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
Swedish:: Förbrukningsartiklar fria från ftalater

Compare criteria

Criterion text

Consumables shall not contain phthalates included on the current candidate list (Article 59 of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)) in levels above 0.1 weight percent (1000 mg/kg) per substance. 0.1 weight percent refers to each individual part of a product.¹

Consumables shall not contain the phthalates listed in the table below in levels above 0.1 weight percent (1000 mg/kg) per substance. 0.1 weight percent refers to each individual part of a product.¹

Ämne	CAS-nr
Di-"isononyl" phthalate (DINP)	28553-12-0 och 68515-48-0
Di-"isodecyl" phthalate (DIDP)	26761-40-0 och 68515-49-1
Di-n-octyl phthalate (DNOP)	117-84-0

Exception

Endotracheal tubes.

¹Percent by weight applies to each individual part of a composite item and thus means, not 0.1 percent of a composite product, but 0.1 percent 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.

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).

Examples of phthalates included on the candidate list:

Ämne	CAS-nr
Bis(2-ethylhexyl) phthalate (DEHP)	117-81-7
Bis(2-methoxiethyl) phthalate	117-82-8
Dipentyl phthalate (DPP)	131-18-0
Diisopentyl phthalate (DIPP)	605-50-5
1,2-Benzenedicarboxylic acid, di-C7-11- branched and linear alkyl esters	68515-42-4
1,2-Benzenedicarboxylic acid, di-C6-C8-branched alkyl esters, C7-rich	71888-89-6
n-pentyl isopentyl phthalate	776297-69-9
Diisobutyl phthalate (DIBP)	84-69-5
Dibutyl phthalate (DBP)	84-74-2
Dihexyl phthalate	84-75-3
1,2-Benzendicarboxylic acid dipentylester, branched and linear	84777-06-0
Benzyl butyl phthalate (BBP)	85-68-7
1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear	68515-50-4
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters	68515-51-5
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters	68648-93-1

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

A Non-Toxic Environment