Regulatory (EU) guidance towards reduced chemical risks : a study on unintended outcomes in biocide applications

This study examines the interactions between the European Union (EU) regulation of chemical substances and product development in the chemical industry. The EU regulatory initiatives that are examined include e.g. REACH, 1998/8/EC, 2004/42/EC and selected voluntary guidance. Specific emphasis of the present thesis is placed on biocide applications with reference to unwanted end-results of the guidance, which aims at reduction of chemical risks. Here, the end result of chemical risk reduction is determined by the interactions between the physico-chemical environment of the application and the prevailing microbial flora. In order to interpret these interactions the research was carried out by addressing the following research questions: First, what are the drivers of the development of new biocide active ingredients, and, which factors hinder such development? Second, which factors of the currently implemented chemicals regulations (e.g. REACH) and directives (e.g. 2004/42/EC, 2000/60/EC), which aim at reduction of environmental and health risks, can increase the microbiological risks associated with products, which may also result in environmental and / or health risks? Third, which factors could drive towards a situation in which the reduction of a specific chemical risk can result in increased use of biocides and therefore lead to increased chemical risk? The present study shows that the currently implemented EU and directives can lead to increases in both microbial and chemical risks. Increases in microbial risks can be expected as the attempt to avoid persistent materials leads to favoring the biodegradable alternatives and the reduction of VOC emissions favors the water based and even VOC-free products and raw-materials. Furthermore, the acknowledged reduction in the available biocide selection due to directive 98/8/EC implementation and lack of new biocide development due to cost associated to in vivo test requirements together with increasingly susceptible products and processes will increase the likelihood of risk of development of resistant microbial species and, i.e. leading to increased microbial risk. The increase in chemical risks due to increased use of biocides is also possible, if the production - scale levels of biocides and the occupational and health risks associated with such amounts are not carefully evaluated. It is therefore proposed that in order to avoid unwanted end-results it is important to improve education for chemical industry product development and purchasing personnel on the evaluation of chemical risks and control of such risks. Moreover, the proactive anticipation of microbial risks during the introduction of new technologies should be assessed. Finally, the development and introduction into usage of alternative means for in vivo tests must be further enforced