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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 svibnja 2024. Database contains 4821 unique substances/entries.
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215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
208-933-7
547-67-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-323-5
11099-02-8
Carc. 1A; STOT RE 1; Skin Sens. 1
252-840-4
36026-88-7
Carc. 1A; 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
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
250-788-7
31748-25-1
Carc. 1A; STOT RE 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
234-349-7
11113-75-0
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
235-260-6
12142-88-0
Carc. 1A; STOT RE 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
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
274-755-1
70692-93-2
Carc. 1A; STOT RE 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
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
237-138-8
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
233-263-7
10101-96-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
244-578-4
21784-78-1
Carc. 1A; STOT RE 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
231-827-7
7757-95-1
Carc. 1A; 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
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
200-193-3
54-11-5
Acute Tox. 2
217-682-2
1929-82-4
Acute Tox. 4
231-714-2
7697-37-2
Ox. Liq. 3; Acute Tox. 3; Skin Corr. 1A
238-076-4
14216-75-2
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
DABCO X-412
413-670-8
103969-79-5
Eye Irrit. 2; Skin Sens. 1
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
233-272-6
10102-44-0
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
200-876-6
75-52-5
Flam. Liq. 3; Acute Tox. 4
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
-
60999-18-0
Acute Tox. 3; STOT RE 2
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
931-755-2
-
yes
931-756-8
-
yes
931-753-1
-
yes
931-754-7
-
yes
939-993-9
-
yes
-
-
yes
938-618-6
-
yes
932-998-7
-
yes
213-589-6
991-42-4
Acute Tox. 4
-
2163-79-3
Acute Tox. 4
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
VULKANISATIONSBESCHLEUNIGER VP KA 9124
404-380-2
110799-28-5
Skin Sens. 1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
KENODOX
404-300-6
116753-76-5
Org. Perox. C
221-817-0
3244-90-4
Acute Tox. 4
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
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
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N,N'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide] EC / List no: 223-873-1 | CAS no: 4104-12-5
-
-
Carc. 1B
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2
ETA; ETA 50 (50 %IGE ZUBEREITUNG); O-ETHYLHYDROXYLAMINE
402-030-3
624-86-2
Flam. Liq. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Sens. 1
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
201-855-4
88-74-4
Acute Tox. 3; STOT RE 2
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
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N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide) EC / List no: 202-111-1 | CAS no: 91-96-3
-
-
Carc. 1B
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
209-136-7
556-67-2
Repr. 2
yes
203-892-1
111-65-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-677-5
124-07-2
Skin Corr. 1C
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
H112339
413-550-5
-
Skin Irrit. 2; Eye Dam. 1
247-761-7
26530-20-1
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
213-853-0
1034-01-1
Acute Tox. 4; Skin Sens. 1
-
-
Skin Corr. 1A; STOT SE 3
-
-
yes
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
214-197-8
1113-02-6
Acute Tox. 3; Acute Tox. 4
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
P Parasites

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