Food additive legislation

Another concept had to be prepared in completion of Directive 88/388/EEC [79], Article 6, in accordance with the procedure set out in Article 10 1. The list of substances or materials authorised in the Community as  

In general a food additive may be permitted in the EU if the European Food Safety Authority [74[ has found that it is harmless to the health of consumers and that it has an established ADI (acceptable daily intake). Besides this, there must be a technological need for the substance. 

Presently food additives have been permitted in the EU by 3 directives in general or for special food use. The additives are divided in the following categories sweeteners, colours and other. Specific criteria of purity for sweeteners and colours have been published in 1995 (95/31/EC last amended by 2004/46/EC, and 95/45/EC, last amended by 2004/47/EC), the other ones in 1996 (96/77/EC, last amended by 2004/ 45/EC). 

An amendment has been adopted by the Council on 16.6.1994 and published on 10.9.1994 allowing national derogations for traditional food products [75]. 

A revision of the Framework Directive by a regulation has been under discussion in Bmssels since 2002 and there will be a regulation on enzymes. 

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European Union Food Additive Legislation (available from http //europa.eu.int/comm/ food/food/chemicalsafety/additives/comm legisl en.htm). 

Safety assessment of preservatives, as for other food additives, is based on reviews of all available toxicological data, including observations in humans and in animal models. From the available data, a maximum level of an additive that has no demonstrable toxic effect is determined. This is called the no observed adverse effect level (NOAEL) and is used to determine the acceptable daily intake (ADI). The ADI refers to the amount of a food additive that can be taken daily in the diet, over a lifetime span, without any negative effect on health. Food additive legislation adopted by the European Union is included in several European Parliament and Council Directives (Directives 95/2/EC and 2006/52/ EC, which have been replaced by the Regulation (EC) 1333/2008 in 2011). 

As for other food additives, the ADI for preservatives has been calculated because, as already mentioned, if they are consumed in inappropriate quantities they may have adverse effects on human health. Legislation on food additives is necessary to establish specific conditions for their use thus, food additive legislation has been developed by the European Union and included in several European Parliament and Council Directives [7,8]. The ADI is 25 mg/kg for sorbic acid [9] and 5 mg/kg body weight for benzoic acid [10]. 

The choice of lecithin is based on European Food additive legislation. Acetylated and hydroxylated lecithins may be applicable in other continents. Stand = standard liquid lecithin, PC fraction = phosphatidylcholine-... 

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. 

Color additives are naturally and synthetically derived. In the past 20 years, consumers have become increasingly aware of the ingredients in their foods and they desire foods be as natural as possible. This fact combined with technological developments have fueled the increases in uses of naturally derived colors. Moreover, additives must be safe and stable in food matfices. Legislation has established which colorants may be used as food additives, taking into account toxicity of compounds and methods of assessment. The European Union currently allows the use of 13 naturally derived colors but 26 colors are exempt from certification... 

Since food colorants are used as food additives, they must also comply with legislative requirements. Food legislation in the European Union (EU) and the United States (US) differs with regard to additives and labeling. Therefore, this section provides an overview of legislation in the EU (Section 7.1.6.1) and the US (Section 7.1.6.2) and discusses colorants permitted for use in food products according to the different requirements. 

Food additives are authorized at the EU level for all 15 member states, as well as for Norway and Iceland. The use of food additives is controlled by legislation that is harmonized across the EU. Domestic legislation in each member state is based on the various additive directives incorporated into specific national legislation. The community legislation on food additives consists of the following directives ... 

Council Directive 89/107/EEC, as amended by Directive 94/34/EC ° — This framework directive provides umbrella legislation under which the individual additives directives are developed. It includes a definition of a food additive, exclusions from the scope of the definition, and a list of food additive categories, one of which is colors. Additionally, general criteria for use of food additives are described. ... 

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

The EU directive includes a list of colorants (coded as E numbers, from E 100 to E 180) suitable for use as food additives and specifies limits of impurities. For details about their codes, sources, and properties see Table 7.2.1. An update of EU legislation on food-related issues was published recently. In addition to the numbered E colorants, other new natural colors for use in the future as natural colorants are under examination (see positions 25 through 34 in Table 7.2.1). ... 

For nonparenteral/ophthalmic use the plastics should meet the requirements of relevant EU food use legislation, and if the material has not been so approved then toxicology data will be required. If the container is to be used for ophthalmic or parenteral products then compliance with the relevant requirements of the Ph Eur or other relevant member state pharmacopeial requirements will be required or appropriate additional data provided. 

The control of food additives has been much discussed in newspapers and other parts of the media and yet, rather surprisingly, there have been few scientific books about additives. There have been detailed reports of the work of expert committees such as the Joint FAO/WHO Expert Committee on Food Additives (e.g. WHO, 2000) and informative commentaries on individual additives and legislative controls, notably those in the European Union (EU) (e.g. Leatherhead Food Research Association, 2000). There have also been articles on work to harmonise worldwide control of additives (Keefe et al., 2000). 

In order to use the food consumption data to predict intakes of food additives it is necessary to combine them with information about the levels in foods. Data on usage have been described above and at the simplest level it is usual to use the maximum permitted levels from national or supra-national legislation. 

Classification of substances often results in some unsatisfactory results, and food additives are no exception. In the evaluation of food additives, functional use is a helpful way of categorising additives. Functional use and level of incorporation are important considerations in assessing the likely intake by consumers. Use and intake level are clearly linked, as the functional effect depends on the amount added. The level of use may be self-limiting by organoleptic considerations. However, whilst it is logical to have functional use as a classification, many additives have more than one functional use, and some could be described as having multiple uses. International documentation differs in its treatment of functional uses. The European Council legislation has three broad classifications ... 

Historically, the so-called safety factor approach was introduced in the United States in the mid-1950s in response to the legislative needs in the area of the safety of chemical food additives (Lehman and Fitzhugh 1954). This approach proposed that a safe level of chemical food additives could be derived from a chronic NOAEL from animal studies divided by a 100-fold safety factor. The 100-fold safety factor as proposed by Lehman and Fitzhugh was based on a limited analysis of subchronic/chronic data on fluorine and arsenic in rats, dogs, and humans, and also on the assumption that the human population as a whole is heterogeneous. Initially, Lehman and Fitzhugh reasoned that the safety factor of 100 accounted for several areas of uncertainty ... 

Di-/ -butyl-4-methylphenol [25377-2/ -i 2,6-Di-/ -butyl-4-methylphenol (di-/ -butyl-/>-cresolDi-/ -butyl- >-cresol or butylated hydroxytoluene (BHT)) is most commonly used as an antioxidant in plastics and mbber. Use in food is decreasing because of legislation and it is being replaced by butylated hydroxy anisole (BHA) (see Antioxidants Food additives). 

Across the globe, countries employ their own legislative controls for food ingredients, but there are two main regions that exert great influence upon world opinion on this issue the European system controlled by the European Parliament with designated E-numbers for permitted food additives, and the system used in the United States where at the federal level the Federal Food, Drag and Cosmetic Act (FFDCA) lays down the framework for food safety. 

Statutory legislation to control the levels of such substances in food has been introduced in the UK and elsewhere. In more recent years, other potentially toxic elements have come into focus. Lead, cadmium and mercury have been the subject of much monitoring of the food chain and other metals, in particular aluminium, are continuing to attract attention. Nitrate and nitrite in food from food additive use is regulated across the European Union, but its presence in food crops has raised concerns. 

Section 409 of the Act requires that a food additive be shown to be safe under its intended conditions of use before it is allowed in food. Congress recognized the Impossibility of determining with absolute certainty that no harm shall result from the intended use of an additive. Therefore, the legislation did not follow a standard of absolute safety. Congress described the safety standard as follows (2) ... 

Use of food additives is widespread and diverse, although some countries have undertaken to reduce it. Denmark was the first to introduce, in 1973, a legal ban on some food additives. In 1984, the ban was extended on food dyes. Norway and Sweden followed the Danish legislative solutions, introducing additional restrictions on food preservatives. However, none of the aforementioned countries has been consistent in imposing these laws and, as a result, consumption of food additives has increased (Madsen 1997). 

Figure 12-5 The Consultative Process Used in the Development of EU Food Legislation. Source Reprinted with permission from R. Haigh and P. Deboyser, Food Additives and the European Economic Community, in International Food Regulation Handbook, R.D. Middlekauff and P. Shubik, eds., 1989, by courtesy of Marcel Dekker, Inc.

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