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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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200-590-1
64-69-7
Acute Tox. 3; Skin Corr. 1A
-
696-33-3
Expl.
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
247-449-0
26087-47-8
Acute Tox. 4
253-178-9
36734-19-7
Carc. 2
604-209-3
140923-17-7
Carc. 2
-
5827-05-4
Acute Tox. 1; Acute Tox. 3
231-753-5
7720-78-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
JOF 2822 5F; JOF 2822 5FL; JOF 4443
420-960-8
77214-82-5
Eye Dam. 1
255-863-8
42509-80-8
Acute Tox. 2; Acute Tox. 3; STOT RE 2; Skin Sens. 1
208-746-0
540-42-1
Flam. Liq. 3
206-045-4
297-78-9
Acute Tox. 1; Acute Tox. 2
200-857-2
75-28-5
Flam. Gas 1; Press. Gas
200-857-2
75-28-5
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
-
51337-71-4
Acute Tox. 4
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
203-745-1
110-19-0
Flam. Liq. 2
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
208-818-1
542-55-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
202-613-0
97-86-9
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Skin Sens. 1B
208-819-7
542-56-3
Flam. Liq. 2; Carc. 1B; Muta. 2; Acute Tox. 4
ZOLDINE RD-4
419-850-2
148348-13-4
Skin Corr. 1B
ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
402-580-4
111439-76-0
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
201-195-7
79-31-2
Acute Tox. 4
201-194-1
79-30-1
Flam. Liq. 2; Skin Corr. 1A
207-366-2
465-73-6
Acute Tox. 2; Acute Tox. 1
202-590-7
97-54-1
Skin Sens. 1A
246-814-1
25311-71-1
Acute Tox. 3
250-610-8
31394-54-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
-
-
yes
-
-
yes
234-284-4
11066-49-2
yes
609-346-2
37205-87-1
yes
247-861-0
26635-64-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-142-8
78-78-4
Flam. Liq. 1; Asp. Tox. 1; STOT SE 3
204-662-3
123-92-2
Flam. Liq. 3
203-769-2
110-45-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-322-1
105-68-0
Flam. Liq. 3
201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
220-114-6
2631-40-5
Acute Tox. 4
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
210-901-2
625-55-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3

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