using versatile analytical techniques for complying with fssai, food safety and standards...
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B Y : D R . S A U R A B H A R O R A
E X E C U T I V E D I R E C T O R A R B R O A N A L Y T I C A L D I V I S I O N
A N D M A N A G I N G D I R E C T O R
A U R I G A R E S E A R C H L T D .
Versatile techniques for Complying to FSSAI regulations
O N E S T O P S O L U T I O N F O R A L L Y O U R F S S A I C O M P L I A N C E N E E D S
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.
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What is Food?
What is food?
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Is this also food?
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This is not food!
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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 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 (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 1st 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 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 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 1st
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 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 (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 5th
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 analytesto methods at any time – Easy methods development
Better S/N for quantitationShorter analysis times than other chromatographic methods
Better accuracy and reproducibility in MRM detection
• 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
LC-MS/MS is worth the investment
Workflow benefits –improved efficiency for food testing analyses
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
Ion filtering
Ion transport
Ion production Ion filtering
Fragmentation
Q3 = LIT
Ion trapping
Q3
LIT
LINAC®
collision cell
Q2
Curtain Gas™
interface
Q0 Q1
Screening and Confirmation:
Workflow: MRM survey –MS/MS – Library Search
Collection of MS/MS…(full scan confirmation)
Library Search Results…
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
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About Arbro and Auriga
About Arbro and Auriga
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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
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Backed by a team of over 250 seasoned professionals in 4 labs!
Accreditations and approvals
FSSAI - 2012
NABL – ISO\IEC 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
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Our Services
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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
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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?
?
A N Y Q U E S T I O N S , C O N T A C T U S A T :F O O D S A F E T Y @ A U R I G A R E S E A R C H . C O M
C O N T A C T - + 9 1 - 8 5 8 8 8 5 1 8 8 8
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Thank You
Powered By: Arbro Pharmaceuticals Ltd. and Auriga Research Ltd.
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