A.I.S.E. use information to support preparation of registration dossiers & communication in the supply chain
General information on exposure scenarios
For many substances, a chemical safety report will have to be submitted as part of the registration dossier. In many cases (e.g. for large volume classified substances), exposure scenarios covering the various uses of substances will have to be generated.
Under REACH, an exposure scenario consists of the combination of four elements: substance properties, product properties, operational conditions (conditions of use) and risk management measures. In other words, the exposure scenario is the communication tool to the user describing how to use a substance in a safe way. Exposure scenarios have to cover all manufacturing and identified uses.
The development of relevant exposure scenarios and CSRs requires communication between registrants (Manufacturers/Importers M/I) and downstream users (DUs). REACH introduces new requirements in this respect.
In practice, it means an unprecedented flow of information will circulate between manufacturers and users of chemicals (substances, preparations and articles). The more complex the supply chain, the more demanding the communication flow.
A.I.S.E. is working with other industry sectors (suppliers and other downstream users) on developing sets of tools and data to allow harmonised and standardised communication in the supply. Without such tools and sector-harmonised data, the communication flow will likely become unmanageable.
The first stage of dialogue within the supply chain concerns alignment on uses. Once M/I and DUs have agreed on a set of uses for further evaluation, exposure assessment follows. Risk Management Measures may have to be considered in order to ensure a use is safe to human health and the environment. The exposure scenario is filed in the CSR together with other information and communicated to DUs via an Annex to the Safety Data Sheet (SDS). The exposure assessment and the CSR content is the responsibility of the registrant. The role of DU is to provide use information to M/I to make a use identified and facilitate the exposure assessment. The DU must implement the operational conditions and RMMs described in the exposure scenario within 12 months after receipt of the extended SDS. However a DU can always decide to develop his own chemical safety assessment.
A.I.S.E. members place many chemical products on the market in the form of mixtures. Many of these mixtures contain several substances (typically 10 - 25 substances). In principle, safe use has to be ascertained for each (dangerous) substance in the formulation. For each substance, the exposure scenario must result in a safe use in the product. The combination of all these exposure scenarios must lead to safe use of the mixture. As DUs, formulators of detergent products have to verify in the exposure scenario received in annex to the SDS that his uses (where applicable) of the substances in formulated products are covered.
Methodologies on how to extract relevant substance information for a mixture and communicate downstream are still under development.