EUROPEAN COMMISSION FINDS EXISTING NANO REGULATION

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 -------------- �0A; ¶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 .