REGULATION OF THE MINISTER OF HEALTH
No. 472/MENKES/PER/V/1996

ON
SECURITY OF HAZARDOUS MATERIALS TO HEALTH

THE MINISTER OF HEALTH,

Considering:

• a. that as a result of the developing sciences and technologies in various sectors, then production, distribution and use of hazardous substances is increasing in number and type;
• b. that the use of hazardous substances that is not compliance to their purpose and handling may result in threats or dangers to the human health and environment;
• c. that one of efforts to avoid or reduce risks of hazardous substances is conducted by disseminating correct information on the handling of hazardous substances to the hazardous substance handlers and the public;
• d. that the Regulation of the Minister of Health Number 453/Menkes/Per/XI/1983 on Hazardous Materials is not proper anymore to the current development of world trade situation so that need to be supplemented and it is necessary to restipulate a Regulation of the Minister of Health concerning the Safeguarding of Materials Dangerous to the Health.

In view of:

• 1. Ordinance of Hazardous Materials Statute Book of 1949 No. 377;
• 2. Law No. 10/1961 on Goods (Statute Book of 1961 No. 215, Supplement to Statute Book No. 2210);
• 3. Law No. 4/1982 on Basic Provisions of Living Environment Management (Statute Book of 1982 No. 12, Supplement to Statute Book No. 3215);
• 4. Law No. 5/1984 on Industry (Statute Book of 1984 No. 22, Supplement to Statute Book No. 3274);
• 5. Law No. 14/1992 on Traffic and Road Transportation;
• 6. Law No. 21/1992 on Services;
• 7. Law No. 23/1992 on Health (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
• 8. Law No. 7/1994 on ratification of the Agreement Establishing the World Trade Organization (Statute Book of 1994 No. 57, Supplement to Statute Book No. 3564);
• 9. Government Regulation No. 7/1973 on Supervision of Circulation, Storage and Usage of Pesticides (Statute Book of 1973 No. 12)
• 10. Presidential Decree No. 44/1974 on the Organisational Principles of Ministries;
• 11. Presidential Decree No. 15/1984 on the organisational structures of ministries;

DECIDES :

To stipulate :

THE REGULATION OF THE MINISTER OF HEALTH CONCERNING SAFEGUARDING OF MATERIALS HAZARDOUS TO HEALTH

Article 1

As used in this Regulation:

• 1. Hazardous substances shall be chemical and biological substances, single and compound, which can endanger health and the environment directly and indirectly, and are toxic, carcinogenic, tetratogenic, mutagenic, corrosive and irritative in nature.
• 2. Safety Data Sheet (LDP) shall be the directive sheet containing information on the physical and chemical properties of hazardous substances, the types of hazards that can be caused, the methods of handling and special treatments relating with emergency in the handling of hazardous substances.
• 3. Director General shall be the Director General of Food and Drug Control.

Article 2

Types of hazardous substances as meant in this Ministerial Regulation are as specified in Attachment I.

Article 3

(1) Any type of hazardous substances that will be distributed or circulated must be registered with the Director General of Drug and Food Control of the Ministry of Health.

(2) Registration of hazardous substances as meant in paragraph (1) can be conducted by the producer, importer, distributor of the hazardous substances by completing registration form and attaching the required documents as per the example form specified in attachment II.

(3) To the producer or legal entity appointed by the producer, who has fulfilled requirements as meant in paragraph (2), registration proof is issued.

Article 4

(1) Any Business entity or individual who manages hazardous substances shall make, develop and have safety data sheet of hazardous substances as per the example in attachment III.

(2) The safety data sheet as meant in paragraph (1) must be posted in such a place so that easy to see and read in order to facilitate the safeguarding actions if required.

Article 5

(1) Any hazardous substance that is circulated must be packed in container or packing properly and safely.

(2) On the container or packing, making must be affixed including preparation name or trade name, active substance name, net weight, warning words and danger sign or symbol, direction of first aid.

(3) Marking as meant in paragraph (2) must be visible, readable, understand able, not detachable and decolouring easily due to rays and weather.

Article 6

(1) Any Business entity or individual who manages hazardous substances shall make periodic report on 3 (three) months basis, containing the receiving, distribution and use and matters related to the occurring processes.

(2) Substance of the report is as per the example in attachment IV.

Article 7

(1) Specially for importers of hazardous substances in the form of borax, formalin, mercury, methanyl yellow, rodamin B and cyanide and its salts, must immediately report their importation or receiving to the Director General not later than 2 (two) weeks as of the receipt of goods as per the example report form as specified in Attachment V.

(2) Importer or distributor who distributes the hazardous substances as meant in paragraph (1) must make special record on:

• - number and quantity of hazardous substances delivered;
• - for what purpose are the hazardous substances used by the orderer as specified in form V.

(3) On the packing of hazardous substances as meant in paragraph (1), its importers name shall be specified. �

Article 8

(1) The Director General of Drug and Food Control or the local Regional Office of the Provincial Heath Ministry, severally or jointly with related agencies can monitor and supervise the implementation of this Ministerial regulation.

(2) The Director General of Drug and Food Control or the local Regional Office of the Provincial Heath Ministry or jointly with related agencies shall conduct capacity building by means of disseminating information, counselling or raining to the community or the hazardous substance handlers in the framework of protection to the human health and environment.

(3) Information dissemination as meant in paragraph (2) above shall be the giving of explanation on threats or dangers that may be resulted by the hazardous substances, method of handling and overcoming in the event of accident and/or intoxication, both directly or through printed media or electronic media.

Article 9

Business entities or individuals managing hazardous substances that commit in any action contradictory to or violate provisions in Article 3 paragraph (1), Article 4, article 5, article 6 paragraph (1), and article 7 paragraphs (1), (2) and (3) of this Ministerial Regulation, either purposely or due to their negligence that result in hazard to the health and safety of human and environment shall be subject to punitive sanction in the form of administrative actions and imprisonment in accordance with the prevailing statutory regulations.

Article 10

Business entities or individuals that manage hazardous substances as specified in attachment I shall fulfil the provisions stipulated in this ministerial regulation not later than 1 (one) year as from the stipulation date of this regulation.

Article 11

Upon enactment of this regulation, the Regulation of the Minister of Health No. 453/Menkes/Per/XI/1983 on Hazardous Materials is declared null and void.

Article 12

(1) Matters of a technical nature that are not yet sufficiently stipulated in this regulation shall be further specified by the Director General.

(2) Any change of types of hazardous substances as meant in Article 2 and Article 7 paragraph (1) can be stipulated by the Director General.

Article 13

This regulation shall take effect as from the date of stipulation.

For public cognizance, this regulation shall be published by publishing it in the State Gazette of the Republic of Indonesia.

Stipulate in Jakarta
On May 9, 1996

MINISTER OF HEALTH,
sgd.
Prof. Dr. SUJUDI