European Union compliance requirements

The PED has definitely the merit that it supersedes, from a legal perspective, the very many old local codes in all European member states, codes such as BS (UK), ISPESL (Italy), TUV (Germany), Stoomwezen (the Netherlands), and UDT (Poland). Compliance with PED allows the manufacturer to CE mark their product as required by the European Union (EU) and is an assurance for the end-users that the selected material to protect their systems is in accordance to the law. Manufacturers approvals, however, are limited in time and need to be renewed regularly, which is an additional guarantee. Therefore, even with the most reputable manufacturers, it is always wise to check the status of the approvals to make sure they have not expired. 

Compliance with the requirements of Directive 2001/20/EC is important. This is because Annex I to Directive 2001/83/EC (as amended) expressly requires that for the purpose of obtaining a marketing authorization, all clinical trials conducted within the European Union to comply with Directive 2001/20/EC. For clinical trials conducted outside the European Union and the data of which are used in support of an application for a marketing authorization, such clinical trials must be designed, implemented, and reported on the basis of principles that are equivalent to the provisions of Directive 2001/20/ EC and carried out in accordance with the ethical principles that are reflected in the Declaration of Helsinki. 

Within the European Union, the European Commission (EC) has codified the GLP requirements for medicinal products in the Introduction and General Principles chapter of Directive 2003/63/EC [31]. Within this document it is stated that nonclinical (pharmacotoxicological) studies must be carried out in conformity with the provisions related to GLP laid down in Council Directives 87/18/EEC3 on the harmonization of regulations and administrative provisions relating to the application of the principles of GLP and the verification of their application for tests in chemical substances and 88/320/EEC4 (corrigenda 1, 2, and 3) on the inspection and verification of GLP [32,33], The OECD principles have been adopted by the European Union and published, in their revised form, in the appendix to Directive 2004/10/EC [32], The GLP Web site of the EC contains detailed reference information and links for member state GLP compliance [34],... 

The programs for assuring GLP compliance have already been described above in Sections 36.4 and 36.5. In summary, the European Union guided by OECD requires registration of all facilities claiming conduct of studies under GLP in a program for GLP compliance.The identified laboratories are inspected... 

Liliana Andonova (Chapter 8) shows how the European Union (EU) approach to sulfur dioxide abatement was successfully applied in eastern and central European countries that were required to comply with EU environmental regulations before applying for membership in the European Union. Early compliance with emissions limits resulted from a severe economic downturn during the transition from a communist to a free market economy, but some countries have been able to control sulfur dioxide levels even as they build a new industrial economy. 

Within the European Union, many organisations have decided on a voluntary basis to implement environmental management systems based on EN ISO 14001 1996 or the EU Eco-management and audit scheme EMAS. EMAS includes the management system requirements of EN ISO 14001, but places additional emphasis on legal compliance, environmental performance and employee involvement it also requires external verification of the management system and validation of a public environmental statement (in EN ISO 14001 self-declaration is an alternative to external verification). There are also many organisations that have decided to put in place non-standardised EMSs. 

Harmonised standards, known as European Norms (EN), provide solutions that enable compliance with the essential requirements of New Approach, or other relevant, Directives. They provide a presumption of conformity but for this to apply the standard must have been published in the Official Journal of the European Union (OJEU). Standards are produced by the European Standards Organisation for a technical sector, e.g. electrical and machinery, and published by national standards bodies, e.g. British Standards Institute (BSI), DIN in Germany, NF in France. 

A new requirement on packages— that of lead-free solder—has initiated a tremendous amount of developmental effort in the past few years. This effort stems from the requirement of packages exported to the European Union (EU) market, to pass Restriction of Hazardous Substances (RoHS) compliance requirements set forth in the Directive 2002/95/EC of the... 

Compliance with the laws is greatly determined by the level of enforcement. In the U.S. helmet use in the late 1980 s and early 1990 s in states that had universal helmet laws was close to 100 percent. Since the beginning of this century use rate in these states has dropped to less than 68 percent (Glassbrenner and Ye, 2006). In the case of helmets, enforcement is quite easy because the absence of a helmet is quite conspicuous - certainly more than the use or non-use of belts. When strictly enforced use rates quickly increase to near full compliance. For example, in the 16 southern European Union countries where helmet use is required, over 90 percent of motorcyclists wear their helmets (Avenoso and Beckmann, 2005). 

There are environmental and social compliance elements to which companies must adhere when sourcing certain materials. If left to their own devices, companies may not act in the best interest of the communities they work in or the people they work with, so laws have been enacted to protect people and environments. For example, two European Union regulations outhne requirements for data collection, labeling, and disposal procedures that must be undertaken if certain materials are sourced and used in production. REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) aims to improve the protection of the environment and human health from the risks imposed by chemicals. What REACH does for chemicals is just like what RoHS does for electronics. The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment protects the environment and society from the harmful disposal of electronic equipment or e-waste. 

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