Directive 2008/112/EC of the European Parliament and of the Council

Direktiva Evropskega parlamenta in Sveta 2008/112/ES

of 16 December 2008

z dne 16. decembra 2008

amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

o spremembi direktiv Sveta 76/768/EGS, 88/378/EGS, 1999/13/ES in direktiv 2000/53/ES, 2002/96/ES in 2004/42/ES Evropskega parlamenta in Sveta z namenom prilagoditve Uredbi (ES) št. 1272/2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi

(Text with EEA relevance)

(Besedilo velja za EGP)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA –

Having regard to the Treaty establishing the European Community, and in particular Article 95 and Article 175(1) thereof,

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti ter zlasti členov 95 in 175(1) Pogodbe,

Having regard to the proposal from the Commission,

ob upoštevanju predloga Komisije,

Having regard to the opinion of the European Economic and Social Committee [1],

ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora [1],

Having consulted the Committee of the Regions,

po posvetovanju z Odborom regij,

Acting in accordance with the procedure laid down in Article 251 of the Treaty [2],

v skladu s postopkom, določenim v členu 251 Pogodbe [2],

Whereas:

ob upoštevanju naslednjega:

(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [3] provides for the harmonisation of the classification and labelling of substances and mixtures within the Community. That Regulation will replace Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [4] as well as Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [5].

(1) Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [3] predvideva uskladitev razvrščanja in označevanja snovi ter zmesi v Skupnosti. Navedena uredba bo nadomestila Direktivo Sveta 67/548/EGS z dne 27. junija 1967 o približevanju zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi [4] ter Direktivo 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov [5].

(2) Regulation (EC) No 1272/2008 builds on the experience with Directives 67/548/EEC and 1999/45/EC and incorporates the criteria for classification and labelling of substances and mixtures provided for by the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) which has been adopted at the international level, within the structure of the United Nations.

(2) Uredba (ES) št. 1272/2008 temelji na izkušnjah direktiv 67/548/EGS in 1999/45/ES ter vključuje kriterije za razvrščanje in označevanje snovi ter zmesi, vsebovane v Globalno usklajenem sistemu za razvrščanje in označevanje kemikalij (GHS), ki je bil sprejet na mednarodni ravni v okviru Združenih narodov.

(3) Certain provisions on classification and labelling laid down in Directives 67/548/EEC and 1999/45/EC also serve for the purpose of application of other Community legislation, such as Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products [6], Council Directive 88/378/EEC of 3 May 1988 on the approximation of laws of the Member States concerning the safety of toys [7], Council Directive 1999/13/EC of 11 March 1999 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations [8], Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles [9], Directive 2002/96/EC of the European Parliament and of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE) [10] and Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products [11].

(3) Nekatere določbe o razvrščanju in označevanju iz direktiv 67/548/EGS in 1999/45/ES so namenjene tudi uporabi druge zakonodaje Skupnosti, kot so Direktiva Sveta 76/768/EGS z dne 27. julija 1976 o približevanju zakonodaje držav članic v zvezi s kozmetičnimi izdelki [6], Direktiva Sveta 88/378/EGS z dne 3. maja 1988 o približevanju zakonodaje držav članic v zvezi z varnostjo igrač [7], Direktiva Sveta 1999/13/ES z dne 11. marca 1999 o omejevanju emisij hlapnih organskih spojin zaradi uporabe organskih topil v nekaterih dejavnostih in obratih [8], Direktiva 2000/53/ES Evropskega parlamenta in Sveta z dne 18. septembra 2000 o izrabljenih vozilih [9], Direktiva 2002/96/ES Evropskega parlamenta in Sveta z dne 27. januarja 2003 o odpadni električni in elektronski opremi (OEEO) [10] ter Direktiva 2004/42/ES Evropskega parlamenta in Sveta z dne 21. aprila 2004 o omejevanju emisij hlapnih organskih spojin zaradi uporabe organskih topil v nekaterih barvah in lakih in proizvodih za ličenje vozil [11].

(4) The incorporation of the GHS criteria into Community legislation leads to the introduction of new hazard classes and categories only partially corresponding to the classification and labelling arrangements provided for by Directives 67/548/EEC and 1999/45/EC. An analysis of the potential effects of the transition from the old to the new system of classification and labelling has led to the conclusion that, by adapting the references to the classification criteria in Directives 76/768/EEC, 88/378/EEC, 2000/53/EC and 2002/96/EC to the new system introduced by Regulation (EC) No 1272/2008, the scope of the respective acts should be maintained.

(4) Vključitev kriterijev GHS v zakonodajo Skupnosti pomeni uvedbo novih razredov in kategorij nevarnosti, ki so le delno v skladu z ureditvami o razvrščanju in označevanju iz direktiv 67/548/EGS in 1999/45/ES. Analiza možnih učinkov prehoda s starega na nov sistem razvrščanja in označevanja je pokazala, da bi bilo treba s prilagoditvijo sklicevanj na kriterije razvrščanja v direktivah 76/768/EGS, 88/378/EGS, 2000/53/ES in 2002/96/ES na nov sistem, uveden z Uredbo (ES) št. 1272/2008, ohraniti področje uporabe zadevnih aktov.

(5) It is also necessary to adapt Directive 76/768/EEC to take into account the adoption of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [12].

(5) Treba je prilagoditi tudi Direktivo 76/768/EGS, da se upošteva sprejetje Uredbe (ES) št. 1907/2006 Evropskega Parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) o ustanovitvi Evropske agencije za kemikalije ter spremembi Direktive 1999/45/ES ter razveljavitvi Uredbe Sveta (EGS) št. 793/93 in Uredbe Komisije (ES) št. 1488/94 ter Direktive Sveta 76/769/EGS in direktiv Komisije 91/155/EGS, 93/67/EGS, 93/105/ES in 2000/21/ES [12].

(6) It is appropriate to bring Directive 1999/13/EC into line with the replacement of risk phrase R40 by two new risk phrases R40 and R68 under Directive 67/548/EEC, so as to ensure a correct transition to the hazard statements laid down in Regulation (EC) No 1272/2008.

(6) Primerno je uskladiti Direktivo 1999/13/ES z zamenjavo opozorilnega stavka R40 z dvema novima opozorilnima stavkoma R40 in R68 na podlagi Direktive 67/548/EGS, da se zagotovi pravilen prehod na stavke o nevarnosti iz Uredbe (ES) št. 1272/2008.

(7) The transition from the criteria for classification contained in Directives 67/548/EEC and 1999/45/EC should be fully completed on 1 June 2015. Manufacturers of cosmetics, toys, paints, varnishes, vehicle refinishing products, vehicles and electric and electronic equipment are manufacturers, importers or downstream users within the meaning of Regulation (EC) No 1272/2008, as are the operators whose activities are covered by Directive 1999/13/EC. All of them should be enabled to design their transition strategy under this Directive in a similar timeframe as under Regulation (EC) No 1272/2008.

(7) Prehod s kriterijev za razvrščanje iz direktiv 67/548/EGS in 1999/45/ES bi moral biti v celoti zaključen 1. junija 2015. Proizvajalci kozmetičnih izdelkov, igrač, barv, lakov, proizvodov za ličenje vozil, vozil ter električne in elektronske opreme kot tudi subjekti, katerih dejavnosti so zajete v Direktivi 1999/13/ES, so proizvajalci, uvozniki ali nadaljnji uporabniki v smislu Uredbe (ES) št. 1272/2008. Po tej direktivi bi morali imeti vsi možnost pripraviti svojo strategijo prehoda v podobnem časovnem okviru kot po Uredbi (ES) št. 1272/2008.

(8) In accordance with point 34 of the Interinstitutional Agreement on better law-making [13], Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and make them public.

(8) V skladu s točko 34 Medinstitucionalnega sporazuma o boljši pripravi zakonodaje [13] se države članice poziva, da za lastne potrebe in v interesu Skupnosti pripravijo tabele, ki naj kar najbolj nazorno prikazujejo povezavo med to direktivo in ukrepi za prenos, ter da te tabele objavijo.

(9) Directives 76/768/EEC, 88/378/EEC, 1999/13/EC, 2000/53/EC, 2002/96/EC and 2004/42/EC should be amended accordingly,

(9) Direktive 76/768/EGS, 88/378/EGS, 1999/13/ES, 2000/53/ES, 2002/96/ES in 2004/42/ES bi bilo zato treba ustrezno spremeniti –

HAVE ADOPTED THIS DIRECTIVE:

SPREJELA NASLEDNJO DIREKTIVO:

Article 1

Člen 1

Amendments to Directive 76/768/EEC

Spremembe Direktive 76/768/EGS

Directive 76/768/EEC is hereby amended as follows:

Direktiva 76/768/EGS se spremeni:

1. the word "preparation" or "preparations" within the meaning of Article 3(2) of Regulation (EC) No 1907/2006, in its version of 30 December 2006, shall be replaced by "mixture" or "mixtures" respectively throughout the text;

1. Beseda "pripravek" v smislu člena 3(2) Uredbe (ES) št. 1907/2006 v njeni različici z dne 30. decembra 2006 se v celotnem besedilu nadomesti z besedo "zmes" v ustreznem številu in sklonu in temu ustrezno se prilagodi tudi stavek v katerem se nahaja.

2. in Article 4a(1), point d shall be replaced by the following:

2. V členu 4a(1) se točka d nadomesti z naslednjim:

"(d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Directive, no later than the date on which such tests are required to be replaced by one or more validated methods listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [] or in Annex IX to this Directive.

"(d) izvajanje testiranja sestavin ali kombinacij sestavin na živalih zaradi izpolnjevanja zahtev te direktive na svojem ozemlju, najpozneje do datuma, ko se zahteva, da se taki testi nadomestijo z eno ali več znanstveno potrjenimi metodami, navedenimi v Uredbi Komisije (ES) št. 440/2008 z dne 30. maja 2008 o določitvi testnih metod v skladu z Uredbo (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) [] ali v Prilogi IX k tej direktivi.

3. from 1 December 2010, Article 4b shall be replaced by the following:

3. Od 1. decembra 2010 se člen 4b nadomesti z naslednjim:

"Article 4b

"Člen 4b

The use in cosmetic products of substances classified as carcinogenic, germ cell mutagenic or toxic for reproduction, of category 1A, 1B and 2, under part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [] shall be prohibited. To that end the Commission shall adopt the necessary measures in accordance with the regulatory procedure referred to in Article 10(2). A substance classified in category 2 may be used in cosmetics if the substance has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found acceptable for use in cosmetic products.

V kozmetičnih izdelkih je prepovedano uporabljati snovi, ki so razvrščene kot rakotvorne, mutagene za zarodne celice ali strupene za razmnoževanje, kategorij 1A, 1B in 2 na podlagi dela 3 Priloge VI k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi []. V ta namen Komisija sprejme potrebne ukrepe v skladu z regulativnim postopkom iz člena 10(2). Snov, razvrščena v kategorijo 2, se lahko uporablja v kozmetičnih izdelkih, če jo je evalviral Znanstveni odbor za varstvo potrošnikov (ZOVP) in ugotovil, da je sprejemljiva za uporabo v kozmetičnih izdelkih.

4. from 1 December 2010, in Article 7a(1), the last sentence of the second subparagraph of point (h) shall be replaced by the following:

4. Od 1. decembra 2010 se v členu 7a(1) zadnji stavek drugega pododstavka točke (h) nadomesti z naslednjim:

"The quantitative information required under (a) to be made publicly accessible shall be limited to substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

"Podatki o količinah, ki se zahtevajo v (a) in ki naj bodo dostopni javnosti, se omejijo na snovi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(a) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(b) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(d) hazard class 5.1.";

(d) razred nevarnosti 5.1."

5. in Annex IX, the first sentence shall be replaced by the following:

5. V Prilogi IX se prvi stavek nadomesti z naslednjim:

"This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the requirements of this Directive and which are not listed in Regulation (EC) No 440/2008.".

"Ta priloga navaja alternativne metode, ki jih je potrdil Evropski center za potrjevanje alternativnih metod (ECVAM) Skupnega raziskovalnega središča, ki so na voljo za izpolnjevanje zahtev te direktive in ki niso navedene v Uredbi (ES) št. 440/2008.".

Article 2

Člen 2

Amendments to Directive 88/378/EEC

Spremembe Direktive 88/378/EGS

Directive 88/378/EEC is hereby amended as follows:

Direktiva 88/378/EGS se spremeni:

1. Beseda "pripravek" v smislu člena 3(2) Uredbe (ES) št. 1907/2006 v njeni različici z dne 30. decembra 2006 se v celotnem besedilu nadomesti z besedo "zmes"v ustreznem številu in sklonu in temu ustrezno se prilagodi tudi stavek v katerem se nahaja.

2. from 1 December 2010, in section 2 of part II of Annex II, point (b) shall be replaced by the following:

2. Od 1. decembra 2010 se v oddelku 2 dela II Priloge II točka (b) nadomesti z naslednjim:

"(b) Toys must not contain, as such, substances or mixtures which may become flammable due to the loss of non-flammable volatile components if, for reasons essential to their functioning, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, such toys contain mixtures which are dangerous as defined in Directive 67/548/EEC or substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures []:

"(b) Igrače same po sebi ne smejo vsebovati snovi ali zmesi, ki bi postale vnetljive zaradi izgube nevnetljivih hlapljivih sestavin, če zaradi bistva svojega delovanja (zlasti materiali in oprema za kemične poskuse, sestavljanje modelov, modeliranje plastične mase ali keramike, emajliranje, fotografijo ali podobne dejavnosti) takšne igrače vsebujejo zmesi, ki so nevarne v skladu z opredelitvijo v Direktivi 67/548/EGS, ali snovi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi []:

(i) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(i) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(ii) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(iii) hazard class 4.1;

(iii) razred nevarnosti 4.1;

(iv) hazard class 5.1.

(iv) razred nevarnosti 5.1.

3. from 1 June 2015, in section 2 of part II of Annex II, point (b) shall be replaced by the following:

3. Od 1. junija 2015 se v oddelku 2 dela II Priloge II točka (b) nadomesti z naslednjim:

"(b) Toys must not contain, as such, substances or mixtures which may become flammable due to the loss of non-flammable volatile components if, for reasons essential to their functioning, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, such toys contain substances or mixtures fulfilling the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures []:

"(b) Igrače same po sebi ne smejo vsebovati snovi ali zmesi, ki bi postale vnetljive zaradi izgube nevnetljivih hlapljivih sestavin, če zaradi bistva svojega delovanja (zlasti materiali in oprema za kemične poskuse, sestavljanje modelov, modeliranje plastične mase ali keramike, emajliranje, fotografijo ali podobne dejavnosti) takšne igrače vsebujejo snovi ali zmesi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi []:

(i) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(i) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(ii) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(iii) hazard class 4.1;

(iii) razred nevarnosti 4.1;

(iv) hazard class 5.1.

(iv) razred nevarnosti 5.1.

4. from 1 December 2010, in section 3 of part II of Annex II, the first paragraph of point 3 shall be replaced by the following:

4. Od 1. decembra 2010 se v oddelku 3 dela II Priloge II prvi odstavek točke 3 nadomesti z naslednjim:

"3. Toys must not contain mixtures which are dangerous within the meaning of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [] or substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

"3. Igrače ne smejo vsebovati zmesi, ki so nevarne v smislu Direktive 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov [], ali snovi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(a) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(b) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(d) hazard class 5.1,

(d) razred nevarnosti 5.1,

in amounts which may harm the health of children using them. In any event it is strictly forbidden to include, in a toy, such substances or mixtures if they are intended to be used as such while the toy is being used.

v količinah, ki lahko škodujejo zdravju otrok, ki igrače uporabljajo. V vsakem primeru je takšne snovi ali zmesi strogo prepovedano vključiti v igračo, če naj bi bile uporabljene kot take ob uporabi igrače.

5. from 1 June 2015, in section 3 of part II of Annex II, the first paragraph of point 3 shall be replaced by the following:

5. Od 1. junija 2015 se v oddelku 3 dela II Priloge II prvi odstavek točke 3 nadomesti z naslednjim:

"3. Toys must not contain substances or mixtures fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

"3. Igrače ne smejo vsebovati snovi ali zmesi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008:

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(a) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(b) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(d) hazard class 5.1;

(d) razred nevarnosti 5.1,

6. from 1 December 2010, in section 4 of Annex IV, the title and point (a) shall be replaced by the following:

6. Od 1. decembra 2010 se v oddelku 4 Priloge IV naslov in točka (a) nadomestita z naslednjim:

"4. Toys containing inherently dangerous substances or mixtures. Chemical toys

"4. Igrače, ki vsebujejo snovi ali zmesi, ki so same po sebi nevarne. Kemijske igrače

(a) Without prejudice to the application of the provisions laid down in Regulation (EC) No 1272/2008, the instructions for use of toys containing mixtures which are inherently dangerous or substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

(a) Brez poseganja v uporabo določb iz Uredbe (ES) št. 1272/2008, navodila za uporabo igrač, ki vsebujejo zmesi, ki so same po sebi nevarne, ali snovi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008:

(i) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(i) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(ii) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(iii) hazard class 4.1;

(iii) razred nevarnosti 4.1;

(iv) hazard class 5.1;

(iv) razred nevarnosti 5.1,

shall bear a warning of the hazardous nature of these substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, which shall be specified concisely according to the type of toy. The first aid to be given in the event of serious accidents resulting from the use of this type of toy shall also be mentioned. It shall also be stated that the toys must be kept out of reach of very young children.";

vsebujejo opozorilo glede nevarnosti teh snovi ali zmesi ter navodila v zvezi z varnostnimi ukrepi, ki jih mora upoštevati uporabnik, da bi se izognil z njimi povezanim nevarnostim, ki so na kratko opisana glede na vrsto igrače. Omeni se tudi prva pomoč v primeru hude nesreče zaradi uporabe te vrste igrače. Navede se tudi, da morajo biti igrače izven dosega zelo majhnih otrok."

7. from 1 June 2015, in section 4 of Annex IV, the title and point (a) shall be replaced by the following:

7. Od 1. junija 2015 se v oddelku 4 Priloge IV naslov in točka (a) nadomestita z naslednjim:

"4. Toys containing inherently dangerous substances or mixtures. Chemical toys

"4. Igrače, ki vsebujejo nevarne snovi ali zmesi, ki so same po sebi nevarne. Kemijske igrače

(a) Without prejudice to the application of the provisions laid down in Regulation (EC) No 1272/2008, the instructions for use of toys containing substances or mixtures fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to that Regulation:

(a) Brez poseganja v uporabo določb iz Uredbe (ES) št. 1272/2008 navodila za uporabo igrač, ki vsebujejo snovi ali zmesi, ki izpolnjujejo kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k navedeni Uredbi:

(i) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(i) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(ii) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(iii) hazard class 4.1;

(iii) razred nevarnosti 4.1;

(iv) hazard class 5.1;

(iv) razred nevarnosti 5.1,

Article 3

Člen 3

Amendments to Directive 1999/13/EC

Spremembe Direktive 1999/13/ES

Directive 1999/13/EC is hereby amended as follows:

Direktiva 1999/13/ES se spremeni:

2. Article 5 shall be amended as follows:

2. Člen 5 se spremeni:

(a) from 1 December 2010, paragraph 6 shall be replaced by the following:

(a) Od 1. decembra 2010 se odstavek 6 nadomesti z naslednjim:

"6. Substances or mixtures which, because of their content of VOCs classified as carcinogens, mutagens or toxic to reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [] are assigned or need to carry the hazard statements H340, H350, H350i, H360D or H360F or the risk phrases R45, R46, R49, R60 or R61 shall be replaced, as far as possible and by taking into account the guidance referred to in Article 7(1), by less harmful substances or mixtures within the shortest possible time.

"6. Snovi ali zmesi, za katere so predpisani stavki o nevarnosti H340, H350, H350i, H360D ali H360F ali opozorilni stavki R45, R46, R49, R60 ali R61 oziroma morajo biti označene z njimi, ker so zaradi deleža HOS v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [] uvrščene med rakotvorne, mutagene ali za razmnoževanje strupene snovi, se v najkrajšem možnem času nadomestijo z manj škodljivimi snovmi ali zmesmi, kolikor je to mogoče in ob upoštevanju smernic iz člena 7(1).

(b) from 1 June 2015, paragraph 6 shall be replaced by the following:

(b) Od 1. junija 2015 se odstavek 6 nadomesti z naslednjim:

"6. Substances or mixtures which, because of their content of VOCs classified as carcinogens, mutagens or toxic to reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [] are assigned or need to carry the hazard statements H340, H350, H350i, H360D or H360F shall be replaced, as far as possible and by taking into account the guidance as mentioned in Article 7(1), by less harmful substances or mixtures within the shortest possible time.

"6. Snovi ali zmesi, za katere so predpisani stavki o nevarnosti H340, H350, H350i, H360D ali H360F oziroma morajo biti označene z njimi, ker so zaradi deleža HOS v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [] uvrščene med rakotvorne, mutagene ali za razmnoževanje strupene snovi, se v najkrajšem možnem času nadomestijo z manj škodljivimi snovmi ali zmesmi, kolikor je to mogoče in ob upoštevanju smernic iz člena 7(1).

(i) the words "the risk phrase R40" shall be replaced by "the risk phrases R40 or R68";

(i) besede "opozorilni stavek R40" se nadomestijo z "opozorilni stavek R40 ali R68";

(ii) the words "the labelling R40" shall be replaced by "the labelling R40 or R68";

(ii) besede "oznaka R40" se nadomestijo z "oznaka R40 ali R68";

(iii) from 1 June 2015, the words "the risk phrases R40 or R68" shall be replaced by "the hazard statements H341 or H351";

(iii) od 1. junija 2015 se besede "opozorilni stavek R40 ali R68" nadomestijo s "stavek o nevarnosti H341 ali H351";

(iv) from 1 June 2015, the words "the labelling R40 or R68" shall be replaced by "the hazard statements H341 or H351";

(iv) od 1. junija 2015 se besede "oznaka R40 ali R68" nadomestijo s "stavek o nevarnosti H341 ali H351";

(d) from 1 June 2015, in paragraph 9, the words "risk phrases" shall be replaced by "hazard statements";

(d) Od 1. junija 2015 se v odstavku 9 besedi "opozorilni stavki" nadomestita z besedami "stavki o nevarnosti".

(e) paragraph 13 shall be amended as follows:

(e) Odstavek 13 se spremeni:

(i) the words "the labelling R40, R60 or R61" shall be replaced by "the risk phrases R40, R68, R60 or R61";

(i) besede "oznaka R40, R60 ali R61" se nadomestijo z "opozorilni stavek R40, R68, R60 ali R61";

(ii) from 1 June 2015, the words "the risk phrases R40, R68, R60 or R61" are replaced by "the hazard statements H341, H351, H360F or H360D".

(ii) od 1. junija 2015 se besede "opozorilni stavek R40, R68, R60 ali R61" nadomestijo s "stavki o nevarnosti H341, H351, H360F ali H360D".

Article 4

Člen 4

Amendment to Directive 2000/53/EC

Spremembe Direktive 2000/53/ES

From 1 December 2010, in Article 2 of Directive 2000/53/EC, point 11 shall be replaced by the following:

Od 1. decembra 2010 se v členu 2 Direktive 2000/53/ES točka 11 nadomesti z naslednjim:

"11. "hazardous substance" means any substance which fulfils the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [];

"11. "nevarna snov" pomeni vsako snov, ki izpolnjuje kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [];

(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(a) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(b) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(d) hazard class 5.1.

(d) razred nevarnosti 5.1.

Article 5

Člen 5

Amendments to Directive 2002/96/EC

Spremembe Direktive 2002/96/ES

Directive 2002/96/EC is hereby amended as follows:

Direktiva 2002/96/ES se spremeni:

2. from 1 December 2010, in Article 3, point (l) shall be replaced by the following:

2. Od 1. decembra 2010 se točka (l) v členu 3 nadomesti z naslednjim:

"(l) "dangerous substance or mixture" means any mixture which has to be considered dangerous under Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [] or any substance which fulfils the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures []:

"(l) "nevarna snov ali zmes" pomeni vsako snov ali zmes, ki jo je treba obravnavati kot nevarno v skladu z Direktivo 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov [], ali vsako snov, ki izpolnjuje kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi []:

(i) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(i) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(ii) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(iii) hazard class 4.1;

(iii) razred nevarnosti 4.1;

(iv) hazard class 5.1.

(iv) razred nevarnosti 5.1;

3. from 1 June 2015, in Article 3, point (l) shall be replaced by the following:

3. Od 1. junija 2015 se točka (l) v členu 3 nadomesti z naslednjim:

"(l) "dangerous substance or mixture" means any substance or mixture which fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures []:

"(l) "nevarna snov ali zmes" pomeni vsako snov ali zmes, ki izpolnjuje kriterije za katerega koli od naslednjih razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [];

(i) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

(i) razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategoriji 1 in 2, 2.14 kategoriji 1 in 2, 2.15 vrste A do F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

(ii) razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;

(iii) hazard class 4.1;

(iii) razred nevarnosti 4.1;

(iv) hazard class 5.1;

(iv) razred nevarnosti 5.1.

4. in section 1 of Annex II, the thirteenth indent shall be replaced by the following:

4. V oddelku 1 Priloge II se trinajsta alinea nadomesti z naslednjim:

- "— components containing refractory ceramic fibres as described in part 3 of Annex VI to Regulation (EC) No 1272/2008".

- "— sestavni deli, ki vsebujejo refraktorska keramična vlakna, kot je opisano v delu 3 Priloge VI k Uredbi (ES) št. 1272/2008,"

Article 6

Člen 6

Amendment to Directive 2004/42/EC

Spremembe Direktive 2004/42/ES

Article 2 of Directive 2004/42/EC is hereby amended as follows:

Člen 2 Direktive 2004/42/ES se spremeni:

(a) in paragraph 3, the word "preparation" shall be replaced by "mixture";

(a) V odstavku 3 se beseda "pripravek" nadomesti z "zmes".

(b) in paragraph 8, the word "preparation" shall be replaced by "mixture".

(b) V odstavku 8 se beseda "pripravek" nadomesti z "zmes".

Article 7

Člen 7

Transposition

Prenos

1. Member States shall adopt and publish by 1 April 2010, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

1. Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo do 1. aprila 2010. O teh predpisih takoj obvestijo Komisijo.

They shall apply those provisions from 1 June 2010.

Navedene predpise uporabljajo od 1. junija 2010.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi. Način sklicevanja določijo države članice.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

2. Države članice predložijo Komisiji besedilo temeljnih predpisov nacionalne zakonodaje, sprejetih na področju, ki ga ureja ta direktiva.

Article 8

Člen 8

Entry into Force

Začetek veljavnosti

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Ta direktiva začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.

Article 9

Člen 9

Addressees

Naslovniki

This Directive is addressed to the Member States.

Ta direktiva je naslovljena na države članice.

Done at Strasbourg, 16 December 2008.

V Strasbourgu, 16. decembra 2008

For the European Parliament

Za Evropski parlament

The President

Predsednik

H.-G. Pöttering

For the Council

Za Svet

The President

Predsednik

B. Le Maire

[1] OJ C 120, 16.5.2008, p. 50.

[1] UL C 120, 16.5.2008, str. 50.

[2] Opinion of the European Parliament of 3 September 2008 (not yet published in the Official Journal) and Council Decision of 28 November 2008.

[2] Mnenje Evropskega parlamenta z dne 3. septembra 2008 (še ni objavljeno v UL) in Sklep Sveta z dne 28. novembra 2008.

[3] OJ L 353, 31.12.2008, p. 1.

[3] UL L 353, 31.12.2008, str. 1.

[4] OJ 196, 16.8.1967, p. 1.

[4] UL 196, 16.8.1967, str. 1.

[5] OJ L 200, 30.7.1999, p. 1.

[5] UL L 200, 30.7.1999, str. 1.

[6] OJ L 262, 27.9.1976, p. 169.

[6] UL L 262, 27.9.1976, str. 169.

[7] OJ L 187, 16.7.1988, p. 1.

[7] UL L 187, 16.7.1988, str. 1.

[8] OJ L 85, 29.3.1999, p. 1.

[8] UL L 85, 29.3.1999, str. 1.

[9] OJ L 269, 21.10.2000, p. 34.

[9] UL L 269, 21.10.2000, str. 34.

[10] OJ L 37, 13.2.2003, p. 24.

[10] UL L 37, 13.2.2003, str. 24.

[11] OJ L 143, 30.4.2004, p. 87.

[11] UL L 143, 30.4.2004, str. 87.

[12] OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.

[12] UL L 396, 30.12.2006, str. 1. Popravljena različica v UL L 136, 29.5.2007, str. 3.

[13] OJ C 321, 31.12.2003, p. 1.

[13] UL C 321, 31.12.2003, str. 1.

[] OJ L 142, 31.5.2008, p. 1.";

[] UL L 142, 31.5.2008, str. 1."

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 200, 30.7.1999, p. 1.";

[] UL L 200, 30.7.1999, str. 1."

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 353, 31.12.2008, p. 1.".

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 200, 30.7.1999, p. 1.

[] UL L 200, 30.7.1999, str. 1.

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

[] OJ L 353, 31.12.2008, p. 1.";

[] UL L 353, 31.12.2008, str. 1."

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