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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 January 2022. Database contains 4812 unique substances/entries.
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215-647-6
1336-21-6
Skin Corr. 1B
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
700-242-3
62037-80-3
yes
441-050-7
-
Skin Irrit. 2; Eye Dam. 1
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
235-185-9
12125-01-8
Acute Tox. 3
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
yes
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
269-511-6
68259-08-5
yes
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
232-989-1
9080-17-5
Skin Corr. 1B
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
232-565-6
9000-90-2
Resp. Sens. 1
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Amylase, alpha-, Bacillus amyloliquefaciens ecnumber: - | casnumber: 152923-48-3
Amylase ecnumber: 232-567-7 | casnumber: 9000-92-4
Amylase, fungal ecnumber: 232-742-8 | casnumber: 9013-01-8
Amylase, β- ecnumber: 232-566-1 | casnumber: 9000-91-3
Amylase, mixture with proteinase ecnumber: 685-079-5 | casnumber: 9001-11-0
Amylase, gluco- ecnumber: 232-877-2 | casnumber: 9032-08-0
Amylase, α-, Aspergillus oryzae ecnumber: 232-588-1 | casnumber: 9001-19-8
Bacteria, complex with amylase and proteinase ecnumber: - | casnumber: 68920-42-3
Amylase, bacterial ecnumber: 232-560-9 | casnumber: 9000-85-5
Amylase, mixed with proteinase, Bacillus cereus-fermented ecnumber: - | casnumber: 68909-35-3
Amylase, α- ecnumber: 232-565-6 | casnumber: 9000-90-2
Amylase, gluco-, Rhizopus oryzae ecnumber: - | casnumber: 152923-55-2
Amylase, iso- ecnumber: 232-956-1 | casnumber: 9067-73-6
-
-
Resp. Sens. 1
-
-
P Parasites
433-560-3
15375-21-0
Repr. 2
-
-
P Parasites
-
-
P Parasites
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
204-371-1
120-12-7
yes
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
yes
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
yes
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
yes
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
yes
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
yes
201-549-0
84-65-1
Carc. 1B
-
-
Acute Tox. 4
231-601-8
7647-18-9
Skin Corr. 1B
233-047-2
10025-91-9
Skin Corr. 1B
232-009-2
7783-56-4
Acute Tox. 3
215-175-0
1309-64-4
Carc. 2
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
-
-
B Bacteria and similar species
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
270-658-3
68475-70-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
297-401-8
93571-75-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-698-0
90989-42-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-279-0
91995-18-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-695-4
90989-39-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B

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