Standards, food additive

Parallel method comparisons are used to establish the validity of a new method developed for five organic pharmaceutical compovmds, food colors, and color additives. The standard methods such as the Japanese Standard Food Additives and Japanese Standard of Cosmetic Ingredients method, based on volumetric and gravimetric titration, have been used to establish new methods developed for the determination of I, Cl, Br, and SO4 in food colors. The results obtained indicate good agreement in both accuracy and precision for procedures based on the oxygen flask method as compared with the standard methods. In addition to anion elemental analysis, method validation has also been carried out for metal analysis such as that of Ce(III), Th(IV), and U(VI), with the results showing acceptable limits of variation. 

JSFA, Japanese Standard Food Additives JSCI, Japanese Standard of Cosmetic Ingredients. 

Fine chemicals are generally considered chemicals that are manufactured to high and weU-defined standards of purity, as opposed to heavy chemicals made in large amounts to technical levels of purity. Fine chemicals usually are thought of as being produced on a small scale and the production of some fine chemicals is in tens or hundreds of kilograms per year. The production of others, especially fine chemicals used as dmgs or food additives (qv), is, however, in thousands of metric tons (see Pharmaceuticals). For example, the 1990 U.S. production of aspirin [50-78-2] and acetaminophen [103-90-2] was on the order of 20,500 t and 15,000 t, respectively. 

Action to compile standards for food-grade chemicals did not take place until after the enactment of the Food Additives Amendment to the Food, Dmg, and Cosmetic Act in 1958 (13). This amendment stated that substances added to foods should be of food-grade quaUty, but it contained no criteria by which such quahty could be determined (see also Colorants forfood, drugs, cosmetics, and medicaldevices). The Food Protection Committee of the National Academy of Sciences—National Research Council (NAS—NRC) therefore undertook the project of producing a Food Chemicals Codex. 

FDA Quality Standards. Although standards for many dmgs and biologicals are included in the USP—NF, and for many food additives in the FCC, the FDA also estabhshes some specifications of its own. In the dmg field, specifications and testing methods for antibiotics and biologicals are set by the FDA. Also, specifications and testing methods are prescribed for colorants. Many food-additive petitions are granted with the requirement that certain specifications are met. 

Center for Eood Safety and AppHed Nutrition (CESAN). This center is responsible for the regulation and approval of food for human consumption, food additives, color additives, and cosmetics. Although CESAN does not regulate meat and poultry, it does set safety and sanitation standards for supermarkets, restaurants, and other retail food estabUshments. 

To further improve the general safety standards, the Delaney Clause was included in the Pood Additives Amendment of 1958. The Delaney Clause states that no food additive or color additive can be deemed safe if it has been found to induce cancer when ingested by humans or animals (23). The Clause acts as an absolute prohibition on the use of any additive found to cause cancer without any regard for whether, or to what extent, the substance is hazardous to human health. As scientific advances continue, both in the realm of food technology and analysis of previously undetected contaminants, the... 

Specifications and Standards Test Methods. Hydroxyethylcellulose is included in the Hst of materials that are in compHance with requirements of the U.S. EDA for use in adhesives and in resinous and polymeric coatings employed on the food-contact surfaces of metal, paper, or paperboard articles, and other substrates intended for use in food packaging as specified in CER 21. HEC made dispersible by cross-linking with glyoxal is cleared only as an adhesive and as a component of paper and paperboard in contact with food. It has not been cleared as a direct food additive. 

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. 

C12 to C20, primarily Ci6 to ( is), used as surface lubricants in the manufacture of food-contact articles. The method, which uses ethyl palmitate (Eastman Chemicals No. 1575 Red Label) as an internal standard, has been validated at 200 ppm total FAME [185]. Other FAME standards (methyl palmitate, methyl stearate, methyl oleate, methyl linoleate and methyl linolenate) are available (Applied Science Laboratories) [116], Worked out examples of additive determinations are given in the Food Additives Analytical Manual [116], which also describes a great many of indirect food additives, such as BHA, BHT, TBHQ, l-chloro-2-propanol, DLTDP, fatty acid methyl esters, w-heptyl-p-hydroxybenzoate, propyl-gallate, sodium benzoate, sodium stearoyl-2-lactylate, sorbitol and phenolic antioxidants. EPA methods 606 and 8060 describe the CGC separation of phthalate esters (direct injection) (cf. Figure 4.2). 

Lidding substrates are required to be sealed to the preformed blister materials. An essential component of lidding material is a coating suitable for heat sealing. The heat sealing lacquers used must comply with FDA standards set forth in the Code of Federal Regulations (CFR) for indirect food additives. 

Table 1.1 The UK Food Standards Agency s research programme on food additives (as of January 2001)...

FOOD STANDARDS AGENCY (2000) Working Party on Food Additives annual review of current research projects, available from lucy.foster V7f00dstandards.gsi.g0v.uk... 

Food Standards Agency Food Additives Unit Room 516C Aviation House 125 Kingsway London WC2B 6NH... 

For many substances the body s own mechanisms for de-toxification and repair mean that low doses of some chemicals can be tolerated without experiencing any adverse effects. However, once a certain threshold has been exceeded then the degree of adverse effect is related to the dose. The highest dose at which no adverse effects are observed in the most susceptible animal species is identified as the No Observed Adverse Effect Level (NOAEL). The NOAEL is used as the basis for setting human safety standards for food additive Acceptable Daily Intakes (ADIs)4... 

The EU Directives 94/35/EC, 94/36/EC and 95/2/EC on sweeteners, colours and food additives other than colours and sweeteners, limit the amounts of certain food additives that can be used and the range of foods in which they are permitted. Similarly, the Codex Committee on Food Additives and Contaminants (CCFAC) has published its General Standard on Food Additives (GSFA), which lists the maximum use levels recorded world-wide. Care should be taken when using data from the EU Directive annexes or the GSFA because the figures represent the maximum permitted in each food group. In practice, use levels may need to be much lower to achieve the desired technical effect, particularly if used in combination with other additives intended for the same purpose. Furthermore, the additive is unlikely to be used in all foods in which it is permitted because other additives compete for the same function in the marketplace. 

In many instances, though not normally for food additives and contaminants, the numerical value of a characteristic (or criterion) in a Standard is dependent on the procedures used to ascertain its value. This illustrates the need for the (sampling and) analysis provisions in a Standard to be developed at the same time as the numerical value of the characteristics in the Standard are negotiated to ensure that the characteristics are related to the methodological procedures prescribed. 

For reference methods, HPLC with various detectors has become the standard reference technique for analysis of food additives, but new developments in this area are mainly linked to detector technology. Diode array detectors have not totally met the expectations of food analysts in terms of their specificity and LC-MS is likely to fill the gap. Specific detection with biosensor chips may also have a future for certain analyses. The use of combined LC-MS/DAD systems is... 

Beyond national approvals the Codex Alimentarius is developing a General Standard for Food Additives which will be the applicable basis for international trade. All and only sweeteners endorsed for food use by JECFA are/or will be listed in this standard. For bulk sweeteners the standard has progressed to permanent while the part dealing with intense sweeteners is still under discussion. 

JSSFA = Japan s Specifications and Standards for Food Additives 7th edition, 2000 with page number (p. ..). 

The use of antioxidants in food products is governed by regulatory laws of the individual country or by internal standards. Even though many natural and synthetic compounds have antioxidant properties, only a few of them have been accepted as generally recognised as safe (GRAS) substances for use in food products by international bodies such as the Joint FAOAVHO Expert Committee on Food Additives (JECFA) and the European Community s Scientific Committee for Food (SCF). 

The Codex Alimentarius is a collection of internationally adopted food standards presented in a uniform manner.6 These food standards aim to protect the consumer s health and ensure fair practices in the food trade. The Codex Alimentarius also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures. Codex standards contain requirements for food including provisions for food additives. 

The standards and limits adopted by the Codex Alimentarius Commission are intended for formal acceptance by governments in accordance with its general principles. Codex Alimentarius permits only those antioxidants which have been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) for use in foods. Antioxidants may be used only in foods standardised by Codex. The antioxidant provisions of Codex Commodity Standards are included in and superseded by the provision of this Standard. Food categories or individual foods where the use of additives are not allowed or are restricted are defined by this Standard. The primary objective of establishing permitted levels of use of antioxidants in various food groups is to ensure that the intake does not exceed the acceptable daily intake (ADI). 

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