title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 21.3.2018

               on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC

               (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 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
                  1
               , and in particular Article 23 thereof,

               Whereas:

               (1)Regulation (EC) No 470/2009 provides for the establishment of maximum residue limits ("MRLs") for pharmacologically active substances intended for use in the Union in veterinary medicinal products administered to food-producing animals and in biocidal products used in animal husbandry.

               (2)Table 1 of the Annex to Commission Regulation (EU) No 37/2010
                  2
                ("Table 1") sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin. In relation to some substances, different MRLs are set out for different species or groups of species and for different target tissues of those species or groups of species.

               (3)Article 11 of Directive 2001/82/EC
                  3
                lays down rules regarding the treatment of food-producing animals affected by a condition for which no veterinary medicinal product is authorised in a Member State. In particular, paragraph 2 of that Article, read together with Article 29 of Regulation (EC) No 470/2009, provides that such animals may be treated with medicinal products containing pharmacologically active substances only if those substances are included in Table 1 of the Annex to Regulation (EU) No 37/2010.

               (4)The Commission is required to adopt detailed rules on the MRLs to be considered for control purposes for foodstuffs derived from animals treated under Article 11 of Directive 2001/82/EC. For specific target tissues of animal species treated in the EU under Article 11 of Directive 2001/82/EC, no MRLs may be included in Table 1 of the Annex to Commission Regulation (EU) No 37/2010. In order to ensure a high level of consumer protection, specific rules are needed to specify which MRLs apply in those cases. The rules should take into account the MRLs established under Regulation (EC) No 470/2009 for different animal species and different target tissues, for which a risk assessment has demonstrated their safety to consumers. Applying the existing MRLs to tissue-species combinations for which no MRL has been set, in combination with the application of the appropriate withdrawal periods or the default minimum withdrawal periods according to Article 11, provides sufficient guarantees for consumer safety.

               (5)For treatments under Article 11 of Directive 2001/82/EC it is most appropriate to refer to MRLs, which are established in Table 1 for species that have a similar anatomy and metabolism, in order to define MRLs, for residues of veterinary medicinal products in animal species not listed in Table 1. Therefore food-producing animal species should be placed into groups and related to each other according to the different anatomical and metabolic relationships between them.

               (6)Preferentially MRLs listed in Table 1 for the same target tissue in a related or more closely related species are considered and as a last resort the lowest MRL for any target tissue in any species.

               (7)In case in Table 1 restrictions are defined regarding the application of the MRL for certain uses, these restrictions apply also to possible uses on other animal species and/ or target tissues.

               (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

               This Regulation lays down the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC.

               Article 2

               1.For the purposes of this Regulation, food-producing animals shall be grouped as follows:

               (a)ruminants

               (b)monogastric mammals

               (c)poultry and ratites

               (d)fin fish

               (e)bees

               (f)crustaceans

               (g)molluscs.

               2.For the purposes of this Regulation, animal species shall be considered to be "related" or "more closely related" to each other as follows:

               (a)animal species belonging, according to paragraph 1, to the same group shall be considered to be "related" species;

               (b)within the ruminants group, ovine and caprine species shall be considered to be "more closely related" to each other than to bovine species and bovine species shall be considered to be "more closely related" to each other than to either ovine or caprine species;

               (c)Equidae and rabbits shall be considered to be equally related to monogastric mammals and ruminants. However, ruminants shall not be considered to be related to either Equidae or rabbits.

               3.For the purposes of this Regulation, different target tissues shall be equated as follows:

               (a)the target tissue "skin and fat" in porcine and poultry species shall be equated to the target tissue "fat" in other animal species, and vice versa;

               (b)the target tissue "skin and muscle" in fin fish shall be equated to the target tissue "muscle" in other animal species, and vice versa;

               (c)the edible parts of crustaceans and molluscs shall be equated to the target tissue "muscle" in other animal species.

               Article 3

               For pharmacologically active substances included in Table 1 of the Annex to Regulation (EU) 37/2010 ("Table 1") for which at least one MRL or provisional MRL has been established, the MRL to be considered for control purposes for a target tissue derived from an animal species treated in the EU under Article 11 of Directive 2001/82/EC ("the treated species") shall be as follows:

               (a)if at least one MRL is established in Table 1 for that target tissue in any species related to the treated species:

               (1)the MRL to be considered for control purposes shall be the lowest of all the MRLs established in Table 1 for that target tissue in species related to the treated species;

               (2)if, however, the treated species is a species referred to in Article 2(2)(b) of this Regulation and MRLs are established in Table 1 for that target tissue in species that are more closely related to the treated species, the MRL to be considered for control purposes shall be the lowest of the MRLs established for that target tissue in those more closely related species;

               (b)if point (a) does not apply, the MRL to be considered for control purposes shall be the lowest of all the MRLs established in Table 1 for that target tissue in species that are not related to the treated species;

               (c)if neither point (a) nor point (b) produces the MRL to be considered for control purposes, the MRL to be considered for control purpose shall be the lowest of all the MRLs established in Table 1 for other target tissues in any animal species;

               (d)in case in Table 1 restrictions are defined regarding the application of the MRL for certain uses, these restrictions equally apply when considering an MRL under article 3(a), 3(b) and 3(c) for possible uses on other animal species and/ or target tissues.

               Article 4

               For pharmacologically active substances included in Table 1 of the Annex to Regulation (EU) No 37/2010 for which no MRL is required, in accordance with Article 14(5) of Regulation (EC) No 470/2009, there shall be no MRL required for control purposes for any target tissue derived from animal species treated in the EU under Article 11 of Directive 2001/82/EC, provided that the restrictions established in Table 1 are complied with.

               Article 5

               The MRLs applicable in Table 1 of the Annex to Regulation (EU) 37/2010 at the time of placing on the market of foodstuffs of animal origin, shall be applicable to the controlled products.

               Article 6

               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, 21.3.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 152, 16.6.2009, p. 11.

                     (2)

                        Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

                     (3)

                        Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 19.3.2018

               on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

               (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 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 4 thereof,

               Whereas:

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

               (2)Article 4 of Regulation (EU) 2015/2283 lays down basic principles on the procedure for the determination of novel food status. Paragraph 1 of that Article requires food business operators to verify whether or not the food which they intend to place on the Union market falls within the scope of that Regulation.

               (3)In order to determine novel food status of a particular food, a consultation request should be submitted. The Member States should verify the validity of such requests. Therefore, it is necessary to establish rules for the verification process.

               (4)Rules should be established in order to ensure that the consultation request for determination of novel food status provides all the information necessary for the evaluation by the Member States.

               (5)In order to ensure that food business operators and the public are informed of the novel food status, the information on the novel food status should be made publicly available.

               (6)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
               Scope and subject matter

               This Regulation lays down rules for the implementation of Article 4 of Regulation (EU) 2015/2283 as regards the procedural steps of the consultation process to determine whether or not a food falls within the scope of that Regulation.

               Article 2
               Definitions

               In addition to the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council
                  2
                and Regulation (EU) 2015/2283, the following definitions shall apply:

               (a)"consultation request" means a request from a food business operator to a recipient Member State to determine novel food status of a particular food;

               (b)"recipient Member State" means a Member State where the food business operator intends to place on the market a particular food for the first time.

               Article 3
               Submission of a consultation request

               1.The food business operator shall consult the recipient Member State as provided for in Article 4(2) of Regulation (EU) 2015/2283 by submitting a consultation request to that Member State.

               2.Where the food business operator intends to place the food on the market simultaneously in several Member States, the food business operator shall submit the consultation request only to one of those Member States.

               Article 4
               Content and presentation of a consultation request

               1.The consultation request shall be submitted electronically to the recipient Member State and shall consist of the following:

               (a)a cover letter;

               (b)a technical dossier;

               (c)supporting documentation;

               (d)an explanatory note clarifying the purpose and relevance of the submitted documentation.

               2.The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.

               3.The technical dossier referred to in paragraph 1(b) shall contain the information necessary to enable the recipient Member State to conclude on the novel food status and shall be drafted in accordance with the template provided in Annex II.

               4.By way of derogation from paragraph 3, an applicant is not required to provide all the elements referred to in Annex II, provided that the applicant has submitted verifiable justification for the absence of each missing element.

               Article 5
               Procedures for verifying the validity of a consultation request

               1.The recipient Member State shall without delay verify whether the consultation request complies with the requirements of Article 4.

               2.Where the food business operator submits insufficient information in the consultation request, the recipient Member State shall request the food business operator to provide additional information or make the relevant updates to the consultation request within the time period specified by the recipient Member State.

               3.The consultation request shall be considered not valid where:

               (a)the food business operator does not provide requested additional information or updated consultation request within the period specified by the recipient Member State;

               (b)the submitted additional information is insufficient to conclude that the consultation request is valid.

               4.The recipient Member State shall decide on the validity of the consultation request and without delay inform the food business operator, the other Member States and the Commission of the decision. Where the consultation request is considered not valid, the recipient Member State shall provide the reasons for that conclusion.

               Article 6
               Procedures for evaluating a valid consultation request

               1.The recipient Member State shall conclude on the novel food status of a food within four months from the date on which it decided on the validity of the consultation request.

               2.Where the recipient Member State identifies that it does not have sufficient evidence to decide on the novel food status of a food, it may request the food business operator to provide additional information. The period of that request shall be determined together with the food business operator.

               The recipient Member State may consult the other Member States and the Commission.

               3.Without prejudice to paragraph 4, a request for additional information referred to in paragraph 2 shall not extend the time period referred to in paragraph 1.

               4.In duly justified cases, the recipient Member State may extend the time period referred to in paragraph 1 by a maximum of four months. The recipient Member State shall inform the food business operator, the other Member States and the Commission of their decision and shall provide justification.

               5.On concluding on the novel food status of a food, the recipient Member State shall without delay notify the food business operator, the other Member States and the Commission of the decision and shall provide justification in accordance with Article 7 of this Regulation.

               Article 7
               Information on the novel food status and publication

               1.The notification referred to in Article 6(5) of this Regulation shall include the following:

               (a)the name and description of the food concerned;

               (b)a statement indicating whether the food concerned is novel, not novel or not novel only in food supplements;

               (c)reasons justifying the statement referred to in point (b);

               (d)where the food is novel food, the most appropriate food category under which it falls in accordance with Article 3(2) of Regulation (EU) 2015/2283.

               2.The Commission shall without delay make the information on the novel food status publicly available on the Commission's website.

               Article 8
               Competent authorities of the Member States

               Member States shall provide the Commission with the contact details of the national competent authorities and the contact details of the respective contact points designated for the purposes of this Regulation by 1 March 2018.

               The Commission shall publish those contact details on the Commission's website by 1 May 2018.

               Article 9
               Confidentiality

               1.Food business operators may request the recipient Member State to agree that the disclosure of certain information submitted as part of the consultation request needs to benefit from confidential treatment where disclosure of such information may harm their competitive position.

               2.For the purpose of paragraph 1, food business operators shall indicate to the recipient Member State the parts of the information provided that they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.

               3.The recipient Member State shall inform the food business operator of its views on which parts of the information are to remain confidential.

               However, confidentiality shall not apply to the following information:

               (a)the name and address of the applicant;

               (b)the name and description of the food;

               (c)a summary of the studies submitted by the applicant;

               (d)where appropriate, the analysis method(s).

               4.In case of the consultation of other Member States pursuant to Article 6(2), second sub-paragraph, the recipient Member state shall inform the Commission and the member states about its views on confidentiality of the consultation request.

               5.After being informed pursuant to paragraph 3, the food business operator may withdraw its consultation request within three weeks during which the confidentiality of the information provided shall be observed.

               6.The Commission and the Member States shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.

               7.Where a food business operator withdraws or has withdrawn its consultation request in accordance with paragraph 5, neither the Commission nor the Member States shall disclose information for which confidentiality was requested by the food business operator pursuant to paragraph 1.

               8.The application of paragraphs 1 to 7 shall not affect the exchange of information between the Commission and the Member States necessary to consider the consultation requests submitted under this Regulation.

               Article 10
               Entry into force and application

               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, 19.3.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 327, 11.12.2015, p. 1.

                     (2)

                        Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

    ---documentbreak---

               EN

               ANNEX

               ANNEX I

               TEMPLATE COVER LETTER ACCOMPANYING A CONSULTATION REQUEST FOR DETERMINATION OF THE NOVEL FOOD STATUS

               Competent authority of the Member State

               Date: ________

               Subject: Consultation request for determination of the novel food status of _____________
                  ___________________________________________________________________________

               The Food business operator(s)/consulting party:

               Company: __________________________________________________________________

               Address: ____________________________________________________________________

               Telephone:__________________________________________________________________

               Email: _____________________________________________________________________

               Contact person: ______________________________________________________________

               submit(s) the present consultation request in order to determine the novel food status of ___________________________________________________________________________

               Yours sincerely,

               Signature ____________________________________

               Enclosures:

               Technical dossier

               Documents in support of the consultation request

               Explanatory note

               ANNEX II

               TEMPLATE TECHNICAL DOSSIER

               The connection between the different pieces of information shall be explained in an explanatory note. In particular, as regards the evidence presented to support a human consumption to a significant degree within the Union before 15 May 1997, where documents from a range of sources must be considered to be able to reach a conclusion.

               Where only parts of the documents are relevant for the determination of the novel food status, those parts shall be highlighted.

               For all foods Section 1 must be completed.

               For extracts, in addition to Section 1, Section 2 must be completed.

               For foods resulting from a production process not used for food production within the Union before 15 May 1997 Section 1 (points 1 to 3, and point 7) and Section 3 must be completed.

               Section 1: All foods (for foods resulting from a production process not used for food production within the Union before 15 May 1997 only points 1 to 3 and point 7)

                        1.
                              Description of the food

                        1.1
                              Name of the food

                        1.2
                              Detailed description of the food, including information whether the food consists of engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283

                        1.3
                              Proposed category of the novel food in accordance with Article 3(2)(a) of Regulation (EU) 2015/2283, where applicable

                        2.
                              Further characterisation of the food and/or source of the food (where relevant)

                        A.
                              Organisms (microorganisms, fungi, algae, plants, animals)

                        2.1
                              Taxonomic name (full Latin name with author name)

                        2.2
                              Synonyms, other names, where applicable

                        2.3
                              Specification of which part of the organism the use for human consumption before 15 May 1997 within the Union refers to, where applicable

                        2.4    Specification about purity/concentration

                        B.
                              Chemical substances

                        2.5
                              CAS number(s) (if this has been attributed)

                        2.6
                              Chemical name(s) according to IUPAC nomenclature rules

                        2.7
                              Synonyms, trade name, common name, where applicable

                        2.8
                              Molecular and structural formulae

                        2.9
                              Specification about purity/concentration

                        3.
                              Conditions of use

                        3.1
                              How is the food intended to be used?

                        3.2
                              Type of product(s) in which the food is intended to be used

                        3.3
                              Level/concentration (or range of levels) in the product(s) in which the food is intended to be used

                        4.
                              Production process

                        4.1
                              Detailed description of the production process. Include a flow process chart to describe the production process.

                        5.
                              History of human consumption of the food within the Union before 15 May 1997

                        5.1
                              To what extent was the food consumed to a significant degree throughout the Union before 15 May 1997? Details shall be provided.

                        5.2
                              To what extent was the food consumed to a significant degree in one Member State before 15 May 1997? Details shall be provided.

                        5.3
                              Was the food consumed only regionally/on a small local scale in the Union before 15 May 1997? Details shall be provided.

                        5.4
                              Was the food available before 15 May 1997 in the Union as an ingredient designed for specific target population (e.g. food for a special medical purpose)? Details shall be provided.

                        6.
                              Consultations on availability in the Union

                        Where food business operators are unsure whether the information in their possession is sufficient to prove that the food concerned has been used for human consumption to a significant degree within the Union before 15 May 1997, they may consult other food business operators or food business operator federations in order to gather sufficient information.

                        6.1
                              Have other food business operators or food business operator federations been consulted? Details should be provided.

                        6.2
                              Is the food currently available on the market within the Union? Details should be provided.

                        7.
                              Additional information

                        7.1
                              Is there any information that the product concerned is used within the Union as medicinal product in accordance with Directive 2001/83/EC
                           1
                        ?

                        7.2
                              Is there any other information which would assist in determining the novel food status? Any information which is relevant even if not specifically requested shall be submitted.

               Section 2: Extracts

                        8.
                              Extracts

                        8.1
                              Any further details of the source material for the extract, if not provided in Section 1. Details shall be provided.

                        8.2
                              Specification of the extract. Details shall be provided.

                        8.3
                              If extracted from a food source, will the intake of any extract components in the food be higher than the intake of these components in the food source? Details shall be provided.

               Section 3: Foods resulting from a production process not used for food production within the Union before 15 May 1997

                        9.
                              Production process

                        9.1
                              Detailed description of the production process. Include a flow process chart to describe the production process.

                        9.2
                              Is the structure or composition of the food affecting its nutritional value, metabolism or level of undesirable substances because of the process by which the food has been prepared?

                        Details shall be provided.

                        9.3
                              Is the food produced from a source that in itself is not normally consumed as part of the diet? Details shall be provided.

                     (1)

                        Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for application of Directive (EU) 2016/1148 of the European Parliament and of the Council as regards further specification of the elements to be taken into account by digital service providers for managing the risks posed to the security of network and information systems and of the parameters for determining whether an incident has a substantial impact

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 30.1.2018

               laying down rules for application of Directive (EU) 2016/1148 of the European Parliament and of the Council as regards further specification of the elements to be taken into account by digital service providers for managing the risks posed to the security of network and information systems and of the parameters for determining whether an incident has a substantial impact

               THE EUROPEAN COMMISSION,

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

               Having regard to Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union
                  1
               , and in particular Article 16(8) thereof,

               Whereas:

               (1)In accordance with Directive (EU) 2016/1148, digital service providers  remain free to take technical and organisational measures they consider appropriate and proportionate to manage the risk posed to the security of their network and information systems, as long as those measures ensure an appropriate level of security and take into account the elements provided for in that Directive.

               (2)When identifying the appropriate and proportionate technical and organisational measures, the digital service provider should approach information security in a systematic way, using a risk-based approach.

               (3)In order to ensure the security of systems and facilities, digital service providers should perform assessment and analysis procedures. These activities should concern the systematic management of network and information systems, the physical and environmental security, the security of supplies and the access controls.

               (4)When carrying out a  risk analysis within the systematic management of network and information systems, digital service providers should be encouraged to identify specific risks and quantify their significance, for example by identifying threats to critical assets and how they may affect the operations, and determining how best to mitigate those threats based on current capabilities and resource requirements.

               (5)Policies on human resources could refer to the management of skills, including aspects related to the development of security related skills and awareness raising. When deciding on an appropriate set of policies on security of operation, the digital service providers should be encouraged to take into account aspects of change management, vulnerability management, formalization of operating and administrative practices and system mapping.

               (6)Policies on security architecture could comprise in particular the segregation of networks and systems as well as specific security measures for critical operations such as administration operations.The segregation of networks and systems could enable a digital service provider to distinguish between elements such as data flows and computing resources that belong to a client, group of clients, the digital service provider or third parties.

               (7)The measures taken with regard to the physical and environmental security should ensure the security of an organisation's network and information systems from damage caused by incidents such as theft, fire, flood or other weather effects, telecommunications or power failures.

               (8)The security of supplies such as electrical power, fuel or cooling could encompass the security of the supply chain that includes in particular the security of third party contractors and subcontractors and their management. The traceability of critical supplies refers to the ability of the digital service provider to identify and record sources of those supplies.

               (9)The users of digital services should encompass natural and legal persons who are customers of or are subscribers to an online marketplace or a cloud computing service, or who are visitors to an online search engine website in order to undertake keyword searches.

               (10)When defining the substantiality of the impact of an incident, the cases laid down in this regulation should be considered as a non-exhaustive list of substantial incidents. Lessons should be drawn from the implementation of this Regulation and from the work of the Cooperation Group as regards the collection of best practice information on risks and incidents and the discussions on modalities for reporting notifications of incidents as referred to in points (i) and (m) of Article 11(3) of Directive (EU) 2016/1148. The result could be comprehensive guidelines on quantitative thresholds of notification parameters that may trigger the notification obligation for digital service providers under Article 16(3) of Directive (EU) 2016/1148. Where appropriate, the Commission could also consider reviewing the thresholds currently laid down in this Regulation.

               (11)In order to enable competent authorities to be informed about potential new risks, the digital service providers should be encouraged to voluntarily report any incident whose characteristics have been previously unknown to them such as new exploits, attack-vectors or threat actor, vulnerabilities and hazards.

               (12)This Regulation should apply on the day following the expiry of the deadline for transposition of Directive (EU) 2016/1148.

               (13)The measures provided for in this Regulation are in accordance with the opinion of the Network and Information Systems Security Committee referred to Article 22 of Directive (EU) 2016/1148,

               HAS ADOPTED THIS REGULATION:

               Article 1

               Subject-matter

               This Regulation specifies further the elements to be taken into account by digital service providers when identifying and taking measures to ensure a level of security of network and information systems which they use in the context of offering services referred to in Annex III to Directive (EU) 2016/1148 and specifies further the parameters to be taken into account to determine whether an incident has a substantial impact on the provision of those services.

               Article 2

               Security elements

               1. Security of systems and facilities referred to in point (a) of Article 16(1) of Directive (EU) 2016/1148 means the security of network and information systems and of their physical environment and shall include the following elements:

               (a)the systematic management of network and  information systems which means a mapping of information systems and the establishment of a set of appropriate policies on  managing information security, including  risk analysis, human resources, security of operations, security architecture, secure data and system lifecycle management and where applicable, encryption and its management.

               (b)

                  physical and environmental security which means the availability of a set of measures to protect the security of digital service providers' network and information systems from damage using an all hazards risk-based approach, addressing for instance system failure, human error, malicious action or natural phenomena

               (c)the security of supplies which means the establishment and maintenance of appropriate policies in order to ensure the accessibility and where applicable the traceability of critical supplies used in the provision of the services;

               (d)the access controls to network and information systems which means the availability of a set of measures to ensure that the physical and logical access to network and information systems, including administrative security of network and information systems, is authorized and restricted based on business and security requirements.

               2. With regard to incident handling referred to in point (b) of Article 16(1) of Directive (EU) 2016/1148, the measures taken by the digital service provider shall include:

               (a)detection processes and procedures maintained and tested to ensure timely and adequate awareness of anomalous events;

               (b)processes and policies on reporting incidents and identifying weaknesses and vulnerabilities in their information systems;

               (c)a response in accordance with established procedures and reporting the results of the measure taken;

               (d)an assessment of the incident's severity, documenting knowledge from incident analysis and collection of relevant information which may serve as evidence and support a continuous improvement process.

               3. Business continuity management referred to in point (c) of Article 16(1) of Directive (EU) 2016/1148 means the capability of an organisation to maintain or as appropriate restore the delivery of services at acceptable predefined levels following a disruptive incident and shall include:

               (a)the establishment and the use of contingency plans based on a business impact analysis for ensuring the continuity of the services provided by digital service providers which shall be assessed and tested on a regular basis for example, through exercises;

               (b)disaster recovery capabilities which shall be assessed and tested on a regular basis for example, through exercises.

               4. The monitoring, auditing and testing referred to in point (d) of Article 16(1) of Directive (EU) 2016/1148 shall include the establishment and maintenance of policies on:

               (a)the conducting of a planned sequence of observations or measurements to assess whether network and information systems are operating as intended;

               (b)inspection and verification to check whether a standard or set of guidelines is being followed, records are accurate, and efficiency and effectiveness targets are being met;

               (c)a process intended to reveal flaws in the security mechanisms of a network and information system that protect data and maintain functionality as intended. Such process shall include technical processes and personnel involved in the operation flow.

               5. International standards referred to in point (e) of Article 16(1) of Directive (EU) 2016/1148 mean standards that are adopted by an international standardisation body as referred to in point (a) of Article 2(1) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council
                  2
               . Pursuant to Article 19 of Directive (EU) 2016/1148, European or internationally accepted standards and specifications relevant to the security of network and information systems, including existing national standards, may also be used.

               6.  Digital service providers shall ensure that they have adequate documentation available to enable the competent authority to verify compliance with the security elements set out in paragraphs 1, 2, 3, 4 and 5.

               Article 3

               Parameters to be taken into account to determine whether the impact of an incident is substantial

               1. With regard to the number of users affected by an incident, in particular users relying on the service for the provision of their own services referred to in point (a) of Article 16(4) of Directive (EU) 2016/1148, the digital service provider shall be in a position to estimate either of the following:

               (a)the number of  affected natural and legal persons with whom a contract for the provision of the service has been concluded; or

               (b)the number of affected users having used the service based in particular on previous traffic  data.

               2. The duration of an incident referred to in point (b) of Article 16(4) means the time period from the disruption of the proper provision of the service in terms of availability, authenticity, integrity or confidentiality until the time of recovery.

               3. As far as the geographical spread with regard to the area affected by the incident referred to in point (c) of Article 16(4) of Directive (EU) 2016/1148 is concerned, the digital service provider shall be in a position to identify whether the incident affects the provision of its services in specific Member States.

               4. The extent of disruption of the functioning of the service referred to in point (d) of Article 16(4) of Directive (EU) 2016/1148 shall be measured as regards one or more of the following characteristics impaired by an incident: the availability, authenticity, integrity or confidentiality of data or related services.

               5. With regard to the extent of the impact on economic and societal activities referred to in point (e) of Article 16(4) of Directive (EU) 2016/1148, the digital service provider shall be able to conclude, based on indications such as the nature of his contractual relations with the customer or, where appropriate, the potential number of affected users, whether the incident has caused significant material or non-material losses for the users such as in relation to health, safety or damage to property.

               6. For the purpose of paragraph 1, 2, 3, 4 and 5, the digital service providers shall not be required to collect additional information to which they do not have access.

               Article 4

               Substantial impact of an incident

               1. An incident shall be considered as having a substantial impact where at least one of the following situations has taken place:

               (a)The service provided by a digital service provider was unavailable for more than 5 000 000 user hours whereby the term user hour refers to the number of affected users in the Union for a duration of sixty minutes;

               (b)The incident has resulted in a loss of integrity, authenticity or confidentiality of stored or transmitted or processed data or the related services offered by, or accessible via a network and information system of the digital service provider affecting more than 100 000 users in the Union;

               (c)The incident has created a risk to public safety, public security or of loss of life;

               (d)The incident has caused material damage to at least one user in the Union where the damage caused to that user exceeds EUR 1 000 000.

               2. Drawing on the best practice collected by the Cooperation Group in the exercise of its tasks under Article 11(3) of Directive (EU) 2016/1148 and on the discussions under point (m) of Article 11(3) thereof, the Commission may review the thresholds laid down in paragraph 1.

               Article 5

               Entry into force

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

               (2)It shall apply from 10 May 2018.

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

               Done at Brussels, 30.1.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 194, 19.7.2016, p. 1.

                     (2)

                        Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).


title: Commission Implementing Regulation (EU) 2018/1500 of 9 October 2018 concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  10.10.2018

                  EN

                  Official Journal of the European Union

                  L 254/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1500
         of 9 October 2018
         concerning the non-renewal of approval of the active substance thiram, and prohibiting the use and sale of seeds treated with plant protection products containing thiram, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
         (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 Article 20(1), Article 49(2) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2003/81/EC (2) included thiram as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

                     Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

                     (3)

                     The approval of the active substance thiram, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2019.

                     (4)

                     An application for the renewal of the approval of thiram was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 20 January 2016.

                     (7)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                     (8)

                     On 27 January 2017 the Authority communicated to the Commission its conclusion (6) on whether thiram can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority identified a high acute risk to consumers and to workers from application of thiram by foliar spraying. Furthermore, it identified a high risk to birds and mammals from all representative uses assessed, including as a seed treatment, even taking into account the application of higher tier refinements in the risk assessment. Residue definitions for risk assessment purposes could not be derived from the incomplete information available on metabolite M1, consequently the assessment of consumer risk through dietary intake could not be completed and maximum residue levels could not be established. Furthermore, the formation of N,N-dimethylnitrous amide (NDMA), a substance of concern given its intrinsic hazard, in drinking water when surface water and groundwater containing thiram and its metabolite DMCS is subject to water treatment processes could not be excluded by the Authority based on the available information and in addition a high risk to aquatic organisms from exposure to DMCS was concluded by the Authority based on the limited information available. Also, based on the information available the Authority could not conclude on the endocrine disrupting potential of thiram.

                     (9)

                     The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted its comments, which have been carefully examined.

                     (10)

                     However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

                     (11)

                     Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance thiram in accordance with Article 20(1)(b) of that Regulation.

                     (12)

                     On 18 May 2018 the applicant wrote to the Commission to withdraw from the renewal application the representative uses concerning application by foliar spraying.

                     (13)

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

                     (14)

                     Taking into account the risk identified for birds and wild mammals from treated seeds the placing on the market and the use of seeds treated with plant protection products containing thiram should be prohibited.

                     (15)

                     The prohibition of placing on the market and use of treated seeds should apply as of 31 January 2020 in order to allow for a sufficient period of transition for the seed supply chain taking into account the limited availability of seeds that are not treated with products containing thiram.

                     (16)

                     Member States should be allowed sufficient time to withdraw authorisations for plant protection products containing thiram.

                     (17)

                     For plant protection products containing thiram, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 30 April 2019 for plant protection products used for foliar application and on 30 January 2020 for other plant protection products, including those used for seed treatment.

                     (18)

                     Commission Implementing Regulation (EU) 2018/524 (7) extended the expiry date of thiram to 30 April 2019 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision is taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

                     (19)

                     This Regulation does not prevent the submission of a further application for the approval of thiram in accordance with Article 7 of Regulation (EC) No 1107/2009.

                     (20)

                     The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Non-renewal of approval of active substance
            The approval of the active substance thiram is not renewed.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 73, on thiram, is deleted.

            Article 3
            Prohibition of placing on the market of treated seeds
            Seeds which have been treated with plant protection products containing thiram shall not be used or placed on the market.

            Article 4
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing thiram as active substance by 30 January 2019 at the latest.

            Article 5
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 30 April 2019 for plant protection products used for foliar application and on 30 January 2020 for other plant protection products, including those used for seed treatment, at the latest.

            Article 6
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            Article 3 shall apply as of 31 January 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 9 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2003/81/EC of 5 September 2003 amending Council Directive 91/414/EEC to include molinate, thiram and ziram as active substances (OJ L 224, 6.9.2003, p. 29).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

            (4)  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).

            (5)  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).

            (6)  EFSA (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance thiram. EFSA Journal 2017;15(7):4700 [29 pp.]. doi:10.2903/j.efsa.2017.4700.

            (7)  Commission Implementing Regulation (EU) 2018/524 of 28 March 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) Strain QST 713, identical with strain AQ 713, clodinafop, clopyralid, cyprodinil, dichlorprop-P, fosetyl, mepanipyrim, metconazole, metrafenone, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, quinoxyfen, rimsulfuron, spinosad, thiacloprid, thiamethoxam, thiram, tolclofos-methyl, triclopyr, trinexapac, triticonazole and ziram. (OJ L 88, 4.4.2018, p. 4).


title: Commission Implementing Regulation (EU) 2018/1586 of 22 October 2018 establishing a derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from coast, the minimum sea depth and the prohibition to fish above protected habitats for shore seines fishing in territorial waters of Croatia

text:
                  23.10.2018

                  EN

                  Official Journal of the European Union

                  L 264/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1586
         of 22 October 2018
         establishing a derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from coast, the minimum sea depth and the prohibition to fish above protected habitats for shore seines fishing in territorial waters of Croatia
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1967/2006 of 21 December 2006 concerning management measures for the sustainable exploitation of fishery resources in the Mediterranean Sea (1), and in particular Article 4(5) and Article 13(5) and (10) thereof,
         Whereas:

                     (1)

                     Article 4(1) of Regulation (EC) No 1967/2006 prohibits fishing with trawl nets, dredges, purse seines, boat seines, shore seines or similar nets above seagrass beds of, in particular, Posidonia oceanica or other marine phanerogams.

                     (2)

                     At the request of a Member State, the Commission may allow a derogation from the first subparagraph of Article 4(1) of Regulation (EC) No 1967/2006, provided that a number of conditions set out in Article 4(5) are fulfilled.

                     (3)

                     Article 13(1) of Regulation (EC) No 1967/2006 prohibits the use of towed gears within 3 nautical miles of the coast or within the 50 m isobath where that depth is reached at a shorter distance from the coast.

                     (4)

                     At the request of a Member State, the Commission may allow a derogation from Articles 13(1) of Regulation (EC) No 1967/2006, provided that a number of conditions set out in Article 13(1) second paragraph, 13(5) and (9) are fulfilled.

                     (5)

                     On 26 January 2016 the Commission received a request from Croatia for a derogation from the first subparagraph of Article 13(1) of that Regulation, for the use of traditional shore seine of large mesh size ‘šabakun’, fishing for greater amberjack (Seriola dumerili), traditional shore seine ‘oližnica’, fishing for sand smelt (Atherina boyeri) and traditional shore seines ‘girarica’ and ‘migavica’, fishing for picarels (Spicara smaris) within the Croatian territorial waters.

                     (6)

                     With the same request, Croatia requested for a derogation from the first subparagraph of Article 4(1) of Regulation (EC) No 1967/2006, for the use of traditional shore seines ‘girarica’ and ‘migavica’, fishing for picarels (Spicara smaris).

                     (7)

                     The request concerns fishing activities already authorised by Croatia and covers vessels which have a track record in the fishery of more than five years and operate under the management plan implemented by Croatia by Ministerial Ordinance (2) in accordance with Article 19(2) of Regulation (EC) No 1967/2006 on 30 March 2018 (‘Croatian management plan’).

                     (8)

                     The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the derogation requested by Croatia and the related management plan in April and October 2016. STECF highlighted need for clarifications on fishing gears used, bycatches, monitoring and scientific data. Croatia provided adequate clarifications to the Commission and revised accordingly the management plan by introducing additional measures on control, fleet management, data collection and monitoring.

                     (9)

                     The derogations requested by Croatia comply with the conditions set out in Article 4(5) and Article 13(5) and (9) of Regulation (EC) No 1967/2006.

                     (10)

                     In particular, there are specific geographical constraints given both the distinct morphological structure of Croatia, comprising of long coastline including numerous islands and the spatial distribution of the target species, which is exclusively limited in certain specific sites and zones in the coastal areas at depths of less than 50 meters. The fishing grounds are therefore limited.

                     (11)

                     With respect to picarels fishing the request concerns fishing activities by vessels of less than or equal to 12 meters overall length and engine power of less than or equal to 85 kW with bottom towed nets traditionally undertaken on Posidonia beds, in accordance with the first subparagraph of Article 4(5) of Regulation (EC) No 1967/2006. In addition the fishing activity with respect to picarels fishing affect approximately 5 % of the area covered by seagrass beds of Posidonia oceanica within the area covered by the management plan and less than 5 % of seagrass beds in the territorial waters of Croatia, in accordance with the requirements of points (ii) and (iii) of the first subparagraph of Article 4(5) of Regulation (EC) No 1967/2006.

                     (12)

                     The fishery cannot be undertaken with other gears, since only shore seines have the technical characteristic necessary to carry out this type of fishery.

                     (13)

                     Moreover, the fishery has no significant impact on the marine environment, as shore seines are very selective gears, they do not touch the seabed and cannot operate above the Posidonia oceanica seabed.

                     (14)

                     The request covers 87 vessels. The derogation requested by Croatia therefore affects a limited number of vessels, compared with the large distribution area of the fleet using these types of gears, representing 1 % of the fleet and 2 % of the gross tonnage (GT).

                     (15)

                     Those vessels are included on a list communicated to the Commission in accordance with Article 13(9) of Regulation (EC) No 1967/2006.

                     (16)

                     The Croatian management plan sets out all relevant definitions on the fisheries concerned and guarantees no further increase of the fishing effort in line with Article 13(9) of Regulation (EC) No 1967/2006 as fishing authorisations will be issued only to specified 87 vessels that are authorised to fish by Croatia. In this respect, it is noted that in line with the Croatian management plan and the Ministerial Ordinance, no fishing grounds for shore seines nets ‘migavica’, ‘girarica’ and ‘šabakun’ are foreseen in the fishing zone stated as ‘A’, while shore seine ‘oližnica’ is permitted only in the fishing subzones stated as ‘E4’ and ‘F2’. Additionally, the use of shore seine nets is prohibited in the areas identified as national parks and special habitats.

                     (17)

                     The fishing activities concerned fulfil the requirements of Article 4 of Regulation (EC) No 1967/2006. Indeed, the seines are hauled in the water column and do not touch the seabed.

                     (18)

                     The requirements of Article 8(1)(h) of Regulation (EC) No 1967/2006 are not applicable since they relate to trawlers.

                     (19)

                     As regards the requirement to comply with Article 9(3) of Regulation (EC) No 1967/2006 establishing the minimum mesh size with regard to use of traditional shore seines ‘oližnica’ fishing for sand smelt (Atherina boyeri), the Commission notes that in accordance with Article 9(7) of that Regulation, Croatia authorised a derogation from Article 9(3) of that Regulation in its management plan, as the fisheries concerned are highly selective, have a negligible effect on the marine environment and are not affected by the provisions in Article 4(5).

                     (20)

                     The Commission notes that Croatia did not authorise a derogation in its management plan from the requirements of Article 9(3) of Regulation (EC) No 1967/2006 with regard to use of traditional shore seine of large mesh size ‘šabakun’, fishing for greater amberjack (Seriola dumerili) and with regard to use of traditional shore seines ‘girarica’ and ‘migavica’, fishing for picarels (Spicara smaris).

                     (21)

                     The fishing activities concerned take place at a very short distance from the coast and therefore do not interfere with the activities of other vessels.

                     (22)

                     The management plan ensures that catches of species mentioned in Annex III of Regulation (EC) No 1967/2006 are minimal since the targeted species are greater amberjack (Seriola dumerili), sand smelt (Atherina boyeri) and picarels (Spicara smaris), which are not mentioned in Annex III of the Regulation (EC) No 1967/2006 and the fishing activities are highly selective.

                     (23)

                     Fishing activities are highly selective and do not target cephalopods.

                     (24)

                     The management plan includes measures for the monitoring of fishing activities, as provided for in the fifth subparagraph of Article 4(5) and in the third subparagraph of Article 13(9) of Regulation (EC) No 1967/2006, thus fulfilling the conditions set out in Article 14 of Council Regulation (EC) No 1224/2009 (3).

                     (25)

                     The requested derogations should therefore be granted.

                     (26)

                     Croatia should report to the Commission in regular intervals and in accordance with the monitoring plan provided for in the Croatian management plan.

                     (27)

                     A limitation in duration of the derogation will allow ensuring prompt corrective management measures in case the report to the Commission shows a poor conservation status of the exploited stock, while providing scope to enhance the scientific basis for an improved management plan.

                     (28)

                     The measures provided for in the Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Derogation

               1.   Article 4(1) of Regulation (EC) No 1967/2006 shall not apply in the territorial waters of Croatia to fishing for picarels (Spicara smaris) by shore seines ‘girarica’ and ‘migavica’.

               2.   Article 13(1), first subparagraph, of Regulation (EC) No 1967/2006, shall not apply in the territorial waters of Croatia to the following fisheries:

                           (a)

                           greater amberjack (Seriola dumerili) by shore seine of large mesh size ‘šabakun’;

                           (b)

                           sand smelt (Atherina boyeri) by shore seine ‘oližnica’; and

                           (c)

                           picarels (Spicara smaris) by shore seines ‘girarica’ and ‘migavica’.

               3.   The shore seines referred to in paragraphs 1 and 2 shall be used by vessels:

                           (a)

                           bearing a registration number set out in the Croatian management plan adopted by Croatia in accordance with Article 19 of Regulation (EC) No 1967/2006;

                           (b)

                           having a track record in the fishery for more than five years and not involving any further increase in the fishing effort deployed; and

                           (c)

                           holding a fishing authorisation and operating under the Croatian management plan

            Article 2
            Monitoring plan and report
            Croatia shall communicate to the Commission, within three years following the entry into force of this Regulation, a report drawn up in accordance with the monitoring plan established in the Croatian management plan.

            Article 3
            Entry into force
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 26 October 2018 to 26 October 2021.

            This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.
            Done at Brussels, 22 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 36, 8.2.2007, p. 6.

            (2)  Pravilnik o obavljanju gospodarskog ribolova na moru obalnim mrežama potegačama, Narodne Novine, OJ 30/2018, as amended by Pravilnik o izmjeni Pravilnika o obavljanju gospodarskog ribolova na moru obalnim mrežama potegačama, OJ 49/2018.

            (3)  Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).


title: Council Implementing Regulation (EU) 2018/1654 of 6 November 2018 implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea

text:
                  7.11.2018

                  EN

                  Official Journal of the European Union

                  L 276/3

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/1654
         of 6 November 2018
         implementing Regulation (EU) 2017/1509 concerning restrictive measures against the Democratic People's Republic of Korea
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2017/1509 of 30 August 2017 concerning restrictive measures against the Democratic People's Republic of Korea and repealing Regulation (EC) No 329/2007 (1), and in particular Article 47(5) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 30 August 2017, the Council adopted Regulation (EU) 2017/1509.

                     (2)

                     On 3 October 2017, the United Nations Security Council Committee established pursuant to United Nations Security Council Resolution 1718 (2006) (the ‘UNSC Committee’) designated four vessels for a port entry ban.

                     (3)

                     On 28 December 2017, the UNSC Committee designated another four vessels for a port entry ban.

                     (4)

                     On 30 March 2018, the UNSC Committee designated 15 vessels for an asset freeze and 25 vessels for a port entry ban. Those vessels are listed in Annex XIV to Regulation (EU) 2017/1509.

                     (5)

                     Further additional information regarding some of those vessels has been published by the UNSC Committee in the list of designated vessels.

                     (6)

                     Annex XIV to Regulation (EU) 2017/1509 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex XIV to Regulation (EU) 2017/1509 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, 6 November 2018.

                  For the Council

                  The President

               H. LÖGER

            (1)  OJ L 224, 31.8.2017, p. 1.

            ANNEX

                        (1)

                        In Annex XIV to Regulation (EU) 2017/1509, entries 1 to 15 under the heading ‘A. Vessels subject to a seizure’, are replaced by the following:

                                    ‘Vessel name

                                    IMO number

                                    Designated as economic resources of

                                    Date of UN designation

                                    1.

                                    CHON MYONG 1
                                    DPRK oil tanker M/V CHON MYONG 1 conducted a ship-to-ship transfer, likely for oil, in late December 2017.

                                    8712362

                                    30.3.2018

                                    2.

                                    AN SAN 1
                                    DPRK tanker M/V AN SAN 1 was involved in ship-to-ship transfer operations, likely for oil, in late January 2018.

                                    7303803

                                    30.3.2018

                                    3.

                                    YU PHYONG 5
                                    DPRK merchant vessel M/V YU PHONG 5 imported refined petroleum products to Nampo, DPRK, on 29 November 2017 through a ship-to-ship transfer conducted on 26 November 2017.

                                    8605026

                                    30.3.2018

                                    4.

                                    SAM JONG 1
                                    DPRK merchant vessel M/V SAM JONG 1 was involved in ship-to-ship transfer operations of oil in late January 2018.

                                    8405311

                                    30.3.2018

                                    5.

                                    SAM JONG 2
                                    DPRK merchant vessel M/V SAM JONG 2 was involved in ship-to-ship transfer operations of oil in late January 2018.

                                    7408873

                                    30.3.2018

                                    6.

                                    SAM MA 2
                                    DPRK oil tanker M/V SAM MA 2 imported refined petroleum products in October, early November and mid-November 2017 through multiple ship-to-ship transfers.

                                    8106496

                                    30.3.2018

                                    7.

                                    YU JONG 2
                                    DPRK oil tanker M/V YU JONG 2 was involved in ship-to-ship transfer operations for oil in November 2017. M/V YU JONG 2 was also involved in a ship-to-ship transfer operation, likely for oil, with M/V MIN NING DE YOU 078 on 16 February 2018.

                                    8604917

                                    30.3.2018

                                    8.

                                    PAEK MA
                                    DPRK vessel M/V PAEK MA was involved in ship-to-ship transfer operations for oil in mid-January 2018.

                                    9066978

                                    30.3.2018

                                    9.

                                    JI SONG 6
                                    DPRK tanker M/V JI SONG 6 was involved in ship-to-ship transfer operations of oil in late January 2018.

                                    8898740

                                    30.3.2018

                                    10.

                                    CHON MA SAN
                                    DPRK vessel M/V CHON MA SAN was involved in ship-to-ship transfer operations for oil in mid-November 2017.

                                    8660313

                                    30.3.2018

                                    11.

                                    NAM SAN 8
                                    DPRK crude oil tanker M/V NAM SAN 8 is believed to have been involved in ship-to-ship transfer operations for oil.

                                    8122347

                                    30.3.2018

                                    12.

                                    YU SON
                                    DPRK tanker M/V YU SON is believed to have been involved in ship-to-ship transfer operations for oil.

                                    8691702

                                    30.3.2018

                                    13.

                                    WOORY STAR
                                    DPRK cargo vessel M/V WOORY STAR is believed to have been involved in illicit transfers of prohibited DPRK goods.

                                    8408595

                                    30.3.2018

                                    14.

                                    JI SONG 8
                                    DPRK cargo vessel M/V JI SONG 8 is owned by Phyongchon Shipping & Marine and is believed to have been involved in illicit transfers of prohibited DPRK goods.

                                    8503228

                                    Phyongchon Shipping & Marine

                                    30.3.2018

                                    15.

                                    HAP JANG GANG 6
                                    Other information: DPRK cargo vessel M/V HAP JANG GANG 6 is owned by Hapjanggang Shipping Corp and is believed to have been involved in illicit transfers of prohibited DPRK goods.

                                    9066540

                                    Hapjanggang Shipping Corp

                                    30.3.2018’

                        (2)

                        In Annex XIV to Regulation (EU) 2017/1509, entries 1 to 33 under the heading ‘B. Vessels which are prohibited entry into ports’, are replaced by the following:

                                    ‘Vessel name

                                    IMO number

                                    Date of UN designation

                                    1.

                                    PETREL 8
                                    Other information: na

                                    9562233
                                    (MMSI: 620233000)

                                    3.10.2017

                                    2.

                                    HAO FAN 6
                                    Other information: na

                                    8628597
                                    (MMSI: 341985000)

                                    3.10.2017

                                    3.

                                    TONG SAN 2
                                    Other information: na

                                    8937675
                                    (MMSI: 445539000)

                                    3.10.2017

                                    4.

                                    JIE SHUN
                                    Other information: na

                                    8518780
                                    (MMSI: 514569000)

                                    3.10.2017

                                    5.

                                    BILLIONS NO. 18
                                    Other information: na

                                    9191773

                                    28.12.2017

                                    6.

                                    UL JI BONG 6
                                    Other information: na

                                    9114555

                                    28.12.2017

                                    7.

                                    RUNG RA 2
                                    Other information: na

                                    9020534

                                    28.12.2017

                                    8.

                                    RYE SONG GANG 1
                                    Other information: na

                                    7389704

                                    28.12.2017

                                    9.

                                    CHON MYONG 1
                                    Other information: DPRK oil tanker M/V CHON MYONG 1 conducted a ship-to-ship transfer, likely for oil, in late December 2017.

                                    8712362

                                    30.3.2018

                                    10.

                                    AN SAN 1
                                    Other information: DPRK tanker M/V AN SAN 1 was involved in ship-to-ship transfer operations, likely for oil, in late January 2018.

                                    7303803

                                    30.3.2018

                                    11.

                                    YU PHYONG 5
                                    Other information: DPRK merchant vessel M/V YU PHONG 5 imported refined petroleum products to Nampo, DPRK, on 29 November 2017 through a ship-to-ship transfer conducted on 26 November 2017.

                                    8605026

                                    30.3.2018

                                    12.

                                    SAM JONG 1
                                    Other information: DPRK merchant vessel M/V SAM JONG 1 was involved in ship-to-ship transfer operations of oil in late January 2018.

                                    8405311

                                    30.3.2018

                                    13.

                                    SAM JONG 2
                                    Other information: DPRK merchant vessel M/V SAM JONG 2 was involved in ship-to-ship transfer operations of oil in late January 2018.

                                    7408873

                                    30.3.2018

                                    14.

                                    SAM MA 2
                                    Other information: DPRK oil tanker M/V SAM MA 2 imported refined petroleum products in October, early November and mid-November 2017 through multiple ship-to-ship transfers.

                                    8106496

                                    30.3.2018

                                    15.

                                    YU JONG 2
                                    Other information: DPRK oil tanker M/V YU JONG 2 was involved in ship-to-ship transfer operations for oil in November 2017. M/V YU JONG 2 was also involved in a ship-to-ship transfer operation, likely for oil, with M/V MIN NING DE YOU 078 on 16 February 2018.

                                    8604917

                                    30.3.2018

                                    16.

                                    PAEK MA
                                    Other information: DPRK vessel M/V PAEK MA was involved in ship-to-ship transfer operations for oil in mid-January 2018.

                                    9066978

                                    30.3.2018

                                    17.

                                    JI SONG 6
                                    Other information: DPRK tanker M/V JI SONG 6 was involved in ship-to-ship transfer operations of oil in late January 2018.

                                    8898740

                                    30.3.2018

                                    18.

                                    CHON MA SAN
                                    Other information: DPRK vessel M/V CHON MA SAN was involved in ship-to-ship transfer operations for oil in mid-November 2017.

                                    8660313

                                    30.3.2018

                                    19.

                                    NAM SAN 8
                                    Other information: DPRK crude oil tanker M/V NAM SAN 8 is believed to have been involved in ship-to-ship transfer operations for oil.

                                    8122347

                                    30.3.2018

                                    20.

                                    YU SON
                                    Other information: DPRK tanker M/V YU SON is believed to have been involved in ship-to-ship transfer operations for oil.

                                    8691702

                                    30.3.2018

                                    21.

                                    WOORY STAR
                                    Other information: DPRK cargo vessel M/V WOORY STAR is believed to have been involved in illicit transfers of prohibited DPRK goods.

                                    8408595

                                    30.3.2018

                                    22.

                                    ASIA BRIDGE 1
                                    Other information: M/V ASIA BRIDGE 1 loaded DPRK coal at Nampo, DPRK, on 22 October 2017 and transferred it to Cam Pha,Vietnam.

                                    8916580

                                    30.3.2018

                                    23.

                                    XIN GUANG HAI
                                    Other information: Merchant vessel M/V XIN GUANG HAI loaded DPRK coal at Taean, DPRK, on 27 October 2017 and transferred it to Port Klang, Malaysia, on 18 December 2017.

                                    9004700

                                    30.3.2018

                                    24.

                                    HUA FU
                                    Other information: M/V HUA FU loaded DPRK coal at Najin, DPRK, on 24 September 2017.

                                    9020003

                                    30.3.2018

                                    25.

                                    YUK TUNG
                                    Other information: M/V YUK TUNG engaged in a ship-to-ship transfer, likely for oil, with M/V RYE SONG GANG in January 2018.

                                    9030591

                                    30.3.2018

                                    26.

                                    KOTI
                                    Other information: M/V KOTI engaged in a ship-to-ship transfer, likely for oil, with M/V KUM UN SAN 3 on 9 December 2017.

                                    9417115

                                    30.3.2018

                                    27.

                                    DONG FENG 6
                                    Other information: M/V DONG FENG 6 loaded DPRK coal at Hamhung, DPRK, on 11 July 2017, for export in violation of UN sanctions.

                                    9008201

                                    30.3.2018

                                    28.

                                    HAO FAN 2
                                    Other information: M/V HAO FAN 2 loaded DPRK coal at Nampo, DPRK, on 3 June 2017, for export in violation of UN sanctions.

                                    8747604

                                    30.3.2018

                                    29.

                                    HAO FAN 6
                                    Other information: M/V HAO FAN 6 loaded DPRK coal at Nampo, DPRK, on 27 August 2017.

                                    8628597

                                    30.3.2018

                                    30.

                                    JIN HYE
                                    Other information: M/V JIN HYE engaged in a ship-to-ship transfer with M/V CHON MA SAN on 16 December 2017.

                                    8518572

                                    30.3.2018

                                    31.

                                    FAN KE
                                    Other information: M/V FAN KE loaded DPRK coal at Nampo, DPRK, in September/October 2017.

                                    8914934

                                    30.3.2018

                                    32.

                                    WAN HENG 11
                                    Other information: M/V WAN HENG 11 engaged in a ship-to-ship transfer, likely for oil, with M/V RYE SONG GANG 1 on 13 February 2018.
                                    Wan Heng 11, formerly a Belize-flagged vessel, is now operating as a DPRK-flagged vessel named the KUMJINGANG3 or Kum Jin Gang 3.

                                    8791667

                                    30.3.2018

                                    33.

                                    MIN NING DE YOU 078
                                    Other information: M/V MIN NING DE YOU engaged in a ship-to-ship transfer, likely for oil, with M/V YU JONG 2 on 16 February 2018.

                                    Does not exist

                                    30.3.2018’