FOOD ADDITIVES pptx

Exploring the Regulatory Landscape of Food Additives:
Ensuring Safety and Compliance in the Food Industry
Presented By
K.SriDivya
Redg No: 621209527005
II/II M-Pharmacy 3rd semester
Pharmaceutical Regulatory Affairs
A.U.College of Pharmaceutical
Sciences
Under the guidance of:
Dr. P. Shailaja
Dept. of Pharmaceutical Regulatory Affairs

TABLE OF CONTENTS
Introduction
Regulatory Framework in U.S.A
•Regulatory Framework in Europe
•Regulatory Framework in Canada &India
05
03
02
Emerging trends and future outlook
WHO& ISO standards for Food Additives
Conclusion
Reference
01
06
07
08
04
A.U.College of Pharmaceutical Sciences
2

INTRODUCTION TO FOOD ADDITIVES
Definition:
It is a chemical or ingredient that is added to the food, for the purpose of processing, preserving,
packaging, transporting or storage of Food. Which are derivatives of Natural or synthetic products. These are
direct and Indirect food additives.
Functions:
 Act as a preservative by inhibiting the growth of microbes
 Maintain safety and freshness
 To improve or maintain Nutritional value
 Enhance the Flavors, Improve Taste, Texture and Appearance
Adverse Effects:
• Allergic reactions
• Gastrointestinal disorders
• Asthma
• Migraine
• Cancer
3

Safety Assessment of Food
 Eating a high amount of anything will be harmful but at a lower level it can be safe
 Some individuals have allergic effects with this additive that might be synthetic or natural sources in that case human
toxicological studies have to be done
 So we can know the toxic effect, and how this additive reacts in the body
 Testing to see if any chance of cancer for long-term use of additives
 Before allowing to use in food wide range of tests have to be performed
 Safety data is obtained from animal experimentations and toxicological studies in the lab
 Thereafter we define acceptable Daily Intake(ADI)
 NO-Observed-Adverse-Effect
 The overall consumption of food Additives is 139lbs/year/person(63kg/person/year)
 If the common additives like spices, sugars, salt, honey, pepper, mustard, and dextrose; are excluded, the consumption
decreases to 5lbs/year(2.3kg/person/year)
 The food additives generally can be divided into six categories
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FOOD ADDITIVE TESTING
• Food Packaging Testing
• Physical &Chemical Properties
• Microbiology Testing
• Residues and Contaminants Testing
• Allergens Testing
• Shelf –Life Testing
• Chemical and nutritional analysis
A.U.College of Pharmaceutical Sciences 5
Antioxidants hydroxytoluene, propyl gallate, phytic acid
Antiputrefactivas sorbic acid, potassium sorbate, benzoic acid, sodium
benzoate
Colorants carmine, amaranth, lemon yellow, sunset yellow
Sweeteners saccharin, cyclamate, aspartame, acesulfame, stevia
Colourretentionagents nitrite, nitrate
Water retention agents phosphate
Flavoring agents spicy agents
Illegal additives Sudan red, basic orange, acid orange, malachite
green, crystal violet, talcum powder, boric acid,
borax

Thicken
ing
Agents
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Food
colourin
g Agents
Food
Preserva
tives
Flavorin
g agents
Antioxid
ants
Stabilize
rs&
Sweeten
ers
FOOD
ADDITIVES
TYPES TO FOOD ADDITIVES

U.S.A REGULATIONS
• The term refers to "any substance the intended use of which results or may reasonably be expected to result --
directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food."
This definition includes any substance used in the production, processing, treatment, packaging, transportation
or storage of food.
• In U.S. Federal Food, Drug, and Cosmetic Act of 1938 states that no carcinogenic substances may be used as
food additives.
GRAS Generally Recognized as a Safe
• There is an existance of GRAS for food additives, so premarket approval requirements for use of food
ingredients are not necessary.
• This regulation establishes GRAS status must be based on the quality and quantity of information
• needed to establish the safety of a food additive.
• The U.S FDA listed all these items as GRAS
• An example, Additive E341(Tricalcium Phosphate) is approved by U.S
• So here E prefix and 341 no stands for the 340-349 subset known as phosphates” under Antioxidant and Acidity Regulation Groups
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REGULATORY FRAME WORKTO FOOD ADDITIVES

 US FOOD SAFETY AND REGULATION
 In the U.S the food regulatory authority is the FDA, the U.S dept of Agriculture (USDA )Food Safety and inspection service
(FSIS) will ensure the safety of poultry, meat and eggs
 FFDCA provides authority to FDA to regulate food
 21CFR 170 gives the definition of Food Additive
 Food Additives are regulated under the food additives Amendment of 1958
 2 Regulatory Mechanisms for food additives
1)FOOD Additive Petition process
a. Where it undergoes a premarket review and approval process which involves
b. Submission of food additive petition
c. Submission of technical data
d. Review by FDA expert subject expertise
e. If the safety levels are not up to level CFR - Code of Federal Regulations Title 21 (fda.gov)
f. Review by administrative procedural step(where new or amended FR are published in FR
g . 2 more rounds of public review
h. Followed by the codification of final regulation in CFR
I . 180 days to act on a FAP
j . Complete the process takes years
k. Review is stopped after getting responses from the petitioner
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2) GRAS PROCESS
 Under sections 201(s) and 409 of the FFDCA, and FDA’s implementing regulations in 21 CFR 170.30, substances may be
regarded as “generally recognized as safe” or GRAS
 It is exempt from FDA pre-market review and approval based on common knowledge and general acceptance among
qualified scientific experts that the substance is safe under its intended conditions of use
 To receive a GRAS designation, the pivotal evidence demonstrating the safety of the ingredient must be publicly available.
This is not the case for approved food additives.
 Any substance that is reasonably expected to become a component of food is a food additive that is subject to premarket
approval by FDA,
 unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience
to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive
definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA)`
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EUROPEAN FOOD REGULATIONS
 The European Food Safety Authority (EFSA) is the official agency tasked with conducting food additive safety reviews,
 Provides independent scientific advice on topics related to food
 communicates to stakeholders regarding existing or potential risks in the food supply chain.
 Established in 2002 to replace the Scientific Committee for Food, EFSA is concerned with matters relevant to:
 Food and feed safety (like animal health and welfare) Most of EFSA’s work is done at the request of the Commission, the
European Parliament, and EU Member States.
 One of EFSA’s largest tasks has been to conduct the re-evaluation of all food additives that were authorized for use in food
prior to 2009, which was mandated through EU legislation in 2008.
EU LAW STATES THAT FOOD ADDITIVES ARE ALLOWED
 No hazard present in the food
 Reasonable need for adding an additive
 They do not mislead the consumer
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APPROVAL PROCESS
 Each food additive is assigned a unique E number, which is assessed for use in E.U states
 E no for European countries are all prefixed by “E” its not applicable to use in other countries
 E letter stands for the Approval of Food Additives in Europe.
 E132 is a food additive approved by the European Union (EU).
 It is used as a synthetic colouring agent in food and drink products.
 The common names for E132 are indigontine and indigo carmine.
 E132 is highly soluble in water and gives a blue colouring.
 It is most commonly used as an additive to capsules and tablets.
 It is a coal tar derivative and may also be used as a biological stain.
 E132 occurs naturally in the shrub Indigofera tinctoria but is always synthesized when used commercially
 E132 has been found by some studies to cause nausea, vomiting, high BP, breathing difficulties and skin irritation.
 It is banned in Norway
Examples of food and drink products that sometimes include E132
sweets
ice creams
bakery products
11

Food Additive Safety and Regulation in Canada
 Health Canada is the department of the Canadian government responsible for overseeing Canadian health, including food
regulations, policies
 The Food Directorate executes tasks such as the evaluation of food additives (and other food products) for their conditions of
use, which then translates to Canadian mandates such as Food and Drug Regulations and Lists of Permitted Food Additives.
Approval process in Canada
 Submission of application: Health Canada, specifically the Food Directorate of the health product and food branch(HPFB)
 Safety Evaluation : Toxicological Studies, Exposure Assessment and Relevant information proposed additive
 Risk assessment: Determine the potential dietary exposure to the additive and assess safety based on estimated intake levels
 Public consultation: Public input
 Decision: Based on safety and risk Health Canada Grant approval for Food Additive.
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REGULATIONS IN CANADA &INDIA

Food Additive Safety and Regulation in India
 Food Safety And Standards (Food Products Standards And Food Additives) Regulations, 2011
 Food Safety Standard Authority of India will Regulated Food Products and Food Additives.
 On 26 July 2021, the Food Safety and Standards Authority of India (FSSAI) published the Food Safety and Standards
(Food Products Standards and Food Additives) Third Amendment Regulations,
 7th Amendment Relating to harmonizing food additives
 Among many changes, one sweetener, alitame, will be disallowed as a permitted food additive in many drinks and sweet
products, while many new standards will be included for several new food products.
Approval Process in INDIA
 Application
 Safety Assessment
 Expert Panel Evaluation
 Risk Analysis
 Approval
 If approved substance is included in Food Safety and Standards(Food Product Standards and Food Additives)
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WHO& ISO standards for Food Additives
WHOREGULATION FOR FOOD ADDITIVES
DEFINITION:
• Substances that are added to food to maintain or improve the safety, freshness, taste, texture, or appearance of food are
known as food additives.
• Many different food additives have been developed over time to meet the needs of food production, as making food on a
large scale is very different from making them on a small scale at home
Examples Some food additives have been in use for centuries for preservation – such as salt (in meats such as bacon or dried
fish), sugar (in marmalade), or sulfur dioxide (in wine).
Flavouring agents and Enzyme Preparations
FUNCTIONS
• preserve Nutritional Quality
• Enhance the stability of Food
• Ensure processed food remains safe
• Maintain good condition throughout its journey from factories or industrial kitchens, during transportation to warehouses
and shops, and finally to consumers
14

WHO response in Evaluating the health risk of food additives
 WHO, in cooperation with the Food and Agriculture Organization of the United Nations (FAO), is responsible for assessing the
risks to human health from food additives.
 Risk assessments of food additives are conducted by an independent, international expert scientific group – the Joint FAO/WHO
Expert Committee on Food Additives (JECFA)
 Only food additives that have undergone a JECFA safety assessment, and are found not to present an appreciable health risk to
consumers, can be used. This applies whether food additives come from a natural source or they are synthetic
 JECFA evaluations are based on scientific reviews of all available biochemical, toxicological, and other relevant data on a given
additive – mandatory tests in animals, research studies and observations in humans are considered.
 The toxicological tests required by JECFA include acute, short-term, and long-term studies that determine how the food additive
is absorbed, distributed, and excreted and the possible harmful effects of the additive or its by-products at certain exposure
levels.
 The starting point for determining whether a food additive can be used without having harmful effects is to establish an
acceptable daily intake (ADI).
 The ADI is an estimate of the amount of an additive in food or drinking water that can be safely consumed daily over a lifetime
without adverse health effects.
15

At a global level: The joint FAO/WHO Expert committee on Food Additives(JECFA)
 International standards for the safe use of food additives
 JECFA IS THE SCIENTIFIC ADVISORY BODY TO THE Food and Agriculture Organization and World Health Organization.
 It also advises the Codex Alimentarius Commission, which has International responsibility for assessing food safety
 They establish ADI for each additive
 Codex standards are the reference for national standards for consumer protection, and for the international trade in food, so that
consumers everywhere can be confident that the food they eat meets the agreed standards for safety and quality, no matter where
it was produced.
 Once a food additive has been found to be safe for use by JECFA and maximum use levels have been established in the Codex
General Standard for Food Additives, national food regulations need to be implemented permitting the actual use of a food
additive.
 The Codex Alimentarius Commission also establishes standards and guidelines on food labelling. These standards are
implemented in most countries, and food manufacturers are obliged to indicate
16

ISO standards :ISO 17034 and ISO/IEC 17025 double accreditation. In the European Union (EU), food additives are encoded by
the “E numbers” which are assessed by the European Food Safety Authority (EFSA)
• colours E100-199
• Preservatives E200-299
• Antioxidants E300-399
• Thickeners, Stabilizers and Emulsifier E400-499
• Ph Regulators and Anti-caking Agents E5-599
• Flavour E600-699
• Antibiotic E700-799
• Sweetener E900-999
• Additional Additives E100-1599
ISO67.220.20
Food additives including salt, vinegar, food preservation additives, etc.
17

EMERGING TRENDS AND FUTURE OUT LOOK
Expansion of the global market, the concentration of production and consumption in North America and Asia Pacific
 In 2019, the global food additives market size was approximately US$40.6 billion, with a compound annual growth rate of
approximately 3.4% from 2016 to 2019
 The global food additives market is dominated by companies such as Cargill, BASF, ADM (Archer Daniels Midland
Company), Ajinomoto and Eastman.
 The food Additive market is estimated to reach a valuation of US$2.44 billion in 2023, and it is estimated to reach
US$4.62 billion by 2023. The market is anticipated to record a CAGR of 6.6% during the forecast period.
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Food Additives Market Size & Share Analysis - Industry Research Report - Growth Trends (mordorintelligence.com)

RECALLED PRODUCTS
The ‘Maggi’ Issue
• It all started with the sampling and testing of Maggi by the office of Commissioner of Food Safety, Uttar Pradesh and recognizing the
serious food safety concerns.
• The FSSAI then advised the Commissioners of Food Safety in various states to draw samples of Maggi and get the same tested from
authorized laboratories.
• Three major violations have been noted by the FSSAI
• Presence of Lead detected in the product in excess of the maximum permissible levels of 2.5 ppm.
• Misleading labelling information on the package reading “No added MSG”, and
• Release of a non-standardised food product in the market, viz. “Maggi Oats Masala Noodles with Tastemaker” without risk
assessment and grant of product approval
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BRAND REJECTED NO List of Rejected PRODUCRS
Tata starbucks 32 Coffee Frappuccino Flavoured Syrup, Vanilla Flavoured Syrup, Hazelnut
Flavoured Syrup, Raspberry Blackcurrant Juice
Herbal life 2 Multivitamin, Mineral & Herbal Tablets, Herbal Calcium Tablets etc
Field Fresh Foods (Del Monte) 3
Egg mayonnaise/ Salad dressing variants, Hot Sauce ( Proprietary Food),
Natural vinegar
Kellogg’s India 1 Kellogg’s Special K-Red Berries

20
As of 30th April 2015, more than 400 Proposals for products have been on assessment for risk/ safety of the
proposed products by the Product Approval & Screening Committee and the Scientific Panel. The list of products
includes products of well-known brands like Tata Starbucks, Kellogg's, Amway, Ranbaxy, Venky’s etc.

CONCLUSION
• They play a crucial role in ensuring the safety and quality of the food we consume.
• Regulations on food additives vary by country, but they generally aim to protect public health by setting strict standards for their use.
These regulations typically involve rigorous testing and approval processes before an additive can be deemed safe for consumption
• They provide a framework for evaluating the safety of additives before they enter the market, preventing the use of potentially
harmful substances.
• Regulations also help maintain transparency by requiring manufacturers to list additives on food labels, allowing consumers to make
informed choices and avoid ingredients they may be sensitive to or wish to avoid.
• Furthermore, regulations ensure that food additives are used in appropriate quantities and under specific conditions, preventing
excessive or unnecessary use.
• They also help establish maximum allowable limits for additives in different food categories, reducing the risk of overexposure.
• Continued research, monitoring, and updates to regulations are necessary to adapt to evolving scientific knowledge and emerging
concerns. Consumers, manufacturers, and regulatory bodies must work together to maintain a balance between innovation and safety
in the food industry.
21

REFERENCE
U.S.A
1.Guidance document for WHO monographers and reviewers evaluating food additives
• (excluding enzyme preparations and flavouring agents), version 1.0
• 2 Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including
• Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact
• Substances, Including Food Ingredients that Are Color Additives | FDA
• 3. Food additive safety: A review of toxicologic and regulatory issues - Peter Pressman, Roger Clemens,
• Wally Hayes, Chada Reddy, 2017 (sagepub.com)
• Food AdditiveTesting - Lifeasible
• 4.11 Types of Food Additives | Fooducate
• 5.Food Additive Standards (sigmaaldrich.com)
• 6. Food additives (who. int)
22

8.Global regulations for the use of food additives and processing aids – ScienceDirect
9.Estimation of toxic hazard—A decision tree approach - ScienceDirect
10.Food safety and regulatory survey of food additives and other substances in human food – ScienceDirect
11.Food additive safety: A review of toxicologic and regulatory issues - Peter Pressman, Roger Clemens,
Wally Hayes, Chada Reddy, 2017 (sagepub.com)
12.Food Chemical Safety | FDA
13.Determining the Regulatory Status of a Food Ingredient | FDA
14.GSFA Online Home Page
15.CXS_192e.pdf (fao.org)
23

INDIA
16.13 ChapterAN2018-19.pdf (mohfw.gov.in)
Compendium_Food_Additives_Regulations_08_09_2020-compressed.pdf (fssai.gov.in)
CANADA
https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted.html
EUROPE
Food additives | EFSA (europa.eu)
ARTICLES
19.https://www.researchgate.net/publication/340066779_62_Food_Additives_Functions_Effects
20._Regulations_Approval_and_Safety_Evaluation 2PDF) 62 Food Additives: Functions, Effects, Regulations,
Approval and Safety Evaluation (researchgate.net)
21.(PDF) Food safety and hygiene: A review (researchgate.net)
22. Evolving regulatory policies regarding food enzymes produced by recombinant microorganisms
- PMC (nih.gov)
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23.(PDF) Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the
US (researchgate.net)
24. Global regulations for the use of food additives and processing aids | Request PDF (researchgate.net)
WHO &ISO REGULATIONS
25. Food additives (who. int)
26ISO - ISO 22000 — Food safety management
27. Food Additive Standards (sigmaaldrich.com)
FUTURE TRENDS
28. What are the future development directions of food additives? (echemi.com)
RECALLED PRODUCTS
Not just Maggi, more than 400 products are rejected by FSSAI including ones from Tata Starbucks, Kellog’s etc (factly.in)
25

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