Legislative Aspects of Nanoparticles

Transcription

1 Legislative Aspects of Nanoparticles Philippe Martin DG Health and Consumer Protection European Commission CSL/JIFSAN Joint Symposium on Food Safety and Nutrition- Nanotechnology in Foods and Cosmetics Greenbelt, MD, 26 June

2 Disclaimer The statements made in this presentation do not necessarily correspond to official positions of the European Commission. 2

3 Outline 1. Nanotechnologies 2. Key questions 3. Legislation 4. Risk assessment 5. Conclusions 3

4 Development speed Old biotechnology Energy Chemistry Mechanics Electronics Semiconductors Informatics Bio Nano Jorma Virtanen, NSC, JY 4

5 Application range Medicine and Health Information Technology Energy Production / Storage Materials Science Food, Water and the Environment Instruments Drug delivery GMR Hard Disk Hydrogen Fuel Cells Lightweight and strong Remediation methods Tunneling microscopy 5

6 Key questions for regulators Definitions: What is meant by nanoscience and by nanotechnologies? When do we need to define these terms? Characterization: What is a nanoparticle? What should we characterize? Policy: Do we need new nano-specific regulation? Do we need labeling? Is it old or new? Pre- or post-market approval? Etc. Risk assessment: Can we assume business as usual? How should we proceed? Standards: Does nano require standards? 6

7 EU legislation: areas Chemicals Occupational safety Products Aerosol dispensers Cosmetics Medical products Cars Pollution Water Waste Air Soil Food & feed 7

8 EU legislation: characteristics Scope: wide Approach: risk-based, technologyneutral, REACH-centered Application: simultaneous Intervention: possible, if needed Specific provisions for nano: none Risk assessment: reviews of methods, tests, and instruments needed; to be performed on a case-by-case basis Risk management: Regulation and implementation and enforcement 8

9 Chemicals Existing legislation New (EINECS, specific properties, different classification and labeling) Dangerous Existing (10t per year <, 4 lists, updates) Banned or controlled REACH New paradigm: Manufacturers, importers or users are responsible for the safe use of chemicals Character: Overarching, complementing, safety assessment-based 1 t per year<: technical dossier (basic) 10 t per year<: safety report (much more complete) Changes knowledge Updates of information Changes in safety 9 data sheet Changes in classification and labeling

10 Cosmetics Positive and negative lists No damage requirement Comitology (= discussion between European Commission and Member States) Risk assessment as basic obligation for manufacturer 10

11 Food The Food Law (178/2002/EC): Food shall not be placed on the market if it is unsafe. (art. 14(1)) Novel foods 15 May 1997< Criteria Modified primary molecular structure Production process not currently used Labeling Food contact materials hazardous quantities EFSA: RA Guidance needed Additives MS measure followed by Community-wide procedure Codex 11

12 Nanofood for thought European Food Safety Authority (EFSA) identified risk assessment of nanoparticles as a priority action for its Advisory Forum and Scientific Committee for 2007 [1] and set up an internal WG on nanotechnology in place; The European Commission will shortly submit a mandate on nanofood to EFSA; FAO/WHO Expert Meeting (not directly requested by Codex) on Food Safety Assessment of the Use of Nanotechnology Techniques with as expected output: Scientific advice on safety assessment of nanotechnology techniques used in food production [2]; Additives raised by German presidency in Codex. [1]_http:// management_plans_2007.par.0001.file.dat/management%20plan%202007%20a dopted.pdf 12 [2] ftp://ftp.fao.org/codex/cac/cac30/al3009ge.pdf

13 RA in the EU Annual Meeting of Chairs of Scientific Committees Food & Feed Medicines Worker Safety Other risks Euroopean Food Safety Authority (EFSA) Euroopean Medicinal Agency (EMEA) Directorate Employment (EMPL) Directorate Health &Consumer Protection (SANCO) Independent agency Independent agency Member State Representatives Independent Committees 13

14 Potential risk of nanomaterials very small (10-9 ) + not yet predictable Hazard higher reactivity (surface/volume ratio) not nec. monotonic Doseresponse Risk mobile ubiquity + Exposure protection measures 14

15 Small with respect to barriers Cell permeability: NP Ø < 60 nm Blood-brain barrier and olfactory nerve permeability: NP Ø < 4 nm nm DNA L = 2 m DNA Ø = 2 nm 15

16 Hard to predict Bulk gold: yellow inert C 1 nm gold NP: blue low reactivity 200 C 3 nm gold NP: reddish catalytic 200 C Catalytic activity 16 Cluster diameter (nm)

17 SCENIHR 2006 RA Methods Q1: Risk Assessment Methods Risk assessment methods may require modification Nano bulk ; Risks unknown or known on case-bycase basis Q2: Adaptation of Risk Assessment Methods New methodologies, methods and equipment needed for routine and non-routine measurements Q3: Knowledge Gaps Characterisation, mechanisms and toxicokinetics Exposure, health effects and environmental fate 17

18 SCCP 2007 NM in cosmetics Q1: SCCP Notes of Guidance Safety Evaluation Test methods for insoluble NPs needed; Adequate characterization of nanomaterials a must; Nano bulk ; RA on case-by-case basis; Insufficient data on hazards, exposure, toxicity, toxicokinetics, translocation and accumulation Special notion to uptake via abnormal skin; Further development of risk assessment methodologies, incl. alternative testing methods and reference materials; Q2: Revision of the evaluation of TiO2 and ZnO opinions ZnO under review 18 TiO 2 review in the light of new information

19 SCENIHR 2007 NMs in TGDs Q1: Risk Assessment Guidance TGDs require modification for nanoparticles Nano bulk; Case by case risk assessment necessary Current TGDs likely to identify the hazards, but nanomaterials needs to be specifically considered; NP characterization in various conditions essential; NP toxicity unpredictable; Exposure and dose-response requires new metrics;) Due consideration of NP translocation, toxicokinetics & potential effects Q2: Improvement of the RA methodologies Validity of existing models and methods for NP behavior needs to be checked; Improvement of inhalation studies, methods and validated tests for NP translocation, metabolism and excretion as well as for effects assessment New or improved standardized ecotoxicity tests for NP (bioavailability, taxa, protocols, translocation, cellular uptake and toxicological mechanisms) Q3: Improvement of the RA methodologies A tiered approach to set out a framework for assessing the potential risks of NP Identifies different adverse effects and different exposure data with nanoparticles. Scientifically valid and cost-effective framework minimizing the use of animals Guides to a safe and sustainable handling of NPs during their lifecycle 19

20 Conclusion Regulation: robust regulatory frameworks even when not nano-specific, yet some difficulties Moving target Knowledge gap Lack of guidance Difficulty of interventions Guidance: Constitute an immediate regulatory priority because they are essential to Specify legal requirements Facilitate demonstration of compliance with legal requirements Create legal certainty Safety standards: needed to establish a level playing field for nanoscience and nanotechnologies-based 20 products and processes in the globalized market

21 Acknowledgement This presentation benefited from the input of members of the European Commission s Interservice Group on Nanotechnologies, an input that is gratefully acknowledged. 21