EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
In Vitro Diagnostic Medical Devices Directive - Hazardous Substances
EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998
This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.
Last updated 26 April 2024. Database contains 4821 unique substances/entries.
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B Bacteria and similar species |
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B Bacteria and similar species |
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257-447-1
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51818-56-5
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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254-875-0
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40292-82-8
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Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B |
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F Fungi |
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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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240-841-2
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16812-54-7
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Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1 |
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258-051-1
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52625-25-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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239-086-1
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14998-37-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1 |
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248-169-1
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27016-75-7
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77900.
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271-853-6
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68610-24-2
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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224-699-9
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4454-16-4
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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223-463-2
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3906-55-6
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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254-642-3
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39819-65-3
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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242-522-3
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18718-11-1
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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284-349-6
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84852-37-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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238-511-8
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14507-36-9
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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237-396-1
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13770-89-3
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Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 4; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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238-753-4
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14708-14-6
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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235-723-2
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12619-90-8
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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234-493-0
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12007-00-0
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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65229-23-4
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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222-068-2
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3333-67-3
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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238-766-5
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14721-18-7
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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206-761-7
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373-02-4
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1 |
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235-103-1
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12068-61-0
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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209-046-8
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553-71-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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238-596-1
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14550-87-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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236-665-0
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13462-88-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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267-897-0
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67952-43-6
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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231-743-0
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7718-54-9
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Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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239-646-5
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15586-38-6
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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209-160-8
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557-19-7
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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233-071-3
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10028-18-9
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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222-101-0
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3349-06-2
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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235-008-5
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12054-48-7
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Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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236-666-6
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13462-90-3
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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16039-61-5
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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236-068-5
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13138-45-9
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Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
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234-823-3
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12035-36-8
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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237-124-1
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13637-71-3
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1 |
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237-563-9
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13842-46-1
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1 |
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235-379-3
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12201-89-7
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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237-205-1
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13689-92-4
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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257-970-5
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52502-12-2
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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247-430-7
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26043-11-8
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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238-278-2
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14332-34-4
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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234-348-1
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11113-74-9
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Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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248-585-3
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27637-46-3
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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Product of blowing smelted nickel ore in a converter to lower the iron content.
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273-749-6
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69012-50-6
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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