Mar 9, 2013

FSS ACT - Q & A

Q-1: Is the new Food Safety and Standards Act 2006 (FSSA) implemented?
Ans: Yes, on 5th August 2011, Food Safety and Standards Act 2006 is fully implemented.
Q-2: Which Acts/Orders related to food is repealed in FSSA, 2006?
Ans: The following Acts/Orders mentioned in second schedule of the Act are going to be repealed in Food Safety and Standards Act, 2006: 1. Prevention of Food Adulteration Act, 1954 2. Fruit Products Order, 1955 3. Meat Food Products Order, 1973 4. Vegetable Oil Products (Control) Order, 1947 5. Edible Oils Packaging (Regulation) Order, 1998 6.Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order, 1967 7. Milk and Milk Products Order, 1992 8. Any other order under Essential Commodities Act, 1955 relating to food The regulations under the above are integrated and published under Food Safety and Standards Rules and Regulations 2011 and are implemented on 5th August 2011.
Q-3: What are the new Rules and Regulations under FSSA?
Ans: Food Safety and Standards Rules 2011. FSS (Licensing and Registration of Food businesses) regulation, 2011 FSS (Packaging and Labeling) regulation, 2011 FSS (Food product standards and Food Additives) regulation, 2011 (part I) FSS (Food product standards and food additives) regulation, 2011 (part II) FSS (Prohibition and Restriction on sales) regulation, 2011 FSS (contaminants, toxins and residues) regulation, 2011 FSS (Laboratory and sampling analysis) regulation, 2011
Q-4: Is it applicable to only to manufacturers of food ?
Ans: No, it is applicable to all the people, who manufacture store, distribute food. It is also applicable to restaurants and street food vendors. It is applicable to all small, medium and large operators.
Q-5: Is it mandatory get a license under the new FSSA ?
Ans: Yes, under the new regime, all the Food Business Operators (FBO) should get a license. However, Petty Food Manufacturer (FBOs having annual turnover less than Rs. 12 lakh or small scale manufacturers with capacity less than 100kg/day temporary vendors etc..) just need to register using the Form A provided in the schedule 2 of FSS licensing and registration regulations along with requested documents /Fee.
Q-6: Where to get the license?
Ans: License for commencing or carrying on food business, which falls under Schedule 1, shall be granted by the Central Licensing Authority. All others will get a state license.
Q-7: How to apply for a license?
Ans: Food Business Operators seeking a central license may use the on-line facility to apply for a license using the FSSAI website or directly using the following link: http://fssai.net/cls/UserLogin/Login.aspx Print outs of the application and documents along with demand draft need to reach the Central licensing officer within 15 days of applying on-line. For state licenses, you may contact the nearest Designated Officer of your state. Fill in the form B provided in the Schedule 2 of FSS licensing and registration regulations along with requested documents /Fee and submit the application.
Q-8: I am a manufacturer with multiple manufacturing locations in many states. Do I need to get just one license as a company or one separate license to each of these locations.
Ans: You need one license for your Company registered office and one license to each of the manufacturing locations.
Q-9: I am a food manufacturer already licensed under the previous Prevention of Food Adulteration Act. Do I need to migrate to FSSA?
Ans: You need to migrate to the FSSA latest by 4th August 2012 even if the validity of your PFA (or FPO or MMPO) is beyond this date.
Q-10: Is there a minimum frequency of analysis under FSSA?
Ans: Yes, As per the licensing conditions of FSS licensing and registration regulations it mandatory to analyse all relevant parameters (chemical and microbiological) mentioned in the FSS Regulations at least once in six months.
Q-11: Can I analyse in my own laboratory as food manufacturer?
Ans: Yes, you can use your own laboratory or get is analyzed in an external but NABL accredited laboratory.
Q-12: I am just importing some food items and selling in India. Do I need a license from FSSAI?
Ans: All importers and exporters of food also need a Central license from FSSAI.
Q-13: What are the requirements of imported foods?
Ans: Refer to Importer's Corner of this site.
Q-14: What is the mode of payment to the FSSAI?
Ans: The payment can me made through a demand draft drawn in favour of "FSSAI, New Delhi" payable at Delhi.
Q-15: We are a manufacture of food additives only. Do we also need a license?
Ans: Yes, even food additive manufacturers need a license from FSSAI.
Q-16: We do no manufacture in India but just import and sell some food ingredients. Do we need a license from FSSAI?
Ans: Yes, You need to get a central license from FSSAI to import.
Q-17: We have a new food ingredient, which is not currently used in India. Which license will apply to us?
Ans: All food business operators manufacturing any article of food containing ingredients or substances or using technologies or processes or combination thereof whose safety has not been established through these regulations or which do not have a history of safe use or food containing ingredients which are being introduced for the first time into the country. Please note that you need to apply for product approval at FSSAI (HQ) separately before applying for license.
Q-18: We run a 100% export unit. Do we need a license?
Ans: Yes, you need to get a central license from FSSAI.
Q-19: We have a catering establishment and comes under the central Government. Do we need to get a license?
Ans: Yes, catering establishments, including central Government agencies like Railways, Airport, Seaport, Defense etc.. also need to get a license from FSSAI.
Q-20: Is there a specific format to get medical fitness certificate for employees of a food business operator?
Ans: Yes, FSSAI has issued a specific format for this purpose. Click here to download.
Q-21: I already have a blended vegetable oil license from Vegetable Oil Product Commission, Delhi. It is valid upto 2013. How do I get the license renewed?
Ans: The Vegetable Oil Products order is now repealed and integrated with the FSSA. Therefore even though a valid license under Vegetable Oil Product Order, you need to get a license under FSSAI before 4th August 2012. You need to follow one of the three conditions and take a license under FSSAI: If you process more than 2 MT per day you need to apply for a central license [Food safety and standard (licensing and Regulation of Food Businesses) Regulations 2011, Schedule I, Regulation 2.1.2(3)]
1. You need to be apply on-line using the link: http://foodlicensing.fssai.gov.in/UserLogin/Login.aspx
2. If you process upto 2MT per day and your annual turnover is more than Rs. 12 lakhs then you need to apply for a state license.
3. If your annual turnover is less than Rs. 12 lakhs, you just need to register under FSSAI ([Food safety and standard (licensing and Regulation of Food Businesses) Regulations 2011, Schedule I, Regulation 1.2.1(4b)]. For further details follow guidelines given in the website : http://foodlicensing.fssai.gov.in/UserLogin/Login.aspx
Q-22: Who should get a state license and who should get a central license?
Ans: Central and State licenses are obtained depending upon the product manufactured, turnover etc.. You may find the details given in the file: State-Central License.pdf
Q-23: My office & warehouse are in the same city. I do not keep any stock at my office. My entire stock lies in my warehouse. My question is for which location should I obtain a FSSAI license?
Ans: You need to get a State or Central license for your warehouse with that address. To check if you need a state or central license, you will need to go through this file.
Q-24: What will be the license formality if warehouse is in more then one place but within same locality (same nagarnigam area and same city)?
Ans: If the warehouses are at different locations, even if they are in the same city, you need to get a separate license for each one of them. However, if multiple warehouses are in the same campus, single license is applicable with campus address. You may use the online portal of FSSAI to send your application. Once this is done, the copy of the application with necessary documents need to be physically submitted at the state licensing authority (Designated Officer) within 15 days of the online application. If the warehouse locations are in different states you should apply for a central license (also do check with the conditions set by FSSAI for State/Central license).
Q-25: Is there any power to state government to refuse the implementation of FSSAI act in their state?
Ans: No. FSSAI acts are mandatory for all food business operators.
Q-26: We are importing non alcoholic cocktail mixers & cordials. Please advice on what licenses we have to get to operate our business on pan India basis.
Ans: In order to import these products you need to get an import license under FSSAI Central Licensing system. If you are also involved in storage and distribution activities, you will need a license for these as well (License as a distributor and License to Market/Sell). If you have multiple locations within India, you will need a separate license for each location/warehouse. Also refer to Q22 above.
Q-27: Does a transporter who transports food item along with other non food item within a single state from city to city or city to small towns have to obtain a FSSAI license.
Ans: Yes. Even transporter of food needs a license. While applying for license, you need to select "Transporter of food" in the application form. Also refer Q-22 above.
Q-28: What if my product is a proprietary product and uses Instant tea extract as an ingredient along with milk powder, sugar and spice powders. Do I have to go for product approval from FSSAI because I use Instant tea extract and there are no specifications covered in FSSAI for the same?
Ans: Yes. You need to get a pre-approval for your proprietary food which uses instant tea extract. If the product is existing please follow the procedure prescribed by FSSAI for proprietary food approval. If it is a new product the follow the procedure give on this file.
Q-29: When does one need to go for product approval at FSSAI headquarters?
Ans: You need to get a product approval if the product falls under the proprietary category or if the product is new/used for the first time in India or its safety is not evaluated or it is a novel food. However, FSSAI has exempted local cuisine and traditional foods like atta, suji, Dal, Savories like Samosa, Bhujia, Gulab Jamun etc..
Q-30: Who is exempted from licenses/registration of FSSAI (food business operator)?
Ans: Farmers who are the primary food producers are exempted under the FSSAI. Also people who prepare food for their household purposes are exempted.
Q-31: Whether sweets made of khoya/dryfruits like rassogulla/kajukatri is proprietary food as there is no specific standards of sweets under FSSAI. Also clarify about namkeens like kurkure/ bhujia/allo bhujia/sev and traditional Indian snacks available in namkeen shops?
Ans: Khoya and dry fruits have standards under FSSAI. However, Currently there is no standard for many foods and these products are considered proprietary foods, which includes namkeens and many traditional indian snacks. FSSAI has exempted these products from getting approval of proprietary foods.
Q-32: We manufacture mint for oral care products. Do we need to get FSSAI license?
Ans: If you have taken a drug license, then your product is considered as a drug and in that case, you do not require a food license. If not, it is covered under the food and you need to take a food license.
Q-33: Are wholesale/retail potatoes/onion/garlic/fruit/vegetable traders covered under the FSSAI act?
Ans: Onion, garlic, potato etc.. are foods and have quality standards under the regulations. If these food item samples are taken and tested they need to comply with the regulations. Also such traders, need to be licensed.
Q-34: Do retailers selling sweets and namkeens from their retail outlet (loose by weight in the presence of purchaser) have to obtain products approval as per law?
Ans: Yes, the recent advisory from FSSAI on pre-approval of proprietary foods mandates all proprietary foods to be pre-approved including the existing ones. However, industry is going to protest this and some solution may be provided soon by FSSAI.
Q-35: Can a proprietorship firm appoint a nominee under FSSAI act and also clarify who can appoint a nominee under the act?
Ans: No, FSSAI has exempted approval of local cuisine and traditional foods like atta, suji, Dal, Savories like Samosa, Bhujia, Gulabjamun etc.. which are commonly consumed in India. However, the retailers of these products also need a license or registration under FSSAI.
Q-36: While giving the sample of proprietary food (sweets & Indian snacks/savouriesor other item not standardised in the act) to food safety officer is it necessary by food business operator to mention all the ingredients used in the preparation of that particular item or are there any guidelines to be followed by food safety officer to draw sample of proprietary food?
Ans: As per the Food regulations, on all pre-packaged products, it is mandatory to provide all the ingredients in the product in the descending order of weight or volume. Also, it is mandatory to provide the category/standard to which the food belongs to. Basis the category or standard (or proprietary food) and the ingredients, the food safety officer will judge the compliance of the product. E.g. if a colour is used, whether or not it is allowed in that particular category etc. In case of products, which are not pre-packed the food manufacture need to provide its ingredients if a food safety officer takes a sample for testing, without, which he cannot judge the compliance of the product. There are no special guidelines as of now for proprietary foods to be followed by the food safety officers to draw samples.
Q-37: I wish to start an outdoor catering service in Mumbai. Do I need any permissions for that? If yes please let me know what all permissions do I require and the procedure for the same.
Ans: First of all you should get the permission from your municipality (No objection Certificate or NOC). You also need an NOC from the pollution control board of your area. with this you need to apply for the FSSAI License / registration for catering at the nearest Food Safety office (Designated officer). If you have vehicles to transport food, you will also need a FSSAI license/registration as transporter.
Q-38: I am transporter who provides tankers and vehicles to different dairys for the transport of raw milk as well as finished milk to different distributors across Gujarat. I have some doubts regarding the new FSSAI rules: What are the documents required to apply for the license? Is there any educational qualification required for the person operating transport business or handling the material?
Ans: You need to fill up the form B provided in the forms document. Also you need to provide the mandatory documents mentioned in this file. Go through and get ready for an inspection as per the check list provided in this document for the transporters. No, there is no specific qualification required for the transporter. However, you need to follow certain basic hygiene principles to ensure food safety. For example the requirements mentioned in the FSS licensing regulations (A. SANITARY AND HYGIENIC REQUIREMENTS FOR STREET FOOD VENDORS AND UNITS OTHER THAN MANUFACTURING/PROCESSING and General Requirements on Hygienic and Sanitary Practices to be followed by all Food Business Operators applying for License in Part II).
Q-39: I am purchasing Spirulina powder from manufacturer and filling it in capsules and marketing it in Tamil Nadu. Do I need to get product approval for the Spirulina capsule from FSSAI?
Ans: Yes. Since Spirulina does not have a standard under FSSAI, it needs to be pre-approved by FSSAI as a proprietary food. However, there is a possibility that FSSAI will say that it comes under 'drug' category and not under food.
Q-40: Does multivitamin and mineral capsule need product approval from FSSAI?
Ans: If it is only multivitamins and minerals it will come under drugs and not foods. However if these things are added to food, only then it would come under FSSAI license.
Q-41: We are planning to start small scale business/industry of Bhujiya (namkeen) manufacturing at Bikaner, Rajasthan Would like to have your guidance on licencing as I am not aware that what kind of licences are required.
Ans: First of all you should get the permission from your municipality, No objection Certificate or NOC. You also need an NOC from the pollution control board of your area. With this you need to apply for the FSSAI License at the nearest Food Safety office (Designated officer). If you have vehicles to transport food, you will also need a FSSAI license/registration as transporter.
Q-42: What is the rule regarding the tea bag pack size. In the market packs with tea bags varying from 1.3g (Tetleys) to 2g (Brook bond) are seen.
Ans: Under Legal Metrology Act, Tea can be packed in 25g, 50g, 100g, 125g, 250g, 500g, 1kg and thereafter in multiples of 1kg. There is no restriction on packs below 25g. Hence manufacturers are free to decide the quantity of tea in each tea bag.
Q-43: Is it necessary to give the nutritional information of the beverage prepared using 2g of tea in 100ml water, along with 100g information of the product?
Ans: When tea leaves are sold in retail, it is only mandatory to provide nutritional information of 100g of tea leaves and it is voluntary to provide the nutritional information of prepared 100ml of tea using 2g tea leaves. However, if the prepared tea is the product sold in retain (ready to drink), then it is important to provide nutritional information of this 100ml prepared tea.
Q-44: I want to market green tea with some herbs. I think it will it be a proprietary product. Do I need to apply/take NOC from FSSAI? Is it mandatory to write the licence no. on the pack? This product is not flavoured.
Ans: Yes, You need to get an NOC from FSSAI for this proprietary food. It is not yet mandatory to write the FSSAI license number on the pack.
Q-45: In Form 'B' question no. 4 asks For the name of a technically qualified person in charge of operations. I just want to know that would I also require to fill this as I will not be manufacturing food, I'll only be supplying food items.
Ans: FSSAI has clarified that Technical qualification is only applicable to the food manufacturers or processors. Hence you can write as Not Applicable or NA.
Q-46: How is the Indian food Code (category) relevant to a food manufacturer? Will it only help in understanding where his food products belong to? I guess this is a means to aid FSSAI to get to know from the number of Central /State Licensing applications that are there a huge or a small number of players in a particular category. Anyways this category numbers is not to be present on the packs. Please correct me if wrong.
Ans: Indian food code helps both the FSS authority and the food business operator to classify foods into a particular category. As of now, it is only useful to get the licenses. However, this may be useful to all in many ways including additive allocation to different foods, Indian food code document uploaded on the FSSAI site also says clearly that only proprietary foods under the category 13 requires pre-approval and other proprietary foods of other category does not require. Similarly for the category 99, it says, they need to get an FSSAI license if they are already under the FDA license. These are also some benefits to all. As of now, it is not necessary to print the category numbers on packs.
Q-47: Can I have the same pack for local and export? If not then what are the differences?
Ans: Labeling regulations may vary from one country to another. Hence before selling a product in a particular country, it is important to understand the labelling requirements of that country. However, it is possible to incorporate these requirements of different countries into one label. As most countries harmonize their labelling requirements with Codex, very few changes may require to sell in a new country. Hence, by incorporating the new requirements into the label meant for India, a common packaging material can be developed and then it is possible to sell in that country also.
Q-48: What is the process to apply for FSSAI License?
Ans: For the registration and license process under FSSAI, please follow the license scheme given in this powerpoint show.
Q-49: 1. I have a Coffee based powder product that needs to be reconstituted into 15g sachets packed in carton of 10 (total weight 150g). Can I continue to pack my product in the same way even after 31st October when the "Non-std size Rules 2011" will cease (150g doesn't fall under Schedule 2)? What are rules regarding MRP on such packs? How do I decide whether MRP is to be printed on individual sachets or only cartons with a statement saying individual sachets not to be sold loose? What if I want to have the liberty of selling both the sachets and the pack as a whole? In such cases how will 150g justify the schedule 2?
Ans: All powders to be reconstituted as beverages need to packed in standards sizes : No restriction below 50g then 75g, 100g, 200, 250g, 400g, 450g, 500g, 750g, 1kg and thereafter multiples of 1kg. Therefore, 15g sachet can be sold individually as there is no restriction on pack sizes below 50g provided it meets all other labeling requirements. A pack of 5 such 15g can also be sold as 15×5=75 and 75g is also a standard pack size. However 10 such packs cannot be sold in a carton and hence you need to stop this pack. Regarding the MRP, single sachet of 15 requires MRP on it as it is for retail sale. The exemption on MRP is only for packs weighing less than 10g under Legal Metrology Act. The carton with 5 packs also require MRP.
Q-50: I am planning to sell home cooked food items on carts in Delhi. What all permissions and licenses do I need to take and from which authorities. Kindly advise?
Ans: First of all you should get the permission from your municipality (No objection Certificate or NOC). You also need an NOC from the pollution control board of your area. With this you need to apply for the FSSAI License / registration for both manufacturing at home as well as for the cart, at the nearest Food Safety office (Designated officer).
Q-51: In Gujarat, village level primary milk producers societies are registered members of the district level dairy cooperative society (union) and supplies entire milk to such society (union). In this case can primary milk producers societies get exemption from registration under FSSA Regulations-2011?
Ans: Yes, members of a registered socieity supplying the entire quantity of milk to the society are exempted from taking a separate license/registration under FSSAI.
Q-52: If I am a dietary supplement manufacturer & I have to obtain an NOC from the centre after that I have also to apply for form-B now as it is the manufacturer's responsibility to maintain the chain till the retailer. How can a CFA (Carrying & Forwarding agent) come into the chain as CFA having 16 to 18 clients from both drug & food. Now how & when CFA apply & how they can come into the chain as manufacturer-storage-Supplier-Distributor-Wholesale-retailer. Please clarify the same.
Ans: In a food chain there are many players (manufacturers, wholesalers, distributors, transporters, retailers etc..) Each player in the food chain need to get a license under FSSAI. Each one has the responsibility to ensure that the produt is stored as per the conditions mentioned on the pack or required by the product. A manufacturer will ensure that the product is stored under the required conditions until it is in his control. Once it changes the hands from the manufacture to a distributor, then onwards the distributor is responsible for this and so on – It is a collective responsibility. However, the manufacturer should ensure that the distributor has the facilities/infrastructure to keep the product in the required conditions.
Q-53: There is a mention of Instant tea in the FSSAct with reference to the quantity of the sample to be collected and mention of Soluble tea in the Packaging and labelling guidelines saying that it being single ingredient need not have nutritional information on the pack .Soluble tea I assume is the same as Instant tea extract /Instant tea. But I couldn't find any Specifications for the either of them in the Act . .Can you please help? Also does a plain tea (unflavoured ) pack need to give the Nutritional information? How about the Flavoured tea? What should the Ingredient list of both these packs contain? Is it mandatory to give Instructions for use even on these packs?
Ans: Soluble tea and instant are the same. However, neither of the term is defined in the FSS regulations as of now. In other words, soluble tea is a proprietary food. However, it is clearly mentioned in the law that this product does not require printing of nutritional information on the packs. According to us, even for the plain tea or flavoured tea it is not necessary to give the nutritional information as this product is not consumed for nutrition, which is highlighted in the law. Further, the ingredients of plain tea is only tea leaves. Hence it is not mandatory to give the ingredients. However, for the flavoured tea , it is important to give the ingredients: Tea leave and also need to give a declaration on the flavor added. It is also important to note that flavoured tea needs a permission from the tea board.
Q-54: Is Stevia allowed to be used as table top sweetener/ in food products? If yes, where can I find the reference in FSS Act, its application in food products .If no ,then how come it is being sold ?
Ans: As of 20th August 2012, Stevia and its compounds are not allowed to be added in any food products in India. If you would like to use this you should make a request to FSSAI product approval committee with relevant safety documents. Current usage/selling, if any, is illegal.
Q-55: Is FSSAI number compulsory on packaging of food, oils etc?
Ans: As of 24th November 2012, the FSSAI License number is not made compulsory. A Notification is being finalized and will be published soon.
Q-56: Is license needed to deal with Spirulina algae powder (food supplement) and repacking the same under a brand name?
Ans: First, you need a NOC from FSSAI according to New Product Approval procedure. Then you need to apply for a central license online (refer to Q-7).

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