View source for Template:LIMS Selection Guide for Manufacturing Quality Control/Standards and regulations affecting manufacturing labs/Regulations and laws around the world

===2.2 Regulations and laws around the world===
As the end of Chapter 1 highlighted, today's regulatory focus on product safety, quality, and efficacy is largely built on the past failures, injuries, and deaths that highlighted the regulatory need.<ref>{{Cite book |last=Center for Policy Alternatives at the Massachusetts Institute of Technology |year=1980 |title=Benefits of Environmental, Health, and Safety Regulation |url=https://books.google.com/books?id=VadeKZOzcmwC&pg=PA1 |publisher=U.S. Government Printing Office |pages=100}}</ref><ref name="AschConsum88">{{Cite book |last=Asch |first=Peter |date=1988 |title=Consumer safety regulation: putting a price on life and limb |url=https://books.google.com/books?id=Pi_nCwAAQBAJ&pg=PA1 |publisher=Oxford University Press |place=New York |pages=3–14 |isbn=978-0-19-504972-5}}</ref><ref>{{Cite book |last=Dwyer |first=Tom |date=1991 |title=Life and death at work: industrial accidents as a case of socially produced error |series=Plenum studies in work and industry |publisher=Plenum Press |place=New York |isbn=978-0-306-43949-0}}</ref><ref>{{Cite book |last=CoVan |first=James |date=1995 |title=Safety engineering |series=New dimensions in engineering |publisher=Wiley |place=New York |isbn=978-0-471-55612-1}}</ref> For example, the consumption of raw milk was associated with a growing number of health issues in the mid- to late 1800s, particularly milk from unscrupulous dairy farms. In the U.S. Northeast during the 1860s, recognition was growing concerning the threat that tainted milk originating from dairy cows being singularly fed distillery byproducts had to human health. Not only was the milk generated from such cows thin and low in nutrients, but it also was adulterated with questionable substances to give it a better appearance. This resulted in many children and adults falling ill or dying from consuming the product. The efforts of Dr. Henry Coit and others in the late 1800s to develop a certification program for milk—which included laboratory testing among other activities—eventually helped plant the seeds for a national food and beverage safety program.<ref>{{Cite book |last=Lytton |first=Timothy D. |date=2019 |title=Outbreak: foodborne illness and the struggle for food safety |chapter=Chapter 2: The Gospel of Clean Milk |publisher=The University of Chicago Press |place=Chicago ; London |pages=24-64 |isbn=978-0-226-61154-9}}</ref> By 1939, the U.S. Public Health Services had drafted the Model Milk Health Ordinance "in order to encourage a greater uniformity of milk-control practice in the United States."<ref name="PHSMilk39">{{cite web |url=http://resource.nlm.nih.gov/101528318 |title=Milk ordinance and code: Recommended by the United States Public Health Service, 1939 |author=U.S. Public Health Service |publisher=U.S. Government Printing Office |date=1939 |accessdate=05 May 2023}}</ref>

While regulation can at times be overbearing and harmful, well-crafted regulations can definitely benefit our society. This can be seen with manufacturing regulations driven on safety, quality, and efficacy principles. How those regulations are implemented around the world may differ slightly, however, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.<ref name="BuzbyFood03">{{cite web |url=https://www.ers.usda.gov/amber-waves/2003/november/food-safety-and-trade-regulations-risks-and-reconciliation/ |title=Food Safety and Trade: Regulations, Risks, and Reconciliation |author=Buzby, J.C.; Mitchell, L. |work=Amber Waves |publisher=U.S. Department of Agriculture, Economic Research Service |date=01 November 2003 |accessdate=05 May 2023}}</ref> 

The following subsections examine some of the more critical regulations that apply to a wide variety of manufacturing industries, from various parts of the world.

====2.2.1 Food and beverage====
[[File:Food-safety-modernization-act-fsma.png|right|300px]]The safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this guide to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences—significant and nuanced—exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing of products.<ref name="BuzbyFood03" /><ref name="WestGlobal18">{{cite web |url=https://www.brookings.edu/research/global-manufacturing-scorecard-how-the-us-compares-to-18-other-nations/ |title=Global manufacturing scorecard: How the US compares to 18 other nations |author=West, D.M.; Lansang, C. |work=Brookings |date=10 July 2018 |accessdate=05 May 2023}}</ref><ref name="GAOFoodSafety05">{{cite web |url=https://www.gao.gov/products/gao-05-212 |title=Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems |author=U.S. Government Accountability Office |date=February 2005 |accessdate=05 May 2023}}</ref><ref name="WhitworthReport22">{{cite web |url=https://www.foodsafetynews.com/2022/02/report-finds-food-testing-policies-different-between-countries/ |title=Report finds food testing policies different between countries |author=Whitworth, J. |work=Food Safety News |date=22 February 2022 |accessdate=05 May 2023}}</ref> 

'''2.2.1.1 Food Safety Act 1990 and Food Standards Act 1999 - ''United Kingdom'''''

The [[wikipedia:Food Safety Act 1990|Food Safety Act of 1990]] and [[wikipedia:Food Standards Agency|Food Standards Act of 1999]] represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.<ref name="SBCFood22">{{cite web |url=https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |archiveurl=https://web.archive.org/web/20230203164750/https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |title=Food safety regulations |publisher=Scarborough Borough Council |date=10 November 2022 |archivedate=03 February 2023 |accessdate=05 May 2023}}</ref><ref name="FSAKey22">{{cite web |url=https://www.food.gov.uk/about-us/key-regulations |title=Key regulations |publisher=Food Standards Agency |date=30 August 2022 |accessdate=05 May 2023}}</ref> The Food Safety Act of 1990 encourages entities to "not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it"; serve or sell food that is of a quality that "consumers would expect"; and ensure food is labeled, advertised, and presented clearly and truthfully.<ref name="SBCFood22" /><ref name="FSAKey22" /> The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) "to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food."<ref name="FSA99Sec1">{{cite web |url=https://www.legislation.gov.uk/ukpga/1999/28/section/1 |title=1999 c. 28, The Food Standards Agency, Section 1 |work=legislation.gov.uk |accessdate=05 May 2023}}</ref> One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labeling policy.<ref name="FSAAbout">{{cite web |url=https://www.gov.uk/government/organisations/food-standards-agency |title=Food Standards Agency |work=Gov.uk |accessdate=05 May 2023}}</ref> Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, ''Salmonella'' testing, temperature control, dairy hygiene, and more.<ref name="FSAGuidReg">{{cite web |url=https://www.gov.uk/search/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency |title=Guidance and regulation: Food Standards Agency (FSA) |work=Gov.uk |accessdate=05 May 2023}}</ref>

'''2.2.1.2 Food Safety and Standards Act of 2006 - ''India'''''

This act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.<ref name="PRSImplement">{{cite web |url=https://prsindia.org/policy/report-summaries/implementation-food-safety-and-standards-act-2006 |title=Implementation of Food Safety and Standards Act, 2006 |work=PRS Legislative Research |accessdate=05 May 2023}}</ref><ref name="FSSAIFood">{{cite web |url=https://fssai.gov.in/cms/food-safety-and-standards-act-2006.php |title=Food Safety and Standards Act, 2006 |publisher=Food Safety and Standards Authority of India |accessdate=05 May 2023}}</ref> However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall "low quality" of food testing laboratories in the country.<ref name="PRSImplement" /> Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.<ref name="FSSAIFood" />

'''2.2.1.3 Food Safety Law - ''China'''''

The [[wikipedia:Food safety in China|Food Safety Law]] is described as "the fundamental law regulating food safety in China."<ref name="UNEPFood15">{{cite web |url=https://leap.unep.org/countries/cn/national-legislation/food-safety-law-2015 |title=Food Safety Law (2015) |author=Food and Agriculture Organization of the United Nations |work=Law and Environment Assistance Platform |publisher=United Nations Environmental Programme |date=24 April 2015 |accessdate=05 May 2023}}</ref> Enacted in 2009 and revised in 2015, the Law "builds up the basic legal framework for food safety supervision and management" and  "introduces many new regulatory requirements," including "not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories."<ref name="UNEPFood15" /> Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.<ref name="USDAChina15">{{cite web |url=https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf |format=PDF |title=China's Food Safety Law (2015) |author=Foreign Agriculture Service Staff |publisher=U.S. Department of Agriculture |work=GAIN Repo |date=18 May 2015 |accessdate=05 May 2023}}</ref>

'''2.2.1.4 Food Sanitation Act and Food Safety Basic Act - ''Japan'''''

The Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted "to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health."<ref name="JLTFood47">{{cite web |url=https://www.japaneselawtranslation.go.jp/en/laws/view/3687/en |title=Food Sanitation Act (Act No. 233 of 1947) |work=Japanese Law Translation |date=24 December 1947 |accessdate=05 May 2023}}</ref> The Food Safety Basic Act recognized the effects of "internationalization" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.<ref name="FSCFoodSafe03">{{cite web |url=https://www.fsc.go.jp/english/basic_act/fs_basic_act.pdf |format=PDF |title=Food Safety Basic Act |publisher=Food Safety Commission of Japan |date=23 May 2003 |accessdate=05 May 2023}}</ref> Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.<ref name="BMFoodJapan18">{{cite web |url=https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/japan/topics/food-product-and-safety-regulation |title=Japan: Food product and safety regulation |work=Asia Pacific Food Law Guide |author=Baker McKenzie |date=2018 |accessdate=05 May 2023}}</ref>

'''2.2.1.5 Food Safety Modernization Act (FSMA) and other acts - ''United States'''''

The [[wikipedia:FDA Food Safety Modernization Act|Food Safety Modernization Act]] of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref><ref name="FDAFood22">{{cite web |url=https://www.fda.gov/animal-veterinary/animal-food-feeds/food-safety-modernization-act-and-animal-food |title=Food Safety Modernization Act and Animal Food |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=05 May 2023}}</ref> It has been described by the FDA as "the most sweeping reform of our food safety laws in more than 70 years."<ref name="FDAFood22" /> The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, safety of food imports, mandatory recall response, and food partnership enhancement.<ref name="FDAFood22" /> However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, good manufacturing practice (GMP) for human food and animal feed, and laboratory accreditation (referred to as the [[LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors|LAAF Rule]]).<ref name="FDAFSMA22">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules |title=FSMA Rules & Guidance for Industry |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=05 May 2023}}</ref>

Another important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.<ref name="USDAOurHist18">{{cite web |url=https://www.fsis.usda.gov/about-fsis/history |title=Our History |author=Food Safety and Inspection Service |publisher=U.S. Department of Agriculture |date=21 February 2018 |accessdate=05 May 2023}}</ref> The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.<ref name="9CFR412">{{cite web |url=https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-412 |title=9 CFR Part 412 - Label Approval |work=Code of Federal Regulations |date=31 October 2022 |accessdate=05 May 2023}}</ref><ref name="FSISFedReg">{{cite web |url=https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules |title=Federal Register Rules |publisher=Food Safety and Inspection Service |accessdate=05 May 2023}}</ref><ref name="NALFoodSafe">{{cite web |url=https://www.nal.usda.gov/human-nutrition-and-food-safety/food-safety-standards |title=Food Safety Standards |author=National Agricultural Library |publisher=U.S. Department of Agriculture |accessdate=05 May 2023}}</ref>

'''2.2.1.6 General Food Law Regulation (GFLR) - ''European Union'''''
The GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178/2002, and it is described as "the foundation of food and feed law" for the EU.<ref name="EUGeneral">{{cite web |url=https://food.ec.europa.eu/horizontal-topics/general-food-law_en |title=General Food Law |work=Food Safety |publisher=European Commission |accessdate=05 May 2023}}</ref> Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.<ref name="WeinrothHist18" /><ref name="EUGeneral" /> As such, the EFSA develops broad and sector-specific guidance<ref name="EFSAGuidance">{{cite web |url=https://www.efsa.europa.eu/en/methodology/guidance |title=Guidance and other assessment methodology documents |publisher=European Food Safety Authority |accessdate=05 May 2023}}</ref>, as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.<ref name="EU2073-2005">{{cite web |url=https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073 |title=Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs |work=EUR-Lex |date=03 August 2020 |accessdate=05 May 2023}}</ref> The EFSA also develops food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate "format for describing food and feed samples and analytical results that is used by EFSA’s data providers."<ref name="EFSAFoodClass">{{cite web |url=https://www.efsa.europa.eu/en/data/data-standardisation |title=Food classification standardisation – The FoodEx2 system |publisher=European Food Safety Authority |accessdate=05 May 2023}}</ref>

'''2.2.1.7 Safe Food for Canadians Act (SFCA) - ''Canada'''''

In November 2012, the SFCA was enacted to place regulatory "focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination."<ref name="ManitobaSafe">{{cite web |url=https://www.gov.mb.ca/agriculture/food-safety/at-the-food-processor/safe-food-for-canadians-act.html |title=Safe Food for Canadians Act |publisher=Manitoba Government |accessdate=05 May 2023}}</ref><ref name="JLWSafeFood19">{{cite web |url=https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html |title=Safe Food for Canadians Act (S.C. 2012, c. 24) |work=Justice Laws Website |publisher=Government of Canada |date=17 June 2019 |accessdate=05 May 2023}}</ref> Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019<ref name="ManitobaSafe" />, the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.<ref name="GoCUnder18">{{cite book |last=Canadian Food Inspection Agency |year=2018 |title=Understanding the Safe Food for Canadians Regulations: A handbook for food businesses |url=https://inspection.canada.ca/food-safety-for-industry/toolkit-for-food-businesses/sfcr-handbook-for-food-businesses/eng/1481560206153/1481560532540?chap=0 |publisher=Government of Canada |isbn=9780660269856}}</ref> An interpretive guide published by the CFIA, ''Understanding the Safe Food for Canadians Regulations: A handbook for food businesses'', summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.<ref name="GoCUnder18" />

====2.2.2 Materials====
[[File:Assessing prototype reference material for testing emissions of VOCs (5940985174).jpg|left|330px]]

Like materials standards, there are too many materials regulations to list for the given scope of this guide. However, several different examples are given below of materials-related regulations found in various parts of the world.

'''2.2.2.1 21 CFR Part 175 and 176 - ''United States'''''

These two regulations from the U.S. Code of Federal Regulations system relate specifically to the materials used to package food. (While the food and beverage industry is the recipient and end user of such materials, the materials researcher and manufacturer is responsible, in part, for developing and producing materials that meet such regulations.) Part 175 dictates what substances can be used as components of adhesives and coatings in food packaging materials<ref name="ECFR21Part175">{{cite web |url=https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175?toc=1 |title=Title 21, Chapter I, Subchapter B, Part 175 |work=Code of Federal Regulations |publisher=Office of the Federal Register; U.S. Government Publishing Office |date=24 April 2023 |accessdate=05 May 2023}}</ref>, and Part 176 addresses what substances can be used as components of paper and paperboard in food packaging materials.<ref name="ECFR21Part176">{{cite web |url=https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175?toc=1 |title=Title 21, Chapter I, Subchapter B, Part 176 |work=Code of Federal Regulations |publisher=Office of the Federal Register; U.S. Government Publishing Office |date=24 April 2023 |accessdate=05 May 2023}}</ref>

'''2.2.2.2 Building Standard Law - ''Japan'''''

Japan's Building Standard Law, broadly speaking, states a minimum set of standards that must be followed concerning the construction of buildings in the country, in order to protect the health and property of those using those buildings. Given the country's infrastructure is affected by snow accumulation, earthquakes, and tsunamis, a modern approach to building regulation was required in 1950. One section of the law addresses the quality of materials used in building construction, particularly in important sections of the home such as the foundation, load-bearing walls, columns, and more. The regulation mandates that such materials must conform to the Japanese Industrial Standard or Japanese Agriculture Standard, or that they be specifically approved by the Minister. This means manufacturers of structural steel, high-strength bolts, concrete, wood-based composite panels, membrane materials, and more are largely beholden to those standards throughout the manufacturing process.<ref name="TomohiroIntro13">{{cite web |url=https://www.bcj.or.jp/upload/international/baseline/BSLIntroduction201307_e.pdf |format=PDF |title=Introduction to the Building Standard Law, Building Regulation in Japan |author=Tomohiro, H. |publisher=Building Center of Japan |date=July 2013 |accessdate=05 May 2023}}</ref>

'''2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - ''United Kingdom'''''

In 1988, the U.K. made into law The Furniture and Furnishings (Fire) (Safety) Regulations, which "were introduced to help reduce the risks of injury or loss of life through fires in the home spread by upholstered furniture."<ref name="OPSSUpdat19">{{cite web |url=https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/822072/furniture-fire-regulations-2016-consultation-government-response-july-2019.pdf |format=PDF |title=Updating The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - Government response to consultation |author=Office for Product Safety & Standards |publisher=Crown |date=July 2019 |accessdate=05 May 2023}}</ref> The regulations set out general testing requirements for foam fillings, non-foam fillings, composite fillings, and cover materials, requiring that they pass various material and combustion requirements.<ref name="BCNewUphol22">{{cite web |url=https://www.businesscompanion.info/en/quick-guides/product-safety/new-upholstered-furniture |title=New upholstered furniture |work=Business Companion |publisher=Chartered Trading Standards Institute |date=December 2022 |accessdate=05 May 2023}}</ref> Various updates have been made to the regulations over time. In 2019, the government, noting "growing evidence linking the specific flame-retardant chemicals most often used in furniture to serious long-term health impacts," acknowledged that updates to regulations on the materials used in furniture making were required, which would in turn further dictate manufacturing processes.

'''2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - ''Australia'''''

In September 2011, Australia's National Environment Protection Council made law the National Environment Protection (Used Packaging Materials) Measure 2011. Signatories of the Covenant agreed to "a voluntary system of industry self regulation" to better ensure "improved environmental outcomes" in regards to packaging material use and re-use.<ref name="FRLNation11">{{cite web |url=https://www.legislation.gov.au/Details/F2011L02093 |title=National Environment Protection (Used Packaging Materials) Measure 2011 |work=Federal Register of Legislation |publisher=Australian Government |date=16 September 2011 |accessdate=05 May 2023}}</ref> However, a 2021 review found that the regulation was lacking in several areas, including with monitoring and enforcement. A December 2022 response by the government agreed, noting, "[l]ack of compliance monitoring and enforcement activity has undermined the effectiveness of, and confidence in, the mandatory co-regulatory arrangement and enabled some businesses to avoid their obligations." Updates to the regulations are expected by 2025, "to ensure that all packaging available in Australia is designed to be recovered, reused, recycled and reprocessed safely in line with circular economy principles. Reforming the regulation of packaging in Australia presents a significant opportunity to improve the way our packaging is designed ..."<ref name="DCCEEWAustr">{{cite web |url=https://www.dcceew.gov.au/environment/protection/waste/plastics-and-packaging/packaging-covenant |title=Australian Packaging Covenant |publisher=Department of Climate Change, Energy, and Environment and Water |date=2023 |accessdate=05 May 2023}}</ref> As this language suggests, such regulatory changes, should they come, will further dictate the materials designed and used in manufacturing processes in the country.

'''2.2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - ''Canada'''''

Enacted in 2016, these regulations—enabled by Canada's Consumer Product Safety Act—dictate the amount of lead and mercury allowed in surface coating materials, stickers, and films under certain circumstances. The testing for those [[heavy metals]] must be done by manufacturers (or their third-party labs) "in accordance with a method that conforms to good laboratory practices."<ref name="JLWSurface22">{{cite web |url=https://laws-lois.justice.gc.ca/eng/regulations/SOR-2016-193/page-1.html |title=Surface Coating Materials Regulations |work=Justice Laws Website |publisher=Government of Canada |date=19 December 2022 |accessdate=05 May 2023}}</ref>

====2.2.3 Pharmaceutical and medical devices====
[[File:Generic Drug Research (5896) (8493711422).jpg|right|340px]]As was similarly noted in the section about pharmaceutical and medical device standards, regulations in this industry are vital for ensuring the safety of consumers and the efficacy of the drugs and devices they use, and they are typically present as some of the most rigorous regulations for the broad world of manufacturing. That said, as serious as pharmaceutical regulation can be, governments can often be slow to act with their regulatory duties<ref name="MPWGSRegul11">{{Cite book |url=https://publications.gc.ca/collections/collection_2012/bvg-oag/FA1-2011-2-4-eng.pdf |format=PDF |last=Office of the Auditor General of Canada |year=2011 |title=Report of the Auditor General of Canada to the House of Commons |chapter=Chapter 4: Regulating Pharmaceutical Drugs - Health Canada |publisher=Minister of Public Works and Government Services |pages=1–38 |isbn=9781100194028}}</ref> or have complex governance structures and difficult-to-enforce rules.<ref name="BasakIndian23">{{cite web |url=https://www.outlookindia.com/national/indian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625 |title=Indian Pharma Irregularities Point To Lack Of Drug Regulation Policies And Better Oversight |author=Basak, S. |work=Outlook |publisher=Outlook Publishing India Pvt. Ltd |date=13 February 2023 |accessdate=05 May 2023}}</ref><ref name="BhattIncon23">{{Cite journal |last=Bhatt |first=Neha |date=2023-01-13 |title=Inconsistent drug regulation spells danger for India’s global pharma ambitions |url=https://www.bmj.com/lookup/doi/10.1136/bmj.p23 |journal=BMJ |language=en |pages=p23 |doi=10.1136/bmj.p23 |issn=1756-1833}}</ref> As these regulatory bodies and their regulations improve, manufacturers of pharmaceuticals and medical devices find themselves needing to be even more efficient in their activities and focused on good manufacturing practices.

The following represent examples of pharmaceutical and medical device regulation around the world. Note that the discussion of GMP and cGMP is discussed further in the next section.

'''2.2.3.1 Current Good Manufacturing Practice (cGMP) regulations - ''United States and other countries'''''

For more on this, see the next section on other industries and regulations.

'''2.2.3.2 Drugs and Cosmetics Act of 1940 - ''India'''''

This act represents the primary regulatory control over the manufacture of pharmaceuticals and cosmetics in India. The act "creates a web of regulatory authorities to govern the process at both the central and the state levels."<ref name="BasakIndian23" /> Like other pharmaceutical regulations in other countries, the act attempts to ensure that drugs, cosmetics, medical devices, and diagnostic devices sold in India are safe, standardized to a certain quality, and effective at what they are said to do. Public health activists, lawyers, and specialized agencies such as the WHO, however, have criticized India's regulatory efforts in recent years for not keeping up with the rapidly growing industry while exhibiting poor transparency, unnecessary complexity, and insufficient statutory backing (as seen with the Central Drugs Standard Control Organisation or CDSCO).<ref name="BasakIndian23" /><ref name="BhattIncon23" /> The country has been attempting to reform the regulatory system by, for example, updating the Indian Pharmacopoeia and the Drugs and Cosmetics Act with more modern, relevant information and improved labeling mechanisms for tracking and tracing drugs.<ref>{{Cite journal |last=Kukade, T.; Punnen, D.; Antani, M. |date=24 June 2022 |title=Mid-Year Regulatory Update 2022: Pharmaceuticals in India |url=https://www.natlawreview.com/article/mid-year-regulatory-update-2022-pharmaceuticals-india |journal=The National Law Review |volume=XII |issue=175}}</ref>

'''2.2.3.3 Food and Drugs Act - ''Canada'''''

Canada's Food and Drugs Act enables its Food and Drug Regulations, which, among other things, helps to "ensure the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality."<ref name="HCDrug22">{{cite web |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/legislation-guidelines.html |title=Drug products legislation and guidelines |author=Health Canada |publisher=Government of Canada |date=20 June 2022 |accessdate=05 May 2023}}</ref> Part C of the regulations addresses drugs in a broad sense, with Division 2 of that part regulating manufacturing controls, quality testing, and records management.<ref name="JLWFoodDrug23">{{cite web |url=https://lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html |title=Food and Drug Regulations (C.R.C., c. 870) |work=Justice Laws Website |publisher=Government of Canada |date=15 February 2023 |accessdate=05 May 2023}}</ref> These regulations are overseen and updated by Health Canada "through a combination of scientific review, monitoring, compliance, and enforcement activities."<ref name="MPWGSRegul11" />

'''2.2.3.4 Pharmaceutical Affairs Act (PAA) and Medical Devices Act (MDA) - ''South Korea'''''

Overseen by the Ministry of Food and Drug Safety (MFDS), these acts help ensure safer and effective pharmaceuticals and medical devices to the people of South Korea. The country's PAA classifies pharmaceuticals as either pharmaceutical ingredients or drug products, which in turn are broken down into new drugs, pharmaceuticals requiring specific data submissions, and generic drugs.<ref name="PBMKorea18">{{cite web |url=https://www.pacificbridgemedical.com/regulation/korea-medical-device-pharmaceutical-regulations/ |title=Korea Medical Device and Pharmaceutical Regulations |publisher=Pacific Bridge Medical |date=12 August 2018 |accessdate=05 May 2023}}</ref> The PAA's goal is described as being "to prescribe matters necessary to deal with pharmaceutical affairs smoothly, thereby contributing to the improvement of the national public health."<ref name="KLRIPharm17">{{cite web |url=https://elaw.klri.re.kr/eng_service/lawView.do?hseq=40196&lang=ENG |title=Pharmaceutical Affairs Act |publisher=Korea Legislation Research Institute |date=25 August 2017 |accessdate=05 May 2023}}</ref> The MDA's goal is "to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for matters concerning the manufacturing, import, distribution, etc. of medical devices."<ref name="KLRIMedDev18">{{cite web |url=https://elaw.klri.re.kr/eng_service/lawView.do?hseq=48691&lang=ENG |title=Medical Devices Act |publisher=Korea Legislation Research Institute |date=12 July 2018 |accessdate=05 May 2023}}</ref> Along with managing the regulations from these acts, the MFDS is also responsible for setting the manufacturing standards and specifications for pharmaceuticals, monitoring certain pre- and post-manufacturing procedures, enforcing good manufacturing practice, reinforcing safety controls, and more.<ref name="PBMKorea18" />

'''2.2.3.5 Pharmaceutical and Medical Device Act (PMD Act) - ''Japan'''''

The PMD Act represents one of the primary pieces of pharmaceutical and medical device regulation in Japan. The PMD Act replaced Japan's Pharmaceutical Affairs Law in November 2014, with the primary goal of using regulation to improve public health by assuring the quality, safety, and efficacy of pharmaceuticals, medical devices, and cosmetics, as well as preventing the expansion of activities harmful to those efforts. Under the PMD Act, manufacturers are expected to demonstrate how their products conform to Japan's regulations and how their operations are guided by a well-defined QMS.<ref name="JPMAPharm20">{{cite book |url=https://www.jpma.or.jp/english/about/parj/eki4g6000000784o-att/2020e_ch02.pdf |format=PDF |title=Pharmaceutical Administration and Regulations in Japan |chapter=Chapter 2: Pharmaceutical Laws and Regulations |author=Regulatory Information Task Force |publisher=Japan Pharmaceutical Manufacturers Association |pages=15–56 |year=2020 |accessdate=05 May 2023}}</ref><ref name="BSIJapan16">{{cite web |url=https://www.bsigroup.com/meddev/LocalFiles/en-US/Brochures/bsi-md-japan-brochure.pdf |format=PDF |title=Japan Pharmaceutical and Medical Device Act |publisher=BSI Group America, Inc |date=November 2016 |accessdate=05 May 2023}}</ref> The act has multiple chapters addressing the manufacturing of drugs, "quasi-drugs," cosmetics, cellular and tissue-based products, medical devices, and ''in vitro'' diagnostic devices, as well as separate chapters on the safety of and standards applicable to drugs.<ref name="JPMAPharm20" /> In regards to manufacturers of medical devices, they should turn to several sets of standards published by Japan's Ministry of Health, Labour and Welfare (MHLW)—MO No. 169 – ''Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostic Reagents'' and MO No. 135 – ''Standards for Good Vigilance Practice (GVP)''—in order to better comply with the PMD Act.<ref name="BSIJapan16" />

====2.3.4 Other industries and regulations====
[[File:GMP GOOD MANUFACTURING PRACTICE.png|left|220px]]Like standards, manufacturing regulations exist beyond industries like the food and beverage, materials, and pharmaceutical industries. From electronics and automotive parts to cosmetics and chemicals, governments around the world place restrictions on and recommendations for testing a variety of manufactured goods. What follows are a few examples of regulations on other industries from various parts of the world.

'''2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - ''United States and other countries'''''

As a broad concept, [[good manufacturing practice]] or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning recipes and choosing starting materials to training personnel and documenting processes.<ref name="ISPEGMP">{{cite web |url=https://ispe.org/initiatives/regulatory-resources/gmp |title=Good Manufacturing Practice (GMP) Resources |publisher=International Society for Pharmaceutical Engineering, Inc |accessdate=05 May 2023}}</ref> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<ref name="PBMKorea18" /><ref name="ISPEGMP" /><ref name="WHOMedicines15">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Medicines: Good manufacturing practices |publisher=World Health Organization |date=20 November 2015 |accessdate=05 May 2023}}</ref>, though it is applicable to most any other production industry.<ref name="CEReg07">{{cite web |url=https://www.controleng.com/articles/regulated-or-not-know-good-manufacturing-practices-gmp/ |title=Regulated or not? Know good manufacturing practices (GMP) |author=''Control Engineering'' Staff |work=Control Engineering |date=14 July 2007 |accessdate=05 May 2023}}</ref><ref name="FDAGMPCosm22">{{cite web |url=https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics |title=Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=05 May 2023}}</ref>

Closely related is the term "current good manufacturing practice" or cGMP. Both "GMP" and "cGMP" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.<ref name="PSDiff21">{{cite web |url=https://www.pharmaspecialists.com/2021/10/difference-between-gmp-and-cgmp.html#gsc.tab=0 |title=Difference Between GMP and cGMP |work=Pharma Specialists |date=13 October 2021 |accessdate=05 May 2023}}</ref><ref name="MoravekTheDiff">{{cite web |url=https://www.moravek.com/the-differences-between-gmp-and-cgmp/ |title=The Differences Between GMP and cGMP |work=Moravek Blog |publisher=Moravek, Inc |date=January 2021 |accessdate=05 May 2023}}</ref> 

In the United States, cGMP—in the context of pharmaceuticals—is enshrined in numerous sections of Title 21 of the Code of Federal Regulations, including "in parts 1-99, 200-299, 300-499, 600-799, and 800-1299."<ref name="FDAcGMP22">{{cite web |url=https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations |title=Current Good Manufacturing Practice (CGMP) Regulations |author=U.S. Food and Drug Administration |date=16 November 2022 |accessdate=05 May 2023}}</ref> The FDA describes these regulations as containing "minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product."<ref name="FDAcGMP22" /> It also states safety, efficacy, and labeling requirements for manufactured drugs. These regulations require careful attention by manufacturers, lest they face seizure of their products, legal injunction, and criminal cases.<ref name="FDAFactsAb21">{{cite web |url=https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps |title=Facts About the Current Good Manufacturing Practices (cGMPs) |author=U.S. Food and Drug Administration |date=01 June 2021 |accessdate=05 May 2023}}</ref>

In the context of food, cGMP principles were first introduced in the U.S. in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.<ref name="FDACurrentGood20">{{cite web |url=https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements |title=Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements |publisher=U.S. Food and Drug Administration |date=31 January 2020 |accessdate=05 May 2023}}</ref> 

GMP and cGMP contexts also exist for other manufacturing industries outside of pharmaceuticals and food, including automotive parts, medical devices, clothing, and more.<ref name="DomingoTheComp22">{{cite web |url=https://qvalon.com/blog/the-complete-guide-to-good-manufacturing-practices-gmp-by-qvalon/ |title=The Complete Guide to Good Manufacturing Practices (GMP) by QVALON |author=Domingo, J. |publisher=QVALON Inc |date=28 January 2022 |accessdate=05 May 2023}}</ref> Additionally, these concepts are not limited to the U.S. For example, the World Health Organization has its own GMP/cGMP guidelines for pharmaceuticals and biological medicines, with more than 100 countries reportedly incorporating those guidelines into their national medicine regulations.<ref name="WHOGMP18">{{cite web |url=https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp |title=Health products policy and standards - Good Manufacturing Practices |publisher=World Health Organization |date=28 September 2018 |accessdate=05 May 2023}}</ref>

'''2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - ''European Union'''''

For the E.U.'s chemical manufacturers and the other manufacturing industries depending on those chemicals, REACH represents one of the most expansive and complicated pieces of regulation in the E.U. Affecting potentially more than 140,000 substances, manufacturers of those substances are now largely responsible for identifying hazards, identifying mitigation methods for those hazards, and managing associated risks. Of particular note are "substances of very high concern" (SVHCs) and how they are authorized and restricted. This regulations means manufacturers must pay closer attention to what substances get put into their products and report on SVHCs making up more than 0.1 percent (by weight) of the product. These regulations may also mean the manufacturer may need to redesign their products with new substances.<ref name="ECIAREACH21">{{cite web |url=https://www.ecianow.org/reach |title=REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) |publisher=Electronic Components Industry Association |date=2021 |accessdate=05 May 2023}}</ref>

'''2.3.4.3 Resolução de diretoria colegiada - RDC nº 529 - ''Brazil'''''

This Brazilian resolution, effective August 2021, revised the country's List of Prohibited Substances in Personal Hygiene, Cosmetics and Perfume Products to include additional substances. While it's not clear what original legislation houses that list, this list makes clear that manufacturers of personal hygiene, cosmetic, and perfume products have to be mindful of the ingredients they use in their manufacturing processes.<ref name="HavensBrazil21">{{cite web |url=https://www.ul.com/news/brazil-revises-list-prohibited-substances-cosmetics |title=Brazil Revises List of Prohibited Substances in Cosmetics |author=Havens, R. |work=UL Solutions |date=02 September 2021 |accessdate=05 May 2023}}</ref>

'''2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - ''European Union'''''

The E.U. uses the RoHS Directive as a means towards restricting the use of specific hazardous materials in the manufacture of electrical and electronic equipment (EEE), namely "lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP)."<ref name="ECRestrict">{{cite web |url=https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive_en |title=Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) |publisher=European Commission |date=2023 |accessdate=05 May 2023}}</ref> By extension, the E.U. is encouraging safer alternatives for the manufacturing of EEE and fewer hazardous substances making their way into ecosystems from waste streams.

'''2.3.4.5  Road Vehicle Standards (RVS) legislation - ''Australia'''''

Coming into effect in July 2021 as a replacement to the Motor Vehicle Standards Act 1989, the RVS legislation brought regulation of road vehicle manufacturing into the twenty-first century, with updates to recalls, model reports, testing, and component type approvals. These regulations are backed by the Australian Design Rules (ADRs), which are national standards for vehicle safety.<ref name="DITRDCARoad23">{{cite web |url=https://www.infrastructure.gov.au/infrastructure-transport-vehicles/vehicles/road-vehicle-standards-laws |title=Road Vehicle Standards laws |author=Department of Infrastructure, Transport, Regional Development, Communications and the Arts |publisher=Australian Government |date=2023 |accessdate=05 May 2023}}</ref><ref name="DITRDCAusDes23">{{cite web |url=https://www.infrastructure.gov.au/infrastructure-transport-vehicles/vehicles/vehicle-design-regulation/australian-design-rules |title=Australian Design Rules |author=Department of Infrastructure, Transport, Regional Development, Communications and the Arts |publisher=Australian Government |date=2023 |accessdate=05 May 2023}}</ref> Approved testing facilities are required to test that vehicles and their components are in compliance with ADRs and other relevant standards.<ref name="DITRDCTesting23">{{cite web |url=https://www.infrastructure.gov.au/infrastructure-transport-vehicles/vehicles/rvs/testing-facilities |title=Testing facilities |author=Department of Infrastructure, Transport, Regional Development, Communications and the Arts |publisher=Australian Government |date=2023 |accessdate=05 May 2023}}</ref>