EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 23 April 2024. Database contains 4753 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
Tar bases, coal, quinoline derivs. fraction; Distillate Bases
274-560-1
70321-67-4
Carc. 1B; Muta. 1B
Tar bases, coal, toluidine fraction; Distillate Bases
293-767-8
91082-53-0
Carc. 1B; Muta. 1B
Tar bases, quinoline derivs.; Distillate Bases
271-020-7
68513-87-1
Carc. 1B; Muta. 1B
Tar brown-coal [An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one-to three-ring aromatic hydrocarbons, their alkyl derivates, heteroaromatics and one-and two-ring phenols boiling in the range of approximately 150°C to 360 °C (302°F to 680°F).]
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
Tar oils, brown-coal; Light Oil [The distillate from lignite tar boiling in the range of approximately 80 °C to 250 °C (176°F to 482 °F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.]
The distillate from lignite tar boiling in the range of approximately 80°C to 250°C (176°F to 482°F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.
302-674-4
94114-40-6
Carc. 1B; Muta. 1B
Tar oils, coal, low-temp.; Tar Oil, high boiling [ distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160 °C to 340 °C (320°F to 644°F).]
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
Tar oils, coal; Carbolic Oil [The distillate from high temperature coal tar having an approximate distillation range of 130 o C to 250 o C (266 oF to 410 oF). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.]
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
Tar, brown-coal, low-temp. [A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.]
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Tar, coal, high-temp., distn. and storage residues; Coal Tar Solids Residue [Coke-and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.]
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
Tar, coal, high-temp., high-solids; Coal Tar Solids Residue [The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700 °C (1292 °F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal-type materials.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
Tar, coal, high-temp., residues; Coal Tar Solids Residue [Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.]
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Tar, coal, high-temp.; Coal tar [The condensation product obtained by cooling, to approxi mately ambient temperature, the gas evolved in the high temperature (greater than 700 °C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
Tar, coal, low-temp, distn. residues; Tar Oil, intermediate boiling [Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300 °C (572 °F). Composed primarily of aromatic compounds.]
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
Tar, coal, low-temp.; Coal oil [The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700 °C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
Tar, coal, storage residues; Coal Tar Solids Residue [The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.]
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
Tar, coal; Coal tar [The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.]
The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
232-361-7
8007-45-2
Carc. 1A
tau-fluvalinate (ISO); cyano-(3-phenoxyphenyl)methyl N-[2-chloro-4-(trifluoromethyl)phenyl]-D-valinate
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
TCA (ISO); trichloroacetic acid
200-927-2
76-03-9
Skin Corr. 1A
TCA-sodium (ISO); sodium trichloroacetate
211-479-2
650-51-1
STOT SE 3
tebuconazole (ISO); 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
tebufenpyrad (ISO); N-(4-tertbutylbenzyl)-4-chloro-3-ethyl-1-methyl-1H-pyrazole-5-carboxamide
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
tebuthiuron (ISO); 1-(5-tert-butyl-1,3,4-thiadiazol-2-yl)-1,3-dimethylurea
251-793-7
34014-18-1
Acute Tox. 4
tecnazene (ISO); 1,2,4,5-tetrachloro-3-nitrobenzene
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
tefluthrin (ISO); 2,3,5,6-tetrafluoro-4-methylbenzyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
tembotrione (ISO); 2-{2- chloro-4-(methylsulfonyl)-3- [(2,2,2-trifluoroethoxy)methyl] benzoyl}cyclohexane-1,3-dione
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
TEPP (ISO); tetraethyl pyrophosphate
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
tepraloxydim (ISO); (RS)-(EZ)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one
604-715-4
149979-41-9
Carc. 2; Repr. 2
terbufos (ISO); S-tert-butylthiomethyl O, O-diethylphosphorodithioate
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
terbumeton (ISO);2-tert-butylamino-4-ethylamino-6-methoxy-1,3,5-triazine
251-637-8
33693-04-8
Acute Tox. 4
terbuthylazine (ISO); N-tert-butyl-6-chloro-N'-ethyl-1,3,5-triazine-2,4-diamine
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
Terphenyl, hydrogenated
262-967-7
61788-32-7
yes
Terphenyl, hydrogenated
262-967-7
61788-32-7
yes
tert-butyl (1R,5S)-3-azabicyclo[3.1.0]hex-6-ylcarbamate
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
tert-butyl (5S,6R,7R)-3-bromomethyl-5,8-dioxo-7-(2-(2-phenylacetamido)-5-thia-1-azabicyclo[4.2.0] oct-2-ene-2-carboxylate
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
tert-butyl (triphenylphosphoranylidene) acetate
1,1-DIMETHYLETHOXY-CARBONYL-METHYLEN-TRIPHENYLPHOSPHORAN; DMY; PHOSPHORANE
412-880-7
35000-38-5
Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
tert-butyl acetate
208-760-7
540-88-5
Flam. Liq. 2
tert-butyl acrylate
216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
tert-butyl formate
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
tert-butyl hydroperoxide
200-915-7
75-91-2
Muta. 2
tert-butyl methyl ether; MTBE; 2-methoxy-2-methylpropane
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
tert-butyl nitrite
208-757-0
540-80-7
Flam. Liq. 2; Acute Tox. 4
tert-butyl propionate
606-566-0
20487-40-5
Flam. Liq. 2
tert-butyl α, α-dimethylbenzyl peroxide
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
tert-butylarsine
TERTIARYBUTYLARSINE; TERTIÄRBUTYLARSIN
423-320-6
4262-43-5
Pyr. Liq. 1; Acute Tox. 2
tetra-ammonium 2-[6-[7-(2-carboxylato-phenylazo)-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazin-2-ylamino]benzoate
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
tetraammine palladium (II)hydrogen carbonate
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
tetraammine platinum (II); hydrogen carbonate
426-730-3
123439-82-7
Acute Tox. 4; Eye Dam. 1
tetraammonium 5-(4-(7-amino-1-hydroxy-3-sulfonato-2-naphthylazo)-6-sulfonato-1-naphthylazo)isophthalate
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
tetraboron disodium heptaoxide, hydrate
235-541-3
12267-73-1
Repr. 1B
yes
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