Chemistry Reference
In-Depth Information
Process of the designation of food additives
Diagram
Ministry of health,
labor, and welfare
Food safety
commission
Request
Confirmation of application
Risk assessment
Chronic toxicity study
Carcinogenicity study
Teratogenicity study
Hearing of opinions
Food safety basic law
Obtainment of documents*
Council (subcommittee)
(Discussion on draft standards)
Public comments
Report/
recommendation
Establishment of
ADI
WTO notification
public comments
3-4 months
Council
(Food sanitation committee
report)
Revision of regulations
Regulations will be enforced
on the date of announcement
or a few months after that date.
Enforcement
Figure 10.1
designation of the food additives process in Japan. (adapted from Japan Food Chemicals
Research Foundation, Japanese guidelines. annex 5: The guidelines for designation of food
additives, and for revision of standards for use of food additives (Excerpt), 1-11, 2010. With
permission.)
d.
Toprovideaidsinthemanufacture,processing,preparation,treatment,packing,transport,or
storageoffood,providedthatthefoodadditiveisnotusedtodisguisetheeffectsoftheuseof
faultyrawmaterialsorofundesirable(includingunhygienic)practicesortechniquesduringthe
courseofanyoftheseactivities.
Thosewhowishtoapplyforthedesignationofafoodadditiveortoapplyfortherevisionof
standardsfortheuseofafoodadditivemaysubmitanapplicationtotheMinisterofHealth,Labor,
andWelfare.Theapplicationshouldbeaccompaniedbyanyrequireddocumentationondraftspeci-
icationsandusestandardsandthesafetyofthefoodadditive.
TheJapanFoodChemicalsResearchFoundation(2010)haslistedthedesignatedadditivesin
Table10.2,asmentionedinArticle12oftheEnforcementRegulationsundertheFoodSanitation
Law.Theseadditivesarelistedinalphabeticalorder.Thereare411intotalasof13December2010.
Thenumberprecedingthenameofeachadditiveisthesequencenumbergiventothecorrespond-
ingadditiveintheoriginalJapanesetable.Amongthoseadditives,anumberofadditivesarelisted,
includingACSK,ASP(α-l-aspartyl-l-phenylalaninemethylester),disodiumglycyrrhizinate,man-
nitol,neotame,SAC,d-sorbitol,SCL(trichlorogalactosucrose),andxylitol.
Table10.2showsthedocumentationrequiredinJapantoapplyforthedesignationoffoodaddi-
tivesandfortherevisionoftheirstandardsforuse.
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