natgillin/translations-raw huggingface dataset:
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the authorisation of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as feed additives for all animal species, requesting those additives to be classified in the category ‘technological additives’ and in the functional group ‘silage additives’.
V skladu s členom 10(2) Uredbe (ES) št. 1831/2003 in v povezavi s členom 7 navedene uredbe sta bila vložena zahtevka za dovoljenje mikroorganizmov Lactobacillus plantarum (NCIMB 41028) in Lactobacillus plantarum (NCIMB 30148) kot krmnih dodatkov za vse živalske vrste ter za njuno uvrstitev v kategorijo „tehnoloških dodatkov“ in funkcionalno skupino „silirnih dodatkov“.
Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
V skladu s členom 7(3) Uredbe (ES) št. 1831/2003 so bili navedenima zahtevkoma priloženi zahtevani podatki in dokumenti.
The applications concern the authorisation of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) as feed additives for all animal species, to be classified in the additive category ‘technological additives’.
Zahtevka zadevata dovoljenje za mikroorganizma Lactobacillus plantarum (NCIMB 41028) in Lactobacillus plantarum (NCIMB 30148) kot krmna dodatka za vse vrste živali in njuno uvrstitev v kategorijo dodatkov „tehnološki dodatki“.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 December 2011 [2] that, under the proposed conditions of use, the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) do not have an adverse effect on animal health, human health or the environment, and that these micro-organisms have the potential to improve the production of silage from all forages by increasing the preservation of dry matter and reducing the loss of protein.
(5) Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojem mnenju z dne 13. decembra 2011 [2] navedla, da mikroorganizma Lactobacillus plantarum (NCIMB 41028) in Lactobacillus plantarum (NCIMB 30148) v predlaganih pogojih uporabe nimata škodljivega vpliva na zdravje živali, ljudi ali na okolje in da lahko ta mikroorganizma izboljšata proizvodnjo silaže za vse vrste krme z ohranjanjem več suhe snovi in zmanjšanjem izgub beljakovin.
The Authority also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Potrdila je tudi poročilo o analitski metodi krmnih dodatkov v krmi, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The assessment of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena mikroorganizmov Lactobacillus plantarum (NCIMB 41028) in Lactobacillus plantarum (NCIMB 30148) je pokazala, da so pogoji za izdajo dovoljenja iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Accordingly, the use of those micro-organisms should be authorised as specified in the Annexes to this Regulation.
Zato bi bilo treba dovoliti uporabo navedenih mikroorganizmov, kakor je opredeljeno v prilogah k tej uredbi.
Since modifications to the conditions of authorisation of the micro-organisms Lactobacillus plantarum (NCIMB 41028) and Lactobacillus plantarum (NCIMB 30148) are introduced and as there are no direct immediate effects on safety, a reasonable period should be allowed to elapse before authorisation in order to allow the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
Ker bodo spremenjeni pogoji za izdajo dovoljenja za mikroorganizma Lactobacillus plantarum (NCIMB 41028) in Lactobacillus plantarum (NCIMB 30148) in ker ni neposrednih varnostnih tveganj, bi bilo treba pred izdajo dovoljenja določiti primerno obdobje, da se lahko vse zainteresirane strani pripravijo na izpolnjevanje novih zahtev zaradi izdaje dovoljenja.
In addition, it is appropriate to allow a transitional period for the disposal of existing stocks of those micro-organisms and of feed containing them.
Poleg tega je primerno, da se omogoči prehodno obdobje za porabo obstoječih zalog navedenih mikroorganizmov in krme, ki ju vsebuje.
The micro-organism specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Mikroorganizem iz Priloge I, ki spada v kategorijo dodatkov „tehnološki dodatki“ in funkcionalno skupino „silirni dodatki“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
The micro-organism specified in Annex II, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Mikroorganizem iz Priloge II, ki spada v kategorijo dodatkov „tehnološki dodatki“ in funkcionalno skupino „silirni dodatki“, se dovoli kot dodatek v prehrani živali v skladu s pogoji iz navedene priloge.
Feed containing the micro-organisms referred to in Article 1 and in Article 2 shall be labelled in accordance with this Regulation at the latest by 19 May 2013.
Krma, ki vsebuje mikroorganizma iz členov 1 in 2, se označi v skladu s to uredbo najpozneje 19. maja 2013.
However, feed containing the micro-organisms referred to in Article 1 and in Article 2 which has been labelled in accordance with the previous conditions of authorisation before 19 May 2013 may continue to be placed on the market until stocks are exhausted.
Vendar se lahko krma, ki vsebuje mikroorganizma iz členov 1 in 2 in je označena v skladu s prejšnjimi pogoji dovoljenja pred 19. majem 2013, daje na trg do porabe zalog.
Existing stocks of the micro-organisms referred to in Article 1 and in Article 2 and of feed containing them at the date of entry into force of this Regulation may continue to be placed on the market and used under the previous conditions of authorisation until they are exhausted.
Obstoječe zaloge mikroorganizmov iz členov 1 in 2 ter krme, ki ju vsebuje, na dan začetka veljavnosti te uredbe se lahko še naprej dajejo na trg in uporabljajo v skladu s pogoji dovoljenja do porabe zalog.
Preparation of Lactobacillus plantarum NCIMB 41028 containing a minimum of 7 × 1010 CFU/g additive
Pripravek iz Lactobacillus plantarum (NCIMB 41028) z najnižjo vsebnostjo 7 × 1010 CFU/g dodatka
Analytical method [1]Enumeration in the feed additive: spread plate method (EN 15787)
Analitska metoda [1]Metoda štetja pri krmnem dodatku: metoda razmaza na plošči (EN 15787)
Identification: pulsed field gel electrophoresis (PFGE)
Identifikacija: gelska elektroforeza v utripajočem polju (PFGE)
Minimum dose of the additive when used not in combination with other micro-organisms as silage additive: 1 × 109 CFU/kg fresh material.
Najnižji odmerek dodatka, kadar se ne uporablja v kombinaciji z drugimi mikroorganizmi kot silirnimi dodatki: 1 × 109 CFU/kg sveže snovi.
For safety: it is recommended to use breathing protection and gloves during handling.
Zaradi varnosti se pri ravnanju priporoča uporaba zaščite za dihala in rokavic.
Preparation of Lactobacillus plantarum NCIMB 30148 containing a minimum of 7 × 1010 CFU/g additive
Pripravek iz Lactobacillus plantarum (NCIMB 30148) z najnižjo vsebnostjo 7 × 1010 CFU/g dodatka
Commission Implementing Regulation (EU) No 842/2012
Izvedbena uredba Komisije (EU) št. 842/2012
concerning the authorisation of a preparation of lanthanum carbonate octahydrate as a feed additive for dogs (holder of authorisation Bayer Animal Health GmbH)
o izdaji dovoljenja za pripravek iz lantanovega karbonata oktahidrata kot krmni dodatek za pse (imetnik dovoljenja Bayer Animal Health GmbH)
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation of lanthanum carbonate octahydrate, CAS number 6487-39-4.
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za pripravek iz lantanovega karbonata oktahidrata (št. CAS 6487-39-4).
The application concerns the authorisation of the preparation lanthanum carbonate octahydrate CAS number 6487-39-4 as a feed additive for dogs, to be classified in the additive category ‘zootechnical additives’.
Zahtevek zadeva dovoljenje za pripravek iz lantanovega karbonata oktahidrata (št. CAS 6487-39-4) kot krmni dodatek za pse in njegovo uvrstitev v kategorijo dodatkov „zootehnični dodatki“.
The use of that preparation was authorised for 10 years for cats by Commission Regulation (EC) No 163/2008 [2].
Z Uredbo Komisije (ES) št. 163/2008 [2] je bila za deset let dovoljena uporaba navedenega pripravka za mačke.
New data were submitted in support of the application for authorisation of lanthanum carbonate octahydrate, CAS number 6487-39-4, for dogs.
Predloženi so bili novi podatki v podporo zahtevku za izdajo dovoljenja za pripravek iz lantanovega karbonata oktahidrata (št. CAS 6487-39-4) za pse.
It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Vendar Agencija ni mogla sprejeti sklepa o dolgoročnih učinkih, potrdila pa je poročilo o analitski metodi krmnega dodatka, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The assessment of lanthanum carbonate octahydrate, CAS number 6487-39-4, shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena lantanovega karbonata oktahidrata (št. CAS 6487-39-4) je pokazala, da so pogoji za izdajo dovoljenja iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.
Zato bi bilo treba dovoliti uporabo navedenega pripravka, kakor je opredeljeno v Prilogi k tej uredbi.
It is appropriate to provide for post-market monitoring as regards long-term adverse effects.
Vendar je primerno zagotoviti poprodajni nadzor glede dolgoročnih škodljivih učinkih.
Functional group: other zootechnical additives (decrease in phosphorus excretion via urine)
Funkcionalna skupina: drugi zootehnični dodatki (zmanjšanje izločanja fosforja z urinom)
Lanthanum carbonate octahydrate
lantanov karbonat oktahidrat
Preparation of lanthanum carbonate octahydrate.
pripravek iz lantanovega karbonata oktahidrata.
At least 85 % lanthanum carbonate octahydrate as active substance
vsaj 85 % lantanovega karbonata oktahidrata kot aktivne snovi.
CAS number 6487-39-4
št. CAS 6487-39-4
Analytical method [1]Quantification of carbonate in the feed additive:
Analitska metoda [1]določanje količine karbonata v krmnem dodatku:
Community method (Commission Regulation (EC) No 152/2009) [2]Quantification of lanthanum in the feed additive and feedingstuff: inductively coupled plasma atomic emission spectrometry (ICP-AES).
metoda Skupnosti (glej Uredbo Komisije (ES) št. 152/2009) [2]določanje količine lantana v krmnem dodatku in krmi: atomska emisijska spektrometrija z induktivno sklopljeno plazmo (ICP-AES).
Post-market monitoring on chronic adverse effects is required.
Zahteva se poprodajni nadzor o dolgoročnih škodljivih učinkih.
In the directions for use of the additive:
V navodilih za uporabo dodatka se navede:
recommended dose of inclusion in moist feed with 20-25 % dry matter content: 340 to 2100 mg per kg
priporočeni odmerek vključitve v vlažno krmo z 20–25-odstotno vsebnostjo suhe snovi: 340 do 2100 mg na kg,
avoid simultaneous use of feeds with high level of phosphorus’
izogibati se je treba hkratni uporabi krme z visoko vsebnostjo fosforja.“
Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
Podrobnosti o analitskih metodah so na voljo na naslednjem naslovu referenčnega laboratorija za krmne dodatke: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx.
for adult dogs
za odrasle pse,
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 March 2012 that, under the proposed conditions of use, lanthanum carbonate octahydrate does not have an adverse effect on the target species [3]. It further concluded that lanthanum carbonate octahydrate has the potential to reduce the phosphorus bioavailability in adult dogs. It could not, however, comment on the long-term effects.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojem mnenju z dne 6. marca 2012 navedla, da lantanov karbonat oktahidrat v predlaganih pogojih uporabe nima škodljivega vpliva na ciljno vrsto [3] ter da lahko zmanjša biološko razpoložljivost fosforja pri odraslih psih.
Commission Implementing Regulation (EU) No 843/2012
Izvedbena uredba Komisije (EU) št. 843/2012
concerning the authorisation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) as a feed additive for turkeys reared for breeding, minor avian species for fattening and reared for laying or breeding and ornamental birds (holder of authorisation BASF SE)
o izdaji dovoljenja za endo-1,4-beta-ksilanazo, ki jo proizvaja Aspergillus niger (CBS 109.713), kot krmni dodatek za purane za razplod, manjše aviarne vrste za pitanje in za nesnice ali razplod ter okrasne ptice (imetnik dovoljenja BASF SE)
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (CBS 109.713).
V skladu s členom 7 Uredbe (ES) št. 1831/2003 je bil vložen zahtevek za izdajo dovoljenja za endo-1,4-beta-ksilanazo (ES 3.2.1.8), ki jo proizvaja Aspergillus niger (CBS 109.713).
The application concerns the authorisation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (CBS 109.713) as a feed additive for chickens reared for laying, turkeys reared for breeding, minor avian species for fattening and reared for laying or breeding and ornamental birds, to be classified in the additive category ‘zootechnical additives’.
Zahtevek zadeva dovoljenje za endo-1,4-beta-ksilanazo (ES 3.2.1.8), ki jo proizvaja Aspergillus niger (CBS 109.713), kot krmni dodatek za piščance za nesnice, purane za razplod, manjše aviarne vrste za pitanje in za nesnice ali razplod ter okrasne ptice in njeno uvrstitev v kategorijo dodatkov „zootehnični dodatki“.
The use of that preparation was authorised for 10 years for chickens for fattening and for ducks by Commission Regulation (EC) No 1096/2009 [2] and for turkeys for fattening by Commission Regulation (EC) No 1380/2007 [3].
Z Uredbo Komisije (ES) št. 1096/2009 [2] je bila za deset let dovoljena uporaba navedenega pripravka za piščance za pitanje in race, z Uredbo Komisije (ES) št. 1380/2007 [3] pa za deset let za purane za pitanje.
New data were submitted in support of the application for the authorisation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (CBS 109.713) for chickens reared for laying, turkeys reared for breeding, minor avian species for fattening and reared for laying or breeding and ornamental birds.
Predloženi so bili novi podatki v podporo zahtevku za dovoljenje za endo-1,4-beta-ksilanazo (ES 3.2.1.8), ki jo proizvaja Aspergillus niger (CBS 109.713), kot krmni dodatek za piščance za nesnice, purane za razplod, manjše aviarne vrste za pitanje in za nesnice ali razplod ter okrasne ptice.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 February 2012 [4] that, under the proposed conditions of use, endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (CBS 109.713) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the feed to gain ratio in all target species.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojem mnenju z dne 2. februarja 2012 [4] navedla, da endo-1,4-beta-ksilanaza (ES 3.2.1.8), ki jo proizvaja Aspergillus niger (CBS 109.713), v predlaganih pogojih uporabe nima škodljivega vpliva na zdravje živali in ljudi ali na okolje ter da lahko njena uporaba izboljša razmerje med krmo in prirastom teže pri vseh ciljnih vrstah.
The assessment of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus niger (CBS 109.713) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Pri oceni endo-1,4-beta-ksilanaze (ES 3.2.1.8), ki jo proizvaja Aspergillus niger (CBS 109.713), se je pokazalo, da so pogoji za izdajo dovoljenja iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.
Zato bi bilo treba dovoliti uporabo navedenega pripravka, kakor je opredeljeno v Prilogi k tej uredbi.
Preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) having a minimum activity of:
pripravek iz endo-1,4-beta-ksilanaze, ki jo proizvaja Aspergillus niger (CBS 109.713) in ki ima najnižjo aktivnost:
Solid form: 5600 TXU [1]/g
v trdni obliki: 5600 TXU [1] /g
Endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713)
endo-1,4-beta-ksilanaza, ki jo proizvaja Aspergillus niger (CBS 109.713)
Analytical method [2]Viscosimetric method based on decrease of viscosity produced by action of endo-1,4-beta-xylanase on the xylan-containing substrate (wheat arabinoxylan) at pH 3,5 and 55 °C
Analitska metoda [2]Viskozimetrična metoda, ki temelji na zmanjšanju viskoznosti zaradi delovanja endo-1,4-beta-ksilanaze na substrat, ki vsebuje ksilan (arabinoksilan iz pšenice) pri pH 3,5 in 55 °C.
Recommended maximum dose per kilogram of complete feedingstuff for all species falling within the scope of this Regulation: 840 TXU.
Priporočeni odmerek na kilogram popolne krmne mešanice za vse vrste, ki jih zajema ta uredba: 840 TXU
For use in feed rich in starch and non-starch polysaccharides (mainly beta-glucans and arabinoxylans).
Za uporabo v krmi, bogati s škrobnimi in neškrobnimi polisaharidi (večinoma beta-glukani in arabinoksilani).
Ornamental birds, minor avian species except ducks and laying birds.
okrasne ptice, manjše aviarne vrste, razen rac in nesnic
Commission Implementing Regulation (EU) No 844/2012
Izvedbena uredba Komisije (EU) št. 844/2012
setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
o opredelitvi določb, potrebnih za izvedbo postopka podaljšanja odobritve aktivnih snovi, kot je določeno z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular Article 19 thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS [1] ter zlasti člena 19 Uredbe,
Regulation (EC) No 1107/2009 provides that the approval of an active substance may be renewed upon expiry.
Uredba (ES) št. 1107/2009 določa, da se odobritev aktivne snovi lahko podaljša ob izteku.
It is appropriate to set out the provisions necessary for the implementation of the renewal procedure.
Ustrezno je opredeliti določbe, potrebne za izvedbo postopka podaljšanja odobritve.
In particular, periods should be set for the different steps of the renewal procedure to ensure that it functions properly.
Zlasti bi bilo treba določiti obdobja za različne stopnje postopka podaljšanja odobritve in s tem zagotoviti njegovo pravilno delovanje.
Rules should be set out as regards confidentiality and the publication of the application for renewal, the supplementary dossiers and their updates.
Določiti bi bilo treba pravila glede zaupnosti in objave vloge za podaljšanje odobritve, dopolnilne dokumentacije in njunih posodobitev.
Rules should also be set out as regards the submission of the application for renewal and its contents and format.
Določiti bi bilo treba tudi pogoje predložitve vloge za podaljšanje odobritve ter njeno vsebino in obliko.
The applicant should be obliged to justify the submission of new information and to list separately studies concerning vertebrate animals that they intend to submit.
Vlagatelji bi morali predložitev novih informacij utemeljiti in ločeno navesti študije, ki jih nameravajo predložiti o vretenčarjih.
Rules should be set out as regards the checking of the application by the rapporteur Member State.
Določiti bi bilo treba pravila glede preverjanja vloge s strani države članice poročevalke.
In order to ensure the proper functioning of the renewal procedure, the rapporteur Member State should, at the applicant’s request, organise prior to the submission of the supplementary dossier, a meeting to discuss the application.
Za zagotovitev pravilnega delovanja postopka podaljšanja odobritve bi morala država članica poročevalka na zahtevo vlagatelja pred predložitvijo dopolnilne dokumentacije organizirati sestanek za obravnavanje vloge.
The supplementary dossiers submitted for renewal should, in particular, include necessary new data and new risk assessments and demonstrate why such data and risk assessments are necessary.
Dopolnilna dokumentacija, predložena za podaljšanje odobritve, bi morala zlasti vključevati potrebne nove podatke in nove ocene tveganja ter ponazoriti, zakaj so takšni podatki in ocene tveganj nujni.
Rules should be set out as regards the establishment of the admissibility of the application by the rapporteur Member State.
Določiti bi bilo treba pravila glede ugotavljanja dopustnosti vloge s strani države članice poročevalke.
Where all applications submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned.
Če so vse predložene vloge nedopustne, bi morala Komisija sprejeti uredbo o zavrnitvi podaljšanja odobritve zadevne aktivne snovi.
Rules should be set out to ensure an independent, objective and transparent assessment of the active substance.
Treba bi bilo določiti pravila, da se zagotovi neodvisno, objektivno in pregledno oceno aktivne snovi.
The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report.
Vlagatelju, državam članicam, razen državi članici poročevalki, in javnosti bi bilo treba dati možnost, da predložijo pripombe na osnutek poročila o oceni podaljšanja odobritve.
The European Food Safety Authority should provide conclusions and organise consultations of experts, except where the Commission informs it that a conclusion is not necessary.
(13) Evropska agencija za varnost hrane bi morala sprejeti sklepe in organizirati posvetovanja strokovnjakov, razen če jo Komisija ne obvesti, da sklep ni potreben.
Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal of the approval of the active substance.
Treba bi bilo določiti pravila glede poročila o podaljšanju odobritve in sprejetju uredbe o podaljšanju ali zavrnitvi podaljšanja odobritve aktivne snovi.