precautionary strategies for managing nanomaterials

PRECAUTIONARY STRA TEGIES FOR

MANAGING NANOMATERIALS

Summary for policy makers

September 2011

The issue: The

precautionary principle

and nanomaterials

New technologies enrich our lives in many differ-ent ways and are valuable in the solution of press-ing social problems. A country such as Germanyalso relies on innovation to stay globally competi-tive. Yet new technologies pose risks whose natureand scope only become known over time. Deci-sions on how to continue developing new tech-nologies and where to restrict them are thereforeoften made in conditions of uncertainty.

In the past, commercial activities were not usuallyrestricted on environmental or health grounds un-less it was scientifically proven to a sufficient de-gree of probability that they caused harm. If, how-ever, as is often the case with innovations, there isa lack of experiments and scientific findings to showthat a substance, production process or productcauses harm, then the sufficient degree of probabil-ity used in the conventional approach to avertingdanger as defined in law is not given. Followingnegative experience, it is now accepted that – sub-ject to rigorous cost-benefit analysis – risks to hu-man health and the environment should also beaverted on a precautionary basis even if the sci-ence is inconclusive. This is the thinking behind theprecautionary principle that is now broadly andfirmly established in legislation as an extension ofthe state objective of environmental protection laiddown in Article 20a of the German Basic Law, ofthe corresponding Community objective laid downin the second sentence of Article 191 (2) of theTreaty on the Functioning of the European Union,and of the international law principle of sustainabledevelopment (see Principle 15 of the Rio Declara-tion).

The precautionary principle notably applies wherescientific evidence is inconclusive or is contestedbetween experts but a preliminary and objectivescientific risk assessment raises justified concernthat a substance, production process or productmay cause harm to human health or the environ-ment. In risk prevention, this abstract concern (orreasonable suspicion) that harm may be caused is

enough to legitimate state action. It allows earlierstate intervention, before the danger threshold isreached.

To avoid exercising precaution for precaution’ssake – which in any case would be legally question-able – it is first necessary to specify trigger criteriafor precautionary intervention. This involves a two-stage process: a (science-based) risk assessmentand normative risk evaluation. If there is then stillany uncertainty about the cause for concern, theprecautionary principle demands a reversal of theburden of proof to enable legislative action. It isthen up to the risk originator to rebut the presump-tion of danger and hence the cause for concern.

When action is required to prevent risk, there are awide range of available options. With an eye to theeconomic rights that open up opportunities for in-novation, the choice of options should be informedby the abstract potential for causing concern, in-cluding the potential extent of any harm.

The introduction and use of nanomaterials is a top-ical example of a situation where the precaution-ary principle ought to play a key role, notablywhere knowledge of the dangers (in the legalsense) is largely absent. The precautionary princi-ple requires the risks and opportunities of nanoma-terials to be systematically identified and assessed.This prepares the ground for regulatory decisionsthat promote a technology’s development whilelimiting the potential risks. By openly balancing op-portunities and risks in this way, the precautionaryprinciple can help build confidence in and publicacceptance for the use of nanomaterials.

The German Advisory Council on the Environment(SRU) is in favour of giving greater place to the pre-cautionary principle in society, government, thelaw and administrative process as a guiding princi-ple for dealing with the uncertainty inherent in newtechnologies. Exploring the example of nanotech-nologies, and specifically nanomaterials, this reportanalyses to what extent the precautionary principleis already in use today, where there are deficits andgaps, and how these can be closed. The subject ofnanotechnologies is especially well suited to an in-vestigation of this kind because it acts as a lens fo-cusing the various threads of social debate sur-

Precautionary strategies for managing nanomaterials

German Advisory Council on the Environment | Precautionary strategies for managing nanomaterials2

In many products sold as ‘nano’ today – such ashousehold items with antibacterial coatings – thenanotechnology component is of limited or disput-ed benefit. Consumer products of this kind, howev-er, only make up a small share of the nanotechnol-ogy spectrum. Technologically and economicallymore important are applications where the incor-poration of nanoprocesses and nanomaterials isless obvious, as with electronics and intermediateproducts in chemical industry production process-es. There is no doubt that nanotechnologies willopen up a vast range of new technological oppor-tunities in the long term. There is reason to hope

that in some areas these opportunities will not onlybe a source of profit economically, but will also de-liver large social benefits, for example in medicine.The environmental opportunities of nanotechnolo-gies are also widely emphasised. However, fewsuch hopes have so far been translated into reality.The few life cycle assessments done to date showthat nanotechnology applications do not alwayshave a fundamentally smaller environmental foot-print. In the longer term, decisive improvementsare nonetheless expected in fields such as solartechnology and energy storage.

rounding the risks of new technologies. For theirprofoundly cross-cutting nature and scope forbringing about fundamental change in whole tech-nological disciplines, nanotechnologies rankamong the key technologies of the 21st century.

At the same time, the potential risks are heteroge-neous and difficult to foresee. This has partly to dowith the new properties of the materials them-selves and partly with the diversity of their struc-tures, products and applications.


German Advisory Council on the Environment | Precautionary strategies for managing nanomaterials 3

Opportunities of nanomaterials

Risks of nanomaterials

An important preliminary finding of risk research isthat nanomaterials differ from their macro counter-parts not just physically and chemically, but also intheir behaviour and effects in living organisms andthe environment. A problem aspect here is thatnanomaterials both differ from conventional mate-rials in ways that may be biologically significantand are also able to move about more easily thanmacro-structured solids in environmental mediaand organisms. Biological impacts are thereforeanother area where nanomaterials cannot be brack-eted together with their conventional equivalentsand should be treated instead as ‘new’ substances.

It is not possible to make general statements aboutthe risks of nanomaterials. On current knowledge,some materials essentially raise no concern, whileresearch on others shows significant potentialrisks. There is no scientific proof so far that nano-materials – as they are made and used today –cause actual harm to the environment or humanhealth. This cannot be taken as an all-clear, how -ever, because for many nanomaterials there is a

lack of standardised test methodologies for a fullrisk assessment and knowledge of their potentialadverse effects is limited. A number of productsand uses raise concern (as defined in the context of the precautionary principle). These include theuse of nanomaterials in consumer sprays, growingsales of consumer products containing silver nano -particles, and the production and use of carbonnanofibres and nanotubes with carcinogenic poten-tial. Many more nanoproducts are expected to comeonto the market in the next few years. There is arisk that the number of products which cause con-cern will grow accordingly. The concentrations ofnanomaterials in manufacturing process es, prod-ucts, waste water and solid waste is also very likelyto increase.

Although properties of some nanomaterials areproblematic, the challenge as seen in the light ofcurrent knowledge lies not so much in specific dan-gers of nanomaterials, but in risk research and reg-ulation barely being able to keep up with the fastdevelopment of technology. A key aspect relates to

specific methodological difficulties in toxicity test-ing – for example in preparation and standardisa-tion of materials to be tested. But an equally largeproblem is the sheer variability of the new materi-

als. Small changes to a single material can producedozens or even hundreds of variants that can eachdiffer in effects and environmental behaviour.



Recommendations for a precautionary approach to

nanomaterials

This report aims to secure consistent application ofthe precautionary principle to nanomaterials. Thisdoes not mean, however, that all potentially riskyproducts and materials should be restricted or pro-hibited. The purpose of the precautionary principleis not to halt innovation, but to balance the oppor-tunities and risks. The SRU proposes a wide rangeof measures to enable this balancing to take placewhen there is cause for concern. The main recom-mendations are summarised in the following.

Key recommendations for action:

— Makers of nanomaterials should be placed un-

der stricter obligation to file data on the risks

of nanomaterials.

— Risk research should be made to account for a

considerably larger portion of publicly funded

nanotechnology research.

— Existing dialogue activities should be ex-

tended to a broad cross-section of society.

— For an overarching definition of nanomateri-

als, an upper size limit of 300 nm is recom-

mended. A smaller size limit may be appropri-

ate for specific regulatory purposes.

— In many areas of the law, there are nano-spe-

cific regulatory gaps that should be closed as

soon as possible on the basis of the precau-

tionary principle. In some areas, however, the

report’s analyses reveal deficits in application

of the precautionary principle that also hold

with regard to other substances and products.

A number of recommendations therefore re-

late to a need for action going beyond the

regulation of nanomaterials.

— To enhance market transparency, existing la-

belling obligations should be supplemented

with an additional ‘nano’ indication. Products

that release nanomaterials or make use of

them to achieve specific properties (such as

antibacterial properties) should also require

mandatory labelling. For other nanoproducts,

a notification requirement should be intro-

duced that feeds into a semi-public product

register.

— Extensive changes are necessary in chemicals

legislation (REACH): Nanomaterials should be

consistently treated as if they were sub-

stances in their own right and registered with

dossiers of their own. A core data set should

have to be submitted for them that ensures

observation or a preliminary risk estimation,

according to their size. Quantity thresholds

must be reduced for nanomaterials and the

standard information requirements need to be

supplemented. Authorisation should be based

more closely on the precautionary principle.

It should also be possible to restrict or pro-

hibit nanomaterials merely on the basis of an

abstract concern.

— In product legislation, it must be ensured in

existing authorisation procedures that nano-

materials are always approved separately. For

weakly regulated products, the foundations

should be laid for powers to intervene on the

basis of the precautionary principle.

— In environmental law, there is a considerable

need for research and assessment. Operators

of industrial facilities should be obliged to

minimise emissions of nanomaterials for which

there is an abstract concern.

1. Intensification of risk research

For the technology to go on developing along re-sponsible lines, it is necessary to close the cur-rently widening gap between technological ad-vancement and knowledge of risk. The followingshould be done to achieve this goal:

Manufacturers of nanomaterials should be placedunder stricter obligation to file data on risks ofnanomaterials. Existing European chemicals legis-lation provides a good framework for this purposebut must be modified for nanomaterials (see be-low).

Risk research should be made to account for a sig-nificantly larger portion of publicly funded nan-otechnology research.

Where scientific risk assessment is not possibledue to a lack of data, a preliminary risk assessmentshould be performed on the basis of specific crite-ria indicating concern or no concern. This makes itpossible to balance risks and opportunities in con-ditions of uncertainty. The SRU proposes criteriaand a decision tree as a basis for determining po-tential concern specific to nanomaterials.

2. Promotion of social dialogue

On balance, the SRU takes a positive view of the dialogue efforts engaged in so far in Germany andat EU level. However, the institutions and dialogueforums established to date have only reached a rel-atively small group of experts. As a result, develop-ment, use and regulation of nanomaterials contin-ues to advance generally out of the broader publiceye. The SRU therefore sees a need to extend exist-ing dialogue activities to a broader cross-section ofsociety. Care should be given in doing so to ensurethat all communication processes operate transpar-ently, address risks and opportunities in equalmeasure, highlight important details, and includenon-experts such as consumers and the interestedpublic. In particular, the SRU advocates mandatingexisting institutions to continue the social dialogueon nanotechnology and further institutionalisingaccompanying social sciences research.

3. Legal framework for the regulation of

nanomaterials

While they have characteristics that set them apart,the nanomaterials manufactured today are basical-ly chemical substances that are already subject tocomprehensive regulation (notably under REACH).They are also used in products that are regulated intheir own right. Any specific rules for nanomateri-als should therefore build on existing law. Howev-er, because so many different policy areas are af-fected (chemicals, waste, pollution control, food,cosmetics, etc.), modifying numerous individuallaws involves a loss of transparency for the public.For systematic reasons, legislation should beadopted laying down certain ground rules on across-sectoral basis for the management of nano-materials. The SRU therefore proposes combiningthe various sector-specific modifications in a singlepiece of legislation so that certain cross-sectoralstipulations can be covered at a general level. Thisgeneral section of the proposed legislation, prefer-ably to be enacted at European level, should firstand foremost provide an overarching definition, require the application of the precautionary princi-ple and establish powers for individual action in-voking that principle. For an overarching definitionof nanomaterials intended to serve as a frameworkfor government and regulation, the SRU recom-mends an upper size limit of 300 nm. This uppersize limit should relate solely to primary particles.Agglomerations and aggregates of primary parti-cles should be covered by the definition withoutany size limit. The definition can be made narrowerfor specific regulatory purposes as appropriate, forexample to exclude certain materials not posingany risk.

4. Closing nano-specific regulatory gaps

Nanomaterials are not normally dealt with sepa-rately in prevailing law. For example, nanoscale titanium dioxide is treated exactly the same in lawas conventional titanium dioxide consisting of larger particles. This raises problems because thenanoscale form of a material can pose differentrisks than the conventional equivalent. Existing legal limits may prove too lax, for example, if ananomaterial is more reactive than the convention-



al material that the limits were originally set for.Risk estimation for nanomaterials normally calls foradditional tests and data that need to be made aseparate requirement. Nano-specific regulatorygaps of this kind should be closed as quickly aspossible. Alongside revision of technical imple-mentation documents, this also requires changesto various areas of the law.

The analyses in this report generally show thatthere are not only specific regulatory gaps with regard to nanomaterials, but also broad deficits inapplication of the precautionary principle in variousareas of chemicals, environmental and product leg-islation that also apply for other substances andproducts. Some of the legislative changes pro-posed in this report may therefore also serve as amodel for regulation of other substances and prod-ucts.

5. Labelling and product register

For precautionary reasons, the SRU considers itnecessary to create greater transparency regardingthe use of nanomaterials in products. On the onehand, authorities must be able to obtain an over -view of the market, not least so that they can re-spond quickly if indications of specific dangers be-come known. On the other hand, consumersshould generally be allowed free choice. Amongother things, the SRU therefore advocates the following:

For products (such as foods) whose ingredients already have to be listed on packaging, labellingshould be supplemented with an additional ‘nano’indication. A new labelling requirement shouldonly be introduced for products that make use ofnanoscale ingredients to achieve specific proper-ties (such as antibacterial properties) or that re-lease nanomaterials.

For products that contain synthetic nanomaterialsbut are not subject to labelling requirements, a no-tification requirement should be introduced. Thenotification requirement should feed into a semi-public product register.

If specific risks are attached to the use of nanoprod-ucts, the fact should be brought to consumers’ at-tention with provision of information on use.

6. Need for reform in chemicals

legislation

Nanomaterials should be consistently treated as ifthey were substances in their own right to ensurethat they are registered, tested, assessed, labelledand treated separately. Nanomaterials should alsobe defined and made a focus of specific legal obli-gations.

In REACH, nanomaterials should have to be regis-tered with dossiers of their own. The transition pe-riods for existing substances and the exceptionsformulated for specific substances should not ap-ply for nanomaterials. Quantity thresholds must bereduced for nanomaterials. The standard informa-tion requirements for registration must also bemodified and supplemented. The SRU additionallyadvocates the introduction of a core data set thatvaries in scope according to the size of a nanoma-terial. A core data set should still have to be sub-mitted if a nanomaterial is produced in quantitiesof less than one tonne per year. For all nanomateri-als where a preliminary risk estimation revealsgrounds for suspicion, a comprehensive chemicalsafety report should be mandatory.

It is also necessary to create, within REACH, a legalbasis for intervention in accordance with the pre-cautionary principle.

The powers to require authorisation under REACHshould be formulated so that the mere possibilityof a severe effect on human health or the environ-ment can justify an authorisation requirement. Thisshould include a rebuttable presumption of dangerin accordance with the precautionary principle,with the burden of proof on the applicant.

It should be possible to prohibit or restrict nanoma-terials as soon as an abstract concern is identified.



7. Need for reform in product legislation

Some areas of product legislation already haveregulatory regimes based on the precautionaryprinciple. Here it is only a matter of ensuring thatthe special characteristics of nanomaterials are taken into account. In general, this means existingauthorisation procedures (such as for foods, foodcontact materials and cosmetics) must be adaptedso that authorisation for nanomaterials has to beapplied for separately. Such authorisation shouldbe granted, firstly, only if use of the nanomaterial isproven to be safe. Pending risk evaluation methodsand related test standards, one option would be togrant provisional approval subject to subsequenttesting. Secondly, authorisation should only begranted if methods exist for detecting the nano -material in a product.

For products that have been subject to weaker reg-ulation to date, the foundations should be laid forauthorities to take action (such as powers to re-quire authorisation or to impose restrictions and labelling requirements) if there is ‘merely’ an ab-stract concern. These powers could be included inthe cross-sectoral legislation proposed by the SRU(see above).

8. Need for reform in environmental law

A basic problem in protecting the environmentfrom nanomaterials is patchy knowledge abouttheir environmental release, behaviour and im-pacts. This means there is not enough of a scientif-ic basis for decision-making in order to set limits atsub-statutory level. The SRU therefore expects thatdecisions will continue to be made on a case-by-case basis in many areas for some time to come.

It can be assumed that only a small number of syn-thetic nanomaterials so far enter the environmentto a greater extent. This volume is expected to in-crease, however. There is therefore an urgent needto ensure that nanomaterials enter the environ-ment in the smallest possible quantities. The SRUidentifies the current priorities in this connection asfollows:

Legislation governing industrial facilities: Use ofinsoluble or barely soluble nanomaterials shouldbe made subject to powers to require approval un-der pollution law. Thought should also be given toestablishing a notification requirement for all pro-duction and use of nanomaterials. The German Major Accidents Ordinance (Störfallverordnung)should be applied to facilities that make or processnanomaterials for which there is cause for concern.

Protection of environmental media: Speedy ap-praisal is needed to decide where prohibitions,quality standards or emission limits can be im-posed for individual nanomaterials or identifiablegroups of nanomaterials. The current state of theart needs to be delineated and suitable testingmethods developed. To ease the burden of proof,emissions of nanomaterials for which an abstractconcern is identified should have to be limited asfar as possible. Authorities should be provided withguidelines for formulating requirements on a case-by-case basis, and need to be given broad informa-tion rights for the purpose.

Waste: There is considerable need for researchhere, for example on the development of suitabletesting methods and on nanomaterial behaviourand release in waste recycling and recovery, incin-eration and landfilling. For precautionary reasons,pending more precise knowledge of the behaviourof nanomaterials in the waste stream, at least pro-duction waste containing nanomaterials should beclassified as hazardous waste. For certain wastecontaining nanomaterials, thought should be givento establishing take-back schemes to prevent suchmaterials from being disposed of as part of munici-pal waste.





This report has shown ways in which the precau-tionary principle can successfully be applied tonanomaterials in practice and the changes thatneed to be made in order to make this possible. Inthe SRU’s opinion, key findings are transferable inprinciple to other technologies and risk areas.

The confidence in technical progress that a demo-cratic society needs can only be ensured if the on-going development of technologies is guided bythe precautionary principle and account is also given to principles of sustainability.

Precaution beyond nanotechnology

Published by:

German Advisory Council on the

Environment (SRU)

Secretariat:

Luisenstraße 4610117 BerlinPhone: +49 (030) 26 36 96 -104Fax: +49 (030) 26 36 96 -109Email: [email protected]: www.umweltrat.de

Images:

p. 1: Bernd Müller (1 – 6)

Design & Production:

BLOCK DESIGN Kommunikation & Werbung

An electronic version of this report and

further information are available online at

www.umweltrat.de

The German Advisory Council on the Environment (SRU) has been advis-ing the German government since 1972. The Council is made up of sevenuniversity professors from a range of different environment-related disci-plines. This ensures an encompassing and independent evaluation froma natural scientific and technical as well as from an economic, legal andpolitical science perspective. The Council has currently the followingmembers:

Prof. Dr. Martin Faulstich (Chair), Technische Universität MünchenProf. Dr. Heidi Foth (Vice Chair), Universität Halle-Wittenberg Prof. Dr. Christian Calliess, Freie Universität Berlin Prof. Dr. Olav Hohmeyer, Universität FlensburgProf. Dr. Karin Holm-Müller, Rheinische Friedrich-Wilhelms-Universität BonnProf. Dr. Manfred Niekisch, Goethe-Universität Frankfurt und Zoologischer Garten FrankfurtProf. Dr. Miranda Schreurs, Freie Universität Berlin

http://www.umweltrat.de

http://www.blockdesign.de

precautionary strategies for managing nanomaterials

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