natgillin/translations-raw huggingface dataset:
The Committee shall be kept informed and, where necessary, shall hold appropriate consultations with a view to reaching a settlement.’
O tem obvestijo Odbor, ki po potrebi pripravi ustrezna posvetovanja z namenom, da se spor reši.“
In Annex 1, Product Sectors, the following Chapter 18 on Biocidal products shall be introduced:
V Prilogi 1 „Proizvodni sektorji“ se doda naslednje poglavje 18 o biocidnih pripravkih:
‘CHAPTER 18
„POGLAVJE 18
BIOCIDAL PRODUCTS
BIOCIDNI PRIPRAVKI
SCOPE AND COVERAGE
PODROČJE UPORABE IN VELJAVNOST
The provisions of this Sectoral Chapter apply to biocidal products as defined in Directive 98/8/EC, with the exemption of:
Določbe tega poglavja se uporabljajo za biocidne pripravke, kot so opredeljeni v Direktivi 98/8/ES, razen:
biocidal products which are or which contain genetically modified or pathogenic micro-organisms, and
biocidnih pripravkov, ki so gensko spremenjeni mikroorganizmi ali patogeni mikroorganizmi ali jih vsebujejo, in
avicides, piscicides and biocides for control of other vertebrates.
avicidov, piskicidov in biocidov za nadzor drugih vretenčarjev.
Commission Directives to include active substances to the Annex I, IA or IB are part of this Chapter.
Direktive Komisije, ki vključujejo aktivne snovi v prilogah I, IA ali IB, so del tega poglavja.
Switzerland will be 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:
Švica lahko omeji dostop do svojega trga glede na zahteve svoje zakonodaje, obstoječe na dan začetka veljavnosti tega poglavja, za:
biocidal products containing octylphenol or its ethoxylates, and
biocidne pripravke, ki vsebujejo oktilfenol ali njegove etoksilate, in
aerosol dispensers containing substances stable in the air.
aerosolne razpršilnike, ki vsebujejo snovi, stabilne v zraku.
The Parties shall jointly review the situation in 2013.
Pogodbenici skupaj preučita stanje leta 2013.
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1), as last amended by Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 (OJ L 262, 6.10.2009, p. 40), hereinafter referred to as “Directive 98/8/EC”
Direktiva 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet (UL L 123, 24.4.1998, str. 1), kakor je bila nazadnje spremenjena z Direktivo 2009/107/ES Evropskega parlamenta in Sveta z dne 16. septembra 2009 (UL L 262, 6.10.2009, str. 40) (v nadaljnjem besedilu: Direktiva 98/8/ES).
Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products (OJ L 228, 8.9.2000, p. 6)
Uredba Komisije (ES) št. 1896/2000 z dne 7. septembra 2000 o prvi fazi programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta o biocidnih pripravkih (UL L 228, 8.9.2000, str. 6).
Commission Regulation (EC) No 1687/2002 of 25 September 2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000 (OJ L 258, 26.9.2002, p. 15)
Uredba Komisije (ES) št. 1687/2002 z dne 25. septembra 2002 o dodatnem obdobju za prijavo nekaterih aktivnih snovi, ki so že bile v prometu za uporabo v biocidnih pripravkih, skladno s členom 4(1) Uredbe (ES) št. 1896/2000 (UL L 258, 26.9.2002, str. 15).
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3)
Uredba Komisije (ES) št. 1451/2007 z dne 4. decembra 2007 o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta o dajanju biocidnih pripravkov v promet (UL L 325, 11.12.2007, str. 3).
Federal Law of 15 December 2000 for the Protection against Dangerous Substances and Preparations (RO 2004 4763), as last amended on 17 June 2005 (RO 2006 2197)
Zvezni zakon z dne 15. decembra 2000 o zaščiti pred nevarnimi snovmi in pripravki (RO 2004 4763), kakor je bil nazadnje spremenjen dne 17. junija 2005 (RO 2006 2197).
Federal Law of 7 October 1983 relating to the Protection of the Environment (RO 1984 1122), as last amended on 20 March 2008 (RO 2008 3437)
Zvezni zakon z dne 7. oktobra 1983 o varstvu okolja (RO 1984 1122), kakor je bil nazadnje spremenjen dne 20. marca 2008 (RO 2008 3437).
Ordinance of 18 May 2005 concerning the placing on the market and the use of biocidal products (Ordinance on Biocidal Products) (RO 2005 2821), as last amended on 2 November 2009 (RO 2009 5401)
Odlok z dne 18. maja 2005 v zvezi z dajanjem v promet in uporabo biocidnih pripravkov (odlok o biocidnih pripravkih) (RO 2005 2821), kakor je bil nazadnje spremenjen dne 2. novembra 2009 (RO 2009 5401).
For the purposes of this Chapter, “Conformity Assessment Bodies” means the competent authorities of the Member States of the European Union and Switzerland for placing biocidal products on the market.
Za namene tega poglavja izraz ‚organi za ugotavljanje skladnosti‘ pomeni pristojne organe držav članic Evropske unije in Švice za dajanje biocidnih pripravkov v promet.
The contact details of the competent authorities of the Member States and of Switzerland can be found on the websites indicated below.
Kontaktni podatki pristojnih organov držav članic in Švice so na voljo na spodaj navedenih spletnih straneh.
Biocides: “Competent Authorities and other Contact Points” http://ec.europa.eu/environment/biocides/pdf/ca_contact.pdf
Biocidi: ‚Pristojni organi in druge kontaktne točke‘ http://ec.europa.eu/environment/biocides/pdf/ca_contact.pdf
Federal Office of Public Health, Notification Authority for Chemicals www.bag.admin.ch/biocide
Zvezni urad za javno zdravje, organ za prijavo kemikalij www.bag.admin.ch/biocide
For the purpose of paragraphs 2-5 of this Section, any reference to Directive 98/8/EC shall, as far as Switzerland is concerned, be understood to equally refer to the equivalent Swiss provisions.
Za namene odstavkov 2–5 tega oddelka se vsakršno sklicevanje na Direktivo 98/8/ES glede Švice razume kot enakovredno sklicevanje na ustrezne švicarske določbe.
Inclusion of active substances in Annex I, IA or IB
Vključitev aktivnih snovi v Prilogo I, IA ali IB
Article 11 of Directive 98/8/EC shall apply between the Parties with the following adaptations:
Člen 11 Direktive 98/8/ES se med pogodbenicama uporablja z naslednjimi prilagoditvami.
inclusion or subsequent changes to the inclusion, of an active substance in Annex I, IA or IB shall also be considered where an applicant has forwarded the required dossier to the competent authority of Switzerland, and where the receiving competent authority has sent the required evaluation to the Commission.
Vključitev ali naknadne spremembe vključitve aktivne snovi v Prilogo I, IA ali IB se obravnavajo, tudi kadar predlagatelj zahtevano dokumentacijo posreduje pristojnemu organu Švice ter pristojni organ prejemnik Komisiji pošlje zahtevano presojo.
Mutual recognition of authorisations between Member States and Switzerland
Medsebojno priznavanje dovoljenj med državami članicami in Švico
Without prejudice to Article 12 of Directive 98/8/EC, a biocidal product that has already been authorised or registered in one Member State or in Switzerland shall be authorised or registered in another Member State or in Switzerland within 120 days, or 60 days respectively, of an application being received by the other Member State or by Switzerland, provided that the active substance of the biocidal product is included in Annex I or IA to Directive 98/8/EC and conforms to the requirements thereof.
Brez poseganja v člen 12 Direktive 98/8/ES se za biocidni pripravek, za katerega je že bilo izdano dovoljenje ali je že bil registriran v eni državi članici ali Švici, izda dovoljenje ali se ga registrira v drugi državi članici ali Švici v 120 dneh oz. 60 dneh od dneva, ko druga država članica ali Švica prejme vlogo, pod pogojem, da je aktivna snov biocidnega pripravka vključena v Prilogo I ali IA k Direktivi 98/8/ES in da je v skladu z zahtevami iz te priloge.
For the mutual recognition of authorisations, the application shall include a summary of the dossier as required in Article 8(2)(a) and Annex IIB, Section X of Directive 98/8/EC and a certified copy of the first authorisation granted.
Vloga za medsebojno priznavanje dovoljenj vključuje povzetek dokumentacije, kot to zahteva člen 8(2)(a) in oddelek X Priloge IIB k Direktivi 98/8/ES, ter overjen izvod prvega izdanega dovoljenja.
For mutual recognition of registration of low-risk biocidal products, the application shall include the data requirements of Article 8(3) of Directive 98/8/EC, except for the efficacy data for which a summary shall suffice.
Vloga za medsebojno priznavanje registracije biocidnih pripravkov z manjšim tveganjem vsebuje zahtevane podatke iz člena 8(3) Direktive 98/8/ES, razen podatkov o učinkovitosti, za katere zadošča povzetek.
The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with the Parties’ law, relating to the conditions for distribution and use of biocidal products intended to protect the health of the distributors, users and workers concerned.
Za dovoljenje lahko veljajo določbe, ki so posledica izvajanja drugih ukrepov v skladu z zakonodajo pogodbenic o pogojih za distribucijo in uporabo biocidnih pripravkov, namenjenih za varovanje zdravja distributerjev, uporabnikov in delavcev.
This mutual recognition procedure shall be without prejudice to measures taken by Member States and by Switzerland pursuant to the Parties’ law intended to protect the health of workers.
Ta postopek medsebojnega priznavanja ne posega v ukrepe, ki so jih države članice ali Švica sprejele v skladu s svojo zakonodajo za varovanje zdravja delavcev.
If, in accordance with Article 5 of Directive 98/8/EC, a Member State or Switzerland establishes that:
Če država članica ali Švica v skladu s členom 5 Direktive 98/8/ES ugotovi, da:
the target species is not present in harmful quantities;
ciljna vrsta ni prisotna v škodljivih količinah;
unacceptable tolerance or resistance of the target organism to the biocidal product is demonstrated; or
je dokazana nesprejemljiva toleranca ali odpornost ciljnega organizma na biocidni pripravek ali
the relevant circumstances of use, such as climate or breeding period of the target species, differ significantly from those in the Member State where the biocidal product was first authorised or in Switzerland, and an unchanged authorisation may therefore present unacceptable risks to humans or the environment,
se okoliščine uporabe, kot so podnebje ali obdobje razmnoževanja ciljne vrste, znatno razlikujejo od okoliščin v državi članici, v kateri je bilo prvič izdano dovoljenje za biocidni pripravek, ali v Švici in bi nespremenjeno dovoljenje lahko pomenilo nesprejemljivo tveganje za ljudi ali okolje,
the Member State or Switzerland may request that certain conditions referred to in Article 20(3)(e), (f), (h), (j) and (l) of Directive 98/8/EC be adjusted to the different circumstances, so that conditions for issue of an authorisation laid down in Article 5 of Directive 98/8/EC are satisfied.
lahko zahteva, da se nekateri pogoji iz člena 20(3)(e), (f), (h), (j) in (l) Direktive 98/8/ES prilagodijo različnim okoliščinam, s čimer se izpolnijo pogoji za izdajo dovoljenja iz člena 5 Direktive 98/8/ES.
Where a Member State or Switzerland believes that a low-risk biocidal product which has been registered by another Member State or by Switzerland does not comply with the definition provided for in Article 2(1)(b) of Directive 98/8/EC, it may provisionally refuse registration thereof and shall immediately communicate its concerns to the competent authority responsible for the verification of the dossier.
Kadar država članica ali Švica meni, da biocidni pripravek z manjšim tveganjem, ki ga je registrirala druga država članica ali Švica, ne ustreza opredelitvi iz člena 2(1)(b) Direktive 98/8/ES, lahko začasno zavrne registracijo tega pripravka, o svojih pomislekih pa nemudoma uradno obvesti pristojni organ, ki je odgovoren za preverjanje dokumentacije.
If, within a maximum period of 90 days, an agreement is not reached between the authorities concerned, the matter will be forwarded to the Commission for a decision in accordance with the procedure laid down in paragraph 4.
Če v obdobju največ 90 dni zadevni organi ne dosežejo sporazuma, se zadeva pošlje v odločanje Komisiji v skladu s postopkom iz odstavka 4.
Notwithstanding paragraphs 2 and 3, where a Member State or Switzerland believes a biocidal product authorised by another Member State or Switzerland cannot meet the conditions set out pursuant to Article 5(1) of Directive 98/8/EC and consequently proposes to refuse the authorisation or the registration or to restrict the authorisation under certain conditions, it shall notify the Commission, other Member States, Switzerland and the applicant and shall provide them with an explanatory document containing the name of the product and its specification and setting out the grounds on which it proposes to refuse or to restrict the authorisation.
Ne glede na odstavka 2 in 3 država članica ali Švica, kadar meni, da biocidni pripravek, za katerega je izdala dovoljenje druga država članica ali Švica, ne more izpolnjevati pogojev iz člena 5(1) Direktive 98/8/ES, in posledično predlaga, da se izdaja dovoljenja ali registracija zavrneta ali dovoljenje omeji pod določenimi pogoji, uradno obvesti Komisijo, druge države članice, Švico in predlagatelja ter jim predloži obrazložitveni dokument, ki vsebuje ime pripravka in njegovo specifikacijo, ter navede razloge, zaradi katerih se predlaga zavrnitev ali omejitev izdaje dovoljenja.
The Commission shall prepare a proposal on these matters in accordance with Article 27 of Directive 98/8/EC for a decision in accordance with the procedure laid down in Article 28(2) of Directive 98/8/EC.
Komisija pripravi predlog o navedenih zadevah v skladu s členom 27 Direktive 98/8/ES za odločanje v skladu s postopkom iz člena 28(2) Direktive 98/8/ES.
If the procedure laid down in paragraph 4 leads to the confirmation of a refusal of a second or subsequent registration by a Member State or by Switzerland, the Member State that had previously registered the low-risk biocidal product or Switzerland shall, where deemed appropriate by the Standing Committee, take this refusal into consideration and review its registration according to Article 6 of Directive 98/8/EC.
Če država članica ali Švica po postopku iz odstavka 4 potrdi zavrnitev druge ali naslednje registracije, država članica, ki je že registrirala biocidni pripravek z manjšim tveganjem, ali Švica, kadar je po mnenju Stalnega odbora primerno, upošteva to zavrnitev in pregleda registracijo v skladu s členom 6 Direktive 98/8/ES.
If this procedure confirms the initial registration, the Member State or Switzerland having introduced the procedure shall register the low-risk biocidal product concerned.
Če ta postopek potrdi prvotno registracijo, država članica ali Švica, ki je postopek uvedla, registrira zadevni biocidni pripravek z manjšim tveganjem.
By way of derogation from paragraph 1, Member States or Switzerland may refuse mutual recognition of authorisations granted for product types 15, 17 and 23 of Annex V to Directive 98/8/EC provided that such a limitation can be justified and does not jeopardise the purpose of this Chapter.
Z odstopanjem od odstavka 1 države članice ali Švica lahko zavrnejo medsebojno priznavanje dovoljenj, izdanih za pripravke vrste 15, 17 in 23 iz Priloge V k Direktivi 98/8/ES, pod pogojem, da je takšno omejitev mogoče utemeljiti in da ni v nasprotju z namenom tega poglavja.
Member States and Switzerland shall inform each other and the Commission of any decision taken in this respect and indicate the reasons therefor.
Države članice in Švica druga drugo ter Komisijo obvestijo o vseh odločitvah, sprejetih v zvezi s tem, in navedejo razloge zanje.
Market access
Dostop do trga
The applicant shall indicate his name or trade name and address on the label of biocidal products.
Predlagatelj na oznaki na biocidnem pripravku navede svoje ime ali trgovsko ime in naslov.
It will be sufficient, for the purposes of Article 8 of Directive 98/8/EC, if the applicant for an authorisation has a permanent office either within the European Union or Switzerland.
Za namene člena 8 Direktive 98/8/ES zadostuje, da ima predlagatelj dovoljenja stalno poslovalnico v Evropski uniji ali Švici.
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.
Pogodbenici se strinjata, da lahko pristojni organi o dovoljenju in drugih odločitvah, povezanih z vlogo iz tega poglavja, obvesti neposredno predlagatelja na ozemlju druge pogodbenice.
In accordance with Article 9 of this Agreement, the Parties shall in particular exchange information referred to in Article 18 of Directive 98/8/EC.
V skladu s členom 9 tega sporazuma si pogodbenici zlasti izmenjujeta podatke iz člena 18 Direktive 98/8/ES.
Confidential information shall be defined and treated in accordance with Article 19 of Directive 98/8/EC.
Zaupne informacije se opredelijo in obravnavajo v skladu s členom 19 Direktive 98/8/ES.
Where a Member State or Switzerland has valid reasons to consider that a biocidal product which it has authorised, registered or is bound to authorise or register pursuant to Article 3 or 4 of Directive 98/8/EC constitutes an unacceptable risk to human or animal health or the environment, it may provisionally restrict or prohibit the use or sale of that product on its territory.
Kadar ima država članica ali Švica tehtne razloge za oceno, da biocidni pripravek, za katerega je izdala dovoljenje ali ga registrirala ali za katerega mora izdati dovoljenje ali ga registrirati v skladu s členom 3 ali 4 Direktive 98/8/ES, da predstavlja nesprejemljivo tveganje za zdravje ljudi ali živali ali za okolje, lahko začasno omeji ali prepove uporabo ali prodajo navedenega pripravka na svojem ozemlju.
It shall immediately inform the Commission, the other Member States and Switzerland of such action and give reasons for its decisions.
O takih ukrepih nemudoma obvesti Komisijo, druge države članice in Švico ter navede razloge za svojo odločitev.
A decision shall be taken on the matter within 90 days in accordance with the procedure laid down in Article 28(3).
O zadevi se v 90 dneh sprejme odločitev po postopku iz člena 28(3).
If Switzerland disagrees with the Commission Decision, the case will be forwarded to the Joint Committee, which will decide on an appropriate course of action, including the possibility to call an expert meeting.
Če se Švica ne strinja z odločitvijo Komisije, se zadeva posreduje Skupnemu odboru, ki sprejme odločitev o ustreznem ukrepanju, vključno z možnostjo sklica srečanja strokovnjakov.
If a settlement is not reached within 90 days, either party may suspend the Biocidal products Chapter in part or in full.
Če se spora ne reši v 90 dneh, lahko vsaka od pogodbenic začasno v celoti ali delno prekine poglavje o biocidnih pripravkih.
Transitional period
Prehodno obdobje
Article 16(1) of Directive 98/8/EC shall apply between the Parties, with the transitional period up to 14 May 2014 for Switzerland.’
Člen 16(1) Direktive 98/8/ES se uporablja med pogodbenicama s prehodnim obdobjem do najpozneje 14. maja 2014 za Švico.“
DECLARATION FROM THE EUROPEAN COMMISSION
IZJAVA EVROPSKE KOMISIJE
In order to ensure the effective application and implementation of the Biocidal products Chapter to be included in Annex 1 to the Agreement and in so far as Switzerland has adopted the relevant acquis communautaire 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 28 of Directive 98/8/EC to assist the Commission in the exercise of its executive powers.In addition, the Commission notes that Swiss experts are invited to participate in the expert group of Competent Authorities for Biocidal Products, which provides assistance to the Commission with the harmonised implementation of Directive 98/8/EC.
Za zagotovitev učinkovite uporabe in izvajanja poglavja o biocidnih pripravkih 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 pripravkih, 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 28 Direktive 98/8/ES, za pomoč Komisiji pri uresničevanju njenih izvedbenih pooblastil.Poleg tega je Komisija seznanjena s tem, da so švicarski strokovnjaki vabljeni k sodelovanju v strokovni skupini pri pristojnih organih za biocidne pripravke, ki Komisiji pomaga pri usklajenem izvajanju Direktive 98/8/ES.
The Commission also notes that the Chairman of the Committee established pursuant to Article 28 of Directive 98/8/EC 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 cases where discussions on the application of Articles 4 and 11 of Directive 98/8/EC are of direct relevance to Switzerland.
Komisija je tudi seznanjena s tem, da lahko predsednik Odbora, ustanovljenega v skladu s členom 28 Direktive 98/8/ES, na zahtevo člana Odbora ali na lastno pobudo k sodelovanju povabi švicarske strokovnjake na razpravo o posebnih zadevah, zlasti v primerih, kadar se razprave o uporabi členov 4 in 11 Direktive 98/8/ES nanašajo neposredno na Švico.
Declaration on Swiss attendance of committees (OJ L 114, 30.4.2002, p. 429).
Izjava o sodelovanju Švice v odborih (UL L 114, 30.4.2002, str. 429).
Annex I to the Agreement was amended by Decision of the EEA Joint Committee No 9/2011 of 1 April 2011 [1].
Priloga I k Sporazumu je bila spremenjena s Sklepom Skupnega odbora EGP št. 9/2011 z dne 1. aprila 2011 [1].
Commission Regulation (EU) No 304/2010 of 9 April 2010 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 2-phenylphenol in or on certain products [3] is to be incorporated into the Agreement.
Uredbo Komisije (EU) št. 304/2010 z dne 9. aprila 2010 o spremembi Priloge II k Uredbi (ES) št. 396/2005 Evropskega parlamenta in Sveta glede mejnih vrednosti ostankov za 2-fenilfenol v ali na nekaterih proizvodih [3] je treba vključiti v Sporazum.
Commission Regulation (EU) No 375/2010 of 3 May 2010 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health [4] is to be incorporated into the Agreement.
Uredbo Komisije (EU) št. 375/2010 z dne 3. maja 2010 o zavrnitvi odobritve zdravstvene trditve na živilih, razen tistih, ki se nanašajo na zmanjšanje tveganja za nastanek bolezni ter na razvoj in zdravje otrok [4], je treba vključiti v Sporazum.