Archive | Nanotechnology Law RSS for this section

G20 Policy Developments in 2017

By Bart Kolodziejczyk

This year’s Group of Twenty (G20) is hosted by Germany. The 2017 annual G20 Summit of the heads of state and government will be the twelfth meeting of the G20, and it will be held on 7–8 July 2017 in the city of Hamburg. However, the hosts prepared a myriad of events, workshops and policy forums throughout the year.

The G20 host focused their G20 presidency on healthcare issues. In addition to issues related to global economic growth and financial market regulation, health is also an important focus of the G20 Summit. For the first time, the science and research community is included in this dialogue as “Science20 Dialogue Forum”. Under the leadership of the German National Academy of Sciences Leopoldina, the science academies of the G20 countries have elaborated science-based recommendations on improving health globally.

At the Science20 Dialogue Forum on Improving Global Health held on 22 March 2017 in Halle (Saale), national and international experts discussed strategies and tools to combat communicable and non-communicable diseases. Moreover, the Science20 Statement was officially handed over to German Federal Chancellor Dr. Angela Merkel. The document provides a basis for the upcoming G20 Summit consultations.

Global health, specifically the management of infectious and non-infectious diseases, causes ongoing and unaddressed issues worldwide for individuals, health systems, and entire economies. The experts gathered at the Science20 Dialogue Forum called for strong short- and long-term data-based strategies to address these health issues. In a nutshell, the Science 20 Statement calls for (a) ensuring strong healthcare and public health systems, (b) apply existing knowledge to prevent diseases, (c) addressing the social, environmental, and economic determinants of health, (d) ensuring access to healthcare and related resources globally, and (e) improving and enhancing the extending strategies for surveillance and data sharing in health.

In addition to Science20, Think20 held another summit called “Global Solutions.” The Think20 or T20 is a network of think tanks and research institutes based in the G20 countries. The role of T20 is to provide evidence-based policy advice to the G20, facilitate interaction among its members and the policy community, and to communicate with the broader public about issues of global importance. This year, the Think20 Engagement Group has come up with a new initiative: the G20 Insights Platform. The policy briefs produced by Task Forces from the Think20 Group, as well as other sources, are clustered in several different policy areas and describe either recommendations or visions.

The number of high-quality contributions in the areas of 2030 Agenda for Sustainable Development and Climate Policy and Finance are of specific importance given the U.S. withdrawal from the Paris Agreement. It is very likely that the climate change and the U.S. position on it will be discussed at the Summit in July. The largest number of briefs contributions have been made in the area of Digitalization, which covers areas such as the opportunities and challenges of the Fourth Industrial Revolution, future of jobs, and blockchain technologies, among others.

Two of the briefs co-authored by the author; Consolidated G20 synthetic biology policies and their role in the 2030 Agenda for Sustainable Development and Nanowaste: Need for Disposal and Recycling Standards have been presented at the Think20 Summit – Global Solutions in Berlin on 29-30 May 2017. While opportunities of both nanotechnology and synthetic biology are widely heralded, issues such as nanowaste and biohacking are often underestimatedss. The two above briefs urge G20 members to develop consolidated policy frameworks to regulate both fields.

All of the above events are only an introduction to the forthcoming G20 Summit where heads of state or heads of government of 20 major economies will work together and based on the outcomes of the above mentioned forums will develop new consolidated policy approaches and regulations to some of the most urging global issues.

The next G20 Summit and Science20 Dialogue Forum will be held under the G20 Presidency of Argentina in Buenos Aires in 2018.


No nano? EU parliament and some member States advocate for greater regulationof nano-technologies

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.

European Commission consults on registers for nanomaterials

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]

European code of conduct for responsible nanosciences and nanotechnologies research

On February 7, 2008, the European Commission adopted Recommendation 2008/345/EC on a code of conduct for responsible nanosciences and nanotechnologies research. [[2008] OJ L 116/46]