European Union member states’ initiatives

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 workshop took place at the Los Alixares Hotel, where 45 lectures were given by prominent members of the scientific community in addition, 49 posters were presented in two very animated sessions. The success of this workshop is due, without doubt, to the excellent tradition initiated at the previous workshops, organised by Prof. R. McWeeny in San Miniato, Pisa (Italy), 1996, and by Prof. S. Wilson in Oxford (United Kingdom), 1997. These workshops create occasions for meetings and discussions on the current state of the art, emerging methods and applications and new trends in this area of science. The three meetings were sponsored and partially supported by the European Union (EU) in the frame of the Cooperation in Science and Technology (COST) chemistry actions. 

The term substance of very hi h concern, abbreviated SVHC, is associated with a new process that was introduced to the European chemicals policy through the implementation of REACH the authorization process. This procedure aims (1) to encourage the substitution of substances of very high concern with less harmful substances or alternative technologies and (2) assure the proper control of risks arising from SVHC s. A substance being subject to authorization must principally not be used or placed on the market for any use within the European Union. However, specific uses of an authorized substance may be excluded from this general prohibition if, for example, they are a priori exempted from authorization or if the manufacturer, importer, or downstream user successfully applied for their authorization. The authorization process is laid down in REACH Articles 55-66 and may be initiated by the ECHA on behalf of the European Commission or by EU member state competent authorities. Substances which are subject... 

European Union s civil service, and comprises approximately 14,000 officials, has the right of initiative, that is, to draw up proposals for Union legislation. The Commission negotiates on behalf of the member states in multilateral and bilateral trade matters and in the drawing up of association and membership agreements with nonmember countries. 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

The Pesticide Risk Assessment Peer Review Unit (PRAPeR) of the European Food Safety Authority (EFSA) is responsible for the peer review of initial risk assessments of active substances. For each substance, a member state carries out this initial risk assessment, which is presented in a draft assessment report (DAR) that is then peer reviewed by experts across the European Union (EU) in a process... 

As a consequence of the new legislation for clinical trials, documentation on the quality and preclinical (i.e., toxicological) data of investigational medicinal products, including radiopharmaceuticals, needs to be submitted to obtain approval from the national health authorities in the member states prior to initiating a clinical study in humans. Furthermore, all clinical trials which started in the European Union after 1 May 2004 need to be recorded in the European EudraCT database (European Commission 2003 b). 

EU Network (2006) Report (m the Situation of Fundamental Rights in the European Union and its Member States in 2005 Conelusions and Recommendations http //ec.etffopa.eu/justice home/ cfr cdf/doc/rapport summary 2005 en.pdf. Accessed 29 May 2010 European Commission (2013) Subject Your request for registration of a proposed eitizens initiative . 13/09/2013, EU Doe. C (2013) 5969 final European Union (2004) CraistitutiOTial Treaty EU Doc. CIG 87/2/94 rev. 2 General Assembly (1960) Declaration on the Granting of Independence to Colonial Countries and Peoples UN Doc. A/RES/1514 (XV)... 

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. 

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