European Union approved additives

The main intense sweeteners currently permitted for use in the major markets of Europe and the United States are not natural and have had to go through a food additive approval procedure. Within the European Union, approval is controlled by the EU Commission, with the aim of achieving harmonisation across member states. The current system allows for temporary national approval (and this was the mechanism by which sucralose was approved in the United Kingdom). This in turn allows the other EU countries time to review the data and either approve or reject each product within a specified period. Within the European Union, approved sweeteners are assigned an E number and can also be assigned a maximum use level within a specific application (e.g. soft drinks). The maximum use levels for sweeteners in soft drinks in the European Union are given in Table 4.2. 

This section aims to present a brief overview of the most significant literature covering general aspects of common techniques used currently for natural food colorant analysis, and specifically current protocols applied to analyze minor natural food colorants whose chemical and technological properties are presented in Sections 2.3 and 7.2. We consider here only pure colorants or extracts that seek or have received approval for use as food additives in the United States and European Union. Legislative aspects are detailed in Sections 7.1 and 7.2. 

Absence of carcinogenity, genotoxicity, developmental and reproductive toxicity and of chronic toxicity effects at low exposure levels are indispensable prerequisites for food additive approvals. All substances approved in the European Union or the USA or deemed generally recognised as safe (GRAS) in the USA fulfil this requirement. 

Polydextrose behaves as a dietary fibre and is approved as a fibre in the United States, Japan and Belgium. Its status as a dietary fibre in the rest of the European Union is currently a little unclear. It is permitted for food use in the United Kingdom under The Miscellaneous Additives Regulations and has the E-number E400. 

European Union. In the EU colorants which may be used in foodstuff are regulated in 94/36/EC On Colours for Use in Foodstuff. (Table 5.5). Food additives listed in EEC Directives are assigned E numbers. Approved dyes within the EU are also defined as food additives and thus carry E numbers. A substance with an E code and number is valid throughout the EU (E = EEC number of food additives). 

The PED has definitely the merit that it supersedes, from a legal perspective, the very many old local codes in all European member states, codes such as BS (UK), ISPESL (Italy), TUV (Germany), Stoomwezen (the Netherlands), and UDT (Poland). Compliance with PED allows the manufacturer to CE mark their product as required by the European Union (EU) and is an assurance for the end-users that the selected material to protect their systems is in accordance to the law. Manufacturers approvals, however, are limited in time and need to be renewed regularly, which is an additional guarantee. Therefore, even with the most reputable manufacturers, it is always wise to check the status of the approvals to make sure they have not expired. 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

Fluoropolymer resins are covered in the United States by Food, Drug and Cosmetic Act 21 CFR and 177.1380 and 177.1550 and in the European Union by the EC Directive 90/128 [5]. Several fluoroplastics (e.g., PTFE, PEA, FEP) have been approved by the FDA for contact with food. Additives, such as stabilizers, antioxidants, and pigments, must be approved to meet the food additive regulations if they have no prior clearance [5]. 

For these reasons the Joint FAO/WHO Expert Committee on Food Additives (JECFA) considered that the tumours in the rat bladder were not relevant to humans. Both JECFA and the European Union Scientific Committee on Food concluded that saccharin was not a hazard and approved it for use. Similarly the FDA withdrew their proposal to ban saccharin in 1991. 

Fluoropolymer resins are covered by Federal Food, Drug and Cosmetic Act, 21 CFR 177.1380 177.1550 in the United States and EC Directive 90/128 in the European Union. The US Food and Drug Administration has approved many fluoropolymers (e.g., PTFE, PFA, and FEP) for food contact. Additives such as pigments, stabilizers, antioxidants, and others must be approved under a food additive regulation if they do not have prior clearance. 

In the European Union (EU), there are lists of approved additives, designated E numbers as described in Table 4.2. The E stands for EC (European Community) and these ingredients have been tested for safety (allergenicity) and passed for use in the EU. Numbers that are not prefixed with an E may be allowed in the UK, for example, but may not have been passed for use in all EU countries. In the USA a different system is used which includes numbers instead. Therefore, for formulation purposes, the up-to-date lists of permitted flavouring and... 

The use of nitrates and nitrites in food (such as vegetables, meat products, and cheese) is regulated in the European Union (Spanish Royal Decree 1118/2007 approving the positive list of additives other than colorings and sweeteners for use in the manufacture of food products and conditions of use). This statute establishes and differentiates between the maximum amount that may be added during manufacture... 

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