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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 19 April 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
fluorotripentylstannane
243-546-7
20153-49-5
Acute Tox. 4
fomesafen (ISO); 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulphonyl)-2-nitrobenzamide
276-439-9
72178-02-0
Acute Tox. 4
formothion (ISO); N-formyl-N-methylcarbamoylmethyl O, O-dimethyl phosphorodithioate
219-818-6
2540-82-1
Acute Tox. 4
furalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(2-furylcarbonyl)-DL-alaninate
260-875-1
57646-30-7
Acute Tox. 4
glyphosate-trimesium; glyphosate-trimethylsulfonium
617-243-9
81591-81-3
Acute Tox. 4
guanidinium benzoate
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
haloxyfop-etotyl (ISO); 2-ethoxyethyl 2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate; haloxyfop-(2-ethoxyethyl)
HALOXYFOP ETHOXYETHYL EST
402-560-5
87237-48-7
Acute Tox. 4
hexachloroacetone
204-129-5
116-16-5
Acute Tox. 4
hexan-1-ol
203-852-3
111-27-3
Acute Tox. 4
hexapentyldistannoxane
247-143-7
25637-27-8
Acute Tox. 4
hydroxo(2-(benzenesulfonamido)benzoato)zinc(II)
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
iodine
231-442-4
7553-56-2
Acute Tox. 4
iprobenfos(ISO); S-benzyl diisopropyl phosphorothioate
247-449-0
26087-47-8
Acute Tox. 4
isobutyl 2-(4-(4-chlorophenoxy)phenoxy)propionate; clofop-isobutyl (ISO)
-
51337-71-4
Acute Tox. 4
isobutyric acid
201-195-7
79-31-2
Acute Tox. 4
isoprocarb (ISO); 2-isopropylphenyl N-methylcarbamate
220-114-6
2631-40-5
Acute Tox. 4
manganese dioxide
215-202-6
1313-13-9
Acute Tox. 4
MCPA-thioethyl (ISO); S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate
246-831-4
25319-90-8
Acute Tox. 4
menazon (ISO); S-[(4,6-diamino-1,3,5-triazin-2-yl)methyl] O, O-dimethyl phosphorodithioate
201-123-4
78-57-9
Acute Tox. 4
metal salts of thiocyanic acid, with the exception of those specified elsewhere in this Annex
-
-
Acute Tox. 4
metamitron (ISO);4-amino-3-methyl-6-phenyl-1,2,4-triazin-5-one
255-349-3
41394-05-2
Acute Tox. 4
methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate
HALOXYFOP R-(+)-ME HERBICIDAL CHEMICAL
406-250-0
72619-32-0
Acute Tox. 4
methyl 3,4-dichlorophenylcarbanilate; SWEP.
620-362-9
1918-18-9
Acute Tox. 4
methyl 3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionate
G 18-1108
403-270-1
6386-39-6
Acute Tox. 4
methyl [2-(1,1-dimethylethyl)-6-methoxypyrimidin-4-yl]ethylphosphonothioate
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
methyl neodecanamide
414-460-9
105726-67-8
Acute Tox. 4
metolcarb (ISO); m-tolyl methylcarbamate; MTMC
214-446-0
1129-41-5
Acute Tox. 4
metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one
244-209-7
21087-64-9
Acute Tox. 4
milbemectin (ISO) [reaction mass of milbemycin A3 (CAS No 51596-10-2) and milbemycin A4 (CAS No 51596-11-3) (30:70)]
-
-
Acute Tox. 4
N, N,N',N'-tetramethyl-p-phenylenediamine
202-831-6
100-22-1
Acute Tox. 4
N,N'-dimethylbenzidine
-
2810-74-4
Acute Tox. 4
N-(2',6'-dimethylphenyl)-2-piperidinecarboxamide hydrochloride
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
N-(2,2,6,6-tetramethyl-1-oxylpiperidin-4-yl)acetamide; (4-acetamido-2,2,6,6-tetra; methyl-1-piperidinyl)oxidanyl
423-840-3
14691-89-5
Acute Tox. 4
N-ethyl-N-methylpiperidinium iodide
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
naptalam-sodium (ISO); sodium N-naphth-1-ylphthalamate
205-073-4
132-67-2
Acute Tox. 4
nitrapyrin (ISO); 2-chloro-6-trichloromethylpyridine
217-682-2
1929-82-4
Acute Tox. 4
norbormide (ISO); 5-(α-hydroxy-α-2-pyridylbenzyl)-7-(α-2-pyridylbenzylidene)bicycle [2.2.1] hept-5-ene-2,3-dicarboximide
213-589-6
991-42-4
Acute Tox. 4
noruron (ISO); 1,1-dimethyl-3-(perhydro-4,7-methanoinden-5-yl)urea
-
2163-79-3
Acute Tox. 4
O,O,O',O'-tetrapropyl dithiopyrophosphate
221-817-0
3244-90-4
Acute Tox. 4
oxalic acid
205-634-3
144-62-7
Acute Tox. 4
oxycarboxin (ISO); 2,3-dihydro-6-methyl-5-(N-phenylcarbamoyl)-1,4-oxothiine 4,4-dioxide
226-066-2
5259-88-1
Acute Tox. 4
papaverine
200-397-2
58-74-2
Acute Tox. 4
pebulate (ISO); N-butyl-N-ethyl-S-propylthiocarbamate
214-215-4
1114-71-2
Acute Tox. 4
phenthoate (ISO); ethyl 2-(dimethoxyphosphinothioylthio)-2-phenylacetate
219-997-0
2597-03-7
Acute Tox. 4
phosnichlor (ISO); O-4-chloro-3-nitrophenyl O, O-dimethyl phosphorothioate
-
5826-76-6
Acute Tox. 4
piperophos (ISO); S-2-methylpiperidinocarbonylmethyl-O, O-dipropyl phosphorodithioate
607-329-4
24151-93-7
Acute Tox. 4
potassium bis(N-carboxymethyl)-N-methyl-glycinato-(2-)N, O,O, N)-ferrate-(1-)monohydrate
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
potassium cyanate
209-676-3
590-28-3
Acute Tox. 4
prochloraz (ISO);N-propyl-N-[2-(2,4,6-trichlorop henoxy)ethyl]-1H-imidazole-1- carboxamide
266-994-5
67747-09-5
Acute Tox. 4
profenofos (ISO)O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
255-255-2
41198-08-7
Acute Tox. 4
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