natgillin/translations-raw huggingface dataset:
Amount EUR
Navođenje ukupne razine jamstva u pogledu ispravnog funkcioniranja sustava upravljanja i kontrole i objašnjenje načina na koji je ta razina dobivena iz kombinacije rezultata revizija sustava, revizija rashoda i revizija financijskih izvještaja.
Results of audits on additional expenditure (8)
Prema potrebi, revizorsko tijelo uzet će u obzir i rezultate revizijskog rada koji su provela druga nacionalna revizorska tijela ili revizorska tijela Unije koji bi mogli utjecati na financijske podatke prijavljene za dotičnu financijsku godinu.
Description
Procjena svih provedenih aktivnosti ublažavanja i korektivnih mjera koje provodi odgovorno tijelo, kao što su financijske korekcije, i navođenje jesu li potrebne dodatne korektivne mjere koje se odnose na sustav ili financijski aspekt.
Fund/project/payment reference no.
PRILOZI GODIŠNJEM IZVJEŠĆU O KONTROLI
Additional expenditure audited (3)
Rezultati revizija sustava (predložak definiran u nastavku)
Amount of errors in the additional expenditure audited (4)
Rezultati revizija rashoda (predložak definiran u nastavku)
Financial corrections implemented by the Responsible Authority on the additional expenditure audited (6)
Rezultati revizija dodatnog rashoda (ako je primjenjivo)
Expenditure linked to interim payments or final payments included in the random/statistical sample
Rezultati revizija sustava
Other (to be described) …
Subjekt koji je predmet revizije (npr. odgovorno tijelo, delegirano tijelo itd.)
If the financial data — i.e. the audit population — is divided into different strata (e.g. advance payments, interim payments or final payments, other), the information is to be provided by strata where applicable.
Naziv revizije
One line for each stratum and the strata parameters must be described in section 5 of the annual control report.
Datum završnog revizijskog izvješća
Column B shall refer to the auditable population, i.e. the “draft accounts” representing all payments made by the Responsible Authority in the current financial year from which the sample was drawn.
Ključni uvjeti (ako je primjenjivo)
If the audit sample drawn from the current financial year includes interim payments and/or final payments clearing advance payments declared in the accounts of previous financial years, these advance payments shall fall within the scope of the audit of expenditure for the sampled interim payments and/or final payment.
[kako je definirano u tablici 1 – Prilogu I. Provedbenoj uredbi Komisije (EU) 2015/378]
However, for reporting purposes only the interim payments or final payments sampled from the draft accounts of the current financial year shall be reported in Table 10.2 (Column C) and taken into consideration for calculating the audit coverage for the current financial year (Column D).
Ukupna procjena (kategorija 1, 2, 3, 4) (kako je definirano u tablici 2 – Prilogu I. Provedbenoj uredbi Komisije (EU) 2015/378)
The “amount of the advance payments” cleared by interim payments and/or final payments and verified within the scope of audits of expenditure shall be reported in Table 10.3, Column M. See also footnote 8.
Komentari
The Audit Authority shall report the errors detected in the sample (as amounts and as percentage of the sample) before any financial corrections are applied by the Responsible Authority as a result of the audit work carried out by the Audit Authority.
Rezultati revizije rashoda
Only the amount of errors relating to the audited interim payments or final payments drawn from the draft accounts of the current financial year shall be taken into consideration for the calculating and reporting of the amount of errors and the error rate in Table 10.2, columns E and F.
Fond/vrsta plaćanja (1)
The amount of detected errors that have an impact on the “amount of advance payments” cleared should be reported in Table 10.3, Column N.
Iznos u eurima koji odgovara populaciji ili podpopulaciji u ‚nacrtima financijskih izvještaja’ iz kojih je dobiven uzorak (2)
The total error rate in the population is the Audit Authority's estimation of the total error rate in the “draft accounts” for the current financial year.
Revizijski uzorak (iznos u EUR) (3)
The total error rate shall be calculated before any financial corrections are applied by the Responsible Authority.
Revizijski uzorak (kao postotak populacije) [D = C/B]
The Audit Authority shall describe the methodology used to estimate the total error rate as well as the underlying calculations (including information on stratification, where applicable) in section 5 of the annual control report.
Iznos pogrešaka koje je revizorsko tijelo uočilo u uzorku EUR (4)
In principle, the total error rate shall be the sum of the projected random errors and, if applicable, the total amount of systemic errors in the population and any uncorrected anomalous errors, divided by the population.
Stopa pogreške % u uzorku
Column I shall disclose the financial corrections implemented by the Responsible Authority solely on the auditable population, i.e. the “draft accounts” for the current financial year from which the sample was drawn.
Ukupna stopa pogreške u populaciji (5)
Any financial corrections relating to the “amount of advance payments” cleared should be reported in Table 10.3, Column O.
Ukupne pogreške u populaciji (iznos u EUR)
Column J should disclose the residual error rate in the accounts after the Responsible Authority has implemented the financial corrections for the current financial year only.
[H = G * B]
Any non-corrected errors in the “amount of advance payments” cleared should not be included in the calculation of the residual error rate for the accounts for the current financial year.
Financijske korekcije
In Table 10.3, the Audit Authority must report the results of any audits carried out on items other than the sampled amounts reported in Table 10.2.
(iznos u EUR) koje je provelo odgovorno tijelo kao rezultat ukupne stope pogreške (6)
If the Audit Authority considers it necessary to carry out additional audits (e.g. risk-based audits, audits on negative or zero payments), the results of these additional audits should also be presented in Table 10.3.
Preostala ukupna stopa pogreške (7)
As defined in Article 38 of Regulation (EU) No 514/2014.
Stratumi (ako je primjenjivo) (1)
The sampling parameters include the sampling unit, population value and size, sample value and size, audit coverage (in EUR and the percentage of items and amounts covered) and the sampling criteria.
Ukupno (A)
For statistical sampling, the materiality level, confidence level, expected error rate and sampling interval should also be indicated.
Ukupno (B)
If non-statistical sampling is applied, the Audit Authority should indicate the steps taken to ensure randomness of the sample (and its representativity) and provide a sufficient sample size to enable the Audit Authority to estimate the total error of the population and draw up a valid audit opinion.
Iznos EUR
For example: eligibility, public procurement, state aid.
10:3 Rezultati revizija dodatnog rashoda (8)
Random, systemic or anomalous errors.
Opis
Flat-rate and/or extrapolated financial corrections may be applicable for example if there are systemic errors and/or if the total error rate on the draft accounts is material.
Fond/projekt/referentni broj plaćanja
Column B of Table 10.2.
Dodatni rashod obuhvaćen revizijom (3)
The overall level of assurance shall correspond to one of the four categories defined in Commission Implementing Regulation (EU) 2017/646: Category 1 (Works well.
Iznos pogrešaka u dodatnom rashodu obuhvaćenom revizijom (4)
No or only minor improvement(s) needed), Category 2 (Works. Some improvement(s) needed), Category 3 (Works partially.
Financijske korekcije koje provodi odgovorno tijelo u odnosu na dodatni rashod obuhvaćen revizijom (6)
approving cyphenothrin as an existing active substance for use in biocidal products of product-type 18
o odobravanju cifenotrina kao postojeće aktivne tvari za uporabu u biocidnim proizvodima vrste 18
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular the third subparagraph of Article 89(1) thereof,
uzimajući u obzir Uredbu (EU) br. 528/2012 Europskog parlamenta i Vijeća od 22. svibnja 2012. o stavljanju na raspolaganje na tržištu i uporabi biocidnih proizvoda, a posebno njezin članak 89. stavak 1. treći podstavak,
Cyphenothrin has been evaluated for use in biocidal products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council, which corresponds to product-type 18 as described in Annex V to Regulation (EU) No 528/2012.
Cifenotrin je ocijenjen za uporabu u biocidnim proizvodima vrste 18, „Insekticidi, akaricidi i proizvodi za suzbijanje drugih člankonožaca”, kako je utvrđena u Prilogu V. Direktivi 98/8/EZ Europskog parlamenta i Vijeća, što odgovara vrsti proizvoda 18 kako je utvrđena u Prilogu V. Uredbi (EU) br. 528/2012.
Greece was designated as a rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 11 April 2013.
Grčka je imenovana državom članicom izvjestiteljicom te je njezino nadležno ocjenjivačko tijelo 11. travnja 2013. podnijelo izvješće o ocjenjivanju, zajedno sa svojim preporukama.
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
U skladu s člankom 7. stavkom 2.
It can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States' evaluation has been completed by 1 September 2013 should be evaluated while taking into account the conditions set out in Article 5 of Directive 98/8/EC.
Delegirane uredbe (EU) br. 1062/2014 Odbor za biocidne proizvode 14. prosinca 2017. sastavio je mišljenje Europske agencije za kemikalije, uzimajući u obzir zaključke nadležnog ocjenjivačkog tijela.
Following the opinion of the European Chemicals Agency, biocidal products of product-type 18 containing cyphenothrin may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.
Na temelju članka 90. stavka 2.
It is therefore appropriate to approve cyphenothrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.
Uredbe (EU) br. 528/2012 može se zaključiti da bi tvari koje su države članice ocijenile do 1. rujna 2013. trebalo ocijeniti u skladu s uvjetima iz članka 5.
The opinion of the European Chemicals Agency concludes that cyphenothrin meets the criteria for being a persistent (P) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council.
Direktive 98/8/EZ.
For the purposes of Regulation (EU) No 528/2012, cyphenothrin meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be therefore considered a candidate for substitution.
U skladu s mišljenjem Europske agencije za kemikalije može se očekivati da će biocidni proizvodi vrste 18 koji sadržavaju cifenotrin ispuniti zahtjeve iz članka 5.
The receiving competent authority or, in the case of an evaluation of an application for a Union authorisation, the evaluating competent authority, should perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a biocidal product containing cyphenothrin.
Direktive 98/8/EZ, ako se zadovolje određene specifikacije i uvjeti koji se odnose na njihovu uporabu.
Since it can be derived from Article 90(2) of Regulation (EU) No 528/2012 that substances for which the Member States' evaluation has been completed by 1 September 2013 should be approved under the terms of Directive 98/8/EC, the period of approval should be 10 years, in accordance with the practice established under that Directive.
Stoga je primjereno odobriti cifenotrin za uporabu u biocidnim proizvodima vrste 18, podložno određenim specifikacijama i uvjetima.
A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
U mišljenju Europske agencije za kemikalije zaključeno je da cifenotrin ispunjava kriterije za vrlo postojane (vP) i otrovne (T) tvari u skladu s Prilogom XIII.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Uredbi (EZ) br. 1907/2006 Europskog parlamenta i Vijeća.
HAS ADOPTED THIS REGULATION:
Za potrebe Uredbe (EU) br. 528/2012 cifenotrin ispunjuje uvjete iz članka 10. stavka 1. točke (d) Uredbe (EU) br. 528/2012 i stoga bi ga trebalo smatrati potencijalnom tvari za zamjenu.
Article 1
Nadležno tijelo primatelj, ili u slučaju ocjenjivanja zahtjeva za odobrenje na razini Unije nadležno ocjenjivačko tijelo, trebalo bi provesti usporedno ocjenjivanje kao dio ocjenjivanja zahtjeva za odobrenje ili produljenje odobrenja biocidnog proizvoda koji sadržava cifenotrin.
Cyphenothrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.
Budući da se na temelju članka 90. stavka 2.
Article 2
Uredbe (EU) br. 528/2012 može zaključiti da bi tvari koje su države članice ocijenile do 1. rujna 2013. trebalo odobriti u skladu s uvjetima iz Direktive 98/8/EZ, rok važenja odobrenja trebalo bi utvrditi na 10 godina, u skladu s praksom utemeljenom tom Direktivom.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Prije odobrenja aktivne tvari zainteresiranim stranama trebalo bi omogućiti primjereno razdoblje za poduzimanje pripremnih mjera potrebnih za ispunjavanje novih zahtjeva.
Done at Brussels, 25 September 2018.
DONIJELA JE OVU UREDBU:
The President
Cifenotrin se odobrava kao aktivna tvar za uporabu u biocidnim proizvodima vrste 18, podložno uvjetima iz Priloga.
OJ L 167, 27.6.2012, p. 1.
Članak 2.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Cyphenothrin, Product type: 18, ECHA/BPC/183/2017, Adopted on 14 December 2017.
Sastavljeno u Bruxellesu 25. rujna 2018.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Za Komisiju
IUPAC Name
Delegirana uredba Komisije (EU) br. 1062/2014 оd 4. kolovoza 2014. o programu rada za sustavni pregled svih postojećih aktivnih tvari sadržanih u biocidnim proizvodima iz Uredbe (EU) br. 528/2012 Europskog parlamenta i Vijeća (SL L 294, 10.10.2014., str. 1.).
Identification Numbers
Direktiva 98/8/EZ Europskog parlamenta i Vijeća od 16. veljače 1998. o stavljanju biocidnih pripravaka na tržište (SL L 123, 24.4.1998., str. 1.).
Minimum degree of purity of the active substance
Mišljenje Odbora za biocidne proizvode o zahtjevu za odobrenje aktivne tvari cifenotrin, vrsta proizvoda: 18, ECHA/BPC/183/2017, doneseno 14. prosinca 2017.
Date of approval
Uredba (EZ) br. 1907/2006 Europskog parlamenta i Vijeća od 18. prosinca 2006. o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH) i osnivanju Europske agencije za kemikalije te o izmjeni Direktive 1999/45/EZ i stavljanju izvan snage Uredbe Vijeća (EEZ) br. 793/93 i Uredbe Komisije (EZ) br. 1488/94 kao i Direktive Vijeća 76/769/EEZ i direktiva Komisije 91/155/EEZ, 93/67/EEZ, 93/105/EZ i 2000/21/EZ (SL L 396, 30.12.2006., str. 1.).
Expiry date of approval
PRILOG
Product type
Uobičajeni naziv
Specific conditions
Kemijski naziv prema IUPAC-u
Cyphenothrin
Identifikacijski brojevi
IUPAC Name:
Najmanji stupanj čistoće aktivne tvari
(RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
Datum odobrenja
EC No: 254-484-5
Datum isteka odobrenja
CAS No: 39515-40-7
Vrsta proizvoda
92 % w/w (total isomers)
Posebne odredbe
1 February 2020
Cifenotrin
31 January 2030
Kemijski naziv prema IUPAC-u:
Cyphenothrin is considered a candidate for substitution in accordance with point (d) of Article 10(1) of Regulation (EU) No 528/2012.
(RS)-α-cijano-3-fenoksibenzil (1RS,3RS;1RS,3SR)-2,2-dimetil-3-(2-metilprop-1-enil)ciklopropankarboksilat
The authorisations of biocidal products are subject to the following conditions:
EZ br.: 254-484-5
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
CAS br.: 39515-40-7
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:
92 % masenog udjela (ukupnih izomera)
professional users;
1. veljače 2020.
toddlers;
31. siječnja 2030.
surface water, sediment, soil and groundwater, following indoor surface treatment;
Cifenotrin se smatra potencijalnom tvari za zamjenu u skladu s člankom 10. stavkom 1. točkom (d) Uredbe (EU) br.
earthworm-eating mammals and fish-eating mammals due to secondary poisoning, following indoor surface treatment.
528/2012.
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Odobrenja za biocidne proizvode podliježu sljedećim uvjetima:
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
S obzirom na rizike utvrđene za ocijenjene uporabe, pri ocjeni proizvoda posebna se pozornost posvećuje sljedećem:
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 (OJ L 152, 16.6.2009, p.
profesionalnim korisnicima;
11).
maloj djeci;
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food lactitol
o izmjeni Provedbene uredbe (EU) 2017/2470 u pogledu uvjeta upotrebe nove hrane laktitol
Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.
Uredbe (EU) 2015/2283 donesena je Provedbena uredba Komisije (EU) 2017/2470 kojom je utvrđen Unijin popis odobrene nove hrane.
Commission Implementing Decision (EU) 2017/450 authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council, the placing on the market of lactitol as a novel food to be used in capsule or tablet in food supplements intended for the adult population.
U skladu s člankom 12.
On 22 March 2018, the company DuPont Nutrition Biosciences ApS made a request to the Commission to change the conditions of use of the novel food lactitol within the meaning of Article 10(1) of Regulation (EU) 2015/2283.
Uredbe (EU) 2015/2283 Komisija odlučuje o odobrenju i o stavljanju nove hrane na tržište Unije i ažuriranju popisa Unije.
The application requested to include powder as an allowed form of lactitol to be used in food supplements.
Provedbenom odlukom Komisije (EU) 2017/450 odobreno je, u skladu s Uredbom (EZ) br. 258/97 Europskog parlamenta i Vijeća, stavljanje na tržište laktitola kao nove hrane za upotrebu u kapsulama ili tabletama u dodacima prehrani namijenjenima populaciji odraslih.
The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) as the amendment of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements is not liable to have an effect on human health.
Društvo DuPont Nutrition Biosciences ApS podnijelo je 22. ožujka 2018. zahtjev Komisiji za izmjenu uvjeta upotrebe nove hrane laktitol u smislu članka 10. stavka 1.
The maximum level of lactitol authorised by Implementing Decision (EU) 2017/450 as a novel food to be used in capsule or tablet in food supplements is 20 g/day.
Uredbe (EU) 2015/2283.
The proposed use level of the novel food lactitol in powder form in the same food category corresponds to the maximum level that is currently authorized.
Tim se zahtjevom traži uključivanje praha kao dopuštenog oblika laktitola za upotrebu u dodacima prehrani.
Therefore, it is appropriate to amend the conditions of use of lactitol to authorise its use in powder form at the existing maximum authorised level.
Komisija nije zatražila mišljenje Europske agencije za sigurnost hrane u skladu s člankom 10. stavkom 3. jer nije vjerojatno da će izmjena uvjeta upotrebe nove hrane laktitol uključivanjem praha kao dopuštenog oblika laktitola za upotrebu u dodacima prehrani imati utjecaj na zdravlje ljudi.
The information provided in the application gives sufficient grounds to establish that the application for changing of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements, comply with Article 12(2) of Regulation (EU) 2015/2283.
Provedbenom odlukom (EU) 2017/450 odobrena je upotreba laktitola kao nove hrane u obliku kapsula ili tableta u dodacima prehrani u najvećoj dopuštenoj količini od 20 g laktitola na dan.
Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements.
Predložena razina upotrebe nove hrane laktitol u obliku praha u istoj kategoriji hrane odgovara najvećoj dopuštenoj količini koja je aktualno odobrena.
The additional form of lactitol to be used in food supplements should be authorised without prejudice to that Directive.
Stoga je primjereno izmijeniti uvjete upotrebe laktitola kako bi se odobrila njegova upotreba u obliku praha u aktualnoj najvećoj dopuštenoj količini.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Na temelju informacija iz zahtjeva za izmjenu uvjeta upotrebe nove hrane laktitol uključivanjem praha kao dopuštenog oblika te tvari za upotrebu u dodacima prehrani može se utvrditi da je taj zahtjev u skladu s člankom 12. stavkom 2.
Article 1
Zahtjevi za dodatke prehrani utvrđeni su Direktivom 2002/46/EZ Europskog parlamenta i Vijeća.