Microsoft word - vguidebook _with annex_ - april12.doc

GUIDEBOOK TO THE REGISTRATION OF PUBLIC HEALTH PESTICIDES AND
REPELLENTS AGAINST VECTORS
SECTION ONE : INTRODUCTION
1.1 Control of Vectors and Pesticides Act (CVPA) 1998
The Control of Vectors and Pesticides Act (CVPA) came into operation on 1 Sep 1998. Under the Act, all public health pesticide products and repellents intended for use against the five vectors (i.e. mosquitoes, flies, rodents, cockroaches and rat fleas) in Singapore are required to be registered with the National Environment Agency (NEA). It is an offence under the Act for any person to advertise, sell or supply vector pesticides and repellents which are not registered. The maximum fine for an offence is $20,000 and/or 3 months’ jail for the first conviction, and $50,000 and/or 6 months’ jail for subsequent convictions. The two main objectives of this registration are to ensure that pesticides and repellents
products sold in Singapore :-
(a) do not pose undue hazards to the public and the environment;
(b) are properly labeled and contain the declared amount of active ingredient(s).
1.2 Types of Pesticides and Repellents Controlled
“Pesticide”, as defined in Section 2 of the Act, includes substance or mixture or preparation of substances which contains one or more synthetic active ingredients and which is used for vector control. These pesticides include those which can be used by households directly (i.e. for general use), and those which should only be handled by licensed pest control operators (i.e. for restricted use) because they are of high toxicity or concentration, require further mixing/dilution, or require specialised equipment to dispense them. Every individual product supplied, imported or manufactured by a supplier, importer or
manufacturer will be given a unique registration number. Pesticides (i.e. organophosphorous
group, organochlorine group and carbamate group) controlled under the Environmental Protection
and Management Act administered by the Pollution Control Department (National Environment
Agency) will require the Hazardous Substances Licence/ Permit. In addition, they are required to be
registered as long as they are used against the five vectors stated above.
(a) Fumigants controlled under the Hydrogen Cyanide (Fumigation) Act, even though these fumigants are used for vector (rodent) control; (b) Repellents of non-chemical properties (e.g. light, ultra-sound); (c) Pesticides/repellents imported solely for re-export purpose; (d) Pesticides solely for agricultural1 and/ or for gardening use; and (e) Pesticides that are targeted at pests other than the five mentioned vectors (i.e. mosquitoes, flies, rodents, cockroaches and rat fleas). 1.3 Product Register
The list of public health pesticides and repellents registered with NEA may be downloaded from the Internet at http://app2.nea.gov.sg/guidebooks.aspx ________________________________________________________________________ 1 Please seek advice from AVA (Agri-Food & Veterinary Authority of Singapore) on the registration of agricultural pesticides. SECTION TWO : APPLICATION OF REGISTRATION
2.1 The Applicant
Any person who advertises, sells and/ or supplies any public health pesticides locally, and is registered under the Business Registration Act/Accounting and Corporate Regulatory Authority (ACRA) to carry out business in Singapore, or in the case of a company, incorporated under the Companies Act, may apply for the registration. 2.2 How to Apply
Application forms (together with the registration guidelines) are obtainable from the following address :- Each application form is for the registration of one pesticide/vector repellent product only.
Completed application forms must be submitted to the above-mentioned address together with all the
relevant documents stated in Paragraph 2.5.
The flow chart in Annex 1 shows how applications are processed by the Department and the processing time is about 2 weeks. 2.3 Application Form
The application form for registration may be downloaded from the Internet at http://app2.nea.gov.sg/data/cmsresource/20090320937593178202.pdf Applicants are requested to fill in the necessary details completely before submission. Incomplete application forms will be returned without consideration. 2.4 Documents Required For Registration
For the registration of a pesticide/vector repellent, the following documents are required :- (a) A copy of the Computer Information Business Profile from the Accounting and Corporate Regulatory Authority (ACRA) of Singapore in full ;
(b) A copy of the applicant’s NRIC/ work permit/ employment pass/ PR status/re-entry permit; (c) A copy of the proposed label of the product; (d) Full and detailed technical reports, including the following: 1. The respective Material Safety Data Sheet (MSDS) of the product or the technical active ingredient (AI). Please see Appendix 3 for the Guidelines for Information to be disclosed in Material Safety Data Sheet. In addition, for all MSDS to be accepted for the registration of the product of concern by the company, a letter of permission from the company (that produces the MSDS) must be submitted. 2. Methods of chemical analysis of the product (ie method for the extraction of the AI 3. The respective toxicity studies of the product and the AI. These studies should identify the laboratory in which the study was carried out and bear the signature of the author of
the report. Should the full toxicity study be unavailable, calculated values of the oral and
dermal LD50 of the product may be accepted. For this purpose, please refer to “The
WHO Recommended Classification of Pesticides By Hazard and Guidelines to
Classification 2009”. Nevertheless, the parameters (substituted into the formula) must
be justified with supporting documents [the MSDS of the active ingredient(s)].
4. Bioefficacy reports of the product on each respective target pest(s). These reports should identify the laboratory in which the study was carried out and bear the signature of the author of the report. The AI concentrations tested in the bioefficacy studies should be equivalent to (or lower than) the application rate recommended on the label. 5. Other related data / information (if any) pertaining to the active ingredients and to the (e) Approval from the other relevant authorities (if any). For pesticides/vector repellents listed under Part II of the Schedule in the Environmental Protection and Management Act, a copy of the Hazardous Substances Licence/Permit issued by the Pollution Control Department (National Environment Agency) must accompany the application. Failure to submit credible, valid and relevant documents will result in the denial of registration. It is therefore crucial that all attachments submitted must bear the source and origin from where the documents are obtained. Documents, especially technical reports (e.g. MSDS and efficacy report of the product), that are self-generated or extracted from technical bulletins or from the internet, will not be accepted. If the product is repackaged by the registrant, the registrant will be considered the product's manufacturer (for registration purposes), i.e. the Application Form (Part IV) and the product label ("Manufactured by") should state the registrant's particulars. However, the relevant technical documents submitted (e.g. MSDS) should originate from the original manufacturer of the product. A non-refundable registration fee of S$160 per pesticide/repellent product should be paid once the registration is approved. Cheques should be crossed and made payable to “National Environment Agency”. SECTION THREE : CRITERIA FOR APPROVAL OF REGISTRATION
3.1 Introduction
Pesticide/repellent products are categorized into two groups (i.e. “For General Use” and For
Restricted Use”). “For General Use” pesticides/repellents are those products which can be used by
householders directly, usually without the need for further dilution or mixing. In this respect, the
formulated product itself (based on the “WHO Recommended Classification of Pesticides By Hazard
and Guidelines to Classification 2009”) should be Unlikely to Present Acute Hazard in Normal
Use.
“For Restricted Use” pesticides/repellents refer to those products which should only be used by pest
control operators because they are of high toxicity or concentration, require further mixing/dilution,
require specialised equipment to dispense them, or have serious effects on human health. All
rodenticide products are also classified under “For Restricted Use”
Generally, a pesticide/repellent product will be registered if :- (i) it contains permitted active ingredients (for “For Restricted Use” products); or it contains permitted active ingredients at a safe level (for “For General Use” products); (ii) its label conforms to standard requirements. 3.2 Active Ingredients
Table 1 shows the list of active ingredients (A.I.) permitted in “General Use” and “Restricted Use” products, highlighted with “ ”. This list is to be used as a guide and is subjected to review as new active ingredients come into the market. 3.3 Labeling of Pesticides
3.3.1 Information Required to Appear on the Product Label A label must be printed on or affixed to every container or package of the product. It must be in English and preferably one other official language of Singapore. The information required on a product label are listed below: - (a) Product/Trade/Brand Name; (b) Composition (% w/w) of the product content (name and percentage of active ingredients, (c) Type of formulation (e.g. aerosol, bait, mat, coil); (d) WHO hazard classification (as stated in “The WHO Recommended Classification of Pesticides by Hazard and Guidelines to Classification 20049”); (e) Hazard warning statement or symbol (Please refer to Annex 2 ); (f) Statement of classification (i.e. “For General Use” or “For Restricted Use”); (g) Net weight or volume of product; (h) Targeted pest(s); (i) Date of manufacture; (j) Date of expiry; (k) Toxicological effect(s) on non-target organism(s) (e.g. fish, birds); (l) Safety precaution(s); (m) Directions for use; (n) Storage and disposal information; (o) Practical treatment statement(s); (p) Guide to Doctor in case of poisoning; (q) Names and addresses of manufacturer and importer; (r) USEPA registration number (if any); (s) NEA registration mark (at least 10 pt. Font size, not less than 3.0mm in height); and (t) such other information as the Director-General Public Health may require. Applicants are advised not to proceed with the printing of the final labels until a product label has
been approved.
Product containers and packages come in different shapes and sizes. Under normal circumstances, the label must contain all the required information [see 3.3.1(a) to (s)]. However, if space is a constraint on the package/container, the following information are required to appear conspicuously on the package/container. (a) Brand Name (b) NEA registration mark (c) Composition of ingredients (d) Type of formulation (e) WHO hazard classification (f) Hazard warning statement or symbol (g) Classified use (h) Net weight or volume of the product (i) Target pests (j) Date of manufacture (k) Date of expiry The remaining information can appear in a separate leaflet/brochure enclosed or attached to the
package only if space is a constraint.
Figures 1 to 3 are some examples of how a good label should be constructed. Figure 1: Sample of Label Without Separate Leaflet For “General Use” Product. TARGET PESTS
DIRECTIONS FOR USE
FOR GENERAL USE
SINNEA XXX/XXXX/XXXX
TOXICOLOGY EFFECT(S) ON
NON-TARGET ORGANISMS
Product is toxic to fish / birds /
STORAGE & DISPOSAL
SAFETY PRECAUTIONS
OIL-BASED AEROSOL
IMPORTED BY
RACTICAL TREATMENT
KEEP OUT OF REACH OF
MANUFACTURED BY
CHILDREN
Unlikely to Present Acute Hazard
in Normal Use
EPA REGISTRATION NO.
ACTIVE INGREDIENTS :
DATE OF MFG
INERT INGREDIENTS :
MEDICAL TREATMENT
DATE OF EXPIRY
XX - XX - XXXX
Figure 2 : Sa mple of Label Without Separate Leaflet For “ Restric ted Use ” Produ ct PRECAUTIONARY STATEMENTS
FOR RESTRICTED USE
DIRECTIONS FOR RESTRICTED USE
SINNEA XXX/XXXX/XXXX
RECOMMENDED RATES. For Fleas, Ticks and EMULSIFIABLE CONCENTRATE
Mites, which are commonly found near the house and may enter the house, spray a 5 ft. band of soil around the house, as well as the house foundation wall to a ACTIVE INGREDIEN
height of 2-3 ft. Repeat application if necessary. T : XXXXXXXX % w/w
INERT INGREDIENTS : XX.XX% w/w
KEEP OUT of any body of water. DO NOT APPLY where runoff is likely to occur. DO NOT CONTAMINATE WATER by cleaning of equipment TOXICOLOGICAL EFFECT(S) ON NON-
TARGET ORGANISMS
KEEP OUT OF REACH OF CHILDREN
This product is toxic to fish / birds / bees. PRACTICAL TREATMENT
WHO CLASS II
IF SWALLOWED - Induce vomiting by giving a tablespoon of salt in a glass of warm water. Repeat until Moderately Hazardous
vomitus is clear. Call a physician immediately. IMPORTED BY XXXXXXXXX
IF INHALED - Remove to fresh air. Call a physician IF IN EYES - Flush eyes with plenty of water for at least STORAGE & DISPOSAL
15 minutes. Call a physician immediately. IF ON SKIN - In case of contact, remove contaminated MANUFACTURED BY :
STORAGE - Do not store next to food or other clothing & immediately wash skin with soap & water. articles intended for consumption by humans or EPA REGISTRATION NO. XX - XXXX
MEDICAL TREATMENT
DISPOSAL - Do not reuse container. Contact TO PHYSICIAN : XXX is a reversible cholinesterase DATE OF MFG : XX - XX - XXXX
licensed industrial waste collector for proper disposal. DATE OF EXPIRY : XX - XX - XXXX
inhibitor. Do not use oximes such as 2-PAM. Give Atropine 2 mg. Intravenously or subcutanously. If in eye Figure 3 : Sam ple of Label With Separate Leaflet. PRACTICAL TREATMENT
IF SWALLOWED - Induce vomiting by giving a FOR GENERAL USE
FOR GENERAL USE
tablespoon of salt in a glass of warm water. SINNEA XXX/XXXX/XXXX
SINNEA XXX/XXXX/XXXX
Repeat until vomitus is clear. Call a physician IF IN EYES - Flush eyes with plenty of water for at least 15 minutes. Call a physician immediately. INSECTICIDE IMPREGNATED CHALK
INSECTICIDE IMPREGNATED CHALK
contaminated clothing & immediately wash skin This product contains :
STORAGE AND DISPOSAL
ACTIVE INGREDIENTS:
STORAGE - Do not store next to food or other articles intended for consumption by humans or INERT INGREDIENTS: .XX% w/w
EFFECTIVE
KEEP OUT OF REACH
DISPOSAL - Do not reuse container. Do not OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
Unlikely to Present Acute
IMPORTED BY:
Hazard in Normal Use
Unlikely to Present Acute Hazard in Normal Use
IMPORTED BY:
MANUFACTURED BY:
EFFECTIVE AGAINST cockroaches & ants. The toxicity of this product to non-target organisms has not been DATE OF MANUFACTURE: XX - XX – XXXX
SAFETY PRECAUTIONS
DIRECTIONS FOR USE
DATE OF EXPIRY: XX - XX - XXXX
Avoid all contact by mouth. Keep away from food & Use it at night, when most insects are likely to appear. drinks. Do not apply to clothing / fabric / bedding. Draw parallel lines 2 to 3 cm apart, across the normal path Keep children / pets away from treated area. of insects or around their hiding places. For effective EPA REGISTRATION NO.
control, store the chalk at cool, dry places. 3.4 Evaluation of Label
Upon submission of the draft label for a product together with the application, the label will be evaluated for compliance with the labeling requirements. Applicants will be informed of any change to the label needed. Once the final label is approved, the registrant must print the approved label and registration mark onto the product container and package before the product may be displayed for sale in the local market. 3.5 Unsuccessful Application
When an application for an existing product is not approved, the importer/trader is given seven days
to ensure that the product is no longer displayed and sold in the market. Importer will be given up to
one month to show proof that the stocks have been retrieved and disposed of, either destroyed in
Singapore or re-exported
SECTION FOUR: SAMPLING PROCEDURE
NEA will check and monitor the registered products from time to time to ensure that they still comply to the required standards. In this respect, arrangement will be made with the registrant to sample the products at site. The registrant will also be required to submit, at his own expense, the sealed samples to an accredited laboratory for the purpose of analysis. The report of analysis (either original or certified true copy) should be submitted to the Department. SECTION FIVE: CANCELLATION OF REGISTRATION AND REMOVAL OF
REGISTRATION MARKS
Under section 11 of the Act, a registration will be cancelled if a registered pesticide/repellent :- (a) is subsequently found to be hazardous; (b) is not being prepared in accordance with the particulars registered in respect of the (c) no longer conforms to prescribed standards; (d) is no longer available for purchase in Singapore; (e) has been registered upon false information provided by the registrant; (f) the registrant of which has failed to comply with any of the conditions subject to which the product has been registered; or he has intervened or failed to comply with the provisions of the Act or regulations; (g) container or package or the label printed/affixed thereto does not comply with the (h) is being advertised in a manner that is false, misleading or deceptive. Upon the cancellation of the registration of a product, the Director General of Public Health may require the registrant to remove, cancel or obliterate the registration mark from every container and package of the product. The registrant may also be required to recall all stocks and to cease the sale, supply or distribution of the product. Written appeals to the Chief Executive Officer (CEO) can be made within 14 days of the date of receipt of the notice informing of conditions imposed on registration or refusal or cancellation of the registration. REGISTRATION OF PUBLIC HEALTH PESTICIDES AND REPELLENTS AGAINST
VECTORS
WHO HAZARD CLASSIFICATION - ACUTE LD50 VALUES OF FORMULATED PRODUCTS
“DANGER – POISON”
“DANGER – POISON”
“WARNING”
CLASS III
“CAUTION”
UNLIKELY TO PRESENT
ACUTE HAZARD IN
NORMAL USE
"CAUTION"

Guidelines for information to be disclosed in Material Safety Data Sheet (MSDS)
(Abridged version omitting items not required for NEA registration. Full version is available as template at
http://www.msdssearch.com/backgroundn.htm)
Section 1 : Product and company
Section 5 : Fire-fighting measures
identification
Section 6 : Accidental release measures
Section 7 : Handling and storage
Section 8 : Exposure controls /
Personal protection
Section 2 : Composition /
Information on ingredients
Section 9 : Physical and chemical properties
Section 3 : Hazards identification
Section 10 : Stability and reactivity
Section 11 : Toxicological information
Section 12 : Ecological information
inhalation: Medical conditions generally Section 13 : Disposal considerations
Section 14 : Transport information
Section 4 : First aid measures
Section 15 : Regulatory information
Section 16 : Other information

Source: http://app2.nea.gov.sg/docs/default-source/training-knowledge-hub/guidebook-to-the-registration-of-public-health-pesticides-and-repellents-against-vectors.pdf?sfvrsn=2