natgillin/translations-raw huggingface dataset:
BIOCIDAL PRODUCTS
Uredba (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov, (UL L 167, 27.6.2012, str. 1), kakor je bila nazadnje spremenjena z Uredbo (EU) št. 334/2014 Evropskega parlamenta in Sveta z dne 11. marca 2014 (UL L 103, 5.4.2014, str. 22) ter z izvedbenimi in delegiranimi akti Komisije, sprejetimi v okviru te uredbe do 10.
SCOPE AND COVERAGE
10.
The provisions of this Sectoral Chapter apply to active substances, biocidal products, biocidal product families, and treated articles, as defined in Article 3 of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (“the Biocidal Products Regulation”, hereinafter referred to as “BPR”), subject to the procedures of the BPR and equivalent Swiss provisions, with the exemption of:
Zvezni zakon z dne 15. decembra 2000 o zaščiti pred nevarnimi snovmi in pripravki (RO 2004 4763), kakor je bil nazadnje spremenjen 13. junija 2006 (RO 2006 2197)
biocidal products which are or which contain genetically modified micro-organisms, and
Zvezni zakon z dne 7. oktobra 1983 o varstvu okolja (RO 1984 1122), kakor je bil nazadnje spremenjen 1. avgusta 2010 (RO 2010 3233)
avicides, piscicides and biocides for control of other vertebrates.
Odlok z dne 18. maja 2005 o dostopnosti na trgu in uporabi biocidnih proizvodov (odlok o biocidnih proizvodih, RO 2005 2821), kakor je bil nazadnje spremenjen 15.
Commission implementing acts pursuant to Article 9, 14(4) and 15(1) of the BPR regarding the approval of active substances, and delegated acts pursuant to Article 28(1) and 28(3) of the BPR, regarding the inclusion of active substances into Annex I of the BPR, are part of this Chapter.
7.
Switzerland is free to limit access to its market according to the requirements of its legislation existing at the date of entry into force of this Chapter concerning:
2014 (RO 2014 2073) (v nadaljnjem besedilu: odlok o biocidnih proizvodih)
biocidal products containing octylphenol or its ethoxylates, and
Odlok z dne 15. avgusta 2014 Ministrstva za notranje zadeve o izvedbenih pravilih v zvezi z odlokom o biocidnih proizvodih (RO 2014 2755)
aerosol dispensers containing substances stable in the air.
Za namene tega poglavja so ‚Organi za ugotavljanje skladnosti‘ organi Evropske unije ter pristojni organi držav članic EU in Švice, ki so pristojni za izvajanje zakonodaje v oddelku I.
Provisions covered by Article 1(2)
Kontaktni podatki pristojnih organov pogodbenic so na voljo na spodaj navedenih spletnih straneh.
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR) (OJ L 167, 27.6.2012, p. 1), as last amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 (OJ L 103, 5.4.2014, p. 22), as well as implementing and delegated acts of the Commission adopted under this regulation until 10.10.2014.
Biocidi:
Federal Law of 15 December 2000 for the protection against dangerous substances and preparations (RO 2004 4763), as last amended on 13 June 2006 (RO 2006 2197)
‚Pristojni organi in druge kontaktne točke‘
Federal Law of 7 October 1983 relating to the protection of the Environment (RO 1984 1122), as last amended on 1 August 2010 (RO 2010 3233)
Zvezni urad za javno zdravje, organ za prijavo kemikalij: www.bag.admin.ch/biocide
Ordinance of 18 May 2005 concerning the making available on the market and the use of biocidal products (Ordinance on Biocidal Products, RO 2005 2821), as last amended on 15.7.2014 (RO 2014 2073) (hereinafter “OPBio”)
Brez poseganja v člen 12(2) tega sporazuma Evropska unija nemudoma in po objavi v Uradnem listu Evropske unije obvesti Švico o izvedbenih in delegiranih aktih Komisije, sprejetih po 10. oktobru 2014, v skladu z Uredbo (EU) št. 528/2012.
Ordinance of 15 August 2014 of the Department of Home Affairs on implementing rules related to the Ordinance on Biocidal Products (RO 2014 2755).
Postopki iz uredbe o biocidnih proizvodih in njenih izvedbenih aktov, ki veljajo med pogodbenicama
For the purposes of this Chapter, “Conformity Assessment Bodies” means the authorities of the European Union and competent authorities of EU Member States and of Switzerland responsible for the application of the legislation in Section I.
Za namene tega poglavja se spodaj navedeni postopki iz uredbe o biocidnih proizvodih ter njenih delegiranih in izvedbenih aktov, kot je navedeno v oddelku I, uporabljajo kot skupni postopki za dopolnitev določb, ki se štejejo za enakovredne.
The contact details of the competent authorities of the Parties can be found on the websites indicated below.
V tem odstavku se sklicevanje na ‚državo članico oziroma države članice‘ ali njihove pristojne organe v členih uredbe o biocidnih proizvodih, ki ‚se uporablja med pogodbenicama‘, razume tako, da poleg svojega pomena iz Uredbe vključuje Švico.
Biocides:
Za namene tega poglavja velja:
“Competent Authorities and other Contact Points”
‚imetnik dovoljenja‘ in osebe iz člena 95 uredbe o biocidnih proizvodih imajo lahko sedež v Evropski uniji ali Švici,
Federal Office of Public Health, Notification Authority for Chemicals: www.bag.admin.ch/biocide
vlagatelji uporabljajo register biocidnih proizvodov (v nadaljnjem besedilu: register) za oddajo vlog in podatkov za vse postopke, kot je določeno v členu 71(3) uredbe o biocidnih proizvodih.
Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Regulation (EU) No 528/2012 adopted after 10 October 2014 without delay after their publication in the Official Journal of the European Union.
Vlagateljem ni treba imeti sedeža v Evropski uniji ali Švici.
Procedures of the BPR and its implementing acts that apply between the Parties
Med pogodbenicama se uporabljajo postopki iz uredbe o biocidnih proizvodih ter izvedbenih in delegiranih aktov, navedeni spodaj:
For the purpose of this Chapter, the subsequently specified procedures of the BPR and of its delegated and implementing acts as referred to in Section I apply as common procedures to complement provisions deemed equivalent.
poglavji II in III ter Delegirana uredba Komisije (EU) št. 1062/2014 v zvezi z odobritvijo aktivnih snovi.
In this Paragraph, a reference to “Member State(s)” or their competent authorities in articles of the BPR that “shall apply between the Parties” shall be understood to include, in addition to its meaning in the Regulation, Switzerland.
Vlagatelji lahko predlagajo pristojni švicarski organ za ocenjevalni pristojni organ,
For the purposes of this Chapter,
člen 27 o biocidnih proizvodih, za katere je bilo dovoljenje izdano v skladu s poenostavljenim postopkom za izdajo dovoljenja,
“Authorisation holders” and persons referred to in Article 95 of the BPR may be established within the European Union or Switzerland.
členi 32–34 in Delegirana uredba Komisije (EU) št. 492/2014 o medsebojnem priznavanju dovoljenj in njihovih podaljšanjih,
Applicants shall use the Register for Biocidal Products (hereinafter “Register”) to submit applications and data for all procedures as foreseen in Article 71(3) of the BPR.
členi 35–37 o ugovorih in odstopanjih,
Applicants do not need to be established within the European Union or Switzerland.
členi 43–46 o dovoljenjih Unije z naslednjimi prilagoditvami: kadar Komisija izda dovoljenje Unije za biocidni proizvod, ga podaljša ali spremeni, odloči, da dovoljenja Unije ne bo izdala, prekliče ali zavrne podaljšanje dovoljenja Unije, Švica ne glede na pravna sredstva sprejme odločitev v 30 dneh v skladu s členom 14a odloka o biocidnih proizvodih o izdaji, podaljšanju, preklicu ali spremembi dovoljenja za navedeni proizvod,
The procedures of the BPR and the implementing and delegated acts listed below shall apply between the Parties:
členi 47–50 in Izvedbena uredba Komisije (EU) št. 354/2013 o sporočanju neželenih učinkov in pravilih o preklicu ali spremembah,
Chapters II and III and Commission Delegated Regulation (EU) No 1062/2014, as regards the approval of active substances.
člen 53 o vzporednem trgovanju,
Applicants may propose the Swiss Competent authority as the evaluating competent authority.
člen 54 o ugotovitvi tehnične ekvivalence aktivnih snovi,
Article 27 as regards biocidal products authorised according to the simplified procedure.
člena 62 in 63 o souporabi podatkov.
Articles 32-34 and Commission Delegated Regulation (EU) No 492/2014 as regards mutual recognition of authorisations and their renewals.
Če je bil zahtevek predložen pristojnemu švicarskemu organu, se vlagatelj preusmeri na Agencijo, njegova zahteva pa se vnese v register,
Articles 35-37 on objections and derogations.
člen 69(2) o imenu in naslovu imetnika registracije ter številki dovoljenja, ki mora biti na oznaki,
Articles 43-46 on Union authorisations, with the following adaptations: when the Commission grants a biocidal product a Union authorisation or renews, amends, decides not to grant the Union authorisation, cancels, or refuses to renew the Union authorisation, Switzerland shall, notwithstanding legal recourse, take a decision within 30 days in accordance with Article 14a OPBio on granting, renewing, cancelling or amending an authorisation for that product.
člen 88 o ukrepih, sprejetih na podlagi novih dokazov,
Articles 47-50 and Commission Implementing Regulation (EU) No 354/2013 as regards the notification of adverse effects and rules on cancellation or amendments.
člen 95 (kot v Uredbi (EU) št. 334/2014) s prehodnim obdobjem iz člena 95(2) do 1. septembra 2016 za dostopnost proizvoda na švicarskem trgu.
Article 53 on parallel trade.
Če Švica namerava odstopati od odločitve, sprejete v skladu s členoma 36(3) in 37(2), v primeru dovoljenj Unije v skladu s členi 44(5), 46(4) in (5) ter členi 47–50, ali odločitev v skladu s členom 88 uredbe o biocidnih proizvodih ali prilagoditi določene pogoje za svoje ozemlje v skladu s členom 12(2) odloka o biocidnih proizvodih, lahko sprejme ustrezne ukrepe ter nemudoma obvesti Komisijo in navede razloge.
Article 54 as regards the establishment of technical equivalence of active substances.
Po potrebi se zadeva pošlje Skupnemu odboru, ki odloči o ustreznih ukrepih.
Articles 62-63 on data sharing.
Izmenjava informacij
In case a request has been submitted to the Swiss competent authority, the applicant shall be re-directed to the Agency and enter its request into the Register.
V skladu s členom 9 tega sporazuma si pogodbenici zlasti izmenjujeta informacije, potrebne za uskladitev postopkov iz tega poglavja, kot je določeno v členu 71 uredbe o biocidnih proizvodih.
Article 69(2) as regards the name and address of the authorisation holder and the authorisation number to be provided on labels.
V skladu s členom 29(4) uredbe o biocidnih proizvodih, razen v primerih, ko se uporablja Izvedbena uredba Komisije (EU) št. 414/2013, Švica zavrne ocenjevanje vloge, če drugi pristojni organ preučuje vlogo za isti biocidni proizvod ali je zanj že izdal dovoljenje.
Article 88 as regards measures taken on the basis of new evidence.
Pogodbenici se strinjata, da lahko pristojni organi o dovoljenju in drugih odločitvah, povezanih z vlogo iz tega poglavja, obvestijo neposredno vlagatelja na ozemlju druge pogodbenice.
Article 95 (as in Regulation (EU) No 334/2014), with the transitional period in Article 95(2) up to 1 September 2016 for making the product available on the market of Switzerland.
Pristojni organi pogodbenic zaščitijo in obravnavajo informacije v skladu s členi 59, 64, 66 in 67 uredbe o biocidnih proizvodih.
If Switzerland intends to deviate from a decision taken pursuant to articles 36(3), 37(2), in the case of Union authorisations pursuant to articles 44(5), 46(4-5), 47-50, or decisions pursuant to article 88 of the BPR, or to adjust certain conditions specifically for its territory pursuant to article 12(2) OPBio, it may take appropriate measures and shall immediately inform the Commission, giving its reasons.
Finančni prispevek za storitve, ki jih zagotavlja Evropska agencija za kemikalije (ECHA)
Where relevant, the case will be forwarded to the Joint Committee, which will decide on an appropriate course of action.
Švica prispeva k odhodkom Agencije za dejavnosti iz tega poglavja z letnim finančnim prispevkom, ki se doda k subvenciji EU iz člena 78(1) uredbe o biocidnih proizvodih.
Information exchange
Ta letni finančni prispevek bo izračunan na podlagi njenega bruto domačega proizvoda (BDP) kot odstotka BDP vseh sodelujočih držav v skladu s formulo, opisano v Dodatku 1.
In accordance with Article 9 of this Agreement, the Parties shall in particular exchange the information needed to coordinate the procedures under this Chapter as foreseen in Article 71 of the BPR.
Letni prispevek bo plačan Agenciji na podlagi obvestila o dolgovanem znesku, ki ga izda ECHA.
Pursuant to Article 29(4) of the BPR, except in cases where Commission Implementing Regulation (EU) No 414/2013 applies, Switzerland shall decline the evaluation of the application if another competent authority is examining an application relating to the same biocidal product or has already authorised it.
Finančni prispevek iz pododstavka (a) se zaračuna od dneva po začetku veljavnosti tega sklepa.
The Parties agree that authorisations and other decisions relating to the application of this Chapter may be notified by the competent authorities directly to the applicant in the territory of the other Party.
Prvi finančni prispevek se sorazmerno zmanjša glede na preostali čas do konca leta po začetku njegove veljavnosti.
Information shall be protected and treated by the competent authorities of the Parties in accordance with Articles 59, 64, 66, 67 of the BPR.
Dodatek 1
Financial contribution for services provided by the European Chemical Agency (ECHA)
Finančni prispevek Švice za storitve, ki jih zagotavlja Evropska agencija za kemikalije (ECHA)
Switzerland shall contribute to the Agency expenditure for activities mentioned in this chapter by an annual financial contribution to be added to the EU subsidy mentioned in Article 78(1) of the BPR.
Letni finančni prispevek Švice k subvenciji iz člena 78 uredbe o biocidnih proizvodih se izračuna na naslednji način: zadnja posodobljena končna vrednost bruto domačega proizvoda (BDP) Švice, ki je na voljo 31. marca vsako leto, se deli z vsoto za isto leto razpoložljivih vrednosti BDP vseh držav, ki sodelujejo pri takšnih dejavnostih.
This annual financial contribution will be calculated in accordance with its Gross Domestic Product (GDP) as a percentage of the GDP of all participating States in accordance with the formula described in Appendix 1.
Dobljeni odstotek bo dodan k subvenciji Unije iz točke (a) člena 78(1) uredbe o biocidnih proizvodih za izračun zneska finančnega prispevka Švice.
The annual contribution will be paid to the Agency based on a debit note issued by ECHA.
Finančni prispevek se plača v eurih.
The financial contribution referred to in Subparagraph (a) shall be incurred as from the day following the entry into force of this Decision.
Švica plača svoj finančni prispevek najpozneje v 45 dneh po prejemu obvestila o dolgovanem znesku.
The first financial contribution shall be reduced proportionally to the remaining time in year after its entry into force.
Za vsakršno zamudo pri plačilu Švica plača zamudne obresti na neplačani znesek od roka plačila.
Appendix 1
Obrestna mera je mera, ki jo uporablja Evropska centralna banka pri svojih glavnih operacijah refinanciranja, kot je objavljena v seriji C Uradnega lista Evropske unije, veljavna na prvi koledarski dan meseca roka za plačilo, povečana za 1,5 odstotne točke.
Financial contribution of Switzerland for services provided by the European Chemical Agency (ECHA)
Finančni prispevek Švice se prilagodi, če se subvencija Evropske unije, vključena v splošni proračun Evropske unije, kot je določeno v členu 78(1)(a) uredbe o biocidnih proizvodih, poveča v skladu s členi 26, 27 ali 41 Uredbe (EU, Euratom) št. 966/2012 Evropskega parlamenta in Sveta z dne 25. oktobra 2012 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije, in razveljavitvi Uredbe Sveta (ES, Euratom) št. 1605/2002.
The annual financial contribution of Switzerland to the subsidy mentioned in Article 78 of the BPR is calculated in the following way: The most updated final figures of the Gross Domestic Product (GDP) of Switzerland available on 31 March of each year shall be divided by the sum of the GDP figures of all the States participating in such activities, available for the same year.
V tem primeru se razlika izplača v 45 dneh po prejemu obvestila o dolgovanem znesku.
The obtained percentage will be applied to the subsidy from the Union referred to in Article 78(1)(a) of the BPR to obtain the amount of the financial contribution of Switzerland.
V primeru, da se subvencija, ki jo prejme ECHA v skladu s členom 78(1)(a) uredbe o biocidnih proizvodih za leto N, ne porabi do 31. decembra leta N ali da se proračun ECHA za leto N zmanjša v skladu s členi 26, 27 ali 41 Uredbe (EU, Euratom) št. 966/2012, se del teh neporabljenih ali zmanjšanih odobritev plačil, ki ustrezajo odstotku prispevka Švice, prenese v proračun Agencije za leto N+1.
The financial contribution shall be paid in Euro.
Prispevek Švice k subvenciji Agencije za leto N+1 se ustrezno zniža.
Switzerland shall pay its financial contribution no later than 45 days after receiving the debit note.
Za zagotovitev učinkovite uporabe in izvajanja poglavja o biocidnih proizvodih iz Priloge 1 k Sporazumu in pod pogojem, da je Švica sprejela ustrezni pravni red Unije ali enakovredne ukrepe v skladu s poglavjem o biocidnih proizvodih, se bo Komisija v skladu z izjavo Sveta o sodelovanju Švice v odborih [1] in členom 100 Sporazuma o Evropskem gospodarskem prostoru posvetovala s švicarskimi strokovnjaki v fazah pripravljanja osnutka ukrepov, ki se nato predložijo odboru, ustanovljenem v skladu s členom 82 Uredbe (EU) št. 528/2012, za pomoč Komisiji pri izvajanju njenih izvedbenih pooblastil.Komisija je seznanjena tudi s tem, da lahko predsednik Odbora, ustanovljenega v skladu s členom 82 Uredbe (EU) št. 528/2012, na zahtevo člana Odbora ali na lastno pobudo povabi švicarske strokovnjake k sodelovanju v razpravi o posebnih zadevah, zlasti tistih, ki se nanašajo neposredno na Švico.
Any delay in payment shall give rise to the payment of default interest by Switzerland on the outstanding amount from the due date.
Poleg tega je Komisija seznanjena, da so švicarski strokovnjaki vabljeni k sodelovanju v skupini pristojnih organov za izvajanje uredbe o biocidnih proizvodih, ki Komisiji pomaga pri usklajenem izvajanju Uredbe (EU) št. 528/2012, in po potrebi v Odboru iz člena 75 Uredbe (EU) št. 528/2012 ter v koordinacijski skupini iz člena 35 Uredbe (EU) št. 528/2012, in sicer pri zadevah v zvezi s poglavjem o biocidnih proizvodih.
The interest rate shall be the rate applied by the European Central Bank to its principal refinancing operations, as published in the C series of the Official Journal of the European Union, in force on the first calendar day of the month in which the deadline falls, increased by 1,5 percentage points.
DODATEK C
Switzerland's financial contribution shall be adapted in case the subsidy from the European Union entered in the general budget of the European Union as defined in Article 78(1)(a) BPR is increased pursuant to Articles 26, 27 or 41 of the Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002.
Spremembe Priloge 1
In this case, the difference shall be due 45 days after receiving the debit note.
Poglavje 14 (Dobra laboratorijska praksa (DLP))
In the event that the subsidy received by ECHA according to Article 78(1)(a) BPR related to a year N is not spent before 31 December of year N or that the ECHA budget of the year N has been lowered according to Articles 26, 27 or 41 of the Regulation (EU, Euratom) No 966/2012, the part of these unspent or lowered payment credits corresponding to the percentage of the contribution made by Switzerland is transferred to the budget of year N+1 of the agency.
Oddelek I (Zakonski in drugi predpisi) bi bilo treba črtati in nadomestiti z naslednjim:
Switzerland's contribution to the Agency subsidy of year N+1 will be reduced accordingly.
„ODDELEK I
In order to ensure the effective application and implementation of the Chapter on Biocidal products in Annex 1 to the Agreement and in so far as Switzerland has adopted the relevant EU acquis or equivalent measures under the Chapter on Biocidal products, the Commission will, in accordance with the Council Declaration on Swiss attendance of committees [1] and Article 100 of the Agreement on the European Economic Area, consult Swiss experts in the preparatory stages of draft measures to be submitted subsequently to the Committee established by Article 82 of Regulation (EU) No 528/2012 to assist the Commission in the exercise of its executive powers.The Commission also notes that the Chairman of the Committee established pursuant to Article 82 of Regulation (EU) No 528/2012 may decide to invite Swiss experts to talk on particular matters, at the request of a member or on his or her own initiative, in particular in those matters of direct relevance to Switzerland.
V zvezi s preskušanjem kemikalij v skladu z DLP se uporabljajo ustrezni deli spodaj navedenih zakonskih in drugih predpisov.
In addition, the Commission notes that Swiss experts are invited to participate in the group of Competent Authorities for the implementation of the Biocidal Products Regulation, which provides assistance to the Commission with the harmonised implementation of Regulation (EU) No 528/2012 and, as appropriate, in the Committee referred to in Article 75 of Regulation (EU) No 528/2012 and in the Coordination Group referred to in Article 35 of Regulation (EU) No 528/2012, for the matters relevant to the Chapter on biocidal products.
Hrana in krma
ATTACHMENT C
Uredba Komisije (ES) št. 429/2008 z dne 25. aprila 2008 o podrobnih pravilih za izvajanje Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 v zvezi s pripravo in predložitvijo vlog ter oceno krmnih dodatkov in izdajo dovoljenj zanje (UL L 133, 22.5.2008, str. 1).
Amendments to Annex 1
Uredba Komisije (EU) št. 234/2011 z dne 10. marca 2011 o izvajanju Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila (UL L 64, 11.3.2011, str. 15), kakor je bila nazadnje spremenjena z Izvedbeno uredbo Komisije (EU) št. 562/2012 (UL L 168, 28.6.2012, str. 21).
Chapter 14 (Good laboratory practice (GLP))
Izvedbena uredba Komisije (EU) št. 503/2013 z dne 3. aprila 2013 o vlogah za odobritev gensko spremenjenih živil in krme v skladu z Uredbo (ES) št. 1829/2003 Evropskega parlamenta in Sveta in o spremembi uredb Komisije (ES) št. 641/2004 in (ES) št. 1981/2006 (UL L 157, 8.6.2013, str. 1).
In Section I, Legislative, regulatory and administrative provisions, should be deleted and replaced by the following:
Nove in obstoječe kemikalije
‘SECTION I
Direktiva Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi, kakor je bila spremenjena z Direktivo Sveta 92/32/EGS z dne 30. aprila 1992 (UL L 154, 5.6.1992, str. 1).