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Using versatile analytical techniques for complying with FSSAI, Food Safety and Standards Regulations

The document provides an overview of the Food Safety and Standards Act, 2006 in India, detailing its purpose, regulations, and compliance requirements for food businesses. It outlines licensing conditions, penalties for non-compliance, food testing requirements, and emphasizes the importance of sanitary practices and consumer safety. Additionally, it introduces various food safety regulations enacted subsequently related to packaging, labeling, contaminants, and food additives.

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Versatile techniques for Complying to FSSAI regulations BY: DR. SAURABH ARORA EXECUTIVE DIRECTOR ARBRO ANALYTICAL DIVI S ION AND MANAGING DIRECTOR AURIGA RESEARCH LTD.
ONE STOP SOLUTION FOR ALL YOUR FSSAI COMPLIANCE NEEDS July 4, 2014 2 Food Safety Helpline Powered By: Arbro Pharmaceuticals Ltd. (Analytical Division) and Auriga Research Ltd.
Outline  What is the Food Safety and Standards Act  Conditions of licensing and penalties  Food testing requirements under the new law  What to test and how to test?  Challenges and versatile techniques as solution  Is LCMSMS worth the investment
What is Food Safety and Standards Act, 2006  Consolidation of all food laws  Better mechanism to control the food business activities in India  Ensures Science based standards for the manufacturing, storage, distribution, sale and imports of food items to fulfill human needs  Facilitate food safety management Systems  Contemporary, comprehensive and ensures a better consumer safety
Why was a new food law needed?  Multiplicity of food laws  Shifting of multi-level and multi-department control to single line of control  Single reference point for all matters relating to food safety standards and enforcements  Shift from regulatory regime to Self compliance through FSMS  Harmonization with International standards  Licensing for all food business operators  Penalties as per the gravity of the offence  Consumer empowerment
The prevalent laws related to food prior to FSS Act, 2006  The Prevention of Food Adulteration Act, 1954  The Fruits Products Order, 1955  The Milk and Milk Products Order, 1992  The Meat Food Products Order, 1973  The Edible Oils Packaging (Regulation)Order, 1988  The Vegetable Oil Products (Control) Order, 1947  The Solvent Extracted Oil, De-oiled Meal and Edible Flour (Control) Order, 1967  Any order under issued under the Essential Commodities Act, 1955 relating to food
Who all are covered under the Act?
Who is a Food Business Operator and what do you mean by food business?  Any person who is involved with the business of food is a food business operator  FSS Act defines 'Food Business' an undertaking whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture of food, import and included food services, catering services, sale of food or food ingredients.
July 4, 2014 What is Food? 9
What is food? July 4, 2014 10
Is this also food? July 4, 2014 11
This is not food! July 4, 2014 12
Are there Penalties?
What are the penalties on non-compliance?  Penalty for carrying food business activity without registration – Fine of Upto Rs. 2 lacs.  Penalty for carrying food business activity without licence – Imprisonment upto 6 months plus fine upto Rs. 5 lacs.  Penalty for obstructing a food safety officer from doing his duty or giving false information – Imprisonment of upto 3 months plus a fine of upto Rs. 1 lac  & for giving false information – Imprisonment of upto 3 months plus a fine of upto Rs. 2 lacs
What are the common offences and penalties?  Sub standard foods – Penalty upto Rs. 5 lacs  Misbranded foods – Upto Rs. 3 lacs  Misleading Advertisements – Upto Rs. 10 lacs  Food containing extraneous matters – Upto Rs. 1 lac  Manufacturing of food under unhygienic and unsanitary conditions – Upto Rs. 1 lac  Unsafe food – Imprisonment upto 6 months Plus fine upto Rs. 1 lac, raising to imprisonment upto life imprisonment plus penalty Rs. 10 lacs  Compensation in case of injury or death of consumer – Not less than Rs. 5 lacs in case of dealth and upto Rs. 3 lacs in case of grievous injury and upto Rs. 1 lac in other cases of injury.
What are the Conditions of Licensing?
What are the Conditions of license?  Every food business operator, whether he is a licensee or got the registration certificate as to comply with the sanitary and hygienic conditions as applicable to him according to Schedule 4 of the licensing regulations  Display a true copy of the license  Provide access to licencing authority to the premises  Intimation to authorities in case of change or modification  Technical person for production process  Periodic annual return  Continued...
What are the Conditions of license?  Continued from last slide..  Products indicated in the license should only be manufactured/ processed  Maintaining sanitary and hygienic standards  Maintaining daily records  Sources and standards of raw materials should be of high quality  Proper & regular cleaning of machine and equipment  Licensee shall buy and sell food products only from or to licensed/registered FBOs  Temperature requirements for supply chains  Testing of food articles by own or NABL accredited laboratories at least once in 6 months
What are the food Testing Requirements?
Is there a need for food testing under the Act?  Regulatory requirement – Testing of food articles at least once every 6 months.  On parameters like;  Regulation Standards  Chemical and Microbiological Contaminants  Nutritional composition  Food Additives  Residues  Food packaging materials
What is the Role of Laboratories Under the Act?  FSSAI recognizes the private food laboratories NABL accredited for carrying out analysis of food samples under FSS Act, 2006.  Counter part of sample for analysis  Periodic testing every 6 months  Water testing certificate for licensing  Test reports for Product Approval
Labs have a critical role!  Results can be used in the court of law  Essential to have high level of accuracy and confidence in the data produced  Use standard methods or  Ability to develop and validate methods to support the rapidly evolving law  Multitude of tests in diverse matrices
Food Safety and standards (Packaging and Labelling) regulation, 2011 ¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 29 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1 st August, 2011 F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by clause (k) of subsection (2) of section 92 read with section 23 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far they relates to Food Safety and Standards (Packaging and Labelling) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Sec. 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby makes the following Regulations, namely,— FOOD SAFETY AND STANDARDS (PACKAGING AND LABELLING) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Short title and commencement 1.1.1: These regulations may be called the Food Safety and Standards (Packaging and labelling) Regulations, 2011 1.1.2: These regulations shall come into force on or after 5th August, 2011 1.2: Definitions— 1.2.1: In these regulations unless the context otherwise requires: 1. “Best before” means the date which signifies the end of the period under any stated storage conditions during which the food shall remain fully marketable and shall retain any specific qualities for which tacit or express claims have been made and beyond that date, the food may still be perfectly safe to consume, though its quality may have diminished. However the food shall not be sold if at any stage the product becomes unsafe. 2. “Date of manufacture” means the date on which the food becomes the product as described; 3. “Date of packaging” means the date on which the food is placed in the immediate container in which it will be ultimately sold; 4. “Infant” means a child not more than twelve months of age; 5. “Lot number” or “code number” or “batch number” means the number either in numericals or alphabets or in combination thereof, representing the lot number or code number or batch number, being preceded by the words “Lot No” or “Lot” or “code number” or “Code” or Batch No” or “Batch” or any distinguishing prefix by which the food can be traced in manufacture and identified in distribution. 6. “Multipiece package” means a package containing two or more individually packaged or labelled pieces of the same commodity of identical quantity, intended for retail either in individual pieces or packages as a whole. 7. “Non- Vegetarian Food” means an article of food which contains whole or part of any animal including birds, fresh water or marine animals or eggs or products of any animal origin, but excluding milk or milk products, as an ingredient; 8. “Prepackaged” or “Pre-packed food”, means food, which is placed in a package of any nature, in such a manner that the contents cannot be changed without tampering it and which is ready for sale to the consumer.
Food Safety and standards (Packaging and Labelling) regulation, 2011  Nutritional labeling  Ingredients  Additives  Lot number, Shelf life  Claims
FOOD SAFETY AND STANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011 1 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1 st August, 2011 F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by clause (i) of sub section (2) section 92 read with section 20 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far as they relates to Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Section 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby make the following Regulations, namely,- FOOD SAFETY AND STANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Short title and commencement- 1.1.1: These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011. 1.1.2: These regulations shall come into force on or after 5th August, 2011 1.2: Definitions- 1.2.1: In these regulations unless the context otherwise requires: 1. “Crop contaminant” means any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging transport or holding of articles of such food as a result of environmental contamination CHAPTER 2 CONTAMINANTS, TOXINS AND RESIDUES 2.1 : METAL CONTAMINANTS 2.1.1 1. Chemicals described in monographs of the Indian Pharmacopoeia when used in foods, shall not contain metal contaminants beyond the limits specified in the appropriate monographs of the Indian Pharmacopoeia for the time being in force. 2. Notwithstanding the provisions of regulation 2.1.1 (1), no article of food specified in Column 2 of the table below shall contain any metal specified in excess of the quantity specified in Column 3 of the said table:
FOOD SAFETY AND STANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011  Metals  NOTS  Pesticides  Antibiotics
FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011 ¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 287 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1 st August, 2011 F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by section clause (e) of sub section (2) of section 92 read with 16 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far they relates to Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Sec. 4 dated 20 th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21 st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby makes the following Regulations, namely,— FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Title and commencement 1.1.1:These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. 1.1.2: These regulatiions shall come into force on or after 5 th August, 2011, except the regulations 2.1.7.(1)(2)(3)(4), 2.1.8 (1)(3), 2.1.11 (1)(2), 2.1.12(1), including table 14 of Appendix A and table 2 of Appendix B which shall come in to force after six months from that date. Provided that wherever the standards given in these regulations are at variance with any of the provisions of the licenses already granted, Food Business Operator shall comply with the provisions of these regulations within six months from the date of commencement of the regulations. 1.2: Definitions In these regulations unless the context otherwise requires: 1. BOILED MILK means milk which has been brought to boil. 2. “De-oiled meal” means the residual material left over when oil is extracted by a solvent from any oil-bearing material; 3. DOUBLE TONED MILK means the product prepared by admixture of cow or buffalo milk or both with fresh skimmed milk, or by admixture of cow or buffalo milk or both that has been standardised to fat and solids-not- fat percentage given in the table below in 2.1.1:1 by adjustment of milk solids. It shall be pasteurised and shall show a negative Phosphatase Test. When fat or dry non-fat milk solids are used, it shall be ensured that the product remains homogeneous and no deposition of solids takes place on standing. 4. “Hydrogenation” means the process of addition of hydrogen to an edible vegetable oil using a catalyst to produce a fat with semi-solid consistency; 5. Flavoured Milk, by whatever name called, may contain nuts (whole, fragmented or ground) chocolate, coffee or any other edible flavour, edible food colours and cane sugar. Flavoured milk shall be pasteurised, sterilised or boiled. The type of milk shall be mentioned on the label.
FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011  Quality standards for foods and additives  Identity of additives  Labeled  Unlabeled  Quantity of additive  Microbiology
What and How to test?
Challenges!!!!!!  So many matrices  So many compounds  Standard methods not available  Different levels - % to ppb  New and evolving regulation  Need for speed, sensitivity and accuracy
What and how to test? S. No. What to test ? How to test? 1. Quality standards Chemical analysis, gravimetric, titrtmetric, chromatography 2. Metal contaminants Chemical, AAS, ICP, ICP-MS 3. Pesticides GC, GCMS, LCMSMS, HPLC 4. NOTS GCMS, LCMSMS, HPLC, GC 5. Vet. Drugs HPLC, LCMSMS 6. Additives Chemical, HPLC, GC, GCMS, LCMSMS 7. Nutritional Parameters Chemical, HPLC, GC, ELISA, LCMSMS, AAS, ICP-MS 8. Microbiology Conventional, ELISA, PCR, LCMSMS 9. Adulterants Chemical, PC, GC, HPLC, TLC, LCMSMS
What we need?  Technique which is almost blind to the matrix – High specificity and selectivity  Versatile techniques  Ability to quickly develop methods  Suit of techniques to cover % to ppb – ppt  High speed – rapid TAT  Low running cost
Solution – Versatile Techniques  Quality parameters – HPLC, GC, Chemical analysis  Inorganic contaminants and adulterants – ICP, ICP-MS  Organic contaminants – LCMSMS and GCMSMS  Additives, vitamins, adulterants – LCMSMS  Microbiology
Is LCMSMS really worth it?
LC-MS/MS is worth the investment Technology benefits – Advantages that LC-MS/MS detection provides over single stage MS or other traditional methodologies: Superior selectivity and sensitivity for quantitation of targeted compounds through MRM double-mass filtering Wider linear range for quantitation using MRM More reliable compound identification through MS/MS fingerprints & compound libraries Easily adaptable to add new analytes to methods at any time – Easy methods development Better S/N for quantitation Shorter analysis times than other chromatographic methods Better accuracy and reproducibility in MRM detection
LC-MS/MS is worth the investment Workflow benefits – improved efficiency for food testing analyses • Ability to do multi-target screening – analyze for hundreds of compounds in a single injection – Additive, Adulterants and Contaminants • Reduced sample preparation time and resources needed • Efficient data processing to get results in minutes, not hours
Are we shooting a fly with a gun?  Absolutely not!  Big challenges  Compounds  Sensitivity  Matrices  TAT  Methods  Cost  Well…… Some times yes!
Problems with LCMSMS  Matrix effects  False positives  No library matching  Cumbersome ion ratios used for confirmation
QTRAP taking LCMSMS a step further
Principle of a Linear Ion Trap - scanning
What makes a QTRAP® a QTRAP®? The Linear Ion Trap (LIT) in a triple quadrupole system  Q3 functions like a regular Triple Quad MS system but also as a LIT with added capabilities – It can trap, dissociate, & accumulate the fragments. Full Triple Quad function, i.e. Multiple Reaction Monitoring (MRM) Fast and high sensitivity full scan experiments, i.e. EPI Turbo V™ source Q3 LIT Ion production Ion filtering Ion filtering Ion transport Fragmentation Q3 = LIT Ion trapping LINAC® collision cell Q2 Curtain Gas™ interface Q0 Q1
Screening and Confirmation: Collection of MS/MS…(full scan confirmation) Library Search Results… Workflow: MRM survey –MS/MS – Library Search Quantification… In case of questionable or contradictory results: –EPI always gives better certainty than ion ratio –No other technique offers MS/MS scans at the same sensitivity level
Summary
Summary  Food Safety and Standards Act. 2006 – New and Evolving  Testing is a regulatory requirement  Have to test for lots of different compounds  Complex and new matrices  Can cover most of the analysis with versatile techniques like – LCMSMS, ICP/ICPMS, HPLC, GC  LCMSMS is indispensible
July 4, 2014 About Arbro and Auriga 45
About Arbro and Auriga July 4, 2014 46 Arbro Analytical Division - top 5 national level labs in India. www.testing-lab.com Arbro is FSSAI approved and is accredited by NABL Established in 1985, laboratory since 1990 Handle more than 600,000 tests each year Working with hotels and restaurants for the past 10 years 4 State of the art laboratories
Our Strengths July 4, 2014 47 Backed by a team of over 250 seasoned professionals in 4 labs!
Accreditations and approvals  FSSAI - 2012  NABL – ISOIEC 17025 : 2005 - 01-08-2003  BIS - 10-01-2005  R & D – DST - 01-06-1990 (Dept. Of Science & Technology)  Directorate of ISM & H - 05-02-2004  APEDA (Agricultural and Processed Food Products Export Development Authority) - 15-01-2004  EIC / EIA - 30-05-2007  Spice Board - 25-10-2007  AGMARK - 23-10-2008  Approved by Russia – FSVPS - 03-05-2009  ISO 9001:2008 - 12-02-1998  Drug Control Dept. NCT, Delhi - 31-01-1995 - GLP  Global Fund -Jan 2011 July 4, 2014 48
Our Services July 4, 2014 49  Annual package  Management and staffing of your in-house lab  Onsite sampling and analysis  Support for licensing  FSMS plan development  FSSAI gap audits – with mobile application and online reporting  Training  Microbiology  Meat species identification  Nutritional analysis for labeling  Residues and contaminants  Testing for food adulterants
Our Services July 4, 2014 50  Label Review  Shelf life studies  Analysis of additives  Claims verification – Fat, Trans fat, GMO, Vitamins, Minerals Etc.  Clinical studies to establish claims like– “helps in weight loss”, “low glycemic index” “good for diabetics”
Questions? ?
ANY QUESTIONS, CONTACT US AT: FOODSAFETY@AURIGARESEARCH.COM CONTACT - +91 -8588851888 July 4, 2014 52 Thank You Powered By: Arbro Pharmaceuticals Ltd. and Auriga Research Ltd.

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In this document
Powered by AI

Introduction to FSSAI regulations and services provided by Arbro & Auriga for compliance.

Outline of the FSS Act, its necessities, and prior laws incorporated into the Act.

Definitions of food business operators and examples illustrating food categories.

Overview of penalties imposed for food law violations, including fines and imprisonment.

Requirements for licensing food businesses, including compliance and operational guidelines.

Importance of food testing under the Act, parameters, and role of accredited laboratories.

Introduction to regulations regarding food packaging and labeling to ensure safety and standards.

Regulations related to contaminants, toxins, and standards for food products and additives.

Discussion of testing methods, challenges, and the need for versatile techniques in food analysis.

Advantages of using LCMSMS technology for food testing, including efficiency and reliability.

Challenges faced with LCMSMS, including issues like matrix effects and false positives.

Discussion on QTRAP technology and its benefits in food safety testing and confirmation processes.

Summary of the evolving nature of food safety regulations and the critical role of versatile testing methods.

Background information on Arbro Analytical Division and Auriga Research, their capabilities and approvals.

Details of services provided, including lab management, auditing, microbiology, and nutritional analysis.

Opportunity for attendees to ask questions related to FSSAI compliance and food safety.

Using versatile analytical techniques for complying with FSSAI, Food Safety and Standards Regulations

  • 1.
    Versatile techniques for Complying to FSSAI regulations BY: DR. SAURABH ARORA EXECUTIVE DIRECTOR ARBRO ANALYTICAL DIVI S ION AND MANAGING DIRECTOR AURIGA RESEARCH LTD.
  • 2.
    ONE STOP SOLUTIONFOR ALL YOUR FSSAI COMPLIANCE NEEDS July 4, 2014 2 Food Safety Helpline Powered By: Arbro Pharmaceuticals Ltd. (Analytical Division) and Auriga Research Ltd.
  • 3.
    Outline  Whatis the Food Safety and Standards Act  Conditions of licensing and penalties  Food testing requirements under the new law  What to test and how to test?  Challenges and versatile techniques as solution  Is LCMSMS worth the investment
  • 4.
    What is FoodSafety and Standards Act, 2006  Consolidation of all food laws  Better mechanism to control the food business activities in India  Ensures Science based standards for the manufacturing, storage, distribution, sale and imports of food items to fulfill human needs  Facilitate food safety management Systems  Contemporary, comprehensive and ensures a better consumer safety
  • 5.
    Why was anew food law needed?  Multiplicity of food laws  Shifting of multi-level and multi-department control to single line of control  Single reference point for all matters relating to food safety standards and enforcements  Shift from regulatory regime to Self compliance through FSMS  Harmonization with International standards  Licensing for all food business operators  Penalties as per the gravity of the offence  Consumer empowerment
  • 6.
    The prevalent lawsrelated to food prior to FSS Act, 2006  The Prevention of Food Adulteration Act, 1954  The Fruits Products Order, 1955  The Milk and Milk Products Order, 1992  The Meat Food Products Order, 1973  The Edible Oils Packaging (Regulation)Order, 1988  The Vegetable Oil Products (Control) Order, 1947  The Solvent Extracted Oil, De-oiled Meal and Edible Flour (Control) Order, 1967  Any order under issued under the Essential Commodities Act, 1955 relating to food
  • 7.
    Who all arecovered under the Act?
  • 8.
    Who is aFood Business Operator and what do you mean by food business?  Any person who is involved with the business of food is a food business operator  FSS Act defines 'Food Business' an undertaking whether for profit or not and whether public or private, carrying out any of the activities related to any stage of manufacture of food, import and included food services, catering services, sale of food or food ingredients.
  • 9.
    July 4, 2014 What is Food? 9
  • 10.
    What is food? July 4, 2014 10
  • 11.
    Is this alsofood? July 4, 2014 11
  • 12.
    This is notfood! July 4, 2014 12
  • 13.
  • 14.
    What are thepenalties on non-compliance?  Penalty for carrying food business activity without registration – Fine of Upto Rs. 2 lacs.  Penalty for carrying food business activity without licence – Imprisonment upto 6 months plus fine upto Rs. 5 lacs.  Penalty for obstructing a food safety officer from doing his duty or giving false information – Imprisonment of upto 3 months plus a fine of upto Rs. 1 lac  & for giving false information – Imprisonment of upto 3 months plus a fine of upto Rs. 2 lacs
  • 15.
    What are thecommon offences and penalties?  Sub standard foods – Penalty upto Rs. 5 lacs  Misbranded foods – Upto Rs. 3 lacs  Misleading Advertisements – Upto Rs. 10 lacs  Food containing extraneous matters – Upto Rs. 1 lac  Manufacturing of food under unhygienic and unsanitary conditions – Upto Rs. 1 lac  Unsafe food – Imprisonment upto 6 months Plus fine upto Rs. 1 lac, raising to imprisonment upto life imprisonment plus penalty Rs. 10 lacs  Compensation in case of injury or death of consumer – Not less than Rs. 5 lacs in case of dealth and upto Rs. 3 lacs in case of grievous injury and upto Rs. 1 lac in other cases of injury.
  • 16.
    What are theConditions of Licensing?
  • 17.
    What are theConditions of license?  Every food business operator, whether he is a licensee or got the registration certificate as to comply with the sanitary and hygienic conditions as applicable to him according to Schedule 4 of the licensing regulations  Display a true copy of the license  Provide access to licencing authority to the premises  Intimation to authorities in case of change or modification  Technical person for production process  Periodic annual return  Continued...
  • 18.
    What are theConditions of license?  Continued from last slide..  Products indicated in the license should only be manufactured/ processed  Maintaining sanitary and hygienic standards  Maintaining daily records  Sources and standards of raw materials should be of high quality  Proper & regular cleaning of machine and equipment  Licensee shall buy and sell food products only from or to licensed/registered FBOs  Temperature requirements for supply chains  Testing of food articles by own or NABL accredited laboratories at least once in 6 months
  • 19.
    What are thefood Testing Requirements?
  • 20.
    Is there aneed for food testing under the Act?  Regulatory requirement – Testing of food articles at least once every 6 months.  On parameters like;  Regulation Standards  Chemical and Microbiological Contaminants  Nutritional composition  Food Additives  Residues  Food packaging materials
  • 21.
    What is theRole of Laboratories Under the Act?  FSSAI recognizes the private food laboratories NABL accredited for carrying out analysis of food samples under FSS Act, 2006.  Counter part of sample for analysis  Periodic testing every 6 months  Water testing certificate for licensing  Test reports for Product Approval
  • 22.
    Labs have acritical role!  Results can be used in the court of law  Essential to have high level of accuracy and confidence in the data produced  Use standard methods or  Ability to develop and validate methods to support the rapidly evolving law  Multitude of tests in diverse matrices
  • 23.
    Food Safety andstandards (Packaging and Labelling) regulation, 2011 ¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 29 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1 st August, 2011 F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by clause (k) of subsection (2) of section 92 read with section 23 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far they relates to Food Safety and Standards (Packaging and Labelling) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Sec. 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby makes the following Regulations, namely,— FOOD SAFETY AND STANDARDS (PACKAGING AND LABELLING) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Short title and commencement 1.1.1: These regulations may be called the Food Safety and Standards (Packaging and labelling) Regulations, 2011 1.1.2: These regulations shall come into force on or after 5th August, 2011 1.2: Definitions— 1.2.1: In these regulations unless the context otherwise requires: 1. “Best before” means the date which signifies the end of the period under any stated storage conditions during which the food shall remain fully marketable and shall retain any specific qualities for which tacit or express claims have been made and beyond that date, the food may still be perfectly safe to consume, though its quality may have diminished. However the food shall not be sold if at any stage the product becomes unsafe. 2. “Date of manufacture” means the date on which the food becomes the product as described; 3. “Date of packaging” means the date on which the food is placed in the immediate container in which it will be ultimately sold; 4. “Infant” means a child not more than twelve months of age; 5. “Lot number” or “code number” or “batch number” means the number either in numericals or alphabets or in combination thereof, representing the lot number or code number or batch number, being preceded by the words “Lot No” or “Lot” or “code number” or “Code” or Batch No” or “Batch” or any distinguishing prefix by which the food can be traced in manufacture and identified in distribution. 6. “Multipiece package” means a package containing two or more individually packaged or labelled pieces of the same commodity of identical quantity, intended for retail either in individual pieces or packages as a whole. 7. “Non- Vegetarian Food” means an article of food which contains whole or part of any animal including birds, fresh water or marine animals or eggs or products of any animal origin, but excluding milk or milk products, as an ingredient; 8. “Prepackaged” or “Pre-packed food”, means food, which is placed in a package of any nature, in such a manner that the contents cannot be changed without tampering it and which is ready for sale to the consumer.
  • 24.
    Food Safety andstandards (Packaging and Labelling) regulation, 2011  Nutritional labeling  Ingredients  Additives  Lot number, Shelf life  Claims
  • 25.
    FOOD SAFETY ANDSTANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011 1 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1 st August, 2011 F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by clause (i) of sub section (2) section 92 read with section 20 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far as they relates to Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Section 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby make the following Regulations, namely,- FOOD SAFETY AND STANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Short title and commencement- 1.1.1: These regulations may be called the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011. 1.1.2: These regulations shall come into force on or after 5th August, 2011 1.2: Definitions- 1.2.1: In these regulations unless the context otherwise requires: 1. “Crop contaminant” means any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging transport or holding of articles of such food as a result of environmental contamination CHAPTER 2 CONTAMINANTS, TOXINS AND RESIDUES 2.1 : METAL CONTAMINANTS 2.1.1 1. Chemicals described in monographs of the Indian Pharmacopoeia when used in foods, shall not contain metal contaminants beyond the limits specified in the appropriate monographs of the Indian Pharmacopoeia for the time being in force. 2. Notwithstanding the provisions of regulation 2.1.1 (1), no article of food specified in Column 2 of the table below shall contain any metal specified in excess of the quantity specified in Column 3 of the said table:
  • 26.
    FOOD SAFETY ANDSTANDARDS (CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011  Metals  NOTS  Pesticides  Antibiotics
  • 27.
    FOOD SAFETY ANDSTANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011 ¹Hkkx III—[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 287 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the 1 st August, 2011 F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by section clause (e) of sub section (2) of section 92 read with 16 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far they relates to Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of India Extraordinary Part III – Sec. 4 dated 20 th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the said notification were made available to the public; And whereas the copies of the Gazette were made available to the public on the 21 st October 2010; And whereas objections and suggestions received from the stakeholders within the specified period on the said draft Regulations have been considered and finalized by the Food Safety and Standards Authority of India. Now therefore, the Food Safety and Standards Authority of India hereby makes the following Regulations, namely,— FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011 CHAPTER 1 GENERAL 1.1: Title and commencement 1.1.1:These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. 1.1.2: These regulatiions shall come into force on or after 5 th August, 2011, except the regulations 2.1.7.(1)(2)(3)(4), 2.1.8 (1)(3), 2.1.11 (1)(2), 2.1.12(1), including table 14 of Appendix A and table 2 of Appendix B which shall come in to force after six months from that date. Provided that wherever the standards given in these regulations are at variance with any of the provisions of the licenses already granted, Food Business Operator shall comply with the provisions of these regulations within six months from the date of commencement of the regulations. 1.2: Definitions In these regulations unless the context otherwise requires: 1. BOILED MILK means milk which has been brought to boil. 2. “De-oiled meal” means the residual material left over when oil is extracted by a solvent from any oil-bearing material; 3. DOUBLE TONED MILK means the product prepared by admixture of cow or buffalo milk or both with fresh skimmed milk, or by admixture of cow or buffalo milk or both that has been standardised to fat and solids-not- fat percentage given in the table below in 2.1.1:1 by adjustment of milk solids. It shall be pasteurised and shall show a negative Phosphatase Test. When fat or dry non-fat milk solids are used, it shall be ensured that the product remains homogeneous and no deposition of solids takes place on standing. 4. “Hydrogenation” means the process of addition of hydrogen to an edible vegetable oil using a catalyst to produce a fat with semi-solid consistency; 5. Flavoured Milk, by whatever name called, may contain nuts (whole, fragmented or ground) chocolate, coffee or any other edible flavour, edible food colours and cane sugar. Flavoured milk shall be pasteurised, sterilised or boiled. The type of milk shall be mentioned on the label.
  • 28.
    FOOD SAFETY ANDSTANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011  Quality standards for foods and additives  Identity of additives  Labeled  Unlabeled  Quantity of additive  Microbiology
  • 29.
    What and Howto test?
  • 30.
    Challenges!!!!!!  Somany matrices  So many compounds  Standard methods not available  Different levels - % to ppb  New and evolving regulation  Need for speed, sensitivity and accuracy
  • 31.
    What and howto test? S. No. What to test ? How to test? 1. Quality standards Chemical analysis, gravimetric, titrtmetric, chromatography 2. Metal contaminants Chemical, AAS, ICP, ICP-MS 3. Pesticides GC, GCMS, LCMSMS, HPLC 4. NOTS GCMS, LCMSMS, HPLC, GC 5. Vet. Drugs HPLC, LCMSMS 6. Additives Chemical, HPLC, GC, GCMS, LCMSMS 7. Nutritional Parameters Chemical, HPLC, GC, ELISA, LCMSMS, AAS, ICP-MS 8. Microbiology Conventional, ELISA, PCR, LCMSMS 9. Adulterants Chemical, PC, GC, HPLC, TLC, LCMSMS
  • 32.
    What we need?  Technique which is almost blind to the matrix – High specificity and selectivity  Versatile techniques  Ability to quickly develop methods  Suit of techniques to cover % to ppb – ppt  High speed – rapid TAT  Low running cost
  • 33.
    Solution – VersatileTechniques  Quality parameters – HPLC, GC, Chemical analysis  Inorganic contaminants and adulterants – ICP, ICP-MS  Organic contaminants – LCMSMS and GCMSMS  Additives, vitamins, adulterants – LCMSMS  Microbiology
  • 34.
  • 35.
    LC-MS/MS is worththe investment Technology benefits – Advantages that LC-MS/MS detection provides over single stage MS or other traditional methodologies: Superior selectivity and sensitivity for quantitation of targeted compounds through MRM double-mass filtering Wider linear range for quantitation using MRM More reliable compound identification through MS/MS fingerprints & compound libraries Easily adaptable to add new analytes to methods at any time – Easy methods development Better S/N for quantitation Shorter analysis times than other chromatographic methods Better accuracy and reproducibility in MRM detection
  • 36.
    LC-MS/MS is worththe investment Workflow benefits – improved efficiency for food testing analyses • Ability to do multi-target screening – analyze for hundreds of compounds in a single injection – Additive, Adulterants and Contaminants • Reduced sample preparation time and resources needed • Efficient data processing to get results in minutes, not hours
  • 37.
    Are we shootinga fly with a gun?  Absolutely not!  Big challenges  Compounds  Sensitivity  Matrices  TAT  Methods  Cost  Well…… Some times yes!
  • 38.
    Problems with LCMSMS  Matrix effects  False positives  No library matching  Cumbersome ion ratios used for confirmation
  • 39.
    QTRAP taking LCMSMSa step further
  • 40.
    Principle of aLinear Ion Trap - scanning
  • 41.
    What makes aQTRAP® a QTRAP®? The Linear Ion Trap (LIT) in a triple quadrupole system  Q3 functions like a regular Triple Quad MS system but also as a LIT with added capabilities – It can trap, dissociate, & accumulate the fragments. Full Triple Quad function, i.e. Multiple Reaction Monitoring (MRM) Fast and high sensitivity full scan experiments, i.e. EPI Turbo V™ source Q3 LIT Ion production Ion filtering Ion filtering Ion transport Fragmentation Q3 = LIT Ion trapping LINAC® collision cell Q2 Curtain Gas™ interface Q0 Q1
  • 42.
    Screening and Confirmation: Collection of MS/MS…(full scan confirmation) Library Search Results… Workflow: MRM survey –MS/MS – Library Search Quantification… In case of questionable or contradictory results: –EPI always gives better certainty than ion ratio –No other technique offers MS/MS scans at the same sensitivity level
  • 43.
  • 44.
    Summary  FoodSafety and Standards Act. 2006 – New and Evolving  Testing is a regulatory requirement  Have to test for lots of different compounds  Complex and new matrices  Can cover most of the analysis with versatile techniques like – LCMSMS, ICP/ICPMS, HPLC, GC  LCMSMS is indispensible
  • 45.
    July 4, 2014 About Arbro and Auriga 45
  • 46.
    About Arbro andAuriga July 4, 2014 46 Arbro Analytical Division - top 5 national level labs in India. www.testing-lab.com Arbro is FSSAI approved and is accredited by NABL Established in 1985, laboratory since 1990 Handle more than 600,000 tests each year Working with hotels and restaurants for the past 10 years 4 State of the art laboratories
  • 47.
    Our Strengths July4, 2014 47 Backed by a team of over 250 seasoned professionals in 4 labs!
  • 48.
    Accreditations and approvals  FSSAI - 2012  NABL – ISOIEC 17025 : 2005 - 01-08-2003  BIS - 10-01-2005  R & D – DST - 01-06-1990 (Dept. Of Science & Technology)  Directorate of ISM & H - 05-02-2004  APEDA (Agricultural and Processed Food Products Export Development Authority) - 15-01-2004  EIC / EIA - 30-05-2007  Spice Board - 25-10-2007  AGMARK - 23-10-2008  Approved by Russia – FSVPS - 03-05-2009  ISO 9001:2008 - 12-02-1998  Drug Control Dept. NCT, Delhi - 31-01-1995 - GLP  Global Fund -Jan 2011 July 4, 2014 48
  • 49.
    Our Services July4, 2014 49  Annual package  Management and staffing of your in-house lab  Onsite sampling and analysis  Support for licensing  FSMS plan development  FSSAI gap audits – with mobile application and online reporting  Training  Microbiology  Meat species identification  Nutritional analysis for labeling  Residues and contaminants  Testing for food adulterants
  • 50.
    Our Services July4, 2014 50  Label Review  Shelf life studies  Analysis of additives  Claims verification – Fat, Trans fat, GMO, Vitamins, Minerals Etc.  Clinical studies to establish claims like– “helps in weight loss”, “low glycemic index” “good for diabetics”
  • 51.
  • 52.
    ANY QUESTIONS, CONTACTUS AT: [email protected] CONTACT - +91 -8588851888 July 4, 2014 52 Thank You Powered By: Arbro Pharmaceuticals Ltd. and Auriga Research Ltd.