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Subject
Date of the request
from risk managers

Date of publication

Conclusion      
Risk Assessment Report in English
Risk Assessment Report

Aluminium ammonium sulfate, aluminium potassium sulfate

21 March 2017 19 December 2017

2.1 mg/kg bw/week (as aluminium) for aluminium

Summary [PDF:123kb] RAR in Jspanese [PDF:1,868kb]
(3-Amino-3-carboxypropyl) dimethylsulfonium chloride
15 February 2011
12 May 2011
No safety concern when used as a flavoring agen
 
1-Methylnaphthalene
5 November 2014
19 May 2015
No safety concern when used as a flavoring agent
1-Penten-3-ol
2 February 2010
28 April 2010
No safety concern when used as a flavoring agent
 
2-(3-Phenylpropyl)pyridine
12 July 2010
7 October 2010
No safety concern when used as a flavoring agent
 
2,3,5,6-Tetramethylpyrazine
21 November 2003
27 May 2004
No safety concern when used as a flavoring agent
 
2,3,5-
Trimethylpyrazine
5 November 2004
17 March 2005
No safety concern when used as a flavoring agent
 
2,3-Diethyl-5-methylpyrazine
12 July 2010
7 October 2010
No safety concern when used as a flavoring agent
 
2,3-
Diethylpyrazine
13 February 2014
26 August 2014
No safety concern when used as a flavoring agent
2,3-
Dimethylpyrazine
8 February 2008
31 July 2008
No safety concern when used as a flavoring agent
2,5-
Dimethylpyrazine
8 February 2008
31 July 2008
No safety concern when used as a flavoring agent
 
2,6-
Dimethylpyrazine
8 February 2008
31 July 2008
No safety concern when used as a flavoring agent
 
2,6-
dimethylpyridine
14 May 2010
15 July 2010
No safety concern when used as a flavoring agent
 
2-Ethyl-3,(5 or 6)-
dimethylpyrazine
21 November 2003
27 May 2004
No safety concern when used as a flavoring agent
 
2-Ethyl-3-methylpyrazine
7 March 2005
18 August 2005
No safety concern when used as a flavoring agent
 
2-Ethyl-5-methylpyrazine
13 March 2009
08 October 2009
No safety concern when used as a flavoring agent
 
2-Ethyl-6-methylpyrazine
6 December 2010
31 March 2011
No safety concern when used as a flavoring agent
 
2-Ethylpyrazine
26 May 2008
27 November 2008
No safety concern when used as a flavoring agent
 
2-Methylbutanol
19 December 2005
12 October 2006
No safety concern when used as a flavoring agent
 
2-
Methylbutyraldehyde
16 October 2008
22 January 2009
No safety concern when used as a flavoring agent
 
2-
Methylpyrazine
26 May 2008
27 November 2008
No safety concern when used as a flavoring agent
 
2-Pentanol
16 October 2008
22 January 2009
No safety concern when used as a flavoring agent
 
3-
Ethylpyridine
15 June 2010
18 February 2013
No safety concern when used as a flavoring agent
 
3-
Methyl-2-butanol
13 March 2009
23 July 2009
No safety concern when used as a flavoring agent
 
3-
Methyl-2-butenal
10 September 2010
27 January 2011
No safety concern when used as a flavoring agent
 
3-
Methyl-2-butenol
2 February 2010
28 April 2010
No safety concern when used as a flavoring agent
 
5,6,7,8-
Tetrahydroquinoxaline
13 March 2009
27 August 2009
No safety concern when used as a flavoring agent
 
5-Ethyl-2-
methylpyridine
15 June 2010
26 August 2010
No safety concern when used as a flavoring agent
 
5-
Methylquinoxaline
7 March 2005
18 August 2005
No safety concern when used as a flavoring agent
 
5-Methylquinoxaline
(revision ofspecifications)
17 October 2012
22 October 2012
The substance and degree of adverse effects on human health are clear (article 11. 1. 2 of the Food Safety Basic Act)
 
5-
Methyltetrahydrofolic
acid calcium
2 August 2007
     
6,7-
Dihydro-5-methyl-
5H-cyclopentapyrazine
16 August 2010
27 January 2011
No safety concern when used as a flavoring agent
 
6-Methylquinoline
21 November 2008
21 May 2009
No safety concern when used as a flavoring agent
Acesulfame Potassium
3 July 2003
28 August 2003
15 mg/kg bw per day (ADI)
 
Acetaldehyde
21 November 2003
21 July 2005
No safety concern when used as a flavoring agent
Advantame
2 April 2012
30 July 2013
5.0 mg/kg bw per day (ADI)
Aluminium calcium silicat
15 August 2005
     
Ammonium alginate
28 March 2005
30 March 2006
ADI not specified
 
Ammonium isovalerate
28 February 2011
18 February 2013
No safety concern when used as a flavoring agent
 
Amyl alcohol
5 November 2004
17 March 2005
No safety concern when used as a flavoring agent
 
Aqueous solution of hypobromous Acid
5 June 2015
10 November 2015
ADI not specified
 
Asparginase produced
using the Aspergillus
niger ASP-72 strain
27 September 2012
27 January 2014
ADI not specified
Azoxystrobin
7 October 2011
15 March 2012
0.18 mg/kg bw per day (ADI)
 
biotin
31 July 2013
20 January 2014
ADI not specified
 
Butanal
19 December 2005
22 March 2007
No safety concern when used as a flavoring agent
 
Butanol
7 March 2005
22 September 2005
No safety concern when used as a flavoring agent
 
Butylamine
14 September 2009
4 March 2010
No safety concern when used as a flavoring agent
 
Calcium Acetate
26 April 2011
15 April 2013
ADI not specified
 
Calcium alginate
28 March 2005
30 March 2006
ADI not specified
 
Calcium L-Ascorbate
3 October 2005
19 June 2008
ADI not specified
Calcium Oxide
26 April 2011
15 April 2013
ADI not specified
 
Calcium silicate
15 August 2005
26 July 2007
ADI not specified
Calcium Sorbate
20 March 2007
20 November 2008
25mg/kg bw per day as sorbic acid (Group ADI as the sum of sorbic acid and calcium, potassium sorbates)
Calcium stearate
4 March 2004
29 July 2004
ADI not specified
 
Canthaxanthin
26 April 2011
14 October
2014
 
Carmine
19 April 2011
     
Chlorous acid
aqueous solution
14 August 2006
19 June 2008
0.029 mg/kg bw per day as chlorite ion (ADI)
 
Chlorous acid
aqueous solution
2 April 2012
09 July 2012
0.029 mg/kg bw per day as chlorite ion (ADI)
Copper Gluconate
2 December 2003
27 May 2004
9 mg/person per day as copper (UL)
 
d-and dl
-alpha-Tocopherol Acetate
15 October 2004
19 December 2005
(withdrawn)
   
d-and
dl-alpha-Tocopherol Acetate
19 December 2005
21 September 2006
ADI not specified
 
Deletion of
specifications for
existingadditives
31 March 2011
7 April 2011
Assessment is explicitly unnecessary (article 11. 1. 1 of the Food Safety Basic Act)
 
Dimethyl dicarbonate 11 January 2018 29 January 2019 No safety concern when used as a food additive Abstract [PDF:195kb] RAR in Japanese [PDF:1,718kb]
Fludioxonil
21 November 2008
16 July 2009
0.33 mg/kg bw per day (ADI)
 
Fludioxonil
21 April 2011
30 June 2011
0.33 mg/kg bw per day (ADI)
 
Glutamyl-
valyl-glycine
12 December 2012
5 August 2013
ADI not specified
 
Glycerol
ester of wood rosin
29 August 2006
3 February 2009
(withdrawn)
   
Hydrogen peroxide
22 May 2012
23 February 2016
ADI not specified
 
Hydroxypropyl
cellulose
16 August 2004
10 March 2005
ADI not specified
 
Hydroxypropyl methylcellulose
26 April 2005
24 August 2006
ADI not specified
 

Hypobromous Acid Water

22 August 2018 2 October 2018 No safety concern when used as a food additive Abstract [PDF:157kb] RAR in Japanese [PDF:1,415kb]
Hypochlorous Acid Water
31 January 2005
25 January 2007
No safety concern when removed before yielding the final products
 
Isoamyl alcohol
5 November 2004
17 March 2005
No safety concern when used as a flavoring agent
 
Isobutanal
19 December 2005
7 December 2006
No safety concern when used as a flavoring agent
 
Isobutanol
21 November 2003
27 May 2004
No safety concern when used as a flavoring agent
 
Isobutylamine, Isopropylamine, sec-Butylamine, Propylamine, Hexylamine, Pentylamine and 2-Methylbutylamine 1 December 2017 29 May 201 No safety concern when used as a flavoring agent Abstract [PDF:180kb]  
Isopentylamine
14 August 2009
12 November 2009
No safety concern when used as a flavoring agent
 
Isopropanol
15 December 2003
9 December 2004
No safety concern when used as a flavoring agent
 
Isopropanol
26 April 2011
29 March 2012
ADI not specified
 
Isopropanol
16 May 2013
27 May 2013
ADI not specified
 
Isoquinoline
29 October 2010
03 February 2011
No safety concern when used as a flavoring agent
 
Isovaleraldehyde
20 March 2007
27 March 2008
No safety concern when used as a flavoring agent
Kojic acid
3 July 2003
24 July 2003
Not acceptable
 
L-Ascorbic
Acid 2-Glucoside
1 July 2003
25 September 2003
ADI not specified
 
Madder color
18 June 2004
2 July 2004
No ADI allocated
Magnesium Oxide
3 July 2003
31 July 2003
ADI not specified
 
Magnesium
Carbonate
3 July 2003
31 July 2003
ADI not specified
 
Magnesium hydrogen
phosphateTrihydrate
28 March 2005
22 March 2012
ADI not specified
 
Magnesium hydroxide
09 March 2006
1 November 2007
ADI not specified
Magnesium silicate
(synyhetic)
15 August 2005
21 January 2010
0.3 mg/kg bw per day (ADI)
Magnesium Stearate
3 July 2003
31 July 2003
ADI not specified
 
Magnesium Stearate 26 May 2016 15 November 2016 ADI not specified Summary [PDF:113kb] RAR in Japanese [PDF:819.37kb]
Methyl Hesperidin
3 July 2003
24 July 2003
No safety concern caused by the revision of content specification
 
Modified Starch
(limited toAcetylated Distarch Adipate,
AcetylatedDistarch Phosphate,
Acetylated Oxidized Starch, StarchSodium Octenyl
Succinate,Starch Acetate,Oxidized Starch,Hydroxypropyl Starch, HydroxypropylDistarch Phosphate,Phosphated Distarch Phosphate,Monostarch Phosphate,
26 November 2004
29 November 2007
ADI not specified
 
Monoammonium L-Glutamate
22 May 2006
13 March 2008
ADI not specified
Natamycin (Pimaricin)
20 October 2003
6 May 2005
0.3 mg/kg bw per day (ADI)
 
Neotame
31 January 2005
19 October 2006
1.0 mg/kg bw per day (ADI)
Nisin
20 October 2003
31 January 2008
0.13 mg/kg bw per day (ADI)
 
Nitrous oxide
20 October 2003
9 December 2004
ADI not specified
 
Peracetic Acid Preparation and Its Chemical Components (Peracetic Acid, 1-Hydroxyethylidene-1,1-diphosphonic Acid, Octanoic Acid, Acetic Acid and Hydrogen Peroxide)
20 November
2013
30 June 2015
No concern relevant to human health as long as used appropriately as additives.
 
Phenethylamine
10 November 2009
18 March 2010
No safety concern when used as a flavoring agent
 
Piperidine
15 March 2010
20 May 2010
No safety concern when used as a flavoring agent
 
Polysorbate 20, 60, 65, 80
8 October 2003
7 June 2007
10 mg/kg bw per day (Group ADI as the sum of polysorbate 20, 60, 65 and 80
Polyvinylpyrroridone (Povidone)
21 June 2005
30 July 2013
ADI not specified
Potassium alginate
28 March 2005
30 March 2006
ADI not specified
 
Potassium lactate
06 February 2007
21 January 2013
ADI not specified
 
Potassium sulfate
19 April 2011
21 January 2013
ADI not specified
 
Propanol
21 November 2003
9 September 2004
No safety concern when used as a flavoring agent
 
Propionaldehyde
21 November 2008
2 April 2009
No safety concern when used as a flavoring agent
 
Protein-glutaminase
2 August 2007
     
Pyrazine
16 August 2010
6 January 2011
No safety concern when used as a flavoring agent
 
Pyrimethanil
10 May 2010
7 June 2012
0.17 mg/kg bw per day (ADI)
 
Pyrrole
4 January 2011
31 March 2011
No safety concern when used as a flavoring agent
 
Pyrrolidine
5 April 2010
3 June 2010
No safety concern when used as a flavoring agent
 
Revision of criteria for use of Hydrogenperoxide
10 February 2012
16 February 2012
It is not concluded as "Assessment is explicitly unnecessary "
 
Revision of Japanese Standards of FoodAdditives
31 October 2006
16 November 2006
Assessment is explicitly unnecessary (article 11. 1. 1 of the Food Safety Basic Act)
 
Revision of Japanese Standards of FoodAdditives
18 January 2006
31 October 2006
(withdrawn)
   
Revision of Specifications and Standards forFood and Food Additives, etc.
31 October 2006
21 December 2006
No concern for food safety
 
Revision of Specifications and Standards forFood and Food Additives, etc.
18 January 2006
31 October 2006
(withdrawn)
   
Revision of testing methods in compositionalstandards of Neotame
22 September 2008
25 September 2008
Assessment is explicitly unnecessary (article 11. 1. 1 of the Food Safety Basic Act)
 
Revisions of specifications and standardsrelated to designation of Saccharin calsium
20 February 2012
23 February 2012
Assessment is explicitly unnecessary (article 11. 1. 1 of the Food Safety Basic Act)
 
Saccharin calcium hemiheptahydrate
22 May 2006
25 August 2011
3.8mg/kg bw per day as saccharin (Group ADI as the sum of saccharin, saccharin calcium and sodium saccharin)
 
Sodium alginate
28 March 2005
30 March 2006
ADI not specified
 
Sodium Aluminium Phosphate, Acidic
26 April 2011
     
Sodium aluminosilicate
15 August 2005
     
Sodium Chlorite
20 October 2003
18 November 2004
0.029 mg/kg bw per day as chlorite ion (ADI)
 
Sodium chlorite
12 March 2013
18 March 2013
The substance and degree of adverse effects on human health are clear (article 11.1.2 of the Food Safety Basic Act)
 
Sodium chlorite
12 August 2015
22 December 2015
0.025 mg/kg bw per day (ADI)
 
Sodium Chlorite (Revision of criteria foruse)
16 April 2009
23 July 2009
0.029 mg/kg bw per day as chlorite ion (ADI)
Sodium Saccharin(Saccharin sodium,Saccharin)
29 November 2011
15 December 2011
3.8 mg/kg bw per day as saccharin (ADI)
 
Sodium selenite
6 November 2015
17 November 2015
 
Sodium Stearoyl Lactylate
6 February 2007
10 July 2008
20 mg/kg bw per day (ADI)
Standard preparation of tar dye
6 April 2004
08 April 2004
Assessment is explicitly unnecessary (article 11. 1. 1 of the Food Safety Basic Act)
 
Sulfites (Potassium Pyrosulfite)
3 July 2003
25 September 2003
No safety concern
 
Sulfites (Sodium Hyposulfite)
3 July 2003
25 September 2003
No safety concern
 
Sulfites (Sodium Pyrosulfite)
3 July 2003
25 September 2003
No safety concern
 
Sulfites (Sodium Sulfite)
3 July 2003
25 September 2003
No safety concern
 
Sulfites (Sulfur Dioxide)
3 July 2003
25 September 2003
No safety concern
 
Sunflower lecithin
2 April 2012
30 July 2013
ADI not specified
 
Tar Color
3 July 2003
25 September 2003
No safety concern caused by the revision of specification
 
trans-2-Methyl-2-butenal
4 January 2011
21 April 2011
No safety concern caused by the revision of specification
 
trans-2-Pentenal
29 October 2010
1 December 2011
No safety concern caused by the revision of specification
 
Triethyl Citrate
26 April 2011

17 February

2015

ADI not specified Abstract[PDF:77.45kb]
Trimagnesium Phosphate
3 July 2003
31 July
2003
No safety concern
 
Trimethylamine
30 November 2009
29 July 2010
No safety concern when used as a flavoring agent
 
Valeraldehyde
20 March 2007
27 March 2008
No safety concern when used as a flavoring agent
Zinc Gluconate
2 December 2003
27 May 2004
30 mg/person/day as zinc (UL)
 
Zinc Gluconate
17 April 2014
13 January 2015
0.63mg/kg bw/day as zinc (UL)
 
Zinc sulfate
21 January 2015
15 September 2015
0.63mg /kg bw/day as Zinc (UL)
 
β-apo-8'-Carotenal
19 April 2011
25 November 2013
0.05 mg/kg bw per day (ADI)
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