REACH Registration Process With Regards to Co-Formulants in Plant Protection Products

摘要

REACH is the European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the registration, evaluation, authorization and restriction of chemical substances. Registration is required for all substances manufactured in or imported into the Community in quantities of 1 tonne or more per registrant per year, unless they are exempted. Active substances for use in plant protection products (PPPs) are exempted as covered by Directive 91/414/EEC, but co- formulants do not qualify for the exemption and are not regarded as registered. REACH brings additional requirements on the use of chemicals across Europe and places a special emphasis on evaluating the safety of their uses to workers, consumers, and the environment. REACH requires the EU manufacturer or importer to develop a chemical safety report (CSR), which demonstrates that all uses (exposure scenarios) of a substance are safe. For the standard communication of exposure scenarios up and down the supply chain, the ECHA use descriptors are used (sector of use category (SU), chemical product category (PC), process category (PROC), environmental release category (ERC), and the article category (AC)). With respect to risk assessment, PROCs and ERCs are the important information. This exposure scenario information, often compiled by the downstream user associations, are used to calculate the risk via general risk assessment tools (e.g., ECETOC TRA), or for more realistic depiction of the actual exposure situation of co-formulant use in PPP e.g., by the ECPA OWB tool. Suppliers must indicate the relevant identified use(s) of a substance in the SDS using a brief description of what the substance is intended to do. This information must be consistent with the identified uses and exposure scenarios set out in the annex to the SDS. Additionally, the SDS in section 8 contains substance specific information (derived no effect level (DNELs), predicted no effect concentration (PNECs)) and where a CSR is required, the risk management measures for the identified uses must be consistent with the information in this section. If the specific use of a substance by a downstream is not covered in the eSDS, the use should be made known to the supplier (to be included in the CSR), the conditions of the specific use must be adapted to those described in the eSDS, or an own CSR has to be performed for that particular use using DNELs and PNECs from the SDS.