Here’s everything you need to answer that vital question. . .
In December 2016, ECHA released details of important new guidance being developed. The guidance covers how to identify substances with endocrine-disrupting (ED) properties, in plant protection and biocidal products.
It is essential to begin by defining the scope of the draft guidance. Here you’ll discover exactly what’s being proposed, and how it could affect your registration.
5 things to acknowledge
- The European Commission is widening the scope of the draft criteria.
- The original draft Plant Protection Product legislation is being split into two.
- The scope of the draft guidance outline has been agreed.
- The ED guidance will apply to specific substances.
- Time frames
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What does this guidance mean for your registration?
The guidance could affect how you conduct your registration program in two ways. Firstly, the new guidance now specifies information sources for ED identification. These sources are mainly the in vitro and in vivo laboratory tests that OECD GD 150 identifies. Secondly, regarding the hazard identification strategy for ED properties. This would now be based on the evaluation of the information in a weight-of-evidence approach.
How to navigate through this landscape successfully
An experienced contract research organisation can help you understand the complexities and implications of this new guidance. They'll work with you to develop a bespoke and successful route to registration.
About the Author
David’s main focus and area of expertise is biocides regulations, including regulatory advice and strategy. The latter often involves preparing documents such as data gap analysis, or setting up and identifying the format of product families. You may also be interested in reading his other blogs;