MALAYSIA S NATIONAL PROJECT TO GATHER PRIMARY SAFETY DATA FOR NANO-BASED PRODUCTS IN THE LOCAL MARKET

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1 MALAYSIA S NATIONAL PROJECT TO GATHER PRIMARY SAFETY DATA FOR NANO-BASED PRODUCTS IN THE LOCAL MARKET Mohd Helme Mohd Helan Principal Assistant Secretary National Nanotechnology Centre Ministry of Science, Technology and Innovation MALAYSIA helme@mosti.gov.my

2 CHALLENGES

3 1 Inventory and database construction Nanosafety Testing Nanosafety Management

4 1 Inventory and database construction 1.1 Local distribution and inventory listing 1. Nanosafety infrastructure and expertise 1. Construct database

5 1 Inventory and database construction 1.1 Local distribution and inventory listing Market study of nano-based products Product information, manufacturer, supplier, distributor, market size, nano-claims and availability Inventory listing and product classification Nanomaterial(s) used

6 1 Inventory and database construction 1.1 Local distribution and inventory listing Beilstein Journal of Nanotechnology 015, 6, pp consumer products 6 companies countries

7 1 Inventory and database construction 1.1 Local distribution and inventory listing Beilstein Journal of Nanotechnology 015, 6, pp Health and Fitness 76 products 4% of total

8 1 Inventory and database construction 1.1 Local distribution and inventory listing Food and agriculture; Energy and environment; Well-being, medical and health care; and Electronics, devices and system

9 1 Inventory and database construction 1. Nanosafety infrastructure and expertise Survey on nano-based testing and infrastructure/facility List of equipment and expertise Local universities, research institutes and testing labs; both public and private Competency laboratory accreditation and certification

10 1 Inventory and database construction 1. Construct database Database from the output of Activity 1.1 and 1. Database from Activities and Accessible on-line for the public Database maintenance

11 1 Nanosafety Testing.1 Review test methods and conduct toxicology studies. Environmental exposure and fate

12 1 Nanosafety Testing.1 Review test methods and conduct toxicology studies Market study of nano-based products (Activity 1.1) 15 samples OECD Test Guidelines, ISO and other validated test procedures Physical chemical properties Toxicology Ecotoxicology

13 1 Nanosafety Testing.1 Review test methods and conduct toxicology studies OECD Environment, Health & Safety Publications Series on the Safety of Manufactured Nanomaterials ENV/JM/MONO(016)7 ENV/JM/MONO(01)40 ENV/JM/MONO(014)4 ENV/JM/MONO(014)1

14 1 Nanosafety Testing. Environmental exposure and fate Biodegradation Bioaccumulation OECD Environment, Health & Safety Publications Series on the Safety of Manufactured Nanomaterials ENV/JM/MONO(014)1

15 1 Nanosafety Management.1 Life cycle assessment

16 1 Nanosafety Management.1 Life cycle assessment Integration of Risk Assessment OECD Environment, Health & Safety Publications Series on the Safety of Manufactured Nanomaterials ENV/JM/MONO(015)0 ENV/JM/MONO(016)6

17 1 Hazard Identification CHALLENGES HAZARD CLASS HAZARD CATEGORY Acute toxicity oral Cat. 1 Cat. Cat. Cat. 4 Acute toxicity dermal Cat. 1 Cat. Cat. Cat. 4 Acute toxicity inhalation Cat. 1 Cat. Cat. Cat. 4 Skin corrosion/irritation Cat. 1A/1B/1C Cat. Serious eye damage/irritation Cat. 1 Cat. Skin sensitization Cat. 1 Germ cell mutagenicity Cat. 1A/1B Cat. Carcinogenicity Cat. 1A/1B Cat.

18 1 Hazard Identification CHALLENGES HAZARD CLASS HAZARD CATEGORY Acute toxicity oral Cat. 1 5 mg/kg Cat. 50 mg/kg Cat. 00 mg/kg Cat mg/kg

19 1 Quality of Data CHALLENGES SAFETY DATA ISO 1705 accreditation OECD GLP certification

20 1 Regulatory CHALLENGES ANNEX IV - Part 1 List of colouring agents allowed for use in cosmetic products Colour index number: 7766 (nano) Colour: Black Annex VII List of UV filters which cosmetic products may contain Substance: Zinc oxide (nano) Max. Authorized Conc.: 5% Substance: Titanium dioxide (nano) Max. Authorized Conc.: 5% Substance: Tris-biphenyl triazine Trisbiphenyl triazine (nano) Max. Authorized Conc.: 10%

21 T H A N K Y O U

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