02016R2031 — EN — 14.12.2019 — 001.001

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Amended by:





Corrected by:









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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

1. This Regulation establishes rules to determine the phytosanitary risks posed by any species, strain or biotype of pathogenic agents, animals or parasitic plants injurious to plants or plant products (‘pests’) and measures to reduce those risks to an acceptable level.

2. Where there is evidence that non-parasitic plants, other than those regulated under Article 4(1) of Regulation (EU) No 1143/2014, pose phytosanitary risks which would have a severe economic, social and environmental impact on the Union territory, those non-parasitic plants may be considered as pests for the purposes of this Regulation.

3. For the purposes of this Regulation, references to third countries shall be read as references to third countries, Ceuta, Melilla and to the territories that are referred to in Article 355(1) TFEU, with the exception of Madeira and the Azores.

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;

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(6) ‘competent authority’ means competent authorities as defined in Article 3(3) of Regulation ►C1 (EU) 2017/625 ◄ of the European Parliament and of the Council ( 1 );

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(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

1. A Union quarantine pest shall not be introduced into, moved within, or held, multiplied or released in, the Union territory.

2. The Commission shall, by means of an implementing act, establish a list of pests which fulfil the conditions listed in Article 3 in respect of the Union territory (‘list 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.

3. Where the results of an assessment show that a pest not included in the list of Union quarantine pests fulfils the conditions listed in Article 3 in respect of the Union territory, or that a pest included in the list of Union quarantine pests no longer fulfils one or more of those conditions, the Commission shall, by means of implementing acts, amend the implementing act referred to in paragraph 2 of this Article accordingly by adding the pest concerned to, or removing it from, that list.

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.

4. The implementing acts referred to in paragraphs 2 and 3 shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 6

Priority pests

1. 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.

2. The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by establishing a list of the priority pests (‘list of priority pests’).

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

1. By way of derogation from Article 5(1), Member States may, on application, temporarily authorise the introduction into, the movement within, and the holding and multiplication in, their territory of Union quarantine pests or pests subject to the measures adopted pursuant to Article 30(1) 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.

2. 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.

3. Authorisations granted pursuant to paragraph 1 shall be limited as to the quantity of the pest that can be introduced, moved, held, multiplied or used and the length of time that are adequate for the activity concerned. Authorisations shall not exceed the capacity of the designated quarantine station or confinement facility.

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).

4. The competent authority shall monitor compliance with the conditions referred to in paragraph 2 and the limitation and the restrictions referred to in paragraph 3 and take the necessary action in the event of non-compliance. Where appropriate, that action shall be the revocation of the authorisation referred to in paragraph 1.

5. 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

1. Where a Member State has evidence that there is an imminent danger of the entry of a Union quarantine pest into the Union territory or into a part of it where that pest is not yet present, the Member State shall immediately notify the Commission and the other Member States of that evidence in writing.

2. 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.

3. Professional operators shall immediately notify the competent authorities of any evidence they may have concerning an imminent danger as referred to in paragraph 1 concerning Union quarantine pests or pests referred to in paragraph 2.

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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 ►C1 (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.

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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.

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Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation ►C1 (EU) 2017/625 ◄ , of the Member State concerned and through the electronic notification system referred to in Article 103.

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Article 12

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

1. Where one of the situations referred to in Article 11 is officially confirmed, the competent authority shall ensure that professional operators whose plants, plant products or other objects may be affected are informed of the presence of the Union quarantine pest without delay.

2. The Commission shall establish and keep up to date a publicly available list of all notifications it has received concerning emerging pests in third countries which may pose a risk to plant health in the Union territory.

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

1. Where a professional operator suspects or becomes aware that a Union quarantine pest or a pest subject to measures adopted pursuant to Article 30(1) is present in plants, plant products or other objects which are under that operator's control, it shall immediately notify the competent authority thereof, in order for that competent authority to take actions in accordance with Article 10. Where appropriate, the professional operator shall also immediately take precautionary measures to prevent the establishment and spread of that pest.

2. The competent authority may decide that the notification referred to in paragraph 1 is not required where a specific pest is known to occur in an area. In such a case, it shall inform the professional operators concerned of that decision.

3. Where a professional operator receives an official confirmation concerning the presence of a Union quarantine pest in plants, plant products or other objects which are under that operator's control, it shall consult the competent authority regarding the action to be taken and shall proceed, as applicable, with the actions referred to in paragraphs 4 to 7.

4. The professional operator shall immediately take the necessary measures to prevent the spread of that pest. Where the competent authority has provided instructions concerning those measures, the professional operator shall act in accordance with those instructions.

5. Where so instructed by the competent authority, the professional operator shall take the necessary measures to eliminate the pest from the plants, plant products or other objects concerned and from that operator's premises, land, soil, water or other infested elements which are under its control.

6. Unless otherwise instructed by the competent authority, the professional operator shall, without delay, withdraw from the market the plants, plant products and other objects which are under that operator's control and in which the pest could be present.

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.

7. Where paragraph 1, 3, 4, 5 or 6 of this Article applies, the professional operator shall, on request, provide to the competent authority all information which is relevant for the members of the public. Without prejudice to Article 13, if action is necessary with regard to the plants, plant products or other objects in which the respective pest may be present, the competent authority shall inform the public as soon as possible of that fact.

Article 15

Measures to be taken by persons other than professional operators

1. Where any person other than a professional operator becomes aware of the presence of a Union quarantine pest or has reason to suspect such a presence, that person shall immediately notify the competent authority. Where that notification is not made in writing, the competent authority shall officially record it. If so requested by the competent authority, that person shall provide that authority with the information which is in its possession concerning that presence.

2. The competent authority may decide that the notification referred to in paragraph 1 is not required where a specific pest is known to be present in an area.

3. The person who made the notification referred to in paragraph 1 shall consult the competent authority on the action to be taken and shall, in accordance with the instructions of the competent authority, take the measures necessary to prevent the spread of that pest and to eliminate it from the plants, plant products or other objects concerned and, where applicable, from that person's premises.

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

1. Where one of the situations referred to in points (a) and (b) of the first paragraph of Article 11 is officially confirmed, the competent authority shall immediately take all necessary phytosanitary measures to eradicate the relevant Union quarantine pest from the area concerned. Those measures shall be taken in accordance with Annex II.

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

2. The competent authority shall without delay investigate the source of the presence of the Union quarantine pest concerned, in particular where that presence may be related to movements of plants, plant products or other objects, and the possibility that the pest concerned has been spread to further plants, plant products or other objects by those movements.

3. Where the measures referred to in paragraph 1 concern the introduction into, or movement within, the Union territory of plants, plant products and other objects, the Member State concerned shall immediately notify those measures to the Commission and the other Member States.

4. The measures referred to in paragraph 1 and the investigations referred to in paragraph 2 shall be taken irrespective of whether the pest is present on public or private premises.

Article 18

Establishment of demarcated areas

1. Where one of the situations referred to in points (a) and (b) of the first paragraph of Article 11 is officially confirmed, the competent authority shall immediately establish one or more areas where the eradication measures referred to in Article 17(1) are to be taken (‘demarcated area’).

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

2. 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.

3. The buffer zone shall be adjacent to the infested zone and shall surround it.

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.

4. By way of derogation from paragraph 1, where upon initial examination the competent authority concludes, in view of the nature of the pest, the plant, plant product or other object concerned and the site where it was found, that the pest concerned can be eliminated immediately, the competent authority may decide not to establish a demarcated area.

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.

5. Where, in accordance with paragraphs 2 and 3, a demarcated area is to extend into the territory of another Member State, the Member State where the pest concerned was found to be present shall immediately contact the Member State into whose territory the demarcated area is to extend in order to allow that Member State to take all appropriate actions, as referred to in paragraphs 1 to 4.

6. Member States shall notify the Commission and the other Member States, by 30 April of each year, of the number and locations of the demarcated areas established, the pests concerned, and the respective measures taken during the preceding calendar year.

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

1. Competent authorities shall at least annually, at appropriate times, carry out a survey of each demarcated area as regards the development of the presence of the pest concerned.

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

2. Where, whether or not as a result of a survey as referred to in paragraph 1, a competent authority finds a presence of the pest concerned in the buffer zone, the Member State concerned shall immediately notify the Commission and the other Member States thereof.

3. Competent authorities shall modify the boundaries of infested zones, buffer zones and demarcated areas, where appropriate, in view of the results of the surveys referred to in paragraph 1.

4. 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.

5. 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:

(a) the biology of the pest and the vector concerned;

(b) the presence of host plants;

(c) the ecoclimatic conditions; and

(d) the likelihood of the eradication measures having been successful.

6. By way of derogation from paragraph 1 of this Article, annual surveys shall not be required to be carried out in the infested zone of demarcated areas established for:

(a) pests subject to eradication measures requiring eight years or more;

(b) pests subject to the containment measures referred to in Article 28(2).

7. The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by further specifying the pests referred to in point (a) of paragraph 6 of this Article and in point (b) of Article 16 and conditions for the application of those derogations.

Article 20

Reports on measures taken in accordance with Articles 17, 18 and 19

1. Where measures are taken by a Member State in an area adjacent to the border with another Member State, a report on the measures taken in accordance with Articles 17, 18 and 19 shall be submitted to that other Member State.

2. Where so requested by the Commission or by any other Member State, a Member State shall submit a report on specific measures taken in accordance with Articles 17, 18 and 19.

Article 21

Amendment of Annex II

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

Article 22

Surveys on Union quarantine pests and pests provisionally qualifying as Union quarantine pests

1. Member States shall carry out risk-based surveys, over specific periods of time, checking at least for:

(a) the presence of any Union quarantine pest; and

(b) signs or symptoms of any pest subject to the measures referred to in Article 29 or to measures adopted pursuant to Article 30(1).

Those surveys shall take place in all areas where the pest concerned was not known to be present.

Those surveys shall not be required to be carried out 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. The design of the surveys referred to in paragraph 1 shall be based on the risk that the pest occurs in the area covered by each survey. They shall consist, at least, of visual examinations by the competent authority and, where appropriate, the collection of samples and performance of tests. Those surveys shall be carried out in all appropriate locations and shall include, where appropriate, premises, vehicles, machinery and packaging used by professional operators and other persons. They shall be based on sound scientific and technical principles and shall be carried out at appropriate times with regard to the possibility to detect the pest concerned.

Those surveys shall take account of scientific and technical evidence, and any other appropriate information, concerning the presence of the pests concerned.

3. Member States shall report to the Commission and the other Member States, by 30 April of each year, the results of the surveys referred to in paragraph 1 which were carried out in the preceding calendar year. Those reports shall include information on where the surveys were conducted, the timing of the surveys, the pests and the plants, plant products or other objects concerned, the number of inspections and samples taken, and the finding of each pest concerned.

The Commission may, by means of implementing acts, set out the format of those reports, as well as instructions on how to fill it in. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 23

Multiannual survey programmes and collection of information

1. Member States shall establish multiannual survey programmes setting out the content of the surveys to be carried out pursuant to Article 22. Those programmes shall provide for the collection and recording of the scientific and technical evidence and other information referred to in the second subparagraph of Article 22(2).

The multiannual survey programmes shall include the following elements in conformity with Article 22(2):

(a) the specific objective of each survey;

(b) the scope of each survey as regards the area concerned and the time scale covered, as well as the pests, plants and commodities targeted;

(c) the survey methodology and quality management including a description of the procedures for visual examination, sampling and testing and their technical justification;

(d) the timing, frequency and numbers of scheduled visual examinations, samples and tests; and

(e) the methods of recording and reporting the information collected.

The multiannual survey programmes shall be for a period of five to seven years.

2. Member States shall, on request, notify their multiannual survey programmes upon their establishment to the Commission and the other Member States.

3. The Commission may adopt implementing acts establishing the format of the multiannual survey programmes and the practical arrangements for the application of the elements set out in paragraph 1 to specific pest risks.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 24

Surveys of priority pests

1. For each priority pest, Member States shall carry out a survey annually, as set out in Article 22(1) and (2). Those surveys shall include a sufficiently high number of visual examinations, sampling and testing, as appropriate for each priority pest, to ensure, as far as it is possible given the respective biology of each priority pest and the ecoclimatic conditions, with a high degree of confidence, the timely detection of those pests.

The surveys shall not be required to be carried out 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. Member States shall report to the Commission and the other Member States by 30 April of each year the results of the surveys referred to in paragraph 1 which were carried out in the preceding calendar year.

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:

▼M1

(a) the roles and responsibilities of the bodies involved in the execution of the plan, in case of a confirmed or suspected presence of the priority pest concerned, as well as the chain of command and procedures for the co-ordination of actions to be taken by competent authorities, other public authorities, as referred to in Article 4(2) of Regulation ►C1 (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 co-ordination with neighbouring Member States and neighbouring third countries, where appropriate;

▼B

(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.

Article 26

Simulation exercises for priority pests

1. Member States shall carry out simulation exercises concerning the implementation of the contingency plans at intervals set according to the biology of the priority pest or pests concerned and the risk posed by that pest or those pests.

Those exercises shall take place with regard to all priority pests concerned within a reasonable period of time and with the involvement of the relevant stakeholders.

Those exercises shall not be required where the Member State concerned has recently taken measures for the eradication of the pest or pests concerned.

2. Simulation exercises concerning priority pests whose presence in one Member State could have an impact on neighbouring Member States may be carried out together by those Member States on the basis of their respective contingency plans.

Where appropriate, Member States may carry out those simulation exercises with neighbouring third countries.

3. Member States shall, on request, make available a report on the results of each simulation exercise to the Commission and to the other Member States.

Article 27

Action plans for priority pests

1. Where the presence of a priority pest is officially confirmed in the territory of a Member State pursuant to Article 10, the competent authority shall immediately adopt a plan (the ‘action plan’) setting out the measures for the eradication of that pest, as provided for in Articles 17, 18 and 19, or its containment, as provided for in Article 28(2), as well as a time schedule for the application of those measures.

The action plan shall include a description of the design and organisation of the surveys to be carried out and set out the number of visual examinations, samples to be taken and laboratory tests to be carried out, as well as the methodology to be applied for the examination, sampling and testing.

The action plan shall be based on the relevant contingency plan and shall be immediately communicated by the competent authority to the professional operators concerned.

2. Each Member State shall, on request, notify the Commission and the other Member States of the action plans it has adopted.

Article 28

Union measures for specific Union quarantine pests

1. The Commission may, by means of implementing acts, set out measures against specific Union quarantine pests. Those measures shall implement, specifically for each of the pests concerned, one or more of the following provisions:

(a) Article 10 concerning measures to be taken in the event of suspicion and official confirmation by competent authorities of the presence of that Union quarantine pest;

(b) Article 14 concerning measures to be taken immediately by professional operators;

(c) Article 15 concerning measures to be taken by persons other than professional operators;

(d) Article 17 concerning eradication of Union quarantine pests;

(e) Article 18 concerning establishment of demarcated areas;

(f) Article 19 concerning surveys and modifications of demarcated areas and lifting of restrictions;

(g) Article 22 concerning surveys on Union quarantine pests and pests provisionally qualifying as Union quarantine pests;

(h) Article 24 concerning surveys for priority pests, as regards the number of visual examinations, samples and tests for particular priority pests;

(i) Article 25 concerning contingency plans for priority pests;

(j) Article 26 concerning simulation exercises for priority pests;

(k) Article 27 concerning action plans for priority pests.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

2. By way of derogation from Article 17, where it is concluded, on the basis of the surveys referred to in Article 19 or other evidence, that the eradication of the Union quarantine pest concerned in a demarcated area is not possible, the Commission shall adopt implementing acts referred to in paragraph 1 of this Article which set out measures with the purpose of containment.

For the purpose of reaching that conclusion, the Commission shall, without delay, take the necessary actions following the submission of the relevant evidence by the Member State concerned or any other source.

3. Where the Commission concludes that prevention measures in areas outside demarcated areas are necessary to protect the part of the Union territory where the Union quarantine pest concerned is not present, it may adopt implementing acts referred to in paragraph 1 setting out such measures.

4. The measures referred to in paragraphs 1, 2 and 3 shall be taken in accordance with Annex II, taking into account the specific risks of the Union quarantine pests concerned, the specific ecoclimatic conditions and risks as regards the Member States concerned and the need to implement the necessary risk-mitigation measures in a harmonised manner at Union level.

5. Until a measure has been adopted by the Commission, the Member State may maintain any measures that it has taken.

6. On duly justified imperative grounds of urgency to address a serious pest risk, the Commission shall adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 107(3). Those acts shall be adopted in accordance with Annex II, taking into account the specific risks of the Union quarantine pests concerned, the specific ecoclimatic conditions and risks as regards the Member States concerned and the need to implement the necessary risk-mitigation measures in a harmonised manner at Union level.

7. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and other Member States of any cases of non-compliance with the measures adopted pursuant to this Article which create a risk of spread of Union quarantine pests.

Article 29

Measures by Member States concerning pests not listed as Union quarantine pests

1. Where the presence of a pest that is not included in the list of Union quarantine pests is officially confirmed in the territory of a Member State, and the Member State considers that that pest may fulfil the conditions for inclusion in the list of Union quarantine pests, it shall immediately assess whether the pest fulfils the criteria set out in Subsection 1 of Section 3 of Annex I. If it concludes that those criteria are fulfilled, it shall immediately take eradication measures in accordance with Annex II. Articles 17 to 20 shall apply.

Where it is concluded, on the basis of the surveys referred to in Article 19 or other evidence, that the eradication of a pest in a demarcated area is not possible, Article 28(2) shall apply mutatis mutandis.

Where the presence of a pest fulfilling the criteria referred to in the first subparagraph is officially confirmed in a consignment of plants, plant products or other objects introduced into, or moved within, the territory of a Member State, that Member State shall take the necessary measures to prevent the entry of that pest into, and its establishment and spread in, the Union territory.

Where a Member State suspects the presence in its territory of a pest fulfilling the criteria referred to in the first subparagraph, Article 10 shall apply mutatis mutandis.

Pending the official confirmation of the presence of that pest, the Member State shall, where appropriate, take phytosanitary measures to mitigate the risk of it spreading.

2. After taking the measures referred to in paragraph 1, the Member State shall assess whether the pest concerned fulfils the criteria for quarantine pests set out in Section 1 of Annex I.

3. The Member State concerned shall notify the Commission and the other Member States of the presence of the pest referred to in paragraph 1. It shall also inform the Commission and the other Member States of the assessment referred to in that paragraph, the measures taken and the evidence justifying those measures.

It shall notify the Commission of the results of the assessment referred to in paragraph 2 within two years of the official confirmation of the presence of that pest.

Notifications of the presence of that pest shall be submitted through the electronic notification system referred to in Article 103.

Article 30

Union measures concerning pests not listed as Union quarantine pests

1. Where the Commission receives a notification as referred to in the first subparagraph of Article 29(3), or has other evidence concerning the presence in, or imminent danger of entry into, or spread within, the Union territory of a pest which is not included in the list of Union quarantine pests and it considers that that pest may fulfil the conditions for inclusion in that list, it shall immediately assess whether, as regards the Union territory, that pest fulfils the criteria set out in Subsection 2 of Section 3 of Annex I.

Where the Commission concludes that those criteria are fulfilled, it shall immediately, by means of implementing acts, adopt measures for a limited time as regards the risks posed by that pest. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Those measures shall, where appropriate, implement, specifically for each of the pests concerned, one or more of the provisions referred to in points (a) to (g) of the first subparagraph of Article 28(1).

2. After adopting the measures referred to in paragraph 1, the Commission shall assess whether the pest concerned fulfils, as regards the Union territory, the criteria for quarantine pests set out in Section 1 of Annex I.

3. Where it is concluded, on the basis of surveys referred to in Articles 19 and 22 or other evidence, that the eradication of the pest concerned in a demarcated area is not possible, the implementing acts referred to in the second subparagraph of paragraph 1 of this Article may set out measures with the purpose of containment.

4. Where it is concluded that prevention measures in areas outside demarcated areas are necessary to protect the part of the Union territory where the pest concerned is not present, the implementing acts referred to in paragraph 1 may set out such measures.

5. The measures referred to in paragraphs 1, 3 and 4 shall be adopted in accordance with Annex II, taking into account the specific risks of the pests concerned and the need to implement the necessary risk-mitigation measures in a harmonised manner at Union level.

6. Until measures have been adopted by the Commission, the Member State concerned may maintain the measures that it has taken pursuant to Article 29.

7. On duly justified imperative grounds of urgency to address a serious pest risk, the Commission shall adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 107(3). Those acts shall be adopted in accordance with Annex II, taking into account the specific risks of the pests concerned and the need to implement the necessary risk-mitigation measures in a harmonised manner at Union level.

8. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and other Member States of any cases of non-compliance with the measures adopted pursuant to this Article which create a risk of spread of the pests referred to in paragraph 1 of this Article.

Article 31

More stringent requirements adopted by Member States

1. Member States may apply within their territories more stringent measures than those adopted pursuant to Article 28(1), (2) and (3) and Article 30(1), (3) and (4), if justified by the objective of phytosanitary protection and in accordance with the principles set out in Section 2 of Annex II.

Those more stringent measures shall not impose, or result in, any prohibitions or restrictions on the introduction into, or movement within and through, the Union territory of plants, plant products and other objects, other than those imposed by Articles 40 to 58 and 71 to 102.

2. Member States shall immediately notify the Commission and the other Member States of measures taken by them in accordance with paragraph 1.

Member States shall, on request, submit to the Commission and the other Member States an annual report on the measures taken in accordance with paragraph 1.







Section 3

Protected zone quarantine pests

Article 32

Recognition of protected zones

1. Where a quarantine pest is present in the Union territory but not in the territory of a Member State or a part thereof, and is not a Union quarantine pest, the Commission may, upon application of that Member State pursuant to paragraph 4, recognise such territory or part thereof as a protected zone in accordance with paragraph 3 as regards that quarantine pest (‘protected zone quarantine pest’).

2. A protected zone quarantine pest shall not be introduced into, moved within, or held, multiplied or released in, the respective protected zone.

Article 8 shall apply mutatis mutandis to the introduction into, movement within, and holding and multiplication in, protected zones of protected zone quarantine pests.

3. The Commission shall, by means of an implementing act, establish a list of protected zones and the respective protected zone quarantine pests. That list shall include the protected zones recognised in accordance with the first subparagraph of point (h) of Article 2(1) of Directive 2000/29/EC, the respective pests listed in Part B of Annex I and Part B of Annex II to Directive 2000/29/EC, and codes specifically attributed to those pests.

The Commission may, by means of implementing acts amending the implementing act referred to in the first subparagraph, recognise additional protected zones where the conditions provided for in paragraph 1 of this Article are fulfilled.

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

The implementing acts referred to in this paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(2).

4. With the application referred to in paragraph 1, the Member State concerned shall submit:

(a) a description of the boundaries of the proposed protected zone, including maps;

(b) the results of surveys showing that, during at least the three years preceding the application, the quarantine pest concerned was not present in the territory concerned; and

(c) evidence that the quarantine pest concerned fulfils the conditions set out in Article 3 with respect to the proposed protected zone.

5. The surveys referred to in point (b) of paragraph 4 shall be carried out at appropriate times and be of appropriate intensity with regard to the possibility of detecting the presence of the quarantine pest concerned. They shall be based on sound scientific and technical principles, and take into account the relevant international standards.

The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by laying down detailed rules for those surveys. Those acts shall be adopted in accordance with the development of scientific and technical knowledge and the applicable international standards.

6. The Commission may recognise temporary protected zones. For that purpose, the conditions set out in paragraphs 1 and 4 and the first subparagraph of paragraph 5 shall apply mutatis mutandis. By way of derogation from the requirement referred to in point (b) of paragraph 4, a survey shall have been carried out over a period of at least one year preceding the application.

The recognition of a temporary protected zone shall last no longer than three years after recognition, and shall expire automatically after three years.

7. Member States shall notify the Commission and the other Member States and inform, via publication on the official website of the competent authority, the professional operators of the boundaries of the protected zones in their territory, including by means of maps.

Article 33

General obligations concerning protected zones

1. With regard to a protected zone, the obligations set out in Articles 9 to 19 shall apply mutatis mutandis to the respective protected zone quarantine pest.

2. A plant, plant product or other object originating in a demarcated area established in a protected zone for the protected zone quarantine pest concerned shall not be moved from that demarcated area into the remaining part of that protected zone or into any other protected zone established for that protected zone quarantine pest.

By way of derogation from the first subparagraph, that plant, plant product or other object may be moved out of that demarcated area through and out of the protected zone concerned only if it is packed and moved in such a way that there is no risk of spreading that protected zone quarantine pest within that protected zone.

3. The demarcated areas established within a protected zone and the eradication measures taken in those areas pursuant to Articles 17, 18 and 19 shall be immediately notified to the Commission and the other Member States.

Article 34

Surveys on protected zone quarantine pests

1. The competent authority shall carry out annual surveys of each protected zone as regards the presence of the protected zone quarantine pest concerned. Article 22(2) shall apply mutatis mutandis to those surveys.

The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by laying down detailed rules for the preparation and the content of those surveys.

2. Member States shall notify the Commission and the other Member States, by 30 April of each year, of the results of the surveys referred to in paragraph 1 which were carried out in the preceding calendar year.

Article 35

Amendment of extent and revocation of recognition of protected zones

1. The Commission may amend the extent of a protected zone on application by the Member State whose territory is concerned.

Where that amendment concerns the extension of a protected zone, Article 32 shall apply mutatis mutandis.

2. On application by the Member State referred to in paragraph 1, the Commission shall revoke the recognition of a protected zone or reduce its extent.

3. The Commission shall revoke the recognition of a protected zone if the surveys referred to in Article 34 have not been carried out in accordance with that Article.

4. The Commission shall revoke the recognition of a protected zone if the respective protected zone quarantine pest has been found to be present in that zone and one of the following conditions is fulfilled:

(a) no demarcated area has been established, in accordance with Article 33(1), within three months of the official confirmation of the presence of that pest;

(b) the eradication measures taken in a demarcated area pursuant to Article 33(1) have not been successful within 24 months of the official confirmation of the presence of that pest, or within a period longer than 24 months where the biology of the pest so justifies and that period is set out in the implementing act adopted pursuant to Article 32(3);

(c) information available to the Commission demonstrates, with regard to the application of measures pursuant, by virtue of Article 33(1), to Articles 17, 18 and 19, gross negligence in reaction to the presence of that pest in the concerned protected zone.

5. The Commission shall revoke the recognition of a protected zone or reduce its extent, pursuant to paragraph 2, 3 or 4 of this Article, by means of an implementing act amending the implementing act referred to in Article 32(3). That implementing act shall be adopted in accordance with the examination procedure referred to in Article 107(2).







CHAPTER III

Union regulated non-quarantine pests

Article 36

Definition of Union regulated non-quarantine pests

A pest is a ‘Union regulated non-quarantine pest’ if it fulfils all of the following conditions and it is included in the list referred to in Article 37:

(a) its identity is established in accordance with point (1) of Section 4 of Annex I;

(b) it is present in the Union territory;

(c) it is not a Union quarantine pest or a pest subject to measures adopted pursuant to Article 30(1);

(d) it is transmitted mainly through specific plants for planting, in accordance with point (2) of Section 4 of Annex I;

(e) its presence on those plants for planting has an unacceptable economic impact, as regards the intended use of those plants for planting, in accordance with point (3) of Section 4 of Annex I;

(f) feasible and effective measures are available to prevent its presence on the plants for planting concerned.

Article 37

Prohibition of the introduction and movement of Union regulated non-quarantine pests on plants for planting

1. Professional operators shall not introduce a Union regulated non-quarantine pest into, or move that pest within, the Union territory on the plants for planting through which it is transmitted, as specified in the list referred to in paragraph 2.

The prohibition laid down in the first subparagraph shall not apply in the following cases:

(a) movement of plants for planting within, or between, the premises of the professional operator concerned;

(b) movement of plants for planting necessary for their disinfection.

2. The Commission shall, by means of an implementing act, establish a list setting out the Union regulated non-quarantine pests and the specific plants for planting, as referred to in point (d) of Article 36, where appropriate with the categories referred to in paragraph 7 of this Article and thresholds referred to in paragraph 8 of this Article.

3. The list referred to in paragraph 2 shall include the pests and the respective plants for planting set out in the following provisions:

(a) Section II of Part A of Annex II to Directive 2000/29/EC;

(b) points (3) and (6) of Annex I and point (3) of Annex II to Directive 66/402/EEC;

(c) Annex I to Directive 68/193/EEC;

(d) the acts adopted pursuant to Article 5(5) of Council Directive 98/56/EC ( 2 );

(e) Annex II to Directive 2002/55/EC;

(f) Annex I and point B of Annex II to Directive 2002/56/EC, and the acts adopted pursuant to point (c) of Article 18 of that Directive;

(g) point (4) of Annex I and point (5) of Annex II to Directive 2002/57/EC;

(h) the acts adopted pursuant to Article 4 of Directive 2008/72/EC; and

(i) the acts adopted pursuant to Article 4 of Directive 2008/90/EC.

Pests listed in Annex I and in Section I of Part A and in Part B of Annex II of Directive 2000/29/EC and listed as a Union quarantine pest pursuant to Article 5(2) of this Regulation, as well as pests subject to measures adopted pursuant to Article 30(1) of this Regulation, shall not be included in that list.

4. The Commission shall, by means of an implementing act, where appropriate, set out measures to prevent the presence of Union regulated non-quarantine pests on the plants for planting concerned, as referred to in point (f) of Article 36 of this Regulation. Those measures shall, where appropriate, concern the introduction into, and the movement within, the Union of those plants. Those measures shall be adopted in accordance with the principles set out in Section 2 of Annex II to this Regulation. Those measures shall apply without prejudice to the measures adopted pursuant to Directives 66/401/EEC, 66/402/EEC, 68/193/EEC and 98/56/EC, Council Directive 1999/105/EC ( 3 ), and Directives 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC.

5. The Commission shall, by means of implementing acts, amend the implementing acts referred to in paragraphs 2 and 4 of this Article where the results of an assessment show that:

(a) a pest not listed in the implementing act referred to in paragraph 2 of this Article fulfils the conditions referred to in Article 36;

(b) a pest listed in the implementing act referred to in paragraph 2 of this Article no longer fulfils one or more of the conditions referred to in Article 36;

(c) amendments to that list are necessary as regards categories referred to in paragraph 7 of this Article or thresholds referred to in paragraph 8 of this Article; or

(d) amendments to measures adopted pursuant to paragraph 4 of this Article are necessary.

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

The Commission may, by means of implementing acts, replace the implementing acts referred to in paragraphs 2 and 4 of this Article for the purpose of consolidating amendments.

6. The implementing acts referred to in paragraphs 2, 4 and 5 shall be adopted in accordance with the examination procedure referred to in Article 107(2).

7. Where point (e) of Article 36 is only fulfilled for one or more of the pre-basic, basic, or certified material, seed or seed potatoes, or standard or CAC material or seed, as referred to in Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC, the list referred to in paragraph 2 of this Article shall set out those categories stating that the prohibition of introduction and movement provided for in paragraph 1 of this Article only applies to those categories.

8. Where point (e) of Article 36 is only fulfilled if the pest concerned is present at an incidence above a certain threshold higher than zero, the list referred to in paragraph 2 of this Article shall set out that threshold stating that the prohibition of introduction and movement provided for in paragraph 1 of this Article only applies above that threshold.

Such a threshold shall only be set if both of the following points are fulfilled:

(a) it is possible for professional operators to ensure that the incidence of that Union regulated non-quarantine pest on those plants for planting does not exceed that threshold;

(b) it is possible to verify whether that threshold is not exceeded in lots of those plants for planting.

The principles for the management of the risk of pests set out in Section 2 of Annex II shall apply.

9. Article 31 shall apply mutatis mutandis to the measures to be taken by the Member States concerning regulated non-quarantine pests and the respective plants for planting.

Article 38

Amendment of Section 4 of Annex I

The Commission is empowered to adopt delegated acts in accordance with Article 105 amending Section 4 of Annex I in order to adapt it to the development of scientific and technical knowledge and of relevant international standards.

Article 39

Union regulated non-quarantine pests used for scientific or educational purposes, trials, varietal selection, breeding or exhibitions

The prohibition provided for in Article 37 shall not apply to Union regulated non-quarantine pests which are present on plants for planting used for scientific or educational purposes, trials, varietal selection, breeding or exhibitions.







CHAPTER IV

Measures concerning plants, plant products and other objects







Section 1

Measures relating to the entire Union territory

Article 40

Prohibition of the introduction of plants, plant products and other objects into the Union territory

1. Certain plants, plant products or other objects shall not be introduced into the Union territory if they originate from all or certain third countries or territories.

2. The Commission shall, by means of implementing acts, adopt a list containing the plants, plant products and other objects referred to in paragraph 1 which are prohibited from being introduced into the territory of the Union, together with the third countries, groups of third countries or specific areas of third countries to which the prohibition applies.

The first of those implementing acts shall include the plants, plant products and other objects as well as their countries of origin as listed in Part A of Annex III to Directive 2000/29/EC.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2) of this Regulation.

In the list established by those implementing acts, the plants, plant products and other objects shall also be identified by their respective code in accordance with the classification in the Combined Nomenclature as laid down in Council Regulation (EEC) No 2658/87 ( 4 ) (‘CN code’) where that code is available. Other codes laid down by Union legislation shall, in addition, be referred to where they specify further the applicable CN code for a specific plant, plant product or other object.

3. Where a plant, plant product or other object originating in or being dispatched from a third country poses a pest risk of an unacceptable level due to the likelihood that it hosts a Union quarantine pest, and that pest risk cannot be reduced to an acceptable level by applying one or more of the measures set out in points 2 and 3 of Section 1 of Annex II, the Commission shall amend the implementing act referred to in paragraph 2 accordingly to include in it that plant, plant product or other object and the third countries, groups of third countries or specific areas of third countries concerned.

Where a plant, plant product or other object included in that implementing act does not pose a pest risk of an unacceptable level, or it poses such a risk but that risk can be reduced to an acceptable level by applying one or more of the measures set out in points 2 and 3 of Section 1 of Annex II, the Commission shall amend that implementing act accordingly.

The acceptability of the level of that pest risk shall be assessed in accordance with the principles set out in Section 2 of Annex II, where appropriate with regard to one or more specific third countries.

Those amendments shall be adopted in accordance with the examination procedure referred to in Article 107(2).

On duly justified imperative grounds of urgency to address a serious pest risk, the Commission shall adopt those amendments by immediately applicable implementing acts, in accordance with the procedure referred to in Article 107(3).

4. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and other Member States where plants, plant products or other objects have been introduced into the Union territory in violation of paragraph 1.

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.

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 plants, plant products or other objects may originate from third countries or within the Union territory.

2. The Commission shall, by means of implementing acts, adopt a list containing the plants, plant products and other objects and the corresponding special requirements as referred to in paragraph 1. That list shall, where applicable, include the third countries, groups of third countries or specific areas within third countries concerned.

The first of those implementing acts shall include the plants, plant products and other objects, the special requirements and, where applicable, their third country of origin as listed in Part A of Annex IV to Directive 2000/29/EC.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2) of this Regulation.

In the list established by those implementing acts, those plants, plant products and other objects shall also be identified by their respective CN code where that code is available. Other codes laid down by Union legislation shall, in addition, be referred to where they specify further the applicable CN code for a specific plant, plant product or other object.

3. Where a plant, plant product or other object poses a pest risk of an unacceptable level due to the likelihood that it hosts a Union quarantine pest, and that pest risk can be reduced to an acceptable level by applying one or more of the measures set out in points 2 and 3 of Section 1 of Annex II, the Commission shall amend the implementing act referred to in paragraph 2 to include in it that plant, plant product or other object and the measures to be applied to it. Those measures and the requirements referred to in paragraph 2 constitute ‘special requirements’.

The measures referred to in the first subparagraph may take the form of specific requirements, adopted in accordance with Article 44(1), for the introduction into the Union territory of particular plants, plant products or other objects which are equivalent to special requirements for the introduction into, and movement within, the Union territory of those plants, plant products or other objects (‘equivalent requirements’).

Where a plant, plant product or other object included in that implementing act does not pose a pest risk of an unacceptable level, or it poses such a risk but that risk cannot be reduced to an acceptable level by the special requirements, the Commission shall amend that implementing act accordingly by removing that plant, plant product or other object from the list or by including it in the list referred to in Article 40(2).

The acceptability of the level of that pest risk shall be assessed, and the measures to reduce that risk to an acceptable level shall be adopted, in accordance with the principles set out in Section 2 of Annex II, where appropriate with regard to one or more specific third countries or parts thereof.

Those amendments shall be adopted in accordance with the examination procedure referred to in Article 107(2).

On duly justified imperative grounds of urgency to address a serious pest risk, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 107(3).

▼M1

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 of this Article, Member States shall adopt the necessary measures, as referred to in Article 66(3) of Regulation ►C1 (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.

▼B

Article 42

Restrictions on the basis of a preliminary assessment for the introduction into the Union territory of high-risk plants, plant products and other objects

1. A plant, plant product or other object originating in a third country and which is not listed in accordance with Article 40 or not sufficiently covered by the requirements referred to in Article 41 or not subject to the temporary measures of Article 49 and which, on the basis of a preliminary assessment, presents a pest risk of an unacceptable level for the Union territory is a ‘high-risk plant’, ‘high-risk plant product’ or ‘high-risk other object’ (‘high-risk plants, plant products or other objects’).

That preliminary assessment shall take into account, as appropriate for the plant, plant product or other object concerned, the criteria set out in Annex III.

2. High-risk plants, plant products or other objects listed in the implementing act provided for in paragraph 3 shall not be introduced into the Union territory from the third countries, groups of third countries or specific areas of third countries of origin concerned by that listing.

3. The Commission shall adopt implementing acts provisionally listing at the appropriate taxonomic level, pending the risk assessment referred to in paragraph 4, the high-risk plants, plant products or other objects referred to in paragraph 1 and, where appropriate, the third countries, groups of third countries or specific areas of third countries concerned.

The first of those implementing acts shall be adopted by 14 December 2018.

In the list established by those implementing acts, those plants, plant products and other objects, where applicable, shall also be identified by their respective CN code where that code is available. Other codes laid down by Union legislation shall, in addition, be referred to where they specify further the applicable CN code for a specific plant, plant product or other object.

4. If it is concluded, on the basis of a risk assessment, that the plant, plant product or other object originating in the third country, group of third countries or specific area of the third country concerned referred to in paragraph 2, on the taxonomic level as listed in the implementing act provided for in paragraph 3 or below that level, does not pose a risk of an unacceptable level by its likelihood to host a Union quarantine pest, the Commission shall adopt an implementing act removing that plant, plant product or other object from the list referred to in that paragraph for the third countries concerned.

If it is concluded, on the basis of a risk assessment, that the plant, plant product or other object originating in the third country, group of third countries or specific area of the third country concerned referred to in paragraph 2 poses an unacceptable risk due to the likelihood that it hosts a Union quarantine pest, and that that pest risk cannot be reduced to an acceptable level by applying one or more of the measures set out in points 2 and 3 of Section 1 of Annex II, the Commission shall adopt an implementing act removing that plant, plant product or other object and the third countries concerned from the list referred to in paragraph 2 and add it to the list referred to in Article 40.

If it is concluded, on the basis of a risk assessment, that the plant, plant product or other object originating in the third country, group of third countries or specific area of the third country concerned referred to in paragraph 2 poses an unacceptable risk, but that that risk can be reduced to an acceptable level by applying one or more of the measures set out in points 2 and 3 of Section 1 of Annex II, the Commission shall adopt an implementing act removing that plant, plant product or other object and the third country, group of third countries or specific area of the third country concerned from the list referred to in paragraph 2 and add it to the list referred to in Article 41.

5. Provided that demand for import of plants, plant products or other objects listed in the implementing act provided for in paragraph 3 is identified, the risk assessment referred to in paragraph 4 shall be carried out within an appropriate and reasonable period of time.

Where appropriate, that assessment may be limited to plants, plant products or other objects of a particular third country of origin or dispatch, or a group of third countries of origin or dispatch.

6. The Commission may, by means of implementing acts, lay down specific rules concerning the procedure to be followed in order to carry out the risk assessment referred to in paragraph 4.

7. The implementing acts referred to in paragraphs 3, 4 and 6 shall be adopted in accordance with the examination procedure referred to in Article 107(2).

Article 43

Specific import conditions for the introduction into the Union territory of wood packaging material

1. Wood packaging material, whether or not actually in use in the transport of objects of all kinds, shall only be introduced into the Union territory if it fulfils all of the following requirements:

(a) it has been subject to one or more of the approved treatments and complies with the applicable requirements set out in Annex 1 to the International Standard for Phytosanitary Measures No 15 Regulation of Wood Packaging Material in International Trade (ISPM15);

(b) it is marked with the mark referred to in Annex 2 of ISPM15 attesting that it has been subject to the treatments referred to in point (a).

This paragraph shall not apply to wood packaging material which is subject to the exemptions provided for in ISPM15.

2. The Commission is empowered to adopt delegated acts in accordance with Article 105 amending the requirements set out in paragraph 1 of this Article to take into account the development of international standards, and in particular of ISPM15.

Those delegated acts may also determine that wood packaging material not subject to the exemptions provided for in ISPM15 is exempted from the requirements of paragraph 1 of this Article or is subject to less stringent requirements.

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).

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2. Where appropriate, the Commission shall carry out investigations in the third country concerned and in accordance with Article 120 of Regulation ►C1 (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.

▼B

Article 45

Information to be provided to travellers and clients of postal services

1. Member States, seaports, airports and international transport operators shall make information available to passengers concerning prohibitions referred to in Article 40(2), requirements referred to in Articles 41(2) and 42(3) and the exemption referred to in Article 75(2) as regards the introduction of plants, plant products and other objects into the Union territory.

They shall provide that information in the form of posters or brochures and, where applicable, on their internet sites.

Postal services and professional operators involved in sales through distance contracts shall also make available to their clients that information concerning plants, plant products and other objects referred to in the first subparagraph at least through the internet.

The Commission may, by means of implementing acts, set out arrangements for the presentation and use of those posters and brochures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

2. Member States shall, on request, submit to the Commission a report summarising the information provided pursuant to this Article.

Article 46

Exception from prohibitions and requirements for frontier zones

1. By way of derogation from Article 40(1), Article 41(1) and Article 42(2), Member States may authorise the introduction into the Union territory of plants, plant products and other objects which fulfil all of the following conditions:

(a) they are grown or produced in areas of third countries in the vicinity of their land border with Member States (‘third country frontier zones’);

(b) they are introduced into areas of Member States immediately across that border (‘Member State frontier zones’);

(c) they are to be subject to processing in those Member State frontier zones in such a manner that any pest risk is eliminated;

(d) they do not pose any risk of spreading Union quarantine pests or pests subject to measures adopted pursuant to Article 30(1) caused by movements within the frontier zone.

Those plants, plant products and other objects shall only be moved into and within the Member State frontier zones, and only under the official control of the competent authority.

2. The Commission is empowered to adopt delegated acts in accordance with Article 105 supplementing this Regulation by setting out the following:

(a) the maximum width of third country frontier zones and Member State frontier zones, as appropriate for the specific plants, plant products and other objects;

(b) the maximum distance of the movement of the plants, plant products and other objects concerned within the third country frontier zones and Member State frontier zones; and

(c) the procedures for the authorisation of the introduction into, and movement within, the Member State frontier zones of plants, plant products and other objects referred to in paragraph 1 of this Article.

The width of those zones shall be such as to ensure that the introduction and movement of those plants, plant products and other objects in the Union territory does not pose any pest risks to the Union territory or parts of it.

3. The Commission may, by means of implementing acts, lay down specific conditions or measures concerning the introduction into Member State frontier zones of particular plants, plant products and other objects, and determine specific third countries which are subject to this Article.

Those acts shall be adopted in accordance with Annex II and, where appropriate, taking into account the development of scientific and technical knowledge and international standards.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

4. Member States shall notify, through the electronic notification system referred to in Article 103, the Commission and the other Member States where plants, plant products or other objects have been introduced into, or moved within, Member State frontier zones or third country frontier zones in violation of paragraphs 1, 2 and 3 of this Article.

That notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the frontier zone concerned.

Article 47

Requirements for phytosanitary transit

1. By way of derogation from Article 40(1), Article 41(1), Article 42(2), Article 72(1) and Article 73, plants, plant products and other objects may be introduced into, and be passed through, the Union territory to a third country, either in the form of transit or transhipment (‘phytosanitary transit’), if they fulfil both of the following conditions:

(a) they are accompanied by a signed declaration of the professional operator in control of those plants, plant products and other objects stating that those plants, plant products or other objects are in phytosanitary transit;

(b) they are packed and moved in such a way that there is no risk of spreading of Union quarantine pests during their introduction into, and passing through, the Union territory.

2. Competent authorities shall prohibit phytosanitary transit if the plants, plant products or other objects concerned do not comply, or there is reasonable evidence that they will not comply, with paragraph 1.

Article 48

Plants, plant products and other objects used for official testing, scientific or educational purposes, trials, varietal selection or breeding

1. By way of derogation from Article 40(1), Article 41(1) and Article 42(2), Member States may, on application, authorise temporarily the introduction into, and the movement within, their territory of plants, plant products and other objects used for official testing, scientific or educational purposes, trials, varietal selection or breeding.

That authorisation shall be granted for the activity concerned only if adequate restrictions are imposed to ensure that the presence of the plants, plant products or other objects concerned does not cause an unacceptable risk of the spread of a Union quarantine pest or pest subject to the measures adopted pursuant to Article 30(1), taking into account the identity, biology and means of dispersal of the pests concerned, the activity envisaged, the interaction with the environment and other relevant factors relating to the pest risk posed by those plants, plant products or other objects.

2. Where an authorisation is granted in accordance with paragraph 1, it shall include all of the following conditions:

(a) the plants, plant products or other objects concerned are to be kept in a location and under conditions found to be appropriate by the competent authorities and referred to in the authorisation;

(b) the activity involving those plants, plant products or other objects is to be carried out in a quarantine station or a confinement facility designated in accordance with Article 60 by the competent authority and referred to in the authorisation;

(c) the activity involving those plants, plant products or other objects is to be carried out by personnel whose scientific and technical competence is found to be appropriate by the competent authority and referred to in the authorisation;

(d) those plants, plant products or other objects are to be accompanied by the authorisation when introduced into, or moved within, the Union territory.

3. The authorisation referred to in paragraph 1shall be limited to the amount and duration that is adequate for the activity concerned and shall not exceed the capacity of the designated quarantine station or confinement facility.

It shall include the restrictions necessary to adequately eliminate the risk of the spread of the relevant Union quarantine pests or pests subject to measures adopted pursuant to Article 30(1).

4. The competent authority shall monitor compliance with the conditions referred to in paragraph 2 and the limitation and the restrictions referred to in paragraph 3 and take the necessary action in case those conditions, that limitation or those restrictions are not complied with.

Where appropriate, that action shall be the revocation of the authorisation referred to in paragraph 1.

5. 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, and movement within, the Union territory of the plants, plant products and other objects concerned;

(b) the procedures and conditions for granting the authorisation referred to in paragraph 1 of this Article; and

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

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 within, the Union territory of plants, plant products and other objects from third countries where the following conditions are fulfilled:

(a) the plants, plant products or other objects are likely to pose newly identified pest risks which are not sufficiently covered by any Union measures and are not linked, or cannot yet be linked, to Union quarantine pests or pests subject to measures adopted pursuant to Article 30(1);

(b) there is insufficient phytosanitary experience, such as in relation to new plant species or pathways, as regards trade in the plants, plant products and other objects concerned originating in or dispatched from the third countries concerned;

(c) no assessment has been carried out as regards the newly identified pest risks for the Union territory in respect of those plants, plant products or other objects from the third countries concerned.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(2).

2. The temporary measures referred to in paragraph 1 shall be adopted taking into account Section 2 of Annex II and Annex IV.

They shall provide for one or more of the following, as necessary in the case concerned:

(a) systematic and intensive inspections and sampling, at the point of introduction, of each lot of plants, plant products or other objects introduced into the Union territory and the testing of samples;

(b) a quarantine period, within a quarantine station or a confinement facility as referred to in Article 60, to verify the absence of the newly identified pest risk concerned in those plants, plant products or other objects;

(c) a prohibition of the introduction of those plants, plant products or other objects into the Union territory.

In the cases referred to in points (a) and (b) of the second subparagraph, the implementing act referred to in paragraph 1 may also set out specific measures to be taken before the introduction into the Union territory of those plants, plant products or other objects.

3. The temporary measures referred to in paragraph 1 shall apply for an appropriate and reasonable period of time, pending the characterisation of pests likely to be associated with those plants, plant products or other objects from those third countries and the full assessment of the risks posed by those pests in accordance with Section 1 of Annex I.

4. On duly justified imperative grounds of urgency to address a serious newly identified pest risk, the Commission shall adopt immediately applicable implementing acts, in accordance with the procedure referred to in Article 107(3). Those acts shall be adopted in accordance with the principles set out in Section 2 of Annex II.

5. By way of derogation from the measures adopted pursuant to paragraph 1 of this Article, Article 48 shall apply to the introduction into, and the movement within, the Union territory of plants, plant products or other objects used for official testing, scientific or educational purposes, trials, varietal selection or breeding.

6. Member States shall submit a report to the Commission and the other Member States, by 30 April of each year, on the application of the measures referred to in point (a) or (b) of the second subparagraph of paragraph 2 during the preceding calendar year.

Member States shall notify the Commission and the other Member States where, following the application of the measures referred to in 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.

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Member States shall notify, through the electronic notification system referred to in Article 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 pursuant to Article 66(3) of Regulation ►C1 (EU) 2017/625 ◄ .

▼B

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.

Article 50

Report from the Commission on the enforcement and effectiveness of measures relating to imports into the Union territory

By 14 December 2021, the Commission shall present a report to the European Parliament and the Council on the enforcement and effectiveness of measures relating to imports into the Union territory, including a cost-benefit analysis, and, where appropriate, present a legislative proposal.

Article 51

Amendment of Annexes III and IV

The Commission is empowered to adopt delegated acts in accordance with Article 105 amending Annexes III and IV in order to adapt them to the development of scientific and technical knowledge and of relevant international standards.

Article 52

Temporary measures by Member States concerning imminent danger

1. Where a Member State considers that the introduction into, or movement within, its territory of plants, plant products or other objects from certain third countries or certain other Member States poses an unacceptable level of pest risk concerning the entry into, and establishment and spread in, its territory of a Union quarantine pest or a pest assessed to fulfil the conditions for inclusion in the list of Union quarantine pests, and that risk is not adequately mitigated by the measures referred to in Article 17(1) and (2), Article 18(1), Article 19(1), Article 28(1) and (2), Article 29(1), Article 30(1) and (3), Article 40(2) and (3), Article 41(2) and (3), Article 42(3), Article 49(1) and Article 53, it shall notify in writing the Commission and the other Member States of the Union measures it would like to be taken, together with the technical or scientific justification for those measures.

2. If a Member State considers that the Union measures referred to in paragraph 1 are not being, or cannot be, taken in sufficient time to mitigate the risk referred to that paragraph, it may take temporary measures to protect its territory against the imminent danger. Those temporary measures, and the technical justification for those measures, shall be notified immediately to the Commission and the other Member States.

3. Where the Commission receives the notification referred to in paragraph 1, it shall immediately assess whether the risk referred to in paragraph 1 is adequately mitigated by the measures referred to in Article 17(1) and (2), Article 18(1), Article 19(1), Article 28(1) and (2), Article 29(1), Article 30(1) and (3), Article 40(2) and (3), Article 41(2) and (3), Article 42(3), Article 49(1) and Article 53, or whether any new measure should be adopted pursuant to those Articles.

4. Where, on the basis of the assessment referred to in paragraph 3, the Commission concludes that the risk referred to in paragraph 1 is not adequately mitigated by the temporary measures taken by the Member State pursuant to paragraph 2, or if those measures are disproportionate or not adequately justified, it may decid