FAQs on Gazette notification of Food Safety and Standards (Fortification of Foods) Regulations, 2018 Food Safety and Standards (Fortification of Foods) Regulations, 2018 has been gazette notified on 2 August 2018, Keeping in view the various representations received seeking clarity on the gazette notification; for the purpose of ease of understanding the sald regulation followitg are the FAQs: Q.1. What is the date of compliance of these regulations? Food Business Operator (FO) shall comply with all the provisions ofthese regulations Dy January, 2019, (Q2:1s Fortification made mandatory forall FBOS or is it stil voluntary In India? Fortification of staples mentioned under Food Safety and Standards (Fortification of Foods) Regulations, 2018 is not mandatory. However, If any Food Business Operators ‘wants to fortify these commodities and use +P logo, then they shall fortity their products as per the standards specified under Food Safety and Standards (Fortification ‘of Foods) Regulations, 2018. Further, the fodization of salt is mandatory a per the provisions of Food Safety and Standarls (Prohibition and Restriction on sales) Regulations, 2018. However, wherever, the standards of any food praduct under “Food Safety and Standards Regulations’ prescribe for addition of particular vitamins/minerals as ¢ mandatory requirement of that particular standard, the samie shall be complied, but i such eases +F logo shall nt be used. Q3. Whether addition of nutrients (vitamins/minerals) other than the provided under Pood Safety and Standards (Fortification of Foods) Regulations, 2018 is permitted? ‘The Food Business Operator (FBO) can add nutrients other than the list provided under Food Safety and Standards (Fortification of Foods) Regulation, 2018, under the category ‘Proprietary food” in quantities not exceeding one RDA of the respective micronutrients, lowever, in that case, FBOs cannot use +F logo and term ther product as ‘Fortified, Q4. Whether after the enforcement of fortification regulations, addition of Vitamin A to Vanaspati is required or not? Ifyes, can these products be claimed as Fortified with Vitamin A"? Vanaspati shall conform to the standards specified under section 22.6 (1) of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011, However, these products cannot be claimed as ‘Fortified’ or use +P logo for is promotion, Q5. Is it mandatory to write the tag line of Fortification —" Sampoorna Poshan Swasth Jeevan” under the logo? No. Every package of fortified food shall earry the words “fortified With sx. (Name of the fortificant)” and the logo, specified in Schedule-Il of the Food Safety and Page 16t3,Standards (Fortification of Foods) Regulation 2018, on its label. Use of tag line “Sampoorna Poshan Swast Jeevan" under the logo is optional 6. What should be the unlt for Vitamin -A.& Vitamin-D in Nutritional Panel” 1st ‘mandatory to write the units in "ug" after L"Yanuary, 2019 or "1U"/"meg" can be written as before? As per the sub-egulation 2.2.2 (2) (i) of Food Safety and Standards (Packaging and Labeling) Regulations, 2011, wherever, numerical information on vitamins and minerals is declared, it shall be expressed in motric units. Further, for ease of convenience, the units may be mentioned as specified in the Food Safety and Standards (Fortification of Foods) Regulations, 2018. Q7. Under which category vitamins and minerals premixes used for food fortification can apply for lleense? Whether +P logo can be used on the package of such premixes? Premises of Vitamins ard minerals for use in fortification of foods are'not for direct constumption and are tc be added to the final formulation. Hence, the same can be licensed under the eatogpry 99:5: Nutrients and thelr preparations and +F logo cannot bbe used on the package o such premixes (Q8. Whether claims ean be made on the packages of fortified food articles? Food Safety and Standards Authority of India has Issued divection dated 22.12.2017 (Annexure-1) specifying the claims that can be mentioned when a food article Is fortified as per the provision made under Food Safety aud Standards (Fortification of Foods) Regulations, 2018. No other claims can be made onthe packages of fortified food articles, 9. Whether overages are allowed w ler this regulation? ‘The Food Safety and Standards (Fortification of Foods) Regulations, 2018 specifies the levels of nutrients in a range and thus, overages are not required, The food product samples should meot the requirements specified inthe aforesald regulations, whenever tested during the whole self ie (0.10. What isthe significance of +F logo? +F logo describes thatthe particular food is fortified with mleronutrients as per the levels specified by Food Safety and Standard Authority of india in the Food Safety and Standards (Portification of Foods) Regulations, 2018, Q.11. Whether the staples mentioned in this regulation need to comply other ‘essential parameters specified under Food Safety and Standards (Food Product ‘Standards and Food Additives) Regulations, 2011? Yes. Staples such as Salt Ol, Mill, Ric, Atta and Maida shall conform tothe standards specified under Food Safety and Standards (Food Product Standards and Food age 2013‘Additives) Regulations, 2011, in adltlon to the provisions specified under Food Safety and Standards (Fortiietion of Foods) Regulations, 2018, Q.12, Whether +F logo can be used on the packages of iodized salt (when fortified with jodiney? ‘As per the direction dated 24 August 2018, odized salt (when fortified with iadine) thas beon exempted from the mandatory requirement of use of + logo on fortified foods under Food Safety and Standards (Fortification of Foods) Regulations, 2018, Q.13. How to obtain + ogo? In order to obtain +F logo, an FBO must endorse the fortified staples via the Food Licensing and Registration System (FLRS) system of FSSAI. A direction on the same has been issued by FSSAL en 21.08.2010 (Annexure-2) Post the endorsement the open file of the +P logo will be available to the FBO for incorporating on the label of fortified products 14. Is there any additional declaration to be made on packages of fortified food products? Commodities which are fortified with iron as per the Food Safety and Standards (Fortification of Foods} Regulations, 2018 shall carry an additional declaration on the pack namely "People with Thalassemia may take under medial supervision” Pope 3f3Annexure - 4 Fite No.Standardsist Forint Riche Fouts} 4USOAE2017 (Par fet) Food Salety and Standards Authority of todia {A statwtory Autorty established under the Food Sfey and Stns Act, 2006) (Gtandards Division) FDA Bhawan, Kova Road, New Delhi - 110002 Sabject: Directions under section 16 (5) of Food Safety and Standards Act, 2006 regarding ‘Health Claims’ permitted under Food Safety and ‘Standards (Fortification of Foods) Regulations, 2016 - rep, ‘The Food Safety and Standards (Fortification of Foods) Hegulations, 2016" have been made operational with effect from 1610-2016 ‘Theseregultiosinclades the Standards for Wheat flout, Rice, Edible ol ile and Salt that may be fortified with Micronusrients like Vitamin A, Vitamin, Iron, Folic Ai Vitamin B12, Zine, Thiamine, Riboflavin, Niacin al Pyridoxine. 2 tn axder ta have uniformity in claims, the following, selentifeally substantiated heath claims are suggested, which may be used in broader Formior the above fortified foods against respective micronuteients fortified In ‘cordance with the above sad regulations: Nutrients [aims — Vitamin A | Helnsagast night blindness, Vitamin [Supports strong bones; Vitamin B12 | Tmpartane for maintaining normal Fanconi of nervous system and blood fo [Folate & Foicacid | important for fostal development and blood Formation lodine [Required for normal growth, tiyrok function; [Ribottavin Niacin 3. Further, the daims shall also comply with the provisions of Food Safety nd Standards Act, 2006 and regulations made thereuler specifically packaging and labelling requirements as laid down unvler the Food Safety and. Standards (Packaging and Labeling ) Regulations, 20114. This issues withthe approval ofthe Competent Authority in exercise ofthe power vested under Soetion 18 (2) ll 16 (5) Fo Safety ae Sadar Ae, 2006, et com Director (Reguanry Complanes) All Pood Safty Commissioner's All Designated Officer's all Authorised OMice's; ITO, FSSAL or uploading on website Copy for information to: {L PPS to Chairverson, PSSAK, 2, PS to CEO, FSSAI, 3 AMDirectors PSSAL age 22Annexure -2. Feo, .29034/FSSA/F16S-FLRS/ WORK IW 18/2016 Food Safety and Standart Authority of India tiepulatory Complance Doan) (jstautary Authontyestabised under Food Safety and Standards At, 2006) 2A nhawan, Kotla Road, New DsiN|~ 110002 ‘Data 2 August 2078 Subject: Fndorserent for 4F logo within the FLRS ~ rg, Sky Madam, Food Safety and Standrds (ortiiaton of Foods) Regulations, 2018 has been Gazette noted cated 2% August 2018. As per the regulation, every package of forte fou shall arr the logo on the label, as spelen the schedule IL of these regulations. " 2, To simplify he angoing process of +F Iago registration an the website of Food Fortification Resource Centre (FFRC), an endorsement procedure has boon integrated within the existing FLRS, wherein FBO wil be able to endorse thet Forti products and abtan COR file of #F lon, 3. All Food Business Operators (FB0s) engaged in manufacturing processing! and relabllng/eepacking? of foried food products shal endorse thr fortified food product in existing. Heense/ registration, The FBO= shall complete this lendorsement by 31% December 2018. The process Rowchart is attached a5 Innere 4. ‘This has the approval of the Competent authority. ‘Yours sincerely, a = apn Ne (Sanyeew Kumar) Deputy Director, Requstory Compliance (Commissioner of Food Safety ofall States/UTs (i) All Central Licensing Authority (ii) All Feed Business Operators Ww) CITO + You are requested to upload iton website and flash 3 trigger on FLRS inthis regare "ve wanda pzsaricot mara gt tr own nan then thy nat ke ie ‘father Replat 0 to eth poh lai by thi ys esProcedure of Endorsement for fortification and use of + loge For the use of FF logo 0» packs of frtifed commexdties for Wheat Four, Rice, Eble Ol, ‘Double Forties Salt and Mik the flloing procedure is toe followed, ‘This procedure 1s based on sel-complince and is created to simplify and structure the usage of + logo, 1, Alte Food Business Operators (FBOs) have to mandatory use +F logo If ‘hoy ae toting thelr products feommedties 3s per the Food Safety and ‘Standard (Frtfcaton of Foods) Regulations, 2016, 2. The FBOs fortying thelr product, shall undertake an endorsement by logging lito the FLAS with thelr existing username and passnord. The process Isas placed In Annexure 1 3. On fling of detals and submission of self compliance certificate, an ‘endorsement on the existing Hcense wil be generated online ismediately log with an CDR Me of the + ago 4, Tes requested that the FBO furnish thelr product pack shet for featuring on the FFRC website thereafter through email (tiesto ssa. goin.PROCESS FLOW CHART ANNEXURE 1 + STE 1 FURS ink 1 log in 10 the eating Heanse/_repstation, Migs /oodiensing fa aul ass ‘+ STEP 3 on Cling, Lens Regitaton Cerificate let wil be deplyed FO has to ‘lckon PROCEED against Lense/Registaton Cerificate num. ‘+ STEP 4 A pop-up wl open with a Undertaking. Only after cicking 7 AGREE" F80 can roceed futher+ STEPS Uso: commode ae per the 5S, standards of otto, repuin wil be played. FEO wil select the product nd enter the Varant'and Brand Home agaist selected category 1+ STE 6 Product deals along wth Foti Logo along wil be shen as endorsement menting tense number ‘Varn Toned Mik One Toned il Syaben Of Sone Ot