Consumables (except for endotracheal tubes) shall not contain phthalates (esters of 1,2 benzene dicarboxylic acid) that exceed 0.1% by weight1 for each substance and each individual part of the consumable item in accordance with the current REACH Candidate List. The table below is an example of phthalates included on the list as of April 2022. The specified CAS number takes precedence over the name of the substance.
|
Substance
|
CAS-number |
1
|
Di(2-etylhexyl)ftalat (DEHP)
|
117-81-7
|
2
|
Bis(2-metoxietyl)ftalat; Di(2-metoxietyl)ftalat (BMEP; DMEP)
|
117-82-8
|
3
|
Dipentylftalat (DPP)
|
131-18-0
|
4
|
Diisopentylftalat (DIPP)
|
605-50-5
|
5
|
1,2-bensendikarboxylsyra di-(C7-11)-alkylestrar, grenade och raka (DHNUP)
|
68515-42-4
|
6
|
Di(grenade C6-C8) alkylftalater (DIHP)
|
71888-89-6
|
7
|
N-pentylisopentylftalat
|
776297-69-9
|
8
|
Diisobutylftalat (DIBP)
|
84-69-5
|
9
|
Dibutylftalat (DBP)
|
84-74-2
|
10
|
Dihexylftalat (DnHP)
|
84-75-3
|
11
|
1,2-bensendikarboxylsyra dipentylester, grenad och rak
|
84777-06-0
|
12
|
Benzylbutylftalat (BBP)
|
85-68-7
|
13
|
1,2-bensendikarboxylsyra dihexylester, grenad och rak
|
68515-50-4
|
14
|
1,2-Benzenedikarboxylsyra, di-C6-10-alkylester
|
68515-51-5
|
15
|
1,2-Benzenedikarboxylsyra, blandad decyl- och hexyl- och octyldiester
|
68648-93-1
|
16
|
Diisononylftalat (DINP)
|
28553-12-0 och 68515-48-0
|
17
|
Diisodecylftalat (DIDP)
|
26761-40-0 och 68515-49-1
|
18
|
Di-n-oktylftalat (DNOP)
|
117-84-0
|
1 % by weight applies to each individual part of a composite item and thus means, not 0.1% of a composite product, but 0.1% of each constituent part.