(1)

The Paris Agreement adopted under the United Nations Framework Convention on Climate Change, approved by the Union on 5 October 2016 (2) (the ‘Paris Agreement’), aims to strengthen the response to climate change, among other means by making investment flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development.

(2)

On 11 December 2019, the Commission adopted its Communication to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions ‘The European Green Deal’ (3). That European Green Deal represents a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. The implementation of the European Green Deal requires that investors are offered clear, long-term signals to avoid stranded assets and to raise sustainable finance.

(3)

Regulation (EU) 2016/1011 requires benchmark administrators to explain in the benchmark statement how environmental, social and governance (‘ESG’) factors are reflected in each benchmark or family of benchmarks provided and published.

(4)

Different ways of explaining how ESG factors are reflected would lead to a lack of comparability between benchmarks and a lack of clarity as to the scope and objectives of the ESG factors. It is therefore necessary to specify the content of that explanation and to lay down a template to be used.

(5)

In order to better adapt the information for investors, the requirement to explain how ESG factors are reflected in each benchmark or family of benchmarks provided and published should take into account the underlying assets on which benchmarks are based. This Regulation should not apply to benchmarks which do not have underlying assets that have an impact on climate change such as interest rate benchmarks and foreign exchange benchmarks.

(6)

The explanation on how ESG factors are reflected should display the corresponding score of the relevant ESG factors vis-à-vis the benchmark, at an aggregated weighted average value. Such score should not be disclosed for each constituent of the benchmarks. Where relevant and appropriate, benchmark administrators should be able to provide additional ESG information.

(7)

Due to their characteristics and objectives, specific disclosure requirements should be set out for EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks, and for significant bond and equity benchmarks.

(8)

In order to provide benchmark users with accurate and up-to-date information, benchmark administrators should update the information provided to reflect any changes made to the benchmark statement, and should indicate the reason and the dates at which the information was updated,

(1)

The Paris Agreement adopted under the United Nations Framework Convention on Climate Change, approved by the Union on 5 October 2016 (2) (the ‘Paris Agreement’), aims to strengthen the response to climate change, among other means by making investment flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development.

(2)

On 11 December 2019, the Commission adopted its Communication to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions ‘The European Green Deal’ (3). The European Green Deal represents a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. The implementation of the European Green Deal requires that investors are offered clear, long-term signals to avoid stranded assets and to raise sustainable finance.

(3)

Regulation (EU) 2016/1011 requires benchmark administrators to explain how for each benchmark provided and published the key elements of the benchmark methodology reflect environmental, social and governance (‘ESG’) factors.

(4)

Different ways of explaining for each benchmark or family of benchmarks how the key elements of the benchmark methodology reflect ESG factors, would lead to a lack of comparability between benchmarks and a lack of clarity as to the scope and objectives of the ESG factors. It is therefore necessary to set out the minimum content of such explanations as well as a template to be used.

(5)

In order to better adapt the information for investors, the requirement to explain how the key elements of the methodology reflect ESG factors for each benchmark or family of benchmarks provided and published should take into account the underlying assets on which benchmarks are based. This Regulation should not apply to benchmarks which do not have underlying assets that have an impact on climate change such as interest rate benchmarks and foreign exchange benchmarks. In accordance with Article 19 of Regulation (EU) 2016/1011, this Regulation should not apply to commodity benchmarks.

(6)

The explanation on how key elements of the benchmark methodology reflect ESG factors should be made at an aggregated weighted average value, and should not be disclosed for each constituent of the benchmarks. Where relevant and appropriate, benchmark administrators should be able to provide additional ESG information.

(7)

In order to provide benchmark users with accurate and up-to-date information, benchmark administrators should update the information provided in the template to reflect any changes made to the methodology, and should indicate the reason and the dates at which the information was updated.

(8)

In order to provide investors with maximum transparency, benchmark administrators should clearly state whether they do or do not pursue ESG objectives,

(1)

The Paris Agreement, adopted under the United Nations Framework Convention on Climate Change approved by the Union on 5 October 2016 (2) (the ‘Paris Agreement’), aims to strengthen the response to climate change, among other means by making investment flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development.

(2)

On 11 December 2019, the Commission adopted its Communication to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions ‘The European Green Deal’ (3). The European Green Deal represents a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. The implementation of the European Green Deal requires that investors are offered clear, long-term signals to avoid stranded assets and to raise sustainable finance.

(3)

Regulation (EU) 2016/1011 establishes EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks. The methodology of those benchmarks is based on the commitments laid down in the Paris Agreement. It is necessary to specify the minimum standards applicable to both types of benchmarks. EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks pursue similar objectives but vary in their level of ambition. Most of the minimum standards should therefore be common to both types of benchmarks, but the thresholds should vary depending on the type of benchmark.

(4)

There are currently not enough data to assess the carbon footprint resulting from decisions made by sovereign entities. Sovereign-based issuances should therefore not be eligible constituents of EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks.

(5)

Because the methodology of EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks is based on the commitments laid down in the Paris Agreement, it is necessary to use the 1,5 °C scenario, with no or limited overshoot, referred to in the Special Report on Global Warming of 1,5 °C from the Intergovernmental Panel on Climate Change (IPCC) (4) (‘IPCC scenario’). That IPCC scenario is in line with the Commission’s objective to reach net zero greenhouse gas (GHG) emissions by 2050, set out in the European Green Deal. To be in line with the IPCC scenario, investments should be reallocated from fossil-fuels dependent activities to green or renewable activities and the climate impact of those investments should improve year after year.

(6)

The sectors listed in Sections A to H and Section L of Annex I to Regulation (EC) No 1893/2006 of the European Parliament and of the Council (5), including the oil, gas, mining and transportation sectors, are sectors that highly contribute to climate change. To ensure that EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks provide a realistic image of the real economy, including of sectors that should actively reduce GHG emissions to make the objectives of the Paris Agreement attainable, the exposure of those benchmarks to those sectors should not be less than the exposure of their underlying investable universe. That requirement should, however, only apply to EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks that are equity benchmarks, to ensure that equity investors who support the objectives of the Paris Agreement maintain their influence, via engagement and voting, on the transition of the company towards more sustainable activities.

(7)

The calculation of GHG emissions should be comparable and consistent. It is therefore necessary to lay down rules about how often those calculations should be updated and, where applicable, about the currency to be used.

(8)

A decarbonisation based only on Scope 1 and Scope 2 GHG emissions could lead to counterintuitive results. It should therefore be clarified that the minimum standards for EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks should not only consider direct emissions from companies, but also emissions assessed on a life-cycle basis and thus including Scope 3 GHG emissions. However, due to the insufficient quality of data currently available for Scope 3 GHG emissions, it is necessary to set out an appropriate phase-in timeline and to allow for the use of fossil fuel reserves for a limited period of time. That phase-in timeline should be based on the list of economic activities set out in Regulation (EC) No 1893/2006.

(9)

Benchmark administrators should have the possibility to overweight companies based on the decarbonisation objectives set by those companies. Specific rules relating to decarbonisation targets reported by individual companies should therefore be set out.

(10)

EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks should demonstrate their ability to decarbonize themselves from one year to the other. That minimum decarbonisation trajectory should be calculated using the IPCC scenario. Furthermore, in order to prevent greenwashing, conditions for the deviation from the decarbonisation trajectory and for the right to continue to label a benchmark as an EU Climate Transition Benchmark or as an EU Paris-aligned Benchmark should be specified.

(11)

The main parameter to calculate the decarbonisation trajectory should be the GHG intensity, because that parameter ensures comparability across sectors and is not biased for or against a particular sector. To calculate the GHG intensity, the market capitalisation of the concerned company is necessary. However, where benchmarks apply to fixed-income corporate instruments, the market capitalisation might not be available for companies that do not have equity securities listed. It should therefore be laid down that where EU Climate Transition Benchmarks or EU Paris-aligned Benchmarks apply to fixed-income corporate instruments, benchmark administrators should be allowed to use GHG emissions calculated on an absolute basis, rather than on the basis of GHG intensity.

(12)

To ensure comparability and consistency of GHG emission data, rules on how to calculate changes in GHG intensity or absolute GHG emissions should be laid down.

(13)

Attaining the objectives of the Paris Agreement requires that both EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks have a baseline percentage reduction in exposure to GHG intensive assets compared to their parent benchmarks or underlying investment universes. However, that percentage reduction should be more significant for EU Paris-aligned Benchmarks, which, by design, are more ambitious than EU Climate Transition Benchmarks.

(14)

EU Paris-aligned Benchmarks should not contribute to the promotion of investments in financial instruments issued by companies that violate global standards such as the United Nations Global Compact (UNGC) Principles. It is therefore necessary to lay down specific exclusion criteria that are based on climate-related or other environmental, social and governance (ESG) considerations. EU Climate Transition benchmarks should comply with those exclusion criteria by 31 December 2022, in accordance with the timeline set out in Regulation (EU) 2016/1011.

(15)

In order to support a decrease in the use of polluting energy sources and a proper transition to renewable ones, it is also appropriate that companies that derive more than a set percentage of their revenues from coal, oil or gas are excluded from the EU Paris-aligned Benchmarks. The changes in the share of those energy sources out of the global primary energy supply from 2020 to 2050, as expected in the IPCC scenario, should be taken into account to set out those specific exclusions. In particular, according to table 2.6 of the Special Report on Global Warming of 1,5 °C from the IPCC, between 2020 and 2050, the use of coal is expected to drop between 57 % and 99 % and the use of oil between 9 % and 93 %, while the use of gas is expected to go up by 85 % or to drop by 88 %. Gas can be used during the transition to a low carbon economy, in particular as a replacement for coal, which explains its wider expected range of evolution, although the expected median decrease of its use is 40 %. For the same reason, it is necessary to exclude companies that derive more than a set percentage of their revenues from electricity generation activities.

(16)

To ensure transparency about the methodology used for the EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks, it is appropriate to lay down rules about the necessary disclosures pertaining to the decarbonisation trajectory and the data sources for both categories of benchmarks. For the same reason, it is appropriate to lay down disclosure requirements for benchmark administrators that use estimations for GHG emissions data, whether or not provided by external data providers.

(17)

In order to support the harmonisation of the methodology for EU Climate Transition Benchmarks and EU Paris-aligned Benchmarks, it is appropriate to lay down rules about the quality and accuracy of data sources,

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.

(2)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application.

(3)

Pursuant to Annex II to Regulation (EC) No 1333/2008, as amended by Commission Regulation (EU) No 232/2012 (3), Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) are currently authorised as food additives in food category 09.2 ‘Processed fish and fishery products including molluscs and crustaceans’, both at a maximum level of 200 mg/kg, for use only in salmon substitutes based on the fish species Theragra chalcogramma and Pollachius virens. On 15 July 2014 and 23 September 2009, the Authority issued opinions establishing the acceptable daily intake (ADI) for Sunset Yellow FCF/Orange Yellow S (E 110) (4) at 4 mg/kg bw/day and the ADI for Ponceau 4R, Cochineal Red A (E 124) (5) at 0,7 mg/kg bw/day. On its opinions of 15 July 2014 and of 21 April 2015 (6), the Authority concluded that none of the exposure estimates for those additives exceeded their respective ADI for any population group.

(4)

On 4 February 2019, an application was submitted for the modification of the conditions of use of Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) contained in food category 09.2 ‘Processed fish and fishery products including molluscs and crustaceans’, to authorise the use of those substances in salmon substitutes based on the fish species Clupea harengus. The application requires the current maximum level of 200 mg/kg, however, it clarifies that the actual use levels are much lower ranging between one and two tenths of the maximum level for both substances. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5)

Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124), when used as colours, impart the desired stable shade, improve organoleptic properties and make salmon substitutes based on the fish species Clupea harengus more visually appealing.

(6)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health.

(7)

Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) are authorised for use in a wide variety of foods. The most recent exposure assessments carried out by the Authority, as referred to in recital 3, confirmed that the overall exposure is well below their ADI even in the most conservative regulatory maximum levels scenario. The authorised uses in salmon substitutes based on Theragra chalcogramma and Pollachius virens were included in those exposure estimates. Since salmon substitutes based on Clupea harengus are intended as an alternative to salmon substitutes based on Theragra chalcogramma and Pollachius virens, the consumption of salmon substitutes by consumers should not significantly change. Furthermore, the use levels for Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) needed to achieve the desired effect in salmon substitutes based on Clupea harengus are substantially lower than the authorised maximum levels. Therefore, it is not expected that the proposed use will have a significant impact on the overall exposure of consumers to those food additives, which therefore should remain below the ADI.

(8)

The entries for Group II, Group III and Lycopene (E 160d) in food category 09.2 ‘Processed fish and fishery products including molluscs and crustaceans’ currently only refer to ‘salmon substitutes’. In order to provide clarity and legal certainty as regards this expression, the wording of those entries should be amended to indicate that the authorised use concerns ‘salmon substitutes’ based on the fish species Theragra chalcogramma, Pollachius virens or Clupea harengus.

(9)

Therefore, it is appropriate to amend food category 09.2 ‘Processed fish and fishery products including molluscs and crustaceans’ in Part E of Annex II to Regulation (EC) No 1333/2008 to authorise the use of Sunset Yellow FCF/Orange Yellow S (E 110) and Ponceau 4R, Cochineal Red A (E 124) in salmon substitutes based on the fish species Clupea harengus and to list in the entries for Group II, Group III and Lycopene (E 160d), the fish species on which ‘salmon substitutes’ may be based.

(10)

Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.

(11)

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

(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)

On 20 December 2018, the company Kemin Foods L.C. (‘the applicant’) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place dried whole cell Euglena gracilis on the Union market as a novel food. The application requested for dried whole cell Euglena gracilis to be used as a novel food in a number of food categories for the general population as follows: breakfast, granola and protein bars; yoghurt; yoghurt beverages; fruit juices, smoothies and nectars, vegetable juices; fruit-flavoured drinks; meal replacement beverages. The applicant also requested for dried whole cell Euglena gracilis to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), excluding food supplements for infants, and in total diet replacement for weight control as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), excluding total diet replacement for weight control for infants.

(4)

The applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application namely, in vitro fermentation studies (5), bacterial reverse mutation test (6), in vivo micronucleus test (7), acute toxicity study in rats (8), 14-day dietary toxicity/palatability study in rats (9), 90-day dietary toxicity study in rats (10).

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 13 May 2019, asking it to provide a scientific opinion by carrying out an assessment for dried Euglena gracilis as a novel food.

(6)

On 25 March 2020, the Authority adopted the scientific opinion on the “Safety of dried whole cell Euglena gracilis as a novel food pursuant to Regulation (EU) 2015/2283” (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(7)

In that opinion, the Authority concluded that dried Euglena gracilis is safe at the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that dried Euglena gracilis under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In accordance with Commission Delegated Regulation (EU) 2017/1798 (12) total diet replacement for weight control are foods intended for healthy overweight or obese adults who intend to achieve weight reduction. Therefore, dried Euglena gracilis may be authorised for use in total diet replacement for weight control only for adults, excluding infants, children and adolescents.

(9)

In its opinion, the Authority considered that the data from the 90-day dietary toxicity study in rats served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of dried Euglena gracilis could not have been reached without the data from the unpublished report of that study.

(10)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the 90-day dietary toxicity study in rats, and to clarify its claim to an exclusive right of reference to that study, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

(11)

The applicant declared that, at the time of the submission of the application, it held proprietary and exclusive right of reference to that study under national law, and that therefore third parties cannot lawfully access or use that study or refer to that data.

(12)

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the 90-day dietary toxicity study in rats contained in the applicant’s file should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of dried Euglena gracilis should be restricted to the applicant for that period.

(13)

However, restricting the authorisation of dried Euglena gracilis and of the reference to the study contained in the applicant’s file for the sole use of the applicant, does not prevent other 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 authorisation under Regulation (EU) 2015/2283.

(14)

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

(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)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and on the update of the Union list.

(4)

On 7 June 2018, the company NuLiv Science (‘the applicant’) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place an extract from Panax notoginseng and Astragalus membranaceus on the Union market as a novel food. The applicant requested for an extract from Panax notoginseng and Astragalus membranaceus to be used as a novel food in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) for the general adult population, excluding food supplements for pregnant women. The applicant also made a request to the Commission for the protection of proprietary data submitted in the application.

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘Authority’) on 22 October 2018, asking it to provide a scientific opinion by carrying out an assessment for an extract from Panax notoginseng and Astragalus membranaceus as a novel food.

(6)

On 24 March 2020, the Authority adopted the scientific opinion on the ‘Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus (AstraGinTM) as a novel food pursuant to Regulation (EU) 2015/2283’ (4). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(7)

In its opinion, the Authority concluded that an extract from Panax notoginseng and Astragalus membranaceus is safe at an intake level of 0,5 mg/kg bw per day which corresponds to a maximum intake of 35 mg/day for the target population, i.e. adults excluding pregnant women.

(8)

The opinion of the Authority gives sufficient grounds to establish that extract from Panax notoginseng and Astragalus membranaceus under the assessed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(9)

In its opinion the Authority considered that the toxicological data from the repeated dose 28-day oral gavage toxicity study with AstraGinTM in rats (5), the bacterial reverse mutation test (Ames test) for AstraGinTM (6), the 90-days repeated dose oral toxicity study of Astragin® in Wistar rats (7), the Panax notoginseng proprietary extract: in vitro micronucleus test in CHO-K1 cells (8), and the Astragalus membranaceus extract: in vitro micronucleus test in CHO-K1 cells (9) served as a basis to establish the safety of the novel food. Therefore, it is considered that the conclusions on the safety of extract from Panax notoginseng and Astragalus membranaceus could not have been reached without the data from the unpublished reports of those studies.

(10)

Following the Authority’s opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the repeated dose 28-day oral gavage toxicity study with AstraGinTM in rats, the bacterial reverse mutation test (Ames test) for AstraGinTM, the 90-days repeated dose oral toxicity study of Astragin® in Wistar rats, the Panax notoginseng proprietary extract: in vitro micronucleus test in CHO-K1 cells, and the Astragalus membranaceus extract: in vitro micronucleus test in CHO-K1 cells, and to clarify their claim to an exclusive right of reference to that data, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

(11)

The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive right of reference to those studies, and that therefore third parties cannot lawfully access or use those studies or refer to that data.

(12)

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the toxicological data from the studies contained in the applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of extract from Panax notoginseng and Astragalus membranaceus, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of an extract from Panax notoginseng and Astragalus membranaceus should be restricted to the applicant for that period.

(13)

However, restricting the authorisation of extract from Panax notoginseng and Astragalus membranaceus and of the reference to the studies contained in the applicant’s file for the sole use of the applicant, does not prevent other 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 authorisation under Regulation (EU) 2015/2283.

(14)

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

(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 22 August 2018, the company Skotan S.A. (‘the applicant’) introduced an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place chromium-enriched biomass of the yeast Yarrowia lipolytica on the Union market as a novel food. The applicant requested for chromium-enriched biomass of the yeast Yarrowia lipolytica to be used as a novel food in food supplements, excluding food supplements for infants and young children. The maximum use levels proposed by the applicant are 2 g per day for children from 3 to 9 years of age, and 4 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 chromium-containing yeast (Yarrowia lipolytica) biomass as a novel food.

(6)

On 23 January 2020, the Authority adopted its scientific opinion ‘Safety of chromium-enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283’ (5). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(7)

In its opinion, the Authority concluded that chromium-containing yeast (Yarrowia lipolytica) biomass is safe under the proposed uses and use levels, when used in food supplements intended for the general population above 3 years of age.

(8)

The opinion of the Authority gives sufficient grounds to establish that chromium-containing yeast (Yarrowia lipolytica) biomass under the proposed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(9)

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

(10)

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

(1)

Regulation (EC) No 1331/2008 lays down procedural arrangements for updating the lists of substances the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (2), Regulation (EC) No 1332/2008 of the European Parliament and of the Council (3) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council (4) (‘the sectoral food laws’).

(2)

Commission Regulation (EU) No 234/2011 (5) lays down provisions regarding the content, drafting and presentation of applications to update the Union lists under each sectoral food law. That Regulation provides for detailed arrangements for checking the validity of applications for food additives, food enzymes and food flavourings and the type of information that should be included in the opinion of the European Food Safety Authority (‘the Authority’).

(3)

Regulation (EU) 2019/1381 of the European Parliament and the Council (6) amended Regulation (EC) No 178/2002 (7) and Regulation (EC) No 1331/2008. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the Authority delivers a scientific risk assessment, including in the area of food additives, food enzymes and food flavourings.

(4)

As regards the placing on the market of food additives, food enzymes and food flavourings and ingredients with flavouring properties for use in and on foods, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst other issues: general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences of non-compliance with that obligation. It also introduced provisions on the public disclosure, by the Authority, of all scientific data, studies and other information supporting applications with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by the Authority in relation to the information submitted by an applicant, where the Commission requests the opinion of the Authority.

(5)

Regulation (EU) 2019/1381 also amended Regulation (EC) No 1331/2008 to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.

(6)

Given the scope and application of all those amendments, Regulation (EU) No 234/2011 should be adjusted to accommodate the changes as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, the arrangements for checking the validity of applications and the information to be included in the opinions of the Authority. In particular, Regulation (EU) No 234/2011 should make reference to the standard data formats and require that applications provide information demonstrating compliance with the notification requirement laid down in Article 32b of Regulation (EC) No 178/2002, It should also clarify that the assessment of compliance with the notification requirement forms part of the verification of the validity of an application.

(7)

Furthermore, taking into account the fact that the Authority is responsible for managing the database of studies in accordance with Article 32b of Regulation (EC) No 178/2002, it should also be made possible for the Commission to consult the Authority as part of the verification of the validity of applications to ascertain that the application fulfils the relevant requirements that are laid down in that Article.

(8)

Where public consultations are performed during the risk assessment in accordance with Article 32c(2) of Regulation (EC) No 178/2002, the opinion of the Authority should also include the results of those consultations, in line with the transparency requirements to which the Authority is subject.

(9)

This Regulation should apply from 27 March 2021 and to applications submitted as of that date, which is the date of application of Regulation (EU) 2019/1381.

(10)

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

(1)

Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.

(2)

Commission Implementing Regulation (EU) 2017/2468 (2) lays down administrative and scientific requirements concerning traditional foods from third countries.

(3)

Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 of the European Parliament and of the Council (4) and Regulation (EU) 2015/2283. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the European Food Safety Authority (‘the Authority’) delivers a scientific risk assessment, including in the area of traditional foods from third countries.

(4)

As regards the placing on the market of traditional foods from third countries, the amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst other issues: general pre-submission advice by the staff of the Authority at the request of a potential applicant or notifier and the obligation to notify studies commissioned or carried out by business operators to support an application or notification and the consequences of non-compliance with that obligation. It also introduced provisions on the public disclosure by the Authority of all scientific data, studies and other information supporting applications, with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by the Authority in relation to the information submitted by an applicant, where the Commission requests the opinion of the Authority.

(5)

Regulation (EU) 2019/1381 also amended Regulation (EU) 2015/2283 to provide for the public disclosure by the Authority of notifications where it submits duly reasoned safety objections as well as to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.

(6)

Given the scope and application of all those amendments, Implementing Regulation (EU) 2017/2468 should be adjusted to accommodate the changes as regards the content, drafting and presentation of notifications and applications referred to in Articles 14 and 16 of Regulation (EU) 2015/2283, the arrangements for verifying the validity of notifications and applications and the information to be included in the opinion of the Authority. In particular, Implementing Regulation (EU) 2017/2468 should make reference to the standard data formats and require that applications provide information demonstrating compliance with the notification requirement laid down in Article 32b of Regulation (EC) No 178/2002. It should also clarify that the assessment of compliance with the notification requirement forms part of the verification of the validity of an application.

(7)

Furthermore, taking into account the fact that the Authority is responsible for managing the database of studies in accordance with Article 32b of Regulation (EC) No 178/2002, it should be made possible for the Commission to consult the Authority as part of the verification of the validity of notifications and applications, in particular with a view to ascertaining that the notification or application fulfils the relevant requirements that are laid down in that Article.

(8)

Where public consultations are performed during the risk assessment in accordance with Article 32c(2) of Regulation (EC) No 178/2002, the opinion of the Authority should also include the results of those consultations in line with the transparency requirements to which the Authority is subject.

(9)

This Regulation should apply from 27 March 2021 and to notifications and applications submitted as of that date, which is the date of application of Regulation (EU) 2019/1381.

(10)

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

(1)

Article 7 of Commission Implementing Regulation (EU) 2019/2072 (2), in conjunction with Annex VI of that Regulation, provides for a list of plants, plant products and other objects whose introduction into the Union territory is prohibited, together with the third countries, groups of third countries or specific areas of third countries to which the prohibition applies, as referred to in Article 40(2) of Regulation (EU) 2016/2031.

(2)

Article 8(1) of Implementing Regulation (EU) 2019/2072, in conjunction with Annex VII of that Regulation, provides for a list of plants, plant products and other objects, originating from third countries, and the corresponding special requirements for their introduction into the Union territory, as referred to in Article 41(2) of Regulation (EU) 2016/2031.

(3)

Moreover, Article 8(2) of Implementing Regulation (EU) 2019/2072, in conjunction with Annex VIII of that Regulation, provides for a list of plants, plant products and other objects, originating in the Union territory, and the corresponding special requirements for their movement within the Union territory, as referred to in Article 41(2) of Regulation (EU) 2016/2031.

(4)

Since the adoption of Implementing Regulation (EU) 2019/2072, it has become clear that, in certain exceptional cases, certain implementing acts, setting out temporary prohibitions or special requirements for the introduction into, or movement within, the Union territory of certain plants, plant products or other objects, need to be adopted pursuant to Articles 28(1), 30(1), 40(2), (41)2, 42(3), 42(4) or 49(1) of Regulation (EU) 2016/2031 to address specific phytosanitary risks, which have not been sufficiently assessed. That will allow the phytosanitary risks addressed through those prohibitions or special requirements to be further assessed in order to determine their phytosanitary status.

(5)

Therefore, Articles 7 and 8 of Implementing Regulation (EU) 2019/2072 should provide that the respective prohibitions or special requirements are to apply without prejudice to those acts.

(6)

Implementing Regulation (EU) 2019/2072 should therefore be amended accordingly.

(7)

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

(1)

Pursuant to Article 6(1) of Joint Action 2008/851/CFSP, the Council authorised the Political and Security Committee to take the relevant decisions on the appointment of the EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (‘Atalanta’).

(2)

On 25 June 2020, the Political and Security Committee adopted Decision (CFSP) 2020/895 (2) appointing Rear Admiral Riccardo MARCHIÒ as EU Force Commander for Atalanta.

(3)

The EU Operation Commander has recommended the appointment of Captain Diogo ARROTEIA as the new EU Force Commander for Atalanta as from 3 December 2020.

(4)

On 22 October 2020, the EU Military Committee supported that recommendation.

(5)

Decision (CFSP) 2020/895 should therefore be repealed.

(6)

In accordance with Article 5 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark does not participate in the elaboration and the implementation of decisions and actions of the Union which have defence implications,

(1)

On 28 November 2014, the Commission received a formal complaint submitted by the German glass producer GMB Glasmanufaktur Brandenburg GmbH (‘GMB’) and its parent company Interfloat Corporation (‘Interfloat Group’), registered in Liechtenstein (together ‘the complainant’). The complainant alleged that its direct competitor Ducat NV (‘Ducatt’) had received unlawful State aid that was incompatible with the internal market from the Flemish Region, Belgium.

(2)

By letter dated 19 May 2016, the Commission informed Belgium that it had decided to initiate the procedure laid down in the first subparagraph of Article 108(2) of the Treaty on the Functioning of the European Union (‘TFEU’) in respect of the alleged State aid granted to Ducatt (‘the Opening Decision’).

(3)

The Opening Decision was published in the Official Journal of the European Union (2). The Commission invited interested parties to submit their comments on the measures described in the Opening Decision.

(4)

The Belgian authorities submitted their comments on the Opening Decision on 20 June 2016 (3) and 19 July 2016.

(5)

The Commission received comments from the complainant on 17 June 2016, 18 August 2016, 13 September 2016 and 6 October 2016. It forwarded them to the Belgian authorities, which commented on them by letter dated 23 January 2017.

(6)

The Commission requested additional information from Belgium on 30 January 2017, which was submitted by the Belgian authorities on 27 March 2017.

(7)

On 14 June 2017, the Belgian authorities informed the Commission of the bankruptcy of Ducatt as of 20 May 2017, following which the Commission met the representatives of Belgium on 23 June 2017.

(8)

On 5 July 2017, the Commission met the complainant and its legal representatives.

(9)

On 10 July 2017, the Belgian authorities submitted additional information to the Commission, which the latter had requested at the meeting on 23 June 2017.

(10)

The Commission requested further information from Belgium on 20 November 2017, 22 June 2018 and 31 January 2020. The Belgian authorities responded on 15 December 2017, 27 August 2018, 4 March and 12 May 2020.

(11)

The Commission also requested further information from the receivers of the Ducatt bankruptcy on 18 July 2017, 25 July 2017, 7 and 9 March 2018, 16 May 2018 and 28 January 2019. The receivers replied on 22 July 2017, 6 March 2018, 9 March 2018, 30 March 2018, 30 May 2018 and 29 January 2019.

(12)

The Commission also engaged in the following correspondence with the complainant: it received letters from the complainant on 3 April 2018, 2 April 2019 and 26 January 2020, to which it replied respectively on 24 April 2018, 6 May 2019 and 10 February 2020. The Commission also had two telephone conversations with the complainant on 26 July 2018 and 27 March 2019.

(13)

On 26 March 2020, the Commission received a letter from the complainant with a formal request to act pursuant to Article 265(2) TFEU.

(14)

Ducatt is a spin-off from Emgo NV (‘Emgo’), a 50/50 joint venture between Philips and Osram, which was established in 1966 as a producer of glass bulbs for the production of incandescent lamps and glass tubes for the production of fluorescent lamps. Ducatt was established in November 2010 by the (then) Innovation Manager at Emgo (via Vercundus BVBA) and the (then) Finance & Accounting Manager at Emgo (via ArsiCO BVBA).

(15)

Due to changes in European Union legislation, prohibiting the sale of incandescent lamps from 1 September 2009, Emgo’s glass bulb business was split off and merged with Ducatt in January 2011 with the aim of safeguarding jobs and its know-how in the glass manufacturing sector. Ducatt’s management aimed to enter the market for glass for solar panels and invested heavily as of 2011 in the necessary machinery.

(16)

In addition to the two founding companies, Vercundus BVBA and ArsiCO BVBA, Ducatt is or has been co-owned to various degrees by the following legal entities: Limburgse Reconversie Maatschappij (‘LRM’), Participatie Maatschappij Vlaanderen (‘PMV’), Capricorn Cleantech Fund (‘CCF’), Quest for Growth (‘QFG’), Belfius, VF Capital (‘VFC’), VMF and Aro. In addition, parts of the shares of the company were, for some time, held by a natural person, namely […] (*).

(17)

The complainant is a producer of glass for solar panels and a direct competitor of the alleged aid beneficiary Ducatt. The complainant alleges that Ducatt received around EUR 70 million of unlawful State aid incompatible with the internal market from the State-owned bank Belfius and LRM and PMV, which are two investment companies owned by the Flemish Region.

(18)

According to the complainant, the alleged aid took the form of loans granted and capital increases performed at non-market conditions dating back to Ducatt’s establishment in 2011. They were used to set up the company and start up its production and continuously to cover its losses.

(19)

The Commission opened the formal investigation procedure to assess whether the following measures in favour of Ducatt constituted State aid within the meaning of Article 107(1) TFEU and, if so, if they were compatible with the internal market.

(20)

The Opening Decision expressed doubts as to whether the following capital increases subscribed by LRM and PMV amounting to EUR […] were granted on market terms:

(21)

The Opening Decision expressed doubts as to whether, in addition to the loans converted to equity as stated in recital (20) above, the following loans granted by LRM and PMV amounting to EUR […] were granted on market terms:

(22)

The Opening Decision furthermore expressed doubts as to whether the capital increase and restructuring of shareholder loans of November 2015 were carried out on market terms. This included, on the one hand, the capital increase subscribed by LRM in cash of EUR […] (beside the conversion of EUR […] from loan 13) and, on the other hand, the takeover of the outstanding parts of loan 10 from other parties by LRM, as well as the write-off of parts of the principals and interest of loans 10, 11 and 12 by LRM.

(23)

On 11 May 2017, the insolvency of Solarworld, Ducatt’s main customer, sales to which generated approximately 30 % of Ducatt’s revenues, was made public.

(24)

Subsequently, on 20 May 2017, the board of Ducatt decided to initiate the bankruptcy procedure for Ducatt. Ducatt was declared bankrupt as of 20 May 2017 by the bankruptcy order issued by the Commercial Court of Hasselt on 23 May 2017, which also appointed three bankruptcy receivers.

(25)

In July 2017, all business activity at Ducatt had definitively ceased after the termination of the contracts of all its employees and the halting of production (4).

(26)

In August 2017, after no bids for the sale of Ducatt’s business as a going concern were received, the bankruptcy receivers sold Ducatt’s non-production-related assets (furniture, computers, spare parts, transport equipment, inventory, packaging materials, cleaning machines, etc.) via an online auction to a number of different buyers.

(27)

Ducatt’s main production-related assets were leased by Ducatt from third parties, which repossessed these production assets as a result of Ducatt’s bankruptcy. In particular, the premises and part of the machinery (production hall with the glass furnace, offices and logistics premises) were repossessed by the lease company LRM Lease NV, whereas the glass treatment lines (for glass coming out of the glass furnace) were repossessed by the lease companies ING Equipment Lease, KBC Lease and ES Finance.

(28)

Based on information provided by Belgium, the production premises and offices are currently empty, whereas parts of the logistics premises are rented out to various logistics companies as storage space. The plan is to tear the production hall down along with the offices, to redevelop the underlying land and to keep the premises currently rented out to logistics companies. The glass furnace has been removed from the production hall and has been dismantled, with the stone parts of the furnace having been sold via an online auction to the highest bidders, and other components of the furnace having been scrapped after failed attempts to sell them via an online auction.

(29)

Belgium has shown that the liabilities of Ducatt in bankruptcy amount to around EUR 33,8 million, of which Ducatt’s liabilities to preferential creditors (mostly personnel, social security, banks and leasing companies) amount to EUR 14,3 million, whereas the assets of Ducatt in bankruptcy amount to around EUR 3,6 million.

(30)

Furthermore, in the event that the Commission found that unlawful State aid that was incompatible with the internal market had been granted to Ducatt by Belgium and ordered the recovery of such State aid, Belgium’s claim for the recovery of State aid in Ducatt’s bankruptcy procedure would not be preferential under Belgian insolvency laws. Since the assets are, by far, insufficient to repay the preferential creditors, there is no realistic chance of non-preferential claims being satisfied, even partially.

(31)

Ducatt’s inevitable liquidation is delayed only by a number of legal procedures pending, which are related to claims from creditors and from some of its employees. The outcome of these procedures will not change the fact that preferential claims exceed Ducatt’s assets.

(32)

The Commission notes that, according to Articles 107 and 108 TFEU, the powers of the Commission are designed to avoid the granting of aid incompatible with the internal market. As far as recovery is concerned, the Court has consistently held that the Commission’s power to order Member States to recover aid regarded by the Commission as being incompatible with the internal market is designed to re-establish the situation prior to granting of State aid that is incompatible with the internal market (5).

(33)

In other words, one of the goals of State aid control is to prevent the granting of unlawful or incompatible State aid. The other goal is to ensure that the situation prior to the distortion of competition caused by State aid incompatible with the internal market is restored.

(34)

In the present case, no aid can be granted any longer to Ducatt. A decision declaring that the measures already granted constitute State aid incompatible with the internal market and ordering their recovery would, in any event, not result in a recovery (such recovery being manifestly impossible), and would not have any influence on the payment of the claims of other creditors.

(35)

More precisely, the Commission notes that Ducatt’s business activity has definitively ceased due to (i) the termination of all contracts with Ducatt’s employees, who are now mostly employed by other employers; (ii) the dismantling of Ducatt’s production facilities and the sale of all non-production-related assets of Ducatt to a number of different buyers.

(36)

Furthermore, the Commission notes that Ducatt’s main production asset, the glass furnace repossessed by LRM Lease, has been dismantled and therefore may not be offered to any market operator anymore, whereas the premises repossessed by LRM Lease have not been used for purposes related to Ducatt’s business activity. Finally, the Commission notes that the glass treatment lines are owned by private undertakings, independent of Ducatt and the Flemish Region, the business strategy of which is to lease the assets and not to conduct any production activity comparable to that of Ducatt. For the above reasons, the Commission considers that any chance of another undertaking continuing Ducatt’s business activity can be ruled out.

(37)

The Commission further notes that a recovery order would not have any impact on the payment of the State aid claims, nor of any other claim. Under Belgian bankruptcy law, the claim for recovery of State aid in the event of a negative Commission decision involving recovery would be registered as a non-preferential creditor claim in the schedule of liabilities of Ducatt. The preferential claims by Ducatt’s creditors in the bankruptcy proceedings significantly exceed the amount of Ducatt’s assets in bankruptcy. Therefore, even if the Commission were to find that Ducatt had received illegal and incompatible State aid, the recovery based on such a decision would be impossible and would not influence the outcome of the reimbursement of the claims of the non-preferential creditors of Ducatt in any way.

(38)

The sole rationale for Ducatt’s continued existence, without any business activity, is to await the outcome of several pending legal procedures related to claims from creditors and former employees. Once these procedures have been terminated, Ducatt will be inevitably liquidated and removed from the company register.

(39)

Under these circumstances, a Commission decision on the qualification of the measures in question as incompatible aid would have no practical effect, and the formal investigation procedure initiated under the first subparagraph of Article 108(2) TFEU in respect of the measures in question no longer serves any purpose,