Regulatory Summary
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).
Dec-09-2024
On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committee (ACC) meeting and its related sessions in November 2022. Products that do not meet the updated standards must be withdrawn immediately. The amendments reflect the ASEAN region’s approach to aligning with global safety standards and protecting the health of consumers in its 10 member states.
Key Updates to the ACD
Annex II – List of substances which must not form part of the composition of cosmetic products
A consolidated list of 37 substances previously banned in the EU, has been added to Annex II of the ACD. These include entries from EU regulations (2019/831, 2019/1966, 2021/850, 2021/1902) that are not currently used in ASEAN countries. Specific compounds such as perboric acid, sodium perborate, boron compounds, octamethylcyclotetrasiloxane (D4), and p-BMHCA have also been included in Annex II.
Titanium Dioxide Regulation
Revised safety criteria for the use of titanium dioxide as a colouring agent (Annex IV) and as a UV filter (Annex VII) have been adopted as per EU standards.
Salicylic Acid Regulation
New limits have been introduced for salicylic acid in the Restricted Substance List (Annexes III) and in the Preservatives list (Annex VI), used in body creams, lotions, and other specific applications.
Implications for Industry
Cosmetic manufacturers, traders, and distributors were granted a two-year grace period to reformulate, test and phase out non-compliant products. With the end of this period concluded, compliance is now mandatory, ensuring that products meet updated safety requirements.
Detailed guidelines for compliance can be found here.
Sep-16-2024
The Philippines Fertilizer and Pesticide Authority (FPA) has recently revised its guidelines for the registration of Plant-Incorporated Protectants (PIPs) to align with the agency's policies on biorational pesticides. The updated guidelines aim to streamline the registration process and ensure the safe and effective use of PIPs in the Philippines.
Key updates:
Plants having numerous PIP incidents must be registered as ‘new products’ with the FPA.
The FPA has revised the definition, clarifying terminology such as "regulated articles," "pest protected plant," and "risk assessment".
Applicants must now include a notarised application form prescribed by the FPA, a copy of the CPR for each individual component PIP, a risk assessment report and a draft commercial product label.
Registration and labelling requirements: Products with single PIPs or stacked PIPs with non-PIPs must be recorded in the FPA registry. A letter of intent, an application form, a Certificate of Product Registration, and a draft product label are required.
Experimental Use Permits: Fully registered single PIPs must apply for an EUP III and provide extra documentation such as a bioefficacy field study methodology and final report.
Stacked PIPs, with or without non-PIPs, can apply for label expansion without additional bioefficacy evidence if the single component PIP has already been registered.
Label requirements for seed bags and tags: Labels must be in English and include certain information such as the name, address of the registration holder and the batch number. Seed bags for GM insect-resistant yellow corn must include a securely attached seed tag.
The amended rules are intended to provide a complete and more transparent framework for the registration and use of PIPs in the Philippines. The recommendations help to promote sustainable and responsible development of agricultural biotechnology by aligning with the FPA's principles on biorational pesticides.
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