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WHO FOOD ADDITIVES SERIES 46:ANNEX 4

ACCEPTABLE DAILY INTAKES, OTHER
TOXICOLOGICAL INFORMATION, AND
INFORMATION ON SPECIFICATIONS

Substance

Specificationsa

ADI and other toxicological recommendations

Flavouring agents

 

 

Furfural

R

0–0.5 mg/kg bw (group ADI)b

Paprika oleoresin

S

Use as a spice is acceptablec

Food colours

 

 

Caramel colour II

Rd

0–160 mg/kg bw

Cochineal extract and carmines

R

May be allergenice

Sweetening agents

 

 

Aspartame–acesulfame salt

N

Aspartame and acesulfame moieties are covered by the ADIs established previously for aspartame (0–40 mg/kg bw) and acesulfame potassium (0–15 mg/kg bw)

D-Tagatose

N

No ADI allocatedf

Miscellaneous substances

 

 

Benzoyl peroxide

R

Additional uses could not be evaluatedg

Calcium intake from calcium

Could not be assessedh salts of food additives

Nitrous oxide

R

Use as a packaging gas could not be assessedi

Stearyl tartrate

R

Additional uses could not be evaluatedg

Trehalose

N

ADI ‘not specified’j

a N, new specifications prepared; R, existing specifications revised; S,specifications exist, revision not considered or required

b Group ADI for furfural, furfuryl alcohol, furfuryl acetate, furfuryl propionate, furfuryl pentanoate, furfuryl octanoate, furfuryl 3-methylbutanoate, methyl 2-furoate, propyl 2-furoate, amyl 2-furoate, hexyl 2-furoate, and octyl 2-furoate

c Paprika oleoresin was not evaluated at the present meeting. The opinion shown in the table was based on the report of the Committee at its fourteenth meeting (WHO Technical Report Series, No. 462, 1971).

d Included in the specifications for caramel colours

e The Committee concluded that cochineal extract, carmines, and possibly carminic acid in foods and beverages may provoke allergic reactions in some individuals.

f An ADI could not be allocated because of concern about the potential of D-tagatose to induce glycogen deposition and hypertrophy in the liver and to increase the concentrations of uric acid in serum.

g No conclusions could be drawn about the acceptability of the uses proposed in the draft General Standard for Food Additives of the Codex Committee on Food Additives and Contaminants because information on toxicity and intake was not available.

h Data on levels of use and the food groups in which calcium salts of food additives are permitted would be required in order to assess calcium intake from calcium salts of food additives.

i No information on intake was available.

j ADI ‘not specified’ is applied to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other) and the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effect and from its acceptable background in food, does not, in the opinion of the Committee, represent a hazard to health. For this reason, and for the reasons stated in the individual evaluation, the establishment of an ADI expressed in numerical form is deemed unnecessary.

Flavouring agents

Substances evaluated by the Procedure for the Safety Evaluation of Flavouring Agents

Flavouring agent

No.

Specificationsa

Conclusions based on current intake

Cinnamyl alcohol and related flavouring agents

Structural class I

3-Phenyl-1-propanol

636

N

No safety concern

3-Phenylpropyl formate

637

N

No safety concern

3-Phenylpropyl acetate

638

N

No safety concern

3-Phenylpropyl propionate

639

N

No safety concern

3-Phenylpropyl isobutyrate

640

N

No safety concern

3-Phenylpropyl isovalerate

641

N

No safety concern

3-Phenylpropyl hexanoate

642

N,T

No safety concern

Methyl 3-phenylpropionate

643

N

No safety concern

Ethyl 3-phenylpropionate

644

N

No safety concern

3-Phenylpropionaldehyde

645

N,T

No safety concern

3-Phenylpropionic acid

646

N

No safety concern

Cinnamyl alcohol

647

N

No safety concern

Cinnamyl formate

649

N

No safety concern

Cinnamyl acetate

650

N

No safety concern

Cinnamyl propionate

651

N

No safety concern

Cinnamyl butyrate

652

N,T

No safety concern

Cinnamyl isobutyrate

653

N

No safety concern

Cinnamyl isovalerate

654

N

No safety concern

Cinnamyl benzoate

760

N,T

No safety concern

Cinnamyl phenylacetate

655

N

No safety concern

Cinnamaldehyde

656

N,T

No safety concern

Cinnamic acid

657

N

No safety concern

Methyl cinnamate

658

N

No safety concern

Ethyl cinnamate

659

N

No safety concern

Propyl cinnamate

660

N,T

No safety concern

Isopropyl cinnamate

661

N

No safety concern

Allyl cinnamate

019

S

No safety concern

Butyl cinnamate

663

N,T

No safety concern

Isobutyl cinnamate

664

N

No safety concern

Isoamyl cinnamate

665

N

No safety concern

Heptyl cinnamate

666

N,T

No safety concern

Cyclohexyl cinnamate

667

N

No safety concern

Linalyl cinnamate

668

N,T

No safety concern

Terpinyl cinnamate

669

N,T

No safety concern

Benzyl cinnamate

670

N

No safety concern

Phenethyl cinnamate

671

N,T

No safety concern

3-Phenylpropyl cinnamate

672

N,T

No safety concern

Cinnamyl cinnamate

673

N,T

No safety concern

alpha-Amylcinnamyl formate

676

N,T

No safety concern

alpha-Amylcinnamyl acetate

677

N,T

No safety concern

alpha-Amylcinnamyl isovalerate

678

N,T

No safety concern

3-Phenyl-4-pentenal

679

N

No safety concern

3-(para-Isopropylphenyl) propionaldehyde

680

N

No safety concern

alpha-Amylcinnamaldehyde dimethyl acetal

681

N,T

No safety concern

para-Methylcinnamaldehyde

682

N

No safety concern

alpha-Methylcinnamaldehyde

683

N

No safety concern

para-Methoxycinnamaldehyde

687

N

No safety concern

ortho-Methoxycinnamaldehyde

688

N

No safety concern

para-Methoxy-alpha-methylcinnamaldehyde

689

N

No safety concern

Structural class II

Cinnamaldehyde ethylene glycol acetal

648

N,T

No safety concern

alpha-Amylcinnamyl alcohol

674

N

No safety concern

5-Phenylpentanol

675

N

No safety concern

alpha-Butylcinnamaldehyde

684

N

No safety concern

alpha-Amylcinnamaldehyde

685

N

No safety concern

alpha-Hexylcinnamaldehyde

686

N

No safety concern

Furfuryl alcohol and related flavouring agentsb

Structural class II

Furfuryl alcoholc

451

R

No safety concern

Furfuryl acetatec

739

N

No safety concern

Furfuryl propionatec

740

N,T

No safety concern

Furfuryl pentanoatec

741

N,T

No safety concern

Furfuryl 3-methylbutanoatec

743

N,T

No safety concern

Furfuralc

450

R

No safety concern

5-Methylfurfural

745

N

No safety concern

Methyl 2-furoatec

746

N

No safety concern

Propyl 2-furoatec

747

N

No safety concern

Structural class III

Furfuryl octanoatec

742

N,T

No safety concern

Amyl 2-furoatec

748

N,T

No safety concern

Hexyl 2-furoatec

749

N,T

No safety concern

Octyl 2-furoatec

750

N,T

No safety concern

2-Benzofurancarboxaldehyde

751

N

No safety concern

2-Phenyl-3-carbethoxyfuran

752

N,T

No safety concern

Phenol and phenol derivatives

Structural class I

Phenol

690

N

No safety concern

ortho-Cresol

691

N

No safety concern

meta-Cresol

692

N

No safety concern

para-Cresol

693

N

No safety concern

para-Ethylphenol

694

N

No safety concern

ortho-Propylphenol

695

N

No safety concern

para-Propylphenol

696

N

No safety concern

2-Isopropylphenol

697

N

No safety concern

4-(1,1-Dimethyl)ethylphenol

733

N

No safety concern

Phenyl acetate

734

N

No safety concern

ortho-Tolyl acetate

698

N,T

No safety concern

para-Tolyl acetate

699

N

No safety concern

ortho-Tolyl isobutyrate

700

N

No safety concern

para-Tolyl isobutyrate

701

N

No safety concern

para-Tolyl 3-methylbutyrate

702

N

No safety concern

para-Tolyl octanoate

703

N

No safety concern

para-Tolyl laurate

704

N,T

No safety concern

para-Tolyl phenylacetate

705

N

No safety concern

2,5-Xylenol

706

N

No safety concern

2,6-Xylenol

707

N

No safety concern

3,4-Xylenol

708

N

No safety concern

2,3,6-Trimethylphenol

737

N,T

No safety concern

Thymol

709

N

No safety concern

Carvacrol

710

N

No safety concern

para-Vinylphenol

711

N,T

No safety concern

Resorcinol

712

N

No safety concern

Guaiacol

713

N

No safety concern

ortho-(Ethoxymethyl)phenol

714

N

No safety concern

2-Methoxy-4-methylphenol

715

N

No safety concern

4-Ethylguaiacol

716

N

No safety concern

2-Methoxy-4-propylphenol

717

N

No safety concern

Guaiacyl acetate

718

N

No safety concern

Guaiacyl phenylacetate

719

N,T

No safety concern

Hydroquinone monoethyl ether

720

N,T

No safety concern

2,6-Dimethoxyphenol

721

N

No safety concern

4-Methyl-2,6-dimethoxyphenol

722

N

No safety concern

4-Ethyl-2,6-dimethoxyphenol

723

N,T

No safety concern

4-Propyl-2,6-dimethoxyphenol

724

N,T

No safety concern

2-Methoxy-4-vinylphenol

725

N

No safety concern

4-Allyl-2,6-dimethoxyphenol

726

N,T

No safety concern

2-Hydroxyacetophenone

727

N

No safety concern

Phenyl salicylate

736

N

No safety concern

4-(para-Hydroxyphenyl)-2-butanone

728

N

No safety concern

Dihydroxyacetophenone

729

N,T

No safety concern

Zingerone

730

N

No safety concern

4-(para-Acetoxyphenyl)-2-butanone

731

N

No safety concern

Vanillylidene acetone

732

N,T

No safety concern

Structural class III

2-Phenylphenold

735

N,T

No safety concern

Pulegone and related flavouring agents

Structural class I

 

 

 

Isopulegol

755

N

No safety concern

opulegyl acetate

756

N

No safety concern

Structural class II

Pulegone

753

N

No safety concern

Isopulegone

754

N

No safety concern

para-Menth-1,4(8)-dien-3-one

757

N

No safety concern

Menthofuran

758

N

No safety concern

a N, new specifications prepared; R, existing specifications revised; S, specifications exists, revision not considered or required; T, the existing new or revised specifications are tentative and information is needed

b Specifications were prepared for furfuryl butyrate, but its safety was not assessed because the Committee had no information on its intake.

c A group ADI of 0–0.5 mg/kg of body weight was established by the Committee at its present meeting for furfural, furfuryl alcohol, furfuryl acetate, furfuryl propionate, furfuryl pentanoate, furfuryl octanoate, furfuryl 3-methylbutanoate, methyl 2-furoate, propyl 2-furoate, amyl 2-furoate, hexyl 2-furoate, and octyl 2-furoate.

d An ADI of 0–0.4 mg/kg of body weight was established for 2-phenylphenol by the 1999 Joint FAO/WHO Meeting on Pesticide Residues (FAO Plant Production and Protection Paper 153, 1999)

Contaminants

Cadmium

The provisional tolerable weekly intake (PTWI) of 7 µg/kg bw was maintained. Ranges of predicted dietary intakes that may be associated with an excess prevalence of renal tubular dysfunction were estimated, as summarized in the following table. These values provide an indication of the risk of potentially sensitive groups within the population at various levels of exposure.

Urinary cadmium excretion and excess prevalence of renal tubular dysfunction in a population predicted according to three different sets of assumptions

Assumptions

Urinary excretion of cadmium (µg/g of creatinine)a

Predicted intake of cadmium

Predicted excess prevalence of renal tubular dysfunction (%)a

µg/dayb

µg/kg bw per day)b,c

Ratio of dietary intake to urinary excretion = 12

2.5

30

0.5

0

Bioavailability of cadmium in diet = 10%

4.2

50

0.8

4

Excretion of absorbed cadmium in urine = 100%

8.2

100

1.7

20

Ratio of dietary intake to urinary excretion = 24

2.5

60

1.0

0

Bioavailability of cadmium in diet = 10%

4.2

100

1.7

4

Excretion of absorbed cadmium in urine = 50%

8.2

200

3.3

20

Ratio of dietary intake to urinary excretion = 48

2.5

120

2.0

0

Bioavailability of cadmium in diet = 5%

4.2

200

3.3

4

Excretion of absorbed cadmium in urine = 50%

8.2

400

6.7

20

It is assumed that there is no significant change in the dietary intake of cadmium over time and 1.2 g of creatinine are excreted per day.

a Values derived primarily from studies of occupational exposure to cadmium

b Cadmium intake corresponding to the excretion in urine in each scenario

c Body weight assumed to be 60 kg. PTWI corresponds to a daily intake of 1 µg/kg bw.

Tin

The PTWI of 14 mg/kg bw was not reconsidered and was maintained. The Committee assessed the acute toxicity of tin, but the data were insufficient for establishing an acute reference dose. It reiterated the conclusion reached at its thirty-third meeting (WHO Technical Report Series No. 776, 1989) that concentrations of tin as low as 150 mg/kg in canned beverages and 250 mg/kg in other canned foods may produce acute manifestations of gastric irritation in certain individuals.
















    See Also:
       Toxicological Abbreviations

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