To ensure safety for humans and the environment, as well as compliance with safety regulatory issues for both material and process when dealing with engineered nanomaterials (ENMs) and nano-enabled products (NEPs), is key to market entry. Considering the final application of each product, LEE-BED can review materials and processes to determine any barriers that need to be addressed within the technical solutions presented for the entire product life cycle.
Pre-safety assessment is based on those elements required to guarantee a high level of protection of human health and environment, including physicochemical properties of the ENMs or NEPs, their intended uses along the supply chain, (eco)toxicological and occupational exposure data, process related information and regulatory issues.
Therefore, pre-safety services offered by LEE BED include three main activities, described below, which are intended to result in the definition of the theoretical scope of the safety aspects to be considered at a later stage.
Regulatory compliance analysis
Consist of a thorough analysis of the available information regarding regulatory requirements that the nanomaterial or nano-enabled products of interest shall meet before being placed on the market, which includes:
- Identification and description of international regulatory requirements (including reporting schemes) within key target markets.
- REACH compliance management, including the definition of the specific requirements for nanoforms and products containing nanoforms, especially in terms registration obligations, chemical safety assessment requirements, testing proposals, and exposure related information to be considered.
- Classification and labelling according to CLP/GHS
- Drafting of material safety data sheets (MSDS)
Risk profiling services
Consists of a preliminary hazard and risk assessment study to determine the (eco)toxicological profile (based on existing data on in vitro and in silico studies) and exposure potential of the materials at all stages of the life cycle, also based on the available information. The preliminary study is intended to support the industry on the identification of the safety issues to be considered on the basis of current product safety regulations, environmental related regulations and current regulatory requirements on Occupational Safety and Health of ENMs and NEPs prior to their placement on the market.
Strategic planning services
Covers the definition of the actions that shall be accomplished to meet regulatory requirements, guarantee a high level of protection to human health and the environment, with a cost/benefit perspective.
LEE-BED offer a swot analysis for each product as a basis to proceed in the right directions according with the information gathered or generated, concerning: applications, end uses, hazard profile and exposure potential.