European Union products

Gardner, B., 2000, Organic Food in the European Union Production, Consumption and the Development of Markets, Agra Europe, London http //www.agra-europe.it. 

The principle of sustainable development and the lack of landfill capacity in Europe are reasons for the introduction of the closed-loop economy in the European Union. Products have to be produced and used in a manner that conserves resources and have to be recovered after use, if their use carmot be avoided entirely. Landfill of waste is not allowed anymore, so the question of disposal is already an issue during the development of a product. If easily disposed materials are used for the production, the disposal cost wiU decrease, and so in consequence will the overall product costs. 

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. 

Soybeans are the most important oilseed in international trade. The United States, Bra2il, and Argentina are the main suppHers to the export markets. In 1994—1995, United States exports of 22.0 x 10 metric tons represented 32% of the domestic production, 16% of the world crop, and 69% of the international trade in soybeans. The European Union, Japan, Mexico, and Taiwan were the largest importers of soybeans (51). Japan, which produces <5% of its soybean needs, is the largest single soybean customer of the United States. Japan imported 3.4 x 10 t in 1994 (51). The United States also exports processed soybean products, eg, oil and meal. For 1990—1993, an average of 47% of the crop was exported as whole beans and processed products. 

Production and consumption statistics for sucrose are shown ia Table 1. World production of sucrose dufing 1993—1994 was - 110 million metric tons, of which - 64% was derived from sugarcane. The largest producer is the European Union (EU), followed closely by India and Bra2il. In 1993—1994, the United States ranked fourth in production. World raw sugar prices from 1990—1995 ranged from 20.20—32. l0/kg (10). 

Eudralex The rules governing medicinal products in the European Union, Vols. 1-9, Office for Official Publications of the European Communities, Luxembourg, 1998. 

The Rules Governing Medicinal Products in the European Union, Volume 10, Clinical Trials. 

The CTD format has been incorporated into the E U regulations and is set out in the revised version of Annex I to directive 2001/82/EC, which was published as Commission Directive 2003/63/EC. It is also supported by detailed guidance in the Rules Governing Medicinal Products in the European Union, Volume 2B - Presentation and content of the dossier - CTD2001 edition. The relationship between the CTD format and the previous four-section format that was used in the E U is shown in Table 6.1. 

The Rules Governing Medicinal Products in the European Union, Volume 2, Notice to Applicants, Medicinal Products for Human Use. http //ec.europa.eu/enterprise/pharmaceuticals/index en.htm. 

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

There are around 250 chemical entities that have been identified as active components of microbiocidal products in the European Union. The aim ofthis chapter is to introduce the range of chemicals in common use and to indicate their activities and applications. 

The main concern regarding the utilization of Monascus pigments relates to the production of the citrinin mycotoxin in Monascus cultures. Several methods for controlling the mycotoxin production were proposed, including selection of non-toxinogenic strains, control of citrinin biosynthesis, and modifications of culture conditions. Despite their wide and traditional food applications in Asian countries, Monascus pigments have not been approved for use in the United States or 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. 

Five synthetic and five natural colorants were identified and quantified in lyo-philized dairy products and fatty foods using an automatic method based on solid phase extraction using a stationary phase followed by RP-HPLC C,g columns for the sequential retention of colorants and diode array detection. Lyophilization of the samples coupled with the separation procedure provided clean extracts despite the complexity of the food matrices and preserved the sample for at least 2 months without changes in colorant concentrations. The detection limits achieved for the colorants were found in a wide range from 0.03 to 75 pg/g of the lyophilized sample, according to the limits established by the European Union. ... 

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. 

If a product is to be exported to different countries, an understanding of the different structures and requirements set by the European Union and United States regulatory authorities is critical. 

---