natgillin/translations-raw huggingface dataset:
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.
Največje dovoljene količine, ki se lahko dodajajo, odražajo meje iz teh znanstvenih mnenj z določitvijo, da so dovoljene količine nitritov v steriliziranih mesnih proizvodih do 100 mg/kg, v drugih mesnih proizvodih pa do 150 mg/kg.
Given the vast variety of (cured) meat products and manufacturing methods within the European Union, the Union legislator held that it was, for the moment, not possible to specify the appropriate level of nitrite for each product.
Glede na široko paleto (soljenih) mesnih proizvodov in načinov proizvodnje znotraj Evropske unije je zakonodajalec Unije menil, da zaenkrat ni mogoče določiti primerne vsebnosti nitritov za vsak proizvod.
They 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.
Nanašajo se na posebne proizvode, ki jih tradicionalno proizvajajo v nekaterih državah članicah in pri katerih ni mogoče nadzorovati dodane količine soli, ki jo meso vsrka zaradi narave postopka proizvodnje teh proizvodov.
The traditional products to which they apply are defined, in particular, through a description of the production method.
Tradicionalni proizvodi, na katere se to nanaša, so opredeljeni zlasti z opisom načina proizvodnje.
The national provisions notified by Denmark on 25 November 2014 are Order No 542 of 27 May 2013 on food additives etc. in foodstuffs (BEK nr 542 af 27.5.2013 (tilsætningbekendtgørelsen), Offentliggørelsedato: 31.5.2013, Fødevarerministeriet).
Nacionalne določbe, ki jih je Danska priglasila 25. novembra 2014, so Odlok št. 542 z dne 27. maja 2013 o aditivih za živila itd. v živilih (BEK nr 542 af 27.5.2013 (tilsætningsbekendtgørelsen), offentliggørelsesdato: 31.5.2013, Fødevareministeriet).
In the context of Decision 2010/561/EU, the Commission has already assessed the more stringent rules applied by Denmark with respect to E249 and E250.
Komisija je v okviru Odločbe 2010/561/EU že ocenila strožja pravila, ki jih Danska uporablja za E249 in E250.
Order No 542, provides that nitrites (E249-250) in meat products may only be used under the conditions specified in its Annex 3.
Odlok št. 542 določa, da se lahko nitriti (E249–E250) uporabljajo v mesnih proizvodih le pod pogoji, ki so določeni v Prilogi 3.
Foodstuff
Toplotno neobdelano predelano meso
Amount of nitrites added (mg/kg)
Skupaj 60 mg/kg, vendar v fermentiranih salamah skupaj 100 mg/kg, v trajno konzerviranih ali delno konzerviranih proizvodih pa skupaj 150 mg/kg
Non-heat-treated processed meat
Toplotno obdelano predelano meso
Total 60 mg/kg, but in fermented salamis, total 100 mg/kg and in entirely preserved or semi-preserved products, total 150 mg/kg
Skupaj 60 mg/kg, vendar ne v tradicionalnih danskih mesnih kroglicah in jetrni pašteti.
Heat-treated processed meat
V trajno konzerviranih ali delno konzerviranih proizvodih skupaj 150 mg/kg, v rullepølse (zvitih mesnih salamah 100 mg/kg, v trajno konzerviranih ali delno konzerviranih proizvodih in soljeni šunki pa skupaj 150 mg/kg
Total 60 mg/kg, but not in traditional Danish meatballs and liver paté.
Tradicionalno soljeni mesni proizvodi, ki so zajeti s posebnimi določbami glede uporabe nitritov in nitratov
In entirely preserved or semi-preserved products, total 150 mg/kg, in rullepølse (rolled-meat sausage), total 100 mg/kg, and in entirely preserved or semi-preserved products and salt cured ham, total 150 mg/kg
Skupaj 60 mg/kg, vendar v slanini tipa Wiltshire in njenih kosih skupaj 150 mg/kg
Traditional cured meat products covered by special provisions relating to nitrites and nitrates
Omejitev 60 mg/kg zato velja za več vrst mesnih proizvodov, medtem ko sta ustrezni najvišji vrednosti iz Uredbe (ES) št. 1333/2008 100 mg/kg ali 150 mg/kg.
Total 60 mg/kg, but in bacon of the Wiltshire type and related cuts, total 150 mg/kg
POSTOPEK
Therefore, the 60 mg/kg limit applies for many types of meat products, whereas the corresponding maximum limits of Regulation (EC) No 1333/2008 are 100 or 150 mg/kg.
Danska je s pismom z dne 25. novembra 2014 uradno obvestila Komisijo o svoji želji po ohranitvi nacionalnih določb glede uporabe nitritnih dodatkov v mesnih proizvodih, ki odstopajo od Uredbe (ES) št. 1333/2008.
PROCEDURE
Komisija je objavila obvestilo v zvezi z uradnim obvestilom v Uradnem listu Evropske unije [8], da bi zainteresirane strani seznanila z danskimi nacionalnimi določbami ter razlogi v podporo zahteve.
By letter of 25 November 2014, Denmark notified the Commission of its wish to maintain national provisions on the use of nitrite additives in meat products that differ from Regulation (EC) No 1333/2008.
S pismom z dne 30. marca 2015 je Komisija tudi druge države članice seznanila z obvestilom ter jim dala priložnost, da v 30 dneh predložijo pripombe.
The Commission published a notice regarding the notification in the Official Journal of the European Union [8] in order to inform interested parties of Denmark's national provisions, as well as the grounds invoked to support the request.
Komisija je v tem roku prejela pripombe Češke in Švedske.
By letter of 30 March 2015, the Commission also informed the other Member States on the notification and gave them the opportunity to submit comments thereon within 30 days.
Češka spoštuje načelo, da se določijo strožje mejne vsebnosti pri uporabi nitritov kot aditivov v mesnih proizvodih v okviru nacionalnih zahtev za danske proizvajalce.
The Commission received comments within this deadline from Czech Republic and Sweden.
Vendar ker se določitev nanaša na proizvode iz drugih držav članic, Češka zahteva ohranitev sedanjih mejnih vsebnosti nitritov v mesnih proizvodih, kot so določene v Uredbi (ES) št. 1333/2008 o aditivih za živila.
The Czech Republic respects setting of stricter limits for using nitrites as additives in meat products in frame of national requirements for Danish producers.
Švedska meni, da so danske nacionalne določbe videti dobro utemeljene in da naj ne bi imele pomembnega vpliva na pogoje na Švedskem.
But as it concerns the products from other Member States the Czech Republic requires keeping current limits for content of nitrites in meat products, which are laid down by the Regulation (EC) No 1333/2008 on food additives.
Na podlagi tega, kar je Danska navedla v uradnem obvestilu, Švedska meni, da ni nobenega razloga za nepodaljšanje obstoječih nacionalnih predpisov.
Sweden is of the view that the national provisions of Denmark appear to be well founded and does not seem to have a significant impact on conditions in Sweden.
Nadaljnje podaljšanje bi EU prav tako omogočilo dovolj časa za pregled vsebnosti nitritov in vključitev trenutnega dela EFSA glede nitritov kot aditivov za živila.
On the basis of what Denmark has indicated in the notification Sweden sees no reason not to accept an extension of the existing national provisions.
PONOVNA OCENA NITRITOV
A further extension would also have the benefit of providing the EU with time for a review of the levels of nitrites, making it possible to incorporate EFSA's ongoing work on nitrites as food additives.
Podatki, ki jih je Danska predložila v podporo svojemu obvestilu o porabi mesnih proizvodov, izpostavljenosti nitritom, razširjenosti botulizma in nastajanju nitrozaminov v predelanih mesnih proizvodih, so bili predloženi EFSA z zahtevo, da jih upošteva pri trenutni ponovni oceni.
RE-EVALUATION OF NITRITES
SPREMLJANJE, KI GA IZVAJA KOMISIJA
For this re-evaluation, EFSA shall examine 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 identify any relevant literature published since the last evaluation of each food additive.
Študija je temeljila na odgovorih na vprašalnik, ki je bil predložen vsem državam članicam.
The data that was provided by Denmark in support of its 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 during the ongoing re-evaluation.
Študija je pokazala, da je tipična količina nitritov, dodanih nesteriliziranim mesnim proizvodom, z nekaterimi izjemami manjša od največje količine EU, a večja od danskih vsebnosti.
MONITORING BY THE COMMISSION
V poročilu je bilo ugotovljeno, da bi bilo treba dodatno preučiti možnost revizije veljavnih najvišjih dovoljenih vsebnosti nitritov [10].
In 2014 the Commission finalised a desk study to monitor the implementation by the Member States of the EU rules on nitrites.
Komisija je zato začela ad hoc študijo o uporabi nitritov v industriji pri različnih kategorijah mesnih proizvodov.
The study was based on the responses to a questionnaire that was submitted to all Member States.
Ta študija bo vključevala preučitev literature in organizacijo delavnice s strokovnjaki za tehnologijo mesa ter anketo med mesno industrijo EU o dejanski uporabi in ravneh uporabe nitritov v različnih opredeljenih vrstah mesnih proizvodov.
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.
Sklepi te študije bi morali biti na voljo do konca leta 2015.
In the report it was concluded that the possibility of reviewing the current maximum levels of nitrites should be further explored [10].
OCENA
The Commission therefore launched an ad hoc study regarding the use of nitrites by industry in different categories of meat products.
DOPUSTNOST
This study will include literature research, organisation of a workshop with experts in meat technology and a survey within the EU meat industry on the actual use and use levels of nitrites according to the different types of meat products identified.
V skladu s členom 114(4) in (6) PDEU lahko država članica po sprejetju usklajevalnega ukrepa ohrani strožje nacionalne določbe zaradi pomembnih potreb iz člena 36 PDEU ali določbe v zvezi z varstvom okolja ali delovnega okolja, če o teh nacionalnih določbah obvesti Komisijo in če Komisija te ukrepe odobri.
Conclusions from this study should be available by the end of 2015.
Dansko uradno obvestilo se nanaša na nacionalne določbe, ki odstopajo od tistih iz dela E Priloge II k Uredbi (ES) št. 1333/2008 v zvezi s kalijevim nitritom (E 249) in natrijevim nitritom (E 250).
ASSESSMENT
Sedanje danske določbe so dejansko že obstajale, ko so bile te najvišje dovoljene vsebnosti prvotno določene v Direktivi 2006/52/ES.
ADMISSIBILITY
Danski Odlok št. 542 dovoljuje dodajanje nitritov mesnim proizvodom samo, če niso presežene določene dodane količine.
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.
Glede na zadevne proizvode so te največje dovoljene količine 60, 100 ali 150 mg/kg, ki so za nekatere proizvode nižje od količin iz Uredbe (ES) št. 1333/2008.
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).
Vendar danske določbe v nasprotju z Uredbo (ES) št. 1333/2008 ne vključujejo izjem pri načelu določanja največjih dodanih količin za nitrite, s čimer ne dovoljujejo dajanja na trg nekaterih tradicionalno proizvedenih mesnih proizvodov iz drugih držav članic.
The current Danish provisions already existed in substance at the time these maximum levels were originally laid down in Directive 2006/52/EC.
Danske določbe so zato strožje od določb iz Uredbe (ES) št. 1333/2008, saj določajo nižje največje dovoljene dodane količine za več vrst proizvodov (v več primerih 60 mg/kg) in ne dovoljujejo dajanja na trg nekaterih tradicionalnih mesnih proizvodov na osnovi največjih dovoljenih vsebnosti ostankov.
The Danish Order No 542 allows the addition of the nitrites to meat products only in so far as specific added amounts are not exceeded.
V skladu s členom 114(4) PDEU je bilo uradno obvestilo dopolnjeno z opisom razlogov, povezanih z eno ali več pomembnimi potrebami iz člena 36 PDEU, v tem primeru z varovanjem zdravja in življenja ljudi.
Depending on the products in question these maximum amounts are 60, 100 or 150 mg/kg, which are lower for certain products than the ones laid down in Regulation (EC) No 1333/2008.
V priloženo poročilo danskega ministrstva za prehrano, kmetijstvo in ribištvo so vključeni dodatni podatki o porabi in uvozu mesnih proizvodov, izpostavljenosti nitritom, razširjenosti botulizma ter nastajanju nitrozaminov v predelanih mesnih proizvodih.
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.
Komisija v skladu z navedenim meni, da je zahteva Danske za pridobitev dovoljenja za ohranitev nacionalnih določb o uporabi nitritov v mesnih proizvodih dopustna v skladu s členom 114(4) PDEU.
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 values.
VSEBINSKA PRESOJA
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.
V skladu s členom 114(4) in prvim odstavkom člena 114(6) PDEU mora Komisija preveriti, ali so izpolnjeni vsi pogoji iz navedenega člena, ki državi članici omogočajo ohraniti njene nacionalne določbe, ki odstopajo od usklajevalnega ukrepa Unije.
An accompanying Report of the Danish Ministry of Food, Agriculture and Fisheries provides additional data on the consumption and imports of meat products, exposure to nitrites, prevalence of botulism and the formation of nitrosamines in processed meat products.
Komisija mora zlasti oceniti, ali so nacionalne določbe utemeljene na podlagi pomembnih potreb iz člena 36 PDEU oziroma ali so povezane z varstvom okolja ali delovnega okolja ter ne presegajo tistega, kar je potrebno za dosego zastavljenih legitimnih ciljev.
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.
Poleg tega mora Komisija, kadar meni, da nacionalne določbe izpolnjujejo navedene pogoje, v skladu s členom 114(6) PDEU preveriti, ali so nacionalne določbe sredstvo za samovoljno diskriminacijo ali prikrito omejevanje trgovine med državami članicami in ali ovirajo delovanja notranjega trga.
ASSESSMENT OF MERITS
Treba je opozoriti, da mora Komisija pri preučevanju, ali so priglašeni nacionalni ukrepi na podlagi člena 114(6) PDEU utemeljeni, glede na rok iz člena 114(4) PDEU upoštevati razloge, ki jih je predložila država članica priglasiteljica.
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.
To pomeni, da mora v skladu z določbami Pogodbe država članica, ki je predložila zahtevo in želi nacionalne ukrepe ohraniti, dokazati upravičenost teh ukrepov.
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.
Kadar pa Komisija razpolaga z informacijami, glede na katere bi bilo treba pregledati usklajevalni ukrep Unije, od katerega priglašene nacionalne določbe odstopajo, lahko take informacije upošteva pri ocenjevanju priglašenih nacionalnih določb.
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.
Stališče Danske
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 grounds’ put forward by the notifying Member State.
Danska trdi, da njena zakonodaja zagotavlja višjo raven varovanja zdravja in življenja ljudi, saj določa nižje največje dovoljene dodane količine nitritov od tistih iz Uredbe (ES) št. 1333/2008 in ne dovoljuje dajanja na trg tradicionalnih mesnih proizvodov, za katere ni mogoče določiti dodanih količin.
This means that, according to the provisions of TFEU, the responsibility of proving that the national measures are justified lies with the requesting Member State that seeks to maintain them.
Danska meni, da so danske določbe popolnoma skladne s priporočili SCF iz let 1990 in 1995 ter z mnenjem EFSA z dne 26. novembra 2003.
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.
Danska prav tako meni, da uravnavanje uporabljenih količin nitrita glede na to, ali vključujejo vnos, ki presega določen zadevni sprejemljiv dnevni vnos (ADI), ne zagotavlja potrebne ravni varovanja zdravja ljudi.
The position of Denmark
Pri ADI, določenem za nitrite, ni upoštevano nastajanje nitrozaminov, ki so povezani z uporabo nitritov v mesnih proizvodih.
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.
Po znanstvenih ocenah so nitrozamini genotoksični, zato ni možno določiti meje, pod katero niso rakotvorni.
Denmark considers that the Danish provisions are fully consistent with the recommendations which the SCF made in 1990 and 1995, as well as with the opinion of EFSA of 26 November 2003.
Danska nadalje poudarja, da je nastajanje nitrozaminov odvisno od dodanih količin nitritov in ne od veliko nižjih količin ostankov, ki so zaradi pretvorbe snovi v živilu običajno prisotni v proizvodu ob zaužitju.
Denmark also considers that regulating the nitrite amounts used on the basis of whether they were considered to involve an intake in excess of the established relevant acceptable daily intake (ADI) does not provide the necessary protection of human health.
Zato celotna znanstvena ocena po njegovem mnenju kaže, (a) da bi bilo treba uporabo čim bolj zmanjšati z uporabo različnih količin v skladu s tehničnimi potrebami za različna živila, (b) da bi bilo treba uporabo nitritov in nitratov urediti glede na dodane količine in ne na količine ostankov ter (c) da bi bilo treba potrebno konzerviranje doseči z uporabo količin, ki jih priporoča EFSA.
The ADI established for nitrites does not take into account the formation of nitrosamines, which are associated with the use of nitrites in meat products.
Danska zato meni, da njene nacionalne določbe sistematično sledijo tem priporočilom, Uredba (ES) št. 1333/2008 v zvezi z nitriti pa ne.
According to scientific evaluations, nitrosamines are genotoxic; as such, it is not possible to establish a limit under which they are not carcinogenic.
Danska poudarja tudi, da njene nacionalne določbe veljajo že vrsto let in da nikoli niso povzročile težav v zvezi s konzerviranjem zadevnih proizvodov.
Denmark further emphasises that the formation of nitrosamines depends on the nitrite amounts that are added, and not on the much lower residual amounts, which, due to the substance's transformation in the foodstuff, are typically present in the product at the time of consumption.
Poleg tega je na Danskem v primerjavi z drugimi državami članicami EU relativno malo primerov botulizma, od leta 1980 pa ni bil zabeležen noben primer botulizma zaradi uživanja mesnih proizvodov.
Thus, in its opinion, the overall scientific assessment demonstrates that (a) the use 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.
Danska navaja, da od leta 2006 na Danskem ni bil zabeležen noben primer botulizma.
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.
Zato se še vedno šteje, da danske odločbe o uporabi nitritov v mesnih proizvodih zagotavljajo celovito zaščito pred zastrupitvijo s hrano.
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.
V zvezi z vzorci porabe so v priloženo poročilo danskega ministrstva za prehrano, kmetijstvo in ribištvo vključeni dodatni podatki o porabi in uvozu mesnih proizvodov ter analiza nitrita v mesnih proizvodih na danskem trgu.
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.
Po mnenju danskih organov poročilo kaže, da je poraba mesnih proizvodov, ki se jim lahko dodajo nitriti, v preteklih letih stabilna.
Denmark notes that no cases of botulism have been recorded in Denmark since 2006.
V zvezi z izpostavljenostjo nitritom priloženo poročilo danskega ministrstva za prehrano, kmetijstvo in ribištvo navaja ocene na podlagi 384 analiz nitritov v predelanih mesnih proizvodih in hladnih mesnih narezkih ter na podlagi podatkov o porabi iz raziskav prehranjevanja.
Thus, the Danish provisions on the use of nitrites in meat products are still considered as providing comprehensive protection against food poisoning.
Na podlagi teh ocen ostaja srednja vrednost izpostavljenosti manjša od ADI za nitrite.
As regards consumption patterns, the Report of the Danish Ministry of Food, Agriculture and Fisheries provides additional data on the consumption and import of meat products as well as an analysis of nitrite in meat products on the Danish market.
Otroci od 4 do 5 let so izpostavljeni 3-krat večji količini na kg telesne teže v primerjavi z odraslimi.