Chemicals, industrial REACH

The aims of the proposed new regulations are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production. 

Increasing international competition and poor public perceptions could jeopardise the sustainability of the EU chemical industry. REACH is a once-in-a-lifetime opportunity and the stakes are high. Whether REACH seals or opens the coffin for many EU chemical businesses will depend on the finer details of its implementation, which appears to be in the hands of the EU Member States, the European Commission and the new European Chemicals Agency. 

Peter Spitz, Petrochemicals The Rise of an Industry (New York John Wiley Sons, 1988), p. 514. V. M. Walsh, J. F. Townsend, B. G. Achilladelis and C. Freeman, Trends in invention and innovation in the chemical industry, reached similar conclusions about the importance of demand and feedstocks (see page 5.20). By contrast, Achilladelis played down the importance of feedstocks in his thesis see Process Innovation in the Chemical Industry, p. 245. The Krauch family form an impressive dynasty. Carl Heinrich s grandfather, also called Carl, was a pharmacist and production manager at Merck (Darmstadt). See Heine Verstand Shicksal, p. 98, and H. Benniga, A History of Lactic Acid Manufacture (Dordrecht Kluwer, 1990), pp. 129-134, 153. 

The chemical industry manufactures a large number of antioxidants (qv) as well as uv stabilizers and their mixtures with other additives used to facilitate resin processing. These companies include American Cyanamid, BASE, Ciba—Geigy, Eastman Chemical, Elf Atochem, Enichem, General Electric, Hoechst—Celanese, Sandoz, and Uniroyal, among others. The combined market for these products in the United States exceeded 900 million in 1994 and will reach 1 billion in the year 2000. 

The primary lesson from this example is that no process is infinitely scalable. Sooner or later, additional scaleup becomes impossible, and further increases in production cannot be single-train but must add units in parallel. Fortunately for the economics of the chemical industry, the limit is seldom reached. 

The objective of the chemical industry is to have robust and flexible chemical reactors. It should also be possible to reach large-scale production of new chemicals in a very short time. The available reactors should be able to produce a large variety of chemicals with high selectivity. To obtain this, we must not only understand how existing reactors work in detail but also develop new reactors. 

The 1990s was a decade of fruition because the computer-based drug discovery work of the 1980s yielded an impressive number of new chemical entities reaching the pharmaceutical marketplace. We elaborate on this statement later in this section, but first we complete the story about supercomputers in the pharmaceutical industry. 

Probably the least stable industrial hydrocarbon. It has been used less often since it became a compound of minor interest in the chemical industry. The compound in the pure state detonates spontaneously. As a by-compound of an old synthesis of butadiene, which is not used anymore, it used to be mixed with butadiene. As soon as its concentration in such a mixture reaches 50%, it detonates. The speed at which its pressure goes up is extremely high and makes it highly explosive. 

D-Pantolactone and L-pantolactone are used as chiral intermediates in chemical synthesis, whereas pantoic acid is used as a vitamin B2 complex. All can be obtained from racemic mixtures by consecutive enzymatic hydrolysis and extraction. Subsequently, the desired hydrolysed enantiomer is lactonized, extracted and crystallized (Figure 4.6). The nondesired enantiomer is reracemized and recycled into the plug-flow reactor [33,34]. Herewith, a conversion of 90-95% is reached, meaning that the resolution of racemic mixtures is an alternative to a possible chiral synthesis. The applied y-lactonase from Fusarium oxysporum in the form of resting whole cells immobilized in calcium alginate beads retains more than 90% of its initial activity even after 180 days of continuous use. The biotransformation yielding D-pantolactone in a fixed-bed reactor skips several steps here that are necessary in the chemical resolution. Hence, the illustrated process carried out by Fuji Chemical Industries Co., Ltd is an elegant way for resolution of racemic mixtures. 

In April 2005, after consulting the UK Chemical Stakeholder Forum, the UK Department for Environment, Food and Rural Affairs unveiled its intended input to EU negotiations on dealing with the highest risk chemicals under REACH. The Chemical Stakeholder Forum was also consulted on which organisation should be the UK s competent body for REACH and on the Chemical Industry Association s plan to create a database of chemicals marketed in the UK. 

Again, it is also important to remember that chemical emergency situations can easily reach beyond the boundaries of any industrial plant. This is to be expected, especially in this age of population explosion with its characteristic urban sprawl. It is not unusual to find, for example, a chemical industrial plant site or other industrial plant that originally was isolated from city dwellers but later became surrounded on all sides by neighbors. The point is that when a chemical spill or chemical disaster occurs in an isolated area there may be no cause for general alarm however, when such a deliberate disaster occurs in the plant site as described in the sugar plant incident, it should be clear that the purpose of PSM, RMP, the Patriot Act, Homeland Security directives, OSHA s Combustible Dust NEP, and other safety/security factors is far-reaching—and absolutely critical to the survival of a free society. 

This is confusing. Why don t risk assessors simply decide what level of exposure is safe for each chemical, and risk managers simply put into effect mechanisms to ensure that industry reaches the safe level Why should different sources of risk be treated differently Why apply a no risk standard to certain substances (e.g., those intentionally introduced into food, such as aspartame) and an apparently more lenient risk-henefit standard to unwanted contaminants of food such as PCBs, methylmercury, and aflatoxins (which the FDA applies under another section of food law) Why allow technological limitations to influence any decision about health What is this risk-henefit balancing nonsense Aren t some of these statutes simply sophisticated mechanisms to allow polluters to expose people to risk ... 

To further this discussion let us divide environmental chemicals into three broad groups. First there is the enormous group of naturally occurring chemicals that reach us primarily through food and products such as cosmetics, but also through other media. Second are industrially produced chemicals that are manufactured for specific purposes. And third are the industrial pollutants - chemical byproducts of fuel use, the chemical industry, and most other types of manufacturing. 

A common position statement issued on 25 October 2004, by the Confederation of British Industry (CBI), the UK s Chemicals Industry Association (CIA) and Greenpeace recognises the ability of a strong REACH regulation to drive innovation "Weshare the view that a requirement within the authorisation procedure... 

The Confederation of British Industry, the Chemical Industries Association and Greenpeace share the common position that substances requiring an authorisation within REACH according to Title VII, Article 54 of the Commission s proposal i.e. substances of very high concern) should be replaced with less hazardous alternatives... 

The political requirement within Europe, that the industry should be responsible for the assessment of the 30,000 substances currently on the market and their applications is in line with the voluntary commitment of responsible care by the chemicals industry. Implementation of this -commitment has so far failed because many users of chemical products have not complied with it. The REACH system proposed by the EU Commission would create a regulative framework for structuring responsibility and information flow along the supply chain, in a binding marmer for the first time. The commercial institutions should respond to this state initiative. 

ECETOC (2004) has proposed a concept of generic threshold values based on hazard categories primarily intended to be used in the risk assessment procedure of industrial chemicals within REACH. The hazard categories are based on EU classihcation limits and for each substance to be risk assessed, inclusion in hazard categories depends on the substance s specific classification (or no classification) according to the Commission Directive 67/548/EC (EC 1967). Three hazard categories have been suggested ... 

A Nordic project has evaluated how different TTC-like concepts have been used, and assessed their potential usability in risk assessment of industrial chemicals within REACH (NCM 2005). The Nordic group considered that if the TTC concept is appropriately derived and used, it might imply a better focus of chemicals at risk. However, it was also stated that, independent of the approach used in risk assessment of industrial chemicals, it is important to maintain a sufficient level of protection and that application of the TTC concept in REACH would imply that limited data may be generated and thus that the level of protection might be influenced. 

The Toxic Substances Control Act (TSCA or TOSCA) was initiated. It has far-reaching effects specifically for the chemical industry and will be discussed in detail in the next section. An immediate effect that it had was to direct the EPA to develop rules to limit manufacture and use of PCBs. 

The chemical industry views sustainable development as a challenge put before all parts of society. In the advances made in its own operations, its improved performance and in the improvements to the hnman condition made through its products, the chemical industry sees cause for optimism and believes that sustainable development can be the intellectual framework around which the chemical industry, other industries and other sectors of society can reach consensus on how to improve living standards and the environment. 

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