MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 22/2015/TT-BYT | Hanoi, July 27, 2015 |
CIRCULAR
EXPERIMENTING PROCEDURE FOR MOSQUITO REPELLENT CREAM
Pursuant to Law on Chemicals No. 06/2007/QH12 dated November 21, 2007;
Pursuant to Law on Products and Goods Quality No. 05/2007/QH12 dated November 21, 2007;
Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;
At request of Director General of Health Environment Management Agency;
Minister of Health promulgates Circular providing guidelines on experimenting procedure for mosquito repellent cream.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular prescribes methods of assessing efficacy and safety of mosquito repellent cream for circulation in Vietnam.
Article 2. Term interpretation
In this Circular, terms below are construed as follows:
1. “CAS number” refers to Chemical Abstract Service Registry number.
2. “WHO code” refers to World Health Organization code.
Chapter II
EXPERIMENTING METHODS
Article 3. Experimenting methods
Employ experimental biology techniques in cages containing mosquitoes and volunteers to assess efficacy, safety and unwanted effects of mosquito repellent cream applied directly on volunteers. Each experiment consists of 3 tests which must all comply with requirements, implementation and assessment under this Circular.
Article 4. Test requirements
1. Requirements for tools and equipment:
a) 40cm x 40cm x 40cm mosquito cages covered by net with 32-36 holes/cm2. 4 cages per test (2 cages for comparison marked in green and numbered 1 and 2, 2 cages for testing marked in red and numbered 3 and 4). Cage opening must have sleeves to prevent mosquitoes from escaping;
b) 1 m of flexible tape measure with accuracy of 1 mm to measure area of application of mosquito repellent cream on arms of volunteers;
c) Personal protective gears: clothes, glasses, netted hats, gloves, face masks, boots, arm sleeves;
d) Test result schedules under Annex 1 attached hereto;
dd) Questionnaires for unwanted effects under Annex 2 attached hereto.
2. Number of volunteers: 4 people (2 men, 2 women). Volunteers must be selected according to Annex 3 attached hereto and must not wear perfume, repellent chemicals or rubbing oil 12 hours prior to testing.
3. Mosquitoes for experiments must be qualified female mosquitoes according to guidelines of WHO (WHO/CDS/CPC/MAL/98.2), reared in class II biological safety cabinets, susceptible to chemicals, at 5 – 7 days old, and not fed with blood but fed with 10% glucose solutions.
4. Laboratories satisfying ISO/IEC 17025:2005 with normal temperature and humidity.
Article 5. Steps of conducting the experiment
1. Preparation:
a) 5 units of the smallest packaging unit according to manufacturers: 4 specimens for testing and 1 for storage. These specimens must be in the same manufacturing, within expiry date and remain intact;
b) Train volunteers to wriggle their arms to let mosquitoes touch them without biting;
c) Clean arms with unscented soap, rinse with water, wash with 70% ethanol and wipe dry before conducting tests;
d) Use flexible tape measure to measure length of the forearm (L), wrist circumference (C) and circumference of exposed section of the elbow (K), calculate exposed area of the arm to attract mosquitoes of 4 people ranging from 300 cm2 – 600 cm2 using formula Lx (K+C: 2) cm2. Cover hands tightly with rubber gloves and wrap left elbow with thick cloth to prevent mosquitoes from biting wanted areas
dd) Split into 2 couples with 1 man and 1 woman each where 1 couple apply mosquito repellent cream according to manufacturers’ instructions on labels 30 minutes before testing while the other couple do not;
e) Prepare 4000 mosquitoes satisfying requirements under Clause 3 Article 4 hereof per experiment;
g) Experiment locations: test and comparison are implemented simultaneously in 2 different chambers with similar temperature and humidity conditions.
2. Experiment:
a) Add 200 mosquitoes in each cage;
b) 2 individuals not applied with mosquito repellent cream insert their left arms to green cages (1 cage for the man, 1 cage for the woman). Volunteers put their arms in the cages for 30 seconds every hour, count number of mosquitoes touching the exposed skin section and stop once a total of 10 mosquitoes have touched the exposed skin section. If less than 10 mosquitoes touch the exposed skin section in 30 seconds, cancel the test results. Tests shall be monitored in the 1st hour, the 2nd hour, the 4th hour, the 6th hour, and the 8th hour (according to effective period of mosquito repellent chemicals on labels). Replace 200 new mosquitoes after every hour;
c) 2 individuals already applying mosquito repellent cream on their left arms insert their left arms to red cages (1 for the man, 1 for the woman). Insert volunteers’ left arms in the cages for 30 seconds every hour and allow the mosquitoes to touch the exposed skin section. Tests shall be monitored in the 1st hour, the 2nd hour, the 4th hour, the 6th hour, and the 8th hour (according to effective period on labels). Replace 200 new mosquitoes after every hour;
d) Repeat the test 3 times in similar conditions, individuals participating in tests and those participating in comparison shall swap places on the 2nd day and the 3rd day;
dd) Test result are recorded under Schedule under Annex 1 attached hereto.
Article 6. Efficacy assessment
Efficacy is determined using following formula:
% of mosquito bite reduced = x 100
Percentage ranging between 90% and 100%: qualified.
Article 7. Safety assessment
Rely on questionnaire to assess unwanted effects of mosquito repellent cream preparations on test participants. Consider unqualified if more than 40% of questioned individuals observe: skin allergies, headaches or vertigo.
Article 8. Result return and experiment specimen storage
1. Result return: experimenting organizations shall respond to experiment results using form under Annex 4 attached hereto.
2. Specimen storage: after conducting experiments, fresh specimen and used specimen must be stored for at least 2 years. Form for storage must contain following information: name of preparations (manufacturing brand, manufacturing batches, date of manufacture, expiry date), active ingredients (CAS number, WHO code), experiment dose, date of experiment, requesting agencies.
Chapter III
IMPLEMENTATION
Article 9. Entry into force
1. This Circular comes into force from January 1, 2016.
2. Experimenting procedures for assessment of efficacy and safety of mosquito repellent chemical for skin application attached to Decision No. 120/2000/QD-BYT dated January 24, 2000 of Minister of Health expires from the effective date hereof.
Article 10. Implementation
Director General of Health Environment Management Agency, Chief of the Ministry Office, Chief Ministry Inspector, Directors, Directors General, General Directors of Departments affiliated to Ministry Office are responsible for implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Health Environment Management Agency) for solution./.
| PP. MINISTER |
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