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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 rujna 2024. Database contains 4821 unique substances/entries.
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230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
229-851-8
6786-83-0
yes
229-352-5
6485-40-1
Skin Sens. 1
229-335-2
6477-64-1
yes
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
228-652-3
6317-18-6
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
227-678-2
5932-68-3
Skin Sens. 1A
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
227-633-7
5912-86-7
Skin Sens. 1A
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
227-419-3
5834-96-8
Acute Tox. 4
227-317-9
5786-97-0
Acute Tox. 2
227-197-8
5707-69-7
Acute Tox. 3
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
227-011-5
5598-13-0
Skin Sens. 1
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
226-066-2
5259-88-1
Acute Tox. 4
226-031-1
5234-68-4
STOT RE 2; Skin Sens. 1
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
225-918-0
5146-66-7
Muta. 1B
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
225-875-8
5131-24-8
Skin Irrit. 2; Skin Sens. 1
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
225-432-9
4845-99-2
Acute Tox. 2
225-399-0
4824-78-6
Acute Tox. 3; Acute Tox. 4
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
224-699-9
4454-16-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
224-580-1
4418-26-2
Acute Tox. 4
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
224-030-0
4170-30-3
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
223-714-6
4032-26-2
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
223-463-2
3906-55-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
223-404-0
3878-19-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
223-393-2
3871-99-6
yes
223-383-8
3864-99-1
yes
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
223-346-6
3846-71-7
yes
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
223-297-0
3813-05-6
Eye Irrit. 2; Skin Irrit. 2
223-292-3
3811-49-2
Acute Tox. 3; STOT SE 1
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
223-228-4
3775-90-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
223-188-8
3766-81-2
Acute Tox. 4
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
223-003-0
3691-35-8
Repr. 1B; Acute Tox. 1; STOT RE 1
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
222-979-5
3687-31-8
yes
222-883-3
3648-18-8
Repr. 1B; STOT RE 1
222-598-4
3547-33-9
Eye Dam. 1
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
222-571-7
3535-84-0
Acute Tox. 2; Acute Tox. 4; STOT RE 2
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
222-182-2
3380-34-5
Eye Irrit. 2; Skin Irrit. 2
222-102-6
3349-08-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
222-101-0
3349-06-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
222-098-6
3347-22-6
Acute Tox. 4
222-068-2
3333-67-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
222-048-3
3327-22-8
Carc. 2
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
221-817-0
3244-90-4
Acute Tox. 4
221-695-9
3194-55-6
Repr. 2; Lact.
yes
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
221-515-9
3129-91-7
Acute Tox. 4
221-499-3
3121-61-7
Flam. Liq. 3; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
yes
221-437-5
3091-32-5
Acute Tox. 4
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
221-221-0
3033-77-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
221-201-1
3030-47-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1

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