The Rules and Regulations Implementing R.A.9711 For Household/Urban Hazardous Substances

THE RULES AND
REGULATIONS
IMPLEMENTING R.A.9711
FOR HOUSEHOLD/URBAN
HAZARDOUS
SUBSTANCES
Maria Theresa M.Gutierrez ,RPh MSc
OIC Center for Cosmetic Regulation & Research
Republic Act 9711: The Food and
Drug Administration Act of 2009
WHAT IS THE DEFINITION OF
HOUSEHOLD/URBAN
HAZARDOUS SUBSTANCES in
BOOK 1 ARTICLE I SECTION 5
OF IRR OF R.A.9711?
Integ.PhilChemist 16 Aug.2013
1. Any substance or mixture of
substances intended for individual or
limited purposes and w/c are toxic,
corrosive, an irritant, a strong
sensitizer, is flammable or
combustible of 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,
but shall not include: agricultural
fertilizers, agricultural pesticides &
agricultural insecticides and other
economic poisons, radioactive
substances or substances intended for
use as: fuels,coolants, refrigerants and
the like
2.Any substance which the FDA finds to
be under the categories enumerated in
paragraph (1) of this section
3. Any toy or other articles intended for
use by children w/c the FDA may
determine to pose an electrical,
chemical, physical or thermal hazard
For this purpose “toys and other articles
intended for use by children” shall refer
to those toys and articles specified to be
for children less than fourteen (14) years
of age and
4.The term HUHS shall not apply to food,
drugs, cosmetics, devices or to
substances intended for use as fuel,
when stored in containers and used in
the heating, cooking or refrigeration
system of a house,
but such term shall apply to any article
w/c is not in itself an agricultural
pesticide but w/c is hazardous
substance as construed in paragraph (1)
of this section, by reason of bearing or
contg such harmful subst. described
therein
WHAT does BOOK II ARTICLE I
SECTION I says about the General
Provisions on licensing of
establishments and registration of
products?
1. The manufacture,importation,
exportation, sale, offering for
sale,distribution, transfer,non-consumer
use, promotion,advertising, or
sponsorship of any health products
without the proper authorization from the
FDA is prohibited.(CPR)
• “NON CONSUMER USERS”…… It may
also refer to users of other health
products who are members of a
certain class of profession or workers
where the use of such health products
may have an effect on health that
requires regulations as determined by
the FDA ( e.g. pest control
operators/applicators)
2.The manufacture,importation,exportation,
sale, offering for sale,distribution, transfer or
retail of any drug or devices; the
manufacture,importation, exportation,
transfer, distribution of any food, cosmetics,
household hazardous substances or urban
pesticides or the operation of a radiation
facility or pest control establishment without
the appropriate authorization from the FDA is
prohibited. (LTO)
Section 3 Approval of application for license
shall be issued a corresponding license to
operate(LTO)
An approved application for health product

registration shall be issued a proper
authorization or a corresponding certificate of
product registration(CPR)
WHAT ARE THE TYPES OF
ESTABLISMENTS GIVEN
LICENSE TO OPERATE &
ALLOWED TO APPLY FOR
CERTIFICATE OF PRODUCT
REGISTRATION?
DISTRIBUTORS
• Importer
• Exporter
• Wholesalers
MANUFACTURERS
• Toll manufacturers
• Packer/repacker
TRADERS
Additional Regulated Entities
• Pest Control Operators

• Accredit Pest Control Applicators
• Warehouses for pesticides
WHAT ARE THE CLASS OF
PRODUCTS UNDER
HUHS?
• Category I-I- Product Containing Petroleum
Distillates
• Category II-
II- Polishes & Waxes
• Category III-
III- Cleansers & Detergents
• Category IV-
IV- Do-
Do-it –yourself, Hobby Items
• Category V-V- Yard & Home Products
(Toys , Pesticides & Pesticide Handlers)
TOBACCO (under TRO at present)
WHAT ARE THE PRODUCTS
UNDER EACH HUHS
CATEGORY?
AO 312 s. 1977 – HHS
Classification
CATEGORY I - Product Containing
Petroleum Distillates
1. Fluids for cigarette lighters and charcoal
2. Paints, lacquers, varnish
3. Solvent paint, lacquer thinner, mineral spirits
4. Kerosene, fuel oil, petroleum distillates
5. Turpentine
6. Adhesives
7. Plastics
CATEGORY II - Polishes and Waxes
– Household polishes and Waxes
CATEGORY III - Cleanser and Detergent
1. Bleaches, unspecified and specified
2. Cleaners and special purpose detergents/soaps
3. Solvent (non-
(non-petroleum distillates)
4. Fabric cleaners
5. Corrosive cleaners (including acids & alkalis)
alkalis)
CATEGORY IV - Do-
Do-It-
It-Yourself and
Hobby Items
1. Glues and cement

2. Dyes
3. Ink and ink cartridges
4. Gem Bluer
5. Educational set and miscellaneous
chemistry set
CATEGORY V - Yard and Home Products
1. Fertilizers (delisted and transferred
regulation to (Fertilizers and Pesticide
Authority (FPA) as per AO 39 s. 1978)
2. Pesticide, insecticide and other
economic poison
3. Room freshener and deodorizer
VALIDITY OF LTO & CPR
TYPE VALIDITY
LTO INITIAL 1 YEAR
RENEWAL 2 YEARS
CPR INITIAL 1 YEAR
RENEWAL 3 YEARS OR
5 YEARS
AUTOMATIC RENEWAL:
1. Application is filed before the expiration date of the license;
2. Prescribed renewal fee is paid upon filing of the application;
3. A sworn statement indicating no change or variation whatsoever
In the establishment is attached to the application.
UPDATES
GUIDELINES
• FDA Circular No.2013-
No.2013-009
Revised Guidelines in Licensing Household Hazardous (HHS)
Establishments
• FDA Circular No. 2013-
2013-013
Registration Amnesty for Non-
Non-compliant Products Specifically
under product classification Category IV- Do--it
IV- Do it--Yourself and
Hobby Items Classified as Household/ Urban Hazardous
Substances
• FDA Circular No. 2013-
2013-015
Deregulation of Bulk Industrial Chemicals Used as Raw
Materials in Cosmetic Products & Household products
considered as Urban Hazardous substance
CCRR WORKS IN
PROGRESS
• Accreditation Seminar for Liaison Officers
(QPIRA-
QPIRA- Qualified Person in the Industry
Regulatory Affairs)
• Stakeholder’s / Consultation Meeting with
Bookstores, Hard wares, Supermarkets &
Groceries.
• e-process for notification FOR LOW RISK
HUHS
• Revised Regulation for the Licensing of
HHS Establishment (draft)
• Subsequent meetings on the classification
of HHS
• Regulation for the GMP of HHS (draft)
• Revised regulations on Household Urban
Pesticides (1st Public Hearing was done,
2nd hearing will be scheduled)
• Administrative Order on Global Harmonized
System on LABELLING OF HHS (1st public
consultation)
• Coordination with DTI-
DTI-BPS for standard
setting of HHS products
• Meeting with DOH and other relevant
agencies on Tobacco Control
BE UPDATED OPEN OUR WEBSITE:
www@fda.gov. ph
CONTACT US:
857-1940 or 857-1984
mtmgutierrez@fda.gov.ph
THANK YOU AND
GOOD DAY!

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THE RULES AND

An approved application for health product

• Pest Control Operators

1. Glues and cement

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