# EUR-Lex - 52012DC0572 - EN

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# 52012DC0572

**COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE Second Regulatory Review on Nanomaterials /* COM/2012/0572 final */**

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COMMUNICATION FROM THE COMMISSION TO
THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL
COMMITTEE

Second Regulatory Review on Nanomaterials

(Text with EEA relevance)

1.           Introduction

This
Communication constitutes the follow-up to the 2008 Commission Communication on
regulatory aspects of nanomaterials[1].

It assesses the adequacy and implementation of EU legislation for
nanomaterials, indicates follow-up actions and responds
to issues raised by the European Parliament[2],
the Council[3]
and the European Economic and Social Committee[4].

It is accompanied by a Commission Staff
Working Paper (SWP) on Nanomaterial Types and Uses, including Safety Aspects[5] which responds to the European
Parliament’s concern that the Commission’s approach to nanomaterials is
jeopardised by the lack of information on the use and on the safety of
nanomaterials that are already on the market. The SWP provides detailed
information on the definition of nanomaterials, nanomaterial markets, uses,
benefits, health and safety aspects, risk assessment, and information and
databases on nanomaterials. Its main conclusions are reflected in sections 3
and 4.

2.           Definition
of nanomaterials

The 2011 Commission Recommendation on the
definition of nanomaterials[6]
defines ‘nanomaterial’ as “a natural, incidental or manufactured material
containing particles, in an unbound state or as an aggregate or as an
agglomerate and where, for 50 % or more of the particles in the number size
distribution, one or more external dimensions is in the size range 1 nm-100 nm.
In specific cases and where warranted by concerns for the environment, health,
safety or competitiveness the number size distribution threshold of 50 % may be
replaced by a threshold between 1 and 50 %. [...]”

The definition is intended to be used by Member States, European
Union agencies and companies. The Commission will use it in EU legislation and
instruments of implementation where appropriate. Where other definitions are
used in EU legislation, provisions will be adapted in order to ensure a
consistent approach, although sector specific solutions may remain necessary. The
Commission will review this definition in 2014.

3.           Benefits of Nanomaterials
and their Contribution to Growth and Jobs; Innovation and Competitiveness

The total annual quantity of nanomaterials
on the market at the global level is estimated at around 11 million tonnes,
with a market value of roughly 20bn €[7].
Carbon black and amorphous silica represent by far the largest volume of
nanomaterials currently on the market[8].
Together with a few other nanomaterials, they have been on the market for
decades and are used in a wide variety of applications.

The group of materials currently attracting
most attention are nano-titanium dioxide, nano-zinc oxide, fullerenes, carbon
nanotubes and nanosilver. Those materials are marketed in clearly smaller
quantities than the traditional nanomaterials, but the use of some of these
materials is increasing fast.

Other new nanomaterials and new uses are
being developed rapidly. Many are used in innovative applications such as
catalysts, electronics, solar panels, batteries and biomedical applications
including diagnostics and tumour therapies.

The benefits of nanomaterials range from
saving lives, breakthroughs enabling new applications or reducing the
environmental impacts to improving the function of everyday commodity products.

Products underpinned by nanotechnology are
forecast to grow from a volume of 200 bn € in 2009 to 2 trn € by 2015.[9] These applications will be
essential for the competitiveness of a wide area of EU products in the global
market. There are also many newly founded SMEs and spin-off companies in this
high technology area. Currently, the direct employment in nanotechnology is
estimated at 300 000 to 400 000 jobs in the EU, with an increasing tendency.[10]

Nanotechnology has been identified as a key enabling
technology (KET) providing the basis for further
innovation and new products.[11] In its
Communication ‘A European strategy for Key Enabling Technologies – A bridge to
growth and jobs’[12]
the Commission has outlined a single strategy for KETs, including nanotechnology, built upon three pillars: technological
research, product demonstration and competitive manufacturing activities.

The applicable legislation must ensure a
high level of health, safety and environmental protection. At the same time, it
should permit access to innovative products and promote
innovation and competitiveness. The regulatory
environment affects time to market, marginal cost structure and allocation of
resources, especially for SMEs. It also creates new business opportunities and
contributes to consumer and investor confidence in the technology.

International collaboration in particular
with our trade partners can stimulate the development and commercialization of
nanotechnology-enabled applications and industries.

In addition to cooperation such as in the OECD or at UN-level, the
Commission has started a regular dialogue with the United States in the context
of the Transatlantic Economic Council (TEC), with a
view to avoiding unnecessary divergences.

4.           Safety Aspects

4.1.        Nanomaterials in the
workplace, in consumer products and in the environment

Natural and incidental man-made nanoparticles
are ubiquitous in the human environment and their presence and behaviour is
generally known and understood. However, limited data exist on manufactured
nanoparticles in the workplace and the environment. There are major technical
challenges to monitor their presence, including those pertaining to their small
size and low concentration levels and to distinguishing
particles of manufactured nanomaterials from natural or incidental
nanoparticles. Detecting nanomaterials in complex
matrices such as cosmetics, food, waste, soil, water or sludge is even more
challenging. While some monitoring methods exist, these often remain to be
validated, which hampers comparability of data.

4.2.        Safety,
risk assessment, and risk/benefit assessment

Since 2004, the Scientific Committee on
Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific
Committee on Consumer Safety (SCCS), the European Food Safety Authority (EFSA)
and the European Medicines Agency (EMA) have been working on the risk assessment
of nanomaterials.

In 2009, SCENIHR concluded that “while
risk assessment methodologies for the evaluation of potential risks of
substances and conventional materials to man and the environment are widely
used and are generally applicable to nanomaterials, specific aspects related to
nanomaterials still require further development. This will remain so until
there is sufficient scientific information available to characterise the
harmful effects of nanomaterials on humans and the environment.”

It further asserted that “health and
environmental hazards have been demonstrated for a variety of manufactured
nanomaterials. The identified hazards indicate potential toxic effects of
nanomaterials for man and the environment. However, it should be noted that not
all nanomaterials induce toxic effects. Some manufactured nanomaterials have
already been in use for a long time (e.g., carbon black, TiO2)
showing low toxicity. Therefore, the hypothesis that smaller means more
reactive, and thus more toxic, cannot be substantiated by the published data.
In this respect nanomaterials are similar to normal chemicals/substances in
that some may be toxic and some may not. As there is not yet a generally
applicable paradigm for nanomaterial hazard identification, a case-by-case
approach for the risk assessment of nanomaterials is still warranted.”[13]

EFSA in its 2011 scientific opinion[14] confirmed that the risk
assessment paradigm used for the evaluation of standard food products is also
appropriate for nanomaterial applications in the food and feed chain and the
need for a case by case approach. Such a case-by-case approach is in place
through the pre-market approval system in food and feed legislation (such as
novel foods, food additives, feed additives, plastic food contact materials). A similar approach was adopted by the EMA for medicinal products.[15]

Despite certain limitations as mentioned by
the Scientific Committees and Agencies, in particular the need for a
case-by-case scientific approach when assessing differences between bulk and
various nanoforms of the same chemical substance, it is possible to perform
risk assessments of nanomaterials today.

Several risk assessments and risk/benefit assessments have been
completed and various products in different sectors have been authorised (such
as 20 medicines and three food contact materials[16]). The SCCS has assessed and
approved the safety of one nanomaterial used as a UV filter and is completing
the assessment of three other nanomaterials. Other substances will be assessed
as the case arises (e.g. UV filters, food and feed
ingredients).

Harmonization and standardization of measurement and test methods in
support of risk assessment of nanomaterials is being promoted through the OECD
and by a Commission Mandate to the European Standards Organisations.[17]

A study launched by the Commission in 2011 on occupational risks of
nanomaterials, and other relevant research, including on the fate of
nanomaterials in the environment and in waste, will provide more insight for
further legislative guidance and risk assessment work.

Research concerning safety and the development of reliable test
methods will also remain a key priority under the EU Framework Programmes and for
the Commission's Joint Research Centre.

5.           REACH
and CLP

Pursuant to REACH[18], chemical substances imported
or manufactured in the EU must in most cases be registered with ECHA,
demonstrating their safe use. The registration dossier or substance may be
subject to evaluation. Depending on its characteristics, any substance may be
subject to authorisation or restrictions. REACH applies equally to substances
for which all or some forms are nanomaterials.[19]

The CLP Regulation[20] provides an obligation to
notify to ECHA substances in the forms as placed on the market, including
nanomaterials, which meet the criteria for classification as hazardous,
independent of their tonnage.

The European Parliament called on the
Commission to evaluate the need to review REACH concerning simplified
registration for nanomaterials manufactured or imported below one tonne,
consideration of all nanomaterials as new substances, and a chemical safety
report with exposure assessment for all registered nanomaterials.

5.1.        Coverage
of nanomaterials in REACH registrations and CLP notifications

Many substances exist in different forms
(solids, suspensions, powders, nanomaterials, etc.). Under REACH, different
forms can be considered within a single registration of a substance. However,
the registrant must ensure the safety of all included forms and provide
adequate information to address the different forms in the registrations,
including the chemical safety assessment and its conclusions (e.g. through
different classifications where appropriate).

The information requirements of REACH
registration apply to the total tonnage of substance, including all forms.
There is no prescription to undertake specific tests for each different form,
or to spell out the way in which the different forms have been addressed in the
registrations, although the REACH dossier structure allows this and the
technical advice from ECHA encourages it.

In close collaboration with ECHA, the
Commission has assessed how nanomaterials have been addressed in REACH
registrations and CLP notifications. As of February 2012, 7 substance
registrations and 18 CLP notifications had selected "nanomaterial" as
the form of the substance in voluntary fields. A further assessment identified
additional substances with nanoforms.[21]

Many registrations for substances known to
have nanomaterial forms do not mention clearly which forms are covered or how
information relates to the nanoform. Only little information is specifically
addressing safe use of the specific nanomaterials supposed to be covered by the
registration dossiers. These findings can partly be explained by the absence of
detailed guidance to registrants on registration for nanomaterials and the
general wording of the REACH annexes.

The Commission Recommendation on a
definition of nanomaterial will clarify terminology, but will in itself not
provide the necessary clarity to the registrants on how to address
nanomaterials in REACH registrations.

The Commission
will therefore, based on available information on technical progress, including
the REACH Implementation Projects on Nanomaterials and experience with the current
registrations, in the upcoming REACH review assess relevant regulatory options,
in particular possible amendments of REACH annexes, to ensure clarity on how
nanomaterials are addressed and safety demonstrated in registrations.

5.2.        Substance
identification and registration timelines

Many substances exist as bulk and
nanoforms. The nanoforms can be seen as forms of the same substance or as distinct
substances. In the latter case, the question arises whether they are treated as
“new” substances and whether they would be subject to immediate registration.[22]

When more experience from the evaluation of registrations is
available, ECHA will provide guidance on treating nanomaterials as forms of a
bulk substance or as distinct substances with the aim of enabling effective
data sharing. The results of the REACH Implementation Project on Nanomaterials
on Substance Identification (RIPoN1) suggest, however, that some flexibility
will be needed. Whether nanoforms have been addressed in one or several
registrations, for the Commission the key issue remains whether the
registration provides clear information on the safe use for all forms of the
substance.

5.3.        Chemical
safety assessment

RIPoN on Information Requirements (RIPoN2)
and the RIPoN on Chemical Safety Assessment (RIPoN3)[23] address – inter alia - the
question whether the existing REACH requirements and the relevant guidance are
appropriate to assess nanomaterials. They contain a number of specific
proposals.

RIPoN 2 concluded that, with a few caveats,
the guidance at the time of the project and the information requirements were
considered applicable for the assessment of nanomaterials. RIPoN3 concluded
that known exposure assessment methods were generally applicable but may still
experience methodological challenges.

The REACH approach to hazard assessment and
risk characterisation, with its built-in flexibility, makes it overall suitable
for nanomaterials. The key remaining question is to what extent data for one
form of a substance can be used to demonstrate the safety of another form, due
to still developing understanding of e.g. drivers of toxicity. In a
case-by-case scientific approach:

·
Clarity is required whether and which nanoforms
of a substance are covered by a registration. These nanoforms should be adequately
characterised, and the user should be able to identify which operational
conditions and risk management measures apply to them.

·
Information should be provided on which forms of
a substance have been tested, with the test conditions adequately documented.

·
Conclusions of a chemical safety assessment
should cover all forms in a registration. Where data from one form of a
substance are used in demonstration of the safe use of other forms, a
scientific justification should be given on how, applying the rules for
grouping and read-across[24],
the data from a specific test or other information can be used for the other
forms of the substance. Similar considerations apply to exposure scenarios and
the risk management measures.

ECHA has updated guidance to take into account the final RIPoN
Reports. ECHA has set up a Group Assessing Already Registered Nanomaterials (GAARN),
who considers in co-operation with the Commission, Member States experts and
stakeholders, a few key nanomaterial registrations. The purpose is to identify best
practices for assessment and reporting of nanomaterials in REACH registrations
and to develop recommendations on how to fill potential information gaps. In
addition, ECHA has set up a Nanomaterials Working Group to give advice on scientific
and technical issues in relation to nanomaterials under REACH.

5.4.        Extension
of REACH obligations to small volume nanomaterials

Most
nanomaterials which are subject to a scientific debate are manufactured or
imported in volumes of 1 tonne per year or more. Small volume nanomaterials are
mostly used in technical applications such as catalysts or in applications
where the nanomaterials are bound in a matrix or enclosed in equipment.
Consumer and environmental exposure to those nanomaterials is likely to be
limited.

In line with SCENIHR’s conclusion that nanomaterials
are similar to normal substances in that some may be toxic and some may not, the
Commission does not consider appropriate at present to change the rules for
when a chemicals safety assessment is required. As regards registration
thresholds and timelines for registration based on volume, the Commission
considers REACH appropriate, subject to actions outlined in chapter 7.

6.           Health,
Safety and Environment protection in EU legislation

The Parliament called on the Commission to
evaluate the need to review a number of areas of legislation, including air,
water, waste, industrial emissions and worker protection legislation.

·
As regards safety and health at work, the
ongoing work can be summarized as follows:

In addition to the study on nanomaterials in the workplace[25], a Nano subgroup of the
Chemicals working party set up under the Advisory Committee on Safety and
Health at Work is working on a draft opinion on risk assessment and management
of nanomaterials at the workplace, to be subsequently endorsed by the Advisory
Committee. A final assessment on a review of occupational health and safety
legislation will be made by 2014 in the light of these activities and
respective conclusions.

·
As regards consumer product safety legislation,
work is under way on adapting the relevant legislation in order to transpose
the horizontal definition and to introduce specific provisions on
nanomaterials; on updating the relevant risk assessment processes; on
strengthening market surveillance; and on improving information and labelling
requirements:

The Commission is committed to implement
the definition of nanomaterials in consumer product safety legislation, when
appropriate. Specific provisions on nanomaterials have been introduced for biocides,
cosmetics, food additives, food labelling and materials in contact with
foodstuff.

At the same time, the Commission undertook
a detailed analysis of how consumer product legislation is being implemented
with reference to nanomaterials. The main challenge remains the implementation
of a proper risk assessment, also in those areas where legislative change has
been implemented.

Therefore, for instance, EFSA has at the request of the Commission
adopted a guidance document[26]
clarifying the data to be provided when submitting an application dossier for a
nanomaterial to be incorporated in food and feed.

Similarly, guidance has recently been developed by the Scientific
Committee on Consumer Safety for cosmetic products.

The Commission takes the view that current legislation on medicinal
products allows an appropriate risk/benefit analysis and risk management of
nanomaterials.

For legislation on medical devices, actions under consideration
include a labelling requirement in a proposal foreseen
for 2012. In addition, the Commission is considering to reclassify devices containing free nanomaterials under Class III, making them subject
to the most severe conformity assessment procedure(s).

The Commission considers that New Approach
and in general consumer product legislation allow nano-specific issues to be
taken into consideration.

Market surveillance is a key element in effective consumer
protection, and the Commission is facilitating a joint surveillance pilot
project with various Member States on the presence of nanomaterials in cosmetic
products.

A main issue in the debate on nanomaterials
is consumer information and labelling of nanomaterials. Nano-ingredient
labelling has been introduced in products of relevance to consumers, notably
food and cosmetics.

Similar provisions can be envisaged for other regulatory schemes
where ingredient labelling already exists, allowing consumers to make an
informed choice.

·
As regards environmental legislation, the
evaluation[27]
of this legislation identified and assessed environmental
exposure pathways for nanomaterials relevant to each piece of legislation, the
level of control afforded over possible releases of nanomaterials and the
associated risks.

The evaluation showed that all
environmental legislation reviewed could be considered to address nanomaterials
in principle. Nevertheless, this might pose challenges and has not been tested
in practice. Principal triggers of pollutant identification are hazard
classification under CLP and exposure information. There is still a
considerable lack of data on exposure to nanomaterials
via the environment. Consequently, no specific
provisions for nanomaterials have yet been established in EU environmental
legislation, triggering measures to control such
pollutants through monitoring, separate treatment or environmental quality
standards. This applies also to the risk management
responses explicitly identified by the European Parliament: new environmental
quality standards, revision of emission limit values, a separate entry for
nanomaterials in the list of waste and the revision of waste acceptance
criteria in landfills. As risk characterisation may
depend on particle size or surface functionalization, it is anticipated that
setting the precise scope, dose metrics and value of any thresholds employed
under environmental legislation, if necessary, would be more challenging than
for conventional pollutants. REACH should generate relevant data in this
respect.

Even when it is possible to show the presence of specific
nanoparticles in environmental media or waste, it would be technically
difficult to separate or eliminate them. Therefore 'end-of-pipe' measures would
not be effective to prevent potential negative impacts on the environment or
health, nor would they allow addressing any emerging recycling challenges or
need for remediation in a cost-effective manner.

Although the Commission does not exclude specific provisions in
downstream environmental legislation, potential risks are normally best
addressed "upstream" by REACH and product legislation. Any CLP classification of a nanomaterial will automatically unlock
some operative provisions across a range of environmental legislation that
serve to control releases of hazardous substances into the environment.

The Commission is also taking steps to ensure that remaining
implementation gaps of the legislation are addressed. For example, revisions of
the selection process for priority substances under the water legislation and
the relevant BREF[28]
documents under industrial emissions legislation, incorporating various
nanomaterial aspects, are already being pursued.

Developing capacity to monitor and model nanomaterials, e.g. in the
environment is necessary. This will facilitate the evaluation of the efficiency
of different tools of the environmental legislation and inform appropriate risk
management strategies. Where necessary, this will be supported by targeted
implementing environmental legislation.

7.           Need
for better accessible information

Transparency of information on
nanomaterials and products containing nanomaterials is essential. This has been
recognised by the Parliament which has called on the Commission to evaluate the
need for notification requirements for all nanomaterials, including in mixtures
and articles, and the Council, which invited the Commission to evaluate the
need for the further development of a harmonized
database for nanomaterials, while considering potential impacts.

Current knowledge about nanomaterials does
not suggest risks which would require information about all products in which
nanomaterials are used. Experience so far shows that, if risks were to be
identified, they could be handled with the existing tools such as the General
Product Safety Directive[29]
and its RAPEX system[30],
or more specific instruments under EU product legislation.

Currently available information (such as
the information presented in the attached Staff Working Paper and the
information generated by existing legislative tools such as REACH and the
Cosmetics Regulation) is considered a good basis for policy making.

As a first step, the Commission will create a web platform with
references to all relevant information sources, including registries on a
national or sector level, where they exist. A first version mainly based on
links to available information will be put on line as soon as possible. The
Commission will assist in the elaboration of harmonised data formats, to
improve exchange of information. In parallel, the Commission will be launching
an impact assessment to identify and develop the most adequate means to
increase transparency and ensure regulatory oversight, including an in-depth
analysis of the data gathering needs for such purpose. This analysis will
include those nanomaterials currently falling outside existing notification,
registration or authorisation schemes.

8.           Conclusions

In the light of current knowledge and
opinions of the EU Scientific and Advisory Committees and independent risk
assessors, nanomaterials are similar to normal chemicals/substances in that
some may be toxic and some may not. Possible risks are related to specific
nanomaterials and specific uses. Therefore, nanomaterials require a risk
assessment, which should be performed on a case-by-case basis, using pertinent
information. Current risk assessment methods are applicable, even if work on
particular aspects of risk assessment is still required.

The definition of nanomaterials will be
integrated in EU legislation, where appropriate. The Commission is currently
working on detection, measurement and monitoring methods for nanomaterials and
their validation to ensure the proper implementation of
the definition.

Important challenges relate primarily to establishing
validated methods and instrumentation for detection, characterization, and analysis,
completing information on hazards of nanomaterials and developing methods to
assess exposure to nanomaterials.

Overall the Commission remains convinced
that REACH sets the best possible framework for the risk management of
nanomaterials when they occur as substances or mixtures but more specific
requirements for nanomaterials within the framework have proven necessary. The
Commission envisages modifications in some of the REACH Annexes and encourages
ECHA to further develop guidance for registrations after 2013.

The Commission will carefully follow
developments, and report back to the Parliament, the Council and the European
Economic and Social Committee within 3 years.

ANNEX

Action || Content || Timeline

Nanomaterial Definition || Implementation of definition into European Union legislation and use in Union Agencies || Done for biocides; adaptation of the definition for cosmetics is in progress

Report on existing measurement methods, possible update of Q&A || 2012

Proposal for a first set of detection, measurement and monitoring methods || 2014

Review of definition || 2014

REACH and CLP || Possible amendment of REACH Annexes || Planning and Timelines will be addressed in REACH Review

CASG(Nano) – Subgroup of REACH and CLP Competent Authorities (CARACAL), advising the Commission on regulatory issues relating to REACH and CLP || Set up in 2008

Evaluation of REACH registration dossiers concerning nanomaterials || Nanomaterials prioritised by ECHA for compliance check; substance evaluation according to the “CoRAP” list (currently including silicon dioxide (NL 2012), silver (NL 2013) and titanium dioxide (F 2014))

ECHA assessment of nanomaterials in REACH registration and CLP notification dossiers || Done (see Appendix 3 of Staff Working Paper)

Nano Support Project (JRC in cooperation with ECHA) || Part 1 (identification of registration dossiers covering nanomaterials, scientific assessment and proposals to address shortcomings) – done and available on http://ec.europa.eu/environment/chemicals/nanotech/pdf/jrc_report.pdf, part 2 (assessment of potential economic and environmental consequences of the technical proposals made in Task I) expected in October 2013

GAARN (Group on Assessing Already Registered Nanomaterials) – Informal group to assess three selected registration dossiers on nanomaterials || Set up in 2012, end of work foreseen in 2013

ECHA Nanomaterial Working Group – Permanent Group to advise ECHA on scientific and technical aspects relating to nanomaterials || Set up in 2012

ECHA Guidance Update for Registration || Done, further updates possible after the end of the next registration round

Update of IUCLID to facilitate submission of structured information on NM || Initial solutions provided already in 2010 (IUCLID 5.2) and recently in 2012 (IUCLID 5.4); further relevant updates expected after the REACH 2013 deadline

Cosmetics || Assessment of individual substances || ETH-50: concluded; titanium dioxide, zinc oxide, HAA299: foreseen for 2012

Joint market surveillance pilot project on nanomaterials in cosmetics || 2013

Medicines || Authorisation of individual medicines || 20 medicines authorised so far, further assessments as the case arises

Food || Mandatory labelling for nano-ingredients in food introduced in labelling Regulation || Labelling applicable from December 2014

Definition of "engineered nanomaterial" in labelling Regulation || Definition to be updated to Commission Recommendation

Pre-market approval under Novel Food Regulation for food under nano form || To be addressed in the Novel Food Proposal foreseen for 2013

Requirement for risk assessment for food additives and food contact materials || For additives and food contact materials risk assessment as the case arises (with authorisation where appropriate)

Food contact materials || Authorisation of individual food contact materials || Two nanomaterials authorised; further assessments as the case arises

Worker Protection Legislation || Study on occupational risks of nanomaterials || 2013

Final assessment on review of occupational health and safety legislation || 2014

OECD Working Party on Manufactured Nanomaterials || Eight subgroups, including one on safety testing of a set of representative manufactured nanomaterials which should provide data on 13 selected nanomaterials || Current Programme started in 2009, with work towards completion of Phase1 well progressed

Mandate M/461 to CEN || Development of methods for nanomaterial characterisation, sampling, measurement and exposure simulation || Work started in 2010, will take several more years

Research, Development and Innovation activities under Horizon 2020 || The proposal for the Regulation establishing Horizon2020 (COM(2011)809) identifies Nanotechnologies as one of the six Key Enabling Technologies (KETs) under the Industrial Leadership pillar. Ensuring the safe development and application of nanotechnologies is one of the main lines of activity. || Final calls under 7th Framework Programme for Research to bridge gap towards Horizon 2020

Nano-ingredient labelling || || Implemented in the Cosmetics and Biocides Regulations

Information on Nanomaterials || Information on Nanomaterial Types and Uses, including Safety Aspects (overview of available information as well as information sources, databases, etc.) || Done (Annexed Staff Working Document)

Web-platform || 2013

Study on nanomaterials falling outside the scope of existing notification or registration requirements and options for getting information || 2013

[1]               COM (2008) 366, 17.6.2008

[2]               Resolution European Parliament on Regulatory Aspects
of Nanomaterials (2008/2208(INI),
24.4.2009

[3]               Conclusions on “improving
environmental policy instruments” of 20 December 2010

[4]               Opinion European Economic and Social Committee;
INT/456 of 25.2.2009, Nanomaterials

[5]               SWD(2012) 288 final

[6]               Commission
Recommendation 2011/696/EU, OJ L 275, 20.10.2011

[7]               SWP, p. 10.

[8]               Carbon black accounts for around 85% of total
nanomaterials on the market in terms of tonnage, synthetic amorphous silica
accounts for another 12%.

[9]               http://www.forfas.ie/media/forfas310810-nanotech_commercialisation_framework_2010-2014.pdf,
referring to Lux Research. Those figures refer to the value of products into
which nanomaterials are incorporated (as opposed to the value of nanomaterials
marketed).

[10]             http://ec.europa.eu/enterprise/sectors/ict/files/kets/hlg_report_final_en.pdf,
p. 13.

[11]             http://ec.europa.eu/enterprise/sectors/ict/key_technologies/kets_high_level_group_en.htm

[12]             http://ec.europa.eu/enterprise/sectors/ict/files/kets/act_en.pdf

[13]             http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf,
p. 52 and p. 56.

[14]             Scientific opinion on "Guidance on the risk
assessment of the application of nanoscience and nanotechnologies in the food
and feed chain” (2011), 9(5):2140.

[15]                http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000345.jsp&mid=WC0b01ac05800baed9

[16]             Namely silicon dioxide, carbon black and titanium
nitride. Silicon dioxide has also been authorised as food additive.

[17]             M/461 EN of 2.2.2010

[18]             Regulation (EC) No 1907/2006 of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH). OJ L 136, 29.5.2007, p.3. Unofficial consolidated version
see:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1907:20110505:en:PDF

[19]             For
an explanation of terminology see http://ec.europa.eu/enterprise/sectors/chemicals/files/reach/nanomaterials_en.pdf

[20]             Regulation (EC) No 1272/2008 of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, OJ L353,
31.12.2008

[21]             For details see SWP, chapter 5.2 and appendix 3.

[22]             Any immediate registration requirement for nanomaterials
treated as new substance could reasonably only apply from the moment that the
interpretation of the REACH provisions was clear enough for registrants to
exclude the interpretation that the nanomaterial is a form of an existing
substance.

[23]             http://ec.europa.eu/environment/chemicals/nanotech/index.htm#ripon

[24]             REACH, Annex XI, section 1.5

[25]             See section 4.2

[26]             Scientific opinion on "Guidance on the risk
assessment of the application of nanoscience and nanotechnologies in the food
and feed chain (2011)”, 9(5):2140.

[27]             http://ec.europa.eu/environment/chemicals/nanotech

[28]             BREFs - Best available technique REFerence Documents
define Best Available Technique (BAT) for individual industrial sectors under
the Industrial Emission Directive

[29]             Directive 2001/95/EC OJ L 11, 15.1.2002.

[30]             http://ec.europa.eu/consumers/safety/rapex/index_en.htm