Technical Advisory Group on Trans Fat Elimination and Validation: virtual meetings report, June-October 2023

Technical Advisory Group on Trans Fat Elimination and Validation Virtual meetings report, June–October 2023

Technical Advisory Group on Trans Fat Elimination and Validation Virtual meetings report, June–October 2023 Technical Advisory Group on Trans Fat Elimination and Validation: virtual meetings report, June–October 2023 ISBN 978-92-4-010111-1 (electronic version) ISBN 978-92-4-010112-8 (print version) © World Health Organization 2024 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. 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To submit requests for commercial use and queries on rights and licensing, see https://www.who.int/ copyright. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. This publication contains the report of the Technical Advisory Group on Trans Fat Elimination and Validation and does not necessarily represent the decisions or policies of WHO. iii Contents Acknowledgements iv Executive summary v 1. Background 1 1.1 Global elimination of industrially produced trans-fatty acids by 2023 1 1.2 Establishment of the WHO Validation Programme 1 1.3 Establishment of the TFATAG 1 1.4 First round of application of the WHO Validation Programme 2 2. Declaration of interests 4 3. TFATAG meetings 5 3.1 First TFATAG meeting (27 June 2023) 5 3.1.1 Introduction 5 3.1.2 Nomination of the chair and vice-chair 5 3.1.3 Review of terms of reference and operating procedures 5 3.1.4 Validation process 6 3.1.5 Technical criteria 6 3.1.6 Country evaluation 6 3.2 Second TFATAG meeting (28 July 2023) 7 3.2.1 Issues encountered 7 3.2.2 Detailed technical criteria 7 3.3 Third TFATAG meeting (10–11 October 2023) 7 3.3.1 Evaluation of country applications 8 3.3.2 Technical criteria 10 4. Review of workplan 11 Annex 1. List of participants 13 Annex 2. Detailed technical criteria (released in January 2024) 15 Annex 3. Revised application form (released in January 2024) 19 iv Acknowledgements The World Health Organization (WHO) would like to express its appreciation to all the members of the WHO Trans Fat Elimination Technical Advisory Group (TFATAG) who provided their time and expertise to conduct country evaluations and contributed to the discussions during the meetings. This TFATAG meeting report was prepared by Dr Rain Yamamoto, Scientist of the Department of Nutrition and Food Safety of WHO, under the supervision of Dr Francesco Branca and Dr Moez Sanaa. Members of the TFATAG included Dr Afaf Ali Amin (National Nutrition Institute, Egypt), Dr Ingeborg Annemar Brouwer (Vrije Universiteit, Netherlands (Kingdom of the)), Dr Laura Cobb (Resolve to Save Lives, United States of America), Mr Faisal Fahad Binsunaid (Saudi Food & Drug Authority, Saudi Arabia), Dr Haiqin Fang (China National Center for Food Safety Risk Assessment, China), Mr Bill Jeffery (Centre for Health Science and Law, Canada), Dr Albert Koulman (University of Cambridge, United Kingdom of Great Britain and Northern Ireland), Dr Sanjit Kanjilal (CSIR- Indian Institute of Chemical Technology, India), Dr Fredirick Lazaro Mashili (Muhimbili University of Health and Allied Sciences, United Republic of Tanzania), Dr R. B. N. Prasad (Food Safety and Standards Authority of India), Dr Bhanuja Wijayatilaka (Ministry of Health, Sri Lanka), Dr Margo Wootan (MXG Strategies, United States of America). The meetings were chaired by Mr Faisal Fahad Binsunaid, and Dr Laura Cobb served as vice-chair. WHO would like to thank the applicant countries for preparing the applications and supporting documents. WHO also expresses great gratitude to the nutrition focal points in WHO regional and country offices, and their national counterparts and colleagues in ministries of health and other sectors for coordinating and supporting the preparation and submission of country applications. vExecutive summary The WHO Validation Programme for Trans Fat Elimination was established to recognize countries for having a normative framework in place to eliminate industrially produced trans-fatty acids (TFA) from national food supplies by granting them a WHO Validation certificate of Trans Fat Elimination. Against this background, in 2023 WHO established the Trans Fat Elimination Technical Advisory Group (TFATAG) with a view to ensuring independence, scientific rigour and transparency in making judgements about the granting of the WHO Validation certificate. The primary role of the TFATAG is to evaluate country applications and advise WHO about whether a WHO Validation certificate should be granted to a country. The first application was opened to countries on 14 April 2023, and had a 1-month deadline. Applications were submitted by 14 countries. Based on a preliminary screening, 10 countries were considered eligible for evaluation by the TFATAG. An Evaluation Team, composed of two to three members of the TFATAG, was formed for each applicant country and conducted an initial evaluation of the dossier submitted by the country. For each of the 10 countries, the relevant Evaluation Team then prepared an assessment report for that country. These reports were then reviewed and assessed by TFATAG according to the technical criteria for validation of trans fat elimination. The TFATAG concluded that Denmark, Lithuania, Poland, Saudi Arabia and Thailand have satisfied the technical criteria, and recommended WHO Validation certificates of Trans Fat Elimination be granted to these five countries. Based on the recommendation from the TFATAG, the Director-General decided to grant a WHO Validation certificate of Trans Fat Elimination to each of Denmark, Lithuania, Poland, Saudi Arabia and Thailand. This document explains the process used for the evaluation of the country applications and briefly summarizes the results of the evaluations by the TFATAG of the country applications.

11. Background 1.1 Global elimination of industrially produced trans-fatty acids by 2023 Elimination of industrially produced trans-fatty acids (iTFA) is identified as a priority target of the World Health Organization’s (WHO) 13th General Programme of Work 2019–2025. Trans-fatty acids (TFA) is one of the main risk factors for noncommunicable diseases. Increased TFA intake (>1% of total energy intake) is associated with coronary heart disease events and mortality.1 WHO released the REPLACE framework for TFA elimination in 2018 and six REPLACE modules in 2019 to support Member States to eliminate TFA from their national food supplies and replace TFA with healthier oils and fats.2 To achieve global elimination of industrially produced TFA, WHO recommends governments introduce best-practice policies. As of the end of 2023, 53 countries have implemented best- practice policies for TFA elimination.3 While good progress has been made over the past years, progress has been uneven across the globe, and more than 4 billion people are still unprotected from the health consequences of TFA consumption. Further, challenges remain with ensuring that compliance with these policies is monitored and enforced. 1.2 Establishment of the WHO Validation Programme In 2023, the WHO Validation Programme for Trans Fat Elimination, which evaluates and validates the status of Member States in their efforts to eliminate industrially produced TFA, was set up. The programme aims to establish accountability and accelerate progress for global elimination of industrially produced TFA. The programme recognizes Member States for having a normative framework in place to eliminate industrially produced TFA, including adequate monitoring and enforcement systems, by granting them a WHO Validation certificate of Trans Fat Elimination.4 1.3 Establishment of the TFATAG Against this background, WHO established the WHO Trans Fat Elimination Technical Advisory Group (TFATAG)5 to ensure independence, scientific rigour and transparency in granting WHO Validation certificates. The TFATAG is the principal advisory group to WHO that makes recommendations to the WHO Director-General on the granting of WHO Validation certificates. The members of the TFATAG were identified through an open call for experts. In forming the group, the WHO Secretariat took into consideration the need for expertise in many disciplinary areas, representation from all WHO regions, and a balanced gender mix. The list of TFATAG members can be found in Annex 1. 1 https://www.who.int/publications/i/item/9789240073630 2 https://www.who.int/teams/nutrition-and-food-safety/replace-trans-fat 3 https://extranet.who.int/nutrition/gina/en/scorecard/TFA 4 https://www.who.int/teams/nutrition-and-food-safety/replace-trans-fat/validation-programme-for-trans-fat-elimination 5 https://www.who.int/groups/trans-fat-elimination-technical-advisory-group-(tfatag) 2 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation 1.4 First round of application of the WHO Validation Programme The first application round was opened to countries on 14 April 2023. Fourteen countries submitted application to WHO based on the general technical criteria outlined below.1 Several countries expressed interest in applying in future. General technical criteria WHO grants the WHO Validation certificate when the cumulative criteria set out below are met: 1. A best-practice TFA elimination policy is in effect in the Member State, which meets the following conditions, as documented by official documentation to be provided by the applicant Member State: a. The best-practice TFA elimination policy provides for: i. mandatory national ban on the production, use or sale of partially hydrogenated oils (PHO ban) OR ii. mandatory national restriction that limits industrially produced TFA to a maximum of 2% of total fat in all fats, oils and foods (industrially produced TFA 2% limit) OR iii. a combination of the PHO ban and industrially produced TFA 2% limit; AND b. The policy above is in effect: the deadline for entry into effect of the policy has passed. 2. The applicant Member State has adequate monitoring and enforcement systems in place, and the required documentation as described below. a. Monitoring system: i. Member State conducts monitoring activities to ensure that there is no industrially produced TFA that is domestically produced. For example: — inspection of oil and fat factories/processing plants to identify engagement in partial hydrogenation and high-temperature refinement of oils — examination of documentation (e.g. receipts, records, inventory, labels, laboratory reports) that oil and fat factories/processing plants and food manufacturing facilities maintain on purchased ingredients and production of their products AND ii. Member State conducts monitoring activities to ensure that there is no industrially produced TFA that is imported from outside the country. For example: — examination of documentation at ports of entry for PHO or products that are likely to have high levels of industrially produced TFA — sampling and testing of products at ports of entry that are likely to have high levels of industrially produced TFA. b. Enforcement system: i. Member State has in place an enforcement system. For example: — systematic tracking of inspections and offences and inspections that are targeted to repeat offenders and high-risk sites — imposing graduated sanctions to violators, as appropriate for the local legal system (e.g. warnings, fines that increase based on severity, product recalls, business license or import permit suspension or termination). 1 Further detailed technical criteria was released after the first cycle of TFATAG evaluation (see Annex 2). 3c. Required documentations: i. Member State presents reports and other documentation to demonstrate that the monitoring and enforcement systems described above are functioning. For example: — monitoring and enforcement report for imported and domestic products (for example: facility inspection reports, laboratory analysis reports, label review reports, or document review reports (e.g., records, bills of lading, customs declarations); and compliance violation reports; and monitoring and enforcement protocols or description of procedures) — monitoring and enforcement protocols or description of procedures. 1. Background 42. Declaration of interests All TFATAG members participating in the meetings completed and submitted a Declaration of Interests form. Declarations of Interests were reviewed by the WHO Secretariat in consultation with the WHO Department of Compliance and Risk Management and Ethics, where necessary. Six of the TFATAG members are currently employed by government agencies with some stake in TFA elimination in their countries. These members shall be excluded from the evaluation and formulation of recommendations for validation of their respective countries. In this regard, Mr Faisal Binsunaid (Saudi Arabia) was recused from the evaluation of Saudi Arabia. Apart from this, WHO concluded that none could give rise to a potential or reasonably perceived conflict of interest related to the subject discussed during the first round of evaluation. All contributing experts were acting in their individual capacity and not as institutional representatives. 53. TFATAG meetings The members of the TFATAG met virtually on 27 June, 28 July and 10–11 October 2023. 3.1 First TFATAG meeting (27 June 2023) The objectives of the first meeting were: f to review the WHO Validation Programme and terms of reference of the TFATAG; and f to review the list of countries that have submitted applications to WHO, and then agree on a process and timeline for completing the evaluations and recommendations for the first round of countries. 3.1.1 Introduction Dr Francesco Branca, Director of the Department of Nutrition and Food Safety, welcomed the participants and provided the opening remarks. The list of participants is provided in Annex 1. Dr Branca emphasized his expectation for the WHO Validation Programme to play an important role in recognizing Member States for their achievements by granting them a WHO Validation certificate of Trans Fat Elimination. He also noted that validation of trans fat elimination gives countries an opportunity to audit the processes that have been established in the country. He thanked all the members of the TFATAG for their commitment to supporting WHO. Dr Rain Yamamoto, Scientist of the Department of Nutrition and Food Safety, presented the background and objectives of the meeting and a summary of interests declared by the TFATAG members. She also presented the WHO initiative and activities to achieve global TFA elimination by 2023. 3.1.2 Nomination of the chair and vice-chair The TFATAG unanimously agreed to select Mr Faisal Fahad Binsunaid as chair and Dr Laura Cobb as vice-chair. 3.1.3 Review of terms of reference and operating procedures The roles of the TFATAG and TFA Evaluation Team and the operational procedures for TFATAG meetings were explained. The WHO Trans Fat Elimination Technical Advisory Group: f is composed of 12 independent international experts with professional experience and technical expertise in areas relevant to TFA elimination (term: 3 + 3 years); f meets at least once a year and is convened by the WHO Secretariat; f reviews and assesses the applications and the accompanying supporting documentation, and considers the evaluation reports prepared by the Evaluation Team; and f makes recommendations on the granting of the WHO Validation certificate to the WHO Director-General, based on such review and assessment. 6 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation A TFA Evaluation Team: f is a subgroup of the TFATAG, and is composed of up to three TFATAG members; f examines country applications including all the supporting documentation; f prepares an evaluation report of the country applications to be reviewed by TFATAG; f may conduct country visits for further examination, if necessary; and f informs the WHO Secretariat if further country information is required. 3.1.4 Validation process The validation process was explained to the TFATAG. 1. A country submits an application and required documentation to WHO Secretariat 2. The WHO Secretariat checks the application and asks an Evaluation Team to assess it 3. The Evaluation Team reviews the application and prepares an evaluation report 4. The TFATAG reviews the application, considers the evaluation report, and submits a summary of their assessment and recommendation to WHO Director-General 5. WHO Director-General makes the final decision, and officially informs the national authority about the granting or rejecting of the certificate 6. When the WHO Validation certificate is granted, the country will be noted in the WHO’s TFA progress report and noted on the TFA country score card (the granting may include a ceremony) 3.1.5 Technical criteria A draft of the detailed technical criteria was presented to and reviewed by the TFATAG. After some discussion, it was agreed that the WHO Secretariat incorporate the views and suggestions of TFATAG members and produce a revised version. 3.1.6 Country evaluation As per the process described in section 3.1.4, after receiving applications from countries, the WHO Secretariat screened the country applications to assess the eligibility of applicant countries. Based on this screening, 10 countries were considered eligible to be evaluated by the TFATAG. The overview of applications submitted by these 10 countries was presented. It was decided that an Evaluation Team would be formed for each of the 10 countries, comprising two to three TFATAG members. The assignment of members to Evaluation Teams was agreed by the TFATAG, and each member subsequently received relevant country application dossiers for their perusal. 73.2 Second TFATAG meeting (28 July 2023) The objectives of the second meeting were: f to discuss any issues encountered by TFATAG members when assessing the application documents submitted by countries; and f to review and discuss the detailed technical criteria for national TFA policy monitoring and enforcement systems. 3.2.1 Issues encountered Issues raised by TFATAG members as they started to assess the country applications included the following: f Specificity of information: Countries often provide a lot of general information (e.g. hundreds of pages of documents) on their enforcement mechanism but it is hard to identify which part is specific to TFA and how it applies to TFA. f Missing information: Critical supporting documents, such as violation reports, are lacking, so it is unclear what enforcement activities countries are actually using on the ground. f Lack of technical detail: Information given on the laboratory analyses conducted by countries is limited (e.g. lack of information about the laboratory method used and the validity of the analyses conducted). f Clarity on information sources: It is unclear whether we can use monitoring data published in a peer-reviewed journal in addition to the data submitted by applicant countries. f Translation difficulties: Most of the supporting documents were submitted in the original languages. It is sometimes difficult to understand the text translated from the original language when using an online translator. It was agreed that an Evaluation Team would prepare a set of questions for each country to get further information and documentation needed for the evaluation. The collected questions were sent to each country by the WHO Secretariat. Responses received from countries were shared with the Evaluation Teams for their review to finalize the evaluation report. 3.2.2 Detailed technical criteria Technical criteria that had been revised based on comments made during the first meeting were presented. While it was noted that monitoring of labels could be challenging and problematic – because they may be unreliable and provide a limited amount of information – label assessment is probably a necessary option for many countries, because laboratory testing is not feasible for them due to lack of resources and technical capacity. Further, a much larger number of samples can be monitored with label assessment than with laboratory testing. Therefore, the TFATAG agreed that, although laboratory assessment is a preferred mechanism for monitoring, label assessment should be allowed when laboratory testing is not feasible. Countries choosing a label option should demonstrate that they have mandatory labelling regulations. As for the details of the technical criteria, it was agreed to finalize them using the learnings obtained from the first round of evaluation. 3.3 Third TFATAG meeting (10–11 October 2023) The objectives of the third meeting were: f to review evaluation report prepared by each Evaluation Team for each country; f to assess whether the applicant countries should be validated for TFA elimination; and f to finalize the detailed technical criteria for TFA policy monitoring and enforcement systems. 3. TFATAG meetings 8 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation 3.3.1 Evaluation of country applications Below is a summary of country evaluations. The discussion was facilitated by Mr Faisal Binsunaid (chair) and Dr Laura Cobb (vice-chair). For the discussion of Saudi Arabia, Mr Faisal Binsunaid recused himself and Dr Laura Cobb took over as chair. 1. Denmark In 2003, Denmark was the first country in the world to introduce best-practice policies for eliminating iTFA (Danish Order no. 160 from 11 March 2003), and since then has monitored iTFA content in foods. When the European Union’s (EU) best-practice policy (Commission Regulation (EU) 2019/649 of 24 April 2019) came into effect, the EU regulation replaced the Danish regulation. Denmark has conducted a testing programme in which both domestic and imported products are analysed to check their compliance with the Danish rules. They provided reports that describe results from the testing programmes conducted in 2003, 2005, 2009, 2012 and 2017, for hundreds of samples covering major TFA food sources and categories. The number of samples decreased during the testing programme as the non-compliance decreased. By 2017, all domestic products were aligned with the regulation and only 2% of imported products did not comply. The laboratory protocol they shared showed that they are using an appropriate laboratory method. It was noted that in recent years their control activity is mainly based on the documentation that food business operators provide (e.g. analysis reports). Their monitoring system is coupled with appropriate enforcement policy and penalty measures. Graduated sanctions to violators are in place, from a warning, to an injunction to a prohibitory order (Food Act no. 1033 from 5 July 2023, Order no. 562 from 17 May 2023) and fines (Order no. 501 from 24 March 2021). When an inspection of a food business operator is conducted, an inspection report is prepared and made publicly available on the Danish Government’s website. The TFATAG concluded that Denmark met the three technical criteria, and agreed to recommend Denmark for validation. 2. Lithuania Lithuania has had a best-practice policy in place since November 2019, while the EU’s best- practice policy went into effect in April 2021 (Commission Regulation (EU) 2019/649 of 24 April 2019). Lithuania has a monitoring system that tests both domestic and imported food products, and covers a wide variety of food categories including foods likely to contain PHO. These foods include confectionaries, margarines, mayonnaise, and other hydrogenated fats. Lithuania provided results from both domestic and imported food products for 2021. The sample size was reasonable and was geographically representative. In subsequent years, the sample size has decreased, but this was considered reasonable given the large sample size in the first year. They shared their laboratory protocol, which showed that they are using an appropriate method. They have a protocol for infringement that includes documenting both violation and response. They also showed significant documentation and follow up of violators including recording on the Lithuanian Government’s website cautionary notices to suppliers about products to take off the market, and financial sanctions (Law on Food No. VIII-1608 of 4 April 2000, Order No. B1-487 of 19 July 2013). Sanctions for infringements are publicly disclosed on their website. In case of non-compliance, a notification of unsafe foodstuffs is issued via Rapid Alert System for Food and Feed (RASFF) and the information is made publicly available to consumers on the website. They also notify other EU countries when they identify a violation. These activities were all supported by submitted documentation. The TFATAG concluded that Lithuania met the three technical criteria, and agreed to recommend Lithuania for validation. 93. Poland Since April 2021, Polish law has limited industrially produced TFA to 2% of fat in food products in line with the EU’s best-practice policy (Commission Regulation (EU) 2019/649 of 24 April 2019). Both domestic and imported food products in the marketplace are monitored; major food sources and categories of iTFA are included in the monitoring. Samples are collected by employees of the State Sanitary Inspectorate from randomly chosen shops in all 16 voivodeships across the country. The samples are analysed through an appropriate laboratory testing method. Their e-database, established in 2017, is required as part of Poland’s National Health Programme. Thus far, the e-database contains data on TFA levels in more than 1000 products from a wide range of food categories that tend to be high in iTFA and is being regularly updated. The e-database is publicly accessible. If inspectors find that a food does not conform to regulatory requirements, official control bodies may apply supervision measures (Commission Regulation (EU) 2017/625 of 15 March 2017; Food and Nutrition Safety Act of 25 August 2006). Graduated sanctions to violators exist and the action taken depends on the type of food and the degree of risk (for example, withdrawal of the product and financial penalties). Decisions of control authorities in cases of food adulteration or health hazards are made public. A notification is also issued through RASFF in such cases. There are a range of enforcement options in place, and details of any enforcement actions are made public. The TFATAG concluded that Poland met the three technical criteria, and agreed to recommend Poland for validation. 4. Saudi Arabia Since 2020, Saudi Food and Drug Authority (SFDA) has enforced a regulation that bans PHO in all food products (SFDA.FD 2483/2018: Trans Fats). They conducted monitoring and evaluation campaigns in 2018, 2020, 2021 and 2022, and assessed both locally produced and imported food products collected from supermarkets and markets. They combined two approaches – laboratory analysis (using an appropriate laboratory testing method) and label analysis, and assessed thousands of samples in each of 2020, 2021 and 2022. SFDA assesses random samples of imported products at the ports of entry by checking the ingredients list and nutritional label to see if TFA is present. In case of inconsistency between an ingredients list and a nutrition label, a lab analysis is conducted. An implementation plan specified the food products that should be covered by the inspection, including margarine, pastries, biscuits, chocolate products and dairy products. Reports show that violations have become less common over time, and a follow-up campaign in 2022 showed there was only 0.5% non-compliance among food products that had violated earlier that year. They shared significant documentation that shows tracking of inspection results and violations. The actions taken by SFDA against violations include: a warning letter; fines if the violation is not remedied within the correction period set by the SFDA (up to 6 months); withdrawal of the manufacturing or import license and withdrawal of the product license, if the violation is not remedied within the correction period set by the SFDA. Once a manufacturing or import license is withdrawn, manufacturing or importing the product becomes illegal. The TFATAG concluded that Saudi Arabia met the three technical criteria, and agreed to recommend Saudi Arabia for validation. 3. TFATAG meetings 10 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation 5. Thailand In January 2019, Thailand enforced a ban prohibiting the production, importation and selling of PHO and food products containing PHO (Notification of the Ministry of Public Health No. 388 B.E.2561 (2018)). For monitoring compliance with the regulation, Thailand combined different approaches: on-site inspection of production, importation and sales facilities; documentation examination; and laboratory analysis (using an appropriate laboratory testing method). Monitoring involved both locally produced products at production and retail facilities and imported products at retail facilities and the border. Major TFA food sources and categories such as margarines and shortenings, and foods potentially containing PHO (e.g. cookies, pastries, chocolate-based desserts, non-dairy creamer, snacks, French fries) were covered. The annual sampling plan was established for 2019, 2020, 2022 and 2023, and hundreds of samples were collected and assessed accordingly. Laboratory reports show that during this period only one imported product was found to be non-compliant. They also have a mechanism to respond to public reporting for suspected products and investigate their compliance. This system was used in the past for four reported products, which were all found to be compliant. Product recall procedures for non-compliance are in place, and penalties include fines and imprisonment. They also conduct a follow-up inspection, and if a repeat offence is found, the food production license may be suspended (Food Act B.E.2522, 1979). Documentation was submitted to substantiate these activities including a violation report showing that a penalty was applied to a non-compliant entity/product. The TFATAG concluded that Thailand met the three technical criteria, and agreed to recommend Thailand for validation. 6. Remaining five countries Two countries – evaluation returned Two countries were evaluated by the TFATAG as not meeting all three technical criteria at this point. Therefore, the evaluation summary, together with advice from the TFATAG, was returned to each country. Once they address the areas identified for improvement, they are welcome to reapply for the WHO Validation Programme. Three countries – evaluation ongoing Three countries were evaluated by the TFATAG as needing to submit more data and information. The additional data and information received from the three countries will be evaluated at the next TFATAG meeting, scheduled in 2024. 3.3.2 Technical criteria Based on the experiences in evaluating the country applications during the first round, the TFATAG elaborated on the original technical criteria and established the detailed technical criteria (Annex 2). It was noted that this is a living document, and that it should be continuously reviewed and updated as needed by considering new observations obtained through country evaluations. The TFATAG also updated the application form (Annex 3), which provides detailed instructions for countries on the required information and supporting documents. The revised application form is expected to facilitate a smoother process for both country applications and TFATAG evaluation. Both the detailed technical criteria and the revised application form were published on the WHO Validation Programme website in January 2024, and are available in English, French and Spanish. 11 4. Review of workplan It was decided that the TFATAG would meet again in 2024 to continue with the evaluation of the remaining three countries from the first round and to start evaluation of a new set of countries. The second round opened for applications in August 2024.

13 Annex 1. List of participants Trans Fat Elimination Technical Advisory Group members Dr Afaf Ali Amin Professor National Nutrition Institute (NNI) Food Safety Department Egypt Dr Ingeborg Annemar Brouwer Head of Department of Health Sciences; Professor Vrije Universiteit Netherlands (Kingdom of the) Dr Laura Cobb Director, Nutrition Policy and Surveillance Cardiovascular Health Initiative Resolve to Save Lives United States of America Mr Faisal Fahad Binsunaid Director Healthy Food Department Saudi Food & Drug Authority Saudi Arabia Dr Haiqin Fang Associate Researcher, Researcher Applied Nutrition Division I China National Center for Food Safety Risk Assessment China Mr Bill Jeffery Executive Director Centre for Health Science and Law, Ottawa Canada Dr Sanjit Kanjilal Senior Principal Scientist CSIR-Indian Institute of Chemical Technology India Dr Albert Koulman Head NIHR BRC Core Metabolomics and Lipidomics Lab NIHR BRC Nutritional Biomarker Laboratory University of Cambridge United Kingdom Dr Fredirick Lazaro Mashili Department Chair; Senior Lecturer Department of Physiology Muhimbili University of Health and Allied Sciences Research Officer East African Centre of Excellence in Cardiovascular Sciences United Republic of Tanzania Dr R. B. N. Prasad Former Chief Scientist & Head, Centre for Lipid Research CSIR-Indian Institute of Chemical Technology India Dr Bhanuja Wijayatilaka Consultant Community Physician, Food Safety Unit, Ministry of Health Sri Lanka Dr Margo G. Wootan President MXG Strategies Adjunct Faculty American University United States of America 14 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation WHO Headquarters (Secretariat) Dr Francesco Branca Director Department of Nutrition and Food Safety World Health Organization Switzerland Dr Rain Yamamoto Scientist Standards and Scientific Advice Unit Department of Nutrition and Food Safety World Health Organization Switzerland Dr Moez Sanaa Head Standards and Scientific Advice Unit Department of Nutrition and Food Safety World Health Organization Switzerland Dr Luz Maria De Regil Head Multisectoral Action in Food Systems Unit Department of Nutrition and Food Safety World Health Organization Switzerland Dr Nimal Ratnayake Consultant Department of Nutrition and Food Safety World Health Organization Switzerland WHO Regional Offices Ms Pyi Pyi Phyo Consultant Nutrition, Physical Activity and Obesity WHO Regional Office for Europe Denmark Dr Victor Villalobos Daniel Consultant Department of Noncommunicable Diseases and Mental Health WHO Regional Office for Americas United States of America 15 Annex 2. Detailed technical criteria (released in January 2024)1 WHO Validation Programme for Trans Fat Elimination Technical Criteria for Monitoring and Enforcement Systems (1st edition, January 2024) Member States’ applications for the WHO Validation certificate must demonstrate that adequate monitoring and enforcement systems are in place to ensure compliance with best-practice trans- fatty acids (TFA) policy.2 Member States’ monitoring and enforcement systems must meet the below technical criteria. I. Required monitoring system features There are two options for the monitoring system: f (Option A) Laboratory testing or label assessment of food items sampled at food outlets; or f (Option B) Inspection of manufacturing facilities and at ports of entry. In both options, it must be demonstrated that the monitoring activities cover reasonably suspected major sources (e.g. specific products previously found to be high in industrially produced TFA (iTFA)) and key food categories that tend to contain high levels of iTFA.3 The monitoring system must cover both domestic and imported sources. Member States may combine different options (e.g. laboratory testing and label assessment; laboratory testing and inspection of documentation) to cover a wide range of iTFA sources. A. Option A: Laboratory testing or label assessment of food items sampled at food outlets Sampling of food items is conducted at food outlets4 that are common sources/venues of iTFA intake among the population. For monitoring food items sampled at food outlets, priority should be given to laboratory testing, but in the event laboratory testing is difficult due to cost or technical challenges, countries may choose to conduct label assessment or a hybrid approach. 1 The technical criteria is available in English, French and Spanish on the WHO website: https://www.who.int/teams/nutrition-and-food-safety/replace-trans-fat/validation-programme-for-trans-fat-elimination. 2 Best-practice policy: i) mandatory national ban on the production, use or sale of PHO (PHO ban): or ii) mandatory national restriction that limits iTFA to a maximum of 2% of total fat in all fats, oils and foods (iTFA 2% limit): or iii) a combination of the PHO ban and iTFA 2% limit. 3 Key food categories may include baking fats (e.g. shortening); cooking/frying oils; vegetable ghee, spreads (e.g. margarine); baked goods (e.g. biscuits, cakes, pastries, doughnuts); baked snacks; non-dairy creamer; confectionaries; fried entrees; fried snacks; frozen foods. 4 Food outlets may include supermarkets/markets; bakeries; restaurants; informal food markets. 16 1. Laboratory testing Measuring the TFA content of the food items sampled at food outlets. Testing must follow procedures described in the WHO simplified protocol1 or the WHO reference protocol2 or by a method that is equivalent3 to the WHO simplified protocol or the WHO reference protocol. OR 2. Label assessment Analysing labels of food products sampled at food outlets to identify foods that list PHO (or similar)4 as an ingredient or declare levels of TFA that exceed 2% of total fats or oils and that are likely to come from non-ruminant sources.5 This approach requires mandatory TFA labelling (a policy document on TFA labelling should be provided by the applicant government). OR 3. Hybrid approach Conducting a label assessment as described above, but submitting a smaller subsample of foods for laboratory testing per WHO protocols or equivalent. OR B. Option B: Inspection of manufacturing facilities and at ports of entry The inspection could be conducted on-site at food manufacturing facilities and at ports of entry, or by examination of relevant documentation. 1. For domestically produced products: For oil and fat factories/processing plants and manufacturing facilities of other foods that are likely to contain iTFA, the following activities must be conducted to make sure that the foods produced are compliant with the regulation: a. Examining documentation (e.g. receipts, records, inventory, labels, laboratory reports, recipes) that facilities maintain on purchased materials and manufacturing of their products or examining their practice (e.g. assessing if the oil and fat factories are engaged in partial hydrogenation). This can be done as part of regular inspection or on an ad-hoc basis as needed (e.g. renewal of the facility operating permit). OR 1 Simplified protocol for measuring trans-fatty acids content as a percentage of total fatty acids in food products: WHO laboratory protocol: Geneva: World Health Organization; 2023. https://apps.who.int/iris/handle/10665/366690 2 Global protocol for measuring fatty acid profiles of foods, with emphasis on monitoring trans-fatty acids originating from partially hydrogenated oils: WHO laboratory protocol: Geneva: World Health Organization; 2020. https://apps.who.int/iris/handle/10665/338049 3 For example, official methods of the Association of Official Analytical Collaboration (AOAC), the American Oil Chemists’ Society (AOCS) and the International Organization for Standardization (ISO). 4 PHO may appear on the ingredients list as “partially hydrogenated vegetable oil”, “hydrogenated vegetable oil”, “hydrogenated vegetable shortening”, or other similar terms. 5 If total TFA > 2% of total fat, and the product contains fat from industrial and ruminant sources: the following are some acceptable approaches for estimating the quantities of TFA from industrial versus ruminant sources: — Using information on the iTFA content in the source vegetable fat/oil product, in combination with the total TFA in the food sample. This information can be obtained by measuring the iTFA content in the source vegetable fat/oil product or by inquiring with the fat/oil supplier, food manufacturers or importers; — Looking at individual fatty acids as markers of dairy fats in mixed fats; and — Testing mixed food products in a laboratory and measuring the ratio of the amount of butyric acid and total TFA. For example, the European Commission has published a technical report (https://publications.jrc.ec.europa.eu/repository/bitstream/JRC125335/JRC125335_01.pdf), which describes a workflow using this approach to estimate the amount of iTFA in food products containing mixtures of PHO and ruminant fats, such as dairy fat and beef tallow. Each country or region must establish the average C4:0 and iTFA values of their dairy products. 17 b. Sampling and testing vegetable oils and fats and other foods processed in the domestic factories. Testing must adhere to laboratory criteria (following procedures described in the WHO simplified protocol1 or the WHO reference protocol2 or by a method that is equivalent3 to the WHO simplified protocol or the WHO reference protocol). AND 2. For imported food products: The following activities must be conducted to make sure that they are compliant with the regulation: a. Checking documentation of imported products at ports of entry (e.g. bills of lading, tariff and customs declarations) or before entry (e.g. import registration submitted by importers, certificate of conformity, laboratory analysis report). OR b. Analysing labels of imported products at ports of entry to identify foods that list PHO (or similar)4 as an ingredient or declare levels of TFA that exceed 2% of total fats or oils and that are likely to come from non-ruminant sources.5 This approach requires mandatory TFA labelling (a policy document on TFA labelling shall be provided by the applicant government). OR c. Sampling and testing of imported food products at ports of entry, following procedures described in the WHO simplified protocol1 or the WHO reference protocol2 or by a method that is equivalent to the WHO simplified protocol or the WHO reference protocol.3 II. Required enforcement system features For food products that do not comply with the regulation, the applicant/concerned Member State must have effective enforcement mechanisms as follows: 1. Systematic tracking of inspections and offences (ideally in a database) and inspections that are targeted based on high risk (e.g. high-risk food categories, repeat offenders, facilities with ability for partial hydrogenation). AND 1 Simplified protocol for measuring trans-fatty acids content as a percentage of total fatty acids in food products: WHO laboratory protocol: Geneva: World Health Organization; 2023. https://apps.who.int/iris/handle/10665/366690 2 Global protocol for measuring fatty acid profiles of foods, with emphasis on monitoring trans-fatty acids originating from partially hydrogenated oils: WHO laboratory protocol: Geneva: World Health Organization; 2020. https://apps.who.int/iris/handle/10665/338049 3 For example, official methods of the Association of Official Analytical Collaboration (AOAC), the American Oil Chemists’ Society (AOCS) and the International Organization for Standardization (ISO). 4 PHO may appear on the ingredients list as “partially hydrogenated vegetable oil”, “hydrogenated vegetable oil”, “hydrogenated vegetable shortening”, or other similar terms. 5 If total TFA > 2% of total fat, and the product contains fat from industrial and ruminant sources: the following are some acceptable approaches for estimating the quantities of TFA from industrial versus ruminant sources: — Using information on the iTFA content in the source vegetable fat/oil product, in combination with the total TFA in the food sample. This information can be obtained by measuring the iTFA content in the source vegetable fat/oil product or by inquiring with the fat/oil supplier, food manufacturers or importers; — Looking at individual fatty acids as markers of dairy fats in mixed fats; and — Testing mixed food products in a laboratory and measuring the ratio of the amount of butyric acid and total TFA. For example, the European Commission has published a technical report (https://publications.jrc.ec.europa.eu/repository/bitstream/JRC125335/JRC125335_01.pdf), which describes a workflow using this approach to estimate the amount of iTFA in food products containing mixtures of PHO and ruminant fats, such as dairy fat and beef tallow. Each country or region must establish the average C4:0 and iTFA values of their dairy products. Annex 2. Detailed technical criteria 18 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation 2. Imposing penalties on violators, as appropriate for the local legal system (e.g. warnings, ticketing, fines that increase based on severity, stop-sale orders, profit disgorgement, product recalls, suspension or termination of business license or import permit, public disclosure of non-compliance, etc.) III. Required documentation Member States must present the following protocols, reports and other documentation to demonstrate that the monitoring and enforcement systems are functioning. f monitoring and enforcement protocols or description of procedures for both imported and domestic products AND f monitoring and enforcement reports for both imported and domestic products (e.g. compliance violation reports, facility inspection reports, product analysis reports). These can be anonymized to protect confidentiality if needed. AND f In case countries are submitting results on label assessment — A policy document on mandatory TFA labelling AND — Information on the percentage of food products assessed that declare the TFA content on the label 19 Annex 3. Revised application form (released in January 2024)1 Trans Fat Elimination Validation Certificate Application Form To apply for the WHO Trans Fat Elimination Validation Certificate, please complete and submit this form, along with the required attachments, to WHO Headquarters Department of Nutrition and Food Safety at tfa@who.int. Requirements: 1. * indicates required question. 2. All supporting documents must be prepared in English. Alternatively, documents can be submitted in languages other than English, but in this case, please include a summary of each document in English. 3. When referencing documentation, please specify the precise section or page containing the relevant information. This facilitates efficient retrieval of the required details. Applicant Information Country: Authority/ Agency: Name Address Primary Point of Contact: Name Title Phone number Email address Secondary Point of Contact (optional): Name Title Phone number Email address 1 The application form is available in English, French and Spanish on the WHO website: https://www.who.int/teams/nutrition-and-food-safety/replace-trans-fat/validation-programme-for-trans-fat-elimination. 20 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Be st -p ra ct ic e TF A re gu la tio n is im pl em en te d* Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e be st -p ra ct ic e TF A re gu la tio n, in cl ud in g its eff ec tiv e da te . Po lic y do cu m en t o n be st -p ra ct ic e po lic y Ad eq ua te m on ito ri ng s ys te m is in p la ce * Ye s: ☐ N o: ☐ Pl ea se p ro vi de a n ov er vi ew o f t he m on ito rin g ac tiv iti es to e ns ur e co m pl ia nc e w ith th e be st -p ra ct ic e po lic y, in cl ud in g th e nu m be r o f s am pl es te st ed a nd /o r l ab el s r ev ie w ed pe r y ea r, an d sa m pl in g pl an . M on ito rin g pr ot oc ol Ad eq ua te en fo rc em en t sy st em is in p la ce * Ye s: ☐ N o: ☐ Pl ea se p ro vi de a n ov er vi ew o f t he e nf or ce m en t a ct iv iti es to tr ac k an d ho ld v io la to rs ac co un ta bl e, in cl ud in g en fo rc em en t a ct io ns a va ila bl e an d th os e ac tu al ly ta ke n. En fo rc em en t p ro to co l a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 21Annex 3. Revised application form (released in January 2024) TF A po lic y im pl em en te d in th e co un tr y* PH O b an ☐ 2% iT FA li m it ☐ M on ito ri ng a nd en fo rc em en t sy st em s i n pl ac e* O pt io n A: La bo ra to ry te st in g or la be l a ss es sm en t o f f oo d ite m s s am pl ed a t f oo d ou tle ts O pt io n B: In sp ec tio n of m an uf ac tu ri ng fa ci lit ie s a nd a t p or ts o f e nt ry Do m es tic a nd im po rt ed p ro du ct s: La bo ra to ry a na ly si s: ☐ (A ns w er Q 1) La be l a na ly si s: ☐ (A ns w er Q 2) Do m es tic p ro du ct s: Ch ec ki ng d oc um en ta tio n: ☐ (A ns w er Q 3) La bo ra to ry a na ly si s: ☐ (A ns w er Q 4) Im po rt ed p ro du ct s: Ch ec ki ng d oc um en ta tio n: ☐ (A ns w er Q 5) La bo ra to ry a na ly si s: ☐ (A ns w er Q 6) La be l a na ly si s: ☐ (A ns w er Q 7) In c as e a co m bi ne d ap pr oa ch is ta ke n, d es cr ib e th e co m bi na tio n: Da te o f Im pl em en ta tio n* M M /D D/ YY YY 22 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation I. M on ito ri ng sy st em O pt io n A: L ab or at or y te st in g or la be l a ss es sm en t o f f oo d ite m s s am pl ed a t f oo d ou tl et s Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 1. L ab or at or y an al ys is Va lid at ed la bo ra to ry m et ho d is u se d Ye s: ☐ N o: ☐ W ha t i s t he la b m et ho d us ed (e .g . W H O , A ss oc ia tio n of O ffi ci al A na ly tic al C ol la bo ra tio n (A O AC ), Am er ic an O il Ch em is ts ’ S oc ie ty (A O CS ), th e In te rn at io na l O rg an iz at io n fo r St an da rd iz at io n (IS O ))? La b m et ho d / p ro to co l Sa m pl in g pl an ex is ts Ye s: ☐ N o: ☐ W ha t i s t he b as is fo r t he s am pl e co lle ct io n? H ow m an y sa m pl es w er e co lle ct ed a nd an al ys ed ? I s i t a re pr es en ta tiv e sa m pl e si ze ? W ha t r at io na le a nd /o r d at a w er e us ed to in fo rm th e sa m pl in g st ra te gy . Sa m pl in g pl an Re po rt s o n la b an al ys is (p ro of o f la b an al ys is ) e xi st Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he la b an al ys is in cl ud in g th e TF A co nt en t i n th e sa m pl es . La b an al ys is re po rt s a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 23Annex 3. Revised application form (released in January 2024) Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 2. L ab el a na ly si s Po lic y on T FA la be lli ng e xi st s Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e TF A la be lli ng re gu la tio n, a nd d es cr ib e an y ex em pt io ns o r v ol un ta ry fe at ur es . Po lic y do cu m en t o n TF A la be lli ng Sa m pl in g pl an ex is ts Ye s: ☐ N o: ☐ W ha t i s t he b as is fo r t he s am pl e co lle ct io n? H ow m an y sa m pl es w er e co lle ct ed a nd an al ys ed ? I s i t a re pr es en ta tiv e sa m pl e si ze ? W ha t s te ps w er e ta ke n to v er ify th e ge ne ra l ac cu ra cy o f n ut rit io n la be ls , p ar tic ul ar ly in re sp ec t o f t ra ns fa t? Sa m pl in g pl an Re po rt s o n la be l an al ys is e xi st Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he la be l a na ly si s i nc lu di ng th e TF A co nt en t i n th e sa m pl es . P le as e in di ca te th e % o f p ro du ct s d ec la rin g TF A co nt en t. La be l a na ly si s r ep or ts a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 24 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation O pt io n B: In sp ec ti on o f m an uf ac tu ri ng fa ci lit ie s a nd a t p or ts o f e nt ry Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 3. C he ck in g do cu m en ta ti on – a t m an uf ac tu ri ng fa ci lit ie s In sp ec tio n pl an ex is ts Ye s: ☐ N o: ☐ W ha t i s t he b as is fo r s el ec tin g th e fa ci lit ie s? H ow o fte n w er e th e in sp ec tio ns c ar rie d ou t? W er e th ey d on e as p ar t o f r eg ul ar in sp ec tio n or in de pe nd en tly ? W ha t i s t he n um be r an d pr op or tio n of fa ci lit ie s i ns pe ct ed fo r e ac h ye ar si nc e in sp ec tio n be ga n? W er e th e fa ci lit ie s i ns pe ct ed re m ot el y? In sp ec tio n pl an Re le va nt do cu m en ta tio n an d/ or p ra ct ic e w as e xa m in ed a t m an uf ac tu ri ng fa ci lit ie s Ye s: ☐ N o: ☐ W ha t t yp es o f d oc um en ts a nd p ra ct ic es w er e ex am in ed (e .g . d oc um en ts : r ec ei pt s, re co rd s, in ve nt or y, la be ls , l ab or at or y re po rt s, re ci pe s; p ra ct ic e: a ss es si ng if th e fa ct or ie s a re e ng ag ed in p ar tia l h yd ro ge na tio n) ? In sp ec tio n re po rt s In sp ec tio n re po rt s ex is t Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he fa ci lit y in sp ec tio n. In sp ec tio n re po rt s a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 25Annex 3. Revised application form (released in January 2024) Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 4. L ab or at or y an al ys is – a t m an uf ac tu ri ng fa ci lit ie s Va lid at ed la bo ra to ry m et ho d is u se d Ye s: ☐ N o: ☐ W ha t i s t he la b m et ho d us ed (e .g . W H O , A ss oc ia tio n of O ffi ci al A na ly tic al C ol la bo ra tio n (A O AC ), Am er ic an O il Ch em is ts ’ S oc ie ty (A O CS ), th e In te rn at io na l O rg an iz at io n fo r St an da rd iz at io n (IS O ))? La b m et ho d / p ro to co l In sp ec tio n pl an ex is ts Ye s: ☐ N o: ☐ W ha t i s t he b as is fo r s el ec tin g th e fa ci lit ie s? H ow o fte n w er e th e in sp ec tio ns c ar rie d ou t? W er e th ey d on e as p ar t o f r eg ul ar in sp ec tio n or in de pe nd en tly ? W ha t i s t he n um be r a nd pr op or tio n of fa ci lit ie s i ns pe ct ed p er y ea r s in ce in sp ec tio ns b eg an ? Sa m pl in g pl an Re po rt s o n la b an al ys is (p ro of o f la b an al ys is ) e xi st Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he la b an al ys is in cl ud in g th e TF A co nt en t i n th e sa m pl es . La b an al ys is re po rt s a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 26 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 5. C he ck in g do cu m en ta ti on – a t p or ts o f e nt ry In sp ec tio n pl an ex is ts Ye s: ☐ N o: ☐ H ow o fte n w er e th e in sp ec tio ns c ar rie d ou t? H ow m an y pr od uc ts w er e in sp ec te d ea ch ye ar si nc e in sp ec tio ns b eg an ? W ha t i s t he p ro po rt io n of p ro du ct s i ns pe ct ed ? In sp ec tio n pl an Re le va nt do cu m en ta tio n an d/ or p ra ct ic e w as e xa m in ed a t po rt s o f e nt ry Ye s: ☐ N o: ☐ W ha t t yp es o f d oc um en ts w er e ex am in ed a t p or ts o f e nt ry (e .g . b ill s o f l ad in g, ta riff a nd cu st om s d ec la ra tio ns ) o r b ef or e en tr y (e .g . i m po rt re gi st ra tio n su bm itt ed b y im po rt er s, ce rt ifi ca te o f c on fo rm ity , l ab or at or y an al ys is re po rt )? In sp ec tio n re po rt s In sp ec tio n re po rt s ex is t Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he fa ci lit y in sp ec tio n. In sp ec tio n re po rt s a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 27Annex 3. Revised application form (released in January 2024) Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 6. L ab or at or y an al ys is – a t p or ts o f e nt ry Va lid at ed la bo ra to ry m et ho d is u se d Ye s: ☐ N o: ☐ W ha t i s t he la b m et ho d us ed (e .g . W H O , A ss oc ia tio n of O ffi ci al A na ly tic al C ol la bo ra tio n (A O AC ), Am er ic an O il Ch em is ts ’ S oc ie ty (A O CS ), th e In te rn at io na l O rg an iz at io n fo r St an da rd iz at io n (IS O ))? La b m et ho d / p ro to co l Sa m pl in g pl an ex is ts Ye s: ☐ N o: ☐ W ha t i s t he b as is fo r t he s am pl e co lle ct io n? H ow m an y sa m pl es w er e co lle ct ed a nd an al ys ed ? I s i t a re pr es en ta tiv e sa m pl e si ze ? Sa m pl in g pl an Re po rt s o n la b an al ys is (p ro of o f la b an al ys is ) e xi st Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he la b an al ys is in cl ud in g th e TF A co nt en t i n th e sa m pl es . La b an al ys is re po rt s a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 28 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) Q 7. L ab el a na ly si s – a t p or ts o f e nt ry Po lic y on T FA la be lli ng e xi st s Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e TF A la be lli ng re gu la tio n, a nd d es cr ib e an y ex em pt io ns o r v ol un ta ry fe at ur es . Po lic y do cu m en t o n TF A la be lli ng Sa m pl in g pl an ex is ts Ye s: ☐ N o: ☐ W ha t i s t he b as is fo r t he s am pl e co lle ct io n? H ow m an y sa m pl es w er e co lle ct ed a nd an al ys ed ? I s i t a re pr es en ta tiv e sa m pl e si ze ? H ow m an y po rt s o f e nt ry a re th er e an d ho w m an y w er e in cl ud ed in th e sa m pl in g pl an ? Sa m pl in g pl an Re po rt s o n la be l an al ys is e xi st Ye s: ☐ N o: ☐ Pl ea se p ro vi de a b rie f d es cr ip tio n of th e re su lts o f t he la be l a na ly si s i nc lu di ng th e TF A co nt en t i n th e sa m pl es . P le as e in di ca te th e am ou nt s o f T FA in e ac h pr od uc t an d in di ca te th e ov er al l % o f p ro du ct s d ec la rin g TF A co nt en t a nd th e % o f p ro du ct s de cl ar in g no n- co m pl ia nt T FA c on te nt . La be l a na ly si s r ep or ts a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. 29Annex 3. Revised application form (released in January 2024) II. E nf or ce m en t s ys te m Ch ec kl is t (“ Ye s” m ea ns a su pp or tin g do cu m en t is p ro vi de d) Pl ea se p ro vi de a b ri ef d es cr ip ti on Do cu m en ta ti on a (P le as e sp ec ify th e do cu m en t t itl e an d th e ex ac t se ct io n or p ag e of th e re le va nt in fo ) A sy st em at ic tr ac ki ng o f in sp ec tio ns a nd off en ce s i s i n pl ac e* Ye s: ☐ N o: ☐ Ar e in sp ec tio n re po rt s o f t ra ns fa t l ev el s a nd d es ig na tio n of w he th er th ey a re n ot co m pl ia nt w ith th e re gu la tio n co m pi le d in a d at ab as e, w eb si te o r r ep or ts ? Da ta ba se , w eb si te , r ep or ts Ri sk -b as ed in sp ec tio ns a re co nd uc te d* Ye s: ☐ N o: ☐ W er e hi gh -r is k fo od c at eg or ie s, b r ep ea t o ffe nd er s, fa ci lit ie s w ith a bi lit y fo r p ar tia l hy dr og en at io n in sp ec te d (e .g . h yd ro ge ne ra tio n to w er s) ? Pe na lti es to vi ol at io ns a re in pl ac e* Ye s: ☐ N o: ☐ W ha t a re th e pe na lti es a ut ho riz ed b y la w ? H ow m an y tim es w er e va rio us p en al tie s ac tu al ly im po se d on s el le rs o f h ig h tr an s- fa t f oo ds ? Vi ol at io n re po rt s a Ex pe ct ed d oc um en ta tio n is in di ca te d as a n ex am pl e. b Fo r e xa m pl e, b ak in g fa ts (e .g . s ho rt en in g) ; c oo ki ng /f ry in g oi ls ; v eg et ab le g he e, s pr ea ds (e .g . m ar ga rin e) ; b ak ed g oo ds (e .g . b is cu its , c ak es , p as tr ie s, d ou gh nu ts ); ba ke d sn ac ks ; n on -d ai ry c re am er ; co nf ec tio na rie s; fr ie d en tr ee s; fr ie d sn ac ks ; f ro ze n fo od s. 30 Report of the first series of meetings of the Technical Advisory Group on Trans Fat Elimination and Validation O th er re le va nt in fo rm at io n (o pt io na l) De sc rib e an y ot he r r el ev an t i nf or m at io n re ga rd in g im pl em en ta tio n, m on ito rin g an d en fo rc em en t o f t he p ol ic y th at m ig ht b e re le va nt to th e TF A va lid at io n ap pl ic at io n. D es cr ib e an y eff or ts to m on ito r a gg re ga te tr an s f at le ve ls in th e ty pi ca l d ie ts o f n at io na l p op ul at io ns a nd v ul ne ra bl e or d is pr op or tio na te ly e xp os ed su b- po pu la tio ns . D es cr ib e an y eff or ts a nd fin di ng s o f a gg re ga te tr an s f at c on su m ed b y an al ys in g re pr es en ta tiv e sa m pl es o f b lo od o r h um an b re as t m ilk .

For more information, please contact: Department of Nutrition and Food Safety World Health Organization Avenue Appia 20, CH-1211 Geneva 27, Switzerland Email: nfs@who.int https://www.who.int/teams/nutrition-and-food-safety