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Commission Regulation (EC) No 1217/2002
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Uredba Komisije (ES) št. 1217/2002
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of 5 July 2002
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z dne 5. julija 2002
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requiring importers or manufacturers of certain Einecs substances to supply certain information and perform certain tests pursuant to Council Regulation (EEC) No 793/93
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o zahtevi, da uvozniki ali proizvajalci nekaterih snovi Einecs predložijo nekatere informacije in izvedejo nekatere preskuse na podlagi Uredbe Sveta (EGS) št. 793/93
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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
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KOMISIJA EVROPSKIH SKUPNOSTI JE –
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Having regard to the Treaty establishing the European Community,
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ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti,
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Having regard to Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances [1], and in particular Article 12(2) thereof,
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ob upoštevanju Uredbe Sveta (EGS) št. 793/93 z dne 23. marca 1993 o oceni in nadzoru tveganja, ki ga predstavljajo obstoječe snovi [1], in zlasti člena 12(2) Uredbe,
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Whereas:
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ob upoštevanju naslednjega:
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(1) A number of Member States have apprised the Commission of valid reasons for believing that certain substances in the European Inventory of Existing Commercial Chemical Substances (Einecs) [2] may, due to the degree of exposure entailed in their production or use, pose a serious risk to humans or the environment.
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(1) Številne države članice so obvestile Komisijo o tehtnih razlogih za domnevo, da lahko nekatere snovi z evropskega seznama obstoječih snovi (Einecs) [2] zaradi stopnje izpostavljenosti, do katere pride pri njihovi proizvodnji ali uporabi, predstavljajo resno tveganje za ljudi ali okolje.
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(2) The manufacturers and importers concerned should therefore be required to provide the Commission with the information in their possession concerning those substances.
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(2) Od teh proizvajalcev in uvoznikov je torej treba zahtevati, da Komisiji predložijo njihove informacije o teh snoveh.
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(3) The manufacturers and importers concerned should also be required to test the substances in question, to draw up a report on those tests and to forward those reports, together with the results of the tests, to the Commission, subject to the possibility provided for by Article 12(3) of Regulation (EEC) No 793/93 that, where a substance is produced or imported as such or in a preparation by several manufacturers or importers, further testing may be performed by one or more manufacturers or importers acting on behalf of the others.
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(3) Od teh proizvajalcev in uvoznikov je prav tako treba zahtevati, da preskusijo obravnavane snovi, da pripravijo poročilo o navedenih preskusih in da ta poročila, skupaj z rezultati preskusov, posredujejo Komisiji, skladno z možnostjo, predvideno v členu 12(3) Uredbe (EGS) št. 793/93, ki pravi, da kadar neko snov kot tako ali v obliki pripravka proizvajajo ali uvažajo različni proizvajalci ali uvozniki, lahko eden ali več proizvajalcev ali uvoznikov v imenu drugih izvede dodatno preskušanje.
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(4) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15 of Regulation (EEC) No 793/93,
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(4) Ukrepi, predvideni s to uredbo, so v skladu z mnenjem odbora, ustanovljenega s členom 15 Uredbe (EGS) št. 793/93 –
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HAS ADOPTED THIS REGULATION:
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SPREJELA NASLEDNJO UREDBO:
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Article 1
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Člen 1
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Manufacturers and importers of one or more of the Einecs substances listed in the Annex to this Regulation shall:
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Proizvajalci in uvozniki ene ali več snovi Einecs, navedenih v Prilogi k tej uredbi:
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(a) provide the Commission with the information specified in the Annex within the time-limits laid down therein;
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(a) predložijo Komisiji informacije, določene v Prilogi, v okviru v njej določenih rokov;
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(b) perform, in relation to each such substance, the tests indicated in the Annex in accordance with the protocols specified therein;
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(b) v zvezi z vsako takšno snovjo izvedejo preskuse, navedene v Prilogi, v skladu z v njej določenimi protokoli;
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(c) provide the Commission with a report on each test, including the results thereof, within the time-limits laid down in the Annex.
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(c) predložijo Komisiji poročilo o vsakem preskusu, skupaj z rezultati, v okviru rokov, določenih v Prilogi.
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Article 2
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Člen 2
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This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
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Ta uredba začne veljati 20. dan po objavi v Uradnem listu Evropskih skupnosti.
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This Regulation shall be binding in its entirety and directly applicable in all Member States.
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Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
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Done at Brussels, 5 July 2002.
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V Bruslju, 5. julija 2002
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For the Commission
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Za Komisijo
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Margot Wallström
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Margot Wallström
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Member of the Commission
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Članica Komisije
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[1] OJ L 84, 5.4.1993, p. 1.
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[1] UL L 84, 5.4.1993, str. 1.
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[2] OJ C 146 A, 15.6.1990, p.1.
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[2] UL C 146 A, 15.6.1990, str. 1.
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ANNEX
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PRILOGA
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The testing/information requirements referred to in this Annex should be addressed to:
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Zahteve za preskušanje/informacije iz te priloge naj se naslovijo na:
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European Commission
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Evropska komisija
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Directorate-General for Environment
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Generalni direktorat za okolje
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Directorate C — Unit C.3 — Chemicals
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Direktorat C - Enota C.3 - Kemikalije
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B-1049 Brussels
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B—1049 Bruselj
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| Einecs No | CAS No | Substance name | Reason(s) for concern | Testing/Information Requirements | Months from the date of entry into force of this Regulation) |
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| Št. Einecs | Št. CAS | Ime snovi | Razlog(-i) za skrb | Zahteve za preskušanje/informacije | Meseci od datuma začetka veljavnosti te uredbe |
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1 | 203-988-3 | 112-59-4 | Diethylene glycol mono-hexyl ether | Human exposure during production and use. Dispersive use in coatings, printing inks and cleaning applications Unavailability of studies on developmental and fertility effects of the substance causes concern because of clear reprotoxicity observed in rodent and non-rodent studies with some ethylene glycol ether derivatives | Fertility Study (EC B.34 [1]/OECD TG 415 [2] or OECD TG 416 [3]) | 18 |
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1 | 203-988-3 | 112-59-4 | Dietilen glikol monoheksil eter | Izpostavljenost ljudi med proizvodnjo in uporabo. Razpršena uporaba v premazih, tiskarskih črnilih in za čistilih. Nerazpoložljivost študij o učinkih snovi na razvoj in plodnost povzroča skrb zaradi jasne toksičnosti za razmnoževanje, opažene v študijah na glodalcih in neglodalcih z nekaterimi derivati etilen glicol etra | Študije plodnosti (EC B.34/OECD TG 415 ali OECD TG 416) | 18 |
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2 | 263-090-2 | 61789-80-8 | Quaternary Ammonium compounds, bis(hydrogenated tallow alkyl) dimethyl, chlorides | Significant increase in consumption volumes of the substance which would pose a potential risk for the environment | Yearly reports from industry of the total production and use volumes of the substance (period 2000-2002) | 6 (volumes year 2000) 18 (volumes year 2001) 24 (volumes year 2002) |
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2 | 263-090-2 | 61789-80-8 | Kvartarne amonijeve spojine, bis (hidrogenirane lojeve alkil) dimetil, kloridi | Znatno povečanje v količinah porabljene snovi, ki bi lahko predstavljale tveganje za okolje | Letna poročila industrije o skupnih proizvedenih in uporabljenih količinah snovi (obdobje 2000 – 2002) | 6 (količina leto 2000) 18 (količina leto 2001) 24 (količina leto 2002) |
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3 | 203-481-7 | 107-31-3 | Methyl formate | High Production Volume Chemical Acute inhalation exposure of experimental animals to the substance has resulted in eye and respiratory tract irritation Uncertainty and impossibility of establishing a scientifically based OEL (SCOEL) due to lack of data Lack of data on prolonged exposure for the establishment of safe exposure level | Subchronic Inhalation Toxicity Study: 90-day repeated inhalation dose study (EC B.29 [3]/OECD TG 413 [4]) | 18 |
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3 | 203-481-7 | 107-31-3 | Metil format | Kemikalija proizvedena v velikih količinah Akutna inhalacijska izpostavljenost preskusnih živali snovi je povzročila draženje oči in dihal Negotovost in nezmožnost vzpostavitve OEL (SCOEL) na znanstveni podlagi zaradi pomanjkanja podatkov Pomanjkanje podatkov o dolgotrajni izpostavljenosti za določitev varne stopnje izpostavljenosti | Študija subkronične inhalacijske toksičnosti: 90 - dnevna študija s ponavljajočim se odmerkom (EC B.29/OECD TG 413) | 18 |
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4 | 200-864-0 | 75-35-4 | 1,1-dichloroethene | High Production Volume Chemical Nervous system disfunctioning upon long term exposure well below present Occupational Exposure Limits (OELs) | Subchronic Inhalation Toxicity Study: 90-day repeated inhalation dose study (recovery period of 4-6 weeks) with special neurological parameters (EC B.29 [3]/OECD TG 413 [6] and OECD TG 424 [5]). General pathology may be waived if this information is available in other studies. | 18 |
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4 | 200-864-0 | 75-35-4 | 1,1-dikloroeten | Kemikalija proizvedena v velikih količinah Motnje v delovanju živčnega sistema ob dolgotrajni izpostavljenosti precej pod trenutnimi mejnimi vrednostmi za poklicno izpostavljenost (OEL) | Študija subkronične inhalacijske toksičnosti: 90 - dnevna študija s ponavljajočim se odmerkom (čas okrevanja 4–6 tednov) s posebnimi nevrološkimi parametri (EC B.29/OECD TG 413 in OECD TG 424). Splošne patološke raziskave se lahko opustijo, če so te informacije na voljo v drugih študijah. | 18 |
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Special neurological parameters: Functional observational battery and motor activity assessment;Assessment of behavioural performance (e.g. visual discrimination performance);Assessment of cognitive function (e.g. delayed alternation, Morris water maze). |
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Posebni nevrološki parametri: Ocena sklopa parametrov funkcionalnih opazovanj ter ocena motorične aktivnosti;Ocena vedenjskega vzorca (npr. sposobnost vidnega razločevanja);Ocena kognitivnih sposobnosti (npr. zapoznele spremembe, Morrisov vodni labirint). |
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All relevant information and full study reports necessary for evaluation of the hazard potential of the substance |
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Vse ustrezne informacije in popolna poročila o študijah, potrebni za ovrednotenje potencialne nevarnosti snovi. |
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5 | 211-309-7 | 637-92-3 | 2-ethoxy-2-methylpropane | Data poor substance Growing potential for wide dispersive use of the substance due to its potential use as a substitute for MTBE Adverse effects may occur upon prolonged exposure | Information on annual production and import volumes Acute Toxicity for Daphnia (EC C.2 [3]/OECD TG 202 [6]) Growth Inhibition Test for Algae (EC C.3 [3]/OECD TG 201 [7]) Developmental Toxicity Study (OECD TG 414 [8]) All relevant information and full study reports necessary for evaluation of the hazard potential of the substance | 18 |
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5 | 211-309-7 | 637-92-3 | 2-etoksi-2-metilpropan | Snov, o kateri je malo podatkov Naraščajoča verjetnost za široko razpršeno uporabo snovi zaradi njene možne uporabe kot nadomestka za MTBE Pri dolgotrajni izpostavljenosti lahko pride do škodljivih učinkov | Informacije o letni proizvedenih in uvoženih količinah. Akutna toksičnost za Daphnia sp. (EC. C.2/OECD TG 202). Preskus zaviranja rasti pri algah (EC. C.3/OECD TG 201). Študija razvojne toksičnosti (OECD TG 414). Vse ustrezne informacije in popolna poročila o študijah, potrebni za ovrednotenje potencialne nevarnosti snovi. | 18 |
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Fertility Study (OECD TG 416 [5]) | 24 |
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Študija plodnosti (OECD TG 416). | 24 |
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[1] In accordance with Annex V of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p.1).
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[2] OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 415: "One-Generation Reproduction Toxicity Study"(Original Guideline, adopted 26 May 1983).
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[3] OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 416: "Two-Generation Reproduction Toxicity Study"(Updated Guideline, adopted 22 January 2001).
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[4] OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 413: "Subchronic Inhalation Toxicity: 90-day Study"(Original Guideline, adopted 12 May 1981).
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[5] OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 424: "Neurotoxicity Study in Rodents"(Original Guideline, adopted 21 July 1997).
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[6] OECD's Guidelines for the Testing of Chemicals - Section 2 - Effects on Biotic Systems TG No 202: "Daphnia sp. Acute Immobilisation Test and Reproduction Test"(Updated Guideline, adopted 4 April 1984).
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[7] OECD's Guidelines for the Testing of Chemicals — Section 2 — Effects on Biotic Systems TG No 201: "Alga, Growth Inhibition Test"( (Updated Guideline, adopted 7 June 1984).
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[8] OECD's Guidelines for the Testing of Chemicals - Section 4 - Health Effects TG No 414: "Prenatal Developmental Toxicity Study" (Updated Guideline, adopted 22 January 2001).
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