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Q&A on trichloroethylene - 2009 UPDATE04/2009 Will trichloroethylene be registered under REACH?European producers and importers must register trichloroethylene (TRI) under REACH. A consortium has been established through REAChCentrum and under the leadership of The Dow Chemical Company. The consortium will prepare the REACH dossier for TRI (IUCLID and the Chemical Safety Report). The consortium is open to other interested registrants. While the registration date is driven by the volume produced and/or imported by the specific legal entity, the consortium is planning for the completion of registration prior to 30th of November 2010. ECSA companies are fully mobilized to comply with REACH and to demonstrate the safe management of chemicals in commerce and in the supply chain. Will TRI fall under authorisation according to Annex XIV under REACH?The REACH process for authorization of chemicals is governed by the European Chemicals Agency (ECHA), which is the sole body responsible for publishing the Candidate List of Substances of Very High Concern (SVHC). This list will undergo further evaluation to determine substances for Authorization. As of May 2009, TRI is not on the SVHC list. ECSA will carefully monitor prospective future proposals. Can I still use TRI and under which conditions?Continued use of TRI is allowed, however, end users should comply with the recommendations and guidelines set forth by ECSA and their suppliers. Following are some recommendations from ECSA: • In applications where TRI is essential to meet quality and safety standards, TRI can continue to be used, provided strict control measures are in place that guarantee compliance with the EU Solvent Emission Directive 1999/13/EC (SED) These statements are based on the following facts and arguments: 1. The product-specific risks of TRI are well known and can be adequately and sufficiently managed by applying proper risk management. This has been recognized by Regulators and is reflected in the prevailing regulations. What is the current classification and labelling of TRI?TRI was re-classified in 2002. The classification was published in Directive 2003/36/EC (25th amendment to the Marketing & Use Directive 76/769/EEC) on 26 May 2003. Member States have since transposed the classification & labeling requirements into national law. The current classification of TRI is Carcinogen Category 2. This classifiucation was based on animal studies that have found that TRI can cause cancer in some strains of rats or mice at high exposure levels. Limited epidemiology data have shown a weak association between trichloroethylene exposure and renal cancer. According to the European Dangerous Substances Regulation 67/548/EEC, the label now used on shipments of trichloroethylene looks as follows:
T R: 36/38,45,67,52/53 S: (2-)45-53-61 Carcinogenicity Cat. 2; Mutagenicity Cat. 3 T: Toxic R45: May cause cancer R36/38: Irritating to eyes and skin R67: Vapours may cause drowsiness R52/53: Harmful to aquatic organisms, may cause long term adverse effects in the aquatic environment S2: Keep out of the reach of children S45: In case of accident or if you feel unwell, seek medical advice immediately S53: Avoid exposure - obtain special instructions before use S61: Avoid release to the environment. Refer to special instructions/Safety data sheets According to the Classification, Labeling and Packaging Directive (CLP) 1272/2008, what is the label of TRI expected to contain?Classification and Labeling will change due to the implementation of the new Classification, Labeling and Packaging Directive (CLP) 1272/2008 by 1st of December 2010. This directive is the implementation of the Global Harmonized System (GHS) in the European Union. Below indicates the Label of TRI according to CLP. H 350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) Apart from the product packaging requiring this label, you are required to review your work practices to ensure that you meet local legislative obligations with respect to handling an R45 product. Additionally: • If your consumption of TRI is more than 1 tonne/year, the EU Solvents Emission Directive, also known as VOC Directive (1999/13/EC) requires your emissions to be less than 2 mg/Nm3 in a vent stack. With this changed classification, the implementation of this Directive may call for substitution of TRI when used as an emissive solvent by a substance deemed to be less harmful within the shortest possible time, if technically possible and taking into account the economic consequences. ECSA is investigating this with each Member State authority. If substitution under the VOC Directive is required, what are the alternatives to TRI?Although a range of possible alternative products may be available, experience has shown that substitution of TRI is not easy and may not be feasible for a number of specific cases, either for technical or economical reasons. In all cases, substitution of TRI needs a thorough evaluation. ECSA continues to work with the authorities to prevent a blanket implementation of forced substitution, and allow the sustainable and continued safe use of TRI. Other chlorinated solvents, such as perchloroethylene (PER) and methylene chloride (MC) are potential alternative substance. They are the closest match of the technical features of TRI, such as low flammability, high solvency power, a wide range of material compatibility and excellent drying and recycling properties. In addition to PER and MC, there may be other alternatives such as aqueous (water-based) alkaline systems, flammable solvents (e.g. hydrocarbons or modified alcohol based formulations), supercritical CO2 or hydrofluorocarbons (HFCs), etc. For example, aqueous systems may be an appropriate choice to clean parts between two water-based manufacturing steps (e.g. galvanising), , since parts are put into water phase again later and no energy-intensive drying step to remove the water is required. Hydrocarbons or aqueous systems may not clean and dry well enough in instances where very clean and very dry surfaces are needed, as incoating or surface hardening applications, the parts involved feature a variety of different metals, blind holes, narrow distances, very fine orifices or large quantities of residual oil,. In these cases, chlorinated solvents are often the best solution as they are compatible with most materials, have a high cleaning power, are easy to dry, do not leave residual films and are easy to recycle with high quality by distillation. In addition, chlorinated solvents are well suited for use in modern closed systems with minimal solvent loss. When used in well-operated metal cleaning systems, chlorinated solvents outperform aqueous cleaning as documented in the Life Cycle Analysis carried out by Ecobilan. However, PER has a lower solvency power and, therefore, requires higher cleaning temperatures to achieve similar performance. This may raise concerns regarding compatibility with specific metal working fluids and temperature-sensitive parts. Methylene chloride (MC) shows excellent cleaning properties at low temperatures, favouring the cleaning of temperature sensitive parts. However, its high volatility makes emission control more difficult and requires special equipment. Hydrofluorocarbons (HFC) and hydrofluorocarbon ethers (HFCE) are very expensive and show very limited solvency power. A thorough evaluation of the global warming potential should also be considered during the selection process A short overview comparingalternatives with TRI is provided in the table below. n-propyl bromide is not included since it has been proposed for classification as a category 2 reproductive toxin and therefore would also be subject to substitution.
Should I invest in alternatives?Certain EU directives may require you to consider alternatives. The replacement of TRI is a complicated task, which needs a thorough investigation of all possible impacts on product quality and linked processes. In order to choose the right cleaning solvent and to get the best solution from a technical, safety, environmental and financial point of view, individual end uses need to be carefully evaluated. A hurried conversion to an alternative without thorough investigation may lead to wrong decisions. ECSA encourages users to contact solvent producers in order to get help in making the right decision. Despite all the good properties that would encourage me to continue to use TRI, is it still responsible to have my workers exposed to TRI?Despite all the good properties that would encourage me to continue to use TRI, is it still responsible to have my workers exposed to TRI? Solvent manufacturers who are members of ECSA and their distributors have made a public commitment to assist their customers to use chlorinated solvents safely and responsibly. This commitment extends to providing literature, training on handling, storage, use, recycling and safe disposal of spent solvents and wastes which arise from its use. As the producers of trichloroethylene, you are bound to oppose any adverse regulation change because of your vested interest, so why should I believe you?We voluntarily hold ourselves accountable to safely handle products from their inception in the research laboratory, through manufacture and distribution, to ultimate reuse, recycle and disposal in support of Responsible Care®. Responsible Care often goes above and beyond what is legally required in most countries, and generates far greater value for our businesses. TRI can be used safely in terms of health, safety and environment by following ECSA recommendations and guidance from your supplier. As with any chemical, the substance should be properly contained and managed to prevent unintended exposure to people or the environment. (Responsible Care® is a trademark of The American Chemistry Council). What are typical applications where TRI can not be substituted?Cleaning with TRI is essential in many industrial processes, particularly in high tech applications such as aerospace manufacturing, automotive safety equipment and precision instrument production. In these processes, TRI is indispensable for maintaining an effective production with high product performance and competitiveness on a world scale. Case study 1TRI is used in manufacturing of high-precision tools with movable parts requiring less than 4-micron tolerances. Cleaning is essential in several process steps. Minor surface alterations can lead to uncontrollable quality losses. For more than 10 years, several alternatives have been tested with the result that TRI cannot be substituted without severe quality diminution and loss of industry leadership and competitiveness. The company has 2000 employees and is operating 17 cleaning machines at its site in Germany. Heavy investments in enclosed machines over the last ten years have reduced consumption from approximately 200 t/yr. to 5 t/yr.. Cleaning efficiency has steadily increased and, currently, goods worth about 400 million EUR/yr. are cleaned consuming 5 t TRI/yr. Worker exposure is far below the MAK value, and emissions in the atmosphere are negligible. Substitution would cause loss of competitiveness and have higher ecological impacts. Substitution of TRI forced by its reclassification and re-labeling to R45 in conjunction with the VOC Directive would lead to a turnover loss of about 400 million EUR/yr. with related consequences. In addition, planned investments of about 1.25 million EUR to further reduce the solvent consumption would not be spent. Case study 2A UK-based company uses TRI in the production of professional electron devices for incorporation in a range of civil and medical applications. The company operates two manufacturing sites in the UK employing 1400 people, and has an annual turnover of Euro 100m. In 1999 they consumed 36 tonnes of trichloroethylene cleaning precision-machined components. This level of consumption will further decline as the company makes necessary additional improvements to meet the requirements of the VOCs Directive. The company continues to use TRI, despite having investigated alternative cleaning processes, because their products require an exceptional degree of internal cleanliness. If the necessary cleanliness is not achieved, the lifetime of the products in use is significantly reduced. Should they be prohibited from using TRI through the reclassification, the company estimates it will need a 12 month programme to evaluate and establish an alternative cleaning process, with a replacement capital cost Euro 250k. However, they also believe that the substitute process represents a significant risk to the product lifetime performance, which would make their products uncompetitive against those manufactured outside the EU where the use of TRI will continue. What are the occupational exposure limits?The exposure limits in the table below are currently unchanged:
Key: The EU Scientific Committee for Occupational Exposure Limits (SCOEL) recently proposed a new Occupational Exposure Limit (OEL) (8-hour TWA) for TRI of 10 ppm with a Short-Term Exposure Limit (15 min) of 30 ppm. Finalization of this proposal is expected in the course of 2009. This could help to demonstrate that TRI can be continuously used if strict control measures are in place guaranteeing compliance with the OEL. How can I help and find out more?You can help protect your business by addressing Regulators, and providing us with information about the issues that you will face if you are forced to substitute TRI. For further information, you may contact your supplier of TRI or any of the manufacturers, or mail us: Revised April 2009
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