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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 lipnja 2024. Database contains 4821 unique substances/entries.
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205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
211-952-3
719-96-0
Skin Irrit. 2
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
UC-129
403-790-9
108673-51-4
Skin Sens. 1
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
UM-229
407-070-5
142859-67-4
Skin Sens. 1
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
423-840-3
14691-89-5
Acute Tox. 4
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
429-640-2
52870-46-9
Eye Irrit. 2
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
220-623-3
2836-04-6
Acute Tox. 3
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1
205-319-0
138-24-9
Acute Tox. 3
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
Skin Sens. 1
202-959-2
101-61-1
Carc. 1B
yes
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
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
-
2810-74-4
Acute Tox. 4
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
RED REN 363
419-500-9
171599-85-2
Eye Dam. 1; Skin Sens. 1
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
Acute Tox. 4; Eye Irrit. 2
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
DDPD
406-610-7
62478-82-4
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
418-290-6
168612-06-4
Eye Irrit. 2; Skin Sens. 1
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
435-470-1
27366-72-9
Repr. 1B
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-831-6
100-22-1
Acute Tox. 4
CARTASOL BRILLIANT YELLOW K-6G; CARTASOL BRILLIANT YELLOW K-6G CONC.; GIALLO BRILLANTE CARTASOL K-6G CONC.; JAUNE BRILLANT CARTASOL K-RWA 3904; RWA 3904
403-340-1
164578-09-0
Eye Dam. 1
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
200-806-4
74-31-7
Skin Sens. 1
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
435-010-8
26157-73-3
Muta. 2
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
429-380-1
133336-92-2
Skin Sens. 1
435-860-1
214417-91-1
Skin Sens. 1
-
-
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
-
-
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
-
-
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
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
201-328-9
81-14-1
Carc. 2
248-505-7
27519-02-4
Skin Sens. 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.
-
-
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.
205-628-0
144-41-2
Acute Tox. 3
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
-
-
B Bacteria and similar species
-
29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
-
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.
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
429-570-2
213990-58-0
Skin Sens. 1
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 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.
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
-
12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
268-585-7
68130-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
206-742-3
371-86-8
STOT SE 1
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Glass Wool EC / List no: - | CAS no: 308066-92-4
Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no: 266-046-0 | CAS no: 65997-17-3
-
-
Carc. 2
-
1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; 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.
-
-
Acute Tox. 4
-
-
F Fungi
206-249-3
315-18-4
Acute Tox. 2; Acute Tox. 4
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
244-209-7
21087-64-9
Acute Tox. 4
410-240-1
139528-85-1
Carc. 2; STOT RE 2
214-446-0
1129-41-5
Acute Tox. 4
METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
204-064-2
115-09-3
Carc. 2; Repr. 1A; Lact.; Acute Tox. 2; STOT RE 1
200-471-4
60-34-4
Carc. 1B
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
228-652-3
6317-18-6
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
203-624-3
108-87-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
209-765-7
592-62-1
Carc. 1B; Repr. 1B
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
N 5297
419-010-5
112941-26-1
Acute Tox. 4; Eye Irrit. 2
236-035-5
13108-52-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1
203-475-4
107-25-5
Flam. Gas 1; Press. Gas
METHFAT
420-670-1
37443-42-8
Eye Dam. 1
204-317-7
119-36-8
Repr. 2; Acute Tox. 4; Skin Sens. 1B
209-060-4
554-12-1
Flam. Liq. 2; Acute Tox. 4
414-460-9
105726-67-8
Acute Tox. 4
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
201-297-1
80-62-6
Flam. Liq. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
209-132-5
556-61-6
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
210-866-3
624-83-9
Flam. Liq. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; Resp. Sens. 1; Skin Sens. 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-819-5
74-88-4
Carc. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 3; Skin Irrit. 2
203-481-7
107-31-3
Flam. Liq. 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-187-3
79-22-1
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
202-501-1
96-34-4
Flam. Liq. 3; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-500-6
96-33-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
203-299-8
105-45-3
Eye Irrit. 2
201-185-2
79-20-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
BROMBENZOAT; BROMOBENZOATE
410-310-1
70264-94-7
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
A5546
402-050-2
59337-93-8
Skin Sens. 1
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
425-190-6
119916-05-1
STOT RE 2
431-720-7
90886-53-6
Skin Corr. 1B; Acute Tox. 4
250-366-2
30864-28-9
Acute Tox. 4; Skin Sens. 1
D,L-ESTER
411-040-7
97101-46-7
Acute Tox. 4; Skin Sens. 1
G 18-1108
403-270-1
6386-39-6
Acute Tox. 4
620-362-9
1918-18-9
Acute Tox. 4
MEFAT
404-130-2
105560-93-8
Eye Dam. 1; Skin Sens. 1
443-120-2
393509-79-0
Eye Dam. 1
LUGALVAN ES 9571
420-940-9
15768-07-7
Eye Irrit. 2; Skin Irrit. 2
JE 127
421-220-7
144740-59-0
Skin Sens. 1
DISPERSE RED CLA 282
416-240-8
155522-12-6
Skin Sens. 1
442-860-3
87333-22-0
Skin Sens. 1
BM
405-270-7
39562-17-9
Skin Sens. 1
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
220-815-7
2905-69-3
Acute Tox. 4; STOT SE 3
432-350-9
81752-87-6
Skin Irrit. 2
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
248-704-9
27871-49-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
241-420-6
17392-83-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
DHPPME; MAK-ME; MEHPOPS; R-MAQ-ME
411-950-4
96562-58-2
Eye Dam. 1
HALOXYFOP R-(+)-ME HERBICIDAL CHEMICAL
406-250-0
72619-32-0
Acute Tox. 4
445-990-9
376588-17-9
Skin Sens. 1
GR138766X
415-670-3
78850-37-0
Eye Dam. 1
210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
240-815-0
16752-77-5
Acute Tox. 2
213-449-4
950-37-8
Acute Tox. 2; Acute Tox. 4
202-905-8
100-97-0
Flam. Sol. 2; Skin Sens. 1
200-659-6
67-56-1
Flam. Liq. 2; Acute Tox. 3; STOT SE 1
200-822-1
74-93-1
Flam. Gas 1; Press. Gas; Acute Tox. 3
200-898-6
75-75-2
Skin Corr. 1B
200-812-7
74-82-8
Flam. Gas 1; Press. Gas
233-606-0
10265-92-6
Acute Tox. 2; Acute Tox. 3
204-817-5
126-98-7
Flam. Liq. 2; Acute Tox. 3; Skin Sens. 1
201-204-4
79-41-4
Acute Tox. 4; Skin Corr. 1A
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1
603-031-3
125116-23-6
Repr. 2; Acute Tox. 4
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
255-349-3
41394-05-2
Acute Tox. 4
205-293-0
137-42-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
615-135-6
70630-17-0
Acute Tox. 4; Eye Dam. 1
260-979-7
57837-19-1
Acute Tox. 4; Skin Sens. 1
-
-
Acute Tox. 4
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2

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