- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of alien and locally absent species in aquaculture
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Mae unrhyw newidiadau sydd wedi cael eu gwneud yn barod gan y tîm yn ymddangos yn y cynnwys a chyfeirir atynt gydag anodiadau.Ar ôl y diwrnod ymadael bydd tair fersiwn o’r ddeddfwriaeth yma i’w gwirio at ddibenion gwahanol. Y fersiwn legislation.gov.uk yw’r fersiwn sy’n weithredol yn y Deyrnas Unedig. Y Fersiwn UE sydd ar EUR-lex ar hyn o bryd yw’r fersiwn sy’n weithredol yn yr UE h.y. efallai y bydd arnoch angen y fersiwn hon os byddwch yn gweithredu busnes yn yr UE. EUR-Lex Y fersiwn yn yr archif ar y we yw’r fersiwn swyddogol o’r ddeddfwriaeth fel yr oedd ar y diwrnod ymadael cyn cael ei chyhoeddi ar legislation.gov.uk ac unrhyw newidiadau ac effeithiau a weithredwyd yn y Deyrnas Unedig wedyn. Mae’r archif ar y we hefyd yn cynnwys cyfraith achos a ffurfiau mewn ieithoedd eraill o EUR-Lex. The EU Exit Web Archive legislation_originated_from_EU_p3
EU_status_warning_original_version
This legislation may since have been updated - see the latest available (revised) version
Wherever possible, information is to be supported with references from the scientific literature, and notations to personal communications with scientific authorities and fisheries experts. Applicants are advised to distinguish between movements to ‘open’ or ‘closed’ aquaculture facilities.
For the purpose of this Annex when an application refers to a proposed translocation, rather than an introduction, the terms introduction/introduced are to be replaced by translocation/translocated.
Provide a brief summary of the document including a description of the proposal, the potential impacts on native species and their habitats and mitigation steps to minimise the potential impacts on native species.
Describe the plans for follow-up assessments of the proposed introduced species’ success and how any negative impacts on native species and their habitats will be assessed.
measures taken to ensure that no other species (non-target species) accompany the shipment;
who will be permitted to use the proposed organisms and under what terms and conditions;
will there be a pre-commercial phase for the proposed introduction?
description of the contingency plan for the removal of species;
description of the quality assurance plan for the proposal, and,
other legislative requirements that need to be met.
To evaluate risks associated with the introduction or translocation of aquatic organisms it is necessary to assess the probability that the organisms will become established and the consequences of that establishment.
The process addresses the major environmental components. It provides a standardised approach for evaluating the risk of genetic and ecological impacts as well as the potential for introducing a non-target species that might impact the native species of the proposed receiving waters.
During the review process, emphasis is not on the ratings but on the detailed biological and other relevant information statements that motivate them. In case of scientific uncertainty, the precautionary principle should be applied.
For the purpose of this Annex, where an application refers to a proposed translocation the terms ‘introduction/introduced’ are to be replaced by ‘translocation/translocated’.
a H = High, M = Medium, L = Low | |||
b VC = Very certain, RC = Reasonably certain, RU = Reasonably uncertain, VU = Very uncertain | |||
c The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice. | |||
d The final rating for the likelihood of establishment and spreading is assigned the value of the element with the lowest rating (for example, high and low ratings for the above elements would result in a final low rating). Again, both events — probability of the organism successfully colonising and maintaining a population in the intended area of introduction (be it a confined environment such as a facility, or a natural habitat) and the probability of spreading beyond the intended area of introduction (estimated as explained above) — need to occur in order to have establishment beyond the intended area of introduction. The final rating for the level of Certainty is assigned the value of the element with the lowest level of certainty (e.g. very certain and reasonably certain ratings would result in a final reasonably certain rating). The harmfulness of a establishment and spreading should be taken into account, together with risk/benefit ration, in arriving at the final rating. | |||
Event | Likelihood(H, M, L)a | Certainty(VC, RC, RU, VU)b | Comments in support of assessmentc |
---|---|---|---|
The introduced or translocated species, escaped or dispersed, successfully colonises and maintains a population in the intended area of introduction beyond the control of the aquaculture facility. | |||
The introduced species or translocated, escaped or dispersed, spreads beyond the intended area of introduction. | |||
Final ratingd |
a The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice. | |||
b The final rating for the consequences of establishment and spreading is assigned the value of the element (individual probability) with the highest rating and the final rating for the level of certainty is assigned the value of the element with the lowest level of certainty. | |||
Event | Likelihood(H, M, L) | Certainty(VC, RC, RU, VU) | Comments in support of assessmenta |
---|---|---|---|
Genetic mixing with local populations leads to a loss of genetic diversity. | |||
Competition (food, space) with or predation on native populations leads to their extirpation. | |||
Other undesirable events of ecological nature | |||
Some of the abovementioned events persist even after removal of the introduced species. | |||
Final ratingb |
A single value is given based on the assessments done in Steps 1 and 2:
a The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice. | |||
b The final categorisation of risk potential takes the value of the highest of the two probabilities when there is no probability increment between the two estimates (i.e. if the Risk of establishment and spreading is high and the risk of ecological consequences is medium, the final rating takes the value of the highest of the two probabilities which is high. When there is a probability increment between the two estimates (i.e. a mixture of high and low) the final value is medium. | |||
Component | Risk potential(H, M, L) | Certainty(VC, RC, RU, VU) | Comments in support of assessmenta |
---|---|---|---|
Establishment and spreading (step 1) | |||
Ecological consequences (step 2) | |||
Final rating of overall risk potentialb |
The result of this assessment will be expressed in terms of the following risk levels:
A high-risk movement:
has a high risk of damaging biodiversity from spreading and other ecological consequences;
operates under farming conditions which would increase the risk of such damage;
involves an aquaculture facility which sells live aquatic animals for further farming or restocking;
as a consequence, the movement is of major concern (major mitigation measures are required). It is advised that the proposal be rejected unless mitigation procedures can be developed to reduce the risk to low.
A medium-risk movement:
has a medium risk of damaging biodiversity from spreading and other ecological consequences;
operates under farming conditions which would not necessarily increase the risk of such damage, taking account of the species and the containment conditions;
involves an aquaculture facility which sells its products mainly for human consumption;
as a consequence the movement is of moderate concern. It is advised that the proposal be rejected unless mitigation procedures can be developed to reduce the risk to low.
A low-risk movement:
has a low risk of damaging biodiversity from spreading and other ecological consequences.
operates under farming conditions which would not increase the risk of such damage;
involves an aquaculture facility which sells its products for human consumption only;
as a consequence the movement is of negligible concern. It is advised that the proposal be approved. Mitigation is not needed.
The proposal can only be approved as presented (no mitigating measures required) if the overall estimated risk potential is low and if the overall certainty for which the overall risk has been estimated is very certain or reasonably certain.
If, as a result of a first analysis, a high or medium category is attributed to the overall risk, then containment or mitigation proposals are to be incorporated in the application, which will be subject to subsequent risk analysis until the final rating for the overall risk becomes low with a very certain or reasonably certain assessment. Descriptions of these additional steps, together with detailed specifications of the containment or mitigation measures, will become an integral part of the risk assessment.
a The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice. | |||
b The final rating under likelihood is assigned the value of the element with the lowest risk rating and the final rating for the level of certainty is also assigned the value of the element with the lowest level of certainty. | |||
Event | Likelihood(H, M, L) | Certainty(VC, RC, RU, VU) | Comments in support of assessmenta |
---|---|---|---|
A non-target species is introduced as a consequence of the introduction or translocation of the aquatic organisms. | |||
The introduced non-target species encounters susceptible habitats or host organisms. | |||
Final ratingb |
a The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice. | |||
b The final rating for the consequences is assigned the value of the highest risk rating and final rating for the level of certainty is also assigned the value of the element with the lowest level of certainty. | |||
Event | Likelihood(H, M, L) | Certainty(VC, RC, RU, VU) | Comments in support of assessmenta |
---|---|---|---|
The non-target species compete with or predate on native populations, leading to their extirpation. | |||
Genetic mixing of the non-target species with local populations leads to a loss of genetic diversity. | |||
Other undesirable events of ecological or pathological nature | |||
Some of the abovementioned events persist even after removal of the non-target species. | |||
Final ratingb |
A single value is given based on the assessments performed in Steps 1 and 2:
a The assessor is referred for guidance to Appendix A and Appendix B of the ICES Code of Practice. | |||
b The final rating under risk potential is assigned the value of the element with the lowest risk rating and the final rating for the level of certainty is also assigned the value of the element with the lowest level of certainty. | |||
Component | Risk potential(H, M, L) | Certainty(VC, RC, RU, VU) | Comments in support of assessmenta |
---|---|---|---|
Establishment and spreading (step 1) | |||
Ecological consequences (step 2) | |||
Final ratingb |
The conditions applicable to the assessment of risk potential associated to the alien species (part 1) are to also apply, mutatis mutandis, to this risk potential associated with non-target species (part 2), including the obligation to introduce containment and mitigation measures.
History, background and rationale for the request:
risk assessment summary information
summary of the ecological and genetic risk assessment
summary of the non-target species risk assessment
Comments:
Mitigation measures:
Concluding statement on total organism potential risk:
Advice to competent authority:
Quarantine is the means by which live animals or plants and any of their associated organisms are maintained in complete isolation from the surrounding environment so as to prevent impact on wild and farmed species and undesirable changes to natural ecosystems.
It is necessary to keep alien or locally absent species in quarantine long enough to detect all non-target species and to confirm the absence of pathogens or diseases. The unit is to be constructed in accordance with the specifications of the competent authority in the Member State of its location which is to be responsible for approving it. The duration of quarantine must be indicated in the permit. If the facility is not located of the receiving Member State, the advisory committee responsible for the facility and the advisory committee in the receiving Member State must agree on the duration.
Operators are to run quarantine facilities in accordance with the following conditions. In addition the operator must have a quality assurance programme and an operating manual.
For the purpose of this Annex where an application refers to a proposed translocation, the terms introduction/introduced are to be replaced by translocation/translocated.
All effluents and wastes generated within the facility must be treated in a manner that effectively destroys all possible target species and associated organisms. To ensure continuous operation and complete containment, quarantine effluent treatment systems must be equipped with fail-safe backup mechanisms.
Treated effluent and waste may contain substances which are harmful to the environment (e.g. antifouling agents) and must be disposed of in a manner which minimises environmental impact.
Details of effluent and solid waste treatment must be prepared, listing the personnel responsible for treatments and timing. The system must be monitored to ensure effective operation and early detection of possible failures.
The organisms which have been transferred must be kept separate from other organisms to ensure containment. This excludes sentinel species which are specifically included to test the effects of the introduced species. The entry of birds, other animals, disease agents and contaminants must be prevented.
Access must be restricted to trained, authorised personnel. Footwear, hands and any material used within the facility should be disinfected (see below) before exiting the facility.
Upon receipt, all life-stages, tanks, water, shipping containers and equipment in contact with the introduced species, including the transport vehicles, must be handled is such a way as to ensure that there is no escape of the species or associated non-target species from the facility. All shipping and packing material must be disinfected, or burned if burning of the material is authorised.
Daily records or mortalities must be maintained and must be available for inspection by the competent authority. All mortalities must be kept on site. No mortalities, tissue or shells are to be discarded without approved treatment to ensure complete disinfection. Heat treatment such as autoclaving or chemical sterilisation may be employed.
Mortalities must be reported to the competent authority and Member States must investigate the cause of mortalities in a timely manner. Mortalities must be stored, transported and disposed of, in accordance with Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption(1).
Regular inspections must be carried out for non-target species. If such a species or a previously undetected disease or parasite is identified in an organism, actions necessary to control the situation must be taken. These actions may include destruction of the organisms and disinfection of the facility.
The required duration of quarantine will vary according to the organism in question, seasonality of non-target species of concern and the rearing conditions.
Quarantine facilities must maintain accurate records of the following:
entry/exit times of personnel,
number of mortalities and method of storage or disposal,
treatment of incoming water and of effluent,
samples submitted to experts to test for non-target species,
any abnormal conditions affecting quarantine operation (power cuts, building damage, serious weather conditions, etc.).
Disinfection involves the application of disinfectants in sufficient concentrations and for sufficient time to kill harmful organisms. The disinfectants and concentrations for quarantine disinfection must be based on complete seawater and freshwater disinfection. Similar concentrations must be used for routine facility disinfection. It is recommended that all disinfectants be neutralised before release into the surrounding environment and facilities using seawater must deal with residual oxidants produced during chemical disinfection. In case of an emergency, such as the finding of an imported parasite or disease agent, sufficient disinfectant must be available to enable treatment of the entire facility.
Rainbow trout, Oncorhynchus mykiss
Brook trout, Salvelinus fontinalis
Common carp, Cyprinus carpio
Grass carp, Ctenopharyntgodon idella
Silver carp, Hypophthalmichthys molitrix
Big head carp, Aristichtys nobilis
Pacific cupped oyster, Crassostrea gigas
Japanese or Manila clam, Ruditapes philippinarum
Large-mouth bass, Micropterus salmoides
Arctic char, Salvelinus alpinus
OJ L 273, 10.10.2002, p. 1. Regulation last amended by Commission Regulation (EC) No 2007/2006 (OJ L 379, 28.12.2006, p. 98).
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys