16.3.2016   

EN

Official Journal of the European Union

L 70/1

(1)

Mutual assistance and support in the face of disasters is both a fundamental expression of the universal value of solidarity between people and a moral imperative, as such disasters may lead to a significant number of people being unable to meet their basic needs, with potential severe adverse effects on their health and lives.

(2)

The impact of both man-made and natural disasters within the Union is increasingly severe. This is linked to a number of factors, such as climate change, but also to other contributing external factors and circumstances which are unfolding in the Union's neighbourhood. The migration and refugee situation currently affecting the Union is a notable example of a situation where, despite the efforts undertaken by the Union to address the root causes located in third countries, the economic situation of Member States may be directly affected.

(3)

This situation led the European Council, on 19 February 2016, to call upon the Commission to put in place the capacity to provide humanitarian assistance internally, in order to support countries facing large numbers of refugees and migrants.

(4)

Man-made or natural disasters may be of such a scale and impact that they can give rise to severe economic difficulties in one or several Member States. They can also occur in one or several Member States already facing severe economic difficulties for other reasons, with the result of exacerbating and aggravating even further the overall economic situation of the Member States concerned. In either case, the response capacity of the Member States concerned would be adversely affected, and the assistance and support being provided to people in need would, in turn, be negatively affected.

(5)

While the Union is already in a position to grant support of a macro-financial nature to Member States, and to express European solidarity to disaster-stricken regions through the European Union Solidarity Fund (EUSF) established by Council Regulation (EC) No 2012/2002 (1), there is currently no appropriate instrument available at Union level to address on a sufficiently predictable and independent basis the humanitarian needs of disaster-stricken people within the Union, such as food assistance, emergency healthcare, shelter, water, sanitation and hygiene, protection and education. Mutual assistance can be offered under the Union Civil Protection Mechanism pursuant to Decision No 1313/2013/EU of the European Parliament and of the Council (2), but the operation of that Mechanism is based on voluntary contributions from Member States. There could also be assistance and support provided through existing Union policy and financing instruments, such as those aimed at establishing an area of freedom, security and justice in the Union. Any such assistance and support would, however, be accessory and ancillary to the pursuit of the principal policy objectives of those instruments and, therefore, be limited in its scope and scale.

(6)

It therefore seems appropriate for the Union to act in a spirit of solidarity to address the basic needs of disaster-stricken people within the Union, and to contribute to reducing the economic impact of those disasters on the Member States concerned.

(7)

Given the similarities in addressing the basic needs of disaster-stricken people within the Union through the provision of emergency support and in providing humanitarian aid to people affected by man-made or natural disasters in third countries, all operations under this Regulation should be conducted in compliance with internationally-agreed humanitarian principles. Those actions constitute measures appropriate to the economic situation of the Member States facing those difficulties and complementing Union action encouraging cooperation between Member States in order to improve the effectiveness of systems for preventing and protecting against natural or man-made disasters.

(8)

Given the need to act in a spirit of solidarity, the provision of emergency support under this Regulation should be financed by the general budget of the Union, as well as by contributions which may be made by other public or private donors.

(9)

The reimbursement of expenses and award of public procurement contracts and grants under this Regulation should be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council (3), taking into account the specific nature of emergency support. It is therefore appropriate to provide that grants and public procurement contracts may be awarded directly or indirectly, and that grants may finance up to 100 % of the eligible costs and be awarded with retroactive effect. The Commission should be able to finance emergency support operations of any organisation which, independent of its legal nature, whether private or public, possesses the requisite experience and uses to that effect direct or indirect management, as appropriate.

(10)

Furthermore, it is appropriate to rely on organisations with which the Commission has concluded framework partnership agreements pursuant to Council Regulation (EC) No 1257/96 (4), in light of the relevance of the experience acquired by those organisations in providing humanitarian aid in close coordination with the Commission. Wherever possible the involvement of local non-governmental organisations should be sought, via partner organisations with framework partnership agreements, in order to maximise synergies and the efficiency of any emergency support provided under this Regulation.

(11)

The financial interests of the Union should be protected by means of proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, unduly paid or incorrectly used and, where appropriate, administrative and financial penalties in accordance with Regulation (EU, Euratom) No 966/2012.

(12)

This Regulation should lay down the basis for providing financial support in the event of natural or man-made disasters in respect of which, in a spirit of solidarity, the Union would be better placed than Member States, acting alone and in an uncoordinated manner, to mobilise appropriate levels of financing and use them to implement operations of a potentially life-saving nature in an economic, efficient and effective manner, thereby allowing a more effective action by reason of its scale and complementarity.

(13)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the scale or effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(14)

The provision of emergency support under this Regulation should be aptly monitored, relying, where need be, on the most relevant expertise available at Union level. Furthermore, the overall implementation of this Regulation should be evaluated.

(15)

Given the urgency of the support needed, this Regulation should enter into force immediately,

16.3.2016   

EN

Official Journal of the European Union

L 70/7

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For pinoxaden the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2005/459/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC, the United Kingdom received on 31 March 2004 an application from Syngenta Crop Protection AG for the inclusion of the active substance pinoxaden in Annex I to Directive 91/414/EEC. Decision 2005/459/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State, the United Kingdom, submitted a draft assessment report on 30 November 2005. In accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant on 6 June 2011. The evaluation of the additional data by the United Kingdom was submitted in the format of addenda to the draft assessment report on 30 January 2012.

(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion (5) on the peer review of the pesticide risk assessment of the active substance pinoxaden on 14 June 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 29 January 2016 in the format of the Commission review report for pinoxaden.

(5)

It has appeared from the various examinations made that plant protection products containing pinoxaden may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve pinoxaden.

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(7)

A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval.

(8)

Without prejudice to the obligations provided for in Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009, the following should, however, apply. Member States should be allowed a period of six months after approval to review authorisations of plant protection products containing pinoxaden. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

(9)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (6) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the Directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (7) should be amended accordingly.

(11)

It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing pinoxaden in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations.

(12)

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

(a)

in the case of a product containing pinoxaden as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2017 at the latest; or

(b)

in the case of a product containing pinoxaden as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2017 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.

16.3.2016   

EN

Official Journal of the European Union

L 70/12

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’, for a scientific assessment, as well as to the Commission and the Member States for information.

(3)

The Authority is to deliver an opinion on the health claim concerned.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

Following an application from InQpharm Europe Ltd, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to a standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight (Question No EFSA-Q-2013-00973 (2)). The claim proposed by the applicant was worded as follows: ‘Helps to reduce body weight’.

(6)

On 16 July 2014, the Commission and the Member States received the scientific opinion from the Authority, which concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of the standardised aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(7)

Following an application from Natural Alternative International, Inc. (NAI), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to beta-alanine and increase in physical performance during short-duration, high-intensity exercise (Question No EFSA-Q-2013-00974 (3)). The claim proposed by the applicant was worded as follows: ‘Beta-alanine increases performance during short-duration high intensity exercise’.

(8)

On 16 July 2014, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of beta-alanine and increase in physical performance during short-duration, high-intensity exercise. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(9)

Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to fat-free yogurts and fermented milks complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context of an energy-restricted diet (Question No EFSA-Q-2014-00126 (4)). The claim proposed by the applicant was worded as follows: ‘Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to reduce body and visceral fat in the context of an energy-restricted diet’.

(10)

On 7 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and reduction of body and visceral fat while maintaining lean body mass in the context of an energy-restricted diet. In that opinion, the Authority also noted that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(11)

Following an application from Federación Nacional de Industrias Lácteas (FeNIL), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet (Question No EFSA-Q-2014-00127 (5)). The claim proposed by the applicant was worded as follows: ‘Fat-free yogurts and fermented milks with live yogurt cultures, with added vitamin D, and with no added sugars, help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet’.

(12)

On 7 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of fat-free yogurts and fermented milks with live yogurt cultures complying with the specifications ‘fat free’, ‘low in sugars’, ‘high protein’, ‘source of calcium’ and ‘source of vitamin D’ for nutrition claims and maintenance of lean body mass in the context of an energy-restricted diet. In that opinion, the Authority also noted that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(13)

Following an application from Avesthagen Limited, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses (Question No EFSA-Q-2014-00153 (6)). The claim proposed by the applicant was worded as follows: ‘Teestar™ lowers blood glucose levels’.

(14)

On 8 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of Teestar™, a fenugreek seed extract standardised by its content of galactomannan, and a reduction of post-prandial glycaemic responses. In that opinion, the Authority also noted that in the absence of evidence for an effect of Teestar™ on post-prandial glycaemic responses in humans, animal studies on potential mechanisms do not provide support for the scientific substantiation of the claim. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(15)

The comments from the applicants received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

(16)

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

16.3.2016   

EN

Official Journal of the European Union

L 70/16

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.

(3)

Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

Following an application from Lycotec Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to L-tug lycopene and reduction of blood low-density lipoprotein (LDL)-cholesterol (Question No EFSA-Q-2014-00590 (2)). The claim proposed by the applicant was worded as follows: ‘L-tug lycopene has been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease’.

(6)

On 26 February 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented, a cause and effect relationship had not been established between the consumption of L-tug lycopene and reduction of blood LDL-cholesterol concentrations. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(7)

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

16.3.2016   

EN

Official Journal of the European Union

L 70/18

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

16.3.2016   

EN

Official Journal of the European Union

L 70/20

(1)

Pursuant to Article 50 of the Act of Accession of Croatia, where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the Council, acting by qualified majority on a proposal from the Commission, shall, to that end, adopt the necessary acts if the original act was not adopted by the Commission.

(2)

Decision No 529/2013/EU of the European Parliament and of the Council (1) sets Member State reference levels for forest management, minimum values for the definition of forest and the base year or period of emissions in Annexes II, V and VI, respectively.

(3)

Following the accession of the Republic of Croatia to the European Union on 1 July 2013, the specific reference level, values for the definition of forest and base year for Croatia should also be included in Annexes II, V and VI to Decision No 529/2013/EU, respectively.

(4)

Decision No 529/2013/EU should therefore be amended accordingly,

(1)

in Annex II, the following is inserted after the entry for Bulgaria:

(2)

in Annex V, the following is inserted for area (ha), tree crown cover (%) and tree height (m), respectively, after the entry for Bulgaria:

(3)

in Annex VI, the following is inserted after the entry for Bulgaria:

16.3.2016   

EN

Official Journal of the European Union

L 70/22

(1)

On 15 January 2014, the company Glycom A/S made a request to the competent authorities of Ireland to place lacto-N-neotetraose on the market as a novel food ingredient.

(2)

On 10 June 2014, the competent food assessment body of Ireland issued its initial assessment report. In that report, it came to the conclusion that lacto-N-neotetraose meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(3)

On 7 July 2014, the Commission forwarded the initial assessment report to the other Member States.

(4)

Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

(5)

On 13 October 2014, the Commission consulted the European Food Safety Authority (EFSA), asking it to carry out an assessment for lacto-N-neotetraose as a novel food ingredient in accordance with Regulation (EC) No 258/97.

(6)

On 29 June 2015, EFSA in its ‘Scientific Opinion on the safety of lacto-N-neotetraose as a novel food ingredient pursuant to Regulation (EC) No 258/97’ (2), concluded that lacto-N-neotetraose is safe for the proposed uses and use levels.

(7)

On 5 October 2015, the applicant sent a letter to the Commission and provided additional information to support the use and approval of 2′-O-fucosyllactose and lacto-N-neotetraose in food supplements for general population (excluding infants) under Regulation (EC) No 258/97.

(8)

On 14 October 2015, the Commission consulted EFSA asking it to carry out an assessment of the safety of these novel foods in food supplements also for children (excluding infants).

(9)

On 28 October 2015, EFSA in its ‘Statement on the safety of lacto-N-neotetraose and 2′-O-fucosyllactose as novel food ingredients in food supplements for children’ (3), concluded that lacto-N-neotetraose is safe for the proposed uses and use levels.

(10)

Commission Directive 96/8/EC (4) lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC (5) lays down requirements for dietary foods for special medical purposes. Directive 2002/46/EC of the European Parliament and of the Council (6) lays down requirements on food supplements. Commission Directive 2006/125/EC (7) lays down requirements for processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC (8) lays down requirements for infant formulae and follow-on formulae. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (9) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Commission Regulation (EC) No 41/2009 (10) lays down requirements for the composition and labelling of foodstuffs suitable for people intolerant to gluten. Commission Implementing Regulation (EU) No 828/2014 (11) lays down the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food. The use of lacto-N-neotetraose should be authorised without prejudice to the requirements of those legislations.

(11)

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

16.3.2016   

EN

Official Journal of the European Union

L 70/27

(1)

On 23 June 2014, the company Glycom A/S made a request to the competent authorities of Ireland to place 2′-O-fucosyllactose on the market as a novel food ingredient.

(2)

On 3 October 2014, the competent food assessment body of Ireland issued its initial assessment report. In that report, it came to the conclusion that 2′-O-fucosyllactose meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(3)

On 9 October 2014, the Commission forwarded the initial assessment report to the other Member States.

(4)

Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

(5)

On 22 December 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an assessment for 2′-O-fucosyllactose as a novel food ingredient in accordance with Regulation (EC) No 258/97.

(6)

On 29 June 2015, EFSA in its ‘Scientific Opinion on the safety of 2′-O-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97’ (2), concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.

(7)

On 5 October 2015, the applicant sent a letter to the Commission and provided additional information to support the use and approval of 2′-O-fucosyllactose and lacto-N-neotetraose in food supplements for general population (excluding infants) under Regulation (EC) No 258/97.

(8)

On 14 October 2015, the Commission consulted EFSA asking it to carry out an assessment of the safety of these novel foods in food supplements also for children (excluding infants).

(9)

On 28 October 2015, EFSA in its ‘Statement on the safety of lacto-N-neotetraose and 2′-O-fucosyllactose as novel food ingredients in food supplements for children’ (3), concluded that 2′-O-fucosyllactose is safe for the proposed uses and use levels.

(10)

Commission Directive 96/8/EC (4) lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC (5) lays down requirements for dietary foods for special medical purposes. Directive 2002/46/EC of the European Parliament and of the Council (6) lays down requirements on food supplements. Commission Directive 2006/125/EC (7) lays down requirements for processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC (8) lays down requirements for infant formulae and follow-on formulae. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (9) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Commission Regulation (EC) No 41/2009 (10) lays down requirements for the composition and labelling of foodstuffs suitable for people intolerant to gluten. Commission Implementing Regulation (EU) No 828/2014 (11) lays down the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food. The use of 2′-O-fucosyllactose should be authorised without prejudice to the requirements of those legislations

(11)

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

16.3.2016   

EN

Official Journal of the European Union

L 70/32

(1)

The procedure for recognition of central counterparties (‘CCPs’) established in third countries set out in Article 25 of Regulation (EU) No 648/2012 aims to allow CCPs established and authorised in third countries whose regulatory standards are equivalent to those laid down in that Regulation to provide clearing services to clearing members or trading venues established in the Union. That recognition procedure and the equivalence decision provided for therein thus contribute to the achievement of the overarching aim of Regulation (EU) No 648/2012 to reduce systemic risk by extending the use of safe and sound CCPs to clear over-the-counter (‘OTC’) derivative contracts, including where those CCPs are established and authorised in a third country.

(2)

In order for a third country legal regime to be considered equivalent to the legal regime of the Union in respect of CCPs, the substantive outcome of the applicable legal and supervisory arrangements should be equivalent to Union requirements in respect of the regulatory objectives they achieve. The purpose of this equivalence assessment is therefore to verify that the legal and supervisory arrangements of the United States of America (USA) ensure that CCPs established and authorised therein do not expose clearing members and trading venues established in the Union to a higher level of risk than the latter could be exposed to by CCPs authorised in the Union and, consequently, do not pose unacceptable levels of systemic risk in the Union.

(3)

On 1 September 2013, the Commission received the technical advice of the European Securities and Markets Authority (ESMA) on the legal and supervisory arrangements applicable to CCPs established in the USA. That technical advice identified a number of differences between the legally binding requirements applicable, at jurisdictional level, to CCPs in the USA and the legally binding requirements applicable to CCPs under Regulation (EU) No 648/2012. This Decision is not only based, however, on a comparative analysis of the legally binding requirements applicable to CCPs in the USA, but also on an assessment of the outcome of those requirements, and their adequacy to mitigate the risks that clearing members and trading venues established in the Union may be exposed to in a manner considered equivalent to the outcome of the requirements laid down in Regulation (EU) No 648/2012).

(4)

In accordance with Article 25(6) of Regulation (EU) No 648/2012, three conditions need to be fulfilled in order to determine that the legal and supervisory arrangements of a third country regarding CCPs authorised therein are equivalent to those laid down in that Regulation.

(5)

According to the first condition, CCPs authorised in a third country must comply with legally binding requirements which are equivalent to the requirements laid down in Title IV of Regulation (EU) No 648/2012.

(6)

The legally binding requirements of the USA for CCPs authorised (the term used in the CFTC framework is ‘registration’) and supervised by the Commodity Futures Trading Commission (CFTC) are contained in the Commodity Exchange Act (‘the CEA’), as amended by Titles VII and VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act (‘the Dodd-Frank Act’), and the CFTC's regulations promulgated thereunder. The CFTC is the competent authority for the supervision of all derivative contracts that are not based on a single security (a bond or share), loan or a narrow based group or index of securities, and is responsible for authorising and regulating CCPs which provide clearing services for those derivative contracts (‘derivative clearing organizations’ or ‘DCOs’). The derivative contracts falling under the competence of the CFTC therefore correspond to a subset of the derivative contracts covered by the provisions on CCPs set out in Regulation (EU) No 648/2012. This Decision relates solely to the equivalence of the legal and supervisory arrangements for DCOs and not to the legal and supervisory arrangements for CCPs which provide clearing services for derivative contracts falling under the competence of the Securities and Exchange Commission (‘SEC’). Where a CCP is authorised as both a clearing agency under the jurisdiction of the SEC and a DCO, this Decision relates to those CCPs only in so far as they provide clearing services for derivative contracts falling under the CFTC's jurisdiction.

(7)

The legally binding requirements applicable to CCPs authorised by the CFTC include high-level standards that are set out by the core principles for DCOs contained in section 5b(c)(2) of the CEA and Subparts A and B of Part 39 of the CFTC Regulations. To be authorised by the CFTC, all CCPs must comply with those core principles. The core principles are complemented by specific enhanced risk management standards applicable to DCOs which have been designated by the Financial Stability Oversight Council of the USA as systemically important and for which the CFTC has been designated as the supervisory agency (‘SIDCOs’). The enhanced risk management standards are set out in Subpart C of Part 39 of CFTC regulations (Regulations 39.30 to 39.42). The high-level standards and the specific enhanced risk management standards for SIDCOs (together, the ‘primary rules’) are applicable to SIDCOs and to DCOs which have not been designated as SIDCOs but have voluntarily opted to be legally bound by those specific risk management standards (‘opt-in DCOs’). Those primary rules comprise the first tier of the legally binding requirements applicable to DCOs.

(8)

Pursuant to the primary rules, DCOs must adopt internal rules and procedures which must be approved by the CFTC. In respect of certain standards set out under the primary rules, the DCO's internal rules and procedures must provide prescriptive detail on the way in which the DCO will meet those standards. Moreover, those internal rules and procedures contain requirements which complement the ones prescribed by the primary rules. Once approved by the CFTC, the internal rules and procedures become legally binding on the DCO and form an integral part of the legal and supervisory arrangements with which those DCOs must comply. In the case of non-compliance with the primary rules or the DCO's internal rules and procedures, the CFTC has the power to sanction those DCOs, including by imposing penalties and suspension or revocation of the authorisation.

(9)

The legally binding requirements in the USA with respect to derivative contracts cleared by DCOs therefore comprise a two-tiered structure. The primary rules for SIDCOs and opt-in DCOs comprise the first tier of the legally binding requirements. The internal rules and procedures of the SIDCOs and opt-in DCOs comprise the second tier of the legally binding requirements. When determining equivalence in accordance with Article 25(6) of Regulation (EU) No 648/2012, the nature and detail of the legal requirements contained within the internal rules and procedures of SIDCOs and opt-in DCOs must, therefore, be considered alongside the primary rules in order to ensure that the legally binding requirements effected through those combined components of the legal and supervisory arrangements can be considered equivalent to the requirements laid down in Title IV of Regulation (EU) No 648/2012.

(10)

The primary rules applicable to SIDCOs and opt-in DCOs complemented by their internal rules and procedures deliver substantive outcomes equivalent to the effects of the rules contained in Title IV of Regulation (EU) No 648/2012. The primary rules include requirements on governance (including organisational requirements, requirements relating to senior management, risk committees, record keeping, qualifying holdings, information transmitted to the competent authority), conflicts of interest, outsourcing, conduct of business, business continuity and segregation, as well as liquidity risk, collateral requirements, investment policy, and settlement risk.

(11)

Although the primary rules with respect to liquidity risks do not require SIDCOs and opt-in DCOs to maintain eligible liquidity resources to meet the ‘cover 2 principle’, that is, liquid resources to cover the default of at least the two clearing members to which it has the largest exposures, those DCOs are nevertheless required to set-up procedures to cover any uncovered liquidity shortfall, ensuring that committed resources are available where losses exceed the default of the clearing member to which it has the largest exposure. Although this is a different approach than the ‘cover 2 principle’ contained in Title IV of Regulation (EU) No 648/2012, it delivers substantive outcomes equivalent to the effects of the rules contained in Title IV of Regulation (EU) No 648/2012.

(12)

The primary rules with respect to participation, exposure management, margin requirements, default funds, other financial resources, default waterfall and default procedures, follow a similar approach to the rules contained in Title IV of Regulation (EU) No 648/2012 but differ in some aspects. With respect to the initial margin applied to clearing member's proprietary positions the primary rules provide for a minimum liquidation period of one day for non-OTC derivative contracts including futures, options, swaps on agricultural energy commodities and metals and five days for all other derivatives, with margin collected on a net basis. Union rules, however, set out minimum liquidation periods of two days for non-OTC derivative contracts and five days for OTC derivative contracts, typically with margin collected on a net basis. With respect to clearing members' proprietary positions therefore, the higher liquidation period of two days for non-OTC derivative contracts in the Union results in CCPs authorised in the Union collecting more margin in respect of those positions. Conversely, in the case of initial margins collected with respect to the positions of clients of clearing members, the primary rules require margin to be collected on a gross basis for all classes of derivative contracts, whereas Union law has no such requirement. This difference between net and gross margin collection results in equivalent outcomes with respect to the amount of margin that DCOs hold with respect to the positions of clients, which compensates for the difference in the liquidation period. Therefore the primary rules on margin requirements can be considered equivalent to Union law in so far as they relate to the positions of clients of clearing members. Further, Union law requires the application of one of three anti-procyclicality measures to ensure that initial margins do not fall too low in stable economic times and do not increase precipitously in times of stress, whereas the primary rules contain no such specific requirement. In doing so, such measures deliver stable and conservative margins. Additionally, the primary rules require SIDCOs and opt-in DCOs to apply the ‘cover 2 principle’ where those DCOs have been designated as being systemically important in multiple jurisdictions or where they are involved in activities with a more complex risk profile. Union rules, in contrast, require the ‘cover 2 principle’ for all CCPs.

(13)

The legal and supervisory arrangements of the USA applicable to DCOs should therefore be deemed equivalent provided that, according to the internal rules and procedures of DCOs that are authorised as SIDCOs and opt-in DCOs, they ensure that DCOs comply with the following requirements. Those requirements are: (1) for non-OTC derivative contracts executed on regulated markets, a liquidation period of two days with respect to the initial margin applied to clearing members' proprietary positions; (2) for all derivative contracts, measures to limit procyclicality which deliver stable and conservative margins, and are equivalent to at least one of the options as laid down in Title IV of Regulation (EU) No 648/2012; and (3) a sufficient pre-funded available financial resources enabling the DCO to withstand the default of at least the two clearing members to which it has the largest exposures under extreme but plausible market conditions taking account of additional risks to which those DCOs are exposed arising from the simultaneous failure of entities in the group of defaulting clearing members.

(14)

The Commission notes that specific features concerning certain listed agricultural derivative contracts executed on regulated markets in the USA and cleared by DCOs relate to markets that largely serve domestic non-financial counterparties in the USA who manage their commercial risks through those contracts and who have a low degree of systemic interconnectedness with the rest of the financial system. The risk arising from clearing those contracts is negligible with respect to clearing members and trading venues established in the Union. As a result, the assessment of equivalence is not substantially affected by the regulatory features applicable to those agricultural derivative contracts.

(15)

It should therefore be concluded that the legal and supervisory arrangements of the CFTC comprising the primary rules and the internal rules and procedures of SIDCOs and the opt-in DCOs which meet the standards set out in this Decision with respect to risk management should be considered legally binding requirements which are equivalent to the requirements laid down in Title IV of Regulation (EU) No 648/2012. Only SIDCOs and opt-in DCOs complying with those legally binding requirements (i.e. the primary rules as complemented by the internal rules and procedures approved by the CFTC and meeting the standards set out in this act) may be eligible for recognition by ESMA, which should verify, in accordance with Article 25(2)(b) of Regulation (EU) No 648/2012, that those standards are part of the internal rules and procedures of any CCP subject to that regime and applying for recognition in the Union. Likewise ESMA monitors in accordance with Article 25(5) of Regulation (EU) No 648/2012 that the equivalent regime as defined in this Decision, including the conditions contained herein, continues to be met and may withdraw the recognition where this is not the case. In particular, ESMA will check that the CCP applies a two-day liquidation period with respect to clearing members' proprietary positions in non-OTC derivative contracts and that the CCP applies measures designed to limit procyclicality that are equivalent in delivering stable and conservative margins to any of the three measures set out under Regulation (EU) No 648/2012, and that the CCP maintains sufficient pre-funded available financial resources enabling it to withstand the default of at least the two clearing members to which it has the largest exposures under extreme but plausible market conditions taking account of additional risks to which those CCPs are exposed arising from the simultaneous failure of entities in the group of the defaulting clearing members.

(16)

According to the second condition under Article 25(6) of Regulation (EU) No 648/2012, the legal and supervisory arrangements in respect of CCPs established in the USA must further provide for effective supervision and enforcement of CCPs in that jurisdiction on an ongoing basis.

(17)

The CFTC conducts ongoing monitoring of DCOs' compliance with risk management requirements through surveillance and risk-based examination procedures including the testing of prudential requirements. The CFTC conducts examinations with examination teams. Upon completion of the examination, the CFTC drafts a report summarising the results of the examination, including any issues of concern. The report outlines any deficiencies perceived, and various measures are available to the CFTC to ensure that DCOs appropriately address any identified issues, including by imposing penalties and suspension or revocation of the authorisation where the deficiencies are not addressed. This report, or information contained in the report, as well as any measure adopted therefrom may be shared with third country regulators under cooperation arrangements.

(18)

It should therefore be concluded that the legal and supervisory arrangements in respect of DCOs provide for effective supervision and enforcement on an ongoing basis.

(19)

According to the third condition under Article 25(6) of Regulation (EU) No 648/2012, the legal and supervisory arrangements of the USA must include an effective equivalent system for the recognition of CCPs authorised under third country legal regimes (‘third country CCPs’).

(20)

Third country CCPs may apply to the CFTC for DCO authorisation. Pursuant to its statutory authority under 7 U.S.C. § 2(i), the CFTC may provide for substituted compliance in respect of third country CCPs to the extent that it has determined comparability between its requirements for DCOs and the requirements of the third country's regulatory regime. Where substituted compliance is provided, a third country CCP authorised as a DCO may meet the CFTC's requirements by complying with the comparable requirements in its own (third country) jurisdiction. The conclusion of a memorandum of understanding between the CFTC and the competent third-country supervisory authority of the applicant CCP is also required for recognition to be granted.

(21)

It should therefore be concluded that the legal and supervisory arrangements of the CFTC provide for an effective equivalent system for the recognition of third country CCPs.

(22)

This Decision is based on the legally binding requirements relating to SIDCOs and opt-in DCOs applicable in the USA at the time of the adoption of this Decision. The Commission, in cooperation with ESMA, should continue monitoring on a regular basis the evolution of the legal and supervisory arrangements for SIDCOs and opt-in DCOs and the fulfilment of the conditions on the basis of which this Decision has been taken.

(23)

The regular review of the legal and supervisory arrangements applicable to SIDCOs and opt-in DCOs in the USA is without prejudice to the possibility of the Commission to undertake a specific review at any time, where relevant developments and, in particular, the verifications undertaken by ESMA or the information available to it as a result of the supervisory cooperation with CFTC in accordance with the procedures and mechanisms referred to Article 25(7) of Regulation (EU) No 648/2012, make it necessary for the Commission to re-assess the equivalence granted by this Decision. Such re-assessment could lead to the repeal of this Decision.

(24)

The measures provided for in this Decision are in accordance with the opinion of the European Securities Committee,

(a)

in the case of clearing members' proprietary positions in derivative contracts executed on regulated markets or designated contract markets pursuant to Section 5 of the Commodity Exchange Act (CEA), 7 USC 7, a liquidation period of two days calculated on a net basis;

(b)

in the case of all derivative contracts, measures designed to limit procyclicality equivalent to at least one of the following:

(a)

they are based on an underlying agricultural product referencing grades, prices, weights, measures or conversion factors for agricultural commodities and their products as published by the United States Department Of Agriculture and traded on a US-designated contract market pursuant to Section 5 of the Commodity Exchange Act (CEA), 7 USC 7, or are based on an underlying agricultural product of sugar, soybean oil, soybean meal, cocoa, coffee, or lumber and traded on a US-designated contract market pursuant to Section 5 of the Commodity Exchange Act (CEA), 7 USC 7;

(b)

they are based on an underlying agricultural product that forms the basis of an agricultural commodity derivative contract offered for clearing by a derivatives clearing organization established in the USA;

(c)

where they specify one or more places of production of the underlying agricultural product, none of those places of production is inside the Union;

(d)

they meet any of the following conditions: