title: Commission Implementing Regulation (EU) 2020/1992 of 2 December 2020 amending Regulation (EC) No 474/2006 as regards the list of air carriers banned from operating or subject to operational restrictions within the Union (Text with EEA relevance)

text:
                  7.12.2020

                  EN

                  Official Journal of the European Union

                  L 410/49

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1992
         of 2 December 2020
         amending Regulation (EC) No 474/2006 as regards the list of air carriers banned from operating or subject to operational restrictions within the Union
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating carrier, and repealing Article 9 of Directive 2004/36/EC (1), and in particular Article 4(2) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 474/2006 (2) establishes the list of air carriers, which are subject to an operating ban within the Union.

                     (2)

                     Certain Member States and the European Union Aviation Safety Agency (‘the Agency’) communicated to the Commission, pursuant to Article 4(3) of Regulation (EC) No 2111/2005, information that is relevant for updating that list. Third countries and international organisations also provided relevant information. The information provided contributes to the determination that the list should be updated.

                     (3)

                     The Commission informed all air carriers concerned, either directly or through the authorities responsible for their regulatory oversight, about the essential facts and considerations which would form the basis of a decision to impose an operating ban on them within the Union or to modify the conditions of an operating ban imposed on an air carrier which is included in the list in Annex A or B to Regulation (EC) No 474/2006.

                     (4)

                     The Commission gave the air carriers concerned the opportunity to consult all relevant documentation, to submit written comments and to make an oral presentation to the Commission and to the Committee established by Regulation (EC) No 2111/2005 (the ‘EU Air Safety Committee’).

                     (5)

                     The Commission has informed the EU Air Safety Committee about the ongoing joint consultations, within the framework of Regulation (EC) No 2111/2005 and Commission Regulation (EC) No 473/2006 (3), with the competent authorities and air carriers of Belarus, the Dominican Republic, Kazakhstan, Moldova, Pakistan and Russia. The Commission also informed the EU Air Safety Committee about the aviation safety situation in Armenia, Congo (Brazzaville), Equatorial Guinea, Indonesia and Kyrgyzstan.

                     (6)

                     The Agency informed the Commission and the EU Air Safety Committee about the technical assessments conducted for the initial evaluation and the continuous monitoring of third country operator (‘TCO’) authorisations, issued pursuant to Commission Regulation (EU) No 452/2014 (4).

                     (7)

                     The Agency also informed the Commission and the EU Air Safety Committee about the results of the analysis of ramp inspections stemming from the Safety Assessment of Foreign Aircraft (‘SAFA’) carried out under the EU Ramp Inspection Programme as provided for in Commission Regulation (EU) No 965/2012 (5).

                     (8)

                     In addition, the Agency informed the Commission and the EU Air Safety Committee about the technical assistance projects carried out in third countries affected by an operating ban under Regulation (EC) No 474/2006. Furthermore, the Agency provided information on the plans and requests for further technical assistance and cooperation to improve the administrative and technical capability of civil aviation authorities in third countries with a view to helping them resolve non-compliance with applicable international civil aviation safety standards. Member States were invited to respond to such requests on a bilateral basis in coordination with the Commission and the Agency. In that regard, the Commission reiterated the usefulness of providing information to the international aviation community, particularly through the International Civil Aviation Organisation’s (‘ICAO’) Aviation Safety Implementation Assistance Partnership tool, on technical assistance to third countries provided by the Union and Member States to improve aviation safety around the world.

                     (9)

                     Eurocontrol provided the Commission and the EU Air Safety Committee with an update on the status of the SAFA and TCO alarming functions, including statistics about alert messages for banned air carriers.

            Union air carriers

                     (10)

                     Following the Agency’s analysis of information resulting from ramp inspections carried out on the aircraft of Union air carriers, as well as standardisation inspections carried out by the Agency, complemented also with information stemming from specific inspections and audits carried out by national aviation authorities, several Member States have taken certain enforcement measures and informed the Commission and the EU Air Safety Committee about those measures.

                     (11)

                     Member States reiterated their readiness to act as necessary in the event that the relevant safety information indicates imminent safety risks as a consequence of a lack of compliance by Union air carriers with the relevant safety standards.

            Air carriers from Belarus

                     (12)

                     Air carriers from Belarus have never been included in Annex A or B to Regulation (EC) No 474/2006.

                     (13)

                     The Commission continued monitoring the progress of the competent authority of Belarus, namely the Aviation Department of Belarus (‘AD-BLR’) in strengthening its capabilities to ensure that operations by air carriers certified in Belarus are conducted in accordance with international safety standards.

                     (14)

                     On 8 October 2020, the Commission, the Agency and representatives of AD-BLR held a technical meeting to discuss the actions undertaken by AD-BLR, including those addressing the Agency’s safety concerns identified during its technical assessments conducted for the initial evaluation and the continuous monitoring of TCO authorisations pursuant to Commission Regulation (EU) No 452/2014.

                     (15)

                     During that meeting, AD-BLR provided information on its new organizational structure, including the recruitment and training of the staff, the functioning of its quality department, the status of the recertification of air carriers certified by AD-BLR and the temporary limitations it imposed to some air carriers, as well as the activities conducted as part of its surveillance program. AD-BLR also noted that the implementation of the corrective action plan developed in response to the deficiencies identified during the Union on-site assessment visit of March 2019 was completed.

                     (16)

                     On 17 November 2020, the Commission informed the EU Air Safety Committee about explanations provided by AD-BLR. On this basis, even if there are some deficiencies with regard to certain air carriers certified by AD-BLR that need rectification, such as the failure to adapt the maintenance program to the type of operations of the aircraft, or deficiencies identified in the management of hard time and life time components, they do not warrant the inclusion of those air carriers in Annex A to Regulation (EC) No 474/2006.

                     (17)

                     In accordance with the common criteria set out in the Annex to Regulation (EC) No 2111/2005, the Commission therefore considers that at this stage with respect to air carriers from Belarus there are no grounds for amending the list of air carriers, which are subject to an operating ban within the Union.

                     (18)

                     Member States should continue verifying the effective compliance of air carriers certified in Belarus with the relevant international safety standards through prioritisation of ramp inspections of all those carriers, pursuant to Regulation (EU) No 965/2012.

                     (19)

                     Where any relevant safety information reveals imminent safety risks as a consequence of a lack of compliance with international safety standards, further action by the Commission may become necessary, in accordance with Regulation (EC) No 2111/2005.

            Air carriers from the Dominican Republic

                     (20)

                     Air carriers from the Dominican Republic have never been included in Annex A or B to Regulation (EC) No 474/2006.

                     (21)

                     A Union on-site assessment visit was conducted from 27 to 31 January 2020 by representatives of the Commission, the Agency and Member States in the Dominican Republic at the offices of the Instituto Dominicano de Aviación Civil (‘IDAC’). Whereas the results of that visit showed that IDAC had the capabilities to oversee the aviation activities in the Dominican Republic, a number of weaknesses in the safety oversight system were identified. Those weaknesses however do not raise immediate safety concerns. IDAC developed a corrective action plan to address the shortcomings identified and sent it to the Commission on 15 April 2020.

                     (22)

                     On 4 November 2020, IDAC provided a progress report on the implementation of its corrective action plan. That progress report provided detailed information for each shortcoming identified, such as the root cause analysis, the corrective action being implemented and its progress, the different tasks of each action and their progress, as well as a detailed follow-up. IDAC estimates that the completion of its corrective action plan stands at 87,66 %.

                     (23)

                     Based on this report, the Commission considers that at this stage IDAC has the necessary ability and willingness to address the safety deficiencies identified during the visit, and that it is effectively implementing its action plan. On those grounds, there was no need for a hearing of IDAC before the EU Air Safety Committee.

                     (24)

                     In accordance with the common criteria set out in the Annex to Regulation (EC) No 2111/2005, the Commission therefore considers that at this stage with respect to air carriers from the Dominican Republic there are no grounds for amending the list of air carriers, which are subject to an operating ban within the Union.

                     (25)

                     Member States should continue verifying the effective compliance of air carriers certified in the Dominican Republic with the relevant international safety standards through prioritisation of ramp inspections of all those carriers, pursuant to Regulation (EU) No 965/2012.

                     (26)

                     Where any relevant safety information reveals imminent safety risks as a consequence of a lack of compliance with international safety standards, further action by the Commission may become necessary, in accordance with Regulation (EC) No 2111/2005.

            Air carriers from Kazakhstan

                     (27)

                     Air carriers from Kazakhstan were removed from Annex A to Regulation (EC) No 474/2006 in 2016 (6).

                     (28)

                     In February 2020, due to an apparent decline in the safety oversight by the competent authorities in Kazakhstan, the Commission opened consultations pursuant to Article 3(2) of Regulation (EC) No 473/2006. The EU Air Safety Committee was provided with an overview of the safety oversight situation in Kazakhstan at its meeting in May 2020.

                     (29)

                     As a follow up to the EU Air Safety Committee’s May 2020 meeting, the Commission and the Agency have maintained a continuous contact with the Civil Aviation Committee of Kazakhstan (‘CAC KZ’) and the Aviation Administration of Kazakhstan Joint Stock Company (‘AAK’) to gather further data and information. In particular, the Commission has asked about the revocation by the AAK of the Air Operator Certificate (‘AOC’) of Sigma Airlines on safety grounds.

                     (30)

                     On 16 October 2020 a meeting between the Commission, the Agency, Member States and representatives from the CAC KZ and from the AAK took place. AAK provided a comprehensive overview of its functions, of its conduct of safety oversight, including an update with respect to the list of AOC holders, registered aircraft, accidents, serious incidents and aviation occurrences and its enforcement measures. It also provided an overview of its surveillance activities, its plans as regards the recruitment and training of technical personnel, and its strategic approach to technical development within the context of aviation safety capacity building. Furthermore, the AAK informed about development of additional oversight procedures, enhanced implementation of the safety oversight programme and steps taken for the implementation of a quality management system.

                     (31)

                     The AAK explained that, together with CAC KZ, it takes actions to improve safety oversight in Kazakhstan, including the necessary modification of the national legal framework, which should lead to a better functional separation between the two competent aviation authorities (AAK and CAC KZ).

                     (32)

                     Based on the information currently available, including the Agency’s TCO authorisation assessments and the information provided by the AAK, both prior to and during the meeting of 16 October 2020, it appears that significant efforts and consequential developments are being made to address the safety situation in Kazakhstan. The Commission, whilst acknowledging the action taken to date, will continue its monitoring and assessment of how the situation develops further. In this context, the Commission intends to carry out, with the assistance of the Agency and Member States, a Union on-site assessment visit to Kazakhstan.

                     (33)

                     In view of the aforementioned evidence of the actions undertaken by the AAK and the CAC KZ, and in accordance with the common criteria set out in the Annex to Regulation (EC) No 2111/2005, the Commission therefore considers that at this stage with respect to air carriers from Kazakhstan, there are no grounds for amending the list of air carriers which are subject to an operating ban within the Union.

                     (34)

                     Member States should continue verifying the effective compliance of air carriers certified in Kazakhstan with the relevant international safety standards through prioritisation of ramp inspections of all those carriers, pursuant to Regulation (EU) No 965/2012.

                     (35)

                     Where any relevant safety information reveals imminent safety risks as a consequence of a lack of compliance with international safety standards, further action by the Commission may become necessary, in accordance with Regulation (EC) No 2111/2005.

            Air carriers from Moldova

                     (36)

                     Air carriers from Moldova, except for three air carriers Air Moldova, Fly One and Aerotranscargo, were included in Annex A to Regulation (EC) No 474/2006 in 2019 (7).

                     (37)

                     On 23 July 2020, at Moldova’s request and as part of continuous monitoring activities, the Commission and representatives of the Civil Aviation Authority of Moldova (‘CAAM’) held a meeting, during which the CAAM provided an overview of its functions, including the basic principles of its conduct of safety oversight. Other information provided by the CAAM included an overview of developments and state-of-play of their corrective action plan addressing the observations and recommendations resulting from the Union on-site assessment visit in February 2019.

                     (38)

                     Furthermore, on 31 July 2020, as a follow-up to the technical meeting, the CAAM provided additional information on the progress made with regard to the corrective action plan addressing the safety deficiencies identified during the Union on-site assessment visit. On the basis of information provided it seems that the CAAM has made some progress in the implementation of international safety standards. However, currently there is not enough evidence justifying lifting the operational restrictions on air carriers from Moldova. The provided information about the improvements should be further verified, preferably during a Union on-site assessment visit to Moldova.

                     (39)

                     In accordance with the common criteria set out in the Annex to Regulation (EC) No 2111/2005, the Commission therefore considers that at this stage with respect to air carriers from Moldova there are no grounds for amending the list of air carriers, which are subject to an operating ban within the Union.

                     (40)

                     Member States should continue verifying the effective compliance of air carriers certified in Moldova with the relevant international safety standards through prioritisation of ramp inspections of all those carriers, pursuant to Regulation (EU) No 965/2012.

                     (41)

                     Where any relevant safety information reveals imminent safety risks as a consequence of a lack of compliance with international safety standards, further action by the Commission may become necessary, in accordance with Regulation (EC) No 2111/2005.

            Air carriers from Pakistan

                     (42)

                        Pakistan International Airlines was included in Annex B to Regulation (EC) No 474/2006 in March 2007 (8) and removed in November 2007 (9).

                     (43)

                     On 24 June 2020, a statement from the Pakistan Federal Minister for Aviation revealed that a high number of the pilot licenses, issued by the Pakistan Civil Aviation Authority (‘PCAA’), were obtained by fraudulent means.

                     (44)

                     This event, and considering also a lack of effective implementation of a Safety Management System (‘SMS’), has led the Agency to suspend the TCO authorisations of Pakistan International Airlines and Vision Air with effect from 1 July 2020. The apparent lack of effective oversight by the PCAA in accordance with international safety standards contributed to that decision.

                     (45)

                     On 1 July 2020, the Commission opened consultations with PCAA pursuant to Article 3(2) of Regulation (EC) No 473/2006. The Commission requested PCAA to provide information about its response to the Federal Minister’s statement. In particular, the Commission requested information about the oversight of Pakistan registered air carriers, including their Safety Management Systems, as well as the evidence that a similar situation does not take place in other sectors, such as cabin crew certification or the licensing of maintenance engineers.

                     (46)

                     On 9 July and 25 September 2020, technical meetings were held with PCAA to discuss the information provided and the actions taken.

                     (47)

                     PCAA has been cooperative and transparent in its dealings with the Commission. It informed the Commission that its examination of the situation ultimately led to the revocation or suspension of the fraudulent licenses, as well as to the decision to stop issuing new licenses as from the end of June 2020. PCAA also informed that new aviation rules had been put in place to deal with the issues raised and, where appropriate, enforcement actions had been taken. With regard to the SMS oversight, PCAA admitted that its implementation is in early stages. It appears that PCAA still needs to effectively identify the root causes of its problems, and to deal with them in a sustainable manner.

                     (48)

                     Based on the information currently available, including the Agency’s TCO authorisation assessment information, it is apparent that PCAA is engaged in a significant effort to enact the corrective actions needed to address the identified safety situation in Pakistan. The Commission, whilst acknowledging the actions taken to date, will continue its monitoring and assessment of how the situation develops further. In this context, the Commission intends to carry out, with the assistance of the Agency and Member States, a Union on-site assessment visit to Pakistan.

                     (49)

                     In view of the aforementioned evidence of the actions undertaken by PCAA and in accordance with the common criteria set out in the Annex to Regulation (EC) No 2111/2005, the Commission therefore considers that at this stage with respect to air carriers from Pakistan there are no grounds for amending the list of air carriers which are subject to an operating ban within the Union.

                     (50)

                     Member States should continue verifying the effective compliance of air carriers certified in Pakistan with the relevant international safety standards through prioritisation of ramp inspections of all those carriers, pursuant to Regulation (EU) No 965/2012.

                     (51)

                     Where any relevant safety information reveals imminent safety risks as a consequence of a lack of compliance with international safety standards, further action by the Commission may become necessary, in accordance with Regulation (EC) No 2111/2005.

            Air carriers from Russia

                     (52)

                     The Commission, the Agency and the competent authorities of the Member States have continued to closely monitor the safety performance of air carriers certified in Russia and operating within the Union, including through prioritisation of the ramp inspections carried out on certain Russian air carriers in accordance with Regulation (EU) No 965/2012.

                     (53)

                     On 22 October 2020, representatives of the Commission and the Agency met with representatives of the Russian Federal Air Transport Agency (‘FATA’) to review the safety performance of air carriers certified in Russia on the basis of reports of ramp inspections carried out in the period between 15 April 2019 and 15 October 2020, and to identify in which cases FATA should strengthen its oversight activities.

                     (54)

                     The review of the SAFA ramp inspections of air carriers certified in Russia did not reveal any significant or recurrent safety deficiency.

                     (55)

                     Based on the information currently available, including information provided by FATA at the meeting, the Commission considers that at this stage FATA has the necessary ability and willingness to address safety deficiencies. On those grounds, there was no need for a hearing of the Russian aviation authorities or of any air carriers certified in Russia before the EU Air Safety Committee.

                     (56)

                     In accordance with the common criteria set out in the Annex to Regulation (EC) No 2111/2005, the Commission therefore considers that at this stage there are no grounds for amending the list of air carriers which are subject to an operating ban within the Union by including air carriers from Russia.

                     (57)

                     Member States should keep verifying effective compliance with the relevant international safety standards by certain air carriers from Russia, through prioritisation of ramp inspections in accordance with Regulation (EU) No 965/2012.

                     (58)

                     Where those inspections detect an imminent safety risk as a consequence of non-compliance with international safety standards, the Commission can impose an operating ban on the Russian certified air carriers concerned and include them in Annex A or Annex B to Regulation (EC) No 474/2006.

                     (59)

                     Regulation (EC) No 474/2006 should therefore be amended accordingly.

                     (60)

                     Articles 5 and 6 of Regulation (EC) No 2111/2005 recognise the need for decisions to be taken swiftly and, where appropriate, urgently, given the safety implications. It is therefore essential, for the protection of sensitive information and the traveling public, that the decisions in the context of updating the list of air carriers which are subject to an operating ban or restriction within the Union, are published and enter into force immediately after their adoption.

                     (61)

                     The measures provided for in this Regulation are in accordance with the opinion of the EU Air Safety Committee established by Regulation (EC) No 2111/2005,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Regulation (EC) No 474/2006 is amended as follows:

                        (1)

                        Annex A is replaced by the text in Annex I to this Regulation;

                        (2)

                        Annex B is replaced by the text in Annex II to this Regulation.

            Article 2
            This Regulation shall enter into force on the 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 in Brussels, 2 December 2020.

                  For the Commission,

                  On behalf of the president,

               Adina VĂLEAN

                  Member of the Commission

            (1)  OJ L 344, 27.12.2005, p. 15.

            (2)  Commission Regulation (EC) No 474/2006 of 22 March 2006 establishing the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council (OJ L 84, 23.3.2006, p. 14).

            (3)  Commission Regulation (EC) No 473/2006 of 22 March 2006 laying down implementing rules for the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council (OJ L 84, 23.3.2006, p. 8).

            (4)  Commission Regulation (EU) No 452/2014 of 29 April 2014 laying down technical requirements and administrative procedures related to air operations of third country operators pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 133, 6.5.2014, p. 12).

            (5)  Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1).

            (6)  Commission Implementing Regulation (EU) 2016/2214 of 8 December 2016 amending Regulation (EC) No 474/2006 as regards the list of air carriers which are subject to an operating ban within the Union (OJ L 334, 9.12.2016, p. 6).

            (7)  Commission Implementing Regulation (EU) 2019/618 of 15 April 2019 amending Regulation (EC) No 474/2006 as regards the list of air carriers which are subject to an operating ban within the Union, (OJ L 106, 17.4.2019, p. 1).

            (8)  Commission Regulation (EC) No 235/2007 of 5 March 2007 amending Regulation (EC) No 474/2006 establishing the Community list of air carriers which are subject to an operating ban within the Community (OJ L 66, 6.3.2007, p. 3).

            (9)  Commission Regulation (EC) No 1400/2007 of 28 November 2007 amending Regulation (EC) No 474/2006 establishing the Community list of air carriers which are subject to an operating ban within the Community (OJ L 311, 29.11.2007, p. 12).

            ANNEX I

                     ‘ANNEX A

                        LIST OF AIR CARRIERS WHICH ARE BANNED FROM OPERATING WITHIN THE UNION, WITH EXCEPTIONS (1)

                                 Name of the legal entity of the air carrier as indicated on its AOC (and its trading name, if different)

                                 Air Operator Certificate (‘AOC’) Number or Operating Licence Number

                                 ICAO three letter designator

                                 State of the Operator

                                    AVIOR AIRLINES

                                 ROI-RNR-011

                                 ROI

                                 Venezuela

                                    BLUE WING AIRLINES

                                 SRBWA-01/2002

                                 BWI

                                 Suriname

                                    IRAN ASEMAN AIRLINES

                                 FS-102

                                 IRC

                                 Iran

                                    IRAQI AIRWAYS

                                 001

                                 IAW

                                 Iraq

                                    MED-VIEW AIRLINE

                                 MVA/AOC/10-12/05

                                 MEV

                                 Nigeria

                                    AIR ZIMBABWE (PVT)

                                 177/04

                                 AZW

                                 Zimbabwe

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Afghanistan, including

                                    Afghanistan

                                    ARIANA AFGHAN AIRLINES

                                 AOC 009

                                 AFG

                                 Afghanistan

                                    KAM AIR

                                 AOC 001

                                 KMF

                                 Afghanistan

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Angola, with the exception of TAAG Angola Airlines and Heli Malongo, including

                                    Angola

                                    AEROJET

                                 AO-008/11-07/17 TEJ

                                 TEJ

                                 Angola

                                    GUICANGO

                                 AO-009/11-06/17 YYY

                                 Unknown

                                 Angola

                                    AIR JET

                                 AO-006/11-08/18 MBC

                                 MBC

                                 Angola

                                    BESTFLYA AIRCRAFT MANAGEMENT

                                 AO-015/15-06/17YYY

                                 Unknown

                                 Angola

                                    HELIANG

                                 AO 007/11-08/18 YYY

                                 Unknown

                                 Angola

                                    SJL

                                 AO-014/13-08/18YYY

                                 Unknown

                                 Angola

                                    SONAIR

                                 AO-002/11-08/17 SOR

                                 SOR

                                 Angola

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Armenia, including

                                    Armenia

                                    AIRCOMPANY ARMENIA

                                 AM AOC 065

                                 NGT

                                 Armenia

                                    ARMENIA AIRWAYS

                                 AM AOC 063

                                 AMW

                                 Armenia

                                    ARMENIAN HELICOPTERS

                                 AM AOC 067

                                 KAV

                                 Armenia

                                    ATLANTIS ARMENIAN AIRLINES

                                 AM AOC 068

                                 AEU

                                 Armenia

                                    ATLANTIS EUROPEAN AIRWAYS

                                 AM AOC 017

                                 LUR

                                 Armenia

                                    MARS AVIA

                                 AM AOC 066

                                 MRS

                                 Armenia

                                    SKYBALL

                                 AM AOC 069

                                 N/A

                                 Armenia

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Congo (Brazzaville), including

                                    Congo (Brazzaville)

                                    CANADIAN AIRWAYS CONGO

                                 CG-CTA 006

                                 Unknown

                                 Congo (Brazzaville)

                                    EQUAFLIGHT SERVICES

                                 CG-CTA 002

                                 EKA

                                 Congo (Brazzaville)

                                    EQUAJET

                                 RAC06-007

                                 EKJ

                                 Congo (Brazzaville)

                                    TRANS AIR CONGO

                                 CG-CTA 001

                                 TSG

                                 Congo (Brazzaville)

                                    SOCIETE NOUVELLE AIR CONGO

                                 CG-CTA 004

                                 Unknown

                                 Congo (Brazzaville)

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Democratic Republic of Congo (DRC), including

                                    Democratic Republic of Congo (DRC)

                                    AIR FAST CONGO

                                 AAC/DG/OPS-09/03

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    AIR KATANGA

                                 AAC/DG/OPS-09/08

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    BUSY BEE CONGO

                                 AAC/DG/OPS-09/04

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    COMPAGNIE AFRICAINE D’AVIATION (CAA)

                                 AAC/DG/OPS-09/02

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    CONGO AIRWAYS

                                 AAC/DG/OPS-09/01

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    KIN AVIA

                                 AAC/DG/OPS-09/10

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    MALU AVIATION

                                 AAC/DG/OPS-09/05

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    SERVE AIR CARGO

                                 AAC/DG/OPS-09/07

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    SWALA AVIATION

                                 AAC/DG/OPS-09/06

                                 Unknown

                                 Democratic Republic of Congo (DRC)

                                    MWANT JET

                                 AAC/DG/OPS-09/09

                                 Unknown

                                 Democratic Republic of Congo
                                 (RDC)

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Djibouti, including

                                    Djibouti

                                    DAALLO AIRLINES

                                 Unknown

                                 DAO

                                 Djibouti

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Equatorial Guinea, including

                                    Equatorial Guinea

                                    CEIBA INTERCONTINENTAL

                                 2011/0001/MTTCT/DGAC/SOPS

                                 CEL

                                 Equatorial Guinea

                                    Cronos AIRLINES

                                 2011/0004/MTTCT/DGAC/SOPS

                                 Unknown

                                 Equatorial Guinea

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Eritrea, including

                                    Eritrea

                                    ERITREAN AIRLINES

                                 AOC No 004

                                 ERT

                                 Eritrea

                                    NASAIR ERITREA

                                 AOC No 005

                                 NAS

                                 Eritrea

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Kyrgyzstan, including

                                    Kyrgyzstan

                                    AIR COMPANY AIR KG

                                 50

                                 Unknown

                                 Kyrgyzstan

                                    AIR MANAS

                                 17

                                 MBB

                                 Kyrgyzstan

                                    AVIA TRAFFIC COMPANY

                                 23

                                 AVJ

                                 Kyrgyzstan

                                    SKY KG AIRLINES

                                 41

                                 KGK

                                 Kyrgyzstan

                                    TEZ JET

                                 46

                                 TEZ

                                 Kyrgyzstan

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Liberia.

                                    Liberia

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Libya, including

                                    Libya

                                    AFRIQIYAH AIRWAYS

                                 007/01

                                 AAW

                                 Libya

                                    AIR LIBYA

                                 004/01

                                 TLR

                                 Libya

                                    AL MAHA AVIATION

                                 030/18

                                 Unknown

                                 Libya

                                    BURAQ AIR

                                 002/01

                                 BRQ

                                 Libya

                                    GLOBAL AVIATION AND SERVICES

                                 008/05

                                 GAK

                                 Libya

                                    LIBYAN AIRLINES

                                 001/01

                                 LAA

                                 Libya

                                    LIBYAN WINGS AIRLINES

                                 029/15

                                 LWA

                                 Libya

                                    PETRO AIR

                                 025/08

                                 PEO

                                 Libya

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Moldova with the exception of Air Moldova, Fly One and Aerotranscargo, including

                                    Moldova

                                    Î.M “VALAN ICC” SRL

                                 MD009

                                 VLN

                                 Moldova

                                    CA "AIM AIR" SRL

                                 MD015

                                 AAM

                                 Moldova

                                    CA "AIR STORK" SRL

                                 MD018

                                 MSB

                                 Moldova

                                    Î M „ MEGAVIATION” SRL

                                 MD019

                                 ARM

                                 Moldova

                                    CA "PECOTOX-AIR" SRL

                                 MD020

                                 PXA

                                 Moldova

                                    CA "TERRA AVIA" SRL

                                 MD022

                                 TVR

                                 Moldova

                                    CA "FLY PR O" SRL

                                 MD023

                                 PVV

                                 Moldova

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Nepal, including

                                    Nepal

                                    AIR DYNASTY HELI. S.

                                 035/2001

                                 Unknown

                                 Nepal

                                    ALTITUDE AIR

                                 085/2016

                                 Unknown

                                 Nepal

                                    BUDDHA AIR

                                 014/1996

                                 BHA

                                 Nepal

                                    FISHTAIL AIR

                                 017/2001

                                 Unknown

                                 Nepal

                                    SUMMIT AIR

                                 064/2010

                                 Unknown

                                 Nepal

                                    HELI EVEREST

                                 086/2016

                                 Unknown

                                 Nepal

                                    HIMALAYA AIRLINES

                                 084/2015

                                 HIM

                                 Nepal

                                    KAILASH HELICOPTER SERVICES

                                 087/2018

                                 Unknown

                                 Nepal

                                    MAKALU AIR

                                 057A/2009

                                 Unknown

                                 Nepal

                                    MANANG AIR PVT

                                 082/2014

                                 Unknown

                                 Nepal

                                    MOUNTAIN HELICOPTERS

                                 055/2009

                                 Unknown

                                 Nepal

                                    PRABHU HELICOPTERS

                                 081/2013

                                 Unknown

                                 Nepal

                                    NEPAL AIRLINES CORPORATION

                                 003/2000

                                 RNA

                                 Nepal

                                    SAURYA AIRLINES

                                 083/2014

                                 Unknown

                                 Nepal

                                    SHREE AIRLINES

                                 030/2002

                                 SHA

                                 Nepal

                                    SIMRIK AIR

                                 034/2000

                                 Unknown

                                 Nepal

                                    SIMRIK AIRLINES

                                 052/2009

                                 RMK

                                 Nepal

                                    SITA AIR

                                 033/2000

                                 Unknown

                                 Nepal

                                    TARA AIR

                                 053/2009

                                 Unknown

                                 Nepal

                                    YETI AIRLINES

                                 037/2004

                                 NYT

                                 Nepal

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Sao Tome and Principe, including

                                    Sao Tome and Principe

                                    AFRICA’S CONNECTION

                                 10/AOC/2008

                                 ACH

                                 Sao Tome and Principe

                                    STP AIRWAYS

                                 03/AOC/2006

                                 STP

                                 Sao Tome and Principe

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Sierra Leone

                                    Sierra Leone

                                    All air carriers certified by the authorities with responsibility for regulatory oversight of Sudan, including

                                    Sudan

                                    ALFA AIRLINES SD

                                 54

                                 AAJ

                                 Sudan

                                    BADR AIRLINES

                                 35

                                 BDR

                                 Sudan

                                    BLUE BIRD AVIATION

                                 11

                                 BLB

                                 Sudan

                                    ELDINDER AVIATION

                                 8

                                 DND

                                 Sudan

                                    GREEN FLAG AVIATION

                                 17

                                 GNF

                                 Sudan

                                    HELEJETIC AIR

                                 57

                                 HJT

                                 Sudan

                                    KATA AIR TRANSPORT

                                 9

                                 KTV

                                 Sudan

                                    KUSH AVIATION CO.

                                 60

                                 KUH

                                 Sudan

                                    NOVA AIRWAYS

                                 46

                                 NOV

                                 Sudan

                                    SUDAN AIRWAYS CO.

                                 1

                                 SUD

                                 Sudan

                                    SUN AIR

                                 51

                                 SNR

                                 Sudan

                                    TARCO AIR

                                 56

                                 TRQ

                                 Sudan

               ’

               (1)  Air carriers listed in Annex A could be permitted to exercise traffic rights by using wet-leased aircraft of an air carrier which is not subject to an operating ban, provided that the relevant safety standards are complied with.

            ANNEX II

                     ‘ANNEX B

                        LIST OF AIR CARRIERS WHICH ARE SUBJECT TO OPERATIONAL RESTRICTIONS WITHIN THE UNION (1)

                                 Name of the legal entity of the air carrier as indicated on its AOC (and its trading name, if different)

                                 Air Operator Certificate (“AOC”) Number

                                 ICAO three letter designator

                                 State of the Operator

                                 Aircraft type restricted

                                 Registration mark(s) and, when available, construction serial number(s) of restricted aircraft

                                 State of registry

                                    AIR SERVICE COMORES

                                 06-819/TA-15/DGACM

                                 KMD

                                 Comoros

                                 All fleet with the exception of: LET 410 UVP.

                                 All fleet with the exception of: D6-CAM (851336).

                                 Comoros

                                    IRAN AIR

                                 FS100

                                 IRA

                                 Iran

                                 All aircraft of type Fokker F100 and of type Boeing B747

                                 Aircraft of type Fokker F100 as mentioned on the AOC; aircraft of type Boeing B747 as mentioned on the AOC

                                 Iran

                                    AIR KORYO

                                 GAC-AOC/KOR-01

                                 KOR

                                 North Korea

                                 All fleet with the exception of: 2 aircraft of type TU- 204.

                                 All fleet with the exception of: P-632, P-633.

                                 North Korea

               ’

               (1)  Air carriers listed in Annex B could be permitted to exercise traffic rights by using wet-leased aircraft of an air carrier which is not subject to an operating ban, provided that the relevant safety standards are complied with.


title: Commission Implementing Regulation (EU) 2020/1993 of 4 December 2020 authorising the placing on the market of selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  7.12.2020

                  EN

                  Official Journal of the European Union

                  L 410/62

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1993
         of 4 December 2020
         authorising the placing on the market of selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

                     (3)

                     Commission Implementing Regulation (EU) 2019/760 (3) authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of Yarrowia lipolytica yeast biomass as a novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), excluding food supplements for infants and young children.

                     (4)

                     On 21 September 2018, the company Skotan S.A. (‘the applicant’) introduced an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place selenium-enriched biomass of the yeast Yarrowia lipolytica on the Union market as a novel food. The applicant requested for selenium-enriched biomass of the yeast Yarrowia lipolytica to be used in food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (5). The maximum use levels proposed by the applicant are 0,2 g per day for children from 3 to 9 years of age, and 1 g per day for adolescents and adults.

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 18 February 2019, asking it to provide a scientific opinion by carrying out an assessment for selenium-containing yeast (Yarrowia lipolytica) biomass as a novel food.

                     (6)

                     On 18 December 2019, the Authority adopted the scientific opinion ‘Safety of selenium-enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283’ (6). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In that opinion, the Authority concluded that selenium-containing yeast (Yarrowia lipolytica) biomass is not of safety concern at the proposed use levels. The Authority also considered that the selenium provided by selenium-containing yeast (Yarrowia lipolytica) biomass is as safe as selenium from other dietary sources.

                     (8)

                     The Authority also noted that, at the use levels proposed by the applicant, the intake of the novel food in combination with a background diet high in selenium could lead to total selenium intakes exceeding the Tolerable Upper Intake Level (‘UL’) for selenium established by the Scientific Committee on Food (7), in all target population groups, except for children from 7 to 9 years of age.

                     (9)

                     In light of the observation made by the Authority relating to the combined intake of selenium, the applicant submitted a modified request to the Commission with regard to the conditions of use of selenium-containing yeast (Yarrowia lipolytica) biomass, in particular concerning the maximum levels of the novel food in food supplements and the population groups for which food supplements are intended. The applicant proposed the novel food to be used in food supplements intended for the general population from 4 years of age, at levels ranging from 50 mg/day to 800 mg/day, that would result in selenium intakes which, combined with the selenium intakes from a background diet high in selenium, would not exceed the UL for selenium.

                     (10)

                     The Commission considers that the Authority’s opinion and the modified conditions of use requested by the applicant give sufficient grounds to establish that selenium-containing yeast (Yarrowia lipolytica) biomass at the proposed uses and use levels when used in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (11)

                     Regulation (EU) 2017/2470 should be therefore amended accordingly.

                     (12)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   Selenium-containing yeast (Yarrowia lipolytica) biomass as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 3
            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, 4 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 authorising the placing on the market of Yarrowia lipolytica yeast biomass as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 125, 14.5.2019, p. 13).

            (4)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

            (5)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

            (6)  EFSA Journal 2020;18(1):5992.

            (7)  SCF (Scientific Committee on Food), 2000. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of selenium. SCF/CS/NUT/UPPLEV/25 Final, 18 pp.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

                        (1)

                        in Table 1 (Authorised novel foods), the following entry is inserted:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    ‘Selenium-containing yeast (Yarrowia lipolytica) biomass

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “selenium-containing yeast (Yarrowia lipolytica) biomass”.
                                    The labelling of food supplements containing selenium-containing yeast (Yarrowia lipolytica) biomass shall bear a statement that the food supplements should not be consumed by infants and children under 4 years of age/children under 7 years of age/children under 11 years of age/children and adolescents under 18 years of age (*1).

                                    Food supplements as defined in Directive 2002/46/EC (1), excluding food supplements for infants and children under 4 years of age

                                    50 mg/day for children from 4 to 6 years of age, resulting in 10 μg of selenium per day
                                    100 mg/day for children from 7 to 10 years of age, resulting in 20 μg of selenium per day
                                    500 mg/day for adolescents from 11 to 17 years of age, resulting in 100 μg of selenium per day
                                    800 mg/day for adults, resulting in 160 μg of selenium per day

                        (2)

                        in Table 2 (Specifications), the following entry is inserted:

                                    Authorised Novel Food

                                    Specification

                                    ‘Selenium-containing yeast (Yarrowia lipolytica) biomass

                                       Description/Definition:

                                    The novel food is the dried and heat-killed selenium-containing biomass of the yeast Yarrowia lipolytica.
                                    The novel food is produced by fermentation in the presence of sodium selenite followed by a number of purification steps including a heat-killing step of the yeast to ensure the absence of viable Yarrowia lipolytica cells in the novel food.

                                       Characteristics/Composition:

                                    Total selenium: 165–200 μg/g
                                    Se-methionine (2): 100–140 μg/g
                                    Protein: 40–50 g/100 g
                                    Dietary fibre: 24–32 g/100 g
                                    Sugars: < 1 g/100 g
                                    Fat: 6–12 g/100 g
                                    Total ash: ≤ 15 %
                                    Water: ≤ 5 %
                                    Dry matter: ≥ 95 %

                                       Heavy metals:

                                    Lead: ≤ 3,0 mg/kg
                                    Cadmium: ≤ 1,0 mg/kg
                                    Mercury: ≤ 0,1 mg/kg

                                       Microbiological criteria:

                                    Total aerobic microbial count: ≤ 5 × 103 CFU/g
                                    Total yeast and mould count: ≤ 102 CFU/g
                                    Viable Yarrowia lipolytica cells (3): < 10 CFU/g (i.e. limit of detection)
                                    Coliforms: ≤ 10 CFU/g

                                       Salmonella spp.: Absence in 25 g
                                    CFU: colony forming units

               (1)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

               (*1)  Depending on the age group the food supplement is intended for.’

               (2)  Expressed as selenium.

               (3)  Applicable at all stages after the heat-treatment step to guarantee the absence of viable Yarrowia lipolytica cells and to be first tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Yarrowia lipolytica cells during packaging and/or storage of the novel food.’


title: Commission Implementing Regulation (EU) 2020/2007 of 8 December 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine, acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantraniliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide

text:
                  9.12.2020

                  EN

                  Official Journal of the European Union

                  L 414/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/2007
         of 8 December 2020
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine, acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantraniliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

                     Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009 whereas part B sets out the active substances approved under Regulation (EC) No 1107/2009 and part E sets out the active substances approved under Regulation (EC) No 1107/2009 as candidates for substitution.

                     (2)

                     The approvals of the active substances 1-decanol, 6-benzyladenine, acequinocyl, aluminium sulfate, amisulbrom, azadirachtin, bupirimate, Candida oleophila strain O, chlorantraniliprole, dithianon, dodine, emamectin, flubendiamide, fluometuron, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, prosulfuron, quinmerac, S-abscisic acid, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate and zinc phosphide will expire between 30 April 2024 and 31 October 2024. However, as Commission Implementing Regulation (EU) 2020/1740 (3) will apply to those active substances and will advance the date of submission of the dossier in support of the renewal of approval by 3 months, it is necessary to provide for a short extension of their respective approval periods to maintain the date of the dossier submission as required under Commission Implementing Regulation (EU) No 844/2012 (4) as applicants need time to prepare and submit the dossiers in the required format.

                     (3)

                     In addition, for emamectin, it appears from information provided by the applicant that delays in preparing the renewal dossier have been incurred due to the COVID-19 pandemic, despite the best efforts of the applicant to mitigate such delays. The designated rapporteur Member State for emamectin, the Netherlands, exceptionally agreed to accept the submission of the application for renewal of approval as required by Implementing Regulation (EU) 2020/1740 by 30 November 2021. Therefore, the approval period of emamectin should be extended also taking this additional period into account.

                     (4)

                     Furthermore, for chlorantraniliprole, it appears from information provided by the applicant that delays in preparing the application for renewal have been incurred due to the COVID-19 pandemic, despite the best efforts of the applicant to mitigate such delays. The designated rapporteur Member State for chlorantraniliprole, Ireland, exceptionally agreed to accept the submission of the application for renewal of approval as required by Implementing Regulation (EU) 2020/1740 by 31 December 2021. Therefore, the approval period of chlorantraniliprole should be extended also taking this additional period into account.

                     (5)

                     Commission Implementing Decision C/2018/3434 (5) established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment.

                     (6)

                     In order to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and taking into account the resources necessary for assessment and decision-making, it is appropriate to extend the approval periods of certain active substances as set out in Implementing Decision C/2018/3434. The approval periods of 1,4-dimethylnaphthalene, Adoxophyes orana granulovirus, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), Bacillus pumilus QST 2808, benalaxyl-M, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam and Streptomyces lydicus strain WYEC 108 should be extended by one year. For the same reasons, it is appropriate to extend the approval periods of the active substances bixafen, Candida oleophila strain O, disodium phosphonate, fluxapyroxad, Paecilomyces fumosoroseus strain FE 9901, penflufen, penthiopyrad, potassium phosphonates and sedaxane by one to three years, respectively.

                     (7)

                     Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (8)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no application for renewal of approval in accordance with Article 5(1) of Implementing Regulation (EU) 2020/1740 is submitted within 3 years before the respective expiry date laid down in the Annex to this Regulation, the Commission will reinstate the expiry date as it was before the adoption of this Regulation, or set it at the earliest possible date thereafter.

                     (9)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as it was before the adoption of the present Regulation or at the date of the adoption of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission adopts a Regulation providing for the renewal of the approval of an active substance referred to in the Annex to this Regulation, the Commission will set, as appropriate under the circumstances, the earliest possible application date.

                     (10)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the third 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, 8 December 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            (3)  Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20).

            (4)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            (5)  Commission Implementing Decision of 6 June 2018 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2022, 2023 and 2024 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council. C/2018/3434 final (OJ C 195, 7.6.2018, p. 20).

            ANNEX
            The Annex to Regulation (EU) No 540/2011 is amended as follows:
            Part A is amended as follows:

                        (1)

                        In the sixth column, expiration of approval, of entry 311, quinmerac, the date 30 April 2024 is replaced by31 July 2024.

                        (2)

                        In the sixth column, expiration of approval, of entry 314, zinc phosphide, the date 30 April 2024 is replaced by31 July 2024.

                        (3)

                        In the sixth column, expiration of approval, of entry 317, 6-benzyladenine, the date 31 May 2024 is replaced by 31 August 2024.

                        (4)

                        In the sixth column, expiration of approval, of entry 323, dodine, the date 31 May 2024 is replaced by 31 August 2024.

                        (5)

                        In the sixth column, expiration of approval, of entry 328, tau-fluvalinate, the date 31 May 2024 is replaced by 31 August 2024.

                        (6)

                        In the sixth column, expiration of approval, of entry 330, bupirimate, the date 31 May 2024 is replaced by 31 August 2024.

                        (7)

                        In the sixth column, expiration of approval, of entry 333, 1-decanol, the date 31 May 2024 is replaced by 31 August 2024.

                        (8)

                        In the sixth column, expiration of approval, of entry 334, isoxaben, the date 31 May 2024 is replaced by 31 August 2024.

                        (9)

                        In the sixth column, expiration of approval, of entry 335, fluometuron, the date 31 May 2024 is replaced by 31 August 2024.

                        (10)

                        In the sixth column, expiration of approval, of entry 341, sintofen, the date 31 May 2024 is replaced by 31 August 2024.

                        (11)

                        In the sixth column, expiration of approval, of entry 343, azadirachtin, the date 31 May 2024 is replaced by 31 August 2024.

                        (12)

                        In the sixth column, expiration of approval, of entry 345, lime sulphur, the date 31 May 2024 is replaced by 31 August 2024.

                        (13)

                        In the sixth column, expiration of approval, of entry 346, aluminium sulfate, the date 31 May 2024 is replaced by 31 August 2024.

                        (14)

                        In the sixth column, expiration of approval, of entry 350, tebufenozide, the date 31 May 2024 is replaced by 31 August 2024.

                        (15)

                        In the sixth column, expiration of approval, of entry 351, dithianon, the date 31 May 2024 is replaced by 31 August 2024.

                        (16)

                        In the sixth column, expiration of approval, of entry 352, hexythiazox, the date 31 May 2024 is replaced by 31 August 2024.

                        (17)

                        In the sixth column, expiration of approval, of entry 353, flutriafol, the date 31 May 2024 is replaced by 31 August 2024.

                  Part B is amended as follows:

                        (1)

                        In the sixth column, expiration of approval, of entry 24, fluxapyroxad, the date 31 December 2022 is replaced by 31 May 2025.

                        (2)

                        In the sixth column, expiration of approval, of entry 26, Adoxophyes orana granulovirus, the date 31 January 2023 is replaced by 31 January 2024.

                        (3)

                        In the sixth column, expiration of approval, of entry 37, C
                           andid
                           a oleophila strain O, the date 30 September 2023 is replaced by 31 December 2024.

                        (4)

                        In the sixth column, expiration of approval, of entry 39, Paecilomyces fumosoroseus strain FE 9901, the date 30 September 2023 is replaced by 31 December 2024.

                        (5)

                        In the sixth column, expiration of approval, of entry 40, potassium phosphonates, the date 30 September 2023 is replaced by 31 January 2026.

                        (6)

                        In the sixth column, expiration of approval, of entry 43, bixafen, the date 30 September 2023 is replaced by 31 May 2025.

                        (7)

                        In the sixth column, expiration of approval, of entry 48, sedaxane, the date 31 January 2024 is replaced by 31 May 2025.

                        (8)

                        In the sixth column, expiration of approval, of entry 49, emamectin, the date 30 April 2024 is replaced by 30 November 2024.

                        (9)

                        In the sixth column, expiration of approval, of entry 50, Pseudomonas sp. strain DSMZ 13134, the date 31 January 2024 is replaced by 31 January 2025.

                        (10)

                        In the sixth column, expiration of approval, of entry 52,
                           Aureobasidium pullulans (strains DSM 14940 and DSM 14941), the date 31 January 2024 is replaced by 31 January 2025.

                        (11)

                        In the sixth column, expiration of approval, of entry 53, pyriofenone, the date 31 January 2024 is replaced by 31 January 2025.

                        (12)

                        In the sixth column, expiration of approval, of entry 54, disodium phosphonate, the date 31 January 2024 is replaced by 31 January 2026.

                        (13)

                        In the sixth column, expiration of approval, of entry 55, penflufen, the date 31 January 2024 is replaced by 31 May 2025.

                        (14)

                        In the sixth column, expiration of approval, of entry 56, orange oil, the date 30 April 2024 is replaced by 31 July 2024.

                        (15)

                        In the sixth column, expiration of approval, of entry 57, penthiopyrad, the date 30 April 2024 is replaced by 31 May 2025.

                        (16)

                        In the sixth column, expiration of approval, of entry 58, benalaxyl-M, the date 30 April 2024 is replaced by 30 April 2025.

                        (17)

                        In the sixth column, expiration of approval, of entry 59, tembotrione, the date 30 April 2024 is replaced by 31 July 2024.

                        (18)

                        In the sixth column, expiration of approval, of entry 60, spirotetramat, the date 30 April 2024 is replaced by 31 July 2024.

                        (19)

                        In the sixth column, expiration of approval, of entry 61, pyroxsulam, the date 30 April 2024 is replaced by 30 April 2025.

                        (20)

                        In the sixth column, expiration of approval, of entry 62, chlorantraniliprole, the date 30 April 2024 is replaced by 31 December 2024.

                        (21)

                        In the sixth column, expiration of approval, of entry 63, sodium silver thiosulfate, the date 30 April 2024 is replaced by 31 July 2024.

                        (22)

                        In the sixth column, expiration of approval, of entry 64, pyridalyl, the date 30 June 2024 is replaced by 30 June 2025.

                        (23)

                        In the sixth column, expiration of approval, of entry 68, 1,4-dimethylnaphthalene, the date 30 June 2024 is replaced by 30 June 2025.

                        (24)

                        In the sixth column, expiration of approval, of entry 69, amisulbrom, the date 30 June 2024 is replaced by 30 September 2024.

                        (25)

                        In the sixth column, expiration of approval, of entry 65, S-abscisic acid, the date 30 June 2024 is replaced by 30 September 2024.

                        (26)

                        In the sixth column, expiration of approval, of entry 66, L-ascorbic acid, the date 30 June 2024 is replaced by 30 September 2024.

                        (27)

                        In the sixth column, expiration of approval, of entry 67, spinetoram, the date 30 June 2024 is replaced by 30 September 2024.

                        (28)

                        In the sixth column, expiration of approval, of entry 70, valifenalate, the date 30 June 2024 is replaced by 30 September 2024.

                        (29)

                        In the sixth column, expiration of approval, of entry 71, thiencarbazone, the date 30 June 2024 is replaced by 30 September 2024.

                        (30)

                        In the sixth column, expiration of approval, of entry 72, acequinocyl, the date 31 August 2024 is replaced by 30 November 2024.

                        (31)

                        In the sixth column, expiration of approval, of entry 73, ipconazole, the date 31 August 2024 is replaced by 30 November 2024.

                        (32)

                        In the sixth column, expiration of approval, of entry 74, flubendiamide, the date 31 August 2024 is replaced by 30 November 2024.

                        (33)

                        In the sixth column, expiration of approval, of entry 75, Bacillus pumilus QST 2808, the date 31 August 2024 is replaced by 31 August 2025.

                        (34)

                        In the sixth column, expiration of approval, of entry 79, Streptomyces lydicus strain WYEC 108, the date 31 December 2024 is replaced by 31 December 2025.

                  Part E is amended as follows:

                        (1)

                        In the sixth column, expiration of approval, of entry 6, prosulfuron, the date 30 April 2024 is replaced by 31 July 2024.

                        (2)

                        In the sixth column, expiration of approval, of entry 7, pendimethalin, the date 31 August 2024 is replaced by 30 November 2024.

                        (3)

                        In the sixth column, expiration of approval, of entry 8, imazamox, the date 31 October 2024 is replaced by 31 January 2025.