natgillin/translations-raw huggingface dataset:
EFSA derived an Acceptable Daily Intake (ADI) of 0,07 mg nitrite ion/kg bw per day and estimated that the exposure to nitrite resulting from its use as food additive did not exceed this ADI for the general population, except for a slight exceedance in children at the highest percentile.
EFSA je utvrdila prihvatljivi dnevni unos (PDU) nitritnog iona od 0,07 mg/kg tjelesne mase po danu te procijenila da izloženost nitritima do koje dolazi zbog njihove upotrebe kao prehrambenih aditiva kod opće populacije ne prelazi taj PDU, osim neznatnog prekoračenja za djecu u najvišem percentilu.
If all sources of dietary nitrite exposure were considered together (food additives, natural presence and contamination), the ADI would be exceeded in infants, toddlers and children at the mean and for all age groups at highest exposure.
Ako bi se skupno razmatrali svi izvori izloženosti nitritima u prehrani (prehrambeni aditivi, prirodna prisutnost i kontaminacija), utvrdilo bi se prekoračenje PDU-a za dojenčad, malu i ostalu djecu pri prosječnoj izloženosti te za sve dobne skupine pri najvišoj izloženosti.
The contribution of nitrites used as food additives represented approximately 17 % (range 1,5-36,0 %) of the overall exposure.
Doprinos nitritâ u uporabi kao prehrambenih aditiva činila je oko 17 % (raspon od 1,5 do 36,0 %) ukupne izloženosti.
Further, EFSA concluded that the exposure to the endogenous nitrosamines was of low concern.
Nadalje, EFSA je zaključila da izloženost endogenim nitrozaminima ne predstavlja visok rizik.
As regards the exposure to exogenous nitrosamines EFSA, based on the results of the systematic review conducted to assess the relationship between nitrite added to meat products and the formation of some volatile nitrosamines of highest toxicological concern, concluded that it was not possible to clearly discern these N-nitroso compounds produced from the nitrite added at the legal limits, from those produced already at the food matrix where nitrite has not been added.
U pogledu izloženosti egzogenim nitrozaminima, EFSA je na temelju rezultata sustavne revizije provedene u cilju procjene odnosa između nitrita dodanih mesnim proizvodima i stvaranja nekih hlapljivih nitrozamina s najvišom razinom toksikološkog rizika zaključila da nije moguće jasno razlučiti N-nitrozo spojeve proizvedene od nitrita dodanih u skladu sa zakonskim ograničenjima od N-nitrozo spojeva proizvedenih na razini prehrambene matrice bez dodavanja nitrita.
Therefore, the overall exposure was calculated although it does not relate only to the use of nitrite as food additive.
Stoga je ukupna izloženost izračunana iako se ne odnosi samo na uporabu nitrita kao prehrambenog aditiva.
There was some concern for the overall exposure to exogenous nitrosamines at high levels for all age groups except for the elderly.
Postojala je određena zabrinutost u pogledu ukupne izloženosti egzogenim nitrozaminima na visokoj razini za sve dobne skupine osim za starije osobe.
Finally, EFSA confirmed evidence to link preformed N-nitrosodimethylamine and colorectal cancers and some evidence to link (i) dietary nitrite and gastric cancers and (ii) the combination of nitrite plus nitrate from processed meat and colorectal cancers.
Konačno, EFSA je potvrdila dokaze o povezanosti preformiranog N-nitrozodimetilamina i raka debelog crijeva, kao i neke dokaze o povezanosti između i. nitrita u prehrani i raka želuca; te ii. kombinacije nitrita i nitrata iz prerađenog mesa i raka debelog crijeva.
In 2014 the Commission finalised a desk study to monitor the implementation by the Member States of the EU rules on nitrites.
Komisija je 2014. dovršila preliminarnu studiju o praćenju provedbe propisa EU-a o nitritima u državama članicama.
The study was based on the responses to a questionnaire that was submitted to all Member States.
Studija se temeljila na odgovorima na upitnik koji je dostavljen svim državama članicama.
It revealed that with some exceptions, the typical amount of nitrites added to non-sterilised meat products is lower than the EU maximum amount, but higher than the Danish levels.
Pokazalo se da je uobičajena količina nitrita dodanih nesteriliziranim mesnim proizvodima, uz pojedine iznimke, niža od najveće dopuštene razine EU-a, no viša od danskih razina.
In the report it was concluded that the possibility of reviewing the current maximum levels of nitrites should be further explored.
U izvješću je zaključeno da je potrebno dodatno istražiti mogućnost revizije trenutačnih najvećih dopuštenih razina nitrita.
The Commission therefore launched an ad hoc study regarding the use of nitrites by industry in different categories of meat products.
Komisija je stoga pokrenula ad hoc studiju povezanu s uporabom nitritâ u industriji u različitim kategorijama mesnih proizvoda.
The study, completed in 2016, concluded that there is a possibility to review the current maximum levels of nitrites authorised in the EU legislation.
U studiji dovršenoj 2016. zaključeno je da postoji mogućnost revizije trenutačnih najvećih dopuštenih razina nitrita odobrenih u okviru zakonodavstva EU-a.
The conclusions of the desk study with the Member States, the ad-hoc study as regards the use of nitrites by industry, the re-evaluation by EFSA and the data reported by Denmark are to be taken into consideration by the Commission in the context of the potential revision of the maximum levels of nitrites under Regulation (EC) No 1333/2008.
Komisija će uzeti u obzir zaključke preliminarne studije s državama članicama, ad hoc studiju povezanu s uporabom nitritâ u industriji, ponovnu procjenu EFSA-e te podatke koje je dostavila Danska, u kontekstu moguće revizije najvećih dopuštenih razina nitritâ u skladu s Uredbom (EZ) br. 1333/2008.
Under Article 114(4) and (6) TFEU a Member State may, after the adoption of a harmonisation measure, maintain its more stringent national provisions on grounds of major needs referred to in Article 36 TFEU, or relating to the protection of the environment or the working environment, provided that it notifies these national provisions to the Commission and the Commission approves these measures.
U skladu s člankom 114. stavcima 4. i 6. UFEU-a država članica može, nakon usvajanja mjere za usklađivanje, zadržati svoje strože nacionalne odredbe na osnovi važnih potreba iz članka 36. UFEU-a ili u vezi sa zaštitom okoliša ili radnom okolinom, ako o tim nacionalnim odredbama obavijesti Komisiju i Komisija odobri te mjere.
The Danish notification relates to national provisions derogating from those of Annex II, Part E to Regulation (EC) No 1333/2008 in relation to potassium nitrite (E 249) and sodium nitrite (E 250).
Obavijest Danske odnosi se na nacionalne odredbe koje odstupaju od onih iz Priloga II. dijela E Uredbe (EZ) br. 1333/2008 u pogledu kalijeva nitrita (E 249) i natrijeva nitrita (E 250).
The current Danish provisions already existed in substance at the time these maximum levels were originally laid down in Directive 2006/52/EC of the European Parliament and of the Council.
Trenutačne danske odredbe već su u načelu postojale u trenutku kada su te najveće dopuštene razine bile izvorno propisane Direktivom 2006/52/EZ Europskog parlamenta i Vijeća.
The Danish Order No 1044 allows the addition of the nitrites to meat products only in so far as specific added amounts are not exceeded.
Danskom Odlukom br. 1044 dopušta se dodavanje nitritâ mesnim proizvodima samo ako se ne prekoračuju utvrđene dodane količine.
Depending on the products in question these maximum amounts are 0 mg/kg, 60 mg/kg, 100 mg/kg or 150 mg/kg, which are lower for certain products than the ones laid down in Regulation (EC) No 1333/2008.
Ovisno o proizvodima o kojima je riječ, te najveće dopuštene količine iznose 0 mg/kg, 60 mg/kg, 100 mg/kg ili 150 mg/kg, što je za određene proizvode niže od količina propisanih Uredbom (EZ) br. 1333/2008.
Moreover, unlike Regulation (EC) No 1333/2008, the Danish provisions do not contain any exceptions to the principle of fixing maximum added amounts for nitrites, thereby not permitting the placing on the market of certain traditionally manufactured meat products from other Member States.
Nadalje, za razliku od Uredbe (EZ) br. 1333/2008 u danskim odredbama nema iznimki od načela utvrđivanja najvećih dopuštenih dodanih količina za nitrite, čime se ne dopušta stavljanje na tržište određenih mesnih proizvoda iz drugih država članica proizvedenih tradicionalnim načinima proizvodnje.
The Danish provisions are therefore more stringent than the provisions of Regulation (EC) No 1333/2008 in so far that they lay down lower maximum added amounts than for several types of products (in many cases 60 mg/kg) and in so far as they do not allow the placing on the market of certain traditional meat products on the basis of maximum residual levels.
Danske su odredbe stoga strože od odredbi Uredbe (EZ) br. 1333/2008 utoliko što određuju niže najveće dopuštene dodane količine za nekoliko vrsta proizvoda (u mnogim slučajevima 60 mg/kg) i utoliko što na temelju najvećih dopuštenih razina ostataka ne dopuštaju stavljanje na tržište određenih tradicionalnih mesnih proizvoda.
In accordance with Article 114(4) TFEU, the notification was supplemented by a description of the grounds relating to one or more of the major needs referred to in Article 36 TFEU, in this case the protection of health and life of humans.
U skladu s člankom 114. stavkom 4. UFEU-a obavijest je dopunjena opisom osnove za jednu ili više važnih potreba iz članka 36.
A Memorandum of the Danish Ministry of Environment and Food and an updated risk assessment from the DTU National Food Institute provide additional information on the consumption and imports of meat products, exposure to nitrites, analysis of nitrites in meat products on the Danish market, prevalence of botulism and the formation of nitrosamines in processed meat products.
UFEU-a, u ovom slučaju zaštite zdravlja i života ljudi. Memorandum danskog ministarstva okoliša i hrane i ažurirana procjena rizika Nacionalnog instituta za hranu DTU-a pružaju dodatne podatke o potrošnji i uvozu mesnih proizvoda, izloženosti nitritima, analizi nitritâ u mesnim proizvodima na danskom tržištu, učestalosti botulizma i stvaranju nitrozaminâ u prerađenim mesnim proizvodima.
In light of the foregoing, the Commission considers that the application submitted by Denmark with a view to obtaining authorisation to maintain its national provisions on the use of nitrites in meat products is admissible under Article 114(4) TFEU.
U svjetlu svega navedenog Komisija smatra da je prijava koju je dostavila Danska kako bi dobila odobrenje za zadržavanje svojih nacionalnih odredbi o uporabi nitritâ u mesnim proizvodima dopuštena u skladu s člankom 114. stavkom 4. UFEU-a.
In accordance with Article 114(4) and (6), first subparagraph, TFEU, the Commission must ascertain that all the conditions enabling a Member State to maintain its national provisions derogating from a Union harmonisation measure provided for in that Article are fulfilled.
U skladu s člankom 114. stavkom 4. i člankom 114. stavkom 6. prvim podstavkom UFEU-a Komisija se mora uvjeriti da su svi uvjeti kojima se državi članici omogućuje zadržavanje njezinih nacionalnih odredbi kojima se odstupa od Unijine mjere usklađivanja iz tog članka ispunjeni.
In addition, when the Commission considers that the national provisions fulfil the above conditions, it must verify, pursuant to Article 114(6) TFEU, whether or not the national provisions are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they constitute an obstacle to the functioning of the internal market.
Osim toga, kada Komisija smatra da nacionalne odredbe ispunjuju navedene uvjete, ona mora provjeriti, u skladu s člankom 114. stavkom 6. UFEU-a jesu li one sredstvo proizvoljne diskriminacije ili prikrivenog ograničenja trgovine među državama članicama te stvaraju li prepreku funkcioniranju unutarnjeg tržišta.
It has to be noted that, in the light of the time frame established by Article 114(6) TFEU, the Commission, when examining whether the national measures notified under Article 114(4) TFEU are justified, has to take as a basis the justifications put forward by the notifying Member State.
Potrebno je napomenuti da Komisija, u svjetlu vremenskog okvira utvrđenog člankom 114. stavkom 6. UFEU-a, prilikom ispitivanja opravdanosti nacionalnih mjera o kojima je obaviještena u skladu s člankom 114. stavkom 4.
The burden of proof lies with the requesting Member State that seeks to maintain its national measures.
UFEU-a, mora kao temelj uzeti obrazloženja koja je navela država članica koja je poslala obavijest. Teret dokazivanja snosi država članica koja podnosi zahtjev i koja želi zadržati svoje nacionalne mjere.
However, where the Commission is in possession of information in the light of which the Union harmonisation measure from which the notified national provisions derogate may need to be reviewed, it can take such information into consideration in the assessment of the notified national provisions.
Međutim kada Komisija raspolaže informacijama s obzirom na koje je možda potrebno revidirati Unijinu mjeru usklađivanja od koje prijavljene nacionalne odredbe odudaraju, ona može te informacije uzeti u obzir pri procjeni prijavljenih nacionalnih odredbi.
THE POSITION OF DENMARK
POLOŽAJ DANSKE
Denmark claims that its legislation ensures a higher level of protection of health and life of humans in that it lays down lower maximum added amounts for nitrites than the ones provided for in Regulation (EC) No 1333/2008, and does not allow the placing on the market of traditional meat products for which no ingoing amounts can be established.
Danska tvrdi da njezino zakonodavstvo osigurava višu razinu zaštite zdravlja i života ljudi tako što propisuje niže najveće dopuštene dodane količine za nitrite nego što su propisane u Uredbi (EZ) br. 1333/2008 i ne dopušta stavljanje na tržište tradicionalnih mesnih proizvoda za koje se ne mogu ustanoviti ulazne količine.
Denmark points out that its provisions were laid down in full compliance with the opinions of the SCF made in 1990 and 1995 and also consider the provisions as justified in light of the opinion of EFSA of 26 November 2003 and of the Danish assessment of the most recent EFSA opinion of 15 June 2017.
Danska naglašava da su odredbe njezina zakonodavstva bile u potpunosti usklađene s mišljenjem SCF-a iz 1990. i 1995. i smatra te odredbe opravdanima i s obzirom na mišljenje EFSA-e od 26. studenoga 2003. i dansku procjenu najnovijeg mišljenja EFSA-e od 15. lipnja 2017.
According to Denmark, the overall scientific assessment demonstrates that (a) the use of nitrites and nitrates should be reduced as far as possible by using differentiated amounts in line with the technical needs related to different foodstuffs, (b) the use of nitrites and nitrates should be regulated in terms of the amounts that are added rather than the residual amounts, and (c) the necessary preservation is achieved by using the amounts recommended by EFSA (2003).
Prema mišljenju Danske, ukupne znanstvene procjene pokazuju da bi: (a) uporabu nitrita i nitrata trebalo što više smanjiti uporabom diferenciranih količina u skladu s tehničkim potrebama povezanima s različitim vrstama hrane, (b) uporabu nitrita i nitrata trebalo regulirati u skladu s količinama koje se dodaju, a ne u skladu s količinama ostataka i (c) potrebno konzerviranje trebalo postići uporabom količina koje preporučuje EFSA (2003.).
In that respect, Denmark considers that its national provisions systematically follow these recommendations, whereas Regulation (EC) No 1333/2008 does not as far as nitrites are concerned.
U tom pogledu Danska smatra da njezine nacionalne odredbe sustavno poštuju te preporuke, dok to Uredba (EZ) br. 1333/2008 ne čini u pogledu nitritâ.
Denmark considers that the concern about using the amounts of nitrites permitted under Regulation (EC) No 1333/2008 relates in particular to the increased risk of the nitrosamines formation.
Danska smatra da se zabrinutost u pogledu uporabe količina nitrita dopuštenih u skladu s Uredbom (EZ) br. 1333/2008 posebno odnosi na povećan rizik od stvaranja nitrozaminâ.
Contrary to the recent EFSA opinion, Denmark considers that the formation of both volatile and non-volatile nitrosamines depends on the amount of nitrites added whilst EFSA acknowledges the link only for the latter.
Suprotno najnovijem mišljenju EFSA-e, Danska smatra da stvaranje i hlapljivih i nehlapljivih nitrozamina ovisi o količini dodanih nitrita, dok EFSA smatra da ta veza postoji samo kod nehlapljivih nitrozamina.
It has been scientifically proven that many volatile nitrosamines are carcinogenic and genotoxic and more recent epidemiological studies refer to the link between the consumption of meat products and the development of various forms of cancer.
Znanstveno je dokazano da su mnogi hlapljivi nitrozamini kancerogeni i genotoksični, dok novije epidemiološke studije upućuju na vezu između potrošnje mesnih proizvoda i razvoja različitih oblika raka.
This lends support to restrictions on the use of nitrites as additives.
To ide u prilog ograničenjima za uporabu nitritâ kao aditiva.
Denmark also points out that the margin up to the ADI is not large for young children, who have the highest exposure to nitrites under the current intake calculations for the Danish population.
Danska također naglašava da granična vrijednost PDU-a nije velika za malu djecu, koja su, prema sadašnjem izračunu za dansko stanovništvo, najizloženija nitritima.
Denmark also stresses that its national provisions have been in place for many years and have never given rise to problems with the preservation of the products concerned.
Danska ujedno naglašava da njezine nacionalne odredbe postoje već mnogo godina i da nikada nije bilo problema s konzerviranjem predmetnih proizvoda.
Moreover, it has a relatively low rate of botulism compared with other EU Member States, and not a single case caused by the consumption of meat products has been recorded since 1980.
Nadalje, ona ima relativno nisku stopu botulizma u usporedbi s drugim državama članicama EU-a, a od 1980. nije zabilježen ni jedan slučaj uzrokovan potrošnjom mesnih proizvoda.
Thus, the Danish provisions on the use of nitrites in meat products are still considered as providing comprehensive protection against food poisoning.
Stoga se još uvijek smatra da danske odredbe o uporabi nitritâ u mesnim proizvodima pružaju sveobuhvatnu zaštitu od otrovanja hranom.
The Memorandum of the Danish Ministry of Environment and Food provides additional data on the consumption and import of meat products, exposure to nitrites as well as on an analysis of nitrites in meat products on the Danish market.
U memorandumu danskog Ministarstva okoliša i hrane pruženi su dodatni podaci o potrošnji i uvozu mesnih proizvoda, izloženosti nitritima te analizi nitritâ u mesnim proizvodima na danskom tržištu.
According to the Danish authorities, the comparison of the most recent data, i.e. between 2012 and 2014, demonstrates an increase in the consumption of meat products, including cold cuts, which contained added nitrites.
Prema danskim tijelima, usporedba najnovijih podataka (od 2012. do 2014.) pokazuje povećanje potrošnje mesnih proizvoda, uključujući nareske, koji sadržavaju dodane nitrite.
This has been in line with the trend observed since 2000 indicating that the Danes are becoming increasingly exposed to nitrites in meat products many of which are covered by the low limit value for nitrites of 60 mg/kg.
To je u skladu s kretanjima zabilježenima od 2000. koja pokazuju da su Danci sve izloženiji nitritima u mesnim proizvodima, od kojih su mnogi obuhvaćeni donjom graničnom vrijednosti za nitrite od 60 mg/kg.
As regards trade, Denmark concludes that, during the period under review, the special Danish rules have not had a negative impact on imports of the selected products to Denmark, showing that imports increased by around 5 % from 2013 to 2016, if the figures for Germany are excluded.
U pogledu trgovine Danska zaključuje da tijekom razmatranog razdoblja posebni danski propisi nisu negativno utjecali na uvoz odabranih proizvoda u Dansku, što je vidljivo iz podatka da se uvoz u razdoblju 2013.–2016. povećao za oko 5 %, izuzmu li se podaci za Njemačku.
Based on the analysis of nitrite in meat products, Denmark claims that nitrite content in products imported to Denmark is no higher than that of Danish products.
Na temelju analize nitrita u mesnim proizvodima Danska tvrdi da sadržaj nitrita u proizvodima uvezenima u Dansku nije viši od onoga u danskim proizvodima.
Therefore, Denmark considers it legitimate to maintain the national rules for the use of nitrites in meat products which are more restrictive than the requirements of Regulation (EC) No 1333/2008.
Stoga Danska smatra legitimnim zadržati nacionalne propise za uporabu nitritâ u mesnim proizvodima, koji su restriktivniji od zahtjeva iz Uredbe (EZ) br. 1333/2008.
According to Denmark, the monitoring carried out in accordance with Decision (EU) 2015/826 demonstrates that the health considerations previously taken into account are still valid.
Prema mišljenju Danske, praćenje provedeno u skladu s Odlukom (EU) 2015/826 pokazuje da pitanja zdravlja koja su prethodno uzeta u obzir i dalje vrijede.
Finally, it contends that the data available show that the Danish provisions do not constitute an obstacle to trade in the products concerned.
Naposljetku, Danska navodi da dostupni podaci pokazuju da danske odredbe nisu prepreka trgovini predmetnim proizvodima.
EVALUATION OF DANISH POSITION
OCJENA DANSKOG STAJALIŠTA
The Danish legislation aims to achieve a higher level of protection of health and life of humans with regard to exposure to nitrites and the possible formation of nitrosamines in meat products, by specifying lower maximum added amounts of nitrite in relation to certain meat products, when compared with the maximum levels provided under Regulation (EC) No 1333/2008 and not allowing the placing on the market of products for which only maximum residual levels can be established.
Cilj je danskog zakonodavstva postići višu razinu zaštite zdravlja i života ljudi u pogledu izloženosti nitritima i mogućeg stvaranja nitrozaminâ u mesnim proizvodima određivanjem niže najveće dopuštene dodane količine nitrita za određene mesne proizvode u usporedbi s najvećim dopuštenim razinama propisanima Uredbom (EZ) br. 1333/2008 i nedopuštanjem stavljanja na tržište proizvoda za koje je moguće utvrditi samo najveće dopuštene razine ostataka.
When assessing whether the Danish legislation is actually adequate and necessary for achieving this objective, a number of factors need to be taken into account.
Pri procjeni jesu li danski propisi doista odgovarajući i neophodni za postizanje tog cilja potrebno je u obzir uzeti niz čimbenika.
In particular, two health risks need to be balanced, the presence of nitrosamines in meat products on the one hand, and the microbiological safety of meat products on the other.
Posebice je potrebno da dva zdravstvena rizika, s jedne strane prisutnost nitrozaminâ u mesnim proizvodima, a s druge strane mikrobiološka sigurnost mesnih proizvoda, budu u ravnoteži.
The latter aspect is more than a mere technological need, but a highly relevant health concern in its own right.
Posljednji aspekt nije samo pitanje obične tehnološke potrebe već i vrlo važno zdravstveno pitanje.
While it is recognised that the levels of nitrites in meat products need to be limited, lower levels of nitrite in meat will not automatically lead to a higher protection of human health.
Iako se priznaje da je razine nitritâ u mesnim proizvodima potrebno ograničiti, niže razine nitrita u mesu neće automatski dovesti do veće zaštite ljudskog zdravlja.
The most appropriate level of nitrite depends on a number of factors acknowledged in the relevant opinions of the SCF and EFSA, e.g. the addition of salt, moisture, pH, shelf-life of the product, hygiene, temperature control, etc.
Najprikladnija razina nitrita ovisi o nizu čimbenika priznatih u relevantnim mišljenjima SCF-a i EFSA-e, tj. o dodatku soli, vlazi, pH-u, roku valjanosti proizvoda, higijeni, kontroli temperature itd.