Exposure Scenarios

Introduction

 

REACH is based on the principle that it is the obligation of the industry to ensure that the substances they manufacture, place on the market or use do not adversely affect human health and the environment.

 

The Chemical Safety Assessment (CSA) identifies and describes the conditions under which the manufacturing and use of a substance can be regarded to be safe. A CSA has to be carried out if the substance is subject to registration under REACH and manufactured or imported at quantities of 10 tons or more per year and registrant.

 

If as a result of the CSA the substance meets criteria that classifies it as dangerous or as PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative), then an exposure assessment will be needed.

 

The final result of the exposure assessment is the Exposure Scenario (ES) which is the set of information that describe the conditions under which the risks associated with the manufacturing and the identified uses of a substance can be controlled. The ES defines the operational conditions and risk management measures that need to be applied to ensure the safe use of the substance during all life stages. The ES is communicated as an attachment to the Safety Data Sheet (SDS). Together SDS and the ES form a new document, the “extended SDS” (extSDS), which is the legal REACH document communicated down the supply chain. There is no standard format for the ES.

 

Timing: Communication of ES later than Deadline

 

Although the first registration deadline is December 1st, 2010, the extSDS for a substance registered will most likely be communicated with some time lag only. The deadline concerns the successful submission of the dossier. The registrant receives his registration number from ECHA after payment of the registration fee. As there will be several steps in the supply chain between the Registrant and the Downstream User there will be unavoidable delays in the communication of Registration Number and extSDS. In the industry it is widely expected that most extSDS will not appear before March 2011. Please refer also to the Cefic Newsletter on communication in the supply chain.

 

Obligations for Downstream Users

 

As a Downstream User you will receive an ES attached to the SDS (extSDS) when the substance that has been registered is classified as dangerous, PBT or vPvB. If you purchase a preparation that contains such substance(s) the SDS will also be extended by Exposure Scenario(s) per respective substance (depending on the registration deadline of the substance).

 

If you receive an SDS with an Exposure Scenario, it is your obligation and responsibility to check and to ensure that your conditions of use are covered by that Exposure Scenario and to apply the recommended risk management measures. This means that, in a first step, you have to compare the conditions described in the Exposure Scenario with your own practices. There are three possible outcomes:

 

• Your use is covered – no further action to take
• Your use differs from the ES – more detailed compliance check is needed
• Your use is not covered by ES – you have to take action by choosing among 4 options:

 

1. Change your conditions of use in order to be compliant
2. Inform suppliers about the missing use / conditions of use
3. Select alternative supplier which has covered missing use / conditions of use in his registration
4. Special uses / conditions of use for which no registrant can be found may need a Downstream User Chemical Safety Report. If you decide to do so, you have to inform ECHA within 6 months after receipt of the extSDS that you will carry out an assessment yourself.
   Exemption: If you use less than 1 ton per year you do not have to do a CSR, but you need to notify ECHA at the latest 6 months after receipt of the extSDS.

 

General timing:

 

If any of your uses / conditions of use appears not to be covered in the extSDS you have a certain time to make the missing use REACH compliant. According to Article 39-1 you may continue to apply this use / conditions of use during a 12-month period which starts at the date you receive the registration number communicated via the extSDS.

 

Reasons for not receiving an ES:

 

There might be several reasons for not receiving an ES:

 

• The substance is exempt
• The substance is manufactured/imported in volumes less than 10t/y
• The substance is not classified as dangerous (non-hazardous substance
• The substance will be registered at later deadline
• The substance in formulation will be registered at later deadline