Will there ever be a European register of nanomaterials?

A register requested since 2009 by public authorities and civil society…

A European Community register of nanoproducts on the European market has been requested for a long time by many actors to cater for the lack of information on nano products on the market and the absence of clear and systematic labeling:

• By the European Parliament¹In April 2009, the European Parliament invited “the Commission to compile by June 2011 an inventory of the different types and uses of nanomaterials on the EU market, while respecting legitimate trade secrets, such as recipes, and to make such an inventory publicly available”(See European Parliament resolution of 24 April 2009 on regulatory aspects of nanomaterials, 2009.). In March 2012, the Science and Technology Options Assessment (STOA) MEPs reiterated this request via “the establishment and implementation of a mandatory notification system for products containing nanoparticles, accessible to the general public where appropriate, so that consumers can make their own informed choices and health agencies can intervene immediately in the event of a proven hazard” NanoSafety – Risk Governance of Manufactured Nanoparticles, STOA, March 2012 (p.107). More recently, on July 18, 2013, the commission ENVI of the European Parliament sent a Letter to the European Commission in which it insisted on the need for a European inventory of consumer products with nanomaterials..
• By the Member States: Many Member States would like to see a proactive and unified policy at European level. For the time being, they have had to act individually at their national level ²(See the report summary in English National Action Plan for the safe use and handling of Nanomaterials, Swedish Ministry of the Environment, October 2013 – in Swedish, English summary starting on page 31) which is not the most appropriate, but the only possibility within their jurisdiction. For want of a better solution, they are deploying measures limited to their country by establishing national registers of nanomaterials and/or products containing them.
  • Germany, where the environment ministry publicly supported the creation of a European register of products containing nanos back in 2012³By the end of 2012, the German Environment Ministry had publicly supported the creation of a European register of products containing nanomaterials, see: Concept for a European Register of Products Containing Nanomaterials, Umweltbundesamt (Federal Environment Agency), December 2012. In March 2014, it published a detailed assessment of the impacts of a European Register of Products Containing Nanomaterials (see Assessment of Impacts of a European Register of Products Containing Nanomaterials, Umweltbundesamt – Federal Environment Agency-, March 2014) according to which:
    – The coatings and inks sectors would be most affected by the implementation of such a register, followed by textiles and paper;
    – a harmonized register at European level is preferable to disparate national registers and would allow for better traceability and risk management, beneficial to consumers, public authorities and companies alike.
    A spokesperson for the environmental agency recently confirmed that, in the absence of a European registry, Germany would set up a federal registry, see Commission forced to reveal nano options, ENDS Europe, March 25, 2014 and European Commission, Member States weigh options for nano inventory, Chemical Watch, March 27, 2014.
  • France was the first country to set up a register of nanomaterials imported, produced and distributed on its territory with the creation of the r-nano register in 2013. It had already expressed its desire for “European harmonization” in 2010⁴See the French authorities’ response to the public consultation “Towards a strategic nanotechnology action plan (SNAP) 2010-2015”, March 2010, then reiterated in 2013⁵Response of the French authorities to the European Commission’s public consultation on the possible revision of the annexes of the REACH regulation to adapt them to nanomaterials, SGAE, September 2013 and again in 2021⁶See page 44 of the PNSE 4
  • Austria, Croatia, the Czech Republic, Denmark, Italy, Luxembourg, the Netherlands, Spain, and Sweden have also expressed their preference for a harmonized Europe-wide registry, along with France and Germany, at a conference in The Hague in April 2013⁷See Considerations on information needs for nanomaterials in consumer products; Discussion of a labelling and reporting scheme for nanomaterials in consumer products in the EU, JRC, April 2014 and Pragmatic steps towards a more effective EU nano policy. Building Blocks for Completing EU Regulation of Nanomaterials (Conference)Ministry of Infrastructure and Environment of the Netherlands, 2013.
• By the Joint Research Centre of the European Commission : The Joint Research Centre (JRC) attached to the European Commission also recently advocated for harmonized procedures at the European level, in April 2014⁸Considerations on information needs for nanomaterials in consumer products; Discussion of a labeling and reporting scheme for nanomaterials in consumer products in the EU, JRC, April 2014.
• By civil society: Civil society has long called for greater transparency on the presence of nanomaterials in consumer products⁹Cf. “Nanogouvernance : comment l’’Union européenne doit-elle mettre en place la traçabilité des nanomatériaux ?”, ETUI, 2011. This is the case in particular of:
  • European consumer associations such as the European Consumers’ Organization (BEUC)¹⁰European strategy on nanotechnology: towards nano consumer protection, BEUC, 3 Oct. 2012 and the European Association for the Coordination of Consumer Representation in Standardization (ANEC) ¹¹ Hazardous chemicals in products – The need for enhanced EU regulations, ANEC, June 2016.
  • trade unions: In fact, this concern is widely shared within the voluntary sector: at the end of October 2012, a coalition ofEuropean non-governmental organizations (NGOs) involved in environmental, consumer or employee protection¹²The European Association for the Coordination of Consumer Representation in Standardization (ANEC), the European Consumers’ Organisation (BEUC), the European Trade Union Confederation (CES or ETUC), the Center for international environmental law (CIEL), ClientEarth, the European environmental citizens organisation for standardisation (ECOS), the European Environmental Bureau (EEB), Women in Europe for a Common Future (WECF) had sent a letter ¹³Letter to the European Commission on the Second Regulatory Review of Nanomaterials, October 23, 2012 to the European Commission in which they criticized, among other things, the Commission’s inaction regarding the establishment of an inventory of nanoproducts.
  • These NGOs reiterated this requirement in an April 2014 position paper published on the environmental advocacy group CIEL website¹⁴Position paper on the regulation of nanomaterials, ClientEarth, EEB, ECOS,ANEC, HCWH and BEUC, April 2014.
• By the World Health Organization (WHO): The European branch of the World Health Organization (WHO) had written in 2013 that governments and international organizations should consider creating mandatory monitoring systems for nanomaterials.”¹⁵Governments and international agencies should consider instituting mandatory monitoring schemes and health surveillance systems”: WHO (Europe), Nanotechnology and human health: Scientific evidence and risk governance, 2013 (p. 91).
• By Austrian¹⁶Cf. A European nano-registry as a reliable database for quantitative risk assessment of nanomaterials? A comparison of national approachesPavlicek A et al, NanoImpact, 21, January 2021 – and even Chinese¹⁷Cf. Regulation of engineered nanomaterials: current challenges, insights and future directions, Environmental Science and Pollution Research, 1-18, 2017: “Compulsory reporting schemes (registration and labelling) for commercial products containing ENMs should be adopted.” scientists

Nonetheless, a register dreaded by some

Harmonization on a European scale of the different national registers in force (or in project) in certain Member States is strongly desired by civil society, Member States and the European Parliament…

Industry federations are more ambivalent on the subject: in their official communication, some say they would prefer a European register rather than a juxtaposition of different national registers… But in reality, the status quo may be more advantageous for them and they are apparently not lobbying for a European register.

• Within the of French and European manufacturers: According to L’Usine Nouvelle, some French industrialists “do not hesitate to say that this will destroy ecomomic activities and encourage relocations to countries where regulations are less restrictive, such as in Asia”¹⁸Nanomaterials: SMEs in search of information, L’Usine Nouvelle, May 21, 2014.. German chemical giant BASF spoke out against the creation of a specific nanomaterials register at the end of May 2014¹⁹No need for nano risk register – BASF, Tce Today, 28 May 2014. As recently as June 2014, European industry federations published a brochure Europe needs safe and innovative nanotechnologies and nanomaterials that defends the status quo.

• In the United States, the Office of the United States Trade Representative is afraid of the infringement of commercial and/or industrial secrecy, the cost to taxpayers, the administrative burden, …²⁰In April 2014, even before the Commission’s consultation was released (see below), the Office of the U.S. Trade Representative (USTR) issued a report (See 2014 Report on Technical Barriers to TradeUnited States Trade Representative (USTR), April 2014, p.72) on technical barriers to trade, including the future – and for the moment still hypothetical – European nano register as well as the national nano registries. USTR believes that these registries infringe on trade and/or industrial secrets, cost taxpayers money, require a significant investment of time, and represent an additional administrative burden.

The European Commission reluctant to create a nano register

Announced in early 2013²¹In March 2013, under pressure from civil society and some Member States, the European Commission opened a discussion on the feasibility of a Europe-wide inventory of nano products: EU Commission to tender for nano register impact assessment, Chemical Watch, 21 March 2013 the European Commission launched a “consultation on transparency measures for nanomaterials on the market” in the summer of 2014. The European Commission received 202 responses to this public consultation²²– 100 responses from the industry
– 102 responses from other stakeholders (including about 10 from public authorities and about 85 from NGOs – including Avicenn – or citizens).
A full summary and analysis of the public consultation was published in January 2015: “Summary of the public consultation on transparency for nanomaterials on the market”..

Yet, since December 2014, the Commission has said it is not in favor of a Europe-wide registry. As anticipated by the newspaper Chemical Watch, no decision had been taken by the Commission before the renewal of the Commission’s executives²³Commission forced to reveal nano options, ENDS Europe, 25 March 2014 and European Commission, member states weigh options for nano inventory, Chemical Watch, 27 March 2014 in the autumn 2014.

One week after the CASG nano meeting on December 4, 2014, Chemical Watch revealed that the establishment of a European register was not envisaged by the Commission²⁴EU nanomaterials register looks unlikely, Chemical Watch, December 11, 2014; see article translated into French Un registre européen des nanomatériaux de plus en plus improbable , le blog Enjeux, January 6, 2015. The French example did not allow consumers to identify products on the market containing nanomaterials, 62% of the substances notified to the French R-Nano register in 2013 are already covered by REACH registrations and 90% should be covered by 2018.

Despite this, in March 2016, the Commission confirmed its rejection of a European registry and imposed instead a far from adequate “observatory website”. At a meeting of the CASG-nano, the commission informed the representatives of the Member States that it was ruling out the creation of a register of nanomaterials, but was instead considering the creation of a public website containing existing information on nanomaterials³⁰Cf. Commission rejects idea of EU nano register, Chemical Watch, 16 March 2016. This “Nano Observatory”, set up by the European Chemicals Agency (ECHA) in the following years, is certainly valuable, but far from living up to expectations.

The European Commission thus claims to “better regulate” (sic) by limiting the costs and administrative burden for companies… without regard for the indignation of NGOs and public authorities. As expected, this “Nano Observatory” does not provide much more information than that obtained by the Member States, powerless against the industrial and commercial secrecy of the companies. Five years after its creation, the lack of information, which has been denounced for many years by many Member States, NGOs and scientists, is still striking.

On April 13, 2016, three European NGOs, ECOS, CIEL (associate members of AVICENN) and Öko-Institute proposed a “Declaration on Waste Containing Nanomaterials” signed by more than 80 organizations from around the world, including AVICENN. Among the list of recommendations is the creation of a European public register of nano-products to help identify the levels and flows of nano waste that the OECD recently emphasized the need for.

Only the industrialists are in solidarity with the European Commission’s decision: David Carlander, CEO of the Nanotechnology Industries Association (NIA), argued that a European registry would be counterproductive to consumer confidence and thus detrimental to European innovation and jobs.³¹Nano registers: are they having the desired effect?“, Chemical Watch, June 2016. In other words, the less we know, the better: a very particular vision of the “Europe of knowledge”…

In the meantime, those who wish to know more can turn to the few existing inventories that we have collected but whose reliability is unfortunately somewhat relative. The latest report by the European Union Observatory for Nanomaterials (EUON) lists only 2,200 products containing nanomaterials on the European market³²Cf. Study of the EU market for nanomaterials, including substances, uses, volumes and key operators, EUON, 2022 – a number that is greatly underestimated.

No registry = no labeling

Let us recall that the absence of such a register and the shortcomings of the registration of nanomaterials in Reach are major obstacles to the labeling of nanomaterials (although mandatory in food, cosmetics and biocides): as many companies (those not upstream of the supply chain) are often unaware that the ingredients sold to them by their suppliers may contain nanomaterials (due to the silence of manufacturers), they cannot add the mention [nano] on their product labels as they should.

Consumers lose out on all fronts: no registry, no labeling…

AVICENN supports the commitment of the French authorities, reiterated in the last National Health and Environment Plan (PNSE 4), to promote the extension of the r-nano register at the European level.