natgillin/translations-raw huggingface dataset:
On 20 January 2011, the German Federal Government requested the Commission, pursuant to Article 114(4) of the Treaty on the Functioning of the European Union (TFEU), the permission to retain the existing provisions provided in German law for the five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances released from toy material, beyond the date of entry into force of Annex II, Part III of Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys [1].
Nemška zvezna vlada je 20. januarja 2011 v skladu s členom 114(4) Pogodbe o delovanju Evropske unije (PDEU) pri Komisiji vložila vlogo za ohranitev obstoječih določb iz nemške zakonodaje o petih prvinah, in sicer svincu, arzenu, živem srebru, bariju in antimonu, ter o nitrozaminih in nitrozabilnih snoveh, ki se sproščajo iz materialov za igrače, še po začetku veljavnosti dela III Priloge II k Direktivi 2009/48/ES Evropskega parlamenta in Sveta z dne 18. junija 2009 o varnosti igrač [1].
Article 114(4) and (6) TFEU
Člen 114(4) in (6) PDEU
Article 114(4) and (6) TFEU provides:
Člen 114(4) in (6) PDEU določa:
If, after the adoption by the Council or by the Commission of a harmonisation measure, 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.
Če po tem, ko Svet ali Komisija sprejme 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.
The Commission shall, within 6 months of the notification, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction to trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market.
Komisija v šestih mesecih po uradnem obvestilu odobri ali zavrne nacionalne določbe, potem ko preveri, ali so morda sredstvo samovoljne diskriminacije ali prikrita omejitev trgovine med državami članicami in ali ovirajo delovanje notranjega trga.
In the absence of a Decision by the Commission within this period the national provisions referred to in paragraphs 4 (…) shall be deemed to have been approved.
Če Komisija v tem roku ne sprejme nobenega sklepa, se šteje, da so nacionalne določbe iz odstavkov 4 […] odobrene.
When justified by the complexity of the matter and in the absence of danger for human health, the Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to 6 months.’
Če to upravičuje zahtevnost zadeve in če ni nevarnosti za zdravje ljudi, lahko Komisija zadevno državo članico uradno obvesti, da se rok iz tega odstavka lahko podaljša za nadaljnje obdobje največ šestih mesecev.“.
Directive 2009/48/EC
Direktiva 2009/48/ES
Directive 2009/48/EC (hereinafter ‘the Directive’) lays down rules on the safety of toys and on their free movement in the European Union.
Direktiva 2009/48/ES (v nadaljnjem besedilu: Direktiva) določa pravila o varnosti igrač in njihovem prostem pretoku v Evropski uniji.
The Directive contains, in Annex II, part III, point 8, specific values for nitrosamines and nitrosatable substances.
Direktiva v točki 8 dela III Priloge II vsebuje posebne vrednosti za nitrozamine in nitrozabilne snovi.
These substances shall be prohibited for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances.
Te snovi so prepovedane za uporabo v igračah za otroke, mlajše od 36 mesecev, ali v drugih igračah, namenjenih dajanju v usta, če je migracija snovi enaka ali večja kot 0,05 mg/kg za nitrozamine in 1 mg/kg za nitrozabilne snovi.
Point 13 of part III of Annex II to the Directive contains specific migration limits for several elements, including lead, arsenic, mercury, barium and antimony.
Točka 13 dela III Priloge II k Direktivi vsebuje posebne mejne vrednosti migracije za več prvin, vključno s svincem, arzenom, živim srebrom, barijem in antimonom.
Three different migration limits exist, related to the type of toy material: dry, brittle, power-like or pliable toy material, liquid or sticky toy material and scraped-off toy material.
Obstajajo tri različne mejne vrednosti migracije glede na vrsto materiala za igrače: suh, lomljiv, prahasti ali prožni material za igrače; tekoči ali lepljivi material za igrače ter material, postrgan s površine igrače.
The following limits shall not be exceeded: 13,5, 3,4 and 160 mg/kg for lead, 3,8, 0,9 and 47 mg/kg for arsenic, 7,5, 1,9 and 94 mg/kg for mercury, 4500, 1125 and 56000 mg/kg for barium, and 45, 11,3 and 560 mg/kg for antimony.
Naslednje mejne vrednosti ne smejo biti presežene: 13,5, 3,4 in 160 mg/kg za svinec; 3,8, 0,9 in 47 mg/kg za arzen; 7,5, 1,9 in 94 mg/kg za živo srebro; 4500, 1125 in 56000 mg/kg za barij ter 45, 11,3 in 560 mg/kg za antimon.
The German national provisions
Nemške nacionalne določbe
The German Consumer Goods Ordinance (Bedarfsgegenständeverordnung) sets requirements for nitrosamines and nitrosatable substances.
Nemška odredba o potrošniškem blagu (Bedarfsgegenständeverordnung) določa zahteve za nitrozamine in nitrozabilne snovi.
These provisions were adopted in 2008, in the context of the absence of specific EU provisions on nitrosamines and nitrosatable substances in toys.
Te določbe so bile sprejete leta 2008, ko ni bilo posebnih določb EU o nitrozaminih in nitrozabilnih snoveh v igračah.
The Consumer Goods Ordinance (Bedarfsgegenständeverordnung) requires that for nitrosamines and nitrosatable substances in toys made of natural or synthetic rubber designed for children under 36 months and intended or likely to be placed in the mouth, the amount released as a result of migration must be so small as not to be laboratory detectable.
Odredba o potrošniškem blagu (Bedarfsgegenständeverordnung) določa, da mora biti pri nitrozaminih in nitrozabilnih snoveh v igračah iz naravnega ali sintetičnega kavčuka za otroke, mlajše od 36 mesecev, ki so namenjene dajanju v usta ali pri katerih je verjetno, da jih bodo otroci dali v usta, sproščena količina pri migraciji snovi tako majhna, da je ni mogoče laboratorijsko zaznati.
The abovementioned Ordinance currently requires the migration of nitrosamines and nitrosatable substances to be below 0,01 mg/kg for nitrosamines and below 0,1 mg/kg for nitrosatable substances.
V skladu z navedeno odredbo je mejna vrednost migracije 0,01 mg/kg za nitrozamine in 0,1 mg/kg za nitrozabilne snovi.
The detailed provisions on nitrosamines and nitrosatable substances are laid down in Annex 4, point 1.b, and Annex 10, point 6, of the Consumer Goods Ordinance (Bedarfsgegenständeverordnung), published on 23 December 1997, and most recently amended by the Ordinance of 6 March 2007.
Podrobne določbe o nitrozaminih in nitrozabilnih snoveh so v točki 1.b Priloge 4 in točki 6 Priloge 10 k Odredbi o potrošniškem blagu (Bedarfsgegenständeverordnung), objavljeni 23. decembra 1997, kakor je bila nazadnje spremenjena z Odredbo z dne 6. marca 2007.
The Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV) concerns in particular the following elements: lead, arsenic, mercury, barium and antimony.
Druga odredba k Zakonu o varnosti naprav in izdelkov (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV) obravnava zlasti naslednje prvine: svinec, arzen, živo srebro, barij in antimon.
The limit values for the abovementioned elements contained in the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV) are those laid down in Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys [2].
Mejne vrednosti za navedene prvine iz Druge odredbe k Zakonu o varnosti naprav in izdelkov (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV) so mejne vrednosti iz Direktive Sveta 88/378/EGS z dne 3. maja 1988 o približevanju zakonodaje držav članic v zvezi z varnostjo igrač [2].
These limits have been applicable in the EU since 1990.
Te mejne vrednosti se v EU uporabljajo od leta 1990.
The maximum daily bioavailability is 0,7 μg for lead, 0,1 μg for arsenic, 0,5 μg for mercury, 25 μg for barium, and 0,2 μg for antimony.
Največja dnevna biološka dostopnost znaša 0,7 μg za svinec, 0,1 μg za arzen, 0,5 μg za živo srebro, 25 μg za barij in 0,2 μg za antimon.
The detailed provisions on the abovementioned elements are laid down in § 2 of the Second Equipment and Product Safety Act Ordinance (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV), most recently amended by the Ordinance of 6 March 2007.
Podrobne določbe o navedenih prvinah so v § 2 Druge odredbe k Zakonu o varnosti naprav in izdelkov (Verordnung über die Sicherheit von Spielzeug – 2. GPSGV), kakor je bila nazadnje spremenjena z Odredbo z dne 6. marca 2007.
At the time of adoption of the Directive (May 2009) Germany voted against its adoption for reasons including its view that the level of protection as regards the chemical requirements is inadequate.
Ob sprejetju Direktive (maja 2009) je Nemčija glasovala proti sprejetju, kot razlog pa je med drugim navedla, da raven zaščite v zvezi z zahtevami o kemičnih snoveh ni ustrezna.
With a first letter of its Federal Ministry of Economic Affairs and Technology, received on 20 January 2011, the German Federal Government requested the Commission, pursuant to Article 114(4) TFEU, the permission to retain the existing provisions provided in German law for the five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances released from toy material, beyond the date of entry into force of Annex II, Part III of the Directive.
Nemška zvezna vlada je s prvim dopisom zveznega ministrstva za gospodarstvo in tehnologijo 20. januarja 2011 v skladu s členom 114(4) PDEU pri Komisijo vložila vlogo za ohranitev obstoječih določb iz nemške zakonodaje o petih prvinah, in sicer svincu, arzenu, živem srebru, bariju in antimonu, ter o nitrozaminih in nitrozabilnih snoveh, ki se sproščajo iz materialov za igrače, še po začetku veljavnosti dela III Priloge II k Direktivi.
The Commission confirmed receipt of the request with letters dated 24 February and 14 March 2011 and set the deadline for her reaction to 5 September 2011 in accordance with Article 114(6) TFEU.
Komisija je z dopisoma 24. februarja 2011 in 14. marca 2011 potrdila prejem vloge ter v skladu s členom 114(6) PDEU kot rok za odgovor določila 5. september 2011.
By letter of 24 June 2011 the Commission informed the other Member States of the notification received from the German Federal Government.
Z dopisom z dne 24. junija 2011 je Komisija druge države članice obvestila o uradnem obvestilu, ki ga je prejela od nemške zvezne vlade.
The Commission also published a notice regarding the notification in the Official Journal of the European Union [3] in order to inform other interested parties of the national provisions the German Federal Government intends to maintain as well as the grounds invoked to that effect.
Komisija je o uradnem obvestilu objavila tudi obvestilo v Uradnem listu Evropske unije [3], da bi druge zainteresirane strani obvestila o nacionalnih določbah, ki jih namerava nemška zvezna vlada ohraniti, in razlogih za njihovo ohranitev.
Article 114(4) concerns cases in which national provisions are notified in relation to an EU harmonisation measure, where the former were adopted and entered into force before the adoption of the latter and where the maintenance of the national provisions would be incompatible with the EU harmonisation measure.
Člen 114(4) zadeva primere, ko država članica v zvezi z usklajevalnim ukrepom EU obvesti Komisijo o nacionalnih določbah, ki so bile sprejete in začele veljati pred sprejetjem usklajevalnega ukrepa EU ter katerih ohranitev bi bila nezdružljiva z usklajevalnim ukrepom EU.
The national provisions were notified in relation to Directive 2009/48/EC, a harmonisation measure adopted on the basis of Article 95 of the former EC Treaty.
Uradno obvestilo o nacionalnih določbah se je nanašalo na Direktivo 2009/48/ES, tj. na usklajevalni ukrep, sprejet na podlagi člena 95 nekdanje Pogodbe ES.
They were adopted and entered into force in 1990 and 2008, therefore before the adoption of that Directive.
Nacionalne določbe so bili sprejete in začele veljati leta 1990 in leta 2008, torej pred sprejetjem navedene direktive.
Furthermore, Article 114(4) requires that the notification of the national provisions be accompanied by a description of the grounds relating to one or more of the major needs referred to in Article 36 or to the protection of the environment or the working environment.
Poleg tega člen 114(4) zahteva, da mora uradno obvestilo o nacionalnih določbah vsebovati opis razlogov, ki zadevajo eno ali več pomembnih potreb iz člena 36 ali varstvo okolja ali delovnega okolja.
The application submitted by Germany contains an explanation of the reasons relating to the protection of the human health which, in the opinion of Germany, justify the maintenance of its national provisions.
V vlogi, ki jo je vložila Nemčija, so pojasnjeni razlogi, ki zadevajo varovanje zdravja ljudi, ki po mnenju Nemčije upravičuje ohranitev nacionalnih določb.
In the light of the foregoing, the Commission considers that the application submitted by Germany with a view to obtaining authorisation to maintain its national provisions on the five elements: lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances, is admissible.
Glede na navedeno Komisija meni, da je vloga Nemčije za pridobitev dovoljenja za ohranitev nacionalnih določb o petih prvinah, in sicer svincu, arzenu, živem srebru, bariju in antimonu, ter o nitrozaminih in nitrozabilnih snoveh dopustna.
Recourse to Article 114(6), third subparagraph TFEU
Sklicevanje na tretji pododstavek člena 114(6) PDEU
After a careful examination of all data and information, the Commission considers that the conditions laid down in Article 114(6), third subparagraph, are met in order for it to have recourse to the possibility of extending the 6-month period within which it has to approve or reject the national provisions notified by Germany.
Komisija po temeljiti preučitvi vseh podatkov in informacij meni, da so izpolnjeni pogoji iz tretjega pododstavka člena 114(6) in se lahko uporabi možnost podaljšanja šestmesečnega roka, v katerem mora odobriti ali zavrniti nacionalne določbe iz uradnega obvestila Nemčije.
The German Federal Government provided several annexes containing detailed justification and scientific information in support of the notified national measures.
Nemška zvezna vlada je predložila številne priloge, ki vsebujejo podrobno utemeljitev in znanstvene informacije v podporo nacionalnim ukrepom iz obvestila.
In particular, health assessment from the BfR on lead, antimony, barium, arsenic and mercury, as well as on nitrosamines and nitrosatable substances, dating from January 2011, was provided.
Zlasti je bila predložena ocena tveganja za zdravje iz januarja 2011, ki jo je pripravil BfR za svinec, antimon, barij, arzen in živo srebro ter za nitrozamine in nitrozabilne snovi.
The information received from the BfR contains detailed and complex toxicological data on the abovementioned substances, as well as extended references to scientific reports and literature.
Informacije BfR vsebujejo podrobne in kompleksne toksikološke podatke o navedenih snoveh ter obširno sklicevanje na znanstvena poročila in literaturo.
It is necessary, in order to proceed to a Commission decision pursuant to Article 114(6) TFEU, to verify if the information provided by Germany was already assessed and considered during the Directive’s revision process, or if it is to be considered as new scientific information.
Za sprejetje sklepa Komisije v skladu s členom 114(6) PDEU je treba preveriti, ali so bile informacije, ki jih je predložila Nemčija, že ocenjene in obravnavane pri pregledu Direktive ali pa jih je treba obravnavati kot nove znanstvene informacije.
The directive foresees, in Article 46, the possibility to amend certain chemical-related provisions in order to ensure alignment on technical and scientific developments.
Direktiva v členu 46 zaradi prilagajanja tehničnemu in znanstvenemu razvoju predvideva možnost sprememb nekaterih določb v zvezi s kemičnimi snovmi.
The five elements concerned by Germany’s request (lead, arsenic, barium, mercury and antimony) can therefore be amended and aligned on the latest scientific information.
Zato se lahko določbe o petih prvinah iz vloge Nemčije (svinec, arzen, barij, živo srebro in antimon) spremenijo in uskladijo z najnovejšimi znanstvenimi informacijami.
The Commission set up, in 2010, a working group on chemical substances in toys (hereinafter ‘the working group’), at the request of Member States.
Komisija je leta 2010 na zahtevo držav članic ustanovila delovno skupino o kemičnih snoveh v igračah (v nadaljnjem besedilu: delovna skupina).
This working group, made up of chemical experts from the Czech Republic, Denmark, Germany, France, Italy, the Netherlands, Austria, Sweden and Industry and Consumer organisations evaluates new scientific information and gives recommendations to Member States and the Commission on how to proceed with the amendment of certain chemical provisions contained in the Directive.
Ta delovna skupina, v kateri sodelujejo strokovnjaki za kemijo iz Nemčije, Danske, Italije, Francije, Švedske, Avstrije, Nizozemske, Češke ter industrijskih združenj in potrošniških organizacij, presoja nove znanstvene informacije ter za države članice in Komisijo pripravlja priporočila glede sprememb nekaterih določb o kemičnih snoveh iz Direktive.
The Commission will seek the opinion of the working group on the detailed justification received from Germany, to determine if it can be considered as new scientific information and therefore used as a basis for amending the chemical provisions of the Directive by setting out stringent requirements.
Komisija bo v zvezi s podrobno utemeljitvijo Nemčije za mnenje prosila delovno skupino, da se ugotovi, ali gre za nove znanstvene informacije, ki se lahko uporabijo kot podlaga za spremembe določb o kemičnih snoveh iz Direktive in za poostritev zahtev.
The next meeting of the working group is foreseen on 31 August 2011.
Naslednje zasedanje delovne skupine bo 31. avgusta 2011.
Furthermore, on 5 April 2011, the working group recommended to Member States experts the amendment of the current values for lead downwards.
Poleg tega je delovna skupina 5. aprila 2011 strokovnjakom držav članic priporočila znižanje veljavnih mejnih vrednosti za svinec.
These recommendations were endorsed by the Commission and experts from Member States.
Komisija in države članice so ta priporočila podprle.
The working group discussed the current limit values for barium, and stated that no new scientific evidence was available; however different assessments by scientific organisations were taken.
Delovna skupina je obravnavala veljavne mejne vrednosti za barij in navedla, da novi znanstveni dokazi niso na voljo, znanstvene organizacije pa so opravile različne ocene.
The working group decided that further discussion is needed.
Delovna skupina je sklenila, da je potrebna nadaljnja razprava.
The working group is expected to finalise its recommendations during the meeting of 31 August 2011, which then will be presented to Member States experts in October 2011.
Pričakuje se, da bo delovna skupina na zasedanju 31. avgusta 2011 dokončala svoja priporočila in jih oktobra 2011 predstavila strokovnjakom držav članic.
The Scientific Committee for Consumer Safety (SCCS) is currently evaluating the seriousness of the risk posed by the presence of nitrosamines and nitrosatable substances in balloons and cosmetic products.
Znanstveni odbor za varstvo potrošnikov trenutno ocenjuje tveganje, ki ga pomenijo nitrozamini in nitrozabilne snovi v balonih in kozmetičnih izdelkih.
This opinion, expected for September 2011, will bring new light on children’s exposure to nitrosamines and nitrosatables substances and on the risk related to this exposure.
To mnenje, pričakovano v septembru 2011, bo prineslo nova spoznanja o izpostavljenosti otrok nitrozaminom in nitrozabilnim snovem ter tveganju zaradi te izpostavljenosti.
The Commission Decision pursuant to Article 114(6), first subparagraph, should therefore await the outcome of the ongoing discussions and evaluations, in order to carefully assess all relevant current or future evidence and draw consequences as regards to the national measures.
Za sklep Komisije v skladu s prvim pododstavkom člena 114(6) je zato treba počakati na izsledke tekočih razprav in ocen, da se skrbno ocenijo vsi zadevni sedanji ali prihodnji dokazi ter sprejmejo sklepi glede nacionalnih ukrepov.
Hence, the Commission considers that it is justified to extend the 6-month period within which it has to approve or reject the national provisions for a further period expiring on 5 March 2012.
Zato Komisija meni, da je šestmesečno obdobje, v katerem mora odobriti ali zavrniti nacionalne določbe, utemeljeno podaljšati za nadaljnje obdobje do 5. marca 2012.
As there are no applicable EU provisions on nitrosamines and nitrosatable substances released from toys, Annex 4, point 1.b, and Annex 10, point 6, of the Consumer Goods Ordinance (Bedarfsgegenständeverordnung) remains as well applicable until 20 July 2013.
Ker o nitrozaminih in nitrozabilnih snoveh, ki se sproščajo iz igrač, ni veljavnih določb EU, se do 20. julija 2013 uporabljata tudi točka 1.b Priloge 4 in točka 6 Priloge 10 iz Odredbe o potrošniškem blagu (Bedarfsgegenständeverordnung).
Therefore, as the national provisions the German Federal Government intends to maintain will not be repealed before 20 July 2013, the Commission concludes that the condition of absence of danger to health is met.
Nacionalne določbe, ki jih namerava ohraniti nemška zvezna vlada, ne bodo razveljavljene pred 20. julijem 2013, saj Komisija meni, da ni nevarnosti za zdravje ljudi.
In the light of the foregoing, the Commission concludes that the application of Germany, completely notified to it on 2 March 2011, with a view of obtaining approval for maintaining the values for lead, arsenic, mercury, barium and antimony, as well as for nitrosamines and nitrosatable substances, for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth, is admissible.
Glede na navedeno je Komisija sklenila, da je vloga Nemčije, v celoti vložena 2. marca 2011 za pridobitev dovoljenja za ohranitev mejnih vrednosti za svinec, arzen, živo srebro, barij in antimon ter nitrozamine in nitrozabilne snovi v igračah za otroke, mlajše od 36 mesecev, ali igračah, namenjenih dajanju v usta, dopustna.
However, in view of the complexity of the matter and of the absence of evidence highlighting a danger for human health, the Commission considers it justified to extend the period referred to in Article 114(6), first subparagraph, for a further period expiring on 5 March 2012,
Vendar Komisija zaradi zahtevnosti zadeve in odsotnosti dokazov o nevarnosti za zdravje ljudi meni, da je utemeljeno podaljšanje roka iz prvega pododstavka člena 114(6), in sicer do 5. marca 2012 –