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Questions & Answers

CTAC / CTACSub Consortium
Applications for REACH Authorization of Certain Uses of Chromium Trioxide

July 2017

Question 1: What is the status of these applications for authorizations?

Response: The ECHA Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) recommended in September 2016 that the European Commission (‘Commission’) grant the authorizations for continuation of the 6 uses of chromium trioxide (EC 215-607-8; CAS 1333-82-01) applied for by the members of the CTACSub Consortium, on the basis that the socio economic benefits of continued use outweigh the health and environmental risks thereof.

The Commission has recently informed the applicants that it is likely to forward to the REACH Committee (Member State representatives) the draft authorization decisions for discussion in September 2017. However, the discussion and adoption may take several months. Therefore, and despite having introduced its applications for authorization as early as May 2015, the CTACSub Consortium can no longer hope that the authorization decisions will be issued before the Sunset Date of September 21, 2017. Indeed, no legal deadline is set by which the Commission must issue its authorization decisions. There are other applications on chromium trioxide that are in the same situation. Moreover, there are applications on uses of other substances that are in a similar situation, in some cases the Sunset Date expired several years ago.

Question 2: Do downstream users of chromium trioxide have to stop using the substance at the Sunset Date?

Response: NO. Article 58(1)(c)(ii) REACH provides that downstream users supplied directly or indirectly by one or more of the 7 applicants may continue their uses of chromium trioxide from those suppliers beyond the Sunset Date until the Commission will have decided on the authorizations. Dr. Hesse was part of the CTAC Consortium and is among the suppliers that are supplied by one or more of the 7 applicants.

Please note though that such continued use is only permitted in as far as the uses are within the remit of the authorization applied for.

Question 3: How does a downstream user know or find out whether the chromium trioxide he uses originates (was supplied directly or indirectly by) from one or more of the 7 CTACSub applicants?

Response: There are several possibilities. In case the substance (or mixture containing chromium trioxide) is supplied directly by the applicants, this is clear. The name of the applicants will be on the label, the safety data sheet and the invoices. In case the substance (or chromium trioxide in mixture) is supplied by distributors or formulators, the safety data sheets, labels and invoices may not contain this information. In this case, the downstream users should ask their suppliers to confirm in writing that the chromium trioxide originates from one of the 7 applicants. This confirmation can be given by Dr. Hesse.

Question 4: Article 66 REACH requires downstream users to notify ECHA within three months of the first supply of a substance subject to authorization with the identity of the company, the authorization number and their contact information. Additional information can be submitted voluntarily or may be mandatory in the future. Is this obligation applicable to downstream users that receive chromium trioxide directly or indirectly from the 7 applicants?

Response: NO. This obligation is not applicable as long as the authorization applications are still pending and have not been granted. As long as there are no authorization decisions, there are no authorization numbers and therefore the notification template in its present form cannot be filled in and submitted to ECHA.

Question 5: What does a downstream user do in case a customer wishes to have evidence that the downstream user is entitled to use chromium trioxide at its facility?

Response: In case an authorization has been granted, the downstream user may provide his customer with a copy of his Article 66 downstream user notification that he submitted to ECHA. As long as the authorizations will not have been granted, the downstream user can only draw up a statement on his letterhead that he is entitled to continue using chromium trioxide pursuant to the transitional regime set out in Article 58(1)(c)(ii) REACH as all chromium trioxide used at its facility is supplied directly or indirectly by one or more of the 7 CTACSub applicants.

We, company X, hereby confirm that all chromium trioxide as a substance or in a preparation that we currently deliver and will in the future deliver to our customer, originates, indirectly by our supplier Dr. Hesse, from one or more of the 7 applicants for REACH authorization organized as CTACSub Consortium. We hereby undertake to inform our customer immediately and before the next delivery should this certification no longer be correct.“

Question 6: What does a downstream user do in case of an inspection?

Response: In case of an inspection, the inspector will ask the downstream user for his Article 66 REACH notification. In this case, the downstream user will have to explain that the Article 66 REACH notification obligation is not yet applicable to him due to the authorization applications still pending, see above.

In addition, the downstream user should be able to demonstrate that he is aware of the details of the applications for authorization applied for. He should be able to demonstrate and have documented by a self-assessment that his activity falls within the scope of the applications for authorization applied for and that he applies as a minimum the operational conditions and risk management measures described in the CTACSub application(s) for authorization (see also question/response 7).

Moreover, he should demonstrate that he is compliant with national legislation on health & safety at the workplace, including occupational exposure limits, the obligation to make a safety assessment for each workplace and to observe the hierarchy of prevention measures for carcinogens at the workplace.

Question 7: How does a downstream user know whether his activity falls within the scope of the CTACSub application for authorization? What does he need to do if this is not the case?

Response: The only way to make this determination is by reviewing in depth the application documents available on the ECHA website, in particular the so-called Broad Descriptions of Uses, the Analyses of Alternatives describing the uses and the Chemical Safety Reports. In case of doubt, he may seek external help from specialized consultants.

If an activity is not described in an Exposure Scenario in the Chemical Safety Reports or if the actual operational conditions and risk management measures at the facility are notin line with the description in the Chemical Safety Reports, the downstream user cannot rely on the pending CTACSub applications for authorization. He is not covered. In such case, he should urgently submit his own application for authorization to ECHA and he must stop at the Sunset Date his use of chromium trioxide until he has obtained his own authorization. Alternatively, he can investigate whether his activity is covered by another authorization pending or granted.

Question 8: Will there be any changes in the future that downstream users must be aware of in relation to the exposure scenarios, operational conditions and risk management measures set out in the CTACSub applications for authorizations?

Response: YES. The RAC has recommended in its Opinions that the Commission set conditions in the authorization decisions (e.g. exposure measurements). As in the case of other authorization decisions, it is expected that such conditions will be set. These conditions must be observed by the downstream users.

It is also possible that the applicants will in the future have to revise their exposure scenarios. Should this be the case, the information and new exposure scenarios will be available through updates in safety data sheets supplied with the chromium trioxide.

Question 9: Is there any practical guidance available that downstream users can utilize to adapt their operating conditions from now on in expectation of the authorizations and in order to be considered as covered by the pending applications during the transitional period pursuant to Article 58 58(1)(c)(ii) REACH?

Response: YES. CTACSub is currently developing and will be publishing before the Sunset Date a series of easily comprehensible illustrative practical Task Sheets (‘Good Practice Sheets’) that set out the operational conditions and risk management measures that are recommended to be applied when handling chromium trioxide. The Task Sheets will also contain advice on personal protective equipment and exposure monitoring. Compliance with these Task Sheets as of the Sunset Date is voluntary but is recommended in order for the downstream user to demonstrate coverage and compliance with the pending applications for authorization.