natgillin/translations-raw huggingface dataset:
In its opinions, the Authority mentioned that, while local irritation is expected to strongly promote carcinogenesis, lower local concentrations of formaldehyde are known to produce DNA adducts and that therefore it deemed it prudent not to consider the exposure to non-irritant concentration as totally risk-free.
V navedenih treh mnenjih je Agencija nadalje ugotovila, da formaldehid vzbuja zaskrbljenost glede varnosti za uporabnike.
The Authority concluded that moreover, on the basis of the present knowledge, a causal association between formaldehyde exposure and leukaemia could not be ruled out.
Formaldehid je strupena snov, močan iritant, močan povzročitelj preobčutljivosti kože in dihal (tudi poklicne astme) in povzroča poškodbe oči.
The Authority concluded that, as regards the requested use in feed of the preparation of formaldehyde, no safe level of exposure of the skin, eyes or the respiratory system to formaldehyde could be identified.
Agencija je v svojih mnenjih navedla, da lahko lokalno draženje močno spodbuja karcinogenezo, za nižje lokalne koncentracije formaldehida pa je znano, da lahko privedejo do aduktov DNK, zato je menila, da izpostavljenost nedražilnim koncentracijam ni preudarno obravnavati kot popolnoma brez tveganj.
Therefore, the Authority recommended that measures should be taken to ensure that the respiratory tract, as well as the skin and eyes, of any person handling the product are not exposed to any dust, mist or vapour generated by the use of formaldehyde.
Agencija je tudi ugotovila, da na podlagi obstoječega znanja ni bilo mogoče izključiti vzročne povezave med izpostavljenostjo formaldehidu in levkemijo.
In addition, the Authority recommended that consideration should be given to whether the strict protection measures, once established, would effectively protect users.
Ugotovila je, da za zahtevano uporabo pripravka formaldehida v krmi ni bilo mogoče opredeliti varne ravni izpostavljenosti kože, oči ali respiratornega sistema formaldehidu.
The Authority 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.
Zato je Agencija priporočila, da bi bilo treba sprejeti ukrepe za zagotovitev, da respiratorni trakt ter koža in oči vsake osebe, ki ravna s proizvodom, niso izpostavljeni prahu, kapljicam ali hlapom, ki nastanejo pri uporabi formaldehida.
Formaldehyde is classified as carcinogenic (category 1B) by inhalation and germ cell mutagenic (category 2) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
Poleg tega je priporočila, da bi bilo treba preučiti, ali bi strogi zaščitni ukrepi, ko bodo vzpostavljeni, učinkovito zaščitili uporabnike.
In the framework of Union legislation on health and safety at work, occupational exposure limits are being developed for formaldehyde.
Preverila je tudi poročilo o analitski metodi krmnega dodatka v krmi, ki ga je predložil referenčni laboratorij, ustanovljen z Uredbo (ES) št. 1831/2003.
The Scientific Committee on Occupational Exposure Limits established by Commission Decision 2014/113/EU has, in its Recommendation of 30 June 2016, pronounced itself on a limit value for formaldehyde based on a mode-of-action assessment, which was then considered by the tripartite Advisory Committee on Safety and Health at Work in accordance with the procedures for establishing occupational exposure limits.
Formaldehid je razvrščen kot rakotvoren (kategorija 1B) pri vdihavanju in mutagen za zarodne celice (kategorija 2) v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta.
In accordance with Article 9 of Regulation (EC) No 1831/2003, the measure on the authorisation of an additive is to take into account the requirements of paragraphs 2 and 3 of Article 5 of that Regulation, as well as Community law and other legitimate factors relevant to the matter under consideration.
V okviru zakonodaje Unije o zdravju in varnosti pri delu se pripravljajo mejne vrednosti za poklicno izpostavljenost formaldehidu.
The risk management decision concerning the authorisation of formaldehyde as a feed additive should therefore be based on all the information available regarding the risks at stake, in particular on the one hand the risks posed by the handling of formaldehyde to users, in particular workers, and on the other hand the risks to animals or to consumers of the animal products concerned that could derive from not using formaldehyde as a feed additive.
Znanstveni odbor za omejitve poklicne izpostavljenosti kemičnim snovem, ustanovljen s Sklepom Komisije 2014/113/EU, je v svojem Priporočilu z dne 30. junija 2016 izrazil svoje stališče glede mejne vrednosti za formaldehid na podlagi študij načina delovanja, kar je nato preučil tristranski Svetovalni odbor za varnost in zdravje pri delu v skladu s postopki za določanje mejnih vrednosti za poklicno izpostavljenost.
In accordance with Union legislation on health and safety at work, and in particular with Article 4 of Directive 2004/37/EC of the European Parliament and of the Council, the employer is to reduce the use of a carcinogen or mutagen at the place of work, in particular by replacing it, in so far as is technically possible, by a substance, mixture or process which, under its conditions of use, is not dangerous or is less dangerous for workers' health or safety.
V skladu s členom 9 Uredbe (ES) št. 1831/2003 ukrep za izdajo dovoljenja za dodatek upošteva zahteve iz odstavkov 2 in 3 člena 5 navedene uredbe ter pravo Skupnosti in druge zakonite dejavnike, povezane z zadevo.
Due to the serious risks for users posed by the handling of formaldehyde, such approach based on replacement is also appropriate for that additive, taking into account the objective of ensuring a high level of protection of human health and users' interests pursued by Regulation (EC) No 1831/2003 and the precautionary principle provided for in Regulation (EC) No 178/2002 of the European Parliament and of the Council.
Odločitev o obvladovanju tveganja v zvezi z izdajo dovoljenja za formaldehid kot krmni dodatek bi zato morala temeljiti na vseh razpoložljivih informacijah o zadevnih tveganjih, zlasti po eni strani tveganjih za uporabnike pri ravnanju s formaldehidom, še posebej za delavce, in po drugi strani tveganjih za živali ali uporabnike zadevnih živalskih proizvodov, do katerih bi lahko prišlo zaradi neuporabe formaldehida kot krmnega dodatka.
As regards possible alternative products to formaldehyde as an additive belonging to the functional group of preservatives, a series of additives are currently authorised in the Union under the same functional group.
V skladu z zakonodajo Unije o zdravju in varnosti pri delu ter zlasti s členom 4 Direktive 2004/37/ES Evropskega parlamenta in Sveta delodajalec zmanjša uporabo rakotvorne ali mutagene snovi na delovnem mestu zlasti tako, da jo nadomesti, če je to tehnično možno, s snovjo, zmesjo ali postopkom, ki pod pogoji uporabe ni nevaren ali je manj nevaren za zdravje in varnost delavcev.
As regards possible alternative products to formaldehyde as an additive belonging to the functional group of hygiene condition enhancers, research is currently being conducted to develop additives which would prove both safe and efficacious in reducing microbiological contamination in feed.
Zaradi resnih tveganj za uporabnike pri ravnanju s formaldehidom je tak pristop na podlagi nadomestitve primeren tudi za navedeni dodatek, ob upoštevanju cilja zagotavljanja visoke ravni varovanja zdravja ljudi in interesov uporabnikov v skladu z Uredbo (ES) št. 1831/2003 in previdnostnega načela iz Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta.
An additive has already been authorised under that functional group and is therefore considered as an alternative, although with a different mechanism of action, in order to reduce the number of bacterial pathogens, including Salmonella spp., in feed, without causing the concerns over users' safety raised by the use of formaldehyde.
Za možne alternativne proizvode za formaldehid kot dodatek iz funkcionalne skupine konzervansov je trenutno v Uniji v okviru iste funkcionalne skupine dovoljena vrsta dodatkov.
Several applications for authorisation of other additives under that functional group have been submitted and are being assessed in accordance with Regulation (EC) No 1831/2003.
Glede možnih alternativnih proizvodov za formaldehid kot dodatek iz funkcionalne skupine pospeševalcev higienskih razmer pa trenutno potekajo raziskave za pripravo dodatkov, ki bi se izkazali za varne in učinkovite pri zmanjševanju mikrobiološke kontaminacije v krmi.
In addition, other authorised feed additives may, as zootechnical additives, improve the quality of animal products through a reduction of contamination with enteropathogens such as Salmonella spp.
V okviru navedene funkcionalne skupine je en dodatek že bil dovoljen in se zato obravnava kot možna alternativa za zmanjšanje števila bakterijskih patogenov v krmi, vključno s Salmonello spp., čeprav ima drugačen mehanizem delovanja, ne da bi vzbujal zaskrbljenost glede varnosti uporabnikov tako kot uporaba formaldehida.
In addition to the possibility of using alternative products to formaldehyde for the envisaged purposes in feed, the implementation of the hygiene requirements and good practices along the feed chain, as provided for in Regulation (EC) No 183/2005 of the European Parliament and of the Council, contributes to the safety and quality of feed through a preventive approach.
Več zahtevkov za izdajo dovoljenj za druge dodatke v okviru navedene funkcionalne skupine je bilo predloženih in se ocenjuje v skladu z Uredbo (ES) št. 1831/2003.
In particular, specific hygiene measures are provided for under that framework for the control, prevention and treatment of feed contaminated with Salmonella.
Drugi odobreni krmni dodatki lahko poleg tega kot zootehnični dodatki izboljšajo kakovost živalskih proizvodov z zmanjšanjem kontaminacije z enteropatogeni, kot je Salmonella spp.
It follows from the above elements that, taking into account the adverse effects of formaldehyde on the health of users handling the substance, in conjunction with the application of the precautionary principle in the protection of workers' health and with the fact that some products and measures, which do not present the same human safety concerns, are available as alternatives to the envisaged uses of formaldehyde in feed, the advantages of formaldehyde do not compensate the health risks.
K varnosti in kakovosti krme s preventivnim pristopom poleg možnosti uporabe alternativnih proizvodov za formaldehid za predvidene namene v krmi prispeva tudi izvajanje higienskih zahtev in dobrih praks po celotni krmni verigi, kot je določeno v Uredbi Evropskega parlamenta in Sveta (ES) št. 183/2005.
Therefore, the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied and accordingly, the authorisation of formaldehyde as a feed additive for use as preservative and hygiene condition enhancer should be denied.
Zlasti so v navedenem okviru določeni posebni higienski ukrepi za nadzor, preprečevanje in obdelavo krme, kontaminirane s salmonelo.
Since further use of formaldehyde may cause a risk to human health, the feed additive belonging to the functional group of ‘preservatives’ for use in skimmed milk for pigs up to the age of 6 months, and premixtures containing it, should be withdrawn from the market as soon as possible.
Iz navedenega izhaja, da ob upoštevanju škodljivih učinkov formaldehida na zdravje uporabnikov, ki s to snovjo ravnajo, v povezavi z uporabo previdnostnega načela pri varovanju zdravja delavcev in dejstvom, da so nekateri proizvodi in ukrepi, ki ne vzbujajo enake zaskrbljenosti glede varnosti ljudi, na voljo kot alternativne možnosti za predvidene uporabe formaldehida v krmi, prednosti formaldehida ne odtehtajo tveganj za zdravje.
For practical reasons however, a limited period should be allowed for the withdrawal from the market of the existing stocks of those products in order to enable operators to comply properly with the withdrawal obligation.
Zato pogoji za izdajo dovoljenja v skladu s členom 5 Uredbe (ES) št. 1831/2003 niso izpolnjeni in izdajo dovoljenja za formaldehid kot krmni dodatek za uporabo kot konzervans in pospeševalec higienskih razmer bi zato bilo treba zavrniti.
As a result, a limited period should also be granted for the withdrawal from the market of skimmed milk containing the additive or the premixtures, and compound feed containing such skimmed milk, in order to take into account the use of those products in the feed chain.
Nadaljnja uporaba formaldehida lahko povzroči tveganje za zdravje ljudi, zato bi bilo treba krmni dodatek iz funkcionalne skupine „konzervansi“ za uporabo v posnetem mleku za prašiče do šestega meseca starosti in premikse, ki ga vsebujejo, čimprej umakniti s trga.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Iz praktičnih razlogov bi moralo biti na voljo omejeno obdobje za umik obstoječih zalog navedenih proizvodov s trga, da bi nosilci dejavnosti lahko ustrezno izpolnili obveznost umika.
HAS ADOPTED THIS REGULATION:
Zato bi bilo treba odobriti tudi omejeno obdobje za umik s trga posnetega mleka, ki vsebuje dodatek ali premikse, in krmnih mešanic, ki vsebujejo tako posneto mleko, da se upošteva uporaba navedenih proizvodov v krmni verigi.
Denial of authorisation
SPREJELA NASLEDNJO UREDBO:
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.
Člen 1
Article 2
Zavrnitev dovoljenja
Withdrawal from the market
Dovoljenje za formaldehid kot krmni dodatek v prehrani živali iz kategorije dodatkov „tehnološki dodatki“ in funkcionalnih skupin „konzervansi“ in „pospeševalci higienskih razmer“ se zavrne.
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.
Člen 2
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.
Umik s trga
Article 3
Obstoječe zaloge formaldehida kot dodatka iz kategorije dodatkov „tehnološki dodatki“ in funkcionalne skupine „konzervansi“ za uporabo v posnetem mleku za prašiče do šestega meseca starosti, in premiksov, ki vsebujejo navedeni dodatek, se čimprej umaknejo s trga, najpozneje pa 28. maja 2018.
Entry into force
Posneto mleko, ki vsebuje dodatek, ali posneto mleko, ki vsebuje premikse, iz odstavka 1, ter krmne mešanice, ki vsebujejo tako posneto mleko, ki so bili proizvedeni pred 28. majem 2018, se čimprej umaknejo s trga, najpozneje pa 28. avgusta 2018.
Done at Brussels, 7 February 2018.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
The President
V Bruslju, 7. februarja 2018
OJ L 268, 18.10.2003, p.
Za Komisijo
29.
Predsednik
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p.
UL L 268, 18.10.2003, str.
1).
29.
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.
Direktiva Sveta 70/524/EGS z dne 23. novembra 1970 o dodatkih v krmi (UL L 270, 14.12.1970, str.
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.
Triinštirideseta Direktiva Komisije 83/466/EGS z dne 28. julija 1983 o spremembi prilog k Direktivi Sveta 70/524/EGS o dodatkih v krmi (UL L 255, 15.9.1983, str.
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.
Kemijski opis dodatka je bil natančneje opredeljen z Direktivo Komisije 85/429/EGS z dne 8. julija 1985 o spremembi prilog k Direktivi Sveta 70/524/EGS o dodatkih v krmi (UL L 245, 12.9.1985, str.
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.
Uredba Komisije (ES) št. 1451/2007 z dne 4. decembra 2007 o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta o dajanju biocidnih pripravkov v promet (UL L 325, 11.12.2007, str.
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.
Uredba (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov (UL L 167, 27.6.2012, str.
EFSA Journal 2014;12(2):3561 and EFSA Journal 2014;12(2)3562.
Sklep Komisije 2013/204/EU z dne 25. aprila 2013 o nevključitvi formaldehida za 20. vrsto pripravkov v Prilogo I, IA ali IB k Direktivi 98/8/ES Evropskega parlamenta in Sveta o dajanju biocidnih pripravkov v promet (UL L 117, 27.4.2013, str.
EFSA Journal 2014;12(7):3790.
18).
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.
EFSA Journal 2014;12(2):3561 in EFSA Journal 2014;12(2):3562.
1).
Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi, o spremembi in razveljavitvi direktiv 67/548/EGS in 1999/45/ES ter spremembi Uredbe (ES) št. 1907/2006 (UL L 353, 31.12.2008, str.
Commission Implementing Regulation (EU) 2018/184
Izvedbena uredba Komisije (EU) 2018/184
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 spremembi Izvedbene uredbe (EU) št. 540/2011 glede podaljšanja obdobij odobritve za aktivni snovi FEN 560 (ki se imenuje tudi sabljasti triplat ali seme sabljastega triplata v prahu) in 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,
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 ter zlasti prvega odstavka člena 17 Uredbe,
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.
Del A Priloge k Izvedbeni uredbi Komisije (EU) št. 540/2011 določa aktivne snovi, ki se štejejo za odobrene v skladu z Uredbo (ES) št. 1107/2009.
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.
Vlogi za obnovitev odobritve aktivnih snovi FEN 560 (ki se imenuje tudi sabljasti triplat ali seme sabljastega triplata v prahu) in sulfuril fluorid sta bili predloženi v skladu z Izvedbeno uredbo Komisije (EU) št. 844/2012.
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.
Vendar bo iz razlogov, na katere vložnik nima vpliva, odobritev navedenih snovi verjetno potekla, preden bo sprejeta odločitev o obnovitvi njune odobritve.
It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.
Zato je treba podaljšati njuni obdobji odobritve v skladu s členom 17 Uredbe (ES) št. 1107/2009.
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.
Ob upoštevanju časa in virov, ki so potrebni za dokončanje ocene vlog za obnovitev odobritev velikega števila aktivnih snovi, ki jim bo odobritev potekla med letoma 2019 in 2021, je bil z Izvedbenim sklepom Komisije C(2016) 6104 oblikovan delovni program, ki združuje podobne aktivne snovi in določa prednostne naloge na podlagi skrbi za varovanje zdravja ljudi in živali ali okolja, kot je določeno v členu 18 Uredbe (ES) št. 1107/2009.
The presumed low-risk substances should be prioritised in accordance with Implementing Decision C(2016)6104.
Snovem, za katere se meni, da so snovi z majhnim tveganjem, bi bilo treba dati prednost v skladu z Izvedbenim sklepom C(2016) 6104.
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).
Ob upoštevanju razdelitve odgovornosti in nalog med državami članicami poročevalkami in soporočevalkami ter razpoložljivih virov, potrebnih za ocenjevanje in odločanje, bi moralo navedeno obdobje trajati eno leto za aktivno snov FEN 560 (ki se imenuje tudi sabljasti triplat ali seme sabljastega triplata v prahu).
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.
Za aktivne snovi, ki ne spadajo v prednostne kategorije v Izvedbenem sklepu C(2016) 6104, bi bilo treba obdobje odobritve podaljšati za dve ali tri leta, ob upoštevanju sedanjega datuma poteka veljavnosti, dejstva, da se v skladu s členom 6(3) Izvedbene uredbe (EU) št. 844/2012 dopolnilna dokumentacija za aktivno snov predloži najpozneje 30 mesecev pred iztekom odobritve, nujnosti zagotovitve uravnotežene razdelitve odgovornosti in nalog med državami članicami poročevalkami in soporočevalkami ter razpoložljivih virov, potrebnih za ocenjevanje in odločanje.
It is therefore appropriate to extend the approval period for the active substance sulfuryl fluoride by 3 years.
Zato je primerno podaljšati obdobje odobritve za aktivno snov sulfuril fluorid za tri leta.