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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 30 svibnja 2024. Database contains 4821 unique substances/entries.
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239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
239-086-1
14998-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
206-761-7
373-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
237-563-9
13842-46-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
240-408-8
16337-84-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
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
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
275-897-7
71720-48-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
294-302-1
91697-41-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
268-755-0
68134-59-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-946-6
15843-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
257-447-1
51818-56-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
258-051-1
52625-25-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
224-699-9
4454-16-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
223-463-2
3906-55-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
254-642-3
39819-65-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-753-4
14708-14-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
209-046-8
553-71-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-596-1
14550-87-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
236-665-0
13462-88-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
267-897-0
67952-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-646-5
15586-38-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-071-3
10028-18-9
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
236-666-6
13462-90-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
16039-61-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
237-205-1
13689-92-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
248-585-3
27637-46-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
11132-10-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-125-2
15060-62-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-533-3
18721-51-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-468-1
85508-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
249-555-2
29317-63-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
300-094-6
93920-10-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
300-093-0
93920-09-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
237-138-8
13654-40-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
222-102-6
3349-08-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
218-744-1
2223-95-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
240-235-8
16083-14-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
237-124-1
13637-71-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
-
1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
240-841-2
16812-54-7
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
234-349-7
11113-75-0
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
-
68130-19-8
Carc. 1A; Repr. 1A; STOT RE 1; Skin Sens. 1
235-008-5
12054-48-7
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
234-348-1
11113-74-9
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
-
132207-32-0
Carc. 1A; STOT RE 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
268-585-7
68130-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-522-3
18718-11-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-511-8
14507-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-766-5
14721-18-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
209-160-8
557-19-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-278-2
14332-34-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
252-840-4
36026-88-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-974-9
15852-21-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-967-0
15851-52-2
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-263-7
10101-96-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-827-7
7757-95-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
34492-97-2
Carc. 1A; STOT RE 1; Skin Sens. 1
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-494-6
12007-01-1
Carc. 1A; STOT RE 1; Skin Sens. 1
238-946-3
14874-78-3
Carc. 1A; STOT RE 1; Skin Sens. 1

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