Philippines Regulatory News

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 Committ...

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 Products that do not meet the updated standards must be withdrawn immediately.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.

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 bi...

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.

*Source

The Food and Drug Administration (FDA) of the Philippines has released an advisory and circular for Pest Control Operators (PCOs) engaged in non-agricultural pest control. Important revisions on licen...

The Food and Drug Administration (FDA) of the Philippines has released an advisory and circular for Pest Control Operators (PCOs) engaged in non-agricultural pest control. Important revisions on licencing, training, and duties for PCOs are outlined in this advisory.

Online License Application

Since June 2023, Pest Control Operators (PCOs) in the Philippines can apply for a License to Operate (LTO) online through the ‘FDA eServices Portal System’. This applies to all PCOs, whether they offer commercial, in-house, or government services. As per FDA Circular No. 2022-010, having an LTO becomes mandatory starting January 1, 2025.

Training and Certification

While specific certifications for Pesticide Handlers and Supervising Pesticide Handlers are still under development, PCOs can currently submit proof of attendance to training from reputable organizations for their staff.

Responsibilities of Pest control operators:

• Use only FDA-registered household/urban pesticide products.

• Ensure appropriate ‘Personal Protective Equipment (PPE)’ is worn during pest control activities.

• Provide safety advice to clients, including re-entry periods after application.

• Display signage at treated premises to warn the public before re-entry.

• Maintain records of pest control activities, including product inventory, equipment maintenance, and pest control reports.

• Report adverse events, pesticide leaks/spills, and related health issues to the FDA.

This update is crucial for all concerned Household/Urban Pesticide Stakeholders. Those who have already filed their applications in Philippines and are ready to register their household pesticides there.

For more information, refer to the FDA Advisory No. 2024-0749 here.

Source

The Department of Environment and Natural Resources (DENR) of the Philippines has released draft Guidelines for Exemption of Impurities, Chemical By-Products, Non-Isolated Intermediates, Alloys, and S...

The Department of Environment and Natural Resources (DENR) of the Philippines has released draft Guidelines for Exemption of Impurities, Chemical By-Products, Non-Isolated Intermediates, Alloys, and Statutory Mixtures. The exemptions will be granted under DENR Administrative Order 1992-29, commonly known as RA 6969. In addition the DENR also released draft Guidelines for Confidential Business Information (CBI) Requests. 

Guidelines for exemptions 

The guidelines will provide guidance on how to obtain exemptions for chemicals that are considered as impurities, chemical by-products, non-isolated intermediates, alloys, and statutory mixtures. Definitions of the different classes of substances can be found here. 

In order to apply for an exemption, businesses would need to provide the following documentation: 

• A signed letter of request  

• 100% composition of the mixture; 

• Safety data sheet;  

• Manufacturing process flow;  

• All supporting documentation justifying the exemption, together with a signed letter of justification. 

Applications must be submitted through the DENR’s Online Permitting and Monitoring System (OPMS) for review and evaluation along with a fee of 1,500 Philippine pesos (approximately US$ 27). The application will be reviewed and evaluated within 15 days of receipt. 

 Except for substances specified in the Chemical Control Orders, once approved, the chemicals would no longer require a permit and would be exempted from Title II of RA 6969. 

Additionally, compounds on the Priority Chemical List (PCL) that are not included by the draft order may apply for an exemption under Section 7.2 of the EMB M.C. 2014-003 guidelines. However, in order to do so, their concentration in mixtures must be less than or equal to 1%. For the responsible disposal of by-products classified as hazardous waste, the draft emphasizes compliance with DENR Administrative Order (DAO) 2013-22.  

Guidelines for Confidential Business Information Requests  

The DENR also issued a draft administrative order to clarify the procedure for obtaining Confidential Business Information (CBI) on chemical assessments mandated by RA 6969.  

The following permit applications and CBI requirements on confidential chemical compositions are covered in the draft: 

• Priority Chemical List (PCL) Compliance Certification or exemption 

• Premanufacture Preimportation Notification (PMPIN) and its exemptions 

• Chemical Control Orders (CCOs) 

All the details on CBI requests can be found in the guidelines here. 

Both draft guidelines would come into force fifteen days after their national publication in a newspaper of general circulation and upon acknowledgment of receipt of a copy hereof by the Office of the National Administrative Register (ONAR), UP Law Center. 

In November 2023, the Environmental Management Bureau of the Department of Environment and Natural Resources (DENR-EMB) released the 2022 and 2023 lists of chemicals and chemical substances to be incl...

In November 2023, the Environmental Management Bureau of the Department of Environment and Natural Resources (DENR-EMB) released the 2022 and 2023 lists of chemicals and chemical substances to be included in the Philippine Inventory of Chemicals and Chemical Substances (PICCS).

All compounds that are currently used, imported, distributed, processed, manufactured, stored, exported, treated, or transported in the Philippines are included in the Philippine Inventory of Chemicals and Chemical Substances (PICCS). The first PICCS was published by the DENR-EMB in 1995 and has been regularly updated since then.

Companies that import and manufacture chemicals that are listed in the PICCS are not required to notify and secure  clearance from the DENR-EMB before manufacturing or importing these chemicals.  

Current update of the PICCS

The list for 2022 contains 96 compounds and 2023 list contains 66. With the addition of these 162 compounds, there are a total of 22,439 compounds in the PICCS.

In September 2022, two chemical control order (CCO) drafts were published by the Department of Environment and Natural Resources (DENR) of the Philippines for benzene and vinyl chloride. The draft ord...

In September 2022, two chemical control order (CCO) drafts were published by the Department of Environment and Natural Resources (DENR) of the Philippines for benzene and vinyl chloride. The draft order adds vinyl chloride to chemical substances to be regulated under CCOs, to reduce the risk of its exposure to human health and the environment. Both CCOs will go into effect 15 days after they are announced in a major publication.

Benzene is used in the production of many polymers and plastics including polystyrene, thus the draft order is applicable to all sectors of its use. If this order gets approved company sectors from importers, distributors, manufacturers and industrial users, commercial users, transporters, to treatment, storage, and disposal (TSD) facilities should register the substance on the Philippines Online Permitting and Monitoring System (OPMS). They will receive the certificate after submitting the necessary documents. For the import of the substance, importers must apply for import clearance via the same system and the clearance will be valid for six months.

The use of benzene will be prohibited if no technically and economically feasible alternatives can be found, in paints, varnishes, coatings, solvents and thinners, glues, cement and rubber goods, solutions for textiles, fabrics, and leathers, inks and dyes and in cleaning and degreasing agents.

In February 2022 the first draft CCO for vinyl chloride was published by the DENR. Vinyl chloride is used to manufacture polyvinyl chloride (PVC), which is used to make many plastic products including pipes, wire and cable coatings, and packaging materials. So, in the second draft of the CCO for vinyl chloride, there is an addition of the prohibited uses section which stipulates that the substance will be banned in aerosols as a propellant or an ingredient. Also, In the chemical management plan, some slight changes have been made relating to registration requirements which include which documents are necessary and what additional details of the chemical are needed.

On 21 January 2022, the Philippine Food and Drug Administration (FDA) has issued Circular No. 2021-011-A which allows the extension of the transition period of HUHS products (Household/Urban Hazardous...

On 21 January 2022, the Philippine Food and Drug Administration (FDA) has issued Circular No. 2021-011-A which allows the extension of the transition period of HUHS products (Household/Urban Hazardous Substances). The FDA Circular No. 2021-011-A replaces and repeals Circular No. 2020-025. The new Circular specifically extends the transitory period by a further two years from the initial due date of 31 December 2021 for the products in Categories III and IV. This indicates that until 31 December 2023, the registration and labeling requirements of the FDA Circular No. 2020-025 will not apply to such items.

In the Philippines, there are five categories into which HUHS products are categorized. The circular applies to products in categories III and IV, which include deodorizers, fresheners, and cleaners respectively.

Only the Certificate of Product Registration (CPR) is impacted by the extension; the License to Operate (LTO) is unchanged. Until 31 December 2023 goods containing HUHSs that are currently on the market but have not been registered may continue to be sold.  However, an LTO is a requirement for all companies participating in or planning to participate in HUHS operations. A copy of the circular and an LTO may be used in place of a CPR for any customs-related activities, including advertising and sales promotions, according to the FDA, The following products come under categories III and IV.

• • Category   III (Cleaners, Air Fresheners and Deodorizers)
• Bleaches
• Cleaners (i.e., corrosive, multi-purpose, surface, etc.)
• Deodorizers
• Dishwashing and laundry detergents/soaps
• Disinfectants (for surfaces)
• Fabric conditioners/softeners and ironing aids
• Air fresheners (i.e., room, car, etc.), aromatics, diffusers
• Moisture-absorbing agents (i.e., desiccants)
• Polishes
• Pool chemicals
• • Category IV (Do-It-Yourself and Hobby Items)
• Adhesives, glues, and sealants
• Care and repair products for automobiles, furniture, and jewellery
• Button batteries
• Colouring materials
• Fabric dyes, tattoo dyes
• Paints, varnishes, and thinners
• Paint stripper
• Rust remover/degreasers