European Level

At the European level, the national organizations from both the EU (European Union, formerly the EEC) and the EETA (European Free Trade Association) are grouped in the CEN (European Committee for Standardization) and its counterpart for the electrical industries CENELEC. The standards published by these two organizations have authority in all EU countries as well as the EFTA countries who have voted their approval, which means that these standards have replaced their corresponding national standards. 

Founded in 1971, COST is an intergovernmental framework for European cooperation in the field of scientific and technical research, allowing the coordination of nationally funded research on a European level. COST actions cover basic and precompetitive research as well as activities of public utility. 

The Japanese Plastic Waste Management Institute is developing a process to convert PVC and other plastic waste materials to fuel oil through pyrolysis. In Eiuope, a free market for plastics waste is now being established by the European Plastics Converters over the internet. The company says it will be possible to establish market prices for recyclates at European level on a supply and demand basis. The European market for recycled plastics is currently worth around 1.18bn US dollars and is predicted to reach 2.53bn US dollars by the endof2001. WORLD... 

European regulatory requirements are based on legal requirements, which are, in the pharmaceutical sector, now effected at the European level by means of Regulations (which are directly binding on the concerned parties) and Directives (which are binding on the member states to which they are addressed in terms of the effect to be achieved, but which allow a degree of freedom as to the precise method of national implementation) and in guidance (often included in... 

The basis for applications will follow the principles laid down in basic European level legislation for the pharmaceutical sector. This is more or less common regardless of the actual mechanism used to gain an approval. The basic requirements for pharmaceutical marketing authorization applications are laid down in Directive 65/65/EEC (as amended). There are no specific requirements for pharmaceutical development or process validation included in the text of that document. 

In the final consequence, it means that the problem of mineral oil migration from board to foodstuff - mainly discussed in Germany - has to be treated and solved on a European level. The possible solutions and drawbacks for the folding boxboard production as packaging material discussed in this chapter include ... 

The equivalent calculation of the environmental impact on the European level for substituting recycled fibre-based packaging material by virgin fibre-based material results in the required amount of 47 Mio t of wood or an equivalent of 110 million m3 of standing timber, an additional annual consumption of 400 Mio m3 of water,... 

Europe has been the biggest market up to now. Future applications will be in environmental protection and security e.g. water-meters and door detection devices. We expect an increase of appr. 15% p.a. The US market shows a delayed response. It might reach the present-day European level of appr. 25 million reed sensors p.a.in 10 years time. Asia the market is growing at an above-average rate. We expect annual increases of 20%. 

Substances of very high concern must be identified as such through the application of a robust, science-based and transparent process, co-ordinated at a European level and subject to European agreement. 

The Commission assesses the results of water quality monitoring against the standards in the Drinking Water Directive. After each reporting cycle the Commission produces a synthesis report, which summarizes the quality of drinking water and its improvement at a European level. The synthesis reports are available to the public (EU 2007). 

There has been a debate at the European level over relaxing DTC advertising in a limited number of therapeutic areas. At the time of writing this chapter these suggested changes have been shelved and there are no plans to allow even limited DTC within the EU. 

The only other reference at a European level appears in Volume 9 (Pharmacovigilance) of the Notice to Applicants issued by the European Commission. The Notice to Applicants does not have the force of law, but represents best practise. Paragraph 1.3.4 states ... 

The legal controls on animal testing were introduced at the European level by a Directive in 1986. The central objectives cited in the formulation of the controls were to avoid disparities in the controls applied across Member States that might affect the functioning of the common market, and also to limit to a minimum the number of animals used in product development whose use was necessary to meet testing requirements, and to ensure, as far as possible, the best care and treatment of the animals during the conduct of the research and in the method of their disposal. 

To protect consumers health, many countries have restricted the use of pesticides by establishing legal directives on maximum residue levels (MRLs) to control their levels in food (28). These MRLs sometimes cause conflicts, because residue levels acceptable in one country may be unacceptable in others. This problem has revealed the need to harmonize the different MRLs, which have been dealt with mainly by two international organizations, the European Union (EU) at the European Level, and the Codex Alimentarius Commision of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) (28,29). 

ETC/ACC - European Topic Centre on Air and Climate Change, de Leeuw F, Horalek J (2009b) Assessment of the health impacts of exposure to PM2.5 at a European level. ETC/ ACC Technical Paper 2009/1. Bilthoven... 

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