Official Journal L 23/2021

25.1.2021

Official Journal of the European Union

L 23/1

COUNCIL REGULATION (EU) 2021/48

of 22 January 2021

amending Regulation (EC) No 147/2003 concerning restrictive measures in respect of Somalia

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 215 thereof,

Having regard to the Council Decision 2010/231/CFSP of 26 April 2010 concerning restrictive measures against Somalia and repealing Common Position 2009/138/CFSP (1),

Having regard to the joint proposal of the High Representative of the Union for Foreign Affairs and Security Policy and of the European Commission,

Whereas:

(1)

Council Regulation (EC) No 147/2003 (2) concerning certain restrictive measures in respect of Somalia restricts the provision of financing, financial assistance and technical assistance related to military activities in relation to goods and technology included in the Common Military List of the European Union (3) to any person, entity or body in Somalia. It also restricts the supply to Somalia of goods that can contribute to the manufacture of improvised explosive devices (‘IEDs’).

(2)

On 12 November 2020, the United Nations Security Council (UNSC) adopted Resolution 2551 (2020). The Resolution, inter alia, amends the exemptions to the arms embargo regarding certain arms supplies and the related financing, financial assistance and technical assistance intended for Somali security forces and expands the list of controlled goods that can contribute to the manufacture of IEDs.

(3)	On 22 January 2021, Council Decision (CFSP) 2021/48 (4) was adopted, amending Decision 2010/231/CFSP in accordance with UNSC Resolution 2551 (2020).

(4)	A certain number of these amendments fall within the scope of the Treaty, and therefore regulatory action at the level of the Union is necessary in order to implement them, in particular with a view to ensuring their uniform application in all Member States.

(5)	Regulation (EC) No 147/2003 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 147/2003 is amended as follows:

(1)

Article 1 is replaced by the following:

‘Article 1

1. It shall be prohibited:

(a)	to provide financing or financial assistance related to military activities, for any sale, supply, transfer or export of goods and technology included in the Common Military List of the European Union (*), directly or indirectly to any person, entity or body in Somalia;

(b)	to provide technical assistance related to military activities in relation to goods and technology included in the Common Military List of the European Union, directly or indirectly, to any person, entity or body in Somalia.

(*) OJ C 98, 15.3.2018, p. 1.’;"

(2)

the following Article is inserted:

‘Article 1a

For the purposes of this Regulation, the following definitions apply:

(a)

“technical assistance” means any technical support related to repairs, development, manufacture, assembly, testing, maintenance, or any other technical service, and may take forms such as instruction, advice, training, transmission of working knowledge or skills or consulting services; including verbal forms of assistance;

(b)

“financing or financial assistance” means any action, irrespective of the particular means chosen, whereby the person, entity or body concerned, conditionally or unconditionally, disburses or commits to disburse its own funds or economic resources, including but not limited to grants, loans, guarantees, suretyships, bonds, letters of credit, supplier credits, buyer credits, import or export advances and all types of insurance and reinsurance, including export credit insurance. Payment as well as terms and conditions of payment of the agreed price for a good or a service, made in line with normal business practice, do not constitute financing or financial assistance;

(c)	“Sanctions Committee” means the Committee of the UN Security Council which was established pursuant to paragraph 11 of UNSCR 751 (1992);

(d)	“territory of the Union” means the territories of the Member States to which the Treaty on the Functioning of the European Union is applicable, under the conditions laid down in that Treaty, including their airspace.’;

(3)

Article 2a is replaced by the following:

‘Article 2a

By way of derogation from Article 1, the competent authority in the Member State where the service provider is established, as indicated on the websites set out in Annex I, may authorise:

(a)

the provision of financing or financial assistance or technical assistance related to military activities in relation to goods and technology included in the Common Military List of the European Union, if the competent authority concerned has determined that such financing or financial assistance, or technical assistance is intended solely for the development of the Somali National Security Forces to provide security for the Somali people;

(b)

(i)	the competent authority concerned has determined that such financing, financial assistance or technical assistance is intended solely for the development of the Somali security sector institutions other than those of the Federal Government of Somalia, to provide security for the Somali people;

(ii)	the Sanctions Committee has not taken a negative decision within five working days of receiving a notification from the Member State providing such financing, financial assistance or technical assistance, of any provision of such financing, financial assistance or technical assistance;

(iii)

the Federal Government of Somalia has been informed in parallel at least five working days in advance in accordance with UNSCR 2551 (2020).’;

(4)

in Article 3, paragraph 1 is replaced by the following:

‘1.

Article 1 shall not apply to:

(a)	the provision of financing or financial assistance for the sale, supply, transfer or export of non-lethal military equipment intended solely for humanitarian or protective use;

(b)	the provision of technical assistance related to such non-lethal equipment, provided that such activities have been notified in advance and for its information only to the Sanctions Committee by the supplying Member State, international, regional or subregional organisation;

(c)

the provision of financing or financial assistance or technical assistance related to military activities in relation to goods and technology included in the Common Military List of the European Union, intended solely for the support of or use by United Nations personnel, including the United Nations Assistance Mission in Somalia (UNSOM), the African Union Mission in Somalia (AMISOM); AMISOM’s strategic partners, operating solely under the latest African Union Strategic Concept of Operations, and in cooperation and coordination with AMISOM; and the European Union Training Mission (EUTM) in Somalia; or

(d)

the provision of financing or financial assistance or technical assistance for the sale, supply, transfer or export of goods and technology included in the Common Military List of the European Union destined for the sole use of States or international, regional and subregional organisations undertaking measures to suppress acts of piracy and armed robbery at sea off the coast of Somalia, upon the request of the Federal Government of Somalia and for which the Federal Government of Somalia has notified the UN Secretary-General, and provided that any measures undertaken shall be consistent with applicable international humanitarian and international human rights law.’;

(5)	Annex III is amended as set out in Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2021.

For the Council

The President

A. P. ZACARIAS

(1) OJ L 105, 27.4.2010, p. 17.

(2) Council Regulation (EC) No 147/2003 of 27 January 2003 concerning certain restrictive measures in respect of Somalia (OJ L 24, 29.1.2003, p. 2).

(3) OJ C 98, 15.3.2018, p. 1.

(4) See page 1 of this Official Journal.

ANNEX

In Annex III, paragraph 3 is replaced by the following:

‘3.

Explosive materials, as follows, and mixtures containing one or more thereof:

Name of the substance	Chemical Abstracts Service Registry number (CAS RN)	Combined Nomenclature (CN) code (1)
Ammonium Nitrate Fuel Oil (ANFO)	6484-52-2 (ammonium nitrate)	3102 30 90 3102 40
Nitrocellulose (containing more than 12,5 % nitrogen w/w)	9004-70-0	ex 3912 20
Nitroglycerin (except when packaged/prepared in individual medicinal doses) unless compounded or mixed with the “energetic material” specified by ML8.a. or powdered metals specified by ML8.c. of the EU Common Military List	55-63-0	ex 2920 90 70
Nitroglycol	628-96-6	ex 2920 90 70
Pentaerythritol tetranitrate (PETN)	78-11-5	ex 2920 90 70
Picryl chloride	88-88-0	ex 2904 99 00
2,4,6-Trinitrotoluene (TNT)	118-96-7	2904 20 00

(1) The nomenclature codes are taken from the Combined Nomenclature as defined in Article 1(2) of Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1) and as set out in Annex I thereto, which are valid at the time of publication of this Regulation and mutatis mutandis as amended by subsequent legislation.’

25.1.2021

Official Journal of the European Union

L 23/5

COUNCIL IMPLEMENTING REGULATION (EU) 2021/49

of 22 January 2021

implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EU) No 101/2011 of 4 February 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia (1), and in particular Article 12 thereof,

Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)	On 4 February 2011, the Council adopted Regulation (EU) No 101/2011.

(2)	On the basis of a review, the entries in Annex I to Regulation (EU) No 101/2011, for four persons should be deleted, and the information regarding the rights of defence and the right to effective judicial protection should be updated for two persons.

(3)	Annex I to Regulation (EU) No 101/2011 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 101/2011 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2021.

For the Council

The President

A. P. ZACARIAS

(1) OJ L 31, 5.2.2011, p. 1.

ANNEX

In Regulation (EU) No 101/2011, Annex I is amended as follows:

(1)

in Part A (List of persons and entities referred to in Article 2), the entries for the following persons are deleted:

22.	Bouthaina Bent Moncef Ben Mohamed TRABELSI

23.	Nabil Ben Abderrazek Ben Mohamed TRABELSI

41.	Akrem Ben Hamed Ben Taher BOUAOUINA

47.	Slim Ben Tijani Ben Haj Hamda BEN ALI;

(2)

Part B (Rights of defence and right to effective judicial protection under Tunisian law) is amended as follows:

(a)

the entries for the following persons are deleted:

22.	Bouthaina Bent Moncef Ben Mohamed TRABELSI

23.	Nabil Ben Abderrazek Ben Mohamed TRABELSI

41.	Akrem Ben Hamed Ben Taher BOUAOUINA

47.	Slim Ben Tijani Ben Haj Hamda BEN ALI;

(b)

the entries concerning the following persons are replaced by the following entries:

‘14.

Samira Bent Mohamed Ben Rhouma TRABELSI

The investigation or trial relating to the misappropriation of public funds or assets is still ongoing. The information on the Council’s file shows that the rights of defence and the right to effective judicial protection were respected in the judicial proceedings on which the Council relied. This is demonstrated in particular by the fact that, on 11 August 2011, Ms Samira Bent Mohamed Ben Rhouma TRABELSI was heard by an investigating judge in the presence of her lawyer.

45.

Montassar Ben Habib Ben Bouali LTAIEF

The investigation or trial relating to the misappropriation of public funds or assets is still ongoing. The information on the Council’s file shows that the rights of defence and the right to effective judicial protection were respected in the judicial proceedings on which the Council relied. This is demonstrated in particular by the fact that in 2011 and 2013 Mr Montassar Ben Habib Ben Bouali LTAIEF was heard by an investigating judge in the presence of his lawyers.’.

25.1.2021

Official Journal of the European Union

L 23/7

COMMISSION IMPLEMENTING REGULATION (EU) 2021/50

of 22 January 2021

authorising an extension of use and a change in the specifications of the novel food ‘2′-fucosyllactose/difucosyllactose mixture’ and amending Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

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

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

(3)	Commission Implementing Regulation (EU) 2019/1979 (3) authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of microbial source 2′-fucosyllactose/difucosyllactose mixture (‘2′-FL/DFL’) as a novel food. Therefore, 2′-FL/DFL was included in the Union list of novel foods.

(4)

On 17 March 2020, the company Glycom A/S (‘the applicant’) submitted an application to the Commission to extend the use and to change the specifications of 2′-FL/DFL in accordance with Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to extend the use of 2′-FL/DFL in milk-based drinks and similar products intended for young children at levels of 1,2 g/L in the ﬁnal product ready for use, marketed as such or reconstituted as instructed by the manufacturer in the authorised uses. In addition, the applicant requested to provide for a more generic description of the production process for the novel food, in particular to remove ‘spray drying’ from the description of the final drying step in the production process as other techniques, for example, freeze drying, are also used; to remove the term ‘amorphous’ from the description of the novel food in its final form as the novel food is a powder or agglomerates depending on the drying method used; and, to include 3-fucosyllactose, one of the minor components of the novel food in the sum of the oligosaccharides comprising the novel food rather than in the sum of the other minor carbohydrates where it is currently listed.

(5)

The requested changes in the conditions of use concerning the extension of use of the novel food in milk-based drinks and similar products intended for young children, and in the specifications concerning the drying method and the appearance of the novel food were part of the original application for the authorisation of 2′-FL/DFL as a novel food in accordance with Regulation (EU) 2015/2283 that was assessed favourably by the European Food Safety Authority (‘the Authority’) in its scientific opinion ‘Safety of 2′-fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283’ (4). Therefore the Commission considers that another opinion of the Authority is not necessary.

(6)

The request to include 3-fucosyllactose in the sum of the oligosaccharides comprising the novel food rather than in the sum of the other minor carbohydrates where it is currently listed, was not included in the original application that was assessed favourably by the Authority. That application made reference to the potential of DFL to be hydrolysed to produce 3-fucosyllactose, which was detected at low levels. The Commission considers that the requested change in the way that 3-fucosyllactose is included in the specifications of 2′-FL/DFL in light of the fact that it is present in the novel food at low levels and below the levels naturally found in human milk, is not liable to change the effects of this authorised novel food on human health. Therefore, the Commission considers that another opinion of the Authority is not necessary.

(7)

It is therefore appropriate to amend the Union list on the conditions of use and on the specifications of 2′-FL/DFL to authorise its use in milk-based drinks and similar products intended for young children at levels of 1,2 g/L in the ﬁnal product ready for use, marketed as such or reconstituted as instructed by the manufacturer, in the authorised uses, to provide for a generic description of the production process for the novel food and to remove ‘spray drying’ from the description of the final drying step in the production process, to remove the term ‘amorphous’ from the description of the novel food, and to include 3-fucosyllactose in the sum of the main oligosaccharides comprising the novel food.

(8)	The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

1. The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 referring to microbial source ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’)’ shall be amended as specified in the Annex to this Regulation.

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

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

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

(3) Commission implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 308, 29.11.2019, p. 62).

(4) EFSA Journal 2019;17(6):5717.

ANNEX

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

(1)

in Table 1 (Authorised novel foods), the conditions under which the novel food ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source)’ may be used are added:

Conditions under which the novel food may be used
‘Specified food category	Maximum levels
Milk-based drinks and similar products intended for young children	1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer’

(2)

in Table 2 (Specifications), the entry for 2′- Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source) is replaced by the following:

Authorised Novel Food

Specification

‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’)

(microbial source)

Description/Definition:

2′-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white powder or agglomerates thereof that is produced by a microbial process.

Source: Genetically modified Escherichia coli strain K-12 DH1

Characteristics/Composition:

Appearance: White to off white powder or agglomerates

Sum of 2′-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose, and 3-Fucosyllactose (% of dry matter): ≥ 92,0 % (w/w)

Sum of 2′-Fucosyllactose and Difucosyllactose (% of dry matter): ≥ 85,0 % (w/w)

2′-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w)

Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w)

D-Lactose: ≤ 10,0 % (w/w)

L-Fucose: ≤ 1,0 % (w/w)

2′-Fucosyl-D-lactulose: ≤ 2,0 (w/w)

Sum of other carbohydrates (*1): ≤ 6,0 % (w/w)

Moisture: ≤ 6,0 % (w/w)

Ash, sulfated: ≤ 0,8 % (w/w)

pH (20 °C, 5 % solution): 4,0 -6,0

Residual protein: ≤ 0,01 % (w/w)

Microbiological criteria:

Aerobic mesophilic total plate count: ≤ 1000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella sp.: Negative/25 g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Residual endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units

(*1) 2′-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.’

25.1.2021

Official Journal of the European Union

L 23/10

COMMISSION IMPLEMENTING REGULATION (EU) 2021/51

of 22 January 2021

authorising a change of the conditions of use of the novel food ‘ trans-resveratrol’ under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

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

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

(3)

Commission Implementing Decision (EU) 2016/1190 (3) authorised the placing on the Union market of trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (4), to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5), in capsule or tablet form, for the adult population.

(4)

On 31 January 2020, the company DSM Nutritional Products Europe (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to change the conditions of use of the novel food ‘trans-resveratrol’. The applicant requested the modification of the delivery formats for food supplements containing the novel food trans-resveratrol, in particular removing the specific delivery formats, capsule or tablet form, as the only allowed forms of the food supplements as listed in the Union list.

(5)	The applicant considers that the modification of the delivery formats for food supplements containing trans-resveratrol is necessary, as it would allow trans-resveratrol to be used in other food supplement forms than capsules or tablets.

(6)

There are a number of novel foods currently authorised in food supplements and listed in the Union list of novel foods for which the delivery formats have not been specified. Therefore, the modification of the delivery formats for food supplements containing trans-resveratrol would ensure consistency regarding the conditions of use of food supplements, as well as provide more options to food business operators to follow consumer preferences.

(7)

The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) as the change of the conditions of use of the novel food trans-resveratrol by removing the specific delivery formats of food supplements is not liable to have an effect on human health. Therefore, it is appropriate to change the conditions of use of the novel food trans-resveratrol to authorise its use in any form of food supplements at the previously authorised maximum level.

(8)

The maximum level of trans-resveratrol in food supplements authorised by Implementing Decision (EU) 2016/1190 and indicated in the Union list of novel foods remains the same. The safety considerations that supported the authorisation of trans-resveratrol in food supplements remain valid and the removal of the specific delivery formats of food supplements does not pose safety concern.

(9)	The Annex to Implementing Regulation (EU) 2017/2470 should therefore be 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,

HAS ADOPTED THIS REGULATION:

Article 1

1. The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the ‘trans-resveratrol’, shall be amended as specified in the Annex to this Regulation.

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

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

(3) Commission Implementing Decision (EU) 2016/1190 of 19 July 2016 authorising the placing on the market of trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 196, 21.7.2016, p. 53).

(4) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

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

ANNEX

In the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Trans-resveratrol’ in Table 1 (Authorised novel foods) is replaced by the following:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘Trans-resveratrol

Specified food category

Maximum levels

1.	The designation of the novel food on the labelling of the food supplements containing it shall be “Trans-resveratrol”.

2.	The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.’

Food supplements as defined in Directive 2002/46/EC for the adult population

150 mg/day

25.1.2021

Official Journal of the European Union

L 23/13

COMMISSION IMPLEMENTING REGULATION (EU) 2021/52

of 22 January 2021

amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,

Whereas:

(1)	Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

(2)

Commission Implementing Regulation (EU) 2019/2094 (3) extended the approval period of the active substances dimoxystrobin, mecoprop-P, metiram, oxamyl and pyraclostrobin until 31 January 2021, and the approval period of the active substances benfluralin, fluazinam, flutolanil and mepiquat until 28 February 2021.

(3)	Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

(4)	Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

(5)

Furthermore, an extension of the approval period is required for the active substances flutolanil, mepiquat and pyraclostrobin to allow the time necessary to carry out an assessment relating to endocrine disrupting properties of those active substances in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

(6)

As regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

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

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

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

(3) Commission implementing Regulation (EU) 2019/2094 of 29 November 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mancozeb, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (OJ L 317, 9.12.2019, p. 102).

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

ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)	in the sixth column, expiration of approval, of row 57, Mecoprop-P, the date is replaced by ‘31 January 2022’;

(2)	in the sixth column, expiration of approval, of row 81, Pyraclostrobin, the date is replaced by ‘31 January 2022’;

(3)	in the sixth column, expiration of approval, of row 115, Metiram, the date is replaced by ‘31 January 2022’;

(4)	in the sixth column, expiration of approval, of row 116, Oxamyl, the date is replaced by ‘31 January 2022’;

(5)	in the sixth column, expiration of approval, of row 128, Dimoxystrobin, the date is replaced by ‘31 January 2022’;

(6)	in the sixth column, expiration of approval, of row 187, Flutolanil, the date is replaced by ‘28 February 2022’;

(7)	in the sixth column, expiration of approval, of row 188, Benfluralin, the date is replaced by ‘28 February 2022’;

(8)	in the sixth column, expiration of approval, of row 189, Fluazinam, the date is replaced by ‘28 February 2022’;

(9)	in the sixth column, expiration of approval, of row 191, Mepiquat, the date is replaced by ‘28 February 2022’.

25.1.2021

Official Journal of the European Union

L 23/16

COMMISSION IMPLEMENTING REGULATION (EU) 2021/53

of 22 January 2021

amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,

Whereas:

(1)	Annex IV to Regulation (EC) No 1210/2003 lists natural and legal persons, bodies or entities associated with the regime of former President Saddam Hussein covered by the freezing of funds and economic resources and by a prohibition to make funds or economic resources available.

(2)	On 18 January 2021, the Sanctions Committee of the United Nations Security Council decided to remove two persons from the list of persons and entities to whom the freezing of funds and economic resources should apply.

(3)	Annex IV to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex IV to Regulation (EC) No 1210/2003 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 January 2021.

For the Commission,

On behalf of The President,

Director-General

Directorate-General for Financial Stability, Financial Services and Capital Markets Union

(1) OJ L 169, 8.7.2003, p. 6.

ANNEX

In Annex IV to Regulation (EC) No 1210/2003, the following entries are deleted:

‘31.	NAME: Zuhair Talib Abd-al-Sattar Al-Naqib. DATE OF BIRTH/PLACE OF BIRTH: Circa 1948. NATIONALITY: Iraq. UNSC RESOLUTION 1483 BASIS: Director, Military Intelligence.’

‘33.	NAME: Amir Rashid Muhammad Al-Ubaidi. DATE OF BIRTH/PLACE OF BIRTH: 1939, Baghdad. NATIONALITY: Iraq. UNSC RESOLUTION 1483 BASIS: Minister of Oil, 1996 to 2003; Head, Organisation of Military Industrialisation, early 1990s.’

25.1.2021

Official Journal of the European Union

L 23/18

COUNCIL DECISION (CFSP) 2021/54

of 22 January 2021

amending Decision 2010/231/CFSP concerning restrictive measures against Somalia

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)	On 26 April 2010, the Council adopted Decision 2010/231/CFSP (1).

(2)

On 12 November 2020, the United Nations Security Council adopted Resolution (UNSCR) 2551 (2020). That Resolution reaffirms a general and complete arms embargo on Somalia and amends the notifications concerning the supply of technical advice, financial and other assistance, and training related to military activities. That Resolution also reaffirms the prohibition on the import of charcoal from Somalia, and confirms the restrictions on the sale, supply and transfer of improvised explosive device components to Somalia.

(3)	Decision 2010/231/CFSP should therefore be amended accordingly.

(4)	Further action by the Union is necessary to implement certain measures in this Decision,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2010/231/CFSP is amended as follows:

(1)

Article 1 is amended as follows:

(a)

in paragraph 3, point (f) is replaced by the following:

‘(f)

the supply, sale or transfer of arms and related material of all types and the supply of technical advice, financial and other assistance and training related to military activities, intended solely for the development of the Somali National Security Forces, or Somali security sector institutions other than those of the Federal Government of Somalia, to provide security for the Somali people. The delivery of the items set out in Annexes II and III, and the provision of technical advice, financial and other assistance, and training related to military activities shall be subject to the relevant approval or notification requirements as follows:

(i)

the supply, sale or transfer of arms and related material of all types set out in Annex II intended solely for the development of the Somali National Security Forces, or Somali security sector institutions other than those of the Federal Government of Somalia, to provide security for the Somali people, shall be subject to approval in advance by the Sanctions Committee on a case-by-case basis, as set out in paragraphs 4a and 4b;

(ii)

the supply, sale or transfer of arms and related material of all types set out in Annex III intended solely for the development of the Somali National Security Forces to provide security for the Somali people, shall be subject to prior notification to the Sanctions Committee as set out in paragraphs 4 and 4b;

(iii)

the supply, sale or transfer of arms and related material of all types set out in Annex III and the supply of technical advice, financial and other assistance and training related to military activities by Member States or international, regional and subregional organisations intended solely for the development of the Somali security sector institutions other than those of the Federal Government of Somalia, to provide security to the Somali people, shall be subject to prior notification to the Sanctions Committee as set out in paragraph 4b, and may be provided in the absence of a negative decision by the Sanctions Committee within five working days of receiving such notification;’;

(b)

paragraph 4 is replaced by the following:

‘4.

The Federal Government of Somalia has the primary responsibility to notify the Sanctions Committee at least five working days in advance of any delivery of arms and related material of all types set out in Annex III to the Somali National Security Forces, as set out under point (f)(ii) of paragraph 3 of this Article. Alternatively, Member States delivering arms and related material to the Somali National Security Forces may notify the Sanctions Committee at least five working days in advance, informing the appropriate national coordinating body within the Federal Government of Somalia of the notification and providing the Federal Government of Somalia with technical support with notification procedures where appropriate, in accordance with paragraphs 13 and 14 of UNSCR 2498 (2019). Notifications shall include details of the manufacturer and supplier of arms and related material of all types, a description of the arms and ammunition including the type, calibre and quantity, the proposed date and place of delivery, and all relevant information concerning the intended destination unit in the Somali National Security Forces, or the intended place of storage.’;

(2)	Annex IV is replaced by Annex I to this Decision;

(3)	Annex V is replaced by Annex II to this Decision.

Article 2

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 22 January 2021.

For the Council

The President

A. P. ZACARIAS

(1) Council Decision 2010/231/CFSP of 26 April 2010 concerning restrictive measures against Somalia and repealing Common Position 2009/138/CFSP (OJ L 105, 27.4.2010, p. 17).

ANNEX I

‘ANNEX IV

LIST OF ITEMS REFERRED TO IN ARTICLE 1C(1)

Tetryl (trinitrophenylmethylnitramine).

Nitroglycerin compounded or mixed with the “energetic material” specified by ML8.a. or powdered metals specified by ML8.c. of the Common Military List of the European Union (1) (except when packaged/prepared in individual medicinal doses).

Equipment that is both specially designed for military use and specially designed for activating, powering with one-time operational output, discharging or detonating Improvised Explosive Devices (IEDs).

“Technology”“required” for the “production” or “use” of the items listed at paragraphs 1 and 2. (The definitions of the terms “technology”, “required”, “production”, and “use” are from the Common Military List of the European Union.)

’

(1) OJ C 98, 15.3.2018, p. 1.

ANNEX II

‘ANNEX V

LIST OF ITEMS REFERRED TO IN ARTICLE 1C(2)

Equipment and devices, not specified by item 2 in Annex IV, that are specially designed to initiate explosives by electrical or non-electrical means (e.g. firing sets, detonators, igniters, detonating chord).

“Technology”“required” for the “production” or “use” of the items listed in paragraph 1. (The definitions of the terms “technology”, “required”, “production” and “use” are from the Common Military List of the European Union.)

Explosive materials, as follows, and mixtures containing one or more thereof:

(a)	Ammonium Nitrate Fuel Oil (ANFO);

(b)	Nitrocellulose (containing more than 12,5 % nitrogen w/w);

(c)	Nitroglycerin (except when packaged/prepared in individual medicinal doses) unless compounded or mixed with the “energetic material” specified by ML8.a. or powdered metals specified by ML8.c. of the Common Military List of the European Union;

(d)	Nitroglycol;

(e)	Pentaerythritol tetranitrate (PETN);

(f)	Picryl chloride;

(g)	2,4,6-Trinitrotoluene (TNT).

Explosives precursors:

(a)	Ammonium nitrate;

(b)	Potassium nitrate;

(c)	Sodium chlorate;

(d)	Nitric acid;

(e)	Sulphuric acid.

’

25.1.2021

Official Journal of the European Union

L 23/22

COUNCIL DECISION (CFSP) 2021/55

of 22 January 2021

amending Decision 2011/72/CFSP concerning restrictive measures directed against certain persons and entities in view of the situation in Tunisia

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union and in particular Article 29 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1)	On 31 January 2011, the Council adopted Decision 2011/72/CFSP (1) concerning restrictive measures directed against certain persons and entities in view of the situation in Tunisia.

(2)

On the basis of a review of Decision 2011/72/CFSP, the restrictive measures should be extended until 31 January 2022, and, in the Annex thereto, the entries for four persons should be deleted and the information regarding the rights of defence and the right to effective judicial protection should be updated for two persons.

(3)	Decision 2011/72/CFSP should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2011/72/CFSP is amended as follows:

(1)	Article 5 is replaced by the following: ‘Article 5 This Decision shall apply until 31 January 2022. It shall be kept under constant review. It may be renewed or amended, as appropriate, if the Council deems that its objectives have not been met.’;

(2)	the Annex is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 22 January 2021.

For the Council

The President

A. P. ZACARIAS

(1) Council Decision 2011/72/CFSP of 31 January 2011 concerning restrictive measures directed against certain persons and entities in view of the situation in Tunisia (OJ L 28, 2.2.2011, p. 62).

ANNEX

In Decision 2011/72/CFSP, the Annex is amended as follows:

(1)

in Part A (List of persons and entities referred to in Article 1), the entries for the following persons are deleted:

22.	Bouthaina Bent Moncef Ben Mohamed TRABELSI

23.	Nabil Ben Abderrazek Ben Mohamed TRABELSI

41.	Akrem Ben Hamed Ben Taher BOUAOUINA

47.	Slim Ben Tijani Ben Haj Hamda BEN ALI;

(2)

Part B (Rights of defence and right to effective judicial protection under Tunisian law) is amended as follows:

(a)

the entries for the following persons are deleted:

22.	Bouthaina Bent Moncef Ben Mohamed TRABELSI

23.	Nabil Ben Abderrazek Ben Mohamed TRABELSI

41.	Akrem Ben Hamed Ben Taher BOUAOUINA

47.	Slim Ben Tijani Ben Haj Hamda BEN ALI;

(b)

the entries concerning the following persons are replaced by the following entries:

‘14.

Samira Bent Mohamed Ben Rhouma TRABELSI

45.

Montassar Ben Habib Ben Bouali LTAIEF

The investigation or trial relating to the misappropriation of public funds or assets is still ongoing. The information on the Council’s file shows that the rights of defence and the right to effective judicial protection were respected in the judicial proceedings on which the Council relied. This is demonstrated in particular by the fact that in 2011 and 2013 Mr Montassar Ben Habib Ben Bouali LTAIEF was heard by an investigating judge in the presence of his lawyers.’.

		ISSN 1977-0677
Official Journal of the European Union		L 23

English edition	Legislation	Volume 64 25 January 2021

Contents		II Non-legislative acts	page
		REGULATIONS
	*	Council Regulation (EU) 2021/48 of 22 January 2021 amending Regulation (EC) No 147/2003 concerning restrictive measures in respect of Somalia	1
	*	Council Implementing Regulation (EU) 2021/49 of 22 January 2021 implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia	5
	*	Commission Implementing Regulation (EU) 2021/50 of 22 January 2021 authorising an extension of use and a change in the specifications of the novel food 2′-fucosyllactose/difucosyllactose mixture and amending Implementing Regulation (EU) 2017/2470 ( 1 )	7
	*	Commission Implementing Regulation (EU) 2021/51 of 22 January 2021 authorising a change of the conditions of use of the novel food trans-resveratrol under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 ( 1 )	10
	*	Commission Implementing Regulation (EU) 2021/52 of 22 January 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin ( 1 )	13
	*	Commission Implementing Regulation (EU) 2021/53 of 22 January 2021 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq	16
		DECISIONS
	*	Council Decision (CFSP) 2021/54 of 22 January 2021 amending Decision 2010/231/CFSP concerning restrictive measures against Somalia	18
	*	Council Decision (CFSP) 2021/55 of 22 January 2021 amending Decision 2011/72/CFSP concerning restrictive measures directed against certain persons and entities in view of the situation in Tunisia	22