In principle, nanomaterials are subject to the same laws and regulations as are chemical substances in general. Nevertheless, it is generally recognised that the specific properties of nanomaterials require adaptations in the present risk assessment and its associated laws and regulations. Governments are fully engaged in formulating policy for nanotechnology that enables dealing with relevant uncertainties. Legislation has now been changed in a number of areas for that purpose. In order to be able to identify the potential risks of these nanomaterials more effectively, additional requirements are often prescribed for the characterisation of nanomaterials and for performing tests. RIVM supports various ministries as well as the EU (European Union) in their efforts to realise the necessary changes.
The definition of a nanomaterial
In order to formulate laws and regulations for nanomaterials, we must first agree on what a nanomaterial is. In October 2011, the European Commission published a Recommendation for a definition of a nanomaterial. The interpretation of RIVM and the implications of this definition for science and policy are described in an RIVM report. The next step is to integrate this definition into the various legislative frameworks. Where necessary, these may also include specific measures for certain types of nanomaterials. This has already been done for biocides (Regulation (EU) No 528/2012) and for ‘novel foods’ (Regulation (EC) 2015/2283) and more recently also for medical devices (Regulation (EU) 2017/745). For REACH, a definition is expected to be included in 2018. For food labelling (Regulation (EU) No 1169/2011) and cosmetics (Regulation (EC) No 1223/2009) definitions were already included. Discussions are presently underway within these frameworks, aimed at harmonising the existing definitions with the Recommendation.
Which laws and regulations are applicable to nanomaterials?
Nanomaterials are not regulated within a separate legislation. Within the existing legal frameworks (in the Netherlands as well as in the EU (European Union)), producers and importers of substances (including nanomaterials) are required to ensure the safety of any products that they bring to the market. Regulators and policymakers consider it important to ensure that nanomaterials are dealt with within the following regulatory frameworks:
- chemical substances (REACH, biocides),
- foods,
- cosmetics,
- protection of workers (health and safety regulations) (in Dutch),
- medical device
- quality of air, soil, and water
Nanomaterials are currently specified in only a very limited number of legislative frameworks: 1) for cosmetics, a risk assessment is required before a product can be introduced to the market, and the term ‘nano’ must be specified in the list of ingredients 2) for foods, nanomaterials are viewed as being ‘novel foods’ that need to be approved separately; in general, nanomaterials must be specified as ‘nano’ in the list of ingredients 3) for biocides, a separate assessment of nanomaterials is required, and these must be listed as ‘nano’ on the label 4) for medical devices, special attention is required if internal exposure is a possibility. The aim of including nanomaterials in the legal and regulatory frameworks is primarily to enhance identification of the potential risks associated with these nanomaterials. For example, a number of additional requirements have been recently agreed upon within the framework of REACH legislation.
Which government entities are involved?
On the website of the Dutch government, you can find additional information on nanotechnology. This website also provides links to the responsible ministries and the most relevant governmental bodies and institutions. The site also contains information about activities that are being financed by the government.