European Union regulatory controls

Other chapters in this book deal with the evolution of the legal controls over medicinal products and the structure of the European Union regulatory systems set up to authorise business activities and dealings in these products, and to enforce the rules and restrictions the law places upon them. This chapter aims to select some specific legal and ethical issues that arise in relation to product development, authorisation and sale and supply both within the United Kingdom and within the context of the European systems. 

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. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

R. Nilsson, Integrating Sweden into the European Union Problems Concerning Chemicals Control, The Politics of Chemical Risk—Scenarios for a Regulatory Future 9, ed. R. Bal and Halffman (Dordrecht, Netherlands Kluwer, 1998), pp. 159-71. 

Most European countries follow the European Directives that list the colorants and specifications for use in foods and drugs in the European Union (EU). The directive that has previously controlled the approved colorants for use in pharmaceuticals in Europe is 78/25/EEC, which refers to a list of colorants from a 1962 directive. " The EC published European Directive 94/36/EC in 1994, which significantly changed the list of approved colorants for use in foods. For example, Allura red AC (FD C red 40) and Brilliant blue FCF (FD C blue 1) were now approved for use in foods, however, these materials did not exist on the list of approved drug colorants because of the cross-referencing of the pharmaceutical directives back to the 1962 list. This has created much confusion throughout industry and the regulatory community. 

Basic professional development courses offered by SCHC are MSDS and Label Preparation Workshops Science, Toxicology and Industrial Hygiene for Hazard Communication and Hazard Determination Risk Assessment. Regulatory courses include Canadian Mexican Hazard Communication Pesticide Consumer Product Labeling Component Disclosure Requirements European Union Hazard Communication Transportation Classification Labeling HMIS/NEPA Labeling and International Chemical Control Laws. 

This part of Chapter 9 sets out a more detailed perspective of how legislation concerning chemicals is implemented in the UK, and it considers how developments have been influenced by traditions. In the context of this chapter, it is not the intention to provide a complete and comprehensive review but rather, by selective illustration, to show how the typical British approach based on informality and regulatory discretion has moved to the more formal and centralised control necessary within the European Union (EU). Where appropriate, reference to other international law is made to indicate where different approaches influence enforcement procedures. 

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