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

Bernadene Magnuson; Ian Munro; Peter Abbot; Nigel Baldwin; Rebeca Lopez-Garcia; Karen Ly; Larry McGirr; Ashley Roberts; Susan Socolovsky

doi:10.1080/19440049.2013.795293

. 2013 Jun 20;30(7):1147–1220. doi: 10.1080/19440049.2013.795293

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

Bernadene Magnuson ^a,^∗, Ian Munro ^b, Peter Abbot ^c, Nigel Baldwin ^b, Rebeca Lopez-Garcia ^d, Karen Ly ^b, Larry McGirr ^b, Ashley Roberts ^b, Susan Socolovsky ^e

PMCID: PMC3725665 PMID: 23781843

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.

Keywords: food additives, novel food, food contact substances, flavouring agents, enzymes, processing aids, nanoscale materials, regulatory framework

Introduction

The purpose of this review is to present an overview and comparison of the regulation of substances added to foods in a number of different countries/jurisdictions, as well as the efforts of internationally recognised scientific and advisory bodies, such as the Codex Alimentarius Commission (CAC) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) with respect to the safety assessment of these substances.

The specific countries/jurisdictions addressed are Argentina, Australia, Brazil, Canada, China, the European Union (EU), Japan, Mexico, New Zealand, and the United States (herein referred to as the “target countries”). The choice of jurisdictions to be included was based on a number of factors, and was intended to include both of well-established and emerging regulatory systems. The substances added to human food that are included in this review are direct food additives, common food ingredients such as sugar, food contact materials, flavouring agents, food enzymes, and/or processing aids. In addition, information pertaining to the development of regulations for nanomaterials falls under the scope of this review. Pesticide residues, drug residues or contaminants (e.g. lead) are not addressed in detail. A full list of included substances and their definitions according to each target country is provided. It should be noted that regulatory information for each country may be updated frequently and this report was written as an overview of the regulatory framework for each country. To the best of our knowledge, regulatory information is current as of June 2012. It is recognised that the definitions of terms used in this document may vary by organisation.

International scientific and advisory committees

The Food and Agriculture Organization (FAO) and the World Health Organization (WHO) established the CAC jointly in 1962 to address safety and nutritional quality of foods, and develop international standards to promote trade (Codex Alimentarius Commission 2006). The CAC is an intergovernmental body composed of delegations from FAO and WHO member states that participate in developing food standards. The CAC develops standards on the basis of sound scientific evidence provided by independent FAO/WHO scientific committees. JECFA, established prior to the CAC in 1956, is the oldest and most active of these. Primary roles of the CAC include establishing international food standards for approved food additives providing maximum levels in foods, maximum limits for contaminants and toxins, maximum residue limits for pesticides and for veterinary drugs used in veterinary animals, and establishing hygiene and technological function practice codes (Codex Alimentarius Commission 2006). The collection of these standards, codes of practice, guidelines and recommendations, constitute what is known as the Codex Alimentarius, a substantial and useful reference. While the standards set by the CAC serve as guidelines to nations, the CAC has no regulatory authority and their standards are not enforceable unless they have been adopted into the regulatory framework for a nation or otherwise indicated (Codex 2011). For example, the World Trade Organization (WTO) refers to the Codex Alimentarius Sanitary and Phytosanitary practice codes in the SPS Agreement for member country food safety purposes.

Expert scientific advice is provided to the CAC by JECFA. Independent scientific committee members are appointed as experts in their own right and not as representatives of their governments or employers. Initially developed by WHO and FAO to address the safety of food additives, JECFA also has extended its activities to evaluate the safety of contaminants and veterinary drug residues in food. Although the outcome of JECFA's evaluations does not have any direct bearing on the regulatory approval of use of a food additive in any specific country, its evaluations are widely recognised and may affect an application for approval for a new food additive in a particular country.

The Joint FAO/WHO Committee on Food Additives (JECFA)

The initial steps of the Committee were to establish general principles regarding the technical purpose of food additives as well as principles for safe use for these substances. Regarding the matter of technical purpose the Committee noted that food additives could serve a valuable technical function in food: (1) to maintain the nutritional quality of food; (2) to enhance keeping quality or stability, with resulting reductions in food wastage; (3) to make food attractive to consumers; and (4) to provide essential aids to processing.

The Committee established the following situations in which food additives should not be used: (1) to deceive the consumer; (2) to result in substantial reduction of the nutritional value of food; (3) when the desired effect can be obtained by good manufacturing practices; or (4) to disguise the use of faulty processing or handling techniques.

With respect to safety evaluation of food additives the Committee again established sound key general principles. They were: (1) it is impossible to establish absolute proof of non-toxicity for all members of the human population; (2) critically designed animal studies can provide a reasonable basis for evaluating the safety of food additives; (3) the decision as to a safe level for a food additive should be based on knowledge of the minimum dietary level that produces no unfavourable response in test animals; (4) decisions on the use of food additives must be based on the considered judgment of properly qualified scientists that the intake of the additive will be below any level which could be harmful to consumers; (5) the fate of the additive during food processing and preparation should be considered because of the possible formation of toxic substances and interaction of the food additive with components of food or other food additives; and (6) consideration should be given to groups within the population who for medical reasons may be especially vulnerable to certain food additives. The Committee went on to recommend that when a food additive is proposed for use, considerations should be given:

to determine if there is a demonstrated benefitto consumers;
to limit the use of food additives in the diets of infants and young children;
to assess whether there are adequate data to derive specifications for identify and purity of the food additive; and
to limit the level of use of food additives to the minimum required to achieve the desired technical effect.

The Committee also noted that permitted lists of food additives should be drawn up because the use of prohibited lists could entail several years of exposure to potentially harmful food additives before sufficient evidence was accumulated to place it on the prohibited list. The use of permitted lists would eliminate this danger. The Committee also agreed with the principle that consumers should be made aware of the presence of food additives in their food and noted that label declaration is the most effective method of achieving this result. With respect to regulatory control at the national level, the Committee noted that methods must be available to measure food additives in foods and that enforcement of levels of use through appropriate food legislation provided a reliable way of governing the use of food additives.

JECFA also established principles and procedures for the testing of food additives to establish the safety of food additive use (JECFA 1958). The Committee noted that food additives may be consumed over a substantial proportion of lifetime and emphasised the need for studies in appropriate animal species that would reflect the conditions of human exposure. The Committee further noted that no single pattern of tests could adequately cover the testing requirements of substances of such diverse structure and function as food additives and therefore the Committee strongly emphasised that the establishment of a uniform set of experimental procedures that would be standardised and obligatory was undesirable. For this reason, which still holds true today, the Committee decided that it was only possible to formulate general recommendations on testing procedures.

The general principles regarding the testing of food additives were identified including: (1) the selection of animal species for testing indicating that background information on species/strain, natural disease rates, tumour incidence, and duration of life was essential for proper interpretation of experimental results; (2) the importance of animal housing, diets, control groups and statistical procedures for the design of studies, and their interpretation; (3) the importance of dose selection emphasising the need to magnify the dose in experimental animals to overcome statistical limitations of the test design and to provide a means of studying dose-response relationships; (4) the need for biochemical mechanistic investigations to detect subtle physiological changes and to assist in data interpretation; and (5) the need to examine the potential for food additives to induce carcinogenesis, stating that no proven carcinogen should be considered suitable for use as a food additive in any amount (JECFA 1958). The results of the toxicological evaluations are the basis for the allocation of an acceptable daily intake (ADI) or tolerable intake for contaminants the Committee considered unavoidable.

The Committee also discussed the pivotal issue relating to the extrapolation of animal studies to humans noting that in most instances a dosage level can be identified that causes no demonstrable effect in animals. It also noted that a margin of safety of 100 could be applied in extrapolating animal data to humans to account for species differences in susceptibility, numerical differences in population ranges between the test animals and the human population, the greater variety of complicating disease processes in the human population, and the possibility of synergistic action among food additives. The Committee noted that application of a 100-fold margin of safety would limit the use of some food additives yet was an adequate margin of safety for most substances proposed for use as food additives at the time.

Additionally, the Committee established specifications for the identity and purity of food additives. From the viewpoint of industry the specifications of the substance/compound helped define suitability for use in food. Items included in the specifications document were: title or name in common usage; synonyms; chemical name (IUPAC); empirical (organic compounds) or chemical formula (inorganic compounds); structural formula; molecular weight; definition (percentage of the stated substance that should be present origin of the material if necessary); description (appearance, taste, odour and other general properties); identification tests; and purity tests (tests for impurities and their nature).

In the early 1990s the CAC recognised the need to formalise the risk analysis process. A definition of risk analysis was developed, through a series of consultations, that embodies risk assessment, risk management and risk communication (CAC 2005). Scientific committees such as JECFA are responsible for risk assessment, which includes hazard identification, hazard characterisation, exposure assessment and risk characterisation. In response to formalisation of the risk assessment process, JECFA has increased its emphasis on exposure assessment, which includes predicted intake for substances new to the market or for which few relevant data exist and estimated intake of food additives and contaminants for which sufficient information exists for such an analysis. Within each jurisdiction, responsibility for each of the three components of risk analysis is often divided among different divisions of the regulatory agencies or to separate bodies. For example, in the EU, the Directorate General for Health and Consumers has risk management responsibility whereas the European Food Safety Authority (EFSA) is an independent body with risk assessment and risk communication responsibilities. Further discussion of the process of risk analysis of components in foods, including risk management and risk communication, is outside the scope of this review.

When one looks back at this early work of the Committee, it is clear that JECFA has played a leading role in setting the worldwide agenda for how food additives, contaminants and adventitious substances in food should be evaluated. Although these deliberations occurred 50 years ago, the general principles and procedures elaborated by JECFA in early meetings have stood the test of time and are still used by the Committee at the present time. The credit for this lies with the early Committee members most of whom were outstanding research scientists and widely recognised experts in their discipline. The early work of JECFA also brought harmonisation of the approach to safety assessment of food additives on a worldwide basis. This resulted in a tremendous advantage to national governments that looked to JECFA for guidance and continue to do so. There can be no doubt that JECFA is the preeminent body dealing with food safety issues internationally.

The International Programme on Chemical Safety (IPCS)

The International Programme on Chemical Safety (IPCS) is a joint venture of the United Nations Environment Programme (UNEP), the International Labour Organisation (ILO), and the WHO. The main objective of the IPCS is to carry out and disseminate evaluations of the effects of chemicals on human health and the quality of the environment. In 1987, in response to numerous recommendations by JECFA, the IPCS convened a Task Force to review current knowledge and advances in toxicological science, and to develop criteria for testing and evaluation of the safety of food additives and contaminants. Thus, in 1987, the Environmental Health Criteria 70 (EHC70) was published, entitled Principles for the Safety Assessment of Food Additives and Contaminants in Food. This document was subsequently updated by the IPCS in 2009, with the publication of EHC240, entitled Principles and Methods for the Risk Assessment of Chemicals in Food (WHO 2009).

These guidelines provide a comprehensive current review of the key issues considered by JECFA during their risk assessments of food chemicals. Topics addressed include the risk assessment paradigm, chemical characterisation and specifications for food chemicals, toxicological studies used for hazard identification and characterisation, dose-response assessments, derivation of health-based guidance values such as ADI, assessment of dietary exposure to chemicals in food, risk characterisation, determination of maximum residue limits for pesticides and veterinary drugs, and approaches for assessment of specific groups of substances such as flavours and novel foods.

Regulations in different jurisdictions

To obtain an understanding of the global regulation of substances intentionally added to food, the regulatory systems and laws pertaining to their safety were reviewed and tabulated for ease of presentation and comparison. The countries that were chosen included: Argentina, Australia, Brazil, Canada, China, the EU, Japan, Mexico, New Zealand, and United States. These countries include both those with well-established regulatory systems (i.e. Australia, Canada, Japan, New Zealand, and the EU and US) and several that are currently in the process of changing and/or modernising their food regulatory systems (i.e. Argentina, Brazil, China and Mexico). Although it is acknowledged that there are many other jurisdictions that were worthy of inclusion in this review, limited resources required selection of those for which we had expertise in, and English versions or translations of regulations.

For each target country, the following information was sought and is summarised in table format (Tables 1–9):

Table 1.

Regulatory framework of chemicals added to food in Argentina.

Regulatory authority	Name: Ministry of Health (Ministerio de Salud) and The National Administration of Drugs, Foods, and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica – ANMAT) Website: Ministry of Health: http://www.msal.gov.ar/ (Ministerio de Salud 2011) ANMAT: http://www.anmat.gov.ar/alimentos/normativas_alimentos_caa.asp (ANMAT2010) Mercosur: http://www.puntofocal.gov.ar/mercosur_sgt_alimentos.htm (Mercosur 2010) Historical overview: ANMAT was created by Presidential Decree 1490/92 (ANMAT 1992) (http://www.anmat.gov.ar/webanmat/Legislacion/NormasGenerales/Decreto_1490-1992.pdf) Role/responsibility: ANMAT is a decentralised body of the National Public Administration, established by Decree 1490/92. It assists in the protection of human health, ensuring the quality of products within its jurisdiction: drugs, food, medical products, diagnostic reagents, cosmetics, dietary supplements and household products. Its jurisdiction covers the entire country. It was created in August 1992. Since then, a body of professionals and technicians work with modern technology effectively to implement the processes of authorisation, registration, regulation, monitoring and control products used in medicine, human food and cosmetics. It depends both technically and scientifically on the norms and directives given to it by the Secretary for Policies, Regulations and Institutions of the Ministry of Health, with a system of economic and financial autarchy. In this context, ANMAT's main objective is “to ensure that medicines, food and medical devices available to the population, have proven effectiveness (achieving the therapeutic, diagnostic or nutrition targets) safety (high ratio benefit/risk) and quality (responding to the needs and expectations of citizenship) …”a
Advisory scientific body	Name: National Committee of Food (CONAL) Website: http://www.conal.gov.ar (CONAL 2011) Historical overview: Created by Presidential Decree 815/99 (http://www.conal.gov.ar/Documentos/Decreto_815/815-99.htm) (CONAL 1999) Role/responsibility: CONAL functions as an advisory body that provides support and monitoring to the National Food Inspection System (Sistema Nacional de Control de Alimentos – SNCA), which enforces the Argentine Food Code (also known as Codigo Alimentario Argentino – CAA) (http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Food%20and%20Agricultural%20Import%20Regulations%20and%20Standards%20-%20Narrative_Buenos%20Aires_Argentina_12-22-2011.pdf) (USDA 2010a). CONAL reviews all the petitions for incorporation to the CAA of new ingredients, food additives and processing aids, as well as materials in contact with foods, etc. When pertinent because of harmonisation requirements with Mercosur, CONAL requests treatment of the matter at the Mercosur level.
Framework regulations	The CAA regulates local food production; however, as harmonised Mercosur regulations become available, the CAA incorporates those regulations into the CAA through Resoluciones Conjuntas issued by the Ministry of Health and the Ministry of Agriculture, Livestock and Fisheries (http://www.anmat.gov.ar/alimentos/normativas_alimentos_caa.asp). The CAA is a set of sanitary provisions, analytical standards and rules for commercial identification of products. It has more than 1400 articles divided into 20 chapters that include general provisions related to food factories and food trade, conservation and food processing, use of utensils, containers, packaging, standards for labelling and advertising of food, technical specifications of the different types of foods and beverages, processing aids, and food additives. Historical overview: The Argentine Food Code was put into force by Law 18,284, regulated by Decree 2126/71, of which Annex I is the text of CAA. It is a regularly updated technical regulation that establishes sanitary standards, analytical standards, and authenticity and quality standards to be complied by companies and individuals, production facilities, and food products that fall into their orbit. This legislation is primarily aimed at protecting the health of the population, and reliance in commercial transactions.
Part of an overarching international organisation	Argentina has been a member of the World Trade Organization since 1995. It is a member of the Codex Alimentarius Commission as well as a member of Mercosur.
Recent and/or pending changes	None known
Regulatory overview of specific food chemical groups
Food ingredients	Definition: As per GRUPO MERCADO COMUN (GMC) 26/03, food ingredients are defined as all substances, including the food additives, which are used in the manufacture or preparation of foods and which are present in the final product in its original or modifiedform. Novel foods: CAA does not define novel foods. Mercosur does not have a definition of novel foods either; however, novel foods are recognised in practice. Regulation: Currently, there are no novel food regulations in the CAA Guidance document: GMC 26/03 Approval process for a new substances (http://www.conal.gov.ar). New food ingredients, novel foods and food additives as well as any request for modification of the CAA should be done according to this guidance. However, if the product requested is considered a novel food in Europe, its inclusion will be delayed until the novel foods chapter of the CAA is written, approved and incorporated into the CAA.
Direct food additives	Definition: Food additives are defined according to GMC 26/03 as any ingredient that is added to foods intentionally, without intent to nurture, in order to modify the physical, chemical, biological or sensory characteristics of foods during its manufacture, processing, preparation, processing, packaging, conditioning, storage, transport or during food handling; it will have, or it can be reasonably expected to have (directly or indirectly) as a result, that the additive itself or its by-products become part of that food. This term does not include contaminants, or nutrients that are incorporated into a food in order to maintain or improve its nutritional properties. GMC 26/03 is currently under revision by the Sub Work Group #3 (SGT#3) Mercosur and a new Definition 2 continues to be discussed and should be gazetted during 2012. Regulation: GMC 11/06 – List of permitted food additives available in Spanish and Portuguese (http://www.mercosur.int/msweb/Normas/normas_web/Resoluciones/ES/GMC_2006_RES-011_ES_RTM-Aditivos%20Alimentarios.pdf) (Mercosur 2006) GMC 34/07 – List of food additives not permitted for use (http://www.puntofocal.gov.ar/doc/r_gmc_34-07.pdf) (Mercosur 2007)Two new regulations for Mercosur, GMC 34/10 and GMC 35/10; however, not all member states have adopted these regulations yet: GMC 34/10 – List of food additives according to good manufacturing practices (http://www.puntofocal.gov.ar/doc/r_gmc_34-10.pdf) GMC 35/10 – List of food additives permitted for use at maximum levels (http://www.puntofocal.gov.ar/doc/r_gmc_35-10.pdf) From the CAA: Article 2 of Decree §2092 of October 1991, states the following: all foods, condiments, beverages, or their raw material and food additives which are manufactured, fractioned, preserved, transported, sold or exposed, must comply with the CAA requirements. When one of those is imported, the CAA requirements will be applied. The Argentine Government also considers products from countries which have food controls comparable to those of Argentina, or when they use the Codex Alimentarius (FAO/OMS) standards, to be in compliance with Argentine standards. (http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Food%20and%20Agricultural%20Import%20Regulations%20and%20Standards%20-%20Narrative_Buenos%20AiresArgentina_12-22-2011.pdf) Guidance document: No authoritative guidance document found Approval process for a new substances: All food additives that are not listed in the GMC11/06 can be submitted for evaluation to CONAL who will then submit a request to the Mercosur Sub Work Group #3 to consider the revision of 11/06 and to proceed to its incorporation. Revision of GMC 11/06 is expected in 2013. Submissions dossier should be addressed to CONAL following the general guidelines set forth at: http://www.conal.gov.ar
Food contact substances (e.g. components of packaging materials)	Definition: According to GMC, food contact substances are defined as any primary container or primary wrapping or container (one that is in direct contact with food). Regulation: GMC 32/07. There is a positive list of substances (in Appendix 1 of regulation GMC 32/07) that are added to plastics to achieve a technical effect in the final product (additives) such as antioxidants, antistatic, foaming, defoaming, fillers, impact modifiers, plasticisers, lubricants, stabilisers, UV protectants, preservatives, hardeners, etc. Included within this list are the substances used to provide a suitable medium polymerisation (e.g. emulsifiers, surfactants, buffers pH, solvents). Guidance document: No authoritative guidance document found Approval process for a new substances: Same as direct food additives
Flavouring agents	Definition: Flavouring agents are substances or mixtures of substances with odoriferous and/or flavour properties that are able to confer or enhance the aroma and/or taste of food. For the purpose of this Technical Regulation, flavourings/flavourings are classified as either natural or synthetic Regulation: Under Mercosur, GMC 10/06. A specified list of flavouring agents (natural or synthetic), including colourants is permitted. Exclusions from the technical regulations include: Substances that give only sweet, salty or sour Substances and food products with odoriferous and/or sapid consumed without processing, with or without reconstitution Substances of plant or animal origin having inherent flavours/flavouring properties, where they are used as sources of flavourings Guidance document: No authoritative guidance document found Approval process for a new substances: Submission to CONAL and subsequent submission to Mercosur. General guidelines (http://www.conal.gov.ar)
Enzymes	Definition: Enzymes or enzyme preparations are defined as substances of animal, plant or microbial origin that act by promoting the desirable chemical reactions Regulation: CAA, Chapter XVI, Articles 1261, 1262 and 1263. Enzymes regulations are not harmonised in Mercosur Guidance document: No authoritative guidance document found Approval process for a new substances: General guidelines (http://www.conal.gov.ar)
Processing aids	Definition: A processing aid is any substance, excluding equipment and utensils, that is not consumed by itself as a food ingredient and which is intentionally used in the processing of raw materials, foods or ingredients, for a technological purpose during treatment or processing. It must be removed from the food or inactivated; the presence of traces of the substances or their derivatives may be admitted in the final product. Regulation: • GMC 18/93 Modification RES GMC 31/92 “Definición y Principios fundamentales referente a empleo de aditivos, ingredientes, coadyuvante de elaboración, contaminantes”. Resolución GMC No. 84/93, incorporated into the CAA by Resolución MSyAS No. 003 dated 11 January 1995 defines the functions of processing aids. Processing aids are not harmonised in Mercosur; the only harmonised regulation is GMC 84/93 which establishes the definitions of the functions of processing aids. Certain processing aids are listed under Chapter XVI of the CAA, but this list is not comprehensive. Guidance document: No authoritative guidance document found Approval process for a new substances: General guidelines (http://www.conal.gov.ar)
Nanoscale materials	Definition: No authoritative statement found Regulation: No authoritative statement found Guidance document: No authoritative guidance information found Approval process for a new substances: No authoritative statement found Efforts towards developing standards and regulations (Locascio et al. 2011): A Working Group for “the development of standards in the areas of health, safety and environmental aspects of nanotechnologies” (http://www.iram.org.ar/): methodologies and data quality analysis for risk assessment. El Centro Cientifico Tecnologico, Consejo Nacional de Investigaciones Cientificas y Tecnicas (CONICET) – Mendoza (Cientificas y Tecnicas (CONICET) – Mendoza (http://www.cricyt.edu.ar) developing assays for acute toxicity and distribution of nanostructured alumina in mammals and toxicity of nanostructured alumina in vertebrates.

Regulatory authority	Name: US Food and Drug Administration (USFDA) Website: http://www.fda.gov/Food/FoodIngredientsPackaging/default.htm Historical overview: Began as the Bureau of Chemistry, as part of the US Department of Agriculture in 1862 The Food and Drugs Act was passed in 1906 Bureau of Chemistry is split into the Food Drug and Insecticide Administration and the Bureau of Chemistry and Soils in 1927 Food Drug and Insecticide Administration is renamed the Food and Drug Administration in 1930 The Federal Food Drug and Cosmetic Act was passed in 1938 The Food Additives Amendment of 1958 was passed in 1958 http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm081229.htm Role/responsibility: Protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labelled Promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonise regulatory requirements, and achieve appropriate reciprocal arrangements Where appropriate, carry out its mission in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products
Advisory Scientific body	Name: USFDA Science Board and USFDA Food Advisory Committee Website: Science Board to the US Food and Drug Administration (Science Board): http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/default.htm Food Advisory Committee: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/default.htm Historical overview: Both the Science Board and the Food Advisory Committee were authorised by the Federal Advisory Committee Act (Pub. L. 92–463) passed in 1972. The Science Board was established on 26 June 1992. The Food Advisory Committee was established on 15 December 1991 (21 CFR §14.100) Role/responsibility: Science Board: Provides advice to the Commissioner and other appropriate officials on a wide variety of food and drug related issues including: specific complex scientific and technical issues important to the agency and its mission emerging issues within the scientific community keeping pace with technical and scientific developments, including in regulatory science agency research upgrading the agency's scientific and research facilities and training opportunities As of 2012, the Board is made up of a committee with a core of 21 voting members knowledgeable in fields including food science, safety, and nutrition; chemistry; pharmacology; toxicology; public health and epidemiology; international health and regulation; and nanotechnology. Food Advisory Committee: Provides advice to the Commissioner and other appropriate officials on emerging food safety, food science, nutrition, and other food-related health issues and may be tasked with making recommendations on matters including: broad scientific and technical food or cosmetic related issues the safety of new foods and food ingredients labelling of foods nutrient needs and nutritional adequacy and safe exposure limits for food contaminants As of 2012, the Committee consists of 17 standing members knowledgeable in the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, and other relevant scientific and technical disciplines
Framework regulations	Food and Drug Regulations: 21 CFR, Chapter 1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm)
Part of an overarching international organisation	The US has been a member of the Codex Alimentarius Commission since it was established in 1963 (http://www.codexalimentarius.org/members-observers/members/en/?no_cache=1) The US also has been a member of the World Trade Organization since 1995 (http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm) http://www.fda.gov/InternationalPrograms/HarmonizationInitiatives/default.htm
Recent and/or pending changes	The Food Safety Modernization Act was signed into law on 4 January 2011. Changes include requiring food facilities to document in writing that all substances at the facility that are intended to be added to food are allowed by the food additive regulatory programme (http://www.fda.gov/food/foodsafety/fsma/default.htm)
Regulatory overview of specific food chemical groups
	The US does not define the term “food ingredient”. Instead, it defines food. Food means, “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article” (21 USC §321(f)). Food includes human food, pet food, animal feed and substances migrating to food from food contact articles (21 CFR §170.3(m)). Any substance that is reasonably expected to become a component of food is a food additive that is subject to premarket approval by the USFDA, unless the substance is generally recognised as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or meets one of the other exclusions from the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Novel foods: The US does not define novel foods. New substances are regulated through a variety of mechanisms described below Regulation: 21 CFR, Chapter 1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm) Guidance document: USFDA guidance regarding substances allowed in food, including new substances is available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/default.htm Approval process for a new substances: There are three ways a food manufacturer can get clearance to add a new substance to its products: A manufacturer or trade association can decide on its own that a substance's use is “generally recognised as safe,” which is commonly known as a “GRAS substance”. This determination must be based on the opinion of “experts qualified by scientific training and experience to evaluate the safety …”. Notice to the USFDA or the public of the safety decision or its use is not required The USFDA approves the use of a substance by issuing a new or amended regulation. The USFDA usually makes this safety determination in response to a petition by a manufacturer or its representative. It provides the public with the opportunity to comment before the chemical use is approved and a regulation is issued. Since 2000, use of this method has fallen dramatically A manufacturer voluntarily asks the USFDA to review its safety assessment of a chemical it wants to use in food by submitting a notification. If the agency's review raises no concerns, the USFDA sends a letter stating that it has “no objections” or “no questions” to the manufacturer's decisionA determination that a particular use of a substance is GRAS (unless established by common use prior to 1958) requires both technical evidence of safety and a basis to conclude that this technical evidence of safety is generally known and accepted (i.e. general recognition of safety). 21 CFR 170.30. In contrast, a determination that a particular use of a food additive is safe via premarket approval requires only technical evidence of safety A substance added directly to food can fall into one of several categories: food additive, prior sanctioned substance, colour additive, or the use of the substance is considered GRAS, depending on its intended use and the mechanism through which approval is sought. Definition: A food additive is a substance “the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food; and including any source of radiation intended for any such use); if such substance is not GRAS or sanctioned prior to 1958¹ or otherwise excluded from the definition of food additives Direct food additives are a subcategory of this larger category. They are substances intentionally added directly to food whose use has been expressly approved by the USFDA, usually in response to a food additive petition from a manufacturer or manufacturer's representative Prior-sanctioned substances are chemicals that were government-approved for use in food prior to 1958 GRAS substances are substances “generally recognized among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to 1 January 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use”. GRAS substances are distinguished from food additives by the type of information that supports the GRAS determination, that it is publicly available and generally accepted by the scientific community, but should be the same quantity and quality of information that would support the safety of a food additive. USFDA notification of the GRAS determination of a chemical's use is voluntary Colour additives are substances that are capable (alone or through reaction with other substances) of imparting colour when added or applied to food. Substances intended to be used solely for purposes other than colouring, that may also impart colour, do not fall within this category. The USFDA must approve all colour additives, typically in response to a colour additive petition. Colour additives cannot be GRAS Regulation: 21 CFR §§70–82 and §§170–189 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm) GRAS Notifications: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/default.htm Guidance documents: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/default.htm#food Approval process for new substances: Same as described for food ingredients above. In this case, the petitions submitted would be food or colour additive petitions. Regarding voluntary notifications, the notification submitted by a manufacturer would be known as a GRAS notification and if the agency's review of this notification raises no concerns, the USFDA would send a letter stating that it has “no questions” regarding the manufacturer's decision
Food contact substances (e.g. components of packaging materials)	In the US, substances added to food indirectly may be known as indirect additives, food contact substances (FCS), FCS below the threshold of regulation, or GRAS substances depending on their use and the method of clearance for use in food. Since 2000, FCSs are the most applicable category. Food contact substances are chemicals not intended to be added directly to or have a technical effect on the food, but which may reasonably expected to become a component of food. These include substances used in packaging, transporting or the production of food Regulation: General: 21 CFR §170–171 Existing indirect additive approvals: 21 CFR §§174–178 and 186 (http://www.accessata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm) FCS notification regulation: 21 CFR 170.3(e)(3) FCS threshold of regulation: 21 CFR 170.39 See also http://www.fda.gov/Food/FoodIngredientsPackaging/FoodContactSubstancesFCS/default.htm Guidance document: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/default.htm Approval process for a new substances: Same as described for food ingredients above. The petition would be known as a food additive petition. Regarding notifications, although a manufacturer could submit a GRAS notification, most manufacturers of FCS choose to submit FCS Notifications because the approval by the USFDA is applicable only to that manufacturer. If a FCS Notification is submitted, the USFDA must object within 120 days
Flavouring agents	Flavouring agents are regulated as both food additives and GRAS substances (see “Direct food additives” above for a description of both). Most flavouring agents in the US have been found to be GRAS by the Flavor and Extract Manufacturers Association (FEMA) expert panel, which makes safety decisions, publishes them, and submits them to the USFDA for review. http://www.femaflavour.org/gras. USFDA has also approved a number of flavours as food additives and GRAS substances Regulation: No specific regulations on flavouring agents. They are regulated as direct food additives or GRAS substances: Regulations regarding labelling of flavours: 21 CFR §101.22 Lists of flavours approved in the regulations can be found at: 21 CFR §§172, 182 and 184 GRAS Notifications: (http://www.fda.gov/FoodFoodIngredientsPackaging/Generally_RecognizedasSafeGRAS/default.htm) Guidance document: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/default.htm Approval process for a new substances: Same as described for direct food additives above. Manufacturers can also seek a determination by FEMA
Enzymes	Definition: There is no specific regulation governing enzymes. They would be regulated as direct or secondary direct additives, or GRAS substances depending on their intended use and the method used to allow the substances in food Regulation: See “Direct food additives” (above) Guidance document: See “Direct food additives” (above) Approval process for new substances: See “Direct food additives” (above)
Processing aids	Definition: A subcategory of direct food additives, are what are known as “secondary direct additives”. These are food additives that have a technical effect in food during processing but that are not intended to have an ongoing technical effect in the food. These are sometimes more commonly known as processing aids. Direct food additives are described above. The USFDA may also consider processing aids to be food contact substances in some cases. Food contact substances are described above Regulation: See “Direct food additives” and “Food contact substances” (above) Guidance document: See “Direct food additives” and “Food contact substances” (above) Approval process for a new substances: See “Direct food additives” and “Food contact substances” (above)
Nanoscale materials	Definition: There is no formal definition for “nanotechnology” or “nanoscale” at this time. However the USFDA has indicated that “In the absence of a formal definition, when considering whether a USFDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology, the USFDA will ask: (1) whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 100 nm); or (2) whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer”. This definition is contained in the USFDA's Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food contact substances, Including Food Ingredients that are Colour Additives, which was issued in April 2012 (FDA 2012). Regulation: There are currently no formal regulations specifically governing nanotechnology or nanoscale materials as applied to food Guidance document: The USFDA has issued draft guidance, most recently in April 2012: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm300661.htm http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm Approval process for a new substances: New substances, whether direct food additives or food contact substances, cannot be GRAS per the USFDA's recently issued draft guidance. Manufacturers seeking approval for a nano-engineered substance must submit a food additive petition or a food contact substance notification. These are described above Efforts towards developing standards and regulations: The USFDA Nanotechnology Task Force, formed in August 2006 to: Develop regulatory approaches Identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from USFDA-regulated products that use nanotechnology materials http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm2006658.htm

Regulatory authority	Name: Ministry of Health (Ministério da Saude) through its regulatory agency Agencia Nacional de Vigilancia Sanitária (ANVISA – National Agency of Sanitary Surveillance) Website: Ministry of Health: http://portal.saude.gov.br/portal/saude/default.cfm (Ministerio daSaude 2011) ANVISA: http://portal.anvisa.gov.br/wps/portal/anvisa/home/(ANVISA 2009). ANVISA website in English: http://www.anvisa.gov.br/eng/legis/index.htm (ANVISA 2003) Mercosur: http://www.mercosul.gov.br (Mercosur 2011) Historical overview: ANVISA was established by Law 9.782, as of 26 January 1999 Role/responsibility: The institutional purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. The latter embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the same. In addition, the agency exercises control over ports, airports and borders and also liaises with the Brazilian Ministry of Foreign Affairs and foreign institutions over matters concerning international aspects of sanitary surveillance
Advisory scientific body	Name: ANVISA is designated an autonomous agency operating under a special regime. This means that it is an independently administered, financially autonomous regulatory agency with security of tenure for its directors during the period of their mandates. It is managed by a Collegiate Board of Directors, comprised of five members Website: http://portal.anvisa.gov.br/wps/portal/anvisa/home Historical overview: No authoritative statement found Role/responsibility: ANVISA's function is to evaluate the safety of use of food additives and ingredients in foods. There are specific work groups, comprised of university professors who give technical support if needed. These groups work mainly in the approval of novel foods and novel food ingredients with functional health claims
Framework regulations	No authoritative statement found
Part of an overarching international organisation	Mercosur (which was established in 1991 and encompasses Argentina, Brazil, Uruguay, Paraguay, and as of 2006, Venezuela) Mercosur standards are influenced by the European Union, the Codex Alimentarius Commission, and the USFDA Brazil has been a member of the World Trade Organization since 1995 Brazil also is a member of the Codex Alimentarius Commission. There is also the Codex Alimentarius Group of Brazil, formed by entities and professors, whose function is to meet the demands of the Codex Committee
Recent and/or Pending changes	None known
Regulatory overview of specific food chemical groups
Food ingredients	Definition: As per GMC 26/03, food ingredients are defined as all substances, including food additives, which are used in the manufacture or preparation of foods and which are present in the final product in its original or modified form. Novel foods: These are the criteria for classification of novel foods: 1 – The following foods must be registered in the category of novel food, if they do not bear functional and/or health claims, given the criteria set out in Resolution No. 16/99: 1.1 – foods with no history of use in the country; 1.2 – foods containing novel ingredients, except those listed in Table 1; 1.3 – foods containing substances already consumed that may be added or used at levels much higher than those currently observed in the foods that constitute part of a regular diet; and 1.4 – food offered in the form of capsules, pills, tablets and the like Regulation: Brazil has a specific regulation for the approval of novel ingredients or novel foods. Novel foods (Resolution No. 16): List of novel foods approved by ANVISA (http://www.anvisa.gov.br/alimentos/comissoes/novos_alimentos.htm) List of novel ingredients approved by ANVISA (http://www.anvisa.gov.br/alimentos/comissoes/novos_ingredientes.htm) Guidance document: No authoritative guidance document found Approval process for a new substances: Pre-market application is required prior to sale (http://portal.anvisa.gov.br/wps/portal/anvisa/home)
Direct food additives	Definition: Defined by GMC 26/03, as any ingredient which added to foods intentionally, without intent to nurture, in order to modify the physical, chemical, biological or sensory characteristics of foods, during its manufacture, processing, preparation, processing, packaging, conditioning, storage, transport or during food handling: it will have, or it can be reasonably expected to have (directly or indirectly) as a result, that the additive itself or its by-products becomes part of that food. This term does not include contaminants or nutrients that are incorporated into a food in order to maintain or improve its nutritional properties. GMC 26/03 is currently under revision by Sub Work Group #3 (SGT#3) Mercosur and continues to be discussed and should be gazetted during 2012 Regulation: GMC 11/06 – List of permitted food additives available in Spanish and Portuguese (http://www.mercosur.int/msweb/Normas/normas_web/Resoluciones/ES/GMC_2006_RES-011_ES_RTM-Aditivos%20Alimentarios.pdf) (Mercosur 2006) GMC 34/07 – List of food additives not permitted for use Two new regulations for Mercosur, GMC 34/10 and GMC 35/10; however, not all member states have adopted these regulations GMC 34/10 – List of food additives according to good manufacturing practices (already internalised in Brazil by means of Resolução RDC 45 dated 3 November 2010) (http://portal.anvisa.gov.br/wps/wcm/connect/11707300474597459fc3df3fbc4c6735/Resolu%C3%A7%C3%A3o±da±Diretoria±Colegiada±±RDC±n±±45±de±03±de±novembro±de±2010.pdf?MOD=AJPERES) GMC 35 10 – List of food additives permitted for use at maximum levels, internalised in Brazil by means of Resolução RDC 46 dated 3 November 2010. Website (http://portal.anvisa.gov.br/wps/wcm/connect/3664e600474597459fc4df3fbc4c6735/RESOLU%C3%87%C3%83O±RDC±N±±46±DE±3±DE±NOVEMBRO±DE±2010±.pdf?MOD=AJPERES) Revision of GMC 11/06 is expected in 2013 Guidance document: http://www.anvisa.gov.br/alimentos/guia_pedidos.pdf Approval process for a new substances: All food additives that are not listed in GMC11/06 can be submitted for evaluation to ANVISA, who will then submit a request to the Mercosur Sub Work Group #3 to consider the revision of 11/06 and to proceed to its incorporation. Requests must be sent first for evaluation to ANVISA and comply with the guidance document listed on the website (http://www.anvisa.gov.br/alimentos/guia_pedidos.pdf)
Food contact substances (e.g. components of packaging materials)	Definition: According to GMC 26/03, food contact substances are defined as the primary container or primary wrapping or container (container that is in direct contact with food) Regulation: GMC 32/07: There is a positive list of substances (in Appendix 1 of regulation GMC 32/07) that are added to plastics to achieve a technical effect in the final product (additives) such as antioxidants, antistatic, foaming, defoaming, fillers, impact modifiers, plasticisers, lubricants, stabilisers, UV protectants, preservatives, hardeners, etc. Included within this list are the substances used to provide a suitable medium polymerisation (e.g. emulsifiers, surfactants, buffers pH, solvents) Guidance document: No authoritative guidance document found Approval process for a new substances: Same as direct food additives
Flavouring agents	Definition: Flavouring agents are substances or mixtures of substances with odoriferous and/or flavour properties that are able to confer or enhance the aroma and/or taste of food. For the purpose of this Technical Regulation, flavourings/flavourings are classified as either natural or synthetic Regulation: Under Mercosur, GMC 10/06 Permitted flavouring agents (natural or synthetic), including colourants are listed Exclusions from the technical regulations include:? The substances which give only sweet, salty or sour? Substances and food products with odoriferous and/or sapid consumed without processing, with or without reconstitution? Substances of plant or animal origin, having inherent flavours/flavouring properties, where they are used as sources of flavourings Guidance document: http://www.anvisa.gov.br/alimentos/guia_pedidos.pdf Approval process for a new substances: All flavouring agents that are not listed in GMC10/06 can be submitted for evaluation to ANVISA, who will then submit a request to the Mercosur Sub Work Group #3 to consider the revision of 10/06 and to proceed to its incorporation. Requests must be sent first for evaluation to ANVISA and comply with the guidance document listed on the website (http://www.anvisa.gov.br/alimentos/guia_pedidos.pdf)
Enzymes	Definition: Enzymes or enzyme preparations are defined as substances of animal, plant or microbial origin that act by promoting the desirable chemical reactions Regulation: Resolução RDC # 26 dated 05/27/2009. Enzymes regulations are not harmonised in Mercosur Guidance document: No authoritative guidance document found Approval process for a new substances: Submissions dossier should be addressed to ANVISA following the guidance document set forth at: http://www.an_visa.gov.br/al_imentos/guia_pedidos.pdf
Processing aids	Definition: Processing aids are any substances, excluding equipment and utensils, which are not consumed as it is as a food ingredient and which is intentionally used in the processing of raw materials, foods or ingredients, for a technological purpose during treatment or processing. It must be removed from the food or inactivated; the presence of traces of the substances or their derivatives may be admitted in the final product Regulation: GMC 18/93 Modificación RES. GMC 31/92 “Definicion y Principios fundamentales referente a empleo de aditivos, ingredientes, coadyuvante de elaboracion, contaminantes”. Resolución GMC No. 84/93 Guidance document: Processing aids are not harmonised in Mercosur, the only harmonised regulation is GMC 84/93 that establishes the definitions of the functions of processing aids (http://www.anvisa.gov.br/alimentos/guia_pedidos.pdf) Approval process for a new substances: Submissions dossier should be addressed to ANVISA following the guidance document set forth at: http://www.anvisa.gov.br/alimentos/guia_pedidos.pdf
Nanoscale materials	Definition: No authoritative statement found Regulation: No authoritative statement found Guidance document: No authoritative statement found Approval process for a new substances: No authoritative statement found Efforts towards developing standards and regulations (Locascio et al. 2011): Committee for the special study of nanotechnology (http://www.abnt.org.br): Developing practices of health, safety, and environment with a scientific basis

Regulatory authority	Name: Ministry of Health (MOH) Website: http://www.moh.gov.cn/publicfiles//business/htmlfiles/wsb/index.htm (Ministry of Health of the People's Republic of China 2010) Historical overview: Established 21 November 1949 Role/responsibility: To draft health laws, regulations and policies; to propose health development programmes and strategic goals; to formulate technical protocols, health standards, and to supervise their enforcement To propose regional health programmes, to conduct overall planning, and to coordinate the nationwide allocation of health resources To supervise communicable disease prevention and treatment, food health, occupational, environmental, radiological and school health. To formulate food and cosmetics quality control protocols and be responsible for their accreditation To organise and guide multilateral and bilateral governmental and non-governmental health and medical cooperation and exchanges and medical aid to other countries, to participate in major health events initiated by international organisations To coordinate medical and health exchanges and collaborations between China and the World Health Organization and other international organisations To undertake other work as designated by the State Council
Advisory scientific body	Name: Same as Regulatory authority (above) Website: Same as Regulatory authority (above) Historical overview: Same as Regulatory authority (above) Role/responsibility: Same as Regulatory authority (above)
Framework regulations	Food Safety Law of the People's Republic of China (adopted at the 7th Session of the 11th Standing Committee of the National People's Congress of the People's Republic of China on 28 February 2009) Implementation Rules of Food Safety Law of the People's Republic of China – Order of State Council of the People's Republic of China No. 557 (adopted at the 73rd Standing Committee Meeting of the State Council on 8 July 2009)
Part of an overarching international organisation	China has been a member of the World Trade Organization since 2001 China is a member of the Codex Alimentarius Commission
Recent and/or pending changes	None known
Regulatory overview of specific food chemical groups
Food ingredients	Definition of food ingredients: any substance, including a food additive, used in the manufacture or preparation of a food and present in the final product although possibly in a modified form. Novel foods are referred to as new resource foods, which are defined as raw food materials or food ingredients, which do not have a significant history of consumption in China (Roberts & Rogerson 2008). Novel foods are separated into four categories: Animals, plants and microorganisms that are not traditionally consumed in China Raw food materials that are derived from animals, plants and microorganisms and are not traditionally consumed in China New varieties of microorganisms that are used during food processing Raw food materials the original composition or structures of which are changed by the adoption of new techniques during production Regulation: Order No. 56 Administrative Measures on Novel FoodGuidance document: English translation of the guidance is available at: http://www.fas.usda.gov/gainfiles/200704/146280956.pdf (USDA 2007) Approval process for a new substances: Premarket application demonstrating safety of the novel food. Applications for novel food shall include the following: Application for hygiene administration permit of novel food (manufacturer must obtain a hygiene license before producing, marketing or using the food additive) Research and production report Brief summary and flow chart of processing techniques Product quality standards Status on research and production at home and abroad, as well as safety-related documents Product label and instructions Other materials helpful to assessment and review A product sample or 30 g of raw material For the importation of novel food, it is also required to submit certificates indicating the production (or marketing) of the food products are permitted in the exporting country (region) or documents showing the traditional consumption history of the food in the exporting country (region), which are issued by relevant departments or institutions of the exporting country (region)
Direct food additives	Definition: “An artificially chemosynthetic or natural substance to be added to foods in order to improve food quality, colour, fragrance and taste, and for the purpose of preservation and processing technology. Nutrition enhancers, gum-based substances in chewing gum, flavouring agents, and processing aids in the food industry are also included in food additives.” Permitted food additives (including colouring agents, sweeteners, and flavour enhancers) are classified according to their function with permitted maximum levels indicated (USDA 2008). A new food additive is a food additive that: Is not included in the national food safety standards Is not included in the public announcement of permitted use issued by the Ministry of Health Whose scope of use or dosage is increased Regulation: National Standard GB-2760-2007 – Hygienic Standards for the Use of Food Additives National Food Safety Standard – Standards for uses of food additives GB-2760-xxxx (Draft for comment; Notified to the WTO as G/SPS/N/CHN/308 on 4 August 2010) Administrative Licensing Regulation for New Varieties of Food Additive (Notified tothe WTO as G/SPS/N/CHN/201 on 8 January 2010) Guidance document: Order No. 73: Measures for Administration of New Food Additives (as of 10 March 2010) (http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Food%20Additive%20Registration_Beijing_China%20-%20Peoples%20Republic%20of5-12-2010.pdf) (USDA 2010b) Approval process for a new substances: Pre-market application demonstrating technological need and safety of the additive. The application shall include: Generic name, functions, dosage and scope of use of additives Documents demonstrating technical necessity and efficiency of additives Quality requirements, manufacturing process and testing methods of food additives, and testing methods of such additives or relevant explanations Safety assessment data, including raw materials or sources, chemical constitution and physical properties, manufacturing process, toxicological safety assessment data, or test report and quality test report Label, specifications, and sample of food additives Data on permission of manufacture and use granted by other countries or regions or international organisations and other data that may be useful in safety assessmentAny application for increase in the scope of use or dosage of food additives may be exempt from provision of materials identified in the fourth point above, unless additional data are required during technical review (http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Food%20Additive%20Registration_Beijing_China%20-%20Peoples%20Republic%20of_5-12-2010.pdf/) Any applicant applying for the initial import of new food additives shall submit the following materials in addition to those specified above: Supporting documents permitting manufacture or sale of such additives in the exporting country or region that are issued by relevant authority or agency thereof Supporting documents examining or certifying the manufacturer that are issued by relevant agency or organisation in the country or region where the manufacturer is located
Food contact substances (e.g. components of packaging materials)	Definition: All materials in contact with the food including the food containers, packaging materials and the things which contact the food in the course of manufacture, transport, sale and serve. The licensing scope of the food-related new product varieties includes: Food materials or mouldings without national food safety standards that are used for food packaging or containerisation and machinery that has direct contact with the food during production or packaging Additives not included in the Hygienic Standards for Additives Used in Food Containers and Packaging Materials (GB 9685) Food materials or mouldings not included in the list of food packaging materials or containers announced by the Ministry of Health and all operational tools and equipment that have direct contact with food during food production, and their processing additives Additives which are included in the Hygienic Standards for Additives Used in Food Containers and Packaging Materials (GB 9685) or the list announced by the Ministry of Health but with the scope or dosage expanded upon New detergent materials which may have food safety risks and are used for food, food production and operational tools and equipment that have direct contact with food during food production and packaging New disinfectant materials which are not included in the List of Food Disinfectant Materials and are used for food, food production and operational tools and equipment that have direct contact with food during food production and packaging Regulation: Hygienic Standards for Additives Used In Food Containers and Packaging Materials (GB 9685) Guidance document: Rules on Administrative Licensing of Food-Related New Product Varieties (Notified to the WTO as G/SPS/N/CHN/120 on 13 August 2009) Approval process for a new substances: Premarket application demonstrating technological need and safety of the additive. If an additive in the food containers or packaging materials meets the following conditions, such additive shall be an exemptible substance and does not need to be reported for examination and approval: The migration volume of the additive is less than 0.01 mg kg⁻¹ (i.e. 10 ppb); the additive is not carcinogenic, mutagenic or a reproductive toxic substance; the additive migrating into food does not cause the food ingredients, structure, colour, smell or taste to change There is multilayer composite packaging with a functional barrier layer and the migration volume of the substance outside the barrier layer is less than 10 ppb
Flavouring agents	Definition: Flavourings (flavour compound): A concentrated and prepared mixture incorporated by flavourings substances and flavouring adjuncts, and used for producing flavour (excluding preparations only producing salty, sweet or sour taste), which may contain or not contain flavouring adjuncts. Usually, they are not directly used for consumption. The flavourings include food flavourings, feed flavourings, flavourings in contact with mouth cavity and lips and the flavourings for dish washing detergent: Oil-soluble liquid flavourings Water-soluble liquid flavourings Emulsified flavourings Paste flavourings Blending powder flavourings Encapsulated powder flavourings Flavouring (flavour compound) adjunct: A food additive and food ingredient necessary for producing, preserving and applying the flavourings. The additive added to food (except flavour enhancer) does not play the role for final aromatic products. Process flavourings: A product or mixture prepared for the purpose of characteristics of odour, which is a kind of product prepared with the ingredients or ingredient mixtures allowed to be used in process flavourings or process flavourings allowably used for food or natural application in food through the preparation process suitable for foods consumed by humans. It can add flavouring substances and flavouring adjuncts to process flavourings. A list of allowable flavourings is available (Annex B, People's Republic of China, 2010) Regulation: National Standard of the People's Republic of China – Flavourings (TBT/N/CHN/575)Guidance document: See “Direct food additives” (above) Approval process for a new substances: See “Direct food additives” (above)
Enzymes	Definition: “Biological products directly extracted from edible or non-edible parts of a plant or animal or fermented and extracted from traditional or genetically modified microorganisms (including but not limited to bacteria, actinomycetes, and fungi) that are used in food processing and have a special catalytic function.” A list of allowable food enzyme preparations is available (Annex C, People's Republic of China, 2010) Regulation: Hygienic Standard for Enzyme Preparations Used in Food Processing (Notified to the WTO as G/SPS/N/CHN/112 on 5 January 2009) Guidance document: See “Direct food additives” (above) Approval process for a new substances: See “Direct food additives” (above)
Processing aids	Definition: A substance or material (not including apparatus or utensils), and not consumed as a food ingredient by itself, and only used to fulfil a certain technological purpose during processing or treatment. Processing aids refers to various kinds of substances to enable food processing to go smoothly, irrelative to food itself, e.g. filtration aids, clarifiers, absorbents, lubricants, mould release agents, decolouring agents, peeling agents, extraction solvents, and nutritional substances for fermentation, etc. Processing aids are regulated under food additives Regulation: See “Direct food additives” (above) Guidance document: See “Direct food additives” (above) Approval process for a new substances: See “Direct food additives” (above)
Nanoscale materials	Definition: Nanoscience and nanotechnology encompass studying the characteristics (manipulating of atom and molecular) and interactions (primary quantum effect) of the matter on nanometre (1–100 nm) scale, as well as the interdisciplinary science and technology using these characteristics. It extends a human's method and ability on understanding and changing the physical world to atomic and molecular level (http://english.nanoctr.cas.cn) (NCNST 2010) Regulation: No regulations pertaining to nanoscale materials are available Guidance document: No authoritative guidance document found Approval process for a new substances: No authoritative statement found Efforts towards developing standards and regulations: Ministry of Science and Technology: Supports standardisation activities in nanotechnology including health, safety, and environmentBio-Environmental Health Sciences of Nanoscale Materials Laboratory, National Center for Nanoscience and Technology of the Chinese Academy of Sciences: Studies the nanotoxicology of manufactured nanomaterials Includes an “Innovative methodology for nanotoxicological studies”

Regulatory authority	Name: Ministry of Health, Labour and Welfare (MHLW) Website: http://www.mhlw.go.jp/english/index.html (MHLW 2011a) Historical overview: In 1947, then MHLW enacted the Food Sanitation Law as the first comprehensive law for food safety/hygiene and introduced a positive list system for food additives. Under the system, only additives designated as safe by the MHLW may be used in foods Since 1947, all food additives have been regulated by this law; however, the designation system had been applied only to chemically synthesised additives until 1995 when the Food Sanitation Law was amended Currently, all types of additives are equally subject to the designation system, synthetic or non-synthetic with minor exceptions Role/responsibility: To protect the health of the public through the strengthening measures for the assurance of food safety Responsibilities include the regulation of the manufacture, import, and sale of food, food additives, food apparatus, containers/packages, and the provision of related information to consumers and businesses (MHLW 2011c). The administration is under the jurisdiction of the Department of Food Safety under the Pharmaceutical and Food Safety Bureau
Advisory scientific body	Name: Food Safety Commission (FSC) Website: http://www.fsc.go.jp/english/index.html Historical overview: The FSC was established on 1 July 2003, as a part of Japanese Cabinet Office, following the founding regulation of Food Safety Basic Law Role/responsibility: The FSC's core role is risk assessment of food-associated hazards that are potentially contained in food including chemical substances (e.g. food additives, pesticides and veterinary medicines), biological (e.g. microorganisms and natural toxins), and novel foods. The FSC also emphasises risk communication on food-related hazards to the general public and also provides emergency response in the case of food poisoning outbreaks
Framework regulations	The food safety administrative work is based on the Food Safety Basic Law (enacted in May 2003) and related laws including the Food Sanitation Law, the Abattoir Law, and the Poultry Slaughtering Business Control and Poultry Inspection Law Other related laws include the Law of Temporary Measures for Enhancing the Control Method of the Food Production Process and the Health Promotion Law The Food Sanitation Law (JETRO 2006) covers various responsibilities, such as the establishment of standards/specifications for food, additives, apparatus, and food containers/packages, and inspection to determine whether these established standards are met
Part of an overarching international organisation	Japan has been a member of the World Trade Organization since 1995 Japan is a member of the Codex Alimentarius Commission
Recent and/or pending changes	The MHLW has deleted 80 substances from the list of existing food additives, as there are currently no uses in the Japanese market (WTO 2010). The list is available at: http://members.wto.org/crnattachments/2010/sps/JPN/10_2581_00_e.pdf (USDA 2010c) The use of those substances as an additive is prohibited in foods produced in or exported to Japan. It should be noted that although a substance withdrawn from the list is prohibited for use as a food additive, it does not mean that the substance is prohibited for use as a food ingredient, e.g. as a health food
Regulatory overview of specific food chemical groups
Food ingredients	Definition: Foods (including food ingredients) are defined as all foods and drinks; provided, however, this term does not include drugs and quasi-drugs in the Pharmaceutical Affairs Law (Article 4, Food Sanitation Law) (JETRO 2006). Novel foods: Novel foods are not defined under Japanese jurisdiction. There are no specific approval procedures for new food or food ingredients. The FSC conducts safety assessment for novel foods that are derived from a genetically modified organism (GMO). The MHLW may prohibit the sale of a food, which could possibly injure human health according to the opinion of the Pharmaceutical Affairs and Food Sanitation Council (Article 7 of the Food Sanitation law). This includes: food that has never before generally served for human consumption; any article containing the same is, or is to be newly sold as food; and any article served for consumption in a different recipe from the ordinary way of consumption Regulation: No authoritative statement found Guidance document: No authoritative guidance document found Approval process for a new substances: No authoritative statement found
Direct food additives	Definition: According to Food Sanitation Law under Article 4 (JETRO 2006), a food additive is defined as a substance used in or on food in the process of manufacturing food or substances used for the purpose of processing or preserving food Consequently, an “additive” includes both substances remaining in the finished food products, such as food colours and preservatives, and substances not remaining in the finished products, such as infiltration-supporting agents Food additives include sweeteners and food colouring agents For food additives produced by recombinant DNA techniques food, a safety assessment is mandatory according to the Food Sanitation Act as of 2001. The “Standards for the Safety Assessment of Genetically Modified Foods (Seed Plants)” (2004) is available in English from the FSC Regulation: Food Safety Basic Law (the translated document is available at: http://www.fsc.go.jp/sonota/fsb_law1807.pdf) (Food Safety Commission 2006) Food Sanitation Law (JETRO 2006) (the translated document is available at: http://www.japaneselawtranslation.go.jp/law/detail/?id=12&vm=04&re=02) (Ministry of Justice2009) There are currently 345 designated food additives approved by the MHLW under Article 10 of the Food Sanitation Law (http://www.mhlw.go.jp/english/topics/foodsafety/foodadditives/index.html) (MHLW 2011b). The MHLW has decided to start evaluating certain food additives with intent to authorise them even when there is no application from a person who wishes to use them. These food additives are those that meet the two standards given below: for which safety assessments have been conducted by the JECFA and whose safety has been confirmed within a certain level; and that are widely used in the US and EU countries and whose need is considered to be high This decision was made from the viewpoint of international harmonisation for substances that are internationally proven safe and widely used in the world. Establishment of specifications and standards: Usually, people continue to consume food additives throughout their lifetime; thus, food additives must be subjected to stringent regulations. All designated chemicals, with a few exceptions, and some natural additives (existing food additives) are currently regulated by specifications and/or standards. These specifications and standards include specifications concerning chemical and physical characteristics, and standards for manufacturing, storage, and use. These standards, along with labelling and storage standards are published in an official compilation of food additives, entitled “Japan's Specifications and Standards for use of Food Additives” (MHLW 2000) Guidance document: A guidance document on food additives is available at: http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/PDF/FILE/Guideline.pdf Approval process for a new substances: The procedures required to apply for designation of a new substance intended to be used as a food additive pursuant to Article 6 of the Food Sanitation Law or for revision of standards for use of a food additive pursuant to Article 7, paragraph 1 of the Food Sanitation Law are provided within the guidance document. A checklist is provided in the last page of the guidance document, which outlines the requirements. It should be noted that all documents should be completed in Japanese; however, all documents except for the summary may be submitted in English. A brief summary of the general requirements include: Summary Chronology on origin or development and overseas use conditions Physicochemical characteristics and specifications: Name Structural formula and rational formula Molecule formula and formula weight Assay Manufacturing methods Description Identification tests Specific properties Purity tests Loss on drying, loss on ignition or water Residues on ignition Method of assay Stability Analytical method for the food additives in foods Principles to establish proposed specifications Effectiveness: Effectiveness and comparison in effect with other similar food additives Stability in foods Effects on nutrients of foods Safety information: Toxicity studies 28-day toxicity study 90-day toxicity study One-year toxicity study Reproduction study Teratogenicity study Carcinogenicity study Combined chronic toxicity/carcinogenicity study Antigenicity study Mutagenicity study General pharmacological study Metabolism/pharmacokinetic studies Daily intake of food additives Proposed standards for use It should be noted that not all of the above requirements are needed if applying for revision of standards for use of a food additive
Food contact materials (e.g. components of packaging materials)	Definition: No authoritative statement found Regulation: No regulations are available on food contact materials. In 1973, the Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA) established the industry's voluntary standards composed of a positive list describing raw materials that can be used safely for food utensils, containers, packaging materials, and the Standard Methods of Analysis that defined specifications for each resin. JHOSPA aims to carry out activities to prevent sanitary hazards caused by food utensils, containers, and packaging materials Guidance document: No authoritative guidance document found Approval process for a new substances: No authoritative statement found
Flavouring agents	Definition: Natural flavouring agents are defined as food additives intended for use in flavouring food and are substances obtained from animals or plants, or mixtures thereof (The Food Sanitation Act, Article 4, Paragraph 3) (JETRO 2006). No specifications are established for natural flavouring agents Regulation: http://www.fantastic-flavour.com/files-downloads/flavour_agents_japan.pdf Guidance document: Refer to direct food additives (above) Approval process for a new substances: Refer to direct food additives (above)
Enzymes	Definition: No authoritative statement found Regulation: Enzymes listed as a permitted food additive can be used in food under the conditions indicated; however, for enzymes produced by genetically modified microorganisms, a safety assessment would be required under Standards for the Safety Assessment of Food (additives) Produced Using Genetically Modified Microorganisms (only available in Japanese) Guidance document: No authoritative guidance document found Approval process for a new substances: No authoritative statement found
Processing aids	Definition: Processing aids defined under labelling standards according to the Food Sanitation Law (JETRO 2006) are substances added to a food in processing the food which are (1) removed from the food before the completion of the food; (2) derived from raw materials of the food and converted into components normally included in the food but do not significantly increase the amounts of the components; or (3) present in the finished food at insignificant levels but do not have any technical or functional effect of these components on the food Regulation: Processing aids are regulated under the same process as food additives. Processing aids that are listed on the permitted list of food additives are permitted for use in foods (Government of Japan 2002) Guidance document: Refer to direct food additives (above) Approval process for a new substances: Refer to direct food additives (above)
Nanoscale materials	Definition: No authoritative statement found Regulation: No authoritative statement found Guidance document: No authoritative guidance document found Approval process for a new substances: No authoritative statement found Efforts towards developing standards and regulations (Locascio et al. 2011): The National Institute of Advanced Industrial Science and Technology (AIST) has sponsored several projects at the Ministry of Economy Trade and Industry (METI) since 2005 (http://www.aist.go.jp/): Standardisation of Nanoparticle Risk Evaluation Method with the objective to develop methods for the characterisation of nanoparticles, develop methods for assessment of health impact and safety of nanoparticles, and develop systems for data collection and data standardisation Risk assessment of manufactured nanomaterials

Regulatory authority	Name: Ministry of Health (SSA) through the Federal Commission for the Protectionagainst Sanitary Risks (COFEPRIS 2010) Website: http://www.cofepris.gob.mx Historical overview: COFEPRIS was established 5 July 2001 with the publication of the “Decreto de Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)” in the “Diario Oficial de la Federación”. This decree established the structure and organisation of a decentralised administrative office with technical, administrative and operative autonomy responsible for the implementation of its legal attributes as related to sanitary regulation, control and support as stated in the General Health Law and other applicable regulations. This new Commission is composed of different General Directions that include: The General Direction of Drugs and Health Technologies, Sanitary Control of Products and Services, Environmental Health, The National Public Health Laboratory and the Direction of Sanitary Control of Publicity Role/responsibility: According to the General Health Law, the Ministry of Health will enforce its legal attributes as related to sanitary regulation, control and support through the Federal Commission for the Protection Against Sanitary Risks as related to (Art. 17 bis): The control and vigilance of health establishments The prevention and control of adverse environmental health effects as related to humanhealth Occupational health and safety The sanitary control of products and services including importation, exportation and of the establishments that process such products The sanitary control of the process, use, maintenance, importation, exportation and final disposition of medical instruments, prosthetics, functional aids, diagnostic agents, odontological supplies, surgical materials, hygienic products and the establishments where these are processed The sanitary control of publicity of activities, products and services The sanitary control of the disposition of human organs, tissue and their components as well as cell cultures International sanitary controls The sanitary control of human organ, tissue and cell donations
Advisory scientific body	Name: See “regulatory authority” (above) Website: See “regulatory authority” (above) Historical overview: See “regulatory authority” (above) Role/responsibility: See “regulatory authority” (above)
Framework regulations	For foods the following regulations apply: General Health Law (Ley General de Salud) The Regulation on Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios) An agreement that establishes the substances allowed as additives and processing aids in foods, beverages and nutritional supplements (ACUERDO por el que se determinan las sustancias permitidas como aditivos y coadyuvantes en alimentos, bebidas y suplementos alimenticios) (Secretaría de Salud México 1999) Applicable Official Mexican Norms (Normas Oficiales Mexicanas)
Part of an overarching international organisation	Mexico has been a member of the World Trade Organization since 1995 Mexico is a member of the Codex Alimentarius Commission
Recent and/or pending changes	Pending (since 2007 2008) update and publication of a new Food Additive Positive List Recently implemented (June 2011) labelling regulation NOM-051-SSA1-2010 mandates nutritional labelling for foods and non-alcoholic beverages as well as quantitative ingredient declaration Upcoming review and publication of NOM-086-SSA1-1994 Foods with Modified Composition to homologate it with the new labelling regulation Upcoming publication (2012) of a new food additive and processing aid positive list that will include limits and approved applications for each compound
Regulatory overview of specific food chemical groups
Food ingredients	Definition of a food ingredient: Any substance or product including the additives that is used in the manufacture, elaboration, preparation or treatment of a food or non-alcoholic beverage and that is present in the final product transformed or not. There are no regulations pertaining to new food ingredients or novel foods Regulation: No authoritative statement found Guidance document: No authoritative guidance document found Approval process for new substances: No authoritative statement found
	Definition: Food additives are defined as those substances added directly to food and drinks during its manufacture in order to provide or intensify aroma, colour or flavour, to improve its stability or its preservation. The term does not include contaminants, substances added to foods to maintain or to improve the nutritional quality, or sodium chloride. Additives always perform a technological function in the final product (USDA 2009) Regulation: General Health Law The Regulation on Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios) contains some specific limits for additives in specific products An agreement that establishes the substances allowed as additives and processing aids in foods, beverages and nutritional supplements (ACUERDO por el que se determinan las sustancias permitidas como aditivos y coadyuvantes en alimentos, bebidas y suplementos alimenticios). This is only a positive list and does not specify limits or specific applications. However, the new 2012 updated list includes limits and specific applications and will list processing aids separately Applicable Official Mexican Norms (Normas Oficiales Mexicanas) (NOM) may establish limits and applications Authorised food additives including colorants and sweeteners provided in English are available in the GAIN report MX6058 (http://www.fas.usda.gov/gainfiles/200607/1462_08414.pdf) (USDA 2006a) The authorised additives must follow the established specifications in the provisions included in the Appendix Chapter VIII of the “Regulations for the Sanitary Control of Goods and Services,” which are provided on the SSA's website (http://www.ssa.gob.mx) In addition, the list of authorised purified substances, enzymes, and synthetic flavoursprovided in English are available in the GAIN report MX6070 (USDA 2006b) The list of permitted food additives is not available in English It is important to consider all levels of regulations. The major challenge is that the documents are not all updated so limits and substances listed in specific NOMs may not be updated with the most recently approved additives Guidance document: Agreement that establishes the substances allowed as additives and processing aids in foods, beverages and nutritional supplements Approval process for a new substances: Through technical consultation presenting a technical dossier to request approval and inclusion in the positive list. After an official approval is obtained, it is important to follow up to ensure that the substance is included in the next update of the positive list (agreement) and any updated applicable NOMs
Food contact substances (e.g. components of packaging materials)	Definition: No authoritative statement found Regulation: The Regulation on Sanitary Control of Products and Services (Reglamento de Control Sanitario de Productos y Servicios – 24th Title) Guidance document: No authoritative guidance document found Voluntary Mexican Norms (NMX) may be available for specific products Approval process for new substances: No specific process. Any approval should be obtained through technical consultation. Although there is no specific, formal process, most major customers will require legal confirmation that a specific compound is allowed. If a company wants to be sure that the product is allowed, then they should consult with the authorities
Flavouring agents	Definition: Substance or blend of substances of natural origin, identical to natural or synthetic with or without solvents and with or without the addition of other additives that are used to give or intensify flavours or aromas to products Regulation: Same as food additives Guidance document: Same as food additives Approval process for new substances: Same as food additives. Usually when the positive list is updated, the FEMA-GRAS lists are reviewed for inclusion
Enzymes	Definition: Biological catalyser protein substance produced by live cells that catalyse specific reactions in diverse production processes. Source: The Regulation on Sanitary Control of Products and Services Regulation: Same as food additives Guidance document: Same as food additives Approval process for a new substances: Same as food additives
Processing aids	Definition: Substance or material, excluding instruments, utensils and additives that is not consumed as a food ingredient by itself and is used intentionally in the production of raw materials, foods or their ingredients to achieve a technological function during the treatment or processing and that can lead to the unintentional presence of residues or derivatives in the final product. Colour aid is the substance that is used to intensify, retain or develop colour Regulation: Same as food additives Guidance document: Same as food additives Approval process for a new substances: Same as food additives
Nanoscale materials	Definition: No authoritative statement found Regulation: No authoritative statement found Guidance document: No authoritative guidance document found Approval process for a new substances: No authoritative statement found Any specific approval should be obtained through technical consultation Efforts towards developing standards and regulations: None known

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Regulatory authority	Ministry of Health (Ministerio de Salud) and The National Administration of Drugs, Foods, and Medical Technology (Administration Nacional de Medicamentos, Alimentos y Tecnología Médica – ANMAT)	Food Standards Australia New Zealand (FSANZ); New Zealand Ministry for Primary Industries (MPI) (formerly Ministry of Agriculture and Forestry – MAF)	Ministry of Health (Ministério da Saude)	Health Canada (HC)	Ministry of Health (MOH)	European Commission (EC) – Directorate General for Health and Consumers	Ministry of Health, Labour and Welfare (MHLW)	Ministry of Health(SSA) through the Federal Commission for the Protection against Sanitary Risks(COFEPRIS)	US Food and Drug Administration (USFDA)
Advisory scientific body	National Committee of Food (CONAL)	FSANZ Board, FSANZ Fellows, and Scientific Advisory Groups	National Health Surveillance Agency; Agencia Nacional de Vigilancia Sanitária (ANVISA)	Same as above	Same as above	European Food Safety Authority (EFSA)	Food Safety Commission	Same as above	USFDA Science Board; USFDA Food Advisory Committee

Country	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Definition	Substances or mixtures of substances with odoriferous and/or flavour properties that are able to confer or enhance the aroma and/or taste of food	Flavourings are defined as intense preparations that are added to foods to impart taste and/or odour, which are used in small amounts and are not intended to be consumed alone, but do not include herbs, spices and substances which have an exclusively sweet, sour or salt taste	Same as for Argentina”	Not defined; however, there are standards of identity and composition for certain flavouring preparations in Division B.10	Food additive and food ingredient necessary for producing, preserving and applying the flavourings. The additive added to food (except flavour enhancer) does not play the role for final aromatic products	Flavourings are products that are not intended to be consumed as such, but which are added to food in order to impart or modify odour and/or taste of food. Flavouring substances are chemically defined substances obtained by chemical synthesis or isolated using chemical processes, and natural flavouring substances	Natural flavouring agents are defined as food additives intended for use in flavouring food and are substances obtained from animals or plants, or mixtures thereof	Substance or blend of substances of natural origin, identical to natural or synthetic with or without solvents and with or without the addition of other additives that are used to give or intensify flavours or aromas to products	Not defined; regulated as substances added directly to food, specifically as direct food additives and GRAS substances
Regulation	Mercosur GMC 10/06	Food Standard 1.3.1 Section 11. FSANZ does not require a risk assessment to be done if the flavours are GRAS by FEMA or others	Same as for Argentina”	Division B.10	National Standard of the People's Republic of China Flavourings (TBT/N/CHN/575)	1334/2008/EC (framework Regulation 2065/2003/EC (smoke flavourings)	Food Sanitation Law	Regulated as food additives	Labelling of flavours: 21 CFR §101.22. Lists of flavours approved in the regulations: 21 CFR §§172, 182 and 184. Proposed rule published in 1997 (62 FR 18938)
Additional regulation details	Permitted list of flavouring substances (natural or synthetic)		Same as for Argentina^a	Certain prohibitions exist in Section B.01.046. Definition of food additive excludes flavouring preparations
Approval process	Application submission to CONAL and subsequent submission to Mercosur	Flavouring agents are regarded as food additives. An application is generally not required for a flavouring agent	Application submission to ANVISA and subsequent submission to Mercosur	Voluntary request a letter of opinion on a flavouring agent (see “approval process for processing aids”)	Same process as direct food additives	New common authorisation procedure under Regulation (EC) No. 1331/2008, data requirements provided in Regulation (EC) No. 234/2011. For smoke flavourings Regulation (EC) 2065/2003 specifies the procedure	Same process as direct food additives	Same process as direct food additives	Same process as substances added directly to food. See “direct food additives” above. Most flavouring agents in the US are reviewed by the Flavor and Extract Manufacturers Association (FEMA) expert panel to determine if their uses are GRAS

PERMALINK

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

Bernadene Magnuson

Ian Munro

Peter Abbot

Nigel Baldwin

Rebeca Lopez-Garcia

Karen Ly

Larry McGirr

Ashley Roberts

Susan Socolovsky

Abstract

Introduction

International scientific and advisory committees

The Joint FAO/WHO Committee on Food Additives (JECFA)

The International Programme on Chemical Safety (IPCS)

Regulations in different jurisdictions

Table 1.

Table 9.

Table 2.

Table 3.

Table 4.

Table 5.

Table 6.

Table 7.

Table 8.

Comparison of the regulatory systems and regulations for food substances in the different jurisdictions

Overview

Regulatory authorities

Table 10.

Participation in international organisations

Table 11.

Direct food additives

Table 12.

Novel foods

Table 13.

Food contact substances

Table 14.

Flavouring agents

Table 15.

Enzymes

Table 17.

Table 16.

Processing aids

Nanoscale materials

Australia and New Zealand

Canada

European Union

United States of America

Table 18.

Conclusions

Acknowledgements

References

ACTIONS

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RESOURCES

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