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
Technical documentation and the product's label
If the requirement has been verified with a self-declaration based on documentation, first take samples of delivered products and check that there is no label that describes treatment with biocidal products1. If there is such a label, the requirement is not met.
If the products do not have a label describing treatment with biocidal products, request information2 about the product from the supplier and check that there is no information describing treatment with biocidal products. If there is such information, the product does not meet the requirement.
For the requirement to be met, the product shall lack information about biocide treatment, both on the label/marking and in the product information.
1Biocidal treated articles shall be labeled in accordance with the Biocide Products Regulation. More information is available on the Swedish Chemicals Agency’s website.
2The information may, for example, consist of product sheets, marketing materials or similar. If a product has been treated with biocides, there shall be information containing the name of the added biocide that may be in the product.
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
Please note that during follow-up, a test protocol is not required to show that the requirement is met. See more information under "Proposed follow-up", under the tab "Criterion text”.
An article marketed as biocide-treated, for example antibacterial shall, according to the Biocides Regulation, be labelled. The information shall also be able to be provided if the supplier does not market the product as biocide-treated, according to Article 58 of the Biocides Regulation. The supplier of the product shall, upon request, be able to provide information on possible biocidal treatment within 45 days, even if the product is not marketed as a biocidal treated product to the consumer, according to the Biocides Regulation. It is thus possible to request the information from the supplier. More information about biocidal treated articles is available on the Swedish Chemicals Agency’s website.
There are currently a limited number of accredited verification bodies according to ISO / IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies), as it is a relatively new standard. However, 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
- 2024-03-15