No. 3-16/ Specified Foods/Notification(Food Additive)/FSSAI-2014.—Whereas the draft of the Food Safety and Standards (Food Products Standards and Food Additives) (Amendment) Regulations, 2015, was published as required by sub- section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and Standards Authority of India number 3-16/ Specified Foods/Notification(Food Additive)/FSSAI- 2014, dated the 28th January, 2015, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of the period of sixty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas the copies of the said Gazette were made available to the public on the 17th February, 2015; And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India; Now, therefore, in exercise of the powers conferred by clause (e) of sub- section (2) of section 92 read with section 16 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations further to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely:- 1. Short title and commencement. – (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2016.

(2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, after regulation 2.13, the following regulations shall be inserted, namely:-

“2.14 Gluten Free Food.-

(1) Gluten free food consist of or is made of one or more ingredients containing rice, millets, ragi, pulses or legumes.

(2) It shall bear the label declaration referred to in sub-regulation 2.4.5 (50) of Food Safety and Standards (Packaging and Labelling) Regulations, 2011.

(3) A food which, by its nature, is suitable for use as part of a gluten free diet shall not be named as ‘special dietary’, “special dietetic” or any other equivalent term, however, such food may bear a statement on the label that ‘this food is by its nature gluten-free’.

(4) For the purpose of labelling of a product as gluten free, when such a product is analysed, the gluten levels shall be below 20 mg/kg as per the method declared by the Organization for Economic Co-operation and Development or the Association of Official Agricultural Chemists.

Provided that it complies with the essential composition provisions for Gluten Free food and such a statement does not mislead the consumer. 2.15 Food specially processed to reduce gluten content to a level 20 -100mg/kg.-

(1) This food consists of or are made of one or more ingredients which may contain rice, millets, ragi, oats, rye, barley, maize, wheat, pulses and legumes containing gluten content in range of 20 -100 mg/kg. (2) It shall bear the label declaration referred to in sub-regulation 2.4.5 (51) and (52) of Food Safety and Standards (Packaging and Labelling) Regulation, 2011.”