SYSTEMS FRAMEWORK REGULATORY

Recent discussions on the REACH legislative proposal have highlighted the need to prioritise regulatory activities [168]. Following the systems framework, regulatory decision-making and... 

Table 6.2 Predicted voting for adopting the system framework regulatory recommendations...

Under the systems framework, regulatory recommendations for professional and consumer products should guide regulators and industry through REACH. Companies would be able to develop recommendation equivalents that could incorporate a wider set of communication and management tools than currently envisaged under REACH. 

To ensure that this team concept is institutionalized and for its continuous improvement, the PAT Team process will be under the FDA s Quality Systems Framework. This should also help in ensuring quality and consistency of reviews, inspections, and other regulatory activities. 

The criteria for the recommendations proposed under the systems framework are based on scientific evidence and previous regulatory decisions that have been subject to rigorous EU legislative processes. It is therefore anticipated that these regulatory guidelines should also conform to international trade laws. Because the decision-... 

Table 6.1 Result of regulatory outcomes following the systems framework - chemical acronyms listed in Abbreviations...

Significant uncertainty exists in the current risk assessment of bisphenol A, which has led to the EU regulatory risk assessment conclusion that further risk data need to be collected, especially because it is a potential endocrine disruptor. Under the systems framework, recommendations would apply during the time necessary to collect further information on bisphenol A, thereby providing a... 

The proposed systems framework s prioritisation method can help decide on measures and monitoring activities that target the control of the probability or the extent of further regulatory action being necessary, for example ... 

EU risk assessment and the application of the systems framework decision-making matrix both indicate otherwise. The prioritisation method could also isolate several substances that should be given particularly low priorities at the EU level (e.g., BA, butadiene, TCE) which demonstrates some of the inefficiencies of the current regulatory system that could continue under REACH. 

Altogether, the systems framework demonstrates just how important the role of future TGD can be for the implementation of REACH. For instance, setting regulatory recommendations that apply... 

The systems framework may therefore provide a basis for the further development of such tools. Fundamentally, while the REACH Implementation Programmes (RIP) are providing guidance, they do not appear to be proposing specific methods or tools to facilitate regulatory decision-making. 

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