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DE RUEHBS #1671/01 3031542
ZNR UUUUU ZZH
R 291542Z OCT 08
FM USEU BRUSSELS
TO RUEHC/SECSTATE WASHDC
INFO RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUCNMUC/EU CANDIDATE STATES COLLECTIVE
RUCNMEU/EU INTEREST COLLECTIVE
RUCNMEM/EU MEMBER STATES COLLECTIVE
RUEHSS/OECD POSTS COLLECTIVE

UNCLAS SECTION 01 OF 04 BRUSSELS 001671 
 
SENSITIVE 
SIPDIS 
 
OES/SAT FOR RUDNITSKY 
EUR/ERA FOR BEH 
 
E.O. 12958: N/A 
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. 
 
-------------------------------------------- 
Communication Traveled a Very Difficult Road 
-------------------------------------------- 
 
¶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.) 
 
--------------------------------------------- ---- 
REACH will handle most manufactured nanomaterials 
--------------------------------------------- ---- 
 
¶3. (SBU) Nanomaterials will fall under the "substance" label 
addressed by REACH, the chemical regulations regime that 
 
BRUSSELS 00001671  002 OF 004 
 
 
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. 
 
------------------------------------------- 
Employers responsible for safety of workers 
------------------------------------------- 
 
¶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. 
 
--------------------------------------------- --------- 
Environmental Protection covered in several Directives 
--------------------------------------------- --------- 
 
¶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. 
 
------------------------------------------ 
All DGs lining up behind the Communiction 
----------------------------------------- 
 
¶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 
 
BRUSSELS 00001671  003 OF 004 
 
 
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. 
 
--------------------------------------------- ----------- 
Commission Wants U.S. Collaboration on Research/Outreach 
--------------------------------------------- ----------- 
 
¶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 
 
BRUSSELS 00001671  004 OF 004 
 
 
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 
.