The main deliverables of WP.6 follow a three-step development process of inception, development and finalization. These are described in the Working Procedures for the UNECE Working Party on Regulatory Cooperation and Standardization Policies. The inception and development documents are shared among experts participating in the project itself, under the general intellectual property rights policy annexed to the Revised Terms of Reference in document ECE/CTCS/WP.6/2022/11.
The main part of the finalization process is a public review where any expert may provide comments using a pre-defined template.
- Public Review
When project teams have finalized their initial drafts, they will be posted for public review in this section for a period of about thirty days. The projects currently in public review follow.
- GRM Project: Integrated risk management in Single Window systems
Project launch date: scheduled 15 February 2023
Expected completion date: 31 May 2024
Project leader: Valentin Nikonov
GRM has developed a series of recommendations on risk management. Recommendation R on Managing Risk in Regulatory Frameworks underlines the importance of ensuring safety without stifling growth and to avoid the two extremes of over- or under-regulation. This recommendation also sets out the basic principles of risk analysis and management. Recommendation S on Applying Predictive Risk Management Tools for Targeted Market Surveillance suggests setting priorities in market surveillance based on the consequence of non-compliance and the probability of finding a non-compliant product.
Recommendation V on Addressing Product Non-Compliance Risks in International Trade proposes to optimize border compliance time and costs while maintaining regulatory requirements through an integrated risk management of product regulators and customs. These requirements support safety measures, sanitary-phytosanitary measures, public health measures, or economic safeguarding measures, for example. This would be in contrast to each individual agency establishing their own risk management system.
A Single Window as defined by UN/CEFACT in its Recommendation 33 on Establishing a Single Window is a facility that allows parties involved in trade and transport to lodge standardized information and documents with a single-entry point to fulfil all import, export, and transit-related requirements. It should effectively coordinate all border agencies including product regulators and customs. Recommendation 33 advises that it can be an integrated system where the data is processed by the single-entry point, or it can be an interfaced system (decentralized) where the data is sent through the single-entry point to each agency for processing or a combination of the two.
In either of the two models proposed by UN/CEFACT Recommendation 33, it is important to apply the principles of WP.6-GRM Recommendation V to ensure that there is not unnecessary delays caused by uncoordinated risk management.
This project was proposed by the WP.6-GRM to the UN/CEFACT Single Window Domain in September 2021 and has since been integrated into the Programme of Work of WP.6 under the 2023 paragraph 14.c.
This project will develop a White Paper guideline to describe the best practices of coordinated risk management among multiple government agencies through a Single Window. It will be a practical example of applying the principles of WP.6 GRM Recommendation V (and preceding recommendations) to the principles of the UN/CEFACT developed Recommendation 33 (and subsequent SW recommendations). It is planned to be developed in close collaboration with the experts of the UN/CEFACT Single Window Domain and eventually proposed as a joint WP.6 - UN/CEFACT deliverable.
- MARS Project: Revision of Recommendation M
Project launch date: 14 August 2023
Expected completion date: 29 February 2024
Project leader: Vera Despotovic
Recommendation M was written in 2007 and suggests to governments to explore the possibility, wherever feasible and where the national legal framework permits, to involve their market surveillance authorities in the fight against counterfeit goods – in a complementary way to existing national legal mechanisms. A conference on the topic was organized on 21 February 2023 to explore the continued pertinence of this recommendation, returns on experience and what should be included in an eventual revision. The experts confirmed the relevance of Recommendation M today and noted a few points that could beneficially be updated:
- reflecting the reference to the updated United Nations Guidelines for Consumer Protection in 2015 in recommendation text;
- consider other relevant UN and European Union documents on strengthening rules for the control of restrictive business practices and
- introducing more assertive and action-oriented language to the recommendation text.
This activity is explicitly listed in the Programme of Work 2023 in paragraph 12(a): “Review for possible updates the Recommendation M on Use of Market Surveillance Infrastructure as a Complementary Means to Protect Consumers and Users against Counterfeit Goods and plan for guidelines on implementation of this recommendation. A webinar on counterfeit products could also be planned in support of this ”
Update Recommendation M with minor adjustments in order to align with UN General Assembly and UNCTAD updated guidance on consumer protection and other relevant UN and European Union references. Integrate a more assertive and action-oriented language.
Develop a brief guideline to demonstrate how implementers can comply with the recommended practices.
- START Project: Common regulatory arrangement (CRA) for trunk pipeline safety in relation to hydrogen
Project launch date: 5 January 2024
Expected completion date: 4 July 2025
Project co-leaders: Frank Lienesch and Roman Samsonov
As outlined in the WP.6 2024 Programme of Work (paragraph 9), “Products placed on markets need to comply with the regulatory requirements in domestic and export markets. Consistent with the requirements of the World Trade Organization (WTO) administered multilateral trading system, technical regulations should be developed with the aim of addressing health, safety and environmental concerns without posing unnecessary barriers to trade. Businesses need to study, understand and comply with such regulatory requirements by implementing standards referenced in national technical regulations. Harmonizing these requirements across borders based on internationally agreed standards can facilitate this process and contribute to common principles for enforcement of product safety, security and market surveillance. This is supported by the Recommendation L on International Model for Transnational Regulatory Cooperation Based on Good Regulatory Practice.”
This project reflects the need for harmonization of conformity assessment procedures and approaches as there are currently a lot of different standards in this area. The project seeks to provide guidance on harmonizing standards and conformity assessment systems for the transportation of hydrogen through trunk pipelines, using the template of Recommendation L for a Common Regulatory Arrangement.
The project team will develop guidance for the harmonization of approaches to the development of standards and conformity assessment systems for the transportation through trunk pipelines of hydrogen.
- Develop a common regulatory arrangement for trunk pipeline safety in relation to hydrogen.
- Develop guidance for the harmonization of the conformity assessment requirements concerning hydrogen transportation.
- Prepare a questionnaire on the application of regulations concerning the transport of hydrogen by trunk pipeline. The resulting questionnaire would be reviewed by the WP.6 Bureau and then circulated for responses by the UNECE Secretariat. The information received would inform the next steps of the project and help to develop the requirements for common approaches.
- Analyse the legislative framework, including national legislation and standards developed for example, within the framework of ISO (TC 67 and TC 197), regulatory documents of the Hydrogen Council, legislation of the EAEU, the EU, US and other countries). This analysis will inform the details of the common regulatory arrangement.
- Develop guidance for the harmonization of the conformity assessment requirements concerning hydrogen transportation.
- START Project: Revision of Recommendation L
Project launch date: 29 January 2024
Expected completion date: 28 January 2025
Project leader: Ronald Tse
The UNECE WP.6 Recommendation L on the International Model for Transnational Regulatory Cooperation Based on Good Regulatory Practices proposes a model to help harmonize laws and technical regulations/directives. It has an objective to establish conformity rates related to risk categories of products as well as market surveillance outcomes which can then feed back into the objectives of the laws and regulations. It might be useful to also consider the impact assessment done for the development of the laws and regulations.
Recommendation L was last updated in 2015. The text of the recommendation states in the third preamble bullet point that the scope is products. The Annex A states in the second preamble bullet point that it is applicable to systems, processes, products and services. Then the rest of the annex refers to an application only to products (product classification, product requirements, market surveillance of products…). It is not clear if the intention was to truly work on systems, processes and services as the rest of the document does not support these. This project will be to clearly broaden the scope of Recommendation L in order to include services. This will result in modification of the text and may result in two separate annexes for the format of a common regulatory arrangement (CRA): one for products and another for services.
There exists a CRA on cybersecurity (a process / service); this may be used as an example of how a CRA on services could be organized. Or this could be seen as the implication of cybersecurity for products (like medical devices). There would thus be a decision to be made if a CRA is only for products; or if it is possible to create a CRA for systems, processes and services.
Annex A may also benefit from some update for a more precise statement of the requirements for the specified elements. For example, Regulatory Scope and Product Groups should be identified based on international standards; the statement of conformity should more specifically contain forms and schemes for confirming conformity, which are considered to provide the necessary level of evidence, determined on the basis of an analysis of the risks specific to a particular product. The main objective is to promote harmonization between countries; this important point may need to be spelled out more clearly.
There has also been a variation in terms used: common regulatory arrangement (CRA), common regulatory framework and common regulatory objective (CRO) (the latter two are not defined in the Recommendation L). This revision would also aim to clarify this point and propose a harmonization of the terms used.
Annex B provides a process which countries could use to notify their adoption of a CRA and a registry maintained by the UNECE secretariat. These provisions have never been applied. The project will aim to check with existing CRAs if such a registry would be doable and if the process in Annex B could be applied. Annex B would be modified accordingly, or abandoned altogether if deemed that it is not doable (also taking into consideration capacity of the WP.6 secretariat to maintain such a registry).
Revision of the text of Recommendation L in order to broaden the scope to include services. This will include a revision of Annex A and potential splitting Annex A into two separate annexes: a model CRA for products (basically the current text) and a separate model CRA for services, processes and systems.
This project will also review Recommendation L Annex B to check if it is doable; this research may result either in the deletion of this annex or updating it to a process which would be achievable.
- WP.6 Bureau Project: Regulatory compliance of products with embedded artificial intelligence or other digital technologies
Project launch date: 6 December 2023
Expected completion date: 30 June 2024
Project leader: Markus Krebsz
In addition to WP.6 key areas of work (market surveillance, risk management, gender-responsive standards, education standards, regulatory cooperation, and standardization) and mindful of increased complexity of product regulation due to digital innovations as well as a quickly changing regulatory landscape, WP.6 is looking to develop new guidance on digital product regulation focussed on regulatory compliance of products with embedded artificial intelligence or other digital technologies(Such work will regard parameters related to technological innovation and sustainable green transition as part of national quality infrastructure and will address Artificial intelligence, machine learning and other aspects of digitalization [e.g. Internet-of-things, connected devices, neurotechnology and robotics] in technical regulation and international regulatory cooperation).
This project also supports the UNECE 70th Commission session (April 2023) proposed theme “Digital and green transformations for sustainable development in the ECE region.” This further supports Decision 16 of the 32nd Session of WP.6 to explore the link between quality infrastructure and the 70th session theme.
Given how quickly technical regulation for innovative products with embedded digital technologies, such as those using artificial intelligence, evolves, and given the multiple regulatory concerns that need to be addressed in digital product regulation, a rethink concerning current compliance models is required.
This project is covered under the WP.6 Programme of Work for 2024 under paragraphs 6 and 7.
This project builds upon the paper on “The regulatory compliance of products with embedded artificial intelligence or other digital technologies.”
This project proposes to develop a Common Regulatory Arrangement as described in Recommendation L. It will further develop annexes to the CRA which may address how the CRA could be applied on a sectoral or product-level basis.
This project will concentrate on the compliance of products which integrate technologies such as artificial intelligence. For this reason, it concerns all four subgroups of WP.6 (MARS, GRM, GRS and START); it is therefore proposed to be monitored directly by the WP.6 Bureau and open to the expertise of all four subgroups.
This project will not be developing how artificial intelligence and other technologies can be used by administrations in their regulatory processes. It will not deal with specific ethical concerns of AI as such but may address societal concerns that are, or will be, addressed in the regulation of industrial products (incl. (but not limited to) technical regulation, standards, requirements on conformity assessment and market surveillance).
This project will also develop a Declaration (similar to the Declaration on Gender-Responsive Standards) which will target the TBT contact point ministries as signatories and encouraging the harmonization of regulations of products with artificial intelligence or other digital technologies.