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2.1 Globally recognized manufacturing standards
2.1.1 Food and beverage
Food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.
2.1.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)
In 1998, the British Retail Consortium (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.[1][2][3][4] The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.[2]
2.1.1.2 Codex Alimentarius
The Codex Alimentarius is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the World Health Organization (WHO).[3] The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."[5] Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.[5] It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.[6] Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)[7], General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).[8]
2.1.1.3 Global Food Safety Initiative (GFSI)
The GFSI is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.[3] Previously known as the GFSI Guidance Document[9], the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."[3] An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.[10] GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.
2.1.1.4 Hazard analysis and critical control points (HACCP)
The hazard analysis and critical control points or HACCP system has been adopted and integrated in various ways over the years[11], but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.[3] Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.[11][12] HACCP also found its way into other standards benchmarked by the GFSI.[11] The concept of HACCP has perhaps changed slightly over the years, but the main principles remain[3]:
- Conduct a hazard analysis.
- Identify CCPs.
- Establish critical limits for those CCPs.
- Establish monitoring procedures for those CCPs.
- Establish corrective action for failed limits.
- Establish verification procedures.
- Establish record keeping and documentation procedures.
2.1.1.5 International Featured Standards (IFS)
The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"[13] or "uniform evaluation system"[3] for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).[13]
2.1.1.6 International Organization for Standardization (ISO) 22000
The ISO 22000 series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.[14] ISO 22000 is based off the ISO 9000 family of quality management system standards and, like other standards, incorporates elements of HACCP.[11] The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.[15] Major standards applicable to manufacturers with laboratories include:
- ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing[16]
- ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing[17]
- ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production[18]
2.1.1.7 Safe Quality Food (SQF) Program
The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety-plus-quality" management certification mechanism that covers the food supply chain from farm to fork.[3] Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.[19] Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.
2.1.2 Materials
2.1.3 Pharmaceutical and medical devices
2.1.4 Other industries
2.2 Regulations and laws around the world
2.2.1 Food and beverage
2.2.2 Materials
2.2.3 Pharmaceutical and medical devices
2.3.4 Other industries
2.3 Other influencing factors
2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)
2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)
- ↑ Pavlović, A. (26 June 2017). "What is BRC? Global food safety standard explained". Ideagen Blog. Ideagen Limited. https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained. Retrieved 21 April 2023.
- ↑ 2.0 2.1 "BRCGS - British Retail Consortium Global Standard" (PDF). Perry Johnson Food Safety Consulting, Inc. April 2020. https://www.pjfsc.com/Downloads/BRC-Overview.pdf. Retrieved 21 April 2023.
- ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "Food Safety and Quality Regulations: A Guide to Global Standards" (PDF). Eagle Product Inspection. May 2019. https://vertassets.blob.core.windows.net/download/45fe7af4/45fe7af4-0500-4163-bd2b-5dd34e824bfd/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf. Retrieved 21 April 2023.
- ↑ British Retail Consortium (August 2018). "Global Standard Food Safety" (PDF). British Retail Consortium. https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf. Retrieved 21 April 2023.
- ↑ 5.0 5.1 "About Codex Alimentarius". Food and Agricultural Organization. 2022. https://www.fao.org/fao-who-codexalimentarius/about-codex/en/#c453333. Retrieved 21 April 2023.
- ↑ "Food laws & regulations". Food and Agricultural Organization. 2022. https://www.fao.org/food-safety/food-control-systems/policy-and-legal-frameworks/food-laws-and-regulations/en/. Retrieved 21 April 2023.
- ↑ "Codes of Practice". Codex Alimentarius. Food and Agricultural Organization. 2022. https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/. Retrieved 21 April 2023.
- ↑ "Contaminants". Codex Alimentarius. Food and Agricultural Organization. 2022. https://www.fao.org/fao-who-codexalimentarius/thematic-areas/contaminants/en/. Retrieved 21 April 2023.
- ↑ "GFSI Releases New Edition of Benchmarking Requirements". Global Food Safety Initiative. 28 February 2017. https://mygfsi.com/press_releases/gfsi-releases-new-edition-of-benchmarking-requirements/. Retrieved 21 April 2023.
- ↑ "Certification". Global Food Safety Initiative. 2022. https://mygfsi.com/how-to-implement/certification/. Retrieved 21 April 2023.
- ↑ 11.0 11.1 11.2 11.3 Weinroth, Margaret D; Belk, Aeriel D; Belk, Keith E (9 November 2018). "History, development, and current status of food safety systems worldwide" (in en). Animal Frontiers 8 (4): 9–15. doi:10.1093/af/vfy016. ISSN 2160-6056. PMC PMC6951898. PMID 32002225. https://academic.oup.com/af/article/8/4/9/5087923.
- ↑ "61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems". Federal Register. U.S. Government Publishing Office. 25 July 1996. https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary. Retrieved 21 April 2023.
- ↑ 13.0 13.1 "IFS: Global Safety and Quality Standards". IFS Management GmbH. https://www.ifs-certification.com/en/. Retrieved 21 April 2023.
- ↑ "ISO 22000 Food safety management". International Organization for Standardization. https://www.iso.org/iso-22000-food-safety-management.html. Retrieved 21 April 2023.
- ↑ "ISO/TC34/SC17". International Organization for Standardization. https://committee.iso.org/home/tc34sc17. Retrieved 21 April 2023.
- ↑ "ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing". International Organization for Standardization. December 2009. https://www.iso.org/standard/44001.html. Retrieved 21 April 2023.
- ↑ "ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing". International Organization for Standardization. December 2013. https://www.iso.org/standard/60969.html. Retrieved 21 April 2023.
- ↑ "ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production". International Organization for Standardization. April 2016. https://www.iso.org/standard/66126.html. Retrieved 21 April 2023.
- ↑ "SQF Code – Edition 9 Downloads". SQF Institute. 24 May 2021. https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/. Retrieved 21 April 2023.