Legislation system, regulatory

REACH has provided a structure in which a well-informed chemicals risk management can be developed. In particular, it creates a legislative and regulatory framework for all substances in which the procurement of data for making reasonably reliable risk assessment is possible. But on the other hand, as we have seen, it does not require the creation of such data for all substances for which it is needed. This should be no surprise. The deficiencies in the previous system of chemicals regulation were so large that it would be unrealistic to believe that they could be solved in one single reform. It is only to be expected that there should be scope for improvement. A discussion is needed that identifies the most important of the potential improvements of the system, and in this spirit we would like to propose three important issues for the further development of REACH. 

OVERVIEW OF REGULATORY ENVIRONMENT/BACKGROUND The Legislation System... 

This is a free, Web-based search system that provides access to structure and nomenclature authority files used for the identification of chemical substances cited in National Library of Medicine (NLM) databases. It also provides structure searching and direct links to many biomedical resources at NLM and on the Internet for chemicals of interest. The database contains over 367000 chemical records, of which over 142 000 include chemical structures, and is searchable by Name, Synonym, CAS Registry Number, Molecular Formula, Classification Code, Locator Code, and Structure, (online from NLM at http //chem.sis.nlm.nig.gov/chemidplus). CHEMLIST (Regulated Chemicals Listing) Contains information on over 230000 chemicals subject to legislative and regulatory control. Covers... 

The system, as described in the first portion of this manuai, is the basic Hazardous Materials Identification System. As noted earlier, it is a flexible system which may stand on its own as a means of worker hazard identification and is also compatible with other existing plant education and training programs. Legislative or regulatory provisions that cail for the special identification of extremely hazardous materials (such as carcinogens) can easily be incorporated into the HMIS. too. 

The American Hospital Association (AHA) is a national organization that represents and serves all types of hospitals, healthcare networks, and their patients and communities. Close to 5000 hospitals, healthcare systems, networks, other providers of care, and 37,000 individual members come together to form the AHA. Advocacy efforts include the legislative and executive branches and include the legislative and regulatory arenas. Founded in 1898, the AHA provides education for healthcare leaders and is a source of information on healthcare issues and trends. 

ISO 14000 A series of generic environmental management standards developed by the International Organization of Standardization, which provides structure and systems for managing environmental compliance with legislative and regulatory requirements and affect every aspect of a company s environmental operations... 

Finally, it should be noted that biofuels can be severely pollutant as their productions involves not only the emission of GHG, but also formaldehyde, acetaldehyde, and other aldehydes deriving firom alcohol oxidation and combustion. The production of a more sustainable biofuel is currentiy imdergoing a certification scheme elaboration phase, which will hopefully result in more sustainable resources (Mata et al., 2013 Devisscher, 2007). However, the need to comply with strict and onerous certification systems may reduce even further the already scarce competitiveness of biofuels with respect to fossil fuels. These aspects will be addressed in the following section where we closely look at legislatives and regulatory issues. 

A government relations office s system for identifying emeiging regulatory or legislative trends... 

The European Commission, as part of its policy to encourage industry to adopt more sustainable practices, created the EMAS system in 1993. EMAS was also seen as a move towards stated the EU goal of encouraging industry to adopt more self-regulatory practices and a move away from command and control type central legislation. 

The text will be based on an interpretation of the legislative requirements and will include consideration of many of the available guidance documents. In addition, consideration has also been taken of published EPARs and the author s own experience of the European regulatory system (which extends over some 25 years). In case of doubt or disagreement, readers are referred to the original texts of the legislation, notes for guidance, and EPARs. 

After a product has been authorised, the regulatory system operates to keep the quality, safety and efficacy of that product under review and to control the way in which it is manufactured, marketed and distributed. The pharmaceutical legislation in Europe has recently been consolidated and, pursuant to Commission consultation and review, amended. The majority of the amendments are due to come into effect in November 2005. What follows, reflects the state of legislation as at close of 2004. 

---