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Under REACH, Downstream Users (DU) should not place on the market substances as such, in mixtures or in articles if they have not been duly registered by the relevant manufacturers or importers (unless they are specifically exempted from registration). For many substances, a chemical safety report will have to be submitted as part of the registration dossier: exposure scenarios covering the various identified uses will have to be generated and communicated to downstream users via safety data sheets, as applicable. REACH gives downstream users the right to communicate their uses, together with specific conditions of use, to their suppliers with a view to make their use an identified use covered in the registration dossier. Distributors should pass on the information in the supply chain. However, REACH does not prescribe any particular format for exchanging information on uses in the supply chain.
Standard processes and tools are necessary to facilitate use communication, exposure scenario development and guarantee that registration dossiers adequately address all (or as many as possible) uses of substances.
Safety Data Sheets
Manufacturers, importers, downstream users and distributors are already today required to compile and supply a Safety Data Sheet (SDS) at the first delivery of a dangerous substance or mixture.
REACH takes over this existing duty in its Article 31 (requirements for the Safety Data Sheets) and in Annex II (guide to the compilation of Safety Data Sheets). Safety data sheets will continue to contain information on the hazards of the substance or the mixture, as well as information on the recommended risk management measures to adequately control any risks to health and environment. In addition, for all those substances for which a chemical safety assessment (CSA) is required and that are classified as hazardous, the relevant exposure scenarios shall be annexed to the Safety Data Sheets (SDS). This obligation to annex exposure scenarios to the SDS has to be fulfilled by: - Downstream users: For substances supplied to them, classified as hazardous, that they place on the market (and that are manufactured or imported in quantities above 10 T/year), and where applicable and where relevant for mixtures they place on the market.
- Distributors: if they have received such information and it is relevant for their customers.
Guidance and Tools
DUCC and its member associations are involved in the development of industry practical guidance, including Guidance on safety data sheets for mixtures, assessing methodologies to combine and integrate information contained in exposure scenarios of individual substances into safety data sheets of mixtures. A catalogue with standard phrases for Exposure Scenario communication has been prepared by different industry sectors, associations and companies. IT providers together with industry have also developed an XML standard for communication between different IT systems.
The download package now contains also an XML standard, prepared by ECHA, for ESCom phrases import in Chesar 1.2.
The use of the harmonised phrase catalogue together with the XML standard by all stakeholder of the Exposure Scenario communication process is essential. The complete package, called ESCom, together with the ESCom phrases import in Chesar 1.2 XML standard, is available for free after registration and acceptance of the license conditions.
UseR (Use Reporting)
To avoid that multiple and inconsistent formats be used by different companies or different DU industry sectors for their use inventories and reporting, DUCC developed the UseR (Use Reporting) template to assist downstream users in informing their suppliers on their uses and conditions of use, thereby assisting on the preparation of registration dossiers.
This template is a tool that DU associations and their members can use for mapping and reporting uses for their respective sectors.
It contains two tables:
- one table for description of uses: this should be done following the Use Descriptor System developed by ECHA.
- one table that, in addition to use descriptors, contains typical basic operational conditions and risk management measures. This additional information is provided to allow exposure assessment at screening level or “Tier-1” level using the ECETOC Targeted Risk Assessment tool (a standard exposure assessment tool under REACH). It has deliberately been kept simple.
Each Downstream User Association is responsible for filling and updating the use information for its sector and post the corresponding tables or inventories on their respective website, so that they are readily accessible by registrants.
Exposure assessment using the BAMA/FEA Indoor Air Model
The REACH Regulation and the Aerosol Dispensers Directive (ADD) both require that all chemicals are used in aerosol in a way that does not adversely affect human health. The BAMA/FEA Indoor Air Model is a simple but powerful tool, independently validated by experts from BRE (UK) who concluded that the Model 'can be used to predict the concentration of aerosol components within a room after a suitable time interval after spraying'.
Note: each company remains individually responsible for compliance with REACH. For more information on supply chain communication, use identification and exposure scenarios, visit the following websites:
Links to the DUCC member associations’ websites posting use and exposure information:
CosmeticsDetergents and cleaning products Paint, printing ink and artists’ colours Construction chemicals Photographic materials and imaging Chemical distributors Adhesives and sealants
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