natgillin/translations-raw huggingface dataset:
In view of this, it was possible to conclude that the standards referred to in Article 5 of the Directive, which the manufacturer claims to have applied, were incorrectly applied, with the result that the risk associated with the presence of lead in the device has not been ruled out.
Glej sodbo Sodišča z dne 22. aprila 2015, Klein/Komisija, C-120/14 P, ECLI:EU:C:2015:252, točka 71.
Conclusion
Department of Health and Human Services, „Toxicological profile for lead“, 2007; National Toxicology Program, U.S.
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and were thus able to adopt a provisional measure to ensure that the device is no longer placed on the market and is withdrawn from the market via the distributors,
Department of Health and Human Services, „Monograph on health effects of low-level lead“, 2012.
HAS ADOPTED THIS DECISION:
Uredba Komisije (ES) št. 1881/2006 z dne 19. decembra 2006 o določitvi mejnih vrednosti nekaterih onesnaževal v živilih (UL L 364, 20.12.2006, str. 5).
Article 1
To poročilo je naslovljeno „Project 164726 – Clinical evaluation report – Ventre plat devices – Version: V2 final May 24, 2016“.
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.
UL L 196, 16.8.1967, str. 1.
Article 2
Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi in zmesi (UL L 353, 31.12.2008, str. 1).
This Decision is addressed to the Member States.
Službe Komisije so proizvajalca večkrat pozvale k posredovanju tega dokumenta francoskim organom, kar je proizvajalec storil več mesecev pozneje, in sicer avgusta 2017.
Done at Brussels, 25 October 2018.
Hkrati so službe Komisije po elektronski poti komunicirale s francoskimi organi, da bi pridobile dodatne informacije.
Member of the Commission
Navedena smernica (Guideline) se nanaša na elementarne nečistoče v zdravilih, torej elemente, ki nimajo terapevtske koristi za pacienta, zato morajo ostati znotraj sprejemljivih mejnih vrednosti.
OJ L 169, 12.7.1993, p. 1.
Točka 6a Priloge I k Direktivi 93/42/EGS določa: „Dokazovanje skladnosti z bistvenimi zahtevami mora vključevati klinično vrednotenje v skladu s Prilogo X.“ Točka 1.1 Priloge X (klinično vrednotenje) k Direktivi zlasti natančno določa: „Po splošnem pravilu morajo potrditev skladnosti z zahtevami v zvezi z lastnostmi in delovanjem iz oddelkov 1 in 3 Priloge I v normalnih pogojih uporabe pripomočka ter ovrednotenje stranskih učinkov in sprejemljivosti razmerja med koristmi in tveganjem iz oddelka 6 Priloge I temeljiti na kliničnih podatkih.“
This report is entitled ‘Addendum to risk assessment No 164726 of 17 February 2017’.
Točka 1 Priloge I k Direktivi 93/42/EGS določa: „Pripomočki morajo biti načrtovani in izdelani tako, da ob uporabi pod predvidenimi pogoji in za predvideni namen ne ogrožajo kliničnega stanja ali varnosti bolnikov ali varnosti in zdravja uporabnikov ali, če je primerno, drugih oseb, pod pogojem, da vsako morebitno tveganje, povezano z njihovo uporabo, predstavlja sprejemljivo tveganje v primerjavi s koristjo za bolnika in da je združljivo z visoko ravnijo zaščite zdravja in varnosti […].“ Točka 6 Priloge I k Direktivi določa: „Vsak nezaželen stranski učinek mora predstavljati sprejemljivo tveganje v primerjavi s predvidenim delovanjem.“
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.
Točka 7.2 Priloge I k Direktivi 93/42/EGS določa: „Pripomočki morajo biti načrtovani, izdelani in pakirani tako, da je kar najbolj zmanjšana nevarnost, ki jo predstavljajo kontaminanti in ostanki, za osebe, ki se ukvarjajo s prevozom, skladiščenjem in uporabo pripomočkov, in za bolnike, ob upoštevanju predvidenega namena izdelka.
See the judgment of the Court of 22 April 2015, Klein v Commission, C-120/14 P, ECLI:EU:C:2015:252, paragraph 71.
Pri tem je treba posebno pozornost posvetiti izpostavljenim tkivom in trajanju ter pogostosti izpostavljenosti.“ Točka 7.5 Priloge I k Direktivi določa: „Pripomočki morajo biti načrtovani in izdelani tako, da je kar najbolj zmanjšana nevarnost, ki jo predstavljajo snovi, ki uhajajo iz pripomočka.
Department of Health and Human Services, ‘Toxicological profile for lead’, 2007; National Toxicology Program, U.S.
Posebno pozornost se v skladu s Prilogo I k Direktivi Sveta št. 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi nameni snovem, ki so kancerogene, mutagene ali strupene za razmnoževanje […].“ Priloga I k Direktivi Sveta 67/548/EGS je postala del 3 Priloge VI k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta.
Commission Implementing Decision (EU) 2018/1622
Izvedbeni sklep Komisije (EU) 2018/1622
of 29 October 2018
z dne 29. oktobra 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 zavrnitvi odobritve nekaterih aktivnih snovi v biocidnih proizvodih v skladu z Uredbo (EU) št. 528/2012 Evropskega parlamenta in Sveta
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,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov ter zlasti tretjega pododstavka člena 89(1) Uredbe,
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.
Delegirana uredba Komisije (EU) št. 1062/2014, kakor je bila spremenjena z Delegirano uredbo Komisije (EU) 2017/698, v Prilogi II določa seznam kombinacij aktivnih snovi/vrst proizvodov, vključenih v program preverjanja obstoječih aktivnih snovi v biocidnih proizvodih, na dan 3. februarja 2017.
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 številne kombinacije aktivnih snovi/vrst proizvodov, vključenih na navedeni seznam, so vsi udeleženci pravočasno odstopili od podpore.
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.
Kar zadeva nekatere aktivne snovi, tvorjene in situ, so bila imena navedenih aktivnih snovi in njihovih predhodnih sestavin, podprtih v programu preverjanja, natančneje pojasnjena.
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 v nekaterih primerih privedlo do ponovne opredelitve aktivne snovi v skladu s členom 13 Delegirane uredbe (EU) št. 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.
Objavljeno je bilo obvestilo s pozivom osebam, ki to želijo, da podprejo navedene kombinacije aktivnih snovi/vrst proizvodov, ki so bile ponovno opredeljene in se trenutno ne podpirajo, vključno z in situ tvorjenimi aktivnimi snovmi za vrste proizvodov iz Priloge II k Delegirani uredbi (EU) št. 1062/2014, in tako prevzamejo vlogo udeleženca.
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 nekatere kombinacije aktivnih snovi/vrst proizvodov prijave niso bile predložene ali pa so bile predložene in zavrnjene v skladu z odstavkom 4 ali 5 člena 17 Delegirane uredbe (EU) št. 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.
V skladu s členom 20 Delegirane uredbe (EU) št. 1062/2014 se navedene kombinacije aktivnih snovi/vrst proizvodov ne bi smele odobriti za uporabo v biocidnih proizvodih.
The active substances listed in the Annex are not approved for the product-types indicated therein.
Aktivne snovi, navedene v Prilogi, niso odobrene za vrste proizvodov iz navedene priloge.
Done at Brussels, 29 October 2018.
V Bruslju, 29. oktobra 2018
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).
Delegirana uredba Komisije (EU) št. 1062/2014 z dne 4. avgusta 2014 o delovnem programu za sistematično preverjanje vseh obstoječih aktivnih snovi, ki jih vsebujejo biocidni proizvodi, iz Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta (UL L 294, 10.10.2014, str. 1).
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 z dne 3. februarja 2017 o spremembi Delegirane uredbe Komisije (EU) št. 1062/2014 o delovnem programu za sistematično preverjanje vseh obstoječih aktivnih snovi, ki jih vsebujejo biocidni proizvodi, iz Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta o dostopnosti na trgu in uporabi biocidnih proizvodov (UL L 103, 19.4.2017, str. 1).
Active substance/product type combinations not approved, including any nanomaterial forms:
Neodobrene kombinacije aktivnih snovi/vrst proizvodov, vključno z vsemi nanooblikami:
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;
in situ tvorjene aktivne snovi za vrste proizvodov iz Priloge II k Delegirani uredbi (EU) št. 1062/2014, razen kadar se aktivna snov tvori iz predhodnih sestavin, navedenih v vnosu tabele iz navedene priloge za zadevne kombinacije aktivnih snovi/vrst proizvodov,
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 snovi/vrst proizvodov iz spodnje tabele, vključno s kakršnim koli tvorjenjem in situ teh snovi z uporabo katerih koli predhodnih sestavin, ki niso navedene v Prilogi II k Delegirani uredbi (EU) št. 1062/2014:
Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014
Številka vnosa v Prilogi II k Delegirani uredbi (EU) št. 1062/2014
Product-type(s)
Vrsta(-e) proizvodov
Cetylpyridinium Chloride
Cetilpiridinijev klorid
Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)
Piridin-2-tiol 1-oksid, natrijeva sol (natrijev pirition)
Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol)
Zmes cis- in trans-p-mentan-3,8 diola (citriodiol)
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)
Tetrakis(hidroksimetil)fosfonijev sulfat (2:1) (THPS)
Didecyldimethylammonium chloride (DDAC (C8-10))
Didecildimetilamonijev klorid (DDAC (C8-10))
6-(Phthalimido)peroxyhexanoic acid (PAP)
6-(ftalimido)peroksiheksanojska kislina (PAP)
Tetrachlorodecaoxide complex (TCDO)
Tetraklorodekaoksid kompleks (TCDO)
Bacillus sphaericus other than Bacillus sphaericus 2362, strain ABTS-1743
Bacillus sphaericus razen Bacillus sphaericus 2362, sev ABTS-1743
Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A
Bacillus thuringiensis subsp. israelensis serotip H14 razen seva AM65-52 in razen seva SA3A
Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ
Aktivni klor: pridobljen z reakcijo hipoklorne kisline in natrijevega hipoklorita in situ
Silver zinc zeolite
Srebrov cinkov zeolit
Silver copper zeolite
Srebrov bakrov zeolit
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
Izvedbeni sklep 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
v skladu s členom 3(3) Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta o komarjih, ki so nenaravno okuženi z bakterijo Wolbachia in se uporabljajo za namene nadzora vektorjev
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,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov ter zlasti člena 3(3) Uredbe,
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.
Francija je 28. septembra 2017 Komisijo zaprosila, naj odloči, ali so bakterije iz rodu Wolbachia (v nadaljnjem besedilu: bakterije) ali kateri koli pripravek, ki vsebuje bakterije, ki se vcepijo v komarje, in komarji, ki so nenaravno okuženi z bakterijami (v nadaljnjem besedilu: nenaravno okuženi komarji) ter se uporabljajo za namene nadzora vektorjev, biocidni proizvodi v smislu člena 3(1)(a) Uredbe (EU) št. 528/2012 ali tretirani izdelki v smislu člena 3(1)(l) navedene uredbe ali nič od navedenega.
According to the information provided by France, these intracellular bacteria are transmitted vertically, maternally inherited and naturally present in around 40 % of arthropods.
Po informacijah, ki jih je predložila Francija, se te znotrajcelične bakterije prenašajo vertikalno, dedujejo po materi in so naravno prisotne v približno 40 % členonožcev.
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.
Pri okužbi komarjev z bakterijami se lahko zmanjša zmožnost nekaterih komarjev, da prenašajo določene patogene viruse in parazite z delovanjem na navedene patogene v komarjih, spodbudi pa se razmnoževanje okuženih samic komarjev in širjenje bakterij v populacijah komarjev.
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.
Poleg tega, ker okuženi samci komarjev niso združljivi z lokalnimi samicami, vnos navedenih okuženih samcev v ciljno populacijo zmanjša njihovo zmožnost za razmnoževanje.
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.
Zato kampanje za nadzor vektorjev temeljijo na izpustih nenaravno okuženih komarjev v populacije komarjev za nadzor nad velikostjo populacije in/ali zmanjšanje njihove sposobnosti prenosa določenih patogenov na ljudi.
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.
Po informacijah, ki jih je predložila Francija, niso vse vrste komarjev ali posamezniki znotraj ene vrste naravno okuženi z bakterijami ali s sevom bakterij, ki jih je mogoče izkoriščati za namene nadzora vektorjev.
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.
Zato je treba nenaravne okužbe izvesti v laboratorijskih pogojih, da se ustvarijo nenaravno okuženi komarji z ustreznim sevom bakterij.
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 je mogoče doseči z različnimi tehnikami okužbe, vključno z vcepitvijo bakterij v odrasle samice komarjev ali citoplazmo jajčec komarjev.
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.
Za namene določb iz člena 3(3) Uredbe (EU) št. 528/2012 je zato pomembno ločeno oceniti status bakterij ali kakršnega koli pripravka, ki vsebuje bakterije, ki se vcepijo v komarje, in status nenaravno okuženih komarjev, ne glede na uporabljeno tehniko okužbe.
The bacteria are micro-organisms within the meaning of Article 3(1)(b) of Regulation (EU) No 528/2012
Bakterije so mikroorganizmi v smislu člena 3(1)(b) Uredbe (EU) št. 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.
Komarji so škodljivi organizmi v smislu člena 3(1)(g) Uredbe (EU) št. 528/2012, saj so lahko neželeno prisotni ali škodljivo vplivajo na ljudi ali živali.
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.
Bakterije delujejo posredno na populacije komarjev, bodisi z nadzorom njihove velikosti ali z zmanjšanjem njihove zmožnosti za prenos določenih patogenov, in bi jih bilo zato treba šteti kot aktivno snov v smislu člena 3(1)(c) Uredbe (EU) št. 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 proizvodov 18 (insekticidi, akaricidi in proizvodi za nadzor drugih členonožcev), kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012, vključuje proizvode, ki se uporabljajo za nadzor členonožcev, vendar ne z njihovim odganjanjem ali privabljanjem.
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.
Ker se bakterije vcepijo v komarje z namenom nadzora populacij komarjev, spada taka uporaba v opis vrste proizvodov 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.
Bakterije ali pripravek, ki vsebuje bakterije, imajo nadzorni učinek na komarje ne le s fizičnim ali mehanskim delovanjem.
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 namene člena 3(1)(a) Uredbe (EU) št. 528/2012 bi bilo treba bakterije šteti kot snov, pripravek, ki vsebuje bakterije, pa kot zmes, ki sestoji iz aktivne snovi ali jo vsebuje.
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.
Posledično so bakterije ali kateri koli pripravek, ki vsebuje bakterije, kot se dostavi uporabniku, ki izvaja vcepitev v komarje, biocidni proizvod v smislu prve alinee člena 3(1)(a) Uredbe (EU) št. 528/2012 in spadajo v vrsto proizvodov 18.
Non-naturally infected mosquitoes are not micro-organisms within the meaning of Article 3(1)(b) of Regulation (EU) No 528/2012.
Nenaravno okuženi komarji niso mikroorganizmi v smislu člena 3(1)(b) Uredbe (EU) št. 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.
Nenaravno okuženi komarji niso snov ali zmes v smislu točk 1 oz. 2 člena 3 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta.
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.
Zato v skladu s točkama (a) in (b) člena 3(2) Uredbe (EU) št. 528/2012 niso niti snov niti zmes za namene navedene 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.
Posledično nenaravno okuženi komarji niso aktivna snov v smislu člena 3(1)(c) Uredbe (EU) št. 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.
Zato nenaravno okuženi komarji ne morejo biti biocidni proizvod v smislu prve alinee člena 3(1)(a) navedene uredbe.
Non-naturally infected mosquitoes are not articles within the meaning of Article 3(3) of Regulation (EC) No 1907/2006.
Nenaravno okuženi komarji niso izdelki v smislu člena 3(3) Uredbe (ES) št. 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.
Zato se v skladu s členom 3(2)(c) Uredbe (EU) št. 528/2012 ne štejejo kot izdelki za namene navedene 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.
Posledično se nenaravno okuženi komarji ne morejo šteti kot tretirani izdelki v smislu člena 3(1)(l) Uredbe (EU) št. 528/2012.