Danish Government initiatives to get better control of nanomaterials Flemming Ingerslev, Section of Chemicals The Danish Environmental Protection Agency
Overview Historical developments in DK Action Plan for chemical 2010-13 Initiatives under the Financial law 2012-15 More knowledge about nanomaterials in DK Amendment of the Danish law for chemicals (March 2013) National database for nano products Preparation of legislation Technical development The Danish Environmental Protection Agency PAGE 2
Early Danish initiatives on nanomaterials Technological foresight: nanotechnology (2004-5) The DK-EPA Nano-network for Danish scientists, regulators and other stakeholders with interest in nano (2006) Survey of existing legislation in DK, covering environment, chemicals, medicine, food, occupational environment. Report: Nanoteknologi og Sundhed, Ministry of Interior and Health, Dec 2007: Survey of nanotechnological consumer products (Survey of Chemical Substances in Consumer Products, No. 81 2007, DK-EPA) Nanotechnology in the Danish Industry (Environmental Project No. 1206 2007, DK-EPA) The Danish Environmental Protection Agency PAGE 3
The Danish Action plan for Chemicals 2010-2013 (1 million Dkr/year) Objectives/initiatives: Knowledge building, Contribute to international regulation, Dialogue and Assessment methods Reports: - NanoRiskCat - A Conceptual Decision Support Tool for Nanomaterials (Environmental Project No. 1372 2011) - Survey on basic knowledge about exposure and potential environmental and health risks for selected nanomaterials (Environmental Project No. 1370 2011) - Assessment of nanosilver in textiles on the Danish market (Environmental Project No. 1432 2012) - Information requirements for nanomaterials IRNANO (Environmental Project No. 1469 2013) The Danish Environmental Protection Agency PAGE 4
Initiatives in Denmark 2012-15 After new government as of 3. October 2011 National Budget Agreement 2012 on Better Control of Nanomaterials and their Safety (Budget, 2012-2015, 24 mio. Dkr) Subproject 1: Knowledge building with focus on exposure pathways and implications for consumers and the environment with regard to the use of nanomaterials (approx. 3/4 of budget) Subproject 2: Development of a nano product database in cooperation with other countries (approx. 1/4 of budget) Coordination with the Center for Nano Safety under the Ministry of Employment (Budget 2012-2014, 30 mio. Dkr) The Danish Environmental Protection Agency PAGE 5
Knowledge on exposure of nanomaterials and consequences for consumers and environment More knowlegde about: Consumers and environment exposure to nanomaterials Possible harmful effects to consumers and the environment caused by nanomaterials Timeframe and Status: Stakeholder dialogue (June 2012) Submission first tenders for project-proposals (Oct-Nov 2012) Contracts for project(s) Overview of nanorisk for the Danish Environment (2013-15; 2,5 mio Dkr) Dermal and oral uptake of Nanomaterials (2x200.000 Dkr) Use of nanomaterials in food, food contact materials, medical equipment, pharmaceuticals, cosmetics (0,5 mio Dkr) Further projects in 2013-15 Publication of reports in 2013-2015 Possibly stakeholder workshop in 2013-15 The Danish Environmental Protection Agency PAGE 6
Knowledge building under FL2012-15 Sub-project 2 Database (DB) nano products Survey of products not in DB Oral absorption Inhalation Dermal absorption Waste Exposure HUMAN RISK Release of NM from products Hazard assessment HUMAN RISK Environmental RISK Industrial point sources Fate in Environment Methodology Scenarios Estimations and assessment of effects Environmental RISK The Danish Environmental Protection Agency PAGE 7
Subproject 2: Nano product database Objective: To provide an overview of the nanoproducts that are on the Danish market, the extent of use and the purposes they are used for. To provide information to sub-project 1 (knowledge building). To inspire to an EU-solution for registration of nano products Timeframe: 2012-2015 then evaluate whether the database should continue The Danish Environmental Protection Agency PAGE 8
Necessary legislation for the nano product database (1) - Act Amendment Act to the Danish Chemicals Act (the necessary authorizations for the minister to regulate further) 14. September 12. October 2012 - Broad public hearing 29. November 2012 March 2013: Negotiations in parliament leading to final agreement (on 12. March 2013) => decision that that focus should be on limiting the administrative burdens for industry. Act and authorizations come into force 1. September 2013 The Danish Environmental Protection Agency PAGE 9
Necessary legislation for the nano product database (2) - Ministerial Order Ministerial Order (detailed regulation on the nano product database) Only on the drawing board First reporting expected to take place in 2014 for 2013 (from September) The Danish Environmental Protection Agency PAGE 10
Present scope of the nano product database Nano products: mixtures and articles that contain or release nanomaterials Excluding e.g. food, food contact materials, medical equipment, pharmaceuticals, cosmetics Definition of nanomaterials follows the EU definition Importers and manufacturers of nano products to report IT-system: www-interface for input-output of data that can be feed into a IUCLID-database As harmonised as possible with other EU-databases (FR, BE, IT) Data-fields: registrant, registration time, use, users, amounts used The Danish Environmental Protection Agency PAGE 11
Why simple registration? Input from public hearing comments (and dilemmas) EU-initiatives are sufficient an EU-register is preferred Complicated definition of nanomaterials unclear what products to report unclear when nano materials are released Lack of available data - and external suppliers will not provide information or will protect their commercial secrets from importers Avoid double registration obligations Heavy administrative burdens on small and medium sized enterprises Competition is harmed and innovation hampered in a promising field Request for more extensive data fields - vs. - Request for fewer data fields Public access to the database necessary - vs. - Public access must be limited to protect reported commercial secrets The Danish Environmental Protection Agency PAGE 12
DK-EPA s preparation of the Nanodatabase Assessment of the administrative burdens for producers and importers. Environmental project no. 1451, The Danish EPA (2012). Possible options for reduction of administrative burdens. Environmental project no. 1462, The Danish EPA (2013). Pilot-project: preparation of technical specifications. Planned project: Technical development of nanoproduct-database Project under tender: Registration of nanomaterials, examples, guidance and workshop The Danish Environmental Protection Agency PAGE 13
Conclusions (at present, 18. March 2013) Nanosafety have been in focus in DK since 2006-7 National action plan for chemicals was the first separate initiative on nanosafety in DK New government lead to new Political agreement in October 2011 => Knowledge building projects (~18 mio Dkr) => Nano product database ready in January 2014 Registration of nano products Registration only by producers and importers Nanomaterials defined according to the Commission recommendation (2011/696/EU) Registrations via www to IUCLID- prepared system The Danish Environmental Protection Agency PAGE 14