(1)

Pursuant to Article 11(1) of Regulation (EU) No 1380/2013, Member States are empowered to adopt fisheries conservation measures in their waters that are necessary to comply with their obligations under Article 6 of Council Directive 92/43/EEC (‘Habitats Directive’) (2), Article 4 of Directive 2009/147/EC of the European Parliament and of the Council (‘Birds Directive’) (3) and Article 13(4) of Directive 2008/56/EC of the European Parliament and of the Council (‘Marine Strategy Framework Directive’) (4).

(2)

Article 6 of the Habitats Directive requires Member States to establish the necessary conservation measures for special areas of conservation that correspond to the ecological requirements of those natural habitat types and species present on the sites as listed in the Annexes of that Directive.

(3)

Article 4 of the Birds Directive requires Member States to establish special conservation measures concerning the habitat of the species mentioned in its Annex I. It also requires Member States to take similar conservation measures for regularly occurring migratory species not listed in its Annex I.

(4)

Pursuant to Article 13(4) of the Marine Strategy Framework Directive, Member States are to adopt programmes of measures to achieve or maintain good environmental status, including spatial protection measures that contribute to coherent and representative networks of marine protected areas, and adequately cover the diversity of the constituent ecosystems, such as special areas of conservation pursuant to the Habitats Directive, special protection areas pursuant to the Birds Directive and marine protected areas as agreed by the Union or Member States concerned in the framework of international or regional agreements to which they are parties.

(5)

Where a Member State considers that measures need to be adopted to comply with its obligations under Union environmental legislation and other Member States have a direct management interest in the fishery to be affected by such measures, the Commission is empowered to adopt such measures by means of delegated acts upon a joint recommendation submitted by the Member States.

(6)

Commission Delegated Regulation (EU) 2017/118 (5) establishes conservation measures in certain marine protected areas in the Kattegat and the marine protected area Bratten area in the North Sea.

(7)

After consulting the North Sea Advisory Council, Denmark, Sweden and Germany submitted to the Commission two joint recommendations to manage fisheries in certain areas of the Kattegat on 2 February 2021. Denmark submitted a joint recommendation to protect soft seabed and reef structures from fisheries with mobile bottom contacting gears in six Marine Strategy Framework Directive (MSFD) areas and one Natura 2000 site in the Danish part of the Kattegat. Sweden submitted a joint recommendation to protect sensitive species and habitat types by only allowing certain fishing gears in four marine protected areas in the Swedish part of the Kattegat.

(8)

The Commission presented these measures by written procedure to an expert group consisting of representatives of the Member States in October 2021.

(9)

The Scientific, Technical and Economic Committee for Fisheries (‘STECF’) reviewed these joint recommendations and concluded (6) that the measures represent a positive step forward towards minimising the negative impacts of fishing activities on the habitats concerned. These joint recommendations are also expected to contribute to the adequate protection of designated and sensitive species and habitat types including the associated ecological functions in the marine protected areas.

(10)

The measures proposed by Denmark aim at prohibiting mobile bottom contacting gears in the designated areas. The STECF concluded (7) that prohibiting these gears in these vulnerable habitats entails a better protection of soft seabed and reef structures (habitat type 1170) from the impact of fishing activities, thereby contributing to achieving environmental targets.

(11)

The measures proposed by Sweden aim at designating restricted fishery areas and areas where fishing operations are prohibited. The STECF concluded (8) that the impact of the proposed fishing gears in restricted fishery areas is likely to be low and that the measures proposed will represent a positive step forward towards minimising the negative impacts of fishing activities on the habitats concerned. The Commission also notes that Member States committed in the joint recommendation to propose further adjustments and restrict the gillnet fishery if deemed necessary.

(12)

Member States suggested control and enforcement measures based on the use of automatic identification system (‘AIS’) for specific areas. The STECF concluded (9) that AIS should be sufficient to undertake real-time monitoring in these areas.

(13)

Delegated Regulation (EU) 2017/118 should be amended to include Scottish pair seine (SPR) in the definition of mobile bottom contacting gear. SPR was unintentionally excluded from the joint recommendations submitted by Denmark in 2015 and 2016 to prohibit the use of mobile bottom contacting gears in Areas 1. Member States requested the Commission to correct this omission.

(14)

Delegated Regulation (EU) 2017/118 and the joint recommendation submitted by Denmark cover only bottom contacting gears that are mobile. For the sake of clarity, the term ‘mobile‘ should therefore be included in the definition of the bottom contacting gears that this Regulation provides for.

(15)

Delegated Regulation (EU) 2017/118 should therefore be amended accordingly.

(16)

This Delegated Regulation is without prejudice to the need for additional conservation measures necessary to comply with the relevant provisions and the Commission’s position regarding compliance by the interested Member States with their obligations under the relevant Union environmental legislation,

(1)

Article 2 is replaced by the following:

(*1)  Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (OJ L 112, 30.4.2011, p. 1).’;"

(2)

Article 3 is replaced by the following:

(3)

Article 5 is replaced by the following:

(4)

Annex I is amended in accordance with point 1 of the Annex to this Regulation;

(5)

Annex II is amended in accordance with point 2 of the Annex to this Regulation;

(6)

Annexes IV and V are added in accordance with points 3 and 4 of the Annex to this Regulation.

(1)

The Commission has examined Greece’s application for the approval of amendments to the specification for the protected geographical indication ‘Επανομή’ (Epanomi), submitted pursuant to Article 105 of Regulation (EU) No 1308/2013.

(2)

The Commission published the application for the approval of amendments to the specification in the Official Journal of the European Union (2), as required by Article 97(3) of Regulation (EU) No 1308/2013.

(3)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(4)

The amendments to the specification should therefore be approved in accordance with Article 99 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)

Based on the definition of credit risk adjustment laid down in Article 4(1), point (95), of Regulation (EU) No 575/2013, only the expected credit losses reflected in the specific credit risk adjustments made by the institution holding the defaulted exposure can be accounted for in the assignment of a risk weight for the purposes of Article 127(1) of that Regulation. However, the credit losses accounted for in the transaction price of the defaulted exposure, which are retained by the selling institution as a realised loss, cannot be recognised after the sale by the purchasing institution. As a result, the applicable risk weight applied to the defaulted exposure may change following the sale of that exposure, even though the transaction price incorporates a discount of an amount equal to the specific credit risk adjustments for expected credit losses booked by the selling institution before the sale. That situation creates a regulatory impediment to the creation of secondary markets for defaulted exposures, as the potential misalignment between the risk weights applied to the defaulted exposure by the selling institution and by the purchasing institution respectively might make the transaction less attractive for the purchasing institution and therefore create undue obstacles for credit institutions to move their defaulted exposures off their balance sheets.

(2)

In order to also account for the possibility that the COVID-19 pandemic might result in an increase in the levels of defaulted exposures across credit institutions, it is desirable to remove any regulatory impediments to the creation of secondary markets for defaulted exposures. It is therefore necessary to ensure that the specific credit risk adjustments recognised for the purposes of Article 127(1) of Regulation (EU) No 575/2013 incorporate any discount in a transaction price of a defaulted exposure that the purchasing institution has not recognised by increasing Common Equity Tier 1 capital. In particular, in order to avoid any undue double recognition of the potential decrease in the level of expected loss by the purchasing institution after the purchase on both Common Equity Tier 1 capital of that institution and for the purposes of determining the risk weight in accordance with Article 127(1) of Regulation (EU) No 575/2013, in case of a revaluation of the defaulted exposure occurring after its purchase, the discount should no longer incorporate the part of the revaluation amount of the defaulted exposure that has been recognised as increasing the institution’s Common Equity Tier 1 capital.

(3)

Commission Delegated Regulation (EU) No 183/2014 (2) should therefore be amended accordingly.

(4)

This Regulation is based on the draft regulatory technical standards submitted to the Commission by the European Banking Authority.

(5)

The European Banking Authority has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 (3),

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected designation of origin ‘Taleggio’, registered under Commission Regulation (EC) No 1107/96 (2).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected designation of origin ‘Monte Etna’, registered under Commission Regulation (EC) No 1491/2003 (2).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Radicchio di Verona’, registered under Commission Regulation (EC) No 98/2009 (2).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Sweden’s application to register the name ‘Äkta Gränna Polkagrisar’ was published in the Official Journal of the European Union (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Äkta Gränna Polkagrisar’ should therefore be entered in the register,

(1)

Commission Implementing Regulation (EU) 2019/2072 (2) lays down, in Part A of Annex II, the list of Union quarantine pests not known to occur in the Union territory. Implementing Regulation (EU) 2019/2072 aims at preventing the entry, establishment and spread of such quarantine pests in the Union territory by setting out special requirements, in Annex VII thereto, for the introduction into the Union territory of certain plants, plant products and other objects.

(2)

Thaumatotibia leucotreta (Meyrick) (‘the specified pest’) is listed as a Union quarantine pest, which is not known to occur in the Union, in Part A of Annex II to Implementing Regulation (EU) 2019/2072. It is also listed as a priority pest in the Annex to Commission Delegated Regulation (EU) 2019/1702 (3). The specified pest is polyphagous and has been intercepted on several host plants during border controls in the Union territory.

(3)

Specific import requirements exist for fruits of Capsicum (L.), Citrus L., other than Citrus aurantiifolia (Christm.) Swingle and Citrus limon (L.) Osbeck, for fruits of Prunus persica (L.) Batsch and of Punica granatum L. to protect the Union territory from the specified pest (4). Citrus L. is a category which covers fruits of Citrus sinensis Pers.

(4)

According to the existing import requirements, information on the country freedom, area freedom of the specified pest, and the use of a systems approach and any post-harvest treatment together with the documentary evidence of the effectiveness of those requirements, needs to be communicated prior to trade. This information should allow for an easier evaluation of the effectiveness of the current special requirements. That effectiveness should be measured depending on the number of non-compliances due to the specified pest on the imported host commodities.

(5)

As non-compliances of consignments with the specific import requirements due to the presence of the specified pest on the host commodities continue to occur during border controls in the Union territory, it is justified to amend the special requirements set out in Annex VII to Implementing Regulation (EU) 2019/2072. In particular, the special requirements relating to the freedom of the place of production, the use of post-harvest treatments and of the systems approach, should be amended to offer better guarantees of pest freedom of the traded fruit commodities.

(6)

The amendment of the special requirements is based on the scientific and technical information of the pest risk analysis performed by the European and Mediterranean Plant Protection Organisation (‘EPPO’), on the commodity risk assessments performed by the European Food Safety Authority for Citrus spp. fruits imported from Israel (5) and South Africa (6), on the relevant scientific literature and on comments received from third countries following a consultation within the World Trade Organisation (Sanitary and Phytosanitary Measures Agreement).

(7)

The respective approval of facilities, requirements for treatment facilities, monitoring, auditing, documentation procedures and record keeping of the applied treatment should be ensured, in order to guarantee phytosanitary safety and traceability.

(8)

At present, the requirements established in Annex VII to Implementing Regulation (EU) 2019/2072 for fruits of Citrus L. are also applicable for Citrus sinensis Pers. Based on the non-compliance data due to the presence of the specified pest on Citrus fruits, the fruits of Citrus sinensis Pers. should be subject to separate requirements, and not to the same requirements as other fruits of Citrus L. This is important in order to better ensure their freedom from the specified pest. Such requirements should include a systems approach with a specific regime of cold treatment, possibly with a precooling step in order to ensure the highest possible probability of pest freedom.

(9)

To allow competent authorities and professional operators to adapt to the systems approach, for Citrus sinensis Pers., an alternative and temporary requirement of a systems approach, which includes a precooling step of the pulp of the fruit to 5 °C, followed by a cold treatment for at least 25 days at a set temperature between – 1 °C and +2 °C should be provided for until 31 December 2022.

(10)

In the case of Citrus sinensis Pers., when the cold treatment is applied during the transport of the fruits concerned, records on the application of that treatment should be kept and made available upon request.

(11)

This Regulation should enter into force and apply as soon as possible in order for the reinforced requirements, which increase the protection of the Union against this pest, to be implemented within the shortest time, in order to take account of consignments of the specified fruits in transport to the Union at the time of entry into force of this Regulation.

(12)

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

(1)

The Czech language version of Commission Implementing Regulation (EU) 2015/1502 (2) contains an error in the Annex, Section 2.1.2 (Identity proofing and verification (natural person)), row concerning the Assurance level ‘High’, column ‘Elements needed’, point 1(c) as regards the identification of the required assurance level.

(2)

The Czech language version of Implementing Regulation (EU) 2015/1502 should therefore be corrected accordingly. The other language versions are not affected.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 48 of Regulation (EU) No 910/2014,

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods 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) has established a Union list of novel foods.

(3)

On 22 January 2020, the company ‘Sabinsa Europe GmbH’ (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place tetrahydrocurcuminoids on the Union market as a novel food. The tetrahydrocurcuminoids are produced by the hydrogenation of curcuminoids extracted from the rhizomes of the turmeric plant (Curcuma longa L.). The applicant requested for tetrahydrocurcuminoids to be used at levels not exceeding 300 mg/day, in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), intended for the adult population, excluding pregnant and lactating women.

(4)

On 22 January 2020, the applicant also made a request to the Commission for the protection of proprietary data for the analytical data (4), a bacterial reverse mutation test (5), an in vitro micronucleus assay (6), a 90-day oral sub-chronic toxicity study and a reproduction/developmental toxicity screening test in rodents (7), submitted in support of the application.

(5)

On 29 July 2020, the Commission, requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of tetrahydrocurcuminoids as a novel food.

(6)

On 27 October 2021, the Authority adopted its scientific opinion on the ‘Safety of tetrahydrocurcuminoids from turmeric (Curcuma longa L.) as a novel food pursuant to Regulation (EU) 2015/2283’ (8) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that tetrahydrocurcuminoids are safe under the proposed conditions of use, for the proposed target populations, at levels not exceeding 140 mg/day. The Authority further stated that such intake, although lower than the 300 mg/day level proposed by the applicant, provides an adequate Margin of Exposure (‘MoE’) to the identified No Observed Adverse Effect Levels (‘NOAELs’) from the subchronic toxicity and the reproductive/developmental toxicity studies. Therefore, that scientific opinion gives sufficient grounds to establish that tetrahydrocurcuminoids when used at levels not exceeding 140 mg/day in food supplements intended for the adult population, excluding pregnant and lactating women, fulfil the conditions for their placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.

(9)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and tests and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(10)

The applicant declared that they held proprietary and exclusive rights of reference to the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11)

The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, and the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place tetrahydrocurcuminoids on the market within the Union during a period of five years from the entry into force of this Regulation.

(12)

However, restricting the authorisation of tetrahydrocurcuminoids and the reference to the scientific data contained in the applicant’s file for the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(13)

It is appropriate that the inclusion of tetrahydrocurcuminoids as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. Non-hydrogenated curcuminoids and/or curcumin have been used in food supplements on the Union market before 15 May 1997. Curcumin and curcuminoids are metabolised in the body via the same metabolic pathways that would metabolise the tetrahydrocurcuminoids. As it cannot be excluded that the intake of curcuminoids from the combined use of both would result in a MoE that is lower than the MoE established by the Authority, it is necessary to inform consumers that food supplements containing tetrahydrocurcuminoids should not be consumed if food supplements containing curcumin and/or curcuminoids are consumed on the same day.

(14)

Tetrahydrocurcuminoids should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

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

(1)

On 23 June 2014, the Council adopted Decision 2014/386/CFSP (1).

(2)

The Union does not recognise and continues to condemn the illegal annexation of Crimea and Sevastopol by the Russian Federation as a violation of international law. The Union remains steadfast in its commitment to Ukraine’s sovereignty and territorial integrity within its internationally recognised borders and dedicated to fully implementing its non-recognition policy.

(3)

On the basis of a review of Decision 2014/386/CFSP, the restrictive measures set out therein should be renewed until 23 June 2023.

(4)

Decision 2014/386/CFSP should therefore be amended accordingly,