Title: Formulating the regulatory framework for the pre-market approval of novel food in Malaysia

Authors: Nor Akhmal Hasmin; Sayidah Asma Basir; Anida Mahmood; Juan Matmin; Vita Cita Emia Tarigan

Addresses: Faculty of Law, UiTM Shah Alam, Selangor, Malaysia ' Faculty of Law, UiTM Shah Alam, Selangor, Malaysia ' Faculty of Law, UiTM Shah Alam, Selangor, Malaysia ' Department of Chemistry, Faculty of Science, University Teknologi Malaysia, 81310 UTM Johor Bahru, Malaysia ' Faculty of Law, Universitas Sumatera Utara, Indonesia

Abstract: Novel foods and novel food ingredients are being introduced in the market to strengthen global food security. However, most of the novel foods lack a history of safe use, due to the novel characteristics and lack of consumptions. Despite the safety concerns, novel foods in Malaysia are not subject to pre-market approval, hence, exposing consumers to potential adverse effects on safety and health. Through a doctrinal analysis, this study critically analyses the pre-market approval for novel food requirements and procedures adopted by the food safety authority in the European Union, Australia New Zealand, and the People's Republic of China. It is to identify the key elements that must be embodied in the legislative framework for pre-market approval of novel food in Malaysia. This study finally suggests some regulatory recommendations on pre-market approval for novel food in Malaysia to strengthen the food safety and food security provisions in Malaysia.

Keywords: food security; food safety; novel foods; pre-market approval; regulatory framework; Malaysia.

DOI: 10.1504/IJPLAP.2025.149435

International Journal of Public Law and Policy, 2025 Vol.11 No.4, pp.373 - 390

Received: 23 Dec 2023
Accepted: 31 Jan 2024
Published online: 31 Oct 2025 *

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