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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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608-492-4
3050-88-2
yes
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
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[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
799-972-3
-
yes
276-743-1
72624-02-3
yes
291-844-0
90481-04-2
yes
-
-
yes
-
57427-55-1
yes
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
618-541-1
9036-19-5
yes
266-578-3
67118-55-2
yes
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
231-906-6
7778-50-9
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
234-329-8
11103-86-9
yes
223-393-2
3871-99-6
yes
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
204-927-3
129-00-0
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
915-270-3
-
yes
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
-
-
yes
939-460-0
1471311-26-8
yes
X4261
401-850-9
255881-94-8
yes
-
-
yes
-
-
yes
show/hide
Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 | CAS no: 68259-08-5
Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-55-0
-
-
yes
272-271-5
68784-75-8
yes
234-363-3
11120-22-2
yes
231-889-5
7775-11-3
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
616-541-6
7789-12-0
yes
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
239-172-9
15120-21-5
yes
231-556-4
7632-04-4
yes
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
616-572-5
7790-84-3
yes
263-467-1
62229-08-7
yes
626-360-4
15244-35-6
yes
262-967-7
61788-32-7
yes
262-967-7
61788-32-7
yes
235-541-3
12267-73-1
Repr. 1B
yes
-
198840-65-2
yes
201-075-4
78-00-2
yes
235-380-9
12202-17-4
yes
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
206-203-2
307-55-1
yes

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