Food additives
Risk assessment by risk manager's mandate
|
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 |
Food Safety
|
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 Hydrogen Sulfite Water | 18 February 2020 | 8 December 2020 | ADI not specified | Abstract[PDF:277kb] | RAR in Japanese[PDF:1,806kb] |
|
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)
|
||
| Azoxystrobin | 31 July 2019 | 10 March 2020 | 0.18 mg/kg bw per day (ADI) | Abstract[PDF:139kb] | RAR in Japanese[PDF:944kb] |
|
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 Carbonate (2nd edition) | 9 October 2019 | 16 June 2020 | No concern for the food safety as long as used appropriately as a food additive | Abstract[PDF:101kb] | RAR in Japanese[PDF:1,735kb] |
|
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
|
||||
| Chitin-glucan | 18 February 2020 |
17 November 2020
|
No safety concern when used appropriately as food additive | Abstract[PDF:280kb] | RAR in Japanese[PDF:647kb] |
|
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)
|
|
RAR in Japanese[PDF:61.7kb] |
|
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] |
| Dipotassium DL-Tartrate | 9 October 2019 | 15 September 2020 | No safety concern when used appropriately as an additive | Abstract[PDF:276kb] | RAR in Japanese[PDF:649kb] |
| Dipotassium L-Tartrate and Metatartaric acid | 9 October 2019 | 18 August 2020 | 24 mg/kg bw per day (L-tartaric acid) (ADI) | Abstract[PDF:269kb] | RAR in Japanese[PDF:1,169kb] |
|
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 2018 | No safety concern when used as a flavoring agent |
Food Safety
|
RAR in Japanees[PDF:1,595kb] |
|
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 | 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
|
||
| Polyvinyl alcohol | 22 June 2022 | 7 June 2023 | ADI not specified | Abstract[PDF:237kb] | RAR in Japanese[PDF:460kb] |
| Polyvinylimidazole - polyvinylpyrrolidone copolymers (PVI/PVP copolymer) | 18 February 2020 | 8 December 2020 | ADI not specified | Abstract[PDF:247kb] | |
|
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
|
||||
| Psicose Epimerase | 11 October, 2018 | 26 March, 2019 | ADI not specified | Abstract[PDF:143kb] | |
|
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 for Food and Food Additives, etc.
|
31 October 2006
|
21 December 2006
|
No concern for food safety
|
||
|
Revision of Specifications and Standards for Food 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)
|
