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, ( / ).

Summary Due to the recent increase in hygienic and environmental interest on the detergent, questions from the public are exploding. Accordingly, the promotion of the safety measures regarding the contaminants originated from the use of detergents and sanitizers is urgently needed. In this study, therefore, we have tried to propose a draft for the revision of the standards for detergent after a thorough literature review, survey on the current domestic situation and clinical laboratory analyses of the detergent effect. From this study we found that the applicability of the term 'detergent' was not clear and it was difficult to differentiate between the type 1 and the type 2 detergents. And as the most important issue, the manufacturing standards for the detergent arouse. In addition to this, there was no standard on the raw material for the type 1 detergent and, the narrow profile of raw materials for the type 2 detergent was prohibiting the development of new products. The ph of the product and the concentration of surfactant were other points of concern, also. Based on the above-mentioned review and analyses, we are proposing followings as a draft for the revision of the current standards and measures for the detergent. - New list of raw materials for the detergent, including type 2 detergent, which were formulated according to the comments of the advisory committee of industries and the pool of raw materials being used currently is provided. - The procedure and materials required to submit at the registration of new materials are suggested. - Standard for ph of the detergent is proposed to be mild alkaline based on the clinical laboratory analyses of the ph effect on hand skin. - The detergent for fruits and vegetables were taken out of the type 1 detergent class for separate handling because that needs higher level of hygienic measures.

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(Regulations of synthetic detergent in Korea) - 7 -

(KS standards of dishwashing detergent),,,,, 100%,, 70% (1) - 100% - - (P 2 0 5 ) 1% - 100% - (P 20 5) 1% - (Refill) - 70% (2) - 70% - - (P 2 0 5 ) 1% - (Refill),,,,, KS M 2751( ), KS M 2752( ), KS M 2753( ), KS M 2754( ), KS M 2755( ) - 8 -

(Comparison of standards of detergent between 'Public Hygiene Law' and KS) ph ( /g) (ppm) (ppm) 1 2 ( ), ( ) 6.0 8.0 6.0 8.0 - - 7.0 10.5 7.0 10.5 (25 ) 6.0 10.5 () 1 1 ( ( - 1 1 ) ) 0.05 0.4 () () 1 2 () () 0.4 () 0.05 (As) 0.05 (Pb) 0.05 (Pb) 2 1 1 1 () (As) (Pb) (Pb) N.D N.D N.D N.D N.D N.D (%) 200 600 ( /l) (%) 90 (%) 35 70 50 20 (%) 0.3 0.1 (%) 3 1.5 (%) 45 (%) : ph,, 6.7g/l. 30. - 9 -

(Regulations of soap and detergent in Japan) - 10 -

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(Standards of detergent in Japan - 'Food Hygiene Law') LAS, AES, 150 30 (Pb) 0.05 / 0.05 / ph 6.0 8.0 6.0 8.0 1 /g 1 /g,. 2. 2 -RS, -V,, BS. 85% ( ) 0.1% 0.5%, 5, 30, 5 2. - 12 -

(Standard and analytical methods of automatic dishwashing detergent in Japan) (NaOH)*1 0.01% JIS K-3304 *2 (P 2 O 5 )*1 0.06% K-3362 90% K-3363 *3 K-3362 *4 *5 K-3362 (As) *1 0.05 /L K-3362 (Pb) *1 1.0 /L K-3362 *6 1g 1 *7 K-3362 *5-13 -

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(Regulations of household products containing toxic substances in Japan) 10%( ) ( ) 5%( ( ) ) 5% ( (aerosol) ) 0.1% ( (aerosol) ) (aerosol) ( ) - 16 -

(Product Performance Test Guidelines in the USA) - 17 -

(FIFRA Efficacy Levels and Claim Support for Hard Surface Sanitizers and Disinfectants) - 18 -

(FIFRA Efficacy Levels and Claim Support for Hard Surface Sanitizers and Disinfectants) - 19 -

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(HARMONIZED EUROPEAN DISINFECTION STANDARDS in EU - Tiered Approach) - 21 -

(Food Domestic and Institutional Applications in EU - Standard test method to be used to supp products) - 22 -

(Bactericidal activity - Food, industrial, domestic and institutional area - Obligatory conditions) - 23 -

(Fungicidal activity - Food, industrial, domestic and institutional area - Obligatory conditions) - 24 -

(Virucidal activity - Food, industrial, domestic and institutional area - Obligatory conditions) (Sporicidal activity - Food, industrial, domestic and institutional area - Obligatory conditions) - 25 -

Biocide,,,,,,. biocide 1980 OECD. Biocide, biocide.,,, biocide. Biocide. - 26 -

(Regulations of the detergents and antimicrobial products in various countries) - 27 -

(Regulations and performance test methods of antimicrobial products in various countries) - 28 -

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(Classification of antimicrobial pesticide in the USA EPA) (Antimicrobial agents) (Sterilizers) (Disinfectants) (Sanitizers) (Antiseptics and Germicides),,,, ( ), :,,,, :,, :,,, :,, FDA - 37 -

(Antimicrobial treatment methods in Japan) sanitation) - 38 -

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(Total number of civil inquiry between 1998-2000) (Contents of civil inquiry between 1998-2000) 1 2. - 49 -

(Number of employee according to company scale) (Number of company by sale amount) - 50 -

(Classes of the detergent) (Interested technical Interest areas by industry) - 51 -

(Problems of the industry on marketing, manufacturing and product development) (Problems of the industry on the new product development) - 52 -

(Concern of the industry over marketing, manufacturing and product development) (Performance test by the standard of detergent for the certification of final product quality) (Existence of Lab-facilities) - 53 -

(Expansion of the facilities and equipment, and supplement of the personel in the future) (Correspondent regulation to the products) - 54 -

(Unification of the detergent regulations) (Problem of the current detergent law) - 55 -

(Priority of the revision of the detergent standard) (Priority of the revision of the standard) - 56 -

(Rationality of the final product standard and specification) (Priority of the revision of product manufacturing standard) - 57 -

(Ingredients, not permitted for the use of detergent class 1) (Classification of antimicrobial product and sanitizer) - 58 -

(Classification of fruit and vegetable washing detergents) (Classification of food washing detergents) - 59 -

(Type of the products on the market and risk management) - 60 -

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(Ingredients list of the detergent) - 62 -

(Ingredients list of the detergent in Japan) - 63 -

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(Advantage and disadvantages of the detergent regulation by ingredient standard) - 65 -

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(Major contents in draft proposal for the revision of detergent standard & specification) - 67 -

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1. SEYMOUR S. BLOCK : Disinfection, Sterilization, and Preservation, Third Edition, LEA&FEBIGER philadelphia(1983) 2. : (1998) 3. : ( ) (1999) 4. : Q&A (1995) 5., : Biocides, (1999) 6. Erich Lueck : Antimicrobial Food Additives character Uses Effects, Springer-Verlag Berlin Heidelberg New York(1980) 7. OECD Environmental Health and Safety Publications No. 9 - Report of the Survey of OECD Member Countries' Approaches to the Regulation of Biocides(Annex 4) - Environment Directorate ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT Paris(1999) 8. Proposals for the Biocidal Products Regulations(BPR) and Approved Code of Practice on test methods for data submitted under the BPR, Health&Safety Commission(1999) 9., (1998) 10. :, (1993) 11. :, (1995) 12. : Q&A -, - (1996) 13. : - ( - 85 -

) - (1990) 14. : ( 3) - - - (1992) 15. :, p.326 (1983) 16. Kenkichi OBA, Reiko TAKEI : - (Risk Management and Synthetic Detergent Problems) (1985) 17. FDA/CFSAN OPA : SANITIZING SOLUTIONS - CHEMISTRY GUIDELINES FOR FOOD ADDITIVE PETITIONS(1993) 18. J. F. GRIFFITH, J. E. WEAVER, H. S. WHITEHOUSE : Safety Evaluation of Enzyme Detergents. Oral and Cutaneous Toxicity, Irritancy and Skin Sensitization Studies, Fd Cosmet. Toxicol. Vol. 7, p.581-593(1969) 19. R. MASON BOLAM, R. HEPWORTH, L. T. BOWERMAN : In-use Evaluation of Safety to Skin of Enzyme-Containing Washing Products, British Medical Journal, 2, p.499-501(1971) 20. (Britannica), Britannica. Inc. 21. : (1999) 22. The Soap and Detergent Association : Cleaning Products Overview - Soaps and Detergents 23. Sanitizing solutions, Code of Federal Regulations Title 21, Vol. 3, Parts 178.1010 (1999) 24. : MSDS(Meterial Safety Data Sheet) 25. : 26. : 27. : 28. : 29. : - 86 -

30. : 31. : 32. Public Health Reasons/Administrative Guidelines 33. Official Journal of the European Communities : DIRECTIVE 98/8/EC OF THE EUROPEAN PARILIAMENT AND OF THE COUNCIL(1998) 34. Official Journal of the European Communities : Community legislation in force - Council Directive 73/404/EEC of 22 Nov. 1973 on the approximation of the laws of the Member States relating to detergents (1973) 35. Official Journal of the European Communities : Community legislation in force - Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (1967) 38. Official Journal of the European Communities : Community legislation in force - 89/542/EEC: Commission Recommendation of 13 September 1989 for the labelling of detergents and cleaning products (1973) 39. Official Journal of the European Communities : Community legislation in force - Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1998) 40. United States Environmental Protection Agency(EPA) : Office of Pesticide Programs - Antimicrobial Pesticide Products(1999) 41. OECD Pesticide Programme : Biocides-non-Agricultural Pesticides (2000) 42. Pascal Cardonnel, Koen. Van Maldegem : The Biocidal Products Directive, European Environmental Law Review(1998) 43. United States Environmental Protection Agency(EPA) : Product Performance Test Guidelines - OPPTS 810.2000 General Requirments for Public Health Uses of Antimicrobial Agents (1997) 44. United States Environmental Protection Agency(EPA) : Product Performance Test Guidelines - OPPTS 810.2100 Products for Use on Hard - 87 -

Surfaces-Basic Efficacy Data Requirement (1997) 45. Aram Beloian : Disinfectants, AOAC OFFICIAL METHODS OF ANALYSIS Chapter 6. p.1-18 (1995) 46. :, 47., (2000) 48. Chemical disinfectants and antiseptics -Basic fungicidal activity- Test method and requirements(phase 1), The European Standard EN 1275 : British standard (1997) 49. Chemical disinfectants and antiseptics -Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas- Test method and requirements(phase 2, step1), The European Standard EN 1650 : British standard (1997) 50. EPA : Product Performance Test Guidelines - OPPTS 810.2000 General Requirements for Public Health Uses of Antimicrobial Agents (1997) - 88 -

() ()

1 : 2 : 3 : ph () 4 : pool I, II 5 : ( ) 6 : () 7 : Q & A ()

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알칼리성가정용식기세척제의 손피부에미치는영향 요약 - 19 -

I. 서론 - 20 -

II. 재료및방법 1. 재료 2. 피험자 3. 피험자모집기준 4. 실험절차 - 21 -

5. 임상실험결과측정 6. 통계분석 - 22 -

9 8 7 6 5 4 3 2 1. - 23 -

0 1 2 3 4 5 6-24 -

III. 결과및결론 - 25 -

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Overall Hand Skin Grades (expressed as deltas) 0.2 0.1 0.0-0.1-0.2-0.3-0.4-0.5-0.6-0.7 0 1 2 3 4 Days ph 7.4 ph 10.0 ph 10.8 Fig. 1. Time-dependent effects of alkalinity of household cleansing solutions on overall hand skin conditions. - 27 -

Dry Hand Skin Grades (expressed as deltas) 0.5 0.4 0.3 0.2 0.1 0.0-0.1-0.2 ph 7.4 ph 10.0 ph 10.8 0 1 2 3 4 Days Fig. 2. Time-dependent effects of alkalinity of household cleansing solutions on dry hand skin conditions. - 28 -

15 Capacitance (expressed as deltas) 10 5 0-5 -10-15 ph 7.4 ph 10.0 ph 10.8-20 0 1 2 3 4 Days Fig. 3. Time-dependent effects of alkalinity of household cleansing solutions on the degrees of hand skin hydration. - 29 -

IV. References 1. Kirsner, R.S., and Froelich, C.W. Soaps and detergents : understanding their composition and effect. Ostomy. Wound Manage. 44(3A Suppl) : 62S -69S, 1998. 2. Marks, R., and Dykes, P.J. The effects of detergent action of cleansing agents on the skin. Wien. Med. Wochenschr. Suppl. 108 : 16-18, 1990. 3. Wolf, R., and Fridman, M. Measuement of the skin-cleaning effects of soaps. Int. J. Dermatol. 35: 598-600, 1996. 4. Burckhardt, W. Neuere untersuchungen uber die alkaliempfindlichkeit der haut. Dermatologica. 94 : 74-96, 1947. 5. Klauder, J.V., and Gross, B.A. Actual causes of certain occupational dermatoses : further study with special reference to effect of alkali on skin, effect of soap on ph of skin, and modern cutaneous detergents. Arch. Derm. Sypn. 63 : 1-23, 1951. 6. Pillsbury, D.M., and Shaffer, B. Cutaneous reaction with reference to the surface ph, the reaction to ointments and solutions of different ph and effect of the skin in modifying the ph of applied solutions. Arch. Derm. Syph. 39 : 253-267, 1939. 7. Suskind, R.R., and Rebello, D. J. A. Role of ph of household cleansing solutions in hand dermatitis. Arch. Derm. Syph. 88 : 61-65, 1963. 8. Michael, F. L., Frank, E.D., Scott, E.M., Martha, O.V., and Debra, D.W. Forearm wash test to evaluate the clinical mildness of cleansing products. J. Soc. Cosmet. Chem. 39 : 355-366, 1988. 9. van Ketel, W. G., Bruynzeel, D.P., Bezemer, P.D., and Stamhuis, H.I. Toxicity of handcleaners. Dermatologica. 168(2) : 94-99, 1984. - 30 -

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