Limitation of biocides (antimicrobial substances)
Level: Core
Products that are treated with biocides (antimicrobial function) contain substances that can be hazardous or toxic to humans and the environment and can accelerate the development of resistance in bacteria.
Details
- Type:
- Technical specification
- ID:
- 11219
- Group:
- Disposable gloves for medical use
Criterion text
Disposable products shall not be treated with biocides – that is, treated with or deliberately containing one or more biocidal products1.
1 Definition according to Article 3 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
Verification
The supplier shall, upon request, be able to present any of for example the following:
- Technical documentation and the product's label or product sheet where it appears that the product is not marketed as a biocidal product.
- dokumentation where it appears that the product is not marketed as a biocidal product.
- 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
Spot check the supplied products and see whether they have a marking/label that declares treatment with biocidal products. Examples of what such a label may look like can be found in the Swedish Chemicals Agency's fact sheet called "Articles treated with biocides". If such a label exists, the product fails to meet the requirement.
Self-declaration verified by an accredited verification body
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 contracting authority can also request a test report or certificate from an accredited body for assessing compliance. A product that is marketed as treated with biocides, such as antibacterial, shall be labelled according to the Biocides Regulation. Information shall still be able to be provided even if the supplier does not market the product as having been treated with biocides, according to Article 58 of the Biocides Regulation.
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
- 11219
- Version date
- 2018-06-05
- Review date
- 2022-03-31