Regulation of chemicals and hazardous and nuclear wastes in the Philippines started in 1990 with the passage of Republic Act 6969 (RA 6969), or the Toxic Substances and Hazardous and Nuclear Waste Control Act of 1990 on October 26, 1990. R.A. 6969 regulates, restricts and prohibits the importation, manufacture, processing, sale, distribution, use and disposal of chemical substances, toxic and hazardous wastes and substances, and other harmful mixtures that present unwarranted risks to the environment and/or injuries to the people. The main implementing agency is the Department of Environment and Natural Resources (DENR) assisted by Inter-Agency Advisory Council composed of representatives from different national agencies and a non-governmental organization on health and safety.
The implementing rules and regulation (IRR) of RA 6969 or DAO 1992-29 was released in July 6, 1992 and implemented a month later. The IRR is divided into five (5) Titles. Title I defines the General Provisions and Administrative Procedures of RA 6969; Title II pertains to Toxic Chemical Substances, Title III covers the requirements in the management of Hazardous and Nuclear Wastes while Title IV and V discuss the common provisions and prohibited acts and penalties, respectively.
Title II of DAO 1992-29 regulates the importation, manufacture, processing, handling, storage, transportation, sale, distribution, use and disposal of chemical substances and mixtures in the Philippines that may pose a threat to public health and the environment. It defines the requirements and mechanisms to be followed in identifying, screening, and evaluating new chemicals before they become commercially available in the Philippines; as well as provides for the evaluation of those chemicals already in use, which by virtue of occurrence, use, or toxicity, may present human health and environmental concerns.
As mandated by RA 6969 and Title II of DAO 29, the DENR-EMB is tasked to develop and establish the following:
- Philippines Inventory of Chemicals and Chemical Substances (PICCS) – an inventory of chemicals and chemical substances currently used in, manufactured in, and imported to the Philippines;
- Philippine Priority Chemicals List (PCL) – chemical substances that were determined to be posing a potentially unreasonable risk to public health, to work place, and to the environment;
- Pre-Manufacturing and Pre-Importation Notification (PMPIN) process and procedure – prior notification of new chemical substances to be manufactured in or imported to the Philippines, and significant new uses of certain existing chemicals and evaluation of their safety; and
- Chemical Control Orders (CCOs) – regulation, limit, gradual phase out, or ban of chemical substances that are determined to pose unreasonable risks to public health and environment.
Application to secure chemical related permits, similar with other environmental permits are now submitted on line using EMB’s Online Permitting and Monitoring System (OPMS). The webpage can be found at the DENR-EMB website (https://opms.emb.gov.ph/https).
Philippines Inventory of Chemicals and Chemical Substances (PICCS)
The PICCS listing was first published by DENR-EMB in 1995, after industries nominated the chemicals and chemical substances that are being used, imported, distributed, processed, manufactured, stored, exported, treated or transported in the country. The list is being updated annually to include new chemicals with PMPIN certification. It has been subsequently published in 2000, 2002, 2005, 2008, 2011, 2013, 2015 and 2017. The latest (2017) PICCS database is available on line on the DENR-EMB website (http://chemical.emb.gov.ph/?page_id=138) and contains more than 47,000 chemicals. An additional 31 chemicals have been added in the PICCS on March 3, 2020, (EMB Memorandum Circular (MC) No. 2020-007) but have not been included in the online database.
The PICCS database contain the following information:
- Chemical name and the Chemical Abstract Service Registry Number (CAS RN), a unique identifying number assigned to a particular chemical or chemical substance.
- CAS Registry Index names that are assigned to chemicals in accordance with International Union of Pure and Applied Chemistry (IUPAC) nomenclature.
- Common name of the chemical or chemical substance, only if different from CAS Registry Index name.
Manufacturers and importers do not need to notify and secure clearance from DENR-EMB before they manufacture or import chemicals included in PICCS; provided that these chemicals are not in PCL and are not subject to CCOs. An exception to this are fuel additives which are required to be reviewed under Republic Act 8749, the Clean Air Act even if the chemical ingredients are already in PICCS. Chemicals and chemical substances not yet included in PICCS have to follow the notification assessment process (PMPIN) before entering the Philippine market.
In the event that the Bureau of Customs or other authorities may request importers to present PICCS certificate before releasing their goods; a tool that can be used is the PICCS Tool which can be found in the OPMS. The user will only need to input the name or CAS number of the chemical and the tool will automatically generate an evaluation report. For a chemical already included in the PICCS, the report will indicate that a permit or clearance is not required for such chemical.
Articles, naturally-occurring substances and radioactive substances, and finished products (pesticides, drugs, food stuff, and cosmetics) that are regulated by other laws in the Philippines are not required for reporting/nomination for inclusion in PICCS through the PMPIN.
Pre-Manufacturing and Pre-Importation Notification (PMPIN)
As stated earlier, chemicals that are not listed in PICCS are considered new chemicals and are required to submit Pre-Manufacture and Pre-Importation Notification (PMPIN) to DENR. MC 2020-005 which was published on February 12, 2020 and took effect 15 days later explains the revised data requirements in the PMPIN procedures.
As of February 11, 2016, submission of the PMPIN application form has to be done online through the OPMS after registration. There are two notification types available; these are Abbreviated PMPIN and Detailed PMPIN. Abbreviated PMPIN should be used if the new chemical being applied for is already listed in either of the chemical inventories of the US, EU, Australia, Japan, Canada and/or Korea and information submitted by the notifier proves the chemical do not pose any risk. The Detailed PMPIN applies when the notifier cannot provide information on chemical risk, or DENR determines that the information submitted is insufficient. PMPIN should be done between 90 to 180 days prior to new chemical manufacture or importation activities.
Exemption from the PMPIN rules include:
- Small scale premises;
- Small quantity chemicals;
- Certain polymeric chemical derivatives;
- Chemical and chemical substances exempt from PICCS requirements;
- Chemicals and chemical substances included in PICCS;
- Non-isolated intermediates;
- Articles; and
- New chemicals manufactured exclusively for export.
The following information need to be inputted on line for both the abbreviated and detailed PMPIN.
Table 1.0 Information Needed for the PMPIN Abbreviated and Detailed Form
Section A: Premise InformationInformation about the premise/company that is considered the principal submitter of the form.
|Section||Information to be Provided|
|Section B: Chemical Identification Information||Chemical identity information:
Proper chemical name/CAS registered chemical name
Chemical and molecular structure
Synonyms for the new chemical
Provide synonyms or analogues of the new chemicals or attach results of x-ray diffraction (non-organic chemicals) or mass spectrum (organic chemicals) analysis for correct identification of the chemical notified.
|Section C: Production, Import and Intended Use||Estimated total quantity of new chemical to be manufactured or imported during the first 12 months of operations and how much will be for site, commercial, industrial and consumer use.|
|Section D: Occupational Exposure (not applicable to importers)||The type of activities the workers will be engaged in the use and production of the new chemical. Maximum number of workers and duration of exposure (h/d) for each type of activity.|
|Section E: Estimate Environmental Release and Disposal of the New Chemical (not applicable to importers)||Estimated quantity (kg) of the new chemical that will possibly be released through air, surface water, groundwater and soil (identify media) with brief statement regarding released control measures planned.|
|Section F: Joint Company (If applicable)||Provide the list of companies requesting to apply jointly with the application with contact person and details.|
In addition, the company must submit a Material Safety Data Sheet (MSDS)/Safety Data Sheet (SDS) of the new chemical; scientific literatures, reports or tests for physico-chemical, toxicological, and environmental properties. The amount and type of data or document to be submitted will differ between the abbreviated and detailed form as shown in Table 2.0 below.
Table 2.0 Physicochemical, Toxicological and Environmental Data Requirement
Appearance and Color;
Odor; Boiling Point;
Vapor Pressure; Melting Point; Purity; Specific Gravity/Density; Water/Octanol Partition Coefficient; Flammability;
Solubility in Water and Other Solvents
Known Stability and Incompatabilities
Carcinogenicity; Mutagenicity; Teratogenicity;
Acute and Chronic Toxicity; and Irritation
Acute and chronic toxicity to animals (fish in particular) and terrestrial plant toxicity;
Bioaccumulation and persistence
It is important to provide documented research data and journal articles from the Philippines and/or other countries to assist DENR to expedite the review process. If DENR determines that the information submitted is not adequate to assess the potential risk of the new chemical, full testing of the new chemical notified may be required. Assessment of the new chemical will take ninety (90) working days for Abbreviated Form and one hundred and twenty (120) working days for Detailed Form.
The documents to be submitted must be in pdf, jpg, jpeg, png or gif filetype with maximum file size of 20MB. If the files are greater than 20MB, these should be split and uploaded separately. The completed application form should be printed and notarized. After which, the notarized form together with the Authorization Letter, Official Receipt of Payment, SEC/DTI Registration, and Business Permit/PEZA Registration should be uploaded on the OPMS.
Once a new chemical has been assessed and approved by DENR-EMB, the company is granted a PMPIN Compliance Certificate or permit by DENR-EMB to import and/or manufacture the new chemical. This permit has no expiry. A Notice of Commencement (NOC) to Import or Manufacture Form together with Bill of Lading/Airway Bill/Seaway Bill, Import Entry Tax Declaration, signed PMPIN Certificate, and Proforma Invoice or Commercial Invoice after the first importation of the new chemical should also be submitted. The product name or the new chemical must be reflected in the document of entry. The new chemical will be listed in the public PICCS a year after the receipt of the NOC, unless Confidential Business Information (CBI) was requested.
In case the notifier or company was not able to comply with the information required by the DENR, a letter explaining the basis of non-compliance will be issued. Reapplication will be required after three (3) months of non-compliance.
If the notifier cannot supply the required information due to physicochemical based constraints of the chemical itself, a position paper on why the information on the chemical cannot possibly be supplied can be submitted. References should be made to published and peer-reviewed articles, journals and books.
Violators shall be subject to fines, imprisonment, dismissal from office, confiscation and forfeiture of chemical substances and mixtures in favor of the government. Foreigners will be subject to deportation and barred from entry into the Philippines.
Administrative violations and fines of not be less than Ten Thousand Pesos (PhP10,000.00) but not more than Fifty Thousand Pesos (PhP50,000.00) will be imposed upon any person or entity found guilty. In addition, criminal offenses may also be imposed with penalties of six (6) months and one (1) day to six (6) years and one (1) day imprisonment and a fine ranging from Six hundred pesos (P600.00) to Four thousand pesos (P4,000.00).
Contributor: Marivic Arago
Brown ＆Green Environmental Services, Inc.