Posted: October 7, 2008

European Commission sees no regulatory void on nanotechnology

(Nanowerk News) While knowledge gaps remain regarding the potential risks of nanotechnologies, the European Commission again expressed confidence that existing EU regulation can be applied to this emerging sector, stressing that the challenge ahead lies in their implementation.
"We are not in a regulatory void," said Cornelis Brekelmans, an official in charge of regulatory aspects of nanotechnology at the European Commission.
Speaking at a conference on 2 October, Brekelmans said this was because EU rules impose a risk assessment on all products, adding that nanomaterials were no exception to this obligation.
"We may decide not to authorise a product," the official warned during the Second Annual Nanotechnology Safety for Successexternal Dialogue Workshop in Brussels. Depending on the outcome of such assessments, the authorities may review, modify or cancel authorisations, he explained.
According to the Commission official, "the real issue is implementation and enforcement". The basis on which a product can be banned must be better identified, he added, calling for enforcement capacities at national level to be strengthened in this respect.
The Commission, he said, remains "convinced that a lot of work still has to be done" on testing, standards and guidelines, while product authorisations must be conducted "on a case-by-case basis".
However, the European consumer organisation (BEUC) argued that the EU's current approach was "not sufficient" due to a lack of clarity over how general safety requirements are to be applied to nanomaterials. The organisation is also worried that regulatory measures might fail in member states due to the huge volume of work.
Cornelis Brekelmans, an official in charge of regulatory aspects of nanotechnology at the European Commission retorted that the absence of specific regulation on nanomaterial was "not really important," describing EU rules on product approvals as "technology neutral". If a specific regulation needed to be modified every time there was a new technology, it would mean we had failed, the official pointed out.
According to Brekelmans, EU regulations are "technology neutral and can cope with new developments". But this does not exclude the possibility of "specific rules on some things" and "we have to keep up-to-date with scientific information," he said, adding that if authorities find new evidence on something, "they might have to go back to what was already agreed upon".
As for the labelling of nanotech-based products, Brekelmans said current rules stated that if there was a risk, it should be indicated. "Whether we want to introduce a labelling on nano as such is a different issue," he said.
Brekelmans's view was challenged by Greens/EFA Group political advisor Axel Singhofen. Arguing that "the reality is not quite how you present it," Singhofen asked whether the Commission was ready to accept a shift to pre-market authorisation for nanomaterials. This would mean that their safety would have to be proven before they could enter the market.
However, Brekelmans said he did not believe that prior authorisation was "the best way forward".
Laura Degallaix from BEUC gave a societal perspective on the issue, arguing that "applications coming to the market are often developed without much transparency despite limited understanding of the potential effects".
She outlined a number of points that BEUC hoped the Commission would take into acoount on nanotech regulation:
  • Use every opportunity to update existing legislation (cf. reviews of cosmetics directive and novel foods).
  • Introduce definitions for nanoparticles, refraining from limiting the size to 100 nm, for example.
  • Allow changes to definitions at later stage.
  • Seek international agreements for nanotech regulation.
  • Apply the precautionary principle approach.
  • Urge industry to produce data.
  • Introduce strict and effective pre-market assessment and authorisation processes.
  • Consider nanoparticles as a "new" substances under EU rules.
  • Ensure adequacy and harmonisation of safety evaluation methodologies.
  • Introduce post-market monitoring systems to assess efforts in the long term.
  • Ensure transparent information and public engagement.
  • As for engaging the larger public, Degallaix said "communication on vague conceptions of nanotechnology will not be successful. Instead, adequate, understandable information on specific applications is needed".
    Next steps
  • 2008: The Commission and EU agencies will start to review existing documents that support implementation of the various directives with regard to their applicability and appropriateness to nanomaterials.
  • 2009: The Commission will publish a second implementation report on nanotechnology.
  • 2011: The Commission will issue a progress report on the implementation of existing regulations on nanomaterials.
  • Background
    Industry is increasingly using nanotechnology in sectors such as healthcare (medicine), consumer products (food, electronics and cosmetics), information technology and the environment. However, a lack of knowledge and understanding of the health and environmental risks associated with nanomaterials highlights the need for more regulation of the sector.
    According to the Commission's recent regulatory reviewPdf (June 2008) on the issue, the current EU legislative framework "covers in principle the potential health, safety and environmental risks in relation to nanomaterials". The Communication on regulatory aspects of nanomaterialsexternal states that nanotechnology is covered under current EU laws on chemicals, consumer products and the environment.
    But the EU executive is recommending that "current legislation may have to be modified in light of new information becoming available, for example as regards thresholds used in some legislation".
    Source: EurActive
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