Product Stewardship

Nanoform silver-based Biocides: the impact on their marketing after the European Commission's "non-approval" decision of silver in nanoform as a biocidal active substance

The substance has not been approved for PTs 2-4-9 because of the lack of support from participants in the active substance review program

The Commission implementing Decision (EU) 2021/1283 on the non-approval of certain active substances in biocidal products for PTs 2-3-4-5, 9-11-13 and 19 is available. The list of the substances is available here.

Among them is listed nano form Silver, as disinfectant (PT2-PT4) and fiber, leather, rubber and polymerized material preservative (PT9).

The ‘non approval’ reason lies in the fact that all partecipants have withdrawn their support and they have not taken it over also after the publication of an open invitation by ECHA.

The substance, therefore, has not been defended by any company and hence cannot be approved, because of lack of data to be evaluated in the context of the review program for biocidal active substances (EU Regulation 1062/2014):

According to Article 89 of the Biocidal Products Regulation (EU Regulation 528/2012, BPR), biocidal products including silver in nanoform can no longer be placed on the market after 12 months from the adoption of this decision, and products already placed on the market (on the shelf) will have to be withdrawn within 18 months.

The "non-approval" decision of silver in nanoform has a strong impact on treated articles sector. Treated articles are mixtures or articles treated or intentionally containing a biocidal substance.

Treated articles with biocidal properties derived from silver in nanoform then will no longer be produced because, even though don’t require authorization, they must contain biocidal active substances under review/approved.

The usable substances for the production of treated articles are in this list (article list 94) available on this link.

The treatment of textiles (including masks), materials and coatings with silver, even in nanoform, had been strongly diffused particularly during the last year and half following the pandemic caused by COVID 19, because of its presumed antiviral efficacy. However, the efficacy (but also the safety for use or and environment) of this active in biocidal couldn’t be verified under the active substance review program.

The use of nanomaterials as disinfectants or for treated articles received a lot of attention during the pandemic. In early 2021, Health Care Without Harm (HCWH) Europe and 12 other health and environmental organizations had written a letter to Bjorn Hansen, executive director of ECHA, to request clarification on the regulatory framing and risk management of articles treated with nanoform biocides in the context of the COVID-19 pandemic.

ECHA’s answer gives information about the regulatory framework of certain products and stresses and emphasizes the fact that treated articles may only contain substances under review or approved, according to the regulation, and that the labelling of such articles (required according to Article 58 of the BPR) ensures sufficient information to the user. Finally, Member States had to supervise the compliance of treated articles in each national market.

However, during the pandemic, products not fully compliant with the Biocides Regulation and treated articles not compliant with respect to the necessary information to be provided to the user were widespread.

In fact, the most recent European Enforcement Program (BEF-1) on compliance with the Biocides Regulation found that, compared to pre-pandemic data (through 2019), there were 36% more cases of treated article labels  non-compliant with BPR provisions.

Sources: European Union, Health Care Without Harm, ECHA

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