Restrictions
1. Invasive alien species of Union concern shall not be intentionally:
(a)
brought into the territory of the Union, including transit under customs supervision;
(b)
kept, including in contained holding;
(c)
bred, including in contained holding;
(d)
transported to, from or within the Union, except for the transportation of species to facilities in the context of eradication;
(e)
placed on the market;
(f)
used or exchanged;
(g)
permitted to reproduce, grown or cultivated, including in contained holding; or
(h)
released into the environment.
2. Member States shall take all necessary steps to prevent the unintentional introduction or spread, including, where applicable, by gross negligence, of invasive alien species of Union concern.
Permits
1. By way of derogation from the restrictions set out in points (a), (b), (c), (d), (f) and (g) of Article 7(1), and subject to paragraph 2 of this Article, Member States shall establish a permit system allowing establishments to carry out research on, or ex-situ conservation of, invasive alien species of Union concern. Where the use of products derived from invasive alien species of Union concern is unavoidable to advance human health, Member States may also include scientific production and subsequent medicinal use within their permit system.
2. Member States shall empower their competent authorities to issue the permits referred to in paragraph 1 for activities carried out in contained holding that fulfil all of the following conditions:
(a)
the invasive alien species of Union concern is kept in and handled in contained holding in accordance with paragraph 3;
(b)
the activity is to be carried out by appropriately qualified personnel as laid down by the competent authorities;
(c)
transport to and from contained holding is carried out under conditions that exclude escape of the invasive alien species as established by the permit;
(d)
in the case of invasive alien species of Union concern that are animals, they are marked or otherwise effectively identified where appropriate, using methods that do not cause avoidable pain, distress or suffering;
(e)
the risk of escape or spread or removal is effectively managed, taking into account the identity, biology and means of dispersal of the species, the activity and the contained holding envisaged, the interaction with the environment and other relevant factors;
(f)
a continuous surveillance system and a contingency plan covering possible escape or spread is drawn up by the applicant, including an eradication plan. The contingency plan shall be approved by the competent authority. If an escape or spread occurs, the contingency plan shall be implemented immediately and the permit may be withdrawn, temporarily or permanently.
The permit referred to in paragraph 1 shall be limited to a number of invasive alien species and specimens that does not exceed the capacity of the contained holding. It shall include the restrictions necessary to mitigate the risk of escape or spread of the species concerned. It shall accompany the invasive alien species to which it refers at all times when those species are kept, brought into and transported within the Union.
3. Specimens shall be considered to be kept in contained holding if the following conditions are fulfilled:
(a)
the specimens are physically isolated and they cannot escape or spread or be removed by unauthorised persons from the holdings where they are kept;
(b)
cleaning, waste handling and maintenance protocols ensure that no specimens or reproducible parts can escape, spread or be removed by unauthorised persons;
(c)
the removal of the specimens from the holdings, disposal or destruction or humane cull is done in such way as to exclude propagation or reproduction outside of the holdings.
4. When applying for a permit, the applicant shall provide all necessary evidence to allow the competent authority to assess whether the conditions set out in paragraphs 2 and 3 are fulfilled.
5. Member States shall empower their competent authorities to withdraw the permit at any point in time, temporarily or permanently, if unforeseen events with an adverse impact on biodiversity or related ecosystem services occur. Any withdrawal of a permit shall be justified on scientific grounds and, where scientific information is insufficient, on the grounds of the precautionary principle and having due regard to national administrative rules.
6. The Commission shall adopt, by means of implementing acts, the format of the document serving as evidence for the permit issued by the competent authorities of a Member State. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2). Member States shall use that format for a document accompanying the permit.
7. For all permits issued in accordance with paragraph 1 of this Article, Member States, shall, without delay, make publicly available on the internet at least the following:
(a)
the scientific and common names of the invasive alien species of Union concern for which the permit has been issued;
(b)
the number or the volume of specimens concerned;
(c)
the purpose for which the permit has been issued; and
(d)
the codes of Combined Nomenclature as provided by Regulation (EEC) No 2658/87.
8. Member States shall ensure that inspections are carried out by their competent authorities to ensure that the establishments comply with the conditions set out in those permits issued.
Authorisations
1. In exceptional cases, for reasons of compelling public interest, including those of a social or economic nature, Member States may issue permits allowing establishments to carry out activities other than those set out in Article 8(1) subject to authorisation by the Commission, in accordance with the procedure laid down in this Article and subject to the conditions set out in Article 8(2) and (3).
2. The Commission shall set up and operate an electronic authorisation system and shall decide on applications for authorisation within 60 days of receipt of an application.
3. Applications for authorisation shall be submitted by Member States using the system referred to in paragraph 2.
4. An application for an authorisation shall include the following:
(a)
details of the establishment or groups of establishments including their name and address;
(b)
the scientific and common names of the invasive alien species of Union concern for which an authorisation is requested;
(c)
the codes of Combined Nomenclature as provided by Regulation (EEC) No 2658/87;
(d)
the number or the volume of specimens concerned;
(e)
the reasons for the requested authorisation;
(f)
a detailed description of the envisaged measures to ensure that escape or spread are not possible from contained holding facilities in which the invasive alien species of Union concern is to be kept in and handled, as well as of the measures to ensure that any transport of the species that may be necessary is carried out under conditions that exclude escape;
(g)
an assessment of the risk of escape of the invasive alien species of Union concern for which an authorisation is requested, accompanied by a description of the risk mitigation measures to be put in place;
(h)
a description of the surveillance system planned and of the contingency plan drawn to cater for possible escape or spread, including an eradication plan where necessary;
(i)
a description of relevant national law applicable to those establishments.
5. Authorisations granted by the Commission shall be notified to the competent authority of the Member State concerned. An authorisation shall be specific to an individual establishment, irrespective of the application procedure followed in accordance with point (a) of paragraph 4, and shall include the information referred to in paragraph 4 and the duration of the authorisation. An authorisation shall also include provisions regarding the supply to the establishment of additional or replacement specimens for use in the activity for which that authorisation is requested.
6. Following an authorisation by the Commission, the competent authority may issue the permit referred to in paragraph 1 of this Article in accordance with Article 8(4) to (8). The permit shall include all provisions specified in the authorisation issued by the Commission.
7. The Commission shall reject an application for an authorisation if any relevant obligations set out in this Regulation are not complied with.
8. The Commission shall, as soon as possible, inform the Member State concerned of any rejection of an application pursuant to paragraph 7 and shall specify the reason for the rejection.
Emergency measures
1. Where a Member State has evidence concerning the presence in, or imminent risk of introduction into its territory of an invasive alien species, which is not included on the Union list but which the competent authorities have found, on the basis of preliminary scientific evidence, to be likely to meet the criteria set out in Article 4(3), it may immediately take emergency measures, consisting of any of the restrictions set out in Article 7(1).
2. The Member State introducing emergency measures in its national territory which include the application of points (a), (d) or (e) of Article 7(1) shall immediately notify the Commission and all other Member States of the measures taken and the evidence justifying those measures.
3. The Member State concerned shall without delay carry out a risk assessment pursuant to Article 5 for the invasive alien species subject to the emergency measures, given the available technical and scientific information, and in any case within 24 months from the date of the adoption of the decision to introduce emergency measures, with a view to include that species on the Union list.
4. Where the Commission receives the notification referred to in paragraph 2 of this Article or has other evidence concerning the presence in or imminent risk of introduction into the Union of an invasive alien species which is not included on the Union list, but is likely to meet the criteria set out in Article 4(3), it shall, by means of implementing acts, conclude, on the basis of preliminary scientific evidence, whether the species is likely to meet those criteria and adopt emergency measures for the Union consisting of any of the restrictions set out in Article 7(1) for a limited time as regards the risks posed by that species, where it concludes that the criteria set out in Article 4(3) are likely to be fulfilled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2).
5. Where the Commission adopts an implementing act referred to in paragraph 4, Member States shall repeal or amend, as appropriate, any emergency measures which they have taken.
6. Where the Commission includes the invasive alien species on the Union list, Member States shall also repeal or amend their emergency measures.
7. When, following the risk assessment carried out pursuant to paragraph 3 of this Article, the Commission does not include the invasive alien species on the Union list, Member States shall repeal their emergency measures taken pursuant to paragraph 1 of this Article and may include that species on a national list of invasive alien species of Member State concern, pursuant to Article 12(1), and consider enhanced regional cooperation in accordance with Article 11.
Invasive alien species of regional concern and species native to the Union
1. Member States may identify, from their national list of invasive alien species of Member State concern established in accordance with Article 12, species native or non-native to the Union that require enhanced regional cooperation.
2. At the request of the Member States involved, the Commission shall act to facilitate the cooperation and coordination among those Member States involved, in accordance with Article 22(1). Where necessary, based on the impact of certain invasive alien species on biodiversity and related ecosystem services as well as on human health and the economy and provided that it is thoroughly substantiated by a comprehensive analysis of the justification for an enhanced regional cooperation carried out by the requesting Member States, the Commission may require, by means of implementing acts, that the Member States concerned apply, mutatis mutandis , in their territory or part of it, Articles 13, 14 and 16, Article 17 notwithstanding Article 18, as well as apply Articles 19 and 20, as appropriate. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(2).
3. Invasive alien species of regional concern which are native to a Member State shall not be subject to the provisions of Articles 13, 14, 16, 17, 19, 20 and 24 in the territory of that Member State. Member States to which those species are native, shall cooperate with the Member States concerned for the assessment of the pathways in accordance with Article 13 and, in consultation with the other Member States, may adopt relevant measures to avoid further spread of those species in accordance with the procedure referred to in Article 22(1).
Invasive alien species of Member State concern
1. Member States may establish a national list of invasive alien species of Member State concern. For those invasive alien species, Member States may apply, in their territory, measures such as those provided for in Articles 7, 8, 13 to 17, 19 and 20, as appropriate. Those measures shall be compatible with the TFEU and be notified to the Commission in accordance with Union law.
2. Member States shall inform the Commission and the other Member States of the species they consider to be invasive alien species of Member State concern and of the measures applied in accordance with paragraph 1.
Action plans on the pathways of invasive alien species
1. Member States shall, within 18 months of the adoption of the Union list carry out a comprehensive analysis of the pathways of unintentional introduction and spread of invasive alien species of Union concern at least in their territory, as well as in their marine waters as defined in point (1) of Article 3 of Directive 2008/56/EC, and identify the pathways which require priority action ('priority pathways') because of the volume of species or of the potential damage caused by the species entering the Union through those pathways.
2. Within three years of the adoption of the Union list, each Member State shall establish and implement one single action plan or a set of action plans to address the priority pathways it has identified pursuant to paragraph 1. Action plans shall include timetables for action and shall describe the measures to be adopted and, as appropriate, voluntary actions and codes of good practice, to address the priority pathways and to prevent the unintentional introduction and spread of invasive alien species into or within the Union.
3. Member States shall ensure coordination with the aim of establishing one single action plan or a set of action plans coordinated at the appropriate regional level in accordance with Article 22(1). Where such regional action plans are not established, Member States shall establish and implement action plans for their territory and as far as possible coordinated at the appropriate regional level.
4. The action plans referred to in paragraph 2 of this Article shall include, in particular, measures based on an analysis of costs and benefits, in order to:
(a)
raise awareness;
(b)
minimise contamination of goods, commodities, vehicles and equipment by specimens of invasive alien species, including measures to tackle transportation of invasive alien species from third countries;
(c)
ensure appropriate checks at the Union borders, other than the official controls pursuant to Article 15.
5. The action plans established in accordance with paragraph 2 shall be transmitted to the Commission without delay. Member States shall review their action plans and transmit them to the Commission at least every six years.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
