ISO 22000:2018 Revision

What’s New in ISO 22000:2018?

The ISO 22000 family of food safety standards first launch in 2005, since then it has been adopted by more than 32,000 organizations worldwide (ISO, 2016) as their food safety management system due to the risk involved in food manufacturing sectors and as response to consumer demand for food safety. The standard revision was first announced around 2012, but it was started in 2014 which took four years to complete the entire revision up to publication in June 2018. The standard has introduced significant changes by adapting to the ISOs common high level structure while creating extended PDCA cycle. Hence, standard has adopted 10 section based high level structure based on identical core text and common terms and definitions which can be compatible with other ISO family standards to reduce the complexities while increasing the adaptability to multiple platform initiative.

The core changes introduced in the revision will affect organizations that wish to maintain their existing system certifications, as well as the organizations that are involved in the auditing compliance. The changes will also effectively impacted on the existing system scope, top management involvement, documentation of the system, application of the risk based approach to organizational needs with a clear focus on the process approach through the Plan-Do-Check-Act (PDCA) cycle. The PDCA cycle has extended by adaptation of separate HACCP cycle which runs inside the PDCA. Additional changes introduced to the standard are differentiation of PRPs, OPRPs and CCPs, adaptation of ISO/TS 22002 (1, 2, 3, 4 and 6) prerequisite programs on food safety, traceability, allergen management, supplier evaluation and acceptance which were the major criticism from GFSI to build their own FSSC 22000 while other minor changes were adapted to clarify and simplify the long held issues in the industry as well as to update international developments in food safety approaches in the last 13 years.

According to the World Health Organization’s estimates one in ten people fall ill and 420,000 die because of contaminated food every year where food safety standards are required to reduce such risks by helping food producers to implement food safety management systems that defend against the potential hazards and risks that lead to contamination.  Hence, ISO 22000 has the advantage over the many private standards due to its generic nature, minimum enforcement levels, voluntary adaptation and as it covers the whole organization. The new ISO 22000:2018 will fully contributes to ensure food safety hazards throughout the whole food chain from farm-to-folk with the enhanced compliances, which is essential as hazards occur at any stage of the food chain. ISO 22000 accommodates communication along the food chain and within the organization. ISO 22000:2018 has ensures fair competition to the other food safety standards as it has consolidated major complains made by public regarding traceability, prerequisite programs, allergen management, food security, other requirements etc.

The Major Changes

The new release has undergone a thorough revision for the standard, since it is the first revision of the standard after 2005. The standard has now been updated with ISO’s high level structure (HLS) and revised to meet today’s food safety challenges, where organizations with previous version certificate must transit to the 2018 version by June 19, 2021. After this date, the 2005 version of the standard will be withdrawn. The standard has tried to capture recent updates in the food safety landscape, changes in business diversity, global commerce and digitalization in food supply chains. The major proposed changes to the standard include modifications to its structure as well as clarifying key concepts.  

The High Level Structure

The expectation to deliver safe, sustainable and socially responsible food has increased significantly for the food sector during last 13 years since the standard was first published. In order to make life easier for businesses using more than one management system standard, the new version of ISO 22000 will follow the same structure as all the other ISO management system standards, the High Level Structure (HLS). Annex SL was developed by ISO as a framework for a generic management system. It’s the framework for a generic management system and the blueprint for all new and revised management system standards going forward. The HLS will help to keep consistency, align different management system standards, offer matching sub-clauses against the top level structure and apply common language across all standards. With the new standard in place, organizations will find it easier to incorporate their food safety management system into core business processes and get more involvement from senior management.

The Risk Approach

The standard now includes a different approach to understanding risk where standard clarifies the Plan-Do-Check-Act cycle, by having two separate cycles in the standard working together by one covering the management system and the other, covering the principles of HACCP. The initiative will combine both organizational and operational risk management into one management system. Application of PDCA cycle to manage business risk while using HACCP to identify, prevent and control food safety hazards, ISO 22000:2018 helps organizations to reduce exposure to risk and improve safety. The risk is now distinguished between the operational level and the strategic level, where strategic level of the management system (business risk), organizations can embrace opportunities in order to reach a business’s specific goals. On the other hand the operational level, users can use the Hazard Analysis Critical Control Point (HACCP) approach. The approach provides the opportunity to consider all the different aspects that might impact any organization, either good or bad, while allowing to prioritize the objectives of the organization’s FSMS to implement in a way that can accommodate the effects of these risks should they occur. The revision has placed a heavy focus on risk in which organization required to tackle the risks in daunting and seemingly overwhelming force for better accommodating risk surround concerns with a FSMS and its processes. Food safety encompasses the prevention, elimination, and control of foodborne hazards, from the site of production to the point of consumption. The potential benefits of combining risk-based thinking, PDCA and the process approach includes focus of FSMS and activities on high risk processes and understanding how processes within the organization are interdependent. It will further help more effective use of resources, improved agility in meeting the requirements of new customers and/or meet new requirements established by existing customers.

The Operation Processes

To help food sector organizations manage the challenges in distinguishing different key terms, a clear description is given of the differences between key terms such as Critical Control Points (CCPs), Operational Prerequisite Programs (OPRPs) and Prerequisite Programs (PRPs). On the operational side, risk-based thinking provides additional benefits to organizations throughout the food chain that includes improved control over food safety activities, customer, statutory and regulatory compliance, facilitated market growth, increased customer/stakeholder and consumer confidence in products, improved risk management and integration with other ISO management systems. In addition, ISO 22000:2018 has been changed it process to offer a dynamic control of food safety hazards through combining interactive communication, systems management, Prerequisite Programs (PRPs), and the principles of HACCP. The standard also clearly describes the differences between these key operation process elements while creating strong links to Codex Alimentarius HACCP principles.

Context of Organization and Interested Parties

The context of organization expanded and the interested parties are added to provide a high-level, strategic understanding of the important issues that can affect, either positively or negatively, the way of an organization manages food safety. It gives food safety team the opportunity to identify and understand factors and parties that affect the intended outcome(s) of the FSMS, which also addresses the concept of preventive action. The organization will need to determine external and internal issues that are relevant to its purpose, while considering the relevant internal and external issues that could have an impact or effect on the FSMS in achieving its intended outcome(s). Hence, system can enable an organization either directly or indirectly involved in the food chain to plan, implement, operate, maintain, and update a FSMS providing safe products and services. It also assures the organization’s conformance to its stated food policy, while evaluating and assessing mutually agreed customer safety requirements and demonstrating conformity with customers and any other interested parties.

Leadership and Commitment  

There is a much greater focus has given on top management to demonstrate their leadership and commitment with respect to the ISO 22000:2018 to ensure consultation and participation of top management in the development, planning, implementation and continual improvement of the food safety management system. Top management have a responsibility to ensure that the importance of effective food safety management and clear communication to the all employees and that they understood to ensure FSMS achieves its intended outcomes. Risk and opportunity ISO 22000:2018 takes a business orientated approach that requires broader risks and opportunities to be identified. This robust approach will enable the identification of opportunities that contribute to further improvement in food safety performance, which will improve their ability to identify and manage risks more effectively making them more resilient.

Documented Information

The basic changes to the system through HLS is the convergence of ‘procedures’ and ‘records’ into ‘documented information’, which gives the freedom for the organization to define the type and extent of documented information to be defined, although some mandatory documentation is still specified, where established controls for documents in the system are retained. Nonetheless, number of requirements relating to basic system elements are clarified and strengthened, including communication systems and needs. Now resource planning is required along with tighter controls over external contributors to system development, where the needs of competence of relevant personnel, both internal and external, are more fully explained, while documented system required for greater control of suppliers of goods and services.

Nanotechnology in Food Safety - III

Applications of Nanotechnology in Food Safety

As nanotechnology opens the door to a whole new array of consumer products, what, industries, food technologists and regulators are doing to improve the safety of our food supply seems limited only by one’s imagination. Since fresh fruits, vegetables, meat and poultry products are major potential vehicles for the transmission of human pathogens leading to foodborne disease outbreaks, there is a major public attention to food safety. Hence, the need to develop new antimicrobials to ensure food safety is major concerns over researchers working on nanotechnology, because of the antimicrobial properties of nanomaterials, where nanotechnology offers great potential for novel antimicrobial agents for the food and food-related industries. Thus, use of nano-antimicrobial agents added directly to foods or through antimicrobial packaging is an effective approach. As a result, the use of nanotechnology by the food and food-related industries is expected to increase, impacting the food system at all stages from food production to processing, packaging, transportation, storage, security, safety and quality. As a matter of fact, one of the most common applications of nanomaterials in food safety is through the uses of nanoscale silver, because historically silver is used as an antimicrobial agent, which is used in a variety of applications today such as dental implants, catheters, and wound healing dressings.

Antimicrobial agents

By reducing the particle size of silver to the nanolevel that exhibits an increased efficiency in its ability to control the bacterial growth, while improving its biocompatibility in mammalian systems. Hence, applications of silver nanoparticles in food packaging has involved its embedding into biodegradable coatings that have successfully inactivated bacteria. It also acts as an anchor through the assistance of certain amino groups to common surfaces, such as glass, that has exhibited successful inhibition in the form of biofilms, and its combination with graphene oxide on these surfaces have even been found to inhibit almost 100% of bacterial attachment. Similar chemicals manipulated at the nanolevel such as titanium oxide (TiO₂), zinc oxide (ZnO), cerium oxide (CeO), and others, have been used as photocatalytic agents in order to create surface reactive oxygen species (ROS) capable of damaging organic matter, such as bacteria, from developing.

Natural antimicrobial extracts, such as nano-encapsulated cinnamaldehyde, thyme oil emulsified with soluble soybean polysaccharide, and mandarin oil nano-emulsions, have also found to be successful additions and alternatives to harsh chemicals for these surfaces as well. Food packaging products have also found the use of selenium and cellulose particles to successfully inhibit the production of ROS that can arise and degrade food quality.

One of the newest nano-enabled techniques that have risen in the fight against microbial agents in food is known as engineered water nanostructures (EWNS). These highly charged and mobile agents contain ROS, allowing for their successful interaction and inactivation of microorganisms on surfaces. By being applied to water through either electro-spraying and/or ionization processes, EWNS has a highly targeted capability to deliver their antimicrobial potential to food-related microorganisms, reaching what has been measured as up to a 99.99% reduction in organismal presence.

Food ingredients for color, texture and flavor

The food industry is beginning to use nanotechnology to develop nanoscale ingredients to improve color, texture and flavor of food, where nanoparticles TiO₂, SiO₂ and amorphous silica are used as food additives, i.e. TiO₂ is used as a coloring in the powdered sugar coating on doughnuts.

Food production and packaging

Nanomaterials used for food packaging provide many benefits such as improved mechanical barriers, detection of microbial contamination and potentially enhanced bioavailability of nutrients. This is perhaps the most common application of nanotechnology in food and food-related industries. A number of nanocomposites, polymers containing nanoparticles, are used by the food industry for food packaging and food contact materials. The use of ZnO and MgO nanoparticles for food packaging has been reported. Amorphous silica is used in food and in food containers and packaging. Nonetheless, engineered water nanostructures generated as aerosols are very effective at killing foodborne pathogens such as Escherichia coli, Listeria and Salmonella on steel food production surfaces. Such food contact substances containing nanomaterials have the potential of migrating from food packaging into food, so this technology still must demonstrate regulatory compliance before it gains wide-spread acceptance in the industry.

Nutrients and dietary supplements

Nanomaterials are used as ingredients and additives (e.g., vitamins, antimicrobials, antioxidants) in nutrients and health supplements for enhanced absorption and bioavailability.

Food storage

The antimicrobial properties of nanomaterials enable them to preserve food during storage and transport. Nanosensors can be used for a variety of applications. Commercial use of nanosensors has been reported to check storage conditions and during food transport in refrigerated trucks for temperature control.

Food nanosensors

Nanomaterials are used as sensors to detect contamination and regulate the food environment. They can detect microbial and other food contaminants. Therefore, they are used as sensors in food production and at packaging plants. They can monitor the condition of food during transport and storage. They can detect nutrient deficiency in edible plants, and dispensers containing nutrients can deliver them to plants when needed. Therefore, nanomaterials can be used as nanosensors and nanotracers with almost unlimited potential by the food industry.

Food Safety Issues in Nanotechnology

Besides a lot of advantages of nanotechnology to the food industry, safety issues associated with the nanomaterial cannot be neglected, where many researchers discussed safety concerns associated with nanomaterial giving emphasis on the possibility of nanoparticles migrate from the packaging material into the food and their impact on consumer’s health. Although a material is being generally regarded as safe (GRAS) substance, additional studies must be required to examine the risk of its nano counterparts because the physiochemical properties in nano-states are completely different from that are in macro-state. Moreover, the small size of these nanomaterials may increase the risk for bioaccumulation within body organs and tissues, i.e. silica nanoparticles which are used as anti-caking agents can be cytotoxic in human lung cells when subjected to exposure. There are a lot of factors that affect dissolution including surface morphology of the particles, concentration, surface energy, aggregation, and adsorption. A model to study the migration of particles from food packaging has been developed by Cushen et al. in 2014, where they studied the migration of silver and copper from nanocomposites and observed that the percentage of nano-filler in the nanocomposites was one of the most crucial parameters driving migration, more so than particle size, temperature, or contact time. Since every nanomaterial has its individual property, therefore, toxicity will likely be established on a case-by-case basis. Further, regulatory authorities must develop some standards for commercial products to ensure product quality, health and safety, and environmental regulations.

Safety of food derived from nanotechnology

Consumers are exposed to nanomaterials by consumption of food and beverages containing these extremely small particles of large reactive surface area of unknown safety. Once absorbed in the gastrointestinal system, they may bio-accumulate in various organs of the body, leading to potentially adverse effects. Thus, application of nanotechnology by the food industry is of public concern. Public acceptance of food and food products containing nanomaterials depends on their perceived safety. According to the journal Nature Nanotechnology, “the food industry will only reap the benefits of nanotechnology, if issues related to safety are addressed and manufacturers are more open about what they are doing.” Food safety concerns over the application of nanotechnology in food is rising due to widespread of novel applications in food industry. The major concerns over the issue are:  

Negatives

Nanoparticles become an indirect source of food contaminant.

Uptake of nanomaterials alters the absorption profile and metabolism in the body.

Toxicity of nanoparticles remains largely unknown.

Lack of effective analytical method and predictive model to evaluate the safety of nanoparticles.

           

Positives

At present, there is no tenable evidence that food derived from nanotechnology is any safer or more dangerous than their conventional counterparts.

Despite no general conclusion has been made by international food safety authorities on the safety of nanofood incorporated with nanomaterials, there is also no evidence that ingested nanomaterials have harmed human health.

Food Safety Regulations on Nanotechnology

Different jurisdictions, such as Australia, European Union, United States and New Zealand, have established committees to monitor the development of nanotechnology and take appropriate action if necessary. In March 2009, the scientific committee of the European Food Safety Agency published an opinion on nanoscience and nanotechnology regarding food and animal feed safety. A guidance document on how to assess potential risks associated with certain food-related uses of nanotechnology followed in May 2011, providing practical recommendations to regulators on how to assess applications from industry to use engineered nanomaterials in food additives, enzymes, flavorings, food contact materials, novel foods, food supplements, feed additives and pesticides.

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry use of nanomaterials in animal feed. However, more research is required to determine the impact of nanomaterials in food on human health to ensure public safety and improve public communication of the safe use of such materials in commercial food supply. Some test methods for nanomaterial safety assessment have been reported, however, no internationally accepted standard protocols for toxicity testing of nanomaterials in food or feed are currently available. Such protocols are in the development stage by organizations such as the International Alliance for Nano Environment, Human Health and Safety Harmonization and the U.S. National Research Council. A uniform international regulatory framework for the evaluation of nanotechnology is a necessity for both human food and animal feed.