The European Laws

European directives are laws that manufacturers must meet before affixing the CE marking to products. The directives are identified with the year and identifier number such as 85/375/EEC for the Product Liability Directive, which was published in the Official Journal on August 7, 1985. Most directives are adopted at a later date, within a specified time limit. For example, article 19 of the Produet Liability Directive 85/375/EEC states that this directive must be brought into force by the member states within three years. 

Basic directives (type A). The basic directives apply to all manufacturers of products and address trade, enforcement, liability, and other issues. It is important to understand the implication of these directives, especially concerning enforcement against product manufacturers. Examples of the basic directives are CE Marking, Conformity Assessment, General Product Safety, and Product Liability. Products, components, and materials not covered by Type B or C directives must still be safe according to the General Product Safety Directive (e.g., comply with standards). 

Telecommunications terminal equipment and satellite earth station equipment 98/13/EEC 11/6/1992 or 5/1/1995 

Directive reference numbers ending with EC were issued after 1993. Directive 98/13/EC replaced 91/263/EEC and 93/97/EEC.  

Product-specific directives (type C). Product-specific directives apply to regulated products, such as telecom and medical, as well as other products where extreme hazards exist, such as machinery listed in Annex IV of 89/392EEC. Involvement of a EU body may be mandatory, but not in all cases. If the class or type of product is regulated by the directive, then a European body must assess it and issue a Type-Exam Certificate prior to CE marking. Product-specific directives cover machinery, pressure vessels, medical products, telecom devices, toys, and others. It is necessary to refer to the relevant directive to see whether the involvement of a EU-notified body is mandatory for the product or machine in question. lYpe C directives take precedence over types A and B directives and refer to them as needed. 

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It has been approximately 5 years since the European law on chemicals REACH came into force. It was implemented to audit the risks of all chemicals on the market by their sales volume and hazardousness. The essential aim of this security check is to determine so-called exposure scenarios, which facilitates the assessment of the occurrence of unacceptable or dangerous exposure created by the evaluated chemical. If these risks are identified, measures are to be taken to reduce the exposure by restrictions on usage or by issuing a ban. 

The Law of the European Community can also play a role within the realm of activation. Apart from the European Employment Strategy already mentioned above, which forced the member states to reconsider their national employment strategies, the European law sets up general requirements via the interdiction of... 

Directives are the European laws published in the Official Journal that give us the essential health and safety requirements (EHSRs) that shall be followed by product suppliers. These are commonly called the Essential Requirements (ERs). The directives deal with legal and procedural issues, such as assessment procedures, certification, implementation, enforcement, technical files, declarations, CE marking, and other basic concepts. Examples of primary directives are the Low-Voltage, Machinery, and EMC directives. The General Product Safety and Product Liability Directives are basic directives dealing with enforcement and civil prosecution that are applied to all products. The directives also mandate the publication and mutual recognition of harmonized standards. 

The paper present the product of Romanian conception which was used having remarkable results both for the parietal stabilization concerning some previous lateral faults, and also for the cases when there was a smaller fault ( resection of two ribs) for which it was considered as obligatory the assuring of the stabilization especially because of the patients age or the breathing function alteration as well as the correlation with the international evolution of these category of products, level of biomedical and biofunctional performances, admissibility condition imposed by the European laws in force regarding the fabrication and conunercialization. 

In Austria, as well as all over Europe, the first and repetition tests of all pressure equipments including steam drums are required for security reasons within fixed time intervals. These repetitive inspections are done differently in the most European countries, but most time these inspections include, according to the European Pressure Equipment Directive" and the specific national law any kind of over-pressurisation (e.g. hydrotest) and visual inside inspection. 

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

In Europe, the formation of the European Economic Community has created a requirement to bring food additive approvals of the member nations into alignment, so as to eliminate differences in laws that hinder the movement of foodstuffs among these nations. Historically the member countries have differed widely in approaches to food additive approval and their tendency to approve new additives. At the time of this writing, a framework directive for food additives and several specific directives for various categories of additives are nearing completion (3). 

Under the EPC an appHcant may file a patent appHcation in one or all of the European countries that are signatories by filing a single appHcation. Unlike the PCT, the EPC is actually a system of law, common to all of the present member countries, estabHshed for the granting of European patents. 

A different system applies to the creation oflegislationat EU level. The EU is based on a series of treaties between member states, which are comparable to constitutional law at national level. Three institutions are involved in the creation of EU law (i) The European Gommission (ii) The Council of the European Union and (iii) The European Parliament. 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 

Kautz, C. H., Lovrude, M. E., Herron, R R. L., McDermott, L. C. (1999). Research on student understanding of the ideal gas law. Proceedings, 2nd International Conference of the European Science Education Research Association (ESERA), Kiel, Germany, I, 83-85. 

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]. 

Food coloring is restricted by law to prevent misuse that may lead to deception of consumers related to reduced value or usability. For this purpose, the European Union implemented food colorant guidelines in 1994 based on the understanding that food coloration presents a technological need. While European Parliament and Council Directive 94/36/EC lists colors and their uses in food, the European Commission Directive 95/45/EC contains specific purity criteria for colors in foodstuffs, e.g., a maximal lead content of 20 ppm. " ... 

Van der Meulen, B. and Van der Velde, M., Food Safety Law in the European Union An Introduction, Wageningen Academic Publishers, Wageningen, 2004. 

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. ... 

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). 

Member states have a number of actions under the Directive. They have to appoint a competent authority (or authorities), transpose the Directive into national law, enforce it and provide information to the European Commission. 

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. 

In the past, product-related standards in the European waste law were rare. This changed with the triumphal success of everyday electronic gadgets and the associated increase in e-scrap. The EC Directive 2002/96/EC - better known as the WEEE directive - aimed to combat the increasing amount of e-waste from electrical and electronic devices [8]. Goal is the avoidance, reduction, and environment-friendly disposal of increasing amounts of electronic waste through extended producer responsibility. This goal has been hindered by a number of pollutants that are included in the devices (RISKCYCLE). 

ECHA points out that some materials currently considered as waste might in future be considered to have ceased to be waste [15]. These materials will then be out of the scope of waste legislation, and - if not covered by an exemption - will potentially fall under REACH. Clarification of end-of-waste criteria is a matter for waste legislation. In accordance with the general principle of subsidiarity of the European Union law, and following the revised Waste Framework Directive, Member States may decide case by case whether certain waste has ceased to be waste, where end-of-waste criteria have not been set at Community level. Member States have already worked for use of this regulation, like, e.g., the Waste Quality Protocol in England, Wales, and Northern Ireland [16]. 

In the European Union (EU) replacement of copper-based fungicides with other methods of disease control is a priority in organic farming policy (Anonymous, 2002). They were due to be prohibited by law for use in organic farming in the EU from March 2002 but the ban was delayed because of the increased risk of crop diseases and associated economic losses for organic producers in the medium to long term, until effective alternative... 

After the war, I said, the European states should get together and equalize their patent laws. And I stressed even then that I did not suggest this because Germany would have an accretion of power after the war. I added that perhaps the idea was a little radical, but that every state should express what it wanted changed. 

Prominent within the EU organizational structure is the European Commission. The major function of the European Commission is to propose new EU legislation and to ensure enforcement of existing legislation. European drug law, therefore, comes under the auspices of the Commission. 

Attempts to harmonize European pharmaceutical laws were accelerated in the 1980s. From 1985 onwards, a substantial number of European pharmaceutical directives have been adopted. This entire legislation has been published in the form of a nine-volume series entitled The Rules Governing Medicinal Products in the European Union (Table 4.11). These volumes form the basis of EU-wide regulation of virtually every aspect of pharmaceutical activity. 

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