European Council Directive

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 addition these directives had to be decided unanimously by the European Council which made their adoption cumbersome and slow. These directives are now referred to as old approach directives. A radical change was needed so that the Community legislation could respond to the needs of both, the completion of the internal market for the products concerned, and the need to offer to industry a flexible legislative environment which would encourage technical progress. 

With the New Approach the number of directives needed to achieve the internal market target significantly decreased. In addition the European Council and the European Parliament were no longer required to deal with detailed technical requirements. Instead they were called upon only to define essential requirements needed to protect the public interest. The main elements of the New Approach can be summarised as follows ... 

In adopting that New Approach, the European Council was aware that this decision had to be accompanied by a policy on assessment of conformity. The Global Approach to conformity assessment provides for procedures to prove compliance of a product with the essential requirements in New Approach directives. 

Regarding the maximum legislated levels of these compounds, the European Council has recently adopted the Directive 2008/105/CE [57] which sets quality standards for the 33 priority pollutants in surface waters. For sediments, however, there are no legislative limits in Europe and to accomplish the legislation it is only necessary to show an improvement in concentration over the previous year s level. 

European Council (1976) Directive 76/464/EEC 4 May 1976 on pollution caused by certain dangerous substances discharged into the aquatic environment of the community. Official Journal of the European Communities... 

European Council (2008) Directive 2008/105/EC of the European Parliament and of the council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing council directives 82/176/EEC, 83/513/EEC, 84/156/ EEC, 84/491/EEC, 86/280/EEC and amending directive 2000/60/EC of the European Parliament and of the Council. Official Journal of the European Communities... 

European Council Directive on "Major Accidents of Certain Industrial Activities," ("Seveso Directive"), 82/501/EEC, June 4,1982, as amended 87/216/EEC, March 19,1987, European Union, Brussels, Belgium. 

European Council Directive 91/414/EEC (Registration Directive), 18 540 European Drinking Water Directive,... 

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... 

European Council Directive 1999/13/EC of March 1999 Commission Decision 2000/541/EC. 

European council. 1988. Council Directive of 22 June 1988 on the approximation of the laws of the member states relating to flavourings for use in foodstuffs and to source materials for their production (88/388/ EEC). OJ LI84, 15.7.1988, p. 61. 

On a global scale, there is good correlation between quality standards for fin it and fruit juice processed in different regions. In the European Union, legislative controls are set up, or modified, by the central European Council of Ministers, usually following discussion with and between trade organisations from the EU member countries. A new directive, once agreed and approved, is translated into the statutory laws of the member countries concerned. 

Continuing with the above example of ER3 of the European Construction Products Directive horizontal emissions test methods (i.e., applicable to multiple product types) have been developed by CEN and ISO for compliance with the CPD and are now available as parts 6, 9,10 and 11 of EN/ISO standard 16000 (see Table 6.1). Furthermore, a program of work led by CEN TC351 has now been instigated under European Council Mandate M/366 to amalgamate and validate these standards. Once this work is completed (estimated 2010) it is understood that chemical emissions testing will become a mandatory part of CE marking for construction products. 

However, because these directives have a very large scope, they cannot be very specific as to the details of the goods they address. To set guidelines on how to address the requirements of the directives, the European Committee for Standardisation (CEN) was empowered by the European Council to draw European Standards. After almost 20 years of efforts on the part of end users and manufacturers who were part of the committee, CEN released in 2004 a set of standards particularly for Safety Valves, EN 4126 Parts 1 through 7, Safety Devices for Protection Against Excessive Pressure (similar to API) ... 

A medicinal product is defined in Article 1.2 of European Council Directive 65/65/EEC as ... 

The EFPIA code outlines the minimum standards that must be incorporated into the national codes of its member associations, e.g. ABPI, LEEM, LIF, Interpharma. This code has been revised to make it consistent with European Council Directive 2001/83/EC, as amended in 2004. National member associations were required to revise their codes to meet the minimum standards of the EFPIA by the end of 2005. 

Some Member States began introducing measures for controlling the marketing and disposal of batteries. In view of this and in order to avoid the creation of barriers to trade and distortion of competition in the Community if this trend was allowed to continue, the European Council approved in March 1991 Directive 91/157/EEC on batteries and accumulators containing certain dangerous substances . 

In connection with the European Council Directive 89/106/EEC on construction products (EEC, 1989) the working group (WG) 7 of TC 264 air quality at the European standardizing organisation CEN defines general standards for environmental test chambers for the determination of VOC emissions from building products (prENV 13419-1,... 

In 1990, at the request of the European Council, the European Commission set up an informal group of scientists, known as the Scientific Expert Group (SEG), to give advice on setting limit values, after having reviewed the different approaches in the Member States. In 1991, the first set of 27 ILVs was proposed by the EC and agreed by Member States on the basis of pre-existing national positions (Directive 91/322/EEC)."... 

A DNA vaccine candidate that has successfully passed all preclinical hurdles needs to be tested clinically by a three-phased scheme as outlined in Chapter 4. As defined by a European Council directive, a clinical trial means ... any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of. .. investigational medicinal product(s), and/or to identify any adverse reactions. .. and/or to study absorption, distribution. 

European Council, 2004, Directive 2004/101/EC of the European Parliament and of the Council of 27 October 2004 Amending Directive 2003/87/EC Establishing a Scheme for Greenhouse Gas Emission Allowance Tradingwithin the Community, in Respect of the Kyoto Protocol s Project Mechanisms. 

European Council (1993) Directive 93/42/EEC of 14 June 1993 concerning medical devices. 

European Council (1990) Directive 90/385/EEC of 20 June 1990 on active implantable medical devices. 

European Council (1998) Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices. 

European Council (1965) Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. 

European Council (2004) Directive 2004/27/EC of 31 March 2004 amending Directive 2001/83/EC on the community code relating to medicinal products for human use. 

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