natgillin/translations-raw huggingface dataset:
The authorisation of formaldehyde as an additive in animal nutrition, belonging to the additive category ‘technological additives’ and to the functional groups ‘preservatives’ and ‘hygiene condition enhancers’, is denied.
U okviru zakonodavstva Unije u području zdravlja i sigurnosti na radu u tijeku je postupak utvrđivanja ograničenja profesionalne izloženosti za formaldehid.
Article 2
Znanstveni odbor za ograničenja profesionalne izloženosti uspostavljen Odlukom Komisije 2014/113/EU u svojoj je Preporuci od 30. lipnja 2016. iznio svoje stajalište o graničnoj vrijednosti za formaldehid utemeljenoj na ocjeni načina djelovanja, koju je zatim u skladu s postupcima za utvrđivanje ograničenja profesionalne izloženosti razmotrio tripartitni Savjetodavni odbor za sigurnost i zdravlje na radu.
Withdrawal from the market
U skladu s člankom 9.
Existing stocks of formaldehyde as an additive belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’ for use in skimmed milk for pigs up to the age of 6 months, and of premixtures containing that additive, shall be withdrawn from the market as soon as possible and at the latest by 28 May 2018.
Uredbe (EZ) br.
Skimmed milk containing the additive or skimmed milk containing the premixtures referred to in paragraph 1, and compound feed containing such skimmed milk, which have been produced before 28 May 2018 shall be withdrawn from the market as soon as possible and at the latest by 28 August 2018.
1831/2003 u mjeri koja se poduzima u pogledu odobrenja dodatka potrebno je uzeti u obzir zahtjeve članka 5. stavaka 2. i 3. te uredbe i pravo Zajednice i ostale zakonite čimbenike relevantne za pitanje koje se razmatra.
Article 3
Stoga bi se odluka o upravljanju rizikom u pogledu odobrenja formaldehida kao dodatka hrani za životinje trebala temeljiti na svim dostupnim informacijama o mogućim rizicima, konkretno s jedne strane o rizicima za korisnike koji rukuju formaldehidom, posebno radnike, a s druge strane o mogućim rizicima za životinje ili potrošače predmetnog proizvoda životinjskog podrijetla u slučaju izostanka uporabe formaldehida kao dodatka hrani za životinje.
Entry into force
U skladu sa zakonodavstvom Unije u području zdravlja i sigurnosti na radu, a posebno s člankom 4.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Direktive 2004/37/EZ Europskog parlamenta i Vijeća poslodavac bi trebao smanjiti uporabu karcinogene ili mutagene tvari na radnom mjestu, posebno tako da je, ako je to tehnički moguće, zamijeni s tvari, smjesom ili postupkom, koji pod uvjetima uporabe nisu opasni ili su manje opasni za zdravlje i sigurnost radnika.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Zbog ozbiljnih rizika za korisnike koji rukuju formaldehidom, taj pristup utemeljen na zamjeni primjeren je i za navedeni dodatak, uzimajući u obzir cilj osiguranja visoke razine zaštite zdravlja ljudi i interesa korisnika iz Uredbe (EZ) br.
Done at Brussels, 7 February 2018.
1831/2003 i načelo predostrožnosti iz Uredbe (EZ) br.
For the Commission
178/2002 Europskog parlamenta i Vijeća.
The President
Kada je riječ o proizvodima koji su zamjena za formaldehid kao dodatak koji pripada funkcionalnoj skupini „konzervansi”, postoji niz dodataka iz iste funkcionalne skupine koji su trenutačno odobreni u Uniji.
OJ L 268, 18.10.2003, p.
Kada je riječ o proizvodima koji bi mogli biti zamjena za formaldehid kao dodatak koji pripada funkcionalnoj skupini „tvari za poboljšanje higijenskog stanja”, u tijeku je istraživanje u cilju razvoja dodataka s pomoću kojih bi se na siguran i učinkovit način smanjila mikrobiološka kontaminacija hrane za životinje.
29.
U toj funkcionalnoj skupini već postoji odobreni dodatak i stoga ga se, iako je njegov mehanizam djelovanja drugačiji, smatra zamjenom za smanjenje broja bakterijskih patogena (uključujući salmonelu – Salmonella spp) u hrani za životinje, čija uporaba za razliku od formaldehida ne uzrokuje zabrinutost u pogledu sigurnosti korisnika.
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p.
Dostavljeno je nekoliko zahtjeva za odobrenje drugih dodataka iz predmetne funkcionalne skupine i u tijeku je njihova procjena u skladu s Uredbom (EZ) br.
1).
1831/2003.
Forty-third Commission Directive 83/466/EEC of 28 July 1983 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 255, 15.9.1983, p.
Osim toga, kvaliteta proizvoda životinjskog podrijetla može se poboljšati s pomoću drugih odobrenih dodataka hrani za životinje, koji kao zootehnički dodaci smanjuju kontaminaciju enteropatogenima kao što je Salmonella spp.
28).
Uz mogućnosti uporabe proizvoda koji su zamjena za formaldehid za previđene namjene u hrani za životinje, provedba higijenskih zahtjeva i dobre prakse uzduž lanca hrane za životinje iz Uredbe (EZ) br.
The chemical description of the additive was made more precise by Commission Directive 85/429/EEC of 8 July 1985 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs (OJ L 245, 12.9.1985, p.
183/2005 Europskog parlamenta i Vijeća zahvaljujući preventivnom pristupu pridonosi sigurnosti i kvaliteti hrane za životinje.
1).
Konkretno, u tom okviru predviđene su posebne higijenske mjere za nadzor i obradu hrane za životinje zaražene salmonelom i sprečavanje takve zaraze.
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p.
Uzimajući u obzir štetne učinke formaldehida na zdravlje korisnika koji rukuju tom tvari, zajedno s primjenom načela predostrožnosti pri zaštiti zdravlja radnika, te činjenicu da su kao zamjena za predviđene uporabe formaldehida u hrani za životinje dostupni određeni proizvodi i mjere koji ne uzrokuju zabrinutost u pogledu sigurnosti ljudi, iz prethodno navedenoga proizlazi da se prednosti upotrebe formaldehida ne mogu mjeriti s rizicima za zdravlje.
3).
Budući da uvjeti za odobrenje predviđeni člankom 5.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p.
Uredbe (EZ) br.
1).
1831/2003 nisu ispunjeni, odobrenje formaldehida kao dodatka hrani za životinje za uporabu kao konzervans i tvar za poboljšanje higijenskog stanja trebalo bi uskratiti.
1).
Međutim, iz praktičnih razloga trebalo bi omogućiti ograničeno razdoblje za povlačenje postojećih zaliha predmetnih proizvoda s tržišta kako bi se gospodarskim subjektima omogućilo da propisno ispune obvezu povlačenja.
Commission Decision 2013/204/EU of 25 April 2013 concerning the non-inclusion of formaldehyde for product-type 20 in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 117, 27.4.2013, p.
Stoga bi trebalo odobriti ograničeno razdoblje i za povlačenje s tržišta obranog mlijeka koje sadržava dodatak ili premiksa i krmnih smjesa koje sadržavaju takvo obrano mlijeko, kako bi se uzela u obzir uporaba tih proizvoda u lancu hrane za životinje.
18).
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
EFSA Journal 2014;12(2):3561 and EFSA Journal 2014;12(2)3562.
DONIJELA JE OVU UREDBU:
EFSA Journal 2014;12(7):3790.
Članak 1.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.
Uskraćivanje odobrenja
1).
Uskraćuje se odobrenje formaldehida kao dodatka hrani za životinje koji pripada kategoriji dodataka „tehnološki dodaci” i funkcionalnim skupinama „konzervansi” i „tvari za poboljšanje higijenskog stanja”.
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride
o izmjeni Provedbene uredbe (EU) br.
(Text with EEA relevance)
540/2011 u pogledu produljenja roka važenja odobrenja aktivnih tvari FEN 560 (također poznat pod nazivom piskavica ili sjeme u prahu piskavice) i sulfuril fluorid
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, and in particular the first paragraph of Article 17 thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije,
Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.
1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ, a posebno njezin članak 17. prvi stavak,
Applications for the renewal of the approval of FEN 560 (also called fenugreek or fenugreek seed powder) and sulfuryl fluoride were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012.
budući da:
However, the approval of those substances is likely to expire for reasons beyond the control of the applicant before a decision has been taken on the renewal of their approval.
U dijelu A Priloga Provedbenoj uredbi Komisije (EU) br.
It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.
540/2011 utvrđene su aktivne tvari koje se smatraju odobrenima na temelju Uredbe (EZ) br.
In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016)6104 established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.
1107/2009.
The presumed low-risk substances should be prioritised in accordance with Implementing Decision C(2016)6104.
Podneseni su zahtjevi za obnavljanje odobrenja aktivnih tvari FEN 560 (također poznat pod nazivom piskavica ili sjeme u prahu piskavice) i sulfuril fluorid u skladu s Provedbenom uredbom Komisije (EU) br.
The approval of those substances should therefore be extended by a period as short as possible.
844/2012.
Taking into account the distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making, that period should be of 1 year for the active substance FEN 560 (also called fenugreek or fenugreek seed powder).
Međutim, zbog razloga koji su izvan kontrole podnositelja zahtjeva, odobrenje za te tvari vjerojatno će isteći prije donošenja odluke o produljenju odobrenja tih tvari.
For active substances which do not fall in the prioritised categories in Implementing Decision C(2016)6104, the approval period should be extended by either 2 or 3 years, taking into account the present date of expiry, the fact that according to Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance shall be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making.
Stoga je potrebno produljiti rok važenja tih odobrenja u skladu s člankom 17.
It is therefore appropriate to extend the approval period for the active substance sulfuryl fluoride by 3 years.
Uredbe (EZ) br.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.
1107/2009.
In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.
S obzirom na vrijeme i sredstva koji su potrebni za dovršenje procjene zahtjevâ za produljenje odobrenja velikog broja aktivnih tvari za koje odobrenja istječu između 2019. i 2021., Provedbenom odlukom Komisije C(2016)6104 utvrđen je program rada u kojemu se grupiraju slične aktivne tvari i određuju prioriteti na temelju pitanjâ sigurnosti za zdravlje ljudi i životinja ili za okoliš, kako je predviđeno člankom 18.
As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.
Uredbe (EZ) br.
Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
1107/2009.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Tvarima za koje se smatra da su manjeg rizika treba dati prioritet u skladu s Provedbenom odlukom C(2016)6104.
HAS ADOPTED THIS REGULATION:
Stoga bi odobrenje za te tvari trebalo produljiti za najkraće moguće razdoblje.
Article 1
Uzimajući u obzir raspodjelu odgovornosti i rada među državama članicama koje djeluju kao izvjestiteljice i suizvjestiteljice te dostupne resurse potrebne za procjenu i donošenje odluke, to bi razdoblje za aktivnu tvar FEN 560 (također poznat pod nazivom piskavica ili sjeme u prahu piskavice) trebalo trajati jednu godinu.
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
Za aktivne tvari koje nisu obuhvaćene prioritetnim kategorijama u Provedbenoj odluci C(2016)6104 rok važenja odobrenja trebalo bi produljiti za dvije ili tri godine, uzimajući u obzir sadašnji datum prestanka odobrenja, činjenicu da se u skladu s člankom 6. stavkom 3.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
844/2012 dopunska dokumentacija za aktivnu tvar dostavlja najkasnije 30 mjeseci prije isteka odobrenja, potrebu da se osigura ujednačena raspodjela odgovornosti i rada među državama članicama koje djeluju kao izvjestiteljice i suizvjestiteljice te raspoložive resurse potrebne za procjenu i donošenje odluke.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Stoga je primjereno produljiti rok važenja odobrenja za aktivnu tvar sulfuril fluorid za tri godine.
Done at Brussels, 7 February 2018.
S obzirom na cilj članka 17. prvog stavka Uredbe (EZ) br.
For the Commission
1107/2009, ako se dopunska dokumentacija ne dostavi u skladu s Provedbenom uredbom (EU) br.
The President
844/2012 najkasnije 30 mjeseci prije datuma prestanka odobrenja utvrđenog u Prilogu toj uredbi, Komisija će kao datum prestanka odobrenja odrediti isti datum koji je vrijedio prije donošenja ove Uredbe ili najraniji mogući datum nakon tog datuma.
OJ L 309, 24.11.2009, p.
S obzirom na cilj članka 17. prvog stavka Uredbe (EZ) br.
1.
1107/2009, u slučajevima u kojima Komisija donese uredbu kojom se predviđa da se odobrenje aktivne tvari iz Priloga ovoj Uredbi ne produljuje jer nisu ispunjena mjerila za odobrenje, Komisija kao datum isteka određuje isti datum koji je vrijedio prije donošenja ove Uredbe ili datum stupanja na snagu uredbe kojom se predviđa da se odobrenje aktivne tvari ne produljuje, ovisno o tome koji je datum kasniji.
Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p.
U slučajevima u kojima Komisija donese uredbu kojom se predviđa produljenje odobrenja aktivne tvari iz Priloga ovoj Uredbi, Komisija će nastojati, u skladu s okolnostima, odrediti najraniji mogući datum primjene.
1).
Provedbenu uredbu (EU) br.
Commission Implementing Regulation (EU) No 844/2012 of 18 September 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 (OJ L 252, 19.9.2012, p.
540/2011 trebalo bi stoga na odgovarajući način izmijeniti.
26).
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Commission Implementing Decision of 28 September 2016 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ C 357, 29.9.2016, p.
DONIJELA JE OVU UREDBU:
9).
Članak 1.
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance penflufen
o izmjeni Provedbene uredbe (EU) br.
(Text with EEA relevance)
540/2011 u pogledu uvjeta za odobrenje aktivne tvari penflufen
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, and in particular Article 13(2)(c) thereof,
uzimajući u obzir Ugovor o funkcioniranju Europske unije,
Commission Implementing Regulation (EU) No 1031/2013 approved the active substance penflufen and included it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011.
1107/2009 Europskog parlamenta i Vijeća od 21. listopada 2009. o stavljanju na tržište sredstava za zaštitu bilja i stavljanju izvan snage direktiva Vijeća 79/117/EEZ i 91/414/EEZ, a posebno njezin članak 13. stavak 2. točku (c),
The approval was restricted to uses to treat seed potato tubers before or during planting limited to one sowing of seeds treated with penflufen every third year in the same field.
budući da:
In accordance with Article 7(1) of Regulation (EC) No 1107/2009, on 13 May 2014 the producer of the active substance Bayer CropScience AG submitted an application to the designated rapporteur Member State, the United Kingdom, seeking an amendment to the conditions of approval of penflufen in order to allow its use on other seeds.
Provedbenom uredbom Komisije (EU) br.
Uses on barley and wheat were described in the dossier.
1031/2013 odobrena je aktivna tvar penflufen i uvrštena je u dio B Priloga Provedbenoj uredbi Komisije (EU) br.
In accordance with Article 9(3) of that Regulation, United Kingdom notified the applicant, the other Member States, the European Food Safety Authority (‘the Authority’) and the Commission on 16 June 2014 that the application was admissible.
540/2011.
The designated rapporteur Member State assessed the new use of the active substance penflufen in relation to potential effects on human and animal health and the environment in accordance with the provisions of Article 4 of Regulation (EC) No 1107/2009, and submitted a draft assessment report to the Commission and to the Authority on 5 August 2015.
To odobrenje ograničeno je na uporabe za tretiranje gomolja sjemenskog krumpira prije ili tijekom sadnje, i to na jedno sijanje sjemena tretiranog penflufenom svake treće godine na istom polju.
In accordance with Article 12(3) of that Regulation additional information was requested from the applicant.
U skladu s člankom 7. stavkom 1.
The United Kingdom evaluated the additional information and submitted an updated draft assessment report to the Commission and to the Authority on 8 July 2016.
Uredbe (EZ) br.
On 3 November 2016 the Authority communicated to the Commission its conclusion on whether the new uses of the active substance penflufen can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
1107/2009 proizvođač aktivne tvari Bayer CropScience AG podnio je 13. svibnja 2014. zahtjev državi članici izvjestiteljici Ujedinjenoj Kraljevini kojim je zatražio izmjenu uvjeta za odobrenje penflufena kako bi se odobrila njegova uporaba na drugim vrstama sjemena.
The Commission presented the draft addendum to the review report for penflufen and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 23 January 2017.
U dokumentaciji su opisane uporabe na ječmu i pšenici.
The applicant was invited to submit comments on the addendum to the review report.
U skladu s člankom 9. stavkom 3. te uredbe Ujedinjena Kraljevina je 16. lipnja 2014. obavijestila podnositelja zahtjeva, ostale države članice, Europsku agenciju za sigurnost hrane („Agencija”) i Komisiju da je zahtjev prihvatljiv.
It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that, when the plant protection product is used to treat seeds or other propagating materials which are sown or planted, the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.
Država članica izvjestiteljica ocijenila je novu uporabu aktivne tvari penflufen u odnosu na moguće učinke na zdravlje ljudi i životinja i na okoliš u skladu s odredbama iz članka 4.
It is therefore appropriate to withdraw the restriction for the use of penflufen for seed potato tubers only and allow its use also for other seeds or other propagating materials.
Uredbe (EZ) br.
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in light of current scientific and technical knowledge, it is necessary and appropriate to amend the conditions of approval while keeping certain conditions and restrictions and to require the applicant to provide confirmatory information provided in the first approval.
1107/2009 te je 5. kolovoza 2015.
Implementing Regulation (EU) No 1031/2013 required the applicant to submit confirmatory information regarding the long-term risk to birds within two years after the entry into force of that Regulation.
Komisiji i Agenciji dostavila nacrt izvješća o ocjeni.
As the applicant submitted that data as part of the dossier seeking the amendment of the conditions of approval of the active substance penflufen the requirement is considered as fulfilled.
U skladu s člankom 12. stavkom 3. te uredbe od podnositelja zahtjeva zatražene su dodatne informacije.
Member States should take advantage of these new pieces of information and check the national authorisations for products containing penflufen, where relevant.
Ujedinjena Kraljevina ocijenila je dodatne informacije i 8. srpnja 2016.
Implementing Regulation (EU) No 1031/2013 also required that information regarding the specification of the technical material as commercially manufactured to be submitted to the Commission.
Komisiji i Agenciji dostavila ažurirani nacrt izvješća o ocjeni.