EU REGULATORY

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

Many different direchves and regulahons set up the current EU regulatory framework for chemicals. The most important ones are mentioned below. 

On 29 October 2003, the Commission adopted a proposal for a new EU regulatory framework for chemicals, the so-called REACH (Registration, Evaluation, and Authorisation of CHemicals). This new regulatory framework achieved all the objectives identified in the White Paper (EU 2001) and thus represents a model of sustainable development by pursuing its three main goals economic (industrial competitiveness), social (health protection and jobs), and environmental. 

The types of harm that chemicals have the capacity to cause (in other words their hazards) are qualitatively different and not commensurate with each other. At one extreme are effects that require reasonably high concentrations of the substance, are immediate and localized (for example flammability, explosivity, corrosiveness and acute toxicity). The causal relationship between a particular chemical exposure and such effects is usually obvious, or at least easy to demonstrate. Those affected generally include those who deal directly with the chemical and it is often possible to handle and store the chemical in such a way that harm is avoided. The existing European Union (EU) regulatory system, dating from the 1967 dangerous substances directive (Council Directive 67/548/EEC) was clearly set up with... 

With this EU approach, analytical strategies are applied that are defensible in Court of Justice and are complying explicitly with the ob jectives of the EU regulatory investigations. 

This chapter will focus on some, but not all, of the areas in which the U.S. Food and Drug Administration (FDA) and the European Union (EU) regulatory authorities have attempted to coordinate their efforts to provide uniform rules and standards for the pharmaceutical industry. Specifically, we will review the efforts to harmonize approaches relating to inspections (including public disclosure of confidential information) and product approval or authorization (including clinical trials). While space limitations do not provide sufficient opportunity to describe each regulatory authority s system or the harmonization attempts in detail, it is our hope to provide some background of where the efforts are now, where the efforts are intended to go, and what we believe will be the results of these efforts. In addition, the author is much more familiar with the U.S. system than the EU system because of his experience and daily exposure with FDA, this chapter will focus more on the U.S. structure. 

The FDA and the EU regulatory authorities seek the same objective when conducting an inspection—to determine whether or not products manufactured at a particular site comply with applicable regulatory requirements so that products distributed to consumers are lawfully produced. There are some general differences between the two inspection approaches, however. (Of course, there maybe exceptions to these general observations.)... 

At the end of the 3 -year transition period, FDA and the EU regulatory authorities that participated in the activities will assess the information obtained during the transition period [25]. Representatives from FDA and the EU will then meet in the Joint Sectoral Committee to jointly determine which regulatory authorities are equivalent, using the criteria described in the annex [26]. Regulatory authorities not listed as equivalent at the end of the transition period may apply for reconsideration at a later date, once the necessary corrective measures have been taken or additional experience is obtained. After equivalence determinations have been completed, the operational period will begin. 

Canada has a system that is intermediate between the EU regulatory system (which is intended to be, at least ultimately, based on directives and/or regulations from the EC) and the U.S. system (where codes and standards are both developed by private companies and can be adopted, or not, by the various state and local governments). The National Building Code (NBC) of Canada can be different from provincial building codes, and standards are issued by private companies. 

The Norwegian approach to REACH constitutes the fullest possible assimilation to the EU regulatory framework for chemicals management (Norwegian Pollution Control Authority [SFT] 2007). The REACH Regulation has been translated into... 

The role of environmental advocacy organisations in the diffusion of chemical safety and environmental policies from the EU to the Central and Eastern Europe states has been surprisingly limited. The vacuum of societal activism on the issue illustrates once again the critical meditating role of actor associations in linking domestic and EU regulatory and normative arenas. 

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