FAQ: Trichloroethylene under REACH

1. Will TRI be banned? What does the sunset date mean?

TRI was added to the authorisation list (Annex XIV) of REACH on April 21st, 2013. This included the confirmation of the sunset date after which TRI cannot be supplied or used except when an authorisation has been granted, or for uses which are exempt from authorisation (such as intermediate use or use for research and development). The sunset date for TRI is 21st of April 2016.

The REACH text states:

"A manufacturer, importer or downstream user shall not place a substance on the market after the sunset date for a use or use it himself if that substance is included in Annex XIV unless the use(s) of that substance has been authorised or the date referred to in article 58(1)(c)(i) [=sunset date] has not been reached." An authorisation is granted for a specific use/application under certain conditions.

2. Do I have to apply for authorisation? If yes, until when?


The entry of TRI into Annex XIV on 21st of April 2013 indicated a latest application date for authorisation which was October 21st, 2014. An application for authorisation can be submitted any time, but in order to take advantage of the so called transitional arrangements an authorisation for TRI should have been filed before the latest application date. This assures that TRI can be used beyond the sunset date, even though the authorisation is not yet granted and the decision process is ongoing. When the application is submitted after the latest application date, the use of TRI would need to stop after the sunset date, until the authorisation has been granted.

Dow has applied for authorisation for the "Use of TRI for industrial parts cleaning (Surface cleaning) in closed systems" as well as for the use of TRI as an extraction agent for bitumen in the asphalt industry (For more information regarding the use of TRI in Asphalt Analytic please contact SAFECHEM). Downstream users can utilise Dow’s authorisation if they meet the criteria which are described in our application. Please review whether your application falls under our authorisation. For more information see Question 8 or Appendix I.

3. When will Dow learn whether an authorisation is granted?


This decision as to whether the authorisation is granted could take up to 2 years. Article 64 of the REACH Regulation gives many details about the authorisation process, including public consultation on alternatives and the decision process at competent authorities including the EU commission.

Practical examples indicate that the authorities will not need this whole period. There are cases where the process from submission until granting of an authorisation took only 8 months. Dow has submitted its authorisation dossier in August 2014 and will closely monitor the process and keep customers informed.

Dow's application and submission of an authorisation dossier does not guarantee the granting of the authorisation. The granting of an authorisation can include further conditions and monitoring arrangements. We expect a final decision still this year or beginning next year.

4. What are the chances for authorisation to be granted? How confident is SAFECHEM?


Dow has submitted a comprehensive authorisation application with clear limitations of the use and including a socio-economic analysis that demonstrates that benefits of continued use of TRI far outweigh the risks. We are confident that an authorisation should be granted. However, it has to be seen whether further conditions and monitoring arrangements will be set by the regulator and what the revision date will be until the authorisation has to be renewed.

Other applications for authorisation for other substances have been granted within approx. 1 year. This does not imply that Dow's application for the "Use of TRI for industrial parts cleaning (Surface cleaning) in closed systems" will be granted on all accounts but it is an indicator for the awareness of the authorities for the importance of some substances in the market.

5. What happens if an authorisation for a certain use is not granted?


The downstream user has to stop using TRI after the sunset date or the date of publication of this decision if this happens to be after the sunset date. Also the manufacturers or importers are not allowed to place the substance on the market apart for those uses where authorisation is granted.

6. What is the difference between CLOSED and ENCLOSED equipment and why was only CLOSED technology included in the authorisation?


Machines like ECSA type III or higher are considered closed systems in the scope of authorisation for surface cleaning for which Dow applied. Please see Appendix V for the differences of types and to learn which type is supported.

Dow didn't apply for authorisation for Industrial Use in Surface Cleaning (enclosed and/or open systems). Even though our safety data sheet (SDS) contains an exposure scenario for the use in enclosed systems and calculations have shown that under certain risk measures safe use can be achieved, this technology is not considered as "Best Available Technology (BAT)" or state-of the art technology.

7. How will REACH be enforced?


The enforcement of REACH is a responsibility of each EU Member State as well as the members of the EEA (Norway, Iceland and Liechtenstein). They must ensure that there is an official system of controls and lay down legislation specifying penalties for non-compliance with the provisions of REACH.

In case you continue to use TRI with the Dow authorisation after the sunset date, you will need to notify ECHA the latest 3 months after the first supply of TRI after the sunset date. ECHA will then inform the member state authorities accordingly.

8. Will our business be able to utilise Dow’s authorisation? What are our responsibilities to benefit from the authorisation?


On the basis of the authorisation granted to Dow as your supplier, you need to:

  • Evaluate whether or not a suitable alternative is available for your specific application (For more information on the Analysis of Alternative please see Question 9).
  • Ensure strict application of the risk management measures and process conditions as outlined in the authorisation dossier (see Appendix I).
  • Notify the European Chemical Agency (ECHA) within three months of the first supply of the substance {Art. 66(1)} after sunset date. Such notifications will be kept in a register maintained by ECHA and will be made available to the Competent Authorities of the Member States on request.

Authorisation for industrial parts cleaning implies compliance with very strict operational conditions and risk management measures. Check and ensure that the use of TRI in your own process and equipment is meeting these conditions and measures. Deviation from these conditions and measures is not allowed under REACH authorisation. In summary the process is characterised by the following minimum Risk Management Measures:

  • Closed loop solvent transfer (for fresh and spent solvent) using safety containers (SAFE-TAINER™) with controlled solvent access only
  • Cleaning in closed equipment with equipment internal solvent abatement and recycling loops, min. ECSA Type III machine equipped with activated carbon or Type IV/V machine (see Appendix V)
  • Sealed cleaning chamber: During parts washing door is blocked until solvent concentration of 1 g/m³ or less is reached
  • Minimisation of exposure during unloading of goods by a combination of technical and organisational measures
  • No direct sewer connection: metal degreasing machines operate in closed system and are not connected to the sewer; therefore there are no direct emissions of wastewater.
  • Other tasks (sampling, analysis, re-stabilisation, equipment cleaning and maintenance) need to be carried out with appropriate personal protective equipment.

Industrial parts cleaning with TRI has been carried out for decades with improved technologies to reduce exposure at the workplace, as well as to minimise emissions to the environment. The Industrial Emission Directive (2010/75/EC) required Member States of the EU to implement controls on the emissions of volatile organic compounds. In surface cleaning, installation consuming more than 1tonne per year of H350 (R45) substances must meet limits of 2 mg/m³ for stack emissions and 10-15% limits for fugitive emissions depending on the size of the installation.


9. What is an Analysis of Alternatives? What is deemed a "suitable" alternative?


The purpose of the Analysis of Alternative (AoA) is to determine if there are any suitable alternative substances or alternative technologies. The AoA will conclude that there is a suitable alternative available when an alternative substance and/or technology and/or their combination:

  • Provide an equivalent function to that provided by the substance or make the substance use redundant
  • Will result in reduced overall risks to human health and the environment, taking into account appropriateness and effectiveness of risk management measures
  • Are technically and economically feasible (for substitution in the uses applied for) and available for the applicant

The AoA is end user specific. In a first stage, end users list substances that might be suitable alternatives as shown in Appendix III. In a second stage the substances are evaluated against the end user specific requirements (see Appendix IV). Substances that do not meet the criteria are no longer considered in the evaluation process. If a substance meets all customer specific requirements at the end of this process, this substance is regarded as suitable alternative that makes the use of TRI redundant. In the last stage the end user has to document his AoA (see Question 11).

10. Why do I need an Analysis of Alternatives?


The evaluation, and conclusion that there is no suitable alternative available, is a position that allows users to benefit from the Dow authorisation.

11. What criteria should my Analysis of Alternatives be based on?


The downstream user needs to document that he has evaluated alternatives and that there is no suitable alternative for his current process (see definition “suitable alternative” Question 9). This can be requested by local authorities taking reinforcement actions for the use of substances under authorisation. We propose that you document your research and evaluation work on suitability of alternatives. A template on the ECHA homepage could be used to structure this documentation work (see Appendix II).

By reviewing all available information from downstream users, Dow has defined 19 critical parameters for the use of TRI in industrial parts cleaning. These parameters have been compared with currently known alternatives for TRI. If certain parameters apply to the downstream user process in combination, suitable alternatives do not currently exist. SAFECHEM can provide further assistance with documenting the AoA on request. Please find the list of these 19 critical use parameters in Appendix IV.

12. What if a suitable alternative cannot be implemented in time?


If no suitable alternative exists or can be adopted before the sunset date, customers using NEU-TRI™ E, NEU-TRI™ L or HI-TRI™ SMG will be covered by an authorisation in case it is granted to Dow/SAFECHEM, provided that the process meets appropriate criteria. Appropriate criteria include: closed systems (ECSA Type III and above), use of closed loop transfer systems for fresh and waste solvent (see also Question 8 or Appendix I).

13. Which SAFECHEM products can possibly substitute TRI?


SAFECHEM provides a variety of products which could possibly substitute TRI, for example:

  • DOWPER™, DOWPER™ MC and DOWPER™ N Perchloroethylene (tetrachloroethylene, PER, Perc or PCE)
  • MECTHENE™ MC Methylene Chloride and Methylene Chloride Technical E (dichloromethane or DCM)
  • DOWCLENE™ Modified Alcohol solvents

All solvents are specially developed to address high surface cleaning requirements.

Please contact SAFECHEM or your distributor for further information.

14. Will potential alternatives go down the same route as TRI?


Perchloroethylene (PER)

PER and TRI are classified differently. TRI is a class one carcinogen and listed on the authorisation list (Annex XIV of REACH). PER is classified as a class two carcinogen. The REACH Dossier of PER has been evaluated under the process of "Substance evaluation" (CoRAP) with the result that no further regulatory action is required. There is currently no indication that this classification will be questioned or changed to classification that meets SVHC (Substance of Very High Concern) criteria.

Only substances that meet the SVHC criteria as listed in article 57 of REACH can be included into the candidate list and added to REACH Annex XIV.

PER does not meet the criteria to be a SVHC based on its current classification, hence should not be included into the candidate list

Methylene Chloride (MDC, DCM)

Methylene Chloride is, like PER, a class two carcinogen. Methylene Chloride does not meet the criteria for an SVHC based on its current classification, hence should not be included into the candidate list.

n-PropylBromide (n-PB)

Due to its classification as toxic for reproduction "Repr.1B" based on effects on fertility, n-PB meets the criteria of an SVHC and has been included into the candidate list in 2013, hence it is not deemed as a suitable alternative. Furthermore n-PB is prioritised for inclusion into Annex XIV of REACH. The decision if n-PB will be included into the authorisation list is expected during 2015.

Modified Alcohols

The DOWCLENE™ Modified Alcohol solvents range does not meet the criteria for an SVHC based on its classification, hence will not be included on the candidate list.

Please reach out to us if you have any additional questions or we may consult you individually:

Richard Starkey
Regional Sales Manager
Mobile: +44 (0) 7976-531695

Barry Eaton
Technical Sales
Mobile: +44 (0) 7971 768927

Ferdinand Pree
EH&S and Quality Manager
Mobile: +49 (0) 211 4389317

Tel: +49 (0) 211 4389-300

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