ISO_NWIPs-for-Ballot

Co-ordination of work: To the best of your knowledge, has this or a similar proposal been submitted to another standards development organization?

If “Yes”, please specify which one(s): Yes No

Presently, there are many kinds of ISO standards regarding quantification by using of NMR, but they are no work item and published standard describing requirements regarding the application of qNMR to ensure metrological traceability for the measurement of food related substances. A statement from the proposer as to how the proposed work may relate to or impact on existing work, especially existing ISO and IEC deliverables. The proposer should explain how the work differs from apparently similar work, or explain how duplication and conflict will be minimized. A listing of relevant existing documents at the international, regional and national levels. Related official methods, technical documents, etc. are shown below. 1. General chapter of the United States Pharmacopoeia (USP): Quantitative method is described in the commentary of NMR. 2. European Federation of National Associations of Measurement, Testing and Analytical Laboratories (EUROLAB) issues Guide to NMR Method Development and Validation - Part I: Identification and Quantification. 3. Bureau international des poids et mesures (BIPM) has published ISRD (qNMR Internal Standard Reference Data). 4. Quantitative methods are described in general chapter of NMR in the China Pharmacopoeia. National level documentsJapan Japan’s Standards are listed as follows, these methods are mandatory for standard materials of chemical compounds such as food additives and pharmaceuticals. 1. Japan’s Specifications and Standards for Food Additives (JSFA), under the Food Sanitation Act in Japan. 2. The Japanese Pharmacopoeia (JP) 17th under the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices 3. Japanese Industrial Standards (JIS) specifies the standards used for industrial activities in Japan. Please fill out the relevant parts of the table below to identify relevant affected stakeholder categories and how they will each benefit from or be impacted by the proposed deliverable(s).

Benefits/impacts

Examples of organizations / companies to be contacted

Industry and commerce large industry

Confidentially self-made reference material and analysis that is SI- traceable using FT-NMR instrument

- Eurofins - Nestlé Ltd. - PepsiCo, Inc - Unilever N.V.

Industry and commerce SMEs

Confidentially self-made reference material and analysis that is SI- traceable using FT-NMR instrument

-Spectral Service AG -DSM Nutritional Products -Sigma-Aldrich

Government

Supply RM/CRM, especially organic compounds

-JRC -FDA -TFDA -AIST

Consumers

By supplying standard substances, it is possible to obtain foods that safety has been confirmed.

General consumers

FORM 4 – New Work Item Proposal Version 06/2018