Regulating the Unknown: National Mandatory Nano Registers on the Rise

How can policymakers adequately regulate nanomaterials if they don’t know what’s out here to regulate? This post is the second in a series of updates on the contentious technological development known as nanomaterials.

Left: Geneva Intern Alexis McGivern, Right: Managing Attorney David Azoulay
By Geneva Intern Alexis McGivern and Managing Attorney David Azoulay

At the heart of nanotechnology regulation is a need for information. Information is the key to developing appropriate regulatory tools to protect workers and the environment from unwanted effects of nanomaterials, ensuring consumers can make educated choices, expanding scientific knowledge by prioritizing research needs, and understanding the complex risks of exposure to nanotechnology.

Thus far, voluntary information gathering schemes have proved ineffective in collecting this important information, as many actors in the industry are not willing to reveal what they deem to be business secrets. The development of mandatory registers is therefore the only viable way of collecting relevant information for regulators.

In 2009, a public discussion on the availability of nano information concluded with a call to establish mandatory registers. Three years later, CIEL, in collaboration with BUND Friends of the Earth Germany and ClientEarth, suggested increased market surveillance through stricter labeling requirements and a mandatory EU nanomaterials register in a report titled High time to act on nanomaterials. This call was further extended and refined in a new report from SSNC. Now five years later, this goal still has not been realized, although some EU Member states have begun to implement national registers.

In February 2012, France became the first country in the world to make information on nanomaterials mandatory (the French register only covers nanomaterials, not the consumer products containing them), setting the stage for future nano registers. The data is annually submitted to the French National Agency for Food Safety, Environment, and Labour, with non-compliance resulting in (rather weak) financial penalties. The reporting requirements for nanomaterial substances include the identity of the declarant, information about the properties of the nanomaterial, uses of the substance, and the identity of the professional users to whom the declarant transferred the substance (which is kept as confidential business information). Registered nanomaterials are given a single identification number that follows them all the way through the supply chain. The register has been successful in providing the French government with useful information, and other countries have started to follow suit; Belgium and Denmark have both recently adopted mandatory nanomaterial reporting schemes.

Belgium, the second country to adopt a mandatory nano register, hopes the register will improve the ability of health and safety officials to respond to potentially hazardous nanomaterials, ensure higher safety standards, and strengthen trust in the new technology. The data will begin to be collected on January 1, 2016 and e-submitted by the same date in 2017. The obligation to register covers both substances and mixtures containing nanomaterials. The register excludes cosmetic, biocides, medications, food products, and paints.

A few months after Belgium, Denmark made its nano register compulsory for producers and importers for mixtures and products containing nano materials, giving it a product focus rather than only concentrating on the nanomaterials. Registration opened on June 20, 2014 and the first reports are due in by August 30, 2015. Like Belgium, the Danish nano register contains a long list of exemptions. All three national registers also exclude substances that are exempt from REACH registration. These exclusions undermine the value of the nano register by concealing important safety information from the public and regulator. Though these national databases are an encouraging step towards increased transparency and widening access to public information, an EU-wide register would greatly harmonize nanotechnology regulatory approaches and trace nanomaterials as they move through markets and across the continent.  It would allow regulators to monitor human or environmental contamination and identify those liable for damages. A wider EU database would allow for important data sharing and a coordinated mitigation strategy, reducing public costs in the long-term and protecting human health and the environment. Paradoxically, while most industries are calling for this kind of Europe-wide legal certainty and legal stability to support the development of the technology, they continue to oppose an EU-wide nano register.

In May, the European Commission launched a public consultation on the possibility of an EU-wide register; the comments are intended to inform an impact assessment of a future EU-wide registry proposal. Five options were envisaged:

  • first, to remain with the status quo;
  • second, to create a “soft law” approach by way of a guide of recommendations for a best practices model for countries seeking to implement national registers;
  • third, a structured approach to gather information in a European Nanomaterials Observatory (i.e.: A compilation of existing information);
  • fourth, to establish a European register of nanomaterials similar to the R-Nano in France; and
  • fifth, to create a European register with substances, mixtures, and associated articles.

An inclusive, EU-wide register is a solution that would make information, which is critical to meaningful regulatory change, available.  The public consultation is open for comments until August 5, 2014. The consultation is being led by the European Union’s Enterprise Directorate General which is notoriously opposed to such a register. It is essential to put pressure on the Commission to implement a European register and ensure continent-wide standards on safety and information. CIEL, in partnership with ECOS and the Öko Institute prepared a template of answers to the questions of the public consultation. We invite you to use it to let the European Commission know how you feel about the unreported use of nanomaterials.

Originally posted on July 31, 2014.