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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 06 rujna 2024. Database contains 4821 unique substances/entries.
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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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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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(R)-EPICHLOROHYDRIN
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424-280-2
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51594-55-9
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Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1 |
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SCH.19927 DIBENZOYLTARTRATE
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404-390-7
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88976-55-0
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Flam. Sol. 1; Skin Sens. 1 |
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PANTERA; QUIZALOFOP-P-TEFURYL
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414-200-4
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119738-06-6
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Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2 |
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201-435-0
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82-68-8
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Skin Sens. 1 |
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602-997-3
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124495-18-7
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Skin Sens. 1 |
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219-455-3
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2439-01-2
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Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1 |
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202-051-6
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91-22-5
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Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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205-711-1
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148-24-3
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Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1 |
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BAS 514 H
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402-780-1
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84087-01-4
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Skin Sens. 1 |
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237-031-6
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13593-03-8
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Acute Tox. 3; Acute Tox. 4 |
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264-151-6
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63449-41-2
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Acute Tox. 4; Skin Corr. 1B |
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610-007-6
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422556-08-9
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Skin Sens. 1 |
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611-516-6
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57369-32-1
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Acute Tox. 4 |
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201-762-9
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87-66-1
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Muta. 2; Acute Tox. 4 |
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This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
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232-382-1
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8012-00-8
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yes |
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236-671-3
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13463-41-7
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Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1 |
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The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
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269-929-9
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68391-11-7
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Carc. 1B; Muta. 1B |
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203-809-9
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110-86-1
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Flam. Liq. 2; Acute Tox. 4 |
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259-686-7
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55512-33-9
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Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1 |
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PYRIDABEN
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405-700-3
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96489-71-3
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Acute Tox. 3 |
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Acute Tox. 4 |
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204-927-3
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129-00-0
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yes |
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108-34-9
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Acute Tox. 2; Acute Tox. 1 |
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236-656-1
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13457-18-6
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Acute Tox. 4 |
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429-520-1
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4023-02-3
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Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1 |
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605-747-1
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175013-18-0
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Acute Tox. 3; Skin Irrit. 2 |
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602-927-1
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123312-89-0
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Carc. 2; Repr. 2 |
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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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68583-29-9
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B Bacteria and similar species |
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205-443-5
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140-93-2
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Acute Tox. 4; Skin Irrit. 2 |
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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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218-893-2
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2275-18-5
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Acute Tox. 1; Acute Tox. 2 |
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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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232-966-6
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9068-59-1
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1 |
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Amylase, mixed with proteinase, Bacillus thuringiensis-fermented
EC / List no:
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68909-36-4
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934-013-6
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39450-01-6
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1 |
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619-000-2
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94125-34-5
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Acute Tox. 4 |
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PROSULFOCARB
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401-730-6
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52888-80-9
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Acute Tox. 4; 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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606-168-7
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189278-12-4
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Carc. 2 |
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245-951-4
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23950-58-5
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Carc. 2 |
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620-432-9
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2122-19-2
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Repr. 2; Acute Tox. 4 |
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201-155-9
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78-90-0
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Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A |
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200-879-2
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75-56-9
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Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3 |
yes |
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203-572-1
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108-32-7
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Eye Irrit. 2 |
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