Legal Document

 

 KINGDOM OF CAMBODIA

 Nation Religion King

 

Royal Government of Cambodia

No. 133 S.E.

 

 

SUBDECREE

On

The Marketing of Infant and Child Feeding Products

 

The Royal Government

 

Pursuant to:

-    The Constitution of the Kingdom of Cambodia.

-  Royal Decree No. NS/RD/0704/124, dated July 15, 2004, on the Appointment of the Royal Government of the Kingdom of Cambodia.

-      Royal Kram No. 02/NS/94, dated July 20, 1994, promulgating the Law on the Organization and Functioning of the Council of Ministers.

-      Royal Kram No. NS/RK/0196/06, dated January 24, 1996, promulgating the Law on the Establishment of the Ministry of Health.

-      Royal Kram No. NS/RK/0196/14, dated January 24, 1996, promulgating the Law on the Establishment of the Ministry of Information.

-      Royal Kram No. NS/RK/0196/16, dated January 24, 1996, promulgating the Law on the Establishment of the Ministry of Commerce.

-      Royal Kram No. NS/RK/0600/001, dated June 21, 2000, promulgating the Law on the Control of Quality, Safety of Products, Goods and Services.

-    Royal  Kram  No.  NS/RK/0895/07,  dated  September  1,  1995, promulgating the Law on the Press.

-    Subdecree  No.  94  S.E.,  dated  September  22,  1997,  on  the  Organization and Functioning of the Ministry of Commerce.

-    Subdecree No. 70 S.E., dated August 5, 1999, on the Organization and Functioning of the Ministry of Information.

-    Sub decree No. 67 S.E., dated October 22, 1997, on the Organization and Functioning of the Ministry of Health.

-    Approval from the Council of Ministers during a plenary session held on October 28, 2005.

 

Hereby decides:

 

Chapter 1

General Provisions

 

Article 1.-

This subdecree aims to contribute to the provision of complete and safe nutrition to infants and small children through the protection and promotion of feeding children with mother’s breast milk and encouraging the provision of additional food as appropriate, and in accordance with the defined ages of infant and child in order to ensure proper use of products to replace mother’s breast milk whenever necessary and on the basis of sufficient information.

 

Article 2.-

This sub decree determines the marketing of infant and child feeding products, including products produced locally and products imported from overseas to serve the purpose of feeding infants until they reach the age of

12 months and small children until they reach the age of 24 months.

This sub decree shall take effect and shall apply to the quality and presence of any information related to the use of products as stipulated in Article 3 of this sub decree.

 

Article 3.-

The types of infant and child feeding products shall include:

A-  Formula-based powder milk  including special formula-based powder milk.

B- All products subject to marketing or indicated as appropriate for feeding infants and small children.

C-   Feeding bottles, nipples and infant pacifiers.

D-    Formula-based milk for children aged from six months.

E-   Other products determined by a joint prakas between the Ministry of Health and relevant ministries.

 

 

Chapter 2

Definitions

 

 

Article 4.-

The following technical terms shall be used for the implementation of this sub decree:

1-   Advertising   refers   to   all   acts   of   producers,   importers   or distributors by whatever means with the aim of marketing, distributing, using or displaying for sale the products mentioned in this sub decree.

The following are parts of advertising:

A- Publication, promotion via television, radio, movie, electronic system, newspaper, video or telephone.

B- Display of business logo, information poster, picture poster or announcements.

C- Exhibition of pictures or product samples.

2- Supplied materials refers to products of any quantity to be provided for consumption within a defined period free of charge or at low prices (80 percent lower than for retail prices) for social affairs purposes including materials to be provided to families in shortage.

3- Advertising to promote usage refers to all methods to be used

Either directly or indirectly to encourage people to use products mentioned in this sub decree.

4-   Marketing refers to the marketing of products, distribution, advertising, public relations in respect of products and information dissemination service.

5-   Small children refers to children aged between 12 months and 24 months.

6-   Sample refers to small quantities of products to be provided free of charge.

7- Items for infants to suckle refers to artificial nipples for infants to suckle, which can also be called plastic nipples.

8- Health staff refers to individuals providing healthcare services or

Individuals currently receiving healthcare training in the healthcare system, either professional or non-professional, including traditional midwives, volunteer staff and non-salaried staff.

9- Marketing staff refers to individuals having relevant functions in marketing products within the scope of this subdecree.

10- Healthcare system refers to the Royal Government’s institutions, nongovernmental organizations or private institutions directly or indirectly involved in healthcare or health education to women as mothers of infants or pregnant women including infant centers and infant and childcare centers. Healthcare staff in the private sector shall also be classified into the said system.

11- Label refers to all business labels, marks, images or descriptions that are written, printed, stenciled, drawn, designed in patterns or tracks or attached to all product containers mentioned in the substance and scope of this sub decree.

12- Label making refers to the inclusion of everything that is written,

Printed or graphic that is shown on a product label according to the real characteristics of the food or displayed nearby food including everything that serves the marketing.

13- Products in mother’s breast milk substitutes refers to any foods that have been marketed or indicated, partly or wholly in place of mother’s breast milk, either appropriate or inappropriate, according to this purpose.

14- Producer refers to a corporation or other entities in the public or private sector with the work or functions to produce products within the scope of this sub decree either directly or via any agent or via any of its subordinate or contractual entities.

15- Infant refers to a child from birth until the age of 12 months.

16- Formula-based milk powder refers to the mother’s breast milk substitute product produced by the factory according to the Codex Aliment Arius standard to fulfill the ordinary demands of infants from birth until the age of six months and according to the physical characteristics of the child.

17- Formula-based milk powder as nutrient refers to milk or milk product that originated from animals, vegetables or grains produced in the factory according to the Codex Aliment Arius standard as a nutrient milk formula and that is marketed and indicated as appropriate for feeding infants and children aged over six months.

18- Special formula-based milk powder refers to formula-based milk powder for infant who were born prematurely or infants who were born underweight or for infants who are allergic to milk or carbohydrates, or who have abnormal physical systems.

in the scope of this sub decree for sale such as normal retail sale including the external case.

20- Additional food refers to any food either produced in a factory or made at home that may complement mother’s breast milk when breast milk alone is not sufficient to meet the demands of infants when they reach the age of six months.

21- Distributor refers to an individual, corporation or other entity in

The public or private sector with the function of marketing wholesale or retail sale of products that are within the scope of this sub decree either directly or indirectly.

22- Initial distributor refers to the sales agent of producer, representative, domestic distributor or broker.

23- Inspection official refers to an individual appointed under the competence of the Department of Medicines, Foodstuffs, Cosmetic Products and Medical Equipment as the inspection official to whom the Minister of Health gives the authority to effectively implement the said function as necessary according to the provisions of this sub decree.

 

 

Chapter 3

Restrictions on Dissemination of Information and Education

 

Article 5.-

The Ministry of Health shall undertake to set out policy and provide appropriate information on feeding infants and small children to families and officials performing their work related to the field of infant and small child nutrition to be aware of the ways to feed infants and small children via dissemination of information and education. Regarding the implementation of the above tasks, the Ministry of Health shall cooperate with the relevant institutions serving in this sector, if necessary.

 

Article 6.-

All pieces of information, materials or educative documents or other materials either in the form of writing, voice record or image relating to infant feeding produced or arranged to be used in the country by any individual:

1- Must clearly explain:

A-    The benefits and superiority of feeding children with mother’s breast milk.

B-   How to initiate and continue feeding the child with mother’s breast milk, including nutrition for the mother.

C-   Recommendations to feed the child with mother’s breast milk  only for six months from birth and to continue feeding the child with mother’s breast milk after [the age of] six months until the child reaches the age of 2 years or over;

D-    Methods and reasons for starting the feeding by bottle or Starting to provide additional foods early. Feeding by bottle or early starting to provide additional foods disturbs child feeding with mother’s breast milk even if feeding by bottle is limited to only two or three times per day.

2- Must have accurate and new information and shall not use any  Image or text that encourages feeding by bottle or that hinders feeding with mother’s breast milk.

3- Must be written in Khmer.

4- Must strictly not refer to any products mentioned in the sub decree and provisions in force or bearing the name, logo, trademark or description of producers or distributors of products with the exception of display in the form of rights reserved.

 

Article 7.-

Should any material or document or information include the topic on infant feeding with breast milk substitutes through feeding by bottle, that material or document or information shall clearly specify:

-      Correct preparation and usage of those products.

-      Estimation of budget spent on the products for feeding infants for a period of six months.

-      Danger  to  health  as  a  result  of  bottle  feeding  and  improper preparation of the products.

-      How to feed infants using a cup.

 

Article 8.-

Should those materials or documents include the topic on infant feeding by providing additional foods, those materials or documents shall have explanations about:

Danger to health as a result of starting to provide additional foods before the infant reaches the age of six months.

-        Those additional foods may be easily prepared at home through using ingredients that are available and easily accessible in the locality at any place of residence.

-        The  benefits  and  value  of  continuing  to  feed  the  child  with mother’s breast milk after the child reaches the age of six months until the child reaches the age of two years or over.

 

 

Chapter 4

Label

 

Article 9.-

The label of products for infant and child other than the requirements mentioned in the Cambodian industry standard shall in addition present the following contents:

A- The product container or label attached bears easy-to-read letters.

B- Text saying that nothing is better than feeding the child only with mother’s breast milk until six months and continuing the feeding using mother’s breast milk until the age of two years or over.

C- Instructions about how to use, and proper use and preparation.

D- Warning with remarks about the danger to health as a result of improper use of defined products.

E- Warning indicating danger to health by starting to use products before reaching the age being instructed to use and the product can be used only when so instructed by health staff.

F- The phrase explains that feeding by cup is more hygienic than feeding by bottle.

G- Must not use words to connote the meaning that this product is used in replacement of mother’s breast milk or similar words

H- Must not bear any representing photo, drawing or graphic besides the presentation of how to prepare the defined products.

I-  The  phrase indicating the  cost  of  total  budget for  feeding the infant within a period of six months.

 

Article 10.-

Products similar to those for feeding infants and children not containing enough nutrients as required by infants and children shall bear the warning that this product is not for feeding infants and children.

 

Article 11.-

On the feeding bottle label or package or container of feeding bottle products or plastic nipple, there shall be [the following] writings:

1-     The words stating nothing is better than mother’s breast milk in feeding infants and small children.

2-    Feeding infants using cups is safer than feeding them by bottle;

3-    Instructions  about  how  to  clean  and  boil  feeding  bottles  and plastic nipples to sterilize them properly.

4-    Warning about danger to health that may be caused by using feeding   bottles,   particularly  sterilization  not   being   properly carried out.

5-     Warning about negative impacts of feeding by bottle and requirement to follow the instructions about careful preparation to ensure the infant does not fall ill.

6-    Name  and  address  of  producer  or  distributor  of  products  or locally-based agent.

7-     Use of plastic nipples and feeding bottles may disturb the child’s feeding by mother’s breast milk.

 

Article 12.-

On the can or label pasted on the can of sweetened condensed cow milk or fat-free cow milk or similar products shall have a clear and distinctive ban stating that the product shall not be used for feeding infants or small children.

 

 

Chapter 5

Prohibition

 

Article 13.-

In case there is no authorization from the Ministry of Health, producers or distributors shall not advertise to promote the use of products for feeding infants and small children as specified in this sub decree by themselves or by assigning their representatives at the points of sale in hospitals or health centers or any other places. The following are parts of the actions to promote prohibition of use:

A- Advertising.

B- Using means as tricks with the aim of selling products including special display, discount card, additional sale, sale by providing commission, discount sale, credit sale, providing incentives for purchase, sale at a special price or provision as gift. However, paragraph B of this article will not impose any restrictions on determination of price policy and implementation with the aim of providing defined products at a cheaper price for a long period of time.

C- Providing one or more defined product samples to any person;

D- Donating  or  distributing  information  document  materials  or education document materials on infant and child feeding or implementing educational functions relating to the feeding of infants and small children can be carried out only if producers and distributors can provide information about the products defined for the health staff whereby the information on scientific matters is restricted and actual matters related to the technical aspects and methods for using defined products and according to the provisions of Article 6 hereof.

 

Article 14.-

In case there is no authorization from the Ministry of Health, producers or distributors, either personally or via any individuals as their representatives, shall not:

A-      Donate or distribute to health staff or hospitals or health centers materials or samples of the defined products.

B-    Donate or distribute to hospitals or health centers any equipment, materials  or  documents  or  services  presenting  or  bearing  the name, label, trademark or description of producers, distributors or of any defined products presenting or promoting the usage of the defined products.

C-    Donate or distribute to hospitals or health centers any materials such  as  pens,  calendars,  posters,  writing  books,  growth monitoring lists and toys presenting or promoting the usage of the defined products.

D-      Provide gifts, contributions or any interests to the health staff or health staff association serving in the maternal and child health sector.

E-    Sponsor any programs, entertainment game programs, telephone networks for consultation or campaigns focusing on pregnant and breastfeeding women, parents of infants and children or family members  and  shall  not  sponsor  any  programs,  entertainment game programs or telephone networks to provide consultation or campaigns related to reproductive health, pregnancy, child delivery, feeding of infant and children or any related topic.

F-       Provide direct or indirect scholarship, sponsor any research or provide   funds   for   meetings,   workshops,   further   education sessions or conferences without authorization from the Minister of Health.

G-     Provide or grant salaries to representatives of professional service providers expert in infant care or staff of similar skill at hospitals or health centers.

H- Include  the  scale  of  sale  of  defined  products  when  paying remuneration to employees and shall not limit a quota for selling the defined products.

 

Article 15.-

In case there is no authorization from the Ministry of Health, all health establishments both public and private as well as health staff serving in the maternal and infant health sector shall not:

A-      Receive  donations,  contributions  or  other  benefits,  budget  or valuable items from producers or distributors or any individuals representing producers.

B-    Present  methods  to  use  formula-based  powder  milk  with  the exception that women, as mothers, or family members are in a very special situation and in such situation there shall be a clear explanation about the danger of consumption of formula-based powder milk including other information as stipulated in Article 6 hereof.

C-     Accept or provide samples or supply defined products to any  individual.

D-      Conduct professional assessment, research study or  implement other  activities  at  hospitals  or  health  centers  related  to  the products defined above.

 

Article 16.-

Producers or distributors of products for feeding infants and children may donate equipment and materials to all health institutions both public and private as per a written request from the entity concerned with the approval from the Minister of Health.

 

 

Chapter 6

Control and Inspection Authorities

 

Article 17.-

The Ministry of Health shall be the responsible competent authorities to cooperate in facilitating the performance of the duty to feed infants and small children effectively with relevant ministries according to their respective duties, as follows:

A-    Provide comments to the National Nutrition Committee about thecnational policy for  promotion of  the  national strategic goal  to protect the feeding of children with mother’s breast milk;

B-   Provide comments on nutrition about:

-   Preparation  of  a  national  strategy  for  the  preparation  of  a public education program and education materials.

-   Promoting the feeding of children with mother’s breast milk;

-   Education   materials   or   documents   and   dissemination   of information related to the topic of the feeding of infants and small children.

-   Continuing education of health staff about the management of mother’s breast milk.

-   Study program for medical students on the management of mother’s breast milk.

C-     Hold consultation with nongovernmental organizations related to the child welfare sector and nutrition development for children or the protection of infants and small children.

D-      Ensure  comprehensive dissemination of  the  laws  and  relevant provisions and dissemination throughout the country.

E-    Examine the report related to the breach of law or various matters in respect of implementation of this sub decree and relevant laws in force.

F-    Release the instructions to the inspection officials to raise various cases against this sub decree or in breach of the laws in force;

G-      Consider any need for the Ministry of Health and the Ministry of Commerce to fully implement the provisions of various laws effectively.

H-       Request and send nutrition substances to a laboratory for testing, if necessary.

I-     Seek funds and assistance from nongovernmental organizations and assisting communities.

J-        Fulfill the necessary roles and competences as specified in the Law on the Control of Quality, Safety of Products, Goods and Services.

K-          Be entitled   to  issue necessary decisions related to the  implementation of this sub decree and relevant laws effectively;

L-    Define national measures to fulfill the roles and duties defined by this sub decree and inspect all necessary action plans.

M-       Perform other relevant duties assigned by the Royal Government.

 

Chapter 7

Penalties

 

Article 18.-

The implementation of various penalties related to the marketing of infant and child feeding products shall comply with the Law on the Control of Quality, Safety of Products, Goods and Services or in accordance with various laws in force.

 

Article 19.-

The competent authorities, in fulfilling their duties, shall comply with the procedures defined in the Law on the Control of Quality, Safety of Products, Goods and Services or in accordance with the Code of Criminal Procedures in force.

 

 

Chapter 8

Transitional Provisions

 

Article 20.-

Within a period of six (6) months after this sub decree takes effect, producers  or  distributors  of  infant  and  child  feeding  products  shall  complete  the  formalities  defined  by  the  Ministry  of  Health  in  proper accordance with the provisions in force.

 

 

Chapter 9

Final Provisions

 

 

Article 21.-

Any provisions contrary to this sub decree shall be abrogated.

 

Article 22.-

The Minister of the Office of the Council of Ministers; the Minister of Health; the Minister of Informatio, the Minister of Commerce; ministers and secretaries of state of all relevant ministries and institutions; and all provincial/city governors shall implement this sub decree from the date of signature onwards.