THEMATIC SESSION ON GOOD REGULATORY PRACTICES: REGULATORY
IMPACT ASSESSMENT AND TRADE-RELATED IMPACTS

11 NOVEMBER 2025, 16:30-18:00

Moderators' Report[1]

At the Tenth Triennial Review, Members agreed to continue holding thematic sessions in conjunction with the TBT Committee's regular meetings from 2025 to 2027 to deepen the exchange of experiences on specific topics. On this basis, the Committee agreed to hold a thematic session on Good Regulatory Practices: Regulatory Impact Assessment (RIA) and Trade-Related Impacts.[2] Information on speakers, presentations and related materials is available on the WTO website.[3]

1  introductory remarks by the moderators

1.1.  WTO Members continue to advance the use of regulatory measures to achieve a wide range of public policy objectives, including safety, health, consumer protection, and economic efficiency. Increasingly, Members recognize that such measures can also generate trade effects, even when trade is not the primary concern of regulators. In this context, RIA has emerged as a key instrument to support evidence-based policymaking, allowing regulators to systematically identify problems, evaluate policy alternatives, and understand the potential domestic and international implications of their decisions.

1.2.  Recent discussions in the WTO have highlighted the role of impact assessment and good regulatory practices in supporting transparent, predictable and trade-facilitating regulatory frameworks. In this context, the importance of reinforcing evidence-based regulatory processes was underscored, including through tools that help regulators identify policy problems. clearly, assess costs and benefits, compare regulatory and non-regulatory options, and prevent unintended trade impacts. It was also noted that strengthening RIA practices and enhancing cooperation, both domestically across ministries and internationally among Members, is critical for avoiding unnecessary barriers to trade while achieving legitimate policy objectives.

1.3.  To promote an interactive exchange, participants were invited at the outset to respond to a short survey accessed through a QR code displayed in the room. The questionnaire aimed to gather delegates' perspectives on how RIAs are used in their regulatory processes, the extent to which trade-related impacts are considered, and the challenges they face. The results of this survey were reviewed at the end of the thematic session, providing useful insights into Members' current practices and highlighting areas where further cooperation, learning and capacity-building may be beneficial.

2  GUIDING QUESTIONS

·_        How different Members have been addressing this issue within their RIA processes and your perspective on the role of RIA in helping Members to balance domestic policy objectives with potential trade effects when designing TBT measures?

·_        How do Members use RIA to assess the trade-related impacts of TBT measures (technical regulations, standards and conformity assessment procedures)? In particular, what methodologies, analytical tools and studies do you employ for this purpose? Please share concrete examples.

·_        How have FTAs helped Members to institutionalize GRPs? Do any of these agreements include commitments regarding the analysis of trade impacts of TBT measures?

·_        What are the recent developments of Members in GRPs implementation, especially with respect to RIA? And how is this tool helping assess the trade effects of technical regulations and conformity assessment procedures?

·_        What are the practical challenges when conducting a RIA, in particular, regarding the identification, qualification, quantification, and mitigation of trade-related impacts? What are the possible solutions to address such challenges?

·_        How can Members ensure that the results of their RIAs inform the regulatory decision‑making process in a manner that minimizes unnecessary barriers to trade?

3  INTERVENTIONS

Round One

3.1.  Dr. Delia Rodrigo (Mexico)[4] highlighted that many regulatory interventions create potential impacts on trade, but in most cases, regulators are not fully aware of this. She noted that RIA is not fully institutionalised in most economies, and this is one of the reasons why regulators do not have the obligation to assess potential effects of proposed regulations, including those related to trade.

3.2.  She recalled that the TBT Committee's Guidelines for conformity assessment procedures emphasizes that incorporating risk assessment into the RIA process helps to properly identify and treat risks. She pointed to examples in Mexico, Costa Rica, Colombia, Brazil and Paraguay, where RIA has been first used before drafting some technical regulations and later become an institutionalized process which also include assessment of trade impacts. She noted that there is evidence that economies that conduct RIAs in a more systematic way, such as Canada, the UK and Australia, and where there is an explicit requirement to conduct RIA and consider trade impacts of proposed regulations, develop regulatory interventions that find a better balance between achieving policy objectives and minimising negative effects on trade.

3.3.  Dr. Rodrigo stressed that trade and economy authorities need to create a culture of evidence and support regulators to better understand trade effects of proposed TBT measures, including through capacity building. In many developing Members, efforts to strengthen national Quality Infrastructure systems. should include the use of RIA to ensure that regulators do not impose unnecessary barriers to trade and, where measures are needed, carefully design regulatory interventions.

3.4.  Mr. Nathan Frey (United States)[5] highlighted that in the United States, the RIA process is embedded in the overall regulatory system through an explicit policy statement that outlines how RIA should be undertaken on a government-wide basis. He explained that this policy specifies that regulators should assess international impacts when designing their regulatory alternatives. He stressed the importance of guidance for regulators on how to conduct analyses of certain public policy problems, noting that such guidance embraces GRP, including employing the least burdensome measures possible, using performance-based approaches whenever possible, and considering impacts not only domestically but also internationally.

3.5.  He noted that the US system embraces inter-agency review of both the regulation and RIA, so other regulators and entities have a chance to analyse trade impacts in more detail before a measure is published for public comment. He emphasized that public consultation is a key aspect of ensuring that TBT measures are properly addressed through RIA, as regulators can inquire with the public about perceived costs and benefits when faced with a lack of information, which is key to filling gaps in regulatory analysis. He underlined that institutionalising RIA as early as possible in the policy development process is key for ensuring its effectiveness, and that if it is conducted only as a box‑checking exercise to justify a decision already made, it has less usefulness to the society.

3.6.  As a specific example, he described regulation of consumer electric appliances in the United States, where a rigorous process mandated by law requires the Department of Energy to conduct stringent testing of appliances. He explained that information collection requests accompany these tests where producers are asked for information on administrative burdens and associated costs, so that the RIA can take into account what it takes to certify a product. He noted that these RIAs are complex but allow more in-depth analysis because of better data on burdens and costs of testing, as well as impacts on consumers.

3.7.  Mr. Lucian Cernat (European Union)[6] explained that the European Union uses impact assessments to evaluate new legislative proposals, ensure they are aligned with broader EU policy goals and societal needs, and minimise unintended consequences, including on international trade. He stated that impact assessments are mandatory when a policy proposal is expected to have significant economic, societal or environmental impacts, or when an initiative has substantial budgetary implications, and also when the European Commission has several policy options to consider.

3.8.  He stressed that the tools and requirements for impact assessments are demanding and referred to the "Better Regulation Toolbox", described as the "Bible of impact assessments" with step-by-step guidance and structured frameworks, including concrete examples and references to state-of-the-art methodologies. He highlighted that there is a specific chapter dedicated to international trade, known as Chapter 27 or Toolbox 27, which focuses on trade impacts of EU legislative proposals. He explained that the tools used for trade-related impact assessments are multifaceted, combining quantitative and qualitative methodologies, economic modelling that takes into account global trade flows, more specific partial-equilibrium modelling for sectors such as chemicals, steel and textiles, and systematic stakeholder consultation.

3.9.  Mr. Cernat highlighted that a successful impact assessment often starts about one year before planning the legislative proposal, because data may need to be collected or existing legislation will need to be evaluated first. He noted that these preparatory steps are required to pass scrutiny by the Regulatory Scrutiny Board, an independent panel attached to the European Commission that gives a pass or fail mark on any impact assessment. He stated that if an impact assessment fails, the European Commission cannot proceed with the legislation until the shortcomings are addressed. As an example related to international trade, he referred to the EU legislation on very stringent CO2 emissions standards for automobiles, explaining that to minimise trade impacts of this measure, the EU decided to use the international standard (the Worldwide Harmonised Light Vehicle Test Procedure) so that car exporters can use the same test in the EU as in other markets.

3.10.  Mr. Zhang Zhen (China)[7] highlighted that when developing TBT measures, China conducts regulatory impact assessment through a structured process that examines trade-related impacts alongside domestic policy objectives. He explained that RIA process is embedded in a multi-level regulatory system covering laws, administrative regulations, departmental rules and national technical standards. He stated that China employs several key methodologies: stakeholder impact analysis through systematic consultation with affected enterprises and industry associations; technical feasibility studies to assess whether measures can be implemented without creating unnecessary trade barriers; comparative regulatory analysis to examine how other economies address similar issues and ensure international compatibility; and implementation assessment to evaluate appropriate timelines that allow both domestic and foreign enterprises to adapt.

3.11.  He described analytical tools such as multi-round expert consultation with technical specialists, legal experts and enterprises, inter-departmental coordination mechanisms, public comment periods to gather broader input, and cost-benefit analysis to balance regulatory objectives against trade facilitation. Using AI-generated content labelling as an example, he explained that China organised technical teams. to conduct in-depth research with key enterprises and universities to understand technological capabilities, implementation costs, and potential impacts on domestic innovation and international competitiveness. He noted that multiple rounds of discussions were held with technical experts, legal experts and enterprises to assess implementation feasibility, consistency with higher-level laws, business impacts, potential unnecessary trade barriers, technical feasibility for both domestic and international companies, adequacy of implementation timelines and compatibility with emerging international practice. Based on feedback, China adopted measures providing clear, technically flexible requirements, ensuring non-discriminatory application, allowing reasonable implementation periods and maintaining flexibility for technological evolution. He noted that this resulted in "1+1+n" framework consisting of one measure, one mandatory national standard and multiple practice guidelines, which took effect in September 2025 after extensive consultation. He concluded that China's approach shows how stakeholder engagement, transparent technical standards and explicit consideration of trade impacts in RIA can achieve regulatory objectives while facilitating trade.

3.12.  Mr. Juan Antonio Dorantes (Mexico)[8] explained that Mexico, like some other economies, has adopted a policy of including RIA and GRP in its trade negotiations. Since 2012–2013, Mexico has discussed RIA and GRP in all trade negotiations. He noted that (i) the Pacific Alliance treaty between Peru, Mexico, Chile and Colombia was the first where Mexico negotiated disciplines on good regulatory practices, including a chapter addressing "Regulatory Improvement"; (ii) the CPTPP contains a chapter on "Regulatory Coherence"; and (iii) the USMCA between the United States, Mexico and Canada contains a much more robust and comprehensive chapter on GRP, which is subject to the dispute settlement mechanism clause and the first explicit notion of trade impact analysis as part of RIA. He further explained that these agreements refer to economic impacts within RIA; however, only the USMCA explicitly requires the inclusion of trade impact analysis in the regulatory agenda. He added that the modernised agreement between Mexico and the European Union, expected to be signed in early 2026, contains a chapter on GRP explicitly referring to RIA and examining trade impacts. He concluded that the notion of trade impact analysis as part of RIA has been strengthened by the work of international organisations such as the OCDE and APEC, as well as the WTO, and that even when Mexico has reinforced international commitments on regulatory practices through FTAs, ensuring that domestic legislation develops in line with evolving work in the international context is paramount.

3.13.  Ms. Claudia Rosas Cárdenas (Peru)[9] explained that implementation of GRP in Peru began more systematically around 2016, when Peru committed to align its regulatory framework with the OECD recommendations on regulatory governance. She recalled that the first step for implementing RIA focused on cutting red tape by simplifying administrative procedures, eliminating duplication or procedures that did not add value, and reducing costs and time for citizens and businesses. She highlighted the adoption in 2019 of the regulation for the analysis of regulatory quality for the executive branch, which helps identify unnecessary, inefficient, unjustified or redundant measures and assists economic stakeholders participating in foreign trade.

3.14.  She noted that in 2021, Peru adopted ex-ante RIA and published an implementation manual, with the tool being implemented gradually in entities of the executive branch and with a view to expanding its scope to regional and local levels. She recalled that in 2023, a legislative decree created the General Law for the Improvement of Regulatory Quality, bringing GRP to the level of law, and that in 2025, a regulation was adopted to develop analysis for regulatory impact. She explained that under the current framework, RIA is not yet compulsory for all technical regulations and conformity assessment procedures, but RIA is planned to be incorporated in the legal framework, and that some regulators already apply RIA when preparing technical regulations. Although not formally compulsory, in practice, RIA has become a tool that helps identify and quantify burdens on economic operators, assess regulatory alternatives, compare with experiences of other economies in the region and avoid duplication.

Round Two

3.15.  Dr. Delia Rodrigo identified three common challenges for RIA in general, which are also relevant for trade-focused analysis: (i) the technical capacities of government officials to conduct quantitative and qualitative analysis; (ii) the lack of data to substantiate necessary quantifications, and (iii) missing trust and confidence between regulators and stakeholders. In this context, she explained that officials are generally not trained to perform these analyses and that data for such analyses may not be readily available or may be held by other regulators, which requires inter‑agency coordination.

3.16.  In this context, she noted that RIA can be implemented gradually and that regulators can start small. For example, regulators and trade and economy authorities can start this process by engaging with stakeholders to obtain information, and developing accessible tools such as questionnaires or quizzes to provide feedback and information needed for analysis. Relatedly, she said that RIA implementation involves cultural and mindset change and that there can be resistance to doing things differently. In addition, ensuring political commitment is important to guarantee that RIA results are integrated into decision-making and that final regulatory instruments reflect the results of the analysis.

3.17.  Mr. Nathan Frey focused on challenges to access to high-quality data for RIA. He noted that the quality and explanatory power of any analysis is only as good as the data that informs. it and stressed that having a systematic way to collect information on the costs and benefits of proposed regulatory measures is vital. He underlined that tying public consultation processes to the publication of RIA helps regulators gain access to better quality information and ensures that analyses have data that reflects marketplace realities. He noted that the consultation process is extremely helpful in filling gaps when a RIA does not initially have all the information needed to assess market impacts. He stressed that the policy of integrating RIA with consultations should also emphasise the role of GRP, including the use of international standards, the use of performance-based approaches whenever possible and the least restrictive measures. He concluded by reiterating the importance of institutionalising RIA policy and linking it consultation processes to ensure the availability of high‑quality for the analyses.

3.18.  Mr. Juan Antonio Dorantes highlighted the importance of having simple guides and procedures for conducting RIA. He observed, as did the moderators, that regulators, when drafting regulations, are often focused on solving a legitimate objective related problem rather than on addressing possible economic or trade impacts of the relevant regulation and stressed that they should consider RIA as a tool that will help them to achieve a better regulatory result.

3.19.  Mr. Dorantes noted that the objective of informing and nurturing regulatory proposals justifies the value of good impact analysis in achieving regulatory objectives, and that simplicity is very important in this process. He also emphasized that the rationale and benefits for conducting RIA should be conveyed to and understood at a political level on a regular basis, especially in countries such as Mexico where staff turnover is high and there is no established teaching curriculum in this area.

3.20.  He expressed scepticism about the effectiveness of conducting RIA on a voluntary basis. In addition, he stressed that Mexico's treaties provide for a central supervisory authority for best practices, namely the Digital Transformation and Telecommunications Agency (formerly the National Commission of Regulatory Improvement), and that it is very important to ensure that this mechanism is not captured by private interests or political factors. He underlined that the authority must be independent and separated from political power to maintain credibility and institutional impact, so that GRP principles are effectively implemented.

3.21.  Ms. Claudia Rosas Cárdenas identified the lack of evidence and data and the difficulty regulators face in processing data as challenges for conducting RIA. She noted that technology can be an ally in the RIA process and that there are different types of software to process qualitative and quantitative data and to make coherent analysis and manage large volumes of information.

3.22.  She pointed to the lack of regulatory culture in various institutions, observing that many regulators do not understand the concrete benefits RIA can bring to solve public policy challenges efficiently. She stressed the importance of changing this mindset and improving implementation of RIAs by ensuring that technical staff in ministries undergo trainings in this area. She also noted difficulties some regulators face in correctly identifying the regulatory problem, which makes identification of regulatory solution particularly challenging.

3.23.  She identified three elements that can ensure that RIA results inform regulatory decision‑making: (i) sound, solid and reliable evidence; (ii) transparency and openness of RIA to all stakeholders; and (iii) support from other GRP instruments such as public consultation. She referred to an example of Peru's public-private dialogues in sectors such as fisheries and agri-food, where stakeholders jointly analyse proposals from different angles and make contributions throughout the regulatory process.

3.24.  Mr. Lucian Cernat reflected on the opportunities and challenges that technologies (such as AI) bring to trade-related impact assessments. He recalled previous remarks about data constraints and gradual implementation of RIA, and added that regulators should start small but think big, noting that technologies increase opportunities for successful implementation of RIA and that RIA should not end with a one-off ex-ante document.

3.25.  Returning to his example of the EU CO2 emissions standards for automobiles, he explained that while compliance was initially checked through mandatory testing involving human intervention and paperwork, today every new car in the European Union is connected to the Internet and fitted with calibrated CO2 sensors. He noted that this allows automatic calculation of fuel consumption and the amount of CO2 emissions per kilometre, and that regulators can know, in real time, whether each car complies with the emissions requirements, without the need for human intervention, paperwork or red tape. He highlighted that compliance regarding CO2 emissions of both foreign and domestically produced cars with the EU legislation is automatic and that regulators now have billions of data points daily from hundreds of millions of cars, which allows them to see whether CO2 emission standards can be made stricter in line with the industry capability. He concluded by highlighting that in such future RIA, regulators will move away from best-guess modelling and instead rely on real-time data to ensure regulations are fit for purpose.

3.26.  Mr. Zhang Zhen discussed the impact of technologies on assessing trade-related impacts of regulatory measures. He identified three main challenges in this area; (i) the speed of technological changes outpaces traditional RIA timeframes; (ii) increasing complexities for quantifying impacts of regulatory measures; and (iii) the lack of comparable data (with traditional RIAs relying on historical data to model trade impacts, evidence-based assessment becomes particularly challenging). In this context, he noted that the challenge for all Members is to develop future-ready RIA approaches that keep pace with technological change while providing the predictability that trade requires. He suggested building regulatory flexibility into measures from the start, using technology itself to improve RIA.

3.27.  He then outlined opportunities emerging technologies bring to the RIA process: (i) digital tools enable broader and faster stakeholder consultation; (ii) data analytics and AI can enhance impact modelling, allowing computational tools to simulate regulatory scenarios, identify potential trade barriers earlier and model complex cross-sector interactions that would be impossible to assess manually; (iii) technologies facilitate international regulatory cooperation, as digital platforms. enable real-time information sharing about regulatory developments, making it easier for countries to align approaches and reduce unnecessary divergence. He underlined that Members that harness technological tools to improve their RIA processes will be better positioned to balance domestic objectives with trade openness.

4  COMMENT BY THE MODERATORS

4.1.  We would like to share with you a number of key takeaway points from the thematic session:

·_        RIA was defined as systematic process for evaluating regulatory options, weighing costs and benefits to select the most effective and efficient solution. Speakers emphasized that when RIA is mandatory and subject to quality control, regulatory interventions tend to achieve a better balance between domestic policy objectives and minimizing trade disruptions.

·_        Our panelists highlighted the importance of embedding RIA early in the regulatory process. Institutionalized guidance, interagency review – including bodies competent for trade –, and public consultation were identified as critical elements to ensure that international impacts are considered. By mentioning practical examples, speakers pointed out that in-depth analysis of alternatives - including non-regulatory options - combined with stakeholder input can help identify the least trade-restrictive measures.

·_        Aligning technical requirements with international standards and choosing the least burdensome and performance-based approaches were presented as effective ways to reduce compliance burdens for exporters.

·_        We heard examples of how international commitments, including those in FTA, have supported the institutionalization of good regulatory practices and introduced obligations to consider trade impacts as an integral part of RIA.

·_        Speakers underlined that the implementation of RIA must be supported by a cultural shift, requiring regulators to view it as a tool for better policymaking rather than an administrative hurdle or box-ticking exercise. Additionally, panelists stressed the importance of political commitment to integrate RIA results into the decision-making process and the final regulations.

·_        Common challenges identified include limited technical capacity for quantitative analysis, lack of reliable data, and resistance to change. Nevertheless, Speakers emphasized that these challenges must not become excuses for not engaging in RIA processes. These challenges can be overcome by gradual RIA implementation, based on simple and user‑friendly procedures, continuous training and public-private dialogue.

·_        Technology was recognized as both a challenge and an opportunity: while rapid innovation can sometimes make traditional assessment outdated even before a measure goes into effect, digital tools and artificial intelligence can enhance data analysis, streamline consultations, and enable real-time monitoring of regulatory impacts.

·_        Forward-looking reflections stressed that technology could transform RIA from a static exercise into a dynamic, evidence-based process. Real-time data collection, automated compliance checks, and international cooperation through digital platforms. can help regulators keep pace with innovation while safeguarding trade openness.

·_        The session reaffirmed that incorporating trade-related considerations into RIA is not merely a technical exercise — it is a strategic approach to designing regulations that achieve legitimate policy objectives without creating unnecessary barriers to trade.

4.2.  We would like to express our appreciation for the insightful contributions from our speakers. They left us with a great deal to reflect on for further work in the Committee to strengthen the use of regulatory impact assessment, enhance cooperation between trade and regulatory authorities, and continue improving how Members identify and assess trade-related impacts when developing TBT measures.

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