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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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919-76-6
Acute Tox. 4
212-634-7
834-12-8
Acute Tox. 4
604-314-4
142844-00-6
yes
209-090-8
555-31-7
Flam. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
231-208-1
7446-70-0
Skin Corr. 1B
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-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
603-801-9
134237-50-6
yes
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
263-004-3
61788-76-9
yes
272-924-4
68920-70-7
yes
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
285-195-2
85049-26-9
yes
283-931-7
84776-07-8
yes
287-477-0
85535-85-9
Lact.
yes
701-376-5
1372804-76-6
yes
292-454-3
90622-53-0
Carc. 1B
287-504-6
85536-22-7
yes
283-930-1
84776-06-7
yes
307-451-5
97659-46-6
yes
281-985-6
84082-38-2
yes
287-476-5
85535-84-8
Carc. 2
yes
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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-
Acute Tox. 4
240-968-3
16919-19-0
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-896-2
16871-90-2
Acute Tox. 3
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-673-3
124-04-9
Eye Irrit. 2
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B Bacteria and similar species
-
-
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.
-
-
yes
-
-
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.
-
-
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
-
-
B Bacteria and similar species
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
206-121-7
302-27-2
Acute Tox. 2
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
251-899-3
34256-82-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT SE 3; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
257-175-3
51404-69-4
yes
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
603-921-1
135410-20-7
Acute Tox. 4
200-473-5
60-35-5
Carc. 2
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
250-241-2
30560-19-1
Acute Tox. 4
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P Parasites
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
-
-
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.
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 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
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
273-688-5
69011-06-9
yes
425-520-9
197179-61-6
Eye Dam. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; 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
419-270-1
123599-82-6
Eye Irrit. 2
219-943-6
2580-56-5
yes
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
426-890-4
77341-67-4
Eye Dam. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
M1
422-060-0
137390-08-0
Acute Tox. 2
416-360-0
162221-28-5
Skin Sens. 1
421-940-1
28698-31-9
Eye Dam. 1
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
429-400-7
199327-61-2
Repr. 1B
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
424-850-0
189702-72-5
Eye Dam. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
202-095-6
91-76-9
Acute Tox. 4
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
239-732-2
15662-33-6
Acute Tox. 4
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
204-327-1
119-47-1
Repr. 1B
yes
441-550-5
-
Self-react. C; Carc. 2
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
-
-
yes
-
-
yes
-
-
yes
210-025-0
602-87-9
Carc. 1B
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
619-823-7
494793-67-8
Carc. 2
414-470-3
95885-13-5
Acute Tox. 4
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
429-290-0
3380-30-1
Eye Dam. 1
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
-
51-14-9
Acute Tox. 4
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
410-530-8
107815-88-3
Skin Sens. 1
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
IMEXINE OAY
412-130-9
3131-52-0
Acute Tox. 4; Eye Dam. 1
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
251-684-4
33813-20-6
Acute Tox. 4
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
204-525-8
122-15-6
Acute Tox. 3
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
202-848-9
100-40-3
Carc. 2
621-345-9
2315-67-5
yes
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
419-240-6
171054-89-0
Eye Dam. 1
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
-
-
yes
-
-
yes
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
211-535-6
659-49-4
Acute Tox. 4
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
202-204-7
92-93-3
Carc. 1B
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4

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