November 14, 2018

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November 12, 2018

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EC Committee Publishes Final Opinion on Colloidal Silver (Nano)

On October 26, 2018, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on colloidal silver (nano).  According to the final opinion, the EC received 63 notifications of cosmetic products containing colloidal silver in nano form.  The final opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products, with a maximum reported concentration limit of one percent and certain specifications.  The EC asked SCCS to produce a safety assessment of the nano form of colloidal silver covered in the notifications, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions.  According to SCCS, only a limited amount of data was provided by the applicants that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics (SCCS 1484/12).  The provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials (SCCS/1524/13).  SCCS states that although other information is available in open literature relating to the toxicity of nano silver, its relevance with respect to the materials of this submission has not been considered by the applicants.  Due to a number of major data gaps, SCCS “is not in the position to draw a conclusion on the safety of colloidal silver in nano form when used in oral and dermal cosmetic products.”  The EC also asked SCCS to address any further scientific concerns with regard to the use of colloidal silver in nano form in cosmetic products.  SCCS concluded that in addition to the safety assessment of colloidal silver in nano form, consideration should also be given to the likely presence of ionic silver in different types of final products.

©2018 Bergeson & Campbell, P.C.

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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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