natgillin/translations-raw huggingface dataset:
Based on the information obtained from the decision notified by the French authorities, from the consultations conducted with the interested parties and in view of all the considerations above, the French authorities were able to conclude that the device may compromise the health and/or safety of persons and were thus able to adopt a provisional measure to ensure that the device is no longer placed on the market and is withdrawn from the market via the distributors,
Na temelju informacija iz odluke koju su dostavila francuska tijela, savjetovanja provedenih sa zainteresiranim stranama te uzimajući u obzir sve prethodno navedeno, razvidno je da su francuska tijela mogla zaključiti da predmetni proizvod predstavlja rizik za zdravlje i/ili sigurnost osoba i da su stoga mogla poduzeti privremenu mjeru kojom se obustavlja stavljanje u promet proizvoda i kojom se on povlači iz prometa na razini distribucije,
The measure adopted by the French authorities on 16 August 2016 regarding the Terrafor and Defiligne medical devices, in order to suspend their placing on the market and provide for the withdrawal of these devices from the market, is justified.
Mjera francuskih tijela od 16. kolovoza 2016. u pogledu medicinskih proizvoda Terrafora i Defilignea, kojom se obustavlja stavljanje u promet tih proizvoda i predviđa njihovo povlačenje iz prometa, opravdana je.
This report is entitled ‘Addendum to risk assessment No 164726 of 17 February 2017’.
Naslov je izvješća „Dopuna procjeni rizika br. 164726 od 17. veljače 2017.”.
See in particular, regarding the safeguard clause of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24), the judgment of the General Court of 15 July 2015, CSF v Commission, T-337/13, ECLI:EU:T:2015:502, paragraphs 46, 79 and 80.
Vidjeti posebno, u pogledu zaštitne klauzule Direktive 2006/42/EZ Europskog parlamenta i Vijeća od 17. svibnja 2006. o strojevima o izmjeni Direktive 95/16/EZ (SL L 157, 9.6.2006., str. 24.), presudu Suda od 15. srpnja 2015., CSF protiv Komisije, T-337/13, ECLI:EU:T:2015:502, točke 46., 79. i 80.
See the judgment of the Court of 22 April 2015, Klein v Commission, C-120/14 P, ECLI:EU:C:2015:252, paragraph 71.
Presuda Suda od 22. travnja 2015., Klein protiv Komisije, C-120/14 P, ECLI:EU:C:2015:252, točka 71.
This report is entitled ‘Project 164726 — Clinical evaluation report — Ventre plat devices — Version: V2 final May 24, 2016’.
Naslov je tog izvješća „Project 164726 – Clinical evaluation report – Ventre plat devices – Version: V2 final May 24, 2016”.
OJ 196, 16.8.1967, p. 1.
SL 196, 16.8.1967., str. 1
https://echa.europa.eu/substance-information/-/substanceinfo/100.028.273
https://echa.europa.eu/substance-information/-/substanceinfo/100.028.273.
The manufacturer did so several months later, in August 2017.
Službe Komisije pozvale su proizvođača u više navrata da taj dokument proslijedi francuskim tijelima, što je proizvođač učinio nekoliko mjeseci nakon toga, u kolovozu 2017.
At the same time, the Commission exchanged e-mails with the French authorities in order to obtain further information.
Službe Komisije paralelno su razmijenile više poruka e-pošte s francuskim tijelima kako bi dobile dodatne informacije.
Moreover, the French authorities refer to the ‘Guideline for elemental impurities – Q3D’ (hereinafter ‘Guideline ICH Q3D’), drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by the European Medicines Agency (EMA) in December 2014 and applied by it to new applications for authorisation to place medicinal products on the market as of June 2016 and to existing authorisations for placing medicinal products on the market as of December 2017.
Osim toga, francuska tijela upućuju na „Smjernice o elementarnim nečistoćama – Q3D” (dalje u tekstu: „Smjernice ICH Q3D”), koje je sastavilo Međunarodno vijeće za usklađivanje tehničkih zahtjeva za lijekove za ljudsku uporabu (ICH), a koje je Europska agencija za lijekove (EMA) donijela u prosincu 2014. te ih od lipnja 2016. primjenjuje na nove zahtjeve za odobrenje za stavljanje u promet lijekova, a od prosinca 2017. na postojeća odobrenja za stavljanje u promet lijekova.
This Guideline concerns elemental impurities in medicinal products, namely elements which do not provide any therapeutic benefit to the patient, with the result that their levels must remain within acceptable limits.
Te se Smjernice odnose na elementarne nečistoće u lijekovima, odnosno na elemente koji ne pridonose liječenju pacijenta, stoga njihova razina mora biti unutar prihvatljivih granica.
Agency for Toxic Substances and Disease Registry, Public Health Service, U.S. Department of Health and Human Services, ‘Toxicological profile for lead’, 2007; National Toxicology Program, U.S. Department of Health and Human Services, ‘Monograph on health effects of low-level lead’, 2012.
Agencija za otrovne tvari i registar bolesti, Služba za javno zdravstvo, Ministarstvo zdravstva i socijalne skrbi SAD-a, „Toksikološka analiza olova”, 2007.; Nacionalni toksikološki program, Ministarstvo zdravstva i socijalne skrbi SAD-a, „Studija o učincima niskih razina olova na zdravlje”, 2012.
Commission Implementing Decision (EU) 2018/1622
Provedbena odluka Komisije (EU) 2018/1622
of 29 October 2018
оd 29. listopada 2018.
on the non-approval of certain active substances in biocidal products pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council
o neodobravanju određenih aktivnih tvari u biocidnim proizvodima u skladu s Uredbom (EU) br. 528/2012 Europskog parlamenta i Vijeća
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,
Commission Delegated Regulation (EU) No 1062/2014, as amended by Delegated Regulation (EU) 2017/698, establishes in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products on 3 February 2017.
U Prilogu II. Delegiranoj uredbi Komisije (EU) br. 1062/2014, kako je izmijenjena Delegiranom uredbom (EU) 2017/698, utvrđen je popis kombinacija aktivnih tvari/vrsta proizvoda koji su 3. veljače 2017. uključeni u program pregleda postojećih aktivnih tvari u biocidnim proizvodima.
For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.
Za niz kombinacija aktivnih tvari/vrsta proizvoda uključenih u navedeni popis svi su sudionici pravodobno povukli svoju potporu.
As regards some active substances generated in situ, the name of those active substances and their precursors which are supported in the review programme has been clarified in a more precise manner.
U pogledu određenih tvari dobivenih in situ, nazivi tih aktivnih tvari i njihovih prekursora koje su podržane u programu revizije detaljnije su objašnjeni.
This has lead in certain cases to a redefinition of the active substance in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014.
To je u nekim slučajevima dovelo do redefiniranja aktivnih tvari u skladu s člankom 13. Delegirane uredbe (EU) br. 1062/2014.
A notification was published inviting persons wishing to support those active substance/product-types combinations which have been redefined and currently not supported, including the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, so that the role of participant may be taken over.
Objavljena je obavijest o podnošenju prijava u kojoj se pozivaju osobe koje žele podržati te kombinacije aktivnih tvari/vrsta proizvoda koje su redefinirane i trenutačno nisu podržane, uključujući aktivne tvari za vrste proizvoda dobivene in situ, navedene u Prilogu II. Delegiranoj uredbi (EU) br. 1062/2014, kako bi mogle preuzeti ulogu sudionika.
For some active substance/product-type combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraphs 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014.
Za određene kombinacije aktivnih tvari/vrsta proizvoda nije podnesena nijedna prijava ili je prijava odbijena u skladu s člankom 17. stavcima 4. ili 5. Delegirane uredbe (EU) br. 1062/2014.
In accordance with Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.
U skladu s člankom 20. te Delegirane uredbe (EU) br. 1062/2014 te kombinacije tvari/vrsta proizvoda ne bi trebalo odobriti za uporabu u biocidnim proizvodima.
The active substances listed in the Annex are not approved for the product-types indicated therein.
Aktivne tvari navedene u Prilogu ne odobravaju se za vrste proizvoda koje su navedene u tom Prilogu.
Done at Brussels, 29 October 2018.
Sastavljeno u Bruxellesu 29. listopada 2018.
Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 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 concerning the making available on the market and use of biocidal products (OJ L 103, 19.4.2017, p. 1).
Delegirana uredba Komisije (EU) 2017/698 оd 3. veljače 2017. o izmjeni Delegirane uredbe (EU) br. 1062/2014 o programu rada za sustavni pregled svih postojećih aktivnih tvari sadržanih u biocidnim proizvodima iz Uredbe (EU) br. 528/2012 Europskog parlamenta i Vijeća o stavljanju na raspolaganje na tržištu i uporabi biocidnih proizvoda (SL L 103, 19.4.2017., str. 1).
Active substance/product type combinations not approved, including any nanomaterial forms:
Kombinacije aktivnih tvari/vrsta proizvoda koje se ne odobravaju, uključujući sve oblike nanomaterijala:
the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, except when the active substance is generated from the precursor(s) mentioned in the entry of the table of that Annex for the concerned active substance/product-type combinations;
dobivanje in situ aktivnih tvari za vrste proizvoda navedene u Prilogu II. Delegiranoj uredbi (EU) br. 1062/2014, osim ako je aktivna tvar dobivena iz prekursora navedenih u unosu u tablici u tom Prilogu za predmetne kombinacije aktivnih tvari/vrsta proizvoda,
the substance/product-type combinations listed in the table below, including any generation in situ of these substances using any precursor that is not mentioned in Annex II to Delegated Regulation (EU) No 1062/2014:
kombinacije tvari/vrsta proizvoda navedene u tablici u nastavku, uključujući svako dobivanje in situ tih tvari s pomoću bilo kojeg prekursora koji nije naveden u Prilogu II. Delegiranoj uredbi (EU) br. 1062/2014:
Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014
Broj unosa u Prilogu II. Delegiranoj uredbi (EU) br. 1062/2014
Product-type(s)
Vrsta (vrste) proizvoda
Cetylpyridinium Chloride
cetilpiridinijev klorid
6-(Phthalimido)peroxyhexanoic acid (PAP)
6-(ftalimido)peroksiheksanska kiselina (PAP)
Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A
Bacillus thuringiensis subsp.israelensis serotip H14, osim soja AM65-52 i osim soja SA3A
Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate)
esfenvalerat / (S)-.alfa.-ciano-3-fenoksibenzil (S)-2-(4-klorofenil)-3-metilbutirat (esfenvalerat)
Commission Implementing Decision (EU) 2018/1623
Provedbena odluka Komisije (EU) 2018/1623
pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on mosquitoes non-naturally infected with Wolbachia used for vector control purposes
u skladu s člankom 3. stavkom 3. Uredbe (EU) br. 528/2012 Europskog parlamenta i Vijeća o komarcima koji su umjetno zaraženi bakterijom Wolbachia radi kontrole vektora
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 Article 3(3) 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 3. stavak 3.,
On 28 September 2017, France requested the Commission to decide whether bacteria of the genus Wolbachia (‘the bacteria’) or any preparation containing the bacteria to be inoculated into mosquitoes, and mosquitoes non-naturally infected with the bacteria (‘the non-naturally infected mosquitoes’) used for vector control purposes are biocidal products within the meaning of Article 3(1)(a) of Regulation (EU) No 528/2012 or treated articles within the meaning of Article 3(1)(l) of that Regulation or neither.
Francuska je 28. rujna 2017. od Komisije zatražila da odluči jesu li bakterije roda Wolbachia („bakterije”) ili bilo koji pripravak koji sadržava bakterije kojima se inokuliraju komarci te komarci umjetno zaraženi bakterijama („umjetno zaraženi komarci”) radi kontrole vektora biocidni proizvodi u smislu članka 3. stavka 1. točke (a) Uredbe (EU) br. 528/2012 ili tretirani proizvodi u smislu članka 3. stavka 1. točke (l) te Uredbe ili nijedno od toga.
According to the information provided by France, these intracellular bacteria are transmitted vertically, maternally inherited and naturally present in around 40 % of arthropods.
Na temelju informacija koje je dostavila Francuska te unutarstanične bakterije prenose se vertikalno, nasljeđuju se po majčinoj strani i prirodno su prisutne u oko 40 % člankonožaca.
The infection of mosquitoes by the bacteria may reduce the ability of some mosquitoes to transmit certain pathogenic viruses and parasites by interfering with those pathogens within the mosquitoes, and promotes the reproduction of infected females mosquitoes and the spread of the bacteria in the mosquito population.
Neki komarci zaraženi tim bakterijama mogli bi imati manju sposobnost za prijenos određenih patogenih virusa i nametnika jer bakterije kojima su zaraženi ometaju te patogene u komarcima i potiču razmnožavanje zaraženih ženki komaraca te širenje bakterija unutar populacije komaraca.
Furthermore, since male mosquitoes infected with the bacteria are incompatible with local females, the introduction of those infected males in the target population reduces its potential for reproduction.
Nadalje, budući da mužjaci komaraca zaraženi bakterijama nisu kompatibilni s lokalnim ženkama, uvođenje tih zaraženih mužjaka u ciljnu populaciju smanjuje njezin potencijal za razmnožavanje.
Therefore, vector control campaigns are based on the release of non-naturally infected mosquitoes within a population of mosquitoes in order to control the population size and/or to reduce their ability to transmit certain pathogens to humans.
Dakle, programi kontrole vektora temelje se na oslobađanju umjetno zaraženih komaraca unutar populacije komaraca u cilju kontrole veličine populacije i/ili kako bi se smanjila njihova sposobnost prenošenja određenih patogena na ljude.
According to the information provided by France, not all species of mosquitoes or individuals within one species are naturally infected with the bacteria, or with a strain of the bacteria that is exploitable for the vector control purposes.
Prema informacijama koje je dostavila Francuska, ne zaraze se sve vrste komaraca ili jedinki unutar jedne vrste prirodno bakterijama ili sojem bakterija koji se može iskoristiti za kontrolu vektora.
Therefore, non-natural infections have to be carried out under laboratory conditions in order to create non-naturally infected mosquitoes with a suitable strain of the bacteria.
Stoga je komarce potrebno umjetno zaraziti u laboratorijskim uvjetima kako bi se stvorili komarci koji su umjetno zaraženi prikladnim sojem bakterija.
That can be achieved by different infection techniques, including the inoculation of the bacteria into adult female mosquitoes or into the cytoplasm of mosquitoes' eggs.
To se može postići različitim tehnikama zaraze, uključujući inokuliranjem bakterijama odrasle ženke komarca ili citoplazme jajašaca komaraca.
For the purpose of the provisions in Article 3(3) of Regulation (EU) No 528/2012, it is therefore relevant to assess separately the status of the bacteria or any preparation containing the bacteria to be inoculated into mosquitoes and the status of the non-naturally infected mosquitoes, irrespectively of the infection technique used.
Stoga je u smislu odredbi iz članka 3. stavka 3. Uredbe (EU) br. 528/2012 potrebno zasebno ocijeniti status bakterija ili pripravaka koji sadržavaju bakterije kojima se inokuliraju komarci te status umjetno zaraženih komaraca, neovisno o korištenoj tehnici zaraze.
The bacteria are micro-organisms within the meaning of Article 3(1)(b) of Regulation (EU) No 528/2012
Bakterije su mikroorganizmi u smislu članka 3. stavka 1. točke (b) Uredbe (EU) br. 528/2012
Mosquitoes are harmful organisms within the meaning of Article 3(1)(g) of Regulation (EU) No 528/2012, since they may have an unwanted presence or a detrimental effect on humans or animals.
Komarci su štetni organizmi u smislu članka 3. stavka 1. točke (g) Uredbe (EU) br. 528/2012 jer je njihova prisutnost nepoželjna ili jer mogu imati štetan učinak na ljude ili životinje.
The bacteria has an indirect action on the mosquitoes population, either by controlling its size or by reducing its ability to transmit certain pathogens, and should therefore be considered an active substance within the meaning of Article 3(1)(c) of Regulation (EU) No 528/2012.
Te bakterije imaju neizravan učinak na populaciju komaraca, ili tako što njima kontrolira veličina populacije komaraca ili tako što se smanjuje sposobnosti komaraca za prijenos određenih patogena, i stoga bi ih se trebalo smatrati aktivnom tvari u smislu članka 3. stavka 1. točke (c) Uredbe (EU) br. 528/2012.
Product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012, includes products used for the control of arthropods, by means other than repulsion or attraction.
Vrsta proizvoda 18, insekticidi, akaricidi i proizvodi za suzbijanje drugih člankonožaca, kako su definirani u Prilogu V. Uredbi (EU) br. 528/2012, obuhvaća proizvode za suzbijanje člankonožaca, na bilo koji način osim tjeranjem ili privlačenjem.
Since the bacteria are inoculated into mosquitoes with the intention to exert a controlling effect on mosquitoes' populations, such use falls under the description of product-type 18.
S obzirom na to da su komarci inokulirani bakterijama radi kontrole populacije komaraca, takva uporaba odgovara opisu vrste proizvoda 18.
The bacteria or the preparation containing the bacteria is exerting a controlling effect on mosquitoes by other means than mere physical or mechanical action.
Bakterijama ili pripravkom koji sadržava bakterije komarci se kontroliraju na bilo koji način osim čisto fizičkim ili mehaničkim djelovanjem.
For the purposes of Article 3(1)(a) of Regulation (EU) No 528/2012, the bacteria or the preparation containing the bacteria should be considered a substance or a mixture, respectively, consisting of or containing an active substance.
Za potrebe članka 3. stavka 1. točke (a) Uredbe (EU) br. 528/2012, bakterije ili pripravak koji sadržava bakterije trebali bi se smatrati tvari odnosno smjesom koja se sastoji od aktivne tvari ili je sadržava.
As a consequence, the bacteria or any preparation containing the bacteria, as it is supplied to the user carrying out the inoculation into mosquitoes, is a biocidal product within the meaning of the first indent of Article 3(1)(a) of Regulation (EU) No 528/2012 and falls within product-type 18.
Kao posljedica toga, bakterije ili bilo koji pripravak koji sadržava bakterije, u obliku u kojem se dostavlja korisniku koji provodi inokulaciju komaraca, biocidni su proizvodi u smislu članka 3. stavka 1. točke (a) prve alineje Uredbe (EU) br. 528/2012 i obuhvaćeni su vrstom proizvoda 18.
Non-naturally infected mosquitoes are not micro-organisms within the meaning of Article 3(1)(b) of Regulation (EU) No 528/2012.
Umjetno zaraženi komarci nisu mikroorganizmi u smislu članka 3. stavka 1. točke (b) Uredbe (EU) br. 528/2012.
Non-naturally infected mosquitoes are not a substance or a mixture within the meaning of points 1 and 2 of Article 3, respectively, of Regulation (EC) No 1907/2006 of the European Parliament and of the Council.
Umjetno zaraženi komarci nisu tvar u smislu članka 3. točke 1. ili smjesa u smislu članka 3. točke 2. Uredbe (EZ) br. 1907/2006 Europskog parlamenta i Vijeća.
Therefore, pursuant to points (a) and (b) of Article 3(2) of Regulation (EU) No 528/2012, they are neither a substance nor a mixture for the purposes of that Regulation.
Oni se stoga u skladu s člankom 3. stavkom 2. točkama (a) i (b) Uredbe (EU) br. 528/2012 ne smatraju ni tvari ni smjesom za potrebe te uredbe.
As a consequence, non-naturally infected mosquitoes are not an active substance within the meaning of Article 3(1)(c) of Regulation (EU) No 528/2012.
Kao posljedica toga, umjetno zaraženi komarci nisu aktivne tvari u smislu članka 3. stavka 1. točke (c) Uredbe (EU) br. 528/2012.
Therefore, non-naturally infected mosquitoes cannot be a biocidal product within the meaning of the first indent of Article 3(1)(a) of that Regulation.
Stoga umjetno zaraženi komarci ne mogu biti biocidni proizvod u smislu članka 3. stavka 1. točke (a) prve alineje te uredbe.
Non-naturally infected mosquitoes are not articles within the meaning of Article 3(3) of Regulation (EC) No 1907/2006.
Umjetno zaraženi komarci nisu proizvodi u smislu članka 3. stavka 3. Uredbe (EZ) br. 1907/2006.
Therefore, pursuant to Article 3(2)(c) of Regulation (EU) No 528/2012, they are not considered articles for the purposes of that Regulation.
Oni se stoga u skladu s člankom 3. stavkom 2. točkom (c) Uredbe (EU) br. 528/2012 ne smatraju proizvodima za potrebe te uredbe.
Consequently, the non-naturally infected mosquitoes cannot be considered treated articles within the meaning of Article 3(1)(l) of Regulation (EU) No 528/2012.
Kao posljedica toga, umjetno zaraženi komarci ne mogu se smatrati tretiranim proizvodima u smislu članka 3. stavka 1. točke (l) Uredbe (EU) br. 528/2012.
The bacteria of the genus Wolbachia or any preparation containing those bacteria used for the purpose of inoculating those bacteria into mosquitoes with the objective of creating non-naturally infected mosquitoes for vector control purposes shall be considered a biocidal product within the meaning of Article 3(1)(a) of Regulation (EU) No 528/2012.
Bakterije roda Wolbachia ili bilo koji pripravak koji sadržava te bakterije za potrebe inokulacije komaraca tim bakterijama u cilju stvaranja umjetno zaraženih komaraca radi kontrole vektora smatraju se biocidnim proizvodom u smislu članka 3. stavka 1. točke (a) Uredbe (EU) br. 528/2012.
Non-naturally infected mosquitoes, irrespectively of the infection technique used, shall be considered neither a biocidal product nor a treated article within the meaning of points (a) and (l) of Article 3(1), respectively, of Regulation (EU) No 528/2012.
Umjetno zaraženi komarci, neovisno o korištenoj tehnici zaraze, ne smatraju se ni biocidnim proizvodom u smislu članka 3. stavka 1. točke (a) ni tretiranim proizvodom u smislu članka 3. stavka 1. točke (l) Uredbe (EU) br. 528/2012.
Commission Implementing Decision (EU) 2018/1635
Provedbena odluka Komisije (EU) 2018/1635
of 30 October 2018
оd 30. listopada 2018.
(notified under document C(2018) 7333)
(priopćeno pod brojem dokumenta C(2018) 7333)