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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 April 2024. Database contains 4821 unique substances/entries.
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233-139-2
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10043-35-3
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Repr. 1B |
yes |
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234-343-4
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11113-50-1
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Repr. 1B |
yes |
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22454-04-2
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yes |
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14890-53-0
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yes |
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25747-83-5
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yes |
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215-604-1
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1333-73-9
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yes |
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233-657-9
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10294-33-4
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Acute Tox. 2; Skin Corr. 1A |
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233-658-4
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10294-34-5
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Press. Gas; Acute Tox. 2; Skin Corr. 1B |
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231-569-5
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7637-07-2
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Press. Gas; Acute Tox. 2; Skin Corr. 1A |
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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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249-205-9
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28772-56-7
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Repr. 1B; Acute Tox. 1; STOT RE 1 |
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232-572-4
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9001-00-7
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1 |
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231-778-1
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7726-95-6
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Acute Tox. 2; Skin Corr. 1A |
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201-175-8
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79-08-3
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Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1 |
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203-623-8
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108-86-1
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Flam. Liq. 3; Skin Irrit. 2 |
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DBBT
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402-210-1
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99688-47-8
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STOT RE 2; Skin Sens. 1 |
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200-825-8
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74-96-4
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Flam. Liq. 2; Carc. 2; Acute Tox. 4 |
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209-800-6
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593-60-2
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Press. Gas; Flam. Gas 1; Carc. 1B |
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236-129-6
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13181-17-4
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Acute Tox. 4 |
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200-854-6
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75-25-2
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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200-813-2
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74-83-9
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Press. Gas; Muta. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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218-277-3
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2104-96-3
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Acute Tox. 4 |
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225-399-0
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4824-78-6
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Acute Tox. 3; Acute Tox. 4 |
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show/hide
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216-882-7
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1689-84-5
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Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1 |
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260-300-4
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56634-95-8
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Repr. 2; Acute Tox. 4; Skin Sens. 1 |
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216-885-3
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1689-99-2
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Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1 |
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200-143-0
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52-51-7
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Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 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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227-317-9
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5786-97-0
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Acute Tox. 2 |
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225-432-9
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4845-99-2
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Acute Tox. 2 |
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206-614-7
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357-57-3
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Acute Tox. 2 |
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P Parasites |
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P Parasites |
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208-077-4
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507-60-8
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Acute Tox. 2 |
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620-359-2
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8065-36-9
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Acute Tox. 3 |
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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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34492-97-2
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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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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255-391-2
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41483-43-6
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Carc. 2; Skin Sens. 1B |
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B Bacteria and similar species |
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B Bacteria and similar species |
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203-449-2
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106-98-9
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Flam. Gas 1; Press. Gas |
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203-788-6
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110-65-6
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Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1 |
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