EU RISK ASSESSMENT

A European Union (EU) risk assessment of di-2-ethylhexylphthalate (DEHP) underestimated the substance s potential damage to the environment, the commission s scientific committee on toxicology (CSTEE) says. The study was completed by a team of Swedish scientists in September 2001 for the European Commission (EC). The Swedish scientists had recommended in September that no measures were required to reduce the risk of pollution from DEHP. But CSTEE will begin a new round of research shortly, as part of a review of the scientists assessment, to determine the extent of environmental risks posed by DEHP. CSTEE says that in many cases there is a need for... 

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. 

This chapter uses the formal EU risk assessment methodology laid down in the European Commission Regulation (1488/94) and follows closely the principles of the technical Guidance Document [1] of the Existing Substances Regulation (793/93). 

Scientific procedures for risk assessment include assessment of risk for human health as well as risk for the environment. A substantial part of the EU risk assessment work was in 1997 delegated to the DG SANCO, in relation to the scandal surrounding BSE (bovine spongiform encephalopathy or mad cow disease ). Risk assessment work not under DG SANCO includes pharmaceuticals, working environment, and health effects caused by lifestyle factors such as diet, smoking, and alcohol consumption (EU 2006f). 

International Uniform ChemicaL Information Database (lUCLID) is the basic tool for data collection and evaluation within the EU risk assessment program for existing substances and has also been accepted by the OECD as the data exchange tool under the OECD Existing Chemicals Program (see Section 2.4.1.6 for details). 

Use of the TTC approach is dependent on rather precise quantitative exposure estimates. Experience from the EU Risk Assessment Program for Existing Substances is that it is very difficult to get sufficient information on the different uses and related exposure to make precise exposure estimates. The Nordic group considered that for substances where only... 

The European Food Safety Authority (EFSA), based in Parma, Italy, since 2005 is the keystone of EU risk assessment regarding food and feed safety. 

The White Paper recognized that certain chemicals may be having significant effects on the health of humans and wildlife and that there is a lack of knowledge about the impacts of many chemicals, described as a huge gap in knowledge of substances (CEC, 2001, p5). With respect to the EU risk assessment process, described as slow and resource-intensive (CEC, 2001, p6), the White Paper made the following specific criticisms ... 

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... 

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 U.S. EPA and many other organizations point out that, when information about potential risks is incomplete, basing decisions to avoid unnecessary health risks is potentially the best option.8 When a good set of scientific data is available on a material, then the Precautionary Principle is not appropriate. Scientific data generated in the EU Risk Assessments or under risk assessment programs, such as REACH, that deem materials safe for continued use should effectively rule out the use of Precautionary Principle. 

The EU Risk Assessment ( Council Regulation [EEC] 793/93 of 23 March 1993 )39 is well recognized as being the leading independent, transparent, and science-based system for assessing chemicals and substances in everyday use.40 The Consumer Products Safety Quality (CPS Q) Unit, formerly known as European Chemicals Bureau (ECB), is part of the Institute for Health and Consumer Protection (IHCP), which is one of the seven scientific institutes in the European Commission s Joint Research Center (JRC).41 The CPS Q is responsible for managing the risk assessment process. As will be discussed in further detail in Section 22.2.2.4.4, the EU Risk Assessment process was revoked on June 1, 2008 and replaced by the REACH Directive. 

Other flame-retardants selected as priority chemicals for the EU Risk Assessment process included tetrabromobisphenol A (TBBPA), hexabromocyclododecane (HBCD), tris(2-chloroethyl) phosphate (TCEP), tris (2-chloropropyl) phosphate (TCPP), tris(2-chloro-l-(chloromethyl)ethyl) phosphate (TDCP), and 2,2-bis(chloromethyl) trimethylene bis (bis(2-chloroethyl)phosphate) (V6). The flame-retardant synergist, antimony trioxide (Sb ), was also identified as a priority substance. Table 22.1 contains information on the EU Risk Assessments on the nine flame-retardants and one synergist. 

The EU Risk Assessment on TBBPA was recently completed with the conclusions of no restrictions for use in any applications.4950 Risk was identified at one specific additive user plant, so an active emissions control program has been put into place to help ensure that emissions do not occur. 

EU Risk Assessment Summary on Flame Retardants as of October 2008... 

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. 

After the finalization of EU Risk Assessments, The European Commission Scientific Committee on Health and Environmental Risks (SCHER) is consulted for their opinion. SCHER is a scientific... 

Discussions and debate related to the inclusion of deca-BDE in the RoHS Directive have been going on for years. It was originally planned that the inclusion of deca-BDE in the RoHS Directive was to be addressed upon completion of the results of the EU Risk Assessment. With a conclusion that there was no need for restrictions, eca-BDE was exempted from the provisions of the RoHS Directive for polymer applications on October 15, 2005. Confusion centering on what was meant by deca-BDE (commercial product with minor impurities or pure congener) came up in the summer of 2006. Since the commercial deca-BDE was the material evaluated in the EU Risk Assessment, major parts of the chemical, polymer, and electronics industries and significant elements within the EU shared this view. 

On April 1, 2008, the European Court of Justice ruled that the European Commission used improper procedures to exempt deca-BDE from RoHS Directive. The ruling did not question positive EU Risk Assessment outcome of deca-BDE. The outcome of this April 1 ruling was that deca-BDE was banned in the use of electronic and electrical equipment after June 30, 2008. 

Flame-retardants that have gone through a EU Risk Assessment under Regulation 793/93/EC should be some of the first substances registered under the REACH. Several flame-retardants have already been tested by the EU and found to be compatible with the strict safety criteria of REACH, such as PBT and CMR criteria. 

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