何当奇
第1楼2007/09/28
REACH AND CO-FORMULANTS
At presstime, the current draft of REACH (common position dated 12 June 2006) specifically mentions plant protection product coformulants – Article 15(1) states that active substances "and co-formulants" manufactured for use in plant protection products only and included in Annex I of 91/414/EEC, "shall be regarded as being registered". Plant protection co-formulants, unless they are active substances, are not listed in Annex I of 91/414/EEC so this clause would seem to be unclear. Their inclusion in Article 15 also seems scientifically unjustified because the intrinsic properties of co-formulants are not considered under 91/414/EEC legislation.
It is, therefore, possible that this phrase may be deleted or amended in the next phases of the legislative process, which began in the first week of October this year. Co-formulants are not included in the equivalent article for biocides (Article 15(2)).
REACH does recognise that a number of substances can be considered to cause minimum risk because of their well known intrinsic properties. These materials are exempt from the obligation to register. A list of 68 materials is presented in Annex IV to the regulation and includes a number co-formulants often used as carriers and fillers in plant protection products (eg, water, sucrose, limestone).
何当奇
第2楼2007/09/28
REACH AND PLANT PROTECTION PRODUCTS
As noted above, plant protection product manufacturers are ‘downstream users’ of coformulants in the supply chain. They will have ‘information in the supply chain’ responsibilities. Apart from feeding information up the chain, they may also have to provide information down through the chain as well. This will be in the form of exposure scenarios detailed in an annex to the safety data sheet. It should be noted that a user is not obliged to supply information up the supply chain for use in the CSR. If a user does not wish to co-operate in the previous user’s CSR he can exclude himself provided he then produces his own CSR.
He will be required to inform the chemicals’ agency if he takes this course of action. Plant protection product manufacturers should also check that their co-formulant suppliers intend to continue to support these materials in the REACH process. A decision made up the supply chain may cause supplies to cease for the downstream user.
Although plant protection active substances are exempt from substantial parts of the REACH regulation, the chemicals and intermediates involved in their manufacture are not. In addition, the co-formulants and ingredients in plant protection products are subject to full registration (to be clarified in the final text when it’s adopted), information in the supply chain, evaluation, and authorisation provisions of REACH.
Manufacturers of co-formulants should now be preparing for REACH by ensuring that they are aware of all their customers and that data will be made available for their substances. Plant protection product manufacturers should also be in contact with their suppliers to ensure that they plan to continue to support and supply co-formulants.
何当奇
第3楼2007/09/28
REACH AND AIS
Active substances manufactured for use in plant protection products only, and already included Annex I of 91/414/EEC (or pending inclusion in Annex I), are considered to be already fully registered under REACH. This obviates the need for the pre-registration, registration and conducting the chemical safety assessment, and no authorisation is required owing to the Annex listing and subsequent National Annex III authorisations. This does not
exclude active substances completely – all requirements related to information in the supply chain and downstream-user obligations are applicable and there is a possibility (albeit a small one) that restrictions could be imposed on a pesticide outside the scope of 91/414/EEC.
It is important to note that this provision only applies to substances within the EU’s plant protection product review process - it does not apply to pesticides that have failed to make it to Annex I listing, but are still being manufactured for export. It also only applies to substances that are used exclusively for plant protection and biocidal use; substances used for non-plant protection, or non-biocidal use, will still fall within the scope of the REACH registration process.
Although REACH does not apply to non-isolated intermediates, it applies to isolated intermediates and transported isolated intermediates. There is, therefore, no specific exclusion for intermediates for plant protection actives, although the registration process for intermediates is much simpler than for other substances in the scope of REACH.