In December 2017, the Philippine Department of Environment and Natural Resources (DENR) released the Polymers and Polymer of Low Concern (PLC) Exemption from the Pre-Manufacture and Pre-Importation Notification (PMPIN) for public comments. Comments may be sent at chemicals.emb.gov.ph.
Pursuant to Section 11 (item c) of Republic Act 6969 (Toxic Substances and Hazardous and Nuclear Waste Control Act) and Section 22, Chapter VI of DENR Administrative Order (DAO) No. 29, Series of 1992 (Implementing Rules and Regulations of RA 6969) that state for the polymer exemption from the Pre-Manufacture Pre-Importation Notification (PMPIN) process, this memorandum circular shall provide specific criteria and requirements of polymers.
This Circular aims to provide guidelines for importers and manufacturers of polymers that are considered or determined by this Office as low concern or low risk to human health and to the environment and to be exempted from the Pre-Manufacture and Pre-Importation Notification (PMPIN) process.
Specific definitions of Cationic Polymer, Functional Group Equivalent Weight, Gel Permeation Chromatography (GPC), Infrared (IR) Spectroscopy, Molecular Weight (MW), Monomer, New Monomer, Reactant, Oligomer and Polymer were given in this Circular.
Among them, Polymer of Low Concern (PLC):
(a) must meet the definition of polymers;
(b) cationic polymer can be exempted if the FGEW is >5000 Daltons; and
(c) must not be unstable, degradable,
decompose, or depolymerize.
This Circular also indicated that to be
exempted from PMPIN process, polymer shall meet any of the following criteria:
of its monomers must be listed in the PICCS;
containing the monomers and other
reactants (including cross linking, chain transfer agents, and post
polymerization reactants) not in the PICCS added at total quantities less than
2 percent (by weight);
3. The low concern polymer shall fall into one of the categories:
- Number Average Molecular Weight (NAMW) equal to or greater than10,000 Da;
- Less than 5% of oligomers with MW lower than 1000 Da and less than 2% of oligomers with MW lower than 500 Da; and
- An FGEW for cationic polymers of greater than 5000 Da.
b. Polymers that have:
- NAMW equal to or greater than 1000Da and less than 10,000 Da,
- Less than 25% of oligomers with MW lower than 1000 Da and less than 10% of oligomers with MW lower than 500 Da, and
- No reactive functional groups in excess of the levels of 2% by weight.
When applying for polymer exemption, applicants shall:
- Submit a duly notarized and accomplished polymer exemption form (signed by the top management i.e.,CEO, President, General Manager (Annex 1).
- Polymer information like specific chemical name, chemical structure, CAS number (if available), use/s of the polymer.
- Safety Data Sheet (SDS) for the polymer alone or as isolated as possible.
- 100% composition including CAS numbers of monomers of the polymer.
- Test data/report to prove that the polymer falls in the criteria of low concern polymer (GPC, IR Spectroscopy and others).
fee of PhP 500.00 per polymer per product.
Besides, applicant can indicate in the polymer exemption form and the covering letter for Confidential Business Information (CBI) applications. The details for CBI shall be sent by the supplier.
All polymers previously granted Exemption are
no longer subject to this policy. All new polymers that meet the criteria are
given one year to comply. Polymers that do not meet the PLC criteria should
comply with the PMPIN procedures.
DENR-EMB shall review the Polymer Exemption application within forty (40)
working days from receipt of the application. In case of incomplete submission
of the requirement, a letter for additional information shall be issued to the
applicant. Failure to submit the additional information within 60 days upon receipt
of letter shall consider their application “null and void”.
The polymers that are exempted shall not be
listed in the PICCS.
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