For more on ECPA, visit the association’s web site at www.ecpa.eu.报告全文如下。
REACH：这对作物保护意味着什么？
REACH – the new regulation for Registration, Evaluation and Authorisation of CHemicals – has finally been adopted formally into EU law. After a compromise agreement was worked out between the Commission, Parliament and Council at the end of November, the final text was passed by a large majority in Parliament on 13th December and finally approved by the Council of Ministers on 18th. It now comes into effect in June this year.
主要规定
广泛产品中使用的大约 30,000 种化学品的制造商和进口商必须提供健康和安全数据，以允许他们继续使用，即使这些化学品可能已经安全使用多年。这将给工业带来进一步的负担，并导致大量的动物试验。所有化学品都必须在 11 年的时间内提交并由将在赫尔辛基设立的新化学品机构批准。优先次序将基于已知的毒性和使用量。
为什么这对植保行业来说是个问题？
REACH 的目的是让所有化学品都在一个共同的评估框架下，而不是继续被大量单独的立法所涵盖。同时，它要求所有在现行安全立法颁布之前已经使用的化学品都必须正式注册和批准。这就是为什么必须对如此大量的化合物进行评估的原因。
Of course, if compounds are already adequately dealt with via existing legislation, their inclusion in REACH serves no additional purpose, and adds considerable costs. All plant protection products are already subject to stringent safety assessment before approval under Directive 91/414. This covers not only the active ingredients but also the so-called co-formulants, which are compounds such as surfactants which improve the efficiency of use of the active ingredients themselves. During the drafting of the new REACH regulation, it was intended that all components of plant protection products – co-formulants as well as active ingredients – should be exempt to avoid unnecessary duplicate testing.
However, the relevant part of the regulation (Article 15) was drafted in such a way that co-formulants would still require registration. Despite the proposal of the Commission to change the wording of Art 15, Council and Parliament did not see this as a high priority issue in the context of a complex, major piece of new legislation. Therefore, it has unfortunately not been corrected, and this requirement will come into force as part of the overall REACH package in June. At the same time, a separate Article (17) would potentially trigger a need for intermediates in pesticides manufacture – themselves never leaving the factory – to go through the full registration process, introducing a further unnecessary burden.
下一步
对于所有复杂的立法，全面实施本身可能是一个漫长的过程，在这种情况下，有专门的 REACH 实施计划 (RIP)，旨在为新法规的实际实施提供指导。 ECPA将积极参与协助进一步明确上述规定的实际执行情况。