Regulatory Outcomes

Automatic bans for carcinogenic, mutagenic or reprotoxic (CMR) substances following the restrictions procedure under Directive 76/769 have been excluded (step 2) because these will continue to apply under REACH. The result of the risk criteria evaluation for each substance according to the decision-making matrix is shown in Table 6.1 (step 3). Based on the selection procedure detailed in Section 5.3.2, the most suitable regulatory outcome 

3 A more detailed description of the application of the methodology is available in the original version of this thesis, as published in 2007. 

7 DEGBE DEGME ii ii ii ii iii iii Yes MS permitting restrictions for cons and prof 

16 Phthalate subgroup based on BBP, DBP, DEHP, DIDP, DINP, DNOP i i i i i ii Yes Restrictions for cons 

KEY cons = consumer products prof = professional products  

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When two signals have opposite effects on a metabolic characteristic such as the concentration of a second messenger X, or the membrane potential Vm, the regulatory outcome results from the integrated input from both receptors. 

Chemical Environment Cons. Profess. National dimensions Regulatory outcome... 

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

Constructing a decision-making matrix that compiles previous decisions and therefore facilitates comparisons of regulatory outcomes ... 

It is noted that the EU scheme is intended to identify HEROs (High Expected Regulatory Outcome substances) as well as possible NEROs (No Expected Regulatory Outcome substances) and that national schemes, such as that in the UK, includes the establishment of a fast-track procedure for chemicals that present a high risk to public health or to the environment. 

In the United States, environmental taxes are virtually nonexistent. Overall, however, and despite these various differences in approaches, we were not able to discern clear differences in regulatory outcomes across the Atlantic in some cases one or more European nations acted sooner or more... 

The Letter of Support was established by the FDA and EMA in 2014 as a means to recognize the potential utility of exploratory biomarkers prior to qualification. C-Path s PSTC was the first biomarker submitter to receive a Letter of Support from the FDA and the EMA. The Letter of Support, as a regulatory outcome, resulted in part from the discussion between PSTC, EMA, and FDA and the realization that greater attention to promising biomarker programs would help facilitate the use of exploratory biomarkers. 

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