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2017 Japan Revision of Collections of Quasi-drugs Additives Standards

  •   26 Dec 2017
  •    Jo Zhou
  •  969
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    • Japan has appended and revised collections of quasi-drug additive standards to include approved additives for quasi-drugs which haven't been listed on "Standards of Quasi-drug Ingredients 2006". The aim is to accelerate application review which is a prerequisite to quasi-drug manufacturing and marketing. Japan issued a "Collections of Quasi-drugs Additives Standards" in 2016.
    • In 2017, the Collection has been revised twice as follows:

    Revision of 2017.9.19

    Adding 9 ingredients to the Collection include:

    1. Otaka Enzyme [IB-0029]
    2. Calyx extract solution [IB-0030]
    3. Haelorno [IB-0031]
    4. Daisies flower extract [IB-0032]
    5. Bleu elastin [IB-0033]
    6. Bisethoxydiglycol cyclohexane dicarboxylate [IB-0034]
    7. (Eicosanedioic acid / tetradecanedioic acid) decaglyceryl solution [IB-0035]
    8. Diisostearic acid dimer linoleyl [IB-0036]
    9. Dihydrogenated rosin Die Merge Rino Rail [IB-0037]

    Revision of 2017.12.6

    Delete 1 ingredient from the Collection, and it will be effective on Jan.4th 2018:

    Calyx extract solution [IB-0030]

    In Japan, approved ingredients for quasi-drugs will be listed on "Standards of Quasi-drug Ingredients 2006", and the application for manufacturing or sale of certain quasi-drugs using listed ingredients can be simplified. There are some approved additives that haven't been listed in the Standard. In order to relieve the burden of applicants, Japan will append "Collections of Quasi-drugs Additives Standards" with these unlisted additives. Applicants do not need to fill out the content description in the application if using additives included in the Collection.

    The Collection records each additive's:

    (1) Reference number

    (2) Japanese name

    (3) Substitution, component content standard or labeling requirement

    (4) Properties

    (5) Confirmation test

    (6) Introduction value

    (7) Purity test

    (8) Drying loss, ignition residue, evaporation or moisture residue

    (9) Quantitative method

    (10) Reagent and reagent solution

    (11) Remarks

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