Registration of New Chemicals: The PMPIN Process

Registration of New Chemicals: The PMPIN Process

Chemicals, whether synthetic or extracted from nature, play an important role, particularly in improving the quality of our life. The benefits they extend to us seem endless - from agriculture, pharmaceuticals to production of goods and services designed to make our lives more comfortable and enjoyable; chemicals are basic inputs to all these industrial or manufacturing processes. Despite the benefits though, some commonly used chemicals can pose unreasonable risks to public health and the environment.

The passage of Republic Act (RA) No. 6969, also known as the “Toxic Substances and Hazardous and Nuclear Wastes Control Act of 1990”, marked a milestone in the national effort to regulate and manage industrial chemicals in use throughout the country. It mandates, among others, manufacturers, importers, distributors and users of chemicals and chemical substances to register with the Department of Environment and Natural Resources (DENR), through the Environmental Management Bureau (EMB). This requirement led to the development of the first edition of the Philippine Inventory of Chemicals and Chemical Substances or the PICCS and published in 2000 by DENR-EMB. It contains approximately 24,000 chemical substances nominated by the chemical industry in 1993. Based on RA No. 6969, the PICCS is set for updating every five years thereafter.

In light of the country’s growing industrialization, however, the possibility of an increased volume and number of chemical substances being manufactured and imported into the country is not remote. It is in this context that the Pre-Manufacture and Pre-Importation Notification or PMPIN was instituted to provide adequate control mechanisms for new chemical substances to be manufactured, imported, distributed and used in the country.

1. What are new chemical substances?

New chemical substances are those chemicals that are not included in the PICCS. As a policy, they cannot be manufactured, imported, distributed or used unless they have undergone the PMPIN process.

2. What are the objectives of the PMPIN process?

This requirement for PMPIN has twin objectives:

a. to screen harmful substances before they enter Philippine commerce; and
b. to ensure that new chemical substances that would pose unreasonable risks to humans and the environment be either denied to be manufactured or imported to the country or be placed under control and restrictions to limit their potential releases.

3. How do manufacturers, importers, distributors and users of new chemicals comply with the PMPIN requirement?

a. The proponents (manufacturers, importers, distributors or users of new chemicals) shall first notify the DENR-EMB of their intent to manufacture, import, distribute or use new chemical substances not sooner than 180 days but not later than 90 days.

b. Together with such notification, the proponent shall submit the appropriate PMPIN form to the DENR-EMB. There are two kinds of PMPIN forms:

1) PMPIN Abbreviated Form
- This form is used when the new chemical to be manufactured or imported is being used without any control in a country with a similar chemical review process as the Philippines, and when sufficient information is submitted by the proponent that clearly exhibits that the new chemical will not pose unreasonable risks to public health and environment.

2) PMPIN Detailed Form
- This form is used when the proponent cannot adequately document the safety of the new chemical, or when the DENR-EMB determines that the information submitted does not contain sufficient documentation to enable the DENR-EMB to determine the safety of the new chemical.

c. Upon receipt of the PMPIN, the DENR-EMB, through its Chemical Review Committee, shall then subject the new chemical to a thorough assessment following the criteria below:

1) Hazard identification
2) Exposure assessment
3) Dose response assessment
4) Risk characterization
5) Risk management

d. After the chemical review/assessment is made, the DENR-EMB shall:

1) issue a PMPIN Compliance Certificate which serves as a clearance to manufacture or import the new chemical;

2) include the new chemical in the PICCS or in the Priority Chemical List if it will pose unreasonable risks to public health and the environment.

3) return the notification to the proponent if the information submitted is incomplete or inadequate to assess accurately the risks posed by the new chemical. No further action shall be undertaken by the DENR-EMB until new and complete information is submitted.

e. Where clearance to manufacture or import has been obtained from the DENR-EMB, the proponent shall submit a Notice of Commencement to Import or Manufacture Form. Only after the submission of this form shall the new chemical be added to the PICCS.

4. Are there exemptions to the PMPIN rules?

Yes. The following are exempted from the PMPIN rules:

a. small quantity chemicals
b. certain polymeric chemical derivatives
c. chemicals and chemical substances exempted from PICCS requirement
d. Non-isolated intermediates
e. Articles

For further inquiries, please contact:

The Chemicals Management Section
Environmental Quality Division
ENVIRONMENTAL MANAGEMENT BUREAU
Department of Environment and Natural Resources (DENR)
Tel. no. 928-12-12; Fax no. 928-12-15.