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Regulating nanomaterials – EU shifting the burden

The current state of EU governance and regulatory oversight for the development, production, marketing, use and disposal of nanomaterials is marked by severe deficiencies. After more than ten years of discussions, two regulatory reviews, the adoption of nano-specific provisions in EU legislation and several guidance documents, nanomaterials are still coming onto the EU market without being properly assessed, labelled and identified.

And there are no specific disposal plans that would reduce possible impacts on human health and the environment. It is high time therefore to question the reasons that led to this situation and to identify the hold ups.
A scattered legal framework

In looking at the legal framework applicable to nanomaterials, we must distinguish between the pieces of legislation with nano-specific provisions and those that are supposed to support their regulatory oversight without these.

For the past seven years, the EU has revised a number of sectoral regulations and included similar nano-specific provisions in each of them. These include the cosmetic products Regulation, biocidal products Regulation, and the regulatory framework for food, including the novel food Regulation and the Regulation on food information to consumers.

All provide a legal definition of nanomaterials, which varies from one regulation to another, a form of declaration or prior authorisation for their marketing and a labelling requirement for products containing them. Unfortunately, none of these regulations are adequately implemented to date.

Under the cosmetic products Regulation, for example, the Commission is required to make available to the public a catalogue of nanomaterials used in the products and annually update the EU Parliament on this. However, due to inconsistent industry notifications, the Commission has declared that the publication of a catalogue is impossible.

In response to numerous requests from the European Parliament and civil society, it continues to delay implementation and to reject enforcement measures that would ensure manufacturers provide adequate information.

In the food arena, industry is resisting implementing the labelling obligation, and enforcement measures are, so far, similarly nonexistent. In April, the French organisation Agir pour l’Environnement tested four processed food products available on the French market.

All four contained nanoparticles, and none appropriately labelled despite a legal obligation dating back to 2011, and in force since December 2014. A survey of over 100 food products, likely to contain similar nanomaterials, showed that none of these were labelled either.

Both these examples demonstrate an obvious resistance to implementation by the relevant industrial actors and a serious lack of political will to enforce these legal obligations by the authorities.

Further to these sectoral regulations, a large portion of the EU regulatory framework theoretically applies to nanomaterials without specific provisions. The most emblematic of these legislative pieces is REACH, but the same applies to the Regulation on classification, labelling and packaging of substances and mixtures (CLP), the water framework Directive, and many more.

Experience, over the past several years, shows that these regulations are mostly useless when it comes to providing adequate governance and oversight of nanomaterials at any stage of their lifecycle.

One reason for this situation is that the implementation of the majority of existing provisions, from secondary legislation, relies on information and data that is currently unavailable.

In that respect, REACH deserves to be analysed separately. Because the adoption of specific nano provisions for REACH has been under discussion for several years now, and it is designed as both a data collecting tool and a risk management mechanism.

REACH plays a specific role in triggering the measures from secondary legislation. Although directives, such as the water framework Directive and waste legislation, provide governance measures that could be useful in protecting European health and environment from the negative impacts of nanomaterials, these are usually triggered by a classification under CLP. However, the latter is based on existing information, which REACH is supposed to deliver, but doesn’t.
The challenge of collecting relevant information

In order to adopt and implement adequate risk reduction and management measures, it is necessary to have information about the hazards of the various nanomaterials on the market, as well as credible exposure scenarios, derived in part from information about their presence and nature.

Since early discussions on the subject in 2008, REACH has been presented as the key to collecting this information. The past few years have demonstrated that this assumption is erroneous, which has lead to the development of national initiatives to, at least, collect information about the presence and nature of nanomaterials already on the market.

In 2008, after the publication of a report commissioned by DG Environment, calling for more transparency on the substances, the Commission refused to develop a new information collection tool, arguing that the first REACH registration deadline, in 2009, would provide all the information needed.

When the deadline passed and no relevant information was collected, the Commission argued that this was the result of a lack of guidance material. It then invited all stakeholders to work on developing such a document so that the information would be made available by the following registration deadline in 2012. When the deadline did not see real improvement on the information on nanomaterials on the market available through REACH, despite the adoption of several guidance documents, the Commission then said that this was the result of a lack of legally binding requirements.

In spite of calls by civil society and member state alike to either develop an ad-hoc piece of legislation or update the core text of REACH to collect this information, the Commission argued that the only timely way to get adequate measures in place for the final 2018 REACH registration deadline was to focus on updating the REACH annexes.

So, again, stakeholders dedicated significant resources to developing adequate annexes. However, these efforts were thwarted when the Commission deliberately delayed the outcome of this work. In March of this year, after two years of silence on the subject, it announced that the revised annexes would not be adopted early enough to be in force for the 2018 registration deadline, prompting widespread outrage among all stakeholders and rekindling ideas to develop a stand-alone nano-patch regulation for the EU regulatory framework.

Faced with Commission obtrusion, and strong resistance from the registrants of substances to voluntarily provide information on registered nanomaterials, Echa decided to use article 46.1 of REACH to request additional information from registrants. However, despite regular declarations of good will and intentions to build trust, registrants have systematically appealed every request for additional information before the Echa Board of Appeal, further delaying transparency and the possibility of carrying out an adequate risk assessment.

Discouraged by the EU Commission’s efforts to maintain the status quo and to block the adaptation of the regulatory framework, a number of member states developed their own national schemes to, at least, collect information about the nature and presence of nanomaterials on the market. This prompted another debate on whether the EU should adopt an information collecting tool (generally referred to as an EU-wide nanomaterial register).

After over two years of circular discussions, a costly impact assessment and a very technical public consultation, the Commission announced its decision not to develop an EU register, citing the need to avoid compliance costs for the industry. Instead, it chose to spend approximately two million euros to task Echa with developing a “nano observatory” which will merely re-package existing information about nanomaterials on the market.

This last decision to create a “nano observatory” raises serious concerns about the process guiding governance decisions on nanomaterials and the choices made by the Commission. Over the last three years, massive public resources were used to effectively block the evolution of the regulatory framework through a series of impacts assessments, public consultations and meetings to support the industry.

In the end, the Commission decided to disregard its own impact assessment. It proposed an option that had not been assessed by this, and did not wait for the Regulatory Scrutiny Board to validate the process.

Refusing to impose any costs on industry for the collection and provision of information on nanomaterials, it has decided to shift financial costs and the burden of health and environmental risks onto society and consumers instead