Authorization process

For their part, the Spanish health authorities have historically been less demanding in the authorization process for new therapeutic substances. 

The Directive requires an authorization process for biocidal products containing active substances listed in positive lists (Annexes I, lA, and IB of the Directive 98/8/EC). In relation to biocides, existing active substances are substances, which have been on the EU Market for biocidal purposes before 14 May 2000. An active substance, which was not on the market before 14 May 2000 is regarded as a new active substance and has to be approved by the Member States before it will be entered on the positive hsts. 

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... 

As mentioned previously, the authorization process starts with the identification of a substance as substance of very high concern (SVHC). For this purpose, the ECHA on behalf of the European Commission or a member state competent authority prepares a dossier. It generally includes a proposal for the identification of a substance as SVHC, a justification for this proposal and information on the substance s use, exposure, and risks as well as on alternatives. The extent of the justification may differ considerably between substances and may range from a sophisticated assessment of the harmful effects caused by the substance to a simple reference to Annex VI Part 3 of the CLP Regulation if a harmonized classification... 

The two most contentious aspects of REACH have been the registration requirements and the authorization process. While no one has argued that substances should not have to be registered, there have been many arguments about the amount of data that must be submitted in the registration dossiers and about how to deal with substances contained in manufactured articles imported from outside the EU. The public availability of information has also been an issue. The focus of the debate about authorization was whether authorizations should be granted where an alternative was available. The debate here can be seen as an argument between risk-based and precautionary approaches. 

To illustrate the point, at a three-hour meeting at McNeese State University s OSHA Support Group in Lake Charles, four major nationally recognized chemical plants and refineries described the details of their MOC systems in November 1997. The four companies described major system differences and about five more attending companies provided information regarding their approaches. There were distinct differences in the review and authorization process philosophy. 

In the authorization process, the importer, user, or manufacturer shall submit a review of possible substitutes, and if relevant develop a substitution plan, and is, inter alia, required to submit (Article 62) ... 

Hi) Regulatory Authority. Process systems dealing with marine vapor recovery must receive U.S. Coast Guard approval before operation. The ERA is required to establish standards for such systems under the Clean Air Act (Title I and HI). It is not clear to the regulated community who will have final authority for approval. What may be considered a state-of-the-art system today may not meet tomorrow s regulatory requirements. 

Two processes are industrially operated the 1G and TVA (Tennessee Valley Authority) processes. In the TVA-process combustion and absorption take place in separate towers, in the IG-process in a single tower. In this process the walls of the towers are protected from the hot phosphorus flame by pumped phosphoric acid. This pumped phosphoric acid removes the heat of reaction by being circulated through a heat exchanger and provides the water for phosphoric acid formation. The acid produced is extracted from the pumped phosphoric acid. Phosphoric... 

The conceptualization and implementation of the authors Process Data Warehousing approach has been illustrated, as realized as part of the research done in the subproject Cl. Aiming at goal-driven information flow management, three different prototypes have been described in their application and evaluation for engineering design process support. 

An example which was published by Pfeifer et al. (2002) illustrates very clearly the functions provided by CoTReM. The authors processed a sediment core obtained from the equatorial upwelling area off the coast of West Africa (Location GeoB4906, water depth 1251 m). The left... 

A quality management strategy is required to assure and continually improve the quality of the business activities nndertaken by any company or operator. The strategy should be an integral part of the corporate management system and define the quality objectives, plans, responsibilities, authorities, processes, and procedures. 

Whenever the operator makes use of the services or products of a contractor, the regulatory body should include the contractor s activities in its inspection programme in all stages of the authorization process. This may comprise inspection and surveillance of the design and manufacturing of components, including, where appropriate, activities performed in other States. 

A.l. This appendix sets out areas of nuclear facilities that may be of particular interest for inspection at different stages of the authorization process. 

Besides published research papers, review articles and works of reference, material for a volume of this type normally arises from an author s own background and experience. In this connection, I wish to acknowledge the work of those of my colleagues and associates in the U.K. Atomic Energy Authority whose work has contributed to the design of various Authority processes which have been discussed. I also wish to thank those outside the Authority, concerned with rare metal extraction, whose factories I have had the privilege of visiting. 

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