EUROPEAN-SEED.COM I EUROPEAN SEED I 11 ES: IS ESA INVOLVED IN THE DRAFTING PROCESS OF THE SECONDARY ACTS, AND WHAT ARE THE MAIN ISSUES AT STAKE? CR: The Plant Health Regulation is an act of primary legislation that sets out broad outlines and principles, which needs to be complemented by secondary acts by the end of 2019. The Lisbon Treaty makes a distinction between two sets of Commission acts –delegated acts, and implementing acts. This secondary legis- lation has to be adopted to ensure the proper implementation of this EU regulation. Delegated acts are defined as non-legisla- tive acts of general application to supplement or amend certain non-essential elements of a legislative act, whereas Implementing acts are to be used where uniform conditions for implement- ing legally binding Union acts are required. Implementing acts should legislate upon the ‘how’ implementation should take place. ESA does a close follow up on the Commission’s work on secondary acts and will give its position on the drafted acts. This is the case for instance on the current stakeholders’ consultation on the plant passport format. ES: IS THERE A LINK BETWEEN THE NEW ISPM ON SEEDS AND THE EU REGULATION? CR: The International Plant Protection Convention (IPPC) is rec- ognized as the international standard setting organization for plant health under the WTO SPS Agreement and has 183 contracting par- ties. The governing body of the IPPC adopted a new International Standard for Phytosanitary Measures (ISPM) on 6 April 2017, which provides guidance to assist official National Plant Protection Organizations (NPPOs) on establishing procedures for phytosanitary import requirements; inspection, sampling and testing of seeds; and on the phytosanitary certification of seeds for export and re-export. ISPMs are not legally binding but contracting parties are required to base their phytosanitary measures on ISPMs developed under the pro- visions of the IPPC. Therefore, the EU Regulation on protective meas- ures against plant pests respects principles set in this ISPM on seeds. ES: WHAT ARE UNION QUARANTINE PESTS AND PROTECTED ZONE PESTS, AND HOW CAN SEED COMPANIES PREVENT THESE? CR: One of the main changes under the new regulation is that it addresses all pests – both quarantine and non-quarantine - which are categorised following risk assessment. Three main categories of pests are identified: •  Union quarantine pests: Not present in the EU or, if present, are localised and under official controls. These pose a high risk to plant health, and strict measures must be taken to prevent their entry or spread within the EU. They must be eradicated immediately if detected. •  Protected zone quarantine pests: Present in most parts of the EU, but absent from certain ‘protected zones’. These pests must not be allowed to enter and spread within these pro- tected zones. •  Regulated non-quarantine pests: Widely present in the EU but, as they have an impact on plant quality, seeds or planting material must be guaranteed free or almost free from the pest. The new Regulation recognises the role that professional operators, including seed companies have to play in the safe production and movement of healthy plants/plant products. Therefore, the professional operators will have to notify any quarantine pest they find in the areas of their control. ES: CAN YOU GIVE AN EXAMPLE OF ‘PRIORITY PESTS’ WHICH WOULD BE SUBJECT TO AN ENHANCED LEVEL OF OBLIGATIONS. CR: The EU plant health regulation identifies priority pests, which are Union quarantine pests with the most severe potential impact on the EU economy, environment or society. They will be subject to enhanced measures including surveys, eradication action plans, contingency plans, and simulation exercises, for which there will be enhanced EU co-financing. ES: ARE ‘REQUIREMENTS OF TRACEABILITY’ NEW, AND HOW WILL IT AFFECT THE EUROPEAN SEED SECTOR? CR: For the purpose of more efficient controls, the professional operators will have to be registered by the national plant protec- tion organisations designated as official competent authorities. The professional operators will also have to ensure the tracea- bility of the regulated plants/plant products they receive from and submit to other professional operators. The European seed sector is well prepared for that as traceability is a key element implemented by seed companies for many years. ES: WHAT IS THE IMPACT OF THE NEW EU REGULATION FOR THE EUROPEAN SEED COMPANIES? CR: Professional operators will be allowed to issue plant pass- ports, under the supervision of the competent authorities. To that purpose they will have to be authorised specifically by the authorities. Moreover, the EU plant health regulation intro- duced the concept of pest risk management plan, which may be established by volunteered operators, ensuring and demon- strating a high level of competence and awareness as regards pest risks and critical points in their professional activities. This will justify a reduced frequency of official controls by national authorities. ESA will provide guidance to its members to implement such plans. Editor’s Note: This article has been condensed for print. Please go to European-Seed.com to read the full version.