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

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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.