14 January 2014
Organizations designing, manufacturing, processing, importing and trading nanomaterials and nanotechnology-based products in the UK can now benefit from using PAS 137 Nanomaterials and nanotechnology based products – Guide to regulation and standards. The specification was developed by BSI, the business standards company and was sponsored by BIS (The Department for Business, Innovation & Skills).
The use of nanomaterials and nanotechnology-based products for applications relating to certain sectors, such as food and pharmaceuticals, is subject to existing regulations that apply to these sectors. How existing regulations cover other sectors is not clear and presents particular problems for small and medium sized enterprises (SMEs). The aim of PAS 137 is to guide organizations in understanding regulations and standards in this area.
Smaller companies that want to enter the nanotechnology market face many challenges in understanding the commercial benefits and also how they can address some of the potential adverse effects of these new materials. Their approach to dealing with the potential risks could have a major impact on their ability to commercialize nanomaterials and nanotechnology-based products.
This guidance has been developed primarily for SMEs, to signpost regulations and standards relevant to the importation and manufacture of nanomaterials and nanotechnology-based products. Some of the organizations involved in the consensus-based development of PAS 137 includes Applied Nanodetectors, Chemical Industries Association, GlaxoSmithKline and the Health and Safety Executive amongst others.
Dr Simon Holland, Chairman of international standards committee for Nanotechnologies as well as the BSI national committee, and member of the drafting panel said: “This document will help to address the significant concern about regulatory procedures held by smaller companies seeking to develop new nanotechnology enabled products. Following this guidance on regulations should enable SMEs to plan their way through the entire product development cycle.”
PAS 137 provides the following:
- A table of regulation identified as being generally applicable irrespective of products produced and activities conducted
- A table of regulation identified as being applicable to particular product types • A table of regulation identified as being applicable to particular activities
- A table of standards identified as being applicable to nanotechnologies
- A table of contact details for organizations that can provide further information about the referenced regulation
- Annexes giving detailed information that supports the interpretation and understanding of the referenced regulation
Dan Palmer Head of Market Development for Manufacturing and Services at BSI said: “PAS 137 will prove invaluable to SMEs because it provides guidance in many fields of regulation and standards including environmental protection, occupational health and safety, consumer protection, product safety and liability, and the management of hazardous substances.”