European Directive

Legislation enacted in recent years to implement the provisions of European Directives has had a major impact in the health and safety field. Whilst only the Electrical Equipment (Safety) Regulations are targeted specifically and uniquely at electrical safety, many of them have requirements that have an influence in this field including, in this context, the safety of electrotechnical control systems on machinery. The purpose of this chapter is to identify those Regulations that have explicit and implicit electrical and control system requirements. 

LEGISLATION STEMMING FROM ARTICLE 95 (lOOA) DIRECTIVES 

As already noted, this legislation stems from the desire to establish a single market within the European Union (EU) inside the boundaries of which 

These Regulations were made on 15 December 1994 by the Secretary of State for Trade and Industry under the Consumer Protection Act 1987 to implement the amended Low Voltage Directive 93/68/EC of 22 July 1993. They extended and replaced the Low Voltage Electrical Equipment (Safety) Regulations 1989 and came into force on 9 January 1995, but were not applicable to equipment placed on the market before 1 January 1997. After this date all new equipment had to comply. 

The aim is to exclude unsafe electrical equipment from being marketed in the EU. To ensure this, the equipment has to comply with the relevant harmonised standard in the absence of such a standard, to an International Electrotechnical Commission (lEC) standard or, failing this, to a BSI standard. The manufacturer has to test the equipment himself to prove its safety or have it tested, preferably by an approved testing laboratory, and make a declaration of conformity with the relevant standards. He has to maintain technical documentation containing prescribed information and from 1 January 1997 had to apply the CE mark to the product, or its packaging, or its instruction sheet, or its guarantee certificate. 

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The Eurosuper as defined by the European Directive of 16 December 1985, offering a minimum RON of 95 and a minimum MON of 85. Found throughout the European countries, it still is fairly scarce in France with 10% of the total demand for unleaded fuels. 

A European Directive, 85/210/EEC, limits benzene content to 5% by volume in all gasolines regular, premium, with or without lead. This level is easily achieved, since the average value in 1993 was less than 3%. in France, for example, average benzene concentrations of 1.7% and 2.6% were reported for leaded and unleaded premium fuels, respectively, in 1993. 

For countries in the European Union, the specifications issued by European directives that replace, when they exist, the national specifications. 

During recent years European directives (machine-, EMC and electric safety directives) in connection with the C 6-marking has imposed new requirements to scarmer systems concerning mechanical and electric safety, documentation, manuals and EMC. 

The proposed European Directive (i.e., EU law) on the patenting of computer-implemented inventions [8] has led to a debate in Europe on the desirability of patents on software. The debate recently culminated in a vote by the European Parliament, which rejected the proposed legislation [9]. 

HPLC is often reported to be the technique of best choice for the quantification of food colorants. According to European Directive 94/36/EC, the quantities of synthetic colorants to be added to foods are restricted and thus reliable methods for their quantification must be established. Approved colorants, defined by E-coded numbers (Table 6.6.2), are permitted for non-alcoholic beverages, confectionery products, and even for caviar (dying fish roe). For example, a specific HPLC chromatographic method for the quantization of 14 synthetic food colorants belonging to azo dye, triphenyhnethane, or quinophthalone classes (E 102,104, 110, 122,123, 124, 127, 128, 129, 131, 132, 133, 142, 151) was reported to check their contents in caviar. ... 

For nonpharmacopeial materials a full specification should be included in the application. This should include appropriate tests and requirements for physical characteristics, identification, relevant purity tests, and performance-related tests. Characteristics likely to influence bioavailability of the finished product should be controlled. Routine tests and specifications should be described. Methods should be validated. The material should be fully characterized, with full data on the chemistry concerned and including consideration of the safety of the excipient. Any relevant European Directive requirements or other international specifications should be met, but additional requirements might apply depending on the intended use of the product—e.g., for materials to be used in sterile products. 

Japan Chemical Week 42, No.2151, 13th Dec. 2001, p.4 RICOH HASTENS COMPLIANCE WITH EUROPEAN DIRECTIVE... 

Although European Directives have been issued on legislative requirements for food contact plastics, European harmonisation of regulations for rubber or thermoplastic elastomers used in contact with food is yet... 

Table 1.5 Allowed and unacceptable uses of CCA-treated wood according to European Directive...

The European Direct Fuel Cell Consortium carries out the largest European program for the commercialization of MCFC. They are developing an innovative direct fuel cell process which is internally reformed and operates on humidified hydrocarbon fuels. They have successfully tested a 292 cell, 155 kW stack (60% of maximum power). 

European Directives can be divided into three categories Framework Directive, Specific Directives, and Individual Directives. The Framework Directive 89/109/EEC applies to all materials and articles in contact with foodstulfs, such as packaging materials, forks, cups, processing machines (in... 

The European Parliament is made up of 626 deputies who are elected by direct imiversal suffrage every five years. It examines all proposals for European directives and regulations, whieh it may aeeept, modify, or refuse. It supervises the work of the European Commission, which it can dismiss with a motion of censure and it votes the annual eommunity budget. 

ILAC, European directives and EA guidelines, pieces of national and regional legislation etc. They are part of the laboratory s documentation system. 

The new European Directive (2001/20/EC) has reinforced the need for European agencies, as well as those of the United States and Japan, to conduct inspections of clinical trials. Sponsors, mindful of the implications of failed inspections, are carrying out audits by their QA units to try to ensure that standards at a particular site meet the regulatory requirements of GCP, and of any future regulatory inspection. Frequently, the inspections will occur 2 or more years after the end of the study. 

The proposed review of PER in the United Kingdom, already considered necessary, was to correspond to the requirements under European Directives. These Directives required that throughout the Community proprietary medicinal products granted licences before 22 November 1976 should be reviewed by 20 May 1990. Indeed, the United Kingdom was among the first to complete this review on time. This review eliminated from the market all medicinal products that were released for clinical use previously without scrutiny and that were ineffective, imsafe or that had an unacceptable benefit to risk ratio. 

European Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (now consolidated as Articles 86 to 100 of... 

The ABPI Code of Practice, in line with European Directive 75/319/EEC, calls for an efficient transfer of information on adverse drug reactions. In the case of defective medicines, an ABPI Batch Recall of Pharmaceutical Products system is in operation. In the ABPI Expanded Syllabus, batch recall is referred to in the Pharmaceutical Technology section and adverse drug reactions in the Pharmacology and Classification of Medicines and the Pharmaceutical Industry and the NHS sections. 

One important forum for international harmonisation is the UNECE-WP29. It has made two proposals for UNECE regulation on hydrogen vehicles that are now under consideration for potential implementation as European Directives. However, a full consensus has not yet been reached at the international level. Non-European players, namely the US and Japan are seen to favour a direct development of global technical regulations. 

The Future of Patenting Draft European Directive on the Legal Protection of Biotechnological Inventions... 

The Council of Europe has listed coumarin as an active principle and the maximum permitted concentrations of coumarin in foodstuffs are given in Aimex II of European directive (88/388/EEC) (European Commission, 1988). The general limit for coumarin in food and non-alcoholic beverages is 2 mg/kg, while in alcoholic beverages and certain caramel confectionary products, the permitted limit is 10 mg/kg and in chewing gum it is 50 mg/kg (Lake, 1999). 

Table 5.7 Preservative limits under European Directive 95/2/EC...

Benzoic acid is generally considered to exhibit an inhibitory effect on microbial growth, although it is of little use for bacterial control, where the greatest problem will occur at pH values above 4, outside the effective limit mentioned above. Improved results are obtained when it is used in conjunction with other preservatives, for example, S02 or sorbic acid, due to synergistic effects. It is interesting to note that the current European Directive, which sets individual limits of 300 rng/1 for sorbic acid and 150 mg/1 for benzoic acid in non-alcoholic flavoured drinks, nevertheless permits a joint preservative use of up to 250 mg/1 sorbic acid with 150 mg/1 benzoic acid. 

Under European Directive 95/2/EC, calcium disodium EDTA is permitted only in a limited number of foods, including some canned and bottled products, with maximum levels specified in each case. In the United States (Code of Federal Regulations) it is permitted to a level of 33 ppm in canned carbonated soft drinks, to promote flavour retention. 

Air Quality is regulated at the European Union level by Directive 2008/50/EC [17] with currently one additional directive (2004/107/EC) [18] covering arsenic, Cd, Hg, Ni and polycyclic hydrocarbons (PAH) in air. The European directives... 

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