EUROPEAN COMMISSION FINDS EXISTING NANO REGULATION

UNCLAS SECTION 01 OF 04 BRUSSELS 001671

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TAGS: EIND EU EUN TPHY TSPL
SUBJECT: EUROPEAN COMMISSION FINDS EXISTING NANO REGULATION
SUFFICIENT; U.S. ENGAGEMENT REMAINS IMPORTANT

REF: BRUSSELS 184


1. (SBU) Summary: In its Communication on the Regulatory
Aspects of Manufactured Nanomaterials issued June 17, 2008,
the European Commission concluded that existing regulation is
sufficient to handle nanomaterials, but left the door open
for new legislation if the Commission determines it needs to
respond - either to perceived risk or to public pressure.
REACH will be the primary regulatory structure under which
most nanomaterials will be handled, and directives covering
novel foods, worker safety, and environment were deemed
sufficient for other aspects. Although REACH is a
bureaucratic nightmare, the decision is a positive
development in the European discussions on nanotechnology,
and in moving away from the typical European response to even
greater regulatory controls; this could promote both
transatlantic and global investment and R&D. All
Directorates General (DG) have lined up behind the
Communication, but it is clear some subtle divisions still
exist, and continued USG engagement is necessary to ensure
the Commission remains on its current path:

-- with the Communication, nanotechnology becomes a shared
competence among five DGs: Enterprise, Environment, Health
and Consumer Protection (SANCO),Research, and Employment and
engagement with each will remain critical to our cooperative
efforts;

-- research to fill existing knowledge gaps remains a key
priority of the Commission, which is very open to bilateral
cooperation with the U.S. as well as through international
forums such as the OECD;

-- with the publication of the Communication, the Commission
now is looking at developing a public outreach strategy,
again expressing interest in cooperation with the U.S.; and

-- U.S. regulatory officials met with Commission
representatives from all major DGs in October, a meeting
which highlighted several areas of convergence, but also some
possible disagreements. USEU recommends that U.S. policy
makers continue to move forward on developing an strategy for
nanotechnology outreach to the EU and continue to engage the
Commission, and member states, through both interservice and
agency to DG cooperation. End summary.

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Communication Traveled a Very Difficult Road
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2. (SBU) A long time in the making, a Communication on the
Regulatory Aspects of Manufactured Nanomaterials was released
by the European Commission, led by DG Enterprise, on June 17,

2008. The Communication, which exclusively addresses
intentionally manufactured nanomaterials, and not naturally
occurring or incidental nanomaterials, concluded that
"current legislation covers to a large extent risks in
relation to nanomaterials and that risks can be dealt with
under the current legislative framework." That this
Communication was published in summer 2008, as opposed to the
original date in September 2007, is an indication of the
contentious nature of the topic within the EU. The
Communication was not only delayed several times, beginning
in late summer 2007, but the format of the paper also changed
frequently. Ultimately, Commission President Jose Manuel
Barroso decided that the EU needed to make an official
statement on the topic; thus the Commission released the
paper as a Communication and not as a Staff Working Paper
(See reftel for background and history of the process.) At
the end, it was decided that nanotechnology is a shared
competence among the five DGs whose Commissioners signed the
Communication: Enterprise, Environment, Health and Consumer
Protection (SANCO),Research, and Employment. (Note: This is
analogous to the U.S. structure, in which several different
agencies have responsibility for nanotechnology and
nanomaterials that fall under the respective remits. End
note.)

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REACH will handle most manufactured nanomaterials
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3. (SBU) Nanomaterials will fall under the "substance" label
addressed by REACH, the chemical regulations regime that

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champions a precautionary approach using the concept: 'no
data, no market'. Registration dossiers will need to be
updated whenever a previously approved bulk substance is
introduced in a nanoform. These updates may involve
different classification and labeling of the form, additional
risk management procedures, and potentially additional
testing or information as needed. This will be decided
depending upon whether or not the new nanoform exhibits
different properties than the bulk form. In this case, the
nanomaterials will be treated as new substances. Data
generated under REACH will inform other regulation in areas
including worker protection, cosmetics, and environmental
protection. REACH also requires the use of Safety Data
Sheets for data dissemination about environment, safety, and
health risks throughout the supply chain, to industrial
users, and to the general public via the Internet. (Comment:
The use of REACH may have been advocated most strongly by DG
Environment. DG Environment remains very proud of the
regulatory structure under REACH, and at least one DG
Environment official has commented that the "U.S. will learn
to love REACH." End comment.)


4. (U) Nanomaterials found in novel foods, medicinal
products, and other goods subject to pre-market controls or
pre-market notifications must be verified by authorities
prior to being marketed, as detailed in the General Product
Safety Directive. Cosmetics and other consumer products
without specific pre-market procedural requirements must
comply with legal directives and will continue to be handled
by existing regulations. However, REACH will apply and take
precedence wherever nanomaterials contained in consumer
products qualify as substances under REACH.

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Employers responsible for safety of workers
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5. (U) Employers are responsible for carrying out a risk
assessment for all substances and work activities at all
levels of the production process, using Framework Directive
89/391/EEC as a basis. Should a risk be identified,
employers must take measures to 'eliminate' this risk.
Specific provisions may prove to be necessary in order to
address particular risks to occupational safety and health
-for example, exposure to carcinogens or mutagens, use of
work equipment, or use of personal protective equipment. The
Directive lays out minimum requirements and Member States may
impose more stringent rules.

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Environmental Protection covered in several Directives
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6. (SBU) Environmental regulation as it relates to
nanotechnology will be covered by several Directives. The
IPPC Directive for integrated pollution prevention and
control would regulate emissions based on the usage of best
available techniques (BAT). The BAT Reference Document could
be amended to include controls specific to nanomaterials.
Any nanomaterials found to pose a major accident hazard would
be regulated in the context of the Seveso II Directive for
accident hazards involving dangerous substances. Directive
2006/12/EC sets the framework to govern safe waste treatment,
whereas Directive 91/689 EEC would cover waste management for
any nanomaterials classified as hazardous as defined in the
Annex to Directive 91/689 EEC. (All substances meeting those
criteria are currently listed as hazardous on the European
Waste List.) The Water Framework Directive aims to reduce
pollution from emissions and discharges of priority
substances, which could include nanomaterials depending on
their properties. Member States will have the ability to
establish quality standards for pollutants representing a
risk to groundwater under the Water Framework Directive. The
EU also has waste legislation that covers specific waste
treatment processes (i.e. landfills, incineration) and
specific waste streams.

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All DGs lining up behind the Communiction
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7. (SBU) Despite the early internal divisins related to the
release of the Communication, conversations between USEU
EconOffs and ommission representatives indicate that all DGs

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now stand behind the statements. However, it remains clear
that DG Environment continues to take a more conservative
view, with DG Enterprise continuing to support an open
investment environment.


8. (SBU) DG Enterprise was pleased with the Commission's
acceptance of existing legislation as a tool for the
regulation of nanomaterials, as it had pushed for precisely
such an approach. (See reftel.) A key focus for Enterprise
at this point is how to approach public outreach. DG
Enterprise would like to host a public dialogue about
nanotechnology between citizens and stakeholders to
understand better consumer expectations, where value can be
added, and how to avoid duplications. This, they believe, is
an ideal opportunity for cooperation with the U.S. They are
eager to learn more about industry's point of view regarding
regulation and the marketing of products containing
nanomaterials, particularly as it applies to both sides of
the Atlantic.


9. (SBU) Henrik Laursen, the DG Environment desk officer for
nanotechnology, expressed concerns about the need for more
information about exposure as part of occupational safety
risk assessments and the concurrent need for improved testing
methodologies. Though he supported the bottom lines in the
Communication, Laursen was very vocal in expressing his
concerns that not enough information is available to make
final decisions. He is very concerned a single negative
event could derail efforts to commercialize nanotechnology
applications and tends to feel as though government action is
required to prevent this possibility. Laursen also explained
that DG Environment also is focused on the end-of-life
treatment of products made with nanomaterials as these
products are released into the environment. (Comment: the
use of REACH, and therefore the amount of testing required,
likely allayed many of DG Environment's concerns with
addressing safety and risk factors in new nanomaterials.
However, several in DG Environment consider the current state
of scientific knowledge may not be enough to answer
adequately all of the technical questions in environmental,
health, and safety analysis. There is little information to
indicate how these considerations will drive future
discussions in the Commission as to regulating new
nanomaterials. End comment.)


10. (SBU) With this Communication, both the Council of EU
Member States and the European Parliament have an opportunity
to comment. In the next year, it is likely only the Council
will address the topic as the Parliament prepares for
elections in June 2009. According to DG Enterprise, the
member states are very anxious to weigh in on the
Communication, though there was no insight given as to how
the different countries may stand on the various issues.

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Commission Wants U.S. Collaboration on Research/Outreach
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11. (SBU) The Commission's decision to use existing
regulation to handle nanomaterials is a mixed blessing in
that the Commission decided against a new blanket regulatory
structure, but at the same time applied the precautionary
principle through the application of REACH. Even with the
choice not to apply new regulation, continued USG engagement
is essential to ensure that the Commission remains on this
path in order to promote common international standards that
will encourage investment and R&D. The various institutions
of the EU recognize that there are still many unknowns
relating to nanomaterials, and this drives much of the
wording in the Communication. While the Communication states
that existing regulation is sufficient to handle the risks,
the door is left open to further legislation if the
Commission determines it needs to respond - either to
perceived risk or to public pressure. The Commission clearly
is concerned about the potential for backlash should there be
any problems with any nanomaterial product on the market, and
believes that research is still needed to answer unresolved
questions about occupational safety and exposure.


12. (SBU) As outreach also appears to be coming to the
forefront in Commission strategy, both DGs Enterprise and
Environment expressed interest in U.S. cooperation in this
area. DG Enterprise, in particular, organized an
inter-service meeting in October when U.S. policy makers

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came to Brussels for DG SANCO's Safety for Success Dialogue
meeting. The Communication provides an opportunity to
enhance nanotechnology research and regulatory cooperation
with the Commission, and the meeting produced a very good
discussion on current regulatory structures in the U.S. and
the EU, as well as areas for future cooperation. The
Commission attendees, several of whom expressed to EconOff
that they would like to see this dialogue formalized, were
very appreciative of the meeting and of the effort put forth
by U.S. representatives. The EU recognizes the importance of
U.S.-EU engagement to avoid divergences that could affect
transatlantic trade.


13. (SBU) Comment: USEU recommends that U.S. policy makers
continue to engage Commission officials and integrate such a
meeting into the international strategy document currently in
draft. Through this engagement, it will be easier to keep
the Commission pointed down the path of using existing
regulation, thereby leaving avenues for innovation open.

SILVERBERG
.