European Union Directive implementation

With a view to harmonising the conduct of clinical trials across the European Union, Directive 2001/20/EEC was finally agreed on 14 December 2000 and was formally adopted in May 2001 with a 3-year transition period for its implementation. The Directive is now fully implemented in the United Kingdom and further information on clinical trials there can be accessed at the MHR A website. Under the provisions of the Directive, all clinical trials now require a Clinical Trial Authorisation (CTA). This is discussed in detail in Chapter 17. 

For example, Germany has implemented the majority of the relevant EEC/European Union Directives through the following national legislation ... 

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. " ... 

In the United Kingdom this is covered by the Control of Major Accident Hazards Regulations 1999 (COMAH), set up by the HSE (Health and Safety Executive) to implement the Seveso II directive of the EC (European Union) see www.hse.gov.uk. The COMAH regulations supersede the previous CIMAH (1984) regulations, set up under Seveso I. 

Most countries also have regulations analogous to the U.S. regulations. For example, the European Union issued the "Seveso II Directive in 1996 (replacing the original 1982 directive) which requires all member states to implement regulations for the control of major accident hazards. Also, in addition to the U.S. government requirements,... 

The Solvent Emissions Directive was adopted in March 1999 by the European Council of Ministers and should be implemented by member states within two years. The adhesives industry uses about 130,000 tonnes of solvents in its products annually and has a key role to play in meeting the Directive s targets. The main impact of emissions reduction will be on adhesives coaters because the adhesive film forms through the evaporation of solvent. For adhesives manufacturers, the main issue is the reduction of fugitive emissions. Both oxidation and recovery are well proven abatement techniques. BELGIUM EUROPEAN COMMUNITY EUROPEAN UNION WESTERN EUROPE... 

In the European Union the key instrument governing the prevention and control of pollution is the 1996 IPPC (Integrated Pollution Prevention and Control) Directive [10]. Member States were required to implement this Directive through national legislation and regulation by September 1999. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

The European Union (EU) environmental policy has put water protection and its sustainable management high on its agenda, reflected by the European Water Framework Directive (WFD), which is now in its implementation phase. 

Contamination of the world s crops by aflatoxin is estimated to cost 10 billion annually, due not only to the direct loss of crops and animals, but also to the maintenance of toxin monitoring services and the indirect cost of human and animal health care (Trail et ah, 1995). Strict legislation will protect the public health in developed countries however, many countries do not have such legislation or testing capacity. Even if such legislation and testing could be implemented, they would reduce the health risk but could not eliminate large-scale economic losses similar to those currently faced by the U.S., the European Union, and other developed countries. 

Protection of water sources is critical to economic viability as well as to human and environmental health. This has been evident for many decades, but just in the 1980s, the European Community started to adopt legislative measures to evaluate and preserve groundwater and also to implement bans on pesticides which at first concerned mainly persistent organochlorine compounds. Along the years, various European Community Directives have addressed these issues in the European Union, among them ... 

The FDA has clarified the minimum requirements for an IND submission in three areas chemistry, toxicology reports (draft) and size (2-3 volumes, each 3" thick) in an attempt to relax current practices somewhat, to the level required for a UK CTX. However, full reports are to be provided within a short time after the initial drafts. (Conversely, however, information needed to conduct human studies in the European Union has increased, recently, with the implementation of the Clinical Trial Directive.)... 

In Europe, the Cosmetics Directive of the European Union (EU) has implemented a ban on animal testing of finished cosmetic... 

In November, 1988, the EU Commission notified the United States that the hormone directive would apply to all meat, including pork and horse-meat. The US Department of Agriculture (USDA) informed the European Union that the United States has no hormonal substances approved for use in pork or horse-meat. The Commission indicated that tlie United States needed a residue testing program for these meats to be in compliance with the directive. In December, 1988, the European Union approved a counterretaliation list, but implementation was postponed until January, 1989, On January 1, 1989, the European Union hormone ban and the US retaliation measures took effect. 

The Statutory Surveillance Programme implements European Union (EU) legislation in accordance with the provisions set out in Directive 96/23/EEC. This Directive sets out the sampling regime and the veterinary drugs that must be monitored by each EU member state. 

The member states of the European Union are obliged to implement the EU Directives into their national laws. 

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