(1)

In accordance with Regulation (EU) 2016/2031, 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) of that Regulation for official testing, scientific or educational purposes, trials, varietal selections, or breeding. Moreover, 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.

(2)

It is necessary to supplement Regulation (EU) 2016/2031 by adopting rules on the exchange of information between Member States and the Commission concerning the introduction into, and movement within, the Union territory of the pests, plants, plant products and other objects concerned, on the procedures and conditions for granting the respective authorisations, as well as on the requirements for the monitoring of compliance and the actions to be taken in the event of non-compliance.

(3)

In order to ensure that the phytosanitary risk linked to the specified activities is eliminated or reduced to an acceptable level, the authorisation of the introduction into, and the movement within, the Union of any specified material should be subject to certain conditions ensuring the submission of a complete and appropriate application, the examination of the nature and objectives of the specified activities, the confirmation that the specified activities are performed in quarantine stations or confinement facilities and the destruction and safe removal of contaminated material.

(4)

In order to ensure monitoring and traceability of the specified material concerned, and to immediately address any associated phytosanitary risk, it is appropriate that, following the granting of that authorisation, the competent authority of the Member State in which the approved specified activity is to be carried out should issue a letter of authority, which should always accompany the specified material concerned.

(5)

Since it has proven to be implemented in an effective and consistent manner, the format of the letter of authority should be similar to the format set out in Annex II to Commission Directive 2008/61/EC (2).

(6)

A single letter of authority should be used for the multiple introductions into, and movements within the Union of specified material subject to the specified activities, and in accordance with special conditions, so as to ensure a proportionate and effective framework for such introductions and movements.

(7)

Official testing is carried out more frequently than the other specified activities. It would therefore be more efficient to allow a more flexible framework for official testing than for the other specified activities.

(8)

Rules should be established concerning the actions to be taken by the competent authorities, in the cases of non-compliance with the provisions of this Regulation, to ensure corrective actions as soon as possible. Those actions should include obligations for the person responsible for the specified activities.

(9)

For purposes of legal certainty and clarity, Directive 2008/61/EC should be repealed.

(10)

This Regulation should apply without prejudice to any rules adopted pursuant to Article 48 of the Regulation (EU) 2017/625 of the European Parliament and of the Council (3) (Official Controls Regulation) with regard to goods exempted from official controls at border control posts.

(11)

In order to allow for the smooth termination of the activities authorised, it is appropriate to extend the validity of the approvals of those activities for a specified period of time.

(12)

For reasons of legal certainty, this Regulation should apply from the same date as Regulation (EU) 2016/2031,

(a)

Article 5(1), on prohibition of introduction, movement, holding, multiplication and release of Union quarantine pests in the Union territory;

(b)

Article 30(1), on Union measures adopted for pests not listed as Union quarantine pests but which may fulfil the conditions for inclusion in that list;

(c)

Article 32(2), on prohibition of introduction, movement, holding multiplication and release of protected zone quarantine pests into protected zones of Union territory;

(d)

Article 40(1), on prohibition of the introduction of certain plants, plants products and other objects from all or certain third countries or territories, into the Union territory;

(e)

Article 41(1), on special and equivalent requirements for introduction and movement of certain plants, plants products and other objects from third countries into the Union territory;

(f)

Article 42(2), on prohibition of the introduction of certain high-risk plants, plants products and other objects from third countries into the Union territory;

(g)

Article 49(1), on temporary measures as regards to the introduction into and the movement within, the Union territory of plants, plants products and other objects from third countries;

(h)

Article 53(1), on prohibition of introduction of plants, plants products and other objects originated from third countries or within the Union territory, into protected zones of Union territory;

(i)

Article 54(1), on special requirements for introduction of plants, plants products and other objects in protected zones of Union territory.

(a)

the rules concerning the exchange of information between Member States and the Commission concerning the introduction into, and movement within, or holding, multiplying or use within the Union, or protected zones therein, of specified pests or plants, plant products and other objects;

(b)

the procedure and the conditions under which a temporary authorisation shall be granted by Member States for the performance of the specified activities;

(c)

the rules concerning the monitoring of compliance, and the actions to be taken in case of non-compliance.

(a)

‘specified pests’ means one of the following:

(b)

‘plants, plant products or other objects’ means the plants, plant products or other objects subjected to measures adopted pursuant to Article 30(1), and listed pursuant to Articles 40(2) and (3), 41(2) and (3), 42(2) and (3), 49(1), 53(2) and (3), and 54(2) and (3) of Regulation (EU) 2016/2031;

(c)

‘specified material’ means any specified pests, plants, plant products or other objects requiring an authorisation within the meaning of this Regulation;

(d)

‘specified activities’ means any activity carried out by any person, including competent authorities, academic institutions, research institutions or professional operators, related to official testing, scientific or educational purposes, trials, varietal selection or breeding, that involves the introduction into, the movement within, holding, multiplication or use in the Union and protected zone thereof, of any specified material.

(a)

the application has been found to be in compliance with Article 4 of this Regulation;

(b)

the nature and objectives of the specified activities proposed in the application have been examined by the competent authority and found to comply with the definition of specified activities provided in Article 2 of this Regulation;

(c)

the specified activities have been confirmed to be performed in quarantine stations or confinement facilities indicated in the application and designated by the competent authority in compliance with Articles 60 and 61 of Regulation (EU) 2016/2031;

(d)

it has been ensured that, following the completion of the specified activity concerned by that authorisation, the specified material has been destroyed and safely removed, or stored under appropriate conditions for further use in accordance with Article 64 of Regulation (EU) 2016/2031.

(a)

the person responsible for the approved activities has notified official testing to the competent authority before it takes place;

(b)

that notification contains the nature and objectives of that official testing;

(c)

the notification contains a confirmation that the official testing is performed in quarantine stations or confinement facilities as referred to in point (c) of Article 5;

(d)

the official testing is carried out in such a way that there is no spread of specified pests during the handling and transport of the specified material prior, during, and after the official testing.

(a)

any infestations of the specified material by any specified pests which are not authorised under this Regulation, or by any other pests considered a risk to the Union, and detected during the specified activities, are notified immediately by the person responsible for the activities to the competent authority. Where the material is a specified pest itself, the monitoring shall concern its potential infestation by other specified pests not authorised under this Regulation, or any other pests considered a risk to the Union by the competent authority, and detected during the specified activities;

(b)

any event resulting in the escape, or likelihood of escape, of pests referred to in point (a) into the environment, is notified immediately to the competent authority by the person responsible for the activities.