If an ingredient supplier submits an extended safety data sheet (eSDS)—a safety data sheet (SDS) with an annexed exposure scenario (ES)—to a downstream user (DU), the recipient needs to comply with the conditions described in the attached ES. Additionally, if the DU's use is not covered, the DU will be responsibile to develop a chemical safety report (CSR). An eSDS will only be received if a REACH registration was filed for quantities of 10 tonnes or more of a substance and if the substance meets the criteria for classification as dangerous. For more information on ES annexes and other changes to the SDS, read the June REACH Update.
This responsibility for the DU to file a CSR applies when the amount of the substance as such or in a preparation as part of the DU's processes reaches one tonne per year or more, whereas the amount is not limited to the actual applied quantity but also includes the quantity stored.
When obtaining the eSDS, the DU must identify if the ES contains the specific operational conditions and risk management measures applied to that DU's uses and operations. In relation, the following criteria must be reviewed upon receiving an eSDS:
• Does the description of use(s) given in the first part of a standardized ES include the way in which the substance is used by the DU?
• Do the operational conditions as described in the ES cover the DU’s use? i.e., do the DU's operations assure human and environmental exposure at reduced or equal levels?
• Do the risk management measures of the ES match the procedures applied by the DU to protect workers, consumers, or the environment?
If the ES of the supplier does not cover the DU’s operational conditions and risk management measures, or the DU’s use of a substance or a preparation is not covered at all, various options exist for the DU, and a decision for the best approach has to be made on a case-by-case basis. Possible steps could include:
• Adjusting to the supplier's conditions of use described in the eSDS; i.e., changing work practices;
• Notifying the supplier of the new use with the aim of making it an identified use within the registrant’s chemical safety assessment;
• Performing a chemical safety assessment;
• Changing to a different supplier of the substance;
• Considering replacing the substance or preparation with those that are less hazardous.
The option of making a use known to the supplier is established in Article 37, where the DU’s duty to identify, apply and recommend risk reduction measures is described. The DU must provide sufficient information or (if appropriate) a use and exposure category (UEC) to the supplier preparing an ES for addition to the chemical safety assessment. For more information on exposure assessment elements, read the August REACH Update.
When a DU prepares the chemical safety report, the ECHA must be notified before the DU can commence or continue using a substance that has been registered by an actor up the supply chain (Article 38).
REACH relies upon communication along the supply chain. According to Title IV, all information regarding substance properties must be passed down the supply chain. While DUs producing preparations generally are required to share all the relevant information they receive from various suppliers for each substance used, such information requirements do not apply to cosmetic products since they are exempt [Title IV-Article 2 (5b)].
To assist suppliers and DUs in structuring their communication and to facilitate standardization of ESs, the ECHA recommends a use descriptor system2 including standardizing short titles to describe a given use. Based on this descriptor system, a DU can quickly establish whether an ES received with an eSDS covers its use(s) of the substance. Several European trade associations have mapped use descriptors for their member industries. For cosmetic product use-mapping, visit the Colipa Web site.
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• A DU must have a chemical safety report (CSR) prepared when using a substance classified as dangerous in total quantities exceeding one tonne/year.
• The CSR provisions apply to the DU when a supplier’s eSDS is received.
• The DU must verify that the supplier’s eSDS covers its own use(s) and specific operational conditions and risk management measures.
• If the DU’s use is not covered in an eSDS, the best follow-up approach must be decided on a case-by-case basis.
• The option of notifying a supplier of a new use includes the DU’s provision of providing sufficient information to allow the supplier to prepare an ES to add to its registration.
• Where a DU prepares a CSR on its own, the ECHA must be informed before that DU can commence or continue using the substance.
• All information on a substance's properties must be passed down the supply chain, except for cosmetic products, which are exempt from these provisions.
• In order to assist in communicating ES requirements, the ECHA recommends a use-descriptor system; i.e., standardized, short titles for given uses.
• Several European trade associations have mapped out use descriptors for their member industries.
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