Bisphenols in plastic, advanced
Level: Advanced
This requirement is set to ensure that bisphenols that have a similar structure and are suspected of having similarly serious characteristics as bisphenol A are not present in the products.
Details
- Type:
- Technical specification
- ID:
- 11260
- Group:
- General criteria
Criterion text
Consumables containing plastic shall not contain bisphenol A or bisphenols with a similar chemical structure to bisphenol A in concentrations exceeding 0.1% by weight for each separate plastic part of the product. The table shows bisphenols identified in a study by the Swedish Chemicals Agency in 20171. The specified CAS number takes precedence over the name of the substance.
| Substance | CAS-number |
| Phenol, 4,4'-(1-methylethylidene)bis (BPA) | 80-05-7 |
| Phenol, 4,4'-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis (BPAF) | 1478-61-1 |
| Phenol, 4,4´-(1-phenylethylidene)bis (BPAP) | 1571-75-1 |
| Phenol, 4,4´-methylenebis (BPF) | 620-92-8 |
|
Phenol, 4,4´-[1,3-phenylenebis(1-methylethylidene)] bis (BPM) |
13595-25-0 |
| Phenol, 4,4´-sulfonylbis (BPS) | 80-09-1 |
| Phenol, 4,4´-cyclohexylidenebis (BPZ) | 843-55-0 |
| Phenol, 4,4´-[1-[4-[1-(4-hydroxyphenyl)-1- methylethyl]phenyl]ethylidene]bis | 110726-28-8 |
| Benzenebutanoic acid, 4-hydroxy-g-(4-hydroxyphenyl)-g-methyl (DPA) | 126-00-1 |
| Phenol, 4,4´-methylenebis[2,6-dimethyl (TMBPF) | 5384-21-4 |
| Phenol, 4,4´,4´´-ethylidynetris (THPE) | 27955-94-8 |
| Fluorene-9-bisphenol | 3236-71-3 |
| Methanone, bis(4-hydroxyphenyl) | 611-99-4 |
| Phenol, 4,4´-(1-methylethylidene)bis[2,6-dibromo TBBPA | 79-94-7 |
| Phenol, 4,4´-(1-methylethylidene)bis[2,6- dichloro(TCBPA) | 79-95-8 |
| Phenol, 4,4'-[methylenebis(oxy-2,1-ethanediylthio)]bis | 93589-69-6 |
| Phenol, 4,4´-(1,3-dimethylbutylidene)bis | 6807-17-6 |
| BisP-IOTD 4,4'-(2-Ethylhexane-1,1-diyl)diphenol | 74462-02-5 |
| Phenol, 4,4´-thiobis[2-(1,1-dimethylethyl)-5-methyl | 96-69-5 |
| Phenol, 4,4´-butylidenebis[2-(1,1-dimethylethyl)-5-methyl | 85-60-9 |
| Phenol, 4,4'-methylenebis[2,6-bis(1,1- dimethylethyl)- | 118-82-1 |
| Phenol, 4,4´,4´´-(1-methyl-1-propanyl-3-ylidene)tris[2-(1,1-dimethylethyl)-5-methyl | 1843-03-4 |
|
Benzenepropanoic acid, 3-(1,1-dimethylethyl)-.beta.-[3-(1,1-dimethylethyl)-4-hydroxyphenyl]-4-hydroxy-.beta.-methyl-, 1,1'-(1,2-ethanediyl)ester |
32509-66-3 |
| Phenol, 4,4´-(1-methylethylidene)bis[2-(1,1-dimethylethyl)- | 79-96-9 |
| Phenol, 4,4'-(1-methylethylidene)bis[2,6-bis(1,1-dimethylethyl)- | 13676-82-9 |
| Phenol, 4,4'-methylenebis[2-(1,1-dimethylethyl)-6-methyl | 96-65-1 |
| Methanone, bis(2,4-dihydroxyphenyl)- | 131-55-5 |
| Methanone, (3,4-dihydroxyphenyl)(2,4,6-trihydroxyphenyl)- | 519-34-6 |
| Methanone, (4-hydroxyphenyl)(2,3,4- trihydroxyphenyl)- | 31127-54-5 |
| 1(3H)-Isobensofuranon, 3,3-bis(4- hydroxifenyl)- | 77-09-8 |
| Phenol, 4,4'-(1,1-dioxido-3H-2,1-benzoxathiol3-ylidene)bis[3-methyl | 2303-01-7 |
| Phenol, 4-[cyclohexylidene(4-hydroxyphenyl)methyl]- | 5189-40-2 |
| Phenol, 4,4'-(2-pyridinylmethylene)bis | 603-41-8 |
| 1-Propanone, 3-(4-hydroxyphenyl)-1-(2,4,6-trihydroxyphenyl)- | 60-82-2 |
| 1,2-Benzenediol, 4,4'-(2,3-dimethyl-1,4-butanediyl)bis | 500-38-9 |
| 3,5-Heptanedione, 1,7-bis(4-hydroxy-3-methoxyphenyl)- | 36062-04-1 |
| 1,3-Benzenediol, 4,4´-thiobis | 97-29-0 |
| Phenol, 2,6-dibromo-4-[1-(3-bromo-4-hydroxyphenyl)-1-methylethyl]- | 6386-73-8 |
| Phenol, 4,4´-(1-methylethylidene)bis[2-(2- propen-1-yl)- (DAL-BPA) | 1745-89-7 |
Verification
Upon the contracting authority's request, it shall be possible to verify these details using technical documentation from the manufacturer or the equivalent.
The supplier’s self-declaration including technical documentation of compliance verified by an accredited verification body, accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
Request technical documentation from the manufacturer proving that bisphenols according to the requirement do not exceed 0.1% by weight in tendered products.
If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard.
Subject matter of contract
Criteria for the sustainable procurement of medical consumables are under continuous development within selected product areas. The areas are chosen on the basis ofbased on the volumes used within regions and municipalities and/or their significantce environmental- and health of aspects. relating to health and the environment.
Information about the criterion
This requirement applies to the advanced level. There is a criterion on the base level that only covers bisphenol A in plastic (Requirement ID 11248), which should also be used when this criterion is set. The contracting authority can also request a test report or certificate from an accredited body for assessing compliance. The contracting authority may also test the contents of the product, which can be regulated in the contract terms.
There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.
Environmental goals
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11260
- Version date
- 2019-05-29
- Review date
- 2022-04-07