WHO Publishes Safety Assessment of Arsenic as a Food Contaminant: JECFA 101st Meeting Monograph

Key Summary

The World Health Organization (WHO) has published the monograph of the 101st meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) on the safety assessment of arsenic as a contaminant in food. The assessment updates toxicological data, dietary exposure estimates and dose-response analyses for inorganic arsenic and organic arsenic compounds, providing a scientific basis for food safety risk management. Although the subject matter is food safety, it may indirectly affect contamination control requirements for raw materials and processes in medical device manufacturing.

Source and Applicability

• Source organisation: WHO Publications – Medical Devices
• Original publication date: 24 July 2026
• Article publication date: 27 July 2026
• Source: WHO Publications – Medical Devices, https://www.who.int/publications/i/item/9789240123632

This article is based on publicly available information from WHO Publications – Medical Devices. Specific requirements remain subject to the latest official publications of the relevant regulatory authorities.

Full Translation of the Core Content

This monograph presents the safety assessment of arsenic as a contaminant in food undertaken by the 101st meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). At the request of the Codex Committee on Contaminants in Foods, the assessment updates previous JECFA evaluations, taking into account inorganic arsenic and a range of small and complex organic arsenic compounds, on the basis of original studies, submitted data and the relevant scientific literature.

The publication reviews biochemical and toxicological data, human observations, methods for arsenic speciation analysis, transfer from animal feed to food, sampling protocols and the effects of processing. It also examines preventive and control measures, levels and patterns of contamination in food commodities, drinking water and breast milk, and dietary exposure estimates from a number of countries and regions. Dose-response analyses were conducted for inorganic arsenic, dimethylarsenate and monomethylarsenate, and the publication includes the Committee's evaluations and recommendations, providing a scientific basis for food safety risk assessment and risk management.

What This Information Means for Medical Device Manufacturers

For updates of this kind published under WHO Publications – Medical Devices, companies should first determine whether the information concerns regulatory policy, guidance and standards, recall and safety, product performance, quality systems or post-market surveillance. Different categories of information have different implications for registration pathways, technical documentation, labelling and instructions for use, risk management and market maintenance, and should not simply be treated as general industry news.

For Chinese medical device manufacturers, the priority is to convert the news into executable compliance actions: confirm whether similar products, similar technology routes or similar risk points are involved; check whether existing documentation still supports the requirements of the target market; and, where necessary, update risk management, performance verification, clinical evaluation, labelling and instructions for use, distributor communications and post-market surveillance records.

Which Documents Should Companies Review First?

Priority should be given to the intended use of the product, the basis for classification, ISO 13485 quality system evidence, risk management files, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, authorisation documents and existing registration certificates.

Common Risks

• Unclear classification rationale
• Incomplete evidence chains in the technical documentation
• Labelling and instructions for use not localised for the target market
• Unclear responsibilities of the authorised representative
• Insufficient arrangements for post-market maintenance

AIMEILI Regulatory Interpretation

This publication was issued by WHO and addresses the safety assessment of arsenic as a food contaminant. Although it is not directly related to medical devices, AIMEILI's regulatory team notes that medical device manufacturers should monitor global regulatory trends in the control of hazardous substances such as arsenic. In medical device manufacturing, raw materials, water systems and the processing environment may carry arsenic contamination risks, and companies should refer to comparable assessment methodologies when establishing internal monitoring mechanisms. At the same time, risk assessment frameworks used in the food safety field offer useful reference points for the biocompatibility evaluation of medical devices. However, this content does not constitute core information on medical device registration or market access, and companies should focus their efforts on medical device regulatory updates that are directly relevant to them.

From the perspective of international medical device registration practice, information of this kind published under WHO Publications – Medical Devices should not be read simply as ordinary news. Companies should first determine whether it concerns regulatory policy, guidance and standards, product approvals, recall and safety, quality systems or post-market surveillance, because each category triggers different internal actions. Where a company is progressing a registration project in a relevant market, the update should be entered into the target-market regulatory tracking table to confirm whether it affects product classification, the registration pathway, the applicant entity, local agent responsibilities or certificate maintenance arrangements.

For Chinese medical device manufacturers, the direct impact of this WHO publication on the safety assessment of arsenic in food will usually be seen in documentation consistency and evidence chain management. Companies should review existing technical files, risk management reports, performance verification data, clinical evaluation or clinical evidence, labelling and instructions for use, quality system certificates and post-market surveillance documents to confirm that they still support the latest regulatory expectations of the target market. Where the information relates to safety notices, recalls, product approvals or regulatory meetings, companies should also assess whether similar products, similar technology routes or similar risk points are likely to attract particular scrutiny from reviewers.

Business Impact and Recommended Actions

At the operational level, AIMEILI recommends three actions. First, record the official source link, publication date, applicable product scope and potentially affected areas in the regulatory tracking log. Second, have regulatory affairs, quality, R&D and sales jointly determine whether labelling, instructions for use, clinical evaluation, risk management or test reports need to be updated. Third, where a product is already marketed locally or a registration application has already been submitted, assess in parallel whether the local agent, importer, distributor and after-sales team need to take communication, change notification, supplementary clarification or post-market surveillance measures.

The value of this type of news lies not simply in knowing what a regulator has published, but in translating public information into executable compliance actions. For companies preparing multi-country registrations, particular attention should be paid to the boundaries of document reuse across markets: the same set of CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one country while requiring localised explanations, language-specific labelling, authorised representative documents or a post-market maintenance plan in another. AIMEILI recommends that, after each significant regulatory update, companies carry out a brief documentation gap review to avoid finding themselves on the back foot during deficiency responses, change notifications or certificate renewals.

FAQ

Can the WHO publication on the safety assessment of arsenic in food be used directly as a basis for a regulatory submission?

No. This publication cannot be used directly as a basis for a medical device registration submission; it is intended for preliminary understanding and project assessment, and formal submissions must still be based on the latest requirements of the target country's regulatory authority, the concluded product classification and the company's own documentation.

What should companies do first when they become aware of this type of update?

Companies should carry out a documentation gap assessment first, to confirm whether the update affects the registration pathway, technical documentation, labelling, quality system or post-market maintenance, and should record the outcome in the regulatory tracking log before deciding on any change actions.

Content Review and Scope of Application

• Author: AIMEILI Regulatory Editorial Team
• Professional review: AIMEILI Medical Device International Registration Project Team
• Source principles: Priority is given to official regulatory authorities, international organisations, standards organisations and publicly available regulatory materials; industry media and project experience are used only as supporting references.
• Scope of application: This article is intended for preliminary understanding, documentation preparation and project planning, and does not replace the formal requirements of the target country's regulatory authority, testing conclusions or legal advice.

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