natgillin/translations-raw huggingface dataset:
The maximum added amount is 150 mg/kg for most meat products in general and 100 mg/kg for sterilised meat products.
UREDBA (EZ) br. 1333/2008
For a few specified cured meat products made traditionally in specific Member States the maximum added amount is 180 mg/kg.
U skladu s općim načelima Uredbe (EZ) br. 1333/2008 odobrenje prehrambenog aditiva ovisi o razumnim tehnološkim potrebama, njegovoj prihvatljivosti sa zdravstvenog gledišta i tome da njegova uporaba ne dovodi potrošača u zabludu.
By way of exception to the general rule, Regulation (EC) No 1333/2008, Annex II, Part E, food category under 8.3.4: ‘Traditionally cured meat products with specific provisions concerning nitrites and nitrates’ lays down maximum residual levels at the end of the production process for certain specified traditional cured meat products, which are produced through traditional manufacturing methods.
U Prilogu II.
There are maximum residual levels of 50 mg/kg, 100 mg/kg and 175 mg/kg applying to different groups of such products, e.g. 175 mg/kg for Wiltshire bacon, dry cured bacon and similar products, and 100 mg/kg for Wiltshire ham and similar products.
Uredbi (EZ) br. 1333/2008 utvrđen je popis prehrambenih aditiva Unije odobrenih za uporabu u hrani i uvjeti njihove uporabe.
Maximum residual levels are the exceptions to the general rule of applying maximum added amounts.
Samo prehrambeni aditivi koji se nalaze na popisu Unije mogu se stavljati na tržište kao takvi i upotrebljavati u hrani u skladu s ondje navedenim uvjetima uporabe.
Those levels only apply to specific products which are traditionally manufactured in certain Member States and for which it is not possible to control the ingoing amount of curing salts absorbed by the meat due to the nature of the manufacturing process associated with these products.
Nitriti se već niz desetljeća upotrebljavaju u mesnim proizvodima, među ostalim kako bi se u kombinaciji s drugim čimbenicima osiguralo održanje mikrobiološke sigurnosti mesnih proizvoda, a pogotovo salamurenih mesnih proizvoda, čime se, među ostalim, sprječava množenje bakterije Clostridium botulinum, koja uzrokuje po život opasan botulizam.
The maximum levels in Regulation (EC) No 1333/2008 are based on the opinions from the Scientific Committee for Food (hereinafter ‘SCF’) of 1990 and 1995 as well as from the European Food Safety Authority (hereinafter ‘EFSA’) of 26 November 2003.
Zakonodavstvo u tom području mora stoga uspostaviti ravnotežu između rizika od nastanka nitrozaminâ zbog prisutnosti nitritâ u mesnim proizvodima, s jedne strane, i zaštitnog učinka nitritâ protiv množenja bakterija, a pogotovo onih koje uzrokuju botulizam, s druge strane.
The maximum amounts that may be added reflect the ranges referred to in these scientific opinions by specifying that up to 100 mg/kg of nitrite are permitted in sterilised meat products and 150 mg/kg in other meat products.
U Uredbi (EZ) br. 1333/2008, u Prilogu II. dijelu E, u kategoriji hrane 8.3: „Mesni proizvodi” utvrđene su najveće dopuštene količine kalijeva nitrita (E 249) i natrijeva nitrita (E 250) koje se smiju dodati tijekom proizvodnje.
Given the vast variety of (cured) meat products and manufacturing methods within the European Union, the Union legislator held that it was not possible to specify the appropriate level of nitrite for each product.
Najveća dopuštena dodana količina jest 150 mg/kg općenito za većinu mesnih proizvoda i 100 mg/kg za sterilizirane mesne proizvode.
NATIONAL PROVISIONS NOTIFIED
Za nekoliko specificiranih salamurenih mesnih proizvoda koji se tradicionalno proizvode u određenim državama članicama najveća dopuštena dodana količina iznosi 180 mg/kg.
The national provisions notified by Denmark on 10 November 2017 are contained in Order No 1044 of 4 September 2015 on additives in foodstuffs (BEK nr.
Kao iznimka od općeg pravila navedena u Uredbi (EZ) br. 1333/2008, u Prilogu II. dijelu E, u kategoriji hrane 8.3.4: „Tradicionalno salamureni mesni proizvodi s posebnim odredbama u pogledu nitrita i nitrata” utvrđene su najveće dopuštene razine ostataka na kraju postupka proizvodnje za određene specificirane tradicionalne salamurene mesne proizvode koji se proizvode tradicionalnim načinima proizvodnje.
1044 af 4.9.2015, Udskriftsdato: 25.9.2017, Fødevareministeriet).
Najveće dopuštene razine ostataka koje se primjenjuju na različite skupine takvih proizvoda iznose 50 mg/kg, 100 mg/kg i 175 mg/kg, odnosno 175 mg/kg za Wiltshire bacon, dry cured bacon i slične proizvode te 100 mg/kg za Wiltshire ham i slične proizvode.
That Order amends Order No 542 of 27 May 2013 which had been previously notified to the Commission and assessed in the context of Decision (EU) 2015/826.
Najveće dopuštene razine ostataka iznimka su od općeg pravila o primjeni najvećih dopuštenih dodanih količina.
Order No 1044 provides that nitrites (E 249 – 250) in meat products may only be used under the conditions specified in Annex 3 thereto.
Te se razine primjenjuju samo na posebne proizvode koji se tradicionalno proizvode u određenim državama članicama i za koje zbog prirode postupka proizvodnje nije moguće kontrolirati ulaznu količinu soli za soljenje koju meso apsorbira.
The groups of foodstuffs referred to in that Annex correspond to the food categories listed in Annex II to Regulation (EC) No 1333/2008 on food additives and supersede the usages arising from it:
Postupak proizvodnje tih posebnih proizvoda opisan je u Uredbi kako bi se omogućila identifikacija „sličnih proizvoda” i kako bi bilo jasno koji su proizvodi obuhvaćeni raznim najvećim dopuštenim razinama.
Foodstuff
S obzirom na veliku raznolikost (salamurenih) mesnih proizvoda i načina proizvodnje u Europskoj uniji, zakonodavac Unije smatrao je da nije moguće specificirati primjerenu razinu nitrita za svaki proizvod.
Amount of nitrites added (mg/kg)
PRIJAVLJENE NACIONALNE ODREDBE
Non-heat-treated meat products
Nacionalne odredbe koje je Danska prijavila 10. studenoga 2017. sadržane su u Odluci br. 1044 od 4. rujna 2015. o aditivima u hrani (BEK nr.
Total 60 mg/kg.
1044 af 4.9.2015., Udskriftsdato:25.9.2017., Fødevareministeriet).
In fermented salamis, however, total 100 mg/kg.
Tom je odlukom izmijenjena Odluka br. 542 od 27. svibnja 2013., koja je prethodno prijavljena Komisiji i ocijenjena u kontekstu Odluke (EU) 2015/826.
Heat-treated meat products
Odlukom br. 1044 određeno je da se nitriti (E 249–250) mogu upotrebljavati u mesnim proizvodima isključivo pod uvjetima navedenima u njezinu Prilogu 3.
In entirely preserved or semi-preserved products, total 150 mg/kg.
Skupine prehrambenih proizvoda navedene u tom Prilogu odgovaraju kategorijama hrane navedenima u Prilogu II.
In rullepølse (rolled-meat sausage), total 100 mg/kg.
Uredbi (EZ) br. 1333/2008 o prehrambenim aditivima i zamjenjuju uporabe koje proizlaze iz njega:
In traditional Danish meat balls and liver pâté, 0 mg/kg.
Prehrambeni proizvod
Traditional cured meat products with specific provisions concerning nitrites and nitrates
Količina dodanih nitrita (mg/kg)
Total 60 mg/kg.
Toplinski neobrađeni mesni proizvodi
In bacon of the Wiltshire type and related products, total 150 mg/kg.
Ukupno 60 mg/kg.
In traditional cured ham (spegeskinke) and related products, 150 mg/kg.
Međutim, u fermentiranim salamama ukupno 100 mg/kg.
Thus lower maximum level for nitrites (E 249 and E 250) of 60 mg/kg applies for many types of meat products, whereas the corresponding maximum limits of Regulation (EC) No 1333/2008 are 100 mg/kg or 150 mg/kg.
Toplinski obrađeni mesni proizvodi
PROCEDURE
U potpuno konzerviranim ili polukonzerviranim proizvodima ukupno 150 mg/kg.
In support of its notification, Denmark submitted information that includes data on consumption and imports of meat products, exposure to nitrites, analysis of nitrites in meat products, prevalence of botulism and updated risk assessment from the DTU National Food Institute.
U rullepølse (kobasici od rolanog mesa) ukupno 100 mg/kg.
The Commission published a notice regarding the notification in the Official Journal of the European Union in order to inform interested parties of Denmark's national provisions, as well as the grounds invoked to support the request.
U tradicionalnim danskim mesnim okruglicama i jetrenoj pašteti 0 mg/kg.
By letter of 28 March 2018, the Commission also informed the other Member States on the notification and gave them the opportunity to submit comments thereon within 30 days.
Tradicionalno salamureni mesni proizvodi s posebnim odredbama u pogledu nitritâ i nitratâ
The Commission received comments within this deadline from Cyprus.
Ukupno 60 mg/kg.
Cyprus does not oppose to the request of Denmark for maintaining more stringent national rules for the use of nitrites in meat products and acknowledges the Danish position that the requested rules are necessary for safeguarding the public health.
U slanini vrste Wiltshire i srodnim proizvodima ukupno 150 mg/kg.
Cyprus can accept the request on the condition that these rules would not constitute a trade barrier or a disproportionate obstacle to the functioning of internal market and possible discrimination against products produced in other Member State and traded in Denmark.
U tradicionalnoj dimljenoj šunki (spegeskinke) i srodnim proizvodima 150 mg/kg.
RE-EVALUATION OF NITRITES
Stoga se niža najveća dopuštena razina nitritâ (E 249 i E 250) od 60 mg/kg primjenjuje za mnoge vrste mesnih proizvoda, dok odgovarajuće najveće količine iz Uredbe (EZ) br. 1333/2008 iznose 100 mg/kg ili 150 mg/kg.
Commission Regulation (EU) No 257/2010 required EFSA to re-evaluate the safety of potassium nitrite (E 249) and sodium nitrite (E 250) as food additives.
POSTUPAK
For this re-evaluation, EFSA examined the earlier opinions of the SCF and EFSA, where available, the original dossier, data submitted by the interested business operator(s) and/or any other interested party and data made available by the Commission and Member States and identified any relevant literature published since the last evaluation of each food additive.
Kao popratnu dokumentaciju uz tu obavijest Danska je dostavila informacije koje uključuju podatke o potrošnji i uvozu mesnih proizvoda, izloženosti nitritima, analizi nitritâ u mesnim proizvodima i učestalosti botulizma te ažuriranu procjenu rizika Nacionalnog instituta za hranu DTU-a.
The data that was provided by Denmark in support of its previous notification on consumption of meat products, the exposure to nitrites, the prevalence of botulism and the formation of nitrosamines in processed meat products was submitted to EFSA with a request to take this into account in the safety re-evaluation.
Komisija je u Službenom listu Europske unije objavila obavijest o prijavi kako bi zainteresirane strane obavijestila o nacionalnim odredbama Danske te razlozima u potporu zahtjevu.
EFSA delivered a Scientific Opinion on the re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) on 15 June 2017.
Dopisom od 28. ožujka 2018.
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.
Komisija je ujedno obavijestila druge države članice o obavijesti i dala im priliku da dostave komentare na nju u roku od 30 dana.
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.
Komisija je u tom roku primila komentare Cipra.
The contribution of nitrites used as food additives represented approximately 17 % (range 1,5-36,0 %) of the overall exposure.
Cipar se ne protivi zahtjevu Danske u pogledu zadržavanja strožih nacionalnih propisa o uporabi nitritâ u mesnim proizvodima te uzima u obzir dansko stajalište prema kojemu su zatraženi propisi nužni zbog zaštite javnog zdravlja.
Further, EFSA concluded that the exposure to the endogenous nitrosamines was of low concern.
Cipar može prihvatiti zahtjev uz uvjet da ti propisi neće činiti prepreku trgovini ili nesrazmjernu prepreku funkcioniranju unutarnjeg tržišta i moguću diskriminaciju proizvoda koji su proizvedeni u drugoj državi članici i kojima se trguje u Danskoj.
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.
PONOVNA PROCJENA NITRITÂ
Therefore, the overall exposure was calculated although it does not relate only to the use of nitrite as food additive.
Uredbom Komisije (EU) br. 257/2010 od EFSA-e se zahtijeva da ponovno procijeni sigurnost kalijeva nitrita (E 249) i natrijeva nitrita (E 250) kao prehrambenih aditiva.
There was some concern for the overall exposure to exogenous nitrosamines at high levels for all age groups except for the elderly.
U okviru te ponovne procjene EFSA je ispitala prethodna mišljenja SCF-a i EFSA-e, ovisno o njihovoj dostupnosti, izvornu dokumentaciju, podatke koje su dostavili zainteresirani poslovni subjekti i/ili bilo koja druga zainteresirana strana te podatke koje su na raspolaganje stavile Komisija i države članice te je utvrdila svu relevantnu literaturu koja je objavljena od zadnje procjene svakog prehrambenog aditiva.
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.
Podaci koje je Danska dostavila u prilog svojoj prethodnoj obavijesti o potrošnji mesnih proizvoda, izloženosti nitritima, učestalosti botulizma i stvaranju nitrozaminâ u prerađenim mesnim proizvodima dostavljeni su EFSA-i sa zahtjevom da ih uzme u obzir tijekom ponovne procjene sigurnosti.
MONITORING BY THE COMMISSION
EFSA je 15. lipnja 2017. izdala znanstveno mišljenje o ponovnoj procjeni kalijeva nitrita (E 249) i natrijeva nitrita (E 250).
In 2014 the Commission finalised a desk study to monitor the implementation by the Member States of the EU rules on nitrites.
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.
The study was based on the responses to a questionnaire that was submitted to all Member States.
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.
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.
Doprinos nitritâ u uporabi kao prehrambenih aditiva činila je oko 17 % (raspon od 1,5 do 36,0 %) ukupne izloženosti.
In the report it was concluded that the possibility of reviewing the current maximum levels of nitrites should be further explored.
Nadalje, EFSA je zaključila da izloženost endogenim nitrozaminima ne predstavlja visok rizik.
The Commission therefore launched an ad hoc study regarding the use of nitrites by industry in different categories of meat products.
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.
The study, completed in 2016, concluded that there is a possibility to review the current maximum levels of nitrites authorised in the EU legislation.
Stoga je ukupna izloženost izračunana iako se ne odnosi samo na uporabu nitrita kao prehrambenog aditiva.
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.
Postojala je određena zabrinutost u pogledu ukupne izloženosti egzogenim nitrozaminima na visokoj razini za sve dobne skupine osim za starije osobe.
ASSESSMENT
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.
ADMISSIBILITY
PRAĆENJE OD STRANE KOMISIJE
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.
Komisija je 2014. dovršila preliminarnu studiju o praćenju provedbe propisa EU-a o nitritima u državama članicama.
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).
Studija se temeljila na odgovorima na upitnik koji je dostavljen svim državama članicama.
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.
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.
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.
U izvješću je zaključeno da je potrebno dodatno istražiti mogućnost revizije trenutačnih najvećih dopuštenih razina nitrita.
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.
Komisija je stoga pokrenula ad hoc studiju povezanu s uporabom nitritâ u industriji u različitim kategorijama mesnih proizvoda.
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.
U studiji dovršenoj 2016. zaključeno je da postoji mogućnost revizije trenutačnih najvećih dopuštenih razina nitrita odobrenih u okviru zakonodavstva EU-a.
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.
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.
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.
PROCJENA
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.
DOPUŠTENOST
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 skladu s člankom 114. stavcima 4. i 6.
ASSESSMENT OF MERITS
UFEU-a država članica može, nakon usvajanja mjere za usklađivanje, zadržati svoje strože nacionalne odredbe na osnovi važnih potreba iz članka 36.
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.
UFEU-a ili u vezi sa zaštitom okoliša ili radnom okolinom, ako o tim nacionalnim odredbama obavijesti Komisiju i Komisija odobri te mjere.
In particular, the Commission has to assess whether or not the national provisions are justified by the major needs referred to in Article 36 TFEU or relating to the protection of the environment or the working environment and do not exceed what is necessary to attain the legitimate objective pursued.
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).
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.
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.
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.
Danskom Odlukom br. 1044 dopušta se dodavanje nitritâ mesnim proizvodima samo ako se ne prekoračuju utvrđene dodane količine.
The burden of proof lies with the requesting Member State that seeks to maintain its national measures.
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.
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.
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.