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INTRODUCTION

Our welfare in our society depends upon a large part on chemicals. Chemicals are everywhere, and are an essential component of our daily lives. However, some chemicals can severely damage our health.  Others could be dangerous if not properly used. There is a disturbing enhancement in health problems that can be explained by the use of chemicals. Some man-made chemicals are found in the most remote places in the environment, but also in animals and humans.  Few years back, the increased insight in the likely negative effect of chemicals led to the awareness, which the environmental chemical legislation then in force could not endow with adequate information about chemicals to judge scientifically.

The regulatory body tasked for chemicals aims “to ensure a high level of protection of human health and the environment”. Years from now, these regulatory bodies will place the burden of proof on industry, which has to collect or generate the data necessary to ensure the safe use of chemicals. This data will be publicly available through the central database held at the Chemicals Agency and will help to close the current information gap on chemicals. It would also provide rules for phasing out and substitution of the most dangerous chemicals. It is balanced by the new Regulation for Classification, Labeling and Packaging of Substances and Mixtures. This Regulation incorporates the classification criteria and labeling rules agreed at UN level, the so-called Globally Harmonized System of Classification and Labeling of Chemicals (GHS). It is based on the principle that the same hazards should be described and labeled in the same way all around the world. Using internationally agreed classification criteria and labeling elements is expected to facilitate trade and to contribute towards global efforts to protect humans and the environment from hazardous effects of chemicals.

Other aspects of environmental chemical legislation include the protection of laboratory animals. In the coming years, further legislative work may be done on endocrine disruptors, combination effects of chemicals and nonmaterial. 

While the term chemical substance is a somewhat technical term used most often by professional chemists, the word chemical is more widely used in the pharmaceutical industry, government and society in general. Thus the word chemical includes a much wider class of substances that includes many mixtures of chemical substances that often find application in many vocations; and is most commonly used only for artificial or processed substances, such as the products of the chemical industry.

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DEFINITION/HISTORY

In chemistry, a chemical substance is a material with a specific chemical composition.A common example of a chemical substance is pure water; it has the same properties and the same ratio of hydrogen to oxygen whether it is isolated from a river or made in a laboratory. Some typical chemical substances are diamond, gold, salt (sodium chloride) and sugar (sucrose). Generally, chemical substances exist as a solid, liquid, gas, or plasma and may change between these phases of matter with changes in temperature or pressure. Chemical reactions convert one chemical substance into another. Forms of energy, such as light and heat, are not considered to be matter, and thus they are not "substances" in this regard.

Chemical substances (also sometimes referred to as a pure substance) are often defined as "any material with a definite chemical composition" in most introductory general chemistry textbooks. According to this definition a chemical substance can either be a pure chemical element or a pure chemical compound. However, there are exceptions to this definition; a pure substance can also be defined as a form of matter that has both definite composition and distinct properties. The chemical substance index published by CAS also includes several alloys of uncertain composition. Non-stoichiometric compounds are a special case (in inorganic chemistry) that violates the law of constant composition, and for them, it is sometimes difficult to draw the line between a mixture and a compound, as in the case of palladium hydride. Broader definitions of chemicals or chemical substances can be found, for example: "the term 'chemical substance' means any organic or inorganic substance of a particular molecular identity, including - (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature".

The concept of a "chemical substance" became firmly established in the late eighteenth century after work by the chemist Joseph Proust on the composition of some pure chemical compounds such as basic copper carbonate.’ He deduced that, "All samples of a compound have the same composition; that is, all samples have the same proportions, by mass, of the elements present in the compound." This is now known as the law of constant composition. Later with the advancement of methods for chemical synthesis particularly in the realm of organic chemistry; the discovery of many more chemical elements and new techniques in the realm of analytical chemistry used for isolation and purification of elements and compounds from chemicals that led to the establishment of modern chemistry, the concept was defined as is found in most chemistry textbooks. However, there are some controversies regarding this definition mainly because the large number of chemical substances reported in chemistry literature need to be indexed.

An element is a chemical substance that is made up of a particular kind of atoms and hence cannot be broken down or transformed by a chemical reaction into a different element, though it can be transmutated into another element through a nuclear reaction. This is so, because all of the atoms in a sample of an element have the same number of protons, though they may be different isotopes, with differing numbers of neutrons.

There are about 120 known elements, about 80 of which are stable - that is, they do not change by radioactive decay into other elements. However, the number of chemical substances that are elements can be more than 120, because some elements can occur as more than a single chemical substance (allotropes). For instance, oxygen exists as both diatomic oxygen (O2) and ozone (O3). The majority of elements are classified as metals. These are elements with a characteristic lustre such as iron, copper, and gold. Metals typically conduct electricity and heat well, and they are malleable and ductile. Around a dozen elements, such as carbon, nitrogen, and oxygen, are classified as non-metals. Non-metals lack the metallic properties described above, they also have a high electronegativity and a tendency to form negative ions. Certain elements such as silicon sometimes resemble metals and sometimes resemble non-metals, and are known as metalloids.

A pure chemical compound is a chemical substance that is composed of a particular set of molecules or ions. Two or more elements combined into one substance, through a chemical reaction, form what is called a chemical compound. All compounds are substances, but not all substances are compounds.

A chemical compound can be either atoms bonded together in molecules or crystals in which atoms, molecules or ions form a crystalline lattice. Compounds based primarily on carbon

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and hydrogen atoms are called organic compounds, and all others are called inorganic compounds. Compounds containing bonds between carbon and a metal are called organometallic compounds.

Compounds in which components share electrons are known as covalent compounds. Compounds consisting of oppositely charged ions are known as ionic compounds, or salts.

In organic chemistry, there can be more than one chemical compound with the same composition and molecular weight. Generally, these are called isomers. Isomers usually have substantially different chemical properties, may be isolated and do not spontaneously convert to each other. A common example is glucose vs. fructose. The former is an aldehyde, the latter is a ketone. Their interconversion requires eitherenzymatic or acid-base catalysis. However, there are also tautomers, where isomerization occurs spontaneously, such that a pure substance cannot be isolated into its tautomers. A common example is glucose, which has open-chain and ring forms. One cannot manufacture pure open-chain glucose because glucose spontaneously cyclizes to the hemiacetal form.

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ENVIRONMENT MANAGEMENT BUREAU

A nation empowered to protect our finite natural resources, attuned to the pursuit of sustainable development, for a clean and healthy environment that enhances the Filipino quality of life for present and future generations.

R.A. 6969Toxic Chemicals, Hazardous and Nuclear Waste Act of 1990

The government identified the chemicals included in the Priority Chemical List (PCL). Listed are 28 chemicals that are regulated by law and out of them, 5 were subjected to Chemical Control Order (CCO). The latter are chemical substances that posed the greatest potential risk both to humans and the environment.

IMPORTATION CLEARANCE FOR CHEMICALS WITH CHEMICAL CONTROL ORDERS OF CYANIDE, MERCURY AND ASBESTOS

Date Applied : _____________Application Control Number : _____________Official Receipt Number : __________________Registry Reference Code ______________________Date Issued _________________________________I. Applicant’s Name:_______________________________________________________II. Business Address: __________________________________Contact Number: ______________III. Contact Person: ___________________________________Contact Number: ______________IV. Position / Designation: ________________________________Fax Number: _________________V. Type of Importer / Distributor of: ____________________________________Storage Facility Address: _________________________________Contact Number: ______________

VI. Environmental and Other Permits IssuedECC No. ______________PO No. ______________Business Permit No. ______________VII. List of Importers / End-usersStorage Facility Address: _________________________________ Contact Number:

______________Storage Facility Address: _________________________________ Contact Number:

______________Storage Facility Address: _________________________________ Contact Number:

______________Storage Facility Address: _________________________________ Contact Number:

______________Storage Facility Address: _________________________________ Contact Number:

______________Storage Facility Address: _________________________________ Contact Number:

______________Storage Facility Address: _________________________________ Contact Number:

______________VIII. Data on Substance Subject to Importation:Brand / Trade / Commercial Name ______________________________________

________Quantity (in kg): ________________________

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Intended Use: _______________________________________________________________________

IX. Shipper’s Information / Transaction DataCountry of Origin __________________________________________Name of Exporting Company

___________________________________________________________Business Address

___________________________________________________________________Mode of Shipment (by air/by sea) _______________________Expected Port of Entry/Loading _________________________________Port Address

_______________________________________________________________________Expected Date of Arrival ____________________X. Present Inventory of Same Substance Subject for Importation (under applicant’s

custody)Quantity (in kg): __________________________Size of Storage Area (in m2): ___________________XI. Attachments : Certificate of Accountability, Proporma Invoice and other documents as

required in the Permit’s Terms and ConditionsXII. Fees__________________OR #__________________ Date___________________I acknowledge that this application form is a legally binding document, and I declare,

under the penalties of perjury, that the same has been accomplished in good faith, verified by me, and, to the best of my knowledge and belief, is true and correct pursuant to the regulations issued under authority thereof.

___________________________________(Authorized Signature over Printed Name

Chemical Importation Tool

Note: This tool is based on the existing requirements of Philippine Drug Enforcement Agency (PDEA), Philippine National Police – Firearms and Explosives Division (PNP-FED), and Department of Environment and Natural Resources – Environmental Management Bureau (DENR-EMB) as of 01 June 2005. Chemical Substances

The regulation on importation of substances and materials may be imposed due to danger to health, safety and the environment. Regulation also applies to precursor substances or essential chemicals for making illegal drugs or explosives.In the Philippines, there are four (4) agencies handling the regulation of substances and materials importation and usage: • Department of Environment and Natural Resources – Environmental Management Bureau (DENR-EMB) for chemicals and mixtures under Chemical Control Orders and Priority Chemicals List;• Philippine National Police – Firearms and Explosives Division (PNP-FED) for Controlled Chemicals and Explosives Ingredients; • Fertilizers and Pesticides Authority (FPA) for fertilizers and pesticides; and, • Philippine Drug Enforcement Agency (PDEA) for Precursors and Essential Chemical Substances

“No approved Therapeutic Claims”

An “Approved by BFAD” label doesn’t mean the product is medicinal. Being sold in a drugstore doesn’t make the product a medication either, as even chocolate bars, chewing gum and groceries are sold in pharmacies these days.

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FERTILIZER PESTICIDE AUTHORITY

MANDATE AND FUNCTIONS OF THE FERTILIZER AND PESTICIDE AUTHORITY

Created under Presidential Decree No. 1144 on May 30, 1977, the Fertilizer and Pesticide Authority (FPA) is a technically-oriented agency mandated to regulate and ensure safety in the manufacture, formulation, importation, distribution, storage, sale, transport, use and disposal of pesticides and fertilizers to ensure their adequate supply among crop growers and other end-users to support the food security program of the country.

It is also mandated to develop both the fertilizer and pesticide industries.Specifically, to ensure the safe use of pesticides and protect human and animal health and the environment from any detrimental effects of pesticides, FPA is vested with the following powers and functions, as described in Section 6 (I) and (III) of PD 1144;

PD 1144CREATING THE FERTILIZER AND PESTICIDE AUTHORITY AND ABOLISHING THE

FERTILIZER INDUSTRY AUTHORITY

Section 1. Creation of the Fertilizer and Pesticide Authority. The Fertilizer and Pesticide Authority, hereinafter referred to as the FPA, is hereby created and attached to the Department of Agriculture for the purpose of assuring the agricultural sector of adequate supplies of fertilizer and pesticide at reasonable prices, rationalizing the manufacture and marketing of fertilizer, protecting the public from the risks inherent in the use of pesticides, and educating the agricultural sector in the use of these inputs.

Section 6. Powers and Functions. The FPA shall have jurisdiction, on over all existing handlers of pesticides, fertilizers and other agricultural chemical inputs. The FPA shall have the following powers and functions:

I. Common to Fertilizers, Pesticides and other Agricultural Chemicals.(1) To conduct an information campaign regarding the safe and effective use of these

products;

(2) To promote and coordinate all fertilizer and pesticides research in cooperation with the Philippine Council for Agriculture and Resources Research and other appropriate agencies to ensure scientific pest control in the public interest, safety in the use and handling of pesticides, higher standards and quality of products and better application methods;

(3) To call upon any department, bureau, office, agency or instrumentality of the government, including government-owned or controlled corporations, or any officer or employee thereof and on the private sector, for such information or assistance as it may need in the exercise of its powers and in the performance of its functions and duties;

(4) To promulgate rules and regulations for the registration and licensing of handlers of these products, collect fees pertaining thereto, as well as the renewal, suspension, revocation, or cancellation of such registration or licenses and such other rules and regulations as may be necessary to implement this Decree;

(5) To establish and impose appropriate penalties on handlers of these products for violations of any rules and regulations established by the FPA;

(6) To institute proceedings against any person violating any provisions of this Decree and/or such rules and regulations as may be promulgated to implement the provisions of this Decree after due notice and hearing.

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(7) To delegate such selected privileges, powers or authority as may be allowed by law to corporation, cooperatives, associations or individuals as may presently exist or be organized to assist the FPA in carrying out its functions, and;

(8) To do any and all acts not contrary to law or existing decrees and regulations as may be necessary to carry out the functions of the FPA.

II. Fertilizers(1) To make a continuous assessment of the fertilizer supply and demand situation, both

domestic and worldwide;

(2) To establish and enforce sales quotas, production schedules, distributions areas and such other marketing regulations as maybe necessary to assure market stability and viable operations in the industry;

(3) To determine and set the volume and prices both wholesale and retail; of fertilizer and fertilizer inputs;

(4) To establish and implement regulations governing the import and export of fertilizer and fertilizer inputs, and when necessary, to itself import and/or export such items, including the negotiating and contracting of such imports and exports;

(5) To import fertilizer and fertilizer inputs exempt from customs duties, compensating and sales taxes and all other taxes, and to purchase naptha locally free from specific taxes and the corresponding duty on the imported crude, and to sell or convey such fertilizer or fertilizer input to any individual association, or corporation likewise exempt from the payment of customs duties and all other taxes;

(6) To control and regulate all marketing companies, whether importer, indentor, wholesaler or retailer; by controlling and regulating prices, terms, mark-ups, distribution channels, promotion, storage and other marketing factors in the domestic fertilizer market;

(7) To regulate and control quality of the different grades of fertilizer and to set new grades when necessary;

(8) To control and regulate all aspects of domestic fertilizer production, including the utilization of idle capacity and the orderly expansion of the industry and to compel the utilization of unused or underutilized capacities of fertilizer companies and to direct any improvements, modifications or repairs as may be necessary to accomplish this;

(9) To approve or to reject the establishment of new fertilizer or fertilizer input plants and the expansion or contraction of existing capacities;

(10) To obtain complete assess to all pertinent information on the operations of the industry, including audited and/or unaudited financial statements, marketing, production, and inventory data;

(11) To control and assist in the financing of the importation of fertilizer and fertilizers inputs of production, of inventory and working capital, and of the expansion of the industry;

(12) To do all such things as may be necessary to maintain an adequate supply of fertilizers to the domestic market at reasonable prices while maintaining the long-term viability of the industry.

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III. Pesticides and Other Agricultural Chemicals(1) To determine specific uses or manners of use for each pesticide or pesticide

formulation;(2) To establish and enforce tolerance levels and good agricultural practices for use of

pesticides in raw agricultural commodities.(3) To restrict or ban the use of any pesticide or the formulation of certain pesticides in

specific areas or during certain periods upon evidence that the pesticide is an imminent hazard, has caused, or is causing widespread serious damage to crops, fish or livestock, or to public health and the environment;

(4) To prevent the importation of agricultural commodities containing pesticide residues above the accepted tolerance levels and to regulate the exportation of agricultural products containing pesticide residue above accepted tolerance levels;

(5) To inspect the establishment and premises of pesticide handlers to insure that industrial health and safety rules and anti-pollution regulations are followed;

(6) To enter and inspect farmers' fields to ensure that only the recommended pesticides are used in specific crops in accordance with good agricultural practice;

(7) To require if and when necessary, of every handler of these products, the submission to the FPA of a report stating the quantity, value of each kind of product exported, imported, manufactured, produced, formulated, repacked, stored, delivered, distributed, or sold;

(8) Should there by any extraordinary and unreasonable increases in prices or a severe shortage in supply of pesticides, or imminent dangers or either occurrences, the FPA is empowered to impose such controls as may be necessary in the public interest, including but not limited to such restrictions and controls as the imposition of price ceilings, controls on inventories, distribution and transport, and tax-free importations of such pesticides or raw materials thereof as may be in short supply.

How do we know whether our product will be classified by BFAD as food, drugs, or cosmetics?Clients may apply for product classification at BFAD. Application documents with sample and complete product information and proof of payment may be submitted at the Policy, Planning, and Advocacy Division - Public Assistance and Compliance Division (PPAD-PAICS), Room 101.

How do we register our products?A local company in the Philippines must secure a License to Operate (LTO) from BFAD before applying for product registration. All issuances and guidelines, checklists of requirements, and forms pertaining to licensing of establishments and product registration may be downloaded from the BFAD Website: http://www.bfad.gov.ph.

How much is the processing fee for licensing or product registration?Fees are listed in Administrative Order No. 50 s. 2001: Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs. This is available thru http://www.bfad.gov.ph/AO/ao 50 2001.pdf. top We need to conduct a specific test analysis for our products.

How can we have our products tested?Clients may access the BFAD Website for the list of recognized laboratories (http://www.bfad.gov.ph/laboratories_modified.htm). The list contains the addresses, contact numbers, and types of analysis offered by the laboratories.

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What types of establishments are required to apply for a License to Operate with BFAD?Establishments involved in the manufacture, packaging, re-packaging, importation, exportation, distribution, and retailing of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products must secure a License to Operate from BFAD.

What types of products are registered with BFAD?BFAD handles the registration of processed foods, drugs, medical devices, in vitro diagnostic reagents, cosmetics, and household hazardous substance products.

Where can we get a copy of the guidelines for licensing of establishment and product registration?Guidelines may be downloaded from the BFAD Website thru the Laws and Regulations link: http://www.bfad.gov.ph/left_laws_regulations.htm. New guidelines may also be downloaded thru the New Issuances link: http://www.bfad.gov.ph/new_issuances.htm.Source: http://www.doh.gov.ph

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NO THERAPEUTIC CLAIMS:

‘No Therapeutic Claims’ By Michael TanPhilippine Daily InquirerFirst Posted 00:21:00 05/25/2008

Filed Under: Health, Lifestyle & LeisureMANILA, Philippines - Comfrey, kargasok tea, noni juice, mahogany seeds. Tell me which ones you remember and I can tell what your age range is. These were the natural medicine fads that came, conquered, and then faded away, usually after the government came out with a study warning about the dangers of using them, or an official notice that these so-called cures have no proven medicinal effect.But these were not short-lived fads, with some of them lingering on for years after they declined in popularity. I still see some of these former celebrity plants being sold by vendors, complete with outrageous claims. Not only that, they’ve been joined by dozens of other products that Filipinos call, generically, “herbal” (er-bal), even if many of them are not derived from plants.Officially, the Bureau of Food and Drugs (BFAD) considers these products “food supplements” rather than drugs (or medicines). If they do go through BFAD review, they are not evaluated for effectiveness. Neither are the safety evaluations too stringent. The only requirement BFAD has is that “no therapeutic claims” are made by distributors, but this rule is observed more in the breach. Often enough, the products are sold without any medicinal claims; sometimes they’ll even have a sticker saying “No Therapeutic Claims,” but promotional materials will often name all kinds of sicknesses for which the supplement is supposedly effective. Sometimes, too, the promotional literature will contain all kinds of testimonies, and so-called scientific explanations for the products’ “effectiveness.” I’ll never forget one explanation on why shark cartilage (now there’s an example of a non-herbal “herbal” cure) prevents cancer: sharks don’t get cancer. Sure.Many people are unaware that an “Approved by BFAD” label doesn’t mean the product is medicinal. Being sold in a drugstore doesn’t make the product a medication either, as even chocolate bars, chewing gum and groceries are sold in pharmacies these days.Be extra careful as well about products sold in Chinese drugstores. Get ready for a shock: while “western” drugstores like Mercury are subject to inspections and strict BFAD rules, the Chinese drugstores are exempt. The reason? They’re considered cultural institutions, and the products they sell are presumably cultural products exempt from BFAD scrutiny.Yet there is a large and growing market for these products. While “western” medicines are identified mainly as products for the sick, food supplements or “natural” medicines are peddled with all kinds of claims that appeal to the healthy and not so healthy, as well as those who are suffering from ailments, usually chronic ones.Food supplements have a particular appeal because of fears that people have of western medicine, often seen as having side effects. Unfortunately, people tend to presume that “natural” means totally safe, and this just isn’t the case.There’s also something very disturbing about the more popular faddish food supplements: they’re imported. We tend to go for these because of our colonial mentality, and are all too willing to pay through our nose for these products. A few years back, I witnessed rural middle-income families spending half of their monthly income to buy Herbalife, which was a US-based chain whose products are sold house to house much like Tupperware. In more recent times, people would spend almost a thousand pesos for a bottle of Garcinia juice. You know what Garcinia is? Mangosteen.We neglect our own resources and folk knowledge in favor of imported, unproven fads. I know it’s a human inclination: stuff from remote places, with strange names like Kargasok, seem so much more effective than plain old luya (ginger) or damong maria. It hasn’t helped that our scientists have moved so slowly on medicinal plants. The Department of Health only approves of 10 local plants. Thirty years ago, freshly graduated from college, I worked as a researcher on medicinal plants. In one year of moving around the country, I was able to list more than a thousand plants being used by local herbalists, and over 70 which were listed in other countries’ official lists of approved medicines.

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These days it almost seems like we have a schizophrenic government when it comes to medicinal plants (okay, okay, so it’s schizo about many other aspects of governance as well). The Department of Health tends to be very cautious and reluctant to endorse medicinal plants, even as it gives a BFAD seal of approval, without explaining that it does so only by classifying natural products as “food."The Department of Education actually likes medicinal plants, but mainly as gardening projects for public schools. Almost nothing is being done to educate our children about the scientific basis for medicinal plants, or traditional medicine in general.These days, the Department of Tourism has jumped into the act, promoting “indigenous medicine” as an exotic come-on for tourists: come get our traditional massage, come use our medicinal plants for aromatherapy.Meanwhile, we neglect research on medicinal plants while a whole underground economy flourishes, selling American food supplements. Some of these products can be effective, but again, too little is being done to educate the public on what works and what doesn’t. Even more importantly, we shouldn’t forget that the best preventive and curative health measures still aren’t western pills, or all these “herbals”: it’s still good nutrition, lots of exercise and a healthy outlook on life.Source: http://showbizandstyle.inquirer.net

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BUREAU OF FOOD AND DRUGS (FOOD AND DRUGS ADMINISTRATION)

BFAD Historical Background

In the light of the tremendous progress in the food and pharmaceutical industry, the late Department of Health (DOH) Secretary Francisco Duque, Sr. created a subcommittee on Food and Drugs in the year 1961-1962 to initiate an administration bill to Congress to enact a law that would ensure the safety, purity and quality of foods, drugs, and cosmetics being made available to the public. The Subcommittee on Food and Drug was chaired by the then Undersecretary for Special Health Services, Dr. Rodolfo Canos, with members Dr. Trinidad Pesigan, Director of the Bureau of Research and Laboratories, Mr. Emilio Espinosa of the Bureau of Health Services, Ms. Amor Cita M. Pallera, Pharmacy Adviser, Office of the Secretary of Health, also as Secretary and Liaison to Congress. Thus, on June 22, 1963, Republic Act No. 3720 was passed into law known as the "Food, Drug and Cosmetic Act".

To carry out the provisions of R.A. 3720, the Food and Drug Administration (FDA) was created and offices and laboratories werebconstructed in the DOH San Lazaro Compound, Sta. Cruz, Manila at a cost of about 2.5M. The Food and Drug Administration became operational with the appointment of its first FDA Administrator, Ms. Luzonica M. Pesigan on May 25, 1966 to Dec. 7, 1977 with Mr. Emilio Espinosa as her Deputy. By virtue of R.A. 3720, the powers, functions, and duties of the Division of Food and Drug Testing of the Bureau of Research and Laboratories and the Board of Food Inspection, all personnel together with all their equipment, supplies, records, files and balance of appropriations were transferred to the FDA.

After the retirement of the Deputy Administrator, Mr. Emilio Espinosa, Mr. Arsenio M. Regala took over as Deputy Administrator on June 1, 1972.With the Integrated Reorganization Plan of 1973, the Narcotic Drugs Division, Bureau of Internal Revenue, Department of Finance was transferred to the Food and Drug Administration headed by Ms. Concepcion M. Fernandez who retired in 1975 with Ms. Rita V. Caoile as the next chief of the same. Mrs. Catalina C. Sanchez took over as the next chief of the Narcotic Drugs Division in 1976.

Mr. Arsenio M. Regala was appointed FDA Administrator on Dec. 13, 1977 upon the retirement of Ms. Luzonica M. Pesigan on Dec. 7, 1977. Ms. Catalina C. Sanchez was appointed Vice Mr. Arsenio M. Regala as Deputy Administrator on January 13, 1978. On his retirement, Mrs. Catalina C. Sanchez was designated Acting Administrator of FDA on April 5, 1982 to Feb. 19, 1984.

On December 2, 1982, Executive Order No. 851 by Section 4, under the Minister of Health Hon. Jesus M. Azurin, the FDA was abolished and created the Bureau of Food and Drugs (BFAD). Ms. Catalina C. Sanchez was appointed the first Director of the BFAD on Feb. 20, 1984 and took her oath on Feb 28, 1984

In 1987, the Bureau moved to its new site in Alabang, Muntinlupa City , and acquired new facilities including state-of-the-art analytical instruments and a modern experimental animal laboratory with the $12M grant from the Government of Japan through Japan International Cooperation Agency (JICA). This new BFAD in Alabang became operational on April 30, 1987.

In 1987, R.A. 3720 was amended by Executive Order 175 to the new title "Foods, Drugs, and Devices and Cosmetics Act."

It was also on the occasion of the inauguration of this new BFAD facility that President Corazon C. Aquino declared publicly the Philippine National Drug Policy (PNDP) together with its four pillars, i.e., Quality Assurance, Rational Use of Drugs, Self- Reliance, and Tailored Procurement. Based on the issuance of E.O. Nos. 174 and 175 amendments to R.A. 5921 "The Pharmacy Law" and R.A. 3720 "Food, Drug, and Cosmetic Act" respectively, the Philippine National Drug Policy Program was organized. Executive Order No. 851 was superseded by E.O. No. 119, s. 1987 under Hon. Alfredo R. A. Bengzon, Sec. of Health, that again reorganized the BFAD on the basis of Administrative Order (A.O.) No. 30, s. 1987, Provisions to Implement the Reorganization of the Department of Health.

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Executive Order No. 102 dated May 24, 1999 was signed and redirected the functions and operations of the Department of Health, with then Hon. Alberto G. Romualdez, Sec. of Health, wherein BFAD was expanded with an added Division, the Policy, Planning, and Advocacy Division. The joining of the National Drug Policy workforce with that of BFAD in Alabang, further strengthened the Bureau to meet new challenges in serving the interests of the Filipino people consistent with the Philippine National Drug Policy and the National Health Policy.On the retirement of Mrs. Catalina C. Sanchez on Feb. 1, 1989, Dr. Cecile P. Gonzales took over (Feb. 1, 1989 - Jan. 31,1991 ), followed by Dr. Quintin L. Kintanar (March 13, 1991 - January 4, 1999); Dr. William D. Torres (Jan. 5, 1999 - August 31, 2002), with Deputy Director for Drugs, Dr. Kenneth Hartigan-Go (June 1, 1999 - June 10, 2001) and the lateral transfer of Mrs. Adelisa C. Ramos, Director III of the DOH Nutrition Service as Deputy Director for Food pursuant to E.O. 102 (November 6, 2000 - Jan 2005). On September 1, 2002, Prof. Leticia Barbara B. Gutierrez was appointed new Director of the Bureau.

VisionThe BFAD is a world-class regulatory agency and center of scientific excellence composed of profesionally competent, legally qualified, efficient, and confident staff with unfettered enforcement capabilities. MissionTo ensure the safety, efficacy, purity, and quality of processed foods, drugs, diagnostic reagents, medical devices, cosmetics and household hazardous substances through state-of-the-art technology, as well as the scientific soundness and truthfulness of production information for the protection of public health.To "ECCITE" (EXCITE) BFAD to live by the following values: Efficiency We produce timely results and achieve the goals we set with the least resources and effort Courtesy We treat ourselves and our clients with respect and dignity befitting all fellow human beings Commitment We dedicate ourselves first of all to the service of the Filipino people IntegrityWe are honest, sincere and transparent Teamwork We work together and cooperate with each to achieve synergy Excellence We set the highest standard of performance and deliver the best quality, competent and professional service Stewardship of the environment

GENERALRepublic Acts / Presidential Decrees / Executive Orders

RA 3720Food, Drug, and Cosmetics Act 1967

EO 175Amendment of Food, Drug, and Cosmetics Act 22 May 1987

PD 881Hazardous Substance Decree 30 Jan 1976

EO 51Adopting a National Code of Marketing of Breastmilk Substitute, Breastmilk Supplements, and Related Products, Penalizing Violations Thereof, and for Other Purposes 20 Oct 1986

IRR of EO 51

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Revised Implementing Rules and Regulations of EO 51: "Milk Code" 15 May 2006 RA 5921

Pharmacy Law 22 May 1987 RA 6675

Generics Act 13 Sept 1988 RA 7394

Consumer Act 13 Apr 1992 RA 7581

Price Act 15 Feb 1993 RA 8172

Asian Law 20 Dec 2005 IRR of RA 8172

Revised Implementing Rules and Regulations of Asin Law RA 8203

Counterfeit Law 19 Nov 1996 RA 8976

Food Fortification 07 Nov 2000 IRR of RA 8976

Implementing Rules and Regulations of Food Fortification Law 07 Nov 2004 RA 9165

Comprehensive Dangerous Drugs Act of 2002 2002 RA 9211

Tobacco Regulation Act of 2003 23 June 2003 IRR of RA 9211

Implementing Rules and Regulations of Tobacco Regulation Act Feb 2004 RA 9257

Expanded Senior Citizen Act of 2003 26 Feb 2004 EO 302

Declaring and Adopting the Philippine Pharmacopeia as the Official Book of Standards and Reference for Pharmaceutical Products and Crude Plant Drugs in the Philippines 29 March 2004

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STOCKHOLM CONFERENCE IN GENEVA

The Stockholm Convention aims to protect human health and the environment from the toxic and bioaccumulative chemicals specified in this Convention. The legal obligation of parties to the Convention include the banning of the manufacture, import, export and use of ten pesticides and industrial chemicals which are all characterized as Persistent Organic Pollutants (POPs). These chemicals are: aldrin, chlordane, DDT, dieldrin, endrin, heptachlor, mirex, hexachlorobenzene, toxaphene, and polychlorinated biphenyls, or PCBs.

The Hazardous Substances and New Organisms Act 1996 prohibit the manufacture, import or use of a POP chemical listed under the Stockholm Convention. Exports are regulated under the Import Control Act 1988.

The Stockholm Conference in Geneva controls:1. Permissions2. Importation 3. Manufacture and use4. Exportation 5. Chemicals to which these controls apply6. Penalties 7. Other permissions

PRESIDENTIAL DECREE No. 1144CREATING THE FERTILIZER AND PESTICIDE AUTHORITY AND ABOLISHING THE FERTILIZER INDUSTRY AUTHORITY

On 18 August 2004 Australia became a party to two international agreements relating to the trade of certain hazardous chemicals. These agreements are the:

-Stockholm Convention on Persistent Organic Pollutants (POPs) -Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous

Chemicals and Pesticides in International Trade

To implement these conventions, controls on import, manufacture, use and exportations have been introduced under the:

-Agricultural and Veterinary Chemicals (Administration) Regulations 1995 (Agvet Regulations)

-Customs (Prohibited Imports) Regulations 1956-Customs (Prohibited Exports) Regulations 1958

PermissionsEach of the Regulations requires a person to lodge a written application for activities

requiring permission, as indicated below. An application for permission under the Agvet Regulations must include information about the applicant and specific information on the activity. In certain circumstances additional information may be required or further information sought to allow the application to be processed.

Applications for permission to import or export chemicals that are controlled under the Agvet Regulations or the Customs Regulations should be made using the online permit application system (please note that this is a secure system). Permits are generally faxed and posted to applicants.

ImportationImportation of chemicals controlled under the Stockholm Convention is prohibited, except

with written permission in the following circumstances:

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Agvet RegulationsCustoms (Prohibited Imports) Regulations

for environmentally sound disposal for use as reference standards or of quantities to be used in laboratory-scale research.

No new importation controls have been introduced for chemicals that are only subject to the Rotterdam Convention, as such imports are already controlled under the Agricultural and Veterinary Chemicals (Administration) Act 1992.

Manufacture and useManufacture and use are prohibited absolutely for chemicals that are subject to the

Stockholm Convention.

No new manufacture or use controls have been introduced for chemicals that are subject to the Rotterdam Convention.Exportation

Exportation of chemicals that are subject to the Stockholm Convention is prohibited, except with written permission in the following circumstances:

Agvet Regulations for environmentally sound disposal Customs (Prohibited Imports) Regulations for use as reference standards or of quantities to be used in laboratory-scale research.

Exportation of chemicals that are subject to the Rotterdam Convention requires written permission. Permission will be granted if the following requirements are met:

Agvet Regulations if the intended use of the export in the importing country is as a 'pesticide'

the importing country is party to the Convention and the export meets the requirements of the importing party

if the chemical is controlled under the Convention as a severely hazardous pesticide formulation and the formulation is a different formulation at a lower concentration or meets the requirments of the importing party

if the chemical is the subject of notification of final regulatory action by Australia (asterix in the table below), additional information is provided by the applicant. This information will be provided to the importing country prior to the granting of permission to export, andthe permission to export to a party to the Convention may require the exporter to fulfill certain conditions as specified in the permit.

Customs RegulationsWhere the intended use of the chemical in the importing country is for non-pesticide use,

or for use as reference standards or of quantities to be used in laboratory-scale research.

Chemicals to which these controls apply For those chemicals that are subject to both the Stockholm the Rotterdam Conventions,

the controls imposed are those under the Stockholm Convention as these are more stringent than those imposed under the Rotterdam Convention.

Note: HCH, lindane, methoxychlor and oxychlordane are also listed on Schedule 9 of the Customs (Prohibited Imports) Regulations 1956 – written permission is required for import. These chemicals are not controlled because of any obligation under any international agreement. Penalties

Under the Agricultural and Veterinary Chemicals (Administration) Act 1992 a person must not import, manufacture, use or export an active constituent for a proposed or existing chemical

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product or a chemical product in contravention of a condition or restriction prescribed by a regulation. A penalty of 300 penalty units may apply.Other permissions

Granting permission under the Customs or Agvet Regulations does not replace any requirement for permission under any other legislation, including from the Australian Pesticides and Veterinary Medicines Authority (APVMA).

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Chemical name

Stockholm Convention

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Chemical name

aldrin (HHDN)

chlordane

DDT (pp’-DDT)

dieldrin (HEOD)

endrin

heptachlor

hexachlorobenzene (HCB)

toxaphene (camphechlor)

mirex

Rotterdam Convention

2,4,5-T

binapacryl 

captafol 

chlordimeform

chlorobenzilate

 dinitro-ortho-cresol and its salts 

dinoseb and its salts

ethylene dibromide (EDB)

ethylene dichloride

ethylene oxide 

fluoroacetamide

HCH (mixed isomers) excludes gamma isomer – see lindane

lindane (g-BHC, g-HCH)

mercury compounds- see table below

methamidophos

methazole*

methyl-parathion

monocrotophos*

parathion (ethyl)*

pentachlorophenol

phosphamidon

tribufos*

Dustable powder containing a combination of benomyl at or above 7%, Carbofuran at or above 10%, thiram at or above 15%

MERCURY COMPOUNDS

Chemical Name CAS no

2-(Acetoxymercuric)ethanol 4665-55-8

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cyano(methylmercuric)guanidine 502-39-6

hydroxymercuri-o-nitrophenol 17140-73-7

mercuric acetate 1600-27-7

mercuric chloride 7487-94-7

mercuric oxide 21908-53-2

mercurous chloride 7546-30-7

mercury 7439-97-6

mercury naphthenate 1336-96-5

mercury oleate 1191-80-6

mercury pentanedione 14024-55-6

mercury phenate 588-66-9

methylmercury 2,3 dihydoxypropyl mercaptide 2597-95-7

methylmercury 8-quinolinolate 86-85-1

methylmercury acetate 108-07-6

methylmercury benzoate 3626-13-9

methylmercury hydroxide 1184-57-2

methylmercury nitrite 2591-97-9

methylmercury propionate 5903-10-6

N-(phenylmercuric urea 2279-64-3

phenylethylmercuric salicylate 54-64-8

phenylmercuric acetate 62-38-4

phenylmercuric ammonium acetate 53404-67-4

phenylmercuric ammonium propionate 53404-68-5

phenylmercuric borate 102-98-7

phenylmercuric carbonate 53404-69-6

phenylmercuric chloride 100-56-1

phenylmercuric dimethyldithiocarbamate 32407-99-1

phenylmercuric formamide 22894-47-9

phenylmercuric hydroxide 100-57-2

phenylmercuric lactate 122-64-5

phenylmercuric laurylmercaptide -

phenylmercuric monoethanol ammonium acetate 5822-97-9

phenylmercuric monoethanol ammonium lactate 53404-70-9

phenylmercuric napthenate 31632-68-5

phenylmercuric nitrate 55-68-5

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phenylmercuric oleate 104-68-9

phenylmercuric propionate 103-27-5

phenylmercuric salicylate 28086-13-7

phenylmercuric thiocyanate 16751-55-6

phenylmercuric threthanol ammonium lactate 23319-66-6

phenylmercuric-2-ethylhexonate 13302-00-6

phenylmercuric-8-quinolinate 26114-17-0