Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC

CHAPTER I

Subject matter, scope and definitions

Article 1

Subject matter and scope

For the purposes of this Regulation, references to the Union territory shall be read as references to the Union territory without Ceuta, Melilla and the territories that are referred to in Article 355(1) TFEU, other than Madeira and the Azores.

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 European Parliament and of the Council (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 marketing stage concerned, which may be the subset or the whole of a lot;

(9) ‘professional operator’ means any person, governed by public or private law, involved professionally in, and legally responsible for, one or more of the following activities concerning plants, plant products and other objects: (a) planting; (b) breeding; (c) production, including growing, multiplying and maintaining; (d) introduction into, and movement within and out of, the Union territory; (e) making available on the market; (f) storage, collection, dispatching and processing;

(10) ‘registered operator’ means a professional operator registered in accordance with Article 65;

(11) ‘authorised operator’ means a registered operator authorised by the competent authority to issue plant passports in accordance with Article 89, to apply a mark in accordance with Article 98, or to issue attestations in accordance with Article 99;

(12) ‘final user’ means any person acting for purposes which are outside that person's trade, business or profession who acquires plants or plant products for personal use;

(13) ‘test’ means an official examination, other than visual, to determine if pests are present or to identify pests;

(14) ‘treatment’ means a procedure, whether official or non-official, for the killing, inactivation or removal of pests, or for rendering those pests infertile, or for the devitalisation of plants or plant products;

(15) ‘incidence’ means the proportion or number of units in which a pest is present in a sample, consignment, field or other defined population;

(16) ‘establishment’ means the perpetuation, for the foreseeable future, of a pest within an area after entry;

(17) ‘eradication’ means the application of phytosanitary measures to eliminate a pest from an area;

(18) ‘containment’ means the application of phytosanitary measures in and around an infested area to prevent the spread of a pest;

(19) ‘quarantine station’ means any official station for holding pests, plants, plant products or other objects in quarantine;

(20) ‘confinement facility’ means any facility, other than quarantine stations, where pests, plants, plant products or other objects are kept under confinement conditions;

(21) ‘traceability code’ means a letter, numerical or alphanumerical code that identifies a consignment, lot or trade unit, used for traceability purposes, including codes referring 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.

CHAPTER II

Quarantine pests

Section 1

Quarantine pests

Article 3

Definition of quarantine pests

A pest is a ‘quarantine pest’, with respect to a defined territory, if it fulfils all of the following conditions:

(a) its identity is established, within the meaning of point (1) of Section 1 of Annex I;

(b) it is not present in the territory, within the meaning of point (2)(a) of Section 1 of Annex I, or, if present, is not widely distributed within that territory, within the meaning of points (2)(b) and (c) of Section 1 of Annex I;

(c) it is capable of entering into, becoming established in and spreading within the territory, or, if present in the territory, but not widely distributed, is capable of entering into, becoming established in and spreading within those parts of that territory where it is absent, within the meaning of point (3) of Section 1 of Annex I;

(d) its entry, establishment and spread would, within the meaning of point (4) of Section 1 of Annex I, have an unacceptable economic, environmental or social impact on that territory, or, if present but not widely distributed, for those parts of the territory where it is absent; and

(e) feasible and effective measures are available to prevent the entry into, establishment in or spread of that pest within, that territory and to mitigate the risks and impact thereof.

Section 2

Union quarantine pests

Article 4

Definition of Union quarantine pests

A quarantine pest is a ‘Union quarantine pest’ if the defined territory referred to in the introductory part of Article 3 is the Union territory and if it is included in the list referred to in Article 5(2).

Article 5

Prohibition of introduction, movement, holding, multiplication or release of Union quarantine pests

The list of Union quarantine pests shall include the pests listed in Part A of Annex I to Directive 2000/29/EC and Section I of Part A of Annex II to that Directive.

Pests which are indigenous to, or established in, any part of the Union territory whether naturally or due to their introduction from outside the Union territory, shall be marked in the list of Union quarantine pests as pests known to occur in the Union territory.

Pests which are not indigenous to, or established in, any part of the Union territory shall be marked in the list of Union quarantine pests as pests not known to occur in the Union territory.

The Commission shall make that assessment available to the Member States.

The Commission may, by means of implementing acts, replace the implementing act referred to in paragraph 2 of this Article for the purpose of consolidating amendments.

Article 6

Priority pests

Union quarantine pests are ‘priority pests’ if they fulfil all of the following conditions:

(a) they fulfil, as regards the Union territory, one or more of the conditions set out in point (2) of Section 1 of Annex I;

(b) their potential economic, environmental or social impact is the most severe in respect of the Union territory as set out in Section 2 of Annex I;

(c) they are listed in accordance with paragraph 2 of this Article.

Where the results of an assessment show that a Union quarantine pest fulfils the conditions referred to in paragraph 1 of this Article, or that a pest no longer fulfils one or more of those conditions, the Commission is empowered to adopt delegated acts in accordance with Article 105 amending the list referred to in the first subparagraph accordingly by adding the pest concerned to, or removing it from, that list.

The Commission shall make that assessment available to the Member States without delay.

Where, in the case of a serious pest risk, imperative grounds of urgency so require, the procedure provided for in Article 106 shall apply to delegated acts adopted pursuant to this Article.

Article 7

Amendment of Section 1 of Annex I

The Commission is empowered to adopt delegated acts in accordance with Article 105 amending Section 1 of Annex I in order to adapt it to the development of scientific and technical knowledge and of relevant international standards.

Article 8

Union quarantine pests used for official testing, scientific or educational purposes, trials, varietal selections or breeding

An authorisation shall be granted for the activity concerned only if adequate restrictions are imposed to ensure that the introduction, movement, holding, multiplication or use of the pest concerned does not result in its establishment or spread within the Union territory, taking into account the identity, biology and means of dispersal of the pest, the activity envisaged, the interaction with the environment and other relevant factors relating to the risk posed by that pest.

Authorisations granted pursuant to paragraph 1 shall include all of the following conditions:

(a) the pest is to be kept in a location and under conditions which: (i) the competent authorities consider to be appropriate; and (ii) are referred to in the authorisation;

(b) the activity involving the pest is to be carried out in a quarantine station or a confinement facility designated by the competent authority in accordance with Article 60 and referred to in the authorisation;

(c) the activity involving the pest is to be carried out by personnel: (i) whose scientific and technical competence is considered to be appropriate by the competent authority; and (ii) who are referred to in the authorisation;

(d) the pest is to be accompanied by the authorisation when introduced into, moved within, or held or multiplied in, the Union territory.

Authorisations shall include the restrictions necessary to adequately eliminate the risk of establishment and spread of the respective Union quarantine pest or pest subject to the measures adopted pursuant to Article 30(1).

The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by laying down detailed rules concerning:

(a) the exchange of information between Member States and the Commission concerning the introduction into, movement within, and holding, multiplication and use in, the Union territory of the pests concerned;

(b) the procedure and conditions for granting the authorisation referred to in paragraph 1; and

(c) the monitoring of compliance and the actions to be taken in the event of non-compliance, as referred to in paragraph 4.

Article 9

Notification of an imminent danger

Paragraph 1 shall also apply to a pest that is not included in the list of Union quarantine pests, where:

(a) the pest is subject to the measures adopted pursuant to Article 30(1); or

(b) the Member State concerned considers that the pest may fulfil the conditions for inclusion in the list of Union quarantine pests.

Article 10

Official confirmation by the competent authorities of the presence of a Union quarantine pest

Where a competent authority suspects, or has received evidence 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 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 the Union territory, it shall immediately take 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 or not.

Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of 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.

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.

Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation  (EU) 2017/625, of the Member State concerned and through the electronic notification system referred to in Article 103.

Article 12

Information on Union quarantine pests to be provided to professional operators by the competent authorities

That list may be part of the electronic system referred to in Article 103.

Article 13

Information on priority pests to be provided to the public by the competent authorities

Where one of the situations referred to in points (a) and (b) of the first paragraph of Article 11 is officially confirmed as regards a priority pest, the competent authority shall inform the public about the measures it has taken or intends to take and about any measures to be taken by relevant categories of professional operators or other persons.

Article 14

Measures to be taken immediately by professional operators

Where those plants, plant products or other objects have left the control of the professional operator, the professional operator shall, unless otherwise instructed by the competent authority, immediately:

(a) inform the persons in the trade chain to whom those plants, plant products and other objects have been supplied of the presence of the pest;

(b) provide those persons with guidelines on the necessary measures to be taken during shipment of the respective plants, plant products and other objects to reduce the risk of spread or escape of the pests concerned; and

(c) recall those plants, plant products or other objects.

Article 15

Measures to be taken by persons other than professional operators

Article 16

Derogations to notification obligations

The notification obligations referred to in Articles 14 and 15 shall not apply where:

(a) a Union quarantine pest is found to be present in the infested zone of a demarcated area established for the containment of that pest, as referred to in Article 18(2);

(b) a Union quarantine pest is found to be present in the infested zone of a demarcated area and subject to eradication measures requiring eight years or more, during the period of those first eight years.

Article 17

Eradication of Union quarantine pests

That obligation to eradicate shall not apply where an implementing act concerning that pest, adopted pursuant to Article 28(2), provides otherwise.

Article 18

Establishment of demarcated areas

The demarcated area shall consist of an infested zone and a buffer zone.

The infested zone shall, as applicable, contain:

(a) all plants known to be infested by the pest concerned;

(b) all plants showing signs or symptoms indicating possible infestation by that pest;

(c) all other plants liable to have been or become contaminated or infested by that pest, including plants liable to be infested due to their susceptibility to that pest and their close proximity to infested plants or common source of production, if known, with infested plants, or plants grown from them;

(d) land, soil, water courses or other elements infested, or liable to be infested, by the pest concerned.

Its extent shall be appropriate in view of the risk of the pest concerned spreading out of the infested zone naturally or by human activities in the infested zone and its surroundings, and shall be decided in accordance with the principles set out in Section 2 of Annex II.

However, where any risk of the pest spreading out of the infested zone is eliminated or reduced to an acceptable level through natural or artificial barriers, no buffer zone shall be required to be established.

In that case, it shall carry out a survey to determine whether any further plants or plant products have been infested. On the basis of that survey, the competent authority shall determine whether there is a need to establish a demarcated area.

This paragraph shall apply without prejudice to any obligation to notify demarcated areas laid down in the implementing acts referred to in Article 104.

Article 19

Surveys and modifications of demarcated areas and lifting of restrictions

Those surveys shall be carried out in accordance with Article 22(2).

Competent authorities may abolish a demarcated area and terminate the respective eradication measures where the pest-free status of that area has been verified. This will be the case where the following two conditions are fulfilled:

(a) the survey referred to in paragraph 1 shows that the area has been found to be free from the pest concerned; and

(b) the pest concerned has not been found to be present in that demarcated area for a sufficiently long period.

When deciding on the modifications referred to in paragraph 3 or the abolition of the demarcated area referred to in paragraph 4, the competent authority concerned shall take into account at least the following factors: