Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 5242 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 EU REGULATORS DELAY CHEMCHINA/ SYNGENTA MERGER DECISION Antitrust regulators in the EU are extending their deadline to April 12 on their decision on ChemChina’s proposed buy of Swiss pes- ticides and seeds group Syngenta. “Sufficient time for the discussion of remedy proposals” is the reason cited by Syngenta in a statement about why the two companies had asked for the extension. The $43-billion bid was made in October. ESA WELCOMES CLARIFICATION OF PATENT LAW The European Commission adopted on Nov. 3, 2016, a clarification notice on certain articles of Directive 98/44. This notice clar- ifies that the intention of the EU legislator when adopting the Directive 98/44 was to exclude products obtained by essentially biological processes from patentability. The Commission studied the legislative history of the Directive, came to the conclusion that this was the legislator’s intent and stated that onlywithsuchaninterpretationtheDirective is consistent. It is however important to know that the Commission’s clarifying notice will only make a difference in practice if it is fol- lowed by the European Patent Office in its patent granting practice, and in that respect it has to be recalled that the Enlarged Board of Appeal of the European Patent Office (EPO), based on the interpretation of the European Patent Convention, came to the opposite conclusion (i.e. that products obtained by essentially biological processes arepatentable)inMarch2015 intheso-called Broccoli II/Tomato II cases. Due to this situ- ation, and due to the fact that the European Patent Office, in principle, is a separate and fully independent body from the European Union and thus is not obliged to follow EU law and its interpretation, it is crucial to find a way to make sure that the EPO will follow the Commission’s interpretation. ENGENIA HERBICIDE FROM BASF APPROVED FOR USE IN THE U.S. BASF’s newest herbicide, Engenia, was granted approval by the US Environmental Protection Agency (EPA). Engenia is the most technologically advanced formulation of the active ingredient dicamba and will provide growers the control of more than 200 broadleaf weeds, including those resist- ant to glyphosate, according to the com- pany. Engenia’s introduction to the market marks an important addition to BASF’s her- bicide growth strategy. The product will be available for use on dicamba-tolerant soy- bean and cotton crops for the 2017 season in North America. Registrations in additional countries will follow. INTERNATIONAL PLANT BREEDING INNOVATION The American Soybean Association (ASA) responded positively Jan. 19 to a notice of proposed rulemaking from USDA on the regulatory framework for plant breeding innovation. ASA welcomed the proposed rule, which continues to require pre-market approval by USDA’s Animal and Plant Health Inspection Service of plants derived through transgenic biotechnology while excluding products from new breeding innovations, such as gene editing. ASA President Ron Moore, a farmer from Roseville, Illinois, said USDA’s proposed rule “acknowledges this distinction, and we look forward to working with the incoming administration to ensure that this key aspect of the rule remains throughout the process.” GHANA’S BOLD BET ON BIOSAFETY Ghana’s National Biosafety Authority (NBA) issued guidelines for the release of genetically modified organisms (GMOs), a landmark step forward for modern biotechnology in the country. Parliament has yet to approve the implementing regulations for the country’s 2011 Biosafety Act (Act 831), which established the NBA as the administrative body with power over all decisions on the use of GMOs in Ghana. However, the NBA was not implemented until February 2015, thus stalling effective implementation of the Act. The document is the result of more than six months of extensive consultation with partner institutions and technical experts in biosafety and biotechnology. Titled the “Biosafety Guidelines for Handling Requests for the Use of Genetically Modified Organisms in Ghana,” the guidelines seek to eliminate the uncertainties around GMO use by providing a clearer process for application, review, and approval/rejection by the NBA. Activities under the scope of the guidelines include confined trials, release into the environment, release onto the market, import/export, and transit of GMOs. THE PHILIPPINES - MULTI-STRESS RESISTANT RICE, AMONG OTHERS, RELEASED FOR COMMERCIAL USE The National Seed Industry Council (NSIC) recently approved 25 new varieties devel- oped by the Philippine Rice Research Institute (PhilRice), International Rice Research Institute (IRRI), University of the Philippines Los Baños (UPLB), Philippine- Sino Center for Center for Agricultural Technology (PhilSCAT), Syngenta, and LongPing Philippines. Popularly known as GSR (Green Super Rice) 8, Rc480 is resistant to multiple abiotic stresses, such as drought, salinity, alkalin- ity, and iron toxicity. It can also grow under saline and drought-prone environments. In addition, it has high and stable yields despite lesser input requirement. Not only that, the super rice can offer a maximum yield of 4.4 t/ha, matures in 107 days after sowing (DAS), and has intermediate resistance to pests, such as yellow stemborer (YSB) and brown plant-hoppers (BPH).