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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 April 2024. Database contains 4821 unique substances/entries.
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236-881-5
13530-68-2
yes
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
221-515-9
3129-91-7
Acute Tox. 4
208-704-1
538-75-0
Acute Tox. 3; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
203-716-3
109-89-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
209-161-3
557-20-0
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
201-559-5
84-75-3
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
276-090-2
71850-09-4
Repr. 1B
yes
248-523-5
27554-26-3
Repr. 1B
210-088-4
605-50-5
Repr. 1B
yes
203-560-6
108-20-3
Flam. Liq. 2; STOT SE 3
203-558-5
108-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
203-326-3
105-74-8
Org. Perox. D
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2
262-784-2
61432-55-1
Acute Tox. 4
233-307-5
10112-91-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
215-629-8
1335-31-5
Expl. 1.1; Acute Tox. 3; STOT RE 2
256-625-6
50563-36-5
Acute Tox. 4; Skin Sens. 1
200-480-3
60-51-5
Acute Tox. 4
210-478-4
616-38-6
Flam. Liq. 2
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
204-065-8
115-10-6
Flam. Gas 1; Press. Gas
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-508-2
107-64-2
Eye Dam. 1
209-805-3
593-74-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
208-884-1
544-97-8
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B

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