natgillin/translations-raw huggingface dataset:
According to the Danish authorities, this Report demonstrates that the consumption of meat products to which nitrites may be added is stable over the years.
Glede nastajanja nitrozaminov v predelanih mesnih proizvodih je dansko ministrstvo za prehrano, kmetijstvo in ribištvo predložilo zbirno poročilo o prisotnosti N-nitrozaminov v predelanih mesnih proizvodih, ki ga je pripravil nacionalni inštitut za prehrano DTU in v katerem je navedeno, da se nižje vsebnosti nitrozaminov najbolje dosežejo z uporabo čim manj nitritov in v kombinaciji z eritorbinsko kislino, askorbinsko kislino ali askorbatom, saj bi to preprečilo morebitno nastajanje nitrozaminov.
As regards the exposure to nitrites, the Report of the Danish Ministry of Food, Agriculture and Fisheries provides estimates based on 384 nitrite analyses in processed meat and meat cold cuts and on consumption data from dietary surveys.
Poleg tega Danska trdi, da njene določbe o nitritih ne delujejo kot ovira za trgovino, pri čemer se sklicuje na številke, ki kažejo, da se mesni proizvodi uvažajo iz drugih držav članic in se je ta uvoz od leta 2010 celo povečal.
Based on these estimates, the mean exposure remains below the ADI for nitrites.
Če povzamemo, Danska meni, da je legitimno, da se tveganje za zdravje ljudi, ki izvira iz izpostavljenosti nitrozaminom, zmanjša z nadaljnjim izvajanjem nacionalne zakonodaje, ki je strožja od zahtev iz Uredbe (ES) št. 1333/2008.
Children aged 4-5 years are exposed to a three-fold higher exposure per kg body weight compared to adults.
Nadzor, ki ga je Danska izvajala v skladu s Sklepom 2010/561/EU, po mnenju Danske kaže na to, da so prej upoštevane ugotovitve v zvezi z zdravjem še vedno veljavne.
As regards the formation of nitrosamines in processed meat products, the Danish Ministry of Food, Agriculture and Fisheries provided summary report on the presence of N-nitrosamines in processed meat products, prepared by the DTU National Food Institute, which concludes that low levels of nitrosamines are best achieved by using as little nitrite as possible and to use it in combination with erythorbic acid, ascorbic acid or ascorbate as this would prevent the possible formation of nitrosamines.
Nenazadnje trdi, da po razpoložljivih podatkih danske določbe ne ovirajo trgovine z zadevnimi proizvodi.
Furthermore, Denmark maintains that its provisions on nitrites do not act as an obstacle to trade, referring to figures showing that imports of meat products from other Member States have been taking place and have even increased since 2010.
Ocena Danskega stališča
In sum, Denmark considers it legitimate to reduce the risk to human health stemming from the exposure to nitrosamines beyond the requirements of Regulation (EC) No 1333/2008 through the continued application of its legislation.
Utemeljitev na podlagi pomembnih potreb iz člena 36 PDEU
According to Denmark, the monitoring, which it undertook pursuant to Decision 2010/561/EU, demonstrates that the health considerations previously taken into account are still valid.
Namen danske zakonodaje je doseči višjo raven varovanja zdravja in življenja ljudi v zvezi z izpostavljenostjo nitritom in morebitnem nastanku nitrozaminov v mesnih proizvodih z določitvijo nižjih največjih dodanih količin nitritov v nekaterih mesnih proizvodih v primerjavi z najvišjimi vsebnostmi iz Uredbe (ES) št. 1333/2008 in s prepovedjo dajanja na trg proizvodov, za katere se lahko določijo samo največje dovoljene vsebnosti ostanka.
Finally, it contends that the data available show that the Danish provisions do not constitute an obstacle to trade in the products concerned.
Pri ocenjevanju, ali je danska zakonodaja dejansko primerna in potrebna za dosego tega cilja, je treba upoštevati številne dejavnike.
Evaluation of the Danish position
Zlasti je treba uravnotežiti dve vrsti zdravstvenih tveganj, in sicer prisotnost nitrozaminov v mesnih proizvodih na eni in mikrobiološke varnosti mesnih proizvodov na drugi strani.
Justification on grounds of major needs referred to in Article 36 TFEU
Slednji vidik je več kot le tehnološka potreba, sam po sebi je tudi zelo pomembno zdravstveno vprašanje.
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.
Sicer se priznava, da je treba vsebnost nitritov v mesnih proizvodih omejiti, vendar nižje vsebnosti nitritov v mesu ne pomenijo samodejno tudi boljšega varovanja človeškega zdravja.
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.
Najprimernejša vsebnost nitritov je odvisna od številnih dejavnikov, ki jih priznavata ustrezni mnenji Znanstvenega odbora za hrano in EFSA, npr. od dodajanja soli, vlage, pH, roka uporabnosti proizvoda, higiene, nadzora temperature itd.
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.
Komisija glede na navedene ugotovitve in ugotovitve iz uvodnih izjav 10 in 11 meni, da je Uredba (ES) št. 1333/2008 načeloma primeren odziv na izziv usklajevanja dveh nasprotujočih si tveganj za zdravje glede na raznolikosti mesnih proizvodov v Uniji.
The latter aspect is more than a mere technological need, but a highly relevant health concern in its own right.
Kljub temu mora Komisija oceniti posebne odločitve, ki jih je sprejel danski zakonodajalec, in izkušnje, pridobljene na podlagi teh pravil, ki so v veljavi daljše obdobje.
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.
S podatki o pojavnosti zastrupitve s hrano in zlasti botulizma je Danska dokazala, da je s svojo zakonodajo doslej dosegla zadovoljive rezultate.
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.
Ti podatki kažejo, da najvišje določene vsebnosti v danski zakonodaji zadoščajo za zagotavljanje mikrobiološke varnosti mesnih proizvodov, ki jih na Danskem trenutno proizvajajo, ter za načine proizvodnje, ki so tam trenutno v uporabi.
In the light of the preceding considerations and those under recitals 10 and 11 above, the Commission considers that, in principle, Regulation (EC) No 1333/2008 constitutes an adequate response to the challenge of reconciling two conflicting health risks in light of the diversity of meat products across the Union.
Komisija ugotavlja, da je danska zakonodaja usklajena z ustreznimi strokovnimi mnenji strokovnih organov Unije.
Nevertheless, the Commission has to evaluate the specific choices made by the Danish regulator and the experience made with these rules, which have been in force for a considerable period of time.
Temelji na uravnavanju najvišjih dodanih vrednosti in upošteva meje dodanih količin nitritov iz teh mnenj, tj. 50–150 mg/kg.
Through the figures it provided on the occurrence of food poisoning and, in particular, botulism, Denmark has demonstrated that it has achieved satisfactory results with its legislation so far.
Hkrati je Danska v primerjavi z Uredbo določila bolj specifične dodane količine za posebne skupine mesnih proizvodov ob upoštevanju vrst mesnih proizvodov in načinov proizvodnje, ki na Danskem prevladujejo.
These data show that the maximum levels specified in the Danish legislation appear to have been sufficient to ensure the microbiological safety of the meat products currently made in Denmark and the production methods currently used in Denmark.
Na podlagi informacij, ki jih je Danska predložila, je poleg tega treba upoštevati, da je večina mesnih proizvodov, ki jih zaužijejo prebivalci Danske, iz tiste skupine mesnih proizvodov, za katero trenutno velja omejitev 60 mg/kg, ki bi jo bilo treba nadomestiti z omejitvijo 100 ali 150 mg/kg.
The Commission notes that the Danish legislation is compatible with the relevant scientific opinions of the Union's scientific bodies.
Čeprav danski proizvajalci tako kot proizvajalci v drugih državah članicah ne bi bili obvezani dvigniti količine nitritov, ki jih trenutno dodajajo svojim proizvodom, do najvišjih dovoljenih vsebnosti iz Uredbe (ES) št. 1333/2008, povišanja dejanske izpostavljenosti danskega prebivalstva nitritom ni mogoče izključiti.
It is based on a regulation of maximum added values and respects the ranges of added amounts of nitrite referred to in these opinions, i.e. 50-150 mg/kg.
Na podlagi trenutno razpoložljivih informacij Komisija meni, da se lahko zahteva po ohranitvi priglašenih ukrepov začasno odobri zaradi varovanja javnega zdravja na Danskem.
At the same time, Denmark has established more specific maximum added amounts for particular groups of meat products, compared with the Regulation, in light of the types of meat products and manufacturing methods prevailing in Denmark.
Odsotnost kakršne koli samovoljne diskriminacije, kakršnega koli prikritega omejevanja trgovine med državami članicami ali kakršne koli ovire za delovanje notranjega trga
In addition, it must be considered that, according to information provided by Denmark, the bulk of the meat products consumed by the Danish population relates to meat products for which there is currently a limit of 60 mg/kg and which would have to be replaced with a limit of 100 or 150 mg/kg.
Odsotnost samovoljne diskriminacije
Although Danish manufacturers, like manufacturers in other Member States, would not be obliged to raise the amounts of nitrites currently added to their products to the maximum levels referred to in Regulation (EC) No 1333/2008, an increase of the actual exposure of the Danish population to nitrites cannot be excluded.
Na podlagi člena 114(6) PDEU mora Komisija preveriti, ali so predlagani ukrepi sredstvo samovoljne diskriminacije.
On the basis of the information available at the moment, the Commission considers that the request to maintain the notified measures can be temporarily accepted on grounds of protection of public health in Denmark.
Da ne pride do kakršne koli diskriminacije, se v skladu s sodno prakso Sodišča podobne situacije ne smejo obravnavati na različne načine, različne situacije pa ne na isti način.
Absence of any arbitrary discrimination, any disguised restriction of trade between Member States or any obstacle to the functioning of the internal market
Danska nacionalna pravila veljajo za domače proizvode in proizvode, proizvedene v drugih državah članicah.
Absence of arbitrary discrimination
Ob odsotnosti kakršnih koli nasprotnih dokazov, se lahko sklepa, da nacionalne določbe niso sredstvo samovoljne diskriminacije.
Article 114(6) TFEU obliges the Commission to verify that the envisaged measures are not a means of arbitrary discrimination.
Odsotnost prikritega omejevanja trgovine
According to the jurisprudence of the Court of Justice, in order for there to be no discrimination, similar situations must not be treated in different ways and different situations must not be treated in the same way.
Nacionalni ukrepi, ki uporabo proizvodov omejujejo v večji meri kot Uredba Unije, bi običajno ovirali trgovino, če se ne pričakuje, da bodo proizvodi, ki so zakonito dani na trg in se uporabljajo v preostalem delu Unije, zaradi prepovedi uporabe dani na trg v zadevni državi članici.
The Danish national rules apply to both domestic products and products made in other Member States.
Namen predpogojev iz člena 114(6) PDEU je preprečiti, da bi se omejitve, ki temeljijo na merilih iz odstavkov 4 in 5 navedenega člena, uporabljale v neprimerne namene in bi s tem prevzele vlogo gospodarskih ukrepov, namenjenih oviranju uvoza proizvodov iz drugih držav članic, torej bi postale sredstvo posredne zaščite nacionalne proizvodnje.
In the absence of any evidence to the contrary, it can be concluded that the national provisions are not a means of arbitrary discrimination.
Ker danska pravila uvajajo strožje standarde pri dodajanju nitritov nekaterim mesnim proizvodom tudi za nosilce dejavnosti v drugih državah članicah v drugače usklajenem območju, lahko pride do prikritega omejevanja trgovanja ali ovire za delovanje notranjega trga.
Absence of a disguised restriction on trade
Vendar se priznava, da je treba člen 114(6) PDEU obravnavati v smislu, da se ne smejo odobriti samo taki nacionalni ukrepi, ki nesorazmerno ovirajo notranji trg.
National measures which restrict the use of products to a greater extent than a Union Regulation would normally constitute a barrier to trade, in so far as products that are legally placed on the market and used in the rest of the Union are not expected, as a result of the prohibition on use, to be placed on the market in the Member State concerned.
V zvezi s tem je Danska predložila podatke o uvozu mesnih proizvodov iz drugih držav članic, ki ne samo, da se je kljub njeni zakonodaji nadaljeval, ampak se je od leta 2010 celo povečal.
The pre-conditions laid down in Article 114(6) TFEU are intended to prevent restrictions based on the criteria set out in paragraphs (4) and (5) thereof from being applied for inappropriate reasons, and constituting in effect economic measures to impede the importation of products from other Member States, that is to say, a means of indirectly protecting national production.
Ob odsotnosti kakršnih koli dokazov, da so nacionalne določbe v resnici ukrep z namenom zaščite nacionalne proizvodnje, se lahko sklepa, da te določbe ne pomenijo prikritega omejevanja trgovanja med državami članicami.
Given that the Danish rules also impose stricter standards on the addition of nitrites to certain meat products on operators based in other Member States in an otherwise harmonised area, they are liable to constitute a disguised restriction of trade or an obstacle to the functioning of the internal market.
Odsotnost ovir za delovanje notranjega trga
It is recognised, however, that Article 114(6) TFEU must be read in the sense that only national measures constituting a disproportionate obstacle to the internal market may not be approved.
Tega pogoja ni mogoče razlagati kot izključitve odobritev katerega koli nacionalnega ukrepa, ki bi lahko vplival na vzpostavitev notranjega trga.
In this connection, Denmark has submitted figures which indicate that imports of meat products from other Member States not only have been taking place in spite of its legislation, but they have even increased since 2010.
Dejansko vsak nacionalni ukrep, ki odstopa od usklajevalnega ukrepa za vzpostavitev in delovanje notranjega trga, v osnovi pomeni ukrep, ki bo verjetno vplival na notranji trg.
In the absence of any evidence suggesting that the national provisions constitute in effect a measure intended to protect national production, it can be concluded that they are not a disguised restriction to trade between Member States.
Za ohranitev uporabnosti postopka iz člena 114 PDEU, je posledično treba v okviru člena 114(6) PDEU pojem ovire za delovanje notranjega trga razumeti kot nesorazmeren učinek glede na zastavljeni cilj.
Absence of obstacles to the functioning of the internal market
Glede na prednosti za zdravje, ki jih je navedla danska vlada v zvezi z zmanjšanjem izpostavljenosti nitritom v mesnih proizvodih, in dejstvo, da na podlagi trenutno razpoložljivih podatkov to na trgovanje ne vpliva oziroma vpliva le v omejenem obsegu, Komisija meni, da se lahko priglašena danska pravila začasno ohranijo na podlagi varovanja zdravja in življenja ljudi, ob upoštevanju dejstva, da niso nesorazmerna in zato ne ovirajo delovanja notranjega trga v smislu člena 114(6) PDEU.
This condition cannot be interpreted in such a way that it precludes the approval of any national measure likely to affect the establishment of the internal market.
Komisija ob upoštevanju te analize meni, da je pogoj o odsotnosti ovir za delovanje notranjega trga izpolnjen.
Indeed, any national measure derogating from a harmonisation measure aimed at the establishment and operation of the internal market constitutes in substance a measure likely to affect the internal market.
Časovna omejitev
Consequently, in order to preserve the useful character of the procedure laid down in Article 114 TFEU, the concept of obstacle to the functioning of the internal market must, in the context of Article 114(6) TFEU, be understood as a disproportionate effect in relation to the pursued objective.
Zgornji sklepi temeljijo na trenutno razpoložljivih informacijah in zlasti na podatkih, ki kažejo, da Danska nadzoruje botulizem kljub nižjim najvišjim mejam nitritov, dodanih določenim mesnim proizvodom, ob tem pa ni motila trgovanja na nesorazmeren način.
Given the health benefits invoked by the Danish government in relation to the reduction of exposure to nitrites in meat products and the fact that, on the basis of currently available figures, trade does not appear to be affected at all or only to a very limited extent, the Commission considers that the notified Danish rules may temporarily continue to be maintained on grounds relating to the protection of health and life of humans having regard to the fact that they are not disproportionate and do, therefore, not constitute an obstacle to the functioning of the internal market in the sense of Article 114(6) TFEU.
Drugi pomemben dejavnik je odstotek porabe mesnih proizvodov na Danskem, v zvezi s katero bi uporaba Uredbe (ES) št. 1333/2008 lahko privedla do povečane izpostavljenosti prebivalcev Danske nitritom in s tem tudi nitrozaminom.
In the light of this analysis, the Commission considers that the condition relating to the absence of obstacles to the functioning of the internal market is fulfilled.
Danska bi morala 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.
Limitation in time
Zbrani podatki se morajo osredotočati zlasti na obvladovanje botulizma.
The above conclusions are based on the currently available information and, in particular, on figures indicating that Denmark has been able to control botulism despite lower maximum levels of nitrite added to particular types of meat products, while not disrupting trade in a disproportionate fashion.
Poleg tega bi morala Danska še naprej zbirati podatke o uvozu mesnih proizvodov iz drugih držav članic.
Another important factor is the rate of consumption in Denmark of meat products in relation to which the application of Regulation (EC) No 1333/2008 could lead to an increase of the exposure of the Danish population to nitrites and thereby nitrosamines.
Danska bi morala zbrane podatke Komisiji predložiti v dveh letih od datuma sprejetja tega sklepa.
Denmark would need to continue to 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.
Poleg tega bi morala Komisija preučiti sklepe EFSA o ponovni oceni nitritov v skladu z Uredbo (EU) št. 257/2010 in o ad hoc študiji glede uporabe nitritov v industriji pri različnih kategorijah mesnih proizvodov.
The data collected should focus in particular on the control of botulism.
Komisija ob upoštevanju navedenega meni, da lahko nacionalne določbe v navedenem obsegu odobri za omejeno obdobje treh let.
In addition Denmark would need to continue to collect data on imports of meat products from other Member States.
SKLEPNA UGOTOVITEV
Denmark would be required to report the collected data to the Commission within two years from the date of adoption of the present Decision.
Po mnenju Komisije se glede na navedene ugotovitve in ob upoštevanju pripomb držav članic o uradnem obvestilu, ki so ga predložili danski organi, zahteva Danske, ki jo je Komisija prejela 25. novembra 2014, po ohranitvi nacionalnih določb o dodajanju nitritov, ki so strožje od tistih iz Uredbe (ES) št. 1333/2008, lahko odobri za obdobje treh let od datuma sprejetja tega sklepa.
Moreover, the Commission should consider the conclusions of the re-evaluation of nitrites by EFSA in accordance with Regulation (EU) No 257/2010 and of the ad hoc study as regards the use of nitrites by industry in different categories of meat products.
Danska bi morala 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 –
Against this background, the Commission considers that the national provisions, to the extent specified above, can be approved for a limited period of 3 years.
SPREJELA NASLEDNJI SKLEP:
CONCLUSION
Člen 1
In the light of the above considerations, and taking account of comments provided by Member States on the notification submitted by the Danish authorities, the Commission is of the opinion that the request by Denmark, received by the Commission on 25 November 2014, for maintaining its national provisions on the addition of nitrites, which are more stringent than those of Regulation (EC) No 1333/2008, can be approved for a period of 3 years from the date of adoption of the present Decision.
Nacionalne določbe o dodajanju nitritov mesnim proizvodom iz Odloka št. 542 z dne 27. maja 2013 o aditivih za živila itd.
Denmark would need to continue to 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,
(BEK nr 542 af 27.5.2013 (tilsætninsgbekendtgørelsen), Offentliggørelsesdato:31.5.2013, Fødevareministeriet), o katerih je Kraljevina Danska v skladu s členom 114(4) Pogodbe o delovanju Evropske unije (PDEU) Komisijo obvestila s pismom z dne 25. novembra 2014, se odobrijo.
Article 1
Ta sklep preneha veljati 22. maja 2018.
The national provisions on the addition of nitrites to meat products contained in 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), which the Kingdom of Denmark notified to the Commission by letter of 25 November 2014, pursuant to Article 114(4) TFEU, are approved.
Člen 3
Article 2
Ta sklep je naslovljen na Kraljevino Dansko.
This Decision shall expire on 22 May 2018.
V Bruslju, 22. maja 2015
Article 3
Za Komisijo
This Decision is addressed to the Kingdom of Denmark.
Član Komisije
Done at Brussels, 22 May 2015.
Sklep Komisije 2010/561/EU z dne 25. maja 2010 o nacionalnih določbah o dodajanju nitritov nekaterim mesnim izdelkom, o katerih je Danska poslala uradno obvestilo (UL L 247, 21.9.2010, str. 55).
For the Commission
Direktiva 2006/52/ES Evropskega parlamenta in Sveta z dne 5. julija 2006 o spremembi Direktive 95/2/ES o aditivih za živila razen barvil in sladil in Direktive 94/35/ES o sladilih za uporabo v živilih (UL L 204, 26.7.2006, str. 10).
Member of the Commission
Uredba Komisije (EU) št. 1129/2011 z dne 11. novembra 2011 o spremembi Priloge II k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta z vzpostavitvijo seznama Unije aditivov za živila (UL L 295, 12.11.2011, str. 1).
Commission Decision 2010/561/EU of 25 May 2010 concerning national provisions notified by Denmark on the addition of nitrite to certain meat products (OJ L 247, 21.9.2010, p. 55).
Uredba (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila (UL L 354, 31.12.2008, str. 16).