natgillin/translations-raw huggingface dataset:
The necessary inspections should be planned, carried out and their results should be reported.
Treba bi bilo načrtovati in izvajati potrebne inšpekcijske preglede ter poročati o njihovih ugotovitvah.
In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework for penalties with a view to imposing effective, proportionate and dissuasive penalties for non-compliance, as non-compliance can result in damage to human health and the environment.
Da se zagotovi preglednost, nepristranskost in doslednost izvedbenih dejavnosti v državah članicah, morajo države članice vzpostaviti ustrezen okvir sistema kaznovanja, v okviru katerega se naložijo učinkovite, sorazmerne in odvračilne kazni za kršitve, saj ima lahko neustrezanje škodljive posledice za zdravje ljudi in okolje.
The measures necessary for the implementation of this Regulation and certain amendments to it should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [19].
Ukrepe, potrebne za izvajanje te uredbe, in nekatere spremembe te uredbe bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [19].
In particular, power should be conferred on the Commission to amend the Annexes in certain cases, to set rules on test methods, to vary the percentage of dossiers selected for compliance checking and to modify the criteria for their selection, and to set the criteria defining what constitutes adequate justification that testing is technically not possible.
Komisiji bi bilo treba podeliti zlasti pooblastila, da v nekaterih primerih spremeni priloge, določa pravila za testne metode, spreminja odstotno postavko za dokumentacijo, izbrano za preverjanje skladnosti, in kriterije za njen izbor, ter določa kriterije za to, kaj predstavlja ustrezno utemeljitev, da testiranje tehnično ni mogoče.
Since these measures are of general scope and are designed to amend non-essential elements of this Regulation or supplement this Regulation by adding new non-essential elements thereto, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te uredbe ali dopolnitvi te uredbe z dodajanjem novih nebistvenih določb, bi jih bilo treba sprejeti po regulativnem postopku s pregledom iz člena 5a Sklepa 1999/468/ES.
It is essential that chemicals be regulated in an effective and timely manner during the transition to full applicability of the provisions of this Regulation and, in particular, during the start-up period of the Agency.
Zelo pomembno je, da se kemikalije med prehodom k celotni uporabi določb iz te uredbe in zlasti v začetnem obdobju delovanja Agencije učinkovito in pravočasno pravno uredijo.
Provision should therefore be made for the Commission to provide the necessary support towards the setting up of the Agency, including the conclusion of contracts and the appointment of an Executive Director ad interim until the Agency's Management Board can appoint an Executive Director itself.
Zato bi bilo treba predvideti, da Komisija zagotovi potrebno podporo za vzpostavitev Agencije, vključno s sklenitvijo pogodb in imenovanjem začasnega izvršnega direktorja, dokler ga ne more imenovati upravni odbor Agencije.
To take full advantage of the work performed under Regulation (EEC) No 793/93 as well as under Directive 76/769/EEC and to avoid such work being lost, the Commission should be empowered during the start-up period to initiate restrictions based on that work without following the full restrictions procedure laid down in this Regulation.
Da se v celoti izkoristi delo, opravljeno v skladu z Uredbo (EGS) št. 793/93 in Direktivo 76/769/EGS, ter prepreči, da bi takšno delo propadlo, bi bilo treba Komisijo v začetnem obdobju pooblastiti za uvedbo omejitev, sprejetih na podlagi tega dela, ne da bi ji bilo treba v celoti upoštevati postopek za določitev omejitev iz te uredbe.
All those elements should be used, as soon as this Regulation enters into force, to support risk reduction measures.
Da bi podprli ukrepe za zmanjševanje tveganja, je treba te elemente uporabljati takoj od začetka veljavnosti te uredbe.
It is appropriate for the provisions of this Regulation to enter into force in a staggered way to smooth the transition to the new system.
Za določbe iz te uredbe je ustrezno, da začnejo veljati postopno, da se tako zagotovi nemoten prehod v nov sistem.
Moreover, a gradual entry into force of the provisions should allow all parties involved, authorities, natural or legal persons as well as stakeholders, to focus resources in the preparation for new duties at the right times.
Poleg tega bi moral postopen začetek veljavnosti določb vsem vpletenim stranem, organom, fizičnim ali pravnim osebam in interesnim skupinam omogočiti, da svoje vire pravočasno usmerijo k pripravi na nove naloge.
This Regulation replaces Directive 76/769/EEC, Commission Directive 91/155/EEC [20], Commission Directive 93/67/EEC [21], Commission Directive 93/105/EC [22], Commission Directive 2000/21/EC [23], Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 [24].
Ta uredba nadomešča Direktivo 76/769/EGS, Direktivo Komisije 91/155/EGS [20], Direktivo Komisije 93/67/EGS [21], Direktivo Komisije 93/105/ES [22], Direktivo Komisije 2000/21/ES [23], Uredbo (EGS) št. 793/93 in Uredbo Komisije (ES) št. 1488/94 [24].
These Directives and Regulations should therefore be repealed.
Zato bi bilo treba te direktive in uredbe razveljaviti.
For the sake of consistency, Directive 1999/45/EC which already addresses matters covered by this Regulation should be amended.
Zaradi doslednosti bi bilo treba Direktivo 1999/45/ES, ki že obravnava zadeve iz te uredbe, spremeniti.
Since the objectives of this Regulation, namely laying down rules for substances and establishing a European Chemicals Agency, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Ker ciljev te uredbe, in sicer določitve pravil za snovi in ustanovitve Evropske agencije za kemikalije, države članice ne morejo zadovoljivo doseči in ker se te cilje laže doseže na ravni Skupnosti, Skupnost lahko sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Skladno z načelom sorazmernosti iz navedenega člena ta direktiva ne prekoračuje okvirov, ki so potrebni za doseganje navedenega cilja.
The Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of Fundamental Rights of the European Union [25].
Uredba upošteva temeljne pravice in načela, ki jih zlasti priznava Listina o temeljnih pravicah Evropske unije [25].
In particular, it seeks to ensure full compliance with the principles of environmental protection and sustainable development guaranteed by Article 37 of that Charter,
Zlasti si prizadeva za zagotovitev popolne usklajenosti z načeli varstva okolja in trajnostnega razvoja, ki ju zagotavlja člen 37 Listine –
TITLE I GENERAL ISSUES
NASLOV I SPLOŠNA VPRAŠANJA
Chapter 1 Aim, scope and application
Poglavje 1 Cilj, obseg in področje uporabe
Chapter 2 Definitions and general provision
Poglavje 2 Opredelitve in splošna določba
TITLE II REGISTRATION OF SUBSTANCES
NASLOV II REGISTRACIJA SNOVI
Chapter 1 General obligation to register and information requirements
Poglavje 1 Splošna obveznost registriranja in zahteve glede obveščanja
Chapter 2 Substances regarded as being registered
Poglavje 2 Snovi, ki se štejejo za registrirane
Chapter 3 Obligation to register and information requirements for certain types of isolated intermediates
Poglavje 3 Obvezno registriranje in zahtevane informacije za določene vrste izoliranih intermediatov
Chapter 4 Common provisions for all registrations
Poglavje 4 Skupne določbe za vse registracije
Chapter 5 Transitional provisions applicable to phase-in substances and notified substances
Poglavje 5 Prehodne določbe, ki se uporabljajo za snovi v postopnem uvajanju in prijavljene snovi
TITLE III DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
NASLOV III SOUPORABA PODATKOV IN PREPREČEVANJE NEPOTREBNEGA TESTIRANJA
Chapter 1 Objectives and general rules
Poglavje 1 Cilji in splošna pravila
Chapter 2 Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
Poglavje 2 Pravila za snovi, ki niso v postopnem uvajanju, in za registracijske zavezance za snovi v postopnem uvajanju, ki se niso predhodno registrirali
Chapter 3 Rules for phase-in-substances
Poglavje 3 Pravila za snovi v postopnem uvajanju
TITLE IV INFORMATION IN THE SUPPLY CHAIN
NASLOV IV OBVEŠČANJE V DOBAVNI VERIGI
TITLE V DOWNSTREAM USERS
NASLOV V NADALJNJI UPORABNIKI
TITLE VI EVALUATION
NASLOV VI EVALVACIJA
Chapter 1 Dossier evaluation
Poglavje 1 Evalvacija dokumentacije
Chapter 2 Substance evaluation
Poglavje 2 Evalvacija snovi
Chapter 3 Evaluation of intermediates
Poglavje 3 Evalvacija intermediatov
Chapter 4 Common provisions
Poglavje 4 Skupne določbe
TITLE VII AUTHORISATION
NASLOV VII AVTORIZACIJA
Chapter 1 Authorisation requirement
Poglavje 1 Zahteva za avtorizacijo
Chapter 2 Granting of authorisations
Poglavje 2 Dodelitev avtorizacije
Chapter 3 Authorisations in the supply chain
Poglavje 3 Avtorizacije v dobavni verigi
TITLE VIII RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS
NASLOV VIII OMEJITVE ZA PROIZVODNJO, DAJANJE V PROMET IN UPORABO NEKATERIH NEVARNIH SNOVI IN PRIPRAVKOV
Chapter 1 General issues
Poglavje 1 Splošna vprašanja
Chapter 2 Restrictions process
Poglavje 2 Postopek za omejitve
TITLE IX FEES AND CHARGES
NASLOV IX PRISTOJBINE IN TAKSE
TITLE X AGENCY
NASLOV X AGENCIJA
TITLE XI CLASSIFICATION AND LABELLING INVENTORY
NASLOV XI POPIS RAZVRSTITEV IN OZNAČITEV
TITLE XII INFORMATION
NASLOV XII INFORMACIJE
TITLE XIII COMPETENT AUTHORITIES
NASLOV XIII PRISTOJNI ORGANI
TITLE XIV ENFORCEMENT
NASLOV XIV IZVRŠEVANJE
TITLE XV TRANSITIONAL AND FINAL PROVISIONS
NASLOV XV PREHODNE IN KONČNE DOLOČBE
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
SPLOŠNE DOLOČBE ZA OCENJEVANJE SNOVI IN PRIPRAVO POROČIL O KEMIJSKI VARNOSTI
GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS
NAVODILA ZA PRIPRAVO VARNOSTNIH LISTOV
CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
KRITERIJI ZA SNOVI, KI SO REGISTRIRANE V KOLIČINAH MED 1 IN 10 TONAMI
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)
IZJEME, ZA KATERE NE VELJA OBVEZNOST REGISTRACIJE V SKLADU S ČLENOM 2(7)(a)
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)
IZJEME, ZA KATERE NE VELJA OBVEZNOST REGISTRACIJE V SKLADU S ČLENOM 2(7)(b)
INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10
ZAHTEVE PO INFORMACIJAH IZ ČLENA 10
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE
ZAHTEVE PO STANDARDNIH INFORMACIJAH ZA SNOVI, KI SO PROIZVEDENE ALI UVOŽENE V KOLIČINI 1 TONE ALI VEČ
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE
ZAHTEVE PO STANDARDNIH INFORMACIJAH ZA SNOVI, KI SO PROIZVEDENE ALI UVOŽENE V KOLIČINI 10 TON ALI VEČ
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE
ZAHTEVE PO STANDARDNIH INFORMACIJAH ZA SNOVI, KI SO PROIZVEDENE ALI UVOŽENE V KOLIČINI 100 TON ALI VEČ
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE
ZAHTEVE PO STANDARDNIH INFORMACIJAH ZA SNOVI, KI SO PROIZVEDENE ALI UVOŽENE V KOLIČINI 1000 TON ALI VEČ
GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X
SPLOŠNA PRAVILA ZA PRILAGODITEV STANDARDNEGA REŽIMA TESTIRANJA IZ PRILOG VII DO X
GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS
SPLOŠNE DOLOČBE ZA NADALJNJE UPORABNIKE ZA OCENJEVANJE SNOVI IN PRIPRAVO POROČIL O KEMIJSKI VARNOSTI
CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES
KRITERIJI ZA IDENTIFIKACIJO OBSTOJNIH SNOVI, SNOVI, KI SE KOPIČIJO V ORGANIZMIH, IN STRUPENIH SNOVI TER ZELO OBSTOJNIH SNOVI IN SNOVI, KI SE ZELO LAHKO KOPIČIJO V ORGANIZMIH
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION
SEZNAM SNOVI, KI SO PREDMET AVTORIZACIJE
DOSSIERS
DOKUMENTACIJA
SOCIO-ECONOMIC ANALYSIS
SOCIALNO-EKONOMSKA ANALIZA
RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES
OMEJITVE PROIZVODNJE, DAJANJA V PROMET IN UPORABE NEKATERIH NEVARNIH SNOVI, PRIPRAVKOV IN IZDELKOV
GENERAL ISSUES
SPLOŠNA VPRAŠANJA
Aim, scope and application
Cilj, obseg in področje uporabe
Aim and scope
Cilj in obseg
The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
Namen te uredbe je zagotoviti visoko raven zaščite zdravja ljudi in okolja, vključno z alternativnimi metodami ocene nevarnosti snovi, kot tudi prosti pretok snovi na notranjem trgu ob pospeševanju konkurenčnosti in inovacij.
This Regulation lays down provisions on substances and preparations within the meaning of Article 3.
Ta uredba vsebuje določbe o snoveh in pripravkih v smislu člena 3.
These provisions shall apply to the manufacture, placing on the market or use of such substances on their own, in preparations or in articles and to the placing on the market of preparations.
Te določbe se uporabljajo za proizvodnjo, dajanje v promet ali uporabo teh snovi kot takih, v pripravkih ali v izdelkih, in dajanje pripravkov v promet, če je tako navedeno.
This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.
Ta uredba temelji na načelu, da morajo proizvajalci, uvozniki in nadaljnji uporabniki zagotoviti, da proizvajajo, dajejo v promet ali uporabljajo takšne snovi, ki nimajo neugodnega učinka na zdravje ljudi ali okolje.
Its provisions are underpinned by the precautionary principle.
Njene določbe temeljijo na načelu previdnosti.
Application
Področje uporabe
radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation [26];
radioaktivne snovi s področja uporabe Direktive Sveta 96/29/Euratom z dne 13. maja 1996 o določitvi temeljnih varnostnih standardov za varovanje zdravja delavcev in prebivalstva pred nevarnostmi zaradi ionizirajočega sevanja [26];
substances, on their own, in a preparation or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
snovi kot take, v pripravku ali izdelku, ki so pod carinskim nadzorom, če niso bile obdelane ali predelane in če so v začasni hrambi v prosti coni ali prostem skladišču, ker se bodo ponovno izvozile ali ker so v tranzitu;
non-isolated intermediates;
neizolirane intermediate;
the carriage of dangerous substances and dangerous substances in dangerous preparations by rail, road, inland waterway, sea or air.
prevoz nevarnih snovi in nevarnih snovi v nevarnih pripravkih po železnici, cesti, celinskih plovnih poteh, morju ali zraku.
Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council [27] is not a substance, preparation or article within the meaning of Article 3 of this Regulation.
Odpadki, kakor je opredeljeno v Direktivi 2006/12/ES Evropskega parlamenta in Sveta [27], ne pomenijo snovi, pripravka ali izdelka v smislu člena 3 te uredbe.
Member States may allow for exemptions from this Regulation in specific cases for certain substances, on their own, in a preparation or in an article, where necessary in the interests of defence.
Države članice smejo v posebnih primerih za določene snovi kot take, v pripravku ali izdelku dovoliti odstopanja od te uredbe, kjer je to potrebno v interesu obrambe.
Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work [28], Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control [29]; Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy [30] and Directive 2004/37/EC;
zakonodajo Skupnosti v zvezi z zaposlitvijo in okoljem, vključno z Direktivo Sveta 89/391/EGS z dne 12. junija 1989 o uvajanju ukrepov za spodbujanje izboljšav varnosti in zdravja delavcev pri delu [28], Direktivo Sveta 96/61/ES z dne 24. septembra 1996 o celovitem preprečevanju in nadzorovanju onesnaževanja [29], Direktivo 98/24/ES, Direktivo 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti na področju vodne politike [30] in Direktivo 2004/37/ES;
Directive 76/768/EEC as regards testing involving vertebrate animals within the scope of that Directive.
Direktivo 76/768/EGS v zvezi s testiranjem, ki vključuje vretenčarje, na področju uporabe navedene direktive.
The provisions of Titles II, V, VI and VII shall not apply to the extent that a substance is used:
Določbe iz naslovov II, V, VI in VII se ne uporabljajo, če se snov uporablja:
in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [31] and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [32];
v zdravilih za humano in veterinarsko uporabo na področju uporabe Uredbe (ES) št. 726/2004, Direktive 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini [31] in Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [32];
in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
v hrani ali krmi skladno z Uredbo (ES) št. 178/2002, vključno z uporabo:
as a food additive in foodstuffs within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption [33];
kot dodatek živilom na področju uporabe Direktive Sveta 89/107/EGS z dne 21. decembra 1988 o približevanju zakonodaj držav članic o aditivih za živila, ki se smejo uporabljati v živilih, namenjenih za prehrano ljudi [33];
as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production [34] and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council [35];
kot aromatski dodatek živilom na področju uporabe Direktive Sveta 88/388/EGS z dne 22. junija 1988 o približevanju zakonodaje držav članic o aromah za uporabo v živilih in izhodnih surovinah za njihovo proizvodnjo [34] in Odločbe Komisije 1999/217/ES z dne 23. februarja 1999 o registru aromatičnih snovi, ki se uporabljajo v živilih ali na njih, pripravljenem skladno z Uredbo (ES) št. 2232/96 Evropskega parlamenta in Sveta [35];
as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [36];
kot dodatek krmi na področju uporabe Uredbe (ES) št. 1831/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [36];
in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition [37].
v prehrani živali na področju uporabe Direktive Sveta 82/471/EGS z dne 30. junija 1982 o nekaterih proizvodih, ki se uporabljajo v prehrani živali [37].
The provisions of Title IV shall not apply to the following preparations in the finished state, intended for the final user:
Določbe iz naslova IV se ne uporabljajo za naslednje pripravke v končni obliki, namenjene končnemu uporabniku:
medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;
zdravila za humano in veterinarsko uporabo na področju uporabe Uredbe (ES) št. 726/2004 in Direktive 2001/82/ES ter kakor je opredeljeno v Direktivi 2001/83/ES;
cosmetic products as defined in Directive 76/768/EEC;
kozmetične izdelke, kakor so opredeljeni v Direktivi 76/768/EGS;
medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as Directive 1999/45/EC;
medicinske pripomočke, ki so invazivni ali se uporabljajo v neposrednem fizičnem stiku s človeškim telesom, če ukrepi Skupnosti določajo določbe za razvrščanje in označevanje nevarnih snovi in pripravkov, ki zagotavljajo enako raven informacij in zaščite kot Direktiva 1999/45/ES;
food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
hrano ali krmo skladno z Uredbo (ES) št. 178/2002, vključno z uporabo:
as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
kot dodatek živilom na področju uporabe Direktive 89/107/EGS;
as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;
kot aromatski dodatek živilom na področju uporabe Direktive 88/388/EGS in Odločbe 1999/217/ES;
as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
kot dodatek krmi na področju uporabe Uredbe (ES) št. 1831/2003;
in animal nutrition within the scope of Directive 82/471/EEC.
v prehrani živali na področju uporabe Direktive 82/471/EGS.
The following shall be exempted from Titles II, V and VI:
Iz naslovov II, V in VI se izvzame naslednje:
substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;
snovi iz Priloge IV, glede na to, da je o njih znanih dovolj podatkov, da zanje zaradi njihovih intrinzičnih lastnosti velja minimalno tveganje;
substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;
snovi iz Priloge V, glede na to, da je zanje registracija neustrezna ali nepotrebna in da izjema zanje v zvezi s temi naslovi ne posega v cilje te uredbe;