Republic of the Philippines FDA

Department of Health
FOOD AND DRUG ADMINISTRATION

14 November 2013

FDA Memorandum Circular

N2.013- 0495

SUBJECT: GUIDELINES ON NOTIFICATION OF SELECTED HOUSEHOLD/

URBAN HAZARDOUS SUBSTANCES (HUHS) PRODUCTS

LL RATIONALE/BACKGROUND

The Food and Drug Administration (FDA) recognizes the need to keep its standards,
rules and regulations at par with the rest of the regulatory agencies across the
globe. Complex
regulations and requirements may potentially pose as barriers to trade and
innovative
technology. To support the country’s economic progress, a more simplified
regulatory
scheme is needed. Industries should be allowed to meet the fast changing needs and
demands
of consumers for safer products. Notification encourages innovations and
technological
advancement as well as national competitiveness of the manufacturing and export
industries,
paving the way for accelerated economic growth.

In this light, the FDA outlines the guidelines for the application of selected HUHS
through the Notification Scheme. This simplified approach places the responsibility
primarily
in ensuring the safety and quality of the products on the companies. However, the
FDA shall
strengthen post-marketing surveillance (PMS) to ensure continuous compliance of the
companies to FDA safety and quality standards.

Section 10 of Republic Act no. 9711 considers a prohibited act “the manufacture,
importation, exportation, sale, offering for sale, distribution, transfer, non-
consumer use,
promotion, advertisement, or sponsorship of any health product which, although
requiring
registration, is not registered with the FDA pursuant to this Act.

II. SCOPE AND COVERAGE

The following products covered are: a) Paints, lacquers, varnish; b) Solvent paint,
lacquer thinner, mineral spirits; c) Adhesives (contact cement); d)Polishes and
Waxes (metal
polish, wood polish, shoe polish); e¢) Bleaches; f) Cleaners; g) Disinfectant
sprays; h)
Detergents (bar, liquid and powder); i) Dishwashing (liquid and paste); j)
Glues/Paste; k)
Fabric (dyes, softeners, conditioners); I) Educational set and miscellaneous
chemistry set
(paste, crayons, pencils, water colors, glue stick/glues. correction fluid/rubber
eraser,
crayons, oil pastels, art paints, chalk, moulding clays); m) Stationeries/ Art
paper (colored
and/or scented); n) Air Fresheners (deodorizer, fabric freshener, aromatherapy
product,
scented candles, gels, oil, spray), and the like. Product notification is
applicable per
formulation per packaging presentation.
III.

Republic of the Philippines FDA

Department of Health
FOOD AND DRUG ADMINISTRATION

GUIDELINES

1.

Applicability
One (1) notification application per product formulation per packaging
presentation is required.

Example 1) A product with five different packaging presentations

with the same formulation will need five separate notification
applications, one cach per packaging presentation.

Example 2) A product with two or three different packaging sizes

but of the same packaging presentation and same formulation will need
only one notification.

Product Information File

A Product Information File (PIF) shall be prepared and kept by the

company following the format as specified in Annex II upon receipt of the
acknowledged notification. Upon audit, a complete PIF shall be readily
available in a suitable paper format, convenient and easily consulted by the
Authorities. The PIF shall be retained for a minimum of three (3) years after
the product is last placed in the market.

For New Products

A notification scheme for the above products shall be implemented.

Prior to the notification, the company must be a holder of valid FDA License
to Operate (LTO) as HUHS Manufacturer or Distributor.

The company or person responsible for placing the product in the

market shall notify the FDA their intent to distribute/market/sell a particular
product by filling out the HUHS Notification Template (Annex I), including
the following details:

A. Product Information (brand name and variants, product format),

B. Source of the product and all other pertinent information as to the name of
the importer/distributor/trader and manufacturer of the product,

Full Ingredient Listing in exact amount or percentage (%) and function of

each ingredient,

Technical Specifications of the finished product and;

Declaration stating among others: the full responsibility over the product,
the availability of product information file, reports of adverse events and
full cooperation on post-marketing activities.

mo 0
For Products with Existing Registration

All existing Certificate of Product Registration (CPR) due for renewal or

seeking amendments shall file for new notification application. This will be
treated as initial application.

For Changes of Information

Any change of information in the product notification shall constitute a new
notification application.

LTO Requirement
A valid LTO shall be required for notification application.
Republic of the Philippines FDA

Department of Health
FOOD AND DRUG ADMINISTRATION

IV. FEES & PAYMENT COLLECTION

Applications shall be charged according to current issuances on fees and charges.

V. TRANSITORY PERIOD
1. Companies may opt to request for the cancellation of their previous application

and existing valid CPRs, and avail of the new Notification scheme. (Note:
Previous payments made are non-refundable and non-transferable)

2. Existing CPR shall remain valid and recognized until expiration or replacement
by
Notification.
3. All applications received prior to the implementation of this Notification
scheme

shall be processed as per procedure prior to Notification, including compliances to

Notice of Deficiencies (NODs).

VI. REQUIREMENTS

1. HUHS Notification Template (Annex I};

2. Proof of payment (official receipt issued by the FDA Cashier);

3. FOR CANCELLATION OF EXISTING REGISTRATION OR

APPLICATION - a letter requesting for cancellation;

4. FOR THOSE WITH EXISTING CPRs — the original CPR.

VII. NOTIFICATION PROCEDURE

1. All HUHS establishments are required to comply with the following

procedure:

A. For New Products

i. Secure the proper HUHS notification template which may be

downloaded at http://www fda.cov.ph.

ii. Completely fill out the fields in the template with the necessary
information and print as is on A4 size paper. A separate sheet may be
attached for the formulation of products exceeding the designated
space provided (Product Ingredient List table under item number 5).

iti. Two (2) copies of notification template in original form shall be

submitted - first copy to be retained by FDA and second copy to be
returned to the applicant company after appropriate acknowledgement.
Each notification application shall be stamped as received upon the
submission of the applicant of the required documents. A claim stub
with a notification number shall be issued upon submission.

B. For Existing Products (where the validity of CPR is about to expire)

i. Follow the Notification Procedure for New Products;
ii. Surrender the original copy of the CPR.
2, Arrange the documents in clear book filler enclosed in red folder.
3. Each company may submit a maximum of five (5) HUHS notification
application per day.
Department of Health
ENT FOOD AND DRUG ADMINISTRATION
4, All HUHS notification applications shall only be received every Thursdays
between 8:00 AM - 3:00 PM at the Public Assistance Information and
Receiving (FDA — PAIR). Application received beyond 3:00 PM shall not be

Republic of the Philippines FDA

3 Fuss wena) Thang Rghe ry =

accommodated.

5. A claim stub or document tacking log for each HUHS notification application
will be issued bearing the notification number.

6. Any inconsistencies found within the notification application are subject to

evaluation and can be a basis for disapproval.

7. The FDA reserves the right to issue a letter/notice to the company in case of

clarification. The agency is not precluded in determining and imposing

remedial actions and legal penalties in a situation when the product subject of
the application failed to conform to any of the existing standards or
specifications set by FDA.

8. Acknowledged notifications and letters of disapproval shall be released at the

FDA —- PAIR trom Mondays to Fridays from 8:00 A.M.-4:00PM

XII. NOTIFICATION LEADTIME

The HUHS notification application shall be processed and completed within twenty-
two (22) working days provided the application complies with the requirements.

XII. NOTIFICATION VALIDITY

The HUHS notification shall be valid for a period of one (1) year.
XIII. SEPARABILITY CLAUSE

If any provision of this issuance is declared unauthorized or rendered invalid by

court
of law or competent authority, those provisions not affected thereby shail remain
valid and
effective.

XIV. EFFECTIVITY

This Order shall take effect immediately.

) ye —

KEXNEXH ¥ HARTIGAN-GO, MD
Acting Director General
Republic of the Philippines
Department of Health Pome mut firm LA
FOOD AND DRUG ADMINISTRATION

PE eg

ANNEX 1

NOTIFICATION OF HOUSEHOLD URBAN HAZARDOUS SUBSTANCES

[Tick where applicable

PARTICULARS OF PRODUCT

1. Name of brand & product

1.1 Brand

FOR FDA USE

Date Received:
Product Notification no: HH =
Valid until;

MARIA THERESA M. GUTIERREZ, RPh, MSc

Officer-In-Charge, Center for Cosmetics Regulation and Research

1.2_Product Name {include scent or fragrance, if applicable)

2. Product type (Tick only one)

Paints, lacquers, varnish

Glues/Paste

Solvent paint, lacquer thinner, mineral spirits Fabric (Dyes, softeners,

conditioners)

Adhesives (contact cement)

Polishes and Waxes {metal polish, wood

polish, shoe polish)

Bleaches

Cleaners

Disinfectant sprays

Detergents (bar, liquid and powder)

Dishwashing ( liquid and paste)

3. Product presentation (Tick only one)

Sachet
Pouch

Doy pack
Plastic bottle

4. Product description (including color, odor, etc)

Educational sel and miscellaneous chemistry
set {paste, crayons, pencils, water colors,
glue stick/glues, correction fluid/rubber
eraser, crayons, Qil Pastels, Art Paints,
chalk, moulding clays)

Stationeries/ Art paper {colored and scented)

Air Fresheners {deodorizer, fabric freshener,
aromatherapy product, scented candles,
gels, oil, spray)

Glass botlle Canister

Spray bottle Others [Specify]

Carbuoy

Plastic gallon —
Republic of the Philippines

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Department of Health )
FOOD AND DRUG ADMINISTRATION FDA...

PRODUCT INGREDIENT LIST

5. Fill-up the full ingredient listing in the provided table

{Please use a separate sheet in the following format]

Full ingredient name (use appropriate acceptable common Function Amount, Percentage
(%)
name or approved nomenclature in standard references,
include CASH if available)

PARTICULARS OF MANUFACTURER (S)'

[Please attach in a separate sheet if there are more than one
manufacturer/assembler]

6. Name of manufacturer:

Address of manufacturer (include country):

Tel: Fax:

PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE PRODUCT IN THE MARKET

7. Name of company:

Address of company:

Tel: Fax:

License to Operate Number

PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY

8. Name of Person;

!"Manufacturar”, in relation to a health product, eans an establish enten a ed in

any and all operations
involved in the production of health products includin preparation, processin , co
poundin , for ulatin ,
fillin , packa in , repacka in , alterin , orna entin , finishin and labelin with
the end in view of its stora e,
sale or distribution.
Republic of the Philippines

Fe
Department of Health );
FOOD AND DRUG ADMINISTRATION FDA = 7 if /

Tel: Fax: E-mail Address:

Designation in the company

PARTICULARS OF IMPORTER?

9. Name of Importer

Address of Importer:

Tel: Fax:

DECLARATION

o | undertake to respond to and cooperate fully with the regulatory authority with
regard to any subsequent post-marketing
activity initiated by the authority.

o l undertake fo ensure that the product's technical and safety information is made
readily available to the regulatory
authority concerned (“the Authority”) and to keep records of the distribution of
the products for product recall purposes.

o I undertake to notify the Authority of fatal or life threatening serious adverse

event as soon as possible by telephone,
facsimile transmission, email or in writing, and in any case, no later than 7
calendar days after first knowledge.

0 | declare that the particulars given in this notification are true, all data, and
information of relevance in relation to the
riotification have been supplied and that the documents enclosed are authentic or
true copies.

o | understand that | shall be responsible for ensuring that each consignment of my

product continues to meet alt the legal
requirements, and conforms to all the standards and specifications of the product
that | have declared to the Authority.

o | understand that | cannot place reliance on the acceptance of my product

notification by the authority in any legal
proceedings concerning my product, in the event that my product has failed to
conform to any of the standards or
specifications that | had previously declared to the Authority.

[Name and Signature of person representing the local company]

[Company Stamp] [Date]

? “Distributor/Importer eans any establish ent thati portsraw aterials, active in

redients and/or
finished products for its own use or for wholesale distribution to other establish
ents or outlets.
Republic of the Philippines pt
Department of Health )
FOOD AND DRUG ADMINISTRATION FDA 14 p
ANNEX II
PRODUCT INFORMATION FILE

The company shall present upon audit the hereunder information as part of the
product information file of each notified product. The company responsible for
placing the
product in the market shall keep a Product Information File (PIF) as part of the
undertaking

“to ensure the product’s technical information to be readily available to the

regulatory
authority concerned”.

The product information required is listed hereunder:

I. Table of Contents

I. Administrative Documents
1. Copy of the Acknowledged Product Notification
2. Valid License to Operate (LTO) with the following supporting documents:
i. For Manufacturers
1. List of HUHS Distributor/s
2. List of product lines
it. For Distributor ( Importer/ Exporter/Wholesaler)

1. List of Product Source/s, including manufacturer and

distributors of the product from where the applicant distributor
sources its product

2. List of product lines

3. FOR IMPORTED HOUSEHOLD PRODUCTS ONLY; the following

documents must be duly authenticated and notarized by the Philippine
embassy in the country of origin of the product
a. Certificate of Free Sale issued by a government authority, OR
b. Certificate of Good Manufacturing Practice, OR
¢. Manufacturing License

III. Technical Information

1. Formulation (in exact amount or percent, and function of each ingredient used)
2. Technical specification of raw materials used as component of the product

(Safety Data Sheet)

Technical specifications of the Finished Product

Certificate of Analysis of the Finished Product

Complete Test Methods done on the Finished Product

Substantiation to support special product claims

Labeling Materials

rl BC ol

IV. Representative Sample (for each packaging size and packaging presentation, with
the
commercial packaging/label consistent with the declared information in the product
notification, and is in accordance to Department of Health Administrative Order no.
311 series of 1977, or the current guidelines set by the department)