Harmonization (standards)

Harmonization is the process of minimizing redundant or conflicting standards which may have evolved independently.[1][2] The name is also an analogy to the process to harmonizing discordant music.

Harmonization is different from standardization. Harmonization involves a reduction in variation of standards, while standardization entails moving towards the eradication of any variation with the adoption of a single standard.[3] The goal for standard harmonization is to find commonalities, identify critical requirements that need to be retained, and provide a common framework for standards setting organizations (SSO) to adopt. In some instances, businesses come together forming alliances or coalitions,[4] also referred to multi-stakeholder initiatives (MSI) with a belief that harmonization could reduce compliance costs and simplify the process of meeting requirements. With potential to reduce complexity for those tasked with testing and auditing standards for compliance.

## Contents

* 1 Harmonization in the Public Sector
* 2 Harmonization in the Private Sector
* 3 See also
* 4 References
* 5 External links

## Harmonization in the Public Sector

A harmonised standard is a European standard developed by a recognised European Standards Organisation: European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications Standards Institute (ETSI).[5] It is created following a request from the European Commission to one of these organisations. Harmonised standards must be published in the Official Journal of the European Union (OJEU).

In the information and communication technologies (ICT) sector, companies initially formed closed groups to develop private standards, for reasons which included competitive advantage. An example being the phrase "embrace, extend, and extinguish" used internally by Microsoft which led to legal action taken by United States Department of Justice.[6] In response, governments and intergovernmental organizations (IGOs) recommended the use of international standards which resulted in standard harmonization. Examples include the Linux operating system, Adobe portable document format (PDF) and the OASIS open document format (ODF) being converted into ISO and IEC international standards. In 2022, EU legislation was passed for all mobile phones, tablets and cameras sold in the EU requiring a USB-C charging port by 2024.[7] The USB Type-C Specification is an IEC international standard, IEC 62680-1-3. This was reaffirmed at the G7 Hiroshima Summit 2023, where cooperating on international standards setting with a commitment to collectively support the development of open, voluntary and consensus-based standards that will shape the next generation of technology.[8]

Harmonization of regulatory standards is seen by economists as a key component in reducing trade costs and increasing interstate trade.[9] Where importing-market standards are harmonized with international standards, such as those from ISO or IEC, the negative effect on developing-country exporters is substantially lessened, or even reversed.[10] The US Government Office of Management and Budget published CircularA-119[11] instructing its agencies to adopt voluntary consensus standards before relying upon private standards. The circular mandates standard harmonization by eliminating or reducing US agency use of private standards and government standards. The priority for governments to adopt voluntary consensus standards is supported by international standards such as ISO supporting public policy initiatives.[12] An example is regulators creating the International Medical Devices Regulatory Forum (IMDRF)[13] and promoting the Medical Devices Single Audit Program (MDSAP). This uses an international standard, ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes. World Bank Group explain that private standards cannot be used in technical regulation and have to be moved into the public standardization system before they can be used as the basis for technical regulations.[14]

## Harmonization in the Private Sector

In comparison to the public sector, where governments, IGOs and regulators work towards a harmonised standard, there are instances where private sector promote harmonization of multiple standards. An example is the private organization ISEAL Alliance accepting multiple schemes as community members[15] using private standards who commit to their code of good practice.[16] Another example is the Global Food Safety Initiative which is a private organization that promotes harmonization using a benchmarking process[17] that results in recognition[18] of multiple scheme owners using private standards. The harmonization approach for multiple private standards has led to criticism from various organizations including the Institute for Multi-Stakeholder Initiative Integrity[19] and The International Food and Agribusiness Management Review.[20]

For food safety, a single international standard, ISO 22000, was proposed in 2007[21] and 2020[22] as a harmonized standard approach used by the public sector. On both occasions, the Global Food Safety Initiative rejected the proposal because promoting ISO 22000 would mean reducing the power of global retailers in terms of control over standards.[23]

Private corporations are not allowed to be members or have voting rights over international standards, because they are consensus-based. Whereas it is possible to have a controlling interest and exert influence if they promote private standards because they are non-consensus. In the environmental sector for “net zero”, corporations continue to promote private standards over international standards. This allows the creation of new terms that are non-consensus and do not follow terms which are defined in international standards such as ISO 14050 Environmental management Vocabulary. An example is the term “insetting” that has been introduced by the private sector, despite it not being part of IWA 42 Net Zero Guidelines.[24] This approach is an obstacle to standard harmonization and received criticism from the New Climate Institute (NCI), where companies are successfully lobbying the standards setting organizations (SSOs) who use private standards to rubber-stamp the inclusion of insetting claims within their net zero pledges.[25]

In the sustainability sector, the ITC created a Standard Map[26] as an informational tool in an attempt to harmonize and group together voluntary sustainability standards (VSS). With over 300 sustainability standards mapped, and financial opportunities with fees that are associated to private standards, this may have led to a perverse incentive. The unintended consequence being a proliferation of private standards, some of which could be primarily seeking monetary gain and may have sabotaged sustainability standards and certification.[27] International standards organizations express that standardization plays a crucial role for the realization of the UN SDGs in their strategies and activities for sustainability.[28] [29]

Similar to reducing and preventing the proliferation of private standards in the information and communication technologies (ICT) sector, governments and IGOs recommend international standards in the food sector. This includes the World Health Organization,[30] the International Trade Centre,[31] UNIDO,[32] the World Trade Organization and the Food and Agriculture Organization.[33] With the public sector recommending standardization over private sector attempts for harmonization, IGOs are encouraging corporation led coalitions to surrender the control they have over private standards. By promoting international standards the private sector can avoid fragmentation and accusations of undue influence and lobbying in the standards setting and multistakeholder governance process.[34] [35]

## See also

* De facto standard
* European Committee for Electrotechnical Standardization
* European Committee for Standardization
* European Telecommunications Standards Institute
* Harmonisation of law
* International Standard
* Multistakeholder governance
* Standardization
* Standards organization
* Tax harmonization
* Technical Standard
* World Standards Cooperation

## References

1. ↑ Pelkmans, J. (1987). "The New Approach to Technical Harmonization and Standardization". JCMS: Journal of Common Market Studies 25 (3): 249–269. doi:10.1111/j.1468-5965.1987.tb00294.x.
2. ↑ Beeler, G. W. (1998). "HL7 Version 3–An object-oriented methodology for collaborative standards development (Presented at the International Medical Informatics Association Working Group 16 Conference on Standardisation in Medical Informatics–Towards International Consensus and Cooperation, Bermuda, 12 September 1997)". International Journal of Medical Informatics 48 (1–3): 151–61. doi:10.1016/S1386-5056(97)00121-4. PMID 9600415.
3. ↑ Fuertes, Iluminada (2008). "Towards Harmonization or Standardization in Governmental Accounting?". The International Public Sector Accounting Standards Board Experience, Journal of Comparative Policy Analysis: Research and Practice 10 (4): 327–345. doi:10.1080/13876980802468766. https://www.tandfonline.com/doi/abs/10.1080/13876980802468766.
4. ↑ "Coalitions of Action". The Consumer Goods Forum (CGF). https://www.theconsumergoodsforum.com/what-we-do/join-our-coalitions-of-action/.
5. ↑ "Harmonised Standards". European Union. https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en.
6. ↑ "U.S. V. MICROSOFT: PROPOSED FINDINGS OF FACT". US Department of Justice. https://www.justice.gov/atr/us-v-microsoft-proposed-findings-fact-2.
7. ↑ "Long-awaited common charger for mobile devices will be a reality in 2024". European Parliament. https://www.europarl.europa.eu/news/en/press-room/20220930IPR41928/long-awaited-common-charger-for-mobile-devices-will-be-a-reality-in-2024.
8. ↑ "G7 Leaders' Statement on Economic Resilience and Economic Security". The White House. May 2023. https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/20/g7-leaders-statement-on-economic-resilience-and-economic-security/.
9. ↑ Schmidt, Julia; Steingress, Walter (2022). "No double standards: Quantifying the impact of standard harmonization on trade" (in en). Journal of International Economics 137: 103619. doi:10.1016/j.jinteco.2022.103619. ISSN 0022-1996. https://www.sciencedirect.com/science/article/pii/S0022199622000514.
10. ↑ Shepherd, Ben (March 2020). International Standards and Trade - What does the research say?. Switzerland: International Organization for Standardization. ISBN 978-92-67-11094-3. https://www.iso.org/publication/PUB100448.html.
11. ↑ "CIRCULAR NO. A-119 Revised". The White House. https://www.whitehouse.gov/wp-content/uploads/2017/11/Circular-119-1.pdf.
12. ↑ "Using and referencing ISO and IEC standards to support public policy". International Organization for Standardization. https://policy.iso.org/home.html.
13. ↑ "International Medical Device Regulatory Forum (IMDRF)". IMDRF. https://www.imdrf.org/.
14. ↑ Kellermann, Martin (2019). Ensuring Quality to Gain Access to Global Markets. Washington, DC: International Bank for Reconstruction and Development / The World Bank and Physikalisch-Technische Bundesanstalt (PTB). p. 76. ISBN 978-1-4648-1372-6. https://thedocs.worldbank.org/en/doc/249621553265195570-0090022019/original/FullQIToolkitReport.pdf.
15. ↑ "ISEAL Community Members". ISEAL Alliance. https://www.isealalliance.org/iseal-community-members.
16. ↑ "ISEAL Codes of Good Practice". ISEAL Alliance. https://www.isealalliance.org/defining-credible-practice/iseal-codes-good-practice.
17. ↑ "Harmonisation". Global Food Safety Initiative (GFSI). https://mygfsi.com/what-we-do/harmonisation/.
18. ↑ "GFSI-Recognised Certification Programme Owners". Global Food Safety Initiative. https://mygfsi.com/how-to-implement/recognition/certification-programme-owners.
19. ↑ "Not Fit-for-Purpose The Grand Experiment of Multi-Stakeholder Initiatives in Corporate Accountability, Human Rights and Global Governance". Institute for Multi-Stakeholder Initiative Integrity. https://www.msi-integrity.org/not-fit-for-purpose/.
20. ↑ Roa, Madhura; Bast, Aalt; de Boer, Alie (2021). "European private food safety standards in global agri-food supply chains: a systematic review". International Food and Agribusiness Management Review 24 (6): 739–754. doi:10.22434/IFAMR2020.0146.
21. ↑ "Joint UNCTAD/WTO informal information session on private standards". World Trade Organization (WTO). https://www.wto.org/english/tratop_e/sps_e/private_standards_june07_e/private_standards_june07_e.htm.
22. ↑ "One Standard for the Food Industry". Global Food Safety Initiative. https://mygfsi.com/news_updates/one-standard-for-the-food-industry-ask-gfsi/.
23. ↑ Soon, Jan Mei; Baines, Richard N. (2013). "Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers?". Laws 2 (Global Food Safety Law and Policy): 1–19. doi:10.3390/laws2010001.
24. ↑ "Net Zero Guidelines". International Organization for Standardization. https://www.iso.org/netzero.
25. ↑ "Corporate Climate Responsibility Monitor 2023". The New Climate Institute. https://newclimate.org/resources/publications/corporate-climate-responsibility-monitor-2023.
26. ↑ "ITC Standards Map". International Trade Centre (ITC). https://www.standardsmap.org/en/home.
27. ↑ Baue, Bill (August 2023). The Lost Decade: Sustainability Standards Sabotage Sustainability. Papelallee 78-79 10437 Berlin, Germany: r3.0 (Redesign for Resilience & Regeneration). https://www.r3-0.org/the-lost-decade/.
28. ↑ Algan, F. M. (2023). "Global Standardization for a Sustainable Future". Curr Res Soc Sci 9 (1): 30–40. doi:10.30613/curesosc.1173926. https://dergipark.org.tr/tr/download/article-file/2644875.
29. ↑ Birkbeck, Carolyn Deere; Sugathan, Mahesh; Boinnard, Sophie; Grekova, Valeriia; Cleeland, Belinda (September 2023). Standards and Related Initiatives in International Cooperation to End Plastic Pollution: Mapping and State of Play. Geneva, Switzerland: Forum on Trade, Environment, & the SDGs (TESS). pp. https://tessforum.org/latest/standards-and-related-initiatives-in-international-cooperation-to-end-plastic-pollution-mapping-and-state-of-play.
30. ↑ "WHO Global Strategy for Food Safety 2022-2030". World Health Organization. https://www.who.int/publications/i/item/9789240057685.
31. ↑ Wozniak, Joseph. "How to Shape the Future of Trade Together". Exemplar Global. https://www.theauditoronline.com/how-to-shape-the-future-of-trade-together/.
32. ↑ "Making standards work for SMEs". United Nations Industrial Development Organization (UNIDO). https://hub.unido.org/news/making-standards-work-smes.
33. ↑ Trade and Food Standards. FAO and WTO. 2017. ISBN 978-92-5-109793-9. https://www.wto.org/english/res_e/publications_e/tradefoodfao17_e.htm.
34. ↑ "Multistakeholderism: a critical look". Transnational Institute. https://www.tni.org/en/publication/multistakeholderism-a-critical-look.
35. ↑ "Who's Tipping the Scales?". IPES-Food. http://www.ipes-food.org/pages/tippingthescales.

## External links

* Vocabulary and RIM Harmonization Process from Health Level 7 (HL7)
* Harmonizing Standards from UL
* Why Standards Harmonization is Essential to Web Accessibility, W3C
* Harmonised Standards, OJEU
* Harmonization, James A. Thomas, ASTM Standards News, March 2005

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