Europe European Conformity

Raw materials or goods which are exported to the USA are subjected to the same restrictions as those which are manufactured within the USA. There is also a duty to ensure that each delivery is authorised by the US customs authorities. Anybody who does not conform to these so-called TSCA (Toxic Substances Control Act) conditions must reckon on a high fine. This article examines in detail all the legal, administrative and financial steps that must be followed before making the first exports, including adhesives. EUROPEAN COMMUNITY EUROPEAN UNION GERMANY USA WESTERN EUROPE... 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

European Company to produce insulin and important suppliers of oestrone,274 Lederle,275 and Roussel Uclaf and Schering AG in Europe.276 Another development arising from this early research on steroids was Barton s pioneering studies in conformational analysis. The reminiscences include those by Fried on the discovery of the fluorosteroids at the Squibb Institute for Medical Research in New Jersey,277 and of studies of the biochemistry of steroid hormones linked to genetics and the history of cancer.278 Clearly, the problems of unravelling the complex mechanisms of steroid action have aroused considerable interest.279... 

All European countries require, in common with the United States, and in conformity with the Declaration of Helsinki, that ethics committees (the European version of institutional review boards in the United States) review protocols from phase I-IV and the general conduct of trials outside the formal protocol document. However, there is wide variation in Europe as to how this procedure is enacted. In countries such as France, Spain and Germany, there is a national system of ethics committees that duplicate similar work at a local level. In the United Kingdom, there are a wide variety of ethics committees, such as commercial committees, those set up by the Royal College of Physicians, and those run by local area health authorities or hospital trusts. 

The European Union was, in effect, created by the Single Europe Act (EC-92), as a region without internal frontiers in which the free movement of goods, persons, and capital is ensured. For various products and classes of products, the European Commission issues directives with regard to safety and other requirements, along with the means for assessing conformity to these directives. Products that comply with the appropriate directives can then carry the CE mark. EU member states ratify these directives into national law. 

All products sold in Europe must now comply with Ce standards. Before the formation of the European Union and the utilization of Ce standards, manufacturers in Europe and those exporting to Europe had to comply with different standards based on the requirements that were dictated by a specific country. Ce provides a single set of safety and environmental standards that is used throughout Europe. The Ce marking on a product ensures conformity to European smndaids. The letters Ce come from the French words Conformity Europeenny. 

There are several ways for product and machine manufacturers to show compliance with the European directives. However, only one way presumes conformity— the use of harmonized European standards. This is why I strongly recommend the application of harmonized standards, also known as European Norms (ENs). Standards play an important role in European Union safety/EMC compliance for products and machines. Standards become valid in Europe after they are published in the Official Journal and are transposed into member states national standards. The ENs are listed or appended to the directives themselves. 

Of the 5,(KK) EN standards issued, over 600 have been published in the OJEC as of this writing, with many more to come. Since most ENs are based on lEC standards, compliance with the EN standards also ensures conformity with equivalent lEC standards. The world is following Europe s lead, and most countries have, or eventually will have, accepted the European standards or the lEC equivalents. Therefore, meeting the European standards will also help manufacturers to comply with the technical standards worldwide. 

The highest level for conformity verification and acceptance in Europe are the voluntary product safety and EMC Approval Marks, issued by European notified and competent bodies. The Approval Mark is backed by an official test report and certificate from a European accredited body (OJEC). 

Health and safety laws in the UK are complex. Recently, new regulations concerning noise, pressure systems, electricity and the use of chemicals have come into effect. Also a spate of directives have been adopted by the European Community aimed at the approximation of occupational health and safety laws of Member States by the time the free market is established in 1993. Conformity with these directives is necessary, not only for continuing high standards of health and safety but also for our trading success as a member of a free Europe. 

Countries in Western Europe generally work to CENEEEC standards. European Union (EU) member countries issue Certificates of Conformity to these standards and accept products and systems certified by other... 

Use of cadmium pigments in polymers is almost universal. Principal polymers of use include HOPE, polystyrene, polypropylene, nylon and ABS. Within Western Europe cadmium pigments are permitted for use in safety applications and in polymers that demand higher processing temperatures. They are also permitted in European toy applications, provided that the colored article conforms to soluble extraction limits of EN71 Part 3. Whereas in Europe the pigments are not permitted to be used in low-density polyethylene (LDPE), they can still be used in masterbatch, which can then be used to color unrestricted polymers. 

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