(1)

Article 19 of Commission Delegated Regulation (EU) 2019/33 (2) provides that the procedure laid down in Article 94 and Articles 96 to 99 of Regulation (EU) No 1308/2013 shall apply mutatis mutandis to the cancellation of a protected designation of origin under Article 106 of Regulation (EU) No 1308/2013.

(2)

Pursuant to Article 19 of Delegated Regulation (EU) 2019/33, Austria’s request to cancel the protected designation of origin ‘Südburgenland’ was published in the Official Journal of the European Union (3).

(3)

As no statement of objection under Article 98 of Regulation (EU) No 1308/2013 has been received by the Commission, the protected designation of origin ‘Südburgenland’ should be cancelled.

(4)

In view of the cancellation of the protection of the designation of origin ‘Südburgenland’, the entry should be deleted from the Union register of protected designations of origin and protected geographical indications for wine referred to in Article 104 of Regulation (EU) No 1308/2013.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

(1)

Pursuant to Article 75(1), third subparagraph, of Regulation (EU) No 1306/2013, from 16 October to 30 November Member States may pay advances of up to 50 % for direct payments under Regulation (EU) No 1307/2013 of the European Parliament and of the Council (2) and prior to 1 December they may pay advances of up to 75 % for area-related and animal-related support measures under Regulation (EU) No 1305/2013 of the European Parliament and the Council (3).

(2)

Due to the crisis resulting from the COVID-19 pandemic in the Member States, farmers have encountered exceptional economic and financial difficulties. Considering the specific vulnerability of those economic operators and in order to mitigate financial and cash flow consequences of that crisis, Commission Implementing Regulation (EU) 2020/531 (4) provided for a derogation from Article 75(1), third subparagraph, of Regulation (EU) No 1306/2013 by allowing Member States to pay a higher level of advances to beneficiaries for the year 2020. As the COVID-19 pandemic still persists in 2021 and farmers are still facing economic disruptions, Member States should be allowed to continue paying increased advance payments in respect of claim year 2021.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on the Agricultural Funds, the Committee for Direct Payments and the Rural Development Committee,

(1)

Commission Regulation (EU) No 965/2012 (2) lays down detailed rules for air operations and in particular for fuel planning and management. Those rules should be updated to reflect recent advances in engine technology and best practices in the domain of air operations, and to take into account worldwide aviation experience and scientific and technical progress in air operations.

(2)

The latest fuel-related amendments to Annex 6 of the Convention on International Civil Aviation (ICAO), being Part I (11th edition), Part III (9th edition) and the new guidance of ICAO Document 9976 ‘Fuel planning manual’ should be incorporated in Regulation (EU) No 965/2012, with the exception of certain requirements applicable to helicopters, where other solutions are considered by EASA as meeting the required level of safety.

(3)

The new rules on fuel/energy planning and management should allow for a level playing field for all interested parties in the internal aviation market and improve competitiveness of the Union aviation industry.

(4)

The new fuel/energy planning and management requirements should support innovation and allow for the smooth integration of new technologies into the air operations domain. Therefore, the term ‘fuel/energy’ should be used instead of the term ‘fuel’, wherever appropriate, to accommodate operations with aircraft that use other energy sources than conventional hydrocarbon-based fuel.

(5)

The requirements related to the different types of operations should be proportionate to the scale and complexity of such operations, as well as to the risks involved in such operations.

(6)

Air operators should be able to use a performance-based planning and management procedures that improve operational efficiency by producing financial and environmental benefits, while maintaining or even improving the level of safety. Therefore, the new requirements for aeroplanes used in commercial air transport (CAT) operations should introduce a comprehensive fuel scheme encompassing three main policies related to fuel: fuel/energy planning, aerodrome selection and in-flight fuel and energy management. This should allow a more flexible management of risk by the operator, leading to potential efficiency gains.

(7)

Safety information collected by EASA suggests that new requirements should be introduced to address the risks associated with refuelling, and more specifically when refuelling with passengers on board, disembarking or embarking, and when refuelling a helicopter with rotors turning.

(8)

The assessment of complex fuel/energy schemes requires enhanced capabilities from the competent authorities, therefore it is necessary to introduce criteria to guide competent authorities when making operational safety risk assessments to support the application of fully performance-based fuel/energy schemes.

(9)

Following the principles of proportionality and better regulation, the fuel and energy requirements for non-commercial operations with complex motor-powered aircraft (NCC) and for specialised operations (SPO) should be better aligned with those for CAT operations. On the other hand, the fuel and energy requirements for non-commercial operators of other-than-complex motor-powered aircraft should be based on safety objectives and should allow a performance-based approach. The new requirements on fuel and energy planning and management should reduce regulatory burden, increase cost-effectiveness and, with some exceptions, lead to harmonisation with requirements laid down by ICAO.

(10)

Commission Regulation (EU) 2018/1042 (3) added to Regulation (EU) No 965/2012 requirements for support programmes, the psychological assessment of flight crew and the systematic and random testing of psychoactive substances to ensure the medical fitness of flight crew and cabin crew members. Those requirements have become applicable in February 2021. The Agency was mandated to continuously evaluate the effectiveness of the new provisions and produce a first evaluation report by August 2022. Taking into account the impact of the Covid-19 pandemic on aviation, it is advisable to allow for more time for the Agency to collect the relevant data for the evaluation. Therefore, it is necessary to postpone the deadline for the completion of the evaluation report to 14 August 2023.

(11)

Regulation (EU) 2018/1042 introduced into Annex I to Regulation (EU) No 965/2012 a point 98(a) which defined the term ‘psychoactive substances’. Commission Implementing Regulation (EU) 2020/2036 (4), which subsequently amended Annex I to Regulation (EU) No 965/2012, inadvertently replaced point 98(a) by new text, defining the term ‘proficient’, and deleted the definition of the term ‘psychoactive substances’. That definition is essential for the consistent interpretation of the provisions introduced by Regulation (EU) 2018/1042 and in particular to clearly define which substances are subject to those provisions and which are not. Therefore, in order to safeguard legitimate expectations of the persons subject to those provisions that definition should be reintroduced in Annex I to Regulation (EU) No 965/2012 with effect from the date of application of the related changes introduced by Regulation (EU) 2018/1042, that is from 14 February 2021.

(12)

The European Union Aviation Safety Agency has prepared a draft implementing rule and submitted it with Opinion 02/2020 (5) in accordance with Article 75(2), points (b) and (c), and Article 76(1) of Regulation (EU) 2018/1139.

(13)

Regulation (EU) No 965/2012 should therefore be amended and corrected accordingly.

(14)

In order to ensure the proper implementation of this Regulation, Member States and affected stakeholders should be given sufficient time to adapt their procedures to the new requirements established by this Regulation. Therefore, its application should be deferred.

(15)

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

(1)

in Article 9b, the second paragraph is replaced by the following:

‘The Agency shall conduct a continuous review of the effectiveness of the provisions concerning support programmes, the psychological assessment of flight crew and the systematic and random testing of psychoactive substances to ensure the medical fitness of flight crew and cabin crew members set out in Annexes II and IV. No later than 14 August 2023, the Agency shall produce a first report on the results of this review.

That review shall involve relevant expertise and shall be based on data gathered, with the assistance of Member States and the Agency, on a long-term basis.’;

(2)

Annexes I, II, III, IV, V, VI, VII and VIII are amended in accordance with Annex I to this Regulation.

(1)

Linear and branched perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (‘C9-C14 PFCAs’), their salts and C9-C14 PFCA- related substances (2) currently mainly occur in the Union as unintended by-products during the manufacture of perfluorinated and polyfluorinated substances containing a carbon chain of less than nine carbon atoms, such as perfluorooctanoic acid (PFOA). Furthermore, it is possible that companies may consider the use of C9-C14 PFCAs, their salts and C9-C14 PFCA- related substances as substitutes for PFOA, its salts and related substances in the future, especially after the Union Law restrictions on PFOA become applicable. Thus, it is necessary to prevent future possible manufacturing and use resulting in increasing releases into the environment.

(2)

On 17 December 2015 and 12 January 2017, respectively, two groups of C9-C14 PFCAs, namely perfluorononan-1-oic acid (‘PFNA’) containing 9 carbon atoms in the chain, as well as its sodium and ammonium salts, and nonadecafluorodecanoic acid (‘PFDA’) containing 10 carbon atoms in the chain, as well as its sodium and ammonium salts, were included in the Candidate List of Substances of Very High Concern (‘SVHC’) to be potentially included in Annex XIV to Regulation (EC) No 1907/2006, as toxic for reproduction in accordance with Article 57(c) of that Regulation, and persistent, bioaccumulative and toxic (‘PBT’) substances, in accordance with Article 57(d) of that Regulation. Moreover, PFNA and PFDA, as well as their sodium and ammonium salts, are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) as carcinogenic, category 2 and toxic to reproduction, category 1B. On 19 December 2012, henicosafluoroundecanoic acid (‘PFUnDA’) containing 11 carbon atoms in the chain, tricosafluorododecanoic acid (‘PFDoDA’) containing 12 carbon atoms in the chain, pentacosafluorotridecanoic acid (‘PFTrDA’) containing 13 carbon atoms in the chain and heptacosafluorotetradecanoic acid (‘PFTDA’) containing 14 carbon atoms in the chain were included in the Candidate List of SVHC, as very persistent and very bioaccumulative (‘vPvB’) substances, in accordance with Article 57(e) of Regulation (EC) No 1907/2006. C9-C14 PFCA-related substances are also to be regarded as PBT or vPvB substances, respectively, due to their transformation or degradation in the environment to C9-C14 PFCAs.

(3)

On 6 October 2017, Germany and Sweden submitted to the European Chemicals Agency (‘the Agency’), a dossier (4) pursuant to Article 69(4) of Regulation (EC) No 1907/2006 (‘the Annex XV dossier’) proposing to restrict the manufacture and placing on the market of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances on their own, and to restrict their use in the production of, and placing on the market in, other substances as a constituent, mixtures and articles or parts thereof. In order to reduce the release of those substances into the environment and to prevent them from being manufactured, placed on the market and used as substitutes for the substances restricted by entry 68 of Annex XVII to Regulation (EC) No 1907/2006 (5), Germany and Sweden proposed a concentration limit of 25 ppb for the sum of C9-C14 PFCAs and their salts and 260 ppb for the sum of C9-C14 PFCA-related substances. Exemptions were proposed by Germany and Sweden for C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances when they occur as unintended by-products during the manufacturing of fluorochemicals with a perfluoro carbon chain equal to or shorter than eight atoms or for use as transported isolated intermediates.

(4)

On 14 September 2018, the Agency’s Committee for Risk Assessment (‘RAC’) adopted its opinion concluding that, subject to modification of the scope and conditions proposed in the Annex XV dossier, a restriction on manufacture, use and placing on the market of C9-C14 PFCAs, their salts and related substances, is the most appropriate Union-wide measure to address the identified risks in terms of effectiveness in reducing those risks. RAC agreed with the concentration limits as proposed by Germany and Sweden. RAC agreed with the exemptions proposed by Germany and Sweden as the proposed restriction is not intended to prevent the manufacture of the fluorochemicals with six or less carbon atoms in the molecular chain. RAC recommended exempting for a limited period the use in the production of pressurised metered-dose inhalers that are critical for the treatment of lung diseases because of the low volumes in the order of few grams involved and the important medical use. RAC expressed the opinion to grant a time-limited exemption for semiconductors that contain low levels of C9-C14 PFCAs and for semi-finished and finished electronic equipment containing specialty semiconductors to be used as replacement parts for finished electronic equipment.

(5)

Furthermore, RAC recommended to apply to the restriction of C9-C14 PFCAs, their salts and C9-C14 PFCA- related substances the same exemptions which apply to the PFOA restriction in entry 68 to Annex XVII of Regulation (EC) No 1907/2006.

(6)

On 29 November 2018, the Agency’s Committee for Socio-Economic Analysis (‘SEAC’) adopted its opinion, indicating that the restriction proposed in the Annex XV dossier, as modified by RAC and SEAC, is the most appropriate Union-wide measure to address the identified risks in terms of its socioeconomic benefits and socioeconomic costs.

(7)

Based on the socioeconomic elements provided in the Annex XV dossier and submitted during the public consultations, SEAC agreed with the exemptions proposed in the Annex XV dossier and recommended by RAC. SEAC concurred with the proposed 18-month deferral of the restriction. In addition, SEAC suggested higher limit values for fluoropolymers that contain perfluoropropoxy-groups or perfluoromethoxy-groups and are used in specific product groups in order to allow their production. Nonetheless, the generic threshold of 25 ppb remains applicable to the final articles manufactured from those materials.

(8)

The Agency’s Forum for Exchange of Information on Enforcement, referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted during the restriction process and its opinion has been taken into account.

(9)

On 16 January 2019, the Agency submitted the opinions of the RAC and SEAC (6) to the Commission.

(10)

Regulation (EU) 2019/1021 of the European Parliament and of the Council (7) was amended in accordance with the decision adopted by the Conference of the Parties (SC-9/12) of the Stockholm Convention on Persistent Organic Pollutants for PFOA (8), which contains some but not all the derogations included in entry 68 of Annex XVII of Regulation (EC) No 1907/2006. Entry 68 of that Annex was effectively replaced by the abovementioned amendment of Regulation (EU) 2019/1021. The exemptions which apply to the use of PFOA, its salts and PFOA-related compounds in the amendment of Regulation (EU) 2019/1021 should also apply to C9-C14 PFCAs, their salts and C9-C14 PFCA- related substances under the same conditions because of the manufacturing process of fluorochemicals in which both group of substances are present as impurities.

(11)

After the finalisation of the RAC and SEAC opinion on the proposed restriction for C9-C14 PFCAs, the Commission received two additional requests for exemptions to allow the production of fluoropolymers and fluoroelastomers, as well as the production of polytetrafluoroethylene (PTFE) micro powders and the use in mixtures and articles for industrial and professional applications. The Commission asked ECHA for a supplementary opinion, as the final products are used in high value applications (9). The Commission received RAC’s and SEAC’s supplementary opinion on 15 December 2020 (10).

(12)

Taking into account the Annex XV dossier, the opinions of RAC and SEAC, the Commission considers that an unacceptable risk to human health and the environment arises from the manufacture, use or placing on the market of linear and/or branched C9-C14 PFCAs, their salts and C9-C14 PFCA- related substances on their own, as a constituent of other substances, in mixtures and in articles, which needs to be addressed on a Union-wide basis. The Commission considers that the proposed restriction, as amended by RAC and SEAC opinions, taking into account its socioeconomic impact and availability of alternatives as well as the alignment of some of the exemptions in this restriction to the exemptions in the amendment of Regulation (EU) 2019/1021 is an appropriate Union-wide measure to address the identified risk.

(13)

Stakeholders should be allowed sufficient time to take appropriate measures to comply with the restriction. Therefore, taking into account the suggestion from the Annex XV dossier as well as RAC’s and SEAC’s considerations, the application of the restriction should be deferred for 18 months. Longer deferrals or overall exemptions should apply to address the particular cases of specific sectors.

(14)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

(1)

Pursuant to Article 300(3) of the Treaty, the Committee of the Regions is to consist of representatives of regional and local bodies who either hold a regional or local authority electoral mandate or are politically accountable to an elected assembly.

(2)

On 20 January 2020, the Council adopted Decision (EU) 2020/102 (2), appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2020 to 25 January 2025.

(3)

An alternate member’s seat on the Committee of the Regions has become vacant following the end of the national mandate on the basis of which Mr Juan José MARTÍNEZ LOZANO was proposed for appointment.

(4)

The Spanish Government has proposed Mr Adrián Ariel ZITTELLI FERRARI, representative of a regional body who is politically accountable to an elected assembly, Director-General de Unión Europea de la Región de Murcia – Asamblea Regional de Murcia (Director-General for European Union Affairs for the Region of Murcia – Regional Assembly of Murcia), as an alternate member of the Committee of the Regions for the remainder of the current term of office, which runs until 25 January 2025,

(1)

The active substance hexaflumuron was approved as an active substance for use in biocidal products of product-type 18 (2).

(2)

The approval of hexaflumuron for use in biocidal products of product-type 18 will expire on 31 March 2022. On 23 September 2020, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for the renewal of the approval of hexaflumuron.

(3)

As hexaflumuron meets the criteria for being a persistent, bioaccumulative and toxic substance (PBT substance), and a very persistent and very bioaccumulative substance (vPvB substance) according to Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3), it meets the exclusion criteria set out in Article 5(1), point (e), of Regulation (EU) No 528/2012.

(4)

On 18 February 2021, the evaluating competent authority of Greece informed the Commission that it had decided, pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary. Pursuant to Article 8(1) of Regulation (EU) No 528/2012, the evaluating competent authority is to perform a full evaluation of the application within 365 days of its validation.

(5)

The evaluating competent authority may, as appropriate, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In such case, the 365-day period is suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of the data requested or by exceptional circumstances.

(6)

Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

(7)

Consequently, for reasons beyond the control of the applicant, the approval of hexaflumuron for use in biocidal products of product-type 18 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of hexaflumuron for use in biocidal products of product-type 18 for a period of time sufficient to enable the examination of the application.

(8)

Considering the time-limits for the evaluation by the evaluating competent authority, for the preparation and submission of the opinion by the Agency and the period of time necessary to decide if at least one of the conditions in Article 5(2), first subparagraph, of Regulation (EU) No 528/2012 is fulfilled and whether the approval of hexaflumuron may therefore be renewed, it is appropriate to postpone the expiry date of approval to 30 September 2024.

(9)

Except for the expiry date of approval, hexaflumuron remains approved for use in biocidal products of product-type 18 subject to the specifications and conditions set out in Implementing Regulation (EU) 2015/1982,