European Commission

The European Commission consists of 25 members. The commissioners are citizens of the 25 member states but are required to act independently and in a nonpartisan way. Only the Commission can initiate proposals for new legislation, following consultations with governments, industry, labor, and special interest groups and, as required, technical experts. The principle of subsidiarily, enshrined in the Treaty of the European Union, hmits legislative proposals to areas where European Union legislation offers benefits over the legislation of individual member states. 

The European Commission, with a staff of about 18 000 people, is the largest of the EU institutions. It is organized into 36 directoratesgeneral and specialized services. The directoratesgeneral of most importance to chemical control requirements are listed in Table 23.1. 

Health and Consumer Protection Internal Market Joint Research Centre 

In addition to initiating Community policy, the European Commission is responsible for 

Executive responsibility for drugs and devices at European Commission level is located within the Directorate-General for Enterprise and Industry. This is the equivalent of a civil service department at national level. As such, the focus is more on the development of policy and legal/administrative provisions. 

Separate units exist to deal with pharmaceuticals and devices. Their general policy aims are to  

The pharmaceutical unit is the more active of the units as there is much greater use of EU-centralised procedures in drug regulation compared to devices. However, the activities of both units can be broken down under four main headings legislation support and guidance external relations and information technology. 

In supporting consistent application of the regulations at national level the units  

In addition to the formal committees specified in directives, the commission is assisted by other expert committees and working groups. Depending on the subject matter, these can be drawn from the regulatory bodies, the scientific community, or industry and end-user associations. 

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Tile new Pressure Equipment Directive (P.E.D.) established by the European Commission recognize acoustic emission as a complementary method which can be used to monitored pneumatic test when hydraulic test could not be perform. 

Hudgell, R.. ]. European Commission, Joint Research Centre, Institute of Advanced Materials, Luxembourg, 1994... 

This work was supported by the European Commission Brite Euram under contract in ref. 1... 

Harmonised standards are technical specifications adopted by one of the European standards organisations following a mandate issued by the European Commission on which Member States were consulted. When published by the Commission in the Official Journal of the European Communities, the hamionised standards give presumption of confomiity to the essential requirements they specify. This means that manufacturers applying these standards do not have to demonstrate the compliance of the manufactured products with the relevant requirements of the directive. 

Gasoline composition may also be regulated in Europe. A tripartite initiative is being carried out among the European Commission, the oil industry, and the automotive industry. Based on an analysis of the required improvements in air quaUty, new regulations are to be written that control vehicle emissions and fuel composition into the twenty-first century. 

The ECPI approach has been adopted by the European Commission in their "Technical Guidance Document on the Risk Assessment of Notified New Substances" as the model for assessment of environmental exposure from additives in plastics. It is important to note, however, that due to the effect of ultraviolet degradation and microbial attack, a significant proportion of the emissions from flexible PVC consists of plasticizer degradation products. In these instances, therefore, the level of plasticizers appearing in the environment will be significantly less than indicated by the plasticizer loss data. 

In the European Union, coal-derived complex chemical substances, ie, those contained in the European Inventory of Existing Commercial Chemical Substances, have been classified for carcinogenicity in the twenty-first adaptation to technical progress of the European Commission (EC) Dangerous Substances Directive 1994 67/548/EEC (57). The EC Regulation 793/93 requires data sets to be submitted by producers or importers to the... 

European Commission for these and other substances by nominated dates. The toxicological data and estimation of exposure will form the basis of risk analysis and deterrnination of the appropriate restriction and control of substances in the workplace (58). Restriction of the sales of dangerous substances and preparations to the general pubHc is enforced under Directive 76/769 EC (59). 

Specialized Experts Working Group of the European Commission, Officialf Eur. Commun. (No. C 94/9) (1992). 

The Eurobachelor (www.eurobachelor.net) is a product of the project Tuning Educational Structures in Europe and was approved by the EuCheMS in 2003. The diploma label will ensure reciprocal recognition to students all over Europe between accredited institutions. The Eurobachelor Eabel Committee is funded by the European Commission and supported by the EuCheMS. 

P.T. C. Harrison, P. Holmes and C. D.N. Humfrey, Sci. Total Environ., 1997, 205, 97. European Commission DGXll, Report EUR 17549 European Workshop on the Impact of Endocrine Disrupters on Hnman Health and Wildlife, Brussels, 1997. 

European Commission, European Workshop on the Impact of Endocrine Disruptors on Human Health and Wildlife, Weybridge, 2—4 Dec. 1996, Environment and Climate Researeh Programme, European Commission, DG XII, Brussels, Report EUR 17549. 

Statutory EQSs have been set in legislation by the European Commission (EC) and in the UK by the Department of Environment (DoE). Other non-statutory operational standards have been developed by the NRA to control discharges and assess water quality. 

The Council of the European Economic Community, established under the 1957 Treaty of Rome, in 1973 issued a declaration on the environment (4), which the European Commission in Brussels has interpreted as giving it authority to issue directives on matters related to the emission of air pollutants, such as one limiting the sulfur content of fuel oil (5). 

Siilivask, K. (1998) Europe, Science and the Baltic Sea, in Euroscientia Forum (European Commission, Brussels) p. 29. 

A concise survey of where the broad domain of optical information processing had got to a few years ago is in a book issued by the European Commission (Kotte et al. 1989), while a good overview of non-linear optical materials is by Bloor (1994). 

Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk. Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances, European Commission, 1996. 

Joint Research Centre of the European Commission, Ispra, Italy... 

Working with the Member States and the European Commission as partners in a European medioines network, the European Medicines Agency ... 

European Commission, Enterprise and Industry Directorate-General http //ec.europa.eu/enterprise/pharmaceuticals/index en.htm. http //ec.europa.eu/enterprise/medical devices/index en.htm. European Medicines Agency... 

The European Commission has mandated CEN/CENELEC to develop many standards to support manufacturers in the realisation of the essential requirements of the Directives. If the Commission determines that an adopted standard is fit for this purpose, then a reference is published in the Official Journal of the EU, which elevates the status of the standard to that of a harmonised standard for European regulatory purposes. 

We would like to gratefully acknowledge EMEA, ISO, EDQM, PIC/S, IMB, ISPE and Health Canada that granted us permission to reproduce selected copyrighted material. We reserve a special acknowledgement and thanks to the European Commission, the FDA and the ICH secretariat, the VICH and the GHTF, who have placed their regulatory documentation in the public domain, and we have reproduced several documents from these sources herein. 

Bixio D, Witgens T (2006) Water Reuse System Management Manual. AQUAREC. European Commission. ISBN 92 79 01934 1, 646 p... 

One of the authors (CH) thanks the European Commission for financial support through the Training and Mobility of Researchers (TMR) Pro-gramm (Grant ERBFMBICT 96.1066). This work has been supported by the Danish Natural Science Research Council (Grant No 9600856). 

ARGUS (2000) The behaviour of PVC in landfill. Final report February 2000. Report prepared for the European Commission Environment Directorate (DGXI.E.3) by ARGUS (Germany) in association with Professor Spillmann (University of Rostook, Germany), Carl Bro (Denmark), and Sigma Plan (Greeoe) (http //ec.europa.eu/environment/waste/studies/pve/landfill.pdf). 

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