Review of the regulation and safety assessment of food substances in various countries and jurisdictions

Abstract

This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.

Emerging trends in European food, diets and food industry

“…In addition, because toxicity is specific for different nanoparticles, a safety and environmental assessment must be performed on a case by case basis (Handfordet al, 2014). Recent evidence do not allow to build a sounds science-based regulatory framework, and thus there are currently no specific regulations on nanotechnology food applications either in EU, USA or elsewhere, (Coles & Frewer;Magnuson et al, 2013). In addition, there is a lack of universal guidelines specifically developed for the safety and environmental assessment of nanotechnology food applications, even though experts from around the globe are working in bringing an international dimension and harmonization to "nanometrology" and standardization of approaches (Magnuson et al, 2013;Schoonjans & Chaudhry, 2017).…”

“…Recent evidence do not allow to build a sounds science-based regulatory framework, and thus there are currently no specific regulations on nanotechnology food applications either in EU, USA or elsewhere, (Coles & Frewer;Magnuson et al, 2013). In addition, there is a lack of universal guidelines specifically developed for the safety and environmental assessment of nanotechnology food applications, even though experts from around the globe are working in bringing an international dimension and harmonization to "nanometrology" and standardization of approaches (Magnuson et al, 2013;Schoonjans & Chaudhry, 2017). However, the current lack of clear governance framework and consequent regulatory uncertainty makes it difficult for developers and manufacturers to know what, if any, regulations should be complied with, and what risk assessments, if any, are appropriate.…”

Comparison of food colour regulations in the EU and the US: a review of current provisions

“…More recently, as regulatory transparency and harmonisation have become a topic in trade agreement negotiations between developed countries like the Transatlantic Trade and Investment Partnership (TTIP) between the European Union (EU) and the US, some studies comparing EU and US food legislation have been published and overviews of specific aspects of both can be found in the literature (Magnuson et al 2013;Baumgartner & Uebe 2014;Wilhelms 2014;Scotter 2015;Stich 2016). The objective of this review is to focus on regulation of colour additives, contrasting food colour regulations in the EU and US, to highlight the most important differences, to elucidate underlying issues and to suggest ways to increase regulatory coherence.…”

“…As trade is becoming more global, sourcing from across continents, regional and national regulations may become trade barriers that increase the transaction costs, more specifically the regulatory compliance costs, leading to economically negative effects. Beyond the economic aspects, technical barriers may impede using globally all available foods through free trade to reduce hunger and poverty (Magnuson et al 2013).…”

Risk assessment of reproductive and developmental toxicity in eye-drop drugs: a consideration based on threshold of toxicological concern

“…Currently, the TTC approach in evaluating DART is employed in food safety (Magnuson et al, 2013). While, for developing pharmaceuticals, the risk assessment using TTC is employed in assessment of mutagenic impurities for carcinogenic risk currently (ICH, 2014).…”