REACH TECHNICAL GUIDANCE

As of April 2006, the preliminary REACH technical guidance documents (TGD) available to date relate to the risk assessment processes of REACH, such as the use of toxicological QSARs and the development of exposure scenarios [126]. 

REACH technical guidance documents (TGD) may prove instrumental for the future development of international guidance. Perhaps more importantly, substances subject to authorisation due to their persistent, bioaccumulative and toxic (PBT) characteristics will also be proposed for inclusion on the International Persistent Organic Pollutant (POP) register or other international conventions... 

Risk Assessment Technical Guidance Document (a. 16), which will presumably apply to registration under REACH. The adequacy of each test can be defined by two basic elements ... 

EU (2005) Work Package 1. Development of the concept of exposure scenarios. General framework of exposure scenarios. Scoping study for technical guidance document on preparing the chemical safety report under REACH, final report. European Union, European Chemicals Bureau (REACH Implementation Project 3.2-1A Lot 1 Commission Service Contract No. 22551-2004-12 FISC ISP BE ... 

RRS = Risk-reduction strategy TGD = Technical guidance document [28] RIPs = REACH implementation projects... 

The SMILES notation is a means by which certain chemical structures can be described using a series of simple letters and numbers expressed in linear fashion, even for complex cyclic structures. This approach is particularly useful as input for computer models when chemical names and CASRN are unknown. As mentioned above, SMILES is an important tool in hazard and exposure modeling used in EPA s voluntary Sustainable Futures Program [1]. It can also be used to identify substances under REACH, and examples are shown in the nomenclature Technical Guidance Document (TGD) along with molecular and structural formulas. 

Technical Guidance Document Substance Identification and Naming in REACH... 

One can even have several different monomers or combinations of monomers to make the same polymer - or various polymer structures resulting from different polymerisation reaction conditions. This makes identification and quantification of the monomer content of a polymer, as required by the REACH legislation and the corresponding official technical guidance, quite challenging. 

The ICH Q8 guidance is currently being developed and is expected to reach the ICH Step 2 in November 2004. It is intended to provide guidance on the contents of Section State-of-the-the-Art Pharmaceutical Science. P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). 

A 247-page draft TGD for producing an Annex XV dossier was published in May 2006 as part of RIP 4.4 [495], which formed the basis for other guidance in 2007. It presents an excellent, highly technical explanation of how to consider alternative regulatory options. For instance, after explaining the interaction of REACH procedures, how to assess information for the harmonisation of classification and labelling... 

Today, the physician of mainstream medicine still does not even remotely have the time to take all lifestyle factors into account (and certainly not provide any broader guidance) without the resource that IT could provide. The best that can be done is referral to a specialist, which may never happen. Neglect of a holistic view is especially noticeable when a patient s illness demands urgent attention, and all effort must be focused on the episodic and reactive (instead of proactive) treatment of the patient. Most often a so-called disease is technically a symptom, of an underlying cause that is not addressed. Symptoms are cured, but by waiting until the patient reaches a state where treatment is essential, the core problem is harder to treat. If truth be told, the inevitable and fundamental nature of any episodic and illness-oriented approach allows a patient to deteriorate to a condition of stress before action is taken. It is even defined as the moment at which the patient is so stressed that he or she takes the decision to be a patient, and often the point of illness is all that the physician ever gets of a glimpse of the patient. 

The corresponding technical reference docmnent on PSA methods (FAK 2005) provides guidance on the methods to be nsed for these assessments. In general, the extent of the analysis for external hazards is limited to a Level 1 PSA (estimation of the core damage freqnencies, no consideration of release frequencies) and to full power operation states. The depth of the required analyses varies between the individual hazards. But for all external hazards the recommendations have not yet reached the same maturity as for plant internal events. 

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