This presentation describes the regulatory requirements for food testing under the Food Safety and Standards Act. 2006 and Food Safety and Standards Regulations 2011. It also covers the various analytical techniques which can be used to meet the requirements.

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 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.

3. 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

4. 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

5. 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

6. 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

7. Who all are covered under the
Act?

8. 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.

9. July 4, 2014
What is Food?
9

10. What is food?
July 4, 2014
10

11. Is this also food?
July 4, 2014
11

12. This is not food!
July 4, 2014
12

13. Are there Penalties?

14. 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

15. 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.

16. What are the Conditions of
Licensing?

17. 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...

18. 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

19. What are the food Testing
Requirements?

20. 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

21. 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

22. 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

23. 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.

24. Food Safety and standards (Packaging and Labelling)
regulation, 2011
 Nutritional labeling
 Ingredients
 Additives
 Lot number, Shelf life
 Claims

25. 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:

26. FOOD SAFETY AND STANDARDS (CONTAMINANTS,
TOXINS AND RESIDUES) REGULATIONS, 2011
 Metals
 NOTS
 Pesticides
 Antibiotics

27. 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.

28. 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

29. What and How to test?

30. 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

31. 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

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 – 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

34. Is LCMSMS really worth it?

35. 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

36. 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

37. Are we shooting a 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 LCMSMS a step
further

40. Principle of a Linear Ion Trap - scanning

41. 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

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. Summary

44. 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

45. July 4, 2014
About Arbro and Auriga
45

46. 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

47. Our Strengths
July 4, 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
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

50. 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”

51. Questions?
?

52. 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.