Page 82 - ELT_1st August 2020_Vol 373_Part 3

T50 EXCISE LAW TIMES [ Vol. 373

(i) New ingredients and additives recommended by the
Scientific Panel for inclusion in Nutraceutical regulations and
proposed to be included in the existing Schedules as per
Annexure-I of the earlier direction are allowed to continue to

be used in the existing formulations after 30th June, 2018 till
such time the proposed amendment, of the Nutraceutical
regulations in this regard are finalized and notified.
However, the Food Business Operators (FBOs) shall comply
with the provision with respect to permissible limits of
ingredients/additives as given at Annexure-I of the earlier
direction.
(ii) The earlier direction dated 29-12-2017 contained list of 33
ingredients, which were not recommended by the Scientific
Panel for inclusion in the Nutraceutical regulations due to
lack of data. The Scientific Panel has again reviewed the use
of these ingredients based on the additional data made
available by the FBOs and the following decisions have been
taken accordingly :
(a) FBOs are allowed to continue to use the ingredients
namely ‘S-acetyl glutathione (50 - 600 mg/day, Max)’
and ‘alpha cyclodextrin’ (already covered under
‘other fibre sources’ as mentioned in Schedule-VI,
Part B of the Nutraceutical regulations) in the
existing products covered under Nutraceutical
Regulations, till such time the proposed amendment
of the Nutraceutical regulations in this regard are
finalized and notified.
(b) FBOs are directed to discontinue the use of
ingredients namely ‘Succinic acid’ and ‘Inosine’ in
the products covered under Nufraceutical
Regulations with immediate effect as they are
withdrawn by the applicant and no further
manufacturing of products using these ingredients is
allowed. However, any such products containing
these ingredients which are already
manufactured/imported are allowed to be sold till
30th September, 2018.
(c) FBOs are directed to discontinue the use of
ingredients namely ‘Para-amino benzoic acid
(PABA)’. ‘Vanadium’, ‘Prenolit’ and ‘Selenium
dioxide’ in the products covered under Nutraceutical
Regulations which immediate effect due to safety
concerns and no further manufacturing of products
using these ingredients are allowed. Any produt
containing these ingredients which are already
manufactured/imported shall be withdrawn from
the market immediately.
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 Criteria given in para 3 of the direction issued vide ZF. No. 1-5/Nutraceuticals/FSSAI-2003,
dated 6th January, 2017.
EXCISE LAW TIMES  1st August 2020  82