REGULATION OF THE MINISTER OF HEALTH
No. 239/Men.Kes/Per/V/85

ON
CERTAIN COLOURING AGENTS DETERMINED AS HAZARDOUS MATERIALS

MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA,

Considering :

• a. that certain colouring agents used to give and or improve the colours of materials or goods are circulating in large quantities among the public, which can be hazardous to human health if used for drugs, food and cosmetics;
• b. that in order to protect society from the danger caused by certain colouring agents as meant in clause a. it is necessary to stipulate a regulation of the Minister of Health concerning certain colouring agents determined as hazardous materials.

In view of :

• 1. The Ordinance of Hazardous Materials Statute Book of 1959 No. 377;
• 2. Law No. 9/1960 on the principles of health (Statute Book of 1960 No. 131, Supplement to Statute Book No. 2068);
• 3. Presidential Decree No. 44/1974 on the organisational principles of ministries;
• 4. Presidential Decree No. 15/1984 on the organisational structures of ministries;
• 5. The Regulation of the Minister of Health No. 235/Men.Kes/Per/XI/1979 on food additives;
• 6. The Regulation of the Minister of Health No. 359/Men.Kes/Per/IX/1983 on cosmetic materials and cosmetic colouring agents;
• 7. The Regulation of the Minister of Health No. 453/Men.Kes/Per/XI/1983 on hazardous materials.

DECIDES :

To stipulate :

THE REGULATION OF THE MINISTER OF HEALTH CONCERNING CERTAIN COLOURING AGENTS DETERMINED AS HAZARDOUS MATERIALS.

CHAPTER I
GENERAL PROVISIONS

Article 1

Hereinafter referred to as :

• 1. Certain colouring agents shall be substances that are used to give and or improve the colours of materials or goods;
• 2. Drugs shall be materials or mixtures of materials that are used to affect or investigate the system of physiology or the condition of pathology within the framework of diagnosis, prevention, cure, rehabilitation, health promotion and contraception;
• 3. Food shall be materials that are used as human food/drinks, including chewing gums and the like, other than drugs;
• 4. Cosmetics shall be materials or mixtures of materials to be rubbed on, stuck to, poured, sprinkled or sprayed on, permeated into, applied to the human body or its parts with the aim of cleansing, maintaining, enhancing appeal or changing appearance, other than drugs;
• 5. Markings shall be letters, pictures or other forms of expression printed on packing containers or labels and brochures;
• 6. Containers shall be anything that is used to contain colouring agents and directly in contact with colouring agents including covers;
• 7. Packing shall be anything that is used for packing containers;
• 8. To import shall be to bring colouring agents into the territory of Indonesia;
• 9. To produce shall be to manufacture, process, change forms, change containers or markings for distribution;
• 10. Distribution shall be procurement, granting, delivery, transportation, local sales and supply, as well as storage for sales;
• 11. The Minister shall be the Minister of Health of the Republic of Indonesia;
• 12. The Director General shall be the Director General of Food and Drug Control.

CHAPTER II
DETERMINATION OF CERTAIN COLOURING AGENTS AS HAZARDOUS MATERIALS

Article 2

(1) Certain colouring agents as contained in the attachment to this ministerial regulation shall be determined as hazardous materials.

(2) Certain colouring agents as meant in paragraph (1) shall not be used for drugs, food and cosmetics, unless their use is licensed by the Director General.

(3) The Director General shall be allowed to add and amend the attachment as meant in paragraph (1).

CHAPTER III
PRODUCTION, IMPORT AND DISTRIBUTION

Article 3

(1) Business organisations or individuals that produce, import and distribute certain colouring agents as meant in Article 2 paragraph (1) shall register themselves to the Director General.

The procedure for registration as meant in paragraph (1) shall be determined by the Director General.

CHAPTER IV
REPORTING OBLIGATION

Article 4

(1) Certain colouring agents as meant in Article 2 paragraph (1) that will be produced or imported for distribution by producers or importers shall be reported to the Director General of Food and Drug Control.

(2) The procedure for reporting as meant in paragraph (1) shall be determined by the Director General.

CHAPTER V
MARKINGS

Article 5

(1) In addition to the requirements according to the effective regulation on markings, the containers and packing of certain colouring agents as meant in Article 2 paragraph (1) shall bear the warning "DILARANG DIGUNAKAN DALAM OBAT, MAKANAN DAN KOSMETIKA" OR "DILARANG DIGUNAKAN DALAM OBAT DAN MAKANAN" (NOT TO BE USED FOR DRUGS, FOOD AND COSMETICS" OR "NOT TO BE USED FOR DRUGS AND FOOD").

(2) The warning as meant in paragraph (1) :

• a. shall be printed in red block letters of the roman alphabet in the Indonesian language within a red box as suited to the form of containers or packing, and shall be legible;
• b. shall be printed directly on containers and packing or on labels stuck to containers and packing and on brochures;
• c. shall not be easily damaged, not easily drop and fade due to light, air and so forth;
• d. shall be printed on the place or part that is easily seen.

Article 6

Certain colouring agents as meant in Article 2 paragraph (1) that fail to meet the requirements as meant in Articles 3, 4 and 5 shall not be distributed.

Article 7

The Director General shall be authorised to order producers or importers to withdraw from distribution certain colouring agents that fail to meet the requirements as meant in articles 4 and 5 of this regulation.

Article 8

Markings other than those as meant in Article 5 of this regulation shall be further stipulated by the Director General.

CHAPTER VI
CONTROL AND SUPERVISION

Article 9

(1) Control and supervision over the implementation of this ministerial regulation shall be conducted by the Director General.

(2) Directives for the realisation of control and supervision as meant in paragraph (1) shall be determined by the Director General.

CHAPTER VII
SANCTIONS

Article 10

Any violation of the provisions in Article 2 paragraph (2), Article 3 paragraph (1), Article 4 paragraph (1), Article 5 and Article 6 shall be subject to punitive actions based on Article 2 paragraph (1) of the Ordinance of Hazardous Materials Statute Book of 1949 No.377 and or other administrative sanctions according to the effective laws.

CHAPTER VIII
TRANSITIONAL PROVISION

Article 11

Business organisations or individuals that manage certain colouring agents as meant in Article 2 paragraph (1) shall fulfil the stipulations in this ministerial regulation not later than 1 (one) year starting from the date of stipulation.

CHAPTER IX
CLOSING PROVISIONS

Article 12

All regulations of the Minister concerning colouring agents that have already existed before the stipulation of this regulation shall remain valid as long as they are not contradictory to this regulation.

Article 13

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

Article 14

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

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

Stipulated in Jakarta
On May 1, 1985

THE MINISTER OF HEALTH,
Sgd,
dr. SUWARDJONO SURJANINGRAT