Circular No. 22/2015/TT-BYT guiding the testing procedure for mosquito-repellent cream

CIRCULAR

Guidelines for the testing procedure of mosquito repellent creami

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Pursuant to the Chemicals Law No. 06/2007/QH12 dated November 21, 2007;

Pursuant to the Product Quality Law No. 05/2007/QH12 dated November 21, 2007;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Medical Environment Management Department;

The Minister of Health issues this Circular guiding the testing procedure for mosquito repellent cream.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the methods for evaluating the efficacy, safety, and adverse effects of mosquito repellent cream for registration and circulation in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the terms and abbreviated notations shall be understood as follows:

1. Chlordane CAS RN is the abbreviation for the English term "Chemical Abstract Service Registry number," which is a summary chemical registration code consisting of a sequence of numbers identifying chemical elements and compounds.

2. WHO code is the abbreviation for the English term "World Health Organization code," which is a chemical code as prescribed by the World Health Organization.

Chapter II

TESTING METHODS

Article 3. Testing Method

Use biological testing methods in mosquito cages with human volunteers to evaluate the efficacy, safety, and adverse effects of mosquito repellent cream directly on human volunteers. Each test includes three trials, and all trials must comply with the requirements, procedures, and evaluation criteria set forth in this Circular.

Article 4. Requirements for Testing

1. Requirements for equipment and devices:

a) Mosquito cages measuring 40cm x 40cm x 40cm made of mesh screens with holes sized 32-36/cm². Four cages are required per trial (two cages marked blue for control, numbered 01 and 02, and two cages marked red for testing, numbered 03 and 04). The cage doors have sleeves to prevent mosquitoes from escaping;

b) A measuring tape of 1 meter with accuracy up to 1 mm to measure the area of mosquito repellent cream applied on the volunteer's arm;

c) Personal protective clothing: shirts, hats with protective nets, goggles, gloves, elbow covers, boots;

d) A record sheet for test results as specified in Appendix 1 attached to this Circular;

đ) A questionnaire for recording adverse effects of the test sample as specified in Appendix 2 attached to this Circular.

2. Number of volunteer participants: four people (two males, two females). Volunteer participants must be selected according to the provisions in Appendix 3 attached to this Circular and must not use perfume, mosquito repellents, or oils on their skin for twelve hours prior to the test.

3. Mosquitoes used for testing must be female mosquitoes meeting the standards as directed by the World Health Organization (WHO/CDS/CPC/MAL/98.2), raised in a Biosafety Level II laboratory, sensitive to chemicals, unfed, and aged between five to seven days, fed on 10% glucose solution.

4. Laboratory facilities must meet ISO/IEC 17025:2005 standards with normal temperature and humidity conditions.

Article 5. Steps for Conducting Tests

1. Preparation:

a) Five units of the smallest packaging of mosquito repellent cream as specified by the manufacturer must be prepared for the test, including four samples for testing and one sample for storage. These samples must be from the same production batch, within their expiration date, and in good condition;

b) Train the volunteers on how to shake their hands so that mosquitoes can touch but not bite;

c) Clean the arms thoroughly with unscented soap, rinse with water, then wash with 70% ethanol and dry before starting the test;

d) Measure the length of the forearm (L), circumference at the wrist (C), and circumference at the elbow joint opening (K), then calculate the exposed arm area for mosquito contact for each of the four people, ranging from 300cm² to 600cm² using the formula L x (K + C : 2) cm². Cover the palms with rubber gloves and cover the upper part of the left elbow with thick fabric to avoid mosquito bites in unintended areas;

đ) Divide into two pairs, where one pair (one male and one female) applies mosquito repellent cream according to the manufacturer's instructions on the label thirty minutes before the start of the test, while the other pair does not apply the cream;

e) Prepare 4,000 mosquitoes meeting the standards specified in Clause 3, Article 4 of this procedure for one test session;

g) Test location: the test and control groups are arranged simultaneously in two different rooms but under similar temperature and humidity conditions.

2. Testing:

a) Place 200 mosquitoes in each cage;

b) Two people who did not apply mosquito repellent cream place their left hand in the blue-marked cages (one cage for a male, one for a female). Every hour, place the hand in the cage for 30 seconds to count the number of mosquitoes touching the exposed area. If more than ten mosquitoes touch the area, the requirement is met. If fewer than ten mosquitoes touch the area within 30 seconds, the test result must be discarded. The test is monitored hourly: 01, 02, 04, 06, 08 (according to the duration of action of the mosquito repellent indicated on the label). After each hour of monitoring, replace 200 new mosquitoes;

c) Two people who applied mosquito repellent cream place their left hand in the red-marked cages (one cage for a male, one for a female). Every hour, place the hand in the cage for 30 seconds to count the number of mosquitoes touching the exposed area of the left hand. Monitor hourly: 01, 02, 04, 06, 08 (according to the duration of action indicated on the label). After each hour of monitoring, replace 200 new mosquitoes;

d) Repeat the test three times under similar conditions, with participants and controls switching roles on the second and third days;

đ) Record the results according to the table specified in Appendix 1 attached to this Circular.

Article 6. Evaluation of Effectiveness

Effectiveness is calculated using the following formula:

Ratio = from 90%-100%: meets requirements.

Article 7. Safety Evaluation

Based on a questionnaire to assess adverse effects of the tested mosquito repellent cream on participants. If more than 2/5 of those surveyed exhibit any of the following symptoms: skin allergy, headache, dizziness, it does not meet requirements.

Article 8. Reporting Results and Sample Retention

1. Reporting results: the organization conducting the testing shall provide the testing results according to the form prescribed in Appendix 4 issued with this Circular.

2. Sample retention: after testing, original samples and used samples must be retained for at least two years. The retention samples need to record the following information: product name (manufacturer, production batch, production date, expiration date), active ingredient (CAS number, WHO code), test dosage, test date, requesting agency.

Chapter III

IMPLEMENTING PROVISIONS

Article 9. Effective Date

1. This Circular takes effect from January 1, 2016.

2. The procedure for evaluating the effectiveness and safety of topical chemicals applied to prevent mosquito bites, promulgated along with Decision No. 120/2000/QĐ-BYT dated January 24, 2000 by the Minister of Health, ceases to be effective from the date this Circular takes effect.

Article 10. Implementation Organization

The Director of the Department of Environmental Health Management, the Head of the Ministry's Office, the Inspector General, the Heads of Departments, Directors of Bureaus, and the Chiefs of General Departments under the Ministry of Health are responsible for implementing this Circular.

During implementation, if there are any difficulties, agencies, organizations, and individuals should report them to the Ministry of Health (Department of Environmental Health Management) for research and resolution./.