REGULATORY

PUBLISHED 06/21/2016 · EDITED 06/22/2016


agpure®-Nanosilver

Proper regulatory status of agpure® formulations

Trafficable according to the Biocides Directive (BPR); (EU) Nr.528/2012

listed in Article 95 , Annex II

CA-Substance-Nr. 7440-22-4 „Elementary Silver (Nanoform)“

Active substance dossier for the active substance agpure nanosilver submitted in due time since 01.Septemper 2015 Assessment expected to be expected: 2020.

Agpure® is the official standard reference material of the OECD for nanosilver.

Biocide approval is applied for the product types (PA) 2, 4 und 9.


Registrations

Approvals according to EU guidelines

*) The registration can be viewed on the eBIOMELD website.

PA 2 - Registration-No. N-73054

Disinfectants and algae, which are not intended for direct use in humans and animals. Products for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feed. […] Products as an additive in textiles, fabrics, masks, paints and other objects or substances to produce treated goods with disinfecting properties.


PA 4 - Registration-No. N-73054

Food and feed sectors Products for the disinfection of equipment, containers, cutlery and crockery, surfaces and pipes used in connection with the manufacture, transport, storage or consumption of food or feed (including drinking water) for humans and animals. Products for inclusion in materials that may come into contact with food.


PA 4 - Registration-No. N-73054

Protectors for fibers, leather, rubber and polymerized materials Products for the protection of fibrous or polymerized materials such as leather, rubber, paper and textile products against microbial damage. This type of product includes biocidal products which counteract the accumulation of microorganisms on the surface of materials and thus inhibit or eliminate the development of odors and / or bring about other advantages.


FOOD AUTHORIZATION

according to EU - directives

Regulation: „... only biocides in food contact may be used which are notified in product type 4 and do not exceed the specific migration limit (SML) .... "

In addition to this, registration is sought with the competent authority, the European Food Safety Authority (EFSA), for agpure® nanosilver.

A treated product with a primary biocide function is considered a biocidal product. We are happy to assist you in finding the right product for your product to stay either treated product or register as a biocidal product.

Any questions?

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