By Anthony Bochon
2014 will be a pivotal year for the future of nanotechnologies in the European Union. It will have a second member State – Belgium – adopting a national register for nanomaterials similar to the register existing in France since January 2013.
On 7 February 2014, the Belgian federal government announced that it has adopted the Royal Decree – a non-legislative text – creating the national register for nanomaterials which would normally enter into force in 2016. However, the government has notified again the legal text under TRIS – the European information system on national technical regulations – with 20 May 2014 as standstill date. Although the notification of the draft legal text in July 2013 did not raise any concerns or attract open criticism from stakeholders, this final draft has been commented on by the United Kingdom. Unlike France where the environmental legislation was amended through a regular parliamentary procedure, Belgium chose to rely on existing legislation on product safety and workers’ health protection to adapt an executive measure, without any debate at the federal parliament level. The Belgian register for nanomaterials will enter into force on 1st January 2016.
Similarly, on 5 November 2013, Denmark notified under TRIS a draft Order on a register of mixtures and articles that contain nanomaterials as well as the requirement for manufacturers and importers to report to the register. It was expected to enter into force on 18 March 2014. Four member States have decided to comment on this draft legislation, namely Austria, Poland, the Netherlands and the United Kingdom. The Commission sent questions to Denmark and the standstill period has been extended until 6 May 2014. There is currently no news about the date of entry into force of this Danish nano register.
The upcoming adoption of two additional national registers to control the placement on the market of manufactured nanomaterials calls in question the future of the European nanotechnology policy, as member States disagree about the creation of an EU-wide register on nanomaterials. The European Commission consulted on this project in mid-2013 (see TTLF’s news in the October 2013 issue). The dissemination of national registers may interfere substantially, at some stage, with the proper functioning of the European internal market and push the Commission to harmonize existing legislation. It remains uncertain, however, if nanotechnologies will be discussed as part of the revision of REACH – the European chemicals regulation – as from 2018.
The upcoming European parliamentary elections will also lead to increasing demands from members of the European Parliament towards, at least specific regulation for nanotechnologies, if not bans on their uses in certain sectors such as foods or cosmetics. A recent delegated regulation of the Commission has crystallized existing tensions around nanotechnologies. When regulation 1169/2011 on food information was adopted seven days after the publication of the Commission’s recommendation on the definition of nanomaterial of 18 October 2011 (2011/696/EU), the regulation included a compromise definition which did not match the newly suggested definition. The Commission was however entrusted with the power to amend the food information regulation.
On 12 December 2013, it adopted the Commission Delegated Regulation (EU) No 1363/2013 of 12 December 2013 amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers as regards the definition of ‘engineered nanomaterials. This amendment was published in the Official Journal of the European Union on 19 December 2013. However, the next day, the same journal announced that the delegated regulation should be considered as null and void. Intense political pressure seems to have been exercised on the Commission to withdraw its delegated regulation. On 18 February 2014, the European Parliament adopted a motion calling the Commission to re-draft its delegated regulation and take into account the objections of the parliament regarding health and safety concerns about the presence of nanomaterials in food. On 12 March 2014, the European Parliament adopted a resolution objecting to the Commission delegated regulation. It stressed that the Commission tried to circumvent the objectives of Regulation 1169/2011 on food information to consumers. The Parliament said that it“considers that the Commission delegated regulation is not compatible with the aim and content of Regulation (EU) No 1169/2011 and that it exceeds the delegated powers conferred on the Commission under the latter.”
Nanotechnologies have already been discussed from the viewpoint of standards during the first talks about the Transatlantic Trade and Investment Partnership. The growing reluctance in the European Union towards nanotechnologies will enlarge the gap that already separates the EU and US approaches towards the “nano” phenomenon. The only field where reconciliation seems possible is intellectual property, as both EU and US stakeholders agree on the need to protect and stimulate innovation in this domain. Nanotechnologies may, like GMOs in the nineties, become a source of lasting conflict between the US and the EU, despite the numerous differences between nanotechnologies and GMOs.
Since 1 January 2013, all manufacturers, importers and traders in France must fulfill the requirements established by the mandatory registration system for nanomaterials. Facing an obvious lack of self-compliance, the French environment minister decided to extend the deadline for the registration to July 1, instead of April 30. This French register is, until now, an isolated national initiative on the monitoring and surveillance of manufactured nanomaterials.
However, other countries such as Italy, Denmark and Belgium are preparing their own national nano-registers. Belgium introduced its draft Royal Decree under the TRIS procedure on July 4, 2013, confirming thereby the growing divergence between EU member states on nanotechnologies regulation. Some countries such as the United Kingdom and Germany are said to be reluctant towards similar projects, which may lead to overregulation, overlaps and conflicting provisions applying to nanomaterials.
The European Commission remains skeptical about the opportunity of providing a specific legal framework for nanomaterials safety, since REACH – the chemicals regulation similar to the US Chemicals Safety Act – already encompasses nanomaterials within its scope of application. As a result, the Commission launched a public consultation on the revision of REACH to include nanomaterials. This deadline expires on September 13, 2013. In the meantime, the Commission also published a call for tender to make an economic impact assessment of the creation of an EU-wide register for nanomaterials and organized a workshop on such project. No EU register appears to be in sight before at least 2015, three years before the next REACH review. [Anthony Bochon]
On February 7, 2008, the European Commission adopted Recommendation 2008/345/EC on a code of conduct for responsible nanosciences and nanotechnologies research. [ OJ L 116/46]