European Union additives

Sorbic acid is produced and marketed in the United States in the dust-free powder form. The 1995 tmckload (TL) Hst price was U.S. 8.60— 8.80/kg for food grade and 12.41/kg for National Formulary (NF) grade. Water-soluble potassium sorbate is marketed as a powder or as granules. The 1995 TL Hst price was U.S. 7.90— 8.15/kg for food grade and 11.75/kg for NF grade. In addition to Eastman, the only U.S. producer, there are four Japanese producers and two producers in the European Union. Worldwide consumption in 1994 was approximately 2700—3000 metric tons and the nameplate productive capacity was approximately 2900—3100 metric tons. 

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. 

Detailed information about carotenoids found in food or extracted from food and evaluated for their potential as food colorants appeared in Sections 4.2 and 6.2. We would like to mention some new data about the utilization of pure carotenoid molecules or extracts as allowed food additives. Looking to the list of E-coded natural colorants (Table 7.2.1), we can identify standardized colorants E160a through f, E 161a, and E161b as natural or semi-synthetic derivatives of carotenoids provided from carrots, annatto, tomatoes, paprika, and marigold. In addition, the extracts (powders or oleoresins) of saffron, - paprika, and marigold are considered more economical variants in the United States and European Union. 

In the past 20 years, consumers have increasingly considered synthetic colorants undesirable or harmful but they are still used extensively in many food products. Official organizations in the United States and European Union have restricted the use of some synthetic colorants as additives in foods (see Table 7.3.1 in Section 7.3). The list of allowed colorants has been reduced to 21. Section 7.3 also discusses details about their structures. 

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. 

The permission to use food colorants is bound to their safety and is strictly regulated by specific laws controlled at national and international levels. Individual country laws differ according to specihc protocols, doses, and interpretations. Currently, the European Union (EU) has authorized 43 colorants as food additives and the United States (US) has authorized about 30. ... 

Colorants were the first food additives subjected to governmental regulation in the United States (US). After successive toxicological evaluations, the Food and Drug Administration established a list of permitted colorants and lakes. Only 7 synthetic pigments (and 2 others with restrictions) and 6 of their lakes are now permitted as food colorants in the US while 17 are permitted in the European Union (EU) see Table 7.3.L - ... 

All individuals and companies have a duty of care to their neighbours, and to the environment in general. In the United Kingdom this is embodied in the Common Law. In addition to this moral duty, stringent controls over the environment are being introduced in the United Kingdom, the European Union, the United States, and in other industrialised countries and developing countries. 

This book includes the results of a Coordination Action funded by the European Union called RISKCYCLE (risk-based management of chemicals and products in a circular economy at a global scale). This project (n. 226552) started the 1st of September of 2009 and ended on the 31st of August 2012. Its main objective was to establish and coordinate a global network of European and international experts and stakeholders from worldwide countries (e.g., European countries, China, India, Brazil, Vietnam) to assess the risks of hazardous chemicals and additives contained in different daily products. 

Oxytetracycline is a broad-spectrum antibiotic, which has been used worldwide in veterinary medicine and in aquaculture for the prevention and treatment of disease and as feed additives to promote growth. The maximum residue limits (MRLs) of OTC and relative substances as described by the US Food and Drug Administration [66] and European Union [67] are presented in Table 4. 

Most countries also have regulations analogous to the U.S. regulations. For example, the European Union issued the "Seveso II Directive in 1996 (replacing the original 1982 directive) which requires all member states to implement regulations for the control of major accident hazards. Also, in addition to the U.S. government requirements,... 

Plastics Additives and Compounding 6, No.2, March-April 2004, p.26-9 FLAME RETARDANTS EUROPEAN UNION RISK ASSESSMENTS UPDATE... 

The European Commission has adopted a directive which limits the emission of volatile organic compounds due to the use of organic solvents in certain industrial activities. The directive sets emission limits for these compounds and lays down operating conditions for industrial installations. In addition, under the directive, new installations must be registered or be authorised to carry out their activities. Further requirements of the directive are listed. EUROPEAN COMMUNITY EUROPEAN UNION WESTERN EUROPE-GENERAL... 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

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). 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

Consideration of the above requirements confirms that in future all methods must be fully validated if at all possible, i.e. have been subjected to a collaborative trial conforming to an internationally recognised protocol. In addition this, as described above, is now a legislative requirement in the food sector of the European Union. The concept of the valid analytical method in the food sector, and its requirements, is described below. 

EUROPEAN UNION, Council Directive 93/99/EEC on the Subject of Additional Measures Concerning the Official Control of Foodstuffs, O.J. L290 of 24.11.1993. 

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. 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

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