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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 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
Aspergillus fumigatus	-	-		F Fungi
Astroviridae	-	-		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.
atrazine (ISO);2-chloro-4-ethylamine-6- isopropylamine-1,3,5-triazine	217-617-8	1912-24-9	STOT RE 2; Skin Sens. 1
atropine	200-104-8	51-55-8	Acute Tox. 2
Australia encephalitis	-	-		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.
avermectin B1a (purity ≥ 80 %)	265-610-3	65195-55-3	Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
azaconazole (ISO);1-{[2-(2,4-dichlorophenyl)-1,3- dioxolan-2-yl]methyl}-1H-1,2.4- triazole	262-102-3	60207-31-0	Acute Tox. 4
azafenidin (ISO); 2-(2,4-dichloro-5-prop-2-ynyloxyphenyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyridine-3(2H)-one	620-425-0	68049-83-2	Repr. 1B; STOT RE 2
azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo [4,5-b]pyridin-3(2H)-yl) methyl] O,O-dimethyl thiophosphate	252-626-0	35575-96-3	Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 1; Skin Sens. 1
azinphos-ethyl (ISO); O,O-diethyl 4-oxobenzotriazin-3-ylmethyl phosphorodithioate	220-147-6	2642-71-9	Acute Tox. 2; Acute Tox. 3
azinphos-methyl (ISO); O,O-dimethyl-4-oxobenzotriazin-3-ylmethyl phosphorodithioate	201-676-1	86-50-0	Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
azobenzene	203-102-5	103-33-3	Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
azocyclotin (ISO); 1-(tricyclohexylstannyl)-1H-1,2,4-triazole	255-209-1	41083-11-8	Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
azothoate (ISO); O-4-(4-chlorophenylazo)phenyl O,O-dimethyl phosphorothioate	227-419-3	5834-96-8	Acute Tox. 4
azoxybenzene	207-802-1	495-48-7	Acute Tox. 4
azoxystrobin (ISO); methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate	603-524-3	131860-33-8	Acute Tox. 3
Babesia divergens	-	-		P Parasites
Babesia microti	-	-		P Parasites
Bacillus anthracis	-	-		B Bacteria and similar species
Bacteroides fragilis	-	-		B Bacteria and similar species
Balantidium coli	-	-		P Parasites
barban (ISO); 4-chlorbut-2-ynyl N-(3-chlorophenyl)carbamate	202-930-4	101-27-9	Acute Tox. 4; Skin Sens. 1
barium calcium cesium lead samarium strontium bromide chloride fluoride iodide europium doped	431-780-4	199876-46-5	Acute Tox. 4; STOT RE 2
barium carbonate	208-167-3	513-77-9	Acute Tox. 4
barium chlorate	236-760-7	13477-00-4	Ox. Sol. 1; Acute Tox. 4
barium chloride	233-788-1	10361-37-2	Acute Tox. 3; Acute Tox. 4
barium perchlorate	236-710-4	13465-95-7	Ox. Sol. 1; Acute Tox. 4
barium peroxide	215-128-4	1304-29-6	Ox. Sol. 2; Acute Tox. 4
barium polysulphides	256-814-3	50864-67-0	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
barium salts, with the exception of barium sulphate, salts of 1-azo-2-hydroxynaphthalenyl aryl sulphonic acid, and of salts specified elsewhere in this Annex	-	-	Acute Tox. 4
barium sulphide	244-214-4	21109-95-5	Acute Tox. 4
Bartonella (Rochalinea) spp.	-	-		B Bacteria and similar species
Bartonella bacillifonnis	-	-		B Bacteria and similar species
Bartonella quintana	-	-		B Bacteria and similar species
basic phenylmercury nitrate	620-403-0	8003-05-2	Acute Tox. 3; STOT RE 1; Skin Corr. 1B
BBP; benzyl butyl phthalate e	201-622-7	85-68-7	Repr. 1B		yes
Bebaru virus	-	-		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.
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride LEXQUAT AMG-BEO (CONCENTRATE)	423-420-1	136920-10-0	Eye Dam. 1; Skin Sens. 1
Belgrade	-	-		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.
benazolin (ISO); 4-chloro-2,3-dihydro-2-oxo-1,3-benzothiazol-3-ylacetic acid	223-297-0	3813-05-6	Eye Irrit. 2; Skin Irrit. 2
bendiocarb (ISO); 2,2-dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate	245-216-8	22781-23-3	Acute Tox. 3; Acute Tox. 2
benfuracarb (ISO); ethyl N-[2,3-dihydro-2,2-dimethylbenzofuran-7-yloxycarbonyl(methyl)aminothio]-N-isopropyl-β-alaninate	617-356-3	82560-54-1	Repr. 2; Acute Tox. 3; Acute Tox. 4
benomyl (ISO);methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate	241-775-7	17804-35-2	Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
benquinox (ISO); p-benzoquinone 1-benzoylhydrazone 4-oxime	207-807-9	495-73-8	Acute Tox. 3; Acute Tox. 4
bensulide (ISO); O, O-diisopropyl 2-phenylsulphonylaminoethyl phosphorodithioate	212-010-4	741-58-2	Acute Tox. 4
bensultap (ISO); 1,3-bis(phenylsulfonylthio)-2-(N,N-dimethylamino)propane	605-769-1	17606-31-4	Acute Tox. 4
bentazone (ISO);3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide	246-585-8	25057-89-0	Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
benz[a]anthracene	200-280-6	56-55-3	Carc. 1B		yes
benz[e]acephenanthrylene	205-911-9	205-99-2	Carc. 1B
benzaldehyde	202-860-4	100-52-7	Acute Tox. 4

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EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

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

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Last updated 24 April 2024. Database contains 4821 unique substances/entries.

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