EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1
EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1
In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances
EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019
This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).
Last updated 26 apríla 2024. Database contains 4917 unique substances/entries.
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202-708-7
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98-86-2
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Acute Tox. 4; Eye Irrit. 2 |
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200-865-6
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75-36-5
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Flam. Liq. 2; Skin Corr. 1B |
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200-816-9
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74-86-2
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Flam. Gas 1; Press. Gas |
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CGA 245704 TECH.
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420-050-0
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135158-54-2
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1 |
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256-634-5
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50594-66-6
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Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1 |
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277-704-1
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74070-46-5
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Carc. 2; Skin Sens. 1A |
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206-121-7
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302-27-2
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Acute Tox. 2 |
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203-453-4
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107-02-8
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Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B |
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201-173-7
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79-06-1
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Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
C Carcinogenic (article 57a) M Mutagen (article 57b) |
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419-560-6
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4369-14-6
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Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1 |
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247-118-0
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25584-83-2
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Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1 |
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201-177-9
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79-10-7
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Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A |
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203-466-5
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107-13-1
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Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1 |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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B Bacteria and similar species |
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204-673-3
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124-04-9
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Eye Irrit. 2 |
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240-110-8
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15972-60-8
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Carc. 2; Acute Tox. 4; Skin Sens. 1 |
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204-123-2
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116-06-3
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Acute Tox. 2; Acute Tox. 3 |
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206-215-8
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309-00-2
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Carc. 2; Acute Tox. 3; STOT RE 1 |
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240-896-2
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16871-90-2
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Acute Tox. 3 |
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240-934-8
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16893-85-9
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Acute Tox. 3 |
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240-968-3
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16919-19-0
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Acute Tox. 3 |
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Acute Tox. 4 |
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270-651-5
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68475-57-0
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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292-456-4
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90622-55-2
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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287-476-5
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85535-84-8
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Carc. 2 |
PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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281-985-6
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84082-38-2
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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307-451-5
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97659-46-6
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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283-930-1
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84776-06-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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287-504-6
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85536-22-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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292-454-3
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90622-53-0
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Carc. 1B |
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701-376-5
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1372804-76-6
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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287-477-0
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85535-85-9
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Lact. |
PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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283-931-7
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84776-07-8
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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285-195-2
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85049-26-9
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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270-652-0
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68475-58-1
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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270-653-6
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68475-59-2
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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270-654-1
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68475-60-5
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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272-924-4
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68920-70-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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263-004-3
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61788-76-9
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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435-660-2
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243662-67-1
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Skin Irrit. 2; Skin Sens. 1 |
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435-650-8
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-
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Acute Tox. 4; Skin Corr. 1A |
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