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Downstream Users Guidance in a Nutshell
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Downstream Users Guidance
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Summary of Obligations
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Definitions

Downstream Users

Using a substance or preparation in an industrial or professional context is a downstream use. Potential downstream user activities include refilling and re-importing, as well as the variety of uses that occur in industrial and professional settings. Consumer use and use of articles is not downstream use. However, the use of substances to produce articles is downstream use, and producers of Articles have some particular obligations under REACH.

Downstream-Users-Chart-700x850Make suppliers aware of your use during the registration processConfirm substances used comply with REACH registration and other requirements.Review and follow supplier Safety Data Sheet (SDS).Use covered by exposure scenario?Evaluate options for use outside the exposure scenarioFormulator or refiller?Provide customers information on hazards and safe conditions of use.Inform supplier when you have new information on hazards or RMM.

Registration Process.

Substance registration under REACH will be conducted in phases during the period 2008 – 2018, and thereafter for new chemicals. Work with the suppliers to make sure they are aware of your use and will include it in the registration dossier as appropriate. Meanwhile, suppliers may be seeking information from you to prepare their registrations and to develop exposure scenarios.

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REACH registration and other requirements.

DUs must not place on the market or use any substances that are not registered in accordance with REACH.

 

This means that your products may contain only substances that are:

REGISTERED

REGISTRATION EXEMPT

Pre-registered and have a registration deadline in the future

Produced/imported by the supplier in amounts below 1 tonne/year.

Contact the supplier to determine and request written confirmation of REACH status. There is a list of registered substances on the ECHA website. There also is a list of pre-registered substances on the ECHA website.


DUs also need to comply with any restrictions imposed through the evaluation and authorization processes under REACH. The supplier will indicate if and when these restrictions apply, usually in the SDS. For substances subject to authorization, you will have to comply with any conditions covering your use and possibly apply for an authorization if your use is not covered by an authorization granted to the supplier.

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Safety Data Sheet.

Over time, REACH will increase the amount of information you receive from suppliers, e.g., on safety data sheets (SDSs). Follow instructions in the SDSs that you receive. DUs must apply appropriate measures to control risk communicated in SDSs or in any other information supplied to them.

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Exposure scenario.

SDSs for substances that meet certain hazard and quantity criteria will have attached exposure scenarios—a new SDS feature under REACH. The exposure scenario will contain a description of the subject use and information on how the substance or preparation may be used safely, including specified risk management measures (RMMs). It is the DU's responsibility to check that your use is consistent with the exposure scenario and take action if it is not. Your use is covered when your actual operational conditions and risk management measures correspond to those specified in the exposure scenario.

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Use outside the exposure scenario.

The following are available options when your use of a substance or preparation varies from the exposure scenario in the extended SDS:

  • make your use/use conditions known to your supplier so that the supplier can prepare an exposure scenario covering your use conditions;
  • change your conditions of use so they comply with the supplier's exposure scenario;
  • find another supplier who provides an exposure scenario covering your conditions of use;
  • prepare your own chemical safety report; or
  • stop using the substance/preparation and find an alternative.

There also are some exemptions that may apply, e.g., for research uses and uses below certain tonnage levels, but in these cases a report to ECHA may be required.

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Formulator or refiller?

A formulator mixes substances and/or preparations to make preparations to place on the market. A refiller transfers substances or preparations from one container to another. Note that if chemical reaction occurs during mixing, you may be a manufacturer under REACH and thus subject to additional obligations.

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Hazards and safe conditions of use.

Formulators and refillers (which are DUs) that supply substances or preparations must recommend appropriate measures to control risk. They must provide SDSs as required under REACH, and communicate certain information (e.g., that a substance is subject to restriction or authorization) by other means if an SDS is not required. When compiling its own SDS, a DU needs to include relevant exposure scenarios and use other relevant information from upstream SDSs supplied. Consider the REACH and CLP requirements in detail if you are a DU developing your own SDSs for substances or preparations that you distribute to others.

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New information on hazards or RMM.

DUs must inform suppliers of any new information they obtain on hazards of a substance, including information related to classification and labeling. New information means information that was not communicated by the supplier and is not available in public databases or literature. New information on hazards can include, but is not limited to, new information about physicochemical properties, stability and reactivity, toxicology, ecological effects, and so forth.

If you have new information that influences classification and labeling and thus would classify the substance differently than the supplier, you have to report this to ECHA, unless you use less than 1 tonner per year of the subject substance.

DUs must also tell suppliers about information they have regarding the appropriateness of risk management measures (RMMs) in exposure scenarios. This could include, for example, knowledge that the RMMs are not effective, that the RMMs address exposure routes that do not occur, or that they contradict classification and labeling.

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The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.