REGULATION

The rapid growth of...

 

nanomaterials’ applications has by far outpaced information and data about the associated safety and health risks. The questions raised, so far, and the limits and gaps in information and data, pose serious challenges to regulation and policy makers.

So far, REACH, the main legislative framework for regulating chemicals and their safe use at European level, has no provisions specifically addressing nanomaterials. REACH deals with substances, in whatever the size, shape or physical state and thus in principle covers substances at the nanoscale.

According to the European Commission and its Second Regulatory Review on Nanomaterials (EC 2012)[52] the current legislation covers in principle the potential health, safety and environmental risks in relation to nanomaterials". This review concludes also that ‘in the light of current knowledge and opinions of the EU Scientific and Advisory Committees and independent risk assessors, nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not. Possible risks are related to specific nanomaterials and specific uses. Therefore, nanomaterials require a risk assessment, which should be performed on a case-by-case basis, using pertinent information. Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required. The definition of nanomaterials will be integrated in EU legislation, where appropriate”.

 

However, unless REACH is amended to refer to the definition of nanomaterials and the current volume limits are amended to include nanomaterials with lower production volumes (i.e. lowered to 10 Kg/year to take into account the increased reactivity of nanomaterials), nanomaterials will continue to “slip through”. Similar amendments should be made to other relevant legislative frameworks such as the regulation on Classification, Labelling and Packaging (CLP) of products, the Occupational health and safety (OHS) related directives, etc.

A further regulatory review with a focus on occupational health and safety issues is ongoing, and expected to be reported to the EC in 2013 focusing on the way “nano” is addressed in the OHS directive, the Chemical Agents Directive, the Carcinogens Directive and other related directives.

 

In the meantime, revisions regarding nanomaterials were introduced in the Cosmetics directive, the Biocides directive, food legislation and medicines. From 2013 the EU requires nanoparticles in cosmetics to be labeled on the ingredients list with the suffix “nano” and require increased safety testing for cosmetics containing nanoparticles. It also prevents nanomaterials from being placed on the food market until being subject to nano-specific, standardized, safety assessments free of animal-testing.

 

Due to the uncertainty and ambiguity of the information and data about the impacts of nanomaterials and nanotechnology applications to human health, the environment and society, public authorities, industry, academia, NGOs and TUs recognize the need for the adaptation or amendment of existing regulation to secure proper governance of nanotechnologies[53]. In particular, NGOs and TUs call for the adoption of fundamental principles of sustainable and responsible development taking as a starting point the application of the precautionary principle when dealing with nanotechnologies.[54] TUs and NGOs formulated explicit resolutions and position statements regarding the governance of nanomaterials and their safe use (ETUC 2008[55], 2010[56]; EEB 2009[57],[58]; Client Earth, CIEL and BUND 2012;[59] MIO-ECSDE 2009[60], 2013).

Several initiatives to set up a voluntary reporting for nanomaterials’ use in Member States have failed (e.g. UK), due to underreporting of the industry. This led regulators in France, Denmark and Belgium to launch mandatory reporting for the use of nanomaterials in preparations and products. In France the decree is applicable from January 2013 and requires companies that manufacture, import, distribute nanomaterials in quantities larger than 100 g to submit to the competent authorities an annual declaration containing the quantity and use related information of nanomaterials.

 

When it comes to monitoring or mandatory reporting of the use of nanomaterials the European Commission has not taken initiatives so far. This has led to a collective initiative of many EU Member States, led by the Netherlands, calling for the introduction of relevant legislation for market surveillance and registration of manufactured nanomaterials and nano-enabled products and the amendments of REACH.

 

Looking beyond Europe, the USA, Canada and Australia on the issue of regulating nanotechnologies and in particular Canada and Australia explicitly identify the need to adopt a precautionary approach.[61]

 

Alongside the above mentioned activities regarding the so called "hard" regulation, different “soft” measures have been introduced as means to facilitate best practice in risk assessment and management, to initiate a constructive dialogue with stakeholders and combine evidence based risk assessment with a precautionary approach.[62] These soft measures include self regulation via codes of conduct, multi-stakeholder dialogue and continuous observation of developments through observatories. However, such measures are not adequate to meet the challenges posed by nanotechnologies.[63]

 

Although it is unclear what type of measures the regulatory regime ought to impose in order to contain the perceived danger posed to humans and the environment by nanomaterials and nano-applications, numerous countries have agreed on the need to adapt existing regulatory systems to tackle emerging nanotechnologies.[64] Lessons learnt from earlier technological revolutions (e.g. genetically modified organisms) clearly articulate the need for finding a balance between industry innovation and risk reduction, through an appropriate regulatory framework.[66] The top priorities of the future regulatory agenda should first focus on workers safety and the higher risk sectors in which nano-products have already been commercialised (chemicals, cosmetics, foods and materials). In addition, attention should be paid to specific risks that might affect developing countries due to their particular environmental and social conditions.

[52] EC 2012.Communication from the commission to the European Parliament, the Council and the European Economic and Social Committee, Second Regulatory Review on Nanomaterials, COM, 2012.

[53] Fairbrother A, Fairbrothe JR. Are environmental regulations keeping up with innovation? A case study of the nanotechnology industry. Ecotoxicology and Environmental Safety, 72 (5): 1327-1330, 2009.

[54] NanoCap NGOs and TUs positions on Nanotechology. (http://www.nanocap.eu/Flex/Site/Page.aspx?PageID=15407&Lang=UK)

[55] ETUC (2008) Resolution on nanotechnologies and nannomaterials. http://www.etuc.org/a/5163

[56] ETUC 2nd resolution on nanotechnologies and nanomaterials, 2010.

[57] EEB position paper on nanotechnologies and nanomaterials, 2009.

(http://www.eeb.org/publication/2009/090228_EEB_nano_position_paper.pdf)

[58],[59] Bund_2012_ High time to act on nanomaterials - A proposal for a ‘nano patch’ for EU regulation.

(http://www.ciel.org/Chem/Nano_EU_13Nov2012.html)

[60] MIO-ESCDE Position Paper on Nanotechnologies, 2009 (http://www.mio-ecsde.org/articles.asp?cMC=7&cID=43&aID=54)

[61] http://www.observatorynano.eu

[62] International Risk Governance Cycle (IRGC) workshop briefing paper. Appropriate risk governance strategies for nanotechnology applications in food and cosmetics. Geneva, 28-29 April, 2009.

[63] Gammel S. Soft Regulation. Basic Ethical concepts. The Ethics Porfolio. Technical University Darmstadt for NanoCap, 2009.

[64] Van Calster G. Regualting nanotechnology in the European Union. European Environmental Law Review, August/September, 2006.

[65] Bowman DM, Hodge GA. Nanotechnology: Mapping the wild regulatory frontier. Futures, 38:1060–1073, 2006.