1. 살균소독제 안전성유효성 평가 Components of Antimicrobial Efficacy 한국보건산업진흥원 조 양 희
살균소독제 안전성유효성 평가
Components of Antimicrobial Efficacy
Formula
Test Method
Use Condition
한국보건산업진흥원 조 양 희

2. 연구 배경 식중독 대형화 추세 다양한 살균소독제 개발 식품에 간접적으로 잔류 살균, 소독, 멸균 등 효능 표시 : 소비자 인식
미생물로 인한 부패 또는 변패 방지 관심증가
다양한 살균소독제 개발
개발 요구 증가 및 선진 외국 제품 개발
무역 마찰 요인
식품에 간접적으로 잔류
안전성 요구
살균, 소독, 멸균 등 효능 표시 : 소비자 인식
유효성 평가 요구

3. 관련 문헌 고찰 국내 시장 현황 연구추진 체계 안전성 평가지침 유효성 평가지침 안전성 평가기준 표시 기준 유효성 평가기준 제품유형 표시 사항
독성 자문위원 제품
적용 범위
안전성
평가지침
유효성
평가지침

4. 식중독 주요 원인 균 비교 순위 일본 한국 미국 1 Salmonella 2 Vibrio Staphylococcus
Clostridium 3
E. Coli 4 5
Bacillus

5. 관련근거 : 식품위생법 제7조제2항, 제9조제2항 및 시행규칙 제4조제1항 살균소독제 인정제도란?
제 호
배경 : 식품위생법 개정 ( 공포, 시행) 신설
관련근거 : 식품위생법 제7조제2항, 제9조제2항 및 시행규칙 제4조제1항
살균소독제 인정제도란?
제2조(정의)제2호 “식품첨가물”이라함은 식품을 제조·가공 또는 보존함에 있어 식품에 첨가·혼합·침윤 기타의 방법으로 사용되는 물질(기구 및 용기·포장의 살균·소독의 목적에 사용되어 간접적으로 식품에 이행될 수 있는 물질을 포함한다.)을 말한다.
기구 등의 살균소독제 제품은 유효성분 및 보조성분의 종류 및 배합비율에 따라 여러종류의 제품 조합이 가능하므로 개개의 제품별로 사용기준에 따른 유효성과 안전성을 검토하여 인정하는 제도임(“기구등 살균소독제의 한시적 기준 및 규격인정”)
살균소독제 제품이란?
일반주방업소, 단체급식업소 등에서 사용하는 식기류, 식품의 가공기구 조리기구, 식품공장의 제조 기기 및 설비 등에 사용되어 유해미생물에 대해 살균소독 작용을 하는 제품으로 사용목적에 따라 살균소독제를 처리한 후 헹구지 않고 사용되거나 음용에 적합한 물로 헹구는 제품
살균소독제 인정제품( ) : 총 152제품

6. 관련규정 평가방법 AOAC EU-BPD Biocides 유럽연합 CEN EPA-FIFRA APs 미 국 한 국 m-CEN*
미 국
한 국
식품위생법
살균소독제
m-CEN*

7. Non-public health products
Control growth of algae, odor-causing bacteria, bacteria which cause spoilage, deterioration or fouling of materials and microorganisms infectious only to animals
Cooling towers, jet fuel, paints, and treatments for textile and paper products
Public health products
Control microorganisms infectious to humans in any inanimate environment
Used to destroy or eliminate all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Spores are considered to be the most difficult form of microorganism to destroy.
1. Sterilizers
(Sporicides)
Hospitals (medical and surgical, instruments and equipment)

8. Public health products
Used on hard inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria but not necessarily their spores.
2. Disinfectants
Hospital use
General used (households, swimming pools, and water purifiers)
3. Sanitizers
Used to reduce, but not necessarily eliminate, microorganisms from the inanimate environment to levels considered safe as determined by public health codes or regulations.
Carpet, Air, Laundry additives, in-tank toilet bowl
Non Food Contact Sanitizers
Food Contact Sanitizers

9. Public health products
3. Sanitizers
Used to reduce, but not necessarily eliminate, microorganisms from the inanimate environment to levels considered safe as determined by public health codes or regulations.
Dish, cooking utensils, equipment and utensils found in dairies, food-processing plants etc.
Non Food Contact Sanitizers
Food Contact Sanitizers
4. Antiseptics and
Germicides
Used to prevent infection and decay by inhibiting the growth of microorganisms.
On living humans or animals
Drug FDA

12. Bacillus subtilis (ATCC 19659) and Clostridium Sporogenes (ATCC 3584)
Level of Activity
Test Method, AOAC
Test Microorganisms
Total No.of Carriers
Performance Standard
STERILIZE-RS
Sporicide Test Method
Bacillus subtilis (ATCC 19659) and Clostridium Sporogenes (ATCC 3584)
Killing on all 720 carriers
720
60 carriers X 2 type of surface X 3 samples X 2 type of test organism
DISINFECTANTS
Use-Dilution (solids & liquids) or Germicidal Spray (sprays)
Salmonella choleraesuis (ATCC 10708) or Stapylococcus aureus (ATCC 6538)
Limited
Efficacy
Must kill 59 out of each 60 carriers
180
60 carriers X 1 type of surface X 3 samples X 1 type of test organism

13. Use-Dilution (solids & liquids) or Germicidal Spray (sprays)
Level of Activity
Test Method, AOAC
Test Microorganisms
Total No.of Carriers
Performance Standard
Use-Dilution (solids & liquids) or Germicidal Spray (sprays)
General
or Broad
Spectrum
Efficacy
Salmonella choleraesuis (ATCC 10708) and Stapylococcus aureus (ATCC 6538)
Must kill 59 out of each 60 carriers
360
60 carriers X 1 type of surface X 3 samples X 2 type of test organism
Hospital or
Medical
Environment
Efficacy
Use-Dilution (solids & liquids) or Germicidal Spray (sprays)
Salmonella choleraesuis (ATCC 10708) and Stapylococcus aureus (ATCC 6538) and Pseudomonas aeroginosa (ATCC 15442)
Must kill 59 out of each 60 carriers
540

14. Enterobacter aerogenes (ATCC 13048)
Level of Activity
Test Method, AOAC
Test Microorganisms
Test Condition
Performance Standard
SANITIZERS
For
Nonfood
Contact
Surfaces
USEPA’s Test Method (91-30,D8)
Stapylococcus aureus (ATCC 6538) and Klebsiella pneumoniae (ATCC 4352) (e)
One test on each represen-tative surface
99.9% reduction compared to control within 5 minutes
Enterobacter aerogenes (ATCC 13048)
For Food Contact Surfaces
ASTM E
* For Halides
Available Chlorine Germicidal Equivalent Concentrat-ion Method
Salmonella typhi (ATCC 6539) or Stapylococcus aureus (ATCC 6538)
One test on each of 3 samples
Concentration equivalent to 50, 100 and 200 ppm available chlorine
3 different batch
( 1 : 60days old)

15. Level of Activity
Test Method, AOAC
Test Microorganisms
Total No.of Carriers
Performance Standard
For Food Contact Surfaces
* For Other
Products
Germicidal and Detergent Sanitizers Method
Escherichia coli (ATCC 11229) Stapylococcus aureus (ATCC 6538)
One test on each of 3 samples
99.999% reduction in each test organism within 30 seconds
Reference : USEPA Pesticide Assessment Guidelines Subdivision G : Product Performance, Part 91-2.

16. Standard Operating Procedure (SOPs)
A part of the Antimicrobials and Plant Pathogens Branch of the Biological and Economic Analysis Division (BEAD)
Standard Operating Procedure (SOPs)
SOPs for antimicrobial testing methods to determine the efficacy of hard surface disinfectants
Antimicrobial Testing Methods & Procedures (ATMP)
Methods
11 ID Numbers (10 open)
Procedures
37 ID Numbers (34 open)
* OPP : Office of Pesticide Programs

17. Ch- 6. Disinfectants Subchapter 1 : PHENOL COEFFICIENT METHODS(3)
Emma Singleton, Chapter Editor, U.S. Food and Drug Administration
Subchapter 1 : PHENOL COEFFICIENT METHODS(3)
Test Disinfectants against
Sallmonella typhi
(ATCC 6539)
Phenol Coefficient Method
First Action 1955
Final Action 1964
AOAC Official Method
955.11
EPA PR(Pesticide Registration) Notice (2001/6/19)
FIFRA SAP (Scientific Advisroy Panel)
“Elimination of Phenol Resistance Testing for Antimicrobial Disinfectant and Sanitizer Pesticides”
First Action 1955
Final Action
Test Disinfectants against
Staphylococcus aureus
(ATCC 6538)
Phenol Coefficient Method
AOAC Official Method
955.12
First Action 1955
AOAC Official Method
Test Disinfectants against
Pseudomonas aeruginosa
(ATCC 15442)
Phenol Coefficient Method

18. Subchapter 2 : HARD SURFACE CARRIER TEST METHODS(6)
AOAC Official Method
955.14
Testing Disinfectants against Salmonella choleraesuis (ATCC 10708)
Use-Dilution Method
First Action 1955
Final Action 1959
Repealde F.A 1988
Surplus 1993
AOAC Official Method
955.15
Testing Disinfectants against Staphylococcus aureus (ATCC 6538)
Use-Dilution Method
First Action 1955
Final Action 1959
Repealde F.A 1988
Surplus 1993
AOAC Official Method
964.02
Testiing Disinfectants against Pseudomonas aeruginosa (ATCC 15442)
Use-Dilution Method
First Action 1964
Surplus 1993
AOAC Official Method
991.47
Testing Disinfectants against Salmonella choleraesuis (ATCC 10708)
Hard Surface Carrier Test Method
First Action 1991
AOAC Official Method
991.48
Testing Disinfectants against Staphylococcus aureus (ATCC 6538)
Hard Surface Carrier Test Method
First Action 1991
AOAC Official Method
991.49
Testing Disinfectants against Pseudomonas aeruginosa (ATCC 15442)
Hard Surface Carrier Test Method
First Action 1991

19. “Andistand” (SMT4-CT98-2222) Project
– Produce Standards (Test Methods) – Antimicrobial efficacy of Chemical Disinfectant and Antiseptics (published : 15, Development : 18)
The Development of Test Methods
Horizontal Working Group
- Harmonization Task Group
- Ring Trial Task Group
– 4 Working Groups(WGs)
HWG
Basic test method (Phase 1), Ring trial tests
3(4)
WG1
Human Medicine market
5(20)
WG2
Veterinary market
3(8)
WG3
Food Hygiene, Domestic and Institutional market
5(7)
“Andistand” (SMT4-CT ) Project
: Inter-, and Intra-laboratory Ring trial tests

20. “Disinfects Surface” or “Surface disinfectant”
Phase
Test Type
Standard
Test Method
Phase 1
Quantitative suspension test under “clean” conditions for basic activity
105 (B)
EN 1040
104 (F)
EN 1275
104 (S)
prEN 14347
Phase 2
Step 1
Quantitative suspension test under conditions representative of practical use
EN 1276
EN 1650
103 (S)
EN 13704
103 (V)
EN 13610
Step 2
Quantitative surface test simulating practical conditions
104 (B)
EN 13697
103 (F)
Phase 3
Field test under practical condition
“No Claim”
“Disinfectant”
“Disinfects Surface” or “Surface disinfectant”

21. US-EPA (AOAC) EU-CEN (EN) 960.09(GDS) 955.16(ACE) Phase 1 P 2-Step 1
기 준
99.999%
Same
99.999%
Staphylococcus aureus
(ATCC 6538) and
Escherichia coli
(ATCC11229)
Salmonella typhi
(ATCC 6539) or
Staphylococcus aureus
(ATCC 6538)
Escherichia coli(ATCC 10536)
Staphylococcus aureus(ATCC 6538)
Pseudomonas aeruginosa(ATCC 15442)
Enterococcus hirea(ATCC 10541)
시험균
시험조건
25°C/30s
20°C/1min
20°C(4,10,40)/5min(15,30,60)
간섭물질
Organic soil(optional)
Bovine Albumin 외 5종
중화제
중화배양액(optional)
기본중화혼합제 외 15종 정량
Suspension 비교
Suspension 정량
Suspension 정량
Suspension 특징
GDS: Germicidal & Detergent Sanitizer
ACE: Avaliable Chlorine Germicidal
Equivalent Concentration 비고
P2-Step1 : Phase 2 Step1

22. ITEM
CEN EN 13697
(2001)
ASTM QCT-1
(2000)
ASTM QCT-2
(2002)
CARRIERS
Stainless Disk
Glass Vial
SOIL LOAD
BSA Alone
Two Level
Tripartite Mix
One Level
REPLIACTES
???
5-10 Test &
3 control
INOCULUM
50㎕
10 ㎕
TEST AGENT
100 ㎕ /Carrier
50 ㎕ /Carrier
ELUTION
Rotation on Beads
Votex/Sonication
CFU ASSAY
-20% Eluate
Pour plate
Entire Eluate, Membrane Filter
PERFORMANCE CRITERION
4 log10
4log10 - 6log10

23. QCT 시험방법 비교 시험법 항목 ASTM E2111 E2197 CEN 13697 AOAC UDM HST Method Type
QHST
QCT
Carrier Type GV SD SC GC
Test Microbes
B(3)/F(1)/S(2)
B(3)/F(1)/S(2)/V(4)
B(3)/F(2)
B(3)
Soil load
TSL
BSA/2S -
IV/SV
10/50㎕
50/100㎕
0.5/10㎖
Test Condition
optional
RT/5m
20℃/10m
R/C MF PC G
Standard
4-6 log
4 log
NG/360

24. 살균소독제 유효성평가 방법 다양화 Harmful Microbes Disease Surrogate Microbes
Coronavirus
SARS
Poliovirus type 1
(Sabin vaccine strain)
HIV
AIDS
norovirus
Food poisoning
Bacillus anthracis
Antrax
Bacillus atrophaeus
Mycobacterium tuberculosis
Tuberculosis
Mycobacterium
terrae

25. HSCT(Hard Surface Carrier Test) Method
1996년 Pesticides Programme 하에 설치 목표
1. 회원국간 자료 요구의 조화
2. 유효성 시험과 허용한계치 선정
3. 환경상 거동과 영향에 대한 시험지침 개발 (인체건강 및 생태계영향)
4. 노출평가와 위해성 평가지침 개발
5. 각 회원국간의 biocide 심사 및 평가의 조화
6. Biocides로 인해 발생가능한 위해성 저감
TFB(Task Force on Biocides) :
1. Efficacy Work
2. Environmental Exposure Assessment