In the EU Biodiversity Strategy, adopted in 2011, so-called invasive alien species (IAS) were identified as a significant and growing threat to biodiversity in the EU and estimated to cause some €12.5 billion worth of damage each year in the Union. The Commission was therefore tasked with developing a legislative instrument to address the problems posed by IAS.  This led, in 2014, to the adoption of Regulation 1143/2014 on the prevention and management of the introduction and spread of IAS/1
Among the threats posed by IAS to biodiversity and related ecosystem services that are identified in the Regulation are severe impacts on native species and the structure and functioning of ecosystems through the alteration of habitats, predation, competition, the transmission of diseases, and through genetic effects by hybridisation. Some 12,000 species in the environment of the Union and in other European countries are alien, of which roughly 10 to 15 per cent are estimated to be invasive.72
The Regulation sets out rules to prevent, minimise, and mitigate the adverse impact on biodiversity of the introduction and spread within the Union, both intentional and unintentional, of IAS (Art 1). Through the Regulation the EU also intends to meet its obligations relating to IAS under the CBD and the Convention on the Conservation of European Wildlife and Natural Habitats/3
The Regulation applies in principle to all IAS, a notion that is defined in several steps. To begin with, ‘alien species’ are understood as any live specimen of a species, subspecies, or lower taxon of animals, plants, fungi, or micro-organisms introduced outside its natural range. Such a species is ‘invasive’ when its introduction or spread has been found to threaten or adversely impact upon biodiversity and related ecosystem services. ‘Introduction’, in turn, is the movement, as a consequence of human intervention, of a species outside its natural range. The natural—that is, without human intervention—movement of species is not covered. Exemptions apply to a number of organisms, either in themselves or when used in specific contexts, that are already regulated under other pieces of EU law/4 (Arts 2 and 3.)
Since there are numerous IAS, it has been deemed important to give priority to addressing those IAS that are of particular concern to the EU. This is done through the development of a list of invasive species of Union concern, the so-called ‘Union list’. The list is adopted by the Commission by means of implementing acts in accordance with a committee procedure. It shall be subject to a comprehensive review every six years but may also be updated between these revisions as appropriate.
An IAS may only be included on the Union list if it meets a number of criteria, including being likely, based on available scientific evidence, to have a significant adverse impact on biodiversity and the related ecosystem services. It may also have an adverse impact on human health or the economy. It must furthermore have been demonstrated, by a risk assessment carried out in accordance with the Regulation, that concerted action at Union level is required to prevent its introduction, establishment, or spread and that the inclusion on the Union list is likely to effectively prevent, minimise, or mitigate its adverse impact. Member States may submit, together with the requisite risk assessment, requests for the inclusion of IAS on the Union list. When adopting or updating the Union list, the Commission must have due consideration to the implementation cost for Member States, the cost of inaction, cost-effectiveness, and socio-economic aspects. (Art 4.)
Specific rules apply with respect to the so-called outermost regions, as defined in Article 355 TFEU, including, inter alia, French Guiana, the Azores, Madeira, and the Canary Islands (Art 6).
Once a species has been listed as an IAS of Union concern, numerous activities involving that species must be prohibited. These include bringing the species into the territory of the Union, placing it on the market, releasing it into the environment, and keeping or breeding it, including in contained holding. The Member States must also take all necessary steps to prevent the unintentional introduction or spread of such species. Derogations may be granted through permit systems established by individual Member States. Permits may only be granted subject to specific conditions and only in order to enable research on, or ex situ conservation of, IAS of Union concern. Where the use of products derived from such species is unavoidable to advance human health, Member States may also include scientific production and subsequent medicinal use within their permit system. In exceptional cases and for reasons of compelling public interest, Member States may issue permits allowing establishments to carry out other activities with IAS of Union concern, but that requires an authorisation by the Commission in each case. (Arts 7—9.)
Transitional rules apply, under certain conditions, to non-commercial owners and commercial stocks of species that are being listed as IAS of Union concern (Arts 31 and 32).
The Regulation allows for emergency measures to be taken when a Member State has evidence concerning the presence in, or imminent risk of introduction into its territory of, an IAS which is not included on the Union list but which it has found, on the basis of preliminary scientific evidence, to be likely to meet the criteria for inclusion on that list. The Member State concerned may then impose any of the restrictions that apply to listed IAS. It must also immediately notify the Commission and all other Member States and carry out a risk assessment in accordance with the relevant provisions in the Regulation. If, following the completion of the risk assessment, the Commission does not include the IAS on the Union list, the Member State must repeal its emergency measures. It may, however, include that species on a national list of IAS of Member State concern. With respect to the species on such a list the Member State concerned may apply in its territory various restrictive measures, as appropriate, provided that the measures are compatible with the TFEU and notified to the Commission. (Arts 10 and 12.)
Within eighteen months of the adoption of the Union list, the Member States are required to carry out a comprehensive analysis of the pathways of unintentional introduction and spread of IAS of Union concern at least in their territory and in their marine waters, and identify the pathways which require priority action (so-called ‘priority pathways’). Within three years of the adoption of the Union list, each Member State shall establish and implement one or more action plans to address the priority pathways identified. The Member States must also have a surveillance system of IAS of Union concern, which collects and records data on the occurrence in the environment of IAS.
Since 2 January 2016, Member States have been required to have in place fully functioning structures to carry out the official controls necessary to prevent the intentional introduction into the Union of IAS of Union concern. Reference is made in the Union list to the categories of goods that are to be subject to such controls. (Arts 13-15.)
When complying with their obligations under the Regulation the Member States shall make every effort to ensure close coordination with all Member States concerned. They shall also endeavour to cooperate with third countries as appropriate, including by using existing structures arising from regional or international agreements. (Arts 11 and 22.)
If IAS are to be stopped it is essential to detect them early and take measures to prevent their establishment and further spread. To do this the Member States shall use surveillance systems and official controls to confirm the presence of any specimen of an IAS in the environment before it has become widely spread, that is, so-called ‘early detection’. If an IAS of Union concern is detected, the Member State must apply eradication measures in order to achieve the complete and permanent removal of the IAS and inform the Commission and the other Member States. In certain circumstances, including when eradication is technically unfeasible or when a cost-benefit analysis demonstrates that the costs will be exceptionally high and disproportionate to the benefits of eradication, the Member State may decide not to apply eradication measures. The decision must be notified to the Commission, which may decide, according to a committee procedure, to reject the decision. If the Member State is allowed not to implement eradication measures it must instead take effective management measures so that the impact on biodiversity, on the related ecosystem services, and, where applicable, on human health or the economy of the IAS is minimised.
Any IAS of Union concern which have been found to be widely spread on the territory of a Member State must also be subject to effective management measures within eighteen months of the IAS being included on the Union list. The measures shall be proportionate to the impact on the environment and be based on an analysis of costs and benefits. (Arts 2, 17, 18, and 19.)
When an ecosystem has been degraded, damaged, or destroyed by IAS of Union concern, the Member State concerned is to carry out appropriate restoration measures to assist the recovery of that ecosystem unless a cost-benefit analysis demonstrates that the costs of those measures will be high and disproportionate to the benefits of restoration. In accordance with the polluter-pays principle, Member States shall aim to recover the costs of the measures needed to prevent, minimise, or mitigate the adverse impact of IAS, including restoration cost. (Arts 20 and 21.)
Although it follows already from the Regulation being based on Article 192(1) TFEU, there is also a provision explicitly stating that Member States may maintain or lay down more stringent national rules with the aim of preventing the introduction, establishment, and spread of IAS, provided that those measures are compatible with the TFEU and are notified to the Commission (Art 23).
The Member States are required to lay down provisions on effective, proportionate, and dissuasive penalties applicable to infringements of the Regulation and take all the necessary measures to ensure that they are applied (Art 30).
The Regulation also contains provisions on, inter alia, reporting and review, information support system, and public participation (Arts 24—29).
-  COM(2011) 244 final (n 5) Target 5 and Action 16 as set out in the Annex.
-   OJ L 3 1 7/35 . 72 Preambular paras 1—3. 73 (‘Bern Convention’) (Bern, 9 September 1979) 1284 UNTS 209. 74 This applies, inter alia, to genetically modified organisms regulated under Directive 2001/ 18/ECof the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC  OJ L 106/1 and tomicro-organisms manufactured or imported for use in plant protection products or biocidal productsauthorised in accordance with applicable EU law.