Republic of the Philippines
Department of Health

OFFICE OF THE SECRETARY

 

 

 

SUBJECT: Revised Implementing Rules And Regulations of Executive Order No. 51, Otherwise Known as The "Milk Code", Relevant International Agreements, Penalizing Violations Thereof, and for Other Purposes

WHEREAS, Section 15 Article II of the 1987 Constitution of the Philippines states that "The State shall protect and promote the right to health of the people and instill health consciousness among them.";

WHEREAS, Section 2, Article II of the 1987 Constitution of the Philippines states in part that "The Philippines x x x adopts the generally accepted principles of international law as part of the law of the land x x x".

WHEREAS, the Philippines ahs adopted the WHO and UNICEF "2002 Global Strategy on Infant and Young Child Feeding", and the various World Health Assembly Resolutions to implement the same, and therefore is legally and morally obligated to follow their provisions.

WHEREAS, towards this end, the State shall support the "2002 Global Strategy on Infant and Young Child Feeding" and exerts efforts to address the provision of safe and adequate nutrition for infants and young children, by the protection, promotion and support of breastfeeding;

WHEREAS, the WHO/UNICEF Global Strategy on Infant and Young Child Feeding recommends not only exclusive breast milk for newborns, but also indigenous, fresh and natural foods in combination with continued breastfeeding for infants and young children. It is guided by the World Health Assembly Resolutions, Codex Alimentarius, and consistent with national laws or national policies;

WHEREAS, adequate and proper nutrition is an important and universally recognized component of each child's right to the enjoyment of the highest attainable standard of health as provided for in the United nations Convention on the Rights of the Child, which the Philippine Senate, in accordance with its constitutional prerogative under Section 21, Article VII., of the 1987 Constitution., ratified on July 26, 1990, and which mandates the Philippines to implement various international agreements relevant to Infant and Young Child Feeding;



WHEREAS, the use of breastmilk, which is widely recognized as the best source of nutrition for babies, promotes the development of emotional bonding between the mother and child, bestows upon the newborn infant protection against infection, provides for the mother natural contraception after delivery, and protects the mothers from closely spaced pregnancy.



WHEREAS, with the resultant healthier population and the redUction  in infant and  under five mortality rates, the country will be Closer ln reaching its targets for the Millennium Development  Goals;



WHEREAS, breastfeeding is the most far-reaching and the least costly strategy for the alleviation of poverty.



NOW THEREFORE, Pursuant to the authority under Section 12(b)(I )  of  Executive Order No. 51 dated 20 October 1986, otherwise known as “National Code of Marketing of Breastmilk Substitutes, Breastmilk Supplements and Related Products,” the Department of Health, through the Honorable Secretary of Health, hereby promulgate the ensuing revised rules and implementing regulations:


RULE I

ENABLING  PROVISIONS



SECTION 1. Title The following shall be referred to as the “Revised Implementing Rules and Regulations of Executive Order No. 51, otherwise known as the ‘Milk Code’, Relevant International Agreements, Penalizing Violations Thereof, And For Other Purposes"

 

SECTION 2. Purpose These Revised Rules and Regulations are hereby promulgated to ensure the provision of safe and adequate nutrition for infants and young children by the promotion, protection and support of breastfeeding and by ensuring the proper use of breastmilk substitutes, breastmilk supplements and related products when these are medically indicated and only when necessary, on the basis of adequate information and through appropriate marketing and distribution.

 

SECTION 3. Scope  and  Coverage.  These Revised Rules and Regulations  shall  apply to the marketing, and practices related thereto, of the following products: breastmilk substitutes, including infant formula; other milk products, foods and beverages, including bottle-fed complementary foods, when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breastmilk; feeding bottles and teats. It also applies to their quality and availability, and to information concerning their use.

 

SECTION 4. Declaration of Principles. — The following are the underlying principles from which the revised rules and regulations are premised upon:

 

a. Exclusive breastfeeding is for infants from 0 to six (6) months.

 

b. There is no substitute nor replacement for breastmilk.

 

c. Appropriate and safe complementary feeding should start from six months onwards in addition to breastfeeding.

 

d. Breastfeeding is still appropriate for young children up to two (24 months) years of age or beyond.

 

e. Infant or milk formula may be hazardous to a child's health and damage child's formative development.

 

f. Advertising, promotions, or sponsorships of infant formula, breastmilk substitutes and other related products are prohibited.

 

g. Other related products such as, but not exclusive of, teats, feeding bottles, and artificial feeding paraphernalia are prohibited in health facilities.

 

h. Government and all concerned stakeholders must continuously accomplish an information, dissemination campaign/strategy, and do further research on the advantages of breastmilk and the hazards of breastmilk substitutes or replacements.

 

i. Milk companies, and their representatives, should not form part of any policy making body or entity in relation to the advancement of breastfeeding.



RULE II

 

DEFINITION OF TERMS

 

SECTION 5. Definition of Terms. - For purposes of these Revised Rules and Regulations, the term:

 

(a) "Advertising" refers to any representation by any means whatsoever for the purpose of promoting the sale or distribution of breastmilk substitutes/supplements and other related products under the scope of this Code;

 

(b) "BFAD" refers to the Bureau of Food and Drugs of the Department of Health;

 

(c) "Breastmilk substitute" means any food being marketed or otherwise represented as partial or total replacement of breastmilk whether or not suitable for that purpose;

 

(d) "Committee" shall refer to the Inter-Agency Committee created under E.O. No. 51, s. 1986 composed of the Secretary of Health, as Chairman, and the Secretary of Trade and Industry, the Secretary of Justice, and the Secretary of Social Welfare and Development, as members;

 

(e) "Complementary" means any food, except milk substitutes, whether manufactured or locally prepared, suitable as a complement to breastmilk to satisfy the nutritional requirements of the infant;

 

(f) "Container" means any form of packaging of products for sale as a normal retail unit, including wrappers;

 

(g) "Distributor" means a person, corporation or any other entity in the public or private sector engaged in the business (whether directly or indirectly) of marketing at the wholesale or retail level a product within the scope of this Code;

 

(h) "DoH" refers to the Department of Health;

 

(i) "Exclusive breastfeeding" means giving only breastmilk without water, liquids, teas, herbal preparations, or other food and fluid intake for the first six months of life;

 

(j) "Gifts of any sort" means any form of financial, personal or commercial reward, inducement, incentives and other favors provided directly or indirectly by manufacturers, distributors, and their representatives, of products within the scope of the Code;

 

(k) "Health care system" means governmental, non-governmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants and pregnant women; and nurseries or child care institutions;

 

(1) "Health Facilities" means health care systems including but not limited to health centers, clinics, birthing and parenting classes venues, hospitals, maternal centers/clinics, birthing homes, barangay health stations, health and nutrition posts and lying in clinics;

 

(m) "Health Worker" means a person working in a component of such health care system, whether professional or non-professional, including volunteer workers. It also includes health workers in private practice. Traditional and other birth attendants, their assistants and other community volunteers involved in health and nutrition promotion and education shall likewise be covered;

 

(n) "Infant" shall refer to a person within the age bracket of 0 -12 months;

 

(o) "Infant Formula" means one of the breastmilk substitutes formulated industrially in accordance with applicable Codex Alimentarius standards;

 

(p) "Label" means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on, or attached to, a container of any product within the scope of this Code;

 

(q) "Latching on" means that with the assistance of the health worker and immediately after its delivery, the infant is placed to the breast of the mother in order to initiate suckling;

 

(r) "Manufacturer" means a corporation or other entity in the public or private sector engaged in the business or function (whether directly or through an agent or an entity controlled by or under contract with it) of manufacturing a product within the scope of this Code;

 

(s) "Marketing firm" refers to an entity that does marketing or provides marketing services;

 

(t) "Marketing Materials" and/or "services" means the promotion, distribution, selling, advertising, public relations, information services, internet promotion and communication and information dissemination, in whatever form, including but not necessarily limited to, mail, email, text messages, telephone calls, website advertising, television, motion pictures, stage plays and radio programs, whether live or taped;

 

(u) "Marketing personnel" means any person whose functions involve the marketing of a product or products within the scope of this Code;

 

(v) "Medically Indicated" means special milk formula indicated for infants with inborn errors of metabolism, i.e. galactosemia, phenylketonuria* and maple syrup urine disease;

 

(w) "Milk company" shall refer to the owner, manufacturer, distributor, of infant formula, follow-up milk, milk formula, milk supplement, breastmilk substitute or replacement, or by any other description of such nature, including their representatives who promote or otherwise advance their commercial interests in marketing those products;

 

(x) "Natural and indigenous food" means locally grown or produced foods which are neither artificial nor processed;

 

(y) "Other milk products, foods and beverages" refers to any provision or drink marketed as a partial or total replacement of breastmilk;

 

(z) "Other related products" refers to all materials used to administer breastmilk substitutes; such as, but not limited to, feeding bottles, teats and other artificial feeding paraphernalia;



(aa) "Products within the scope of this Code" shall pertain to breastmilk substitutes and infant formula, including bottle-fed complementary foods, as well as teats and other commodities which intend to replace or substitute, in whole or in part, breastmilk and breastfeeding;

 

(bb) "Promotions" means employing any method, scheme, or design, of directly or indirectly, encouraging or enticing people, or group of persons, in whatever form, whether by chance or skill, to purchase or acquire products within the scope of the Code;

 

(cc) "Sample" refers to single or small quantities of a product provided for free;

 

(dd) "Sponsorships" shall refer to milk companies, and their agents/representatives, hosting, initiating, or otherwise providing games, sport or cultural events, charities, dances/balls, conventions, meetings, youth and women seminars or classes, and other like activities, for the purpose of promoting, directly or indirectly, their products covered within the scope of this Code;

 

(ee) "Supplies" refers to quantities of a product provided for use over an extended period, free or at a low price, for social purposes, including those provided to families in need.

 

(ff) "Young Child" means a person from the age of more than twelve (12) months up to the age of three (3) years (36 months).

 

RULE III

 

INFORMATION AND EDUCATION

 

SECTION 6. Responsibility. - The Department of Health shall take measures to promote, protect, support and monitor appropriate infant and young child feeding (IYCF) practices. Appropriate IYCF practices include the following:

 

• Proper Latching-on immediately after birth and initiation of breastfeeding within the first thirty (30) minutes thereafter

• exclusive breastfeeding from 0 - 6 months

• appropriate complementary feeding from 6 months onwards

• continuous breastfeeding up to two (2) years of age or beyond

 

The goals will be achieved by providing women access to the support that they require — in the family, the community, and the workplace. DOH shall provide objective, updated and consistent information and training of health workers and the general public on infant and young child nutrition in partnership with the local governments and civil societies without any conflict of interest.

 

SECTION 7. — Hazards and Complete Information on Breastmilk Substitutes and Replacements. - It is the responsibility of the State to inform the general public on the hazards of the production, preparation and use of breastmilk substitutes and other products covered by the Code. When medically indicated and only when necessary, the use of breastmilk substitutes is proper if based on complete and updated information.

 

SECTION 8. Information and Education. - The government shall ensure that objective and consistent information is provided on infant and young child feeding, for use by families and those involved in the field of infant nutrition. This responsibility shall cover the planning, provision, design and dissemination of information, and the control thereof.

 

a) In this regard, The Department of Health in collaboration with the national agencies, local government units, including non - governmental organizations and members of civil society, shall :

 

a.1. Plan, provide, design, disseminate and regulate information related to infant and young child nutrition and the implementation of the Milk Code;

 

a.2. Formulate and implement a communication plan, which among others will indicate key messages on infant and young child nutrition;

 

a.3. Create a Technical Working Group to serve as a clearing house for all information and training materials on infant and young child nutrition and the Milk Code; and

 

a.4. Assist Local Government Units (LGU's) and other partners in developing strategies to promote breastfeeding and infant and young child nutrition.

 

b) Informational and educational materials intended to reach pregnant women and mothers of infants, including women of reproductive age, which materials shall include clear information on all of the ensuing; (1) the benefits and superiority of breastfeeding; (2) maternal nutrition, and the preparation for and maintenance of breastfeeding; (3) the negative effect on breastfeeding of introducing partial bottle-feeding; (4) the difficulty of reversing the decision not to breastfeed; and (5) where needed, the proper use of infant formula, whether manufactured industrially or home-prepared. When such materials contain information about the use of infant formula, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods; and in particular, the health hazards of unnecessary or improper use of infant formula and other related products including information that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately.

 

c) The promotion, protection and support of breastfeeding and the proper implementation of the Milk Code shall be an integral part of all information, education, and communication plans and training activities of the Department of Health (DoH), as well as that of the Department of Education (DEPED), Department of Social Welfare and Development (DSWD), Local Government Units (LGU's), and other such concerned agencies/individuals.

 

RULE IV

 

RESEARCH

 

SECTION 9. Research, Ethics Committee, Purpose. - The DOH shall ensure that research conducted for public policy purposes, relating to infant and young child feeding should, at all times, be free from any commercial influence/bias; accordingly, the health worker or researcher involved in such must disclose any actual or potential conflict of interest with the company/person funding the research. In any event, such research and its findings shall be subjected to independent peer review. Towards accomplishing these ends;

 

a. Assistance for research and clinical trials given by manufacturers and distributors are allowed only upon approval by an ethics committee led by DOH. The same committee shall monitor said researches.

 

b. The researches shall be conducted in accordance with an approved protocol. Any changes in the protocol after it has been approved will be subject to a new review and approval by the Ethics Committee.

 

c. Assistance for research maybe allowed subject to the following conditions:

 

c.1. Researches involving well or ill infants and children as subjects shall be limited to physiological factors and therapeutic studies;

 

 c.2. These studies should in no case be harmful to the subject; and

 

c.3. Should be limited to those with potential benefits for the particular subject.

 

d. Recipients of research awards shall not allow themselves, their organizations or their subjects, to be used directly or indirectly for any promotional activity related to products within the scope of the Code. These may be by way of display of posters and streamers patronizing the Company, their products, and/or as lecturers/speakers or testimonials in the promotion of the products that undermine breastfeeding.

 

e. Assistance for support of laboratory costs, reagents and other materials shall be allowed only upon approval and review by the Ethics Committee regarding their use based on a submitted protocol.

 

SECTION 10. Public Disclosure. - For transparency purposes, a disclosure and/or disclaimer of the sponsoring company should be done by the company itself, health worker, researcher involved through verbal declaration during the public presentation of the research and in print upon publication.



RULE V

 

ADVERTISING, PROMOTION, MARKETING And SPONSORSHIPS

 

SECTION 11. Prohibition. - No advertising, promotions, sponsorships, or marketing materials and activities for breastmilk substitutes intended for infants and young children up to twenty-four (24) months, shall be allowed, because they tend to convey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or otherwise exaggerate breastmilk substitutes and/or replacements, as well as related products covered within the scope of this Code.

 

Section 12. Authority of the Inter-Agency Committee (IAC). - The Inter Agency Committee (IAC) shall review all advertising, promotion or other marketing materials, whether written, audio, visual, cinema, theater, audio-visual and electronics, including but not limited to mail, email, text messages, telephone calls and website advertising, and for communication and information dissemination in any form, for products within the scope of this Code.

 

The Committee shall develop/update substantive and procedural guidelines for reviewing advertising, promotional and marketing materials, including its screening when deemed appropriate. All such materials must have been approved and consented to in writing by the Committee before the Company's first public or commercial exhibition.



All approved advertisement and/or promotional materials for milk supplements, complementary food, feeding bottles & teats and related products must bear the messages both in English and in Filipino.

 

The DOH based on the latest scientific information and products may modify the messages, provided that wide dissemination of the message to all concerned is ensured.

 

SECTION 13. "Total Effect". - Promotion of products within the scope of this Code must be objective and should not equate or make the product appear to be as good or equal to breastmilk or breastfeeding in the advertising concept. It must not in any case undermine breastmilk or breastfeeding. The "total effect" should not directly or indirectly suggest that buying their product would produce better individuals, or resulting in greater love, intelligence,- ability, harmony or in any manner bring better health to the baby or other such exaggerated and unsubstantiated claim.

 

SECTION 14. Prior Written Consent and Approval of Committee. — No advertising, promotion or other marketing materials whether written, audio, visual, audio-visual, and electronic for products within the scope of this Code, which are marketed as partial or total replacement of breastmilk, including bottle-fed complementary foods shall be printed, published, distributed, exhibited, and broadcasted or in any manner released to the public without the prior written consent and approval of the Committee.

No blanket or general approval shall be allowed. Such written approval must be specific in product and time bound.

 

SECTION 15. Content of Materials. - The following shall not be included in advertising, promotional and marketing materials:

 

a. Texts, pictures, illustrations or information which discourage or tend to undermine the benefits or superiority of breastfeeding or which idealize the use of breastmilk substitutes and milk supplements. In this connection, no pictures of babies and children together with their mothers, fathers, siblings, grandparents, other relatives or caregivers (or yayas) shall be used in any advertisements for infant formula and breastmilk supplements;

 

b. The term "humanized", "maternalized", "close to mother's milk" or similar words in describing breastmilk substitutes or milk supplements;

 

 c. Pictures or texts that idealize the use of infant and milk formula.

 

RULE VI

 

PROHIBITED ACTS

 

SECTION 16. All health and nutrition claims for products within the scope of the Code are absolutely prohibited. For this purpose, any phrase or words that connotes to increase emotional, intellectual abilities of the infant and young child and other like phrases shall not be allowed.

 

SECTION 17. False or misleading information or claims of products within the scope of the Code arc prohibited.

 

SECTION 18. No financial or material inducements or gifts of any sort to promote products within the scope of this Code shall be offered or given by milk companies nor accepted by health workers and/or members of their families.

 

SECTION 19. Manufacturers, distributors and marketing firms or their representatives of products within the scope of this Code are prohibited from donating or giving directly or indirectly, samples and supplies to any member of the general public, to hospitals, and other health facilities, including their personnel and members of their families.

 

SECTION 20. Manufacturers, distributors and marketing firms or their representatives of products within the scope of this Code are prohibited from using the health workers and the health care system in die dissemination, distribution and promotion of products within the scope of the Code.

 

SECTION 21. Gifts of any sort from milk companies/manufacturers, distributors, and representatives of products within the scope of this Code, with or without company name or logo or product or brand name shall not be given to any member of the general public, to hospitals and other health facilities, including their personnel and members of their families.

 

SECTION 22. No manufacturer, distributor or representatives of products covered by the Code shall be allowed to conduct or be involved in any activity on breastfeeding promotion, education and production of Information. Education, and Communication (I EC) materials on breastfeeding, holding of or participating as speakers in classes or seminars 14 women and children activities and to avoid the use of these venues to market their brands or company names.

 

SECTION 23. There shall be no point of sale advertising, giving of samples or any promotion devices to induce sales directly to the consumers at the retail level, such as special displays, discount coupons, premiums, rebates, special sales, bonus and tic-in sales, loss-leaders, prices or gifts for the products within the scope of this Code.

 

SECTION 24. Neither the container nor the label of milk products within the scope of this Code shall have pictures of babies and children together with their mothers, fathers, siblings, grandparents, other relatives or caregivers (or yayas) or such other pictures and graphics of similar import.

 

RULE VII

 

CONTAINERS/LABELS

 

SECTION 25. Appropriate Use. - Containers and labels shall be designed to provide the necessary information about the appropriate use of the products within the scope the Code and in such a way as not to undermine, or equate it to, breastfeeding.



SECTION 26. Content. - Each container/label shall contain such message, in both Filipino and English languages, and which message cannot be readily separated therefrom, relative the following points:



a) The words or phrase "Important Notice" or "Government Warning" or their equivalent;  

 

b) A statement of the superiority of breastfeeding;

 

c) A statement that there is no substitute for breastmilk;

 

d) A statement that the product shall be used only on the advice of a health worker as to the need for its use and the proper methods of use;

 

e) Instructions for appropriate preparation, and a warning against the health hazards of inappropriate preparation, and

 

f) The health hazards of (the use) unnecessary or improper use of infant formula and other related products including information that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately.

 

SECTION 27. Infant Feeding Warning. - Food products within the scope of this Code marketed for infant feeding, which do not meet all the requirements of an infant formula but which can be modified to do so, shall carry on the label, a warning that the unmodified product should not be the sole source of nourishment of an infant.

 

SECTION 28. BFAD's Authority. - The labels of food products within the scope of this Code shall, in addition to the requirements in the preceding paragraphs, conform to the rules and regulations of the BFAD.

 

RULE VIII

 

QUALITY AND STANDARD

 

SECTION 29. Quality. - The quality of products is an essential element for the protection of the health of infants and young children and therefore shall be of highly recognized standard.

 

SECTION 30. Standards. - Food products within the scope of this Code shall, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission and also the Codex Code of Hygienic Practice for Foods for Infants and Children.

 

SECTION 31. Against Adulteration and the Like. - To prevent quality deterioration, adulteration or contamination of food products within the scope of this Code, distribution outlets, shall not be allowed to open cans and boxes for the purpose of retailing them by the cup, bag or in any other form.

 

RULE IX

 

HEALTH WORKERS And The HEALTH CARE SYSTEM

 

SECTION 32. Primary Responsibility of Health Workers. - It is the primary responsibility of the health workers to promote, protect and support breastfeeding and appropriate infant and young child feeding. Part of this responsibility is to continuously update their knowledge and skills on breastfeeding. No assistance, support, logistics or training from milk companies shall be permitted.

 

SECTION 33. Role of Academe and Others. - The academe and allied health institutions shall ensure basic education and training on Infant and Young Child Feeding (ICYF) and lactation management.

 

SECTION 34. Classes, Seminars For Women. - In order to protect women of reproductive age, including pregnant mothers, milk companies and their representatives, shall not be allowed to hold any activity in the guise of classes, seminars, recreation activities, fora, and the like, regardless whether or not such activities are intended to promote the products covered by the Code.

 

SECTION 35. No Promotions. - The health workers and the health care system shall not be used for dissemination, distribution and promotion of products within the scope of this Code. No health care facility should be used for promotions of products within the scope of this Code nor as venues that undermine breastfeeding.

 

RULE X

 

MONITORING And IMPLEMENTATION

 

SECTION 36. Monitoring, Implementation, Functions. - The Department of Health shall be primarily responsible for the monitoring, implementation and enforcement of the Milk Code and these Implementing Rules and Regulations.

In coordination with other agencies involved in the implementation of the Code, the Department shall adopt such appropriate monitoring guidelines for the national, regional and provincial levels. It shall likewise provide regular training on monitoring compliance and enforcement on violations of the Milk Code for all persons engaged in or volunteering to help in the monitor and implementation of the Code. The Department may request for the assistance of non — governmental organizations, civil society, and concerned international agencies in order to better monitor the implementation of these rules.

Accordingly, a monitoring team, composed of the ensuing, is hereby created and established :

 

National level:

 

 ■ National Center for Disease Prevention and Control (NCDPC)

 

 ■ National Center for Health Facilities and Development (NCHFD)

 

■ Government/Non-government Organizations/Civil Societies without any conflict of interest with the breastfeeding culture, and/or direct or indirect connection, financial or otherwise, or with commercial interest within the scope of the Code

 

 ■ Ad Hoc International Agencies such as the United Nations Children's Emergency      Fund (UNICEF) and/or the World Health Organization (WHO)

 

Regional/Provincial/City/Municipal/Barangay levels (in collaboration with their respective Local Government Units):

 

■ Center for Health Development Offices

 

■ Provincial Health Offices

 

■ City Health Offices

 

■ Municipal Health Offices/Rural Health Units

 

■ Barangay Health Office

 

■ GOs/NGOs/Civil Societies

 

The Monitoring Team shall have the following functions:

 

■ Monitors compliance as well as problems encountered in the implementation of   the Milk Code.

 

■ Reviews/acts on reports of violations of the provisions of the Code.

 

■ Verifies reports of violations of the Milk Code.

 

■ Monitors labels of products within the scope of the Code and marketing practices in various distribution centers.

 

■ Recommends sanctions or punitive actions for violations of the Milk Code to the Bureau of Food and Drugs.

 

■ Submits regular reports on the status of the Milk Code implementation to the Bureau of Food and Drugs.

 

SECTION 37. Report to the Secretary of Health. - Monitoring Teams comprised of duly accredited teams from non-governmental organizations, and/or civil society may report their findings to the Office of the Secretary of Health who shall appropriately respond thereto with sufficient dispatch.

 

SECTION 38. Role of DoH/BFAD in IAC. — The Department of Health shall convene and chair the Inter - Agency Committee (IAC) with BFAD acting as its Member/Secretariat.

 

RULE XI

 

FILING Of ADMINISTRATIVE And CRIMINAL COMPLAINT

 

SECTION 39. Role of Bureau of Food and Drugs (BFAD). - The Bureau of Food and Drugs (BFAD) shall investigate and verify reports of violations; when appropriate, apply administrative sanctions against the violators; and/or file criminal complaints against persons and entities found to have violated, singly or repeatedly, the provisions of the Code or these implementing rules and regulations.

 

SECTION 40. National Level Violations.- Reports of violations of the Milk Code committed at the national level shall be filed and investigated at the Bureau of Food and Drugs.

 

SECTION 41. Regional/Provincial Level Violations. - Problems/violations arising at the regional/provincial levels shall be filed, investigated and resolved at these levels. The regional/provincial level shall notify BFAD of any action taken relative to the aforesaid problems/violations. Violations that require prosecution or imposition of administrative sanction as stated in these rules shall be elevated to the BFAD for appropriate action.

 

SECTION 42. Meaning of National/Regional/Provincial Level Violations. When the violation consists of commercial exhibition or advertisement for those products within the scope of this Code and found in areas beyond regions, then the violation is deemed to be national. When found or existing in a specific region only, then regional and so on down to the other geographical areas.




SECTION 43. Issuance of Cease and Desist Orders (CDO's). — Immediately upon receipt of the report of violation, the investigating officer shall conduct an ex parte examination of the evidence presented. If a prima facie case is established, a Cease and Desist Order (COO) shall be issued by the BFAD Director or the DoH Regional Director, as the case may be.

 

Non-compliance with the CDO shall be ground for the imposition of administrative sanctions as stated in Section 47 (f) hereof. The issuance of the CDO shall be without prejudice to the imposition of the appropriate administrative sanction, if so warranted, after due notice and hearing.

 

SECTION 44. Authority of the IAC To Issue CDO. The IAC Secretariat shall have the authority to determine if any advertising, marketing, or promotional material violates these Rules and Regulations. In such case, the IAC Secretariat shall issue a CDO, signed by the IAC Chairperson stopping the further release, printing, broadcast, or dissemination of the violative advertising, marketing, or promotional material.

 

In instances where the CDO is not complied with, the rules stated in the second paragraph of the preceding section shall apply.

 

SECTION 45. Role of the Department of Justice. — The Department of Justice (DoJ) shall cause the criminal prosecution of the violators of this Code.

 

RULE XII

 

ADMINISTRATIVE SANCTIONS

 

SECTION 46. Administrative Sanctions. - The following administrative sanctions shall be imposed upon any person, juridical or natural, found to have violated the provisions of the Code and its Implementing Rules and Regulations:

 

 a) violation — Warning;

 

b) 2" violation - Administrative fine of a minimum of Ten Thousand (P10,000.00) to Fifty Thousand (P50,000.00) Pesos depending on the gravity and extent of the violation, including the recall of the offending product;

 

c) 31d violation — Administrative Fine of a minimum of Sixty Thousand (P60,000.00) to One Hundred Fifty Thousand (P150,000.00) Pesos, depending on the gravity and extent of the violation, and in addition thereto, the recall of the offending product, and suspension of the Certificate of Product Registration (CPR);

 

d) 4th violation — Administrative Fine of a minimum of Two Hundred Thousand (P200,000.00) to Five Hundred (P500,000.00) Thousand Pesos, depending on the gravity and extent of the violation; and in addition thereto, the recall of the product, revocation of the CPR, suspension of the License to Operate (LTO) for one year;

 

e) 5`11 and succeeding repeated violations - Administrative fine of One Million (P 1,000,000.00) Pesos, the recall of the offending product, cancellation of the CPR, revocation of the License to Operate (LTO) of the company concerned, including the blacklisting of the company to be furnished the Department of Budget and Management (DBM) and the Department of Trade and Industry (DTI);

 

f) An additional penalty of Two Thousand Five Hundred (P2,500.00) Pesos per day shall be made for every day the violation continues after having received the order from the IAC or other such appropriate body, notifying and penalizing the company for the infraction.

 

For purposes of determining whether or not there is "repeated" violation, each product violation belonging or owned by a company, including those of their subsidiaries, are deemed to be violations of the concerned milk company and shall not be based on the specific violating product alone.

 

SECTION 47. Fees, Charges and Fines. — All fees collected, charges imposed and administrative fines that have accrued as a consequence of the implementation of these Rules shall be for the account and income of the Bureau of Food and Drugs.

 

SECTION 48. Against Public Employees.- In accordance with the Administrative Code and pertinent Civil Service rules and regulations, erring government employees found to be liable, and depending on the gravity of said violation, shall be imposed the appropriate penalty by the disciplining authority.

 

SECTION 49. Liability of Manufacturers/Distributors. - Manufacturers and Distributors of the products covered by the Code shall be directly liable for any violation of the provisions of the Code and its IRR. Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefore, shall be made accountable.

Agents/Representatives of the Manufacturers or Distributors of the products within the scope of the Code, who commit any violation of the provisions of the Code and its implementing rules and regulations shall be jointly and solidarily liable with the said manufacturers and distributors.

 

RULE XIII

 

CRIMINAL PENALTIES

 

SECTION 50. Penalties. - Any person who violates the provisions of this Code or these rules and regulations shall, upon conviction, be punished by a penalty of two (2) months to one (1) year imprisonment or a fine of not less than One Thousand Pesos (P1,000.00) nor more than Thirty Thousand Pesos (P30,000.00) or both. Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefore, shall be penalized.

 

RULE XIV

 

MISCELLANEOUS PROVISIONS



Section 51. Donations Within the Scope of This Code. - Donations of products, materials, defined and covered under the Milk Code and these implementing rules and regulations, shall be strictly prohibited.

 

Section 52. Other Donations By Milk Companies Not Covered by this Code. Donations of products, equipments, and the like, not otherwise falling within the scope of this Code or these Rules, given by milk companies and their agents, representatives, whether in kind or in cash, may only be coursed through the Inter Agency Committee (IAC), which shall determine whether such donation be accepted or otherwise.

 

SECTION 53. Construction. All doubts in the implementation and interpretation of the provisions of these implementing rules and regulations shall be resolved in favor of and for the promotion of breastfeeding and against breastmilk substitutes and replacements.

 

SECTION 54. Supplemental Administrative Issuances. — The Secretary of Health, or his duly authorized representative, may issue such additional implementing rules and regulations as may be necessary to further clarify any part of this IRR.

 

SECTION 55. Continuous Review on Prescription Policy. — The Department of Health shall evaluate every year, or as necessary, its policy of whether or not to subject the sale of infant formula or breastmilk substitutes, to prescription.

 

SECTION 56. Extending Prohibition For Brand names and Company Logo Identification. — The Department shall periodically review whether or not to allow or prohibit the use of brand names or company logos of products within the scope of this Code which are similar to the brand names or logos utilized for products not covered by this Code, including the physical appearance of the container, taking into consideration the possibility of product confusion, the balance between a free market economy as against the decline and fall of breastfeeding rates among mothers and women of reproductive age, and public welfare and benefit being its ultimate yardstick. Accordingly, any modification of existing policy should first undergo public consultations with all concerned stakeholders before its actual implementation.

 

RULE XV

 

FINAL PROVISIONS

 

SECTION 57. Repealing Clause. — All orders, issuances, and rules and regulations or parts thereof inconsistent with these revised rules and implementing regulations are hereby repealed and modified accordingly.

 

SECTION 58. Separability Clause. — If for any reason, any part or provision of these Revised Rules and Implementing Regulations, be declared invalid or unconstitutional, such invalidity or unconstitutionality shall not affect the other provisions which shall remain in full force and effect.

 

SECTION 59. Effectivity. — These Revised Rules and Regulations shall take effect fifteen (15) days after its publication in a newspaper of general circulation with the requisite copy submitted to the University of the Philippines Law Center.

 

Approved by the National Committee of the Department of Health in its Regular meeting  of 15th May 2006, at the Office of the Secretary, San Lazaro Compound, Rizal Avenue, Sta. Cruz, City of Manila.

 

FRANCISCO T. DUQUE III,MD,MSc ETHELYN P. NIETO,MD

Secretary of health Undersecretary of health

 

ALEXANDER A. PADILLA MARGARITA M. GALON,MD,MHA

Undersecretary of health Undersecretary of health



JADE F. DEL MUNDO,MD MARIO C. VILLAVERDE,MD

Undersecretary of health Assistant secretary of health

 

DAVID J. LOZADA jr., MD NEMESIO T.GAKO,MD

Assistant secretary of health Assistant secretary of health




Attested by:

 

ROBERT LOUIE P. SO, MD

Head executive assistant




 

 








 






THE IMPLEMENTING RULES AND REGULATION OF

REPUBLIC ACT NO. 10028

 

ENTITLED

 

AN ACT EXPANDING THE PROMOTION OF BREASTFEEDING, AMENDING FOR THE PURPOSE REPUBLIC ACT NO. 7600, OTHERWISE KNOWN AS “AN ACT PROVIDING INCENTIVES TO ALL GOVERNMENT AND PRIVATE HEALTH INSTITUTIONS WITH ROOMING-IN AND BREASTFEEDING PRACTICES AND FOR OTHER PURPOSES''

 

Pursuant to Republic Act No. 10028, the following Implementing Rules and Regulations are hereby formulated for the effective implementation of this law by authorized officials and representatives of the Department of Health, in consultation with other concerned government agencies, non-government organizations. private sectors, parents and students.

 

RULE I

 

ENABLING PROVISIONS

 

Section 1. Title - These rules shall be known and cited as the Rules and Regulations Implementing Republic Act No.10028 also known as the "Expanded Breastfeeding Promotion Act of 2009.

 

Section 2. Purpose - These Rules are promulgated to prescribe the procedure and guidelines for the Implementation of the Expanded Breastfeeding Promotion Act of 2009 in order to facilitate the compliance therewith and to achieve the objectives thereof pursuant to Section 18 of RA 10028.

 

Section 3. Construction - These Rules shall be liberally construed and applied in accordance with and in furtherance of the policy and objectives of the law. In case of conflict and/or ambiguity, which may arise in the implementation of these Rules, the agencies concemed shall issue the necessary clarification.



Section 4. Declaration of Policy - The State adopts rooming-in as a national policy to encourage, protect and support the practice of breastfeeding. It shall create an environment where basic physical, emotional, and psychological needs of mothers and infants are fulfilled through the practice of rooming-in and breastfeeding.

 

The State shall likewise protect working women by providing safe and healthful working conditions, taking into account their maternal functions, and such facilities and opportunities that will enhance their welfare and enable them to realize their full potential in the service of the nation. This is consistent with international treaties and conventions to which the Philippines is a signatory such as the Convention on the Elimination of Discrimination Against Women (CEDAW), which emphasizes provision of necessary supporting social services to enable parents to combine family obligations with work responsibilities; the Beijing Platform for Action and Strategic Objective, which promotes harmonization of work and family responsibilities fbr women and men; and the Convention on the Rights of the Child, which recognizes a child's inherent right to life and the State's obligations to ensure the child's survival and development. Breastfeeding has distinct advantages which benefit the infant and the mother, including the hospital and the country that adopt its practice. It is the first preventive health measure that can be given to the child at birth. It saves children irom dying. It also enhances the mother-infant relationship. Furthermore, the practice of breastfeeding could save the country valuable foreign exchange that would otherwise be used for milk importation. Breastmilk is unequalled as the best food for infants because it contains essential nutrients completely suitable their needs' lt is also nature's first immunization, enabling the infant to fight potential serious infection. It contains growth factors that enhance the maturation of an infant's organ systems' .

 

Towards this end, the State shall promote and encourage breastfeeding ancl provide the specific measures that would present opportunities for mothers to continue expressing their milk and/or breastfeeding their infant or young child.

 

RULE II

 

DEFINITION OF TERMS

 

Section 5. Definition of terms - As used in these Rules, the following terms shall have the meaning as indicated hereunder:



Advocacy - a process to bring about change in the policies, laws and practices of influential individuals, groups and institutions. It involves many people and/or organizations working together toward a shared vision of change'

 

Age of gestation - the length of time the fetus is inside the mother's Womb.

 

Bottle feeding - the method of feeding an infant using a bottle with artificial nipples, the contents of which can be any type of fluid.

Breastfeeding - the method of feeding an infant directly from the human breast.

Breastmilk - the human milk from a mother.

 

Breastmilk substitute - any food being marketed or otherwise represented as partial or total replacement of breastmilk whether or not suitable for that purpose.

 

DOH - refers to the Department of Health.

 

DOLE - refers to the Department of Labor and Employment.

Donor breast milk - the human milk from a non-biological mother.

 

Expressed breastmilk - the human milk which has been extracted from the breast by hand or by breast pump. It can be fed to an infant using a dropper, a nasogastric tube, a cup and spoon or a bottle.

 

Expressing milk - the act of extracting human milk from the breast by hand or by pump into a container.

 

Formula feeding - the feeding of a newborn with infant formula usually by bottle feeding. It is also called artificial feeding.

 

Health institutions - are hospitals, health infirmaries, health centers. lying-in centers, or puericulture centers with obstetrical and pediatric services.

 

Health personnel - are professionals and workers who manage and/or administer the entire operations of health institutions and/or who are involved in providing maternal and child health services.

 

Health Promotion - a process of enabling people to take action to improve health. It is anchored on five action areas; building healthy public policy, creating a supportive environment, developing personal skills, strengthening community action, and reorienting health services.

 

Health Workers - All Persons who are engaged in health and health-related work, and all persons employed in all hospitals, sanitaria, health infirmaries, health centers, rural health units, barangay health stations, clinics and other health-related establishments, whether government or private, and shall include medical, allied health professional, administrative and support personnel employed regardless of their employment status. It includes clinic personnel at the workplace.

 

Healthy Workplace - a place where everyone works together to achieve an agreed vision for health, safety and well-being of workers, their families and the surrounding community.

 

Human Milk Bank - is a service established for the purpose of collecting, screening, processing, storing and distributing donated human milk to meet the specific medical needs of individuals for whom human milk is prescribed.

 

Incentives - The expenses incurred by a private health and non-health institution, establishment or institution, in complying with the provisions of the Act, shall be deductible expenses for income tax purposes up to twice the actual amount incurred: provided, that the deduction shall apply for the taxable period when the expenses were incurred: provided, further, that all health and non-health facility, establishments and institutions shall comply with the provisions of The Act within six (6) months after its approval.

 

Infant - a child within zero (0) to twelve (12) months of age.

 

Infant formula - the breastmilk substitute formulated industrially in accordance with applicable Codex Alimentarius standards, to satisfy the normal nutritional requirements of infants up to six (6) months of age, and adopted to their physiological characteristics.

 

Lactation management - the general care of a mother-infant nursing couple during the mother's prenatal, immediate postpartum and postnatal periods. it deals with educating and providing knowledge and information to pregnant and lactating mothers on the advantages of breastfeeding, the risks associated with breastmilk substitutes and milk products not suitable as breastmilk substitutes such as, but not limited to, condensed milk and evaporated milk, the monitoring of breastfeeding mothers by health workers and breastfeeding peer counselors for service patients to ensure compliance with the DoH, world Health organization (wHo) and the united Nations children's,Fund (UNICEF) on the implementation of breastfeeding policies, the physiology of lactation, the establishment and maintenance of lactation, the proper care of the breasts and nipples, and such other matters that would contribute to successful breastfeeding.

 

Lactation stations - Private, clean, sanitary, and well-ventilated rooms or areas in the workplace or public places where nursing mothers can wash up breastfeed or express their milk comfortably and store this after"ward. Also known as Breastfeeding room/arealstation.

 

Low birth weight infant - a newborn weighing less than two thousand five hundred (2,500) grams at birth.

 

Milk Donor - a healthy lactating mother who volunteers to donate her milk.

 

Milk Storage Facility - any private, clean, sanitary and well ventilated area or space in a health institution designated for the purpose of collecting and storing milk among mothers separated from their own babies due tc medical reasons. This should be differentiated from the lactation station which primarily serves nursing mothers working in health or non-health facilities.

 

Mother's milk - the breast milk from the newborn's own mother.



Networking - the process of linking up diverse individuals or groups bringing about their mutual agreement to share one another's resources and competencies as a way of serving mutual interests.

 

Nursing employee - any female worker, regardless of employment status, who is lactating or breastfeeding her infant andlor young child.

 

Non-health facility establishment or institution - public places and workplaces, as herein defined.

 

Philippine Health Promotion Program through Healthy Places (PHPP) - a national multi-sectoral health promotion strategy which aims to communicate health messages and build health supportive environment through advocacy, networking and community action as per Administrative Order No. 341: Implementing PHPP through Healthy Places.

Private Sector Organizations - refer to privately owned companies, corporations, associations, foundations, and the like.

 

Public Sector - the portion of society controlled by national, state or provincial and local governments.

 

Public place - enclosed or confined areas such as schools, public transportation terminals, shopping malls, and the like.

 

Rooming-in - the practice of placing the newborn in the same room as the mother right after delivery up to discharge to facilitate mother-infant bonding and to initiate breastfeeding. The infant may either share the mother's bed or be placed in a crib beside the mother.

 

Seriously ill mothers - are those who are: with severe infections; in shock, in severe cardiac or respiratory distress; or dying; or those with other conditions that may be determined by the attending physician as serious.

 

The Act - refers to the Expanded Breastfeeding Promotion Act of 2009.

 

Wet-nursing - the feeding of a newbom from another mother's breast when his/her own mother cannot breastfeed.

 

Workplace - work premises, whether private enterprises or gor.'ernment agencies, including their subdivisions, instrumentalities and government owned and controlled corporations.

 

Workplace Policy - a documented set of broad guidelines, formulated after an analysis of all internal and external factors that can affect a firm's objectives, operations, and plans. Formulated by the firm's board of directors, workplace policy lays down the firm's response to known and knowable situations and circumstances. It also determines the formulation and implementation of strategy, and directs and restricts the plans, decisions, and actions of the firm's officers in achievement of its objectives.

 

Young child - a child from the age of twelve (12) months and one (1) day up to thirty-six (36) months.

 

RULE III

 

BREASTFEEDING IN THE WORKPLACE AND PUBLIC PLACES

 

Section 6. Objective - These Rules and Regulations seek to clarify the scope and application of the Act in order that the proper parties may avail of its benefits

 

Section 7. General Statement on Coverage - This Rule shall apply to all establishments whether operating for profit or not which employ in any workplace, nursing employees, unless exempted by the Secretary of Labor and Employment, under Section B hereof.

 

Section 8. Exemption - A private establishment may apply for an exemption to establish lactation station at the DOLE Regional Office having jurisdiction over said establishment. An application for exemption may be granted by the DOLE Regional Director upon determination that the establishment of a lactation station is not feasible or necessary due to the peculiar circumstances of the workplace taking into account, among others, the number of women employees, physical size of the establishment and average number of women who will use the facility. Due substantiation shall be made by the employer to support the application for exemption. The exemption granted by DOLE shall be for a renewal period of two (2) years.

 

Public sector may apply for an exemption from the Chairperson of the Civil Service Commission. The exemption granted by Civil Service Commission shall be for a renewal period of two (2) years.

 

Section 9. Workplace Policy - Every workplace shall develop a clear set of guidelines that protects, promotes and supports breastfeeding program. The written policy should be developed in consultation with the workers, approved and properly disseminated to all concern. The Nursing/Lactating employees should be oriented on the proper handling, labeling, and storage of their own expressed breastmilk. The policy should be part of the company's general policy or manual of operation, and the policy should operationalize the provision of this IRR.

 

Section 10. Minimum Requirements in the Establishment of Lactation Stations - It is hereby mandated that health and non-health facilities, establishments or institutions, including public places, shall establish lactation stations as appropriate. Lactation stations shall be accessible to the breastfeeding women. It shall be adequately provided with the necessary equipment and facilities and other items, the standards of which shall be defined by the Department of Health. The lactation station shall be clean, well ventilated, comfortable and free from contaminants and hazardous substances, and shall ensure privacy for the women to express their milk and/or in appropriate cases, breastfeed their child. In no case, however, shall the lactation station be located in the toilet.

 

Section 11. Workplace compliance with the Milk Code - In addition, the establishments shall take strict measures to prevent any direct or indirect promotion, marketing, and/or sales of infant formula and/or breastmilk substitutes within the lactation stations, or in any event or circumstances which may be conducive to the same, to affect exclusive breastfeeding up to six months and the introduction of appropriate complementary food from six months while continuing to breastfeed for two years and beyond.

 

Section 12. Lactation Periods - Nursing employees are entitled to break intervals in addition to the regular time-off for meals to breastfeed or express milk. The employee shall notify their immediate supervisor before leaving their station. These intervals which include the time it takes an employee to get to and from the workplace lactation station shall be counted as compensable hours worked. The DOLE may adjust the same but in no case shall such intervals be less than 40 minutes for every 8- hour working period. Duration and frequency of breaks may be agreed upon by employees and employers with the minimum being 40 minutes. Usually, there could be 2-3 breastmilk expressions lasting to l5-30 minutes each within a workday.

 

Section 13. Access to Breastfeeding Information - Employers shall ensure that staff and employees shall be made aware of The Act and this IRR. All pregnant employees shall be provided with information on how they can combine breastfeeding and work once they return to work. As such, employers are encouraged to link with the Department of Health, NGOs, and professional groups thru the local government unit in their area to avail of the breastfeeding/IYCF program for working mothers as part of their human resource development program.

 

Regular breastfeeding education should be provided for pregnant women focusing on capacitating them with skills and knowledge necessary to continue breastfeeding/expressing breastmilk after returning to work. The information that will be provided to mothers should include manual breast milk expression, cup feeding, handling, storage and transporting of expressed breastmilk

 

The company should organize, initiate and conduct adequate orientation on lactation management, support program for nursing employees.

 

Section 14. Department of Health Certification - Any health and non-health facility, establishment or institution satisfying the requirements of Section l0 and Section i2 of these Rules relative to a proper lactation station may apply with their respective Local Government Unit for a 'working mother-baby friendly' certification. The DOH will issue the guidelines for "working mother-bab1-friendly establishments".

 

CHDs may coordinate with the LGU's and other institutions to be able to review applications, and verify compliance and eventually issue the certification.

 

The Center for Health Developments (CHD's) at the regional level, will be in charge of the DOH certification.

 

The Department of Health shall maintain a list of "working mother-baby-friendly establishments," which it shall make available to the public.

 

The DOH may create an awarding mechanism for the health and non health facilities that successfully comply with the Act.

 

Section 15. Eligibility for Tax Incentives - Apart from the minimum requirements under Section 10 of these Rules, establishments may provide other suitable facilities or services within the lactation station, all of which, ripon due substantiation, shall be considered eligible for purposes of availing the incentives provided for under the new Section 19 of the Act.

 

The expenses incurred by a private health and non-health facility, establishment or institution, in complying with the provisions of the Act and this IRR, shall be deductible expenses for income tax purposes up to twice the actual amount incurred, subject to the following conditions:

 

The deduction shall apply for the taxable period when the expenses were incurred;

 

That all health and non-health facility, establishments and institutions shall comply with the provisions of this IRR within six (6) months after its approval; and

 

That such facilities, establishments or institutions shall secure a "Working Mother-Baby-Friendly Certificate" from the Department of Health to be filed with the Bureau of Internal Revenue, before they can avail of the incentive.

 

The Bureau of Internal Revenue shall provide for guidelines in the availment of incentives under this Act.

 

Section 16. Eligibility for additional appropriation - Government facilities, establishments or institutions shall receive an additional appropriation equivalent to the savings they may derive as a result of complying with the provisions of the Act. The additional appropriation shall be included in their budget for the next fiscal year.

 

Government facilities, establishments or institutions, may report and provide evidence for savings generated due to the implementation of the law, considering but not limiting to the following:

 

a. Reduced cost of procurement, sterilization, management of infant formula paraphernalia;

b. Reduce costs due to absenteeism;

c. Increase productivity;

d. Reduce illness of the babies;

e. Others.

 

The Department of Budget and Management shall allocate funds equivalent to the savings of the appropriate Government agency and issue guidelines on how to access such appropriations.

 

RULE IV

 

MILK STORAGE AND MILK BANKING IN HEALTH INSTITUTIONS

 

Section 17. Milk Storage Facility - All health institutions adopting rooming-in and breastfeeding shall provide "milk storage facilities". These facilities are not the same as milk banks.

 

The Act subscribes to the rooming-in policy such that the mothers should have early skin-to-skin contact and early initiation of breastfeeding. In case the mother and baby are separated and direct breastfeeding is not possible, there will be a need for milk expression and milk storage. A11 mothers should receive instructions on hand expression, storage and transport of breastmilk. There must be a dedicated and trained person who will supervise and assist the mothers who will use the facility and the health facility should fully comply with Executive Order 51.

 

The following are the minimum requirements for a milk storage facility:

 

a. Well-ventilated space or area solely intended for milk collection and storage

 

b. Refrigerator or freezer or its equivalent (ice cooler) following the guidelines for proper storage of breastmilk set by the Dept of Health

 

c. Sterile milk containers, hard plastic, food grade

 

d. Lavatory with water and soap

 

e. Table and comfortable chairs f. Manual or electric breast pumps (optional).

 

f. Manual or electric breast pumps (optional).



Section 18. Milk Banks - Health institutions that are encouraged to put up milk banks include, but not limited to, Medical Centers and Regional Hospitals. A Human milk bank should only be used as a temporary solution when the mother and baby are separated. Milk Banks may be source of breastmilk for infants that are victims during an emergency andlor a disaster. The importance of breastfeeding should at all opportunities be emphasized to all mothers through counselling. Mothers of human milk bank recipients should be counselled in lactation or re-lactation by trained milk bank personnel.

 

Milk banks should operate on a non-profit basis, but a minimal processing fee may be charged to cover for the screening, processing and administrative costs. However, inability to pay the said fee should not be a reason for non-availment of the milk for patients in need. These milk banks must have their own permanent, dedicated staff/personnel who are trained in human milk banking and lactation management.

 

Section 19. Defined Areas in the Milk Bank:

 

A. Wash area -  it has a deep lavatory/sink with direct water source and soap dispenser, clean hand towels or dryer for the donor mothers to facilitate aseptic milk collection.

 

B. Milk expression area - provision of chairs and table where mothers can collect their milk.

 

C. Processing and Storage Area - This area is located in the innermost area of the facility and is a room separate tiom the other milk bank areas for proper sanitary control. this area must be air-conditioned to maintain certain equipment.

 

D. Office/Administrative space - milk bank records are kept here.

 

Section 20. Minimal equipment and structures in the processing area:

 

a. Pasteurizer

b. freezers (milk bank facilities with large volume supply of milk

c. requiring prolonged storage of more than a week would need an upright, -20o C freezer)

d. refrigerator with thermometer e. storage wall cabinets

f.  working table

g. Deep sinks/lavatories

h. sterile, rigid, plastic milk containers  

 

Section 21. Milk Bank certification or accreditation by the DOH - Human milk banks should be registered, licensed and monitored by the Department o1' Health (Bureau of Health Facilities and Services). Human milk banks should follow the guidelines set by the Department of Health defining the proper donor screening, collection, storage, transport, processing and distribution of human milk. Training on milk banking will be provided by reference human milk banks accredited by the Department of Health.

 

section 22. Source of Donor Human Milk - Donation of human milk must be made on a voluntary basis. Donors must pass the screening procedures set forth by the Department of Health and Human milk donors may come from, but.not limited to the following:

 

a. Lying-in clinics/maternity clinics

 

b. Health Centers

 

c. Community Support Group

 

d. Government agencies and Private enterprises with lactation stations

 

e. Private individuals

 

Section 23. Availment of pasteurized human milk - An outline of recipient prioritization shall be set forth in a separate list of milk banking guidelines by the Department of Health. Pasteurized human milk should be dispensed onh, with a prescription from a physician. Pasteurized human milk may be given if there is either a maternal or infant indication, as recommended by the attending physician.

 

RULE V

 

BREASTFEEDING INTEGRATION IN THE CURRICULUM

 

Section 24. Roles and Responsibilities - The following are the rules and responsibilities of concerned government agencies, bodies, academic and professional organizations.

 

(a) Department of Health (DOH)

 

Provide technical assistance/input in the development of materials or curriculum in line with breastfeeding, infant, young child feeding (IYCF) and other breastfeeding-related education.

 

(b) Department of Education (DepEd)

 

1. Issue memoranda, orders and directives promoting and supporting breastfeeding;

 

2. Integrate breastfeeding and breastfeeding- related concepts in the basic education curriculum of all private and public institutions, both formal and non-formal sectors, through the following strategies:

 

2.1 Identify learning areas and points of entry where core message about breastfeeding can be continuously developed and integrated;

 

2.2 Develop instructional materials and related information, education and communication materials;

 

2.3 Develop advocacy programs for parents on breastfeeding;

 

2.4 Review and revise existing instructional materials to ensure that these will not undermine the promotion, protection and support for breastfeeding;

 

2.5 Ensure assessment and evaluation of knowledge, skills and attitudes (KSA) of pupils/students teachers and parents on breastfeeding.

 

3. Develop awareness and competency of teaching, administrative and non-teaching personnel as well as parents on breastfeeding.

 

(c) Commission on Higher Education (CHED)

 

1. Ensure integration of breastfeeding-related concepts in the curriculum of Higher Educational Institutions (HEIs), both public and private, including State Universities and Colleges (SUCs), and local colleges through the following strategies:

 

2. Issue CHED Memorandum Orders (CMO) and CHED Special Orders (CSO) pursuant to the implementation of the Act 10028, and future policy and program developments to all concerned stakeholders through the various regional offices;

 

3. Encourage HEIs to promote breastfeeding through instruction, research and extension services; and

 

4. Assess, monitor and evaluate the breastfeeding integration in the curriculum.

 

(d) Technical Education and Skills Development Authority (TESDA)

 

Ensure integration of breastfeeding- related concepts in the curriculum of technical vocational institutions, both public and private. through identification of modules or vocational qualifications where breastfeeding can be integrated.

 

(e) Professional Regulations Commission (PRC)

 

1. Ensure inclusion of breastfeeding and breastfeeding-related concepts in professional licensure examinations;

 

2. Develop and implement sanction mechanisms for a professional that have violated any of the provisions o1'the Act; and

 

3. Address complaints of patients, relatives and the society on the violations concerning breastfeeding-related issues.

 

(f) Academe

 

1. Implement issuances on integration of breastfeeding concepts in the curricula;

 

2. Develop competencies for faculty members and instructors;

 

3. Provide related learning experiences (RLEs); and 4. Ensure provision of positive and supportive environment to promote and support breastfeeding.

 

(g) Academic Organizations

 

1. Protect, promote and support breastfeeding through advocacy in organizational activities, forum and conventions among its members;

 

2. Recognize schools, higher educational institutions supportive of breastfeeding advocacy through awards, incentives, etc. ;

 

3. Encourage and support relevant breastfeeding research among its members, and

 

4. Provide financial support in academic-based breastfeeding programs.

 

(h) Professional and Socio-Civic Organizations

 

1. Adhere and implement among its members national policies and legislation on the protection, promotion and support of breastfeeding;

 

2. Protect, promote and support breastfeeding through advocacy in organizational activities, forum, convention among its members;

 

3. Incorporate provisions on organizations' Code of ethics to promote, protect and support breastfeeding in accordance to Convention on the Rights of the Child (CRC), Patients' Rights and gender and Sensitivity principles; and

 

4. Encourage and support relevant breastfeeding research among its members.

 

RULE VI

 

CONTINUING EDUCATION, RE-EDUCATION AND TRAINING OF HEALTH WORKERS AND HEALTH INSTITUTIONS

 

Section 25. continuing Education, Re-education and training of Health Workers and Health Institutions - The Department of Health with the assistance of other govemment agencies, professional and non-governmental organizations shall conduct continuing information, education, re-education and training programs fbr physicians, nurses, midwives, nutritionist-dietitians, community health workers and traditional birth attendants (TBAs) and other health and nutrition workers and allied professionals on current and updated lactation management. As such, tire DOH through its Health Human Resource Development Bureau (HHRDB) and its other units, shall:

 

a. Develop and implement a capacity development plan to provide training more intensively until such time that breastfeeding has been fully integrated in the medical and allied curricula; 2. 3. t2

 

b.Organize a pool of trainers and experts from government, NGOs, academe, private organizations who can be tapped by the health and non-health facilities, establishments or institutions to transfer the necessary knowledge and skills required for the implementation of this Act;

 

c.Develop and update common messages that will be adopted in training and other IEC materials to ensure consistency and correctness of the content of trainings on breastfeeding and lactation management;

 

d.In coordination with the Civil Service Commission, to develop an orientation course on breastfeeding for government employees"

 

RULE VII

 

PUBLIC EDUCATION AND AWARENESS PROGRAM ON BREASTFEEDING PROMOTION

 

Section 26. Celebration of Breastfeeding Awareness Month - In order to raise awareness on the importance of and to further promote breastfeeding, the month of August in each and every year throughout the Philippines shall be known as "Breastfeeding Awareness Month".

 

The DOH shall be the lead agency in the celebration of BF awareness month through inclusion of BF awareness month in the monthly health events and issuance of Department of Memorandum to all DOH health facilities, attached agencies and other concerned offices/departments.

 

Section 27. Public education and awareness program - to ensure the meaningful observance of breastfeeding month, a.comprehensive national public education and awareness program shall be undertaken in order to achieve the following objectives:

 

  1. To protect, promote and support breastfeeding in the Philippines as the normal, natural and preferred method of feeding infants and young children;

 

  1. To guarantee the rightful place of breastfeeding in society ar a time honored tradition and nurturing value as well as a national health policy that must be enforced;

 

  1. To provide information about the benefits and superiority of breastfeeding and the high risks and costs of bottle-feeding;

 

  1. To generate awareness on, and full enforcement of, national and international laws, codes, policies and programs on the promotion and protection of safe and adequate nutrition for infants and young children by promoting and protecting breastfeeding and by regulating the marketing of certain foods and feeding bottles, teats and pacifiers; and

 

  1. To instill recognition and support and ensure access to comprehensive, current and culturally appropriate lactation care and services for all women, children and families, including support for breastfeeding mothers in the work force.

 

The DOH shall lead in the development and implementation of the comprehensive national public education and awareness program on breastfeeding promotion at all levels in collaboration with other government agencies, non-government organizations, media groups, developmental partners, professional and civic groups through the following strategies:

 

a. Philippine Health Promotion Program (PHPP) through Healthy Places/Settings - a national multi-sectoral health promotion strategy which aims to communicate health messages and build health supportive environment through advocacy, networking and community action as per Administrative Order No. 341; There are 16 healthy places/settings namely: schools, workplaces, hospitals, . hotels, vehicles and terminals, ports, restrooms, markets, eating places, prisons, homes, resorts, movie-houses, streets and barangays;

 

b. communication for Behavioral Impact (COMBI) - includes branding of behavior based on modern techniques of marketing along with other strategies to promote exclusive breastfeeding for 6 months.

 

c. Advocacy - Advocacy is a process to bring about change in the policies, laws and practices of influential individuals, groups and institutions. The primary audience on this strategy is the Local Chief Executives for them to provide support including budget in the implementation of the above strategies on BF promotion;

 

d. Networking - a process of linking up diverse individuals or groups, bringing about their mutual agreement to share one another's resources and competencies as a way of serving mutual interests;

 

At the same time the Department of Social Welfare and Development (DSWD) will support the national breastfeeding awareness program through the following strategies:

 

  1. Plan and implement public education and awareness program for Republic Act 10028 In its relevant programs, services and projects.

 

  1. Integrate Lactation management and breastfeeding principles and policies as appropriate in program manuals.

 

  1. Develop a modular outreach approach to conduct a sustain adequate orientation on lactation management support program for pregnant nursing employees and end clients in its centers, residential care facilities and crisis intervention units (CIUs)

 

  1. All other Government, Non-governmental institutions and private sector are encouraged to support and contribute to the public education and awareness program on breastfeeding.

 

RULE VIII

 

MONITORING

 

Section 28. Monitoring, Implementation, Functions/ Implementing Institutional Arrangements/Mechanism - Implementing Agency - The Department of Health shall be principally responsible for the implementation and enforcement of the provisions of the Act.

 

Section 29. Implementation mechanism - is the responsibility of DOH, DOLE, LGUs, Employers, Trade Unions, NGOs, BIR, DTI, and others concerned partners.

 

Section 30. Monitoring guidelines - In coordination with other agencies involved in the implementation of the Act, the Department of Health shall adopt such appropriate monitoring guidelines for the national, regional and provincial levels. It shall likewise provide regular training on monitoring compliance and enforcement on violations of the Act for all persons engaged in or volunteering to help in the monitoring and implementation of the Act. The Department may request for the assistance of non-governmental organizations, civil society, and concerned international agencies in order to better monitor the implementation of those rules. Accordingly, a monitoring team, composed of the following, is hereby created and established:

 

  1. National level:

DOH (NCDPC, NCHP, NCHFD, NNC, BHFS)

Council for the Welfare of Children (CWC)

PhilHealth

Department of Social Welfare and Development (DSWD)

Department of Interior and Local Government (DILG)

DOLE

Bureau of Internal Revenue (BIR)

Civil Service Commission

Government/Non- government Organizations/ Civil Societies without any conflict of interest with the breastfeeding culture, and/or direct or indirect connection, financial or otherwise, or with commercial interest within the scope of the Act Ad Hoc International Agencies such as the United Nations Children's Emergency Fund (UNICEF) and/or the World Health Organization (WHO)

 

(b) Regional/Provincial/City/Municipal/Barangay levels  (in collaboration with their respective Local Government Units):

 

Center for Health Development Offices

National Nutrition Regional Offices

Regional DSWD, DILG, DOLE, CWC

Provincial Health Offices

City Health Offices

Licensing Units and Offices

Municipal Health Offices/Rural Health Units

Barangay Health Office

GOs/NGOs/CiviI Societies

 

(c) The Monitoring Team shall have the following functions:

 

1. Monitor compliance as well as problems encountered in the implementation of the Act.

 

2. Review/act on reports of violations of the provisions of the Act.

 

3. Verifies reports of violations of the Act.

 

4. Recommend sanctions or punitive actions for violations of the Act to the Secretary of Health.

 

5. Submit regular reports on the status of the implementation of the Act to the Secretary of Health.

 

Section 31. Report to the Secretary of Health - Non-governmental organizations, labor unions, religious groups and/or civil societies may report their findings to the Office of the Secretary of Health who shall appropriately respond thereto with sufficient dispatch.

 

RULE IX

 

ADMINISTRATIVE SANCTIONS

 

Section 32. Sanctions - One year after the issuance of this IRR, any private non-health facility, establishment and institution which unjustifiably refuses or fails to comply with Sections 10 and 12 of this Rules shall be imposed a fine of not less than Fifty thousand pesos (Php50,000.00) but not more than Two hundred thousand pesos (Php200,000.00) on the first offense. On the second offense, a fine of not less than Two hundred thousand pesos (Php200,000.00) but not more than Five hundred thousand pesos (Php500,000.00). On the third offense, a fine of not less than Five hundred thousand pesos (Php500,000.00) but not more than One million pesos (php1,000,000.00) and the cancellation or revocation of the business permits or licenses to operate.

 

In all cases, the fine imposed should take into consideration' among others, number of women employees, physical size of the establishment, and the average number of women who visit.

 

In addition, the Secretary of Health is hereby empowered to impose sanctions on health institution for the violation of the Act and the rules issued thereunder. Such sanctions may be in the form of reprimand oI censure and in case of repeated willful violations, suspension of the permit to operate of the erring health institution. Heads, officials and employees of government health and non-health facilities, establishments and institutions who violate the Act shall further be subject to the following administrative penalties:

 

First offense - Reprimand

Second offense - Suspension for one (1) to thirty (30) days and

Third offense - Dismissal

 

This shall be without prejudice to other liabilities applicable under civil service law and rules.

 

RULE X

 

FUNDING

 

Section 33. Funding - Government agencies, including their subdivisions and instrumentalities, shall use their respective budget for gender and development or their budgets for repairs, maintenance and materials acquisition to comply with Section 10 of these Rules.

 

RULE XI

 

FINAL PROVISIONS

 

Section 34. Separability clause - If any clause, sentence, paragraph or part of the Act shall be declared to be invalid, the remainder of the Act or anv provision not affected thereby shall remain in force and effect.

 

Section 35. Repealing Clause - All laws, presidential decrees, executive orders, rules and regulations or parts thereof which are not consistent with the Act are hereby repealed, amended or modified accordingly.

 

Section 36. Effectivity Clause - The Act shall take effect fifteen (15) days after its publication in the Official Gazette or in at least two (2) newspapers of' general circulation, whichever comes earlier.







(Sgd) ENRIQUE T. ONA, MD, FPCS,

FACS Secretary of Health



 
















 







Republic of the Philippines
CONGRESS OF THE PHILIPPINES
Metro Manila

Fourteenth Congress
Third Regular Session

Begun and held in Metro Manila, on Monday, the twenty-seventh day of July, two thousand nine.

 

REPUBLIC ACT No. 10028

 

AN ACT EXPANDING THE PROMOTION OF BREASTFEEDING, AMENDING FOR THE PURPOSE REPUBLIC ACT NO. 7600, OTHERWISE KNOWN AS "AN ACT PROVIDING INCENTIVES TO ALL GOVERNMENT AND PRIVATE HEALTH INSTITUTIONS WITH ROOMING-IN AND BREASTFEEDING PRACTICES AND FOR OTHER PURPOSES"

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

Section 1. Short Title. - This Act shall be known as the "Expanded Breastfeeding Promotion Act of 2009".

Section 2. Section 2 of Republic Act No. 7600 is hereby amended to read as follows:

Sec. 2. Declaration of Policy. - The State adopts rooming-in as a national policy to encourage, protect and support the practice of breastfeeding. It shall create an environment where basic physical, emotional, and psychological needs of mothers and infants are fulfilled through the practice of rooming-in and breastfeeding.

"The State shall likewise protect working women by providing safe and healthful working conditions, taking into account their maternal functions, and such facilities and opportunities that will enhance their welfare and enable them to realize their full potential in the service of the nation. This is consistent with international treaties and conventions to which the Philippines is a signatory such as the Convention on the Elimination of Discrimination Against Women (CEDAW), which emphasizes provision of necessary supporting social services to enable parents to combine family obligations with work responsibilities; the Beijing Platform for Action and Strategic Objective, which promotes harmonization of work and family responsibilities for women and men; and the Convention on the Rights of the Child, which recognizes a child's inherent right to life and the State's obligations to ensure the child's survival and development.

"Breastfeeding has distinct advantages which benefit the infant and the mother, including the hospital and the country that adopt its practice. It is the first preventive health measure that can be given to the child at birth. It also enhances mother-infant relationship. Furthermore, the practice of breastfeeding could save the country valuable foreign exchange that may otherwise be used for milk importation.

"Breastmilk is the best food since it contains essential nutrients completely suitable for the infant's needs. It is also nature's first immunization, enabling the infant to fight potential serious infection. It contains growth factors that enhance the maturation of an infant's organ systems.

"Towards this end, the State shall promote and encourage breastfeeding and provide the specific measures that would present opportunities for mothers to continue expressing their milk and/or breastfeeding their infant or young child.

Section 3. Section 3 of Republic Act No. 7600 is hereby amended to read as follows:

"Sec. 3. Definition of Terms. - For purposes of this Act, the following definitions are adopted:

"a) Age of gestation - the length of time the fetus is inside the mother's womb.

"b) Bottlefeeding - the method of feeding an infant using a bottle with artificial nipples, the contents of which can be any type of fluid.

"c) Breastfeeding - the method of feeding an infant directly from the human breast.

"d) Breastmilk - the human milk from a mother.

"e) Breastmilk substitute - any food being marketed or otherwise represented as partial or total replacement of breastmilk whether or not suitable for that purpose.

"f) Donor milk - the human milk from a non-biological mother.

"g) Expressed breastmilk - the human milk which has been extracted from the breast by hand or by breast pump. It can be fed to an infant using a dropper, a nasogastric tube, a cup and spoon, or a bottle.

"h) Expressing milk - the act of extracting human milk from the breast by hand or by pump into a container.

"i) Formula feeding - the feeding of a newborn with infant formula usually by bottle feeding. It is also called artificial feeding.

"j) Health institutions - are hospitals, health infirmaries, health centers, lying-in centers, or puericulture centers with obstetrical and pediatric services.

"k) Health personnel - are professionals and workers who manage and/or administer the entire operations of health institutions and/or who are involved in providing maternal and child health services.

"l) Health workers - all persons who are engaged in health and health-related work, and all persons employed in all hospitals, sanitaria, health infirmaries, health centers, rural health units, barangay health stations, clinics and other health-related establishments, whether government or private, and shall include medical, allied health professional, administrative and support personnel employed regardless of their employment status.

"m) Infant - a child within zero (0) to twelve (12) months of age.

"n) Infant formula - the breastmilk substitute formulated industrially in accordance with applicable Codex Alimentarius standards, to satisfy the normal nutritional requirements of infants up to six (6) months of age, and adopted to their physiological characteristics.

"o) Lactation management - the general care of a mother-infant nursing couple during the mother's prenatal, immediate postpartum and postnatal periods. It deals with educating and providing knowledge and information to pregnant and lactating mothers on the advantages of breastfeeding, the risks associated with breastmilk substitutes and milk products not suitable as breastmilk substitutes such as, but not limited to, condensed milk and evaporated milk, the monitoring of breastfeeding mothers by health workers and breastfeeding peer counselors for service patients to ensure compliance with the Department of Health, World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) on the implementation of breastfeeding policies, the physiology of lactation, the establishment and maintenance of lactation, the proper care of the breasts and nipples, and such other matters that would contribute to successful breastfeeding.

"p) Lactation stations - private, clean, sanitary, and well-ventilated rooms or areas in the workplace or public places where nursing mothers can wash up, breastfeed or express their milk comfortably and store this afterward.

"q) Low birth weight infant - a newborn weighing less than two thousand five hundred (2,500) grams at birth.

"r) Nursing employee - any female worker, regardless of employment status, who is breastfeeding her infant and/or young child.

"s) Mother's milk - the breastmilk from the newborn's own mother.

"t) Non-health facilities, establishment or institution - public places and working places, as defined in subparagraphs (u) and (y), respectively.

"u) Public place - enclosed or confined areas such as schools, public transportation terminals, shopping malls, and the like.

"v) Rooming-in - the practice of placing the newborn in the same room as the mother right after delivery up to discharge to facilitate mother-infant bonding and to initiate breastfeeding. The infant may either share the mother's bed or be placed in a crib beside the mother.

"w) Seriously ill mothers - are those who are: with severe infections; in shock, in severe cardiac or respiratory distress; or dying; or those with other conditions that may be determined by the attending physician as serious.

"x) Wet-nursing - the feeding of a newborn from another mother's breast when his/her own mother cannot breastfeed.

"y) Workplace - work premises, whether private enterprises or government agencies, including their subdivisions, instrumentalities and government-owned and -controlled corporations.

"z) Young child - a child from the age of twelve (12) months and one (1) day up to thirty-six (36) moths.

Section 4. Section 4 of Republic Act No. 7600 is hereby amended to read as follows:

Sec. 4. Applicability. - The provisions in this Chapter shall apply to all private enterprises as well as government agencies, including their subdivisions and instrumentalities, and government-owned and -controlled corporations.

Upon application to, and determination by, the Secretary of the Department of Labor and Employment for the private sector, and the Chairperson of the Civil Service Commission for the public sector, all health and non-health facilities, establishments and institutions may be exempted for a renewable period of two (2) years from Section 6 of this Act where the establishment of lactation stations is not feasible or necessary due to the peculiar circumstances of the workplace or public place taking into consideration, among others, number of women employees, physical size of the establishment, and the average number of women who visit.

All health and non-health facilities, establishments or institutions which are exempted in complying with the provisions of this Act but nevertheless opted to comply are entitled to the benefits herein stated: Provided, That they give their employees the privilege of using the same.

Section 5. Section 10 of Republic Act No. 7600 is hereby amended to read as follows:

Sec. 10. Provision of Facilities for Breastmilk Collection and Storage for Health Institutions. - The health institution adopting rooming-in and breastfeeding shall provide equipment, facilities, and supplies for breastmilk collection, storage and utilization, the standards of which shall be defined by the Department of Health. Health institutions are likewise encouraged to set up milk banks for storage of breastmilk donated by mothers and which have undergone pasteurization. The stored breastmilk will primarily be given to children in the neonatal intensive care unit whose own mothers are seriously ill.

Section 6. A new Section 11, under a new Chapter, is added to read as follows:

CHAPTER III
Lactation Stations

Sec. 11. Establishment of Lactation Stations. - It is hereby mandated that all health and non-health facilities, establishments or institutions shall establish lactation stations. The lactation stations shall be adequately provided with the necessary equipment and facilities, such as: lavatory for hand-washing, unless there is an easily-accessible lavatory nearby; refrigeration or appropriate cooling facilities for storing expressed breastmilk; electrical outlets for breast pumps; a small table; comfortable seats; and other items, the standards of which shall be defined by the Department of Health. The lactation station shall not be located in the toilet.

In addition, all health and non-health facilities, establishments or institutions shall take strict measures to prevent any direct or indirect form of promotion, marketing, and/or sales of infant formula and/or breastmilk substitutes within the lactation stations, or in any event or circumstances which may be conducive to the same.

Apart from the said minimum requirements, all health and non-health facilities, establishments or institutions may provide other suitable facilities or services within the lactation station, all of which, upon due substantiation, shall be considered eligible for purposes of Section 14 of this Act.

Section 7. A new Section 12 is hereby added to read as follows:

Sec. 12. Lactation Periods. - Nursing employees shall granted break intervals in addition to the regular time-off for meals to breastfeed or express milk. These intervals, which shall include the time it takes an employee to get to and from the workplace lactation station, shall be counted as compensable hours worked. The Department of Labor and Employment (DOLE) may adjust the same: Provided, That such intervals shall not be less than a total of forty (40) minutes for every eight (8)-hour working period.

Section 8. Section 11, which shall be under the renumbered Chapter IV of Republic Act No. 7600, is hereby amended to read as follows:

"CHAPTER IV"
"INFORMATION, EDUCATION AND RE-EDUCATION DRIVE"

"SEC. 13. Continuing Education, Re-education and Training of Health Workers and Health Institutions.- The Department of Health with the assistance of other government agencies, professional and nongovernmental organizations shall conduct continuing information, education, re-education, and training programs for physicians, nurses, midwives, nutritionist-dietitians, community health workers and traditional birth attendants (TBAs) and other health worker on current and updated lactation management.

Information materials shall be given to all health workers involved in maternal and infant care health institutions."

Section 9. Section 12 Information Dissemination and Educational Programs of Pregnant Women and Women of Reproductive Age. - During the prenatal, perinatal and postnatal consultations and/or confinements of the mothers or pregnant women in a health institution and the health worker to immediately and continuously teach, train and support the women on current and updated lactation management and infant care, through participatory strategies such as organization of mothers' clubs and breastfeeding support groups and to distribute written information materials on such matters free of charge.

"The Department of Health is hereby mandated to develop and provide breastfeeding programs for working mothers whose employees are encouraged to avail of it as part of their human resource development programs.

"To equip women of reproductive age with accurate information on maternal nutrition and proper nourishment in preparation for successful and sustainable breastfeeding, the Department of Health is likewise mandated to produce and make available relevant information and programs which should be disseminated to all city, municipal and barangay health centers.

"Employers are also highly encouraged to develop breastfeeding or lactation support programs which main functions are to assess the needs of lactating employees with adequate information regarding lactation management in the form of brochures, pamphlets and other educational materials."

Section 10. A new Section 15 is hereby added to read as follows:

"SEC. 15. Integration of Breastfeeding Education in the Curricula. - To encourage and promote breastfeeding, the Department of Education, the Commission on higher Education. And the Technical Education, and the Technical Education and Skills Development Authority shall integrate in the relevant subjects in the elementary, high school and college levels, especially in the medical and education, the importance, benefits, methods or techniques of breastfeeding, and change of societal attitudes towards breastfeeding."

Section 11. A new Section 16 is hereby added to read as follows:

"SEC. 16. Breastfeeding Awareness Month. - To raise awareness on the importance of and to further promote breastfeeding, the month of August in each and every year throughout the Philippines shall be known as "Breastfeeding Awareness Month."

Section 12. A new Section 17. Is hereby added to read as follows:

"SEC. 17. Public Education and Awareness Program. - To ensure the meaningful observance of breastfeeding month as herein declared, a comprehensive national public education and awareness program shall be undertaken in order to achieve the following objectives:

"a) To protect, promote and support breastfeeding in the Philippines as the normal, natural and preferred method of feeding infants and young children;

"b) To guarantee the rightful place of breastfeeding in society as a time honored tradition and nurturing value as well as a national health policy that must be enforced;

"c) To provide information about the benefits and superiority of breastfeeding and the high risks and costs of bottlefeeding;

"d) To generate awareness on, and full enforcement of, national and international laws, codes, policies and programs on the promotion and protection of safe and adequate nutrition for infants and young children by promoting and protecting breastfeeding and regulating the marketing of certain foods and feeding bottles, teats and pacifiers; and

"e) To instill recognition and support and ensure access to comprehensive, current and culturally appropriate lactation care and services for all women, children and families, including support for breastfeeding mothers in the work force.

"The Department of Health shall lead in the implementation of the comprehensive national public education and awareness program on breastfeeding through a collaborative interagency and multi-sectoral effort at all levels."

Section 13. A new Section 18, which shall be under the renumbered Chapter V of Republic Act No. 7600, is hereby added to read as follows:

CHAPTER V
Miscellaneous Provisions

"Sec. 18. Department of Health Certification. - Any health and non-health facility, establishment or institution satisfying the requirements of Sections 6 and 7 herein relative to a proper lactation station may apply with the local Department of Health office for a 'working mother-baby friendly' certification. The Department of Health shall promulgate guidelines to determine eligibility for such certification, which shall include an annual Department of Health inspection to confirm the continued compliance with its standards.

"The Department of Health shall maintain a list of 'mother-baby-friendly' establishments, which it shall make available to the public."

Section 14. Section 13 of Republic Act No. 7600 is hereby renumbered and amended to read as follows:

"Sec. 19. Incentives. - The expenses incurred by a private health and non-health facility, establishment or institution, in complying with the provisions of this Act, shall be deductible expenses for income tax purposes up to twice the actual amount incurred: Provided, That the deduction shall apply for the taxable period when the expenses were incurred: Provided, further, That all health and non-health facilities, establishments and institutions shall comply with the provisions of this Act within six (6) months after its approval: Provided, finally, That such facilities, establishments or institutions shall secure a "Working Mother-Baby-Friendly Certificate" from the Department of Health to be filed with the Bureau of Internal Revenue, before they can avail of the incentive.

"Government facilities, establishments or institutions shall receive an additional appropriation equivalent to the savings they may derive as a result of complying with the provisions of this Act. The additional appropriation shall be included in their budget for the next fiscal year."

Section 15. A new Section 20 shall be added to read as follows:

"Sec. 20. Implementing Agency. - The Department of Health shall be principally responsible for the implementation and enforcement of the provisions of this Act."

Section 16. Section 14 of Republic Act No. 7600 is hereby renumbered and amended to read as follows:

"Sec. 21. Sanctions. - Any private non-health facility, establishment and institution which unjustifiably refuses or fails to comply with Sections 6 and 7 of this Act shall be imposed a fine of not less than Fifty thousand pesos (Php50,000.00) but not more than Two hundred thousand pesos (Php200,000.00) on the first offense.

"On the second offense, a fine of not less than Two hundred thousand pesos (Php200,000.00) but not more than Five hundred thousand pesos (Php500,000.00).

"On the third offense, a fine of not less than Five hundred thousand pesos (Php500,000.00) but not more than One million pesos (Php1,000,000.00) and the cancellation or revocation of the business permits or licenses to operate.

"In all cases, the fine imposed should take into consideration, among others, number of women employees, physical size of the establishment, and the average number of women who visit.

"In addition, the Secretary of Health is hereby empowered to impose sanctions on health institution for the violation of this Act and the rules issued thereunder. Such sanctions may be in the form of reprimand or censure and in case of repeated willful violations, suspension of the permit to operate of the erring health institution.1avvphi1

"Heads, officials and employees of government health and non-health facilities, establishments and institutions who violate this Act shall further be subject to the following administrative penalties:

"First offense - Reprimand;

"Second offense - Suspension for one (1) to thirty (30) days; and

"Third offense - Dismissal.

"This shall be without prejudice to other liabilities applicable under civil service law and rules."

Section 17. Funding. - Government agencies, including their subdivisions and instrumentalities, shall use their respective budget for gender and development or their budgets for repairs, maintenance and materials acquisition to comply with Section 6 hereof.

Section 18. Rules and Regulations. - The Department of Health, as the lead agency, in coordination with the Department of Labor and Employment, the Department of Trade and Industry, the Department of Justice, the Department of Social Welfare and Development, the Department of Education, the Department of the Interior and Local Government, the Civil Service Commission, the Commission on Higher Education, the technical Education and Skills Development Authority and professional and nongovernmental organizations concerned, shall issue within one hundred and twenty (120) days upon its effectivity the rules and regulations necessary to carry out the provisions of this Act.

Section 19. Separability Clause. - If any clause, sentence, paragraph or part of this Act shall be declared to be invalid, the remainder of this Act or any provision not affected thereby shall remain in force and effect.

Section 20. Repealing Clause. - All laws, presidential decrees, executive orders, rules and regulations or parts thereof which are not consistent with this Act are hereby repealed, amended or modified accordingly.

Section 21. Effectivity Clause. - This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in at least two (2) newspapers of general circulation, whichever comes earlier.

Approved,

 

(Sgd.) PROSPERO C. NOGRALES
Speaker of the House of Representatives

(Sgd.) JUAN PONCE ENRILE
President of the Senate

This Act which is a consolidation of Senate Bill No. 1698 and House Bill No. 879, 4012 and 6076 was finally passed by the Senate and the House of Representatives on December 16, 2009.

 

(Sgd.) MARILYN B. BARUA-YAP
Secretary General
House of Represenatives

(Sgd.) EMMA LIRIO-REYES
Secretary of Senate



Approved: March 16, 2010

(Sgd.) GLORIA MACAPAGAL-ARROYO
President of the Philippines

 

(Source: http://www.lawphil.net/statutes/repacts/ra2010/ra_10028_2010.html)

 

 

 

MALACAÑANG
MANILA

BY THE PRESIDENT OF THE PHILIPPINES

EXECUTIVE ORDER NO. 51

ADOPTING A NATIONAL CODE OF MARKETING OF BREASTMILK SUBSTITUTES, BREASTMILK SUPPLEMENTS AND RELATED PRODUCTS, PENALIZING VIOLATIONS THEREOF, AND FOR OTHER PURPOSES

WHEREAS, in order to ensure that safe and adequate nutrition for infants is provided, there is a need to protect and promote breastfeeding and to inform the public about the proper use of breastmilk substitutes and supplements and related products through adequate, consistent and objective information and appropriate regulation of the marketing and distribution of the said substitutes, supplements and related products;

WHEREAS, consistent with Article 11 of the International Code of Marketing of Breast-milk Substitutes, the present government should adopt appropriate legislation to give effect to the principles and aim of the aforesaid International Code;

NOW, THEREFORE, I, CORAZON C. AQUINO, President of the Philippines, do hereby order:

SECTION 1. Title. – This Code shall be known and cited as the “National Code of Marketing of Breastmilk Substitutes, Breastmilk Supplements and Other Related Products”.

SECTION 2. Aim of the Code. – The aim of the Code is to contribute to the provision of safe and adequate nutrition for infants by the protection and promotion of breastfeeding and by ensuring the proper use of breastmilk substitutes and breastmilk supplements when these are necessary, on the basis of adequate information and through appropriate marketing and distribution.

SECTION 3. Scope of the Code. – The Code applies to the marketing, and practices related thereto, of the following products: breastmilk substitutes, including infant formula; other milk products, foods and beverages, including bottle-fed complementary foods, when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breastmilk; feeding bottles and teats. It also applies to their quality and availability, and to information concerning their use.

SECTION 4. Definition of Terms. – For the purposes of this Code, the following definition of terms shall govern:

(a) “Breastmilk Substitute” means any food being marketed or otherwise represented as a partial or total replacement for breastmilk, whether or not suitable for that purpose.

(b) “Complementary Food” means any food, whether manufactured or locally prepared, suitable as a complement to breastmilk or to infant formula, when either becomes insufficient to satisfy the nutritional requirements of the infant. Such food is also commonly called “weaning food” or “breastmilk supplement.”

(c) “Container” means any form of packaging of products for sale as a normal retail unit, including wrappers.

(d) “Distributor” means a person, corporation or any other entity in the public or private sector engaged in the business (whether directly or indirectly) of marketing at the wholesale or retail level a product within the scope of this Code. A “primary distributor” is a manufacturer’s sales agent, representative, national distributor or broker.

(e) “Infant” means a person falling within the age bracket of 0-12 months.

(f) “Health care system” means governmental, non-governmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants and pregnant women; and nurseries or child care institutions. It also includes health workers in private practice. For the purpose of this Code, the health care system does not include pharmacies or other established sales outlets.

(g) “Health Worker” means a person working in a component of such health care system, whether professional or non-professional, including volunteer workers.

(h) “Infant Formula” means a breastmilk substitute formulated industrially in accordance with applicable Codex Alimentarius standards to satisfy the normal nutritional requirements of infants up to between four to six months of age, and adapted to their physiological characteristics. Infant formula may also be prepared at home in which case it is described as “home-prepared”.

(i) “Label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on, or attached to, a container of any product within the scope of this Code.

(j) “Manufacturer” means a corporation or other entity in the public or private sector engaged in the business or function (whether directly or through an agent or an entity controlled by or under contract with it) of manufacturing a product within the scope of this Code.

(k) “Marketing” means product promotion, distribution, selling, advertising, product public relations, and information services.

(l) “Marketing personnel” means any person whose functions involve the marketing of a product or products coming within the scope of this Code.

(m) “Sample” means single or small quantities of a product provided without costs.

(n) “Supplies” means quantities of a product provided for use over an extended period, free or at a low price, for social purposes, including those provided to families in need.

SECTION 5. Information and Education.

(a) The government shall ensure that objective and consistent information is provided on infant feeding, for use by families and those involved in the field of infant nutrition. This responsibility shall cover the planning, provision, design and dissemination of information, and the control thereof, on infant nutrition.

(b) Information and educational materials, whether written, audio, or visual, dealing with the feeding of infants and intended to teach pregnant women and mothers of infants, shall include clear information on all the following points: (1) the benefits and superiority of breastfeeding; (2) maternal nutrition, and the preparation for and maintenance of breastfeeding; (3) the negative effect on breastfeeding of introducing partial bottle-feeding; (4) the difficulty of reversing the decision not to breastfeed; and (5) where needed, the proper use of infant formula, whether manufactured industrially or home-prepared. When such materials contain information about the use of infant formula, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods; and, in particular, the health hazards of unnecessary or improper use of infant formula and other breastmilk substitutes. Such materials shall not use any picture or text which may idealize the use of breastmilk substitutes.

SECTION 6. The General Public and Mothers.

(a) No advertising, promotion or other marketing materials, whether written, audio or visual, for products, within the scope of this Code shall be printed, published, distributed, exhibited and broadcast unless such materials are duly authorized and approved by an inter-agency committee created herein pursuant to the applicable standards provided for in this Code.

(b) Manufacturers and distributors shall not be permitted to give, directly, or indirectly, samples and supplies of products within the scope of this Code or gifts of any sort to any member of the general public, including members of their families, to hospitals and other health institutions, as well as to personnel within the health care system, save as otherwise provided in this Code.

(c) There shall be no point-of-sale advertising, giving of samples or any other promotion devices to induce sales directly to the consumers at the retail level, such as special displays, discount coupons, premiums, special sales, bonus and tie-in sales for the products within the scope of this Code. This provision shall not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long term basis.

(d) Manufacturers and distributors shall not distribute to pregnant women or mothers of infants any gifts or articles or utensils which may promote the use of breastmilk substitutes or bottle feeding, nor shall any other groups, institutions or individuals distribute such gifts, utensils or products to the general public and mothers.

(e) Marketing personnel shall be prohibited from advertising or promoting in any other manner the products covered by this Code, either directly or indirectly, to pregnant women or with mother of infants, except as otherwise provided by this Code.

(f) Nothing herein contained shall prevent donations from manufacturers and distributors of products within the scope of this Code upon request by or with the approval of the Ministry of Health.

SECTION 7. Health Care System. –

(a) The Ministry of Health shall take appropriate measures to encourage and promote breastfeeding. It shall provide objective and consistent information, training and advice to health workers on infant nutrition, and on their obligations under this Code.

(b) No facility of the health care system shall be used for the purpose of promoting infant formula or other products within the scope of this Code. This Code does not, however, preclude the dissemination of information to health professionals as provided in Section 8(b).

(c) Facilities of the health care system shall not be used for the display of products within the scope of this Code, or for placards or posters concerning such products.

(d) The use by the health care system of “professional service” representatives, “mothercraft nurses” or similar personnel, provided or paid for by manufacturers or distributors, shall not be permitted.

(e) In health education classes for mothers and the general public, health workers and community workers shall emphasize the hazards and risks of the improper use of breastmilk substitutes particularly infant formula. Feeding with infant formula shall be demonstrated only to mothers who may not be able to breastfeed for medical or other legitimate reasons.

SECTION 8. Health Workers. –

(a) Health workers shall encourage and promote breastfeeding and shall make themselves familiar with objectives and consistent information on maternal and infant nutrition, and with their responsibilities under this Code.

(b) Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code shall be restricted to scientific and factual matters and such information shall not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding. It shall also include the information specified in Section 5(b).

(c) No financial or material inducements to promote products within the scope of this Code shall be offered by manufacturers or distributors to health workers or members of their families, nor shall these be accepted by the health workers or members of their families, except as otherwise provided in Section 8(e).

(d) Samples of infant formulas or other products within the scope of this Code, or of equipment or utensils for their preparation or use, shall not be provided to health workers except when necessary for the purpose of professional evaluation or research in accordance with the rules and regulations promulgated by the Ministry of Health. No health workers shall give samples of infant formula to pregnant women and mothers of infants or members of their families.

(e) Manufacturers and distributors of products within the scope of this Code may assist in the research, scholarships and continuing education, of health professionals, in accordance with the rules and regulations promulgated by the Ministry of Health.

SECTION 9. Persons Employed by Manufacturers and Distributors. – Personnel employed in marketing products within the scope of this Code shall not, as part of their job responsibilities, perform educational functions in relation to pregnant women or mothers of infants.

SECTION 10. Containers/Label. –

(a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products, and in such a way as not to discourage breastfeeding.

(b) Each container shall have a clear, conspicuous and easily readable and understandable message in Pilipino or English printed on it, or on a label, which message can not readily become separated from it, and which shall include the following points:

(i) the words “Important Notice” or their equivalent;

(ii) a statement of the superiority of breastfeeding;

(iii) a statement that the product shall be used only on the advice of a health worker as to the need for its use and the proper methods of use; and

(iv) instructions for appropriate preparation, and a warning against the health hazards of inappropriate preparation.

(c) Neither the container nor the label shall have pictures or texts which may idealize the use of infant formula. They may, however, have graphics for easy identification of the product and for illustrating methods of preparation.

(d) The term “humanized”, “maternalized” or similar terms shall not be used.

(e) Food products within the scope of this Code marketed for infant feeding, which do not meet all the requirements of an infant formula but which can be modified to do so, shall carry on the label a warning that the unmodified product should not be the sole source of nourishment of an infant.

(f) The labels of food products within the scope of this Code shall, in addition to the requirements in the preceding paragraphs, conform with the rules and regulations of the Bureau of Food and Drugs.

SECTION 11. Quality. –

(a) The quality of products is an essential element for the protection of the health of infants, and therefore shall be of high recognized standard.

(b) Food products within the scope of this Code shall, when sold or otherwise distributed, meet applicable standards recommended by the Codex Alimentarius Commission and also the Codex Code of Hygienic Practice for Foods for Infants and Children.

(c) To prevent quality deterioration, adulteration or contamination of food products within the scope of this Code, distribution outlets, including the smallest sari-sari store, shall not be allowed to open cans and boxes for the purpose of retailing them by the cup, bag or in any other form.

SECTION 12. Implementation and Monitoring. –

(a) For purposes of Section 6(a) of this Code, an inter-agency committee composed of the following members is hereby created:

Minister of Health Chairman
Minister of Trade and Industry Member
Minister of Justice Member
Minister of Social Services and Development Member

The members may designate their duly authorized representative to every meeting of the Committee.

The Committee shall have the following powers and functions:

(1) To review and examine all advertising, promotion or other marketing materials, whether written, audio or visual, on products within the scope of this Code;

(2) To approve or disapprove, delete objectionable portions from and prohibit the printing, publication, distribution, exhibition and broadcast of, all advertising promotion or other marketing materials, whether written, audio or visual, on products within the scope of this Code;

(3) To prescribe the internal and operational procedure for the exercise of its powers and functions as well as the performance of its duties and responsibilities; and

(4) To promulgate such rules and regulations as are necessary or proper for the implementation of Section 6(a) of this Code.

(b) The Ministry of Health shall be principally responsible for the implementation and enforcement of the provisions of this Code. For this purpose, the Ministry of Health shall have the following powers and functions:

(1) To promulgate such rules and regulations as are necessary or proper for the implementation of this Code and the accomplishment of its purposes and objectives.

(2) To call the assistance of government agencies and the private sector to ensure the implementation and enforcement of, and strict compliance with, the provisions of this Code and the rules and regulations promulgated in accordance herewith.

(3) To cause the prosecution of the violators of this Code and other pertinent laws on products covered by this Code.

(4) To exercise such other powers and functions as may be necessary for or incidental to the attainment of the purposes and objectives of this Code.

SECTION 13. Sanctions. –

(a) Any person who violates the provisions of this Code or the rules and regulations issued pursuant to this Code shall, upon conviction, be punished by a penalty of two (2) months to one (1) year imprisonment or a fine of not less than One Thousand Pesos (P1,000.00) nor more than Thirty Thousand Pesos (P30,000.00) or both. Should the offense be committed by a juridical person, the chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefor, shall be penalized.

(b) Any license, permit or authority issued by any government agency to any health worker, distributor, manufacturer, or marketing firm or personnel for the practice of their profession or occupation, or for the pursuit of their business, may, upon recommendation of the Ministry of Health, be suspended or revoked in the event of repeated violations of this Code, or of the rules and regulations issued pursuant to this Code.

SECTION 14. Repealing Clause. – All laws, orders, issuances, and rules and regulations or parts thereof inconsistent with this Executive Order are hereby repealed or modified accordingly.

SECTION 15. Separability Clause. – The provisions of this Executive Order are hereby deemed separable. If any provision thereof be declared invalid or unconstitutional, such invalidity or unconstitutionality shall not affect the other provisions which shall remain in full force and effect.

SECTION 16. Effectivity – This Executive Order shall take effect thirty (30) days following its publication in the Official Gazette.

DONE in the City of Manila, this 20th day of October, in the year of Our Lord, Nineteen Hundred and Eighty-Six.

(Sgd.) CORAZON C. AQUINO
President of the Philippines

By the President:

(Sgd.) JOKER P. ARROYO
Executive Secretary

Source: Presidential Management Staff

Office of the President of the Philippines. (1986). [Executive Order Nos. : 1-170]. Manila : Presidential Management Staff.