EU RISK REDUCTION

Figure 5.3 Existing EU risk-reduction strategy process (adapted from [464-466])...

Several years later, official EU risk-reduction strategies (RRS) for DEGBE and DEGME were produced, but discussions of possible restrictions largely focussed on applications outside industrial settings relevant to France. France therefore decided to adopt much lower occupational exposure limits than those decided at the EU level, essentially banning most industrial uses of the two substances. 

Any exposure Follows current EU risk reduction TGD that specifies significant release to the environment may occur during consumer use [202] Supplier must organise take-back of unused or remainingconsumer products sold in quantities greater than 5 litres or 5 kg containers (Example only - size of contaciner reviewed)... 

Any exposure octa-BDE [306] follows current EU risk reduction TGD guidelines [485] Supply of correct PPE or provide training when selling product unless selling to a certified or licensed professional user The provision does not include sale of the product in pellet form... 

Priority substances were selected, which are considered to be of particular concern to human health and/or the environment. The suppliers of these priority substances had to provide any missing studies to complete a EU notification Base Set (Table 1). A rapporteur Competent Authority evaluates the full review dossier on behalf of the EU. The final output is a risk assessment (see Section 14), with final recommendations on how to deal with the substance i.e., it may be of no concern, require risk reduction or restriction, or further data may be needed before a decision is made. 

The German Environmental Ministry is reported to have attacked European proposals to ban substances such as specific flame retardants in forthcoming regulations for recycling electrical and electronic equipment. Initial proposals from the EU Commission on the disposal of waste electrical and electronic equipment, include a phaseout of PBDEs, despite preliminary findings under EU risk assessment that there is no need for risk reduction from the two types, decaBDE and octaBDE mainly used in such equipment. The Ministry is said to be concerned at the excessively prescriptive and restrictive system being proposed, and that substance restrictions should not be addressed in waste legislation, but should be based on life cycle risk assessments. 

Unlike the discussion on environmental policy in the 1980s, support for a strict continuation of environmental and health policy appears rather to have waned. After some scandalous classic hazards were reduced, actions for precautionary risk reduction again appear to be weighted more against the requirements of industrial and economic policy. This is also reflected in the fact that the latest initiatives by the EU Commission in the area of enviromnental and chemicals pohcy were accompanied by an intensive discussion of the correct method for assessing the consequences of legislation. 

European eco-labeling of paper products, and in the existing European eco-labeling for cleaners under Regulation 1980/2000/EC. In addition, the EU Commission made further recommendations on risk reduction measures for EDTA. First, it asked EU Member States to establish Environmental Quality Standards (EQS) for EDTA, and the national pollution reduction measures to achieve those EQS in 2015 should be included in the river basin management plans in line with the provisions of Directive 2000/60/EC. Second, EU Member States should specify in IPPC permits measures on EDTA to operate to BAT by October 2007, taking into account local circumstances. Further, as BAT is developed, this should be incorporated into the permits. 

While PBBs have not been used for many years, as a consequence of the results of the EU Risk Assessments, the PBDPEs penta and octabromodiphenyl ether have been banned, while decabro-modiphenyl ether (DBDPE) was shown to necessitate no risk reduction measures. Thus, following... 

Review of RoSH published on 10 December 2008 will impose a review with REACH directive The risk assessment for short chain (C10—C13) chloroparaffins (SCCPs) was completed with the conclusion that the use of SCCPs in metal working and leather processing poses a risk to the aquatic environment. As a consequence, risk reduction measures have been implemented (EU Directive 2002/45). No significant risks to human health were identified. In all applications where they are used as flame retardants, no risk of secondary poisoning through accumulation in the environment or the food chain was found. Further studies of SCCPs have been specified by EU Regulation 642/2005 emissions and biodegradation in marine environment. 

The EU Risk Assessment (Part I—Environment was completed in 2005) identifies a risk of accumulation in the food chain, and suggests risk reduction measures for all applications. Part II—Human Health are under evaluation... 

The EU Risk Assessments on the four chlorophosphate flame-retardants—TCPP, TDCP, TCEP, and V-6—were recently finalized.54 57 For TCPP, TDCP, and TCEP all had some risks identified, so risk reduction strategy for each is in progress. The classification and labeling proposal is in preparation for TCPP. No risks were identified for V-6, hence this material will have no risk phrases associated with it. 

The Restrictions place conditions for the manufacture, placing on the market, or use of certain substances in the EU that are deemed to have unacceptable risks. Proposals for restrictions will be prepared by Member States or by the Agency on behalf of the Commission in the form of a structured Dossier. This Dossier is required to demonstrate that there is a risk to human health or the environment that needs to be addressed at Community level and to identify the most appropriate set of risk reduction measures. Deadlines for the procedure to prepare a Commission decision are set out in the Regulation. Interested parties will have an opportunity to comment and the Agency will provide opinions on any proposed restriction. 

The recommendations for chemicals prioritised for risk-reduction measures correspond to the current proposal for the new EU-legislation, REACH, and also to the environmental quality objective a Non Toxic Environment adopted by the Swedish parliament. The tool is also appreciated by companies and organisations outside Sweden, as a source of knowledge or inspiration. This tool may be used and further developed by Asian ASEM countries to suit their chemicals management needs. 

Furthermore, from a regulatory vantage point, it can be mentioned that several risk reduction measures have been taken for these chemicals both within the European Union and in international conventions. The use of Penta, Octa and Deca in electrical and electric equipment is, for example, restricted in EU legislation through the RoHS Directive (2002/95/EC). Penta is also included (and Octa is suggested for inclusion) in the Stockholm Convention on persistent organic contaminants. Thus, decision-makers appear to have treated the available and often uncertain information on Penta, Octa and Deca as if their properties, use and emission were known to pose intolerable risks (at least to the extent reflected by the above described risk reduction measures). 

DEHP assessment (205) has shown no risk reduction measures are necessary for the general population, but measures could be taken to reduce risk of exposure in children s toys (although DEHP is not used in toys intended to be put in the mouth) and medical devices (against the opinion of the EU s Scientific Committee on Medicinal Products and Medical Devices). Prior to these results some formulators had already begun to change from DEHP to DINP (119). 

Interview questions needed to address the research questions, but were elaborated and defined after the literature review. Specifically, the questions needed to cover 10 broad topic areas relating to policy, rules, practice and experiences with official risk reduction strategy processes at national and EU levels (as described in Section 2.3.4 and defined in Appendix 2.4). These 10 topic areas were anticipated as minimising potential overlaps between interviewee reports of national and EU dimensions while being sufficiently wide to group variations in interviewee responses. 

To protect occupational and consumer health from DCM, Germany set technical standards on DCM sales. National measures would not have been practical for regulating the trade and marketing of DCM in the EU. Action to restrict the marketing of dangerous substances to protect human health or the environment must comply with Article 95 of the EC Treaty relating to the internal market. Objecting to immediate adoption of EU standards to ensure adequate risk reduction, the UK - a major producer of DCM - declared that it was necessary to conduct full risk assessments of alternative substances, as well as a detailed socio-economic analysis of... 

As a first step, relevant consumer uses would need to be listed (listed uses). Safe and permissible uses would then be removed from subsequent EU regulatory risk reduction processes12. While companies must follow recommendations, regulatory risk reduction may deem it necessary to supplement these with more prescriptive duties. 

Tolerable uses would apply to substances when overall risk reduction is necessary, but setting EU-wide restrictions or authorisations is identified as ineffective, inefficient or unnecessary. For instance, it may be that risk reduction is necessary in only a few Member States due to particular industrial activities (e.g., reduction of the probability... 

VII National dimensions where risks are limited to specific occurrences within certain Member States, interpretation of risk levels and regulatory controls vary significantly between Member States, and control measures do not mandate EU harmonised regulation for achieving risk reduction (see Box 5.3,). 

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