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The development of regulations for food nanotechnology

Foods that may contain nanomaterials or otherwise involve the application of nanotechnology are generally governed by existing national and/or regional legislative and regulatory frameworks, and in some cases more...

The development of regulations for food nanotechnology

Published on: 25/11/2021

Foods that may contain nanomaterials or otherwise involve the application of nanotechnology are generally governed by existing national and/or regional legislative and regulatory frameworks, and in some cases more than one organization is responsible for statutory implementation. But there is currently no piece of legislation entirely dedicated to regulation of NMs, neither in the EU nor in any other country.
Recommendation from the European Union on the definition of a nanomaterial (accessible online at: https://bit.ly/3xnjG64), also see Communication from the Commission to the European Parliament, The Council and the European Economic and Social Committee, the Second Regulatory Review on Nanomaterials here https://bit.ly/3l6WIeW, published statements on nanotechnology relevant to foods that may include working definitions for nanomaterials. But the variations in the type, nature, and extent of the review process depend on the statutory authority governing the food substance/product and its regulatory status in different countries. In this prospective, in Eurasia, only France, by Grenelle II Law, Decree n° 2012-232, Order of 6 august 2012, establishes a system of compulsory declaration for all nanomaterials relevant to food products. And for the pharmaceutical products, the French Ministry of Environment / General Directorate for Risk Prevention / Department of chemical products, diffuse pollution and agriculture, European Commission, European Medicines Agency, establish a system of compulsory declaration for all manufactured nanomaterials.

Russian federation by Federal Law of 21 of November, 2011, on the Fundamentals of Protection of the Public Health” and others, Implements the following provisions, among others: Methods of classification of products and Nano industry technologies in terms of their potential danger; Guidelines on selection order for the for the nanomaterials control sampling; Control for nanomaterials applied in food products, used in the chemical industry, in packaging materials, and applied in agriculture; and various testing for nanomaterials in the tissues of animals and plants.
Also, the Russian Federal Service for Surveillance on Consumer Rights Protection and Human Well-being, Ministry of Health and Social Development of the Russian Federation by Federal Law of 12 April, 2010 N 61-FZ on the Circulation of Medicines (with amendments of 27 July, 11 October, 29 November 2010, 6 December 2011, controls all pharmaceuticals and medical purpose products, irrespective of use/non-use of nanotechnology components in its composition. The control over medical products, manufactured using nanotechnologies is performed in the form of state registration by an authorized Russian Federation state agency, also in the form of licensing the manufacture of appropriate products.
A number of government-sponsored regulatory science research and other research programmes, infrastructure, and institutions support foods product evaluations as well as research and development applications. Six areas of multilateral interest include metrology and analytical methods, toxicology research, exposure science, pathogen detection, nutrient bioavailability and efficacy, and food preservation.

Active government-sponsored regulatory science research and other research programmes, institutions, and infrastructures are on-going and target specific areas of inquiry (e.g. Metrology and Analytical Methods). The need for additional guidance to assess the potential risk and for recommendations to ensure the safe use of NMs has been identified, and several expert bodies are active in this field, such as the EU Scientific Committees and Agencies, the Organization for Economic Cooperation and Development (OECD), the International Standard Organization (ISO) or the US Food and Drug Administration (FDA). Relevant regulatory issues to be considered for NMs include a definition of the term “nanomaterial”, registration or authorization procedures, specific information requirements for risk assessment, risk management and provisions to increase the transparency and traceability on the commercial use, by e.g. labelling or by notifying to a register for products containing NMs.

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