natgillin/translations-raw huggingface dataset:
It is necessary to update the list of designated national reference laboratories to assist the Community Reference Laboratory referred to in in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 (CRL) for testing and validation of detection methods in order to take account of changes of designation of national reference laboratories by Member States and to include those in the Member States which recently joined the Union.
Posodobiti je treba seznam imenovanih nacionalnih referenčnih laboratorijev za pomoč referenčnemu laboratoriju Skupnosti, navedenemu v prvem odstavku člena 32 Uredbe (ES) št. 1829/2003 (RLS), pri preskušanju in validaciji metod odkrivanja, da se upoštevajo spremembe v imenovanju nacionalnih referenčnih laboratorijev v državah članicah in vključijo laboratoriji v državah članicah, ki so se nedavno pridružile Uniji.
Transitional measures should be laid down to allow applicants who have received the acknowledgement of the application for an authorisation by the national competent authority according to Regulation (EC) No 1829/2003 before the entry into force of this Regulation to pay the financial contributions according to Regulation (EC) No 1981/2006.
Določiti bi bilo treba prehodne ukrepe, da se vložnikom, ki so prejeli potrditev o prejemu vloge za odobritev s strani pristojnega nacionalnega organa v skladu z Uredbo (ES) št. 1829/2003 še pred začetkom veljavnosti te uredbe, omogoči plačilo finančnih prispevkov v skladu z Uredbo (ES) št. 1981/2006.
Due consideration should be given to public research institutions established in the EU applying for GMO authorisations related to projects mainly financed by the public sector, and a reduction of the amount of the financial contribution should therefore be foreseen in such cases.
Upoštevati bi bilo treba javne raziskovalne ustanove v EU, ki zaprosijo za odobritev GSO v zvezi s projekti, ki se financirajo predvsem iz javnega sektorja, zato bi bilo treba v takih primerih predvideti zmanjšanje višine finančnega prispevka.
Regulation (EC) No 1981/2006 should therefore be amended accordingly.
Uredbo (ES) št. 1981/2006 bi bilo zato treba ustrezno spremeniti.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food chain and Animal Health,
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali –
In Article 2, point (a) is replaced by the following:
v členu 2 se točka (a) nadomesti z naslednjim:
the assessment, through a ring trial according to international standards, involving national reference laboratories of the method performance criteria set by the applicant as compliant with the document entitled “Definition of minimum performance requirements for analytical methods of GMO testing” referred to:
ocenjevanje s pomočjo primerjalnega preskušanja meril za izvajanje metode v skladu z mednarodnimi standardi, v katerega so vključeni nacionalni referenčni laboratoriji, pri čemer metodo določi vlagatelj kot pritožnik v skladu z dokumentom z naslovom ‚,Opredelitev minimalnih zahtev za izvajanje analiznih metod preskušanja GSO‘:
in the case of genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food produced from or containing ingredients produced from genetically modified plants or feed produced from genetically modified plants, in point 3.1.C.4. of Annex III to Commission Implementing Regulation (EU) No 503/2013;in all other cases, in point 1(B) of Annex I to Regulation (EC) No 641/2004;
pri gensko spremenjenih rastlinah, namenjenih živalski krmi ali človeški hrani, živilih ali krmi, ki vsebujejo ali so sestavljeni iz gensko spremenjenih rastlin, in živilih, ki vsebujejo ali so sestavljeni iz sestavin, proizvedenih iz gensko spremenjenih rastlin, ali krmi, proizvedeni iz gensko spremenjenih rastlin, iz točke 3.1.C.4 Priloge III k Izvedbeni uredbi Komisije (ES) št. 503/2013,v vseh drugih primerih iz točke 1(B) Priloge I k Uredbi (ES) št. 641/2004;
In Article 2, the following definitions are added:
v členu 2 se dodajo naslednje opredelitve:
“GMO containing a single transformation event” means a GMO that has been obtained through a single transformation process;
‚GSO‘ ki vsebuje posamezen transformacijski dogodek‘, pomeni GSO, ki je bil pridobljen s posameznim transformacijskim dogodkom;
“GMO containing stacked transformation events” means a GMO containing more than one single transformation event obtained by conventional crossing, co-transformation or re-transformation.’
‚GSO‘ ki vsebuje zložbe transformacijskih dogodkov‘, pomeni GSO, ki vsebuje več kot en posamezen transformacijski dogodek, pridobljen z običajnim križanjem, hkratno transformacijo ali ponovno transformacijo.“;
For each application for a GMO containing a single transformation event, a flat-rate contribution of EUR 40000 shall be paid by the applicant to the CRL.
Vlagatelj mora za vsako vlogo za GSO, ki vsebuje posamezen transformacijski dogodek, referenčnemu laboratoriju Skupnosti plačati pavšalni prispevek v višini 40000 EUR.
The CRL shall request the applicant to pay an additional contribution of EUR 65000 where a full validation procedure of a method of detection and identification for a GMO containing a single transformation event is required in accordance with the following provisions:
Referenčni laboratorij Skupnosti od vlagatelja zahteva, da plača dodatni prispevek v višini 65000 EUR, kadar je potreben popolni postopek validacije metode odkrivanja in identifikacije za GSO, ki vsebuje posamezen transformacijski dogodek, v skladu z naslednjimi določbami:
Annex III to Implementing Regulation (EU) No 503/2013, when the application is related to:
Priloga III k Izvedbeni uredbi (EU) št. 503/2013, kadar se vloga nanaša na:
food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants; or
živila, proizvedena iz sestavin, ki so proizvedene iz gensko spremenjenih rastlin, ali jih vsebujejo, ali krme, proizvedene iz takih rastlin, ali
Annex I of Regulation (EC) No 641/2004 in all other cases.
Priloga I k Uredbi (ES) št. 641/2004 v vseh drugih primerih.
For each application for a GMO containing stacked transformation events, where the method of detection and identification of each single transformation event that constitutes the GMO has been validated by the CRL or where the validation is pending, the flat-rate contribution depends on the number (N) of single transformation events that constitute the GMO and shall be calculated as EUR 20000 + (N × EUR 5000).
Za vsako vlogo za GSO, ki vsebuje zložbe transformacijskih dogodkov, kjer je metodo odkrivanja in identifikacije vsakega posameznega transformacijskega dogodka, ki sestavlja GSO, validiral referenčni laboratorij Skupnosti, ali če ta postopek še teče, je pavšalni prispevek odvisen od števila (N) posameznih transformacijskih dogodkov, ki sestavljajo GSO, in se izračuna po formuli 20000 EUR + (N × 5000 EUR).
Only the GMO containing stacked transformation events with the highest number of single transformation events is to be considered in this calculation.
Ta izračun se upošteva samo pri GSO, ki vsebujejo zložbe transformacijskih dogodkov, z najvišjim številom posameznih transformacijskih dogodkov.
For each application for a GMO containing stacked transformation events that consists of one or more single transformation event(s) for which the method of detection and identification has not been validated by the CRL or for which no validation is pending, the contribution shall be calculated as follows: Article 3(1) and 3 (2) shall apply to single transformation event(s) for which no validated method exists and Article 3(3) shall apply to the GMO containing stacked transformation events, N corresponding to the number of single transformation events composing the GMO for which a validated method exists.
Za vsako vlogo za GSO, ki vsebuje zložbe transformacijskih dogodkov, ter je sestavljen iz enega ali več posameznih transformacijskih dogodkov, kjer metode odkrivanja in identifikacije ni validiral referenčni laboratorij Skupnosti, ali če postopek ne teče, se pavšalni prispevek izračuna po členu 3(1) in (2) za posamezne transformacijske dogodke, za katere validirana metoda ne obstaja, oz. členu 3(3) za GSO, ki vsebujejo zložbe transformacijskih dogodkov, pri čemer N ustreza številu posameznih transformacijskih dogodkov, ki sestavljajo GSO, za katere validirana metoda obstaja.
The CRL shall reduce the amount of the additional contribution referred to in paragraph 2, in proportion of the costs saved:
Referenčni laboratorij Skupnosti zmanjša višino dodatnega prispevka iz odstavka 2 sorazmerno s prihranjenimi stroški:
where the material needed to perform the full validation procedure is supplied by the applicant; and/or
kadar vlagatelj zagotovi vse potrebne snovi za izvajanje popolnega postopka validacije in/ali
where the applicant provides data that refers to modules, such as DNA extraction protocols and species specific reference systems, already validated and published by the CRL.
kadar vlagatelj zagotovi podatke o modulih, kot so postopki ekstrakcije DNK in vrstno specifičnih referenčnih sistemov, ki jih je referenčni laboratorij Skupnosti že validiral in objavil.
Where the costs of the validation of the method of detection and identification proposed by the applicant exceed by at least 50 % the amount of the financial contributions mentioned under paragraphs 1, 2 and 3, a further contribution shall be requested.
Kadar stroški validacije metode odkrivanja in identifikacije, ki jo predlaga vlagatelj, za vsaj 50 % presežejo višino finančnih prispevkov iz odstavkov 1, 2 in 3, se zahteva dodatni prispevek.
The further contribution shall cover 50 % of the part of the costs exceeding the amount of the contributions referred to in paragraphs 1, 2 and 3.
Dodatni prispevek pokrije 50-odstotni delež stroškov, ki presegajo višino prispevkov iz odstavkov 1, 2 in 3.
The contributions provided for in paragraphs 1 to 6 remain due in case of withdrawal of the application, without prejudice to Article 5(3)’.
Tudi v primeru umika vloge se morajo prispevki iz odstavkov 1 do 6 plačati, ne glede na člen 5(3).“;
Where the applicant is a SME, has its head office established in a developing country, or is a public research institution established in the EU whose application relates to a project financed mainly by the public sector, the financial contributions referred to in Article 3(1) to (4) shall be reduced by 50 %’.
Kadar je vlagatelj MSP ali ima glavni sedež v državi v razvoju ali je javna raziskovalna ustanova s sedežem v EU, katere vloga se nanaša na projekt, ki se financira predvsem iz javnega sektorja, se finančni prispevki iz člena 3(1) do (4) zmanjšajo za 50 %.“;
Article 3(6) shall not apply to applicants referred to in Article 4(1).’
Člen 3(6) se ne uporablja za vlagatelje iz člena 4(1).“;
Paragraphs 1, 2 and 3 are replaced by the following:
odstavki 1, 2 in 3 se nadomestijo z naslednjim:
The applicant shall provide evidence that the contribution referred to in Article 3(1), 3(3) and/or 3(4) has been paid to the CRL when it submits the samples of the food and feed and their control samples to the CRL in accordance with Articles 5(3)(j) or Article 17(3)(j) of Regulation (EC) No 1829/2003.
Vlagatelj predloži dokazilo, da je referenčnemu laboratoriju Skupnosti plačal prispevek iz člena 3(1), 3(3) in/ali 3(4), ko referenčnemu laboratoriju Skupnosti predloži vzorce živil in krme in njihove kontrolne vzorce v skladu s členom 5(3)(j) ali členom 17(3)(j) Uredbe (ES) št. 1829/2003.
Where, as provided for in Article 3(2), a full validation procedure is required, the CRL shall notify the applicant in writing of this fact and require the payment of the amount in accordance with that provision, prior to starting step 4 (collaborative trial) of its validation process.
Kadar je potreben popolni postopek validacije metode, kot je določeno v členu 3(2), referenčni laboratorij Skupnosti o tem pisno obvesti vlagatelja in v skladu z navedeno določbo od njega zahteva plačilo zneska pred začetkom četrtega koraka (medlaboratorijski preskus) postopka validacije.
Where, as provided for in Article 3(6), the CRL expects the costs of the validation of the detection method proposed by the applicant to exceed by at least 50 % the amount of the financial contributions referred to in Article 3(1) to (4), it shall notify the applicant in writing of the estimated amount of the further costs.
Kadar referenčni laboratorij Skupnosti pričakuje, kot je določeno v členu 3(6), da bodo stroški validacije metode odkrivanja, ki jo predlaga vlagatelj, presegli višino finančnih prispevkov iz člena 3(1) do (4) za najmanj 50 %, referenčni laboratorij Skupnosti pisno obvesti vlagatelja o predvidenem znesku dodatnih stroškov.
If, within one month of the date of receipt of the notification, the applicant withdraws its application, the further contribution referred to in Article 3(6) shall not be due.
Če v enem mesecu od datuma prejema obvestila vlagatelj umakne vlogo, dodatnega prispevka iz člena 3(6) ni treba plačati.
After completion of the validation of the detection method, the CRL shall notify the applicant in writing the actual and duly justified costs incurred in carrying out the validation of the method of detection and require payment of the contribution due in accordance with Article 3(6).’
Po zaključku validacije metode odkrivanja referenčni laboratorij Skupnosti pisno sporoči vlagatelju dejanske in ustrezno utemeljene stroške, ki so nastali pri izvajanju validacije metode odkrivanja, in od njega zahteva plačilo dolgovanega prispevka v skladu s členom 3(6).“;
Paragraph 5 is deleted.
odstavek 5 se črta;
The first subparagraph of paragraph 7 is replaced by the following:
prvi pododstavek odstavka 7 se nadomesti z naslednjim:
‘The contributions provided for in paragraph 2 and 3 shall be payable by the applicant within 45 days of the date of reception of the notification. Step 4 (collaborative trial) of the validation process shall not be started before those contributions are received’.
„Vlagatelj plača prispevke iz odstavkov 2 in 3 v 45 dneh od datuma prejema obvestila. Četrti korak (medlaboratorijski preskus) postopka validacije se začne šele po prejetju navedenih prispevkov.“;
In Article 6, paragraph 2 is replaced by the following paragraphs 2 and 3:
v členu 6 se odstavek 2 nadomesti z naslednjima odstavkoma 2 in 3:
The national reference laboratories listed in Annex II shall be selected randomly for participation in an international collaborative validation trial and shall receive 2400 EUR from the CRL as a contribution to the costs for their participation.
S seznama nacionalnih referenčnih laboratorijev iz Priloge II se naključno izberejo laboratoriji za sodelovanje v mednarodnem medlaboratorijskem validacijskem preskusu in od referenčnega laboratorija Skupnosti prejmejo 2400 EUR za kritje stroškov njihovega sodelovanja.
In case of Article 4(1) this amount shall be proportionally reduced.
V primeru iz člena 4(1) se ta znesek sorazmerno zniža.
The CRL and those national reference laboratories listed in Annex II that participate in a validation study shall enter into a written agreement to define the relations between them, notably in financial matters.’
Referenčni laboratorij Skupnosti in tisti nacionalni referenčni laboratoriji, našteti v Prilogi II, ki sodelujejo v validacijski študiji, sklenejo pisni sporazum z namenom opredelitve odnosov med njimi, zlasti na področju finančnih zadev.“;
In Annex I, point (a) is replaced by the following:
v Prilogi I se točka (a) nadomesti z naslednjim:
be accredited according to EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories”, or an equivalent international standard which ensures that the laboratories:
biti akreditirani v skladu z EN ISO/IEC 17025 o „,Splošnih zahtevah za usposobljenost preskuševalnih in kalibracijskih laboratorijev“ ali enakovrednim mednarodnim standardom, ki zagotavlja, da imajo laboratoriji:
possess the equipment needed to carry out the required analysis,
potrebno opremo za izvajanje zahtevanih analiz,
have sufficient data-processing capacity to produce technical reports and to enable rapid communication with the other laboratories participating in the testing and validation of detection methods;
zadostno zmogljivost obdelave podatkov za pripravo tehničnih poročil in zagotovitev hitre izmenjave informacij z drugimi laboratoriji, ki sodelujejo pri preskušanju in validaciji metod odkrivanja.
Laboratories listed in Annex II to this Regulation which are not yet accredited are admitted until 31 December 2014 if the laboratory declares to be in the process of accreditation and provides proof of technical competences to the CRL’.
Laboratoriji, našteti v Prilogi II k tej uredbi, ki še niso akreditirani, so odobreni do 31. decembra 2014, če laboratorij izjavi, da je v postopku pridobivanja akreditacije in referenčnemu laboratoriju Skupnosti predloži dokazila o tehnični usposobljenosti.“;
Annex II is replaced by the Annex to this Regulation.
Priloga II se nadomesti s Prilogo k tej uredbi.
Articles 3 to 5 of Regulation (EC) No 1981/2006 on financial contributions shall continue to apply to applicants who have received the acknowledgement of the application for an authorisation by the national competent authority according to Regulation (EC) No 1829/2003 before the entry into force of this Regulation.
Členi 3 do 5 Uredbe (ES) št. 1981/2006 o finančnih prispevkih se še naprej uporabljajo za vložnike, ki so prejeli potrditev o prejemu vloge za odobritev s strani pristojnega nacionalnega organa v skladu z Uredbo (ES) št. 1829/2003 pred začetkom veljavnosti te uredbe.
OJ L 157, 8.6.2013, p. 1.
UL L 157, 8.6.2013, str. 1.
http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf, CRL and European Network of GMO laboratories, 13 October 2008.
http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf, Referenčni laboratorij Skupnosti in Evropsko omrežje laboratorijev GSO, 13. oktober 2008.
OJ L 157, 8.6.2013, p. 1.’
UL L 157, 8.6.2013, str. 1.“;
National reference laboratories assisting the CRL for testing and validation of methods for detection, as referred to in Article 6(1)
Nacionalni referenčni laboratoriji, ki referenčnemu laboratoriju Skupnosti pomagajo pri preskušanju in validaciji metod odkrivanja in identifikacije, kot je navedeno v členu 6(1)
Until 1 January 2014.
Do 1. januarja 2014.
Elláda
Grčija
Éire
Irska
Hrvatska
Hrvaška
România
Romunija
Commission Implementing Regulation (EU) No 121/2014
Izvedbena uredba Komisije (EU) št. 121/2014
concerning the authorisation of L-selenomethionine as a feed additive for all animal species
o izdaji dovoljenja za L-selenometionin kot krmni dodatek za vse živalske vrste
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-selenomethionine.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za dovoljenje za L-selenometionin.
That application concerns the authorisation of L-selenomethionine, an organic compound of selenium, as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.
Navedeni zahtevek zadeva dovoljenje za L-selenometionin, organsko spojino selena, kot krmni dodatek za vse živalske vrste in njegovo uvrstitev v kategorijo dodatkov „nutritivni dodatki“.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 May 2013 [2] that, under the proposed conditions of use, L-selenomethionine does not have an adverse effect on animal health, human health or the environment and that its use may be considered as an efficient source of selenium for all animal species.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojem mnenju z dne 2. maja 2013 [2] navedla, da uporaba L-selenometionina pod predlaganimi pogoji uporabe nima škodljivega vpliva na zdravje živali in ljudi ali na okolje ter da je lahko pomemben vir selena za vse živalske vrste.
The assessment of L-selenomethionine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena L-selenometionina je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
The Authority concluded that the limitation of the supplementation with organic selenium established for other organic compounds of selenium should also apply to L-selenomethionine.
Agencija je sklenila, da bi se morala omejitev dodajanja organskega selena, ki je določena za druge organske spojine selena, uporabljati tudi za L-selenometionin.
Furthermore, in case different compounds of selenium are added to the feed, the supplementation with organic selenium should not exceed 0,2 mg per kg complete feed.
Poleg tega dodajanje organskega selena, kadar se krmi dodajajo različne spojine selena, ne bi smelo presegati 0,2 mg/kg popolne krmne mešanice.
The applicant delivered supplementary data consequently to the abovementioned opinion of the Authority to prove the stability of the additive once it is incorporated in premixtures containing compounds of trace elements.
Vložnik je predložil dodatne podatke v odgovor na navedeno mnenje Agencije za dokaz stabilnosti dodatka, ko je vključen v premikse, ki vsebujejo spojine elementov v sledovih.
Selenium in mg/kg of complete feed with a moisture content of 12 %
Selen v mg/kg popolne krmne mešanice z vsebnostjo vlage 12 %
Solid preparation of L-selenomethionine with a selenium content < 40 g/kg
trdni pripravek L-selenometionina z vsebnostjo selena < 40 g/kg
Organic selenium in form of L-selenomethionine (2-amino-4-methylselanyl-butanoic acid) from chemical synthesis
organski selen v obliki L-selenometionina (2-amino- 4-metilselanil-butanojska kislina) iz kemične sinteze
Chemical formula: C5H11NO2Se
kemijska formula: C5H11NO2Se
CAS number: 3211-76-5
št. CAS: 3211-76-5
Crystalline powder with L-selenomethionine > 97 % and
kristalinični prah z L-selenometioninom > 97 % in
Analytical method [1]For the determination of L-selenomethionine in the feed additive: high performance liquid chromatography and inductively coupled plasma mass spectrometry (HPLC-ICPMS) after triple proteolytic digestion.
Analitska metoda [1]Za določanje L-selenometionina v krmnem dodatku: tekočinska kromatografija visoke ločljivosti in masna spektrometrija z induktivno sklopljeno plazmo (HPLC-ICPMS) po trojni proteolitski razgradnji.
For the determination of total selenium in the feed additive: inductively coupled plasma mass spectrometry (ICPMS), or inductively coupled plasma atomic emission spectrometry (ICP-AES).
Za določanje skupnega selena v krmnem dodatku: masna spektrometrija z induktivno sklopljeno plazmo (ICPMS) ali atomska emisijska spektrometrija z induktivno sklopljeno plazmo (ICP-AES).
For the determination of total selenium in premixtures, compound feed and feed materials: hydride generation atomic absorption spectrometry (HGAAS) after microwave digestion (EN 16159:2012).
Za določanje skupnega selena v premiksih, krmnih mešanicah in posamičnih krmilih: atomska absorpcijska spektrometrija s hidridno tehniko (HGAAS) po mikrovalovni razgradnji (EN 16159:2012).
For user safety: breathing protection, safety glasses and gloves shall be worn during handling.
Za varnost uporabnika je treba med ravnanjem nositi zaščito za dihala, zaščitna očala in rokavice.
Technological additives or feed materials included in the preparation of the additive shall ensure a dusting potential < 0,2 mg selenium/m3 air.
Tehnološki dodatki ali posamična krmila, vključena v pripravek dodatka, zagotovijo potencial prašnosti v višini < 0,2 mg selena/m3 zraka.
In the directions for use of the additive and premixtures, indicate the storage and stability conditions.
V navodilih za uporabo dodatka in premiksa je treba navesti pogoje skladiščenja in obstojnosti.