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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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272-233-8
68784-25-8
yes
250-863-4
31906-04-4
Skin Sens. 1A
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
202-807-5
99-98-9
Acute Tox. 3
200-453-6
60-09-3
Carc. 1B
yes
204-616-2
123-30-8
Muta. 2; Acute Tox. 4
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
216-381-3
1570-64-5
Acute Tox. 3; Skin Corr. 1A
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
203-402-6
106-48-9
Acute Tox. 4
203-176-9
104-12-1
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
203-397-0
106-43-4
Acute Tox. 4
204-581-3
122-88-3
Acute Tox. 4
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
217-862-0
1987-50-4
yes
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
204-626-7
123-42-2
Eye Irrit. 2
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-453-1
95-80-7
yes
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-204-7
92-93-3
Carc. 1B
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
211-535-6
659-49-4
Acute Tox. 4
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
202-848-9
100-40-3
Carc. 2
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
204-525-8
122-15-6
Acute Tox. 3
251-684-4
33813-20-6
Acute Tox. 4
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
210-025-0
602-87-9
Carc. 1B
204-327-1
119-47-1
Repr. 1B
yes
239-732-2
15662-33-6
Acute Tox. 4
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
202-095-6
91-76-9
Acute Tox. 4
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
219-943-6
2580-56-5
yes
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
273-688-5
69011-06-9
yes
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
250-241-2
30560-19-1
Acute Tox. 4
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
200-473-5
60-35-5
Carc. 2
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
257-175-3
51404-69-4
yes
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
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
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
206-121-7
302-27-2
Acute Tox. 2
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
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
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
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
204-673-3
124-04-9
Eye Irrit. 2
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
240-896-2
16871-90-2
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-968-3
16919-19-0
Acute Tox. 3
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
287-476-5
85535-84-8
Carc. 2
yes
281-985-6
84082-38-2
yes
283-930-1
84776-06-7
yes
287-504-6
85536-22-7
yes
292-454-3
90622-53-0
Carc. 1B
287-477-0
85535-85-9
Lact.
yes
283-931-7
84776-07-8
yes
285-195-2
85049-26-9
yes

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