ECHA

Communication throughout the supply chain is at the core of REACH. Safety data sheets are the main means to do that. SUMIs - Safe Use of Mixture Information - templates are the new arrival. Are you up-to-date?

How thoroughly should I check the information in the safety data sheet (SDS) received from my supplier? 

You should be able to judge whether the information is reliable. Check that the SDS is up-to-date, that it is consistent throughout and in line with the labelling information. Make sure also that it contains the information you need under the various sections .

You should be confident that the content of the SDS complies with the requirements of REACH to identify, apply and recommend risk management measures. You should also recognise if you need to communicate new information on hazardous properties or any other information that may affect the risk management measures identified in the SDS to your supplier.

I manufacture the substance for my own use only and do not supply it to any customers. Do I need to do a REACH compliant SDS for my workers?

You are not a supplier, so you don't need to provide an SDS. However, as an employer, you do have to give information to your workers, for example, on the hazardous chemical agents and appropriate risk management measures. You need to find an appropriate and documented way to do this.

Where is the SUMI (Safe Use of Mixture Information)* template available?

The template is being developed by the Downstream Users of Chemicals Co-ordination group (DUCC) and should be made available by the end of 2015. For an overview, have a look at a recent material presented at the meeting of the Exchange Network for Exposure Scenarios (ENES).

A library of SUMIs, containing sector-specific advice for common uses and based on an agreed template, is also under development. The first batch will be available on the DUCC website in the end of 2015 or early 2016. Contact DUCC if you would like to get involved in this project.

As a downstream user/formulator, do I have to supply SUMIs to my customers or are the SDSs enough?

If a safety data sheet is required for a mixture, you must provide it to your customers. You also have to provide relevant information from the exposure scenarios of the constituent substances. A SUMI is one way you can do that. Other options include incorporating the information in the SDS or by forwarding the relevant exposure scenarios.

Should I prepare a DU chemical safety report when I have new uses for a substance that is not classified as hazardous and the supplier does not react to my plea to include these new uses in an update of his registration dossier?

If the substance is not classified as hazardous, there is no legal obligation to prepare a chemical safety report. If the substance is hazardous, check chapter 4 of the Guidance for downstream users for more information about your obligations.

* The Safe Use of Mixture Information is an approach being developed at the sector association level that harmonises the communication of safety advice for mixtures. It aims to provide easy to understand and consistent advice to end users of chemicals on how to use hazardous mixtures safely. SUMIs will not replace safety data sheets (SDS) but can be annexed or integrated into the SDS.

AUTHORISATION

As a downstream user using a substance that is on the Authorisation List in a mixture with a concentration below the classification levels, do I have to submit an application for authorisation to continue using the substance?

Uses of substances when they are present in mixtures below the applicable concentration limits do not require authorisation. Formulation of a mixture requires authorisation (by the formulator or an actor up the supply chain), unless a generic exemption applies (see Q&A 1027 and 1030).

DOWNSTREAM USER CHEMICAL SAFETY REPORT (DU CSR)

What length does ECHA expect the ‘normal' DU CSR on unsupported use to be?

There is no general rule for the length of a DU CSR. It is the content that matters. The length depends on the complexity of the case. Examples/excerpts are given in Practical Guide 17 on How to prepare a downstream user chemical safety report.

In what language should I write the DU CSR?

The DU CSR is an internal company document and you are free to choose the language. However, remember that your national authorities may request to see it. If you supply the substance as such or in a mixture to your customers (except the general public), the relevant exposure scenario annexed to the SDS must be supplied in the official language of the Member State where the substance or mixture is placed on the market. Fore more details see chapter 8 of the Practical Guide 17 on How to prepare a downstream user chemical safety report.

Do I need to submit my DU CSR when reporting an unsupported use to ECHA?

Downstream users do not need to submit their DU CSR to ECHA. Information about the use is submitted to the Agency in the downstream user report (see Q&A 487).

Is the information submitted on the use known only by the DU and ECHA?

This information is confidential but is made available to the Member State authorities when required for regulatory risk management decision making. An overview of the DU reports on ECHA's website reports statistics only.

USING INFORMATION

Can I use the information published from dossiers on ECHA's website?

How can I contact the data owner? You need to contact the registrant if you want to use the information, such as including it in a publication. The names of the registrants are included in the Registered substances database. You need to contact the registrant directly and discuss the possibility of using the data.

Once you have permission from the data owner, you can use the data.

Further information:

• Exchange Network for Exposure Scenarios (ENES) 
• CSR/ES Roadmap 
• Downstream user guidance 
• Downstream Users of Chemicals Co-ordination group (DUCC) 
• Questions & answers 
• Practical Guide 17 
• Checklist for safety data sheets
• Terminology – in 23 languages

Text by Monique Pillet

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