natgillin/translations-raw huggingface dataset:
The safety of these types of cosmetic products highly depends on responsible risk management including warnings and extensive guidance for use.
Varnost teh vrst kozmetičnih izdelkov je zelo odvisna od odgovornega obvladovanja tveganja, vključno z opozorili in obsežnimi navodili za uporabo.
On the basis of the scientific assessment of thioglycolic acid and its salts their use should be allowed in products intended for eyelash waving and for use as depilatories.
Na podlagi znanstvene ocene tioglikolne kisline in njenih soli bi bilo treba dovoliti njihovo uporabo v izdelkih za kodranje trepalnic in uporabo kot depilacijska sredstva.
However, in order to avoid any risk connected with the self-application of products intended for eyelash-waving by consumers, they should be allowed for professional use only.
Da pa bi se izognili kakršnemu koli tveganju, povezanemu s samouporabo izdelkov za kodranje trepalnic, bi morali biti ti dovoljeni samo za poklicno uporabo.
In order to allow professionals to inform consumers about possible adverse effects of the application of products containing thioglycolic acid and its salts on eyelashes and to lower the risk of skin sensitisation to those products, appropriate warnings should be printed on their labels.
Da bi poklicni uporabniki potrošnike lahko obvestili o morebitnih škodljivih učinkih uporabe izdelkov, ki vsebujejo tioglikolno kislino in njene soli, na trepalnicah in da bi zmanjšali tveganje za preobčutljivost kože pri uporabi navedenih izdelkov, bi bilo treba na njihovih etiketah navesti ustrezna opozorila.
Annex III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.
Prilogo III k Uredbi (ES) št. 1223/2009 bi bilo zato treba ustrezno spremeniti.
The application of the restrictions relating to hair dye substances should be deferred to allow the industry to comply with the requirements for hair dye products.
Uporabo omejitev v zvezi s snovmi za barvanje las bi bilo treba odložiti in tako industriji omogočiti, da bo izpolnjevala zahteve za izdelke za barvanje las.
In particular, undertakings should be granted 12 months to place on the market compliant products and to withdraw from the market non-compliant products after the entry into force of this Regulation.
Zlasti bi bilo treba podjetjem po začetku veljavnosti te uredbe odobriti obdobje dvanajstih mesecev za dajanje na trg izdelkov, ki izpolnjujejo zahteve, in za umik s trga izdelkov, ki ne izpolnjujejo zahtev.
Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
Priloga III k Uredbi (ES) št. 1223/2009 se spremeni v skladu s Prilogo k tej uredbi.
It shall apply from 10 August 2015, except the provisions in point 2 of the Annex which shall apply from 10 August 2016.
Uporablja se od 10. avgusta 2015, razen določb iz točke 2 Priloge, ki se uporabljajo od 10. avgusta 2016.
Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment (OJ L 66, 4.3.2004, p. 45).
Sklep Komisije 2004/210/ES z dne 3. marca 2004 o ustanovitvi znanstvenih odborov na področju varstva potrošnikov, javnega zdravja in okolja (UL L 66, 4.3.2004, str. 45).
Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (OJ L 241, 10.9.2008, p. 21).
Sklep Komisije 2008/721/ES z dne 5. septembra 2008 o vzpostavitvi svetovalne strukture znanstvenih odborov in strokovnjakov na področju varstva potrošnikov, javnega zdravja in okolja ter razveljavitvi Sklepa 2004/210/ES (UL L 241, 10.9.2008, str. 21).
Annex III to Regulation (EC) No 1223/2009 is amended as follows:
Priloga III k Uredbi (ES) št. 1223/2009 se spremeni:
entry 2a is replaced by the following:
vnos 2a se nadomesti z naslednjim:
Thioglycolic acid and its salts
Tioglikolna kislina in njene soli
Hair waving or straightening products
Izdelki za kodranje in ravnanje las
General use
Splošna uporaba
ready for use pH 7 to 9,5
Pripravljeno za uporabo pH 7 do 9,5
Professional use
Poklicna uporaba
Rinse eyes immediately if product comes into contact with them.
Če pride izdelek v stik z očmi, jih nemudoma izperite.
Warnings to be printed on the label:
Na nalepki je treba navesti:
Follow the instructions’
Upoštevajte navodila.“
Depilatories
Depilatorji (oz. sredstva za depilacijo)
ready for use pH 7 to 12,7
Pripravljeno za uporabo pH 7 do 12,7
Other hair rinse-off products
Drugi izdelki za lase, ki se izperejo
Products intended for eyelash waving
Izdelki za kodranje trepalnic
For professional use
Za poklicno uporabo
ready for use pH 7 to 9,5
Pripravljeno za uporabo pH 7 do 9,5
the following entries 288 to 296 are added:
dodajo se naslednji vnosi 288 do 296:
3-[(4-amino-3-methyl-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-N,N,N -trimethylpropan-1-aminium, methylsulfate salt
3-[(4-amino-3-metil-9,10-diokso-9,10-dihidroantracen-1-il) amino]-N, N, N-trimetilpropan-1-amonijak, metilsulfatna sol
Hair dye substance in oxidative hair dye products
Snov za barvanje las v neoksidativnih izdelkih za barvanje las
Hair dye substance in non-oxidative hair dye products
Po mešanju pod oksidativnimi pogoji najvišja dovoljena koncentracija, ki se uporabi na laseh, ne sme preseči 2,0 %.
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %
Za (a) in (b):
For (a) and (b):
ne uporabljajte z nitrozirajočimi dejavniki;
Do not use with nitrosating agents
največja vsebnost nitrozamina: 50 μg/kg
Maximum nitrosamine content: 50 μg/kg
hranite v vsebnikih, ki ne vsebujejo nitritov.
Keep in nitrite-free containers
Na etiketo natisnite: mešalno razmerje.
To be printed on the label: The mixing ratio.
Barve za lase lahko povzročijo resne alergijske reakcije.
Hair colorants can cause severe allergic reactions.
Preberite in upoštevajte navodila.
Read and follow instructions.
Ta izdelek ni namenjen za uporabo na osebah, mlajših od 16 let.
This product is not intended for use on persons under the age of 16.
Začasni tatu s črno kano lahko poveča tveganje za alergije.
Temporary “black henna” tattoos may increase your risk of allergy.
Ne barvajte si las, če:
Do not colour your hair if:
imate izpuščaje na obrazu ali občutljivo, razdraženo in poškodovano lasišče,
you have a rash on your face or sensitive, irritated and damaged scalp,
ste kadar koli po barvanju las že imeli reakcijo,
you have ever experienced any reaction after colouring your hair,
ste v preteklosti imeli reakcijo na začasni tatu s črno kano.‘
you have experienced a reaction to a temporary “black henna” tattoo in the past.”
Spojina fosforjeve kisline s 4-[(2,6-diklorofenil) (4-imino-3,5-dimetil-2,5-cikloheksadien-1-iliden) metil]-2,6-dimetilanilin (1:1)
Phosphoric acid compound with 4-[(2,6-dichlorophenyl) (4-imino-3,5-dimethyl-2,5-cyclohexadien-1-ylidene) methyl]-2,6-dimethylaniline (1:1)
Po mešanju pod oksidativnimi pogoji najvišja dovoljena koncentracija, ki se uporabi na laseh, ne sme preseči 0,2 %.
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,2 %
Natrijev 4-[(9,10-dihidro-4-hidroksi-9,10-diokso-1-antril)amino]toluen-3-sulfonat
Disodium 2,2′-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)
1,4-benzendiamin, 2-(metoksimetil)
Sodium, 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
1,4-benzendiamin, 2-(metoksimetil)-, sulfat
1,4-Benzenediamine, 2-(methoxymethyl)
Po mešanju pod oksidativnimi pogoji najvišja dovoljena koncentracija, ki se uporabi na laseh, ne sme preseči 1,8 % (preračunano na prosto bazo)
1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate
metilmorfolinijev propilamino-4-hidroksiantrakinon, metil sulfat
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % (calculated as free base)
Na etiketo natisnite:
Methylmorpholiniumpropylamino-4-hydroxyanthraquinone, methyl sulfate
Etanol, 2,2′-[[3-metil-4-[(E)-(4-nitrofenil)azo]fenil]imino]bis-
To be printed on the label:
ste v preteklosti imeli reakcijo na začasni tatu s črno kano.‘“
Ethanol, 2,2′-[[3-methyl-4-[(E)-(4-nitrophenyl)azo]phenyl]imino]bis-
mino-5-hidroksi-3-(4-nitrofenilazo)-6-(fenilazo)-2,7-naftalendisulfonska kislina, dinatrijeva sol
you have experienced a reaction to a temporary “black henna” tattoo in the past.”’
dinatrijev 3-hidroksi-4-[(E)-(4-metil- 2-sulfonatofenil)diazenil]-2-naftoat
Commission Implementing Regulation (EU) 2015/1191
Izvedbena uredba Komisije (EU) 2015/1191
concerning the non-approval of Artemisia vulgaris L. as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
o neodobritvi Artemisia vulgaris L. kot osnovne snovi v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet
In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l`Agriculture Biologique (ITAB) for the approval of Artemisia vulgaris L. as basic substance.
V skladu s členom 23(3) Uredbe (ES) št. 1107/2009 je Komisija 26. aprila 2013 prejela zahtevek inštituta Institut Technique de l'Agriculture Biologique (ITAB) za odobritev Artemisia vulgaris L. kot osnovne snovi.
That application was accompanied by the information required under the second subparagraph of Article 23(3).
Navedenemu zahtevku so bili priloženi podatki, ki so obvezni v skladu z drugim pododstavkom člena 23(3).
The Authority presented to the Commission a Technical Report on the substance concerned on 25 August 2014 [2].
Agencija je 25. avgusta 2014 [2] Komisiji predložila tehnično poročilo o zadevni snovi.
The Commission presented the review report [3] and the draft of this Regulation on the non-approval of Artemisia vulgaris L. to the Standing Committee on Plants, Animals, Food and Feed on 27 January 2015.
Komisija je 27. januarja 2015 Stalnemu odboru za rastline, živali, hrano in krmo predložila poročilo o pregledu [3] in osnutek te uredbe o neodobritvi Artemisia vulgaris L.
The documentation provided by the applicant shows that Artemisia vulgaris L. fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4].
Iz dokumentacije, ki jo je predložil vložnik, je razvidno, da Artemisia vulgaris L. izpolnjuje merila za živila, kot so opredeljena v členu 2 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta [4].
However, alcoholic beverages from Artemisia species are included in Part B of Annex III to Regulation (EC) No 1334/2008 of the European Parliament and of the Council [5], which sets maximum levels of certain substances, naturally present in flavourings and food ingredients with flavouring properties, in certain compound food as consumed to which flavourings and/or food ingredients with flavouring properties have been added.
Vendar so alkoholne pijače iz vrste Artemisia navedene v delu B Priloge III k Uredbi (ES) št. 1334/2008 Evropskega parlamenta in Sveta [5], ki določa mejne vrednosti nekaterih snovi, ki so naravno prisotne v aromah in sestavinah živil z aromatičnimi lastnostmi ter v nekaterih sestavljenih živilih, kot so zaužita, med katere so bile dodane arome in/ali živilske sestavine z aromatičnimi lastnostmi.
According to Article 6 of Regulation (EC) No 1334/2008, in the compound foods listed in that Part B, the maximum levels are not to be exceeded as a result of the use of flavourings and/or food ingredients with flavouring properties.
V skladu s členom 6 Uredbe (ES) št. 1334/2008 mejne vrednosti v sestavljenih živilih iz dela B ne smejo biti presežene zaradi uporabe arom in/ali sestavin živil z aromatičnimi lastnostmi.
The Artemisia species can therefore not be used as a foodstuff without qualification.
Zato se vrste Artemisia ne morejo uporabljati kot živilo brez opredelitve.
Specific concerns were identified in the Technical Report of the Authority regarding exposure to thujone, eucalyptol and camphor and the risk to operators, workers, bystanders, consumers and non-target organisms.
V tehničnem poročilu Agencije so bili izraženi posebni pomisleki glede izpostavljenosti tujonu, evkaliptolu in kamforju ter glede tveganja za izvajalce, delavce, druge navzoče osebe, potrošnike in neciljne organizme.
The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report.
Komisija je vložnika pozvala, naj predloži pripombe k tehničnemu poročilu Agencije in k osnutku poročila o pregledu.
Consequently, it has not been established, in the Commission review report, that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied.
Zato ni bilo ugotovljeno, da so zahteve iz člena 23 Uredbe (ES) št. 1107/2009 v zvezi z vrstami uporabe iz poročila Komisije o pregledu, izpolnjene.
It is therefore appropriate not to approve Artemisia vulgaris L. as basic substance.
Zato je primerno, da se Artemisia vulgaris L. kot osnovna snov ne odobri.
This Regulation does not prejudice the submission of a further application for the approval of Artemisia vulgaris L. as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
Ta uredba ne vpliva na predložitev ponovnega zahtevka za odobritev Artemisia vulgaris L. kot osnovne snovi v skladu s členom 23(3) Uredbe (ES) št. 1107/2009.
Non-approval as basic substance
Neodobritev osnovne snovi
The substance Artemisia vulgaris L. is not approved as basic substance.
Snov Artemisia vulgaris L. se ne odobri kot osnovna snov.
Outcome of the consultation with Member States and EFSA on the basic substance application for Artemisia vulgaris for use in plant protection as insecticide/repellent on orchards, vineyards and vegetables.
Rezultat posvetovanja z državami članicami in Agencijo o uporabi osnovne snovi Artemisia vulgaris v fitofarmacevtskih sredstvih kot insekticid/repelent v sadovnjakih, vinogradih in na zelenjavi.
EFSA supporting publication 2014:EN-644.
Povezane objave EFSA 2014:EN-644. str. 36.
36pp.
Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane (UL L 31, 1.2.2002, str. 1).
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
Uredba (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih ter spremembi Uredbe Sveta (EGS) št. 1601/91, uredb (ES) št. 2232/96 in (ES) št. 110/2008 ter Direktive 2000/13/ES (UL L 354, 31.12.2008, str. 34).
Commission Implementing Regulation (EU) 2015/1192
Izvedbena uredba Komisije (EU) 2015/1192
approving the active substance terpenoid blend QRD 460, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
o odobritvi aktivne snovi mešanica terpenoidov QRD 460 v skladu z Uredbo (ES) št. 1107/2009 Evropskega parlamenta in Sveta o dajanju fitofarmacevtskih sredstev v promet in spremembi Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011
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 13(2) 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] in zlasti člena 13(2) Uredbe,
In accordance with Article 7(1) of Regulation (EC) No 1107/2009, the Netherlands received on 14 September 2011 an application from AgraQuest Inc. (now Bayer CropScience AG) for the approval of the active substance terpenoid blend QRD 460.
V skladu s členom 7(1) Uredbe (ES) št. 1107/2009 je Nizozemska 14. septembra 2011 prejela zahtevek družbe AgraQuest Inc. (zdaj Bayer CropScience AG) za odobritev aktivne snovi mešanica terpenoidov QRD 460.
In accordance with Article 9(3) of that Regulation, the Netherlands, as rapporteur Member State, notified the Commission on 4 October 2011 of the admissibility of the application.
V skladu s členom 9(3) navedene uredbe je Nizozemska kot država članica poročevalka 4. oktobra 2011 obvestila Komisijo o dopustnosti zahtevka.
On 30 July 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘the Authority’) assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
Država članica poročevalka je 30. julija 2013 Komisiji predložila osnutek poročila o oceni, pri čemer je en izvod poslala Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija), v katerem je ocenila, ali je verjetno, da bo aktivna snov izpolnila merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009.
In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority.
V skladu s členom 12(3) Uredbe (ES) št. 1107/2009 je zahtevala, da vložnik predloži dodatne informacije državam članicam, Komisiji in Agenciji.
The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in May 2014.
Država članica poročevalka je maja 2014 Agenciji predložila oceno dodatnih informacij v obliki posodobljenega osnutka poročila o oceni.
On 26 August 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance terpenoid blend QRD 460 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 [2].
Agencija je 26. avgusta 2014 vložniku, državam članicam in Komisiji poslala svoj sklep o tem, ali se pričakuje, da bo aktivna snov mešanica terpenoidov QRD 460 izpolnila merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009 [2].
On 29 May 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for terpenoid blend QRD 460 and a draft Regulation providing that terpenoid blend QRD 460 is approved.
Komisija je 29. maja 2015 Stalnemu odboru za rastline, živali, hrano in krmo predložila poročilo o pregledu za mešanico terpenoidov QRD 460 in osnutek uredbe, ki določa, da se mešanica terpenoidov QRD 460 odobri.
It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the Commission review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
V zvezi z eno ali več reprezentativnimi rabami vsaj enega fitofarmacevtskega sredstva, ki vsebuje aktivno snov, zlasti v zvezi z rabami, ki so bile proučene in podrobno navedene v poročilu Komisije o pregledu, je bilo ugotovljeno, da so merila za odobritev iz člena 4 Uredbe (ES) št. 1107/2009 izpolnjena.
It is therefore appropriate to approve terpenoid blend QRD 460.
Zato je primerno, da se mešanica terpenoidov QRD 460 odobri.
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.
V skladu s členom 13(2) Uredbe (ES) št. 1107/2009 v povezavi s členom 6 Uredbe ter ob upoštevanju sedanjih znanstvenih in tehničnih dognanj pa je treba vključiti nekatere pogoje in omejitve.
The active substance terpenoid blend QRD 460, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Aktivna snov mešanica terpenoidov QRD 460, kot je opredeljena v Prilogi I, se odobri v skladu s pogoji iz navedene priloge.
Terpenoid blend QRD 460
Mešanica terpenoidov QRD 460
CIPAC No: 982
Št.
α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;
Mešanica terpenoidov QRD 460 je mešanica treh sestavin:
p-cymene: 1-isopropyl-4-methylbenzene;
α-terpinena: 1-izopropil-4-metilcikloheksa-1,3-dien;
d-limonene: (R)-4-isopropenyl-1-methylcyclohexene.
p-cimena: 1-izopropil-4-metilbenzen;
The nominal concentration of each component in the active substance as manufactured should be as follows:
d-limonena: (R)-4-izopropenil-1-metilcikloheksen.
α-terpinene: 59,7 %;
Nominalna koncentracija vsake sestavine v aktivni snovi, kot je proizvedena, mora biti naslednja:
α-terpinene: 89 %;
Vsaka sestavina mora imeti naslednjo minimalno čistost:
10 August 2015
d-limonen: 93 %.
10 August 2025
10. avgust 2015
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account.
10. avgusta 2025
In this overall assessment Member States shall pay particular attention to:
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu mešanice terpenoidov QRD 460 ter zlasti dodatka I in II k poročilu.
the stability of formulations on storage;
V tej celoviti oceni morajo biti države članice zlasti pozorne na:
the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;
obstojnost formulacije pri shranjevanju,
the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;
varnost izvajalcev in delavcev ter zagotoviti, da je v pogojih uporabe po potrebi predpisana uporaba ustrezne osebne zaščitne opreme,
the protection of surface water and aquatic organisms;
zaščito podtalnice, kadar se aktivna snov uporablja na območjih z občutljivimi tlemi in/ali neugodnimi podnebnimi razmerami,
the protection of bees and non-target arthropods.
zaščito površinskih voda in vodnih organizmov,
Conditions of use shall include risk mitigation measures, where appropriate.
zaščito čebel in neciljnih členonožcev.
The applicant shall submit confirmatory information as regards:
Pogoji uporabe po potrebi vključujejo ukrepe za zmanjšanje tveganja.
the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis.
Vložnik predloži potrditvene informacije o:
It should be confirmed that there are no relevant impurities present in the technical material;
tehničnih specifikacijah aktivne snovi, kot je proizvedena, (treba je zagotoviti analizo 5 serij za mešanico) podprtih s sprejemljivimi in potrjenimi analitskimi metodami.
the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.
Treba je potrditi, da v tehničnem materialu ni pomembnih nečistoč;
The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.
enakovrednosti materiala, uporabljenega v toksikoloških in ekotoksikoloških študijah, s potrjenimi tehničnimi specifikacijami;
Further details on identity and specification of active substance are provided in the review report.
Vložnik Komisiji, državam članicam in Agenciji navedene informacije predloži do 10. februarja 2016.
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
PRILOGA II