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India FSSAI Rescinds Importation Approval of 4 Hypoallergenic Infant Formula

On August 31st, FSSAI rescinded the import approval of 4 hypoallergenic baby products: Similac Total Comfort Optigro (Birth to 12 Months); Similac Total Comfort Intellipro 2 (for after 6 Months); NAN OPTIPRO HA 1 and NAN OPTIPRO HA 2.

On August 31st, 2018, the Food Safety and Standards Authority of India (FSSAI) issued a notice related to import of specialty foods for IEM disorders. Based on the recommendation of the Scientific Panel, this notice rescinded the importation approval of the following four products with immediate effect.

(a) Abbott Similac Total Comfort Optigro (Birth to 12 Months) [permitted in December 2017]

(b) Abbott Similac Total Comfort Intellipro2 (for after 6 Months) [permitted in December 2017]

(c) Nestle NAN OPTIPRO HA 1 [permitted in June 2017]

(d) Nestle NAN OPTIPRO HA 2 [permitted in June 2017]

Special foods for IEM and allergic conditions are not manufactured in India and as such in certain instances FSSAI permits importation of these foods which are detailed within positive lists of approved imported foods for special medical purpose (click here for details).

FSSAI's Scientific Panel has begun the work of developing standards for these special foods, however this is expected to be a lengthy process. In the interim, the Scientific Panel recommended that the import of special food products may be permitted by FSSAI for 2 years or until their standards are developed or notified, whichever is earlier. However in this instance the 4 products banned from import are not approved any more by the FSSAI.

Additionally, on June 29th, 2018, food business operators were directed to discontinue the use of 14 ingredients with immediate effect due to the lack of adequate data. Click here to read India Prohibits the Use of 14 Food Ingredients in Functional Foods.

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