GHS Implementation for Toxic Chemicals Safety

Legal basis and related issuances

The Order is issued pursuant to Sections 4(c) and 15 of Republic Act No. 6969.
It implements the DAO No. 29, Series of 1992 captioned “Implementing Rules and Regulations of Republic Act 6969.”
It is also pursuant to JAO No. 01, Series of 2009 dated 25 May 2009, captioned “The Adoption and Implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).”
The Order’s penalty rules are anchored on Section 15 of Republic Act No. 6969, and Section 43, Chapter XII, Title V of DAO No. 29, Series of 1992, plus other existing pertinent laws. (Section 12)

Policy, objectives, and intent

The Order is anchored on the State policy under Section 2 of Republic Act No. 6969 and the objective under Section 4(c). (Section 1)
The Order aims to inform and educate the populace regarding hazards and risks across the life cycle of toxic chemicals and other selected hazardous substances and mixtures. (Section 1)
The Order’s objectives include: procedural guidelines for preparing and submitting SDS and labels; strengthening labeling/re-labeling implementation; and promoting awareness and capability for GHS adoption for safe use and management. (Section 1.1–1.3)
The Order advances chemical safety objectives through GHS-based communication of hazards and protective measures on labels and SDS. (Section 1 and Section 2.7)

Core definitions adopted

A Chemical Control Order (CCO) is a policy issuance that prohibits, limits, or regulates the use, manufacture, import, transport, process, storage, possession, and wholesale of priority chemicals determined to be regulated, phased-out, or banned due to serious risks to public health, workplace, and the environment. (Section 2.1)
A Chemical is any organic or inorganic substance of a particular molecular identity including any element or uncombined chemical and any combination of such substances, or any mixture of two, excluding radioactive materials. (Section 2.2)
A Chemical Substance is any organic or inorganic substance or particular molecular identity excluding radioactive materials, but including any element or uncombined chemical, and combinations occurring wholly or in part as a result of chemical reaction or occurring in nature. (Section 2.4)
Confidential Business Information (CBI) is a trade secret meeting secrecy, commercial value, and reasonable-steps requirements, with reference to WTO TRIPS Article 39, paragraph 2. (Section 2.5)
A Container includes any bottle, box, drum, cylinder, bag, barrel, vessel, tank, among others, that contains hazardous chemical substances and mixtures. (Section 2.6)
GHS is a system that standardizes and harmonizes classification and labeling by: defining hazards; creating classification processes using available data against hazard criteria; and communicating hazard information and protective measures through labels and SDS. (Section 2.7)
Hazards are inherent characteristics of chemical substances and mixtures that are potentially dangerous or capable of harm, including interference with biological processes and abilities to burn, explode, corrode, etc. (Section 2.8)
A Label is written, printed, or graphic hazard information elements affixed to, printed on, or attached to the immediate container of a hazardous product or to the outside packaging of a hazardous product. (Section 2.13)
A Mixture is a solution composed of two or more chemicals/chemical substances in which they do not react. (Section 2.14)
A New chemical is any chemical substance imported into or manufactured in the country after 31 December 1993, not included in PICCS, and re-nominated and distributed by DENR-EMB in 1995. (Section 2.15)
A Safety Data Sheet (SDS) is prepared by the manufacturer and contains important physical, ecological, health, safety and toxicological information on chemical substances or mixtures, or ingredients used at the workplace, transported, and utilized by consumers. (Section 2.21)
A Worker is any person from an industrial or service sector exposed to industrial toxic chemicals and mixtures, including laboratory personnel, emergency responders, transporters, warehouse staff, etc. (Section 2.24)

Scope, coverage, and timelines

The Order covers all toxic chemical substances and mixtures manufactured, imported, distributed, used, stored, and transported in the Philippines. (Section 3)
The Order covers toxic chemicals and chemical substances under the Priority Chemical List (PCL), Chemical Control Order (CCO), high volume toxic chemicals, dangerous chemicals identified under IATA and IMDG, and mixtures used by the industrial sector. (Section 3)
The Order addresses classification, labeling, and SDS requirements to convey chemical hazard information and protect the public and the environment from potential health risks and effects. (Section 3)

Implementation timeline by chemical category

Full and strict compliance for single substances and compounds covered under CCO and PCL Chemicals initially listed is scheduled for 2016. (Section 4.1)
Full and strict compliance for High Volume Toxic Chemicals is scheduled for 2017. (Section 4.2)
Full and strict compliance for Toxic Chemicals under the IATA and IMDG list of Dangerous Goods is scheduled for 2018. (Section 4.3)
Full and strict compliance for Mixtures is scheduled for 2019. (Section 4.4)

SDS and label obligations

All chemical importers, manufacturers, suppliers, and distributors must prepare SDS and labels for all covered industrial toxic chemical and mixtures that meet GHS harmonized criteria for physical, health, and environmental hazards. (Section 5.1.1)
When securing permits, licenses, and clearances, all chemical importers, manufacturers, suppliers, and distributors must submit SDS and labels using the GHS format, duly transmitted with a notarized letter assuming full accountability, and in accordance with standard operating procedures (SOPs). (Section 5.1.2)
EMB Chemical Management staff must initially screen submitted SDS and labels for GHS compliance, and the GHS Review Committee must review them; verification by the Committee may be undertaken when necessary. (Section 5.2.1)
Information sources from recognized international organizations and principals may be used for verification. (Section 5.2.2)

Accessibility, inspection, and training

SDS of all toxic chemicals used must be accessible and available to all workers at all times. (Section 5.3.1)
Covered toxic chemicals and mixtures must be labeled and marked visibly. (Section 5.3.2)
Appropriate pictograms, signal words, hazard, and precautionary statements must be placed at the storage facility/premises and on the transportation/vehicle. (Section 5.3.3)
Each company must conduct training, by a competent person, on interpretation/identification of labels and use of SDS, in accordance with GHS requirements/guidelines, to ensure workers properly understand the information. (Section 5.4)

Label standards and GHS content rules

The importer, manufacturer, supplier, and distributor must ensure each container of chemical substances within the premise/facility and in transport is labeled, tagged, or marked. (Section 6.1.1)
GHS labels must contain: product identifier; supplier identifier; chemical identity; symbols/pictograms; signal words; hazard and precautionary statements; and must be placed at the storage facility/premises and on transportation/vehicle to clearly convey hazards and risks and key information. (Section 6.1.2)

Product identifiers and ingredient declarations

The product identifier on the label must be consistent with the composition declared in the SDS. (Section 6.1.2.1.1)
Labels must include the chemical identity of substances consistent with the composition declared in the SDS. (Section 6.1.2.1.2)
For a substance/mixture covered under UN RTDG, the label must use the UN number for proper shipping on the package. (Section 6.1.2.1.3)
Labels for containers must clearly indicate the ingredients unless covered by a CBI agreement. (Section 6.1.2.1.3)

Supplier and chemical identity requirements

Supplier identification on labels must state the name, address, and telephone number of the manufacturer or supplier, consistent with SDS information. (Section 6.1.2.2)
Labels must include chemical identity as determined by IUPAC and by the CAS Registry number or technical name. (Section 6.1.2.3)

Pictograms, symbol precedence, and signal words

The Order governs the use and reproduction of GHS pictograms and standard symbols. (Section 6.1.2.4.1)
GHS hazard pictograms must be square set at point and in white, red and black colors. (Section 6.1.2.4.2)
Where health hazard precedence applies:
- If the skull and crossbones applies, the exclamation mark must not appear. (Section 6.1.2.4.3.1)
- If the corrosive symbol applies, the exclamation mark must not appear where it is used for skin or eye irritation. (Section 6.1.2.4.3.2)
- If the health hazard symbol appears for respiratory sensitization, the exclamation mark must not appear where it is used for skin sensitization or for skin or eye irritation. (Section 6.1.2.4.3.3)
Signal words are “Danger” and “Warning.” If “Danger” applies, “Warning” must not appear. (Section 6.1.2.5.1)
Use of the signal word depends on classification results under GHS criteria. (Section 6.1.2.5.2)

Hazard statements and allowed omissions

A complete hazard statement must include the hazard statement, including optional use of a hazard statement code (H-Code). (Section 6.1.2.6.1)
A single harmonized statement must be used for each hazard category within each hazard class. (Section 6.1.2.6.2)
The hazard statement depends on GHS classification criteria results. (Section 6.1.2.6.3)
All assigned hazard statements must appear on the label, except when:
- If H410 “Very toxic to aquatic life with long lasting effects” is assigned, H400 “Very toxic to aquatic life” may be omitted. (Section 6.1.2.6.4.1)
- If H411 “Toxic to aquatic life with long lasting effects” is assigned, H401 “Toxic to aquatic life” may be omitted. (Section 6.1.2.6.4.2)

Precautionary statements and allowed omissions

A complete precautionary statement must include the precautionary statement, including optional use of a precautionary statement code (P-Code). (Section 6.1.2.7.1)
Precautionary statements must include: prevention; response in cases of accidental spillage and exposure; handling; storage; and disposal information. (Section 6.1.2.7.2)
All assigned precautionary statements must appear on the label, except when:
- If H412 “Harmful to aquatic life with long lasting effects” is assigned, H402 “Harmful to aquatic life” may be omitted. (Section 6.1.2.7.3.1)
- If H314 “Causes severe skin burns and eye damage” is assigned, H318 “Causes serious eye damage” may be omitted. (Section 6.1.2.7.3.2)
GHS label sizes and requirements must depend on container size; minimum label dimensions depend on the container size and are based on the Guidance Manual on Labeling. (Section 6.1.2.7.4)

SDS composition and mandatory content

SDS must identify the toxic substance or mixture and the manufacturer or supplier through:
- the name of the substance or mixture preparation; (Section 6.2.1.1)
- the complete name, address, and telephone number of the manufacturer or supplier; (Section 6.2.1.2)
- recommended use(s); (Section 6.2.1.3)
- restrictions of use(s); and (Section 6.2.1.4)
- emergency information services and phone/contact numbers for manufacturer, importer, supplier, or local distributor. (Section 6.2.1.5)

Hazard identification content

SDS hazard identification must include:
- a description of the hazards of the substance/mixture; (Section 6.2.2.1)
- appropriate signal word and hazard statements; (Section 6.2.2.2)
- precautionary statements associated with hazards described in the section; (Section 6.2.2.3)
- hazard symbols may be provided as pictograms or graphical reproduction on appropriate backgrounds. (Section 6.2.2.3)

Composition and ingredient details

SDS composition must identify the chemical by:
- CAS Registry Number; (Section 6.2.3.1.1)
- IUPAC names, CAS number, and Brand names as appropriate; and (Section 6.2.3.1.2)
- Product code. (Section 6.2.3.1.3)
SDS must state impurities and stabilizing additives that are classified and contribute to classification. (Section 6.2.3.2)
SDS must state concentration or concentration ranges of hazardous ingredients hazardous to health or the environment within GHS context and present above cut-off levels. (Section 6.2.3.3)
SDS must provide ranges of percentages of chemical in descending order by mass or by volume. (Section 6.2.3.4)

First aid, fire-fighting, and release response

SDS must provide first-aid measures by relevant routes of exposure and include:
- instructions including immediate medical attention and expectation of delayed effects if exposure occurs; (Section 6.2.4.1.1)
- movement of the exposed individual to fresh air; (Section 6.2.4.1.2)
- removal and handling of clothing and shoes; (Section 6.2.4.1.3)
- PPE use by first-aid responders. (Section 6.2.4.1.4)
SDS must provide the most important immediate and chronic (delayed) symptoms/effects. (Section 6.2.4.2)
SDS must provide information on clinical testing and medical monitoring for delayed effects, specific details on antidotes (if known), and contraindications. (Section 6.2.4.3)
SDS fire-fighting measures must include:
- appropriate fire extinguishing media and indicate inappropriate media; (Section 6.2.5.1)
- measures against specific hazards from the chemical (including hazardous combustion products); (Section 6.2.5.2)
- protective actions during fire-fighting and appropriate PPE to be used. (Section 6.2.5.3)
SDS accidental release measures must include:
- emergency procedures and appropriate PPE for spills/releases; (Section 6.2.6.1)
- containment and clean-up methods and materials; (Section 6.2.6.2)
- environmental precautions. (Section 6.2.6.3)

Handling, storage, exposure, properties, stability

SDS must include handling and storage information covering:
- safe handling and storage instructions considering ventilation requirements; storage room/vessel designs; quantity limits under storage conditions; and packaging compatibilities. (Section 6.2.7.1.1–6.2.7.1.4)
- safe storage conditions including protection against natural disasters/risks; incompatibilities to avoid explosive atmosphere, corrosive conditions, flammability hazards, evaporative conditions, incompatible substances/mixtures, and potential ignition sources; and measures against weather conditions, ambient pressure, temperature, sunlight, humidity, and vibration. (Section 6.2.7.2.1–6.2.7.2.3)
- advice on maintaining integrity using stabilizers and anti-oxidants. (Section 6.2.7.3)
SDS must state exposure controls and personal protection including:
- PPE needed to minimize potential illness or injury; (Section 6.2.8.1)
- type of PPE consistent with occupational hygiene practices and alongside other control measures (engineering controls, ventilation, isolation); (Section 6.2.8.2)
- appropriate exposure control measures tied to intended modes of use. (Section 6.2.8.3)
SDS must identify physical and chemical properties and specify appropriate units, reference conditions, and methods of determination for numerical interpretation, including:
appearance; odor; odor threshold; pH; melting point/freezing point; initial boiling point/boiling range; flash point; evaporation rate; flammability (solid, gas); upper/lower flammability or explosive limits; vapour pressure; vapour density; relative density; solubility(es); partition coefficient n-octanol/water; auto-ignition temperature; decomposition temperature; and viscosity. (Section 6.2.9.1–6.2.9.18)
SDS stability and reactivity must include:
chemical stability; hazardous reactions; conditions to avoid (e.g. static discharge, shock or vibration); incompatible materials; hazardous decomposition products; and reactivity information may be based on general class/family data when it adequately represents anticipated hazard. (Section 6.2.10.1–6.2.10.6)

Toxicological and ecological, disposal, transport

SDS must include toxicological information covering:
concise and complete description of toxicological effects and data used to identify effects; likely routes of exposure; symptoms related to characteristics; immediate and delayed effects after short or long-term exposure; acute and chronic health effects; summary of animal data when human data are not available (including data source); and numerical measures of toxicity such as acute toxicity estimates. (Section 6.2.11.1–6.2.11.7)
SDS must include ecological information covering:
ecotoxicity (aquatic and terrestrial where available); persistence and degradability; bioaccumulative potential; mobility in soil; and other adverse environmental effects including environmental fate, ozone depleting potential, photochemical ozone creation potential, endocrine disrupting potential, and global warming potential. (Section 6.2.12.1–6.2.12.5.5)
SDS must include disposal consideration describing waste residues and safe handling and disposal methods, including disposal of any contaminated packaging. (Section 6.2.13)
SDS must include transport/shipment information covering:
UN number; UN proper shipping name; transport hazard class(es); packing group if applicable; marine pollutant (Yes/No); special precautions users must be aware of or comply with within or outside premises; and a statement on unavailability of relevant information. (Section 6.2.14.1–6.2.14.7)
SDS must include national regulations and references identifying safety, health, and environmental regulations specific to the chemical, and specifying whether the product is under a CCO and PCL for local chemicals/substances or mixtures. (Section 6.2.15.1–6.2.15.2)

Other SDS format rules and revision cycle

SDS must be presented in English. (Section 6.2.16.1)
SDS must include information on preparation and revision such as pages and date of issuance, date of revision, and revision number. (Section 6.2.16.2)
SDS must be updated every five (5) years or earlier where there are known changes in product composition that may affect classification. (Section 6.2.16.3)
SDS must be composed of sixteen (16) sections in the GHS-based order of arrangement and presentation. (Section 6.2.16.4)
SDS must include key/legend to abbreviations and acronyms used. (Section 6.2.16.5)
SDS must include literature references and sources of data compiled in the SDS. (Section 6.2.16.6)

GHS Review Committee and operations

A GHS Review Committee is created as a collegial body from a multi-sectoral group including the academe, industry, concerned EMB-Regional Office, chemical management group, research and development group, and concerned government agencies, formed through a Special Order. (Section 7)
The Committee reviews and evaluates classification, appropriate chemical labeling, and SDS in accordance with the adopted GHS. (Section 7)
The Committee composition, including duties and responsibilities, must be approved prior to operation. (Section 7)
The Committee is headed by the EMB Director, and the Chemical Management Section acts as the Secretariat. (Section 7)
EMB collaborates with the GHS Review Committee for regular monitoring of compliance with Order requirements. (Section 11)

CBI limits and confidentiality exceptions

CBI claims are limited to the names of chemicals and their concentrations in mixtures. (Section 8)
The rules for CBI take priority over the rules for product identification. (Section 8)
No disclosure of information is allowed except in:
- instances where CBI protection compromises the health and safety of users; and (Section 8.1)
- emergency situations. (Section 8.2)

Transition, revision, and monitoring

A transition program supports implementation through:
- capability building and research to support the implementation period for high volume chemicals and mixtures; (Section 9.1)
- continuing training on GHS courses (basic, intermediate and advance) and IEC efforts; (Section 9.2)
- discussion/consultation on building blocks among sectors through the National Coordinating Council under Joint Administrative Order 2009-1. (Section 9.3)
The DENR, in coordination with other concerned agencies, may review, revise, modify, update, and supplement the requirements and procedures applicable to the Order, particularly upon implementation of GHS by a majority of industrialized countries. (Section 10)
Compliance with Order requirements must be monitored regularly by the EMB, in collaboration with the GHS Review Committee. (Section 11)

Penalties, separability, and effectivity

Violations of provisions specified in the Order subject violators to administrative violations and fines under Section 15 of Republic Act No. 6969, as well as Section 43, Chapter XII, Title V of DAO 29, Series of 1992, and other existing pertinent laws. (Section 12)
Separability applies: if any provision or portion is declared unconstitutional or invalid, the remaining provisions remain valid and enforceable. (Section 13)
Effectivity follows Section 14: fifteen (15) days after publication in the Official Gazette or in a newspaper of general circulation, and upon acknowledgment of receipt by the ONAR. (Section 14)