Limitation of phthalates (vinyl gloves)
Level: Core
Different types of chemicals are used for different types of glove. Plasticisers in gloves can increase their environmental impact as well as constituting a health risk, as documented for phthalates as a chemical group, which is based on the substance phthalic acid. Phthalates used as plasticisers in plastic – especially PVC (vinyl) – can be avoided by setting this requirement.
Details
- Type:
- Technical specification
- ID:
- 11078
- Group:
- Disposable gloves for medical use
Criterion text
Phthalates, diesters of orthophthalic acid, in concentrations above 0.1 % by weight (1000 mg/kg) for each substance shall not be included in disposable polyvinyl chloride (PVC) gloves.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Technical documentation verifying that the tendered gloves do not contain orthoesters of phthalic acid as a plasticiser, or
-
The supplier’s self-declaration, including technical documentation of compliance, shall be verified by an accredited verification body that is accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
Check that the tendered vinyl gloves do not contain phthalates, in accordance with the requirement.
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
The tenderer or supplier shall be able to provide information regarding all stages of production. If it is required that gloves shall not contain a certain substance or chemical, it shall not be used in the manufacturing process. It is possible to test polyvinyl chloride (PVC) gloves to detect specific phthalates.
This requirement applies only to products that contain plasticisers; nitrile gloves, for example, are manufactured without chemical plasticisers such as phthalates. Disposable gloves made from vinyl may be an alternative for wearers who have developed an allergy to rubber chemicals.
However, vinyl gloves are not recommended when in contact with chemicals, disinfectants or cleaning agents, since they do not resist chemicals, offering no protection at all, and these substances can negatively affect the function of the gloves.
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
- 11078
- Version date
- 2018-06-05
- Review date
- 2024-03-15