(1)

On 17 March 2008, the Council adopted Regulation (EC) No 242/2008 (2) concluding the Fisheries Partnership Agreement between the Republic of Côte d'Ivoire and the European Community (3) (the ‘Agreement’). The Agreement was then tacitly renewed and is still in force.

(2)

The last Protocol to the Agreement expired on 30 June 2018.

(3)

The Commission has negotiated, on behalf of the Union, a new Protocol implementing the Agreement (the ‘Protocol’). The Protocol was initialled on 16 March 2018.

(4)

In accordance with Council Decision (EU) 2018/1069 (4), the Protocol was signed on 1 August 2018, subject to its conclusion at a later date.

(5)

The Protocol has been applied on a provisional basis as from the date of its signature.

(6)

The objective of the Protocol is to enable the Union and the Republic of Côte d'Ivoire (‘Côte d'Ivoire’) to work more closely on promoting a sustainable fisheries policy, sound exploitation of fisheries resources in Ivorian waters, and Côte d'Ivoire's efforts to develop a blue economy.

(7)

The Protocol should be approved.

(8)

Article 9 of the Agreement establishes the Joint Committee responsible for monitoring its implementation (the ‘Joint Committee’). Furthermore, in accordance with Article 5(4) and Articles 6 and 7 of the Protocol, the Joint Committee may approve certain amendments to the Protocol. In order to facilitate the approval of such amendments, the Commission should be empowered, subject to specific conditions, to approve those amendments under a simplified procedure,

(1)

Regulation (EU) 2019/216 of the European Parliament and of the Council (2) provides that the tariff rate quotas included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 are to be apportioned between the Union and the United Kingdom based on the EU-27 share in the quota usage set out in the Annex to that Regulation.

(2)

As a result, measures need to be adopted in order to implement the apportionment of the relevant tariff rate quotas for certain agricultural products set out in Part A of the Annex to Regulation (EU) 2019/216. In particular, it should be established that the tariff rate quota quantities set out in the Regulations opening the respective tariff rate quotas are replaced by the new quantities resulting from the apportionment implemented by this Regulation.

(3)

Within certain tariff rate quotas included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 quantities have been allocated to particular third countries as part of the Union's international commitments. It is therefore necessary to apportion those specifically allocated quantities between the Union and the United Kingdom, based on the apportionments set out in Regulation (EU) 2019/216 and taking into account historic trade flows between those third countries, the Union and the United Kingdom.

(4)

As the day from which the relevant Article of Regulation (EU) 2019/216 will possibly begin to apply is likely to be a day falling in a quota period that has started running, it is necessary to provide for specific rules for the implementation of the apportionment for the quantities not yet allocated on that day for the tariff rate quotas in respect of which the quota period begins before the day from which Article 1(2) of Regulation (EU) 2019/216 applies and ends after that day. However, in such cases the apportioned tariff rate quota quantities should not exceed the new quantities available for the EU-27 as set out in this Regulation for each tariff rate quota managed by the simultaneous examination method, taking into account the quantities allocated in the Member States other than the United Kingdom before the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

(5)

In order to ensure legal certainty and transparency for the operators, the Commission should publish the quantities that are available following the apportionment of those tariff rate quotas within two working days from the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

(6)

It is also necessary to lay down rules on the validity of rights and obligations deriving from import licences issued and import rights allocated by the license issuing authorities of the United Kingdom or by the licence issuing authorities of other Member States.

(7)

In order to ensure that from the day from which Article 1(2) of Regulation (EU) 2019/216 applies imports under the tariff rate quotas included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 are performed only by operators established in the Union, it is necessary to provide for a specific rule concerning the validity of import licences and import rights transferred to operators established in the United Kingdom and not used by that day.

(8)

In the interest of legal certainty and transparency for the operators, it should be clarified that, except where import licences were issued and import rights were allocated by the licence issuing authorities in the United Kingdom, the Union rules in force as regards rights and obligations deriving from import licences and import rights, including those concerning securities, remain applicable. In addition, rules concerning import licences transferred to operators established in the United Kingdom need to be laid down.

(9)

The agreement in the form of an Exchange of Letters on the consultations between the European Community and the Kingdom of Thailand under GATT Article XXIII (3), approved by Council Decision 96/317/EC (4), provides for the opening of an additional autonomous annual tariff quota of 10 500 tonnes of manioc starch, of which 10 000 tonnes are reserved for Thailand and 500 tonnes are available for all third countries. For management purposes, those 500 tonnes were added to WTO tariff quota under order number 09.0132 (CN 1108 14 00 manioc starch) that needs to be apportioned in view of the United Kingdom's withdrawal from the Union. In view of this, the tariff quota of 500 tonnes (CN 1108 14 00 manioc starch) needs to be separated from the quantities that should be apportioned in view of the United Kingdom's withdrawal from the Union and as such should be made available under a separate order number.

(10)

This Regulation should apply from the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

(11)

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

(1)

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

(2)

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

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

(4)

Commission Implementing Decision (EU) 2015/545 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market in the Union of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food to be used in a number of foods.

(5)

Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees.

(6)

On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. (ATCC PTA-9695) oil to fruit and vegetable purees.

(7)

The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation for extension of use of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to fruit and vegetable purees and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(8)

On 10 September 2018, the company DSM Nutritional Products Europe also made a request to the Commission to authorise the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food as listed in the Union list and from the labelling of foods containing it.

(9)

The Applicant considers that the change of the designation and the labelling requirements for Schizochytrium sp. (ATCC PTA-9695) oil is necessary because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of foods containing Schizochytrium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers.

(10)

There are four oils from Schizochytrium sp. currently authorised and listed in the Union list of novel foods. However, Schizochytrium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specified on the label. Therefore, the change of the designation and labelling of Schizochytrium sp. (ATCC PTA-9695) oil will ensure consistency in the designation and labelling of all oils from Schizochytrium sp. authorised as novel foods without having a negative impact on human health and consumer interests.

(11)

Considering the removal of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC PTA 9695)’ should be included in the specifications as it is necessary for a proper identification of the novel food. Therefore, the specifications of the entry ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be amended accordingly.

(12)

The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil, the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil and the subsequent updating of the Union list are not liable to have an effect on human health.

(13)

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

(1)

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

(2)

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

(3)

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

(4)

Commission Implementing Decision (EU) 2016/376 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of synthetic 2′-fucosyllactose as a novel food ingredient.

(5)

Commission Implementing Decision (EU) 2017/2201 (5) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient.

(6)

On 23 June 2016, the company Glycom A/S (the Applicant), informed the Commission, pursuant to Article 5 of Regulation (EC) No 258/97, of its intention to place on the market 2′-fucosyllactose produced by bacterial fermentation with Escherichia coli strain K-12.

(7)

In the notification to the Commission, the Applicant also submitted a report issued on 10 June 2016 by the competent authority of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, which, on the basis of the scientific evidence submitted by the Applicant, had concluded that 2′-fucosyllactose produced with Escherichia coli strain K-12 is substantially equivalent to the synthetic 2′-fucosyllactose authorised by Commission Implementing Decision (EU) 2016/376.

(8)

On 16 August 2018, the Applicant made a request to the Commission to change in the specifications of the 2′-fucosyllactose produced with Escherichia coli strain K-12 within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The requested changes concern a decrease in the levels of the 2′-fucosyllactose from 90 % to 83 %, and increases in the levels of the minor saccharides present in the novel food, namely an increase in the levels of D-lactose from up to 3,0 % to up to 10,0 %, an increase in the levels of difucosyl-D-lactose from up to 2,0 % to up to 5,0 %.

(9)

To ensure that the overall purity of the novel food following the introduction of the above changes in its specifications, remains as high as the currently authorised 2′-fucosyllactose produced by either Escherichia coli strain K12 or Escherichia coli strain BL 21, the Applicant also proposes that the overall levels of 2′-fucosyllactose together with the minor saccharides (D-lactose, L-fucose, difucosyl-D-lactose, and 2′-fucosyl-D-lactulose) in the novel food is equal or higher than 90,0 %.

(10)

The proposed changes in the specifications of the novel food are due to the modifications in its manufacturing process that entail the replacement of the crystallisation purification step with a spray drying step which is currently used in the production of 2′-fucosyllactose by Escherichia coli strain BL21. This change in the purification step of the novel food production requires the increase in the use of D-lactose as the fermentation substrate in the production of 2′-fucosyllactose that explains the slight decrease in the level of 2′-fucosyllactose and the concomitant slight increases in the levels of D-lactose and of difucosyl-D-lactose in the final novel food. These proposed changes in the manufacturing are deemed necessary by the Applicant in order to reduce the energy and environmental impact of the 2′-fucosyllactose manufacturing process and to reduce the cost per unit produced.

(11)

The proposed changes do not alter the safety considerations that supported the authorisation of the 2′-fucosyllactose produced with Escherichia coli strain K-12. Therefore, it is appropriate to amend the specifications of the novel food ‘2′-fucosyllactose’ at the proposed levels of 2′-fucosyllactose, of D-lactose, of difucosyl-D-lactose, and of the overall levels of 2′-fucosyllactose together with the minor saccharides (D-lactose, L-fucose, difucosyl-D-lactose, and 2′-fucosyl-D-lactulose).

(12)

The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food ‘2′-fucosyllactose’ comply with Article 12 of Regulation (EU) 2015/2283.

(13)

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

(14)

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

(1)

The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

(2)

Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex IX to that Agreement, which contains provisions on financial services.

(3)

Regulation (EU) No 600/2014 of the European Parliament and of the Council (3) and Directive 2014/65/EU of the European Parliament and of the Council (4) are to be incorporated into the EEA Agreement.

(4)

Annex IX to the EEA Agreement should therefore be amended accordingly.

(5)

The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,

(1)

The terms of office of 14 Judges and five Advocates-General of the Court of Justice expired on 6 October 2018.

(2)

Mr Andreas KUMIN has been nominated for the post of Judge of the Court of Justice.

(3)

The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr Andreas KUMIN to perform the duties of Judge of the Court of Justice,