ECHA: First four conclusion documents on substance evaluation published on ECHA website

ECHA/NA/13/41

The substance evaluation on ethylene oxide, tributyl phosphate, m-tolylidene diisocyanate and toluene has been concluded and the related conclusion documents are published. If needed, the authorities may consider actions for further risk management.

Helsinki, 26 November 2013 – Substance evaluation started in 2012 and Member States evaluated 36 substances. The first four cases from this batch are now concluded. In these cases the designated evaluating Member State decided not to ask any further information on these substances and hence no draft decision was prepared. The evaluating Member State has instead finalised its assessment and drawn conclusions about the suspected risks. This information is available in the conclusion documents. Additional information is available in the substance evaluation reports published on ECHA website.

The conclusion document summarises the evaluating Member State's view on the potential need for risk management. However, this conclusion alone is not starting any new regulatory process and is not binding to the Member States or the Commission. The registrants, Member State competent authorities and the Commission are invited to take note of the conclusions drawn by the four Member States, and to consider if further actions for ensuring the safe use of the substances is necessary.

The four substances and the main conclusions drawn by the evaluating Member States are:

Ethylene oxide, EC 200-849-9, CAS 75-21-8 (evaluating Member State Austria)

Community level agreement is needed on an acceptable risk level for workers and the general population with regard to the carcinogenic potential of substances, including ethylene oxide.

In addition to the existing harmonised classification, the substance also fulfils classification criteria for skin sensitisation Category 1, H317 (May cause an allergic skin reaction).

Tributyl phosphate, EC 204-800-2, CAS 126-73-8 (Hungary)

There is no need for any additional risk management measures and the evaluation confirmed that the current CLP classification for the human health endpoints is appropriate.

m-Tolylidene diisocyanate (TDI), EC 247-722-4, CAS 26471-62-5 (Poland)

The risks were verified to be under appropriate control. However, exposure to TDI is linked with the development of occupational asthma. If current occupational exposure limits are complied with and good control of exposures at work places is followed, isocyanate related asthma can be minimised.

Toluene, EC 203-625-9, CAS 108-88-3 (Finland)

The available EU indicative occupational exposure limit (50 ppm) could be too high, and should be reconsidered by the Commission's Scientific Committee on Occupational Exposure Limits. Evaluation agrees with  the EU Risk Assessment Report from 2002 and concludes that 20 ppm is an appropriate long-term Derived No Effect Level-value for workers through the inhalation route.

Further information

From the publication of the CoRAP, the 17 designated Member States had 12 months to evaluate substances listed for 2012 and, where justified, to prepare a draft decision requesting the registrant(s) to submit further information to clarify any possible risk. The final decision will be taken by ECHA after consultation of the Member State Competent Authorities and potentially of the Member State Committee (MSC). The decision will be taken by the European Commission if there is no unanimity at the MSC.

As for other evaluation decisions, registrants of the substances listed on the CoRAP will have an opportunity to comment before any final decision is taken. If a Member State decides within the 12 months that no further information is needed, it prepares a conclusion of the assessment recommending possible future regulatory risk management measures if deemed necessary.

ECHA's role in the substance evaluation is to prepare and adopt the Community Rolling Action Plan and to coordinate and support the evaluation work performed by the Member States. ECHA also adopts the decisions requesting further information. However, the conclusions and substance evaluation reports made, do not represent the position of ECHA but only that of the evaluating Member State.

Published conclusion documents and substance evaluation reports are available in the dynamic CoRAP table; click details on the right-hand side of the specific substance row.

CoRAP table

Substance evaluation web pages