For Official Use ENV/CHEM/NANO(2015)33€¦ · ENV/CHEM/NANO(2015)33 2 On 19 September 2013, the...

For Official Use ENV/CHEM/NANO(2015)33 Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 03-Nov-2015

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_____________ English - Or. English ENVIRONMENT DIRECTORATE

CHEMICALS COMMITTEE

Working Party on Manufactured Nanomaterials

53RD JOINT MEETING FEEDBACK ON THE COUNCIL RECOMMENDATION

15th Meeting of the Working Party on Manufactured Nanomaterials

4-6 November 2015

OECD Conference Centre

Paris, France

Mr. Peter KEARNS, tel: +33 (0)1 45 24 16 77; email: [email protected]

JT03385671

Complete document available on OILS in its original format

This document and any map included herein are without prejudice to the status of or sovereignty over any territory, to the delimitation of

international frontiers and boundaries and to the name of any territory, city or area.

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ENV/CHEM/NANO(2015)33

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On 19 September 2013, the OECD Council adopted a Recommendation on the Safety Testing and

Assessment of Manufactured Nanomaterials [C (2013)107]. This followed a proposal by the Chemicals

Committee at the 50th Joint Meeting in June 2013. Amongst other things this Recommendation includes

an article (IX) through which the Council “instructs the Chemicals Committee to monitor closely the

technical aspects of implementation of this Recommendation and to report to Council within three years of

its adoption and thereafter as appropriate”. In other words, the Chemicals Committee should forward a

report to the Council on or before 19 September 2016.

In order to prepare this report in June 2015, the secretariat invited the Heads of Delegation to the

Working Party on Manufactured Nanomaterials to provide responses related to the implementation of the

Council Recommendation. This request was based on a series of issues identified and agreed by the

Chemicals Committee at the 53rd

Joint Meeting held in June 2015.

This document summarises the responses received to date from ten delegations. It is organised into

four parts. The first part includes some background information related to the process by which the review

will proceed and the issues to be addressed. The second part is a summary of the responses received from

delegations, and organised by the issues identified by the Chemicals Committee. The third part (Annex I)

is the full set of responses received from each delegation; while the fourth part (Annex II) is a summary

of the responses in the form of a table.

At this stage, it is important for additional delegations to provide input into this exercise. It will be

difficult to draft a convincing report on the basis of responses from only ten delegations. At the same time,

the WPMN should agree how best to include information related to recommendations arising from WPMN

workshops could be included in the annex to the Recommendation (paragraph 3).

ACTION REQUIRED: The WPMN is invited to:

I) provide additional responses to the implementation of the

Council Recommendation; and

ii) Agree on how best to incorporate recommendations into the

annex to the Recommendation.

http://www2.oecd.org/oecdinfo/info.aspx?app=OLIScoteEN&Ref=C(2013)107


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TABLE OF CONTENTS

Introduction and Issues to be addressed ....................................................................................................... 4 Responses received to date organized by issue ............................................................................................ 4

How would your country describe the implementation of the Recommendation? .................................. 4 What specific measures been taken nationally to implement the Recommendation (any references or

supporting documentation will be of value)? ........................................................................................... 7 What, if any, further measures are necessary to ensure future implementation? ..................................... 9 Does your country have any additional suggestions to facilitate implementation which should be

addressed by the Chemicals Committee or the WPMN? ....................................................................... 10 What additional activities could be initiated to disseminate this Recommendation to all stakeholders

and other international organisations? .................................................................................................... 11 Should any additional documentation be added to the Annex at this stage (any references or supporting

documentation will be of value)? ........................................................................................................... 13 Should any existing documentation should be updated in the Annex be revised and updates? ............. 14 If any existing documentation should be updated, please indicate priorities with approximate

timelines; ................................................................................................................................................ 14 Please provide any additional information relevant for this annex with any supporting material. ........ 14

ANNEX I. ORIGINAL SUBMISSIONS ON THE IMPLEMENTATION OF THE COUNCIL

RECOMMENDATION ................................................................................................................................. 15

ANNEX II ..................................................................................................................................................... 31

SUMMARY TABLE OF RESPONSES ....................................................................................................... 31


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Introduction and Issues to be addressed

The Chemicals Committee has identified: I) the process by which the report will be drafted; and ii)

those issues of substance which should be addressed in the report [ENV/JM (2015)7]. In terms of process,

the Working Party on Manufactured Nanomaterials (WPMN) will play the major role in preparing input to

the draft. As a next step, the Chemicals Committee will consider the current status of the report at the 54th

Joint Meeting in February 2016.

The Chemicals Committee also identified a series of issues of substance to be addressed when

considering input into the report [ENV/JM (2015)7]:

• How would your country describe the implementation of the Recommendation?

• What specific measures been taken nationally to implement the Recommendation (any

references or supporting documentation will be of value)?

• What, if any, further measures are necessary to ensure future implementation?

• Does your country have any additional suggestions to facilitate implementation which

should be addressed by the Chemicals Committee or the WPMN?

• What additional activities could be initiated to disseminate this Recommendation to all

stakeholders and other international organisations?

• Please provide any additional information regarding the implementation of this

recommendation with any supporting material.

• Should any additional documentation be added to the Annex at this stage (any references

or supporting documentation will be of value)?

• Should any existing documentation referenced in the Annex be revised and updated?

• If any existing documentation should be updated, please indicate priorities with

approximate timelines;

• Please provide any additional information relevant for this annex with any supporting

material.

In June 2015, the Heads of Delegation to the Working Party on Manufactured Nanomaterials were

invited to provide responses to the above list of issues. To date, only ten responses have been received and

are compiled below; more are needed. Despite this, one major recommendation occurs in a number of

responses and this relates to the information to be included or updated in the annex. A number of

delegations have recommended that information related to recommendations arising from WPMN

workshops could be included in the annex to the Recommendation. The WPMN will need to discuss how

best this can be achieved.

Responses received to date organized by issue

How would your country describe the implementation of the Recommendation?

Australia

• Reforms to the National Industrial Chemicals Notification and Assessment Scheme

(NICNAS) are currently underway that aim to streamline the assessment process for

industrial chemicals to reduce the regulatory burden on the sector.

http://www2.oecd.org/oecdinfo/info.aspx?app=OLIScoteEN&Ref=ENV/JM(2015)7


http://www.nicnas.gov.au/



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• In line with the OECD Council Recommendation, consideration will be given to the

regulatory approach for nanomaterials in the implementation of these reforms.

Germany

• The implementation of the recommendation is on its way but not yet finalised.

• Regarding recommendation 1, a proposal for an appropriate implementation of

nanomaterials in the European chemical regulation framework is still lacking.

• With regard to the 2nd recommendation, Germany has taken the initiative to develop a

nonspecific TG and GD as well is involved in such initiatives led by other countries.

Adopted TG/GD should be available in the coming years. An issue of prime importance

for bringing forward the implementation refers to a legally binding MN definition, which

complies with the existing working definition on OECD level. However, the delegation

highlights that it is a European business, not a national one.

• Germany supports both the transfer of recommendations and needs of WPMN to the

research community and the transfer of research have been addressed by the

declassification and publication of the dossiers output to WPMN and regulators.

Japan

• Regarding recommendation 1, the Ministry of Economy, Trade, and Industry (METI)

calls on the industries to voluntarily report their management activities including

appropriate handling measures of the manufactured nanomaterials, and publicises them

on METI’s website (only in Japanese).1

• The programme started in 2010, and since then, 31 companies in total have participated

in the programme (30 companies’ information is available as of July

• Regarding recommendation 2, the Ministry of Health, Labour and Welfare (MHLW) has

applied the OECD Test Guidelines before amendment taking into account the specific

properties of manufactured nanomaterials.

• Regarding recommendation 3, METI is under development of intracheal administration

method for nanomaterials. To share with WPMN experts about the developing of

intratracheal administration method, METI has a plan to hold a seminar, “WPMN

information sharing seminar on in vivo Inhalation Toxicity Screening Methods for

Manufactured Nanomaterials”, which will be cosponsored by the US Environmental

Protection Agency (USEPA) in September 2015.

• Regarding recommendation 4, Japan has been regularly providing information on its

latest activities to the Tour de Table in each meeting of WPMN.

Korea

• The Ministry of Environment (MOE), Republic of Korea has prepared the legal ground

for survey of circulation status of nano materials in the regulation on statistical research

of chemical substances.

• Korea has been implementing the OECD Recommendation by reflecting it into a master

plan for nanosafety management in which relevant ministries have participated, and by

building a system for legal base of nanosafety management.

1 (URL; http://www.meti.go.jp/policy/chemical_management/other/nano_program.html)

http://www.meti.go.jp/policy/chemical_management/other/nano_program.html


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• Korea has been also participating in the OECD WPMN sponsorship programme for

testing of manufactured nanomaterials. Many safety testings on nanomaterials, including

nanosilver, nanogold, MWCNT, TiO2, SiO2, zinc oxide and calcium, have been

conducted pursuant to the OECD test guidelines with GLP compliance. To assess the

toxicity of nanomaterials, we have performed single dose toxicity, repeated dose toxicity,

toxicokinetics and physico-chemical properties study in accordance with the OECD test

guidelines in Nanotoxicology Project. Also, we have published articles in relating

international journals.

• The reports of nanomaterials studies also have disclosed through a web-based nanosafety

information system of the Ministry of Environment (MoE) and a research management

system of the Ministry of Food and Drug Safety (MFDS), etc.

Netherlands

• RIVM recently published the report “Assessing health & environmental risks of

nanoparticles: Current state of affairs in policy, science and areas of application2 in

which RIVM concludes that the existing models and techniques used to assess the risks

of nanomaterials are not yet sufficiently tuned to determine how harmful nanomaterials

are to humans and the environment.

United States

• Issuing the proposed TSCA section 8(a) rule described above. Regulation of new

chemical substances that are nanomaterials with consent orders and SNURs.

European Union

• The content of the current Recommendation (application of the existing chemicals

framework, use of OECD TG, adapted, and collaboration under OECD) is considered as

being successfully implemented.

• They underline that the nanomaterial specificities would effectively relate to differences

in regulatory routes and outcomes (e.g. pre-market notification, labelling requirements),

while the risk assessment frames do not deviate from the approach applied to chemicals

and are implemented in coherence with the Recommendation.

2 (www.rivm.nl/bibliotheek/rapporten/2014-0157.html)

http://www.rivm.nl/bibliotheek/rapporten/2014-0157.html


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What specific measures been taken nationally to implement the Recommendation (any references or

supporting documentation will be of value)?

Germany

• Back in 2013, Germany hosted the OECD Expert Meeting on Environmental Fate and

Ecotoxicology of Nanomaterials in Berlin (29th - 31st of January 2013. The discussions,

findings and recommendations of this workshop were published in a comprehensive

report which includes useful guidances on how to properly test MN for their fate and

effects in the environment:

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2

014)15&doclanguage=en. .

• UBA took the lead on the development of a draft test guideline for agglomeration

behaviour of nanomaterials in different aquatic media and a draft guidance document on

agglomeration and dissolution behaviour of nanomaterials in aquatic media – decision

tree.

• Within that framework the project “Development of a decision support tool for the

investigation of environmental behaviour of nanomaterials on the basis of their

dispersion stability and solubility as a function of environmental conditions” was

launched and has been awarded to the University of Vienna (Austria).

• In addition to that a draft for a new OECD Test Guideline will be developed for the

examination of agglomeration behaviour of nanomaterials in aquatic media. For this aim

influencing factors have to be identified and valid, as well as pragmatic approaches for

suitable methods and techniques have to be developed.

http://www.umweltbundesamt.de/en/research-development-projects

• Germany is involved as partner in additional working group, e.g. on the Guidance

Document on Aquatic (and Sediment) Toxicology Testing of Nanomaterials,

nanospecific Guidance Document for OECD 305, Test Guideline for dissolution rate of

nanomaterials in the aquatic environment and the nanospecific Guidance of OECD 312

Soil Column Leaching.

Japan

• MHLW made plan for risk assessments for nanomaterials for preventing occupational

health damage and implements it.

Korea

• Based on the Act on Registration, Evaluation, etc. of Chemical Substances, Korea has

built a system for measuring particle size distribution including nanometer, length of

chemical substance which is in the form of fibre and diameter distributions in December

2014. This is specified in a testing method (corresponding to the OECD TG110) of

particle size distribution, fibre length and diameter distributions.

• Additionally, Korea has been running a pilot project for supporting testing and analysis

on properties (such as size, shape, specific surface area, etc.) of nanomaterials since



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December 2014, with a view to help the industry implement the OECD

Recommendation.

• Korea established the master plan for nanosafety management (2011~2016) at national

level, in which the central government (including MoE, the Ministry of Trade, Industry

and Energy, the Ministry of Science, ICT and Future Planning, the Ministry of

Employment and Labor and MFDS) has participated by taking measures (such as

measurement and analysis of nanomaterials, safety system for nanomaterials, etc.) to deal

with the issue respectively. MoE designated nanomaterials as the subject to hazard

examination pursuant to the Act on Registration, Evaluation, etc. of Chemical

Substances. The Act enforced in January 2015. MoE also has been monitoring the status

of nanomaterials distribution in the Korean market according to the MoE Notice under

the Chemicals Control Act.

United States

• The United States currently leads or co-leads four projects to develop or amend OECD

Test Guidelines relative to manufactured nanomaterials.

• The United States and the other members of the WPMN apprise the Chemicals

Committee on a regular basis of any technical issues related to the safety testing and

assessment of nanomaterials that need to be addressed on April 6, 2015.

• US EPA proposed one-time reporting and recordkeeping requirements for new and

existing chemical substances that are nanoscale materials under the authority of section

8(a) of TSCA.

• On June 11, 2015 US EPA conducted a public meeting to receive public comments and

to answer any clarifying questions regarding the rule.

European Union

• The OECD Test Guidelines are a cornerstone in EU regulatory frameworks governing

potential risk of chemicals. These are implemented into the EU legislation via the Test

Method Regulation and are mandatory to be used for e.g. registrants under REACH when

complying with REACH information requirements. This important message has also

been formally communicated and recognized in the Second Regulatory Review on

nanomaterials (COM(2012) 572 final). The EU Recommendation on the definition of

nanomaterial (2011/696/EU) has been adopted in 2011.

• The European Chemicals Agency has an appendix dedicated to nanomaterials including

general recommendation on the approach to risk assessment as well as provisions related

to specific information requirements and the reference to the OECD guidance on the

sampling and dosimetry.

• Ensuring in full the effective implementation for nanomaterials under REACH is

however still work in progress, as the REACH technical Annexes are presently being

revised to ensure that the information requirements clearly reflect the specific

nanomaterial considerations, such as adequate physico-chemical characterisation, and to

ensure continuous relevance and applicability of any included triggers and/or conditions

for waiving.

• When preparing the opinions, SCCS would accept studies carried out according to

OECD guidelines, providing that a) the nanomaterials used in tests are appropriately

characterised and match with those under evaluation in the dossier, and b) the study has

been carried out with due care of the nano-specific aspects as detailed under section 6.3


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of the Guidance Supporting the implementation of the regulation on food and feed, the

European Food Safety Authority (EFSA) has already in 2011 published a guidance on

the risk assessment of the application of nanoscience and nanotechnologies in the food

and feed chain 3that effectively embeds the approach outlined in the Recommendation.

• As an indication of EU’s support and engagement in ensuring the TGs applicability to

nanomaterials, ECHA is currently chairing the SG-TA overseeing the progress and this

post was before held by JRC

What, if any, further measures are necessary to ensure future implementation?

Belgium

• Proposes to add the next phrase to paragraph 6 of the document:

• “In relation to article IV, the Secretariat can offer a summary of activities undertaken by

WPRPW in this field and their main outcomes” and to take into account the whole

lifecycle of the nanomaterials, including the stage ‘waste’. It is important that this type of

activity will also be reported to the Council.

Germany

• The Rolling Work Plan of the SG TA of the OECD WPMN lists all ongoing and

planned, but also still outstanding initiatives, needed to appropriately adapt the OECD

Test Guideline Program to the specific properties of MN. These outstanding initiatives

include, e.g. a new Test Guideline of transformation of MN in order to address the aging

of MN in biological systems/environmental media and comprehensive Guidance (which

may be in a form of a Test Guideline or a Guidance Document) to govern the

investigation of bioaccumulation of MN in filtrating organisms, i.e. bivalves.

• Furthermore, the measures and the units have to be unified as agreed and advised in the

recommendations from the categorization workshop 2014 in Washington. This applies

especially for the of physical-chemical properties.

• After unification it is essential to have evaluated and comparable methods. Although the

sponsorship programme was a big step forward, this is still a worldwide challenge and

needs strong support from OECD.

• Besides of the improvement of risk assessment tools regarding the specifics of

nanomaterials also the nanospecific implementation of the regulation framework on the

European level is urgently needed.

Japan

• Does not see necessity of any new measures since we keep the present measures going

on for securing safety of nanomaterials.

United States

• The efforts undertaken by the WPMN should continue to reflect the focus on risk

assessment issues most relevant to regulatory risk assessments. These issues focus on all

3 (http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2140.pdf)

http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2140.pdf


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aspects of risk assessments, including hazard assessments and exposure evaluations. The

WPMN is currently implementing a project to investigate the different tiers of risk

assessments (ranging from screening to detailed levels of assessment) and identify

different levels of uncertainties used to inform assessment outcomes and risk

management measures.

European Union

• As indicated above, work at EU level continues. Internationally, we do not have any

additional suggestions at this time. It is important to continue with the process of

adaptation of OECD TG as identified. Further needs may be identified following of SG-

TA assessment of data under the sponsorship programme.

• A specific issue already driven by need to reduce animal testing, but exacerbated by the

EU ban on animal testing of cosmetic ingredients/products, is the need to ensure that the

existing efforts on developing OCED recommendations for (accepted/validated)

alternative methods should ensure they can be used also for safety evaluation of

nanomaterials.

Does your country have any additional suggestions to facilitate implementation which should be

addressed by the Chemicals Committee or the WPMN?

Belgium

• Specifies that the whole lifecycle of the nanomaterials has to be considered, including the

stage ‘waste’. It is important that this type of activity will also be reported to the Council.

• They propose thus to add the next phrase to paragraph 6 of the document: “In relation to

article IV, the Secretariat can offer a summary of activities undertaken by WPRPW in

this field and their main outcomes”.

Japan

• Since Japan is aware that neither safety information on nanomaterials nor test guidelines

(TG) are sufficient for now, Japan has a view that developing TGs should be further

addressed in relation to the 3rd recommendation of ENV/JM(2015)7. From this view

point, Japan would like to provide its following suggestions;

• Volunteer member countries of OECD try to make TGs with an intratracheal

administration method for manufactured nanomaterials,

• Activities for development of new TGs or amendment of existing TGs for application to

manufactured nanomaterials should be accelerated to establish methodologies to assess

environmental fate and toxicity, and Volunteer member countries of OECD conduct

hazard assessment, as OECD, of typical nano-materials including three carbon materials

based on the Dossier published from the OECD sponsorship program.

• In addition, knowledge and methodologies on detection and measurement of

manufactured nanomaterials in the environment (air, water or soil) should be shared

among OECD member countries.



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Korea

• Korea would like to kindly request that the OECD develops test guidelines and guides

persistently while considering properties of nanomaterials, which are essential to build a

system for nanomaterials safety management and R&D projects.

What additional activities could be initiated to disseminate this Recommendation to all stakeholders and

other international organisations?

Germany

• Strives forward to make its nanosafety research public available. The German

“Knowledge Base DaNa 2.0” might serve as a good example of presentation of

nanosafety data to the public: http://nanopartikel.info/en/dana-start-en. In Germany,

public funded research results are obliged to be made publically available. For example,

information on ongoing research and reports on research results funded by the Federal

Ministry of the environment and supervised by the Federal Environment Agency are

accessible.4 The dissemination of this recommendation with regard to the amendments

of the current OECD Test Guidelines for the purpose of testing MN to the scientific

community is of special importance. Therefore, research programmes on nanosafety, e.g.

the European Horizon2020 Programme, should inform research projects under this

program of these initiatives and should support their collaboration. Research groups

should be encouraged to consider OECD Guidance on testing MN.

• Furthermore, in the global research community there are plenty of data collected which

aren`t available to the public (e.g. data showing negative results are hard to publish in

scientific journals).In addition, final results of bigger research projects are often not

presented in a completed and summarising manner (e.g. project reports). If safety data

are available, they are often hard to interpret for the society. Thus, a clear and reliable

appraisal of data is needed.

Japan

• Information on the website is annually updated by the manufactures. Nanomaterials

subject to this programme are carbon nano tubes (CNTs), carbon black, titanium dioxide,

fullerene, zinc oxide and silica (six materials in total). The programme started in 2010,

and since then, 31 companies in total have participated in the programme (30 companies’

information is available as of July 2015). Even though this programme is a voluntary

activity, these manufacturing companies are grateful that METI provides them a place for

publicising their relevant safety activities. From 2015 from nanomaterial users’ point of

view, METI’s programme can allow them to collect various information on

nanomaterials including safety data in one place.

• Above mentioned METI’s programme is based on a report published in 2008 regarding

the safety management of nanomaterials, which concluded that 1) METI encourages

4 http://www.umweltbundesamt.de/en/topics/chemicals/nanotechnology/research-development-projects

http://nanopartikel.info/en/dana-start-en

http://www.umweltbundesamt.de/en/topics/chemicals/nanotechnology/research-development-projects


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manufactures’ voluntary stewardship, and 2) METI collects information on hazard,

production volume and use category of nanomaterials, and also METI makes that

information publicly available.

• Based on the report, in 2009, METI published a notification “the Safety Management of

Nanomaterials by Manufactures” under the name of the Director General of

Manufacturing Industries Bureau. Japan has actively participated in the related workshop

and has presented its recent achievements in their research. In addition, the National

Institute of Advanced Industrial Science and Technology of Japan (AIST) also

contributes to sharing information among WPMN member countries by co-organising

the “WPMN information sharing seminar on in vivo Inhalation Toxicity Screening

Methods for Manufactured Nanomaterials” with USEPA in September 2015.

• Specifically regarding recommendation 5, the test data with a focus on CNTs and

fullerenes produced in the AIST project “Research and Development of Nanoparticle

Characterization Methods (2006FY-2010FY)” (funded by the New Energy and Industrial

Technology Development Organisation (NEDO)) has been published on the AIST

website. The same data set is also available to the public through the OECD “Testing

Programme of Manufactured Nanomaterials –Dossiers and Endpoints”. As mentioned in

the response for RECOMMENDATION I, safety data submitted by manufactures has

been also available to the public on the METI’s website since 2010 (only in Japanese).

Korea

• In order to implement, coordinate and communicate the national master plan for nano

safety management in an effective way, Korea has established ‘Policy Council for

Nanomaterials Safety’ where relevant ministries participate in. In addition, each relevant

ministry holds regular workshops for stakeholders (e.g. industry, NGO, etc.) to

communicate and share information for building a system for nano safety management.

European Union

• Up to date, the collaborative effort under WPMN has also provided important

contribution to ensure increased availability of safety data on nanomaterials to the public

and thereby raised the confidence in these materials. Further efforts in increasing the

transparency are also being made through the EU member states national activities,

publication of the opinions of EU scientific committees (in particular SCCS, EU

Scientific Committee on Consumer Safety, and SCENIHR on Emerging and newly

identified risks SCCS; see http://ec.europa.eu/health/scientific_committees/index_en.htm

) and the web platform of the European Commission

(https://ihcp.jrc.ec.europa.eu/our_databases/web-platform-on-nanomaterials).

• Increasing volume of nano specific information is also expected to appear via ECHA’s

dissemination portal as well as global databases such as eChemPortal.

• The efforts to date have been appropriate, assuming that, as in EU, the messages from the

Recommendation are disseminated within the respective constituencies. A specific

continuous effort is required to ensure that the ongoing research activities adequately

consider the Recommendations and to follow the recommendation on the availability of

safety data related to nanomaterials to the public.

United States

• We are committed to making safety data related to nanomaterials available to the public.

http://ec.europa.eu/health/scientific_committees/index_en.htm

https://ihcp.jrc.ec.europa.eu/our_databases/web-platform-on-nanomaterials


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• The United States Environmental Protection Agency (US EPA) has published the

following TSCA new chemicals Significant New Use Rules (SNURs) since WPMN 14:

80 FR 5457 February 2 2015 (Polymer of terephthalic acid and ethyl benzene with multi-

walled carbon nanotube, direct final rule), 80 FR 32003 June 5 2015 (graphene

nanoplatelets, direct final rule), 80 FR 32879 June 10 2015 (functionalized CNT,

proposed rule).

• We believe that this Recommendation has been appropriately disseminated to

stakeholders and others by the OECD Secretariat and member countries. We encourage

the continued dissemination of information relevant to the activities of the WPMN.

Should any additional documentation be added to the Annex at this stage (any references or supporting

documentation will be of value)?

Germany

• We strongly suggest amending the annex of the council recommendation by adding the

reports and recommendations of the different OECD WPMN Horizontal Meetings

(Inhalation Toxicity, Physicochemical Characterisation, Genotoxicity, Toxicokinetics,

Environmental Fate and Ecotoxicology). These reports include valuable information in a

better level of detail for different areas of concern. Some reports already include specific

recommendations which are more topical than the information listed in the document of

the annex, e.g. document ENV/JM/MONO (2009)21 on the applicability of Test

Guidelines to MN.

Japan

• Risk assessment could be implemented easily, cost-effectively and speedy, by combining

in vitro and in silico including QSAR, Read-across and categorization to substitute in

vivo test. They are available, they should be published immediately and if necessary

included in Annex.

United States

• We recommend adding to the Annex any updates/outcomes from OECD expert meetings

to improve the applicability of the OECD Test Guidelines to nanomaterials (e.g.,

Physical- Chemical Properties of Manufactured Nanomaterials and Test Guidelines, June

2014, Washington, DC; Categorization of Manufactured Nanomaterials, September

2014, Washington, DC; Inhalation Test Guidelines and Guidance to Nanomaterials, and

Information-Sharing Seminar on In Vivo Inhalation Toxicity Screening Methods for

Manufactured Nanomaterials, September 2015, Washington, DC).

European Union

• We agree to amend the annex of the Council recommendation by adding the reports and

recommendations of the different OECD WPMN Horizontal Meetings as they include


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specific recommendation supporting the implementation of the recommendation going

beyond those presently listed.

Should any existing documentation should be updated in the Annex be revised and updates?

• None identified.

If any existing documentation should be updated, please indicate priorities with approximate timelines;


Please provide any additional information relevant for this annex with any supporting material.



15

ANNEX I. ORIGINAL SUBMISSIONS ON THE IMPLEMENTATION OF THE COUNCIL

RECOMMENDATION

AUSTRALIA

Have any new activities (e.g. regulatory changes, guidance, voluntary, etc.) been initiated to

implement the OECD Council Recommendation5? If yes, please explain.

• Reforms to the National Industrial Chemicals Notification and Assessment Scheme

(NICNAS) are currently underway that aim to streamline the assessment process for

industrial chemicals to reduce the regulatory burden on the sector, while also ensuring

Australia’s robust safety standards are maintained6. In line with the OECD Council

Recommendation consideration will be given to the regulatory approach for

nanomaterials in the implementation of these reforms.

BELGIUM


implement the OECD Council Recommendation? If yes, please explain.

• In answer to the ‘Review of the OECD Council Recommendation on the Safety Testing

and Assessment of Manufactured Nanomaterials’: BE supports the proposition of the

Secretariat. It is clear that the WPMN has a central role in the process of elaborating this

report. However, the whole lifecycle of the nanomaterials has to be considered, including

the stage ‘waste’. It is important that this type of activity will also be reported to the

Council.

• We propose thus to add the next phrase to paragraph 6 of the document:

“In relation to article IV, the Secretariat can offer a summary of activities undertaken by

WPRPW in this field and their main outcomes”.

CANADA



• A consultation document on a Proposed Approach to Address Nanoscale Forms of

Substances on the Domestic Substances List was published with a public comment

period ending on May 17, 2015. The proposed approach outlines the Government’s plan

to address nanomaterials considered in commerce in Canada (on Canada’s public

inventory). The proposal is a stepwise approach to acquire and evaluate information,

followed by any necessary action. A follow-up stakeholder workshop is being planned

to discuss next steps and possible approaches to prioritize future activities.7 A mandatory

5 Recommendation of the Council on the Safety Testing and Assessment of Manufactured Nanomaterials

6 http://www.nicnas.gov.au/about-nicnas/nicnas-reforms

7 The consultation document is available at: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-1



http://acts.oecd.org/Public/Info.aspx?lang=en&infoRef=C(2013)107

http://www.nicnas.gov.au/about-nicnas/nicnas-reforms

http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-1


16

information gathering survey was published on July 25, 2015. The purpose of the survey

is to collect information to determine the commercial status of certain nanomaterials in

Canada. The survey targets 206 substances considered to be potentially in commerce at

the nanoscale. The list of 206 substances was developed using outcomes from the

Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative

to identify nanomaterial types. These nanomaterial types were cross-referenced with the

Domestic Substances List to develop a preliminary list of substances which are

potentially intentionally manufactured at the nanoscale. The focus of the survey aligns

with the Proposed Approach to Address Nanoscale Forms of Substances on the Domestic

Substances List (see above) and certain types of nanomaterials were excluded during the

development of the list of substances. The information being requested by the survey

includes substance identification, volumes, and uses. This information will feed into the

Government’s proposed approach to address nanomaterials on the Domestic

Substances.8 .

CZECH REPUBLIC In response, I inform you as follows:

• I am unable to provide any information that and how the OECD Recommendation on the

Safety Testing and Assessment of Nanomaterials has been implemented by the Czech

authorities. Czech Republic does not participate in the Safety Testing Programme co-

ordinated by WPMN and, to my knowledge, safety testing of nanomaterials is not an

issue dealt with by the Czech government and its central institutions. Safety testing of

manufactured nanomaterials is conducted by various academic institutions in the country

but whether they are aware of the Recommendation and observe it, is not known to me.

• I am not aware of any relevant developments in human health and environmental safety

of manufactured nanomaterials as organized in Czech Republic at a national level.

GERMANY


• In summary, the Council recommends to manage the risks of Manufactured

Nanomaterials (MN) by applying the existing chemical regulatory frameworks and

OECD Test Guidelines (TG) and adapt them as appropriate to take into account the

specific properties of MN as well as to develop new TG and/or adopt existing TG (by the

development of specific Guidance Documents) in the light of experience with testing

MN. In addition it recommends making safety data related to MN available to the public.

• In the view of the German delegation, the implementation of the recommendation is on

its way but not yet finalised.

• - Regarding recommendation 1, Germany, like other member states, is involved in the

discussion on EU level regarding the nanospecific adaptation on existing European

legislation (e.g. REACH). A proposal for an appropriate implementation of

nanomaterials in the European chemical regulation framework is still lacking.

• - With regard to the 2nd recommendation, the SG TA of the OECD WPMN established a

Rolling Work Plan including all ongoing, planned, desired and required initiatives to

amend the OECD Test Guideline Program to MN. Germany has taken the initiative to

develop a nanospecific TG and GD as well is involved in such initiatives led by other

countries. Adopted TG/GD should be available in the coming years.

8 List.available at: http://gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php

http://gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php


17

• National measures regarding the Recommendations are on nanosafety research and active

participation in international and European committees. BfR is strongly engaged in both

activities. An issue of prime importance for bringing forward the implementation refers

to a legally binding MN definition, which complies with the existing working definition

on OECD level. However, this is a European business, not a national one.

• Germany is involved in several national and European research projects (as direct or

associated partner) to serve as interlink between research, regulation and the activities of

OECD WPMN. This supports both the transfer of recommendations and needs of

WPMN to the research community and the transfer of research has been addressed by the

declassification and publication of the dossiers output to WPMN and regulators, the later

recommendation of the OECD WPMN sponsorship programme.

• Furthermore, Germany strives forward to make its nanosafety research public available.

The German “Knowledge Base DaNa 2.0” might serve as a good example of presentation

of nanosafety data to the public. 9. In Germany, public funded research results are

obliged to be made publically available. For example, information on ongoing research

and reports on research results funded by the Federal Ministry of the environment and

supervised by the Federal Environment Agency are accessible to public.10

What specific measures been taken nationally to implement the Recommendation (any


• Back in 2013, Germany hosted the OECD Expert Meeting on Environmental Fate and

Ecotoxicology of Nanomaterials in Berlin (29th - 31st of January 2013). At this WPMN

Horizontal Meeting specific recommendation were phrased which formed the starting

point for a number of initiatives aiming the development of new TG or GD for existing

TG taking into account the specific properties of MN. The discussions, findings and

recommendations of this workshop were published in a comprehensive report which

includes useful guidance on how to properly test MN for their fate and effects in the

environment:11

• As follow up of the OECD Expert Meeting on Environmental Fate and Ecotoxicology of

Nanomaterials in Berlin (29th - 31st of January 2013) UBA took the lead on the

development of a draft test guideline for agglomeration behaviour of nanomaterials in

different aquatic media and a draft guidance document on agglomeration and dissolution

behaviour of nanomaterials in aquatic media – decision tree.

• Within that framework the project “Development of a decision support tool for the

investigation of environmental behaviour of nanomaterials on the basis of their

dispersion stability and solubility as a function of environmental conditions” was

launched and has been awarded to the University of Vienna (Austria).

• Aim of the project is the development of a tiered approach for the investigation of

agglomeration and dissolution behaviour of nanomaterials as a prerequisite for

continuing studies on environmental behaviour. The work of this project is supposed to

provide basis information for an OECD Guidance Document for the investigation of

environmental fate of nanomaterials in aquatic media. In addition to that a draft for a new

OECD Test Guideline will be developed for the examination of agglomeration behaviour

of nanomaterials in aquatic media. For this aim influencing factors have to be identified

and valid, as well as pragmatic approaches for suitable methods and techniques have to

9 http://nanopartikel.info/en/dana-start-en

10 http://www.umweltbundesamt.de/en/topics/chemicals/nanotechnology/research-development-projects 11http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2014)15&doclanguag=en.


http://www.umweltbundesamt.de/en/topics/chemicals/nanotechnology/research-development-projects


18

be developed. 12The first draft of the Test Guideline is available and will be validated by

a comprehensive round robin test this summer. In September of this year, a

WNT/WPMN face-to-face meeting will take place at the OECD headquarters in Paris in

order to discuss the proposal for the Test Guideline on agglomeration behaviour of

nanomaterials in different aquatic media. Next to the draft of the Test Guideline, the

status of the draft Guidance Document on agglomeration and dissolution behaviour of

nanomaterials in aquatic media and the status of the draft Test Guideline on dissolution

rate of nanomaterials in aquatic media will be presented at the meeting and the way

forward will be discussed. The meeting will be followed by a WNT commenting round.

• Next to this initiative, Germany is involved as partner in additional working group, e.g.

on the Guidance Document on Aquatic (and Sediment) Toxicology Testing of

Nanomaterials, nanospecific Guidance Document for OECD 305, Test Guideline for

dissolution rate of nanomaterials in the aquatic environment and the nanospecific

Guidance of OECD 312 Soil Column Leaching.


• The Rolling Work Plan of the SG TA of the OECD WPMN lists all ongoing and

planned, but also still outstanding initiatives, needed to appropriately adapt the OECD

Test Guideline Program to the specific properties of MN. These outstanding initiatives

include, e.g. a new Test Guideline of transformation of MN in order to address the aging

of MN in biological systems/environmental media and comprehensive Guidance (which

may be in a form of a Test Guideline or a Guidance Document) to govern the

investigation of bioaccumulation of MN in filtrating organisms, i.e. bivalves.

Furthermore, for the implementation of an appropriate nanospecific risk assessment, the

development of Test Guidelines for the description of important physical-chemical

parameters with respect to of environmental and health safety is crucial. The measures

and the units have to be unified as agreed and advised in the recommendations from the

categorization workshop 2014 in Washington. This applies especially for the of physical-

chemical properties. After unification it is essential to have evaluated and comparable

methods. Although the sponsorship programme was a big step forward, this is still a

worldwide challenge and needs strong support from OECD. Besides of the improvement

of risk assessment tools regarding the specifics of nanomaterials also the nanospecific

implementation of the regulation framework on the European level is urgently needed.

Does your country have any additional suggestions to facilitate implementation which


• Member states should support and speed up the process by appropriate financial and

personnel contribution to the corresponding OECD secretariats (WNT, WPMN).

• A public available and comprehensive report of the detailed realization of the different

council recommendations in the following years in each of the member states might

increase pressure to implement.

What additional activities could be initiated to disseminate this Recommendation to all


12




19

• The dissemination of this recommendation with regard to the amendments of the current

OECD Test Guidelines for the purpose of testing MN to the scientific community is of

special importance. Therefore, research programmes on nanosafety, e.g. the European

Horizon2020 Programme, should inform research projects under this program of these

initiatives and should support their collaboration. Research groups should be encouraged

to consider OECD Guidance on testing MN.

• Furthermore, in the global research community there are plenty of data collected which

aren`t available to the public (e.g. data showing negative results are hard to publish in

scientific journals).In addition, final results of bigger research projects are often not

presented in a completed and summarising manner (e.g. project reports). If safety data

are available, they are often hard to interpret for the society. Thus, a clear and reliable

appraisal of data is needed.

Please provide any additional information regarding the implementation of this


• We strongly suggest amending the annex of the council recommendation by adding the

reports and recommendations of the different OECD WPMN Horizontal Meetings

(Inhalation Toxicity, Physicochemical Characterisation, Genotoxicity, Toxicokinetics,

Environmental Fate and Ecotoxicology). These reports include valuable information in a

better level of detail for different areas of concern. Some reports already include specific

recommendations which are more topical than the information listed in the document of

the annex, e.g. document ENV/JM/MONO (2009)21 on the applicability of Test

Guidelines to MN.

JAPAN


RECOMMENDS that Members, to manage the risks of manufactured nanomaterials, apply the

existing international and national chemical regulatory frameworks or other management systems,

adapted to take into account the specific properties of manufactured nanomaterials. For the

purpose of such adaptation, Members should use the tools in the documents listed in the Annex to

this Recommendation of which it forms an integral part. This Annex may be amended by the

Chemicals Committee, in accordance with Section VII below.

• The Ministry of Economy, Trade, and Industry (METI) calls on the industries to

voluntarily report their management activities including appropriate handling measures

of the manufactured nanomaterials, and publicises them on METI’s website (only in

Japanese)13. Such information also includes safety data which is obtained by the

participating companies. Information on the website is annually updated by the

manufactures. Nanomaterials subject to this programme are carbon nano tubes (CNTs),

carbon black, titanium dioxide, fullerene, zinc oxide and silica (six materials in total).

The programme started in 2010, and since then, 31 companies in total have participated

in the programme (30 companies’ information is available as of July 2015). Even though

this programme is a voluntary activity, these manufacturing companies are grateful that

13 (URL; http://www.meti.go.jp/policy/chemical_management/other/nano_program.html)

http://www.meti.go.jp/policy/chemical_management/other/nano_program.html


20

METI provides them a place for publicising their relevant safety activities. From

nanomaterial users’ point of view, METI’s programme can allow them to collect various

information on nanomaterials including safety data in one place. Above mentioned

METI’s programme is based on a report published in 2008 regarding the safety

management of nanomaterials, which concluded that 1) METI encourages manufactures’

voluntary stewardship, and 2) METI collects information on hazard, production volume

and use category of nanomaterials, and also METI makes those information publicly

available. Based on the report, in 2009, METI published a notification “the Safety

Management of Nanomaterials by Manufactures” under the name of the Director General

of Manufacturing Industries Bureau.

II. RECOMMENDS that Members, in the testing of manufactured nanomaterials, apply the OECD

Test Guidelines, adapted as appropriate to take into account the specific properties of

manufactured nanomaterials and using the tools listed in Section I of the Annex to this

Recommendation, and the OECD Principles of Good Laboratory Practice, set forth respectively in

Annexes I and II to the Decision of the Council concerning the Mutual Acceptance of Data in the

Assessment of Chemicals [C(81)30(Final), as amended].

The Ministry of Health, Labour and Welfare (MHLW) has applied the OECD Test Guidelines

before amendment taking into account the specific properties of manufactured nanomaterials.

III. RECOMMENDS that Members update, according to OECD rules and procedures, the OECD

Test Guidelines set out in Annex I to the Decision of the Council concerning the Mutual

Acceptance of Data in the Assessment of Chemicals [C(81)30(Final), as amended] to include new

test guidelines specific to, or existing test guidelines amended in the light of experience with,

manufactured nanomaterials.

METI is under development of intracheal administration method for nanomaterials. To share

with WPMN experts about the developing of intratracheal administration method, METI has a

plan to hold a seminar, “WPMN information sharing seminar on in vivo Inhalation Toxicity

Screening Methods for Manufactured Nanomaterials”, which will be cosponsored by the US

Environmental Protection Agency (USEPA) in September 2015. This contribution by METI is

based on the five-year programme “Development of Innovative Methodology for Safety

Assessment of Industrial Nanomaterials” launched by METI in 2011. The programme aims to

develop fundamental hazard assessment methodology leading to a tiered risk assessment

approach for industrial nanomaterials. The programme was composed of two R&D themes: 1)

establishment of equivalence criteria of nanomaterials and 2) establishment of an intratracheal

administration method as low-cost and convenient method for hazard assessment to acquire

basic hazard information. METI also contributes providing technical comments from its

experts to the WPMN discussions on amendment of the test guideline for inhalation test taking

into account the nano-specific properties.

IV. RECOMMENDS that Members apprise the Chemicals Committee on a regular basis of any

technical issues related to the safety testing and assessment of nanomaterials that need to be

addressed, including engagement with other international initiatives, development or update of

specific tools for manufactured nanomaterials, and any possible amendment to the documents in

the Annex to this Recommendation.

Japan has been regularly providing information on its latest activities to the Tour de Table in


21

each meeting of WPMN. Japan has actively participated in the related workshop and has

presented its recent achievements in their research. In addition, the National Institute of

Advanced Industrial Science and Technology of Japan (AIST) also contributes to sharing

information among WPMN member countries by co-organising the “WPMN information

sharing seminar on in vivo Inhalation Toxicity Screening Methods for Manufactured

Nanomaterials” with USEPA in September 2015.

V. RECOMMENDS that Members make safety data related to nanomaterials available to the

public.

The test data with a focus on CNTs and fullerenes produced in the AIST project “Research and

Development of Nanoparticle Characterization Methods (2006FY-2010FY)” (funded by the

New Energy and Industrial Technology Development Organisation (NEDO)) has been

published on the AIST website. The same data set is also available to the public through the

OECD “Testing Programme of Manufactured Nanomaterials Dossiers and Endpoints”. As

mentioned in the response for RECOMMENDATION I, safety data submitted by

manufactures has been also available to the public on the METI’s website since 2010 (only in

Japanese).



MHLW made plan for risk assessments for nanomaterials for preventing occupational health

damage and implements it.


Japan does not see necessity of any new measures since we keep the present measures going

on for securing safety of nanomaterials.



Since Japan is aware that neither safety information on nanomaterials nor test guidelines (TG)

are sufficient for now, Japan has a view that developing TGs should be further addressed in

relation to the 3rd recommendation of ENV/JM(2015)7. From this view point, Japan would

like to provide its following suggestions;

Volunteer member countries of OECD try to make TGs with an intratracheal administration

method for manufactured nanomaterials,

Activities for development of new TGs or amendment of existing TGs for application to

manufactured nanomaterials should be accelerated to establish methodologies to assess

environmental fate and toxicity, and



22

Volunteer member countries of OECD conduct hazard assessment, as OECD, of typical nano-

materials including three carbon materials based on the Dossier published from the OECD

sponsorship program.

In addition, knowledge and methodologies on detection and measurement of manufactured

nanomaterials in the environment (air, water or soil) should be shared among OECD member

countries.



No idea at this moment.



None at this moment.

Should any additional documentation be added to the Annex at this stage (any references or

supporting documentation will be of value)?

None at this moment

Risk assessment could be implemented easily, cost-effectively and speedy, by combining in

vitro and in silico including QSAR, Read-across and categorization to substitute in vivo test.

They are available, they should be published immediately and if necessary included in Annex.

Should any existing documentation referenced in the Annex be revised and updated?

Japan does not see any necessity to revise or update the annexed documents.

If any existing documentation should be updated, please indicate priorities with

approximate timelines;

N. A.

Please provide any additional information relevant for this annex with any supporting

material.


23

None at this moment.

KOREA


implement the OECD Council Recommendation14? If yes, please explain.

The Ministry of Environment (MOE), Republic of Korea has prepared the legal ground for

survey of circulation status of nano materials in the regulation on statistical research of

chemical substances.


Korea has been implementing the OECD Recommendation by reflecting it into a master plan

for nanosafety management in which relevant ministries have participated, and by building a

system for legal base of nanosafety management.

Korea has been also participating in the OECD WPMN sponsorship programme for testing of

manufactured nanomaterials. Many safety testings on nanomaterials, including nanosilver,

nanogold, MWCNT, TiO2, SiO2, zinc oxide and calcium, have been conducted pursuant to the

OECD test guidelines with GLP compliance. To assess the toxicity of nanomaterials, we have

performed single dose toxicity, repeated dose toxicity, toxicokinetics and physico-chemical

properties study in accordance with the OECD test guidelines in Nanotoxicology Project. Also,

we have published articles in relating international journals.

The reports of nanomaterials studies also have disclosed through a web-based nanosafety

information system of the Ministry of Environment (MoE) and a research management system

of the Ministry of Food and Drug Safety (MFDS), etc.



Based on the Act on Registration, Evaluation, etc. of Chemical Substances, Korea has built a

system for measuring particle size distribution including nanometer, length of chemical

substance which is in the form of fibre and diameter distributions in December 2014. This is

specified in a testing method (corresponding to the OECD TG110) of particle size distribution,

fibre length and diameter distributions.

Additionally, Korea has been running a pilot project for supporting testing and analysis on

properties (such as size, shape, specific surface area, etc.) of nanomaterials since December

2014, with a view to help the industry implement the OECD Recommendation.


24

Korea established the master plan for nanosafety management (2011~2016) at national level,

in which the central government (including MoE, the Ministry of Trade, Industry and Energy,

the Ministry of Science, ICT and Future Planning, the Ministry of Employment and Labor and

MFDS) has participated by taking measures (such as measurement and analysis of

nanomaterials, safety system for nanomaterials, etc.) to deal with the issue respectively. MoE

designated nanomaterials as the subject to hazard examination pursuant to the Act on

Registration, Evaluation, etc. of Chemical Substances. The Act enforced in January 2015.

MoE also has been monitoring the status of nanomaterials distribution in the Korean market

according to the MoE Notice under the Chemicals Control Act.


None

Does your country have any additional suggestions to facilitate implementation which should

be addressed by the Chemicals Committee or the WPMN?

Korea would like to kindly request that the OECD develops test guidelines and guides

persistently while considering properties of nanomaterials, which are essential to build a

system for nanomaterials safety management and R&D projects.



In order to implement, coordinate and communicate the national master plan for nano safety

management in an effective way, Korea has established ‘Policy Council for Nanomaterials

Safety’ where relevant ministries participate in. In addition, each relevant ministry holds

regular workshops for stakeholders (e.g. industry, NGO, etc.) to communicate and share

information for building a system for nano safety management.



None


25

NETHERLANDS



RIVM recently published the report “Assessing health & environmental risks of nanoparticles:

Current state of affairs in policy, science and areas of application” 15The report provides an

overview of the scientific knowledge of risk assessments of nanoparticles and nanomaterials

and their applications. RIVM concludes that the existing models and techniques used to assess

the risks of nanomaterials are not yet sufficiently tuned to determine how harmful

nanomaterials are to humans and the environment. The report includes a description of the

current European regulatory regime. General insights have been amplified for some distinct

fields such as consumer products, food, medical applications, workplace applications and the

environment.

UNITED STATES



Issuing the proposed TSCA section 8(a) rule described above. Regulation of new chemical

substances that are nanomaterials with consent orders and SNURs.


The view of the United States is that the Recommendation is being successfully implemented.

We believe that the collaborative work of the WPMN according to the Recommendation has

been helpful in furthering international and domestic progress in testing manufactured

nanomaterials and in assessing and managing the risks of these substances. The United States

has been implementing the specific recommendations outlined in the document, and our

interactions with the other OECD member countries indicate that they follow these

recommendations as well.

What specific measures have been taken nationally to implement the Recommendation?

The United States has been applying its existing chemical regulatory framework under the

U.S. Toxic Substances Control Act (TSCA) to manage the risks of manufactured

nanomaterials, taking into account the specific properties of these substances. We use the

OECD Test Guidelines and Guidance Documents, working with other OECD member

countries to adapt them to take into account the specific properties of manufactured

nanomaterials. The United States currently leads or co-leads four projects to develop or amend

15 (www.rivm.nl/bibliotheek/rapporten/2014-0157.html).

http://www.rivm.nl/bibliotheek/rapporten/2014-0157.html


26

OECD Test Guidelines relative to manufactured nanomaterials. The United States and the

other members of the WPMN apprise the Chemicals Committee on a regular basis of any

technical issues related to the safety testing and assessment of nanomaterials that need to be

addressed. We are committed to making safety data related to nanomaterials available to the

public.

The United States Environmental Protection Agency (US EPA) has published the following

TSCA new chemicals Significant New Use Rules (SNURs) since WPMN 14: 80 FR 5457

February 2 2015 (Polymer of terephthalic acid and ethyl benzene with multi-walled carbon

nanotube, direct final rule), 80 FR 32003 June 5 2015 (graphene nanoplatelets, direct final

rule), 80 FR 32879 June 10 2015 (functionalized CNT, proposed rule).

On April 6, 2015 US EPA proposed one-time reporting and recordkeeping requirements for

new and existing chemical substances that are nanoscale materials under the authority of

section 8(a) of TSCA. Persons who manufacture or process these chemical substances as

nanoscale materials would be required to notify US EPA of certain information, including

specific chemical identity, production volume, methods of manufacture and processing, use,

exposure and release information, and available health and safety data. On June 11, 2015 US

EPA conducted a public meeting to receive public comments and to answer any clarifying

questions regarding the rule.


We believe that efforts undertaken by the WPMN should continue to reflect the focus on risk

assessment issues most relevant to regulatory risk assessments. These issues focus on all

aspects of risk assessments, including hazard assessments and exposure evaluations. The

WPMN is currently implementing a project to investigate the different tiers of risk assessments

(ranging from screening to detailed levels of assessment) and identify different levels of

uncertainties used to inform assessment outcomes and risk management measures.

Does your country have any additional suggestions to facilitate implementation which should

be addressed by the Chemicals Committee or the WPMN?

At this time, we do not have any additional suggestions to facilitate implementation. As new

initiatives are discussed and developed by the WPMN, they will be brought to the attention of

the Chemicals Committee, as is current practice.



We believe that this Recommendation has been appropriately disseminated to stakeholders and

others by the OECD Secretariat and member countries. We encourage the continued

dissemination of information relevant to the activities of the WPMN.


27


Recommendation with any supporting material.

We do not have any additional information to provide at this time.

Suggested updates and additions to the Annex:

We recommend adding to the Annex any updates/outcomes from OECD expert meetings to

improve the applicability of the OECD Test Guidelines to nanomaterials (e.g., Physical-

Chemical Properties of Manufactured Nanomaterials and Test Guidelines, June 2014,

Washington, DC; Categorization of Manufactured Nanomaterials, September 2014,

Washington, DC; Inhalation Test Guidelines and Guidance to Nanomaterials, and Information-

Sharing Seminar on In Vivo Inhalation Toxicity Screening Methods for Manufactured

Nanomaterials, September 2015, Washington, DC).

EUROPEAN UNION



EC: Not in the interval since WPMN-14. For general reflections see separate document on the

Council recommendation.


The content of the current Recommendation (application of the existing chemicals framework,

use of OECD TG, adapted, and collaboration under OECD) is considered as being successfully

implemented.

It should be noted that a successful implementation of the Recommendation is currently seen

as independent from whether the legislations have no specific nanomaterial provisions (e.g.

REACH regulation (EU) 1907/2006) as well as in the implementation of regulation where

specific nanomaterial provisions already exist (e.g. Biocidal Products regulation (EU)

528/2012, Cosmetics regulation (EU) 1223/2009) and was put in force prior to the

Recommendation. In the latter cases, the nanomaterial specificities would effectively relate to

differences in regulatory routes and outcomes (e.g. pre-market notification, labelling

requirements), while the risk assessment frames do not deviate from the approach applied to

chemicals and are implemented in coherence with the Recommendation.

EU has been actively participating in and supports the collaborative efforts under OECD

WPMN/WNT due to its fundamental function as underpinning in particular existing


28

methodologies for hazard assessment. In this respect, the ongoing development of revising the

existing OECD TGs and GDs is of very high importance. Up to date, the collaborative effort

under WPMN has also provided important contribution to ensure increased availability of

safety data on nanomaterials to the public and thereby raised the confidence in these materials.

Further efforts in increasing the transparency are also being made through the EU member

states national activities, publication of the opinions of EU scientific committees (in particular

SCCS, EU Scientific Committee on Consumer Safety, and SCENIHR on Emerging and newly

identified risks SCCS16.

Increasing volume of nano specific information is also expected to appear via ECHA’s

dissemination portal as well as global databases such as eChemPortal.



As in the majority of jurisdictions, the OECD Test Guidelines are a cornerstone in EU

regulatory frameworks governing potential risk of chemicals. These are implemented into the

EU legislation via the Test Method Regulation and are mandatory to be used for e.g.

registrants under REACH when complying with REACH information requirement. In this

context, the reassuring message the Council Recommendation has provided, has enabled an

implementation of the existing provisions also for nanomaterials.

This important message has also been formally communicated and recognized in the Second

Regulatory Review on nanomaterials (COM(2012) 572 final). As a lock and key and to

facilitate more consistent application across the different regulations, the EU Recommendation

on the definition of nanomaterial (2011/696/EU) has been adopted in 2011.

In the main chemicals regulation REACH, the Guidance on Information Requirements and

Chemical Safety Assessment 17 by the European Chemicals Agency has an appendix

dedicated to nanomaterials including general recommendation on the approach to risk

assessment as well as provisions related to specific information requirements and the reference

to the OECD guidance on the sampling and dosimetry.

Ensuring in full the effective implementation for nanomaterials under REACH is however still

work in progress, as the REACH technical Annexes are presently being revised to ensure that

the information requirements clearly reflect the specific nanomaterial considerations, such as

adequate physico-chemical characterisation, and to ensure continuous relevance and

applicability of any included triggers and/or conditions for waiving.

The described approach is explicitly taken over also in a number of guidance documents that

support implementation of other EU legislation. One such document is Guidance on the Safety

16http://ec.europa.eu/health/scientific_committees/index_en.htm ) and the web platform of the European Commission

(https://ihcp.jrc.ec.europa.eu/our_databases/web-platform-on-nanomaterials

17http://www.echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment



http://www.echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment


29

Assessment of Nanomaterials18 by the SCCS - EU Scientific Committee on Consumer Safety

providing, inter alia, opinions under Cosmetics Regulation. When preparing the opinions,

SCCS would accept studies carried out according to OECD guidelines, providing that a) the

nanomaterials used in tests are appropriately characterised and match with those under

evaluation in the dossier, and b) the study has been carried out with due care of the nano-

specific aspects as detailed under section 6.3 of the Guidance. For the implementation of

cosmetics regulation a similar document has also been produced by a working group of the

International Cooperation on Cosmetics Regulation (ICCR) - to which the EC is a partner19.

Supporting the implementation of the regulation on food and feed, the European Food Safety

Authority (EFSA) has already in 2011 published a guidance on the risk assessment of the

application of nanoscience and nanotechnologies in the food and feed chain 20that effectively

embeds the approach outlined in the Recommendation.

As an indication of EU’s support and engagement in ensuring the TGs applicability to

nanomaterials, ECHA is currently chairing the SG-TA overseeing the progress and this post

was before held by JRC. EU will continue to support the work until the identified and agreed

test guidelines are revised and will work with other members on the way forward as potentially

new challenges are identified.


As indicated above, work at EU level continues. Internationally, we do not have any additional

suggestions at this time. It is important to continue with the process of adaptation of OECD

TG as identified. Further needs may be identified following of SG-TA assessment of data

under the sponsorship programme.

A specific issue already driven by need to reduce animal testing, but exacerbated by the EU

ban on animal testing of cosmetic ingredients/products, is the need to ensure that the existing

efforts on developing OCED recommendations for (accepted/validated) alternative methods

should ensure they can be used also for safety evaluation of nanomaterials.



No additional suggestions at this time.



18 (http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_005.pdf

19 (http://iccrnet.org/files/6114/0475/3840/2013-11_Safety_Approaches_to_Nanomaterials_in_Cosmetics.pdf)

20 (http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2140.pdf)

http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_005.pdf

http://iccrnet.org/files/6114/0475/3840/2013-11_Safety_Approaches_to_Nanomaterials_in_Cosmetics.pdf

http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/2140.pdf


30

The efforts to date have been appropriate, assuming that, as in EU, the messages from the

Recommendation are disseminated within the respective constituencies. A specific continuous

effort is required to ensure that the ongoing research activities adequately consider the

Recommendations and to follow the recommendation on the availability of safety data related

to nanomaterials to the public.



We agree to amend the annex of the Council recommendation by adding the reports and

recommendations of the different OECD WPMN Horizontal Meetings as they include specific

recommendation supporting the implementation of the recommendation going beyond those

presently listed.


31

ANNEX II

SUMMARY TABLE OF RESPONSES

Australia - Current reforms to the NICNAS (to streamline the assessment process for industrial

chemicals / to maintain the standards/ to reduce regulatory burden on the sector)

- Consideration will be delivered on the Recommendation during the implementation

of these reforms.

Belgium - The whole lifecycle of the nanomaterials has to be considered including the

stage “waste”

-“In relation to article IV, the Secretariat can offer a summary of activities

undertaken by WPRPW in this field and their main outcomes” should be added

to paragraph 6 of the Recommendation.

Canada - Publication and public comment on May 17, 2015 on a Proposed Approach to

Address Nanoscale Forms of Substances on Domestic Substances List. (to address

nanomaterials considered in commerce in Canada / to evaluate information)

- A workshop is planned to prioritize future activities, http://www.ec.gc.ca/lcpe-

cepa/default.asp?lang=En&n=1D804F45-

Publication on July 25. 2015 of a mandatory information gathering survey. (to

determine the commercial status of nano in Canada / It targets 206 substances,

including substance identification, volumes, uses. ). It will feed into the Government’s

approach to address nanomaterial on the Domestic Substances. :


Czech

Republic

- Unable to provide information on the implementation of the Council

Recommendation

- No participation in the Safety Testing Programme.

- Not aware of any relevant developments organized in Czech Republic at a national

level.

Germany - Implementation of the Recommendation not yet finalised.

-> Art.1 of the Recommendation, lack of a proposal for an appropriate

implementation of nano in the European chemical regulation framework.

-> Art.2, Germany is developing a nanospecific TG and GD that should be available

http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-

http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-



32

in the coming years.

- Issue of prime importance should be to refer to a legally binding MN definition

which complies with the existing working definition on OECD level. But it is a

European business according to Germany.

- Germany supports transfer of recommendations and needs of WPMN to the research

community. + makes its nanosafety research public available ( German Knowledge

Basa DaNa 2.0)http://nanopartikel.info/en/dana-start-en.

- Publication of the report on how properly test MN for fate and effects in the

environment, after the OECD Expert Meeting on Env. Fate and Ecotoxicology of NM

in Berlin, 2013.

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mon

o(2014)15&doclanguage=en. + development of a draft guidance doc on agglomeration

and dissolution behaviour of NM in aquatic media awarded by the University of

Vienna -> to provide information for an OECD Guidance Document for investigation.

+ draft for a new OECD TG will be developed.

http://www.umweltbundesamt.de/en/research-development-projects. It will be

presented at the WNT/WPMN.

- Germany is also partner in additional working group.

- The Rolling Work Plan of the SG TA of the OECD WPMN needs to address the

aging of MN in biological systems/ environmental media and comprehensive

Guidance to govern the investigation of bioaccumulation of MBN in filtrating

organisms…Also the development of TG for the description of physical-chemical

parameters with respect to the environmental and health is crucial.

- Measures and units have to be unified and evaluated and comparable methods

are needed, as agreed in Washington in 2014.

- An urgent nanospecific implementation of the regulation framework on the

European level is needed.

- Germany advises that member states should support and speed up the process

by appropriate financial and personal contribution to the OECD secretariats.

Pressure to implement might be found in a public report in each member states.

- As regards the dissemination of the Recommendation, research programmes on

nanosafety, e.g. the European Horizon 2020 Programme, should inform research

projects under the programme of OECD TG. Research groups should be

encouraged to consider OECD Guidance on testing MN. Concerning the

transparency of data, a clear and reliable appraisal of data is needed Final

results should be compiled in a completed and summarising manner.

- Germany suggests amending the annex, adding the reports and

recommendations of the different OECD WPMN Horizontal Meetings which are

more topical sometimes compared to the list annexed to the Annex.

Japan -> In relation with Art.1 of the Recommendation, and based on a report of 2008 and a

notification of 2009 regarding the safety management of NM, METI suggests




33

industry to report their management activities including handling measures of

the MN and safety data and publicises them on METI’s website. From July 2015,

30 companies’ information is available, that provides manufacturing companies a

place for publicising relevant safety activities and NM users’ access to data.

-> In relation with Art.2 of the Recommendation, MHLW has applied the OECD TG

taking into account the specific properties of MN.

-> In relation with Art.3 of the Recommendation, METI plans to hold a seminar to

share about the developing intratracheal administration method for NM and

cosponsored by USEPA in Sept. 2015. Its aims is to develop a fundamental hazard

assessment methodology that leads to a tiered risk assessment approach for industrial

NM and provides technical comments from its experts to the WPMN discussions of

the TG for inhalation test including nanoproperties.

-> In relation with Art.4 of the Recommendation, the AIST contributes to sharing

information among WPMN member countries by co-organising the seminar on in vivo

Inhalation Toxicity Screening Methods for MN with USEPA in Sept

. 2015.

-> In relation with Art.5 of the Recommendation, Japan published on the AIST

website of the test data focused on CNTs and made safety data available to the public

on the METI’s website since 2010.

-MHLW made plan for risk assessments for NM to prevent occupational health

damage and implements it.

-Developing TGs should be further addressed in relation to Art.3 of the

Recommendation of ENV/JM(2015)7. ->member countries should try to make

TGs with an intratracheal administration method for MN / Development of new

TGs or amendment of the existing should be accelerated to establish

methodologies to assess environmental fate and toxicity / Hazard assessment

should be conducted by volunteer members countries of OECD, as OECD

including three carbon materials based on the Dossier published from the OECD

sponsorship program.

- Japan highlights that knowledge and methodologies on detection and

measurement of MN in the environment should be shared among OECD member

countries. Also, risk assessment could be implemented easily, cost-effectively and

speedy, by combining in vitro and in silico including QSAR, Read-across and

categorisation to substitute in vivo test, and should be published immediately and

added to the Annex.

Korea - MOE prepared the legal ground for survey of circulation status of NM in the

regulation on statistical research of chemical substances. Many safety testings on

nanomaterials have been conducted pursuant to the OECD TGs with GLP compliance,

articles have been published in international journals Reports of NM studies have

disclosed through a web-based nanosafety information system of the MoE and a

research management system of the MFDS.

- Korea built a measuring system for particle size distribution corresponding to the



34

OECD TG110 and runt a project for supporting testing and analysis on properties of

NM since December 2014 to help the industry implements the OECD

Recommendation.

-Korea established the master plan for NS management at national level and the

government took measures to deal with the issue. (Act on Registration, Evaluation,

etc. of Chemicals Substances in January 2015). She also monitored the status of NM

distribution in the Korean market according to the MoE Notice under the Chemicals

Control Act.

- Korea requests that OECD develops TG and guides persistently considering

properties of NM to build a system for NM safety management and R&D

projects.

- Korea established “Policy Council for NM Safety” to implement, coordinate and

communicate effectively the national master plan for NS management. Each ministry

holds regular workshops for stakeholders to share data for the construction of a system

for NS management.

Netherlands - Recent publication of the report “Assessing health & environmental risks of

nanoparticles”.

- RIVM concludes that the existing models and techniques used to assess the risks

of NM are not yet sufficiently tuned to determine how harmful NM are to

humans and the environment

United

States

- Successful implementation of the Recommendation.

- The US has been applying its chemical regulatory framework under the TSCA to

manage risks of MN taking its specific properties into account.

- The US currently leads 4 projects to develop and amend OECD TGs and apprises the

Chemicals Committee of any technical issues related to the safety testing and

assessment of NM.

- As regards transparency of the data, the US EPA published the TSCA new chemicals

Significant New Use Rules since WPMN 14 and required persons manufacturing

chemical substances as nanoscale materials to notify US EPA an available health and

safety data. It also conducted a public meeting to receive public comments on June 11,

2015.

-Efforts of the WPMN should reflect more the focus on risk assessment issues

most relevant to regulatory risk assessment. These issues focus on all aspects of

risk assessments, including hazard ones and exposure evaluations.

-The US encourages continuing dissemination of information relevant to the

activities of the WPMN.

- The US recommends adding to the Annex any updates/ outcomes form OPECD

expert meetings to improve the applicability of the OECD TGs to NM.

European

Union

- Successful implementation of the Recommendation. Nevertheless, the NM

specifities would effectively related to differences in regulatory routes and outcomes,

while the risk assessment frames do not deviate from the approach applied to

chemicals and are implemented in coherence with the Recommendation.


35

- According to the EU the ongoing development of revising the existing OECD

TGs and GDs is of very high importance, in particular existing methodologies for

hazard assessment.

- The collaborative effort under WPMN provided contribution to ensure increased

availability of safety data on nanomaterials to the public and raised the confidence in

these materials.

- Also helped in increasing transparency through the EU activities, publications of the

opinions of scientific committees see

http://ec.europa.eu/health/scientific_committees/index_en.htm ) and the web platform

of the European Commission (https://ihcp.jrc.ec.europa.eu/our_databases/web-

platform-on-nanomaterials

- Increasing volume of nano specific information is expected to appear via

ECHA’s dissemination portal + on global databases such as eChemPortal.

-The OECD TGs are implemented into the EU legislation via the Test Method

Regulation and are mandatory to be used for e.g. registrants under REACHwhen

complying with REACH information requirement. This has been communicated in the

Second Regulatory Review on NM (COM(2012)572 final), and the EU

Recommendation (2011/696/EU) on the definition of NM has been adopted in 2011.

-However the implementation for NM under REACH is still work in progress, as the

REACH technical Annexes are presently revised to ensure the information

requirements reflect the specific NM considerations.(adequate physic-chemical

characterisation & continuous relevance and applicability of any triggers/ conditions

for waiving.) This is taken over also in guidance document ts supporting the

implementation of other EU legislation (for ex., Guidance on the SAFETY

Assessment of NMs) by the SCCS-EU…

- The European Food Safety Authority published in 2011 guidance on the risk

assessment of the application of nanoscience and nanotechnologies in the food and

feed chain that embeds the approach outlined by the Council Recommendation.

- ECHA is also chairing the SG-TA overseeing the progress, post before held by JRC.

- EU will continue to support the work until the identified and agreed TGs are revised

and work with other members.

- EU highlights that are important to continue with the process of adaptation of

OECD TGs as identified. Further needs may be identified following of SG-TA

assessment of data under the sponsorship programme.

- A specific issue driven by need to reduce animal testing is the need to ensure

that the existing efforts on developing OECD Recommendations for alternative

methods should ensure they can be used also for safety evaluation of Nano Materials.

-good dissemination of the recommendation. But specific effort should be made

to ensure that the ongoing research activities adequately consider the

recommendations and to follow the Recommendation on the availability of safety

data related t nanomaterials to the public.





36

-EU agrees to amend the annex of the Council Recommendation by adding the

reports and recommendations of the different OECD WPMN Horizontal

Meetings as included in the specific recommendation supporting the

implementation of the recommendation going beyond those presently listed.

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