Dealing with nanosafety around the globe - Regulation vs. innovation

International Journal of Pharmaceutics

Volumn 509, Issue 1-2, 2016, Pages 95-106

  Wacker, Matthias G ^a   Proykova, Ana ^b   Santos, Gustavo Mendes Lima ^c  

^a FRAUNHOFER INSTITUTE FOR MOLECULAR BIOLOGY AND APPLIED ECOLOGY IME   (Germany)

^b UNIVERSITY OF SOFIA   (Bulgaria)

^c Agencia Nacional de Vigilancia Sanitaria Brazil   (Brazil)

Author keywords

ANVISA; EFSA; EMA; Law; Nanomaterials; Nanoparticles; OECD; Regulations; Rules

Indexed keywords

COSMETIC; NANOMATERIAL;

ASIA; BIOACCUMULATION; BRAZIL; COSMETIC INDUSTRY; DRUG LEGISLATION; DRUG PACKAGING; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL PROTECTION; ENVIRONMENTAL RELEASE; EUROPEAN UNION; EVALUATION STUDY; FOOD PACKAGING; FOOD SAFETY; GENOTOXICITY; IN VITRO STUDY; INDUSTRIAL HYGIENE; LAW; MICELLE; MICROTECHNOLOGY; MUTAGENICITY; NANOENCAPSULATION; NANOMEDICINE; NANOTECHNOLOGY; NANOTOXICOLOGY; OCCUPATIONAL SAFETY; ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT; PARTICLE SIZE; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; PRODUCT SAFETY; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; STANDARDIZATION; SURFACE AREA; SURFACE PROPERTY; TOXICOKINETICS; UNITED STATES; ZETA POTENTIAL; HEALTH; HUMAN; LEGISLATION AND JURISPRUDENCE; PROCEDURES;

ASIA; BRAZIL; CONSUMER PRODUCT SAFETY; EUROPEAN UNION; GLOBAL HEALTH; HUMANS; NANOSTRUCTURES; NANOTECHNOLOGY; UNITED STATES;

EID: 84973488165     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2016.05.015     Document Type: Review

References (91)

1. ABDI, 2013. Sectoral Monitoring Report - nanotechnology in the health area: marketing, safety and regulation.
2. ANVISA, 2000. Resolution RDC n. 23, 15 providing a basic manual of procedures for the registration and exemption of registration for foods.
3. ANVISA, 2014. Resolution RDC n. 1358 to establish the Internal Committee for Nanotechnology of the Brazilian Health Surveillance Agency and other measures.
4. ANVISA, 2015. Resolution RDC n. 7, 10 on technical requirements for the regulation of toiletries, cosmetics and perfumes and other measures.
5. ANVISA, 2015. Resolution RDC n. 15, 24 on technical requirements for the granting of registration toiletries, cosmetics and children's perfumes and other measures.
6. ANVISA, 2015. Resolution RDC n. 40, 26 on the registration requirements for medical products.
7. ANVISA, 2015. Resolution RDC n. 60, 10 defining the criteria for granting and renewal of drug registration with synthetic and semi-synthetic active ingredients, classified as new, generic and similar, among other provisions....
8. J. Baumann, Y. Sakka, C. Bertrand, J. Koser, and J. Filser Adaptation of the Daphnia sp: acute toxicity test: miniaturization and prolongation for the testing of nanomaterials Environ. Sci. Pollut. Res. Int. 21 2014 2201 2213
9. S. Beyer, A. Moosmann, A.S. Kahnt, T. Ulshofer, M.J. Parnham, N. Ferreiros, S. Wagner, and M.G. Wacker Drug release and targeting: the versatility of polymethacrylate nanoparticles for peroral administration revealed by using an optimized in vitro-toolbox Pharm. Res. 2015
10. U. Bhardwaj, and D.J. Burgess A novel USP apparatus 4 based release testing method for dispersed systems Int. J. Pharm. 388 2010 287 294
11. Brazilian Chamber of Deputies, 2013. Bill n. 6741/2013 amending law no. 9605 (1998).
12. S. Brunauer, P.H. Emmett, and E. Teller Adsorption of gases in multimolecular layers J. Am. Chem. Soc. 60 1938 309 319
13. J.W. Card, D.C. Zeldin, J.C. Bonner, and E.R. Nestmann Pulmonary applications and toxicity of engineered nanoparticles Am. J. Physiol. - Lung Cell. Mol. Phys. 295 2008 L400 L411
14. DIN, 2014. Determination of the specific surface area of solids by gas adsorption - BET method (DIN ISO 9277:2014-01).
15. EC, 2011. Commission Recommendation on the Definition of Nanomaterials (2011/696/EU).
16. ECHA, 2012. Guidance on information requirements and chemical safety assessment.
17. ECHA, 2013. Human health and environmental exposure assessment and risk characterisation of nanomaterials - Best practice for REACH registrants (ECHA-14-R-10-EN).
18. ECHA, 2013. IUCLID 5 - Guidance and Support - Nanomaterials in IUCLID 5 (v 2.0).
19. ECHA, 2014. How to ensure the safe use of nanomaterials under REACH - Part I-III (Webinar).
20. EFSA Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain EFSA J. 9 2011 2140 2176
21. EFSA Guidance for submission for food additive evaluations EFSA J. 2012 10
22. EFSA Annual Report of the EFSA Scientific Network of Risk Assessment of Nanotechnologies in Food and Feed for 2014 2014 EFSA supporting publication
23. EMA, 2006. Reflection paper on nanotechnology-based medicinal products for human use (EMEA/CHMP/79769/2006).
24. EMA, 2013. Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products (EMA/CHMP/13099/2013).
25. EMA, 2013. Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products (EMA/325027/2013).
26. EMA, 2013. Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product.
27. EMA, 2013. Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product (EMA/CHMP/806058/2009/Rev. 02).
28. EPA (OCSPP), 2010. Nanoscale Materials; Reporting Under TSCA Section 8(a) (2070-AJ54).
29. EPA (OCSPP), 2010. Nanoscale Materials; Significant New Use Rule (SNUR) (2070-AJ67).
30. EPA (OCSPP), 2014. Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule (2070-AJ54).
31. EU, 2002. Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food. Safety Authority and laying down procedures in matters of food safet.
32. EU, 2004. Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
33. EU, 2011. Regulation (EU) No. 1169/2011 on the provision of food information to consumers.
34. EU, 2011. Regulation (EU) No. 1223/2009 on cosmetic products.
35. EU, 2013. Commission delegated regulation (EU) No 1363/2013 of 12 December 2013 amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers as regards the definition of 'engineered nanomaterials'.
36. EU, 2013. Corrigendum to Commission Delegated Regulation (EU) No 1363/2013 of 12 December 2013 amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers as regards the definition of 'engineered nanomaterials'.
37. A. Engel, M. Ploger, D. Mulac, and K. Langer Asymmetric flow field-flow fractionation (AF4) for the quantification of nanoparticle release from tablets during dissolution testing Int. J. Pharm. 461 2013 137 144
38. FDA, 1938. Federal Food, Drug, and Cosmetic Act (FD&C Act).
39. FDA, 1958. Food Additive Amendment.
40. FDA, 2000. Redbook: Guidance for Industry and Other Stakeholders Toxicological Principles for the Safety Assessment of Food Ingredients.
41. FDA, 2002. Liposome Drug Products - Chemistry, Manufacture, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.
42. FDA, 2007. Nanotechnology - A report of the US Food and Drug Administration Nanotechnology Task Force.
43. FDA, (2014a). Final Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives.
44. FDA, (2014b). Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.
45. FDA, (2014c). Final Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.
46. FDA, (2015a). Final Guidance for Industry: Use of Nanomaterials in Food for Animals.
47. FDA, (2015b). Use of Nanomaterials in Food for Animals.
48. T.J. Franz percutaneous absorption: on the relevance of in vitro data J Investig Der 64 1975 190 195
49. M. Geiser, O. Quaile, A. Wenk, C. Wigge, S. Eigeldinger-Berthou, S. Hirn, M. SchÃ, C. Schleh, W. M.A;tildller, M.A. Mall, and W.G. Kreyling Cellular uptake and localization of inhaled gold nanoparticles in lungs of mice with chronic obstructive pulmonary disease Part. Fibre Toxicol. 10 2013 19-19
50. C. Gido, P. Langguth, J. Kreuter, G. Winter, H. Woog, and E. Mutschler Conventional versus novel conditions for the in vitro dissolution testing of parenteral slow release formulations: application to doxepin parenteral dosage forms Pharmazie 48 1993 764 769
51. A. Guillot, A.C. Couffin, X. Sejean, F. Navarro, M. Limberger, and C.M. Lehr Solid phase extraction as an innovative separation method for measuring free and entrapped drug in lipid nanoparticles Pharm. Res. 2015
52. ICCP, 2011. Report of the Joint Regulator - Industry Ad Hoc Working Group: Currently Available Methods for Characterization of Nanomaterials....
53. ISO, 2009. Biological evaluation of medical devices (ISO-110993:2009).
54. D.S. Jarvis, and N. Richmond Regulation and Governance of Nanotechnology in China: Regulatory Challenges and Effectiveness 2011
55. C. John, and K. Langer Asymmetrical flow field-flow fractionation for human serum albumin based nanoparticle characterisation and a deeper insight into particle formation processes J. Chromatogr. A 1346 2014 97 106
56. D. Juenemann, E. Jantratid, C. Wagner, C. Reppas, M. Vertzoni, and J.B. Dressman Biorelevant in vitro dissolution testing of products containing micronized or nanosized fenofibrate with a view to predicting plasma profiles Eur. J. Pharm. Biol. 77 2010 257 264
57. KATS, 2009. KS A 6202 Guidance to safe handling of manufactured nanomaterials in workplace/industry. 27 p.
58. W.G. Kreyling, M. Semmler-Behnke, and Q. Chaudhry A complementary definition of nanomaterial Nano Today 5 2010 165 168
59. MHLW, 2008. Notification on present preventive measures for the prevention of exposure at workplaces manufacturing and handling nanomaterials.: 27 p.
60. L. Ma-Hock, A.O. Gamer, R. Landsiedel, E. Leibold, T. Frechen, B. Sens, M. Linsenbuehler, and B. van Ravenzwaay Generation and characterization of test atmospheres with nanomaterials Inhalation Toxic 19 2007 833 848
61. H.M. Mansour, Y.-S. Rhee, and X. Wu Nanomedicine in pulmonary delivery Int. J. Nanomed. 4 2009 299 319
62. R.C.M. Marques, R. Loebenberg, and A. Almukainzi Simulated biological fluids with possible application in dissolution testing diss Technology 18 2011 15 28
63. A.D. Maynard Don't define nanomaterials Nature 475 2011 31-31
64. F.J. Miller, J.S. Kimbell, R.J. Preston, J.H. Overton, E.A. Gross, and R.B. Conolly The fractions of respiratory tract cells at risk in formaldehyde carcinogenesis Inhal. Toxicol. 23 2011 689 706
65. T. Miller, R. Rachel, A. Besheer, S. Uezguen, M. Weigandt, and A. Goepferich Comparative investigations on in vitro serum stability of polymeric micelle formulations Pharm. Res. 29 2011 448 459
66. NIOSH, 2013. Current strategies for engineering controls in nanomaterial production and downstream handling processes.; Publication no. 2014-102.
67. OECD, 1997. Test No. 471: Bacterial Reverse Mutation Test.
68. OECD, 1997. Test No. 476: In vitro Mammalian Cell Gene Mutation Test.
69. OECD, 2004. Test No. 428: Skin Absorption: In Vitro Method.
70. OECD, 2010. Test No. 487: In Vitro Mammalian Cell Micronucleus Test.
71. OECD, 2014. Genotoxicity of Manufactured Nanomaterials: Report of the OECD Expert Meeting (ENV/JM/MONO(2014)34.
72. OECD, 2014. Report of the OECD expert meeting on physical chemical properties of manufactured nanomaterials and test guidelines: Series on the Safety of Manufactured Nanomaterials No. 41 (ENV/JM/MONO(2014)15).
73. OECD, 2016. Physical-chemical parameters: measurements and methods relevant for the regulation of nanopaterials: OECD Workshop Report Series on the Safety of Manufactured Nanomaterials No. 63 (ENV/JM/MONO(2016)2).
74. Poto, M.; 2011. Food and nano-food within the Chinese regulatory system: no need to have overregulation. Less physicality can produce more power.
75. J. Qiu Nano-safety studies urged in China Nature 489 2012 350
76. D. Sättler, F. Schnöder, N. Aust, A. Ahrens, C. Bögi, T. Traas, and J. Tolls Specific environmental release categories - A tool for improving chemical safety assessment in the EC - report of a multi-stakeholder workshop Integr. Environ. Assess. Manag. 8 2012 580 585
77. SAC, 2004. GB/T19591-2004 Nano-titanium dioxide.
78. SAC, 2004. GB/T 19619-2004 Terminology for nanomaterials.
79. SAC, 2006. GB/T 20307-2006 General rules for nanometer-scale length measurement by SEM.
80. SAC, 2009. GB/T 22925-2009 Nanotechnology-treated clothes.
81. SCCS, 2012. Guidance on the Safety Assessment of Nanomaterials in Cosmetics.
82. SCCS, 2012. The SCCS's Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation.
83. SCENIHR, 2010. Scientific Basis for the Definition of the Term Nanomaterial.
84. SCENIHR, 2015. Final Opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.
85. SFDA, (2012). SFDA letter no. 57: Soliciting non-special purpose cosmetics. from http://www.sda.gov.cn/WS01/CL0781/69195.html.
86. X.-L. Shi, Q. Wang, K. Hu, and X.-M. Wang Exploration on the safety assessment of nanomaterials in China Interface 2 2012 387 392
87. K.C. Stone, R.R. Mercer, P. Gehr, B. Stockstill, and J.D. Crapo Allometric relationships of cell numbers and size in the mammalian lung Am. J. Respir. Cell Mol. Biol. 6 1992 235 243
88. W. Utembe, K. Potgieter, A.B. Stefaniak, and M. Gulumian Dissolution and biodurability: important parameters needed for risk assessment of nanomaterials Part. Fibre Toxicol. 12 2015 11
89. M. Villa Nova, C. Janas, M. Schmidt, T. Ulshoefer, S. Gräfe, S. Schiffmann, N. de Bruin, A. Wiehe, V. Albrecht, M.J. Parnham, M. Luciano Bruschi, and M.G. Wacker Nanocarriers for photodynamic therapyâ€rational formulation design and medium-scale manufacture Int. J. Pharm. 491 2015 250 260
90. M.G. Wacker Nanotherapeutics-product development along the nanomaterial discussion J. Pharm. Sci. 103 2014 777 784
91. V. Weissig, T.K. Pettinger, and N. Murdock Nanopharmaceuticals (part 1): products on the market Int. J. Nanomed. 9 2014 4357 4373