Low Risk Substances

Crops & Chemicals Europe sponsored by: SCC

In case you might have missed the presentation of Dr Bernd Brielbeck on low risk substances at Crops & Chemicals Europe 2017, we are summarising the main contents here briefly.

The general political environment for Plant Protection Products is currently difficult in Europe. The recent confusion about the renewal of Glyphosate exemplifies this sufficiently. In contrast, low risk active substances are seen positively and business opportunities can be expected to thrive in this section of the market in the future. Even the European Parliament has put forward an initiative in 2015 already calling for measures to support such active ingredients.

A broad variety of legislations and initiatives have been adopted. They call for the sustainable use of agro chemicals, the greening of agriculture and the establishment of ecological focus areas, all of which might eventually benefit low risk active substance approvals. Regulation 1291/2013 establishes Horizon 2020; a framework for research and innovation, assigning between 2014 and 2020 80 billon Euro to such work. All details of such legislation can be found on slide 4 of the presentation published on the conference website.

The above initiatives must be seen in the context of limited availability of low risk substances in the market, i.e. seven at the time of the conference. The AIR 4 (Annex I renewal) programme is also taking this fact into account, by grouping the active substances according to their presumed (low risk) properties!

To allow more active substances with adequate properties to fall under the low risk categories, SANTE/11953/2015 and SANTE/12376/2015 are currently establishing revised criteria for such substances, as well as amending Regulation 1107/2009 to further this goal.

A brief check of the above intentions against real life realities does reveal some sobering facts. The scientific approach is, in various cases, hampered due to the strict and “regulatory” execution of data requirements by the authorities. Also, practical issues such as the limited number of GLP compliant CROs competent in working with microorganisms, often, but not necessarily always, low risk substances, can impede progress. Dossiers based on literature data, encouraged in the case of low risk substances, might be complicated by copy right issues. Uncertainty on the implementation of new guidance on endocrine disrupting properties might lead to a loss of natural, presumably low risk substances, as Vitamin D3 or caffeine and others.

The conclusion drawn is positive! All issues addressed in the Parliament Initiative are important to further the cause of low risk substances and provide the European agriculture with versatile and safe active substances again. Little needs to be added – they have just to be done and transferred to the regulatory system!

Of course, Dr Brielbeck will be glad to address any particular questions you might have on the subject and which could not be addressed adequately in this brief summary. Please feel free to contact him by phone (+49 (0)671-29846-158) or email (bernd.brielbeck@scc-gmbh.de).

Dr Bernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides at SCC 

Tel: +49 (0)671-29846-158

Email: bernd.brielbeck@scc-gmbh.de

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