Procesos de Gestión

It is clear that there is still a lot of information missing to be able to estimate the risks of nanomaterials to humans and the environment. However, there are already many hundreds of products on the market, the number of which will increase considerably in the coming years. In the meantime it will be

necessary to find a way of dealing as sensibly as possible with the lack of knowledge. Various analyses have already shown that it will certainly be five to ten years before sufficient information is generated to be able to estimate the risks of nanomaterials to the same extent as those of chemical substances not in nano form (Maynard et al., 2006).

An integrated analysis of the available information across the individual subpopulations shows a number of directions for improvements may be found for dealing as responsibly and as effectively as possible with the unknowns in terms of the risks to humans and the environment. Table 9.1 provides an overview of starting points for management measures within the target populations of workers,

patients, consumers and the environment. For this purpose an analysis was made of the available information (in outline) for these populations. The information on possible starting points with regard to the admittance and use of nanomaterials from the table below should be combined with toxicity data.

The basic principle applied for toxicity is that toxic effects cannot be ruled out. There are, for example, indications that carbon nanotubes of certain dimensions could cause toxic effects which are comparable to the early stages of asbestos-related cancer (Poland et al., 2008). Effects however, cannot be

generalised, either. Just as we cannot speak of the toxicity of chemical substances, so we cannot speak of the toxicity of nanoparticles.

Based on the foregoing and Table 9.1 the following pointers can be defined.

For researchers and workers involved in the production, processing and application of nanoparticles or products containing nanoparticles it has been established that they are working with nanoparticles which may to a greater or lesser extent be toxic. In the same way as working with chemical substances not in a nano form, for this group attention should be focused on minimizing exposure to free

nanoparticles. For this it is important that ‘good practices’ are developed in the short term to limit exposure to nanomaterials. Various steps have already been taken in this direction.

For patients however, exposure is intended, but the right balance has to be found between the positive effects (action) of the drug and possible toxicity. For other medical applications a balance will also have to be found between the intended effect and possible adverse effects. These products are already subject to strict admittance requirements and continual evaluation will therefore be necessary to determine whether the admittance requirements sufficiently provide for a proper estimate of the risks of nanomaterials in this application.

For consumers it is difficult to identify good places to start to reduce the potential risks. It is insufficiently clear in which products nanomaterials are present. Assessments of exposure are

furthermore surrounded by more uncertainties because for many products there is no information on the form in which the substance is present in a product as there is for chemical substances not in nano form. Besides this, exposure is determined by use of the products and that use in itself it difficult to determine. In addition, less toxicological data has to be provided than for pharmaceuticals, for example. A distinction can be made, however, between food and non-food products. Some substances used in food products (such as food additives) are subject to stricter requirements than the substances used in non-food products. Substances in nano form are essentially also covered by REACH. REACH offers opportunities for gathering more information on the nano form of chemical substances. Tightening up the regulatory framework or the requirement to provide information to the consumer provide further options. In France, for example, legislation is in preparation on the labelling of products which contain nanomaterials.

For the environment the most important opportunities lie at the source, such as limiting emissions. Tables B6.1 and B6.2 in Annex 6 provide a more detailed overview of aspects which could or should be taken into account in exposure to nanomaterials.

Table 9.1 Possible options for control measures relating to the admittance and use of nanomaterials in relation to the exposure of workers, the general population and the environment.

Risk situation Admittance Use Conclusion

Researchers, production and processing workers • Various H&S measures to prevent/limit

concentration of a substance in a medium (or working environment)

1 (workers: researchers, production and processing workers and those involved in

professional applications

Professionally applied products

• Limited influence over presence of substances • Control possible through legislation? • Risk research for specific applications?

Various H&S measures to limit duration and frequency of contact with nanomaterials

Various H&S measures possible to limit actual dose / external exposure

(governing regulations)

Medical applications:

• strict admittance procedures and mandatory risk management (for medical technology). Availability is often controlled (drugs not freely available). • Considered use based on thorough research of risks.

• Safe use of product based on knowledge and expertise of doctor/specialist.

• Dose in drug itself is controlled • Controlled dosage under

supervision of doctor/ specialist • Dose based on risk research Food industry:

• Use based on estimate of risks (more than for consumer products).

• Novel Food Directive may be applicable: admittance requirements

• Some, but not all, products with nanoparticles are monitored.

• Limited influence over use in food products is possible.

• Labelling

• Providing consumer information

• Limited options to influence dose in foods

• Providing consumer information • Tightening-up legislation 2 (general

population)

Consumer products:

• Limited influence over presence of substances • Control possible through legislation? • Risk research for specific applications?

• Limited options

• Providing consumer information

• Limited options

• Providing consumer information • Tightening-up legislation 3 (via the

environment)

• Emissions to the environment can be tackled at source, particularly at production stage

• Possibly through legislation?