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

Figures & data

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 (ANMAT 2010) 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) …”
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-%20 Narrative_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 modified form.
	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%20Aires_Argentina_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 Modificación 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.

Table 2. Regulatory framework of chemicals added to food in Australia/New Zealand.

Regulatory authority	Name: Food Standards Australia New Zealand (FSANZ)
	Website: http://www.foodstandards.gov.au (FSANZ 2011c)
	Historical overview: The first national agency to regulate food in Australia (National Food Authority) was established in June 1991. This became the Australia New Zealand Food Authority in July 1996, and FSANZ was established on 1 July 2002 FSANZ is a statutory authority operating under the Food Standards Australia New Zealand Act 1991 (Commonwealth of Australia 2007). The act provides a focus for cooperation between governments, industry, and the community to establish and maintain uniform food regulation in Australia and New Zealand FSANZ establishes food standards for Australia and New Zealand. There is an agreement (established in July 1996) between the governments of Australia and New Zealand that establishes FSANZ’s role in setting joint food standards, i.e. standards that apply in both countries The agreement does not cover some areas, such as maximum residue limits, food hygiene provisions and export requirements relating to third country trade. It also contains provisions that allow New Zealand to opt out of a joint standard for exceptional reasons relating to health, safety, environmental concerns or cultural issues. In such cases, FSANZ may be asked to prepare a variation to a standard to apply only in New Zealand In Australia only, FSANZ develops standards for primary production and processing and for food hygiene, as well as setting residue limits for agricultural and veterinary products. Equivalent New Zealand standards are developed and administered by the New Zealand Ministry for Primary Industries (MPI), formerly MAF. MPI is also responsible for implementation and enforcement of food standards and requirements for exported foods
	Role/responsibility: FSANZ is responsible for developing and administering the Australia New Zealand Food Standards Code (the Code) – see below FSANZ is governed by a Board with a wide range of expertise and experience in food matters, with members drawn from Australia and New Zealand As of February 2001, the Legislative and Governance Forum on Food Regulation (the Forum) is primarily responsible for the development of domestic food regulatory policy and guidelines for setting domestic food standards. The Forum also has the capacity to adopt, amend or reject standards and to request that these be reviewed FSANZ recently implemented the Code Interpretation Service (CIS) on a cost-recovery basis to provide coordinated guidance on Chapters 1 and 2 of the Australia New Zealand Food Standards Code In Australia, enforcing compliance with the Code for all foods is the responsibility of State/Territory Health Departments within Australia. For imported foods, enforcing compliance is the responsibility of the Australian Quarantine Inspection Service (AQIS) In New Zealand, enforcing compliance with the Code for all foods is the responsibility of the New Zealand Ministry for Primary Industries (MPI), formerly MAF
Advisory scientific body	FSANZ Board: The FSANZ Board is selected by the Australian Minister for Health and Aging in Consultation with the Food Regulation Ministerial Council and must include qualified people from a wide range of expertise. Members of the Board have been drawn from specialist areas – public health, food science, human nutrition, consumer affairs, food allergy, medical science, microbiology, food safety, biotechnology, veterinary science, primary food production, the food industry, food processing or retailing, small business, international trade, food regulation, consumer rights and consumer affairs policy, the National Health and Medical Research Council (NHMRC) and government FSANZ Fellows: FSANZ Fellows provide expert advice on applications, proposals and other risk assessment activities of the agency. FSANZ Fellows, within their relevant areas of expertise, also peer review FSANZ work and provide training to FSANZ staff Scientific Advisory Groups (SAG): These ad hoc advisory groups are set up to advise FSANZ on particular scientific issues, e.g. health claims, iodine and folic acid fortification and dairy primary production and processing
	Role/responsibility: See above
Framework regulations	Australia New Zealand Standards Code (the Code): The Code regulates all aspects of food including labelling, the addition of food additives, processing aids, nutritive substances, levels of contaminants, approval of new foods (novel foods, genetically modified (GM) foods and irradiated foods), composition of standardised and special purpose foods, and applying in Australia only, food safety programmes and food processing and primary production (http://www.foodstandards.gov.au) (FSANZ 2011a)
Part of an overarching international organisation	Australia and New Zealand are both members of the World Trade Organization since 1995, and they are both members of the Codex Alimentarius Commission
Recent and/or pending changes	No major changes to the regulatory framework anticipated. Refer to the new Science Strategy above
Regulatory overview of specific food chemical groups
Food ingredients	Food ingredients as such are not defined under the Australia New Zealand food regulations. Ingredients are generally considered to be either foods or substances added to food. FSANZ is reviewing the regulation of novel foods and nutritive substances as of March 2012. Due to problems with the definition of these terms a new approach is being considered based on criteria for “eligible foods” (i.e. foods in the wider sense including ingredients, additives and other substances added to food). Any non-eligible foods would be prohibited and will require appropriate safety assessment. Novel foods (including novel food ingredients): Novel foods are defined as a non-traditional food with no history of safe use and the food requires an assessment of the public health and safety considerations having regard to: the potential for adverse effects in humans; or the composition or structure of the food; or the process by which the food has been prepared; or the source from which it is derived; oro patterns and levels of consumption of the food; or any other relevant matters. A non-traditional food is defined as: a food that does not have a history of human consumption in Australia/New Zealand; or a substance derived from a food where that substance does not have a history of human consumption in Australia/New Zealand other than as a component of that food; or any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia/New Zealand. Categories of novel foods may include but are not limited to: plants or animals and their components; plant or animal extracts; herbs, including extracts; dietary macro-components; single chemical entities; microorganisms, including probiotics; and foods produced from new sources, or by a process not previously applied to food.
	Foods produced using gene technology or irradiated foods are regulated separately from novel foods and will be not discussed further within this report
	Regulation: Novel foods and novel food ingredients are regulated under Food Standard 1.5.1. This standard prohibits the sale of these foods unless they are listed in the table to Clause 2 under Food Standard 1.5.1 and comply with any special conditions of use in that table Food Standard 1.3.4 describes standards for the identity and purity of novel food ingredients
	Guidance document: Application Handbook (http://www.foodstandards.gov.au): General application requirements are provided in Sections 2 and 3.1 Specific requirements for novel foods are provided in Section 3.5.2
	Approval process for a new substances: An application to vary the code is required to approve the use of a novel food ingredient or a novel food. All application forms must conform to the general requirements (under Section 3.1 of the Application Handbook). Section 3.5.2 Novel Foods (within the handbook) lists additional requirements specific to novel foods. A summary of the requirements are listed below: Indicate whether the applicant is requesting for exclusive permission for the novel food (if applicable): Will need to indicate the specific class of food and brand of the food Technical information on novel food: Description of novel food (if it falls under one of the major categories listed below) Physical and chemical properties Impurity profile Manufacturing process Specification for identity and purity Analytical method for detection Safety information of novel food: Depending on which major category that novel foods falls below (plants or animals and their components; plant or animal extracts; herbs (both non-culinary and culinary) including extracts; single chemical entities; dietary macro-components; microorganisms (including probiotics); food ingredients derived from new sources; or foods produced by a process not previously applied to food), different requirements are specified (see Section 3.5.2 of handbook) Dietary exposure to novel food: List of the foods or food groups proposed to contain the novel food Proposed use level of novel food for each food or food group Percentage of the food group in which the novel food is proposed to be used or the percentage of the market likely to use the novel food ingredient Data to indicate whether the food or the food in which the novel food ingredient is used, is likely to replace another food from the diet (if applicable) Information regarding the use of the novel food/novel food ingredient in other countries (if applicable) Nutritional impact of the novel food Information related to potential impact on consumer understanding and behaviour Information related to impact on the food industry (industry applicants only)
Nutritive substances	Definition: Nutritive substance means a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides
	Regulation: Nutritive substances cannot be added to certain special purpose foods without express permission. These are: Standard 2.9.1 Infant Formula Products Standard 2.9.2 Food for Infants Standard 2.9.3 Formulated Meal Replacements and formulated supplementary foods Vitamins and minerals are regulated under Standard 1.3.2
	Guidance document: Application Handbook: General application requirements are provided in Sections 2 and 3.1. Specific requirements for nutritive substances are provided in Section 3.3.3.
	Approval process for a new substances: An application to vary the code is required to approve the use of a nutritive substance or to change the permissions of a currently used nutritive substance. All application forms must conform to the general requirements (under Section 3.1 of the Application Handbook). A summary of the requirements are listed below: General information on the application Technical information on the nutritive substance: Identity of the nutritive substance Chemical and physical properties Impurity profile Manufacturing process Specifications for identity and purity Analytical method for detection Information related to the safety of the nutritive substance: Toxicokinetics or metabolism of the nutritive substance Studies in animals or humans that is relevant to the toxicity of the nutritive substance Information on dietary exposure to the nutritive substance: A list of food groups or foods proposed to contain the nutritive substance The maximum proposed level of the nutritive substance for each food group or food Information related to the nutritive impact of a nutritive substance other than vitamins and minerals: Nutritional purpose of adding the nutritive substance to each food Information related to the nutritive impact of a vitamin or mineral: Information to demonstrate a need to permit the addition of a vitamin or mineral Information to demonstrate the permitted addition of a vitamin or mineral has the potential to address a deficit or deliver a health benefit Information related to the potential impact on consumer understanding and behaviour: Information to demonstrate consumer awareness and understanding Information to demonstrate consumer awareness and understanding Information on the actual and/or potential behaviour of consumers in response to proposed foods Information that the nutritive substance will not adversely affect any subpopulation Information related to impact on the food industry: Data on the projected impact on the food industry
Direct food additives	Definition: Direct food additive is not a term used in Australia/New Zealand A food additive is any substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which is intentionally added to a food to achieve one or more of the technological functions specified in Schedule 5. It or its by-products may remain in the food. Food additives are distinguishable from processing aids and vitamins and minerals added to food for nutritional purposes
	Regulation: Food additives may only be added to food where expressly permitted in Food Standard 1.3.1. Additives can only be added to food in order to achieve an identified technological function according to good manufacturing practice (GMP). Some additives have specific permissions and maximum use levels allowed in food and other additives are limited to GMP (see Schedules 1–5 below). Specific flavourings, sweeteners and colouring agents are regulated as food additives Schedule 1 of Standard 1.3.1 contains information on the permitted uses of food additives (including sweeteners) by food type Schedule 2 of Standard 1.3.1 contains miscellaneous food additives permitted according to GMP in processed foods specified in Schedule 1 Schedules 3 and 4 of Standard 1.3.1 contain colouring agents permitted to GMP and to specified levels in processed foods specified in Schedule 1 Schedule 5 lists the technological functions that may be performed by food additives Standard 1.3.4 describes standards for the identity and purity of food additives
	Guidance document: Application Handbook: General application requirements are provided in Sections 2 and 3.1 Specific requirements for food additives are provided in Section 3.3.1
	Approval process for a new substances: Application to vary the code is required to approve the use of a new food additive or to change the permissions of a currently used food additive. The following information are required: Technical information on food additive: Nature and technological function Identification of food additive Chemical and physical properties of food additive Impurity profile Manufacturing process Specification for identity and purity Food labelling information Analytical method for detection Safety information of food additive: Toxicokinetics and metabolism of food additive and if applicable, its degradation products and/or major metabolites Information on the toxicity of food additive and if applicable, its degradation products and major metabolites Safety assessment reports prepared by international agencies or other national government agencies, if available Dietary exposure to food additive: List of food groups or foods proposed to contain food additive, or changes to currently permitted foods Maximum proposed level or concentration range of food additive for each food group or food, or proposed changes to the currently permitted levels Percentage of the food group in which the food additive is proposed to be used or the percentage of the market likely to use the food additive Information regarding the use of the food additive in other countries (if applicable)
Food contact substances (e.g. components of packaging materials)	Definition: Food contact substances are defined as any materials in contact with food, including packaging material, which may include materials such as moisture absorbers, mould inhibitors, oxygen absorbers, promotional materials, writing or other graphics Food contact substances may be placed in contact with food, provided such articles or materials, if taken into the mouth, are not capable of being swallowed or of obstructing any alimentary or respiratory passage and are not otherwise likely to cause bodily harm, distress or discomfort
	Regulation: Food Standard 1.4.3 Food Standard 1.4.1
	Guidance document: Food Standard 1.4.3 deals with food contact materials in general terms, and does not specify individual packaging materials for food contact or how they should be produced or used. However, with respect to plastic packaging products, the standard refers to the Australian Standard for Plastic Materials for Food Contact Use, AS 2070-1999. This Standard provides a guide to industry about the production of plastic materials for food contact use. AS 2070, in turn, refers to regulations of the United States and European Economic Community directives relevant to the manufacture and use of plastics Standard 1.4.1 – Contaminants and Natural Toxicants of the Food Standard Code regulates the levels of these substances that can be present in food from any source, including as a result of contact with food packaging materials. Even if a specific contaminant or toxicant is not listed in the standards, it sets out an expectation that all other contaminants and toxicants be kept to levels as low as reasonably achievable
	Approval process for a new substances: Applications for food packaging materials are generally unnecessary if there is approval in the European Union or United States. At present it is voluntary that plastic materials for food contact use comply with the Australian Standard AS 2070-1999 FSANZ has been considering its approach to chemicals that migrate from packaging into food for several years now, and it is envisaged that their approach may change to become more prescriptive and mandatory. Thus, in future, it may become mandatory to comply with either EU or US regulations under the Standard Code pending discussions with stakeholders
Flavouring agents	Definition: Flavouring agents, as such, are not defined in the Food Standards Code Flavourings are defined as intense preparations which 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 Some flavourings are listed on the approved list of food additives with limitations “Permitted flavouring substances are those which are either: a) listed in at least one of the following publications: Food Technology, A Publication of the Institute of Food Technologists, Generally Recognized as Safe (GRAS) lists of flavoring substances published by the Flavor and Extract Manufacturers” Association of the United States from 1960 to August 2007; or Chemically defined flavoring substances, Council of Europe, November 2000; or United States Code of Federal Regulations, 2007, 21 CFR Part 172.515; or (b) a substance that is a single chemical entity obtained by physical, microbiological, enzymatic, synthetic or chemical processes, from material of vegetable or animal origin either in its raw state or after processing by traditional preparation process including drying, roasting, and fermentation”
	Regulation: Food Standard 1.3.1 Section 11
	Guidance document: An application is generally not required for flavourings and therefore no guidance is provided in the Application Handbook
	Approval process for a new substances: Flavourings are regarded as food additives. An application is generally not required for flavourings
Enzymes	Definition: Enzymes, as such, are not specifically defined in the Food Standards Code Enzymes are considered to be processing aids. They may be used in the course of manufacture of any food, provided the enzyme is derived from the corresponding source or sources specified in the tables of Sections 15, 16, and 17 of Food Standard 1.3.3. Refer to processing aids (below)
	Regulation: Enzymes are regulated as processing aids (below)
	Guidance document: Refer to processing aids (below)
	Approval process for a new substances: Refer to processing aids (below)
Processing aids	Definition: Processing aid means a substance listed in clauses 3–19 [of Standard 1.3.3] where: the substances used in the processing of raw materials, foods or ingredients, to fulfil a technological purpose relating to treatment or processing but does not perform a technological function in the final food; and the substance is used in the course of manufacture of a food at the lowest level necessary to achieve a function in the processing of that food, irrespective of any maximum permitted level specified
	Regulation: Food Standard 1.3.3 – Processing aids
	Guidance document: Refer to the Application Handbook General application guidelines are provided in Sections 2 and 3.1 Specific requirements for processing aids are provided in Section 3.3.2
	Approval process for a new substances: Application to vary the code is required to approve the use of a new processing aid or to change the permissions of a currently used processing aid. The following information are required in the application: Technical information on processing aid: Information on the type of processing aid Identification of processing aid Chemical and physical properties of processing aid Manufacturing process Specification for identity and purity Analytical method for detection Safety information of a chemical processing aid: General information on the industrial use of the chemical General information on the use of the chemical as a food processing aid in other countries Toxicokinetic and metabolism data on the processing aid, and if necessary its metabolites Information on the toxicity of the processing aid, and if necessary its major metabolites Safety assessment reports prepared by international agencies or other national government agencies, if available Safety information of an enzyme processing aid: General information on the use of the enzyme as a food processing aid in other countries Toxicity information of the enzyme processing aid Information on the potential allergenicity of the enzyme processing aid Safety assessment reports prepared by international agencies or other national government agencies, if available Additional information related to the safety of an enzyme processing aid derived from a microorganism: Information regarding the source microorganism Information regarding the pathogenicity and toxicity of the source microorganism Information on the genetic stability of the source organism Additional information related to the safety of a processing aid derived from a genetically modified microorganism: Information on the methods used in the genetic modification of the source organism Dietary exposure to the processing aid: List of foods or food groups likely to contain the processing aid or its metabolites Levels of residues of the processing aid or its metabolites for each food or food group Percentage of the food group in which the processing aid is likely to be present or the percentage of the market likely to use the processing aid Information relating to the levels of residues in foods in other countries
Nanoscale materials	Definition: The term “nanotechnology” is usually applied to the process of controlling the size and shape of materials at the atomic and molecular scale. Generally, the term is defined as deliberately engineered matter less than 100 nm in size in one dimension (http://www.foodstandards.gov.au/consumerinformation/nanotechnologyandfoo4542.cfm)
	Regulation: No authoritative statement found for food applications
	Guidance document: No specific guidance document found for food applications
	Approval process for a new substances: Any new food substances that are manufactured using nanotechnologies that may present safety concerns will have to undergo a comprehensive scientific safety assessment under the appropriate standard before they can be legally supplied in Australia (http://www.foodstandards.gov.au/consumerinformation/nanotechnologyandfoo4542.cfm) Applications for food additives, processing aids, novel foods and nutritive substances must include particle size, size distribution and morphology, where the substance(s) is particulate in nature and will remain so in the final food
	Efforts towards developing standards and regulations (Locascio et al. 2011): National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (http://www.nicnas.gov.au): Active role in international activities to develop best-practice testing protocols and risk assessment methodologies Focused on industrial chemicals that are in the form of nanomaterials

Table 3. Regulatory framework of chemicals added to food in Brazil.

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 da Saude 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/alimentos/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

Table 4. Regulatory framework of chemicals added to food in Canada.

Regulatory authority	Name: Health Canada (HC) Food Directorate
	Website: http://www.hc-sc.gc.ca/fn-an/index-eng.php (Health Canada 2011)
	Historical overview: The Food and Drugs Act was introduced in 1920 http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/info-renseign/hist-eng.php
	Role/responsibility: Establishing policies, setting standards, and providing advice and information on the safety and nutritional value of food Promoting the nutritional health and well-being of Canadians by collaboratively defining, promoting and implementing evidence-based nutrition policies and standards Administering the provisions of the Food and Drugs Act that relate to public health, safety and nutrition
Regulatory enforcement	Name: Canadian Food Inspection Agency (CFIA)
	Website: http://www.inspection.gc.ca/english/toce.shtml (CFIA 2011)
	Historical overview: Established in 1997 by the Canadian Food Inspection Agency Act Prior to the establishment of the CFIA, inspection and related services for food safety and animal and plant health were provided by Agriculture and Agri-Food Canada, HC, and the Department of Fisheries and Oceans (http://www.oag-bvg.gc.ca/internet/English/parl_oag_199809_12_e_9318.html#mp) (OAG 1998)
	Role/responsibility: Enforce the food safety and nutritional quality standards established by HC and for animal health and plant protection, to set standards and carry out enforcement and inspection (http://www.inspection.gc.ca/english/util/faqe.shtml) Plans and priorities link directly to the Government of Canada’s priorities for bolstering economic prosperity, strengthening security at the border and the safety of the food supply, protecting the environment and contributing to the health of Canadians (http://www.inspection.gc.ca/english/agen/agene.shtml)
Framework regulations	Food and Drug Regulations: http://laws.justice.gc.ca/PDF/Regulation/C/C.R.C.,_c._870.pdf
Part of an overarching international organisation	Canada has been a member of the Codex Alimentarius Commission since it was established in 1963 (http://www.hc-sc.gc.ca/fn-an/intactivit/codex/activit/strateg-codex-2008-2012-eng.php) (Health Canada 2009a) Canada also has been a member of the World Trade Organization since 1995
Recent and/or pending changes	None known
Regulatory overview of specific food chemical groups
Food ingredients	Food ingredients are defined as an individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a pre-packaged product: The use of a food ingredient does not require pre-market approval unless it meets the definition of a novel food. Novel foods are defined according to Division B.28.001 as: a substance, including a microorganism, that does not have a history of safe use as a food; a food that has been manufactured, prepared, preserved or packaged by a process that: has not been previously applied to that food, and causes the food to undergo a major change; and a food that is derived from a plant, animal or microorganism that has been genetically modified such that: the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism; the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism
	Regulation: Novel Foods – Division B.28 (http://laws.justice.gc.ca/eng/C.R.C.-C.870/page-1.html#anchorbo-ga:l_B-gb:l_28)
	Guidance document: A guidance document is available on novel foods, whether whole foods, food products or food ingredients, that are derived from plant or microbial sources. The safety assessment criteria for novel foods derived from animals are under development. Manufacturers or importers of novel foods derived from animal sources should consult with the Food Directorate to discuss which type of information is appropriate to the evaluation of the safety of a particular product (http://www.hc-sc.gc.ca/fn-an/index-eng.php)
	Approval process for a new substances: The mechanism by which HC controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as described in Division 28 of Part B of the Food and Drug Regulations. Manufacturers or importers are required under these regulations to submit information to HC regarding the product in question in order to determine the product’s safety prior to sale. If the information provided in the notification for a novel food is not considered adequate to determine the novel food’s safety, additional data supporting the safety of the food will be required. The type of information required to conduct the safety assessment of a novel food will depend on a number of factors such as the nature of the food, processing methods and the intended use. The approaches used to assess the safety of novel foods are outlined in the guidance document; however, the types of studies considered appropriate to demonstrate the safety of a novel food change with scientific knowledge and development. These guidelines are to be used in conjunction with information available in the scientific literature and from research and development conducted by the manufacturer. Since novel foods represent a diverse range of products, not all types of data outlined in the guidance document will be appropriate for a specific submission. Petitioners should consider the novel characteristics of their particular product when addressing the criteria in the guidance document. Consultation with the Food Directorate is encouraged during the development phase of a product to determine the specific data necessary to demonstrate the safety of the product. Information sufficient to establish that a novel food is safe for consumption may include experimental data as well as sound scientific rationales. To enhance the efficiency of the review process, petitioners should prepare their safety assessment data packages according to the following headings, as applicable: History of use Dietary exposure Detail of novel process History of organism(s) Characterisation of derived line/strain Genetic modification considerations Nutritional considerations Toxicology considerations Allergenicity considerations Chemical considerations Microbiological considerations
Direct food additives	Definition: According to the Food and Drugs Regulations B.01.001, “a food additive means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food, but does not include: Any nutritive material that is used, recognised or commonly sold as an article or ingredient of food; Vitamins, mineral nutrients and amino acids, other than those listed in the tables to Division 16 Spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives; Agricultural chemicals, other than those listed in the tables to Division 16, Food packaging materials and components thereof; and Drugs recommended for administration to animals that may be consumed as food”. It should be noted that a substance not present in the final food but which has affected the characteristics of that food would be regulated as a food additive. The official food additive provisions are listed in the tables of B.16.100 of the Food and Drug Regulations (Department of Justice 2011). Listings of permitted food additives include the common name of the food additive, a list of the foods in which the additive may be used, and the maximum level of use. Table III lists food additives that may be used as colouring agents; Table IX lists sweeteners permitted for use as a food additive. In Canada, food contact substances are regulated separately from food additives (see “Food contact substances” section below). Enzymes that are used in food processing are regulated as food additives or may be considered processing aids, depending on their context of use. Flavouring agents and processing aids do not require a submission like a food additive but petitioners can request a letter of opinion from Health Canada (see “Flavouring agents, Enzymes, and Processing Aids” section below)
	Regulation: Division B.16 (http://laws.justice.gc.ca/eng/C.R.C.-C.870/page-1.html)
	Guidance document: http://www.hc-sc.gc.ca/fn-an/index-eng.php
	Approval process for a new substances: A submission for a food additive is required if a petitioner is seeking approval for use in Canada of a new food additive not currently regulated in the Food and Drug Regulations. A petitioner is also required to present a submission for an extension of use of an existing food additive, e.g. the use of an existing food additive in a different food or the use of a food additive at a higher maximum level of use. In these latter cases, there may not be a need to resubmit data already available at HC. The four possible scenarios are summarised as follows: Requests for the use of a new food additive (which is a food additive that has never before been approved for use in retail foods in Canada) Requests to extend the use of an already permitted food additive Requests to change the maximum level of use of an already permitted food additive Requests to add a new organism to the list of permitted sources of enzymes used as food additives In the case of submissions on new food additives (those which do not appear anywhere in the Food Additives Tables of the Food and Drug Regulations), detailed data and scientific information meeting the requirements of Section B.16.002 of the Food and Drug Regulations are required in order to support the development of specifications and verify conformity of the additive with those specifications, develop and verify analytical methods, establish claims of efficacy, demonstrate residue levels or reaction products, determine human exposure to a food additive in any given application, and demonstrate the absence of any negative health effects of the food additive when used in the prescribed manner. General requirements include: Identity of the food additive Method of manufacture Chemical and physical properties Specifications Purpose/function of food additive Directions for use Efficacy data demonstrating the technical effect Residue data Proposed maximum level of use Analytical data (for new food additives only, not required for extension of use or changes to maximum levels of use of current food additives listed in Division 16 of the Food and Drug Regulations). Safety data Food intake data Toxicological data Pharmacokinetic studies Human clinical studies Nutritional safety considerations Microbiological data (if food additive is derived from microbial sources or is genetically modified or in the case of antimicrobials, efficacy of preservatives) Labelling information A sample of the food additive Other non-statutory requirements for submissions on food additives: Consumer benefits and food quality considerations Information on evaluations, approvals, and authorisations of other national/international bodies (such as JECFA, USFDA, EU food safety authorities, Australia and New Zealand food standards, and/or Codex Alimentarius Commission) Environmental assessment of new food additives: The Canadian Environmental Protection Act, 1999 (CEPA 1999) is the primary federal legislation respecting the protection of the environment and human health. The goal of CEPA 1999 is to contribute to sustainable development through pollution prevention. In 2001, HC announced its intent to develop environmental assessment regulations for a new substances regulated under the Food and Drugs Act
Food contact substances (e.g. components of packaging materials)	Definition: Food contact or packaging materials have been excluded from the food additive requirements. Food contact or packaging materials are controlled separately under Division 23, Part B of the Food and Drug Regulations (http://laws.justice.gc.ca/eng/C.R.C.-C.870/page-1.html#anchorbo-ga:l_B-gb:l_23) “No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food” (http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/guide_packaging-emballage01-eng.php). This link also lists the documents that can be submitted voluntarily
	Regulation: Division 23, B.23.001 (http://laws.justice.gc.ca/eng/C.R.C.-C.870/page-1.html#anchorbo-ga:l_B-gb:l_23)
	Guidance document: Packaging materials (on a trade name basis, not by generic name) intended for use with foods in Canada may be submitted voluntarily to the Health Products and Food Branch (HPFB) for a pre-market assessment of their chemical safety and subsequent issuance of an advisory opinion on their acceptability in relation to Section B.23.001 of the Food and Drugs Act and Regulations dealing with the potential transfer of harmful chemicals to foods. Any type of material, whether it is in the form of a finished product such as a laminated film, a container, etc. or a formulated product such as a plastic resin, a colour concentrate, etc. may be submitted to the branch for a pre-market assessment. In addition, suppliers of single additives such as antioxidants, ultra violet absorbers, etc. may also independently request letters of opinion for their own products before selling them to formulators or converters. Thus, in terms of data requirements, food packaging submissions may be divided into two distinct categories namely, those on formulated products and finished articles, which are normally submitted by converters and formulators and those on specific constituents or single additives which usually originate from raw material suppliers
	Approval process for a new substances: The following information is provided as a guide to the food packaging industry to assist in the preparation of submissions to HPFB:1. Formulated products and finished articles (formulators/converters). Two elements of information are required initially for a formulated product or a finished packaging article namely, the product’s identity and its intended food packaging uses. The information to be provided under each element is as follows: Product identity: Trade name and number (mostly for records purposes) Structure (e.g. laminate) Composition (in the form of a quantitative listing of all components in which each one is identified by proper chemical name and/or trade name, grade and supplier) Specifications Chemical/physical properties relative to proposed use Proposed usage: Form of finished package (e.g. bottle, film, casing, etc.) Dimensions of package (volume, wall thickness, etc.) Packaging ratio, i.e. weight of food/unit area of packaging material (g/in^2) Conditions (time, temperature) to which packaging article will be exposed during packaging, distribution and use by consumers Estimate of projected market penetration 2. Specific constituents/single additives (raw material supplies). Four elements of information are required for a submission on a new additive or a single constituent in a food contact material. They include information on the product’s identity, its proposed usage, data on its extractability characteristics, and toxicological data. The information to be included under each of these four elements is as follows: Product identity: Chemical name Chemical formula (empirical and structural) Molecular weight Manufacturing process (including a detailed description and a schematic diagram) Purity specifications (residual reactants, by products, etc.) Chemical and physical propertiesProposed usage: Intended technical effect or purpose (e.g. antioxidant, stabiliser, ultraviolet absorber, etc.) Types of substrates or polymers Maximum use level in each type of polymer Efficacy data to demonstrate that the additive will do what it is intended to do at the proposed use levels Types of foods involved Conditions of use (time, temperature, etc. to which the packaging material will be exposed, whether during processing, transport or handling by consumers)Migration/extraction data: Extraction studies data are required to identity and quantify the potential contaminants in foods. These studies are usually conducted using food simulants under conditions that reflect as close as possible those of the proposed end-use applicationsToxicological data: The submitted toxicological data should provide the basis for the petitioner’s safety determination for the packaging material constituent under the proposed conditions of use. The toxicological studies recommended by HPFB for its safety assessment are based on levels of concern that are determined by the level of dietary exposure. Dietary exposures that fall below 0.025 µg kg^–1 bw are considered to be below the threshold of toxicological concern and toxicological data need not be submitted
Flavouring agents	Definition: No authoritative statement found
	Regulation: No specific regulations on flavouring agents. Section 4 of the Food and Drug Act applies. No application/submission required for use of flavouring agents in food within Canada. Standards of identity and composition are available in Division B.10 pertaining to specific flavouring preparations (such as essences or extracts obtained from aromatic plants) (http://laws.justice.gc.ca/eng/C.R.C.-C.870/page-1.html#anchorbo-ga:l_B-gb:l_10). Flavours or flavouring preparations not mentioned in Division 10 are considered unstandardised food ingredients. Certain prohibitions exist in Section B.01.046. The definition of food additive excludes flavouring preparations. On request, the Bureau of Chemical Safety evaluates safety of use of these ingredients and issues a letter of opinion
	Guidance document: No authoritative guidance document found
	Approval process for a new substances: Applicants can voluntary request a letter of opinion on a flavouring agent (see “approval process for processing aids”)
Enzymes	Definition: Not specifically defined in the Food and Drug Regulations. Enzymes that are used in food processing are regulated as food additives or may be considered processing aids, depending on their context of use. An enzyme meets the definition of a food additive, as described in Section B.01.001 of the Food and Drug Regulations, when it affects the characteristics of the food and/or it or its by-products become part of the food. It is the physical enzyme residues, not enzyme activity, that are considered in determining if enzyme residues remain in or on a food
	Regulation: Enzymes approved as food additives are listed within Table V of Section B.16.100 Listings of permitted enzymes as food additives include the common name of the enzyme, permitted sources of the enzyme, a list of the foods in which the enzyme may be used, and the maximum level of use
	Guidance document: See “Direct food additives” (above)
	Approval process for a new substances: See “Direct food additives” (above)
Processing aids	Definition: According to the Food Directorate, “a food processing aid is a substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food”. This definition implies the absence of residues of any given chemical and its by-product in the final food product, which is different from Australia’s definition of a processing aid (in which the absence of by-products is not mentioned). Also, characteristics of the final food must not be affected by the use of any given chemical classified as a processing aid. The definition of processing aid in Canada differs from the definition used by the Codex Alimentarius Commission. The CAC definition does not have a limitation on residue levels and does not refer to affecting the characteristics of the food. These restrictions must be included in the Directorate’s definition because a substance is considered to be a food additive, under the Canadian regulatory definition of food additive, if use of the substance results in residues in the food or affects the characteristics of the food
	Regulation: There is no regulatory definition of food processing aid in Canada. Canadian regulators have typically used “processing aid” in an informal manner for substances used as adjuncts in food processing and manufacture. Most processing aids are not mentioned in the Regulations and unlike food additives, there is no regulatory requirement for preclearance of new processing aids by the Minister of Health. Like all substances used with food, the use of a processing aid is ultimately controlled by Section 4, Part I of the Act which states:“No person shall sell an article of food that: has in or on it any poisonous or harmful substance; is unfit for human consumption; consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; is adulterated; or was manufactured, prepared, preserved, packaged or stored under unsanitary conditions”
	Guidance document: Not applicable
	Approval process for a new substances: The use of a processing aid does not require a submission like a food additive but a petitioner may seek a so-called “Letter of Opinion” from the Bureau of Chemical Safety of HC’s Food Directorate, confirming that, under its conditions of use, the substance in question is considered to be a processing aid and is acceptable for use.
Nanoscale materials	Definition: Nanotechnology is described as the application of nanoscience to develop new materials and products, and involves the manipulation of matter at the nanometre scale. In the food sector, nanotechnology could be used to preserve food, improve nutritional values and enhance flavours (http://www.hc-sc.gc.ca/dhp-mps/nano-eng.php) (Health Canada 2009b). Health Canada considers any manufactured product, material, substance, ingredient, device, system or structure to be nanomaterial if: it is at or within the nanoscale in at least one external dimension, or has internal or surface structure at the nanoscale; or it is smaller or larger than the nanoscale in all dimensions and exhibits one or more nanoscale properties/phenomena. For the purposes of this definition: the term “nanoscale” means 1–100 nm, inclusive; the term “nanoscale properties/phenomena” means properties which are attributable to size and their effects; these properties are distinguishable from the chemical or physical properties of individual atoms, individual molecules and bulk material; and the term “manufactured” includes engineering processes and the control of matter (http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php)
	Regulation: No authoritative statement found. No reference to nanomaterials is stated in the acts and regulations; however, HC is using the existing legislative and regulatory framework to regulate applications of nanotechnology, but it is recognised that new approaches may be necessary in future to keep pace with the advances in this area. Within the Health Portfolio, a Nanotechnology Working Group has been established to gather information, identify areas where additional regulations may need to be considered, and to act as a discussion forum for issues related to nanotechnology (http://www.hc-sc.gc.ca/dhp-mps/nano-eng.php)
	Guidance document: Only general guidance has been given (http://www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php). In order to identify and assess potential risks and benefits (where applicable) of nanomaterials, the following types of information may be required, when relevant: Intended use, function and purpose of the nanomaterial, and information regarding any end product in which it will be used Manufacturing methods Characteristics, and physical chemical properties of the nanomaterial such as: composition, identity, purity morphology structural integrity catalytic or photo-catalytic activity particle size/size distribution electrical/mechanical/optical properties surface-to-volume ratio chemical reactivity surface area/chemistry/charge/structure/shape water solubility/dispersibility agglomeration/aggregation (or other properties) and descriptions of the methods used to assign these determinations Toxicological, eco-toxicological, metabolism and environmental fate data (both generic and specific) to the nanomaterial if applicable Risk assessment and risk management strategies, if considered or implemented
	Approval process for a new substances: No authoritative statement found
	Efforts towards developing standards and regulations (Locascio et al. 2011): National Institute for Nanotechnology (Alberta) (http://www.nrc-cnrc.gc.ca/eng/ibp/nint.html) Developing methods to assess the risk of nanomaterials, such as developing in vitro assays, in vivo studies and tests for systemic responses

Table 5. Regulatory framework of chemicals added to food in China.

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 Food
	Guidance 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 to the 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%20of_5-12-2010.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”

Table 6. Regulatory framework of chemicals added to food in the European Union.

Regulatory authority	Name: European Commission (EC) – Directorate General for Health and Consumers
	Website: http://ec.europa.eu/food/food/index_en.htm (EC 2011)
	Historical overview: The Treaty of Rome, establishing the European Economic Community (EEC), signed on 25 March 1957, and entered into force on 1 January 1958 (Europa 2007a) The Treaty establishing the European Atomic Energy Community (also known as Euratom) was signed at the same time and the two are jointly known as the Treaties of Rome (Europa 2007b)
	Role/responsibility: The EC is the European Union’s (EU) executive body.Their responsibilities include: Proposing and enforcing regulation Representing and upholding the interests of Europe as a whole Drafting proposals for new European laws Managing the day-to-day business of implementing EU policies and allocating EU funds Ensuring that everyone abides by the European treaties and lawsThe responsibilities of the Directorate General for Health and Consumers is to ensure food and consumer goods sold in Europe are safe, that the EU’s internal market works for the benefit of consumers, and that Europe helps protect and improve its citizen’s health
Advisory scientific body	Name: European Food Safety Authority (EFSA)
	Website: http://www.efsa.europa.eu/
	Historical overview: The establishment of EFSA (also known as the Authority) was one of the key measures contained in the Commission’s White Paper on Food Safety which was published in January 2000 Regulation 178/2002/EC providing a legal basis for the Authority was formally adopted on 28 January 2002 Two additional Commission Regulations were adopted: 1304/2003/EC, which set up the procedure applied by EFSA to request for scientific opinions referred to it, and 2230/2004/EC, which established rules with regard to the network of organisations operating in the fields within the EFSA’s mission EFSA’s work covers all stages of food production and supply, from primary production to the safety of animal feed, right through to the supply of food to consumers. It collects information and analyses new scientific developments in order to identify and assess any potential risks to the food chain. It can carry out scientific assessment on any matter that may have a direct or indirect effect on the safety of the food supply, including matters relating to animal health, animal welfare, and plant health. EFSA also gives scientific advice on non-food and feed genetically modified organisms as well as on nutrition in relation to EU legislation. It can communicate directly with the public on any issue within its area of responsibility. The five committees which were transferred to EFSA in May 2003 include: Scientific Committee on Food (SCF) Scientific Committee on Animal Nutrition Scientific Committee on Veterinary Measures relating to Public Health Scientific Committee on Plants Scientific Committee on Animal Health and Animal Welfare
	Role/responsibility: The Authority shall provide scientific advice and scientific and technical support for the Community’s legislation and policies in all fields which have a direct or indirect impact on food and feed safety. It shall provide independent information on all matters within these fields and communicate on risks (178/2002/EC, article 22)
Framework regulations	178/2002/EC – General principles and requirements of food law, establishing the EFSA and laying down procedures in matters of food safety
Part of an overarching international organisation	The EU has been a member of the World Trade Organization since 1995 The EU is a member of the Codex Alimentarius Commission
Recent and/or pending changes	On 16 December 2008, the regulations of the Package on Food Improvement Agents were adopted. This includes regulations on food additives, food enzymes, and flavourings and food ingredients with flavouring properties, and an additional fourth regulation (Regulation (EC) No. 1331/2008, adopted on 16 December 2010) establishing a common authorisation procedure for additives, enzymes, and flavourings
Regulatory overview of specific food chemical groups
Food ingredients	Food ingredients are defined as: Any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form Where an ingredient of the foodstuff is itself the product of several ingredients, the latter shall be regarded as ingredients of the foodstuff in question The following shall not be regarded as ingredients: the constituents of an ingredient which have been temporarily separated during the manufacturing process and later reintroduced but not in excess of their original proportions; additives whose presence in a given foodstuff is solely due to the fact that they were contained in one or more ingredients of that foodstuff, provided that they serve no technological function in the finished product, which are used as processing aids; and substances used in the quantities strictly necessary as solvents or media for additives or flavourings In certain cases, decisions may be taken in accordance with the procedure laid down in Article 20 (2) in Directive 2000/13/EC as to whether the conditions described above are satisfied.
	Novel foods: Novel foods are foods and food ingredients that have not been used for human consumption to a significant degree within the Community before 15 May 1997
	Regulation: Regulation 258/97/EC for Novel Foods (http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN& numdoc=31997R0258&model=guichett)
	Guidance document: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31997H0618:EN:HTML
	Approval process for a new substances: Foods commercialised in at least one member state before the entry into force of the Regulation on Novel Foods on 15 May 1997, are on the EU market under the “principle of mutual recognition”. In order to ensure the highest level of protection of human health, novel foods must undergo a safety assessment before being placed on the EU market. Only those products considered to be safe for human consumption are authorised for marketing. Companies who want to place a novel food on the EU market need to submit their application in accordance with Commission Recommendation 97/618/EC, which outlines the scientific information and the safety assessment report required
	Novel foods or novel food ingredients may follow a simplified procedure, only requiring notifications from the company, when they are considered by a national food assessment body as “substantially equivalent” to existing foods or food ingredients (as regards to their composition, nutritional value, metabolism, intended use, and the level of undesirable substances contained therein)
Direct food additives	Definition: Food additives are substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose described in Regulation (EC) No. 1333/2008, e.g. such as the preservation of food. All food additives should be covered by this Regulation, and therefore in the light of scientific progress and technological development the list of functional classes should be updated (currently there are 26 functional classes listed in the Annex I to Regulation (EC) No. 1333/2008). However, substances should not be considered as food additives when they are used for the purpose of imparting flavour and/or taste or for nutritional purposes, such as salt replacers, vitamins and minerals. Moreover, substances considered as foods which may be used for a technological function, such as sodium chloride or saffron for colouring, and food enzymes also should not fall within the scope of Regulation (EC) No. 1333/2008. However, preparations obtained from foods and other natural source material that are intended to have a technological effect in the final food and which are obtained by selective extraction of constituents (e.g. pigments) relative to the nutritive or aromatic constituents, should be considered additives within the meaning of Regulation (EC) No. 1333/2008. The new Regulation (EC) No. 1333/2008 does not apply to the following substances unless they are used as food additives: Processing aids Substances used for the protection of plants and plant products in conformity with Community rules relating to plant health Substances added to foods as nutrients Substances used for the treatment of water for human consumption falling within the scope of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption Flavourings, which fall within the scope of Regulation (EC) No. 1334/2008 Regulation (EC) No. 1333/2008 does not apply to food enzymes falling within the scope of Regulation (EC) No. 1332/2008 with effect from the date of adoption of the Community list of food enzymes in accordance with Article 17 of that Regulation
	Regulation: Regulation (EC) No. 1333/2008 includes the Community list of approved food additives for use in foods and conditions of use (Annex II as amended by Commission Regulation (EU) No. 1129/2011) and the Community list of food additives approved for use in food additives, food enzymes, food flavourings and nutrients and their condition of use (Annex III as amended by Commission Regulation (EU) No. 1130/2011). Food additives in Annex II are listed on the basis of the categories of food to which they may be added. Food additives in Annex III are listed on the basis of the food additives, food enzymes, food flavourings and nutrients or categories thereof to which they may be added. Before these Community lists apply (1 June 2013) the Annexes to Directives 94/35/EC, 94/36/EC and 95/2/EC are still valid. A food additive may be included in the Community lists only if it meets general conditions: no safety concerns at the level of use proposed; there is a technological need; the consumer is not misled; and there are advantages and benefits for the consumer. Other more specific conditions exist for sweeteners and colours. Links to more information on food additives including the legislation are available at: http://ec.europa.eu/food/food/fAEF/additives/framework_reg_fA_en.htm/. All authorised food additives have to fulfil purity criteria which are set out in detail in three Commission Directives (EC) No. 10/2009 (food additives other than sweeteners and colours, amending Directive 2008/84/EC), 2008/60/EC (sweeteners), and 2008/128/EC (colours). It should be noted that new regulations on purity criteria were adopted on 9 March 2012 (Regulation (EU) No. 231/2012 on specifications for food additives listed in Annexes II and III) which will repeal the mentioned directives as of 1 December 2012. Food additives must be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. Therefore, when the EC is informed about new scientific evidence relating to a permitted food additive, it requests EFSA to assess the new data. In addition to this ongoing observation the EC has also asked the EFSA to undertake a re-evaluation of all currently permitted food additives (Regulation (EU) No. 257/2010). Regulation (EC) No. 1333/2008 on food additives: The regulation, except transitional provisions, has been in application since 20 January 2010 The regulation strengthens the principle of food safety and consumer information. It allows a more efficient and simplified procedure for authorisation of food additives by comitology. The consolidation of all food additives legislation in one single legal instrument makes legislation user-friendly for citizens and business operators. Comitology is the procedure by which the Commission prepares the draft legislation and member states vote at the Standing Committee on the Food Chain and Animal Health. If a qualified majority is in favour, it is then passed to the European Parliament and the Council, which have 2 months to object. If they do not object, it is published in the Official Journal and then it is EU law In accordance with Article 30 of Regulation (EC) No. 1333/2008, additives that are permitted in food under Directives 94/35/EC, 94/36/EC, and 95/2/EC and their conditions of use were entered in the Community list of food additives in Annex II to the regulation. To that end the compliance with their general and specific conditions of use was reviewed. The new EU lists amending Annexes II and III to Regulation EC 1333/2008 were adopted on 11 November 2011 The use of food additives already permitted in Directives 94/35/EC, 94/36/EC, and 95/2/EC will continue to be permitted until the application of Annex II as amended by Regulation (EU) No. 1129/2011 (1 June 2013)
	Guidance document: The Practical Guidance for Applicants was prepared to provide applicants with information that aims at facilitating the preparation and submission of applications for establishing or updating (adding, removing or changing conditions, specifications or restrictions) the Community lists. The links to other relevant documents are made in this guidance (http://ec.europa.eu/food/food/fAEF/authorisation_ application_en.htm) as well as additional guidance documents (EFSA Panel 2012)
	Approval process for a new substances: Applicants who wish to introduce new additives into the EU market, or seeking to revise existing provisions regulating individual additives already authorised within the EU, or seeking confirmation that an already approved additive made from a new source or by a new method of production is acceptable, must submit an application. Beside the Practical Guidance for Applicants there is also the Guidance on Submissions for Food Additive Evaluations by the SCF which provides details on the administrative and technical data required, and the range of toxicological tests generally required for new food additives, and on the format for formal submissions on additives. It must be noted that EFSA is preparing a new guidance document, which will replace the old one. The requirements for the application are also mentioned in Regulation (EU) 234/2011, which implements Regulation (EC) No. 1331/2008. The general requirements consist of: Administrative data Risk assessment data: Identity of the substance Information on particle size Presence of impurities Microbiological characteristics Proposed chemical and microbiological specifications Manufacturing process Methods of analysis in foods Reaction and fate in food Case of need and proposed uses Exposure Additives produced by microbiological processes Additives produced from genetically modified organisms Information on national authorisations Proposed normal and maximum use levels Toxicological data: General framework for the toxicological evaluation of food additives Study protocols Toxicological section of the dossier (core studies and other studies) Data reporting Review of results and conclusions Risk management data: Function and technological need Investigations on the efficacy Advantages and benefits for the consumer Information why the use would not mislead the consumer Compliance with specific conditions for sweeteners and colours
Food contact substances (e.g. components of packaging materials)	Definition: Food contact materials and articles are those which in their finished state are intended to be brought into contact with food, or are already brought into contact with food and intended for that purpose or can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal and foreseeable conditions of use. This includes packaging materials but also cutlery, dishes, processing machines, containers etc. The term also includes materials and articles that are in contact with water intended for human consumption but it does not cover fixed public or private water supply equipment
	Regulation: Framework Regulation (EC) No. 1935/2004. Food contact materials should be safe and should not transfer their components into the foodstuff in unacceptable quantities. The transfer of constituents from food contact materials into food is referred to as migration. In the context of the framework Regulation, specific Regulations on plastics (10/2011/EU), Active and intelligent (A&I) FCM substances (450/2009/EC), Recycling of plastics (282/2008/EC), Regenerate cellulose (Directive 2007/42/EC), ceramics (Directive 84/500/EEC) have been published. The specific Regulation on plastic FCM contains a positive list of monomers and additives, which can be used for their manufacture. The EU Food Contact Materials Database lists all approvals and conditions of use from the above Regulations and Directives. It is available at: https://webgate.ec.europa.eu/sanco_foods/main/?event=display/. To ensure the protection of the health of the consumer and to avoid any contamination of the foodstuff, two types of migration limits have been established for plastic materials: An overall migration limit (OML) of 60 mg (of substances) kg^–1 (of foodstuff or food simulants) that applies to all substances that can migrate from food contact materials to foodstuffs A specific migration limit (SML) applies to individual authorised substances and is fixed on the basis of the toxicological evaluation of the substance. The SML is generally established according to the acceptable daily intake (ADI) or the tolerable daily intake (TDI) set by the SCF in the past and by EFSA since 2003. To set the limit, it is assumed that every day throughout his/her lifetime, a person weighing 60 kg eats 1 kg of food packed in plastics containing the relevant substance at the maximum permitted quantity
	Guidance document: The guidance document on the submission of a food contact material for evaluation by EFSA by the Panel on Additives, Flavourings, Processing Aids, and Materials in Contact with Food is available at: http://www.efsa.europa.eu/en/scdocs/scdoc/21r.htm
	Approval process for a new substances: General requirements include: Identity of the substance Physical and chemical properties of the substance Intended use of the substance Authorisation of the substance (authorisation for use of the substance in EU member states and other countries) Migration data on the substance Data on the residual content of the substance in the food contact material Microbiological properties of the substance Toxicological data General requirements Core tests (not all types of studies may be applicable for the substance of interest – all tests should be carried out according to EU or OECD guidelines, and including good laboratory practice) Three mutagenicity studies in vitro 90-day oral toxicity studies, normally in two species Studies on absorption, distribution, metabolism and excretion Reproduction studies in one species Developmental toxicity studies, normally in two species Long-term toxicity/carcinogenicity, normally in two species Additional studies/special investigations may be required if prior knowledge, or structural considerations indicate that other biological effects such as peroxisomal proliferation, neurotoxicity, immunotoxicity or endocrinological events may occur Dermal or inhalation sensitisation studies, if applicable Depending on the chemical nature of the substance to be used in food contact materials, the list of required tests mentioned above may be modified Additional details available in the guidance document
Flavouring agents	Definition: Flavouring substances are defined chemical substances that include flavouring substances obtained by chemical synthesis or isolated using chemical processes, and natural flavouring substances. Flavourings are used to improve or modify the odour and/or taste of foods for the benefit of the consumer. Flavourings and food ingredients with flavouring properties should only be used if they fulfil the criteria specified in Regulation (EC) No. 1334/2008. They must be safe when used, and certain flavourings should therefore undergo a risk assessment before they can be permitted in food
	Regulation: New Regulation (EC) No. 1334 was adopted on 16 December 2008; however, as of 20 January 2011, this new regulation repeals Directives 88/388/EEC and 91/71/EEC. In order to protect human health, this Regulation should cover flavourings, source materials for flavourings and foods containing flavourings. It should also cover certain food ingredients with flavouring properties which are added to food for the main purpose of adding flavour and which contribute significantly to the presence in food of certain naturally occurring undesirable substances (hereinafter referred to as food ingredients with flavouring properties), their source material and foods containing them. The Regulation sets out flavourings and source materials for which an evaluation and approval is required. The Regulation prohibits the addition of certain substances as such to food and sets maximum levels for certain substances, which are naturally present in flavourings and in food ingredients with flavourings properties, but which may raise concern for human health. As of 20 January 2010, Regulation (EC) No. 1334/2008 on flavouring and certain food ingredients with flavouring properties amended the following: Council Regulation (EEC) No. 1601/91, Regulations (EC) No. 2232/96 and (EC) No. 110/2008, and Directive 2000/13/EC; however, Regulation (EC) No. 2232/96, laying down a Community procedure for flavouring substances, will continue to apply until the date of application of the Union list of flavourings and source materials. Smoke flavourings are regulated under Regulation (EC) No. 2065/2003
	Guidance document: The guidance document is available at: http://ec.europa.eu/food/food/fAEF/authorisation_application_en.htm
	Approval process for a new substances: After the completion of the evaluation programme but at the latest by 31 December 2010, the EU list of flavouring substances for use in or on foods in the EU shall be adopted [Article 5 (1) of Regulation (EC) No. 2232/96]. New substances follow the authorisation procedure laid down in Regulation (EC) No. 1331/2008 on the common authorisation procedure for food additives, food enzymes and food flavourings. Data requirements for flavouring substance application include: Manufacturing process Specifications Data on dietary and non-dietary sources Assessment of dietary exposure Assessment of the genotoxic potential of the flavouring substance Examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (if applicable)Other requirements are specified for other categories of flavouring substances (see the guidance document for full details)
Enzymes	Definition: A food enzyme is defined as a product obtained from plants, animals or microorganisms or products thereof including a product obtained by a fermentation process using microorganism containing one or more enzymes capable of catalysing a specific biochemical reaction and added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods. A food enzyme preparation is defined as a formulation consisting of one or more food enzymes in which substances such as food additives and/or other food ingredients are incorporated to facilitate their storage, sale, standardisation, dilution or dissolution (see Article 3 of Regulation (EC) No. 1332/2008). Regulation (EC) No. 1332/2008 does not include food enzymes used in the production of food additives falling within the scope of Regulation (EC) No. 1333/2008 or processing aids. The scope of this Regulation does not extend to enzymes that are not added to food to perform a technological function but are intended for human consumption, such as enzymes for nutritional or digestive purposes
	Regulation: Regulation (EC) No. 1332/2008 on food enzymes amends Council Directive 83/417/EEC, Council Regulation (EC) No. 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No. 258/97. This Regulation harmonises for the first time the rules for food enzymes in the EU. It applies from 20 January 2009, except labelling provisions which apply from 20 January 2010. National provisions concerning the placing on the market and the use of food enzymes and food produced with food enzymes continue to apply in the member states until the adoption of the Union list of enzymes applies. According to Regulation (EC) No. 1332/2008, only food enzymes included in the Community list may be placed on the market as such and used in foods, in accordance with the specifications and conditions of use provided for in Article 7
	Commission’s website: http://ec.europa.eu/food/food/fAEF/enzymes/index_en.htmEFSA’s guidance on food enzymes. Guidance document: http://www.efsa.europa.eu/en/scdocs/scdoc/1305.htm (EFSA 2009) http://www.efsa.europa.eu/en/efsajournal/pub/2193.htm
	Approval process for a new substances: Food enzymes shall be subject to safety evaluation by EFSA and approval via an EU list. A 2-year period has been fixed in this Regulation for submission of applications on existing enzymes and new enzymes. This period started on 11 September. The inclusion of a food enzyme in the EU list will be considered by the Commission on the basis of Article 6 of Regulation (EC) No. 1332/2008, namely the opinion from EFSA, and also other general criteria such as technological need and consumer aspects. For every food enzyme included in the positive list, specifications including the purity criteria and the origin of the food enzyme shall be laid down. Data required for risk assessment and for risk management of food enzymes are laid down in Regulation (EC) No. 234/2011
Processing aids	Definition: According to Article 3.2(b) of Regulation (EC) No. 1333/2088 a processing aid shall mean any substance which is not consumed as a food by itself; is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product
	Regulation: Processing aids are not harmonised at EU level with the exception of food enzymes used as processing aids (see above “enzymes”) and extraction solvents used in the production of foodstuffs and food ingredients (Directive 2009/32/EC). If a processing aid does not meet the criteria outlined in the definition (above), it can be regulated as a food additive, and the applicable Regulation (EC) No. 1333/2008 (regulations for food additive) would be applicable
	Guidance document: Refer to direct food additives
	Approval process for a new substances: There is no approval process for processing aids at the EU level
Nanoscale materials	Definition: The Commission has adopted a Recommendation for a definition of “nanomaterial” for regulatory purposes which it intends to integrate progressively and where necessary in the EU food Law (http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/1202& format=HTML& aged=0& language=EN& guiLanguage=en) (Stamm et al. 2012)
	Regulation: Existing legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials. Recently, specific provisions on the risk assessment of nanomaterials were introduced in EU legislation on food additives and food contact materials (EC 2009). A definition of “engineered nanomaterial” and a mandatory labelling requirement for all food ingredients containing such nanomaterials were introduced in the Regulation on Food Information to consumers. For example, food additives that are prepared through nanotechnology would be considered as new additives. In Article 12 of 1333/2008/EC, “when a food additive is already included in a Community list and there is a significant change in its production methods or in the starting materials used, or there is a change in particle size, for example through nanotechnology, the food additive prepared by those new methods or materials shall be considered as a different additive and a new entry in the Community lists or a change in the specifications shall be required before it can be placed on the market”
	Guidance document: In November 2009, the EC asked EFSA to prepare a guidance document on how to assess potential risks related to certain food-related uses of nanotechnology. Given the knowledge which is currently available, the guidance to be developed will provide practical recommendations on how to assess applications from industry to use engineered nanomaterials in food additives, enzymes, flavourings, food contact materials, novel foods, food supplements, feed additives, and pesticides. The proposed guidance document was published and comments requested. This guidance document was published in May 2011 (http://www.efsa.europa.eu/en/efsajournal/doc/2140.pdf)
	Approval process for a new substances: No authoritative statement found
	Efforts towards developing standards and regulations: The EC has given the Finnish Institute of Occupational Health (FIOH), and Finland as a country, the opportunity to coordinate the EU-funded NanoSafety Cluster, which is a cluster of projects promoting nanomaterial safety: This project includes all nanosafety-related areas, such as toxicology, ecotoxicology, exposure assessment, risk management and standardisation The objective of NanoSafety Cluster is to standardise and harmonise nanotoxicology research and research methods British Standards Institute (BSI): National committee NTI/1 on Nanotechnologies Safety of the Nano-Materials Interdisciplinary Research Centre (SnIRC) Develop internationally agreed in vivo and in vitro protocols and models for investigating the routes of exposure, bioaccumulation and toxicology of nanoparticles in humans and non-human organisms

Table 7. Regulatory framework of chemicals added to food in Japan.

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 Justice 2009)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 highThis 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

Table 8. Regulatory framework of chemicals added to food in Mexico.

Regulatory authority	Name: Ministry of Health (SSA) through the Federal Commission for the Protection against 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 human health 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/200607/146208414.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 flavours provided 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

Table 9. Regulatory framework of chemicals added to food in the USA.

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 contaminantsAs 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 1958^1 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.accessdata.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/GenerallyRecognizedasSafeGRAS/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

Table 10. Authoritative bodies among the target countries.

	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 (Administración 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 AdvisoryCommittee

Table 11. Participation of target countries in international organisations.

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Member of CODEX	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Member of the World Trade Organization	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Additional participation in international organisations	Mercosur	–	Mercosur	–	–	–	–	–	–

Table 12. Comparison of the regulations on direct food additives among the target countries.

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Definition of a food additive includes:	Any ingredient 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, the additive itself or its by-products become part of that food	Any substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which is intentionally added to a food to achieve one or more of the technological functions specified in Schedule 5. It or its by-products may remain in the food	Same as for Argentina^a	Any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food. It should be noted that a substance not present in the final food but which has affected the characteristics of that food would be regulated as a food additive	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	Substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose. Preparations obtained from foods and other natural source material that are intended to have a technological effect in the final food and which are obtained by selective extraction of constituents relative to the nutritive or aromatic constituents, should be considered additives	Substances 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	Substances added directly to food and non-alcoholic beverages during its manufacture in order to provide or intensify aroma, colour or flavour, to improve its stability or its preservation. Additives always perform a technological function in the final product	Substances that may become a component or otherwise affect the characteristics of food and which do not fit into any other category. Subcategories include direct food additives which are intentionally added directly to food and “Secondary direct additives” which may more commonly be known as processing aids
Definition of a food additive does not include:	Contaminants or nutrients that are incorporated into a food in order to maintain or improve its nutritional properties		Same as for Argentina^a	Any nutritive material used, recognised or commonly sold as an article or ingredient of food; vitamins, mineral nutrients and amino acids, other than those listed in Division 16; spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives; agricultural chemicals, other than those listed in Division 16, food packaging materials and components thereof; and drugs for administration to animals that may be food		Substances used for the purpose of imparting flavour and/or taste or for nutritional purposes. Substances considered as foods which may be used for a technological function, such as sodium chloride or saffron for colouring, and food enzymes		Contaminants, substances added to foods to maintain or to improve the nutritional quality, or sodium chloride	Contaminants or substances that are not intended to be added directly to food or have a technical effect, but which may reasonably be expected to become a component of food
Regulation	Mercosur regulations, GMC 11/06, GMC 34/10, and GMC 35/10	Food additives may only be added to food where expressly permitted in Food Standard 1.3.1	Same as for Argentina^a	Division B.16	Order No. 73: Measures for Administration of New Food Additives	1333/2008/EC	Food Sanitation Law	Regulation on Sanitary Control of Products and Services	21 CFR §§70–82, and §§170–189. Proposed rule published in 1997 (62 FR 18938)
Additional regulation details	Permitted list of food additives according to GMC 11/06. Food additives used according to GMP (GMC 34/10). Food additives used according to maximum levels (GMC 35/10)	Additives can only be added to food in order to achieve an identified technological function according to GMP. Some additives have specific permissions and maximum use levels allowed in food and other additives are limited to GMP. Specific flavouring agents, sweeteners, and colouring agents are regulated as food additives	Same as for Argentina^a	Permitted list of food additives	Permitted list of food additives	Community list of food additives 129/2011 and 1130/2011	Approved food additives list containing 411 additives (under Article 10 of Food Sanitation Law)	Permitted list of food additives
Approval process	Pre-market application is required. Submission to CONAL, who will forward petition to Mercosur’s Sub Work Group #3	Pre-market application is required	Pre-market application is required. Submission to ANVISA, which will forward petition to Mercosur’s Sub Work Group #3	Pre-market application is required for a new substances, for an extension of the use of a permitted food additive, changing the maximum level of a permitted food additive, or adding a new organism to the list of permitted sources of enzymes used as a food additive	Pre-market application is required for new food additives; a new food additive is an additive that is not included in the national food safety standards, not included in the public announcement of permitted use issued by the MOH, and whose scope of use or dosage is increased	Pre-market application is required (new common authorisation procedure under Regulation (EC) No. 1331/2008. Details found in Regulation (EU) 234/2011 that implements Regulation (EC) No. 1331/2008 and in Practical Guidance for Applicants. New additives, or seeking to revise existing provisions regulating individual additives already authorised, or seeking confirmation that an approved additive made from a new source or method is acceptable, must submit an application	Pre-market application is required for a new substance intended to be used as a food additive and for applying for revision of standards for use of a food additive	Pre-market application is required	Pre-market application in the form of a food or colour additive petition. Exempt from food additive petition if prior sanctioned or use determined to be GRAS

Note: ^aRegulations pertaining to Argentina follow Mercosur Standards. Brazil also follows Mercosur Standards.

Table 13. A comparison of the regulations on novel foods among the target countries.

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Definition	No formal definition; however, novel foods are recognised in practice	A non-traditional food with no history of safe use and food requires an assessment of public health and safety considerations. Non-traditional food is defined as a food that does not have a history of human consumption in Australia/New Zealand; a substance derived from a food, where that substance does not have a history of human consumption in Australia/New Zealand other than as a component of that food; or any other substance, where that substance, or the source from which it is derived, does not have a history of human consumption as a food in Australia/New Zealand	Foods with no history of use in the country; foods containing novel ingredients, except those listed in Table 1; 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 food offered in the form of capsules, pills, tablets and the like	(1) Substance, including a microorganism, that does not have a history of safe use as a food; (2) a food that has been manufactured, prepared, preserved or packaged by a process that has not been previously applied to that food, and causes the food to undergo a major change; and (3) a food that is derived from a plant, animal or microorganism that has been genetically modified	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	Novel foods are foods and food ingredients that have not been used for human consumption to a significant degree within the Community before 15 May 1997	Not defined	Not defined	Not defined
Regulation	No authoritative statement found	Food Standard 1.5.1.	Resolution No. 16	Division B.28	Order No. 56 Administrative Measures on Novel Food	258/97/EC	No authoritative statement found	No authoritative statement found	Regulated as direct food additives or food contact substances depending on use
Additional regulation details		This standard prohibits the sale of these foods unless they are listed in Food Standard 1.5.1 and comply with any special conditions of use		This provision prohibits the sale of these foods unless the manufacturer or importer of the novel food (1) has notified the Director in writing of their intention to sell or advertise for sale the novel food (which includes providing data to support the safety of the novel food); and (2) has received a written notice from the Director (called a Letter of No Objection)		Foods commercialised in at least one member state before the entry into force of the Regulation on Novel Foods on 15 May 1997 are on the EU market under the “principle of mutual recognition”
Approval process	Requests for modification to follow guidance document GMC 26/03. If the product requested is considered a novel food in Europe its inclusion will be delayed until the novel foods chapter is written, approved and incorporated to the CAA	Pre-market application is required. FSANZ is reviewing the regulation of novel foods and nutritive substances. Criteria for “eligible foods” (i.e. foods in the wider sense including ingredients, additives and other substances added to food) is proposed. Any non-eligible foods would be prohibited and will require an appropriate safety assessment	Pre-market application is required	Pre-market application is required (safety assessment)	Pre-market application is required	Pre-market application is required (safety assessment)	No authoritative statement found	No authoritative statement found	Regulated as direct food additives or food contact substances depending on use

Table 14. Comparison of the regulations on food contact substances among the target countries.

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Definition	Primary container or primary wrapping or container. Container that is in direct contact with food	Any materials in contact with food, including packaging material, which may include materials such as moisture absorbers, mould inhibitors, oxygen absorbers, promotional materials, writing or other graphics	Same as for Argentina^a	Anything in which any food is wholly or partially contained, placed or packed	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	Food contact materials and articles are those which in their finished state are intended to be brought into contact with food, or are already brought into contact with food and intended for that purpose or can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal and foreseeable conditions of use. Includes packaging materials cutlery, dishes, processing machines, containers, etc. The term also includes materials and articles in contact with water intended for human consumption. Fixed water installations are excluded, however	Not defined	Not defined	Any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting or holding food if such use is not intended to have a technical effect in such food
Regulation	Mercosur GMC 32/07	Food Standard 1.4.1 and 1.4.3	Same as for Argentina^a	Division 23, Part B	Hygienic Standards for Additives Used in Food Containers and Packaging Materials (GB 9685)	1935/2004/EC. This is the framework Regulation with general provisions for all FCM	No authoritative statement found	No authoritative statement found	General: 21 CFR §170–171. Existing indirect additive approvals: 21 CFR §§174–178 and 186. FCS notification regulation: 21 CFR 170.3(e)(3). FCS Threshold of regulation: 21 CFR 170.39. Proposed rule published in 1997 (62 FR 18938) for GRAS determinations
Additional regulation details	There is a positive list of substances that are added to plastics to achieve a technical effect in the final product	Food contact substances may be placed in contact with food, provided such articles or materials, if taken into the mouth, are not capable of being swallowed or of obstructing any alimentary or respiratory passage and are not otherwise likely to cause bodily harm, distress or discomfort	Same as for Argentina^a			(EU) 10/2011 is the specific Regulation for plastic FCM with a positive list of substances. (EC) 450/2009 is the specific Regulation for A&I FCM. Regulation (EC) 282/2008 is specific for Recycling of plastics. Directive 2007/42/EC is specific for Regenerate cellulose film. Directive 84/500/EEC is specific for ceramics. For all those materials for which no specific measure is adopted at the EU level, national legislation in member states may exist
Approval process	Same process as direct food additives	Applications for food packaging materials are generally unnecessary if there is approval in the EU or US. Plastic materials for food contact use may comply with the voluntary Australian Standard AS 2070-1999	Same as for Argentina^a	Voluntary submission to the Health Products and Food Branch (HPFB) for a pre-market assessment of their chemical safety	Pre-market application is required	Pre-market application is required only for substances for which a positive listing is not set out specifically. Regulation at the EU includes plastics, A&I FCM and Regenerated cellulose film. For the other materials the general provisions of the framework Regulation 1935/2004 apply and specific measures may exist at the national level	JHOSPA established the industry’s voluntary standards composed of a positive list of raw materials that can be used safely for food utensils, containers, packaging materials, and Standard Methods of Analysis with specifications for each resin	Although no specific process, most major customers require legal confirmation that the compound is allowed. Any approval should be obtained through technical consultation	Pre-market request for review in the form of a food contact notification, a threshold of regulation exemption request, or a GRAS determination. Notification to the USFDA of GRAS determinations is voluntary. The USFDA review of GRAS notifications is not considered a formal approval

Notes: ^aRegulations pertaining to Argentina follow Mercosur Standards. Brazil also follows Mercosur Standards.JHOSOA, Jopan Hygienic Orefin and Styrene Plastics Association.

Table 15. Comparison of the regulations on flavouring agents among the target countries.

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^a	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^a	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

Note: ^aRegulations pertaining to Argentina follow Mercosur Standards. Brazil also follows Mercosur Standards.

Table 16. Comparison of the regulations on enzymes among the target countries.

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Definition	Enzymes or enzyme preparations are substances of animal, plant or microbial origin that act by promoting the desirable chemical reactions	Not specifically defined in the Food Standards Code	Enzymes or enzyme preparations are substances of animal, plant or microbial origin that act by promoting the desirable chemical reactions	Not specifically defined in the Food and Drug Regulations	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 food enzyme is defined as a product obtained from plants, animals or microorganisms, or products thereof including a product obtained by a fermentation process using a microorganism containing one or more enzymes capable of catalysing a specific biochemical reaction and added to food for a technological purpose at any stage of the manufacturing, processing, preparation, treatment, packaging, transport or storage of foods	Not defined	Biological catalyser protein substance produced by live cells that catalyse specific reactions in diverse production processes	Not defined
Regulation	CAA, Chapter XVI, Articles 1261, 1262 and 1263. Enzymes regulations are not harmonised in Mercosur	Enzymes may be used in the course of manufacture of any food, provided the enzyme is derived from the corresponding source or sources specified in the tables of Sections 15–17 of Food Standard 1.3.3 (standard for processing aids)	Resolução RDC # 26 dated 27 May 2009 (on the ANVISA site). Enzymes regulations are not harmonised in Mercosur	Enzymes are regulated as food additives or may be considered processing aids depending on their context of use	Enzymes are regulated as food additives	Regulation (EC) No. 1332/2008 (Regulation (EC) No. 1332/2008 does not include food enzymes used in the production of food additives within the scope of Regulation (EC) No. 1333/2008 or processing aids). The scope of this regulation does not extend to enzymes that are not added to food to perform a technological function but are intended for human consumption such as enzymes for nutritional or digestive purposes	Enzymes listed as a permitted food additive can be used in food under the conditions indicated	Enzymes are regulated as food additives	Enzymes are regulated as substances added directly to food, specifically as direct food additives, secondary direct food additives, or GRAS substances
Approval process	Application submission to CONAL	Same process as processing aids	Application submission to ANVISA	Same process as direct food additives and processing aids	Same process as direct food additives	New common authorisation procedure under Regulation (EC) No. 1331/2008 and Regulation (EC) No. 234/2011	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

Table 17. Comparison of the regulations on processing aids among the target countries.

	Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Definition	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	Substances used in the processing of raw materials, foods or ingredients to fulfil a technological purpose relating to treatment or processing but does not perform a technological function in the final food; and the substance is used in the course of manufacture of a food at the lowest level necessary to achieve a function in the processing of that food, irrespective of any maximum permitted level specified	Same as for Argentina	Substance used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food	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	Any substance that is not consumed as a food by itself; is intentionally used in the processing of raw materials, foods or their ingredients to fulfil a certain technological purpose during treatment or processing; and may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product	Substances added during processing food which are: (1) removed from food before completion of the food; (2) derived from raw materials of food and converted into components normally included in food but do not significantly increase the amounts of 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	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	Substances that have a technical effect in food during processing but that are not intended to have an ongoing technical effect in the food
Regulation	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	Food Standard 1.3.3, a general standard for 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	No specific regulations on most processing aids. If a substance does not meet the specific criteria for the definition of a processing aid as outlined above, it may be considered to be a food additive and the regulations pertaining to food additives would be applicable	Processing aids are regulated as food additives	Processing aids are not regulated at the EU level, with the exception of extraction solvents used in the production of foodstuffs and food ingredients (Directive 2009/32/EC). If a substance does not meet the criteria for the definition of a processing aid, as outlined in the definition above, it can be considered as a food additive and Regulation (EC) No. 1333/2008 would be applicable	Processing aids are regulated as food additives	Processing aids are regulated as food additives	Regulated as food additives or in some cases as food contact substances. When approved in the regulations, they are known as “secondary direct additives”
Approval process	Application submission to CONAL	Pre-market application is required	Application submission to ANVISA	May seek a so-called “Letter of Opinion” which confirms that, under its conditions of use, the substance is considered a processing aid and use is acceptable	Same process as direct food additives	As they fall out of the scope of EU legislation, there is no process for their approval. Nevertheless, member states or the COM may address the issue of their safety to EFSA	Same process as direct food additives	Same process as direct food additives	Same process as substances added directly to food except where the USFDA may consider them to be food contact substances. See “direct food additives” and “food contact substances” above

Table 18. Summary of the developing approaches to risk assessment of nanomaterials among the target countries.

Argentina	Australia/New Zealand	Brazil	Canada	China	European Union	Japan	Mexico	USA
Argentina has established or is participating in various groups for the development of standards in the area of nanomaterials (see nanoscale materials under Table 1 for further details)	Any new food substances manufactured using nanotechnologies that may present safety concerns will have to undergo a comprehensive scientific safety assessment under the appropriate standard before they can be legally sold in those countries (see nanoscale materials under Table 2 for further details)	Brazil has established or is participating in groups for the development of standards in the area of nanomaterials (see nanoscale materials under Table 3 for further details)	Health Canada is using existing legislative and regulatory frameworks to regulate applications of nanotechnology, but it recognises that new approaches may be necessary in future to keep pace with the advances in this area, particularly given that there currently is inadequate information on risks associated with nanomaterials. Various acts (and regulations contained therein) are envisioned by Health Canada to be relevant to nanomaterials. Health Canada has indicated that in order to identify and assess potential risks and benefits (where applicable) of nanomaterials, a list of documents is required). For further details, see nanoscale materials under Table 4.	China has established or is participating in various groups for the development of standards in the area of nanomaterials (see nanoscale materials under Table 5 for further details)	EFSA published an opinion on nanotechnologies and a guidance document on risk assessment was published in May 2011. Existing legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials. Recently, specific provisions on risk assessment of nanomaterials were introduced in EU legislation on food additives and food contact materials. A definition of “engineered nanomaterial” and a mandatory labelling requirement for food ingredients containing such nanomaterials were introduced. Examination of the definition for food additives already incorporates nanoscale materials (i.e. food additives prepared through nanotechnology would be considered new food additives). EFSA considers the risk assessment paradigm applicable to nanomaterials, but suggests that a risk assessment of nanomaterials in food and feed take into consideration specific properties of nanomaterials in addition to those common to the equivalent non-nanoforms. For further details, see nanoscale materials under Table 6.	Japan has established or is participating in groups for the development of standards in the area of nanomaterials (see nanoscale materials under Table 7 for further details)	No specific documents on the regulation of nanomaterials for food-related uses were identified	The USFDA issued draft guidance on nanotechnology and food in April 2012. There is no formal definition for “nanotechnology” or “nanoscale” at this time, however the guidance contains considerations the USFDA takes into account when evaluating nanomaterials. New nano-engineered 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. See “food contact substances” and “food additives” above. For further details see nanoscale materials under Table 9.

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