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Instructions for establishment registration and processing, filing for acidified and low-acid canned foods

Acid Food
 
A food that has a natural pH of 4.6 or below.
 
Acidified Food
 
A low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85.
 
Authorized Company Representative
 
The person authorized by the company to sign the registration and process filing forms on its behalf. That person should possess the knowledge necessary to answer technical questions concerning filed processes.

Instrumentation and Advanced Analytical Techniques

    1.    Chromatography is defined as an analytical technique where by a mixture of chemicals may be separated by virtue of their differential affinities for two immiscible phases. One of these, the stationary phase, consists of a fixed bed of small particles with a large surface area, while the other, the mobile phase or “eluant”, is a fluid that moves constantly through, or over the surface of, the fixed phase.

    2.    The chromatogram evaluated qualitatively by determining the Rf or retention factor, for each of the eluted substances.

    3.    The Rf is a measure of that fraction of its total elution time that any compound spends in the mobile phase.

    4.    If the liquid phase is a polar substance (e.g. polyethylene glycol) and the mobile phase is non polar, the process is termed normal-phase chromatography

    5.    When the stationary phase is non polar (e.g. octadecylsilane) and the mobile phase is polar, the process is reversed-phase chromatography

    6.    The chromatographic separation of mixtures of large molecules such as proteins may be accomplished by a mechanism called size exclusion chromatography or gel permeation chromatography.

    7.    Separation of certain molecules is accomplished by a mechanism called affinity Chromatography in which specific binding between an antibody (stationary phase) and antigen (analyte) occur.

Introduction

Since long time fermentation process is in use for the production of functional food products for human welfare. SSF is a cost effective industrially important method that could be used by food industries to improve the nutritional profile of natural substrates (Salar and Purewal, 2016; Postemsky et al., 2017). The process is being carried out by trained microbiologists in the presence of aseptic conditions using suitable starter culture on steam sterilized substrates. Steam sterilized substrates possess minimal amount of moisture so as to support the microbial growth during the fermentation period. Growth of microbial strains on specific substrates during the fermentation time results in formation of koji (antioxidant rich fermented product). Selection of substrates and starter microbial strains is an important step in the fermentation process which will determine the nutritional properties of fermented product. One of the major advantages of SSF at industrial level is its potential to be utilized on cereal grains, fruits, vegetables and even agricultural wastes (Salar et al., 2012; Postemsky and Curvetto, 2015; Bhanja et al., 2009). Most common substrates that are being used as solid platform for the growth of microbial strains are cereal grains.

Introduction
The characteristics of bacteria used in the study and identification of bacteria depend upon the behavior of populations or cultures rather than of individual organisms. Nutrient materials provided in a form, suitable for growth, are known as culture media. A Growth Media or culture medium is a liquid or gel designed to support the growth of microorganisms or cells.
I. Types of Culture Media
Different types of culture media may be used for cultivation of microorganisms such as liquid, solid and semi-solid.
i) Liquid Culture Media: Includes nutrient broth, Glucose broth, litmus milk etc. these media are used for the preparation of large number of microorganisms, fermentation studies and various other tests.
ii) Solid Media: A little agar, gelatin or silica gel; is added to a liquid medium to impart a degree of firmness to it. Nutrient agar, Blood agar, etc. are examples of solid media that are used for developing surface colony growth of bacteria and mold.
iii) Agar Slant Media: Test tubes or small bottles containing about 5ml. of solid medium, e.g. nutrient agar, dissolved and allowed to cool in a sloping position.
iv) Stab Media: Tubes or bottles containing agar medium are allowed to solidify in the upright position.
v) Semi solid Media: These are more jelly like due to lower percentage of the solidifiers. These media are particularly used for determining motility of bacteria.

1. Sample: One or more units selected from a population of units, or a portion of material selected from a larger quantity of material
2. The Standard Operating Procedures (SOPs) should contain full working instructions as well as information on applicability, expected performance, internal quality control (performance verification) requirements and calculation of results. It should also contain information on any hazards arising from the method, from standards or from reagents.
3. Analytical Samples: The quantity of the analytical sample to be used is usually indicated in tests and assays. Unless otherwise specified, the quantity used may deviate by 10% from that stated. All quantitative determinations should be conducted on triplicate test portions and in these cases, the amount actually taken should be accurately weighed or measured and the result of the analysis calculated on this exact quantity. When substances are to be “accurately weighed” in a test or assay, the weighing is to be performed in such manner as to limit the error to ± 0.1% or less. Quantities smaller than 100 mg should be weighed to the nearest 0.1 mg.

In today’s global food industry, packaging has evolved into an essential component that extends beyond basic containment. The rapid expansion of food distribution networks and increasing consumer demand for quality, convenience, and safety have transformed packaging into a sophisticated, multi functional system. Food packaging now serves critical roles in preservation, safety, marketing, and sustainability, aligning with both global and regional standards that cater to a wide array of consumer needs. This chapter provides an overview of the importance of food packaging, discusses the current landscape in both global and Indian markets, identifies key trends and challenges, and explores packaging’s role in the modern food supply chain. Each section aims to illustrate how food packaging impacts food quality, longevity, and overall consumer satisfaction, highlighting the industry’s ongoing innovations and adaptations to regulatory and environmental concerns. 1.1 Definition and Significance of Food Packaging Definit

Food preservation involves treating and safely handling food to prevent or delay spoilage while retaining colour, texture, flavour and nutritional value. Food deterioration may result from microbial growth, indigenous enzymes, oxidation, physical damage, insects, moisture, temperature and other environmental conditions. Bacteria, fungi and other microorganisms contaminate food through soil, water, air and biological sources. The effectiveness of preservation therefore depends on controlling intrinsic factors such as pH, water activity, nutrients and redox potential, together with extrinsic factors such as temperature, humidity and storage atmosphere. Understanding these mechanisms provides the scientific foundation for selecting safe and effective preservation methods.

Food processing is a fundamental component of the food industry that transforms raw materials of plant and animal origin into safe, nutritious, convenient and value-added products. This chapter introduces the basic concepts and evolution of food processing, tracing its development from traditional practices to modern technologies driven by consumer demand. It explains the major purposes of processing, including shelf-life extension, food variety, safety and preservation of nutritive value. The chapter also examines primary, secondary and tertiary processing and discusses the effects of processing on macronutrients and micronutrients. Understanding these fundamentals provides a foundation for evaluating conventional and emerging food-processing technologies.

Food safety and hygiene has been an age-old concern. However, today it has become an important aspect due to the rise in foodborne illnesses for the past few decades globally. It is estimated by WHO that annually 600 million suffer from foodborne diseases as a result of unsafe food consumption while 4,20,000 deaths are recorded globally.

Food Science is one of the ancient sciences and the genesis originates to the very beginning of human civilization. The advent of food science was associated with practice and observation by humans before establishment of scientific concepts. The ancient man knew that roasting or smoking of meat improves the edible quality and digestibility. As a consequence, he started practicing the same much before the reasons for the same could be established. Many of the modern preservation concepts had their origin in prehistoric period itself as humans could use techniques such as dehydration, fermentation and pickling to their advantage to improve the sensory attributes of the products and also to enhance their shelf life. Humans during the Pre-Neolithic period about 2,50,000 years before used fire for cooking meat. During the Paleolithic period humans not only roasted food but also developed grinding, pounding and drying. During the Mesolithic era, humans were desperate for food and got involved in extensive hunting and fishing. During the same time domestication of animals took place and animal husbandry became a reality (Stewart and Amerine 1982). The Neolithic period made qualitative changes in the food habits of humans and they changed from a food gathering and hunting society to one of food production (Heizer and Elsasser 1980).

Several centuries ago, perhaps as early as 6000-8000 BC, ancient man learned to domesticate species of animals for obtaining milk for their consumption. These included cows, buffaloes, sheep, goats, and camels, all of which are still used in various parts of the world for the production of milk for human use. The significance of milk as the most wholesome single food available in nature has never been debated. It is as ancient as mankind itself. The role and consumption pattern of milk in the traditional diet varies widely in different regions of the world. The tropical countries have not been traditional milk consumers, whereas in Europe (especially Scandinavia) and North America, milk and milk products have been traditional parts of the diet.

The human body consists of trillions of cells and to be healthy it needs variety of foods and nutrients. The food around the globe includes a variety of spices which have many health benefits. It has been found that spices and vegetables in the diet are very important for living healthy. The traditional foods, nuts, seeds, wild fruits and vegetables which are used in the diet are grown in specific areas. Traditional food system plays a significant role towards maintaining the well-being and the health of people in any specific region.

Human beings have been concerned about the concept of food safety since time immorial. Around the globe there has been major improvement in food safety management in the last twenty years. Looking into the progress made on the ways to make food safe and how to make them free from pathogens, this book, will explain food hygiene, the journey of research been taken in food safety till date and the challenges that we are going to face in future to ensure food safety and its wholesomeness. It also includes the role and responsibilities of the various sectors of society, namely governments, food industry, consumers and academia.

In the beginning of the twentieth century many modern food safety policies have been established. In the packing of meat and in food processing industries a lot of work has been done (Sinclair 1906). Another second generation policy includes the outbreak in the United States in early 1990s’ of pathogen E. coli O157:H7 and the BSE scandal of the late 1990s in the UK Lopman et al., (2003) have discussed on viral outbreak in europe. Currently, the crisis has come due to the economic and technological transformations which have taken place in food and the food supply system. As these changes have many health risks the public is very concerned. Therefore, the control forms of safety regulation and food safety laws have come into the picture. These policies include continuous line inspection, visual product inspection and detailed specification of approved hygiene practices. There is a need of a public health-focused policy which works towards the preventive integrated management of foodborne hazards from farm to table. This includes the use of modern science based risk management tools which will increase the efficiency accurately towards public health. A lot needs to be worked out for better implications. Current efforts to modernize food safety policy around the world are being worked out by the use of risk analysis and cost-benefit analysis in public administration and also the quality management in industry. The role of public economics plays an important role in food safety policies. For the social benefits the policy makers need to take decision on the costs and strengthening of the risk assessment. Today there are globalized markets and this can influence the health globally. Emerging economies like China are industrializing and urbanizing rapidly like that of Europe and North America.

There are many bacteria and fungi which produce biofilms. These are made up of living, reproducing microorganisms. These microbes form communities and adhere tightly to the surfaces and are resistant to many antibiotics. Many pathogenic microorganisms form biofilms which are difficult to be removed and are harmful.Such microbial colonies produce an extracellular polymeric substance (EPS) to protect them. The dental plaque was the first documented evidence of microbial biofilms. When such microorganisms get a moist environment they attach themselves to any object and reproduce forming an attachment by secreting a slimy, glue-like substance. It is possible with metals, plastics, natural materials, medical implants, kitchen counters, contact lenses, walls of a hot tub or swimming pool. Initially it was the investigation of many scientists to show the presence of biofilms

Beneficial effects of biofilms have also been shown (Rosche et al., 2009) especially in agriculture (Bogino et al., 2013; Berlanga and Guerrero, 2016) where it can be utilized as a biological control agents. They are used as biofertilizers to enhance crop production (Timmusk et al., 2017), hazardous pollutants can be removed (Irankhah et al., 2019). 

Indian Food Processing Industry (FPI) is one of the most untapped industries with abundant raw material to grow at a higher rate. FPI has been identified as a priority list in the “MAKE IN INDIA” program by the Government of India to boost its domestic manufacturing and export share. In the last few years, FPI has emerged as a high-growth and high-profit sector due to its immense potential for value addition while processing food products at various stages. The degree of processing of value addition to agricultural produce in India (20 %) is very low as compared to other countries, such as China (40 %), Brazil (70 %), and Malaysia (80 %). In India, the degree of processed food products ranges between 2 per cent (fruits and vegetables) and 35 per cent (milk) for various agriculture products. Hence there exist a huge potential for the growth of this sector in India. The export value of FPI was US$29.12 billion in 2016 and its share in world import was 2.18 per cent (Agarwal & Neogi, 2017).

India’s food processing sector covers fruit and vegetables; spices; meat and poultry; milk and milk products, alcoholic beverages, fisheries, plantation, grain processing, and other consumer product groups like confectionery, chocolates and cocoa products, soya-based products, mineral water, high protein foods, etc. The output of India’s food processing sector is expected to reach USD 535 Billion by 2025-26 (Invest India, 2020). Out of this, foreign investment is around Rs.10,000 crores (APEDA, 2020). Besides this, Government has also approved proposals for joint ventures; foreign collaboration, industrial licenses, and 100 per cent export-oriented units envisaging an investment.

Newer technologies involve fermentation by specific strains of lactic acid bacteria which bring specific fermentation under controlled conditions to a specific fermented product with enhanced organoleptic, nutritional and therapeutic qualities. Today health is of primary concern. It is important to have nutritionally balanced food with good bacteria. For this, probiotic foods top the list. The functional food concept was initially developed in Japan in 1990‘s as there were many side effects of allopathic medicines. A regulatory system has been initiated by the ministry of health and welfare to approve certain foods to improve health. These are now recognized as Foods for specialized health use (FOSHU). According to American dietic association (ADA) these foods are potential healthful food or food ingredients that may provide health benefits beyond the traditional nutrients. Probiotics are beneficial microorganisms. Probiotic foods as yogurt and sauerkraut are very well known. Fermentation increases the nutrient content and taste with the shelf life.

Veterinary public health deals with the contributions of veterinary medicine to public health. It is concerned, in the first instance, with the control and elimination of zoonoses and also with the following areas of activity:
    ·    Food hygiene (production, processing and distribution of foods of animal origin)
    ·    Environmental contamination and degradation by animal wastes and animal products
    ·    Comparative medicine (eg. Studies in animals on naturally appearing cancer, cardiovascular disease, metabolic and other disorders encountered in humans)
    ·    Laboratory animal medicine
    ·    Education and training in VPH and communication with the public
    ·    Reproduction biology
    ·    Aspects of mental and societal health
    ·    Emergency veterinary functions in natural disasters and other catastrophes.

1.1 Importance of Food Process Engineering

Food occupies the first position among the hierarchal needs of human beings. It is more important than shelter and clothing. After production and be forec on sumpti on, food commodities are subjected to nume rous unfavourable physical, chemical, microbial or parasitic factors which may cause their spoilage or disease when consumed. To prevent such spoilage, a process engineer has to understand these and provide remedial measures. The two primary goals of processing operation are first to minimize post harvest losses and second value addition of raw food commodities through preservation and processing.

Present level of production of different types of food commodities and their estimated post-harvest losses along with monetary values are given in Table 1.1. It shows that various food items get lost, to the tune of 65 million tonnes, worth Rs. 76,000 crores per annum, during post-harvest phase. A substantial amount of these losses could be prevented if appropriate agro processing centers, having backward linkage with farmers to ensure constant supply of quality raw food materials, are established and operated. Profit generated through value addition must also be shared with farmers, who are only people in the world to create wealth every year, in the form of food, fiber and other commodities necessary for human survival. It can bring sea change in rural areas, where 65-70% population live, in respect of economy, health and happiness.

It sounds simple, but the above process is fairly complex and requires lot of coordination in order to succeed. The major challenge is to minimize the losses during the various post harvest operations and keep the food as fresh as possible. In order to do so, one must first try to understand the various causes of post harvest losses of food commodities and the various factors that influence theses causes. Secondly, we must use those food processing operations that will not only extend the shelf life of the produce but also convert the raw food commodities to more acceptable product to the consumer.

Concept of Inventory

‘Inventory’ may be defined as ‘usable but idle resource’. If resource is some physical and tangible object such as materials, then it is generally termed as stock. Thus stock or inventory are synonymous terms though inventory has wider implications. Broadly speaking, the problem of inventory management is one of maintaining, for a given financial investment, an adequate supply of something to meet an expected demand pattern. This could be raw materials work in progress finished products or the spares and other indirect materials. Inventory can be one of the indicators of the management effectiveness on the materials management front. Inventory turnover ratio (annual demand/average inventory) is an index of business performance. A soundly managed organization will have higher inventory turnover ratio and vice-versa. Inventory management deals with the determination of optimal policies and procedures for procurement of commodities. Since it is quite difficult to imagine a real work situation in which the required material will be made available at the point of use instantaneously, hence maintaining, inventories becomes almost necessary. Thus inventories could be visualized as ‘necessary evil’.

In today’s innovation driven economies, turning a great idea or new technology into something investors want to fund takes careful planning. This process is called investor readiness. which means making sure the idea works, has a market, and is presented in a way that makes investors feel confident. Therefore, Investor readiness means the preparedness of an innovation to attract and secure investment from potential investors. It has all the essential parameters in place that an investor would evaluate before deciding to invest. For inventors, this means showcasing innovation’s business potential, potential for growth, and the capability to provide a return on investment. Understanding investor readiness is important because it directly influences scalability and growth of invention. Even the most innovative ideas can struggle to find the financial benefits without showcasing business potential.
Why it is important to discuss investor readiness
Investor readiness is the state in which a technology, its value proposition, and its founding team are significantly prepared to engage with securing funding from potential investors. Without investor readiness, even high-potential innovations may fail to reach the market due to gaps in business clarity, legal assurance, or team maturity. TTOs play an important role in this process by acting as intermediaries between inventor and investors. Modern day TTOs are more inclined to prepare technologies and associated teams to attract investment. This expanded mandate of TTOs and brought in investor readiness. It requires a wellstructured approach focused on aligning academic innovations with investor expectations. TTOs help in creating this readiness by guiding researchers through commercial pathways, derisking technologies, and translating technical advancements into investment suitable.