Revised Labeling Guidelines for Specific Household/Urban Hazardous Substances such as Household Pesticide Products
Pursuant to Presidential Decree No. 881 (PD 881) dated 30th January 1976 which empowered the Secretary of Health to regulate the labeling, sale and distribution of hazardous substances, Administrative Order No. 311 series of 1977 (A.O. 311 s. 1977) was issued to provide the labeling requirements for hazardous substances, including pesticides, insecticides and other economic poison.
Since that time, there have been considerable developments in pesticide and chemicals management which affect pesticide labeling. Of particular importance for labeling of chemicals was the publication in 2003 of the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals which was adopted in the Philippines in 2009 by virtue of Joint DTI-DENR-DA-DOF-DOH-DILG-DOLE-DOTC Administrative Order No. 01 series of 2009.
This Administrative Order is being issued to provide revised guidelines on the labeling of household pesticide, institutional use pesticide and/or public health pesticide products with the adoption of GHS and the Guidelines on Good Labeling Practice for Pesticides published by the Food and Agriculture Organization (FAO) of the United Nations to protect the health and welfare of the consumers and the general public.
The objectives of this Administrative Order are:
- To revise the existing labeling guidelines for household pesticide, institutional use pesticide and/or public health pesticide products with the adoption of GHS and the Guidelines on Good Labeling Practice for Pesticides (Revised) published by the FAO of the United Nations.
- To strengthen the implementation of proper labeling requirements for household pesticide, institutional use pesticide and/or public health pesticide products.
- To protect the health and welfare of the public by ensuring that establishments placing household pesticide, institutional use pesticide and/or public health pesticide products in the market strictly comply to pertinent labeling standards through post-market surveillance (PMS) activities.
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These guidelines shall cover household pesticide, institutional use pesticide and/or public health pesticide products in any form that is destined to be applied by end-users and the establishments that are engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of household pesticides and public health pesticides.
The guidelines do not concern the labeling of pesticides in an industrial setting, i.e. active ingredients, bulk pesticide formulations destined for reformulation, repackaging or disposal, or other pesticide formulation components. Since these pesticides or pesticide components are not intended for direct use, but are generally considered industrial chemicals, it is recommended that classification and labelling of these compounds follow the GHS.
Similarly, the contents and layout of safety data sheets (SDS) that may accompany pesticide shipments or consignments should follow the provisions of the GHS. However, the registrant must ensure that the SDS which accompanies the product is not inconsistent with the approved label.
- DEFINITION OF TERMS
As used in these Guidelines,
- Active ingredient means the part of the product that provides the pesticidal actio
- Co-formulant means a non-active ingredient component of a formulated product.
- Color band means a band printed at the bottom part of the label of a color indicating the acute hazard of the pesticide product.
- Container means any object used to hold a pesticide produc
- Department refers to the Department of Health
- Distribution means the process by which pesticides are supplied through trade channels to local or international market
- Distributor/Importer/Exporter means any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If the distributor/importer/exporter sells to the general public, it shall be considered a retailer.
- Distributor/Wholesaler means any establishment that procures raw materials, active ingredients and/or finished products from a local establishment for local distribution on wholesale basis.
- Establishment means sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of such consumer products, including the facilities and installation needed for its activities.
- FDA refers to the Food and Drug Administration
- Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed and for the envisaged mode of applicati
- GHS is an acronym for Globally Harmonized system of Classification and Labeling of Chemicals. The GHS is a system for standardizing and harmonizing the classification and labeling of chemicals. It is a logical and comprehensive approach to
- Defining health, physical and environmental hazards of chemicals
- Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; and
- Communicating hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS).
- Harmonization refers to establishing a common and coherent basis for hazards classification and communication of chemicals, and the appropriate elements relevant to means of transport, consumers, workers and environmental protection can be selected/chosen.
- Hazard means the inherent property of a substance, agent or situation having the potential to cause undesirable consequences (e.g. properties that can cause adverse effects or damage to health, the environment or property).
- Hazard statement means a statement assigned to a hazard class and category that describes the nature of the hazards of a pesticide, including, where appropriate, the degree of haz
- Household/Urban Hazardous Substances means:
- Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, xxxxxxxxxx;
- Any substance which the FDA finds to be under the categories enumerated in clause (4.12.1) of this paragraph;
- xxxxxxxxxx; and
- This term shall not apply to food, drugs, cosmetics, devices or to substances intended for use as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which is a hazardous substance, as construed in paragraph (4.12.1), by reason of bearing or containing such harmful substances described therein.
- Integrated Pest Management (IPM) means the careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep pesticides and other interventions to levels that are economically justified and reduce or minimize risks to human and animal health and/or the environment.
- Integrated Vector Management (IVM) means the rational decision-making process for the optimal use of resources for disease vector control. It aims to improve efficacy, cost-effectiveness, ecological soundness and sustainability of disease vector control interventions for control of vector-borne disease
- ISO refers to International Standards Organization
- IUPAC refers to International Union of Pure and Applied Chemistry
- Label means an appropriate group of written, printed, or graphic information elements that are affixed to, printed on, or attached to the immediate container of a hazardous product, or to the outside packaging of a hazardous product.
- Leaflet means a part of the product label that is supplied in the form of a detachable or separate leaflet(s), booklet(s) or similar, rather than attached permanently to the containe
- Manufacturer means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing and labeling with the end view of its storage, sale or distribution. A trader shall be categorized as a manufacturer.
- Packaging means the container together with the protective wrapping used to carry pesticide products via wholesale or retail distribution to use
- Pesticide refers to any substance, or mixture of substances, or microorganisms including viruses, intended for repelling, destroying or controlling any pest, including vectors of human or animal disease, nuisance pests, unwanted species of plants or animals causing harm during or otherwise interfering with the production, processing, storage, transport, or marketing of food, agricultural commodities, wood and wood products or animal feeding stuffs, or which may be administered to animals for the control of insects, arachnids or other pests in or on their bodies. The term also includes pesticide synergists and safeners, where they are integral to the satisfactory performance of the pesticide.
A pesticide, for the purpose of this Order, shall be specific to:
- Household Pesticide – refers to a pesticide used for the control of pests in homes, yards and gardens, domestic and/or commercial establishments such as schools, malls, condominiums, hospitals, buildings, manufacturing sites, warehouses, golf courses, etc. but shall exclude chemicals used in commercial agricultural production. The term also refers to any material or mixture of substance used for the control of insect pests, rodents, plant diseases, and weeds that are found in places of human habitation, work and recreation. Examples of insect pests are flies, mosquitoes, cockroaches, ants, termites, bedbugs, and others.
Household pesticides shall include products such as, but not limited to, mosquito coils, aerosol sprays, insect repellents for personal use, rodenticides concentrates and baits, cockroach sprays and baits, and others.
Household pesticides can be classified as follows:
- For Institutional Use – refer to household pesticide products intended to be used or applied to institutions such as but not limited to schools, malls, condominiums, hospitals, buildings, manufacturing sites, warehouses, golf courses, etc. under a pest control program.
- For Public Health Use – refer to household pesticide products used in the control of pests of public health significance and for vector control such as but not limited to dengue control, malaria control, etc.
- Ready-to-Use – refer to household pesticide products that can be sold or bought over-the-counter including ready-to-use formulations. The labels of these ready-to-use household pesticides shall indicate the phrase “Keep out of reach of children” and storage shall be under lock and key.
- Pesticide industry means all those organizations and individuals engaged in manufacturing, formulating or marketing pesticides and pesticide product
- Pesticide legislation means any laws or regulations introduced to regulate the manufacture, marketing, distribution, labelling, packaging, use and disposal of pesticides in their qualitative, quantitative, health and environmental aspect
- Pictogram means a graphical composition that may include a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific informati
- Post-marketing Surveillance refers to activities involved in safety, efficacy, and quality monitoring of health products. This shall also include among others, adverse events reporting, product safety update reporting, collection and testing of health products in the market.
- Precautionary statement means a phrase (and or/pictogram) that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to a pesticide, or improper storage or handling of a pesticid
- Product (or pesticide product) means the formulated product (pesticide active ingredient(s) and co- formulants), in the form in which it is packaged and sol
- Public Health Pesticide refers to a pesticide that is used in the control of pests of public health significance. They include vector control pesticides, household pesticides, and professional pest management pesticides (i.e. pesticides used by pest control operators). For the purpose of this guideline, public health pesticides do not include disinfectants.
- Release date means the date from which the supplier guarantees a shelf-life of at least 2 years, unless stated otherwise, under actual conditions of storage in the area where the technical grade active ingredient or formulation is to be market
- Retailer means any establishment which sells or offers to sell any health product directly to the general public.
- Risk is the probability and severity of an adverse health or environmental effect occurring as a function of a hazard and the likelihood and the extent of exposure to a pestici
- Safety Data Sheet (SDS) refers to a document prepared by the manufacturer that contains important physical characteristics, ecological, health, safety and toxicological information on chemical substances or mixtures, or ingredients used at the workplace, transported, and utilized by consumer.
- Signal word means a word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label.
- Standard means a set of conditions to be fulfilled to ensure the quality and safety of a product.
- Symbol means graphical element intended to succinctly convey information.
- Trader means any establishment which is a registered owner of a health product and procures the raw materials and packing components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products.
- Toxicity means a physiological or biological property which determines the capacity of a chemical to do harm or produce injury to a living organism by other than mechanical m
- GENERAL PROVISIONS
- Product Content Information
The following information identifying the contents of the container should appear on all labels:
a) Product name
- Product category (e.g. insecticide, rodenticide, etc.).
- Type of formulation – name and code, according to the International Formulation Coding Syste
- Active ingredient name (according to ISO) or other locally used common name, or, in the absence of either, the chemical designation according to IUPAC).
If the active ingredient is a microbial agent, it is best identified by genus and species (and if appropriate, also by subspecies and/or isolate/strain number).
- Active ingredient content. This should normally be expressed as "contains X g a.i. per kg" (for solids [including mosquito coils], viscous liquids, aerosols or volatile liquids) or "contains X g a.i. per liter" (for other liquids). For vaporising mats, contents are expressed as mg/ma
If the active ingredient is a microbial agent, content may be expressed as International Toxic Units (ITU) per mg product or as the number of viable units (spores, cells, colony forming units (cfu), etc.) per unit weight or volume of product.
For specific types of pesticides or formulations, other appropriate units for active ingredient content may be applicable (e.g. % w/w or % w/v for certain household pesticides).
- Name/identity and concentration of hazardous co-formulants (i.e. all substances [e.g., solvents, adjuvants] in the formulation that contribute to the classification of the formulated product) (if any). For example, petroleum distillates must be listed and highlighted to promote effective medical treatment.
- Net contents of the pack. This should be expressed in metric units (e.g. liter, gram, kilogram, which can be abbreviated to L, g and
h) Batch number
- Registration number
- Hazard and Safety Information
The following hazard and safety information should appear on all labels:
- Hazard symbol(s) (if any) (see Annex F)
- Signal word (if any) (see Annex D)
- Hazard statement(s) (if any) (see Annex D)
- Precautionary statements or warnings (see Annex E)
e) Precautionary pictograms
Precautionary pictograms reinforcing the safety text should be included (see Annex F).
f) Hazard color band
A hazard color band, may be printed at the lower part of the label to indicate the acute toxicity of the formulated product (see Annex G).
- A tactile warning for the blind and visually impaired. The word PESTICIDE should be printed in Braille on all labels of products which are supplied to the general public. In addition, a tactile warning of danger, in the form of a raised triangle or three raised dots placed in a triangle, is required for pesticide products supplied to the general public which are classified as dangerous (see Annex H).
h) First aid and medical advice
Labels should carry first aid and medical advice, where relevant (See Annex I). Additional information regarding symptoms and antidotes may be added, where appropriate, for particular products.
The following statements should appear, as a minimum, on all labels:
If medical advice is needed, have product container or label at hand
i) Product or user category
The appropriate product or user category should appear on the label (e.g. professional use products, restricted use products, household pesticides, public health pesticides).
j) Accidental spills advice
Instructions for containing and/or cleaning up spills of the pesticide should be provided (See Annex J).
- Directions for Use
Clear directions or instructions for use should appear on the label (See Annex K). These generally encompass the following elements:
a) Field of use
There should be an initial, brief statement on the field of use of the product.
- Directions for use
The directions for use on the label must clearly indicate how, when and where the product can be legally used with maximum efficacy and minimum risk. This information may be repeated and/or expanded in a separate/attached leaflet, but the essential instructions must always be displayed on the label.
c) Storage and disposal
Recommended storage conditions should be specified on the label. Furthermore, essential information on recycling or disposal of empty containers and left-over pesticides should also be provided.
- Supplier Identification
The name, address, telephone number and email address of the local distributor or supplier should always be indicated on the label. This will often be the marketing authorization holder (MAH) of the product.
In case the MAH and the local distributor/supplier are different, contact details for the MAH should also appear on the label.
The manufacturer's name and other unique identifiers may appear on the label.
- Other Information
In addition to the contents, hazard and safety information and directions for use discussed above, the following information may also appear on all labels:
- Statutory heading. A statutory heading may be included, such as:
Compliance with the following conditions of use is a legal requirement
It is a violation of law to use this product in a manner inconsistent with its labeling
- The release date of the product should always appear on the label
- Shelf-life or expiry date, for products with a shelf-life of less than 2 years from the release date.
- Legal responsibility and/or warranty statement.
- A QR-Code (Quick Response Code) may be put on the label, which can be used by a user owning a smart phone to link to further product and risk information (e.g. additional medical advice) on the web site of the pesticide compan However, information provided on a company web site cannot replace the required label information.
- Contact details of the national/regional poison center or other similarly qualified instituti
- SPECIFIC PROVISIONS
- Annex A: Label Layout
- Annex B: Style and Format of Text
- Annex C: Use of Color
- Annex D: Signal Words and Hazard Statements
- Annex E: Precautionary Statements and Warnings
- Annex F: Use of Symbols, Pictograms and Illustrations
- Annex G: Color Bands
- Annex H: Tactile Warnings
- Annex I: First Aid and Medical Device
- Annex J: Accidental Spills Advice
- Annex K: Directions for Use
- Annex L: Avoiding Misleading Statements or Claims
- Annex M: Special Purpose Labels
- TRANSITION PERIOD
To support the effective implementation of this Order, the following activities shall be undertaken:
- Development of capability building program that will initiate research to support the implementation period of high volume chemicals and mixtures;
- Continuing training on GHS courses (basic, intermediate and advance) as well as information, education and communication (IEC) efforts; and
- Discussion/consultation on the building blocks (among sectors) of the country through the National Coordinating Council (Joint Administrative Order 2009-1).
- SEPARABILITY CLAUSE
If any part or term of provision of this Order shall be declared invalid or unenforceable, the validity or enforceability of the remaining portions or provisions shall not be affected and this order shall be construed as if it did not contain the particular invalid or enforceable part, term or provision.
- PENALTY CLAUSE
Any violations of the provisions specified in this Administrative Order will subject those persons responsible thereof to administrative sanctions under Presidential Decree No. 881, Republic Act No. 7394, Republic Act No. 9711 and their corresponding implementing rules and regulations and other existing pertinent laws.
- REPEALING CLAUSE
This Order effectively amends Administrative Order No. 311 s. 1977. The provisions of previous Orders and other related issuances inconsistent with or contrary to the provisions of this Administrative Order are hereby revised, modified, repealed or rescinded accordingly.
This Administrative Order shall take effect fifteen (15) days from completion of publication in the Official Gazette or in two (2) newspapers of general circulation and registration with the UP Law Center.