Downstream Users and their obligations under REACH
Dicembre 2, 2015
Quali sono gli obblighi per gli utilizzatori a valle?
Dicembre 7, 2015
Last week, besides defining what downstream users are according to REACH, we not only split downstream users between industrial and professional, but also listed their main roles and obligations.
Today we are going within more details, even if concise, about downstream users’ main activities and timelines, concerning obligations under REACH. They are:
Inform supplier of a use when the substance is not yet registered
The downstream user needs to make a request twelve months before the registration deadline, and the supplier has to assess the risk of that use. The next and last registration deadline is 31 May 2018 for substances in quantities between 1-100 tonnes/year. Downstream users need to inform their suppliers of their uses by 31 May 2017 at the latest. This is a voluntary action.
Identify and apply appropriate measures in the safety data sheet
When a downstream user receives a safety data sheet (SDS), he needs to identify and apply appropriate measures to adequately control the risks at his site. This must be done within 12 months of receiving a SDS for a registered substance.
Implement the measures communicated in the exposure scenario or take alternative actions
When a downstream user receives an exposure scenario with a SDS, he must additionally check whether the exposure scenario covers his own use of the substance and his conditions of use.
If a downstream user establishes that the use and/or conditions of use of his substance, as such or in a mixture, are not covered by the exposure scenario received from his supplier, then a number of options are available, including:
- implement the conditions of use described in the exposure scenario he has received;
- make his use known to his supplier with the aim of making it an “identified use” and included in an updated exposure scenario;
- substitute the substance with a different substance for which an exposure scenario is not required or where an exposure scenario(s) is available which covers his conditions of use. Alternatively, substitute the process with a process not requiring the substance;
- find another supplier who provides the substance or mixture with an exposure scenario that covers his use; or prepare a downstream user chemical safety report (DU CSR) (check first if any exemptions apply).
Preparing a downstream user chemical safety report
If the use is outside the conditions described in any exposure scenario supplied to the downstream user, and the alternative actions referred to above are not feasible, he has to prepare a downstream user chemical safety report (DU CSR) unless:
- A safety data sheet is not required
- A chemical safety report is not required to be completed by the registrant
- The substance is present in a mixture in a concentration below that for which a chemical safety report is required
- The downstream user uses the substance or mixture in a total quantity of less than one tonne per year
- The downstream user uses the substance for process oriented research and development (PPORD)
A DU CSR has to be completed within twelve months of receipt of the safety data sheet for a registered substance. Downstream users have to inform ECHA that they intend preparing a chemical safety report within six months. However, the DU CSR does not have to be submitted to ECHA.
Downstream user report to ECHA
Downstream users need to report to ECHA within six months of receipt of the safety data sheet for a registered substance if:
- They prepare a downstream user chemical safety report (DU CSR), and the particular use for which the prepare it is greater than 1 tonne per year.
- They are exempt from preparing a DU CSR because the total use of a substance or mixture is less than one tonne per year
- They are exempt from preparing a DU CSR because they use the substance for process oriented research and development (PPORD).
- They have a different classification of a substance to that of all their suppliers.
The situations where DU CSR exemptions apply and where reporting is required are summarised in the Table below.
|
Total Use (tonnes per year) |
Particular Use (tonnes per year) | Used for PPORD? | DU CSR required? | Need to report to ECHA? |
|
<1 |
Not relevant | Not relevant | Exempt |
Yes |
|
>1 |
Not relevant | Yes | Exempt |
Yes |
|
>1 |
>1 | No | Yes |
Yes |
|
>1 |
<1 | No | Yes |
No |
Communicate information to suppliers
Downstream users need to inform suppliers if the suggested risk management measures are inappropriate and whenever new information on hazards becomes available.
This obligation is laid down in Article 34 of REACH. If it is necessary, this should be undertaken without delay.
Communicate information regarding safe use to own customers
Downstream users who supply hazardous substances, as such or in a mixture, have to communicate information regarding the safe use to their own customers. This should be in the form of a safety data sheet or otherwise, as required.
Downstream users need to update this information without delay if:
- New information on risk management measures or hazards becomes available
- An authorisation was granted or refused
- A restriction has been imposed
Comply with any Authorisation requirements
If a downstream user uses a substance that is on the Authorisation List, he needs to substitute it with a safer alternative. If he wants to continue to use the substance, his supplier or the downstream user, himself, needs to apply for an authorisation for that use, and additional obligations apply. This decision needs to be made as soon as the substance is included in the Authorisation List as the processing of the authorisation application takes time.
If a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers his use, the downstream user has to notify ECHA of his use.
If a substance is subject to authorisation, the supplier must communicate this in Section 15 of the safety data sheet (SDS) or in the other information supplied in line with Article 32 of REACH. The authorisation number shall also be included on the label.
Comply with any Restriction requirements
If a restriction applies to a substance that a downstream user uses, he may only continue to use it if he complies with the conditions of the restriction. Any EEA supplier must include information on whether a substance he supplies is subject to a restriction in Section 15 of the safety data sheet or in other information supplied in accordance with Article 32 of REACH.
Comply with requirements regarding substances in articles
If a downstream user produces or imports an article containing an SVHC in a concentration above 0.1 % (w/w), he must provide recipients of the article with sufficient information to allow safe use. This duty applies as soon as a substance appears on the candidate list. The information should be provided on supply to downstream users and, if requested by consumers, within 45 days of receipt of the request.
In addition, if the SVHC is present in those articles in quantities totalling over 1 tonne per producer or importer per year, the downstream user should notify ECHA.
If a downstream user produces or imports articles that intentionally releases a substance (such as a scented bin liner) and the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, then he should register the substance contained in those articles with ECHA. However, if the substance has already been registered for that use then a registration or notification is not required.
Source: European Chemical Agency (www.echa.europa.eu)
