Phthalate-free consumables
Level: Core
Phthalates that are hazardous to the health are used as active additives and plasticisers in some plastics. This group of plasticisers can be avoided by using this requirement, thereby reducing the risk of exposure for patients and personnel.
Details
- Type:
- Technical specification
- ID:
- 11249
- Group:
- General criteria
Criterion text
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.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Technical documentation that the product does not contain phthalates in concentrations higher than stated in the requirement, in accordance with the requirement.
- 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.
- The contracting authority can also request that one or more products be tested by an independent laboratory or other testing institute.
Proposed follow-up
The supplier shall be able to provide information about which phthalates are included in the tendered product, as well as any residues that can be found in the final product.
Check the technical documentation or analytical protocols to ensure that listed phthalates are not used in concentrations that exceed those stated in the requirement for supplied products.
The contracting authority can also request that one or more products be tested by an independent laboratory or other testing institute.
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
Endotracheal tubes have been exempted from this requirement. In that product segment, only polyvinyl chloride plastic (PVC) can usually provide the desired medical function and patient safety. An award criterion can be set to drive the market towards using alternatives to phthalates as plasticisers; Phthalate-free endotracheal tubes (Requirement ID 11252).
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
- 11249
- Version date
- 2019-05-29
- Review date
- 2022-04-07