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As seed companies are urged to keep track of their genetic resources European Seed offers an overview of the Nagoya Protocol and what it means to the industry. EDITORS NOTE This is part two of a two-part series exploring the Nagoya Protocol and its impact on the European seed industry. The first part can be found online in Volume 2 Issue 1 of European Seed at european-seed.com. ENSURING BIODIVERSITY 22 I EUROPEAN SEED I EUROPEAN-SEED.COM BY MARCEL BRUINS n this part two of the mini-series on the Nagoya Protocol NP we take a closer look at the European implementation of the NP. European Seed sat down with Szonja Csrg director intellectual property and legal affairs of the European Seed Association ESA. European Seed The 64 species covered by the the International Treaty on Plant Genetic Resources for Food and Agriculture ITPGRFA are not covered by the Nagoya Protocol. So is it fair to say that only those companies breeding with species outside the Annex I are to be worried about the Nagoya Protocol Szonja Csrg Indeed Article 44 of the Nagoya Protocol states that Where a special- ised international access and benefit sharing ABS instrument applies that is consistent with and does not run counter to the objectives of the Convention on Biodiversity CBD and this Protocol this Protocol does not apply for the Party or Parties to the specialised instru- ment in respect of the specific genetic resource covered by and for the purpose of the special- ized instrument. This is of course a very lengthy and legal- istic sentence but it is worth having a closer look at it and spending some time to interpret its different elements to better understand what is exactly excluded from the scope of the Nagoya Protocol and what is not. First the above provision of the Nagoya Protocol does not refer to the ITPGRFA specifically but to specialised international access and benefit-sharing instruments and thinking about the structure of the ITPGRFA it has to be acknowledged that it is not the treaty itself but only its multilateral system MLS that constitutes a specialised international ABS instrument. The scope of the treaty covers all PGRFA whereas the scope of the MLS is lim- ited to the species listed on Annex I. These are excluded from the EU legislation as long as they are utilized for food and agriculture and come from a country that is party to the ITPGRFA. It is not completely clear yet whether genetic resources that are not placed in the multilateral system andor are available in situ in countries that are Contracting Parties of the ITPGRFA fall within or outside the scope of the EU leg- islation. According to the provisions of the treaty genetic resources belonging to species on Annex I do not become automatically part of the MLS but have to be placed in there by the Contracting Parties. So far only a bit more than 30 Contracting Parties have notified their collections to the MLS from the more than 130. Therefore the following questions may be useful to ask in a check-list1 Does the genetic resource belong to an Annex I crop Was it accessed in a country that is Party to the ITPGRFA Has that Party placed the specific genetic resource in the MLS of the treaty Is it coming from an ex situ collection Is the purpose of the use research breeding or training for food and agriculture ES Several companies have decided to challenge the EU Regulation implement- ing the Nagoya Protocol in front of the General Court of the EU. Why are they doing this What is wrong with this EU Regulation Should other companies join SZ In general terms it has to be mentioned that the EU Regulation 5112014 is a dispro- portionally intrusive measure in terms of the compliance burden it imposes on users of genetic resources and very vague and impre- cise in many of its provisions. Consequently it creates significant legal uncertainty for users who have to comply with the due diligence and related obligations and their consequences. It is not a plant breeding-specific view on the reg- ulation but a cross-sectorial assessment that the amount of legal uncertainty created by the regulation is huge but it does affect plant breeders in an entirely distinct and burden- some fashion. Apart from these shortcomings one of the main reasons for the plant breeding companies to challenge the validity of the reg- ulation lies in the disproportionate nature of the obligations it imposes on the plant breed- ing sector since genetic resources are not merely an ancillary part of their business and more specifically in the conflict it creates with the long-lasting tradition of breeders to rely on the breeders exemption. The main obligation for users under the EU regulation is the so-called due diligence obligation according to which users have to seek keep and transfer to subsequent users all the information on the genetic resources that are specified in the regulation Article 4.2. Since Article 2 of the regulation states that it applies to genetic resources in respect of which Parties to the Nagoya Protocol exercise sovereign rights whether the due diligence obligation has to be carried out in respect of commercial plant varieties accessed under the breeders exemption remains a matter dependent on how the country of access defines its own sovereignty over genetic resources. If a breeder access- ing a commercial variety under the breeders exemption has to seek all the information foreseen in the regulation regarding the genetic resources incorporated in the com- mercial variety the breeders exemption will become totally meaningless and the admin- istrative burden on the plant breeders will be unbearable. Not to mention the fact that the regulation basically requires the plant breed- ing sector who heavily rely on the breeders exemption to completely change the way it has been working for centuries.