Plant Health Regulation

32016R2031 → 02016R2031-20191214

Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) plants means living plants and the following living parts of plants: (a) seeds, in the botanical sense, other than those not intended for planting; (b) fruits, in the botanical sense; (c) vegetables; (d) tubers, corms, bulbs, rhizomes, roots, rootstocks, stolons; (e) shoots, stems, runners; (f) cut flowers; (g) branches with or without foliage; (h) cut trees retaining foliage; (i) leaves, foliage; (j) plant tissue cultures, including cell cultures, germplasm, meristems, chimaeric clones, micro-propagated material; (k) live pollen and spores; (l) buds, budwood, cuttings, scions, grafts; (2) plant products means unmanufactured material of plant origin and those manufactured products that, by their nature or that of their processing, may create a risk of the spread of quarantine pests. Except where otherwise provided in the implementing acts adopted pursuant to Articles 28, 30 and 41, wood shall only be considered as a plant product if it fulfils one or more of the following criteria: (a) it retains all or part of its natural round surface, with or without bark; (b) it has not retained its natural round surface due to sawing, cutting or cleaving; (c) it is in the form of chips, particles, sawdust, wood waste, shavings or scrap, and has not undergone processing involving the use of glue, heat or pressure or a combination thereof to produce pellet, briquettes, plywood or particle board; (d) it is, or is intended to be, used as packaging material, whether or not it is actually in use for transport of goods; (3) planting means any operation for the placing of plants in a growing medium, or by grafting or similar operations, to ensure their subsequent growth, reproduction or propagation; (4) plants for planting means plants intended to remain planted, to be planted or to be replanted; (5) other object means any material or object, other than plants or plant products, capable of harbouring or spreading pests, including soil or growing medium; (6) competent authority means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the central authority or authorities European Parliament and of a Member State, or, where applicable, the Council Regulation (EU) 2017/625 of a third country, responsible for the organisation European parliament and of the Council of 15 March 2017 on official controls and of other official activities, or any other authority activities performed to which that responsibility has been conferred, in accordance with Union legislation ensure the application of food and feed law, rules on official controls; animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).; (7) lot means a number of units of a single commodity, identifiable by its homogeneity of composition, origin and other relevant elements, forming part of a consignment; (8) trade unit means the smallest commercial or other useable unit applicable to the … 336 unchanged words … to a lot, batch, series, date of production or professional operator documents; (22) phytosanitary measure means any official measure having the purpose to prevent the introduction or spread of quarantine pests or to limit the economic impact of regulated non-quarantine pests.

32016R2031 → 02016R2031-20191214

Article 10 Official confirmation by the competent authorities of the presence of a Union quarantine pest Where a competent authority suspects suspects, or has received evidence concerning concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of its the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within, within the Union territory, it shall immediately take the any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation (EU) 2017/625 (to officially confirm), whether that pest is present (to officially confirm). That official confirmation shall be based on a diagnosis from an official laboratory designated by the competent authority in accordance with conditions and requirements set out in Union legislation on official controls. or not. Pending the official confirmation of the presence of the that pest, the Member State States concerned shall, where appropriate, applicable, take phytosanitary measures to eliminate the risk of spread of the that pest. The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.

32016R2031 → 02016R2031-20191214

Article 11 Notification of Union quarantine pests by the Member States to the Commission and the other Member States A Member State shall notify the Commission and the other Member States where its competent authority officially confirms any of the following situations: (a) the presence in its territory of a Union quarantine pest not known to be present there; (b) the presence of a Union quarantine pest in a part of its territory where it was previously not present; (c) the presence in its territory of a Union quarantine pest in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within, the Union territory. Notification Notifications under the first paragraph shall be made by the single authority, as referred to in Union legislation on official controls, Article 4(2) of Regulation (EU) 2017/625, of the Member State concerned and through the electronic notification system referred to in Article 103.

32016R2031 → 02016R2031-20191214

Article 25 Contingency plans for priority pests 1. Each Member State shall draw up and keep up to date for each priority pest which is capable of entering into and becoming established in its territory, or a part thereof, a separate plan containing information concerning the decision-making processes, procedures and protocols to be followed, and the minimum resources to be made available and the procedures to make available further resources in the event of an officially confirmed or suspected presence of that pest (the contingency plan). Member States shall, at an appropriate stage, consult all relevant stakeholders in the process of drawing up and keeping up to date the contingency plans. No contingency plans shall be required to be drawn up for pests for which it is unequivocally concluded that they cannot become established or spread in the Member State concerned due to its ecoclimatic conditions or to the absence of the host species. 2. Each contingency plan shall include the following: (a) the roles and responsibilities of the bodies involved in the execution of the plan plan, in the event case of an officially a confirmed or suspected presence of the priority pest concerned, as well as the chain of command and procedures for the coordination co-ordination of actions to be taken by competent authorities, other public authorities, as referred to in Article 4(2) of Regulation (EU) 2017/625, delegated bodies or natural persons involved, as referred to in Article 28(1) of that Regulation, laboratories and professional operators, including the coordination co-ordination with neighbouring Member States and neighbouring third countries, where appropriate; (b) access of competent authorities to premises of professional operators, other relevant operators and natural persons; (c) access of competent authorities, where necessary, to laboratories, equipment, personnel, external expertise and resources necessary for the rapid and effective eradication or, where appropriate, containment of the priority pest concerned; (d) measures to be taken concerning the provision of information to the Commission, the other Member States, the professional operators concerned and the public as regards the presence of the priority pest concerned and the measures taken against it in the event that the presence of the pest concerned is officially confirmed or suspected; (e) arrangements for recording findings of the presence of the priority pest concerned; (f) the available assessments as set out in Article 6(2) and any assessment of the Member State as regards the risk of the priority pest concerned for its territory; (g) the risk management measures to be taken as regards the priority pest concerned, in accordance with Section 1 of Annex II, and the procedures to be followed; (h) principles for the geographical demarcation of demarcated areas; (i) protocols describing the methods of visual examinations, sampling and laboratory testing; and (j) principles concerning the training of personnel of the competent authorities and, where appropriate, the bodies, public authorities, laboratories, professional operators and other persons referred to in point (a). Where appropriate, the items referred to in points (d) to (j) of the first subparagraph shall take the form of instruction manuals. 3. Contingency plans may be combined for multiple priority pests with similar biology and range of host species. In those cases, the contingency plan shall consist of a general part common to all priority pests covered by it and of specific parts for each priority pest concerned. 4. Within four years from the date of establishment of the list of priority pests, Member States shall establish a contingency plan for the priority pests included in that list. Within one year from the date of the inclusion of any further pest concerned in the list of priority pests, Member States shall establish a contingency plan for that priority pest. Member States shall regularly review and, where appropriate, update their contingency plans. 5. Member States shall, on request, communicate their contingency plans to the Commission and to the other Member States, and shall inform all relevant professional operators through publication on the internet.

32016R2031 → 02016R2031-20191214

Article 41 Plants, plant products and other objects subject to special and equivalent requirements 1. Certain plants, plant products or other objects may only be introduced into, or moved within, the Union territory if special requirements, or equivalent requirements, are fulfilled. Those … 498 unchanged words … shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 107(3). 4. In the event that plants, plant products or other objects have been introduced into, or moved within, the Union territory in violation of paragraph 1, 1 of this Article, Member States shall adopt the necessary measures, as referred to in Union legislation on official controls, Article 66(3) of Regulation (EU) 2017/625, and shall notify the Commission and other Member States through the electronic notification system referred to in Article 103. Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.

32016R2031 → 02016R2031-20191214

Article 44 Setting out of equivalent requirements 1. The Commission shall set out equivalent requirements, by means of implementing acts, on request of a particular third country, if both of the following conditions are fulfilled: (a) the third country concerned ensures, through the application under its official control of one or more specified measures, a level of phytosanitary protection which is equivalent to the special requirements in respect of the movement within the Union territory of the plants, plant products and other objects concerned; (b) the third country concerned demonstrates to the Commission that the specified measures referred to in point (a) achieve the level of phytosanitary protection referred to in that point. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2). 2. Where appropriate, the Commission shall carry out investigations in the third country concerned and in accordance with Article 120 of Regulation (EU) 2017/625, to verify whether the conditions referred to in points (a) and (b) of the first subparagraph of paragraph 1 of this Article are fulfilled. Those investigations shall comply with requirements for Commission investigations as referred to in Union legislation on official controls.

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

32016R2031 → 02016R2031-20191214

Article 49 Temporary measures concerning plants, plant products and other objects likely to pose newly identified pest risks or other suspected phytosanitary risks 1. The Commission may adopt, by means of implementing acts, temporary measures as regards the introduction into, and movement … 541 unchanged words … points (a) or (b) of the second subparagraph of paragraph 2, a pest has been found to be present which is likely to pose newly identified pest risks. Member States shall notify, through the electronic notification system referred to in Article 103, 103 of this Regulation, the Commission and the other Member States of any case where the introduction of a plant, plant product or other object into the Union territory was refused, or its movement within the Union territory prohibited, because the Member State concerned considered that the prohibition referred to in point (c) of the second subparagraph of paragraph 2 of this Article was violated. Where applicable, that notification shall include the measures taken by that Member State on the plants, plant products or other objects concerned, as referred concerned pursuant to in Union legislation on official controls. Article 66(3) of Regulation (EU) 2017/625. Where applicable, the third country from which the plants, plant products or other objects were dispatched for introduction into the Union territory shall also be notified.

32016R2031 → 02016R2031-20191214

Article 76 Conditions to be fulfilled by a phytosanitary certificate 1. Without prejudice to obligations under the International Plant Protection Convention (IPPC) and taking into account relevant international standards, the competent authority shall only accept a phytosanitary certificate accompanying plants, plant products or other objects to be introduced from a third country, if the content of that certificate complies with Part A of Annex V. Where the plants, plant products or other objects are to be introduced from a third country from which they do not originate, the competent authority shall only accept a phytosanitary certificate complying either with Part A or Part B of Annex V. It shall not accept that phytosanitary certificate where the additional declaration referred to in Article 71(2), where applicable, is not present or not correct, and where the statement referred to in Article 71(3), where applicable, is not present. It shall not accept a phytosanitary certificate for re-export if that phytosanitary certificate is not accompanied by the original phytosanitary certificate for export, or a certified copy of the original phytosanitary certificate for export. 2. The competent authority shall only accept a phytosanitary certificate if it fulfils the following requirements: (a) it is issued in at least one of the official languages of the Union; (b) it is addressed to the national plant protection organisation of a Member State; and (c) it has been issued no more than 14 days before the date on which the plants, plant products or other objects covered by it have left the third country in which it was issued. 3. In the case of a third country which is a contracting party to the IPPC, the competent authority shall only accept the phytosanitary certificates issued by the official national plant protection organisation of that third country or, under its responsibility, by a public officer who is technically qualified and duly authorised by that official national plant protection organisation. 4. In the case of a third country which is not a contracting party to the IPPC, the competent authority shall only accept the phytosanitary certificates issued by the authorities which are competent in accordance with the national rules of that third country and notified to the Commission. The Commission shall inform the Member States and the operators, through the electronic notification system referred to in Article 103, in accordance with point (a) of Article 132 of Regulation (EU) 2017/625, of the notifications received. The Commission is empowered to adopt delegated acts acts, in accordance with Article 105 supplementing 105, to supplement this Regulation concerning the conditions for acceptance referred to in the first subparagraph of this paragraph paragraph, to ensure the reliability of those certificates. 5. Electronic phytosanitary certificates shall only be accepted when provided through, or in electronic exchange with, a computerised information management system for official controls at Union level. the IMSOC referred to in Article 131(1) of Regulation (EU) 2017/625.

32016R2031 → 02016R2031-20191214

Article 77 Invalidation of phytosanitary certificate 1. Where a phytosanitary certificate has been issued in accordance with Article 71(1), (2) and (3), and the competent authority concerned concludes that the conditions referred to in Article 76 are not fulfilled, it shall invalidate that phytosanitary certificate and ensure that it no does not accompany any longer accompanies those plants, plant products or other objects concerned. In that case, and in respect of the plants, plant products or other objects concerned, the competent authority shall take one of the measures to be taken set out in the event Article 66(3) of non-compliant consignments entering the Union from third countries, referred to in Union legislation on official controls. Regulation (EU) 2017/625. Upon invalidation, the certificate concerned shall bear on its face and in a prominent position a triangular stamp in red, marked certificate cancelled from the respective competent authority, together with its denomination and the date of invalidation. It shall be in capital letters, and in at least one of the official languages of the Union. 2. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and other Member States where a phytosanitary certificate was invalidated pursuant to paragraph 1 of this Article. The third country which had issued that phytosanitary certificate shall also be notified by the Member State concerned. 3. The Commission may, by means of implementing acts, set out technical arrangements concerning the invalidation of the electronic phytosanitary certificates, as referred to in Article 76(5). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

32016R2031 → 02016R2031-20191214

Article 91 Pest risk management plans 1. Authorised operators may have in place pest risk management plans. The competent authority shall approve those plans, if they fulfil all of the following conditions: (a) they set out measures which are appropriate for those operators to fulfil the obligations set out in Article 90(1); (b) they fulfil the requirements set out in paragraph 2 of this Article. Authorised operators implementing an approved pest risk management plan may be subject to inspections with a reduced frequency. frequency, as referred to in point (b) of Article 22(3) of Regulation (EU) 2017/625. 2. The pest risk management plans shall cover, where appropriate in the form of standard operating procedure manuals, at least the following: (a) the information required under Article 66(2) concerning the registration of the authorised operator; (b) the information required under Articles 69(4) and 70(1) concerning the traceability of plants, plant products and other objects; (c) a description of the production processes of the authorised operator and its activities as regards movement and sales of plants, plant products and other objects; (d) an analysis of the critical points referred to in Article 90(1) and the measures taken by the authorised operator to mitigate the pest risks associated with those critical points; (e) the procedures in place and actions foreseen where quarantine pests are suspected or found to be present, the recording of those suspicions or findings and the recording of the actions taken; (f) the roles and responsibilities of the personnel involved in the notifications referred to in Article 14, the examinations referred to in Article 87(1), the issuance of plant passports pursuant to Article 84(1), Article 93(1) and (2) and Article 94, and the attaching of plant passports pursuant to Article 88; and (g) the training provided to the personnel referred to in point (f) of this paragraph. 3. Where the competent authority becomes aware that the professional operator concerned does not apply the measures referred to in point (a) of the first subparagraph of paragraph 1, or that a pest risk management plan is no longer up to date with any of the requirements referred to in point (b) of the first subparagraph of paragraph 1, that authority shall without delay take the measures necessary to ensure that non-compliance with those conditions does not continue. Those measures may include the withdrawal of the approval of that plan. Where the competent authority has taken measures in accordance with the first subparagraph other than the withdrawal of the approval of the plan, and the non-compliance continues, that authority shall without delay withdraw that approval.

32016R2031 → 02016R2031-20191214

Article 94 Plant passports replacing phytosanitary certificates 1. By way of derogation from Article 87, 87 of this Regulation, where a plant, plant product or other object, introduced into the Union territory from a third country which, for movement within the Union territory, requires a plant passport pursuant to Article 79(1) and Article 80(1), 80(1) of this Regulation, the passport shall be issued if the checks by means under Article 49(1) of official controls at the border control post Regulation (EU) 2017/625. concerning its introduction have been completed satisfactorily and have led to the conclusion that the plant, plant product or other object concerned fulfils the substantive requirements for issuance of a plant passport according in accordance with to Article 85 of this Regulation and, where appropriate, Article 86. 86 of this Regulation. The replacement of a phytosanitary certificate by a plant passport may be carried out at the place of destination of the plant, plant product or other object concerned, instead of the point of entry, where checking at the place of destination is allowed, as referred to in Union legislation on official controls. 2. By way of derogation from the first subparagraph of paragraph 1, Member States may decide to replace a phytosanitary certificate at the place of entry of the plant, plant product or other object concerned into the Union territory by a certified copy of the original phytosanitary certificate. That certified copy of the original phytosanitary certificate shall be issued by the competent authority and shall accompany the movement of the plant, plant product or other object concerned only up to the point where the plant passport is issued and only within the territory of the respective Member State. 3. The competent authority shall retain the phytosanitary certificate for at least three years. That retainment may take the form of storage of the information contained in the phytosanitary certificate in a computerised database. Where point (a) of Article 101(2) applies, that phytosanitary certificate shall be replaced by a certified copy thereof.

32016R2031 → 02016R2031-20191214

Article 100 Phytosanitary certificate for export from the Union 1. Where, for the export of a plant, plant product or other object from the Union territory to a third country, a phytosanitary certificate is required by the phytosanitary import requirements of that … 391 unchanged words … elements referred to in paragraph 2 of this Article and Part A of Annex VIII to adapt them to the development of the relevant international standards. 5. Electronic phytosanitary certificates for export shall be provided through, or in electronic exchange with, a computerised information management system for official controls at Union level. the IMSOC.

32016R2031 → 02016R2031-20191214

Article 101 Phytosanitary certificate for re-export from the Union 1. For the re-export of a plant, plant product or other object which originates in a third country and has been introduced into the Union territory from that, or another, third country, a … 371 unchanged words … to adopt delegated acts in accordance with Article 105 amending Part B of Annex VIII to adapt it to the development of the relevant international standards. 6. Electronic phytosanitary certificates for re-export shall be provided through, or in electronic exchange with, a computerised information management system for official controls at Union level. the IMSOC.

32016R2031 → 02016R2031-20191214

Article 102 Pre-export certificates 1. The competent authorities of the Member State from which the plants, plant products or other objects referred to in Article 100(1) are exported and the competent authorities of the Member State in which the plants, plant products or other objects were grown, produced, stored or processed shall exchange the necessary phytosanitary information as the basis for issuing the phytosanitary certificate for export. 2. The exchange of information referred to in paragraph 1 shall take the form of a harmonised document (pre-export certificate), in which the competent authorities of the Member State, in which the plants, plant products and other objects were grown, produced, stored or processed, certify compliance of those plants, plant products or other objects with specific phytosanitary requirements concerning one or more of the following: (a) the absence, or presence below a specified threshold, of particular pests in the plants, plants products or other objects concerned; (b) the origin of the plants, plant products or other objects concerned in a specific field, production site, place of production or area; (c) the pest status in the field, production site, place of production or area of origin or country of origin of the plants, plant products or other objects concerned; (d) the results of the inspections, sampling and testing of the plants, plant products or other objects concerned; (e) the phytosanitary procedures applied to the production or processing of the plants, plant products or other objects concerned. 3. The pre-export certificate shall be issued, on request of the professional operator, by the competent authorities of the Member State in which the plants, plant products or other objects were grown, produced, stored or processed, while those plants, plant products or other objects are on the premises of the professional operator concerned. 4. The pre-export certificate shall accompany the plants, plant products and other objects concerned during their movement within the Union territory, unless the information contained in it is exchanged between the Member States concerned through, or in electronic exchange with, a computerised information management system for official controls at Union level. the IMSOC. 5. Without prejudice to the requirements set out in paragraph 3, the pre-export certificate may be issued when the plants, plant products or other objects have left the premises of the professional operator concerned, provided that inspections and, where necessary, sampling have been carried out, confirming the compliance of those plants, plant products or other objects with one or more of the specific phytosanitary requirements referred to in paragraph 2. 6. The pre-export certificate shall contain the elements and shall be in the format as set out in Part C of Annex VIII. The Commission is empowered to adopt delegated acts in accordance with Article 105 amending Part C of Annex VIII in order to adapt it to the development of scientific and technical knowledge and of relevant international standards. 7. The Commission may, by means of implementing acts, lay down the procedures for the issuance of the pre-export certificate. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

32016R2031 → 02016R2031-20191214

Article 103 Establishment of electronic notification system The Commission shall establish an electronic system for the submission of notifications by the Member States. That system shall be connected to, and compatible with, a computerised information management system for official controls at Union level. the IMSOC.

32016R2031 → 02016R2031-20191214

Article 109 Repeals 1. Directive 2000/29/EC is repealed, with the exception without prejudice to Article 165(2), (3) and (4) of the following provisions: (a) Article 1(4); (b) the introductory part and points (g), (i), (j), (k), (l), (m), (n), (p), (q) and (r) of Article 2(1); (c) Article 11(3); (d) Article 12; (e) Article 13; (f) Article 13a; (g) Article 13b; (h) Article 13c; (i) Article 13d; (j) Article 21(1) to (5); (k) Article 27a; (l) Annex VIIIa. Regulation (EU) 2017/625. 2. The following Directives are repealed: (a) Directive 69/464/EEC; (b) Directive 74/647/EEC; (c) Directive 93/85/EEC; (d) Directive 98/57/EC; (e) Directive 2006/91/EC; (f) Directive 2007/33/EC. 3. References to the acts repealed in accordance with paragraphs 1 and 2 shall be construed as references to this Regulation and shall be read in accordance with the correlation table set out in Annex IX.

32016R2031 → 02016R2031-20191214

ANNEX VIII CONTENTS OF PHYTOSANITARY CERTIFICATES FOR EXPORT, RE-EXPORT AND PRE-EXPORT AS REFERRED TO IN ARTICLE 100(3), ARTICLE 101(4) AND ARTICLE 102(6) PART A Phytosanitary certificates for export as referred to in Article 100(3) 1. The phytosanitary certificate for movement out of the Union … 1,327 unchanged words … followed by the quantity of the plants, plant products or other objects included in that consignment, expressed by number or weight; (k) the following text: This is to certify that the plants, plant products or other regulated articles described above were imported into …(country/ … (country/ contracting party of re-export) from …(country/ … (country/ contracting party of origin) covered by phytosanitary certificate No … ☐ original ☐ □original □ certified true copy of which is attached to this certificate, that they are ☐ packed ☐ □packed □ repacked in ☐ original ☐ □original □ new containers, that based on the ☐ original □original phytosanitary certificate and ☐ additional □additional inspection, they are considered to conform with the current phytosanitary requirements of the importing country/contracting party, and that during storage in …(contracting … (contracting party of re-export) the consignment has not been subjected to the risk of infestation or infection. in which text the required information shall be filled and the applicable boxes ticked; (l) the words Additional declaration, followed by the additional declaration referred to … 788 unchanged words … and identification of field/production site/area (with ref. to (A)-(G) above as appropriate): 7 Other official information [e.g. related to phytosanitary import requirements, treatment of consignment, etc.] 8 Place of issue: Contact details (phone/email/fax): Date: 9 Name and signature of the authorised officer (Stamp of the competent authority)