EU-directives

A modular scanner system for NDE has been developed. It consists of a selection of individual electronics and motor module components, supported by scanner configuration and control software. The modules are used as standard building blocks for construction of job specific, dedicated scanners as well and general purpose scanners. The use of modular scanner components significantly reduce the work, time and cost not only for the design and manufacture but also for establishing documentation and ensure compliance with the relevant EU-directive requirements. 

The relevant regulations governing the conduct of clinical trials in the U S are shown in Table 5.4. As they also reflect the principles of GCP, they are quite similar in requirements to those of the E U. However, because they apply to a single jurisdiction, they are framed to provide more prescriptive detail than can be found in the equivalent EU directives. Similarly, they are supported by the ICH- and FDA-specific guidelines. As most of the practices are the same as discussed in the previous section, the chapter will now just examine some of the aspects that are unique to the US regulations. 

The EU laws follow three principles related to consumer health (1) protection, (2) fraud prevention, and (3) trade barriers. The union tried to harmonize the laws of different countries, particularly in recent years when the enlargement of the European Community became dynamic. Color Directive 94/36/EC contains horizontal provisions that refer to common laws in different countries and vertical directives that apply to specific foods. The EU directives take into account the recommendations of the Scientific Committee for Food (SCF), the Codex AUmen-tarius Commission, and the Joint Food and Agriculture OrganizationAVorld Health Organization (FAOAVHO) Expert Committee on Food Additives (JECFA). 

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). ... 

The EU Directive on Packaging and Packaging Waste sets a recovery target for used packaging of 25% by 2001 and 50-65% by 2005. It is likely that recycling of postconsumer plastics will require substantial polymer/additive analyses. 

The EU Directive on industrial emissions [4] which often is called IED was adopted on 24 November 2010 (it was a result of merging seven different EU Directives including the IPPC Directive into one directive). The directive regulates emissions from large industrial installations within the EU. The directive was put into force on... 

The use of DMF in biocidal products was prohibited in the EU according to EU Directive 98/8/EC [15]. However, the directive did not restrict the import of articles treated with DMF into the EU. As a consequence, the European Union made a temporary restriction to place products containing DMF on the market in 2009 (Decision 2009/251/EC). The restriction was on 15 May 2012 made permanent by the EC Regulation 412/2012 amending Annex XVII to EC Regulation 1907/2006 (REACH) [12]. The text in REACH states that articles or any parts thereof in concentrations greater than 0.1 mg/kg shall not be placed on the market. 

The subindex of flammability describes the flammability of liquid e.g. in the case of a leakage. Flammability of liquids is measured by their flash points and boiling points. The classification used is based on the EU directive (Pyotsia, 1994). Substances are divided into non-combustible, combustible, flammable, easily flammable and very flammable (Table 11). 

EU (2001) EU directive 2001/83/EC. http //eur-lex.europa.eu/LexUriServ/site/en/consleg/2001/L/ 02001L0083-20070126-en.pdf. Cited 30 Dec 2008 EMEA (2008) European Medicines Agency. EPARs for authorised medicinal products for human use. http //www.emea.europa.eu/htms/human/epar/a.htm. Cited 30 Dec 2008 ICH (2008) The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). http //www.ich.org. Cited 30 Dec 2008 ISMP (2005) The Institute for Safe Medication Practices. List of confused drug names. http //www.ismp.org/Tools/confuseddrugnames.pdf. Cited 30 Dec 2008... 

CDD/Fs presence in municipal wastewater treatment plant (MWTP) influents results in the PCDD/Fs presence in effluents and sludge. Evidence of polychlorinated dibenzo-p-dioxins and dibenzofurans formation within the MWTP was also found. All this aspects are discussed in the paper, with special attention to sewage sludge, because of further utilization demand according to EU directives. 

The introduction of EU directives on Waste Electrical and Electronic Equipment and Reduction of Hazardous Substances has highlighted the need for precise and repeatable elemental analysis of heavy metals in the plastics production process. X-ray fluorescence (XRF) spectroscopy has emerged as the most economical and effective analytical tool for achieving this. A set of certified standards, known as TOXEL, is now available to facilitate XRF analyses in PE. Calibration with TOXEL standards is simplified by the fact that XRF is a multi-element technique. Therefore a single set of the new standards can be used to calibrate several heavy elements, covering concentrations from trace level to several hundred ppm. This case study is the analysis of heavy metals in PE using an Epsilon 5 XRF spectrometer. 

The enforcement in Denmark of EU Directives on food packaging materials is discussed. Enforcement activities considered include studies of total migration from food contact materials, migration from kitchen-and tableware made of melamine plastics and migration of di(2-ethylhexyl)adipate from plasticised PVC films. Activities which need to be undertaken to increase the effectiveness of enforcement activities in the field of migration are described, including development of selfinspection programmes in industry, European network of enforcement, more rapid analysis and provision of information to the consumer. 2 refs. 

EU DIRECTIVE COULD MAKE SALE OF SOME ADHESIVES ILLEGAL... 

Many rubber products, when exported to the member states of the European Union, must comply with the requirements of the relevant legislation approach. The EU Directives of New Approach and Directives of Sectoral Approach are legislative provisions that must especially be followed. Directives of New Approach confine the requirements to the protection of health, property and environment and the safety requirements. The Directives of New Approach lay down the uniform procedure of approval of conformity. Harmonised European standards, giving detailed specifications of the product, follow these Directives. Detailed requirements are given in the Directives of Sectoral Approach and they have to be interpreted individually. The essential concepts are explained and a review of the most important documents is presented. 

Since EU Directive 2005/33/EC bans high-sulphur heavy oil (bunker fuel) as fuel on ships from 2010, this source may become relevant as a cheap feedstock for hydrogen production in the future. 

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. 

The actual levels at which additives are used in foods may differ from those listed in the EU Directives since these are intended to achieve the maximum technological effect. In practice use levels might be much lower. For example, it is not always necessary to create very intense colours and the amount of colourant needed will also depend on the natural colour of the matrix. Similarly, many sweeteners are used in combinations in order to control costs whilst avoiding unpleasant side-flavours. This means that in order to gain an accurate impression... 

EU Directive 95/2/EC on food additives other than colours and... 

While the above EU Directive lists the criteria only, the JECFA specifications refer to analytical methods in a Guide to Specifications35 or describe the analytical method in the specification monograph itself. Similarly, the Food Chemicals Codex lists and describes the necessary analytical methods for purity control. 

The EU Directive 95/2/EC which covers the additives in this chapter limits the amount of certain additives to particular uses or quantities, usually based on the ADI. It also has special limits for foods intended for products for young children. For example, modified starches listed in Part 3 of Annex VI, although ADI Not specified , are restricted to 50g/kg in weaning foods for infants and young children. In the past a series of different and sometimes confusing expressions such as ADI Not limited or Acceptable were used instead of ADI Not specified , and older texts must, therefore, be read with caution Appendices 2 and 3 list the ADI allocated by the Scientific Committee for Food in the EU and by JECFA at an international level to the additives in this chapter. 

Directive = The number of the relevant EU Directive on purity criteria (specification) for the additive listed. 

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