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Document L:2022:311:FULL

Official Journal of the European Union, L 311, 2 December 2022


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 311

European flag  

English edition

Legislation

Volume 65
2 December 2022


Contents

 

I   Legislative acts

page

 

 

REGULATIONS

 

*

Regulation (EU) 2022/2343 of the European Parliament and of the Council of 23 November 2022 laying down management, conservation and control measures applicable in the Indian Ocean Tuna Commission (IOTC) Area of Competence, amending Council Regulations (EC) No 1936/2001, (EC) No 1984/2003 and (EC) No 520/2007

1

 

 

II   Non-legislative acts

 

 

REGULATIONS

 

*

Commission Implementing Regulation (EU) 2022/2344 of 29 November 2022 on the reimbursement, in accordance with Article 17(3) of Regulation (EU) 2021/2116 of the European Parliament and of the Council, of the appropriations carried over from financial year 2022

54

 

*

Commission Implementing Regulation (EU) 2022/2345 of 1 December 2022 correcting the Swedish language version of Implementing Regulation (EU) 2017/373 laying down common requirements for providers of air traffic management/air navigation services and other air traffic management network functions and their oversight, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU) 2016/1377 and amending Regulation (EU) No 677/2011 ( 1 )

58

 

*

Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices ( 1 )

60

 

*

Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose ( 1 )

94

 

*

Commission Implementing Regulation (EU) 2022/2348 of 1 December 2022 amending Annex I to Implementing Regulation (EU) 2021/605 laying down special control measures for African swine fever ( 1 )

97

 

 

DECISIONS

 

*

Council Decision (EU) 2022/2349 of 21 November 2022 authorising the opening of negotiations on behalf of the European Union for a Council of Europe convention on artificial intelligence, human rights, democracy and the rule of law

138

 

*

Council Decision (EU) 2022/2350 of 21 November 2022 appointing a member, proposed by the Italian Republic, of the Committee of the Regions

142

 

*

Political and Security Committee Decision (CFSP) 2022/2351 of 29 November 2022 on the appointment of the EU Mission Force Commander of the European Union military mission to contribute to the training of the Malian Armed Forces (EUTM Mali), and repealing Decision (CFSP) 2022/657 (EUTM Mali/2/2022)

143

 

*

Council Decision (CFSP) 2022/2352 of 1 December 2022 on an assistance measure under the European Peace Facility to support the Georgian Defence Forces

145

 

*

Council Decision (EU) 2022/2353 of 1 December 2022 on an assistance measure under the European Peace Facility to strengthen the capacities of the Armed Forces of Bosnia and Herzegovina

149

 

*

Council Decision (CFSP) 2022/2354 of 1 December 2022 on an assistance measure under the European Peace Facility to support the deployment of the Rwanda Defence Force in Mozambique

153

 

*

Council Decision (CFSP) 2022/2355 of 1 December 2022 on an assistance measure under the European Peace Facility to strengthen the capacities of the armed forces of the Islamic Republic of Mauritania

157

 

*

Council Decision (CFSP) 2022/2356 of 1 December 2022 on an assistance measure under the European Peace Facility to support the Lebanese Armed Forces

161

 

*

Commission Implementing Decision (EU) 2022/2357 of 1 December 2022 amending Implementing Decision (EU) 2019/451 as regards the harmonised standard for retroreflecting road studs ( 1 )

165

 

*

Commission Implementing Decision (EU) 2022/2358 of 1 December 2022 on the French measure establishing a limitation on the exercise of traffic rights due to serious environmental problems, pursuant to Article 20 of Regulation (EC) No 1008/2008 of the European Parliament and of the Council (notified under document C(2022) 8694)  ( 1 )

168

 

*

Decision (EU) 2022/2359 of the European Central Bank of 22 November 2022 adopting internal rules concerning restrictions of rights of data subjects in connection with the European Central Bank’s internal functioning (ECB/2022/42)

176

 

 

Corrigenda

 

*

Corrigendum to Commission Implementing Regulation (EU) 2022/2105 of 29 July 2022 laying down rules on conformity checks of marketing standards for olive oil and methods of analysis of the characteristics of olive oil ( OJ L 284, 4.11.2022 )

199

 


 

(1)   Text with EEA relevance.

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.


I Legislative acts

REGULATIONS

2.12.2022   

EN

Official Journal of the European Union

L 311/1


REGULATION (EU) 2022/2343 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 23 November 2022

laying down management, conservation and control measures applicable in the Indian Ocean Tuna Commission (IOTC) Area of Competence, amending Council Regulations (EC) No 1936/2001, (EC) No 1984/2003 and (EC) No 520/2007

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

The objective of the Common Fisheries Policy (CFP), as set out in Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3), is to ensure the exploitation of marine biological resources in a way that contributes to long-term environmental, economic and social sustainability.

(2)

The Union has, by means of Council Decision 98/392/EC (4), approved the United Nations Convention of 10 December 1982 on the Law of the Sea. By means of Council Decision 98/414/EC (5), the Union has approved the Agreement for the Implementation of that Convention relating to the Conservation and Management of Straddling Fish Stocks and Highly Migratory Fish Stocks, which contains principles and rules with regard to the conservation and management of the living resources of the sea. In the framework of its wider international obligations, the Union participates in efforts made in international waters to conserve fish stocks.

(3)

Pursuant to Council Decision 95/399/EC (6), the Union is a contracting party to the Agreement for the establishment of the Indian Ocean Tuna Commission (IOTC).

(4)

The IOTC adopts annual conservation and management measures (CMMs) by way of resolutions that are binding on contracting parties and on cooperating non-contracting parties to the IOTC, including on the Union. This Regulation implements resolutions of the IOTC, adopted between 2000 and 2021, except for measures which already form part of Union law.

(5)

To ensure compliance with Regulation (EU) No 1380/2013, Union legislation has been adopted to establish a system of control, inspection and enforcement, which includes the fight against illegal, unreported and unregulated (IUU) fishing. In particular, Council Regulation (EC) No 1224/2009 (7) establishes a Union system for control, inspection and enforcement with a global and integrated approach so as to ensure compliance with all the rules of the CFP. Council Regulation (EC) No 1005/2008 (8) establishes a Community system to prevent, deter and eliminate IUU fishing. Those Regulations already include provisions covering a number of the measures laid down in IOTC resolutions. It is therefore not necessary to include those provisions in this Regulation.

(6)

In accordance with Article 4 of Regulation (EU) 2019/473 of the European Parliament and of the Council (9), the European Fisheries Control Agency (EFCA) should, at the Commission’s request, assist the Union and the Member States in their relations with third countries and regional international fisheries organisations of which the Union is a member. When needed for the implementation of Union obligations, EFCA should, at the Commission’s request, coordinate control and inspection activities by Member States on the basis of international control and inspection programmes, which may include programmes implemented in IOTC CMMs, in accordance with Article 9 of Regulation (EU) 2019/473. EFCA may draw up, in concert with the Member States concerned, joint operational inspection and surveillance programmes for that purpose by establishing joint deployment plans. It is therefore appropriate to adopt provisions that include EFCA, when so designated by the Commission, as the body designated by the Commission that receives from Member States and transmits to the IOTC Secretariat information relating to control and inspection, such as at sea inspection reports and notifications of the control observers scheme.

(7)

Taking into account the situation of fish stocks and the need to ensure effective control activities and a level-playing field for all operators in the IOTC area, and pursuant to Articles 28 and 29 of Regulation (EU) No 1380/2013, Union actions in international fisheries organisations are to be based on the best available scientific advice so as to ensure that fishery resources are managed in accordance with the objectives laid down in Article 2 of that Regulation, and the Union is to ensure that Union fishing activities outside Union waters are based on the same principles and standards as those applicable under Union law, including those relating to control of fishing activities, while promoting a level-playing field for Union operators vis-à-vis third-country operators.

(8)

The IOTC Rules of Procedure establish English and French as its official languages. In order to permit operators to effectively carry out their activities falling within the scope of this Regulation and to avoid obstacles in communication with the competent port authorities, the transhipment declaration should be submitted in one of the official languages of the IOTC.

(9)

When Member States and the Commission conduct research on certain species in the IOTC area, such as oceanic whitetip sharks, thresher sharks and blue sharks, they should also consider the impact of climate change on their abundance.

(10)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (10), and delivered formal comments on 23 May 2022. Personal data processed in the framework of this Regulation is to be treated in accordance with the applicable provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council (11) and Regulation (EU) 2018/1725. In order to ensure effective enforcement of this Regulation, it is necessary to store those personal data for a period of 10 years. In the event that the personal data in question are needed in order to follow up an infringement, inspection or judicial or administrative procedures, it should be possible for those data to be stored for a period exceeding 10 years, but no longer than 20 years.

(11)

In order to swiftly implement into Union law future IOTC resolutions amending or supplementing the ones established in this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending provisions concerning the use of non-entangling and biodegradable fish aggregating devices (FADs), ports designated under the IOTC rules, information per vessel for the list of active vessels for tuna and swordfish, the percentage of observer coverage and field samplers coverage for artisanal fisheries, conditions of chartering, the percentage of inspections for port landings, reporting deadlines and Annexes 1 to 10 to this Regulation that cover IOTC requirements for catch reporting, birds mitigation measures, data collections and FADs, chartering requirements, transhipment declaration and certain bigeye tuna statistical programme documents, as well as references to IOTC conservation and management measures that relate to principles for design and deployment of FADs to reduce entanglement, FAD reporting, marking and identification of vessels, IUU reporting documents, bigeye tuna statistical programme documents, port state entry notifications, minimum standard port Member State inspection procedures, reporting forms for infringements and catch and fishing measures reporting templates. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (12). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(12)

As this Regulation provides a new and comprehensive set of rules, the provisions concerning IOTC CMMs laid down in Council Regulations (EC) No 1936/2001 (13), (EC) No 1984/2003 (14) and (EC) No 520/2007 (15) should be deleted. Those Regulations should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation implements into Union law management, conservation and control measures established by the Indian Ocean Tuna Commission (IOTC) that are binding on the Union.

Article 2

Scope

This Regulation shall apply to:

(a)

Union fishing vessels which operate in the Area;

(b)

Union fishing vessels in the case of transhipments and landings of IOTC species outside the Area; and

(c)

third-country fishing vessels making use of ports in Member States and which carry IOTC species or fishery products originating from such species.

Article 3

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)

‘the Agreement’ means the Agreement for the establishment of the Indian Ocean Tuna Commission;

(2)

‘the Area’ means those parts of the Indian Ocean as defined in Article II of and Annex A to the Agreement;

(3)

‘Union fishing vessel’ means any vessel of any size flying the flag of a Member State, equipped for commercial exploitation of marine biological resources, including support vessels, fish processing vessels, vessels engaged in transhipment and carrier vessels equipped for the transportation of fishery products, except container vessels;

(4)

‘IOTC species’ means tuna and tuna-like species and sharks listed in Annex B to the Agreement, and other species caught in association with those species;

(5)

‘contracting parties and cooperating non-contracting parties’ or ‘CPCs’ means contracting parties to the Agreement or cooperating non-contracting parties;

(6)

‘conservation and management measure’ or ‘CMM’ means an applicable conservation and management measure adopted by the IOTC pursuant to Articles V(2)(c) and IX(1) of the Agreement;

(7)

‘unfit for human consumption’ means a fish that is meshed or crushed in the purse seine, or is damaged due to depredation, or has died and spoiled in the net where a gear failure has prevented both the normal retrieval of the net and catch, and efforts to release the fish alive without including a fish that is considered undesirable in terms of size, marketability or species composition, or a fish that is spoiled or contaminated as the result of an act or omission of the crew of the Union fishing vessel;

(8)

‘fish aggregating device’ or ‘FAD’ means a permanent, semi-permanent or temporary object, structure or device of any material, man-made or natural, which is deployed and/or tracked for the purpose of aggregating target tuna species for consequent capture;

(9)

‘drifting FAD’ or ‘DFAD’ means a FAD not tethered to the bottom of the ocean;

(10)

‘anchored FAD’ or ‘AFAD’ means a FAD tethered to the bottom of the ocean;

(11)

‘data buoys’ means floating devices, either drifting or anchored, that are deployed by governmental or recognised scientific organisations or entities for the purpose of electronically collecting and measuring environmental data, and not for the purpose of fishing activities;

(12)

‘IOTC transhipment declaration’ means the document set out in Annex 7;

(13)

‘IMO number’ means a 7-digit number, which is assigned to a vessel under the authority of the International Maritime Organization (IMO);

(14)

‘chartering’ means an agreement or an arrangement by which a fishing vessel flying the flag of a CPC is contracted for a defined period of time by an operator in another CPC without a change of flag; the ‘chartering CPC’ refers to the CPC that holds the quota allocation or fishing possibilities and the ‘flag CPC’ refers to the CPC in which the chartered vessel is registered;

(15)

‘carrier vessel’ means a support vessel engaged in transhipment and receiving IOTC species from another vessel;

(16)

‘e-Port State Measures application’ or ‘e-PSM application’ means the web-based application designed and developed to facilitate and assist a CPC to implement the IOTC resolutions related to port State measures;

(17)

‘illegal, unreported and unregulated fishing’ or ‘IUU fishing’ means fishing activities as defined in Article 2, points (1) to (4), of Regulation (EC) No 1005/2008.

CHAPTER II

MANAGEMENT AND CONSERVATION

SECTION 1

Tropical Tunas

Article 4

Discard ban

1.   Union purse seine vessels shall retain on board and land all catches of tropical tunas (bigeye tuna (Thunnus obesus), yellowfin tuna (Thunnus albacares) and skipjack tuna (Katsuwonus pelamis)), except where the master of the vessel determines that:

(a)

fish are unfit for human consumption, or

(b)

there is insufficient storage capacity to accommodate tropical tuna and the non-targeted species caught during the final set of a trip.

2.   Fish referred to in paragraph 1, point (b), may only be discarded if the master and crew attempt to release the tropical tuna and the non-targeted species alive as soon as possible, while taking into consideration the safety of the crew, and no further fishing is undertaken after the discard until the tropical tuna and the non-targeted species on board the vessel have been landed or transhipped.

3.   The master of a Union fishing vessel shall record the exceptions referred to in paragraph 1, points (a) and (b), in the relevant logbook, including estimated tonnage and species composition of discarded fish, and estimated tonnage and species composition of retained fish from that set.

4.   For the purposes of this Article, non-targeted species includes non-targeted tuna species, as well as rainbow runner (Elagatis bipinnulata), dolphinfish (Coryphaena hippurus), triggerfish (family Balistidae), billfish (families Xyphiidae and Istiophoridae), wahoo (Acanthocybium solandri) and barracuda (family Sphyraenidae).

Article 5

Prohibition of fishing on data buoys

1.   Union fishing vessels shall not intentionally fish within one nautical mile of a data buoy or interact with a data buoy in the Area, in particular by:

(a)

encircling the buoy with fishing gear;

(b)

tying up to or attaching the vessel, or any fishing gear, part or portion of the vessel, to a data buoy or its mooring; or

(c)

cutting a data buoy anchor line.

2.   By way of derogation from paragraph 1, Union fishing vessels may operate within one nautical mile of data buoys provided that they operate under scientific research programmes of Member States notified to the IOTC and they do not interact with those data buoys.

3.   Union fishing vessels shall not take on board a data buoy in the Area, unless the owner responsible for that buoy has explicitly authorised or requested them to do so.

4.   Union fishing vessels operating in the Area shall keep watch for moored data buoys at sea and shall take all reasonable measures to avoid fishing gear entanglement or directly interacting in any way with those data buoys. When a Union fishing vessel’s gear becomes entangled with a data buoy, it shall remove the entangled fishing gear with as little damage to the data buoy as possible.

5.   Union fishing vessels shall report to their flag Member States any data buoy that they have observed to be damaged or otherwise inoperable, along with the details of observation, the buoy’s location, and any discernible identifying information on it. Member States shall send such reports, and information on the location of data buoys assets that they have deployed throughout the Area to the Commission, in accordance with Article 51(5).

SECTION 2

Billfishes

Article 6

Billfishes

1.   Union fishing vessels shall not retain on board, tranship, or land, any specimens of striped marlin (Tetrapturus audax), black marlin (Istiompax indica), blue marlin (Makaira nigricans) or Indo-pacific sailfish (Istiophorus platypterus) with a lower jaw fork length of less than 60 cm. If they catch such fish, they shall return them immediately to the sea, in a manner that maximises post-release survival potential without compromising the safety of the crew.

2.   Union fishing vessels catching striped marlin, black marlin, blue marlin or Indo-pacific sailfish shall record the relevant catch and effort data in accordance with Annex 1.

3.   Member States shall implement a data collection programme to ensure accurate reporting of striped marlin, black marlin, blue marlin or Indo-pacific sailfish catches in accordance with Article 51(1).

4.   Member States shall report on actions taken to monitor catches and to manage fisheries for the sustainable exploitation and conservation of striped marlin, black marlin, blue marlin and Indo-pacific sailfish in their national scientific report in accordance with Article 51(6).

SECTION 3

Blue Sharks

Article 7

Blue sharks

1.   Catches of blue shark (Prionace glauca) by Union fishing vessels shall be recorded in the logbook in accordance with Article 14 of Regulation (EC) No 1224/2009.

2.   Member States shall implement data collection programmes to ensure improved reporting of accurate blue shark catch, effort, size and discard data. Member States shall report data on catches of blue sharks in accordance with Article 51(1).

3.   Member States shall include in their implementation report information on the actions taken to monitor catches of blue sharks in accordance with Article 51(5).

4.   Member States are encouraged to undertake scientific research on blue shark that would provide information on key biological, ecological, behavioural characteristics, life-history, migrations, post-release survival and guidelines for safe release and identification of nursery grounds, as well as improving fishing practices. Such information shall be included in the reports that are sent to the Commission in accordance with Article 51(6).

SECTION 4

Fishing using aircraft, FADs and artificial lights

Article 8

Prohibition of the use of aircraft to catch fish

1.   Union fishing vessels, including support and supply vessels, shall not use aircraft or unmanned aerial vehicles as fishing aids. Any occurrence of a fishing operation undertaken in the Area with the aid of aircraft or an unmanned aerial vehicle shall be immediately reported to the flag Member State, the Commission or a body designated by it. The Commission, or a body designated by it, shall inform the IOTC Secretariat thereof without delay.

2.   Aircraft and unmanned aerial vehicles may be used for scientific, monitoring, control and surveillance purposes.

Article 9

Fish aggregating devices

1.   Union fishing vessels shall record fishing activities in association with drifting FADs and anchored FADs, separately, using the specific data elements set out in Annex 2. Member States shall send that information to the Commission in accordance with Article 51.

2.   Daily information on all active FADs shall be transmitted to the Commission containing the following information: date, instrumented buoy identification and assigned vessel and daily position, compiled at monthly intervals and submitted not earlier than 60 days but no later than 90 days after the monthly compilation of the information concerned. The Commission shall send that information to the IOTC Secretariat.

3.   Member States shall draw up national management plans for the use of drifting FADs by their purse seine vessels. Those management plans shall:

(a)

as a minimum follow the guidelines set out in Annex II to CMM 19/02;

(b)

include initiatives or surveys to investigate, and to the extent possible, minimise the capture of small bigeye and yellowfin tuna and non-target species associated with FADs; and

(c)

include guidelines to prevent, to the extent possible, the loss or abandonment of FADs.

4.   No later than 75 days before the IOTC annual meeting, Member States shall submit to the Commission, in accordance with Article 51(5), a report on the progress of the management plans of FADs, including reviews of the initially submitted management plans and reviews of the application of the principles of Annex V to CMM 19/02. The Commission shall send that information to the IOTC Secretariat no later than 60 days before the IOTC annual meeting.

Article 10

Non-entangling and biodegradable FADs

1.   Union fishing vessels shall use non-entangling designs and materials for the construction of FADs ensuring that the surface structure of the FAD is not covered or is covered only with non-meshed material. If a sub-surface component is used, it shall not be made from netting but from non-meshed materials, such as ropes or canvas sheets.

2.   Union fishing vessels shall endeavour to transition to the use of biodegradable FADs in all circumstances except for materials used for the instrumented buoys.

3.   Operators shall endeavour to conduct trials using biodegradable materials to facilitate the transition to the use of only biodegradable material for drifting FADs construction by their fleets.

Article 11

Prohibition of the use of artificial lights to attract fish

1.   Union fishing vessels shall not use, install or operate surface or submerged artificial lights for the purpose of aggregating tuna and tuna-like species beyond territorial waters.

2.   The use of lights on drifting FADs is prohibited.

3.   Where Union fishing vessels encounter drifting FADs equipped with artificial lights in the Area, they shall immediately remove them and bring them back to port.

4.   Union fishing vessels shall not conduct fishing activities around or near any vessel or drifting FAD equipped with artificial lights for the purpose of attracting tuna and tuna-like species in the Area.

5.   Navigation lights and lights necessary to ensure safe working conditions shall not be subject to the prohibition laid down in paragraph 1.

SECTION 5

Transhipments in port

Article 12

Transhipment

All transhipment operations of IOTC species shall take place in ports designated in accordance with Article 5 of Regulation (EC) No 1005/2008, or in ports designated and publicised for that purpose by a CPC and communicated to the IOTC Secretariat.

Article 13

Transhipment operations

1.   Transhipment operations in port may only be undertaken in accordance with the following procedure:

(a)

prior to transhipping, the master of a Union fishing vessel shall notify the following information to the port state authorities, at least 48 hours in advance:

the name of the fishing vessel and its number in the IOTC record of fishing vessels;

the name of the carrier vessel, and the product to be transhipped;

the tonnage by product to be transhipped;

the date and location of transhipment;

the major fishing grounds of the tuna and tuna-like species and sharks catches;

(b)

the master of a Union fishing vessel shall record and transmit by electronic means a transhipment declaration in accordance with Article 22 of Regulation (EC) No 1224/2009.

2.   No later than 15 days after the transhipment, the master of a Union fishing vessel concerned shall complete the IOTC transhipment declaration and transmit it to its flag Member State in one of the official languages of the IOTC, along with the vessel’s number in the IOTC record of fishing vessels. The master of a Union carrier vessel shall also, within 24 hours after the transhipment, complete and transmit to the competent port state authorities the IOTC transhipment declaration in one of the official languages of the IOTC.

Article 14

Landing of transhipped catches by Union carrier vessels

1.   By way of derogation from Article 17(1) of Regulation (EC) No 1224/2009, the period for prior notification shall be at least 48 hours before the estimated time of arrival at the port.

2.   Member States where transhipped catches are landed shall take the appropriate measures to verify the accuracy of the information received and shall cooperate with the flag Member State of the carrier vessel, the port State where the transhipment took place and the flag states of the catching fishing vessels involved to ensure that landings are consistent with the catch amount reported for each fishing vessel. That verification shall be carried out in such a way that the carrier vessel suffers the minimum interference and inconvenience and that degradation of the fish is avoided.

3.   The master of a Union carrier vessel landing in a third country shall, at least 48 hours before entry into port and in addition to the prior notification referred to in paragraph 1, give prior notification in accordance with the national legislation of the third country in whose port the vessel intends to land transhipped catches. The master shall also send the IOTC transhipment declaration in one of the official languages of the IOTC to the competent authorities of the State in which transhipped catches are to be landed and shall not land before being authorised to do so.

4.   Where landings take place in a third country, the master of the carrier vessel shall cooperate with the port state authorities.

5.   Flag Member States of the Union fishing vessels shall include details on the transhipments by its vessels in their reports in accordance with Article 51(5).

CHAPTER III

PROTECTION OF CERTAIN MARINE SPECIES

SECTION 1

Elasmobranchs

Article 15

General conservation measures for sharks

1.   Union fishing vessels shall take all reasonable steps to apply the IOTC identification guides and handling practices.

2.   Union fishing vessels shall, to the extent possible, promptly release unharmed unwanted shark species caught alive on board of vessels, with the exception of blue sharks. Such catches shall be reported in the logbook in accordance with Article 14 of Regulation (EC) No 1224/2009, including the status on release (dead or alive).

3.   Member States shall report data on all catches of sharks, including all available historical data, estimates and life status of discards and release (dead or alive) and size frequencies of sharks caught by their fishing vessels to the Commission, in accordance with Article 51(1).

Article 16

Oceanic whitetip sharks

1.   Union fishing vessels shall not retain on board, tranship, land, store, sell or offer for sale any part or whole carcass of oceanic whitetip sharks (Carcharhinus longimanus).

2.   By way of derogation from paragraph 1, scientific observers shall be allowed to collect biological samples from oceanic whitetip sharks taken in the Area that are dead at haul back, provided that the samples are a part of a research project approved by the IOTC Scientific Committee or the IOTC Working Party on Ecosystems and Bycatch.

3.   Where possible, Member States and the Commission shall endeavour to conduct research on oceanic whitetip sharks taken in the Area, in order to identify potential nursery areas.

Article 17

Thresher sharks

1.   Union fishing vessels shall not retain on board, tranship, land, store, sell or offer for sale any part or whole carcass of thresher sharks of all species of the family Alopiidae.

2.   By way of derogation from paragraph 1, scientific observers shall be allowed to collect biological samples from thresher sharks taken in the Area that are dead at haul back, provided that the samples are a part of a research project approved by the IOTC Scientific Committee or the IOTC Working Party on Ecosystems and Bycatch.

3.   Recreational and sport fishers shall release all thresher sharks alive. Under no circumstances shall they retain them on board, tranship, land, store, sell or offer them for sale. Member States shall ensure that recreational and sport fishers carrying out fishing with risk of catching thresher sharks are equipped with instruments suitable for releasing the animals alive.

4.   Member States and the Commission shall endeavour to conduct research on thresher sharks taken in the Area, in order to identify potential nursery areas.

Article 18

Mobulid rays

1.   Union fishing vessels shall be prohibited from intentionally setting any gear type around a mobulid ray (species of the genus Mobula) if the animal is sighted prior to commencement of the set.

2.   Union fishing vessels shall not retain on board, tranship, land, store, sell or offer for sale any part or whole carcass of a mobulid ray.

3.   Union fishing vessels shall promptly release alive and unharmed, to the extent practicable, mobulid rays caught unintentionally as soon as they are seen in the net, on the hook, or on the deck, in a manner that will result in the least possible harm to the individual rays captured. They shall take all reasonable steps to apply handling procedures for mobulid rays, while taking into consideration the safety of the crew.

4.   Notwithstanding paragraph 3, where a Union purse seine vessel unintentionally catches and freezes a mobulid ray in the course of its operations, it shall surrender the whole mobulid ray to the responsible governmental authorities, or other competent authority, or discard it at the point of landing. Mobulid rays surrendered in that manner may not be sold or bartered but may be donated for the purposes of domestic human consumption.

5.   Union fishing vessels shall use proper mitigation, identification, handling and releasing techniques and keep on board all necessary equipment to release mobulid rays.

Article 19

Whale sharks

1.   Union fishing vessels shall be prohibited from intentionally setting a purse seine net around a whale shark (Rhincodon typus) in the Area, if it is sighted prior to the commencement of the set.

2.   Where a whale shark is unintentionally encircled or entangled in the fishing gear, Union fishing vessels shall:

(a)

take all reasonable steps to ensure its safe release, in line with available IOTC Scientific Committee’s best practice guidelines for the safe release and handling of whale sharks, while taking into consideration the safety of the crew;

(b)

report the incident to the vessel’s flag Member State, with the following information:

the number of individuals;

a short description of the interaction, including details of how and why the interaction occurred, if possible;

the location of the encirclement;

the steps taken to ensure safe release; and

an assessment of the life status of the whale shark on release, including whether it was released alive but subsequently died.

SECTION 2

Other Species

Article 20

Cetaceans

1.   Union fishing vessels shall be prohibited from intentionally setting a purse seine net around a cetacean in the Area, if it is sighted prior to the commencement of the set.

2.   Where a cetacean is unintentionally encircled in a purse seine net, or caught by other gear types fishing for tuna and tuna-like species associated with cetaceans, Union fishing vessels shall:

(a)

take all the reasonable steps to ensure its safe release, in line with the IOTC Scientific Committee’s available best practice guidelines for the safe release and handling of cetaceans, while taking into consideration the safety of the crew;

(b)

report the incident to the vessel’s flag Member State, with the following information:

the species (if known);

the number of individuals;

a short description of the interaction, including details of how and why the interaction occurred, if possible;

the location of the encirclement;

the steps taken to ensure safe release; and

an assessment of the life status of the animal on release, including whether the cetacean was released alive but subsequently died.

3.   Member States shall report the information referred to in paragraph 2, point (b), of this Article through logbooks in accordance with Article 14 of Regulation (EC) No 1224/2009 including the status upon release (dead or alive), or when an observer is on board through observer programmes and send it to the Commission, in accordance with Article 51(1) and (5).

Article 21

Marine turtles

1.   Union fishing vessels shall apply the following mitigation measures:

(a)

longline vessels shall carry line cutters and de-hookers in order to facilitate the appropriate handling and prompt release of marine turtles (species of families Cheloniidae and Dermochelyidae) that have been caught or entangled, taking all reasonable steps to ensure safe release and handling following the IOTC handling guidelines;

(b)

purse seine vessels shall, to the extent practicable:

avoid encirclement of marine turtles, and if a marine turtle is encircled or entangled, take practicable measures to safely release the turtle in accordance with the IOTC handling guidelines;

release all marine turtles found entangled in FADs or fishing gear;

where a marine turtle is entangled in the net, stop the net roll as soon as the turtle comes out of the water; before resuming the net roll, the operator shall disentangle the turtle without injuring it, and assist its recovery before returning it to the water; and

carry and employ dip nets, when appropriate, to handle marine turtles.

2.   Union fishing vessels shall bring aboard, if practicable, any captured marine turtle that is comatose or inactive as soon as possible and foster its recovery, including aiding in its resuscitation, before safely returning it to the water.

3.   Member States shall ensure that Union fishing vessels use proper mitigation, identification, handling and de-hooking techniques and keep on board all necessary equipment for the release of marine turtles, taking all reasonable steps in accordance with handling guidelines in the IOTC Marine Turtle Identification Cards provided in IOTC handling guidelines referred to in paragraph 1, point (a).

4.   Member States shall report on the implementation of the Guidelines of the Food and Agriculture Organization of the United Nations (FAO) to Reduce Sea Turtle Mortality in Fishing Operations.

5.   Member States shall send all data on their vessels interactions with marine turtles to the Commission, in accordance with Article 51(1). Those data shall include the level of logbook or observer coverage and an estimate of total mortality of marine turtles incidentally caught in their fisheries.

6.   Union fishing vessels shall record all incidents involving marine turtles during fishing operations, including status on release (dead or alive) in the logbooks in accordance with Article 14 of Regulation (EC) No 1224/2009. They shall report such incidents to their flag Member States with information, where possible, on the species, location of capture, conditions, actions taken on board and location of release. Member States shall send that information to the Commission, in accordance with Article 51(1).

Article 22

Seabirds

1.   Union fishing vessels shall use mitigation measures to reduce in levels of seabird bycatch across all fishing areas, seasons and fisheries. In the area south of 25 degrees South latitude, all longline vessels shall use at least two of the three mitigation measures set out in Annex 4 and shall comply with the minimum standards for those measures. The design and deployment of bird scaring lines shall comply with the additional specifications set out in Annex 5.

2.   Union fishing vessels shall record data on incidental seabird bycatch by species, in particular through the Regional Observer Scheme referred to in Article 30, and report them to the Commission in accordance with Article 51(1). Observers shall, to the extent possible, take photographs of seabirds caught by Union fishing vessels and transmit them to national seabird experts or the IOTC Secretariat for confirmation of identification.

3.   Member States shall inform the Commission, or a body designated by it, as to how the Regional Observer Scheme referred to in Article 30 is implemented, in accordance with Article 51(5).

CHAPTER IV

CONTROL MEASURES

SECTION 1

General conditions

Article 23

Documentation on board Union fishing vessels

1.   Union fishing vessels shall maintain fishing logbooks in accordance with this Regulation. The original recording contained in the fishing logbooks shall be kept on board the fishing vessel for at least 12 months.

2.   Union fishing vessels shall carry on board valid documents issued by the competent authority of the flag Member State including:

(a)

licence, permit or authorisation to fish and terms and conditions attached to the licence, permit or authorisation;

(b)

vessel’s name;

(c)

port in which the vessel is registered and the registration number(s);

(d)

international call sign;

(e)

names and addresses of the owner(s) and, if applicable, the charterer;

(f)

overall length; and

(g)

engine power, in kw/horsepower, where appropriate.

3.   Member States shall verify the validity of the documents to be carried on board fishing vessels regularly, and at least once a year.

4.   Member States shall ensure that all documents carried on board and any further amendments to them are issued and certified by the competent authority and that fishing vessels are marked in such a way that they can be readily identified with generally accepted international standards, such as the FAO Standard Specification for the Marking and Identification of Fishing Vessels.

SECTION 2

Record of vessels

Article 24

Record of authorised fishing vessels

1.   The following Union fishing vessels shall be registered in the IOTC record of fishing vessels:

(a)

vessels of 24 metres or more in overall length;

(b)

vessels of less than 24 metres in overall length, if they fish outside the exclusive economic zone (EEZ) of a Member State.

2.   Union fishing vessels that are not registered in the IOTC record referred to in paragraph 1 shall not be authorised to fish for, retain on board, tranship or land IOTC species or support any fishing activity or set DFADs in the Area.

This paragraph shall not apply to vessels of less than 24 metres in overall length operating in the EEZ of a Member State.

3.   Member States shall submit to the Commission the list of vessels complying with the requirements of paragraph 1 which are authorised to operate in the Area. That list shall include the following information for each vessel:

(a)

name of vessel(s), register number(s);

(b)

IMO number;

(c)

previous name(s) (if any) or indication of its non-availability;

(d)

previous flag(s) (if any) or indication of its non-availability;

(e)

details of previous deletion from other registries (if any) or indication of their non-availability;

(f)

international radio call sign(s) (if any) or indication of its non-availability;

(g)

port of registration;

(h)

type of vessel(s), overall length (m) and gross tonnage (GT);

(i)

total volume of fish hold(s) in cubic metres;

(j)

name and address of owner(s) and operator(s);

(k)

name and address of beneficial owner(s), if known and different from vessel owner/operator, or indication of their non-availability;

(l)

name, address and registration number of company operating the vessel (if any);

(m)

gear used;

(n)

time period(s) authorised for fishing and/or transhipping;

(o)

colour photographs of the vessel showing:

the starboard and portsides, each showing the whole structure;

the bow;

(p)

at least one colour photograph clearly showing at least one of the external markings specified in point (a).

4.   Member States shall promptly notify the Commission of any addition to, deletion from, or amendment of the IOTC record. The Commission shall send that information to the IOTC Secretariat without delay.

5.   During each year, the Commission shall, if necessary, provide the IOTC Secretariat with updated information on Union fishing vessels registered in the IOTC record referred to in paragraph 1.

Article 25

Communication of information

The information to be notified by Member States to the Commission in accordance with Article 24 of this Regulation shall be submitted in an electronic format in accordance with Article 39 of Regulation (EU) 2017/2403 of the European Parliament and of the Council (16).

Article 26

Authorisation of fishing vessels

1.   Member States shall issue an authorisation to fish for IOTC species for fishing vessels flying their flag in accordance with Article 21 of Regulation (EU) 2017/2403.

2.   Member States shall submit to the Commission an updated template of the official authorisation to fish outside national jurisdictions, and update the information in the template whenever necessary. The Commission shall send this information to the IOTC Secretariat without delay. The template shall include the following information:

(a)

name of the competent authority;

(b)

name and contact of personnel of the competent authority;

(c)

signature of the personnel of the competent authority; and

(d)

official stamp of the competent authority.

3.   The template referred to in paragraph 2 shall be used exclusively for monitoring, control and surveillance purposes. A difference between the template and the authorisation carried onboard the vessel shall not constitute an infringement, but shall prompt the controlling State to clarify the issue with the identified competent authority of the flag State of the vessel in question.

Article 27

Obligations for Member States issuing fishing authorisations

1.   Member States shall:

(a)

authorise their vessels to operate in the Area only if they are able to fulfil the requirements and responsibilities under the IOTC Agreement, this Regulation and CMMs;

(b)

take the necessary measures to ensure that their fishing vessels comply with this Regulation and CMMs;

(c)

take the necessary measures to ensure that their auxiliary fishing vessels keep on board valid certificates of vessel registration and valid authorisations to fish or tranship;

(d)

ensure that their authorised fishing vessels have no history of IUU fishing activities or that, if a vessel has such a history, the new owner has provided sufficient evidence demonstrating that:

the previous owners and operators have no legal, beneficial or financial interest in, or control over that vessel;

the parties involved in the IUU incident have officially resolved the matter and sanctions have been completed; and

having taken into account all relevant facts, their auxiliary fishing vessels are not engaged in or associated with IUU fishing;

(e)

ensure, to the extent possible under national legislation, that the owners and operators of their auxiliary fishing vessels are not engaged in or associated with tuna fishing activities conducted by vessels not registered in the IOTC record referred to in Article 24(1); and

(f)

take the necessary measures to ensure, to the extent possible under national legislation, that the owners of auxiliary fishing vessels registered in the IOTC record referred to in Article 24(1) are citizens of, or legal entities in, the flag Member State, so that any control or punitive action can be taken against them where required.

2.   Member States shall report the results of the review of the actions and measures taken pursuant to paragraph 1 of this Article to the Commission, or to a body designated by it, in accordance with Article 51(5).

3.   Member States which issue licences to their authorised fishing vessels shall report annually to the Commission, or to a body designated by it, all measures taken in accordance with Annex I to CMM 05/07, using the format set out in Annex II to CMM 05/07, and in accordance with Article 51 of this Regulation.

Article 28

Measures against vessels not registered in the IOTC record of vessels

1.   Union fishing vessels not registered in the IOTC record referred to in Article 24(1) shall not fish for, retain on board, tranship or land IOTC species in the Area.

2.   To ensure the effectiveness of this Regulation with regard to species covered by statistical document programmes, Member States shall:

(a)

validate statistical documents only for Union vessels registered in the IOTC record;

(b)

require that, when imported into the territory of a CPC, the species covered by statistical document programmes caught by Union fishing vessels in the Area shall be accompanied by statistical documents; and

(c)

cooperate, when importing catch of species covered by statistical document programmes, with the flag Member States of vessels catching those species to ensure that statistical documents are not forged or do not contain misinformation.

3.   Member States shall notify the Commission, or a body designated by it, of any factual information showing that there are reasonable grounds for suspecting that vessels not registered in the IOTC record are engaged in fishing for or transhipment of IOTC species in the Area. The Commission, or a body designated by it, shall notify the IOTC Secretariat of that information immediately.

Article 29

Record of active vessels fishing for tuna and swordfish

1.   Member States with vessels fishing for tunas and swordfish in the Area shall, using the appropriate IOTC report template, submit to the Commission by 1 February of each year a list of fishing vessels flying their flag that were active in the Area during the previous year and that:

(a)

are 24 metres in overall length or above, or

(b)

in the case of vessels shorter than 24 metres in overall length, operated in waters outside the EEZ of their Member State.

2.   Member States with vessels fishing for yellowfin tunas in the Area shall, using the appropriate IOTC report template, submit to the Commission by 1 February of each year a list of all fishing vessels flying their flag which have fished for yellowfin tuna in the Area during the previous year.

3.   The Commission shall forward the information referred to in paragraphs 1 and 2 to the IOTC Secretariat before 15 February of each year.

4.   The list of vessels referred to in paragraph 1 shall contain the following information for each vessel:

(a)

the IOTC number;

(b)

name and registration number;

(c)

IMO number, if available;

(d)

previous flag (if any);

(e)

international radio call sign (if any);

(f)

vessel type, length and gross tonnage (GT);

(g)

name and address of owner, charterer or operator (where relevant);

(h)

main target species; and

(i)

period of authorisation.

SECTION 3

Regional Observer Scheme

Article 30

Regional Observer Scheme

1.   In order to improve the collection of scientific data, Union fishing vessels of 24 metres in overall length and above, and those under 24 metres fishing outside the EEZ of a Member State, shall ensure that at least 5 % of the number of operations or sets for each gear type while fishing in the Area are covered by observers endorsed by the Regional Observer Scheme.

2.   When purse seine vessels are carrying an observer as referred to in paragraph 1, that observer shall also monitor the catches at landing to identify the composition of bigeye tuna catches.

3.   Paragraph 2 shall not apply to Member States that already have a sampling scheme the coverage of which fulfil requirements set out in paragraph 1.

Article 31

Observers’ obligations

1.   Observers on board Union fishing vessels shall:

(a)

record and report their fishing activities and verify positions of the vessel;

(b)

observe and estimate catches as far as possible with a view to identifying catch composition and monitoring discards, by-catches and size frequency;

(c)

record gear type, mesh size and attachments employed by the master;

(d)

collect information to enable the cross-checking of entries recorded in the logbooks (species composition and quantities, live and processed weight and location, where available); and

(e)

carry out scientific work as requested by the IOTC Scientific Committee.

2.   The observer shall, within 30 days of completion of each trip, provide a report to the flag Member State. The report shall be provided by area of 1°latitude by 1°longitude. Member States shall send each report to the Commission, or to a body designated by it, within 140 days from reception, and shall ensure that the reports from the observer placed on the longline fleet are sent regularly throughout the year. The Commission, or the body designated by it, shall forward the reports to the IOTC Secretariat within 10 days of their receipt.

Article 32

Field samplers

1.   Field samplers shall monitor the number of landings by Union artisanal fishing vessels at the landing place. As regards artisanal fishing vessels, the samplers should cover at least 5 % of the total number of fishing trips by such vessels or of the total number of active fishing vessels.

2.   Field samplers shall collect information on land during unloading of fishing vessels. Field sampling programmes can be used for quantifying catch, retained bycatch and collecting tag returns.

3.   Field samplers shall monitor catches at the landing place with a view to estimating catch-at-size by type of boat, gear and species, or carry out such scientific work as requested by the IOTC Scientific Committee.

Article 33

Member States obligations

1.   Member States shall recruit qualified observers to place on board vessels flying their flag.

2.   Member States shall:

(a)

take the necessary measures to ensure that observers are able to carry out their duties in a competent and safe manner;

(b)

ensure that observers alternate vessels between their assignments;

(c)

ensure that the vessel on which an observer is placed provides suitable food and lodging during the observer’s deployment of the same level as that of the officers on board, where possible;

(d)

ensure that the master of a vessel cooperates with observers in order for them to carry out their duties safely including providing access, as required, to the retained catch, and catch which is intended to be discarded; and

(e)

bear the cost of the observer scheme.

3.   Member States shall report the number of vessels monitored and the coverage achieved by gear type to the Commission, in accordance with Article 51(6).

SECTION 4

Monitoring and surveillance

Article 34

Vessel monitoring system (VMS)

1.   Member States shall, no later than two working days following detection or notification of technical failure or non-functioning of the vessel monitoring device on board a Union fishing vessel, forward the geographical position of the vessel to the IOTC Secretariat, or shall ensure that these positions are forwarded to the IOTC Secretariat by the master or the owner of the vessel, or their representative.

2.   Where a Member State suspects that one or more vessel monitoring devices on board the vessel of another flag Member State or another CPC do not meet required operational conditions, or have been tampered with, it shall immediately notify the Commission, or a body designated by it. The Commission, or the body designated by it, shall forward the notification to the IOTC Secretariat and the vessel’s flag State.

Article 35

Chartering

1.   Chartering shall be subject to the following conditions:

(a)

the flag CPC has consented in writing to the chartering agreement;

(b)

the duration of the fishing operation under the chartering agreement does not exceed 12 months in any calendar year;

(c)

fishing vessels to be chartered shall be registered with the responsible CPC which shall explicitly agree to comply with the CMMs and enforce them on their vessels; all flag CPCs shall effectively fulfil their duty to control their fishing vessels to ensure compliance with CMMs;

(d)

fishing vessels to be chartered shall be registered in the IOTC record referred to in Article 24 and shall be authorised to operate in the Area;

(e)

if the chartered vessel is allowed by the chartering CPC to operate in the high seas, the flag CPC shall be responsible for controlling the high seas fishing conducted pursuant to the chartering arrangement;

(f)

chartered vessels shall report VMS and catch data to both the chartering CPC and flag CPC, and to the IOTC Secretariat, as provided in the Charter Notification Scheme set out in Annex 6;

(g)

all catches, including bycatches and discards, taken pursuant to the chartering agreement shall be counted against quota or fishing possibilities of the chartering CPC; the observer coverage on board such chartered vessels shall be counted against the coverage rate of the chartering CPC for the duration of its fishing activity under the chartering agreement;

(h)

the chartering CPC shall report to the IOTC all catches, including bycatches and discards, and other information required by the IOTC;

(i)

chartered vessels shall be duly equipped with VMS, and fishing gear shall be marked for effective fishery management;

(j)

observer coverage of at least 5 % of fishing effort;

(k)

chartered vessels shall have a fishing licence issued by the chartering CPC and shall not be on the IOTC IUU vessel list, that of any other regional fisheries management organisation (RFMO), or on the Union IUU vessel list;

(l)

chartered vessels shall not be authorised to use the quota of the flag CPC, and under no circumstances shall chartered vessels be authorised to fish under more than one chartering agreement at the same time;

(m)

landing shall take place in the ports of the CPC, or under the direct supervision of CPC, in order to ensure that the activities of the chartered vessels do not undermine CMMs.

Article 36

Chartering notification scheme

1.   The chartering Member State shall notify the Commission of any vessel to be identified as chartered in accordance with this Article without delay within 15 days and no later than 72 hours before commencement of fishing activities under a chartering agreement, by submitting electronically the following information with respect to each chartered vessel:

(a)

the name (in both original registration language and Latin alphabets), registration number of the chartered vessel, and IMO number;

(b)

the name and contact address of the beneficial owner of the vessel;

(c)

the description of the vessel, including the overall length, type of vessel and the type of fishing method(s) to be used under the chartering agreement;

(d)

a copy of the chartering agreement and any fishing authorisation or licence it has issued to the vessel, including the quota allocation or fishing possibility assigned to the vessel, and the duration of the chartering arrangement;

(e)

its consent to the chartering agreement; and

(f)

the measures adopted to implement the provisions included in the chartering agreement.

2.   The flag Member State shall notify the Commission of any vessel to be identified as chartered in accordance with this Article, without delay within 17 days and no later than 96 hours before commencement of fishing activities under a chartering agreement by submitting electronically the information with respect to each chartered vessel referred to in paragraph 1.

3.   Upon receiving the information from Member States set out in paragraph 1 or 2, the Commission shall forward the following information to the IOTC Secretariat:

(a)

its consent to the chartering agreement;

(b)

the measures adopted to implement the provisions included in the chartering agreement; and

(c)

its agreement to comply with CMMs.

4.   Member States referred to in paragraphs 1 and 2 shall immediately inform the Commission of the start, suspension, resumption and termination of the fishing operations under the chartering agreement.

5.   Member States chartering fishing vessels shall report to the Commission by 10 February of each year the particulars of chartering agreements made in the previous calendar year, including information on catches taken and fishing effort deployed by the chartered vessels as well as the level of observer coverage achieved on the chartered vessels in accordance with Article 35(1), point (j). The Commission shall forward that information to the IOTC Secretariat by 28 February of each year.

Article 37

Vessels with no nationality

Where a Member State’s vessel or aircraft makes any sighting of fishing vessels that are suspected of, or confirmed as, being without nationality that may be fishing in the high seas of the Area, that Member State shall report the sighting to the Commission, or to a body designated by it. The Commission, or the body designated by it, shall forward the information to the IOTC Secretariat immediately.

Article 38

Fishing vessels with flags of convenience

Member States shall, as regards large scale tuna longline vessels with flags of convenience (FOCs):

(a)

refuse landing and transhipment by flag of convenience vessels which are engaged in fishing activities diminishing the effectiveness of the measures laid down in this Regulation or measures adopted by the IOTC;

(b)

take every possible action to urge their importers, transporters and other operators concerned to refrain from transacting in and transhipping tunas and tuna-like species caught by vessels carrying out flag of convenience fishing activities;

(c)

inform their general public of fishing activities which are carried out by large scale tuna longline vessels with FOCs and which diminish the effectiveness of IOTC conservation and management measures, and urge their general public not to purchase fish harvested by such vessels;

(d)

urge their manufacturers and other business people concerned to prevent their vessels and equipment or devices from being used for flag of convenience longline fishing operations; and

(e)

monitor and exchange information concerning flag of convenience fishing vessels activities, including the port sampling activities conducted by the IOTC Secretariat.

CHAPTER V

CATCH DATA

Article 39

Record of catch and effort data

1.   Union fishing vessels shall keep an electronic logbook to record data that includes, as minimum requirements, the information and data set out in Annex 1.

2.   The logbook shall be completed by the master of the fishing vessel and be submitted to the flag Member State, as well as to the coastal State in whose EEZ the Union fishing vessel has fished. Only the part of the logbook corresponding to the activity deployed in the coastal State EEZ shall be provided to the coastal State.

3.   Member States shall report to the Commission all the data for any given year on an aggregated basis in their annual reports, in accordance with Article 51(1).

Article 40

Bigeye tuna catch certificate

1.   All bigeye tuna imported into the territory of a Member State shall be accompanied by an IOTC Bigeye Tuna Statistical Document, as provided for in Annex 8, or an IOTC bigeye tuna re-export certificate which meets the requirements of Annex 9.

2.   By way of derogation from paragraph 1, bigeye tuna caught by purse seine vessel or pole and line (bait) vessels and destined principally for the canneries in the Area are not subject to this statistical requirement.

3.   The documents referred to in paragraph 1 shall be validated in accordance with the format set out in Annex IV to CMM 03/03 and the following rules:

(a)

the IOTC bigeye tuna statistical document shall be validated by the flag Member State of the vessel that caught the tuna, or if the vessel is operating under a chartering arrangement, by the State that exported the tuna;

(b)

the IOTC bigeye tuna re-export certificate shall be validated by the State that re-exported the tuna;

(c)

statistical documents for bigeye tuna caught by Union vessels may be validated by the Member State where the products are landed, provided the corresponding quantities of bigeye tuna are exported outside the Union from the territory of the Member States of landing.

4.   By 15 March of each year, for the period from 1 July to 31 December of the previous year, and by 15 September of each year, for the period from 1 January to 30 June of the current year, Member States that import bigeye tuna shall report to the Commission the data collected under the bigeye tuna statistical document programme, using the format set out in Annex III to CMM 03/03. The Commission shall examine the information and shall transmit it to the IOTC Secretariat by 1 April and 1 October, respectively.

5.   Member States which export bigeye tuna shall examine export data upon receiving the import data referred to in paragraph 4 of this Article, and shall report the results to the Commission annually, in accordance with Article 51(5).

CHAPTER VI

PORT STATE MEASURES, INSPECTION, ENFORCEMENT AND IUU

SECTION 1

Port state measures

Article 41

Points of contact and designated ports

1.   A Member State wishing to grant access to its ports to third-country fishing vessels carrying IOTC species caught in the Area or fishery products originating from IOTC species that have not been previously landed or transhipped shall:

(a)

designate the port to which third-country fishing vessels may request entry pursuant to Article 5 of Regulation (EC) No 1005/2008;

(b)

designate a point of contact for the purposes of receiving prior notice pursuant to Article 6 of Regulation (EC) No 1005/2008;

(c)

designate a point of contact for the purposes of receiving inspection reports pursuant to Article 11(3) of Regulation (EC) No 1005/2008.

2.   Member States shall transmit any changes to the list of designated points of contact and designated ports to the Commission, or to a body designated by it, at least 30 days before the changes take effect. The Commission, or the body designated by it, shall forward that information to the IOTC Secretariat at least 15 days before the changes take effect.

Article 42

Prior notice

1.   By way of derogation from Article 6(1) of Regulation (EC) No 1005/2008, the period for prior notification shall be at least 24 hours before the estimated time of arrival at the port or immediately after the end of the fishing operations, if the time distance to the port is less than 24 hours.

2.   By way of derogation from Article 6(1) of Regulation (EC) No 1005/2008, the information to be provided by masters of third country fishing vessels or their representatives shall be that required under Annex 10 to this Regulation which shall be accompanied by a catch certificate validated in accordance with Chapter III of Regulation (EC) No 1005/2008 if those third-country fishing vessels carry on board IOTC fishery products.

3.   The prior notice referred to in Article 6 of Regulation (EC) No 1005/2008 and the information required under paragraph 2 of this Article may be transmitted electronically through e-PSM application.

4.   Port Member States may request any additional information in order to determine whether the fishing vessels referred to in paragraph 1 have engaged in IUU fishing or related activities.

Article 43

Authorisation to enter, land and tranship in ports

1.   After receiving the relevant information pursuant to Article 42, a port Member State shall decide whether to authorise or deny the third-country fishing vessel entry into and use of its ports. Where a third-country fishing vessel has been denied entry, the port Member State shall inform the flag State of the vessel and the Commission, or a body designated by it. The Commission, or the body designated by it, shall forward the information to the IOTC Secretariat without delay. Port Member States shall deny entry to fishing vessels included in the IOTC IUU vessel list, that of any other RFMO or the Union IUU vessel list.

2.   Where a prior notice has been received through e-PSM application, the port Member State shall communicate its decision to authorise or deny entry into port through the same application.

3.   Pursuant to Article 8(1) of Regulation (EC) No 1005/2008, in the case of carrier vessels, the IOTC transhipment declaration is required and shall be submitted at least 48 hours prior to the intended time of landing. In order to ensure that landings are consistent with the reported catch amount of each catching fishing vessel, the Member States where transhipped catches are to be landed shall take the appropriate measures to verify the accuracy of the information received and shall cooperate with the flag State of the carrier vessel, any port State involved in the transhipments to be landed and the flag states of the catching fishing vessels involved. That verification shall be carried out in such a way that the carrier vessel suffers the minimum interference and inconvenience and that degradation of the fish is avoided.

4.   Where a landing or transhipment declaration is received by the port Member State from a catching fishing vessel pursuant to Article 8(1) of Regulation (EC) No 1005/2008, the port Member States shall take appropriate measures to verify the accuracy of the information received and shall cooperate with the flag CPC to ensure that landings and/or transhipments are consistent with the amount of catches reported for each catching vessel.

5.   Each port Member State shall submit to the Commission by 15 June of each year the list of fishing vessels that are not flagged to that port Member State and which have landed in its ports tuna and tuna-like species caught in the Area in the preceding calendar year. That information shall be included in the appropriate IOTC report template and shall detail the catch composition by weight and species landed. The Commission shall examine such reports and transmit them to the IOTC Secretariat by 30 June of each year.

SECTION 2

Inspection

Article 44

Port inspection

1.   Each year, each port Member State shall inspect in its designated ports at least 5 % of all landings or transhipments related to IOTC species made by fishing vessels that are not flagged to that port Member State.

2.   Inspections shall involve the monitoring of the entire landing or transhipment and include a cross-check between the quantities, by species, recorded in the prior notice and the quantities by species actually landed or transhipped. When the landing or transhipment is completed, the inspector shall verify and note the quantities by species of fish remaining on board.

Article 45

Inspection procedure

1.   This Article shall apply in addition to the rules on the inspection procedure laid down in Article 10 of Regulation (EC) No 1005/2008.

2.   Inspectors from port Member States shall be properly qualified inspectors authorised for that purpose, and shall carry a valid document of identity that they shall present to the master of the vessel to be inspected.

3.   As a minimum standard, port Member States shall ensure that their inspectors carry out the tasks set out in Annex II to CMM 16/11. Port Member States, in carrying out inspections in their ports, shall require the master of the vessel to give inspectors all necessary assistance and information, and to present relevant material and documents as may be required, or certified copies thereof.

4.   In the written report of the results of each inspection, each port Member State shall, as a minimum, include the information set out in Annex III to CMM 16/11. Within three working days of the completion of the inspection, the port Member State shall transmit a copy of the inspection report and, upon request, an original or certified copy thereof, to the master of the inspected vessel, to the flag State, to the Commission, or to a body designated by it. The Commission, or the body designated by it, shall forward the report to the IOTC Secretariat.

5.   By 15 June of each year, each port Member State shall submit to the Commission the list of fishing vessels not flagged to that port Member State which have landed in its ports tuna and tuna-like species caught in the IOTC area the preceding calendar year. That information shall detail the catch composition by weight and species landed. The Commission shall forward that information to the IOTC Secretariat by 1 July of each year.

SECTION 3

Enforcement

Article 46

Procedure in the case of evidence of infringements of IOTC measures during port inspections

1.   If the information collected during the inspection provides evidence that a fishing vessel has committed a breach of the IOTC measures, this Article shall apply in addition to Article 11 of Regulation (EC) No 1005/2008.

2.   The competent authorities of the port Member State shall forward a copy of the inspection report to the Commission, or to a body designated by it, as soon as possible and in any case within three working days. The Commission, or the body designated by it, shall transmit that report to the IOTC Secretariat and to the flag CPC point of contact without delay.

3.   Port Member States shall promptly notify the action taken in the event of infringements to the competent authority of the flag CPC and to the Commission, or to a body designated by it. The Commission, or the body designated by it, shall transmit that information to the IOTC Secretariat.

Article 47

Alleged infringements reported by Member States

1.   Member States shall submit to the Commission, using the reporting form of Annex I to CMM 18/03, any documented information that indicates possible instances of non-compliance by any fishing vessel with IOTC conservation and management measures in the Area over the past two years at least 80 days in advance of the annual meeting of the IOTC. The Commission shall examine that information and, if appropriate, forward it to the IOTC Secretariat at least 70 days in advance of the compliance committee meeting.

2.   The documented information referred to in paragraph 1 shall be accompanied by the information concerning the IUU fishing activity of each of the listed vessels, including:

(a)

reports regarding the alleged IUU fishing activity relating to CMMs in force;

(b)

trade information obtained on the basis of relevant trade statistics such as those from statistical documents and other verifiable national or international statistics;

(c)

any information obtained from other sources or gathered from fishing grounds, such as:

information gathered from inspections undertaken in port or at sea;

information from coastal states including VMS transponder or Automatic Identification System (AIS) data, surveillance data from satellites or airborne or seaborne assets;

IOTC programmes, except where such a programme stipulates that information gathered is to be kept confidential; or

information and intelligence collected by third parties.

Article 48

Alleged infringements reported by CPC and the IOTC Secretariat

1.   Where the Commission receives from a CPC or the IOTC Secretariat any information indicating alleged IUU fishing activities by a Union fishing vessel, it shall transmit that information to the Member State concerned without delay.

2.   The Member State concerned shall provide the Commission with the findings of any investigation undertaken in relation to the allegations of non-compliance by fishing vessels flying its flag, and any actions taken to address compliance concerns, at least 45 days in advance of the annual meeting of the IOTC. The Commission shall forward that information to the IOTC at least 15 days in advance of the annual meeting.

Article 49

Draft IOTC IUU vessel list

1.   If the Commission receives official notification of the inclusion of a Union fishing vessel in the draft IOTC IUU vessel list from the IOTC Secretariat, it shall transmit that notification, including the supporting evidence and any other documented information provided by the IOTC Secretariat, to the flag Member State concerned.

2.   The Member State concerned shall provide comments no later than 30 days in advance of the annual meeting of the IOTC Compliance Committee. The Commission shall examine and forward that information to the IOTC Secretariat at least 15 days in advance of the annual meeting of the Compliance Committee.

3.   Once notified by the Commission, the authorities of the flag Member State concerned shall:

(a)

notify the owner and the operators of the fishing vessel of its inclusion in the draft IOTC IUU vessel list and of the possible consequences that may result from that inclusion being confirmed in the IUU vessel list adopted by the IOTC; and

(b)

closely monitor the vessels included in the draft IOTC IUU vessel list, in order to determine their activities and detect possible changes of name, flag, or registered owner of those vessels.

Article 50

Provisional IOTC IUU vessel list

1.   In order to prevent a Union fishing vessel included in the draft IOTC IUU vessel list, as referred to in Article 49, from being included in the provisional IOTC IUU vessel list, the flag Member State shall provide the following information to the Commission demonstrating that:

(a)

the vessel has, at all relevant times, complied with the conditions of its authorisation and:

conducted fishing activities in a manner consistent with the CMMs,

conducted fishing activities within the waters under the jurisdiction of a coastal State in a manner consistent with the laws and regulations of that coastal State, or

fished exclusively for species not covered by the Agreement; or

(b)

effective punitive action has been taken in response to the IUU fishing activities in question, including prosecution and imposition of sanctions of adequate severity to be effective in securing compliance and deterring further infringements.

2.   The Commission shall examine the information referred to in paragraph 1 and transmit it to the IOTC Secretariat without delay.

CHAPTER VII

FINAL PROVISIONS

Article 51

Data reporting

1.   No later than 15 June of each year, Member States shall submit to the Commission, using the table set out in Annex II to CMM 18/07, the information for the preceding calendar year, concerning the following elements:

(a)

estimates of the total catch by species and gear, if possible quarterly, separated, whenever possible, by retained catches in live weight and by discards in live weight or numbers, for all species under the IOTC mandate as well as the most commonly caught elasmobranch species according to records of catches and incidents;

(b)

total catch data concerning cetaceans, marine turtles and seabirds data as referred to in Articles 20, 21 and 22, respectively;

(c)

for purse seine and pole and line fisheries, data on catch and effort stratified by fishing mode and extrapolated to the total national monthly catches for each gear; documents describing the extrapolation procedures shall also be submitted routinely;

(d)

for longline fisheries, data on catches by species, in numbers or weight, and effort as the number of hooks deployed, provided by 5° grid area and monthly strata; documents describing the extrapolation procedures shall also be submitted routinely;

(e)

a summary of the most recent yellowfin tuna catches in accordance with Article 39;

(f)

zero catches, that shall be reported using the table set out in Annex II to CMM 18/07.

2.   In addition to the information referred to in paragraph 1, Member States shall include the following fishing effort data by the purse seiners fleet using supply vessels and FADs:

(a)

the number and characteristics of purse seine supply vessels, operating under their flag, or assisting purse seine vessels operating under their flag, or licensed to operate in their EEZ, which have been operated in the Area;

(b)

number and days at sea by purse seine vessels and purse seine supply vessels by 1° grid area and month to be reported by the flag Member State of the supply vessel;

(c)

the positions, dates and the time of setting, FAD identifier and type, and FAD design characteristics of each FAD.

3.   The information referred to in paragraph 1, for type of vessels and in regard to provisional and final data, shall be submitted to the Commission on the following dates:

(a)

provisional data for longline fleets operating on the high seas for the previous year shall be submitted no later than 15 June of each year; final data shall be submitted no later than 15 December of each year;

(b)

final data for all other fleets, including supply vessels, shall be submitted no later than 15 June each year.

4.   The Commission shall analyse the information, and send it to the IOTC Secretariat by the specific deadlines provided for in this Regulation.

5.   Member States shall submit to the Commission 75 days before the annual meeting of the IOTC information for the preceding calendar year, containing the information on actions taken to implement their reporting obligations for all IOTC fisheries, including shark species caught in association with IOTC fisheries, in particular the steps taken to improve their data collection for direct and incidental catches. The Commission shall compile the information in a Union implementation report and send it to the IOTC Secretariat.

6.   Flag Member States shall send annually to the Commission a national scientific report, no later than 45 days before the session of the IOTC Scientific Committee, at a date communicated by the Commission, containing the following information:

(a)

general fisheries statistics;

(b)

report on the implementation of Committee recommendations;

(c)

the progress achieved undertaking research as provided in Article 15(3), Article 16(3), Article 17(4) and Article 18(5); and

(d)

other relevant information related to fishing activities for IOTC species as well as sharks, other byproduct and bycatch species.

7.   The report referred to in paragraph 6 shall be drawn up in accordance with the template prescribed by the Scientific Committee of the IOTC. The Commission shall send to the flag Member States the required template. The Commission shall analyse the information in the report, compile it in a Union report and send it to the IOTC Secretariat.

Article 52

Confidentiality and data protection

1.   Data collected and exchanged in the framework of this Regulation shall be treated in accordance with the applicable rules on confidentiality pursuant to Articles 112 and 113 of Regulation (EC) No 1224/2009.

2.   The collection, transfer, storage or other processing of any data pursuant to this Regulation shall be in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725.

3.   Personal data processed under this Regulation shall not be stored for a period longer than 10 years, except if the personal data are necessary to enable the follow-up of an infringement, an inspection, or judicial or administrative procedures. In those cases, the personal data may be stored for 20 years. If personal data are retained for a longer period, those data shall be anonymised.

Article 53

Guidelines

The Commission shall provide Member States which have fishing opportunities in the fisheries managed by the IOTC with any guidelines developed by the IOTC, in particular with regard to:

(a)

identification guides and handling practices for sharks;

(b)

handling procedures for mobulid rays;

(c)

the IOTC Scientific Committee’s best practice guidelines for the safe release and handling of whale sharks;

(d)

the IOTC Scientific Committee’s best practice guidelines for the safe release and handling of cetaceans; and

(e)

handling guidelines on marine turtles.

The Member States concerned shall ensure that those guidelines are provided to the masters of their vessels engaged in the fisheries concerned. Those masters shall take all reasonable steps to apply such guidelines.

Article 54

Procedure for amendments

1.   Where necessary in order to implement into Union law amendments or supplements to the existing IOTC resolutions which become binding on the Union, and insofar as amendments to Union law do not go beyond the IOTC resolutions, the Commission is empowered to adopt delegated acts in accordance with Article 55 for the purpose of amending:

(a)

description of FADs in Article 10;

(b)

CPC ports to be used for transhipment in Article 12;

(c)

information per vessel for the list of active vessels for tuna and swordfish, set out in Article 24(3);

(d)

percentage of observer coverage set out in Article 30(1);

(e)

field samplers coverage for artisanal fisheries set out in Article 32(1);

(f)

conditions of chartering set out in Article 35(1);

(g)

percentage of inspections for port landings set out in Article 44(1);

(h)

reporting deadlines set out in Article 29(1) and (3), Article 45(5) and Article 51;

(i)

Annexes 1 to 10;

(j)

references to international acts set out in Article 9(3), point (a), Article 9(4), Article 21(4), Article 23(4), Article 27(3), Article 40(3) and (4), Article 42(3), Article 45(3) and (4), Article 47(1) and Article 51(1).

2.   Any amendments adopted in accordance with paragraph 1 shall be strictly limited to the implementation into Union law of amendments and supplements to the IOTC resolutions concerned that are binding on the Union.

Article 55

Exercise of the delegation

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Article 54 shall be conferred on the Commission for a period of five years from 22 December 2022. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.   The delegation of power referred to in Article 54 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.   A delegated act adopted pursuant to Article 54 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 56

Amendments to Regulations (EC) No 1936/2001, (EC) No 1984/2003, and (EC) No 520/2007

1.   Article 2, point (b) and Articles 20 to 21a of Regulation (EC) No 1936/2001 are deleted.

2.   Article 1, point (b), Article 8, point (b), and Annexes VII, XII, XIV, and XVIII to Regulation (EC) No 1984/2003 are deleted.

3.   Article 4(2) and Articles 18 to 20 of Regulation (EC) No 520/2007 are deleted.

Article 57

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 23 November 2022.

For the European Parliament

The President

R. METSOLA

For the Council

The President

M. BEK


(1)  OJ C 341, 24.8.2021, p. 106.

(2)  Position of the European Parliament of 4 October 2022 (not yet published in the Official Journal) and decision of the Council of 24 October 2022.

(3)  Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).

(4)  Council Decision 98/392/EC of 23 March 1998 concerning the conclusion by the European Community of the United Nations Convention of 10 December 1982 on the Law of the Sea and the Agreement of 28 July 1994 relating to the implementation of Part XI thereof (OJ L 179, 23.6.1998, p. 1).

(5)  Council Decision 98/414/EC of 8 June 1998 on the ratification by the European Community of the Agreement for the implementing of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 relating to the conservation and management of straddling stocks and highly migratory fish stocks (OJ L 189, 3.7.1998, p. 14).

(6)  Council Decision 95/399/EC of 18 September 1995 on the accession of the Community to the Agreement for the establishment of the Indian Ocean Tuna Commission (OJ L 236, 5.10.1995, p. 24).

(7)  Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).

(8)  Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) No 2847/93, (EC) No 1936/2001 and (EC) No 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 1447/1999 (OJ L 286, 29.10.2008, p. 1).

(9)  Regulation (EU) 2019/473 of the European Parliament and of the Council of 19 March 2019 on the European Fisheries Control Agency (OJ L 83, 25.3.2019, p. 18).

(10)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

(11)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(12)  OJ L 123, 12.5.2016, p. 1.

(13)  Council Regulation (EC) No 1936/2001 of 27 September 2001 laying down control measures applicable to fishing for certain stocks of highly migratory fish (OJ L 263, 3.10.2001, p. 1).

(14)  Council Regulation (EC) No 1984/2003 of 8 April 2003 introducing a system for the statistical monitoring of trade in bluefin tuna, swordfish and bigeye tuna within the Community (OJ L 295, 13.11.2003, p. 1).

(15)  Council Regulation (EC) No 520/2007 of 7 May 2007 laying down technical measures for the conservation of certain stocks of highly migratory species and repealing Regulation (EC) No 973/2001 (OJ L 123, 12.5.2007, p. 3).

(16)  Regulation (EU) 2017/2403 of the European Parliament and of the Council of 12 December 2017 on the sustainable management of external fishing fleets, and repealing Council Regulation (EC) No 1006/2008 (OJ L 347, 28.12.2017, p. 81).


ANNEX 1

Record once per set/shot/operation

Note: for all gears in this Annex use the follow format for date and time

For date: when recording date of the set/shot/operation: record the YYYY/MM/DD

For time: record 24hr time as either the local time, GMT or national time and clearly specify which time has been used.

OPERATION

For longline:

Date of set

Position in latitude and longitude: either position at noon or position of start of gear or area code of operation (e.g. Seychelles EEZ, high seas, etc.) may be optionally used

Time of starting setting and, when possible, retrieving the gear

Number of hooks between floats: if there are different hooks counts between floats in a single set then record the most representative (average) number

Total number of hooks used in the set

Number of light–sticks used in the set

Type of bait used in the set: e.g. fish, squid, etc.

Optionally, sea surface temperature at noon with one decimal point (XX.XoC)

For purse seine:

Date of set

Type of event: fishing set or deployment of a new fish aggregating device (FAD)

Position in latitude and longitude and time of event, or if no event during the day, at noon

If fishing set: specify if the set was successful, its duration, the hold utilised, type of school (free swimming school or FAD associated. If FAD associated, specify the type (e.g. log or other natural object, drifting FAD, anchored FAD, etc.). Refer to the CMM 18/08

Procedures on a FADs management plan, including a limitation on the number of FADs, more detailed specification of catch reporting from FAD sets, and the development of improved FAD designs to reduce the incidence of entanglement of non-target species (or any subsequent superseding Resolution)

Optionally, sea surface temperature at noon with one decimal point (XX.XoC)

For gillnet:

Date of set: record the date for each set or day at sea (for days without sets)

Total length of net (meters): floatline length used for each set in meters

Start fishing time: record the time when starting each set and, when possible, gear retrieving

Start and end position in latitude and longitude: record start and end latitude and longitude that represent the area that your gear is set between or, if no set, record the latitude and longitude at noon for days without sets

Depth at which net is set (meters): approximate depth at which the gillnet is set

For Pole and Line:

Fishing effort information in logbooks shall be recorded by day. Catch information in logbooks shall be recorded by trip or, when possible, by fishing day.

Date of operation: record the day or date

Position in latitude and longitude at noon

Number of fishing poles used during that day

Start fishing time (record the time immediately after bait fishing is complete and the vessel heads to the ocean for fishing. For multiple days, the time at which search starts should be recorded) and end fishing time (record the time immediately after fishing is complete from the last school; on multiple days this is the time fishing stopped from the last school). For multiple days number of fishing days should be recorded.

Type of school: FAD associated and/or free school

CATCH

Catch weight (kg) or number by species per set/shot/fishing event for each of the species and form of processing in section ‘Species’ below:

For longline by number and weight

For purse seine by weight

For gillnet by weight

For pole and line by weight or number

SPECIES

For longline:

Primary Species

FAO code

Other Species

FAO code

Southern bluefin tuna (Thunnus maccoyii)

SBF

Shortbill spearfish (Tetrapturus angustirostris)

SSP

Albacore (Thunnus alalunga)

ALB

Blue shark (Prionace glauca)

BSH

Bigeye tuna (Thunnus obesus)

BET

Mako sharks (Isurus spp.)

MAK

Yellowfin tuna (Thunnus albacares)

YFT

Porbeagle shark (Lamna nasus)

POR

Skipjack tuna (Katsuwonus pelamis)

SKJ

Hammerhead sharks (Sphyrna spp.)

SPN

Swordfish (Xiphias gladius)

SWO

Silky shark (Carcharhinus falciformis)

FAL

Striped marlin (Tetrapturus audax)

MLS

Other bony fishes

MZZ

Blue marlin (Makaira nigricans)

BUM

Other sharks

SKH

Black marlin (Istiompax indica)

BLM

Seabirds (in number) (1)

 

Indo–Pacific sailfish (Istiophorus platypterus)

SFA

Marine Mammals (in number)

MAM

 

 

Marine turtles (in number)

TTX

 

 

Thresher sharks (Alopias spp.)

THR

 

 

Oceanic whitetip shark (Carcharhinus longimanus)

OCS

 

 

Optional species to be recorded

 

 

 

Tiger shark (Galeocerdo cuvier)

TIG

 

 

Crocodile shark (Pseudocarcharias kamoharai)

PSK

 

 

Great white shark (Carcharodon carcharias)

WSH

 

 

Mantas and devil rays (Mobulidae)

MAN

 

 

Pelagic stingray (Pteroplatytrygon violacea)

PLS

 

 

Other rays

 

For purse seine:

Primary Species

FAO code

Other species

FAO code

Albacore (Thunnus alalunga)

ALB

Marine turtles (in number)

TTX

Bigeye tuna (Thunnus obesus)

BET

Marine mammals (in number)

MAM

Yellowfin tuna (Thunnus albacares)

YFT

Whale sharks (Rhincodon typus) (in number)

RHN

Skipjack tuna (Katsuwonus pelamis)

SKJ

Thresher sharks (Alopias spp.)

THR

Other IOTC species

 

Oceanic whitetip shark (Carcharhinus longimanus)

OCS

 

 

Silky sharks (Carcharhinus falciformis)

FAL

 

 

Optional species to be recorded

FAO code

 

 

Mantas and devil rays (Mobulidae)

MAN

 

 

Other sharks

SKH

 

 

Other rays

 

 

 

Other bony fish

MZZ

For gillnet:

Primary Species

FAO code

Other Species

FAO code

Albacore (Thunnus alalunga)

ALB

Shortbill spearfish (Tetrapturus angustirostris)

SSP

Bigeye tuna (Thunnus obesus)

BET

Blue shark (Prionace glauca)

BSH

Yellowfin tuna (Thunnus albacares)

YFT

Mako sharks (Isurus spp.)

MAK

Skipjack tuna (Katsuwonus pelamis)

SKJ

Porbeagle shark (Lamna nasus)

POR

Longtail tuna (Thunnus tonggol)

LOT

Hammerhead sharks (Sphyrna spp.)

SPN

Frigate tuna (Auxis thazard)

FRI

Other sharks

SKH

Bullet tuna (Auxis rochei)

BLT

Other bony fish

MZZ

Kawakawa (Euthynnus affinis)

KAW

Marine turtles (in number)

TTX

Narrow barred Spanish mackerel (Scomberomorus commerson)

COM

Marine mammals (in number)

MAM

Indo–Pacific king mackerel (Scomberomorus guttatus)

GUT

Whale sharks (Rhincodon typus) (in number)

RHN

Swordfish (Xiphias gladius)

SWO

Seabirds (in number) (2)

 

Indo–Pacific sailfish (Istiophorus platypterus)

SFA

Thresher sharks (Alopias spp.)

THR

Marlins (Tetrapturus spp., Makaira spp.)

BIL

Oceanic whitetip shark (Carcharhinus longimanus)

OCS

Southern bluefin tuna (Thunnus maccoyii)

SBF

Optional species to be recorded

 

 

 

Tiger shark (Galeocerdo cuvier)

TIG

 

 

Crocodile shark (Pseudocarcharias kamoharai)

PSK

 

 

Mantas and devil rays (Mobulidae)

MAN

 

 

Pelagic stingray (Pteroplatytrygon violacea)

PLS

 

 

Other rays

 

For pole and line:

Primary Species

FAO code

Other Species

FAO code

Albacore (Thunnus alalunga)

ALB

Other bony fish

MZZ

Bigeye tuna (Thunnus obesus)

BET

Sharks

SKH

Yellowfin tuna (Thunnus albacares)

YFT

Rays

 

Skipjack tuna (Katsuwonus pelamis)

SKJ

Marine turtles (in number)

TTX

Frigate and bullet tuna (Auxis spp.)

FRZ

 

 

Kawakawa (Euthynnus affinis)

KAW

 

 

Longtail tuna (Thunnus tonggol)

LOT

 

 

Narrow barred Spanish mackerel (Scomberomorus commerson)

COM

 

 

Other IOTC species

 

 

 

REMARKS

Discard of tuna, tuna-like fish and sharks to be recorded by species in weight (kg) or number for all gears should be recorded in the remarks.

Any interactions with whale sharks (Rhincodon typus), marine mammals, and seabirds should be recorded in the remarks.

Other information should also be written in the remarks.

Note: The species included in the logbooks are regarded as minimum requirement. Optionally other frequently caught shark and/or fish species should be added as required across different areas and fisheries.


(1)  When a CPC is fully implementing the observer program the provision of seabird data is optional

(2)  When a CPC is fully implementing the observer program the provision of seabird data is optional


ANNEX 2

Guidelines for preparation of drifting fish aggregating device (DFAD) management plans

To support obligations in respect of the DFAD management plan (DFAD–MP) to be submitted to the Commission by Member States with fleets fishing in the IOTC area of competence, associated to DFADs, DFAD–MP should include:

1.

An objective

2.

Scope

Description of its application with respect to:

 

vessel-types and support and tender vessels

 

DFAD numbers and DFAD beacon numbers to be deployed

 

reporting procedures for DFAD deployment

 

incidental bycatch reduction and utilisation policy

 

consideration of interaction with other gear types

 

plans for monitoring and retrieval of lost DFADs

 

statement or policy on ‘DFAD ownership’

3.

Institutional arrangements for management of the DFAD–MPs:

 

institutional responsibilities

 

application processes for DFAD and/or DFAD beacons deployment approval

 

obligations of vessel owners and masters in respect of DFAD and/or DFAD beacons deployment and use

 

DFAD and/or DFAD beacons replacement policy

 

reporting obligations

4.

DFAD construction specifications and requirements:

 

DFAD design characteristics (a description)

 

DFAD markings and identifiers, including DFAD beacons

 

lighting requirements

 

radar reflectors

 

visible distance

 

radio buoys (requirement for serial numbers)

 

satellite transceivers (requirement for serial numbers)

5.

Applicable areas:

details of any closed areas or periods e.g. territorial waters, shipping lanes, proximity to artisanal fisheries, etc.

6.

Applicable period for the DFAD–MP.

7.

Means for monitoring and reviewing implementation of the DFAD–MP.

8.

DFAD logbook template (data to be collected specified in Annex 3).

Guidelines for preparation of anchored fish aggregating device (AFAD) management plans

To support obligations in respect of the AFAD management plan (AFAD–MP) to be submitted to the IOTC Secretariat by CPCs with fleets fishing in the IOTC area of competence, associated to AFADs, AFAD–MP should include:

1.

An objective

2.

Scope:

Description of its application with respect to:

a)

vessel types

b)

AFAD numbers and/or AFAD beacons numbers to be deployed (per AFAD type)

c)

reporting procedures for AFAD deployment

d)

distances between AFADs

e)

incidental bycatch reduction and utilisation policy

f)

consideration of interaction with other gear types

g)

the establishment of inventories of the AFADs deployed, detailing AFAD identifiers, characteristics and equipment of each AFAD as laid down in point 4 of this Annex, coordinates of the AFAD’s mooring sites, date of set, lost and reset

h)

plans for monitoring and retrieval of lost AFADs

i)

statement or policy on ‘AFAD ownership’

3.

Institutional arrangements for management of the AFAD–MP:

a)

institutional responsibilities

b)

regulations applicable to the setting and use of AFADs

c)

AFAD repairs, maintenance rules and replacement policy

d)

data collection system

e)

reporting obligations

4.

AFAD construction specifications and requirements:

a)

AFAD design characteristics (a description of both the floating structure and the underwater structure, with special emphasis on any netting materials used)

b)

anchorage used for mooring

c)

AFAD markings and identifiers, including AFAD beacons if any

d)

lighting requirements, if any

e)

radar reflectors

f)

visible distance

g)

radio buoys, if any (requirement for serial numbers)

h)

satellite transceivers (requirement for serial numbers)

i)

echo sounder

5.

Applicable areas:

a)

coordinates of mooring sites, if applicable

b)

details of any closed areas e.g., shipping lanes, Marine Protected Areas, reserves etc.

6.

Means for monitoring and reviewing implementation of the AFAD–MP.

7.

AFAD logbook template (data to be collected specified in Annex IV).

ANNEX 3

Data collection for drifting fish aggregating devices (DFADs) and anchored fish aggregating devices (AFADs)

DATA COLLECTION FOR DFADs

a)

For each activity on a DFAD, whether followed by a set or not, each fishing, support and supply vessel to report the following information:

i.

Vessel (name and registration number of the fishing, support or supply vessel)

ii.

Position (as the geographic location of the event (Latitude and Longitude) in degrees and minutes)

iii.

Date (as DD/MM/YYYY, day/month/year)

iv.

DFAD identifier (DFAD or beacon ID)

v.

DFAD type (drifting natural FAD, drifting artificial FAD)

vi.

DFAD design characteristics

Dimension and material of the floating part and of the underwater hanging structure

vii.

Type of the activity (visit, deployment, hauling, retrieving, loss, intervention to service electronic equipment).

b)

If the visit is followed by a set, the results of the set in terms of catch and bycatch, whether retained or discarded dead or alive. CPCs to report this data aggregated per vessel at 1*1 degree (where applicable) and monthly to the Secretariat

DATA COLLECTION FOR AFADs

a)

Any activity around an AFAD.

b)

For each activity on an AFAD (repair, intervention, consolidation, etc.), whether followed or not by a set or other fishing activities:

i.

Position (as the geographic location of the event (Latitude and Longitude) in degrees and minutes)

ii.

Date (as DD/MM/YYYY, day/month/year)

iii.

AFAD identifier (i.e. AFAD marking or beacon ID or any information allowing to identify the owner).

c)

If the visit is followed by a set or other fishing activities, the results of the set in terms of catch and bycatch, whether retained or discarded dead or alive.


ANNEX 4

Mitigation measures for seabirds in longline fisheries

Mitigation

Description

Specification

Night setting with minimum deck lighting

No setting between nautical dawn and before nautical dusk.

Deck lighting to be kept to a minimum.

Nautical dusk and nautical dawn are defined as set out in the Nautical Almanac tables for relevant latitude, local time and date.

Minimum deck lighting should not breach minimum standards for safety and navigation.

Bird-scaring lines (Tori lines)

Bird-scaring lines shall be deployed during the entire longline setting to deter birds from approaching the branch line.

For vessels greater than or equal to 35 m:

Deploy at least 1 bird-scaring line. Where practical, vessels are encouraged to use a second tori pole and bird scaring line at times of high bird abundance or activity; both tori lines should be deployed simultaneously, one on each side of the line being set.

Aerial extent of bird-scaring lines must be greater than or equal to 100 m.

Long streamers of sufficient length to reach the sea surface in calm conditions must be used.

Long streamers must be at intervals of no more than 5 m.

 

 

For vessels less than 35 m:

Deploy at least 1 bird-scaring line.

Aerial extent must be greater than or equal to 75 m.

Long and/or short (but greater than 1 m in length) streamers must be used and placed at intervals as follows:

Short: intervals of no more than 2 m.

Long: intervals of no more than 5 m for the first 55 m of bird scaring line.

Additional design and deployment guidelines for bird-scaring lines are provided in Annex 5 to this Regulation.

Line weighting

Line weights to be deployed on the snood prior to setting.

Greater than a total of 45 g attached within 1 m of the hook or;

Greater than a total of 60 g attached within 3,5 m of the hook or;

Greater than a total of 98 g weight attached within 4 m of the hook.


ANNEX 5

Supplemental Guidelines for Design and Deployment of Tori Lines

Preamble

Minimum technical standards for deployment of tori lines are found in Annex 4 to this Regulation, and are not repeated here. These supplemental guidelines are designed to assist in the preparation and implementation of tori line regulations for longline vessels. While these guidelines are relatively explicit, improvement in tori line effectiveness through experimentation is encouraged, within the requirements of Annex 4 to the Regulation. The guidelines take into account environmental and operational variables such as weather conditions, setting speed and ship size, all of which influence tori line performance and design in protecting baits from birds. Tori line design and use may change to take account of these variables provided that line performance is not compromised. On-going improvement in tori line design is envisaged and consequently review of these guidelines should be undertaken in the future.

Tori line design (see Figure 1)

1.

An appropriate towed device on the section of the tori line in the water can improve the aerial extension.

2.

The above water section of the line should be sufficiently light that its movement is unpredictable to avoid habituation by birds and sufficiently heavy to avoid deflection of the line by wind.

3.

The line is best attached to the vessel with a robust barrel swivel to reduce tangling of the line.

4.

The streamers should be made of material that is conspicuous and produces an unpredictable lively action (e.g. strong fine line sheathed in red polyurethane tubing) suspended from a robust three-way swivel (that again reduces tangles) attached to the tori line.

5.

Each streamer should consist of two or more strands.

6.

Each streamer pair should be detachable by means of a clip so that line stowage is more efficient.

Deployment of tori lines

1.

The line should be suspended from a pole affixed to the vessel. The tori pole should be set as high as possible so that the line protects bait a good distance astern of the vessel and will not tangle with fishing gear. Greater pole height provides greater bait protection. For example, a height of around 7 m above the water line can give about 100 m of bait protection.

2.

If vessels use only one tori line it should be set to windward of sinking baits. If baited hooks are set outboard of the wake, the streamer line attachment point to the vessel should be positioned several meters outboard of the side of the vessel that baits are deployed. If vessels use two tori lines, baited hooks should be deployed within the area bounded by the two tori lines.

3.

Deployment of multiple tori lines is encouraged to provide even greater protection of baits from birds.

4.

Because there is the potential for line breakage and tangling, spare tori lines should be carried onboard to replace damaged lines and to ensure fishing operations can continue uninterrupted. Breakaways can be incorporated into the tori line to minimize safety and operational problems should a longline float foul or tangle with the in-water extent of a streamer line.

5.

When fishers use a bait casting machine (BCM), they must ensure coordination of tori line and machine by: i) ensuring the BCM throws directly under the tori line protection, and ii) when using a BCM (or multiple BCMs) that allows throwing to both port and starboard, two tori lines should be used.

6.

When casting branchline by hand, fishers should ensure that the baited hooks and coiled branchline sections are cast under the tori line protection, avoiding the propeller turbulence which may slow the sink rate.

7.

Fishers are encouraged to install manual, electric or hydraulic winches to improve ease of deployment and retrieval of tori lines.

Image 1

Longline (Gear Configuration): Average branch line length (meters): straight length in meters between snap and hook.

Translation:

 

Float

 

Sea level

 

Sea-surface temperature

 

Float line length

 

Main line material

 

Average length between branches

 

Branch line length

 

Light sticks

 

Leader/trace type

 

Hook type

 

Bait type

 

Hooks between floats (hooks per basket)


ANNEX 6

General provisions of chartering agreement

The chartering agreement shall contain the following conditions:

The flag CPC has consented in writing to the chartering agreement;

The duration of the fishing operations under the chartering agreement does not exceed 12 months in any calendar year.

Fishing vessels to be chartered shall be registered to responsible contracting parties and cooperating non-contracting parties, which explicitly agree to apply IOTC conservation and management measures and enforce them on their vessels. All flag contracting parties or cooperating non-contracting parties, concerned shall effectively exercise their duty to control their fishing vessels to ensure compliance with IOTC conservation and management measures.

Fishing vessels to be chartered shall be on the IOTC record of vessels authorized to operate in the IOTC Area of Competence.

Without prejudice to the duties of the chartering CPC, the flag CPC shall ensure that the chartered vessel complies with both the legislation of the chartering CPC and of the flag CPCs and shall ensure compliance by chartered vessels with relevant Conservation and Management Measures established by IOTC, in accordance with their rights, obligations and jurisdiction under international law. If the chartered vessel is allowed by the chartering CPC to go and fish in the high seas, the flag CPC is then responsible for controlling the high seas fishing conducted pursuant to the charter arrangement. The chartered vessel shall report VMS and catch data to both the CPCs (chartering and flag) and to the IOTC Secretariat.

All catches (historical and current/future), including bycatch and discards, taken pursuant to the chartering agreement, shall be counted against the quota or fishing possibilities of the chartering CPC. The observer coverage (historical, current/future) on board such vessels shall also be counted against the coverage rate of the chartering CPC for the duration that the vessel fishes under the Charter Agreement.

The chartering CPC shall report to the IOTC all catches, including bycatch and discards, and other information required by the IOTC, and as per the Charter Notification Scheme detailed in Part IV of CMM 19/07.

Vessel Monitoring Systems (VMS) and, as appropriate, tools for differentiation of fishing areas, such as fish tags or marks, shall be used, according to the relevant IOTC Conservation and Management Measures, for effective fishery management.

There shall be observer coverage of at least 5 % of fishing effort.

The chartered vessels shall have a fishing license issued by the chartering CPC, and shall not be on the IOTC IUU list, and/or IUU list of other Regional Fisheries Management Organisations.

When operating under charter agreements, the chartered vessels shall not, to the extent possible, be authorized to use the quota (if any) or entitlement of the flag Contracting Parties or Cooperating Non-Contracting Parties. In no case shall the vessel be authorized to fish under more than one chartering agreement at the same time.

Unless specifically provided in the chartering agreement, and consistent with relevant domestic law and regulation, the catches of the chartered vessels shall be unloaded exclusively in the Ports of the chartering Contracting Party or under its direct supervision in order to assure that the activities of the chartered vessels do not undermine IOTC Conservation and Management Measures.

The chartered vessel shall at all times carry a copy of the charter documentation.


ANNEX 7

IOTC Transhipment Declaration

Carrier Vessel

Fishing Vessel

Name of the Vessel and Radio Call Sign: Flag:

Flag State license number:

National Register Number, if available: IOTC Register Number, if available:

Name of the Vessel and Radio Call Sign: Flag:

Flag State license number:

National Register Number, if available: IOTC Register Number, if available:


 

Day

Month

Hour

Year

 

Agent’s name:

Master’s name of LSTV:

Master’s name of Carrier:

Departure

 

 

 

from

 

 

 

 

Return

 

 

 

to

 

Signature:

Signature:

Signature:

Transhipment

 

 

 

 

 

 

 

 

Indicate the weight in kilograms or the unit used (e.g. box, basket) and the landed weight in kilograms of this unit: ________kilograms

LOCATION OF TRANSHIPMENT

Species

Port

Sea

Type of product

 

 

 

 

Whole

Gutted

Headed

Filleted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

If transhipment effected at sea, IOTC Observer Name and Signature:


ANNEX 8

IOTC Bigeye Tuna Statistical Document

DOCUMENT NUMBER

IOTC BIGEYE TUNA STATISTICAL DOCUMENT

EXPORT SECTION

1.

FLAG OF COUNTRY/ENTITY/FISHING ENTITY

2.

DESCRIPTION OF VESSEL AND REGISTRATION NUMBER (if applicable)

Vessel Name…

Registration Number…

LOA (m) …

IOTC Record No. (if applicable): …

3.

TRAPS (if applicable)

4.

POINT OF EXPORT (City, State/Province, Country/Entity/Fishing Entity)

5.

AREA OF CATCH (check one of the following)

(a)

Indian

(b)

Pacific

(c)

Atlantic

 

*

In case of (b) or (c) checked, the item 6 and 7 below do not need to be filled out.

6.

DESCRIPTION OF FISH

Product Type (*1)

Time of Harvest (mm/yy)

Gear Code (*2)

Net Weight

(Kg)

F/FR

D/GG/DR/FL/OT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

*1

= F=Fresh, FR = Frozen, RD = Round, GG = Gilled and Gutted, DR = Dressed, FL = Fillet

OT = Other, describe the type of product

*2

= When the Gear Code is OT, describe the type of gear,

7.

EXPORTER CERTIFICATION I certify that the above information is complete, true, and correct to the best of my knowledge and belief.

Name:… Company name: … Address: … Signature: … Date: … License Number (if applicable): …

8.

GOVERNMENT VALIDATION I validate that information listed above is complete, true, and correct to the best of my knowledge and belief.

Total weight of the shipment: Kg

Name& Title… Signature: … Date: … Government Seal…

IMPORT SECTION:

9.

IMPORTER CERTIFICATION I certify that the above information is complete, true, and correct to the best of my knowledge and belief.

Importer Certification (Intermediate Country/Entity/Fishing Entity)

Name… Address: … Signature: … Date: … License # (if applicable): …

Importer Certification (Intermediate Country/Entity/Fishing Entity)

Name: … Address: … Signature: … Date: … License # (if applicable): …

Final Point of Import

City: … State/Province: … Country/Entity/Fishing Entity: …

NOTE: If a language other than English or French is used in completing this form, please add an English translation of this document.

INSTRUCTIONS:

DOCUMENT NUMBER: Block for the issuing Country to designate a country coded Document Number.

(1)   

FLAG COUNTRY/ENTITIES/FISHING ENTITIES: Fill in the name of the country of the vessel that harvested the Bigeye tuna in the shipment and issued this Document. According to the Recommendation, only the flag state of the vessel that harvested the Bigeye tuna in the shipment or, if the vessel is operating under a charter arrangement, the exporting state can issue this Document.

(2)   

DESCRIPTION OF VESSEL (if applicable): Fill in the name and registration number, length overall(LOA) and IOTC Record number of the vessel that harvested the Bigeye tuna in the shipment.

(3)   

TRAPS (if applicable): Fill in the name of the trap that harvested the Bigeye tuna in the shipment.

(4)   

POINT OF EXPORT: Identify the City, State or Province, and Country from which the Bigeye tuna was exported.

(5)   

AREA OF CATCH: Check the area of catch. (If (b) or (c) checked, items 6 and 7 below do not need to be filled out.)

(6)   

DESCRIPTION OF FISH: The exporter must provide, to the highest degree of accuracy, the following information.

NOTE: One row should describe one product type

(1)   

Product Type: Identify the type of product being shipped as either FRESH or FROZEN, and in ROUND, GILLED AND GUTTED, DRESSED, FILLET or OTHER form. For OTHER, describe the type of products in the shipment.

(2)   

Time of Harvest: Fill in the time of harvest (in month and year) of the Bigeye tuna in the shipment

(3)   

Gear Code: Identify the gear type which was used to harvest the Bigeye tuna using the list below. For OTHER TYPE, describe the type of gear, including farming.

(4)   

Net product weight: in kilograms.

(5)   

EXPORTER CERTIFICATION: The person or company exporting the Bigeye tuna shipment must provide his/her name, company name, address, signature, date the shipment was exported, and dealer license number (if applicable).

(6)   

GOVERNMENT VALIDATION: Fill in the name and full title of the official signing the Document. The official must be employed by a competent authority of the flag state government of the vessel that harvested the Bigeye tuna appearing on the Document or other individual or institution authorised by the flag state. When appropriate, this requirement is waived according validation of the document by a government official, or if the vessel is operating under a charter arrangement, by a government official or other authorised individual or institution of the exporting state. The total weight of the shipment shall also be specified in this block.

(7)   

IMPORTER CERTIFICATION: The person or company that imports Bigeye tuna must provide his/her name, address, signature, date the Bigeye tuna was imported, license number (if applicable), and final point of import. This includes imports into intermediate countries/entities/fishing entities. For fresh and chilled products, the signature of the importer may be substituted by a person of a customs clearance company when the authority for signature is properly accredited to it by the importer.

GEAR CODE:

GEAR CODE

GEAR TYPE,

BB

BAITBOAT

GILL

GILLNET

HAND

HANDLINE

HARP

HARPOON

LL

LONGLINE

MWT

MID-WATER TRAWL

PS

PURSE SEINE

RR

ROD AND REEL

SPHL

SPORT HANDLINE

SPOR

SPORT FISHERIES UNCLASSIFIED

SURF

SURFACE FISHERIES UNCLASSIFIED

TL

TENDED LINE

TRAP

TRAP

TROL

TROLL

UNCL

UNSPECIFIED METHODS

OT

OTHER TYPE

RETURN A COPY OF COMPLETED DOCUMENT TO: (the name of the office of the competent authority of the flag state).


ANNEX 9

IOTC bigeye tuna re-export certificate

DOCUMENT NUMBER

IOTC BIGEYE TUNA RE-EXPORT CERTIFICATE

RE-EXPORT SECTION:

1.

RE-EXPORTING COUNTRY/ENTITY/FISHING ENTITY

2.

POINT OF RE-EXPORT

3.

DESCRIPTION OF IMPORTED FISH

Product Type(*)

Net Weight

(Kg)

Flag country/Entity/Fishing Entity

Date of Import

F/FR

RD/GG/DR/FL/OT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

DESCRIPTION OF FISH FOR RE-EXPORT

Product Type(*)

Net Weight

(Kg)

 

F/FR

RD/GG/DR/FL/OT

 

 

 

 

 

 

 

 

 

 

 

 

*F

= FRESH, FR = Frozen, RD = Round, GG = Gilled and Gutted, DR = Dressed, FL = Fillet

OT = Other(Describe the type of product)

5.

RE-EXPORTER CERTIFICATION: I certify that the above information is complete, true and correct to the best of my knowledge and belief.

Name/Company Name… Address… Signature… Date… License Number (if applicable) …

6.

GOVERNMENT VALIDATION: I validate that the above information is complete, true and correct to the best of my knowledge and belief.

Name & Title… Signature… Date… Government Seal…

IMPORT SECTION:

7.

IMPORTER CERTIFICATION: I certify that the above information is complete, true and correct to the best of my knowledge and belief.

Importer Certification (Intermediate Country/Entity/Fishing Entity)

Name: … Address: … Signature: … Date: … License # (if applicable) …

Importer Certification (Intermediate Country/Entity/Fishing Entity)

Name: … Address: … Signature: … Date: … License # (if applicable) …

Importer Certification (Intermediate Country/Entity/Fishing Entity)

Name: … Address: … Signature: … Date: … License # (if applicable) …

Final Point of Import

City: … State/Province: … Country/Entity/Fishing Entity: …

NOTE: If a language other than English or French is used in completing this form, please add the English translation of this document.

INSTRUCTIONS

DOCUMENT NUMBER: Block for the issuing Country/Entity/Fishing Entity to designate a Country/Entity/Fishing Entity coded document number.

(1)   

RE-EXPORTING COUNTRY/ENTITY/FISHING ENTITY

Fill in the name of the Country/Entity/Fishing Entity which re-exports the Bigeye tuna in the shipment and issued this Certificate. According to the Recommendation, only the re-exporting Country/Entity/Fishing Entity can issue this Certificate.

(2)   

POINT OF RE-EXPORT

Identify the City/State Province and Country/Entity/Fishing Entity from which the Bigeye tuna was re-exported.

(3)   

DESCRIPTION OF IMPORTED FISH

The exporter must provide, to the highest degree of accuracy, the following information: NOTE: One row should describe one product type. (1)Product type: Identify the type of product being shipped as either FRESH or FROZEN, and in ROUND, GILLED AND GUTTED, DRESSED, FILLET or OTHER form. For OTHER, describe the type of products in the shipment. (2) Net weight: Net product weight in kilograms. (3) Flag Country/Entity/Fishing Entity: the name of the Country/Entity/Fishing Entity of the vessel that harvested the Bigeye tuna in the shipment. (4) Date of import: Imported date.

(4)   

DESCRIPTION OF FISH FOR RE-EXPORT

The exported must provide, to the highest degree of accuracy, the following information: NOTE: One row should describe one product type. (1) Product type: Identify the type of product being shipped as either FRESH or FROZEN, and in ROUND, GILLED AND GUTTED, DRESSED FILLET or OTHER form. For OTHER, describe the type of products in the shipment. (2) Net weight: Net product weight in kilograms.

(5)   

RE-EXPORTER CERTIFICATION

The person or company re-exporting the Bigeye tuna shipment must provide his/her name, address, signature, date the shipment was re-exported, and re-exporter’s license number (if applicable).

(6)   

GOVERNMENT VALIDATION

Fill in the name and full title of the official signing the Certificate. The official must be employed by a competent government authority of the re-exporting Country/Entity/Fishing Entity appearing on the Certificate, or other individual or institution authorised to validate such certificates by the competent government authority.

(7)   

IMPORTER CERTIFICATION

The person or company that imports Bigeye tuna must provide his/her name, address, signature, date the Bigeye tuna was imported, license number (if applicable) and re-exported final point of import. This includes imports into intermediate Countries/Entities/Fishing Entities. For fresh and chilled products, the signature of the importer may be substituted by a person of a customs clearance company when the authority for signature is properly accredited to it by the importer.

RETURN A COPY OF THE COMPLETED CERTIFICATE TO: (the name of the office of the competent authority of the re-exporting Country/Entity/Fishing Entity).


ANNEX 10

Information to be provided in advance by vessels requesting port entry

1.

Intended port of call

 

2.

Port State

 

3.

Estimated date and time of arrival

 

4.

Purpose(s)

 

5.

Port and date of last port call

 

6.

Name of the vessel

 

7.

Flag State

 

8.

Type of vessel

 

9.

International Radio Call Sign

 

10.

Vessel contact information

 

11.

Vessel owner(s)

 

12.

Certificate of registry ID

 

13.

IMO ship ID, if available

 

14.

External ID, if available

 

15.

IOTC ID

 

16.

VMS

No

Yes: National

Yes: RFMO(s)

Type:

17.

Vessel dimensions

Length

 

Beam

 

Draft

 

18.

Vessel master name and nationality

 

19.

Relevant fishing authorization(s)

Identifier

Issued by

Validity

Fishing area(s)

Species

Gear

 

 

 

 

 

 

 

 

 

 

 

 

20.

Relevant transhipment authorization(s)

Identifier

 

Issued by

 

Validity

 

Identifier

 

Issued by

 

Validity

 

21.

Transhipment information concerning donor vessels

 

Date

Location

Name

Flag State

ID number

Species

Product form

Catch area

Quantity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

22.

Total catch onboard

23.

Catch to be offloaded

Species

Product form

Catch area

Quantity

Quantity

 

 

 

 

 

 

 

 

 

 


II Non-legislative acts

REGULATIONS

2.12.2022   

EN

Official Journal of the European Union

L 311/54


COMMISSION IMPLEMENTING REGULATION (EU) 2022/2344

of 29 November 2022

on the reimbursement, in accordance with Article 17(3) of Regulation (EU) 2021/2116 of the European Parliament and of the Council, of the appropriations carried over from financial year 2022

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2021/2116 of the European Parliament and of the Council of 2 December 2021 on the financing, management and monitoring of the common agricultural policy and repealing Regulation (EU) No 1306/2013 (1), and in particular Article 17(3), second subparagraph, thereof,

After consulting the Committee on the Agricultural Funds,

Whereas:

(1)

In accordance with Article 12(2), first subparagraph, point (d), of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (2), non-committed appropriations relating to the actions financed by the European Agricultural Guarantee Fund (EAGF) as referred to in Article 4(1) of Regulation (EU) No 1306/2013 of the European Parliament and of the Council (3) may be carried over to the following financial year. Such carryover is limited to 2 % of the initial appropriations voted by the European Parliament and by the Council and to the amount of the adjustment of direct payments as referred to in Article 8 of Regulation (EU) No 1307/2013 of the European Parliament and of the Council (4) which was applied during the preceding financial year.

(2)

In accordance with Article 17(3), second subparagraph, of Regulation (EU) 2021/2116, for financial year 2022, appropriations carried over in accordance with Article 12(2), first subparagraph, point (d), of Regulation (EU, Euratom) 2018/1046 remain available and the overall amount of non-committed appropriations available for reimbursement represents more than 0,2 % of the annual ceiling for EAGF expenditure.

(3)

In accordance with Article 17(4) of Regulation (EU) 2021/2116, the reimbursement only applies to final beneficiaries in those Member States where financial discipline applied (5) in the preceding financial year.

(4)

In accordance with Article 1(1) of Commission Implementing Regulation (EU) 2021/951 (6), financial discipline is applied to direct payments in respect of calendar year 2021 to establish the crisis reserve. The crisis reserve has been partially called on in financial year 2022 for an amount of EUR 350 million by Commission Delegated Regulation (EU) 2022/467 (7), leaving EUR 147,3 million available. Moreover, on the basis of the execution of 2022 EAGF appropriations under shared management for the period from 16 October 2021 to 15 October 2022 and an estimated execution under direct management from 1 January 2022 to 31 December 2022, additional non-committed appropriations will remain in the 2022 EAGF budget.

(5)

On the basis of the Member States’ declarations of expenditure for the period from 16 October 2021 to 15 October 2022, the financial discipline reduction effectively applied by the Member States in the financial year 2022 amounts to EUR 495,6 million.

(6)

Of this amount of financial discipline applied in financial year 2022, EUR 485,2 million of unused appropriations, which remains within the limit of 2 % of the initial appropriations relating to the actions referred to in Article 4(1) of Regulation (EU) No 1306/2013, can be carried over to financial year 2023 following a decision of the Commission in accordance with Article 12(3) of Regulation (EU, Euratom) 2018/1046.

(7)

In order to ensure that the reimbursement to the final recipients of unused appropriations as a result of the application of financial discipline remains proportionate to the amount of the financial discipline adjustment, it is appropriate that the Commission determines the amounts available to the Member States for the reimbursement.

(8)

The amounts established by this Regulation are definitive and apply, without prejudice to the application of reductions in accordance with Article 41 of Regulation (EU) No 1306/2013, to any other corrections taken into account in the monthly payment decision concerning the expenditure effected by the paying agencies of the Member States for October 2022, in accordance with Article 18(3) of Regulation (EU) No 1306/2013 and to any deductions and supplementary payments to be made in accordance with Article 18(4) of that Regulation or to any decisions which will be taken within the framework of the clearance of accounts procedure.

(9)

In accordance with the introductory phrase of Article 12(2) of Regulation (EU, Euratom) 2018/1046, the non-committed appropriations may be carried over to the following financial year only. It is therefore appropriate for the Commission to determine eligibility dates for the expenditure of the Member States in relation to the reimbursement in accordance with Article 17(3) of Regulation (EU) 2021/2116, taking into account the agricultural financial year as defined in Article 35 of that Regulation.

(10)

Regulation (EU) 2021/2116 is to apply from 1 January 2023 as set out in Article 106 of that Regulation. Therefore, this Regulation should apply as of the same date,

HAS ADOPTED THIS REGULATION:

Article 1

The amounts of the appropriations that will be carried over from financial year 2022 in accordance with Article 12(2), first subparagraph, point (d), and Article 12(2), third subparagraph, of Regulation (EU, Euratom) 2018/1046 and that in accordance with Article 17(3) of Regulation (EU) 2021/2116 are made available to the Member States for the reimbursement to the final beneficiaries, are laid down in the Annex to this Regulation.

The amounts that will be carried over are subject to the carryover decision of the Commission in accordance with Article 12(3) of Regulation (EU, Euratom) 2018/1046.

Article 2

Member States’ expenditure in relation to the reimbursement of the appropriations carried over shall only be eligible for Union financing if the relevant amounts have been paid to the beneficiaries before 16 October 2023.

Article 3

This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 November 2022.

For the Commission,

On behalf of the President,

Wolfgang BURTSCHER

Director-General

Directorate-General for Agriculture and Rural Development


(1)  OJ L 435, 6.12.2021, p. 187.

(2)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

(3)  Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).

(4)  Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608).

(5)  Financial discipline does not apply in financial year 2022 in Croatia in accordance with Article 8(2) of Regulation (EU) No 1307/2013.

(6)  Commission Implementing Regulation (EU) 2021/951 of 11 June 2021 fixing the adjustment rate for direct payments pursuant to Regulation (EU) No 1306/2013 of the European Parliament and of the Council in respect of the calendar year 2021 (OJ L 209, 14.6.2021, p. 93).

(7)  Commission Delegated Regulation (EU) 2022/467 of 23 March 2022 providing for exceptional adjustment aid to producers in the agricultural sectors (OJ L 96, 24.3.2022, p. 4).


ANNEX

Amounts available for reimbursement of appropriations carried over

(amounts in EUR)

Belgium

7 097 289

Bulgaria

11 255 446

Czechia

12 925 229

Denmark

11 696 658

Germany

65 935 967

Estonia

2 749 659

Ireland

15 643 791

Greece

18 069 199

Spain

66 186 860

France

99 836 686

Italy

42 101 124

Cyprus

412 283

Latvia

4 020 097

Lithuania

6 763 226

Luxembourg

481 848

Hungary

17 623 016

Malta

42 930

Netherlands

9 351 194

Austria

8 115 108

Poland

30 712 998

Portugal

9 178 262

Romania

21 215 691

Slovenia

1 049 202

Slovakia

6 377 030

Finland

6 987 416

Sweden

9 419 153


2.12.2022   

EN

Official Journal of the European Union

L 311/58


COMMISSION IMPLEMENTING REGULATION (EU) 2022/2345

of 1 December 2022

correcting the Swedish language version of Implementing Regulation (EU) 2017/373 laying down common requirements for providers of air traffic management/air navigation services and other air traffic management network functions and their oversight, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU) 2016/1377 and amending Regulation (EU) No 677/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Article 43(1), points (a) and (f) thereof,

Whereas:

(1)

The Swedish language version of Commission Implementing Regulation (EU) 2017/373 (2) contains an error in Subpart B, Section 4, point ATS.TR.400, point (b), of Annex IV as regards alerting service. That error alters the meaning of the provision.

(2)

The Swedish language version of Implementing Regulation (EU) 2017/373 should therefore be corrected accordingly. The other language versions are not affected.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127 of Regulation (EU) 2018/1139, delivered on 6 January 2020,

HAS ADOPTED THIS REGULATION:

Article 1

(Does not concern the English language)

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 December 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 212, 22.8.2018, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/373 of 1 March 2017 laying down common requirements for providers of air traffic management/air navigation services and other air traffic management network functions and their oversight, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU) 2016/1377 and amending Regulation (EU) No 677/2011 (OJ L 62, 8.3.2017, p. 1).


2.12.2022   

EN

Official Journal of the European Union

L 311/60


COMMISSION IMPLEMENTING REGULATION (EU) 2022/2346

of 1 December 2022

laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), and in particular Article 1(2), in conjunction with Article 9(1), thereof,

Whereas:

(1)

Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Regulation (EU) 2017/745 further requires the Commission to adopt for groups of products without an intended medical purpose listed in its Annex XVI, common specifications addressing, at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.

(2)

From the date of application of the common specifications, Regulation (EU) 2017/745 is to apply also to those groups of products without an intended medical purpose.

(3)

In order for manufacturers to be able to demonstrate the conformity of products without an intended medical purpose with regard to application of risk management, the common specifications should cover the application of risk management as set out in the second sentence of Section 1 and in sections from 2 to 5, 8 and 9 of Annex I to Regulation (EU) 2017/745. Consequently, in accordance with Article 9(2) of Regulation (EU) 2017/745, products without an intended medical purpose that are in conformity with the common specifications are to be presumed to be in conformity with the requirements set out in those provisions.

(4)

The common specifications should in principle be laid down for all groups of products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745. However, as Regulation (EU) 2017/745 regulates the placing on the market, making available on the market or putting into service in the Union, common specifications are not needed for products for which there is no information available about them being marketed in the Union. For example, there is no information on the following products being marketed in the Union: contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices; active implantable products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixing a part of the body; active devices intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction; active implantable equipment intended to be used to reduce, remove or destroy adipose tissue. In addition, for some products the information available is not sufficient to allow the Commission to draw up common specifications. That is for example the case for some other items intended to be introduced into or onto the eye.

(5)

Sunbeds and equipment using infrared optical radiation to warm the body or parts of the body intended for treatment of tissues or parts of the body under the skin should not be considered products for skin treatment for the purposes of Annex XVI to Regulation (EU) 2017/745. Consequently, they should not be covered by this Regulation.

(6)

The group of products listed in point 6 of Annex XVI to Regulation (EU) 2017/745 is intended for brain stimulation where only electrical currents or magnetic or electromagnetic fields penetrate the cranium. Invasive devices intended for brain stimulation, such as electrodes or sensors that are partially or totally introduced into the human body, should not be covered by this Regulation.

(7)

Regulation (EU) 2017/745 requires a product without a medical purpose listed in Annex XVI to that Regulation, when used under the conditions and for the purposes intended, to present no risks at all or present a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.

(8)

The groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 cover a wide variety of devices for different applications and intended uses. A common methodology for risk management should be drawn up to ensure a harmonised approach by manufacturers of different groups of devices and to facilitate a coherent implementation of the common specifications.

(9)

In order to ensure appropriate risk management, it is necessary to identify specific risk factors to be analysed and minimised and to identify specific risk control measures to be implemented with respect to each group of products listed in Annex XVI to Regulation (EU) 2017/745.

(10)

In order to facilitate the implementation of risk management by manufacturers of both medical devices and products without an intended medical purpose risk management for both groups of products should be based on the same harmonised principles and the requirements should be compatible. The rules on the application of risk management should therefore be in line with well-established international guidance in the field, including the international standard ISO 14971:2019 on application of risk management to medical devices.

(11)

Regulation (EU) 2017/745 provides that the clinical evaluation of products without an intended medical purpose are to be based on relevant clinical data concerning performance and safety. Such data are to include information from post-market surveillance, post-market clinical follow-up, and, where applicable, specific clinical investigation. As in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose, where all available results on clinical investigations relate to medical devices only, clinical investigations should be performed for products without an intended medical purpose.

(12)

Where clinical investigations are performed to confirm the conformity with the relevant general safety and performance requirements, it is not possible to complete the clinical investigations and the conformity assessment within six months. For such cases transitional arrangements should be laid down.

(13)

Where a notified body has to be involved in the conformity assessment procedure, it is not possible for the manufacturer to complete the conformity assessment within 6 months. For such cases transitional arrangements should be laid down.

(14)

Transitional provisions should be laid down also for products covered by Annex XVI to Regulation (EU) 2017/745 for which notified bodies have issued certificates in accordance with Council Directive 93/42/EEC (2). Also for those products, it is not possible for the manufacturer to complete clinical investigations and the conformity assessment within 6 months.

(15)

In order to ensure the product safety during the transitional period, it should be allowed to continue to place the products on the market and to make them available on the market or put them into service, provided that the products in question were already lawfully marketed in the Union before the date of application of this Regulation, that they continue to comply with the requirements of Union and national law applicable before the date of application of this Regulation and that their design and intended purpose are not significantly changed. As the purpose of putting in place the transitional arrangements is to allow the manufacturers enough time to conduct the required clinical investigations and conformity assessment procedures, the transitional arrangements should cease where manufacturers do not proceed with the clinical investigations or conformity assessment procedure, as applicable, within a reasonable timeframe.

(16)

The Medical Device Coordination Group has been consulted.

(17)

The application date of this Regulation should be deferred as provided for in Regulation (EU) 2017/745.

(18)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,

HAS ADOPTED THIS REGULATION:

Article 1

Common specifications

1.   This Regulation lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.

Annex I lays down common specifications for all those groups of products without an intended medical purpose.

Annex II lays down common specifications for contact lenses as specified in Section 1 of that Annex.

Annex III lays down common specifications for products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, with the exception of tattooing products and piercings, as specified in Section 1 of that Annex.

Annex IV lays down common specifications for substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing, as specified in Section 1 of that Annex.

Annex V lays down common specifications for equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty as specified in Section 1 of that Annex.

Annex VI lays down common specifications for high intensity electromagnetic radiation (for example, infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment as specified in Section 1 of that Annex.

Annex VII lays down common specifications for equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as specified in Section 1 of that Annex.

2.   The common specifications laid down in this Regulation cover the requirements set out in the second sentence of Section 1 and in Sections 2 to 5, 8 and 9 of Annex I to Regulation (EU) 2017/745.

Article 2

Transitional provisions

1.   A product for which the manufacturer intends to perform, or is performing, a clinical investigation to generate clinical data for the clinical evaluation in order to confirm the conformity with the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/745 and the common specifications set out in this Regulation, and in the conformity assessment of which a notified body has to be involved in accordance with Article 52 of that Regulation, may be placed on the market or put into service until 22 June 2028, provided that the following conditions are met:

(a)

the product was already lawfully marketed in the Union before 22 June 2023 and continues to comply with the requirements of Union and national law that were applicable to it before 22 June 2023;

(b)

there are no significant changes in the design and intended purpose of the product.

By way of derogation from the first subparagraph of this paragraph, from 22 June 2024 until 22 December 2024, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if the sponsor has received from the Member State concerned a notification, in accordance with Article 70(1) or (3) of Regulation (EU) 2017/745, confirming that the application for the clinical investigation of the product is complete and that the clinical investigation falls within the scope of the Regulation (EU) 2017/745.

By way of derogation from the first subparagraph, from 23 December 2024 until 22 June 2026, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if the sponsor has started the clinical investigation.

By way of derogation from the first subparagraph, from 23 June 2026 until 22 June 2028, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if a written agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer.

2.   A product for which the manufacturer does not intend to perform a clinical investigation, but in the conformity assessment of which a notified body has to be involved in accordance with Article 52 of that Regulation, may be placed on the market or put into service until 22 June 2025, provided that the following conditions are met:

(a)

the product was already lawfully marketed in the Union before 22 June 2023 and continues to comply with the requirements of Union and national law that were applicable to it before 22 June 2023;

(b)

there are no significant changes in the design and intended purpose of the product.

By way of derogation from the first subparagraph, from 22 September 2023 until 22 June 2025, a product that meets the conditions laid down in that subparagraph may only be placed on the market or put into service, if a written agreement for the performance of the conformity assessment has been signed by the notified body and the manufacturer.

3.   A product to which this Regulation applies and which is covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC may be placed on the market or put into service until the dates laid down in paragraph 1, first subparagraph, and paragraph 2, first subparagraph, as applicable, also after the expiry date of such certificate, provided that the following conditions are met:

(a)

the product was already lawfully marketed in the Union before 22 June 2023 and continues to comply with the requirements of Directive 93/42/EEC, except for the requirement to be covered by a valid certificate issued by a notified body where the certificate expires after 26 May 2021;

(b)

there are no significant changes in the design and intended purpose of the product;

(c)

after the expiry date of the certificate issued by a notified body in accordance with Directive 93/42/EEC, the appropriate surveillance of the compliance with the conditions referred to in points (a) and (b) of this paragraph is ensured by way of a written agreement signed by the notified body that has issued the certificate in accordance with Directive 93/42/EEC or a notified body designated in accordance with Regulation (EU) 2017/745 and the manufacturer.

Article 3

Entry into force and date of application

1.   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2.   It shall apply from 22 June 2023. However, Article 2(3) shall apply from 22 December 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 1 December 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 117, 5.5.2017, p. 1.

(2)  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).


ANNEX I

Scope

1.

This Annex applies to all the devices covered by Annexes II to VII.

Risk Management

2.   General requirements

2.1.

Manufacturers shall establish and document responsibilities, operative modalities and criteria for the execution of the following steps of the risk management process:

(a)

risk management planning;

(b)

identification of hazards and risk analysis;

(c)

risk evaluation;

(d)

risk control and evaluation of residual risks;

(e)

risk management review;

(f)

production and post-production activities.

2.2.

Top-level management of the manufacturers shall ensure that adequate resources are allocated and that competent personnel is assigned for risk management. Top-level management shall define and document a policy for establishing criteria for risk acceptability. Such policy shall take into account the generally acknowledged state of the art, known concerns related to safety expressed by interested parties and shall include the principle that risks are to be eliminated or reduced as far as possible by means of control measures without adversely affecting the overall residual risk. Top-level management shall ensure that the risk management process is executed and shall review its effectiveness and suitability at planned intervals.

2.3.

The personnel responsible for performing risk management tasks shall be appropriately qualified. They shall have, where that is needed for the performance of tasks, proven and documented knowledge of and experience in using the particular device, equivalent devices without an intended medical purpose or analogous devices with a medical purpose, as well as knowledge of the technologies involved and risk management techniques. Evidence of qualification and competences of personnel, such as education, training, skills and experience, shall be documented.

An analogous device with a medical purpose shall be understood as the same device with a medical purpose or a medical device for which equivalence to the same device with a medical purpose has been demonstrated by the manufacturer in accordance with Section 3 of Annex XIV to Regulation (EU) 2017/745 of the European Parliament and of the Council (1).

2.4.

The results of the risk management activities, including the reference to the device, the reference to the persons who carried out the activities and the dates of execution of such activities, shall be recorded. For every identified hazard, the records shall provide traceability to the results of risk analysis, risk evaluation, risk control and evaluation of residual risks.

2.5.

Based on the results of the risk management process, manufacturers shall define the categories of users and consumers that are to be excluded from the use of the device or for which special conditions of use have to be applied. A consumer shall be understood as a natural person on whom a product without an intended medical purpose is intended to be used.

2.6.

Throughout the entire lifecycle of a device, the manufacturer shall establish a system to ensure a continuous systematic update of the risk management process in relation to that device.

3.   Risk management planning

3.1.

Risk management planning documents shall include:

(a)

references and description of the device, including its parts and components;

(b)

a list of the activities to be performed in each step of the risk management process, their scope and the actions for the verification of completion and effectiveness of the risk control measures;

(c)

a specification of the life cycle phases of the device covered by each activity included in the plan;

(d)

a specification of responsibilities and authorities for the execution of the activities, for the approvals of the results and for the risk management review;

(e)

a specification of criteria for risk acceptability based on the policy referred to in Section 2.2;

(f)

a specification of criteria for the collection of relevant information from the production and from the post production phases and for the use of such information to review and update, if necessary, the risk management results.

3.2.

The criteria for risk acceptability shall include the description of the criterion for the acceptability of the overall residual risk. The method for the evaluation of the overall residual risk shall be defined and documented.

3.3.

In defining the criteria for risk acceptability in accordance with the principles established by the policy referred to in Section 2.2, manufacturers shall consider that all risks, including those related to surgical intervention, are to be eliminated or reduced as far as possible. If the undesirable side-effects are of transient nature and do not require medical or surgical intervention to prevent life-threatening illness or permanent impairment of a body function or permanent damage to a body structure, residual risks may be considered as being acceptable. If one or more of the conditions laid down in this Section is not met, the manufacturer shall provide a justification explaining the reasons for the acceptability of the risks.

4.   Identification of hazards and risk analysis

4.1.

Documents for the identification of hazards and risk analysis shall:

(a)

include a description of the device, its intended use and the reasonably foreseeable misuse;

(b)

list the qualitative and quantitative characteristics that could affect the safety of the device;

(c)

list the known and the foreseeable hazards associated with the device, its intended use, its characteristics and its reasonably foreseeable misuse, when used in both normal and fault conditions;

(d)

list the hazardous situations resulting from the consideration of the foreseeable events for each identified hazard;

(e)

include the qualitative or quantitative terms and descriptions, or the categorization, for the estimation of the severity and the probability of occurrence of harms.

(f)

for each hazardous situation, list the estimated severity and probability of occurrence of harms and the resulting estimation of risks.

4.2.

The description of the intended use of the device shall include information on the part of the human body or type of tissue interacted with, the categories of users and consumers, the use environment and the treatment procedure.

4.3.

In the risk analysis manufacturers shall take into account the specificities of various user and consumer groups. This includes considering whether the user is a healthcare professional or a lay person. In the case of a lay person distinction shall be made between a person without qualification for the use of the device and a person who uses a device in the context of his or her professional activities, and who, although not being a healthcare professional, has a proven qualification for the use of the device. It shall be presumed by the manufacturer that all those user and consumer groups have access to the device unless the device is only sold directly to healthcare professionals.

4.4.

Manufacturers shall consider clinical data as one of the sources of information for the risk analysis and for the estimation of the severity and the probability of occurrence of harms.

4.5.

Where due to the nature of the devices or for ethical reasons data on the probability of occurrence of harm cannot be generated, manufacturers shall estimate the risk on the basis of the nature of the harm and a worst case estimate of the probability of the harm occurring. In the technical documentation manufacturers shall provide evidence justifying the reason for not providing data on the probability of occurrence of harm.

4.6.

The description of the scope for the risk analysis shall be recorded.

5.   Risk evaluation

5.1.

For any hazardous situation, manufacturers shall evaluate the estimated risks and determine whether the risks are acceptable in accordance with the criteria referred to in Section 3.1, point (e).

5.2.

Where the risk is not acceptable, risk control shall be performed.

5.3.

Where the risk is acceptable, risk control is not needed and the final estimated risk shall be considered as a residual risk.

6.   Risk control and evaluation of residual risks

6.1.

Documents for risk control and evaluation of residual risks shall include:

(a)

a list of the implemented risk control measures and the evaluation of their effectiveness;

(b)

a list of the residual risks after completed implementation of the risk control measures;

(c)

the evaluation of acceptability for residual risks and for the overall residual risk, in accordance with the criteria referred to in Section 3.1, point (e);

(d)

the verification of the effects of the risk control measures.

6.2.

Risk control measures to be implemented by the manufacturer shall be selected from the following categories of risk control options:

(a)

inherent safety ensured by design;

(b)

inherent safety ensured by manufacturing;

(c)

protective measures in the device or in the manufacturing process;

(d)

information for safety and, where appropriate, user training.

Manufacturers shall select risk control measures in the priority order from points (a) to (d). Measures from a risk control option shall not be implemented unless the measures from the previous option cannot be implemented or, where implemented, have not resulted in the risk acceptability.

6.3.

Manufacturers shall ensure that the information for safety is not limited to the instruction for use or to the label, but also available by other means. Information integrated in the device itself that the user cannot disregard and public information easily accessible to the user shall be considered. Where appropriate, user training shall be considered. The information shall be presented taking into account the degree of understanding of users and consumers as referred to in Section 9.

6.4.

Risk control measures shall be taken even if the performance of the device is thereby reduced as long as the main function of the device is maintained.

6.5.

When deciding on risk control measures, manufacturers shall verify whether the risk control measures generate new harm, hazards or hazardous situations and whether the estimated risks for previously identified hazardous situations are affected by those measures. The reduction of a risk shall not increase one or several other risks so that the overall residual risk could be increased.

7.   Risk management review

7.1.

Documents for risk management review shall include a review before the release for commercialisation of the device. The review shall ensure that:

(a)

the risk management process has been carried out in accordance with the risk management planning documents referred to in Section 3.1;

(b)

the overall residual risk is acceptable and the risks have been eliminated or reduced as far as possible;

(c)

the system to collect and review information on the device from the production and the post-production phases is implemented.

8.   Production and post-production activities

8.1.

Documents for production and post production activities shall:

(a)

specify the system to collect and review information on the device from the production and the post-production phases;

(b)

list the sources of publicly available information on the device, on equivalent devices without an intended medical purpose or on analogous devices with a medical purpose;

(c)

specify the criteria to evaluate the impact of the information collected on the results of previous risk management activities and the consequent actions on the device.

As part of the system to collect and review information on the device from the post-production phases, manufacturers shall consider clinical data from the post market surveillance, and, where applicable, clinical data from the summary of safety and clinical performance referred to in Article 32 of Regulation (EU) 2017/745 or the post-market clinical follow-up referred to in Part B of Annex XIV to that Regulation.

8.2.

For the specification of the criteria to evaluate the impact of the information collected, the manufacturer shall consider:

(a)

hazards or hazardous situations that have not been identified previously;

(b)

hazardous situations for which the risk is no longer acceptable;

(c)

whether the overall residual risk is no longer acceptable.

Any impact of the information collected affecting the effectiveness and suitability of the risk management process shall be considered as an input for the top-level management review referred to in Section 2.2.

8.3.

For the specification of the consequent actions on the results of previous risk management activities, manufacturers shall consider an update of the former results of the risk management activities to:

(a)

include new hazards or hazardous situations and evaluate the related risks;

(b)

re-evaluate hazardous situations, residual risks and the overall residual risk no longer acceptable;

(c)

establish the need for actions in relation to the devices already made available on the market.

8.4.

Manufacturers shall take account of any changes in risks identification, analysis and evaluation which could arise from new data or changes in device use environment.

Information for safety

9.

When providing information for safety referred to in Section 6.2, point (d), and on the risks linked to the use of the device referred to in Sections 11.2, point (c) and 12.1, point (c), manufacturers shall take into account:

(a)

the different degree of understanding of users and consumers, with particular emphasis on devices intended to be used by lay persons;

(b)

the work environment where the device is intended to be used, especially in case of use outside a medical or otherwise professionally controlled work environment.

10.

If the device is intended by the manufacturer only for a non-medical purpose, information supplied with the device shall not bear any clinical benefit claim or statement. If the device is intended by the manufacturer for a medical and non-medical purpose, information provided for the non-medical purpose shall not bear any clinical benefit claim or statement.

11.   Label

11.1.

The label shall bear the words “non-medical purpose:” followed by a description of that non-medical purpose.

11.2.

If feasible, manufacturers shall specify on the label:

(a)

the information regarding the categories of users and consumers referred to in Section 2.5;

(b)

the expected performance of the device;

(c)

the risks arising from the use of the device.

12.   Instructions for use

12.1.

The instructions for use shall include:

(a)

the information regarding the categories of users and consumers referred to in Section 2.5;

(b)

a description of the expected performance of the device, in such a way so that the user and the consumer understands which non-medical effect can be expected from the use of the device;

(c)

a description of the residual risks of the device, including their control measures, presented in a clear and easily understandable way so that the consumer can make an informed decision on whether to be treated with it, have it implanted or otherwise use it;

(d)

the expected lifetime or the expected resorption period of the device and any necessary follow-up;

(e)

reference to any harmonised standard and common specifications applied.


(1)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1).


ANNEX II

Scope

1.

This Annex applies to contact lenses listed in Section 1 of Annex XVI to Regulation (EU) 2017/745. Contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices and other items intended to be introduced into or onto the eye are not covered by this Annex.

Risk management

2.

When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 3 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 4 of this Annex.

3.   Specific risks

3.1.

Manufacturers shall analyse and eliminate or reduce as far as possible the risks linked to the following aspects:

 

Design and manufacturing

(a)

the shape of the device, in particular in view of avoiding irritation by edges or sharps, disconnection or dislocation from the cornea, wrinkling or folding, unequal pressure on the cornea related to positioning;

(b)

the selection of raw materials for lens, for surface treatments and, if relevant, for lens storage solutions in view of biological safety, biocompatibility, chemical and biological contaminants as well as permeability of oxygen and compatibility with lens storage solutions;

(c)

biological safety and biocompatibility of the final product, with its packaging and storage solution, including consideration of at least the aspects of cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute toxicity, implantation, sterilization residues and degradation products, extractable and leachable substances. Where the cumulative contact duration is expected to exceed 30 days, aspects of subchronic toxicity, chronic toxicity and genotoxicity shall also be considered;

(d)

microbiological properties, including bioburden, microbiological contamination of the final device, residual bacterial endotoxins, sterility, contact lens disinfection and preservation;

(e)

appropriateness of the primary packaging in terms of keeping the lens sterile, permanently covered by storage fluid and avoiding degradation of the product, for example by leaching of container or cover materials, by intrusion of microbial contaminations;

(f)

the effect of long-term storage and the conditions of storage on the stability and properties of the lens;

 

Distribution chain

(a)

lack of pre-use testing of suitability of lens wearing performed by ophthalmologist, optometrist, specialised optician or qualified contact lens specialist;

(b)

lack of expertise of distributors outside the classic optician distribution chain with regard to both the selection of appropriate lenses and their use, storage and safe transport;

(c)

lack of expertise of distributors outside the classic optician distribution chain with regard to safety or handling advice to the users;

 

User-related hazards/risks

(a)

lack of experience with and training on the use of contact lenses of certain uses;

(b)

identification of contra-indications under which contact lenses shall not be used;

(c)

possible reduced availability to the cornea of tear film and oxygen;

(d)

lack of hygiene, such as failure to wash and dry hands prior to users placing, using and removing lenses resulting in possible infection, severe inflammation or other diseases of the eye;

(e)

possible vision hindrance and reduced transmission of light;

(f)

any possible factors that could cause deterioration of eye sight such as coloration, lack of precise fitting to the eye’s surface and lack of correction;

(g)

identification of any non-medical conditions under which contact lenses are not be used. Conditions to be considered shall include driving, piloting or operating heavy machinery and water-based activities such as showering, bathing and swimming;

(h)

increased risk of eye damage if the lenses are worn extensively (for example for long periods, consecutive multiple use);

(i)

increased risk of eye damage if lenses are still worn when eye redness and irritation occur;

(j)

the effect of duration of use on any of the risks mentioned above;

(k)

possible misuse of the primary packaging as containment for storage between several uses;

(l)

for multiple use contact lenses, risks linked to re-use and irregular re-use by the same consumer;

(m)

lack of familiarity of consumers with emergency measures in case of any undesirable side-effects.

4.   Specific risk control measures

(a)

The field of vision shall not be reduced by the lens, including in case of reasonably foreseeable dislocation or imprecise placing. The lens shall permit transmission of sufficient light for adequate visibility under any condition of use.

(b)

All materials of the lens and the inner side of its primary packaging, including its storage solution, shall be biocompatible, non-irritating and non-toxic. In addition, the substances used for colouring of or printing on the contact lenses shall not leach under the intended conditions of use.

(c)

Lenses and the inner side of their primary packaging, including its storage solution shall be sterile and non-pyrogenic. If in contact with the eye, the storage liquid shall not injure the cornea, eye and the surrounding tissue.

(d)

Lenses shall be designed so as not to compromise the health of the cornea, eye and surrounding tissue. Lens features such as low oxygen permeability, imprecise placing, dislocation, sharp edges, abrasion, unequal mechanical pressure distribution shall be considered.

(e)

As regards lenses for multiple use, the manufacturer shall either provide effective maintenance liquids and means for cleaning and disinfecting together with the lens sufficient for the entire lifetime of the lens, or indicate the required maintenance liquids and means for cleaning and disinfecting. The manufacturer shall also either provide or indicate any other equipment or tools for the maintenance and cleaning of the lenses for multiple use.

(f)

As regards lenses for multiple use, the manufacturer shall validate the maximum number of re-uses and maximum duration of use (for example in hours per day and/or number of days).

(g)

Manufacturers shall consider whether eye drops need to be used to compensate for dryness. Where such eye-drops are needed, manufacturers shall define criteria to demonstrate their suitability;

(h)

Manufacturers shall establish a procedure for the identification of any undesirable side-effects by the user and how to deal with them, including reporting to the manufacturer of such undesirable side-effects;

(i)

The instructions for use and the label shall be designed and written in a manner so that they can be understandable by a lay person and that enables a lay person to use the device safely.

Information for safety

5.   Label

5.1.

The outer packaging intended to be provided to users shall contain the following indications:

(a)

where devices are intended for single use, in addition to the internationally recognized symbol, in bold font of largest used size on the label the text “Do not re-use”;

(b)

indication of the dimensions of the lens (outer diameter of the lens and base curve radius);

(c)

the recommendation to read the instructions for use.

6.   Instructions for use

6.1.

The instructions for use shall contain:

(a)

in bold font of largest used size in the instructions the text: “Do not re-use”, in addition to the internationally recognized symbol, where devices are intended for single use;

(b)

a warning “Used lenses shall not be used by other persons”;

(c)

the indication of the dimensions of the lens (outer diameter of the lens and base curve radius);

(d)

the indication of the materials of the lens, including its surface and colouring pigments;

(e)

the indication of water content and oxygen permeability;

(f)

an indication of the possible effect of incorrect storage conditions on the quality of the product and maximum storage time;

(g)

instructions on what to do in case of displacement;

(h)

hygiene measures prior to use (for example washing and drying hands), during use and after use;

(i)

a warning “Do not contaminate lenses with make-up or aerosols.”;

(j)

a warning “Do not clean lenses with tap water.”;

(k)

for multiple use lenses, a detailed description of the cleaning and disinfection procedure, including the description of the necessary equipment, tools and solutions, which shall be named in detail; a description of required storage conditions;

(l)

for multiple use lenses, the maximum number of re-uses and maximum duration of use(s) (for example in hours per day and/or number of days);

(m)

where the use of eye drops is recommended, a description of suitable eye drops and the description on how to use them;

(n)

listing of contraindications under which contact lenses are not to be used. Such a list shall include: dry eyes (inadequate tear fluid), use of eye medication, allergies, inflammation or redness in or around the eye, poor health affecting the eye such as cold and flu, previous medical intervention which may adversely affect the use of the device, any other systemic illness affecting the eye;

(o)

a warning: “Do not use whilst participating in traffic-related situations (for example driving, riding a bike), operating machinery or whilst undertaking water-related activities such as showering, bathing and swimming.”;

(p)

a warning: “Avoid activities where possible vision hindrance and reduced transmission of light create a risk.”;

(q)

a statement regarding increased risk of eye damage in case of continuous wear when eye redness and irritation occur;

(r)

a warning “Do not use after date of expiry.”;

(s)

a clear indication of the maximum wearing time;

(t)

a warning “Do not use lenses beyond maximum wearing time.”;

(u)

a warning “Do not use lenses during sleeping periods”;

(v)

a statement on the increased risk of eye damage if the lenses are worn extensively (for example multiple re-uses);

(w)

a warning “Do not use in excessively dry or dusty environments.”;

(x)

a warning “Do not re-use the primary packaging as containment for storage between uses.”, where primary packaging is not intended by the manufacturer for such use;

(y)

a warning: “Do not re-use the storage solution.”;

(z)

a list of risks linked to ocular health associated with lens wear, as identified by risk analysis, including, if applicable, reduced availability to the cornea of water and oxygen (oxygen transmissibility);

(aa)

a list of possible undesirable side-effects, their probability of occurrence and their indicators;

(bb)

instructions on how to deal with complications, including emergency measures;

(cc)

an instruction “Remove the lens immediately in case of:

irritation or eye pain such as stinging, burning, itching, foreign body sensation;

reduced comfort when compared with previous wearing of an identical lens;

unusual secretions or excessive tear-flow,

redness of the eye,

severe or persistent dryness,

reduced or blurred vision linked to the use of the lens.

If any of these symptoms continue after removal of the lens, contact a qualified healthcare professional, such as an ophthalmologist, or an optometrist, authorised by national law to treat such symptoms. The continuation of these symptoms might indicate a more serious condition.”;

(dd)

information on when and how to report undesirable side-effects to the manufacturer.


ANNEX III

Scope

1.

This Annex applies to products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, listed in Section 2 of Annex XVI to Regulation (EU) 2017/745. Tattooing products, piercings and products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of fixation of body parts are not covered by this Annex. This Annex does not apply to active implantable devices.

Risk management

2.

When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 3 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 4 of this Annex.

The risk analysis shall include a section on risks that are related to the specific non-medical intended purpose of introducing the device into the human body through surgically invasive means, taking into account specific characteristics of potential users and consumers of the device.

3.   Specific risks

3.1.

Manufacturers shall take into account the following aspects and related risks:

(a)

physical and chemical characteristics and full composition of the implant;

(b)

the selection of raw materials in view of biological safety, biocompatibility and chemical and biological additives or contaminants;

(c)

for resorbable devices, resorption and life-time in the body, indicating the half-life and the end of the resorption;

(d)

biological safety and biocompatibility of the final product, including consideration of at least the aspects of cytotoxicity, sensitisation, irritation, material mediated pyrogenicity, acute systemic toxicity, subacute toxicity, subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, implantation, sterilisation residues and degradation products, extractable and leachable substances;

(e)

microbiological properties, including bioburden, microbiological contamination of the final device, residual bacterial endotoxins and sterility;

(f)

the specific anatomical location for which clinical and other data support the use of the device;

(g)

consumer specific factors (for example previous accidents, special conditions, age restrictions);

(h)

potential interactions with magnetic field, (for example heating related to magnetic resonance imaging);

(i)

use of accessories (for example delivery instruments designed to be specifically used with the device for the implantation procedure) and their compatibility with the implant;

(j)

time interval between implantations, where applicable.

3.2.

Where appropriate, manufacturers shall in particular analyse, eliminate or reduce as far as possible risks related to the following hazards or harms:

(a)

microbiological contamination;

(b)

presence of manufacturing debris;

(c)

implantation procedure related aspects (including use errors);

(d)

implant failure (for example rupture, unintended degradation);

(e)

implant dislodgement and migration;

(f)

asymmetry;

(g)

implant visibility through the skin;

(h)

implant deflation and wrinkling;

(i)

gel bleeding and leakage;

(j)

sweating and silicone migration;

(k)

local inflammation and swelling;

(l)

regional swelling or lymphadenopathy;

(m)

capsule formation and contracture;

(n)

discomfort or pain;

(o)

hematoma;

(p)

infection and inflammation;

(q)

superficial wound;

(r)

wound dehiscence;

(s)

extrusion of implant and interruption of wound healing;

(t)

scarring and scar hyperpigmentation and hypertrophy;

(u)

nerve injury;

(v)

seroma;

(w)

compartment pressure problems and compartment syndrome;

(x)

limitation in cancer diagnosis;

(y)

over-sized implants;

(z)

vascular damage;

(aa)

breast implant associated anaplastic large cell lymphoma (BIA-ALCL);

(bb)

granuloma, including siliconoma where applicable;

(cc)

necrosis.

4.   Specific risk control measures

(a)

Devices shall be sterile and non-pyrogenic. Where implants are supplied non-sterile with the intention to be sterilised before use, adequate instruction for sterilisation shall be provided.

(b)

The safe use of the device shall be supported by clinical and other data considering the anatomical location.

(c)

Long-term data shall be collected to evaluate the presence of non-degradable substances originating from the devices.

(d)

Presence of substances referred to in Section 10.4.1, points (a) and (b), of Annex I to Regulation (EU) 2017/745 shall be evaluated independently of their concentration.

(e)

Manufacturers shall provide training on the implantation and safe use of the device. That training shall be accessible to users.

Information for safety

5.   Label

5.1.

The label shall contain:

(a)

in bold font of largest used size on the label the text: “Only to be implanted in an appropriate medical environment by appropriately trained medical doctors who are qualified or accredited in accordance with national law.”;

(b)

a clear indication that devices are not to be used in persons who are less than 18 years old;

(c)

the overall qualitative composition of the product.

6.   Instructions for use

6.1.

The instructions for use shall contain:

(a)

on top in bold fonts of largest used size in the instructions of use the text: “Only to be implanted in an appropriate medical environment by appropriately trained medical doctors who are qualified or accredited in accordance with national law.”;

(b)

a clear indication that devices are not to be used in persons who are less than 18 years old;

(c)

the recommendation for the user to consider any previous procedures, accidents, conditions, medications or other simultaneous treatments of the consumer that may affect the procedure (for example skin diseases, traumas and auto-immune diseases);

(d)

the instruction for the user to consider any specific risks that may be applicable to activities of the consumer (for example profession, sports or other activities regularly performed by the consumer);

(e)

a comprehensive list of contra-indications. This list shall include keloid scars;

(f)

the overall qualitative and quantitative composition of the product;

(g)

the recommendation for the user on a post-implantation monitoring time in order to identify any potential undesirable side-effects;

(h)

an indication of the appropriate time interval between treatments, where applicable;

(i)

a requirement for the user to provide the consumer with a copy of the annex provided for in Section 6.2 before the consumer is treated with the device.

6.2.

The instructions for use shall contain an annex, written in a language commonly understood by lay persons and in the form that is easy to be handed over to all the consumers. The annex shall contain:

(a)

information listed in Section 12.1, points (a) to (e), of Annex I;

(b)

a list of all residual risks and potential side-effects, including those commonly related to surgery such as bleeding, potential drug interactions and the risks associated with anaesthesia, in a clear way;

(c)

information on when and how to report undesirable side-effects to the manufacturer, information on device removal, information on when to contact a healthcare professional;

(d)

details on volume and size of the device;

(e)

the statement “The users received appropriate training on how to safely use the device.”, where relevant.


ANNEX IV

Scope

1.

This Annex applies to substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing, listed in Section 3 of Annex XVI to Regulation (EU) 2017/745. This Annex only applies to the means for introduction into the body, for example syringes and dermarollers, where they are prefilled with the substances, combinations of substances or other items listed in Section 3 of Annex XVI to Regulation (EU) 2017/745. This Annex does not apply to active devices.

Risk management

2.

When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 3 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 4 of this Annex.

3.   Specific risks

3.1.

Manufacturers shall take into account the following aspects and related risks:

(a)

physical and chemical characteristics of the device;

(b)

the selection of raw materials in view of biological safety, biocompatibility and chemical and biological additives or contaminants;

(c)

biological safety and biocompatibility of the final product, including consideration of at least the aspects of cytotoxicity, sensitisation, irritation, material mediated pyrogenicity, acute systemic toxicity, subacute toxicity, subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, implantation, sterilisation residues and degradation products, extractable and leachable substances;

(d)

resorption and life-time in the body, indicating the half-life and the end of the resorption, including the possibility of metabolisation (for example enzymatic degradation of the filler material such as hyaluronidase for hyaluronic acid fillers);

(e)

microbiological properties, bioburden, microbiological contamination of the final device, residual bacterial endotoxins and sterility;

(f)

the specific anatomical location of injection or introduction;

(g)

consumer specific factors (for example previous and current treatments (medical and surgical), age restrictions, pregnancy, breast-feeding);

(h)

if applicable, risks related to the use of local anaesthetic, either as part of the product or stand-alone;

(i)

for non-resorbable devices, the risk associated with the removal of the device;

(j)

aspects associated with the use of the device, including:

injection technique;

means of injection (for example rollers, catheters or needles);

maximum quantity injected depending on location and applied technique;

possible repeated injections;

force required to administer the product;

product temperature;

transfer of the product (for example from a vial to a syringe).

3.2.

Where appropriate, manufacturers shall analyse, eliminate or reduce as far as possible risks related to the following hazards or harms:

(a)

microbiological contamination;

(b)

presence of manufacturing debris;

(c)

hazards associated with the procedure to inject or otherwise introduce the device (including use errors);

(d)

migration of the device;

(e)

device visibility through the skin;

(f)

unintended local inflammation and swelling;

(g)

regional swelling or lymphadenopathy;

(h)

capsule formation and contracture;

(i)

discomfort or pain;

(j)

hematoma;

(k)

infection and inflammation;

(l)

superficial wound;

(m)

interruption of wound healing;

(n)

scarring and scar hyperpigmentation and hypertrophy;

(o)

nerve injury;

(p)

seroma;

(q)

compartment pressure problems and compartment syndrome;

(r)

granuloma, including siliconoma where applicable;

(s)

edema;

(t)

vascular damage;

(u)

severe allergic reactions;

(v)

blindness;

(w)

necrosis.

4.   Specific risk control measures

(a)

Devices shall be sterile non-pyrogenic and intended for single use.

(b)

The safe use of the device shall be supported by clinical and other data considering the anatomical location.

(c)

Long-term data shall be collected to evaluate the presence of non-degradable substances originating from the devices.

(d)

Manufacturers shall provide training on the administration and safe use of the device. That training shall be accessible to users.

(e)

Presence of substances referred to in Section 10.4.1, points (a) and (b), of Annex I to Regulation (EU) 2017/745 shall be evaluated independently of their concentration.

Information for safety

5.   Label

5.1.

The label shall contain:

(a)

in bold fonts of largest used size on the label the text: “Only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law”.

(b)

a clear indication that devices are not to be used in persons who are less than 18 years old.

6.   Instructions for use

6.1.

The instructions for use shall contain:

(a)

on top in bold font of largest used size in the instructions for use the text: “Only to be administered by appropriately trained healthcare professionals who are qualified or accredited in accordance with national law.”;

(b)

a clear indication that devices are not to be used in persons who are less than 18 years old;

(c)

precise and detailed technical information for a good administering practice;

(d)

description of treatment of the most common side-effects, such as overdosing, swelling, hardening, nodules and immune responses, with the instruction to consult a medical professional if needed;

(e)

instructions for users as to how and when new injections can be placed at previously injected locations;

(f)

a list of constituents, which specifies:

all constituents responsible for the intended action with specification of their concentration and, where applicable, their molecular weight range, their particle size and their degree of cross-linking, together with the method used for its determination;

other constituents such as cross-linking agents, solvents, anaesthetics and preservatives, with specification of their concentration;

(g)

the recommendation for the user to consider any previous procedures, accidents, conditions, medications or other simultaneous treatments of the consumer that may affect the procedure (for example skin diseases, traumas and auto-immune diseases);

(h)

the recommendation for the user of a post-administration monitoring time in order to identify any potential undesirable side-effects;

(i)

a requirement for the user to provide the consumer with a copy of the annex provided for in Section 6.2 before the consumer is treated with the device.

6.2.

The instructions for use shall contain an annex, written in a language commonly understood by lay persons and in the form that is easy to be handed over to all the consumers. The annex shall contain:

(a)

information listed in Section 12.1, points (a) to (e), of Annex I;

(b)

all residual risks and potential undesirable side-effects listed in a clear way and described in a language commonly understood by lay persons. This includes a clear declaration on the presence of any substances referred to in Section 10.4.1 of Annex I to Regulation (EU) 2017/745, heavy metals or other contaminants;

(c)

information on when and how to report undesirable side-effects to the manufacturer;

(d)

information on when to contact healthcare professional;

(e)

any contra-indications to the procedure;

(f)

the statement “The users received appropriate training on the conditions to safely use the device.”, where relevant.

In addition, a specific part of the annex shall be designed to record information on the location, the number and the volume of the injections, for each consumer. The manufacturer shall recommend the healthcare professional to fill in this specific part.


ANNEX V

Scope

1.

This Annex applies to equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty, listed in Section 4 of Annex XVI to Regulation (EU) 2017/745. This Annex does not apply to active implantable devices.

Definitions

2.

For the purpose of this Annex, the following definitions apply:

(1)

“liposuction” means the surgical removal of localised subcutaneous fat deposits by aspiration;

(2)

“liposuction devices” means devices intended by the manufacturer to be used for the purpose of liposuction;

(3)

“lipolysis” means the localised destruction of fat deposit;

(4)

“lipolysis devices” means devices intended by the manufacturer to be used for the purpose of lipolysis;

(5)

“lipoplasty” means the modification of body contours by removal of excess fat;

(6)

“lipoplasty devices” means devices intended by the manufacturer to be used for the purpose of lipoplasty.

Risk management

3.

When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 4 of this Annex and, where relevant to the device, adopt the specific risk control measures listed in Section 5 of this Annex.

4.   Specific risks

4.1.

Where relevant as regards the device in question, manufacturers shall take into account the following aspects and related risks:

(a)

the volume of adipose tissue which may be removed or, in the case of lipolysis, destroyed and the expected metabolic effect, including the metabolisation of released tissue components, taking into account the probable different characteristics of the person undergoing treatment;

(b)

the minimum time lapse between subsequent procedures;

(c)

the anatomical location of the use of the device;

(d)

the cannula type, for example the diameter and nature of the tip of the cannula;

(e)

the amount of suction which will be applied;

(f)

the use and subsequent metabolisation of infiltrative fluid with a justification for the choice of fluid and its composition;

(g)

the type of liposuction which the device is intended to provide, for example dry or wet, and the type of anaesthetic;

(h)

whether the device is a simple liposuction device, i.e. blunt cannula suction, or whether it incorporates any other mechanism of action, for example the use of laser energy or ultrasound;

(i)

the age distribution, gender and body-mass-index of the population to which the clinical data or other sources of data relate;

(j)

the way in which energy is emitted.

4.2.

Where relevant as regards the device in question, manufacturers shall analyse, eliminate or reduce as far as possible risks related to the following hazards or harms:

(a)

post-operative seroma;

(b)

tissue injury, organ perforation and bleeding;

(c)

post-operative ecchymosis and edema;

(d)

interference with active implantable or active body-worn medical devices and with metallic passive medical devices or other metallic objects present on or inside the body;

(e)

thermal injury;

(f)

mechanical injuries, including those caused by unintended cavitation, and corresponding side-effects;

(g)

inflammation.

4.3.

For liposuction devices, in addition to the risks listed in Section 4.2, manufacturers shall analyse, eliminate or reduce as far as possible the following risks:

(a)

haemorrhage;

(b)

perforation of abdominal viscera, thorax or peritoneum;

(c)

pulmonary embolism;

(d)

bacterial infections such as necrotizing fasciitis, gas gangrene and sepsis;

(e)

hypovolemic shock;

(f)

thrombophlebitis;

(g)

seizures;

(h)

risks related to local anaesthetic use: consideration should be given to lidocaine-induced cardiotoxicity or lidocaine-related drug interactions for tumescent liposuction.

4.4.

For lipolysis devices, in addition to those risks listed in Section 4.2, manufacturers shall in particular analyse, eliminate or reduce as far as possible risks related to the following hazards or harms:

(a)

burns to incision sites and overlying tissue;

(b)

other harmful effects of the internal or external local discharge of energy;

(c)

over-exposure;

(d)

neurovascular and local tissue injury, including reduction in cutaneous sensory nerve function;

(e)

remodelling of collagen that may lead to neoformations;

(f)

reorganisation of the dermis, with reference to reticular dermis;

(g)

body deformity or similar poor aesthetic outcome causing the need for medical intervention;

(h)

for lipolysis devices that are surgically invasive, the hazards linked to the types and sizes of incision.

When complying with requirements of this section, manufacturers shall take account of the nature of the tissue and its hydration status.

5.   Specific risk control measures

5.1.

All materials coming into contact with the body shall be biocompatible, non-irritating, and non-toxic when used in accordance with the instructions for use.

5.2.

Invasive parts of the devices shall be sterile and pyrogen-free before use.

5.3.

Lipolysis devices shall include controls for the application time, the waveform, the energy applied and the temperature reached on or in the body. The controls shall include simultaneous visual and audible automatic alarms for cases where a critical value is reached for one parameter (for example temperature, energy and pressure level and duration of use) or for a combination of parameters.

5.4.

Where applicable, manufacturers shall make sure the devices have the following functions: low energy preset, emergency stop function (for example emergency stop switch), automatic deactivation in case of over-exposure or excessive liposuction, respectively.

5.5.

Liposuction devices, lipolysis devices and lipoplasty devices shall not be used in private environments by lay persons.

5.6.

Manufacturers shall provide training to users on safe and effective use of the device.

Information for safety

6.   Instruction for use

6.1.

The instructions for use shall contain a comprehensive list of contra-indications for the consumer. It shall include the following contra-indications:

(a)

coagulant disorders, being treated with anticoagulant medications;

(b)

uncontrolled hypertension;

(c)

diabetes mellitus;

(d)

phlebitis and vasculitis;

(e)

cancer or tumours;

(f)

extreme obesity (body mass index above 40);

(g)

pregnancy;

(h)

vascular fragility;

(i)

recent surgery (6 weeks);

(j)

skin infections and open lesions;

(k)

varicose veins in the area of treatment;

(l)

medical conditions, such as heart, lung, or circulatory system disease;

(m)

age less than 18;

(n)

incapability to understand the consequences, implications and risks of the medical procedures (for example liposuction, lipolysis, lipoplasty) where the devices are used;

(o)

elevated body temperature (pyrexia).

In addition to the contra-indications listed in the first subparagraph, for lipolysis devices employing radiofrequency electric currents or electromagnetic fields, the list shall contain the following:

(a)

any metallic passive medical device or other metallic object present on or inside the body;

(b)

any active implantable or active body-worn medical device.

6.2.

The instructions for use shall list the body parts on which the device cannot be used.

6.3.

The instructions for use shall contain a comprehensive list of adverse effects for the consumer. This list shall include the following adverse effects:

(a)

hyper- or hypovolaemia;

(b)

bradycardia;

(c)

venous thromboembolism;

(d)

fat embolism;

(e)

infection;

(f)

fluid accumulation;

(g)

skin erythema or panniculitis;

(h)

contour irregularities.

6.4.

The instructions for use shall contain a comprehensive list of warnings. This list shall include the following warning:

“Liposuction, lipolysis and lipoplasty are not reliable methods for weight reduction. Consideration should be given to exercise and dietary as well as lifestyle modification, both as alternatives to liposuction and lipolysis and in order to maintain any reduction in adipose tissue which these procedures may achieve. Devices have not been validated for the treatment of clinically diagnosed obesity and therefore should not be used for such purposes.”.

6.4.1.

In addition to the warning referred to in Section 6.4, for liposuction devices, the instructions for use shall contain the following warning:

“The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and the consumer’s safety. The capacity of providing adequate, timely fluid management is essential for the consumer’s safety.”.

6.4.2.

In addition to the warnings referred to in Sections 6.4 and 6.4.1, for liposuction devices that may use a tumescent fluid, the instructions for use shall contain the following warnings:

(a)

“Careful consideration shall be given to consumer suitability with respect to medication which has the potential to cause bradycardia or hypotension as this has been reported as the cause of death in a number of consumers undergoing tumescent liposuction. Consumers taking drugs such as beta-adrenergic antagonists, non-dihydropyridine calcium-channel blockers, cardiac glycosides, and centrally acting alpha-adrenergic agonists shall be subject to very careful consideration as deaths have been reported due to bradycardia and hypotension. The procedure has to be preceded by a medical consultation which has to be documented and during which chronic disease and drugs taken by patient need to be considered.”;

(b)

“Consumers shall be warned that they may experience extended post-operative analgesia (for example for 24 hours or more) which may result in reduced sensation in the areas infiltrated and therefore consumers shall be warned to protect themselves from injury.”.

6.4.3.

In addition to the warning referred to in Section 6.4, for lipolysis devices, the instructions for use shall contain the following warning:

“Liver or cardiovascular dysfunction, such that the transient release of glycerol or free fatty acid, may be associated with increased risk.”.

6.5.

For liposuction and lipolysis devices, the instructions for use shall contain the following warning:

“Devices intended for invasive use shall only be used in an appropriate medical environment by appropriately trained medical doctors who are qualified or accredited in accordance with national law. The medical doctor who carries out the procedure shall be assisted by at least one medical doctor or allied health professional who is qualified or accredited in accordance with national law.

All staff involved in the procedure shall be trained and shall keep their knowledge of basic cardiac life support and in the checking of equipment and emergency drugs used for resuscitation purposes up-to-date. Medical doctors performing the procedure shall also be trained in advanced cardiac life support.

The medical doctor or allied health professional responsible for anaesthetic management shall ensure appropriate monitoring of the consumer both during the procedure and after it. With respect to tumescent liposuction, appropriate post-procedure monitoring shall be in place as lidocaine levels have been found to rise for up to 16 hours post-delivery.”.

6.6.

The instructions for use shall contain the requirement for the user to provide the consumer with a copy of the annex provided for in Section 6.7 before the consumer is treated with the device.

6.7.

The instructions for use shall contain an annex, written in a language commonly understood by lay persons and in the form that is easy to be handed over to all the consumers. The annex shall contain:

(a)

information listed in Section 12.1, points (a), (b) and (c), of Annex I;

(b)

the statement “The users received appropriate training on the conditions to safely use the device.”, where relevant;

(c)

information on when and how to report undesirable side-effects to the manufacturer;

(d)

a recommendation to undergo a medical consultation, including a diagnostic examination, of the areas intended for the treatment.


ANNEX VI

Scope

1.

This Annex applies to high intensity electromagnetic radiation (for example infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment, listed in Section 5 of Annex XVI to Regulation (EU) 2017/745.

For the purposes of this Annex, skin resurfacing includes skin rejuvenation.

For the purposes of this Annex, tattoo removal includes removal of permanent make-up.

For the purposes of this Annex, other skin treatments include non-medical treatment of nevi flammei, haemangioma, teleangiectasia, pigmented skin areas, and scars that are not injury within the meaning of Article 2, point (1), second indent, of Regulation (EU) 2017/745. For example, this Annex applies to devices intended to treat acne scars, but it does not apply to devices for other acne treatment.

This Annex does not apply to equipment using infrared optical radiation to warm the body or parts of the body and to sunbeds.

Definitions

2.

For the purpose of this Annex, the following definitions apply:

(1)

“device for professional use” means a device that is intended to be used in a healthcare environment or otherwise controlled professional environment by professionals having proven qualification in the safe and effective use of the device;

(2)

“device for home use” means a device that is intended to be used in private environments, not in a controlled professional environment, by lay persons.

Risk management

3.

When carrying out the risk management process provided for in Annex I to this Regulation, as part of the analysis of risks associated with the device, manufacturers shall consider the specific risks listed in Section 4 of this Annex an