natgillin/translations-raw huggingface dataset:
I overensstemmelse med aftalens generelle bestemmelser stiller medlemsstaterne og Schweiz de nødvendige oplysninger til hinandens rådighed med henblik på at sikre en korrekt gennemførelse af direktiv 2008/43/EF.«
That information shall include all available details, in particular the data necessary for the identification of the lift or safety component for lifts concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
Dette kapitel finder ikke anvendelse på eksplosivstoffer, der er beregnet til de væbnede styrkers eller politiets brug i henhold til national lovgivning, eller på fyrværkeriartikler og ammunition.
In case of a disagreement between the Parties on measures pursuant to paragraphs 6 and 7 above, the issue will be forwarded to the Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.
TILLÆG J
ATTACHMENT I
Ændringer til bilag 1
In Annex 1, Product Sectors, Chapter 20, Explosives for civil use should be deleted and replaced by the following one:
KAPITEL 3
‘CHAPTER 20
LEGETØJ
EXPLOSIVES FOR CIVIL USE
I afsnit I, Love, forskrifter og administrative bestemmelser, Bestemmelser i henhold til artikel 1, stk. 2, affattes henvisningen til Den Europæiske Unions og Schweiz' bestemmelser således:
Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1)
»Den Europæiske Union
Commission Directive 2008/43/EC of 4 April 2008 setting up, pursuant to Council Directive 93/15/EEC, a system for the indication and traceability of explosives for civil uses (OJ L 94, 5.4.2008, p.
Europa-Parlamentets og Rådets direktiv 2009/48/EF af 18. juni 2009 om sikkerhedskrav til legetøj (EUT L 170 af 30.6.2009, s. 1), senest ændret ved Kommissionens direktiv (EU) 2017/898 (EUT L 138 af 25.5.2017, s. 128) (i det følgende benævnt »direktiv 2009/48/EF«)
8), as amended by Commission Directive 2012/4/EU (OJ L 50, 23.2.2012, p.
Forbundslov af 20. juni 2014 om fødevarer og råvarer (RO 2017 249)
18), hereinafter referred to as “Directive 2008/43/EC”
Bekendtgørelse af 16. december 2016 om fødevarer og råvarer (RO 2017 283), senest ændret den 2. maj 2017 (RO 2017 2695)
Commission Decision 2004/388/EC of 15 April 2004 on an Intra-Community transfer of explosives document (OJ L 120, 24.4.2004, p.
Bekendtgørelse af 15. august 2012 fra forbundskontoret for indre anliggender om sikkerhed ved legetøj (RO 2012 4717), senest ændret den 1. maj 2017 (RO 2017 1525)
43), as amended by Commission Decision 2010/347/EU (OJ L 155, 22.6.2010, p.
Bekendtgørelse af 16. december 2016 fra forbundskontoret for indre anliggender om håndhævelsen af fødevarelovgivningen (RO 2017 359)
54), hereinafter referred to as “Decision 2004/388/EC”
Bekendtgørelse af 17. juni 1996 om det schweiziske akkrediteringssystem og om udpegelse af prøvningslaboratorier og overensstemmelsesvurderingsorganer (RO 1996 1904), senest ændret den 20. april 2016 (RO 2016 261)«
Federal Act of 25 March 1977 on explosive substances (Explosives Act) as last amended on 12 June 2009 (RO 2010 2617)
KAPITEL 12
Ordinance of 27 November 2000 on explosives (Explosives Ordinance), as last amended on 25 November 2015 (RO 2016 247)
MOTORKØRETØJER
The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designation of authorities notified by the Parties.
I afsnit I, Love, forskrifter og administrative bestemmelser, Bestemmelser i henhold til artikel 1, stk. 2, affattes henvisningen til Den Europæiske Unions og Schweiz' bestemmelser således:
For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter 5 of Directive 2014/28/EU.
Europa-Parlamentets og Rådets direktiv 2007/46/EF af 5. september 2007 om fastlæggelse af en ramme for godkendelse af motorkøretøjer og påhængskøretøjer dertil samt af systemer, komponenter og separate tekniske enheder til sådanne køretøjer (rammedirektiv) (EUT L 263 af 9.10.2007, s. 1), senest ændret ved Europa-Parlamentets forordning (EU) 2015/758 af 29. april 2015 (EUT L 123 af 19.5.2015, s. 77), og under hensyntagen til listen over retsakter i bilag IV til direktiv 2007/46/EF, med efterfølgende ændringer indtil 29. april 2015 (herefter benævnt »rammedirektiv 2007/46/EF«)
for the purpose of the obligations in Articles 5(5)(b) and 7(3) of Directive 2014/28/EU and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted.
Bekendtgørelse af 19. juni 1995 om tekniske forskrifter for motordrevne transportkøretøjer og påhængsvogne dertil (RO 1995 4145), senest ændret den 16. november 2016(RO 2016 5195)
for the purpose of the obligations in Articles 5(3) and 7(7) of Directive 2014/28/EU and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the explosive has been placed on the market in either the European Union or Switzerland.
Bekendtgørelse af 19. juni 1995 om typegodkendelse af vejkøretøjer (RO 1995 3997), med efterfølgende ændringer indtil 16. november 2016 (RO 2016 5213) og under hensyntagen til ændringer vedtaget i henhold til proceduren i afsnit V, stk. 1.«
In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity or, where applicable, the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the explosive has been placed on the market in either the European Union or Switzerland.
Afsnit V, stk. 1, Ændringer til bilag IV hhv. retsakterne i bilag IV til direktiv 2007/46/EF, affattes således:
For the purpose of the obligation in Article 6(2) of Directive 2014/28/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 6(1) of Directive 2014/28/EU or the corresponding Swiss provisions.
Ændringer til bilag IV hhv. retsakterne i bilag IV til direktiv 2007/46/EF
Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 39 of Directive 2014/28/EU.
Med forbehold af artikel 12, stk. 2, skal Den Europæiske Union give Schweiz meddelelse om ændringer til bilag IV og de retsakter, der er opført i bilag IV til direktiv 2007/46/EF efter den 29. april 2015, straks efter deres offentliggørelse i Den Europæiske Unions Tidende.
Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 40 of Directive 2014/28/EU, directly or by means of designated representatives.
Schweiz skal straks give Den Europæiske Union meddelelse om de relevante ændringer af den schweiziske lovgivning, senest på datoen for anvendelsen af disse ændringer i Den Europæiske Union.«
Procedure for dealing with explosives presenting a risk not restricted to the national territory
KAPITEL 14
Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an explosive covered by this chapter presents a risk to the health or safety of persons or to the property or the environment covered by Directive 2014/28/EU respectively the relevant Swiss legislation, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:
GOD LABORATORIEPRAKSIS
where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the explosives' being made available on their national market, to withdraw the explosive from that market or to recall it.
I afsnit I, Love, forskrifter og administrative bestemmelser, Bestemmelser i henhold til artikel 1, stk. 2, affattes henvisningen til Den Europæiske Unions og Schweiz' bestemmelser således:
This information shall include all available details, in particular the data necessary for the identification of the non-compliant explosive, the origin of the explosive, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.
Fødevarer og foderstoffer:
failure of the explosive to meet requirements relating to the health or safety of persons, or to the protection of property or the environment and safety requirements referred to in the relevant legislation in Section I, or
Kommissionens forordning (EF) nr. 429/2008 af 25. april 2008 om gennemførelsesbestemmelser til Europa-Parlamentets og Rådets forordning (EF) nr. 1831/2003 for så vidt angår udarbejdelse og indgivelse af ansøgninger samt vurdering og godkendelse af fodertilsætningsstoffer (EUT L 133 af 22.5.2008, s. 1).
shortcomings in the harmonised standards referred to in the relevant legislation in Section I.
Kommissionens forordning (EU) nr. 234/2011 af 10. marts 2011 om gennemførelse af Europa-Parlamentets og Rådets forordning (EF) nr. 1331/2008 om en fælles godkendelsesprocedure for fødevaretilsætningsstoffer, fødevareenzymer og fødevarearomaer (EUT L 64 af 11.3.2011, s. 15).
Switzerland, or Member States shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the explosive concerned.
Kommissionens gennemførelsesforordning (EU) nr. 503/2013 af 3. april 2013 om ansøgninger om tilladelse til genetisk modificerede fødevarer og foderstoffer i henhold til Europa-Parlamentets og Rådets forordning (EF) nr. 1829/2003 og om ændring af Kommissionens forordning (EF) nr. 641/2004 og (EF) nr. 1981/2006 (EUT L 157 af 8.6.2013, s. 1).
Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the explosive concerned, such as withdrawal of an explosive from their market, without delay.
Nye og eksisterende kemikalier
justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant explosive is withdrawn from their markets, and shall inform the Commission accordingly,
Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 af 18. december 2006 om registrering, vurdering og godkendelse af samt begrænsninger for kemikalier (REACH), om oprettelse af et europæisk kemikalieagentur og om ændring af direktiv 1999/45/EF og ophævelse af Rådets forordning (EØF) nr. 793/93 og Kommissionens forordning (EF) nr. 1488/94 samt Rådets direktiv 76/769/EØF og Kommissionens direktiv 91/155/EØF, 93/67/EØF, 93/105/EF og 2000/21/EF (EUT L 396 af 30.12.2006, s. 1), senest ændret ved Kommissionens forordning (EU) nr. 348/2013 af 17. april 2013 (EUT L 108 af 18.4.2013, s. 1).
Where a Member State or Switzerland finds that, although an explosive that an economic operator has been made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to the property or the environment, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland.
Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 af 16. december 2008 om klassificering, mærkning og emballering af stoffer og blandinger og om ændring og ophævelse af direktiv 67/548/EØF og 1999/45/EF og om ændring af forordning (EF) nr. 1907/2006 (EUT L 353 af 31.12.2008, s. 1), senest ændret ved Kommissionens forordning (EU) nr. 944/2013 af 2. oktober 2013 (EUT L 261 af 3.10.2013, s. 5).
That information shall include all available details, in particular the data necessary for the identification of the explosive concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.
Lægemidler
The Commission shall without delay enter into consultation with the Member States, Switzerland and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary, propose appropriate measures.
Europa-Parlamentets og Rådets forordning (EU) nr. 536/2014 af 16. april 2014 om kliniske forsøg med humanmedicinske lægemidler og om ophævelse af direktiv 2001/20/EF (EUT L 158 af 27.5.2014, s. 1).
unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.
Veterinærlægemidler
Identification of products
Europa-Parlamentets og Rådets direktiv 2001/82/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for veterinærlægemidler (EFT L 311 af 28.11.2001, s. 1), senest ændret ved Kommissionens direktiv 2009/9/EF af 10. februar 2009 (EUT L 44 af 14.2.2009, s. 10).
Both Parties shall ensure that undertakings in the explosives sector which manufacture or import explosives or assemble detonators shall mark explosives and each smallest packaging unit with a unique identification.
Plantebeskyttelsesmidler
Where an explosive is subject to further manufacturing processes, manufacturers shall not be required to mark the explosive with a new unique identification unless the original unique identification is no longer marked in compliance with Directive 2008/43/EC and/or the Explosives Ordinance.
Europa-Parlamentets og Rådets forordning (EF) nr. 1107/2009 af 21. oktober 2009 om markedsføring af plantebeskyttelsesmidler og om ophævelse af Rådets direktiv 79/117/EØF og 91/414/EØF (EUT L 309 af 24.11.2009, s. 1).
The unique identification shall comprise the components prescribed in the Annex to Directive 2008/43/EC and Annex 14 to the Explosives Ordinance and shall be mutually recognised by both parties.
Kommissionens forordning (EU) nr. 284/2013 af 1. marts 2013 om fastsættelse af datakrav vedrørende plantebeskyttelsesmidler i henhold til Europa-Parlamentets og Rådets forordning (EF) nr. 1107/2009 om markedsføring af plantebeskyttelsesmidler (EUT L 93 af 3.4.2013, s. 85).
This three-digit code shall be mutually recognised by both Parties if the manufacturing site or the manufacturer is located in the territory of one of the Parties.
Biocidholdige produkter
Provisions governing the supervision of transfers between the European Union and Switzerland
Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter (EUT L 167 af 27.6.2012, s. 1).
Explosives covered by this Chapter may be transferred between the European Union and Switzerland only in accordance with the following paragraphs.
Kosmetiske produkter
Approval to transfer explosives shall be obtained by the consignee from the recipient competent authority.
Europa-Parlamentets og Rådets forordning (EF) nr. 1223/2009 af 30. november 2009 om kosmetiske produkter (EUT L 342 af 22.12.2009, s. 59).
The competent authority shall verify that the consignee is legally authorised to acquire explosives and that he is in possession of the necessary licenses or authorisations.
Vaske- og rengøringsmidler
The economic operator responsible for the transfer shall notify the competent authorities of the transit Member State or Member States or Switzerland of any movements of explosives through the Member State concerned or Switzerland and shall obtain prior approval of the transit Member State concerned or Switzerland.
Europa-Parlamentets og Rådets forordning (EF) nr. 648/2004 af 31. marts 2004 om vaske- og rengøringsmidler (EUT L 104 af 8.4.2004, s. 1).
Where a Member State or Switzerland considers that there is a problem regarding the verification of the entitlement to acquire explosives referred to in paragraph 3, that Member State or Switzerland shall forward the available information on the subject to the European Commission which shall inform the other Member States and Switzerland accordingly through the Committee established under Article 10 of this Agreement.
Medicinsk udstyr
Where the competent authority of the consignee in the Member State or Switzerland approves a transfer, it shall issue to the consignee a document which includes all the information referred to in paragraph 10(5).
Europa-Parlamentets og Rådets forordning (EU) 2017/745 af 5. april 2017 om medicinsk udstyr, om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009 og om ophævelse af Rådets direktiv 90/385/EØF og 93/42/EØF (EUT L 117 af 5.5.2017, s. 1).
Such a document shall accompany the explosives until they arrive at their stated destination.
Forbundslov af 7. oktober 1983 om beskyttelse af miljøet (RO 1984 1122), senest ændret den 20. juni 2014 (RO 2016 689)
It shall be produced at the request of the competent authorities.
Forbundslov af 15. december 2000 om beskyttelse mod farlige stoffer og præparater (RO 2004 4763), senest ændret den 20. juni 2014 (RO 2016 689)
A copy of this document shall be retained by the consignee who shall present it, upon request, for examination by the competent authority of the consignee in the Member State or Switzerland.
Bekendtgørelse af 5. juni 2015 om beskyttelse mod farlige stoffer og præparater (RO 2015 1903), senest ændret den 22. marts 2017(RO 2017 2593)
Where transfers of explosives must be specially supervised in order to comply with special security requirements in the territory or part of the territory of a Member State or Switzerland, prior to the transfer the following information shall be provided by the consignee to the competent authority of the consignee in the Member State or Switzerland:
Bekendtgørelse af 18. maj 2005 om biocidholdige produkter (RO 2005 2821), senest ændret den 28. marts 2017 (RO 2017 2441)
the names and addresses of the economic operators concerned;
Bekendtgørelse af 12. maj 2010 om godkendelse af plantebeskyttelsesmidler (RO 2010 2331), senest ændret den 22. marts 2017 (RO 2017 2593)
the number and quantity of the explosives being transferred;
Forbundslov af 15. december 2000 om lægemidler og medicinsk udstyr (RO 2001 2790), senest ændret den 21. juni 2013 (RO 2013 4137)
a full description of the explosive in question and of the means of identification, including the United Nations identification number;
Bekendtgørelse af 17. oktober 2001 om lægemidler (RO 2001 3420), senest ændret den 23. marts 2016 (RO 2016 1171)«
where the explosives are to be placed on the market, information on compliance with conditions for placing on the market;
I afsnit III, Udpegende myndigheder, affattes kontaktoplysningerne for de myndigheder i Den Europæiske Union, der fører tilsyn med god laboratoriepraksis, således:
the means of transfer and the itinerary;
»For Den Europæiske Union:
the expected dates of departure and arrival;
http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_da«.
where necessary, the precise points of entry to and exit from Member States or Switzerland.
KAPITEL 16
The information referred to in point (a) shall be sufficiently detailed in order to enable competent authorities to contact the economic operators and to obtain confirmation that the economic operators concerned are entitled to receive the consignment.
BYGGEVARER
The competent authority of the consignee in the Member State or Switzerland shall examine the conditions under which the transfer may take place, with particular regard to the special security requirements.
I afsnit I, Love, forskrifter og administrative bestemmelser, Bestemmelser i henhold til artikel 1, stk. 2, affattes den første henvisning til Den Europæiske Unions bestemmelser således:
If the special security requirements are satisfied, approval for the transfer shall be granted.
»Europa-Parlamentets og Rådets forordning (EU) nr. 305/2011 af 9. marts 2011 om fastlæggelse af harmoniserede betingelser for markedsføring af byggevarer og om ophævelse af Rådets direktiv 89/106/EØF (EUT L 88 af 4.4.2011, s. 5), senest ændret ved Kommissionens delegerede forordning (EU) nr. 574/2014 af 21. februar 2014 (EUT L 159 af 28.5.2014, s. 41), samt Kommissionens gennemførelsesretsakter og delegerede retsakter vedtaget i henhold til denne forordning inden den 1. december 2016 (i det følgende benævnt forordning (EU) nr. 305/2011)«
In the event of transit through the territory of other Member States or Switzerland, those States or Switzerland shall likewise examine and approve, the particulars concerning the transfer.
I afsnit I, Love, forskrifter og administrative bestemmelser, Bestemmelser i henhold til artikel 1, stk. 2, udgår følgende henvisninger til Den Europæiske Unions bestemmelser:
Where the competent authority of a Member State or Switzerland considers that special security requirements referred to in paragraph 10(4) and 10(5) are unnecessary, explosives can be transferred on their territory or part thereof without prior provision of information within the meaning of paragraph 10(5).
Kommissionens beslutning 96/581/EF af 24. juni 1996 om proceduren for attestering af byggevarer i henhold til artikel 20, stk. 2, i Rådets direktiv 89/106/EØF (geotekstiler) (EFT L 254 af 8.10.1996, s. 59)
The recipient competent authority shall then grant an approval for a fixed period and liable to suspension or withdrawal at any time on the basis of a reasoned justification.
Kommissionens beslutning 97/464/EF af 27. juni 1997 om proceduren for attestering af byggevarer i henhold til artikel 20, stk. 2, i Rådets direktiv 89/106/EØF for så vidt angår spildevandstekniske byggevarer (EFT L 198 af 25.7.1997, s. 33)
The document referred to in paragraph 10(4), which must accompany the explosives until they arrive at their destination, shall refer solely to the abovementioned approval.
Kommissionens beslutning 2000/147/EF af 8. februar 2000 om gennemførelse af Rådets direktiv 89/106/EØF for så vidt angår klassificering af byggevarer efter ydeevne med hensyn til reaktion ved brand (EFT L 50 af 23.2.2000, s. 14)«
Without prejudice to the normal checks which the country of departure shall carry out in its territory, at the request of the competent authorities concerned, the consignees and the economic operators concerned shall forward to the authorities of the country of departure and to those of country of transit all relevant information they possess concerning the transfer of explosives.
I afsnit I, Love, forskrifter og administrative bestemmelser, Bestemmelser i henhold til artikel 1, stk. 2, affattes henvisningen til Schweiz' bestemmelser således:
No economic operator may transfer explosives unless the consignee has obtained the necessary authorisations for the transfer in accordance with the provisions of paragraphs 10(2), 10(4), 10(5) and 10(6).
»Schweiz
For the purposes of implementing paragraphs 4 and 5, the provisions of Decision 2004/388/EC shall apply.
Forbundslov af 21. marts 2014 om byggevarer (RO 2014 2867)
In accordance with the general provisions of this Agreement, the Member States and Switzerland shall keep at each other's disposal any relevant information needed to ensure a proper implementation of Directive 2008/43/EC.’