Nanotech Legislative Review

This Report reviews all legislation that applies to nanomaterials. It calls for further research into the nature and risk associated with nanomaterials and proposes that these products comply with health and environmental legislation currently in force to safeguard public health and safety.

Background

The Commission Communication of 2004 “Towards a European Strategy for Nanotechnology” highlighted the need for an investigation and assessment of possible health, safety and environmental risks linked to nanotechnology, which have never been properly tested before. 

In 2005 the Commission launched its Action Plan 2005-2009 which proposed that all nanomaterials should have to comply with high levels of public health, safety and consumer and worker protection as well as environmental protection standards set by the EU. The Commission therefore announced a regulatory review of EU legislation in the relevant sectors applicable to nanomaterials.

Main Objectives of this Report

The proposal is for a review all EU legislation covering chemicals, worker and consumer protection, products and environmental protection and how they apply to nanomaterials. The Commission suggests a cautious, risk adverse approach should be adopted towards nanomaterials requiring implementation of a high level of protective legislation. The Commission Communication announced that an assessment of the scientific and industrial knowledge base would be carried out in addition to the implementation of legislation.

Main Elements of the Communication

Nanomaterials lack definition, but are generally considered to be manufactured or engineered nano-sized and nanostructured materials, that is to say, on a scale of one-billionth of a metre. Although some nanomaterials or nanoparticles occur naturally or are unintentionally produced, they are not addressed in the consultation. Instead, this Report covers nanomaterials that are either in production, placed on the market or both. Furthermore the review of legislation only addresses levels of protection in the following areas:

• health
• worker safety
• consumer protection (including product safety)
• environment

The findings of the Commission are that current legislation barely covers potential health and environmental risks. The protection of health and safety and the environment needs to be enhanced by improving current legislation. The Commission highlights the problem of the implementation of legislation and regulatory instruments - it requires detailed knowledge of the subject matter. A greater understanding of the risks involved with such products is therefore necessary and the Commission calls upon authorities and agencies in the Member States to do more to monitor and assess nanomaterials. This also explains why the Report pays particular attention to the need for improving scientific knowledge with regards to nanotechnology. 

The Commission points out that existing legislation could and should be used to regulate certain aspects of nanomaterials such as;

• REACH (for the manufacture, placing on the market and use of chemical substances),
• Worker protection Framework Directive 89/391/EEC,
• IPPC Directive 2008/1/EC,
• Water Framework Directive 2000/60
• Waste Directives.

The Report also suggests the possibility of adapting existing Directives that apply to risks associated with other substances to the risks related to nanomaterials. More specific measures could also be envisaged, such as a specific Regulation on nanomaterials. It highlights the need for improving risk management measures and market surveillance by authorities and agencies through the use of:

• early-warning systems
• safeguard clauses
• mutual exchange of information. 

Future measures suggested by the Commission could include:

• pre-market controls
• testing
• a labelling requirement
• official authorisation for the placement of high risk products on the market

The main finding of the report is the lack of information on essential questions which needs to be expanded and improved in order to provide:
• a characterisation
• lifecycle and
• uniform standardisation of nanomaterials
• scientific analytical measurement standards

Improvement of legislation and implementation of existing rules will require regulatory guidance, thresholds to be established as well as test methods, risk assessment methods and the need for better scientific understanding of all properties and risks associated with nanomaterials particularly in regards to data of toxic and eco-toxic effects, waste management and use in food or cosmetics.

What’s next?

The European Parliament has argued that the REACH Regulation is not inadequate and that information campaigns and research activities are necessary for the protection of citizens from dangerous nanomaterials in cosmetics and novel foods. The Commission stressed that nanomaterials have many benefits and risks are still unknown and that data must be collected on toxicology levels and exposure before proceeding to a specific legislation on nanomaterials. The Commission will issue a full report on its progress in these areas in the next few years. Further reports by the European Parliament and the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks are expected to be published soon.