(1)

On 8 January 2019, the Council adopted Implementing Regulation (EU) 2019/24 (2) implementing Article 2(3) of Regulation (EC) No 2580/2001, establishing an updated list of persons, groups and entities to which Regulation (EC) No 2580/2001 applies (‘the list’).

(2)

The Council has provided, where practically possible, all the persons, groups and entities with statements of reasons explaining why they were entered into the list.

(3)

By way of a notice published in the Official Journal of the European Union, the Council informed the persons, groups and entities on the list that it had decided to keep them thereon. The Council also informed the persons, groups and entities concerned that it was possible to request a statement of the Council's reasons for entering them into the list where such a statement had not already been communicated to them.

(4)

The Council has reviewed the list as required by Article 2(3) of Regulation (EC) No 2580/2001. When carrying out that review, the Council took into account the observations submitted to it by those concerned as well as the updated information received from the competent national authorities on the status of listed individuals and entities at the national level.

(5)

The Council has verified that competent authorities, as referred to in Article 1(4) of Council Common Position 2001/931/CFSP (3), have taken decisions with regards to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for in Regulation (EC) No 2580/2001.

(6)

The list should be updated accordingly and Implementing Regulation (EU) 2019/24 should be repealed,

(1)

Annex I to Commission Regulation (EU) No 10/2011 (2) establishes a Union list of authorised substances which may be used in the manufacture of plastic materials and articles intended to come into contact with food.

(2)

Since the last amendment to Regulation (EU) No 10/2011, the European Food Safety Authority (‘the Authority’) has published a scientific opinion on the permitted uses of an already authorised substance that may be used in food contact materials (‘FCM’). In order to ensure that Regulation (EU) No 10/2011 reflects the most recent findings of the Authority, that Regulation should be amended.

(3)

The substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (FCM substance No 1059, CAS number 147398-31-0) has been authorised by Commission Regulation (EU) 2019/37 (3) to be used either alone or blended with other polymers in contact with dry or solid foods for which food simulant E is assigned in Table 2 of Annex III to Regulation (EU) No 10/2011 on the basis of two scientific opinions (4) (5) published by the Authority. The Authority has adopted a new favourable scientific opinion (6) extending the use of this substance alone or blended with other polymers in the manufacture of plastics intended to come into contact with all foods. In the later opinion, the Authority concluded that this substance is not of a safety concern for the consumer if it is used either alone or blended with other polymers in contact with all foods under contact conditions of 6 months or more at room temperature or below, including hot fill or short heating-up phases, provided that the migration of all oligomers with a molecular weight below 1 000 Da does not exceed 5,0 mg/kg food or food simulant. The Authority's conclusion is based on the worst-case migration testing conditions set out in point 2.1.4 of Chapter 2 of Annex V to Regulation (EU) No 10/2011 for long term contact conditions (6 months or more) with food at room temperature or below. In accordance with the provisions of point 2.1.5 of Chapter 2, of Annex V to that Regulation, these worst-case migration testing conditions also address contact conditions of less than 6 months at room temperature or below. Therefore, the use of this substance alone or blended with other polymers in the manufacture of plastics intended to come into contact with all foods under contact conditions of less than 6 months at room temperature or below, including hot fill or short heating-up phases will also be of no safety concern, provided that the migration of all oligomers with a molecular weight below 1 000 Da does not exceed 5,0 mg/kg food or food simulant. In addition, the Authority also confirmed in this opinion that the specific migration limit of 0,05 mg/kg food set for the degradation product crotonic acid in the previous authorisation of FCM substance No 1059, should also apply under this extended use. The entry for this substance in Table 1 of point 1 of Annex I to Regulation (EU) No 10/2011 should therefore include the uses of this substance with all foods and in all conditions, in column 10 of that Table.

(4)

The authorisation of the FCM substance No 1059 provided for in this Regulation, requires that the total migration of all oligomers with a molecular weight below 1 000 Da does not exceed 5,0 mg/kg food or food simulant. As analytical methods to determine the migration of these oligomers are complex, a description of those methods is not necessarily available to competent authorities. Without that description, it is not possible for the competent authority to verify that the migration of oligomers from the material or article complies with the migration limit for these oligomers. Therefore, business operators placing on the market the final article or material containing that substance should be required to include in the supporting documentation referred to in Article 16 of Regulation (EU) No 10/2011 a description of the method and a calibration sample if required by the method.

(5)

Annex I to Regulation (EU) No 10/2011 should therefore be amended accordingly.

(6)

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

(1)

By letter received on 16 November 2016, the French authorities notified the Commission that the Cidrerie de la Brique, 23 Route de la Brique, 50700 Saint-Joseph, which had been legally marketing the product in question under the name ‘Cidre Cotentin’/‘Cotentin’ continuously for more than five years, had raised an objection during the national opposition procedure. Considering that this company met the conditions laid down in Article 15(1) of Regulation (EU) No 1151/2012, the French authorities asked the European Commission to grant it a transitional period lasting until 30 June 2020.

(2)

By means of Commission Implementing Regulation (EU) 2018/939 (2), the Commission entered the name ‘Cidre Cotentin’/‘Cotentin’ (PDO) in the register of protected designations of origin and protected geographical indications, without granting the Cidrerie de la Brique the transitional period provided for in Article 15(1) as requested by the French authorities. Implementing Regulation (EU) 2018/939 entered into force on 23 July 2018.

(3)

By emails sent on 10 and 12 April 2019, the French authorities explained why the Cidrerie de la Brique was eligible for a transitional period under Article 15(1) of Regulation (EU) No 1151/2012 and once again asked the Commission to grant it.

(4)

The company in question, established within the geographical area defined in the specification for the protected designation of origin ‘Cidre Cotentin’/‘Cotentin’, does not follow the specification and would therefore contravene Article 13(1) of Regulation (EU) No 1151/2012 if it were to use the designation concerned.

(5)

The Cidrerie de la Brique therefore met the conditions laid down in Article 15(1) of Regulation (EU) No 1151/2012 for the granting of a transitional period in which to make legal use of the sales name after its registration. A transitional period lasting until 30 June 2020 should therefore be granted, during which time the Cidrerie de la Brique may make use of the protected name ‘Cidre Cotentin’/‘Cotentin’ (PDO).

(6)

Since the name has been protected since 23 July 2018, when Implementing Regulation (EU) 2018/939 registering the name ‘Cidre Cotentin’/‘Cotentin’ (PDO) entered into force, the authorisation to use the protected name should apply retroactively from that date.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

(1)

On 19 January 2015, the Council adopted Decision (CFSP) 2015/77 (1) appointing Mr Lars-Gunnar WIGEMARK as the European Union Special Representative (EUSR) in Bosnia and Herzegovina. The EUSR's mandate is to expire on 31 August 2019.

(2)

Mr Johann SATTLER should be appointed as the EUSR in Bosnia and Herzegovina for the period from 1 September 2019 to 31 August 2021.

(3)

The EUSR will implement the mandate in the context of a situation which may deteriorate and could impede the achievement of the objectives of the Union's external action as set out in Article 21 of the Treaty,

(1)

On 27 December 2001, the Council adopted Common Position 2001/931/CFSP (1).

(2)

On 8 January 2019, the Council adopted Decision (CFSP) 2019/25 (2) updating the list of persons, groups and entities subject to Articles 2, 3 and 4 of Common Position 2001/931/CFSP (‘the list’).

(3)

In accordance with Article 1(6) of Common Position 2001/931/CFSP, it is necessary to review at regular intervals the names of persons, groups and entities in the list to ensure that there are grounds for keeping them thereon.

(4)

This Decision sets out the result of the review that the Council has carried out in respect of persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply.

(5)

The Council has verified that competent authorities, as referred to in Article 1(4) of Common Position 2001/931/CFSP, have taken decisions with regard to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for therein.

(6)

The list should be updated accordingly and Decision (CFSP) 2019/25 should be repealed,

(1)

The European Medicines Agency (‘EMA’ or ‘the Agency’) was set up by Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products;

(2)

The Agency conducts administrative inquiries and disciplinary proceedings in line with the rules laid down in the Staff Regulations of Officials of the European Union, and the Conditions of Employment of Other Servants of the European Union, the Agency may also carry out preliminary activities related to cases of potential irregularities reported to OLAF (according to Regulation (EU, Euratom) No 883/2013), process whistleblowing cases, process (formal and informal) procedures of harassment, process internal and external complaints, conduct internal audits, carry out investigations by the Data Protection Officer in line with Article 45(2) of Regulation (EU) 2018/1725 and (IT) security investigations handled internally or with external involvement (e.g. CERT-EU);

(3)

The Agency processes several categories of personal data, such as identification data, contact data, professional data. The European Medicines Agency represented by its Executive Director is responsible as data controller. Internally, the Head of Administration and Corporate Management Division has been appointed to act by delegation as data controller for the activities concerned by this Decision (for the purpose hereof, hereinafter referred as ‘Controller’). If the administrative enquiry or disciplinary proceedings concerns the Head of Administration and Corporate Management Division, the Deputy Executive Director shall be the Controller for that the relevant enquiry or proceedings. The personal data are stored in an electronic file and in paper form. The paper file is stored in a locked cupboard which is only accessible to staff members authorised by senior management. The electronic files are stored in a secure electronic environment which is designed and maintained to prevent accidental or unlawful destruction, loss, alteration, transfer, unauthorised disclosure of, or access to, personal data to internal and external partners who are not authorised to have access to such data;

(4)

The personal data processed are retained in accordance with Article 13 of the EMA implementing rules on the conduct of administrative enquiries and disciplinary procedures of 8 June 2012, as explained in Article 2(3) of this Decision;

(5)

This Decision on internal rules should apply to all processing operations carried out by the Agency in the performance of its administrative inquiries and disciplinary proceedings, as well as in the performance of preliminary activities related to cases of potential irregularities reported to OLAF, process whistleblowing cases, process (formal and informal) procedures of harassment, process internal and external complaints, conduct internal audits, carry out investigations by the Data Protection Officer in line with Article 45(2) of Regulation (EU) 2018/1725 and (IT) security investigations handled internally or with external involvement (e.g. CERT-EU). This Decision should apply to processing operations carried out prior to the opening of the procedures referred to above, during these procedures and during the monitoring of the follow-up to the outcome of these procedures.

(6)

This Decision on internal rules should also apply to activities linked to assistance and cooperation provided by the Agency outside of its administrative enquiries to other Union institutions, bodies, offices and agencies, competent authorities of the Member States and international organisations to protect their processing operations; as well as to activities related to cooperation with, and the transmission of information regarding an administrative enquiry or disciplinary proceedings to, EU institutions and bodies. To that effect, the Agency should consult those institutions, bodies, offices, agencies, authorities or organisations on the relevant grounds for imposing restrictions and on the necessity and proportionality of the restrictions;

(7)

The Agency has to give justifications explaining why the restrictions are strictly necessary and proportionate in a democratic society and respect the essence of the fundamental rights and freedoms;

(8)

Within this framework the Agency is bound to respect, to the maximum extent possible, the fundamental rights of the data subjects during the above procedures, in particular but not limited to those relating to the right of access and rectification, right to erasure, as enshrined in Regulation (EU) 2018/1725;

(9)

However, the Agency may be obliged to defer the information to data subject and other data subject's rights in order to protect, in particular, its own investigations and procedures, the investigations and proceedings of other public authorities, as well as the rights of other persons related to its investigations and procedures;

(10)

The Agency may thus defer the information for the purposes to protect its administrative inquiries and disciplinary proceedings, the investigations and proceedings of other public authorities as well as to protect the identity of informants and other persons involved in the procedures, including whistle-blowers and witnesses who should not suffer negative repercussions in relation to their cooperation. In particular, Article 5(3) of the EMA implementing rules on the conduct of administrative enquiries and disciplinary procedures of 8 June 2012 provides for an obligation to inform any staff member who may personally be involved in an investigation, provided that such notification does not hinder the inquiry. This constitutes a restriction of the application of data subjects' rights, in particular Articles 14 to 21, 35 and 36 of Regulation (EU) 2018/1725. Therefore, in accordance with Article 25 of the same Regulation, internal rules shall be laid down to ensure that such a restriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society;

(11)

Pursuant to Article 25(8) of Regulation (EU) 2018/1725, the Controller may defer or refrain from providing information on the reasons for the application of a restriction to the data subject, if the notification would in any way compromise the purpose of the restriction. In order to ensure that the data subject's right to be informed in accordance with Articles 16 and 35 of Regulation (EU) 2018/1725 is restricted only as long as the reasons for the deferral last, the Agency should regularly review its position.

(12)

Where a restriction of other data subjects' rights is applied, the Controller should assess on a case-by-case basis whether the communication of the restriction would compromise its purpose;

(13)

In accordance with the principle of proportionality, the Agency should monitor regularly (about every six months) that the conditions which justify a particular restriction still exist. Accordingly, the Agency should lift the restriction when the conditions that justify the restriction no longer apply;

(14)

The Agency should consult the Data Protection Officer (the ‘DPO’) at the moment of deferral of information or when other restriction of data subjects' right is applied, as well as on the occasion of the assessment of the conditions as to whether the restriction is still justified,