Identification of downstream uses
In view of REACH, i2a has currently developed the exposure scenarios (ESs) for diantimony trioxide, antimony metal and sodium hexahydroxoantimonate with November 2010 as EU-REACH registration deadline, and for diantimony pentoxide, sodium antimonate (A), diantimony tris(ethylene glycolate) and diantimony trisulfide with May 2013 as EU-REACH registration deadline based on the information we gathered via our members.
As defined in EU-REACH legal text, an exposure scenario is the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate.
This compilation of information includes ‘operational conditions’ and ‘risk management measures’. If you want to read more about exposure assessments, please check ECHA Guidance D: Exposure Scenario Building.
Why identify the downstream use?
All antimony substances covered by i2a (except antimony metal (CAS N° 7440-36-0) and antimony pentoxide (CAS N° 1314-60-9)) meet the criteria for classification as ‘‘hazardous’ in accordance with Regulation (EC) No 1272/2008 , but not for PBT or vPvB (cfr. Annex XIII of REACH). If the yearly tonnage is > 10 tonnes for these substances, i2a developed the appropriate exposure scenarios for all identified uses in cooperation with the concerned registrants. The identified uses are uses within a registrant’s company, by his customers and by companies supplied with chemicals by your customers.
What if your use is not covered in the ES?
If you, as a (potential) member of i2a or as a downstream user (DU) who received an antimony substance (registered under EU-REACH) from an i2a member, note that your use is not covered in the exposure scenarios of the joint Registration Dossier, you have the legal obligation to ensure
- that your use is included in the exposure scenario section of the existing dossier. For this, you need to make sufficient information on the use and the conditions of use available to your supplier in order to do the assessment
- that a new Chemical Safety Assessment, including the appropriate exposure scenarios and risk management measures, is performed by yourself within 12 months after receiving the chemical and eSDS with a REACH registration number. If you do not meet this tight deadline, you can no longer continue using the substance for that use.
Therefore, i2a strongly encourages DU to carefully check the ES, and to provide i2a the missing information (eventually via your supplier) to ensure you are REACH compliant and are allowed to continue using the substance in the future.
Why assign the use descriptor for your identified use?
Under EU-REACH, i2a prepared the exposure scenarios (ESs) for i2a members. The first step of this process required building up a short title of the ES which flags the scope and applicability of the ES. In order to cover all the uses in the supply chain and to ease and standardize the communication between supplier and users, the user descriptor system was developed.
Each registrant is also obliged to include a brief general description of all identified uses in his technical dossier (section 3.5-3.7 in IUCLID 5.5).
If you are a downstream user or are interested in a letter of access for one of our REACH registered antimony substances, please check the basic list of identified uses which serve to prepare the Occupational or Consumer Exposure Scenarios.
i2a has made two guidances available to help downstream users to check the ‘safe use’ of a substance: ‘ES: Eurometaux guidance for DU-mmies’ and ‘Guidance on how to check environmental compliance with the ES’
If you think that your use is not covered, please contact i2a via e-mail at Reach@antimony.be. This way, we can consider implementing the missing information during a future update of the REACH dossiers.