical

58
Q

T or F : the artificial chemical flavouring needs to be structurally related to the natrually occuring flavouring susbtances

A

false, it does not need to be chemically structurally related altgought most of the time it is the case

59
Q

vanilla extract obtained from the pods is an example of ____

A

natural flavour complexes which are in the category of flavouring that are mixtures from plants / animals

60
Q

how are natural flavour complexes obtained ?

A

from the extractons from animals or vegetables by physical, enzymes or fermented methods. They will be classified as natural

61
Q

T or F: most NFCs contain as many as 250 chemically identified volatile constituents with likely more to be discovered

A

true and a limited number of these constituents are responsible for the flavour effect of the NFC

62
Q

What are themral process flavourings ?

A

Produced by heating together substances which individually may not have flavouring properties (Maillard reaction). This process is similar to the changes that happen when a food is heated

63
Q

How is the safety evaluation of flavourings done ?

A

Based on a chemical group approach (FGE ; flavouring group evaluation)

64
Q

For using the flavouring group evaluation for the risk assessement of food flavourings, the _____ of the flavouring needs to be known

A

the chemical structure needs to be known so that the compound is placed within a group of compounds with similar structures or else EFSA needs to do the individual evaluation of the flavouring substance

65
Q

What si the group based evaluation (FGE) procedure for chemically defined flavouring substances

A
66
Q

the concept of ____ is used in the case of flavourings since they are used in low amounts

A

threshold of toxicological level

67
Q

The compounds are groupes in _____

A

3 different cramer class

68
Q

What are the different cramer classes

A
  • *Class I** : contains flavouring substances that have simple chemical structures and efficient modes of metabolism, which would suggest a low order of oral toxicity - TTC is 1800 µg / day
  • *Class II** : contains flavouring substances that have structural features that are less innocuous, but are not suggestive of toxicity - TTC is 540 µg / day
  • *Class III :** comprises flavouring substances that have structural features that permit no strong initial presumption of safety, or may even suggest significant toxicity - TTC is 90 µg/ day
69
Q

What is the purpose of classifying each flavourings in a cramer class

A

each cramer class has its own TTC (Threshold of toxicological concern) and it the exposure is below the TTC then there is no concern and no further testing needs to be done.

70
Q

T or F : the cramer class I is for compounds that are presumed to have a certain toxicity

A

false, that would be class III

71
Q

What are the assumptions about the threshold of toxicological concern TTC approach

A
  1. Certain exposure levels are insignificnt from the toxicological point of view
  2. Low level of exposure with negligible risk
  3. a compound has low priority if below the TCC
72
Q

T or F : the class III in the cramer class has the highest TTC

A

false, it is the class I since class I as low oral toxicity

73
Q

How is the TTC calculated for each cramer class ?

A

first the compound is classified inside a class based on its structure. The TTC is the fifth percentile NOEL (so 95% of the compounds within the class have higher NOEL) and then divided by 100 (UF)

74
Q

What was the argument of the GRAS use of diacetyl causing lung cancer

A

GRAS = safe at intendeduseand uselevels and resultinglevels of exposure

75
Q

Popcorn lung is caused by ____ and the medical condition is called ___

A

popcorn lung also called bronchiolitis obliterans (fibrosis / inflammation of the airways)
caused by diacetyl

76
Q

What is the read accross principle ?

A

if you do not have NOEAL for the componud you can use the NOAEL of other structurally related compounds.

77
Q

What can be done in the instance that the evaluated compound level of use exceed the TTC ?

A

The read accross principle

78
Q
A

Food Toxicology -TOX30306 (9 decks)

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