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Packaging, Label claims. Regulatory aspects of nutraceutical products in India.

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Packaging, Label claims. Regulatory aspects of nutraceutical products in India.

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Packaging,
label claims.
regulatory aspects of nutraceutical products in India.
INTRODUCTION (Packaging)
TYPES OF PACKAGING
Objective of Packaging
Consideration for packaging
FUNCTIONS OF PACKAGING
Factors for package design in international market
Introduction (Labelling)
Function of labels
Objective of labeling
Which Information Is Mandatory
Contents in a Nutraceutical label
Definition of Nutrition Claim/s
Definition of Health Claim/s
New FDA Labeling Requirements
Regulation of Nutraceuticals in India
Food Safety and Standards Authority of India (fssai)
Regulatory Requirements in India
Registration Process in India

Packaging,
label claims.
regulatory aspects of nutraceutical products in India.
INTRODUCTION (Packaging)
TYPES OF PACKAGING
Objective of Packaging
Consideration for packaging
FUNCTIONS OF PACKAGING
Factors for package design in international market
Introduction (Labelling)
Function of labels
Objective of labeling
Which Information Is Mandatory
Contents in a Nutraceutical label
Definition of Nutrition Claim/s
Definition of Health Claim/s
New FDA Labeling Requirements
Regulation of Nutraceuticals in India
Food Safety and Standards Authority of India (fssai)
Regulatory Requirements in India
Registration Process in India

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Packaging, Label claims. Regulatory aspects of nutraceutical products in India.

  1. 1. Packaging, label claims. Regulatory aspects of nutraceutical products in india Prepared By: MOHAMMAD KHALID (Assistant Professor) Krishna Pharmacy College, Bijnor (UP)
  2. 2. contentINTRODUCTION (Packaging) TYPES OF PACKAGING Objective of Packaging Consideration for packaging FUNCTIONS OF PACKAGING Factors for package design in international market Introduction (Labelling) Function of labels Objective of labeling Which Information Is Mandatory Contents in a Nutraceutical label Definition of Nutrition Claim/s Definition of Health Claim/s New FDA Labeling Requirements Regulation of Nutraceuticals in India Food Safety and Standards Authority of India (fssai) Regulatory Requirements in India Registration Process in India
  3. 3. INTRODUCTION Packaging is a process of covering, wrapping of goods into a package. Packaging involves designing & producing the wrapper for a product. Packaging is next to grading and branding Packaging is essential for Offering goods in safe, and secured position to consumer
  4. 4. TYPES OF PACKAGING Primary Packaging: The material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. Secondary Packaging: Secondary packaging is outside the primary packaging, perhaps used to group primary packages together. Tertiary packaging: Tertiary packaging is used for bulk handling, warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers.
  5. 5. TYPES OF PACKAGING Designed for consumer- convenience & appeal, marketing consideration & display The main emphaises- Is on marketing CONSUMER PACKAGING INDUSTRIAL PACKAGING • Industrial packaging is- focuses on the handling convenience & protection during transportation • The main emphaises- is on logistics
  6. 6. Objective of Packaging Physical protection: The objects enclosed in the package may require protection from, among other things, shock, vibration, compression, temperature etc. Eg : Egg, Bottles. Barrier protection: A barrier from oxygen, water vapor, dust, etc., is often required. Controlled atmospheres are also maintained in some food packages, keeping the contents clean & fresh. Eg: Fruits, Vegetables
  7. 7. Continue….. Containment or Agglomeration: Small objects are typically grouped together in one package for reasons of efficiency. Eg: Chocolates, Biscuits Marketing: The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. Package graphic design and physical design have been a important phenomenon. Eg: Chips, Biscuits
  8. 8. Continue….. Security: Packages can be made with improved tamper resistance to deter tampering and also can have tamper evident features to help indicate tampering. Eg: Coke drinks, water bottles. Convenience: Packages can have features that add convenience in distribution, handling, stacking, display, sale, opening, reclosing, use, dispensing, and reuse. Eg: Sauce, Jam
  9. 9. Continue…. Portion control: Single serving packaging has a precise amount of contents to control usage. Commodities can be divided into packages that are a more suitable size for individual households. Eg: Milk, Ice creams
  10. 10. Consideration for packaging Prevention - Use packaging where needed Minimization – Minimize mass & Volume Reuse - Encourage reuse of packages Recycling - Reprocess materials into new products Disposal - Use disposable, eco-friendly packages
  11. 11. FUNCTIONS OF PACKAGING PRIMARY FUNCTION Presentation Convenience Economy Preservation Protection
  12. 12. Primary functions……… PRESENTATION: Presentation of product should be attractive & eye catching.
  13. 13. PROTECTION: Protection increases life cycle of a product PRESERVATION: It preserves original colours, Quality, favour etc. ECONOMY: Packaging of a product should be economy CONVENIENCE: Packaging should be light to handle
  14. 14. Secondary Function Identification Labeling SuitabilityHandling Containment
  15. 15. Secondary function Containment: Premeasured, preweight and then placed in box Identification: Packaging helps to indentify the products easily Labeling: It helps to promote the sale of goods Handling: When package is light in weight it facilitate easy handling of cargo Suitability: Packaging should be match with the product
  16. 16. Factors for package design in international market Physical characteristics Language, colour and size Economy Container Convenience
  17. 17. Indian institute of packaging The Indian institute of packaging was setup in Mumbai on 14th may 1966. Indian institute of packaging is a registered body under the societies registration Act Laboratories are in Delhi , Chennai & Kolkata
  18. 18. Role of IIP in export packaging Grapes
  19. 19. Labeling
  20. 20. Introduction Labeling is any written, electronic, or graphic communications on the packaging or on a separate but associated label. Display of information about a product on its container, packaging, or the product itself.
  21. 21. Introduction…… Label :- ( As per IP) Any printed packing material, including package inserts that provide information on the article The oxford dictionary defines a label as “a slip of paper, card, liner, metal for attaching to an object and indicating its nature, owner, name,etc
  22. 22. Function of labels To identify the product Provide ingredients Purpose /use of the product Decoration as evidence Child safety Other information like maximum retail price(MRP), Batch NO, Shelf-life, etc
  23. 23. Objective of labeling Brand Identification: Labeling helps in the identification and principal place of business of the person by or for whom the prepackaged product was manufactured, processed, produced or packaged for resale
  24. 24. CONTINUE….. Description: Labels provide the information regarding the food product. It describes the contents, nutritional values, cost, product usage methods, shelf life etc
  25. 25. CONTINUE…. Promotion: Finally labels helps in promoting the product through attractive and bright graphics replacing paper labels glued on cans and bottles.
  26. 26. Who uses product labeling Pharmaceutical Food Personal care Bio-tech Beverages Cosmetics Medical devices Nutraceuticals
  27. 27. Which Information Is Mandatory Labeling of packaged food products shall include the following information:
  28. 28. Some international labeling symbols in use are as follows
  29. 29. Contents in a Nutraceutical label As per the Indian Regulations a food label must have- Product name and category of food An ingredient list in descending order of weight Logo for Vegetarian / Non-Vegetarian food Nutrition facts panel or information which includes energy, protein, carbohydrate (sugar) & fat The shelf life (Use by or Best before date) Storage conditions The name & address of the manufacturer, packer and / or seller The country of origin (in case of imported foods) The weight Instructions for use.
  30. 30. Example of simple nutraceutical label
  31. 31. Definition of Nutrition Claim/s Nutrition claim means any representation which states, suggests or implies that a food has particular nutritional properties-  Include energy value, protein, fat and carbohydrates, vitamins and minerals  What does not constitute nutrition claims:  Mandated - Listing of Ingredients - Nutrition Panel – QUID Nutrient content claim is a nutrition claim that describes the level of a nutrient contained in a food. (Examples: “source of calcium”; “high in fibre and low in fat”.) Nutrient comparative claim is a claim that compares the nutrient levels and/or energy value of two or more foods. (Examples: “reduced”; “less than”; “fewer”; “increased”; “more than”.)
  32. 32. Definition of Health Claim/s Health claim any representation that states, suggests or implies of relationship between a Food or a Constituent of that Food & Health Health claims include Nutrient function claims - a nutrition claim that describes the physiological role of the nutrient in growth, development and normal functions of the body. Other function claims - Specific beneficial effects of food consumption on normal functions or biological activities of the body. Reduction of disease risk claims - Linking consumption of a food to the reduced risk of developing a disease or health- related condition
  33. 33. New FDA Labeling Requirements On May 20, 2016, the U.S. Food and Drug Administration (FDA) finalized significant changes to food, beverage, and supplement labeling, including updates to daily values, serving sizes, the Nutrition Facts chart, and more. The new rules become effective on July 26, 2016 and require most food manufacturers to comply by July 26, 2018.
  34. 34. Regulation of Nutraceuticals in India No clear regulatory framework exists: The prevention of Food Adulteration Act, 1954 Food Products Order Drugs and Cosmetics Act (Ayurvedic, Unani & Siddha Drugs Technical Advisory Board) The Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954
  35. 35. Food Safety and Standards Authority of India (fssai) General Requirements: Every pre-packaged food shall carry a label containing information Label in pre-packaged food shall be applied in such a manner that they will not become separated from the container The particulars of declaration required under these regulations to be specified on the label shall be in English or Hindi Pre-packed food shall not be described or presented on any label or in any label manner that is false, misleading
  36. 36. continue.…. The disclosure of information on food labels in India is primarily governed by the Prevention of Food Adulteration Act of 1954, which focuses mainly on basic product information with less emphasis on health and nutritional information. Recent amendments regarding Packaging and labeling of food under part VII of the Prevention of Food Adulteration Rules of 1955 mandate the disclosure of health and nutritional claims on food labels along with basic information. Chapter IV, paragraph 23 of the FSSAI clearly states that no person shall manufacture, distribute, sell or expose for sale, nor dispatch or deliver to any agent or broker for the purpose of sale, any packaged food product that is not marked and labelled in the manner of specific by regulation.
  37. 37. Continue…. Health claims establish a relationship between a food & disease or medical condition. For example claims like ‘Good for Heart’, ‘Good for Growing Children’ etc. Nutritional claims quickly inform a consumer of nutritional value of a product for example ‘Low Fat’ or Zero Cholesterol’.
  38. 38. Continue…. Food Safety and Standards Authority (FSSA), defines “foods for special dietary uses or functional foods or nutraceuticals or health supplements” FSSAI has been created for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. Health Claim: “Health claims” means a relationship between a food or a constituent of that food and health. Health claims can further be grouped into: Nutrient content claim Reduction of disease claim Structure/Function claim
  39. 39. Nutrition Content Claim: A nutritional claim suggests a food has beneficial nutritional properties, such as “low fat”, “no added sugar” and “high in fiber”. A Claim is a statement that suggests a relationship between food and health. For instance a Food can "help lower cholesterol", "help reinforce the body’s natural defenses" or "enhance learning ability" Reduction of Disease Claim: Any claims states or implies that the consumption of dietary supplements or one of its constituents significantly reduce the risk factor in the development of human disease. Structure/Function Claim: Structure claim is a statement on label of a food or dietary supplement about how that product affects the human body structure
  40. 40. Regulatory Requirements in India 1. Product Evaluation: Examination of each active ingredients & additive. Various steps in the product evaluation include: Developing extracts of documents Sample collection (in the presence of witnesses) Sample dispatch to the concerned authority (different processes for bulk package and single package) Food analysis If analysis is not complete within the stipulated period of time, further action plan by the designated officer Adjudication proceedings (holding enquiry, appeal procedure, hearing, etc.)
  41. 41. Continue…. 2. Licenses: To get Product registered in India, number of licenses (almost 4 - 5) might be required which include: Import licensing Manufacturing licensing Marketing licensing and Other state and national level clearances/licenses required from the regulatory side, which need to be taken care of before launching these products in India.
  42. 42. Continue…. 3. Health and label claims: “Health claims” means any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health. This includes: India specific labeling and packaging requirements Packaging of the consignment composition of the consignment and approach to market the same Need for sample material and declaration for registration Label content and claim Structure - function claim
  43. 43. Registration Process in India Apply to the state licensing Authority for site registration in form A Application is processed by the authority 7 days period Inspection is done within 30 days Approval of the site Rejection of the application Manufacture shall apply for manufacturing license in form B
  44. 44. A unique application number has been issued Queries are sent to the application on the incomplete application 60 days 60 days After receiving the missing information Inspection is done on the premises 30 days 30 days Granting of Licence Rejection of Licence Manufacture shall start the business
  45. 45. References https://www.slideshare.net/shraddhakurdekar/packaging-ppt-17317595 http://www.authorstream.com/Presentation/bristolmaverick-604326- packaging-and-labeling-food-industries/ https://www.slideshare.net/GOVINDYADAV28/presentation-on- nutraceutical-labeling?from_action=save https://www.slideshare.net/Adrienna/nutrition-labeling-claims-india-2012 Regulation of nutraceuticals in India, http://www.gpo.gov/fdsys/pkg/FR- 1997-09-23/html/97- 24737.htm (Accessed on Feb 2014)pdf (Accessed on march 2014) Health claims in India, http://www.fssai.gov.in (Accessed on march 2014) Regulatory_prespective_Nutraceuticals_whitepaper_Dec2011(Accessed on march 2014)

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