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Welcome to GPC Philippines - Regulation

Republic Act 6969, “Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990”, is the key law on chemical management in Philippine. The mandate was published by Chemical Management Section (CMS), Department of Environment and Natural Resources (DENR). 

A list of Administrative Orders and Memorandum Circulars among relevant enforcement units have entered into force to implement the Rules and Regulation of Republic Act 6969 (RA 6969). It is first and foremast DAO 1992-29 to take shape the legal framework of chemical management. The framework comprises four national approaches and one international approach: Philippine Inventory of Chemical and Chemical Substances (PICCS), Pre-Manufacture Pre-Importation Notification (PMPIN), Priority Chemical List (PCL), Chemical Control Order (CCO), and Globally Harmonized System of Classification and Labelling of Chemicals (GHS). 

 

National Regulation 

Implementation officer(s) 

Chemical Management Section (CMS), Department of Environment and Natural Resources (DENR)  

CMS-DENR-EMB 

Law 

Republic Act 6969 (RA 6969) approved on October 26, 1990 

“Toxic Substances and Hazardous and Nuclear Wastes Control Act” 

DAO 1992-29 Implementing Rules and Regulations of Republic Act 6969 

Objectives 

  • Collect data: To keep an inventory of chemicals that are presently being imported, manufactured, or used, indicating. Their existing and possible uses, test data, names of firms manufacturing or using them. 
  • Monitoring and regulation: The importation, manufacture, processing, handling, storage, transportation, sale, distribution, use and disposal of chemical substances and mixtures that present unreasonable risk or injury to health or to the environment. 
  • Open data: Inform and educate the populace regarding the hazards and risks attendant to the manufacture, handling, storage, transportation, processing, distribution, use and disposal of toxic chemicals and other substances and mixtures. 
  • Control: limit entry/in transit of hazardous and nuclear wastes. 

Scope 

(Non) hazardous chemical substances and mixtures in the Philippines 

Target  

Importer-distributors/importer-user-manufacturers/user-manufacturers or any combination of thereby chemicals 

Compliance obligations 

 

  • Philippine Inventory of Chemical and Chemical Substances (PICCS) 
  • Pre-Manufacture and Pre-Importation Requirements (PMPIN) 
  • Priority Chemical List (PCL) 
  • Chemical Control Order (CCO)  

External Links 

Authority’s Application Forms for chemical management applications: https://chemical.emb.gov.ph/?page_id=132 

The application and issuance of certificate/permit: https://opms.emb.gov.ph/accounts/login/ 

 

Chemical Inventory in Philippine  

Philippine Inventory of Chemical and Chemical Substances (PICCS) is an industry-reported list of all existing chemicals and chemical substances used, imported, distributed, processed, manufactured, stored, exported, treated or transported in the Philippines. The updated version (May, 2021) of inventory has so far included 22, 277 chemical substances.  

Exemption:  

  • Non-chemical substances 
  • Naturally occurring substances 
  • Small-quantity chemicals manufactured or distributed (not imported) for market test and research and development in quantities less than 1,000 kg per year 
  • Mixtures  
  • Radioactive substances, pesticides, drugs, foodstuffs, and consumer products that are regulated by other laws in the Philippines 
  • By-products (Wastes)

New chemical substances that are not included in PICCS and mixtures have to be notified in Pre-Manufacture and Pre-Importation Requirements (PMPIN) before manufacturing, processing, and importation. Upon approval by the authority, new substances and mixtures will be added into the inventory while manufacturers, processors, and importers are allowed to proceed with operations.  

Exemption:  

  • Articles  
  • Naturally occurred substances  
  • Radioactive substances and finished products regulated by other laws 
  • Polymer listed in PICCS or not in the list but with small quantities (2%) 

Based on toxicity level, quantity of importation, and use of industry, chemical substances identified as hazardous and can pose threat to public health, workplace, and the environment are shortlisted in the Priority Chemical List (PCL). In total, 48 toxic substances are on the updated list (December 2005). Importers, distributors, manufacturers are required to secure a PCL compliance certificate for their businesses.  

Exemption: 

  • Chemicals are components of products less than or equals to 1 percent concentration 
  • Chemicals covered by the Chemical Control Orders (CCOs)


 

 

 

After assessment, DENR-EMB will gradually move the chemicals on the PCL to Chemical Control Order (CCO). In this case, DENR-EMB plans more precisely to control, prohibit, and phase out these chemicals from the Philippines. Importers, users, distributors, manufacturers, and different waste service providers of these controlled chemicals are required to follow general requirements of application. 

 

To comply with various regulations regarding certificate of conformity, a national harmonized Online Permitting and Monitoring System (OPMS) is available. The service covers the compliance certificates for PMPIN and PCL and the certificate/permit required by PICCS (also known as PICCS Tool). 

 

Complementary regulations 

About fines and fee

DMC 2005-003 

Prescribing graduated administrative fines  

DMC 2000-12 

Schedule of Fees  

DAO 2016-28 

Providing for New Fees and Charges for Various Services of the Environmental Management Bureau 

About PICCS

EMB MC 2020-007 

Additional Chemicals in PICCS 

EMB MC 2021-08 

Updated Philippine Inventory of PICCS 

DMC 2002-12  

Delegation Of Authority to The EMB Regional Offices to Issue  

-“Permit to Transport” for Hazardous Wastes 

-“Certification” and “Importation Clearance” for Chemicals and Chemical Substances 

About PMPIN

DAO 2019-18 

Polymers and Polymer of Low Concern Exemption from the PMPIN Process 

EMB MC 2020-005 

Data Requirements for PMPIN Procedures 

About PCL

DAO 1998-58 

Priority Chemicals List 

DAO 2005-27 

Revised Priority Chemical List 

DAO 2007-23 

Prescribing Additional Requirements for the Issuance of PCL Compliance Certificate 

EMB MC 2014-003 

Supplemental Guidelines for the DAO 2007-23  

EMB MC 2016-003 

Implementation of Online Processing of PCL and PMPIN 

EMB MC 2017-007 

Clarification on the Coverage of Laboratory Facilities under DAO 2007-23  

EMB MC 2020-010 

Clarification to DAO 2007-23  

About CCO -general rules 

DAO 2005-05 

Toxic Chemical Substances for Issuance of Chemical Control Orders 

EMB MC 2015-002 

 

Harmonization of Registration Forms, Issued Certificates and Procedures for Chemical Control Orders (CCOs), and Small Quantity Importation (SQI) 

About CCO -specifics chemical categories

Mercury and Mercury Compounds, Cyanide and Cyanide Compounds, Asbestos,  

Polychlorianted Biphenyls, Ozone Depleting Substances, Lead and Lead Compounds, Arsenic and Arsenic Compounds Other related CCO policies, Chromium (VI), Cadmium 

https://chemical.emb.gov.ph/?page_id=44 

 

 

Adoption of GHS 

Philippines adopts UN GHS 4th revision and sets up a four-phase implementation timeline in DAO 2015-09. Currently, Philippines is moving to the fourth phase. Phase one covers the chemical substances listed in PIC and CCO. High volume (500 metric tons or more per year) toxic chemicals are included in phase two. According to the MC2017-010, 232 substances are subject to the system. Phase three expands the inclusion to toxic chemicals described under the International Air Transport Association (IATA) and International Maritime Dangerous Goods (IMDG). The final phase is expected to cover mixtures which a draft policy (Guidelines on the implementation of GHS Classification and Labelling Requirements for mixtures) is now in the process of public consultation. Philippines is expected to adopt the 8th revision in 2022.1 

Status 

Adopt UN GHS Rev.4 

Regulation(s)  

DAO 2015-09: Rules and Procedures for the Implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in Preparation of Safety Data Sheet (SDS) and Labelling Requirements of Toxic Chemical Substances 

EMB MC 2015-011: Guidance Manual for Department Administrative Order 2015-09, “Rules and Procedures for the Implementation of the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals in Preparation of Safety Data Sheets (SDS) and Labelling Requirements of Toxic Chemical Substances 

MC2017-010: Guidelines in the implementation of GHS classification and labelling requirement for HVCs 

EMB2020-09: Guidelines In the Implementation of Globally Harmonized System (GHS) Classification and Labelling Requirements for Chemicals Under International Air Transport Association (IATA) And International Maritime Dangerous Goods (IMDG) 

Scope 

Chemical substances, (high volume) toxic chemicals, dangerous chemicals (identified by IATA and IMDG) 

Exemption  

Chemicals used in the preparation/production of cosmetics, pharmaceuticals, foods, and pesticides 

Language 

English used as the primary language in preparing the SDS 

Comments 

Next step:  compulsory GHS compliance for toxic mixtures. 

 

Chemical regulations from other ministries 

Food and Drug Administration  

The Rules and Regulations for Implementing RA. 9711 for Household/Urban Hazardous Substances (FDA Act of 2009) 

Philippine National Police 

Rules and Regulations for the Control and Supervision of the Importation, Sale and Possession of Chemicals Used as Ingredients in the Manufacture of Explosives and for other purposes (RA 8294, EO No. 552) 

Occupational Safety and Health Center 

Rules and Regulations in the Implementation of the Occupational Health and Safety Standards when Handling Chemicals in the Workplace (PD 442) 

Philippine Drug Enforcement Agency 

Implementing Rules and Regulations for the Registration and Management of Dangerous Drugs and Controlled Precursors and Essential Chemicals (RA 9165) 

Bureau of Customs 

Customs Memorandum Order No. 9-2015: A regulated imports list includes all regulated chemicals except for those in PICCS and the procedures for acquiring permits.  

 

 

The Fertilizer and pesticides authority of the Philippines is responsible for regulating plant protection products (PPP). It draws its power from Section of PD 1144, which states that the Fertilizer and Pesticide Authority (FPA) has jurisdiction over the usage and regulations of plant protection products. Therefore, they are responsible for Safeguarding the population against the risks of pesticide use and inform the agricultural sector on how to utilize these chemicals. 

Biorational pesticide is a different category of pesticide compared to conventional pesticides. They are classified into two parts: biochemical pest control agents (e.g., pheromones, hormones, natural plant growth regulators, and enzymes) and microbiological pest control agents (e.g., pheromones, hormones, natural plant growth regulators, and enzymes) (e.g., microorganisms).  

All pesticides intended for commercial use in the Philippines should be registered with the Fertilizer and Pesticide Authority, according to Section 9 of PD 1144 and Article II, Sec. 1 of FPA Rules and Regulations No. 1, Series of 1977. Biopesticides are used as a substitute or supplementary products for plant protection. They are also used extensively and somewhat less hazardous than typical biopesticides. But regulated and monitored by the FPA.  

The producers are asked to carry out the testing. They are keeping in mind the safety and security of all.  Biopesticides have been seen as an integrated pest management policy by the countries. There are also different kinds of biopesticide products mandated by the authorities to follow a different route to get the marketplace's approvals. Biopesticides are still in an evolving phase of their innovations. Countries are assessing their efficacies and have been making ad-hoc decisions about specific products through emergency approvals.  

  • To promote the safe use of plant protection products and dissemination of the correct information among society.  

  • The Philippine Council for Agriculture and Resources Research and other authorized agencies; works in tandem with each other to ensure that to safeguard public health through rational pest control, safety in the use and handling of pesticides, higher product standards, and quality better application methods. 

  • To determine the actual application or application methods for each pesticide or pesticide composition.  

  • To restrict the importation of plant protection goods with pesticide residues above permissible tolerance levels and limit PPP exportation with pesticide residues exceeding acceptable tolerance levels.  

  • Regular audits of PPP license holders at their workplaces and premises to ensure compliance with industrial health, safety, and anti-pollution regulations. 

  • All pesticide handlers must obtain a license from the Fertilizer and Pesticide Authorities (FPA), as per Section 9 of PD 1144 and Sections 1 and 2 of Article III of the FPA Rules and Regulations No. 1, Series 1977. 

  • All the commercial applicators, before marketing and selling PIP and other agricultural pesticide compounds, all technological developers, dealers, importers, and other handlers of PIP and other agricultural pesticide substances must take license numbers from competent authorities in the Philippines. Otherwise, it will be considered a civil or criminal offense. 

Requirements for the registration:  

  • Due to their distinctive and contained nature, FPA will register PIPs and other agricultural pesticidal compounds based on the general principles of biorational pesticides, with the appropriate adjustments.  

  1. Approach to testing- The method for assessing PIPs and other agricultural pesticidal compounds must be in line with Section 3.2.2.  

Data Requirements: According to Section 3.3.2, The following data is necessary for product analysis of PIPs and other agricultural pesticide chemicals.  

  • The product name (gene, protein/s, or substance) and the trade name{s) (if different), the company code numbers.  

  1. Confidential Statement of Formula- The application should contain a statement of confidential information.  

  1. Ingredient Information- Refer to Section 3.3.2.C for the details.  

  1. Transformation process- Data-related sources of genes and DNA elements, the transformation process, genetic stability, etc.  

 

 

  1. Product Identity - The product name and trade name(s) must be included in each authorization of a biochemical PCA that is a pesticide product (if different). It's possible to provide the corporate code number(s). 

  1. Confidential Statement of Formula- This group's product analysis criteria are as follows: A confidential statement of formula would be included in the product registration application. Each variant formula of a product requires its con information of the procedure. In addition, the correct FPA form must be filled correctly. 

  1.  Information on Ingredients- The following information (if available) about each ingredient mentioned in the confidential statement of formula required by paragraph (B) & must be included in an application form:   

1. Each biochemical (including microbial toxins) can be identified by:  

a. Biochemical name(s) from the Chemical Abstracts Index of Nomenclature, 1972-1976, or     another well-defined name   

b. The Chemical Abstracts Service (CAS) Registry Number(s)  

c. The structural formula(s), empirical formula(s)  

d. The count of the biochemical present in the product in recognized units of potency. 

  1. The name of the genus of the organism by which the biochemical was derived or is commonly associated. 

  1. The specificity or host range of the biochemical activity and mode of action. 

  1. Ingredients, other than biochemicals, can be identified by-  

  • Percentage composition (by weight) of each ingredient. 

  • Whether the substance is a purposefully inserted active component or an impurity. 

  • The chemical name for the Chemical Abstracts or other well-defined name. 

  • The CAS registry number. 

  • The product name, the trade name, and the common name (if established). 

  • The experimental or internal code number. 

Assume that at any point throughout the manufacturing process, the existence of components harmful or sensitizing to humans or other non-target mammalian species is detected. In that instance, data must be supplied demonstrating that the chemicals are either not present in the final biochemical product or are present in proportions that are too small to represent a risk.   

  1. Discussion on the Formation of Unintentional Ingredients - A discussion of the potential production and presence of unintended components in the product in proportions that may cause undesirable human or environmental impacts must be included in a registration application. Such involuntary components may be introduced during the manufacturing process through the starting material, process solvents, equipment, packaging, and other sources; the manufacturing process should also be provided. 

  1. Physical and Chemical Properties- Each manufacturing-use product and each end-use product should provide data on physical and chemical characteristics to support their registration.  

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