Regulation (EU) 2016/2031 of the European Parliament of the CouncilShow full title

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(1) (‘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).

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, Member States shall adopt the necessary measures, as referred to in Union legislation on official controls, 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.

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).

2. Where appropriate, the Commission shall carry out investigations in the third country concerned to verify whether the conditions referred to in points (a) and (b) of the first subparagraph of paragraph 1 are fulfilled. Those investigations shall comply with requirements for Commission investigations as referred to in Union legislation on official controls.

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.

Member States shall notify, through the electronic notification system referred to in Article 103, 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 was violated. Where applicable, that notification shall include the measures taken by that Member State on the plants, plant products or other objects concerned, as referred to in Union legislation on official controls.

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 decide, by means of implementing acts, that those measures are to be repealed or amended. Until such an implementing act has been adopted by the Commission, the Member State may maintain the measures that it has taken.

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

(1)

Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).