Regulatory aspects of nanomaterials
The European Parliament adopted by 362 votes to 4, with 5 abstentions, a resolution on regulatory aspects of nanomaterials, in response to the Commission’s Communication on this issue.
The text adopted by Parliament had been tabled by the Greens/EFA, EPP-ED, PES, ALDE and GUE/NGL groups, pursuant to Rule 45(2) of the Rules of Procedure, as an alternative motion for a resolution to the motion for a resolution contained in the own-initiative report tabled by the Committee on the Environment, Public Health and Food Safety.
The resolution recalls that the current discussion about nanomaterials is characterised by a significant lack of knowledge and information, leading to disagreement starting at the level of definitions: (a) concerning the size: approximate indication of the size ("in the order of 100 nm or less") versus a specific size range ("between 1 and 100 nm"); (b) concerning different/new properties; (c) concerning problematic properties.
MEPs stress that a fully developed set of harmonised definitions is not currently available and that there is no clear information about the actual use of nanomaterials in consumer products.
In this context, the Parliament does not agree with the Commission's conclusions that: (a) current legislation covers in principle the relevant risks relating to nanomaterials; (b) the protection of health, safety and the environment needs mostly to be enhanced by improving implementation of current legislation, when due to the lack of appropriate data and methods to assess the risks relating to nanomaterials it is effectively unable to address their risks.
Therefore, the Commission is called upon to: (i) review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental or safety impacts over their life cycle; (ii) ensure that legislative provisions and instruments of implementation reflect the particular features of nanomaterials to which workers, consumers and/or the environment may be exposed.
MEPs call for the introduction of a comprehensive science-based definition of nanomaterials in Community legislation as part of nano-specific amendments to relevant horizontal and sectoral legislation and call on the Commission to promote the adoption of a harmonised definition of nanomaterials at the international level and to adapt the relevant European legislative framework accordingly.
The Parliament considers that it is particularly important to address nanomaterials explicitly within the scope of at least legislation on chemicals (REACH and biocides), food (foodstuffs, food additives and food and feed products from genetically modified organisms), relevant legislation on worker protection, as well as legislation on air quality, water quality and waste.
The Parliament calls specifically on the Commission to evaluate the need to review worker protection legislation concerning inter alia: (a) the use of nanomaterials only in closed systems or in other ways that exclude exposure of workers as long as it is not possible to reliably detect and control exposure; (b) a clear assignment of liability to producers and employers arising from the use of nanomaterials; (c) whether all exposure routes (inhalation, dermal and other) are addressed.
The Commission is called upon to compile before June 2011 an inventory of the different types and uses of nanomaterials on the European market, to make this inventory publicly available and to report on the safety of these nanomaterials.
The Parliament also reiterates its call for the provision of information to consumers on the use of nanomaterials in consumer products: all ingredients present in the form of nanomaterials in substances, mixtures or articles should be clearly indicated in the labelling of the product (e.g. in the list of ingredients, the name of such ingredients should be followed by the word 'nano' in brackets).
Moreover, MEPs stress the need:
- for a major stepping up of the funding of research into the environmental, health and safety aspects of nanomaterials over their life cycle;
- to promote coordination and exchange between Member States on research and development, risk assessment, guidance development and regulation of nanomaterials;
- to propose, as soon as possible, the establishment of a permanent and independent European network responsible for monitoring nanotechnologies and nanomaterials, and a basic and applied research programme on the methodology for this monitoring (particularly metrology, detection, toxicity and epidemiology);
- to launch an EU-wide public debate on nanotechnologies and nanomaterials and on the regulatory aspects of nanomaterials;
- to develop stringent ethical guidelines, particularly for nanomedicine, such as the right to privacy, free and informed consent and the limits set on non-therapeutic human enhancement;
- to pay special attention to the social dimension of the development of nanotechnology by ensuring the active participation of the social partners concerned from the earliest possible stage.