natgillin/translations-raw huggingface dataset:
Commission Decision (EU) 2015/826 approved Danish national provisions on the addition of potassium nitrite (E 249) and sodium nitrite (E 250) (nitrites) to meat products contained in Order No 542 of 27 May 2013 on additives in foodstuffs (BEK nr.
S Sklepom Komisije (EU) 2015/826 so bile odobrene danske nacionalne določbe o dodajanju kalijevega nitrita (E 249) in natrijevega nitrita (E 250) (v nadaljnjem besedilu: nitriti) mesnim proizvodom iz Odloka št. 542 z dne 27. maja 2013 o aditivih v živilih (BEK nr.
542 af 27.5.2013 (tilsætningbekendtgørelsen), Offentliggørelsesdato: 31.5.2013, Fødevareministeriet), which the Kingdom of Denmark notified to the Commission by letter of 25 November 2014, pursuant to Article 114(4) of the Treaty on the Functioning of the European Union (TFEU).
542 af 27.5.2013 (tilsætningbekendtgørelsen), Offentliggørelsesdato: 31.5.2013, Fødevareministeriet), o katerem je Kraljevina Danska v skladu s členom 114(4) Pogodbe o delovanju Evropske unije (PDEU) Komisijo obvestila s pismom z dne 25. novembra 2014.
These national provisions are approved until 22 May 2018.
Te nacionalne določbe so odobrene do 22. maja 2018.
Regulation (EC) No 1333/2008 of the European Parliament and of the Council lays down the levels and other conditions of use of nitrites in meat products.
Uredba (ES) št. 1333/2008 Evropskega parlamenta in Sveta določa vsebnosti in druge pogoje uporabe nitritov v mesnih proizvodih.
According to Decision (EU) 2015/826 Denmark should monitor the situation and collect data on whether the application of the levels laid down in Regulation (EC) No 1333/2008 achieve the required level of protection and if not, whether it would lead to an unacceptable risk to human health.
Danska mora v skladu s Sklepom (EU) 2015/826 še naprej spremljati situacijo in zbirati podatke o tem, ali uporaba vsebnosti iz Uredbe (ES) št. 1333/2008 dosega zahtevano raven varovanja in če ne, ali bi to lahko privedlo do nesprejemljivega tveganja za zdravje ljudi.
By letter of 10 November 2017, Denmark notified the Commission of its intention to maintain national provisions on the use of nitrite additives in meat products that differ from Regulation (EC) No 1333/2008.
Danska je s pismom z dne 10. novembra 2017 uradno obvestila Komisijo o svoji nameri po ohranitvi nacionalnih določb glede uporabe nitritnih dodatkov v mesnih proizvodih, ki odstopajo od Uredbe (ES) št. 1333/2008.
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 Technical University of Denmark (DTU) National Food Institute.
Danska je v podporo svojemu obvestilu predložila informacije, ki vključujejo podatke o porabi in uvozu mesnih proizvodov, izpostavljenosti nitritom, analizi nitritov v mesnih proizvodih, razširjenosti botulizma in posodobljeno oceno tveganja nacionalnega inštituta za prehrano pri Danski tehniški univerzi (DTU).
Article 114(4) TFEU provides that, ‘If, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 36, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.’
Člen 114(4) PDEU določa, da „če po tem, ko Evropski parlament in Svet, Svet ali Komisija sprejmejo usklajevalni ukrep, država članica meni, da mora ohraniti nacionalne določbe zaradi pomembnih potreb iz člena 36 ali določbe, ki zadevajo varstvo okolja ali delovnega okolja, o teh določbah pa tudi o razlogih za njihovo ohranitev uradno obvesti Komisijo“.
REGULATION (EC) No 1333/2008
UREDBA (ES) št. 1333/2008
Under the general principles of Regulation (EC) No 1333/2008 the approval of a food additive is subject to a reasonable technological need, its acceptability from a health point of view and its use not being misleading for the consumer.
V skladu s splošnimi načeli Uredbe (ES) št. 1333/2008 je odobritev aditivov za živila odvisna od upravičene tehnološke potrebe, njihove sprejemljivosti z vidika zdravja in njihove uporabe, ki ni zavajajoča za potrošnika.
Nitrites have been used in meat products for many decades, inter alia, to secure, in conjunction with other factors, the preservation and microbiological safety of meat products, in particular cured meat products, inhibiting, amongst other things, the multiplication of Clostridium botulinum, the bacteria responsible for life-threatening botulism.
Nitriti se v mesnih proizvodih uporabljajo že desetletja, med drugim, skupaj z drugimi dejavniki za konzerviranje in mikrobiološko varnost mesnih proizvodov, zlasti soljenih mesnih proizvodov, in zavirajo, med drugim, množenje bakterije Clostridium botulinum, ki povzroča življenjsko nevarni botulizem.
At the same time, it is recognised that the presence of nitrites in meat products can give rise to the formation of nitrosamines, some of which have been found to be carcinogenic.
Hkrati se priznava, da lahko prisotnost nitritov v mesnih proizvodih povzroča nastanek nitrozaminov, med katerimi je bilo za nekatere ugotovljeno, da so rakotvorni.
Regulation (EC) No 1333/2008, Annex II, Part E, food category 8.3: ‘Meat products’ lays down maximum amounts for potassium nitrite (E 249) and sodium nitrite (E 250) that may be added during manufacture.
Živilska kategorija 8.3 v delu E Priloge II k Uredbi (ES) št. 1333/2008: „Mesni proizvodi“ določa največje količine kalijevega nitrita (E 249) in natrijevega nitrita (E 250), ki se lahko dodajajo med proizvodnjo.
The maximum added amount is 150 mg/kg for most meat products in general and 100 mg/kg for sterilised meat products.
Največja dovoljena dodana količina je 150 mg/kg za večino mesnih proizvodov na splošno in 100 mg/kg za sterilizirane mesne proizvode.
For a few specified cured meat products made traditionally in specific Member States the maximum added amount is 180 mg/kg.
Za nekaj določenih soljenih mesnih proizvodov, ki jih tradicionalno proizvajajo v določenih državah članicah, je največja dovoljena dodana količina 180 mg/kg.
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.
Z odstopanjem od splošnega pravila so v delu E Priloge II k Uredbi (ES) št. 1333/2008 v kategoriji 8.3.4: „Tradicionalno soljeni mesni proizvodi s posebnimi določbami glede uporabe nitritov in nitratov“ določene najvišje dovoljene vsebnosti ostankov za nekatere tradicionalno soljene mesne proizvode, ki se proizvajajo na tradicionalne načine proizvodnje, ob koncu proizvodnega postopka.
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.
Najvišje dovoljene vsebnosti ostankov so 50 mg/kg, 100 mg/kg in 175 mg/kg za različne skupine takih proizvodov, npr. 175 mg/kg za Wiltshire bacon, dry cured bacon in podobne proizvode ter 100 mg/kg za Wiltshire ham in podobne proizvode.
Maximum residual levels are the exceptions to the general rule of applying maximum added amounts.
Najvišje dovoljene vsebnosti ostankov so izjeme od splošnega pravila za največje dodane količine.
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.
Nanašajo se le 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 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.
Glede na široko paleto (soljenih) mesnih proizvodov in načinov proizvodnje znotraj Evropske unije je zakonodajalec Unije menil, da ni mogoče določiti primerne vsebnosti nitritov za vsak proizvod.
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.
PRIGLAŠENE NACIONALNE DOLOČBE
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.
Nacionalne določbe, ki jih je Danska priglasila 10. novembra 2017, vsebuje Odlok št. 1044 z dne 4. septembra 2015 o aditivih v živilih (BEK nr.
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.
Navedeni odlok spreminja Odlok št. 542 z dne 27. maja 2013, ki je bil predhodno priglašen Komisiji in ocenjen v Sklepu (EU) 2015/826.
1044 af 4.9.2015, Udskriftsdato: 25.9.2017, Fødevareministeriet).
Odlok št. 1044 določa, da se lahko nitriti (E 249–E 250) uporabljajo v mesnih proizvodih le pod pogoji, ki so določeni v Prilogi 3 k navedenemu odloku.
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.
Skupine živil iz navedene priloge se ujemajo s kategorijami iz Priloge II k Uredbi (ES) št. 1333/2008 o aditivih za živila in nadomeščajo uporabe, določene v njej:
Order No 1044 provides that nitrites (E 249 – 250) in meat products may only be used under the conditions specified in Annex 3 thereto.
Živilo
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:
Količina dodanih nitritov (mg/kg)
Foodstuff
Toplotno neobdelani mesni proizvodi
Amount of nitrites added (mg/kg)
Skupaj 60 mg/kg.
Non-heat-treated meat products
V fermentiranih salamah skupaj 100 mg/kg.
Total 60 mg/kg.
Toplotno obdelani mesni proizvodi
In fermented salamis, however, total 100 mg/kg.
V trajno konzerviranih ali delno konzerviranih proizvodih skupaj 150 mg/kg.
Heat-treated meat products
V rullepølse (zvitih mesnih salamah) skupaj 100 mg/kg.
In entirely preserved or semi-preserved products, total 150 mg/kg.
V tradicionalnih danskih mesnih kroglicah in jetrni pašteti 0 mg/kg.
In rullepølse (rolled-meat sausage), total 100 mg/kg.
Tradicionalno soljeni mesni proizvodi, ki so zajeti s posebnimi določbami glede uporabe nitritov in nitratov
In traditional Danish meat balls and liver pâté, 0 mg/kg.
Skupaj 60 mg/kg.
Traditional cured meat products with specific provisions concerning nitrites and nitrates
V slanini tipa Wiltshire in povezanih proizvodih skupaj 150 mg/kg.
Total 60 mg/kg.
V tradicionalni soljeni šunki (spegeskinke) in povezanih proizvodih 150 mg/kg.
In bacon of the Wiltshire type and related products, total 150 mg/kg.
Zato se za mnogo vrst mesnih proizvodov uporablja nižja najvišja vsebnost nitritov (E 249 in E 250) 60 mg/kg, ustrezni najvišji vsebnosti iz Uredbe (ES) št. 1333/2008 pa sta 100 mg/kg ali 150 mg/kg.
In traditional cured ham (spegeskinke) and related products, 150 mg/kg.
POSTOPEK
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.
Danska je v podporo svojemu obvestilu predložila informacije, ki vključujejo podatke o porabi in uvozu mesnih proizvodov, izpostavljenosti nitritom, analizi nitritov v mesnih proizvodih, razširjenosti botulizma in posodobljeni oceni tveganja nacionalnega inštituta za prehrano DTU.
PROCEDURE
Komisija je objavila obvestilo v zvezi z uradnim obvestilom v Uradnem listu Evropske unije, da bi zainteresirane strani seznanila z danskimi nacionalnimi določbami ter razlogi v podporo zahteve.
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.
S pismom z dne 28. marca 2018 je Komisija tudi druge države članice seznanila z uradnim 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 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 Cipra.
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.
Ciper ne nasprotuje zahtevi Danske za ohranitev strožjih nacionalnih pravil za uporabo nitritov v mesnih proizvodih in priznava dansko stališče, da so zahtevana pravila potrebna za zaščito javnega zdravja.
The Commission received comments within this deadline from Cyprus.
Ciper lahko zahtevo sprejme pod pogojem, da ta pravila ne bi pomenila trgovinske omejitve ali nesorazmerne ovire za delovanje notranjega trga in morebitne diskriminacije proizvodov, proizvedenih v drugi državi članici in s katerimi se trguje na Danskem.
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.
PONOVNA OCENA NITRITOV
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.
Uredba Komisije (EU) št. 257/2010 je od agencije EFSA zahtevala, da ponovno oceni varnost kalijevega nitrita (E 249) in natrijevega nitrita (E 250) kot aditivov za živila.
RE-EVALUATION OF NITRITES
Pri tej ponovni oceni je EFSA proučila svoja prejšnja mnenja in mnenja SCF, originalno dokumentacijo, kadar je bila na voljo, podatke, ki so jih predložili zainteresirani nosilci dejavnosti in/ali katera koli druga zainteresirana stran, ter podatke, ki so jih dale na voljo Komisija in države članice, in identificirala vso zadevno literaturo, objavljeno od zadnje ocene posameznega aditiva za živila.
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.
Podatki, ki jih je Danska predložila v podporo svojemu predhodnemu 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 ponovni oceni varnosti.
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.
EFSA je 15. junija 2017 podala znanstveno mnenje o ponovni oceni kalijevega nitrita (E 249) in natrijevega nitrita (E 250).
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.
EFSA je izpeljala sprejemljiv dnevni vnos (ADI) 0,07 mg nitritnega iona/kg telesne teže na dan in ocenila, da pri splošni populaciji izpostavljenost nitritom kot posledica njihove uporabe kot aditiva za živila ni presegala tega ADI, z izjemo rahlega preseganja pri otrocih pri najvišjem percentilu.
EFSA delivered a Scientific Opinion on the re-evaluation of potassium nitrite (E 249) and sodium nitrite (E 250) on 15 June 2017.
Če bi upoštevali vse vire prehranske izpostavljenosti nitritom skupaj (aditivi za živila, naravna prisotnost in kontaminacija), bi bil ADI presežen pri dojenčkih, malčkih in otrocih že pri srednji izpostavljenosti, pri najvišji izpostavljenosti pa pri vseh starostnih skupinah.
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.
Prispevek nitritov, ki se uporabljajo kot aditivi za živila, predstavlja približno 17 % (razpon 1,5–36,0 %) celotne izpostavljenosti.
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.
EFSA je poleg tega ugotovila, da je izpostavljenost endogenim nitrozaminom majhen vzrok za zaskrbljenost.
The contribution of nitrites used as food additives represented approximately 17 % (range 1,5-36,0 %) of the overall exposure.
Glede izpostavljenosti eksogenim nitrozaminom je EFSA na podlagi rezultatov sistematičnega pregleda, opravljenega za oceno povezave med nitriti, dodanimi mesnim proizvodom, in nastankom nekaterih hlapnih nitrozaminov z najvišjim toksikološkim tveganjem ugotovila, da teh N-nitrozo spojin, ki nastanejo iz dodanih nitritov v zakonskih vsebnostih, ni mogoče jasno razločiti od N-nitrozo spojin, ki nastanejo že v spektru živila brez dodanih nitritov.
Further, EFSA concluded that the exposure to the endogenous nitrosamines was of low concern.
Zato je bila skupna izpostavljenost izračunana, čeprav se ne nanaša samo na uporabo nitritov kot aditiva za živila.
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.
Izražena je bila določena zaskrbljenost glede skupne visoke izpostavljenosti eksogenim nitrozaminom pri vseh starostnih skupinah, razen pri starejših.
Therefore, the overall exposure was calculated although it does not relate only to the use of nitrite as food additive.
EFSA je potrdila dokaze o povezavi predhodno nastalega N-nitrozodimetilamina ter raka debelega črevesa in danke ter nekatere dokaze o povezavi (i) prisotnosti nitritov v hrani z rakavimi obolenji želodca ter (ii) kombinacije nitritov in nitratov iz predelanega mesa z rakom debelega črevesa in danke.
There was some concern for the overall exposure to exogenous nitrosamines at high levels for all age groups except for the elderly.
SPREMLJANJE, KI GA IZVAJA KOMISIJA
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.
Komisija je leta 2014 zaključila teoretično študijo za spremljanje izvajanja pravil EU o nitritih v državah članicah.
MONITORING BY THE COMMISSION
Študija je temeljila na odgovorih na vprašalnik, ki je bil predložen vsem državam članicam.
In 2014 the Commission finalised a desk study to monitor the implementation by the Member States of the EU rules on nitrites.
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.
The study was based on the responses to a questionnaire that was submitted to all Member States.
V poročilu je bilo ugotovljeno, da bi bilo treba dodatno proučiti možnost revizije veljavnih najvišjih dovoljenih vsebnosti nitritov.
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.
Komisija je zato začela ad hoc študijo o uporabi nitritov v industriji pri različnih kategorijah mesnih proizvodov.
In the report it was concluded that the possibility of reviewing the current maximum levels of nitrites should be further explored.
Študija, dokončana leta 2016, je pokazala, da obstaja možnost pregleda sedanjih najvišjih dovoljenih vsebnosti nitritov, dovoljenih v zakonodaji EU.
The Commission therefore launched an ad hoc study regarding the use of nitrites by industry in different categories of meat products.
Komisija mora v zvezi z morebitno revizijo najvišjih dovoljenih vsebnosti nitritov iz Uredbe (ES) št. 1333/2008 upoštevati ugotovitve teoretične študije z državami članicami, ad hoc študijo o uporabi nitritov v industriji, ponovno oceno EFSA in podatke, ki jih je sporočila Danska.
The study, completed in 2016, concluded that there is a possibility to review the current maximum levels of nitrites authorised in the EU legislation.
OCENA
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.
DOPUSTNOST
ASSESSMENT
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.
ADMISSIBILITY
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).
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.
Sedanje danske določbe so dejansko že obstajale, ko so bile te najvišje dovoljene vsebnosti prvotno določene v Direktivi 2006/52/ES Evropskega parlamenta in Sveta.
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).
Danski Odlok št. 1044 dovoljuje dodajanje nitritov mesnim proizvodom samo, če niso presežene določene dodane količine.
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.
Glede na zadevne proizvode so te največje dovoljene količine 0 mg/kg, 60 mg/kg, 100 mg/kg ali 150 mg/kg, ki so za nekatere proizvode manjše od količin iz Uredbe (ES) št. 1333/2008.