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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 01 May 2024. Database contains 4821 unique substances/entries.
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212-758-1
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867-27-6
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Acute Tox. 3 |
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204-801-8
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126-75-0
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Acute Tox. 1; Acute Tox. 2 |
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213-052-6
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919-86-8
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Acute Tox. 3 |
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241-109-5
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17040-19-6
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Acute Tox. 3; Acute Tox. 4 |
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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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237-198-5
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13684-56-5
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Repr. 2 |
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213-800-1
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1014-69-3
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Acute Tox. 4 |
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204-424-9
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120-78-5
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Skin Sens. 1 |
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DIRECT BLUE 199
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416-180-2
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12222-04-7
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Acute Tox. 4; STOT RE 2 |
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218-961-1
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2303-16-4
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Carc. 2; Acute Tox. 4 |
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PINOLENE
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417-870-6
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83648-84-4
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Skin Irrit. 2; Skin Sens. 1 |
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686-814-2
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34363-01-4
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Skin Irrit. 2; Skin Sens. 1 |
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204-697-4
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124-40-3
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Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B |
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204-697-4
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124-40-3
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Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1 |
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205-575-3
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142-96-1
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Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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203-921-8
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111-92-2
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Flam. Liq. 3; Acute Tox. 4 |
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DNOAI
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408-190-0
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7585-14-0
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Pyr. Liq. 1; Skin Corr. 1B |
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210-937-9
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626-23-3
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Flam. Liq. 3; Acute Tox. 4 |
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CM 26-137
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406-052-4
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125078-60-6
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Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1 |
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203-733-6
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110-05-4
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Org. Perox. E; Flam. Liq. 2; Muta. 2 |
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233-689-3
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10311-84-9
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Acute Tox. 2; Acute Tox. 3 |
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205-016-3
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131-17-9
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Acute Tox. 4 |
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234-454-8
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12004-35-2
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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GENIPLEX A
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401-610-3
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122012-52-6
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Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
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422-670-7
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150202-11-2
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Repr. 2; Acute Tox. 3; STOT RE 2 |
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240-973-0
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16919-58-7
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Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
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239-793-5
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15699-18-0
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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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74195-78-1
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Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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231-786-5
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7727-54-0
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Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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237-499-1
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13820-41-2
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Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
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206-373-8
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333-41-5
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Acute Tox. 4 |
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206-382-7
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334-88-3
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Carc. 1B |
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200-181-8
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53-70-3
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Carc. 1B |
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205-878-0
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189-64-0
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Carc. 1B; Muta. 2 |
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205-886-4
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191-30-0
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Carc. 1B; Muta. 2 |
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202-327-6
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94-36-0
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Org. Perox. B; Eye Irrit. 2; Skin Sens. 1 |
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ZK RT 1507
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417-760-8
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134164-24-2
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STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1 |
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200-824-2
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74-95-3
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Acute Tox. 4 |
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AMINODARONE OXALATE; SR33580A
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448-700-9
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500791-70-8
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STOT RE 2; Eye Dam. 1; Skin Sens. 1 |
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201-039-8
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77-58-7
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Muta. 2; Repr. 1B; STOT RE 1 |
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DBB
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401-040-5
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75113-37-0
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Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1 |
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217-635-6
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1918-00-9
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Acute Tox. 4; Eye Dam. 1 |
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214-787-5
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1194-65-6
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Acute Tox. 4 |
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202-564-5
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97-17-6
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Acute Tox. 4 |
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214-118-7
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1085-98-9
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Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1 |
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204-210-5
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117-80-6
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Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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SILAN DCS
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407-180-3
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770722-36-6
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Skin Corr. 1A |
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220-487-5
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2782-57-2
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Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3 |
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201-207-0
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79-43-6
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Skin Corr. 1A |
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201-199-9
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79-36-7
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Skin Corr. 1A |
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