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”	Not defined; however, there are standards of identity and composition for certain flavouring preparations in Division B.10	Food additive and food ingredient necessary for producing, preserving and applying the flavourings. The additive added to food (except flavour enhancer) does not play the role for final aromatic products	Flavourings are products that are not intended to be consumed as such, but which are added to food in order to impart or modify odour and/or taste of food. Flavouring substances are chemically defined substances obtained by chemical synthesis or isolated using chemical processes, and natural flavouring substances	Natural flavouring agents are defined as food additives intended for use in flavouring food and are substances obtained from animals or plants, or mixtures thereof	Substance or blend of substances of natural origin, identical to natural or synthetic with or without solvents and with or without the addition of other additives that are used to give or intensify flavours or aromas to products	Not defined; regulated as substances added directly to food, specifically as direct food additives and GRAS substances
Regulation	Mercosur GMC 10/06	Food Standard 1.3.1 Section 11. FSANZ does not require a risk assessment to be done if the flavours are GRAS by FEMA or others	Same as for Argentina”	Division B.10	National Standard of the People's Republic of China Flavourings (TBT/N/CHN/575)	1334/2008/EC (framework Regulation 2065/2003/EC (smoke flavourings)	Food Sanitation Law	Regulated as food additives	Labelling of flavours: 21 CFR §101.22. Lists of flavours approved in the regulations: 21 CFR §§172, 182 and 184. Proposed rule published in 1997 (62 FR 18938)
Additional regulation details	Permitted list of flavouring substances (natural or synthetic)		Same as for Argentinaa	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.