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Nanoremediation: Information for Decision Makers from NanoRem

FAQ: What affects regulatory acceptance for nanoremediation (nZVI)?

Each EU Member State will have a legal and regulatory framework for dealing with remediation that may be driven by European Directives (for example, the Industrial Emissions Directive) or national legislation (for example planning, contaminated land legislation). A nanoremediation project may involve engagement with a number of regulators, for example to address:

  • Chemical classification, labelling and packaging
  • Health and safety
  • Achieving remediation objectives (for example, to return an installation to baseline conditions (IED) or through planning conditions to support redevelopment)
  • Control of emissions (to air, land and water) from the remediation process
In general there will be a lead regulator for remediation, depending on the circumstances and Member State. For example, for remediation being carried out under planning the lead regulator will be the local authority, consulting the Environment Agency on controlled water issues. However, the regulation of the emissions from the remediation process will be controlled through environmental permitting by the Environment Agency.
Each regulator will have different requirements, enforced under different national legislation and will have a variable knowledge of in situ remediation in general and nanoremediation in particular. It is therefore recommended, when dealing with each regulator, to provide as much relevant information as possible in a clear and concise format. In some cases, for example permit applications, information may be required in a standard format and guidance on how to complete an application will be provided by the regulatory body. The regulatory framework should be sufficiently developed in all or most Member States to accommodate the use of nanoparticles in remediation.

However, similar to any new technology, there may be some additional barriers or perceived barriers to deployment to address with the regulators. These may include:

  • Stringent, precautionary approaches or policy (for example the voluntary moratorium on the release of engineered nanoparticles to the environment in Germany and the UK)
  • Perception of low benefits and high risks (compared to other remediation technologies), leading to doubts expressed on the usefulness or effectiveness of nanoremediation
  • The ability to measure nanoparticle transport and impact. 
Other FAQs and thematic pages address perception issues and summarise the current scientific knowledge on the release of nanoparticles for remediation of groundwater. This FAQ addresses information needs to address current regulatory requirements.


What aspects of nanoremediation are likely to be regulated?

Chemical classification of the nanoparticle reagent
is a fundamental part of the safe management, handling and use of chemicals and is a requirement within the European Community for most chemicals and mixtures. Sufficient information should be provided to ensure that the supply chain can understand the intrinsic hazards of a product, and therefore the specific controls or protective measures that need to be put in place to mitigate risks. In reaching a decision on how to regulate nanoparticles, the European Commission concluded that REACH(Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (European Regulation on classification, labelling and packaging of substances and mixtures) offered the best possible framework for the risk management of nanomaterials when they occur as substances or in mixtures. However, within this framework more specific requirements for nanomaterials have proven necessary and this is currently under review. As a minimum, a Safety Data Sheet (SDS) should be prepared if a nanomaterial may be dangerous to the supply chain and the product should be labelled in accordance with CLP.

Health and safety responsibilities fall on virtually everyone, from the client to individual workers, involved in contracting, designing, carrying out the remediation operation and post-remediation activities such as maintenance and monitoring. Ensuring that the proposed work and site conditions are not going to put workers and others at risk requires planning, organisation and supervision, whatever the size of the project. A health and safety plan for a specific nanoremediation project should include elements of planning, assessment of risks, implementing measures to mitigate and control risks, checking performance and acting on lessons learned from a review of performance.

The remediation process itself will be regulated to ensure that remediation objectives are achieved and that emissions from remediation activities to air, land and water are under appropriate control. These dual objectives may be the responsibility of more than one regulator.

In common with other technologies, remediation objectives will be set for the target contaminants, for example a concentration at a compliance point, documented mass reduction in a source zone or plume, or demonstration of suitable containment. In addition, the impact of introducing engineered nanoparticles to the aquifer may need to be assessed in terms of the predicted persistence and migration of the nanoparticles themselves, or the release of potentially hazardous substances, such as surfactant coatings or dissolved metal ions from bi-metallic nanoparticles. The regulator will expect to see information on the source/s of nanoparticles, potential pathways, exposure and receptors in a conceptual model (See FAQ: How safe is nanoremediation to use and what are the possible risks associated with it?) and the verification report should demonstrate that identified risks have been effectively managed.

Other effects on aquifer properties, such as short-term pH-Eh changes or permanent effects on hydraulic conductivity may be of concern at some sites. It should however be remembered that such effects are also likely to occur with other in situ remediation technologies, such as in situ biostimulation or redox manipulation.

The remediation operation will usually be controlled by a permit, or relevant exemption, to prevent and control emissions that may cause pollution. The escape of nanoparticles from the treatment zone (below ground) may represent an emission that currently is difficult to measure directly (See FAQ: How safe is nanoremediation to use and what are the possible risks associated with it?) and therefore to control through permit conditions. The NanoRem project is addressing direct and surrogate means of tracking and modelling nanoparticle transport in the laboratory and these methods will be tested at one or more of the pilot sites.

Table 1, below, shows a summary of information that may be required by the regulators discussed above. This table is based on NanoRem partners’ regulatory experience across Europe, primarily from SDS and permitting requirements. It is intended only as a guide and does not presuppose the requirements of the national regulators. Early engagement with local regulators is recommended to expedite approval for deployment.


Table 1 Regulatory information requirements for nanoparticle deployment (See NanoRem nZVI Risk Benefit Appraisal Report)


Nanoparticle properties

Site details/conditions

Visual & olfactory description


Operator


Chemical composition (incl. coating /stabiliser)

Site address


Particle size

Injection location/s


Particle shape


Current use


Specific surface area


Previous use



Bulk density

Contaminant type, phase & distribution



pH of suspension

Aquifer properties



Hazard description

Conceptual model



Acute toxicity of fresh particles

Environmental risk assessment



Chronic toxicity of fresh particles

Receptors & their location



Toxicity of reacted particles



Remediation approach

Reactivity in air


Injection method


Reactivity in water

Mass injected


First aid measures


Number of injections


Accidental release measures


Process emissions


Handling & storage


Process control


Exposure control & PPE


Deployment risks



Ecological information

Predicted persistence & migration



Disposal considerations


Contingency plan


Transport information


QA/QC plan








Monitoring of NPs & analytical plan

   

Further Information


Thematic Pages:





Related FAQs:

How safe is nanoremediation to use and what are the possible risks associated with it?

Full Report

This information is drawn from 
the NanoRem report: 'A Risk/Benefit Appraisal for the Application of Nano-Scale Zero Valent Iron (nZVI) for the Remediation of Contaminated Sites'. The full report including additional information, detail and referencing can be downloaded from: www.nanorem.eu/Displaynews.aspx?ID=525.

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Taking Nanotechnological Remediation Processes from Lab Scale to End User Applications for the Restoration of a Clean Environment.
This project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement No. 309517
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