Regulatory groups

The safety assessment of flavoring substances has been undertaken by several national and international authorities including JECFA, the FEMA Expert Panel, the SCF and the CE. 

The JECFA safety evaluation procedure for flavoring substances leads the evaluator through a decision tree with two branches, one for substances that are metabolized to innocuous end products and the second for substances that are not metabolized to innocuous end products (Fig. 9.1). The decision tree is applied using a series of questions  

Do the intended conditions of use result in an exposure greater than the human exposure threshold for the structural class  

Does a NOEL exist on the substance which provides an adequate margin of safety  

Does adequate toxicology exist on the substance or do one or more structurally related substances have an adequate NOEL  

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Calcium—zinc soaps are used in many PVC food container appHcations because these heat stabilizers are universally accepted as safe by the U.S. FDA, German BGA, Japanese JHPA, and other government regulatory groups. 

The process of method development and validation covers all aspects of the analytical procedure and the best way to minimize method problems is to perform validation experiments during development. To perform validation studies, the approach should be viewed with the understanding that validation requirements are continually changing and vary widely, depending on the type of product under test and compliance with any necessary regulatory group. 

The output of the ECETOC work program is delivered in published reports and papers, through scientific representation in the activities of international organizations and regulatory groups and through presentations and organization of specialized workshops and fora. 

All regulatory documents presumably are subject to a tripartite review process. The submission is reviewed by the corporate Regulatory group, which proofs, considers issues of conformity to internal policy and to FDA guidance and checks the factual statements. A Quality Assurance review then rechecks all the previous items and independently confirms all facts and statements. Finally, a corporate review (at or near the top of the organization) precedes the final signatures and confirms conclusions and plans. 

Central development and support teams should ensure that the quality of suppliers supporting central activities have been assessed. Centrally organized supplier audits should be conducted in conjunction with regulatory groups that are familiar with the organization s operating model. Suppliers supporting local modifications should also be subject to supplier assessment. 

To fulfill these objectives, a number of basic test protocols have been developed and mandated by different regulatory groups. Table 3 gives an overview of these protocols. Historically, the philosophy underlying these test designs made maximization of the biological response equivalent to having the most sensitive test. 

Each of these regulatory groups typically has a cadre of environmental toxicologists, risk assessors, and consultants that provides input to the setting of regulatory concentrations of chemicals. Likewise, the industry regulated by these agencies also utilizes similar expertise. 

The first priority of a regulatory group should be the establishment of SOP on SOPs —that is, how they are to be created, reviewed, implemented, and revised. If a policy applies across corporate groups including information technology,... 

Tabi.b 2-3. Safety Regulatory Groups and Information Sources... 

Academic, industrial, and regulatory groups with strong expertise in population-based techniques and analyses have habits and traits in common that make them effective. These include cross-disciplinary support of population pharmacokinetic... 

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