SNWG Responds to BfR's Statement Concerning Nanosilver

The Silver Nanotechnology Working Group (SNWG) prepared a May 2, 2011, statement regarding the German Federal Institute for Risk Assessment's (BfR) April 12, 2011, statement concerning consumer products containing nanosilver. SNWG notes that, in December 2009, BfR published an opinion advising against the use of nanosilver in consumer products. Industry and other groups, including SNWG, asked BfR to reconsider its position, and BfR held a workshop on February 17, 2011, on nanosilver. SNWG states that, despite BfR’s assurance that follow-up dialogue would occur after the workshop, BfR instead issued its April 12, 2011, statement, which restated BfR’s initial opinion.  According to SNWG, BfR has “essentially ignore[d] the facts presented to BfR during the workshop.” SNWG reviews BfR’s concerns regarding nanosilver -- the use of silver aims to replace normal hygiene measures, the potential for bacterial resistance from silver, and claims of unusual effects of nanosilver -- and addresses each. SNWG highlights the benefits to consumers from antimicrobial products, including longer shelf-life and protection from the degrading action and colonization of bacteria. SNWG notes that BfR disregarded multiple references regarding the low risk of resistance to silver and wrongly singled out nanosilver to address a concern about silver resistance in general. Finally, SNWG rebuts BfR’s assumptions concerning the use of silver and nanosilver, and concludes that the “mode of action is therefore not unusual in comparison to other silver forms employed in the marketplace or used throughout history.” SNWG describes additional issues of concern regarding BfR’s position on nanosilver, including its misunderstanding of materials and history; the selective harm to small- and medium-sized enterprises; and its preemption of the European Union regulatory process.

BfR Cautions Against Broad Use of Nanosilver in Consumer Products

On April 12, 2011, the German Federal Institute for Risk Assessment (BfR) issued a statement entitled “Safety of Nano Silver in Consumer Products: Many Questions Remain Open,” which reports BfR’s conclusions from a February 2011 workshop discussing existing risks and possible options for comprehensive consumer protection from nanosilver. According to BfR, “the situation continues to be characterised by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available.” BfR states: “Articles of daily use and consumer products may not constitute any health risk based on statutory provisions during proper use or foreseeable misuse. Since no final safety assessment for man and the environment is available so far for nanoscale forms of silver due to the missing data, BfR continues to advise against a broad use of nano silver in consumer products.”

Germany's BfR Recommends Manufacturers Not Use Nanoscale Silver Ions in Consumer Products

On June 10, 2010, the Federal Institute for Risk Assessment (BfR) issued a press release entitled “Nanosilver has no place in food, textiles or cosmetics,” which states “BfR currently advises against using nanoscale silver ions in consumer products.” According to BfR, manufacturers of consumer products “have made use of the antimicrobial properties of silver ions for some time now,” and “silver particles in the nanorange have likewise been used.” BfR states: “It is not possible at the present time to determine in a definitive manner whether nanosilver constitutes a health risk for consumers,” and “we recommend that manufacturers refrain from using nanosilver in consumer products.” The press release states:

BfR feels there is a need for research to elucidate the fundamental issues in conjunction with the use of nanoscale silver as an antimicrobial material. On what scale do consumers come into contact with nanoscale particles? How big is the danger of resistance development?

BfR recommends refraining from using any nanoscale silver in consumer products until a definitive safety assessment becomes available. In any case nanoscale additives in food require approval. Nanosilver has not been approved for use in food. BfR welcomes this in the context of the yet to be answered questions about risk assessment.

BfR has published an Opinion on this subject.