EMB Memorandum Circular No. 2020-005 establishing the Data Requirements for Pre-Manufacture and Pre- Importation Notification (PMPIN) Procedures

Republic of the Philippines Department of Environment and Natural Resources ENVIRONMENTAL MANAGEMENT BUREAU DENR Compound, Visayas Avenue, Diliman Quezon City 1116 Telephone Nos.: (632)927-15-17, 928-37-25; Fax No.: (632) 920-22-58 Website: http://www.emb.gov.ph. / Email: mail@emb.gov.ph EMB MEMORANDUM CIRCULAR No. 2020 0-0---5 F:~ 1 .·: 2020 SUBJECT: DATA REQUIREMENTS FOR PRE-MANUFACTURE AND PRE IMPORTATION NOTIFICATION (PMPIN) PROCEDURES Pursuant to Republ ic Act 6969 otherwise known as the "Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990", and DENR Adm inistrative Order (DAO) No. 29, Series of 1992, the " Implementing Ru les and Regulations of Republ ic Act 6969", this Order is hereby issued to provide consolidated Rules and Regul ations fo r submissions of data for new chem icals under the Pre-Manufacture and Pre- Importation Notification (PMPIN) process. Section 1. Policy and Objectives ft is the pol icy of the State to regulate, restrict or prohib it the importation, manufacture, process ing, sale, distribution, use and disposal of chemical substances and mixtures that present unreasonable risk and/or injury to hea lth or the environment. Pursuant to this po licy statement, th is Order ai ms to prov ide the complete data requirements for assessment and eva luation of new chemica ls. Section 2. Definition of Terms As used in this Order, the followi ng terms are hereby defined : 2.1 Abbreviated Form - Form used for new chemica ls that are already listed in the chemica l inventories of either US, Canada, Japan, Australia, Europe, and/or Korea. 2.2 Article - A manufactured item: ( 1) which is formed to a specific shape or des ign during manufacture, (2) which has end use fu nction(s) dependent in who le or in part upon its shape or des ign du ri ng end use, and (3) which has either no change of chemica l composition during its end use or on ly those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that flu ids and partic les are not cons idered articles regardl ess of shape or des ign. 2.3 Bureau - refers to the Environmental Management Bureau of the Department of Environment and Natural Resources. 2.4 CAS RN - refers to the Chemica l Abstract Service Registry Number, wh ich is a unique identifying number adopted by the Chemical Abstract Service to number chemica ls and to ass ign them a runn ing number as accepted in the CAS databank. Protect the environment ... Protect life ... Page I of 11 ~-.. Department of Environment and ~ Natural Resources = ENVIRONMENTAL MANAGEMENT BUREAU O ffice of the Dfrector MC No. 2020-005 lllllllllllllllllllllllllllllllllllllllllllllllllll!IIIIIIIIIIIIIIII 20.02.12*19;54:21•000146 2.5 Department - refers to the Department of Environment and Natural Resources 2.6 Detailed Form - Form used for new chemicals not listed in the chemical inventories of neither US, Canada, Japan, Australia, Europe, nor Korea 2. 7 Importer - any local juridical person or corporation that undertakes the entry of a product or substance into the country. 2.8 IUPAC Nomenclature - systematic method of naming organic and inorganic chemical compounds as recommended by the International Un ion of Pure and Appl ied Chemistry (IUPAC). 2. 9 Lethal Concentration 50 (LC50) - lethal concentration required to kill 50% of the test population. 2.10 Lethal Dose 50 (LOSO) - the lethal dose at wh ich 50% of the test population is killed in a given period oftime 2. 11 Manufacturer - any juridical person or corporation that undertakes the physical or chemical transformation ofchemical(s) already listed in the Phi lippine Inventory of Chemicals and Chemical Substances (PICCS) into a new chemical. 2. 12 Material Safety Data Sheet I Safety Data Sheet (MSDS/SDS) - refers to a detai led informational document prepared by the supp lier, manufacturer or importer of a chemical/product. Information in the SOS includes physicochemical, toxicological, and environmental properties of the chemical/product, as well as safety procedures, spills, leaks, storage, handling, and regulatory information. 2.1 3 Naturally-occurring substances- any chemical substance that is naturally occurring and ( I) is unprocessed or processed only by manual, mechanical or grav itational means; or by dissolution in water or by flotation or by heating so lely to remove water; and (2) extracted from air by any means. It includes raw agricultural commodi ties, water, ai r, natural gas, crude oil, rocks, ores and mineral s. 2. 14 New Chemica l - a chemica l not yet listed in the PICCS 2.1 5 Notifier - local person(s) or entities engaged in importation or manufactu re of new chemicals, and whose name will be ind icated on the issued permit. 2.16 Phi lipp ine Inventory of Chemicals and Chemical Substances (PICCS) - refers to the updated list of chemicals and chemical substances currently being imported and/or manufactured and assessed by the Department 2. 17 Premises - shall include, but not limited to, buildings or parts of bui ldings, tents, stalls or other fac ility structures whether permanent or temporary. Section 3. General Procedure The fo llowing are the procedures for notification of new chemicals under the PMPIN process. New chemicals are required for notification under DENR Adm inistrative Order (DAO) No. 29, Series of 1992, the " Implementing Ru les and Regulations of Republic Act 6969". In support to EMB Memorandum Circular 2016-003, all PMPIN applications shall be applied to the On line Permitting and Monitoring System (OPMS) webs ite. 3.1 Abbreviated Form The notifier shall register using the Abbreviated Form if he/she is applying for a new chemical already listed in either of the chemical inventories of US, EU, Australia, Japan, Canada and/or Korea. Page 2 of 11 a Department of Environment and ~ ~~~~6~~;~f~t°iMNAGEMENT BUREAU Office of the Directo r MC No . 2020-005 11111111 11111111111111111111111111 1111111111111111111'11111111 11111!1] 20.02.12• 19:54:26•000148 3.1 .1 The company shall submit a du ly accompl ished and notarized Abbreviated Form (see instructions in Annex A). The signatory should be the President/CEO/General Manager or an authorized representative of the notify ing company. 3.1.2 The company shall submit a Material Safety Data Sheet (MSDS)/Safety Data Sheet (SOS) of the new chemical. 3 .1.3 The company shall submit scientific literatures, reports or tests for physico-chemical, toxicological, and environmental properties compliant with Good Laboratory Practices (GLP). 3.2 Detailed Form The notifier shall register using the Detailed Form if he/she ts applying for chemicals not appl icable with Section 3.1. 3.2.1 T he company shall submit a duly accomplished and notarized Detailed Form (see instructions in Annex 8). The s ignatory should be the President/CEO/General Manager or an authorized representative of the notifying company. 3.2.2 The company shall submit a Material Safety Data Sheet (MSDS)/Safety Data Sheet (SOS) of the new chem ical. 3.2.3 T he company sha ll submit tests fo r physico-chemical, tox ico logical, and environmental properties compl iant with Good Laboratory Practices (GLP) . Section 4. Specific Requirements The following specific req uirements for each application should be written on the notarized application forms . 4.1. Application Deta ils 4. 1.1 Name and address of the notifier 4. 1.2 Proper chemical name/CAS registered chemical name/IUPAC name 4.1.3 CAS RN (if available) 4.1.4 Chemical and molecular structure 4.1.5 Trade Name 4.1.6 Anticipated weight in kilograms per annum of the chemical substance being imported or manufactured by the notifier 4.1. 7 100% composition of product with complete CAS RN; where in the new chemical is a component of the product being imported 4. 1.8 Intended use of the chemical 4.2. Physicochemica l Properties ~• Department of Environment and ~ Natural Resources ~ ENVIRONMENTAL MANAGEMENT BUREAU Offlco of the Director MC No. 2020- 005 1111rn1111111111111111111111111111111111111111111111111111111 111111111 20.02.12•19,54;30•000148 Page 3 of 11 4.2. 1 4 .2.2 4 .2.3 4.2.4 4.2.5 4.2.6 4 .2.7 4.2 .8 4 .2.9 4 .2.10 Appearance and co lor Odor Boiling Point/Range Melting Point/Range Specific Gravity/Density Vapor Pressure Water/octanol partition coefficient Flamma bility So lubility in water and other solvents Known stabi lity and incompatibilities 4.3. Toxicological and En vironmental/Ecological Properties 4.3.1 Acute oral and dermal toxicities in terms of Lethal Dose 50 (LOSO) 4.3.2 Acute inhalat ion toxicity in terms of Lethal Concentrat ion 50 (LCS0) 4.3.3 Chronic toxic ity 4.3.4 Irritation on ski n and eyes 4 .3.5 Respiratory/skin sensitization 4 .3.6 Carc inogenic, teratogenic and mutagenic properties 4.3.7 Acute toxicities for either fish, inve11ebrates and/or a lgae 111 terms of LC50/EC50 4.3 .8 Degradability 4.3.9 Bioaccumulation and persistence 4.4. For Detailed applications, the Phys icochem ical, Toxicological and Environmental/Ecological Properties should be accompanied with laboratory tests. Section 5. Confidential Business Information The confidentia lity of information shall be consistent with Secti on 40 of DAO 92-29. The following are additiona l procedures/information requ ired for notifications where certa in information are requested to be considered confidential by the notifier or their supplier, due to confidential information regarding trade secrets (formu lations). The PMPIN Certificate to be issued sha ll only ind icate the name of the product they will be importing. 5.1 In the case of importation ofa new chemical in a mixture, the company shall submit an updated and adeq uate Materia l Safety Data Sheet (MSDS)/Safety Data Sheet (SOS) of the product where the new chemical is a component. 5.2 The company shall subm it 100% composition of the product to be imported, including a ll the CAS RN of the components of the product. The phys icochemical, toxicolog ical and environmenta l prope11ies of the new chemical shal l a lso be subm itted. In case of confidentia lity of the information, the supp lier or manufacturer may submit a du ly accomp li shed Confidential Business Information Form (Annex C) a long w ith the data subject to requirements to the Bureau by mail or emai l at chem ica ls@emb.gov .ph and correspond ing justification Section 6. Chemical Review Committee (CRC) Page 4 of 11 A Department of Environment and ~ ~~~11b~:£~~1•t MANAGEMENT BUREAU Office of the Director MC No. 2020-005 llllllllllllllllllllllll!IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII 20.02.12•19:54:35•000146 For app lications for new chemicals under the Detai led Form, a Chemical Review Committee shall be inv ited to evaluate the new chem icals. This technical working group shall include but not limited to representatives of the academe and other regu latory agencies (specifically those poss ibly involved with the new chemical). Section 7. Justification of Information If the notifier is unable to supply information for application(s) due to physicochemical based constraints of the chemical itself, the notifier shall submit a position paper on why the information on the chemical cannot possibly be supplied, with references to published and peer-reviewed a11icles, journals and books. Th is also appli es to given information based on "similar substances". The validity shall be evaluated by the Chem ical Review Committee (CRC), if needed. Section 8. Issuance of Certificate Assessment of the new chemica l shall be ninety (90) working days for Abbreviated Form and one hundred and twenty (120) working days for Detai led Form. After assessment of the new chemical, the Depa11ment shall issue a PMPIN Compliance Certificate, or a letter. A letter shall be issued on the basis of non-compliance of the notifier to the info rmation required by the Department. After three (3) months of non-compliance, reapplication will be needed. The company sha ll submit a Notice of Commencement (NOC) after the first impo11ation of the new chemica l. Submiss ion shall include Filled-up NOC Form, Bill of Lading/Airway Bi ll/Seaway Bill, Import Entry Tax Declaration, signed PMPIN Certificate, and Proforma Invoice or Commercial Invoice. The product name or the new chemical must be reflected in the document of entry. Section 9. Listing of new chemicals in the PICCS After receipt of the Notice of Commencement, the new chemical shall be listed in the public PICCS after a year, unless requested for Confidential Business Information (CBI). Notifiers will be invited every year for clarification and updates. Section 10. Exemption from PMPIN The fo ll owing substances are not required for reporting/nomination for inclusion in PICCS through the PMPIN: l 0.1 Articles I 0.2 Natural ly-occurring substances I 0.3 Radioactive substances, and fi nished products (pestic ides, drugs, foodstuff, and cosmetics) that are regulated by other laws in the Philippines ~,,. Department of Environment and ~ Natural Resources =,:;- ENVIRONMENTAL MANAGEMENT B UREAU Office of the Director MC No . 2020- 005 Iii l!I Ill I II llllillllll Ill II I ll~I I I I II 111111111111111111 20.02.12• 19:54:39•000148 Page 5 of 11 Section 11. Capacity Building In support to the effective implementation of this Order, continuing train ing and information, education and comm unication (IEC) efforts on notification of new chemicals for both regulated comm unity and regulators shall be unde11aken Section 12. Revision of Requirements The Depai1ment may amend, modify, and/or supplement the requirements and standards in this Circular after prior consultation with the stakeholders and after due notice and hearing with the public on matters to be rev ised. The Bureau Director may issue clarificatory guidelines, if necessary. Section 13. Penalty Provision Any fal sifi cat ion of information or violation of the requirements specified in this Order shall subject the person(s) liable thereof to the appl icable admin istrative and criminal sanctions as provided for under Sections 4 1 and 43 of DAO 92-29. Section 14. Separability Clause All provisions in the DENR Administrat ive Order (DAO) No. 29, Series of 1992, and other issuances inconsistent herewith are deemed repealed, superseded and/or mod ified accordingly. Should any provis ions or portion of this Order be declared unconstitutional or invalid, all the other provisions of this Order shall remain valid and enforceable. Section 15. Effectivity This Memorandum Circular shall take effect fifteen (15) days after its publication in a newspaper of general circulati on and upon acknowledgment of receipt ofa copy thereof by the Office of the National Administrative Register (ONAR), UP Law Center. s::-. Department of Environment and ~ Natural Resources ~ ENVIRONMENTAL MANAGEMENT BUREAU Office of the Director MC No. 2020-005 llllllllllllllllll1llllllllllllll 11!;11111111111111111 20.02.12•19:54:4 •00 0148 Page 6 of 11 ANNEX A PMPIN Abbreviated Form Instruction Confidential Business Information (CBI). Mark if you claim CBI for any of the sections. Please provide in separate page the justification for claiming CBI and attach. Section A. Fi ll in the information about the premise/firm that is considered the principal submitted of this form Section B. Provide the chemical identify information. Consult DENR if you need assistance in obtaining the information required. It will expedite the review process if synonyms or analogues to the new chemicals can be presented. Otherwise attach the resu lts of x-ray diffraction (non-organic chemicals) or Mass spectrum (organic chemicals) analysis to enable DENR review committee for correct identification of the chemical notified. Section C. Estimate the total quantity of new chemical to be manufactured or imported during the first 12 months of operations. Estimate how much of the intended production or imp01t wi ll be used in any of the four categories on an annual basis. Industrial use is defined as any use during manufacturing and process operations. Commercial use is interpreted as any use aiming at consumer services. Section D. (not applicable to importers) Estimate the type of activities the workers will be engaged in the use and production of the new chemical. For each type of activity provide information about the maximum number of workers and minimum hours per day that the will be exposed to the new chemical Section E. Estimate the quantity ofthe new chemical that will possibly be released through air, surface water, groundwater and soil. Also, provide a brief statement regarding released control measures planned. Section F. Submission of the Abbreviated Form is primarily based on the premise that the new chemical is used in another country with similar chemical review process as the Ph ilippines. It is important that the notifier provides all the information required in this section to expedite the review process. Section G. Provide any document describing the physicochemical characteristics of the new chemical notified. Documented research data from other countries will be helpful. Notifiers with such information will assist DENR to expedite the review process. Section H. Present a short description of potential toxicological effects of the new chemical (if any) and provide any document describing those effects. Documented research data and journal artic les from other countries will be helpful. Health effects data may include carcinogenicity, sensitization, acute toxicity and irritation. Notifiers with such information will assist DENR to expedite the review process. Section I. Present a short description of potential environmental effects of the new chemical (if any) and provide any document describing those effects. Documented research data and journal articles from other countries w ill be helpful. Environmental effects may include acute and chronic toxicity to animals (fi sh in pa,ticular) and terrestrial plant toxicity. Info rmation Page 7 of 11 concerning the fate of the chemical upon release to the environment will be important. Notifiers with such information will assist DENR to expedite the review process. Section J. Provide the list of companies requesting to apply in joint with th is application . Submit the contact person and details. The abbreviated form wi ll be automatically printed after filling up the appropriate fields in the Online Permitting and Monitoring System. You are advised to review the printed abbreviated form prior to notarization. Page 8 of 11 ANNEXB PMPIN Detailed Form Instruction Confidential Business Information (CBI). Mark if you claim CBI for any of the sections. Please provide in separate page the justification for claiming CBI and attach. Section A. Fi ll in the information about the premise/firm that is cons idered the principal submitted of this form Section B. Provide the chemical identify information. Consu lt DENR if you need assistance in obtaining the information required. It wi ll expedite the review process if synonyms or analogues to the new chemicals can be presented. Otherwise attach the results of x-ray diffraction (non-organic chemicals) or Mass spectrum (organic chemicals) analysis to enable DENR review committee for correct identification of the chemical notified. Section C. Estimate the total quantity of new chemical to be manufactured or imported during the first 12 months of operations. Estimate how much of the intended production or import will be used in any of the four categories on an annual basis. Industrial use is defined as any use during manufacturing and process operations. Commercial use is interpreted as any use aiming at consumer services. Section D. (not applicable to impo11ers) Estimate the type of activities the workers will be engaged in the use and production of the new chemical. For each type of activity provide information about the maximum number of workers and minim um hours per day that the will be exposed to the new chemical Section E. Estimate the quantity of the new chemical that will possibly be released through a ir, surface water, groundwater and soi l. Also, provide a brief statement regarding released control measures planned. Section F. Submission of information concerning the regulatory status of this chemical in other countries will expedite the review process. Section G. Provide any test results on the physicochemical characteristics of the new chemical notified. Documented research data from other countries will be helpful. Notifiers with such information will assist DENR to expedite the review process. The test results should include: Boiling Point, Vapor Pressure, Melting Point, Purity, S. Gravity, Wate r/Octanol partition coefficient, solubility in water, and solubility in organic compounds Section H. Present the test results of potential toxicological effects of the new chemical and provide any document describing those effects. Submit documented research data and journal articles from Philippines or other countries. When you submit the test resu lts, ensure that the fu ll name and address of the laboratory which conducted the tests in the Philippines or in other countries are c learly indicated. The health effects data may include carc inogenicity, sensitization, acute toxicity and irritation. Notifiers with such information will assist DENR to expedite the review process. DENR may require full testing of the new chemical notified if it determines that the information submitted in not adequate to assess the potential risk of the new chemical. Page 9 of 11 Section I. Present the test results of potential environmental effects of the new chemical and provide any document describing those effects. Submit documented research data and journal articles from Philippines or other countries will be helpful. When you submit the test results, ensure that the full name and address of the laboratory which conducted the tests in the Philippines or in other countries are clearly indicated. Environmental effects may include acute and chronic toxicity to animals (fish in particular) and terrestrial plant toxicity. Information concerning the fate of the chemical upon release to the environment will be important and must be submitted if available. Notifiers with such information will assist DENR to expedite the review process. DENR may require full testing of the new chemical notified if it determines that the information submitted in not adequate to assess the potential risk of the new chemical. Section J. Provide the list of companies requesting to apply in joint with this application. Submit the contact person and details. The detailed form will be automatically printed after filling up the appropriate fields in the Online Permitting and Monitoring System. You are advised to review the printed abbreviated form prior to notarization. Page 10 of 11 Confidential Business Information (CBI) Form Substance Information Trade/Product Name: Exporter (Manufacturer/Supplier) Company Name: Company Address: Contact Person: Contact Number: Email Address: - - ---------- Importer (Applicant) Company Name: Company Address: Contact Number: Emai l Address: -------- CBI Request for documents submitted () 100% Composition of Ingredients ( ) Laboratory Reports () Sections marked in the submitted PMPfN ()Others: Justification(s) Signature over Printed Name Contact Person President/General Manager/ ANNEXC Date Page 11 of 11