66 I EUROPEAN SEED I EUROPEAN-SEED.COM REGULATORY KEEPING YOU INFORMED OF LEGISLATIVE AND REGULATORY CHANGES IN EUROPE AND ABROAD — FROM LAWSUITS TO APPROVALS TO OTHER REGULATORY ISSUES AFFECTING YOUR BUSINESS. NATIONAL WITHDRAWAL DATES CONFIRMED FOR NEONICOTINOIDS On 27 April 2018, the Standing Committee on Plants, Animals, Food and Feed voted to adopt restricting the three neonico- tinoid active substances: imidacloprid, clothianidin and thiamethoxam to green- house use only. All outdoor use, including seed treatment, will be banned after 19 December 2018. The withdrawal date for the authori- sation for sale and distribution of existing stocks of the neonicotinoids: imidaclo- prid, clothianidin and thiamethoxam, has been confirmed as 19 September 2018. INTERNATIONAL BASF ACQUIRES VEGETABLE SEEDS BUSINESS FROM BAYER BASF closed the acquisition of Bayer’s global vegetable seeds business, mainly operating under the brand Nunhems. The acquired vegetable seeds business com- prises 24 crops and about 2,600 varieties. The addition of the vegetable seeds business enhances BASF’s global offer to farmers. It strengthens BASF’s seed platform and complements the recently expanded Agricultural Solutions port- folio, which includes seeds and traits, chemical and biological crop protection, soil management, plant health, pest con- trol and digital farming. This closing completes BASF’s acqui- sition of a significant range of businesses and assets with combined 2017 sales of €2.2 billion, which Bayer offered to divest in the context of its takeover of Monsanto. The all-cash purchase price amounts to a total of €7.6 billion, subject to certain adjust- ments at closing. CANOLA INDUSTRY CONCERNED ABOUT PMRA’S PROPOSED DECISION TO PHASE OUT VALUABLE TECH Canada’s Pest Management Regulatory Agency (PMRA) released proposed deci- sions to phase out the outdoor use of clothi- anidin and thiamethoxam, two important products used by canola growers to pre- vent damage caused by flea beetles. The canola industry continues to support PMRA’s science-based deci- sion-making process. The canola industry relies on continued investment in agricul- tural innovation, which is facilitated by predictable and science-based regulatory approval processes. The proposed decisions are of con- cern for the canola industry as a ban will reduce yield and increase the risks faced by growers. With more than 22 million acres of canola in Canada in 2018, ban- ning these plant protection tools would have a dramatic impact. BAYER: CONDITIONS FOR BEGINNING MONSANTO INTEGRATION FULFILLED The integration of Monsanto into the Bayer Group can begin following the com- pletion on 16 August of the divestment by Bayer to BASF of certain Crop Science businesses with a total sales volume of around 2.2 billion euros. Bayer already became the sole owner of Monsanto Company on June 7, 2018. One of the requirements of the U.S. Department of Justice was that Bayer and Monsanto remain separate companies and continue to operate separately until com- pletion of these divestments to BASF, and that has now taken place. As regards the glyphosate verdict in California on August 10, 2018, Bayer believes that the jury’s decision is at odds with the weight of scientific evi- dence, decades of real world experience and the conclusions of regulators around the world that all confirm glyphosate is safe and does not cause non-Hodgkin’s lymphoma. The National Institutes of Health (NIH) recently reaffirmed glypho- sate does not cause cancer. The U.S. Environmental Protection Agency (EPA), the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA) and other regulators around the world have also concluded that glypho- sate can be used safely. The jury’s verdict is just the first step in this case, and it remains subject to post-trial motions in the trial court and to an appeal, as announced by Monsanto. JAPAN DISCUSSES GENOME EDITING TECHNOLOGY On August 7, 2018, Japan’s Ministry of Environment (MOE) committee met for the first time to discuss handling of genome editing technology under the Cartagena Protocol on Biosafety. Committee members agreed that “Site- directed nucleases-1” should not be regulated under the existing genetic engi- neering regulation. Other types of mod- ification will be discussed in the coming months before the committee concludes its opinion by the end of October 2018. After internal discussions on the reg- ulatory handling of genome editing tech- nology, Japan’s Ministry of Environment (MOE) held its first committee meeting for Japanese Fiscal Year (JFY) 2018 (April 2018 – March 2019) to discuss handling of genome editing technology under Cartagena Protocol on Biosafety.