natgillin/translations-raw huggingface dataset:
Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to the safety of refined shrimp peptide concentrate for hypo-, normo-, and hyper-tensive consumers due to its putative antihypertensive effects, its potential side effects related to its postulated inhibition of the angiotensin converting enzyme (ACE) and potential cardiac effects, and its potential interactions with medicines used in the treatment of blood pressure disorders.
Zahtjev za stavljanje na tržište u Uniji rafiniranog koncentrata peptida kozice kao nove hrane podnesen je državi članici u skladu s člankom 4.
In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 21 September 2017, asking it to carry out an additional assessment for refined shrimp peptide concentrate as novel food ingredient in accordance with Regulation (EC) No 258/97.
Uredbe (EZ) br. 258/97 te ispunjava i zahtjeve utvrđene u Uredbi (EU) 2015/2283.
On 2 February 2018, the Applicant made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application namely, a de novo peptide synthesis study, the analytical report of the ACE inhibitory effects study, an acute oral toxicity study, an in vitro bacterial reverse mutation assay, a 90-day oral toxicity study, an assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and a double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate in dietary supplements in healthy humans with mild or moderate hypertension.
Nadležno tijelo Finske izdalo je 8. ožujka 2017. izvješće o početnoj ocjeni.
This request was reiterated by the Applicant in a subsequent application submitted on 29 March 2018.
U tom je izvješću zaključilo da rafinirani koncentrat peptida kozice ispunjava kriterije za novi sastojak hrane utvrđene u članku 3. stavku 1.
On 18 April 2018, the Authority adopted ‘Scientific Opinion on the safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283’.
Uredbe (EZ) br. 258/97.
That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
Komisija je 13. ožujka 2017. izvješće o početnoj ocjeni proslijedila ostalim državama članicama.
That opinion gives sufficient grounds to establish that refined shrimp peptide concentrate, in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.
Ostale države članice uložile su obrazložene prigovore u roku od 60 dana propisanom u članku 6. stavku 4. prvom podstavku Uredbe (EZ) br. 258/97 u pogledu sigurnosti rafiniranog koncentrata peptida kozice za potrošače s hipotenzijom, normotenzijom i hipertenzijom zbog njegovih navodnih antihipertenzijskih učinaka, mogućih nuspojava povezanih s pretpostavljenom inhibicijom angiotenzin-konvertirajućeg enzima (ACE) i mogućih učinaka na srce te mogućih interakcija s lijekovima koji se upotrebljavaju u liječenju poremećaja krvnog tlaka.
In its opinion, the Authority considered that the data from the 90-day oral toxicity study served as a basis to assess the toxicity profile of refined shrimp peptide concentrate and to establish the related No Observed Adverse Effect Level (NOAEL).
S obzirom na prigovore koje su uložile ostale države članice, Komisija je 21. rujna 2017. zatražila od Europske agencije za sigurnost hrane („Agencija”) da provede dodatnu ocjenu rafiniranog koncentrata peptida kozice kao novog sastojka hrane u skladu s Uredbom (EZ) br. 258/97.
The data from the assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and the data from the double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate dietary supplement in healthy humans with mild or moderate hypertension, served as the basis to establish the safety of the novel food for this category of consumers.
Podnositelj zahtjeva Komisiji je 2. veljače 2018. podnio zahtjev za zaštitu vlasnički zaštićenih podataka za niz studija koje je dostavio u potporu zahtjevu, i to de novo studiju sinteze peptida, analitičko izvješće o ispitivanju inhibitornih učinaka ACE-a, studiju akutne oralne toksičnosti, bakterijski test povratnih mutacija in vitro, 90-dnevnu studiju oralne toksičnosti, studiju o ocjeni antihipertenzijskih učinaka i sigurnosti rafiniranog koncentrata peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom te studiju o dvostruko slijepom placebom kontroliranom paralelnom ispitivanju za ocjenu antihipertenzijskog učinka i sigurnosti rafiniranog koncentrata peptida kozice u dodacima prehrani kod zdravih osoba s blagom ili umjerenom hipertenzijom.
Therefore, it is considered that the conclusions on the safety of refined shrimp peptide concentrate, could not have been reached without the data from the unpublished reports of these studies.
Taj je zahtjev podnositelj zahtjeva ponovio u naknadnom zahtjevu podnesenom 29. ožujka 2018.
Following receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the study reports, and to clarify their claim to an exclusive right of reference to those studies, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.
Agencija je 18. travnja 2018. donijela „Znanstveno mišljenje o sigurnosti rafiniranog koncentrata peptida kozice kao nove hrane u skladu s Uredbom (EU) 2015/2283”.
The Applicant also declared to hold proprietary and exclusive rights of reference to the studies under national law at the time the application was submitted, and that therefore third parties could not lawfully access or use those studies.
To je mišljenje u skladu sa zahtjevima članka 11.
The Commission has assessed all the information provided by the Applicant and considers that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283.
Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the 90-day oral toxicity study, the assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and the double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate dietary supplement in healthy humans with mild or moderate hypertension, contained in the Applicant's file and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation.
U mišljenju se iznosi dovoljno informacija na temelju kojih se može utvrditi da je rafinirani koncentrat peptida kozice u skladu s člankom 12. stavkom 1.
As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.
Uredbe (EU) 2015/2283 kada se upotrebljava kao sastojak u dodacima prehrani u predloženim upotrebama i količinama.
However, restricting the authorisation of this novel food and of the reference to the 90-day oral toxicity study, to the assessment study of the antihypertensive effects and safety of the refined shrimp peptide concentrate in healthy humans with mild or moderate hypertension, and to the double-blind, placebo-controlled, parallel study on the assessment of anti-hypertensive effect and safety of a the refined shrimp peptide concentrate dietary supplement in healthy humans with mild or moderate hypertension, contained in the Applicant's file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation.
U svojem mišljenju Agencija smatra da su podaci iz 90-dnevne studije oralne toksičnosti upotrijebljeni kao osnova za ocjenu profila toksičnosti rafiniranog koncentrata peptida kozice i utvrđivanje povezane količine bez opaženog štetnog učinka (NOAEL).
As the source of the novel food comes from crustaceans, and may contain traces of fish, of other crustaceans, and of molluscs, which are listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council as substances or products which cause allergies or intolerances, food supplements containing refined shrimp peptide concentrate should be appropriately labelled following the requirements of Article 21 of that Regulation.
Podaci iz studije o ocjeni antihipertenzijskih učinaka i sigurnosti rafiniranog koncentrata peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom te podaci iz studije o dvostruko slijepom placebom kontroliranom paralelnom ispitivanju za ocjenu antihipertenzijskog učinka i sigurnosti dodatka prehrani rafinirani koncentrat peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom, upotrijebljeni su kao osnova za utvrđivanje sigurnosti nove hrane za tu kategoriju potrošača.
Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements.
Stoga se smatra da zaključci o sigurnosti rafiniranog koncentrata peptida kozice ne bi mogli biti doneseni bez podataka iz neobjavljenih izvješća o tim studijama.
The use of refined shrimp peptide concentrate should be authorised without prejudice to that Directive.
Nakon primitka mišljenja Agencije Komisija je zatražila od podnositelja zahtjeva da dodatno pojasni dano obrazloženje u pogledu njegova zahtjeva za zaštitu vlasničkih podataka iz izvješća o studijama i da pojasni zahtjev za isključivo pravo upućivanja na te studije, kako je navedeno u članku 26. stavku 2. točkama (a) i (b) Uredbe (EU) 2015/2283.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Podnositelj zahtjeva izjavio je i da je u trenutku podnošenja zahtjeva bio nositelj vlasničkih i isključivih prava upućivanja na studije u skladu s nacionalnim pravom te da stoga treće osobe nisu mogle imati zakonit pristup tim studijama niti se koristiti njima.
HAS ADOPTED THIS REGULATION:
Komisija je ocijenila sve informacije koje je dostavio podnositelj zahtjeva te zaključila da je podnositelj zahtjeva dostatno potkrijepio ispunjenje zahtjeva utvrđenih u članku 26. stavku 2.
Refined shrimp peptide concentrate as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
U skladu s tim, kako je predviđeno u članku 26. stavku 2.
For a period of five years from the date of entry into force of this Regulation only the initial Applicant:
Uredbe (EU) 2015/2283, Agencija 90-dnevnu studiju oralne toksičnosti, studiju o ocjeni antihipertenzijskih učinaka i sigurnosti rafiniranog koncentrata peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom i studiju o dvostruko slijepom placebom kontroliranom paralelnom ispitivanju za ocjenu antihipertenzijskog učinka i sigurnosti dodatka prehrani rafinirani koncentrat peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom, koje su sadržane u dokumentaciji podnositelja zahtjeva i bez kojih Agencija ne bi mogla ocijeniti novu hranu, ne bi smjela upotrijebiti u korist budućeg podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe.
Company: Marealis AS;
Slijedom toga, stavljanje na tržište u Uniji nove hrane odobrene ovom Uredbom trebalo bi ograničiti na podnositelja zahtjeva tijekom razdoblja od pet godina.
Address: Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway
Međutim, ograničenje upotrebe odobrenja te nove hrane i upućivanja na 90-dnevnu studiju oralne toksičnosti, na studiju o ocjeni antihipertenzijskih učinaka i sigurnosti rafiniranog koncentrata peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom i na studiju o dvostruko slijepom placebom kontroliranom paralelnom ispitivanju za ocjenu antihipertenzijskog učinka i sigurnosti dodatka prehrani rafinirani koncentrat peptida kozice kod zdravih osoba s blagom ili umjerenom hipertenzijom, koje su sadržane u dokumentaciji podnositelja zahtjeva, isključivo na podnositelja zahtjeva ne sprečava druge podnositelje zahtjeva da podnesu zahtjev za odobrenje stavljanja na tržište iste nove hrane pod uvjetom da se njihov zahtjev temelji na zakonito pribavljenim informacijama koje podupiru odobrenje u skladu s ovom Uredbom.
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Marealis AS.
Budući da se nova hrana dobiva od rakova i može sadržavati tragove ribe, drugih rakova i mekušaca, koji su navedeni u Prilogu II.
The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation
Uredbi (EU) br. 1169/2011 Europskog parlamenta i Vijeća kao tvari ili proizvodi koji uzrokuju alergije ili netolerancije, dodatke prehrani koji sadržavaju rafinirani koncentrat peptida kozice trebalo bi na odgovarajući način označiti u skladu sa zahtjevima članka 21. te uredbe.
The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC and to the provisions of Regulation (EU) No 1169/2011.
Direktivom 2002/46/EZ Europskog parlamenta i Vijeća utvrđeni su zahtjevi o dodacima prehrani.
Article 2
Upotrebu rafiniranog koncentrata peptida kozice trebalo bi odobriti ne dovodeći u pitanje tu direktivu.
The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EC) No 2015/2283, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Marealis AS.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Article 4
Rafinirani koncentrat peptida kozice, kako je naveden u Prilogu ovoj Uredbi, uvrštava se na Unijin popis odobrene nove hrane utvrđen u Provedbenoj uredbi (EU) 2017/2470.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe isključivo je prvotnom podnositelju zahtjeva,
This Regulation shall be binding in its entirety and directly applicable in all Member States.
društvu: Marealis AS,
Done at Brussels, 30 October 2018.
Adresa: Stortorget 1, Kystens Hus, 2nd floor, N–9008 Tromsø.
For the Commission
Poštanska adresa: P.O.
The President
odobreno stavljati na tržište u Uniji novu hranu iz stavka 1., osim ako budući podnositelj zahtjeva dobije odobrenje za novu hranu bez upućivanja na podatke zaštićene u skladu s člankom 2. ove Uredbe ili uz suglasnost društva Marealis AS.
OJ L 327, 11.12.2015, p. 1.
Unos na Unijin popis iz stavka 1. uključuje uvjete upotrebe i zahtjeve za označivanje utvrđene u Prilogu ovoj Uredbi.
Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
Odobrenjem iz ovog članka ne dovode se u pitanje odredbe Direktive 2002/46/EZ i odredbe Uredbe (EU) br. 1169/2011.
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).
Članak 2.
Marealis A.S., 2009-2016.
Uredbe 2015/2283, ne smiju se upotrebljavati u korist budućih podnositelja zahtjeva tijekom razdoblja od pet godina od datuma stupanja na snagu ove Uredbe bez suglasnosti društva Marealis AS.
EFSA Journal 2018; 16(5):5267.
Članak 4.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
ANNEX
Sastavljeno u Bruxellesu 30. listopada 2018.
the following last column is added in Table 1 (Authorised novel foods):
Predsjednik
‘Data Protection’
SL L 327, 11.12.2015., str. 1.
Conditions under which the novel food may be used
Marealis A.S., 2009.–2016.
Additional specific labelling requirements
EFSA Journal 2018.; 16(5):5267.
Other requirements
Uredba (EU) br. 1169/2011 Europskog parlamenta i Vijeća od 25. listopada 2011. o informiranju potrošača o hrani, izmjeni uredbi (EZ) br. 1924/2006 i (EZ) br. 1925/2006 Europskog parlamenta i Vijeća te o stavljanju izvan snage Direktive Komisije 87/250/EEZ, Direktive Vijeća 90/496/EEZ, Direktive Komisije 1999/10/EZ, Direktive 2000/13/EZ Europskog parlamenta i Vijeća, direktiva Komisije 2002/67/EZ i 2008/5/EZ i Uredbe Komisije (EZ) br. 608/2004 (SL L 304, 22.11.2011., str. 18.).
‘Refined shrimp peptide concentrate
PRILOG
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘refined shrimp peptide concentrate’.
(Odobrena nova hrana):
Applicant: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway
(Odobrena nova hrana):
During the period of data protection the novel food refined shrimp peptide concentrate is authorised for placing on the market within the Union only by Marealis AS unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Marealis AS.
Odobrena nova hrana
Food Supplements as defined in Directive 2002/46/EC for the adult population
Dodatni posebni zahtjevi za označivanje proizvoda
1200 mg/day
Ostali zahtjevi
The following entry is inserted in Table 2 (Specifications) in alphabetical order:
Zaštita podataka
Authorised Novel Food
„Rafinirani koncentrat peptida kozice
Description
Najveće dopuštene količine
Refined shrimp peptide concentrate is a peptide mixture obtained from northern shrimp (Pandalus borealis) shells and heads via a series of purification steps following enzymatic proteolysis using a protease from Bacillus licheniformis and/or Bacillus amyloliquefaciens.
Pri označivanju hrane koja sadržava novu hranu navodi se ‚rafinirani koncentrat peptida kozice’.
Characteristics/Composition
Podnositelj zahtjeva: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N–9008 Tromsø.
Total Dry matter (%): ≥ 95,0 %
Poštanska adresa: P.O. Box 1065, 9261 Tromsø, Norveška
Peptides (w/weight dry matter): ≥ 87,0 % of which peptides with molecular weight < 2 kDa: ≥ 99,9 %
Tijekom razdoblja zaštite podataka stavljanje na tržište u Uniji nove hrane rafinirani koncentrat peptida kozice odobreno je isključivo podnositelju zahtjeva Marealis AS, osim ako budući podnositelj zahtjeva dobije odobrenje za novu hranu bez upućivanja na vlasnički zaštićene znanstvene dokaze ili znanstvene podatke zaštićene u skladu s člankom 26.
Fat (w/w): ≤ 1,0 %
Uredbe (EU) 2015/2283 ili uz suglasnost društva Marealis AS.
Carbohydrates (w/w): ≤ 1,0 %
Datum prestanka zaštite podataka: 20. studenoga 2023.”
Ash (w/w): ≤ 15,0 %
Dodaci prehrani u smislu Direktive 2002/46/EZ namijenjeni odrasloj populaciji
Calcium: ≤ 2,0 %
1200 mg dnevno
Potassium: ≤ 0,15 %
Sljedeći unos umeće se abecednim redom u tablicu 2.
Sodium: ≤ 3,5 %
(Specifikacije):
Heavy Metals
Odobrena nova hrana
Arsenic (inorganic): ≤ 0,22 mg/kg
Specifikacija
Arsenic (organic): ≤ 51,0 mg/kg
Opis
Cadmium: ≤ 0,09 mg/kg
Rafinirani koncentrat peptida kozice je smjesa peptida dobivena od ljuštura i glava sjeverne kozice (Pandalus borealis) nizom postupaka pročišćavanja nakon enzimske proteolize s pomoću proteaze bakterija Bacillus licheniformis i/ili Bacillus amyloliquefaciens.
Lead: ≤ 0,18 mg/kg
Svojstva/sastav
Total mercury: ≤ 0,03 mg/kg
Ukupna suha tvar (%): ≥ 95,0 %
Microbiological criteria:
Peptidi (m/m suhe tvari) ≥ 87,0 % od čega peptidi molekularne mase < 2 kDa: ≥ 99,9 %
Total viable cell count: ≤ 20000 CFU/g
Masti (m/m): ≤ 1,0 %
Salmonella: ND/25g
Ugljikohidrati (m/m): ≤ 1,0 %
Listeria monocytogenes: ND/25g
Pepeo (m/m): ≤ 15,0 %
Coagulase positive Staphylococcus aureus: ≤ 200 CFU/g
Kalcij: ≤ 2,0 %
Pseudomonas aeruginosa: ND/25g
Kalij: ≤ 0,15 %
Mould/yeast: ≤ 20 CFU/g
Natrij: ≤ 3,5 %
Escherichia coli: ≤ 20 CFU/g
Arsen (organski): ≤ 51,0 mg/kg
CFU : Colony Forming Units
Kadmij: ≤ 0,09 mg/kg
CFU : Colony Forming Units ND : Not Detectable’
Listeria monocytogenes: ND/25 g
renewing the derogation from Council Regulation (EC) No 1967/2006 as regards the minimum distance from coast and the minimum sea depth for boat seines fishing for transparent goby (Aphia minuta) in certain territorial waters of Italy
o produljenju odstupanja od Uredbe (EZ) br. 1967/2006 u pogledu najmanje udaljenosti od obale i najmanje dubine mora za potegače otvorenog mora koje love mliječ ružični (Aphia minuta) u određenim teritorijalnim vodama Italije
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 isobaths where that depth is reached at a shorter distance from the coast.
Člankom 13. stavkom 1.
A derogation from Article 13(1) of that Regulation for the use of boat seines by vessels fishing for transparent goby (Aphia minuta) in the territorial waters of the Geographical Sub-Area 9, as defined in Annex I to Regulation (EU) No 1343/2011 of the European Parliament and of the Council was granted until 31 March 2014 by Commission Implementing Regulation (EU) No 988/2011.
Na zahtjev države članice Komisija može dopustiti odstupanje od članka 13. stavka 1.
An extension of the derogation was granted until 31 March 2018 by Commission Implementing Regulation (EU) 2015/2407.
Uredbe (EZ) br. 1967/2006 ako su ispunjeni određeni uvjeti utvrđeni u članku 13. stavcima 5. i 9.
Italy provided up-to-date information justifying the extension of the derogation.
Provedbenom uredbom Komisije (EU) br. 988/2011.
Italy adopted the management plan by Decree in accordance with Article 19(2) of Regulation (EC) No 1967/2006.
Provedbenom uredbom Komisije (EU) 2015/2407 odobreno je produljenje tog odstupanja do 31. ožujka 2018.
The management plan adopted is put in place to accompany the entire duration of the derogation.
Italija je donijela plan upravljanja na temelju Odluke u skladu s člankom 19. stavkom 2.
The Scientific, Technical and Economic Committee for Fisheries (STECF) assessed the derogation requested by Italy and the related updated management plan in July 2018.
Uredbe (EZ) br. 1967/2006.
The overall assessment by the STECF is positive, information on its biology and ecology, fleet and effort are well presented.
Doneseni plan upravljanja primjenjuje se tijekom čitavog trajanja odstupanja.