Memo to registrants - implementation of program

2720 promenade Riverside DriveOttawa, OntarioK1A 0K9 Telephone/Téléphone: Fax/Télécopieur: Memorandum To/Note adressée All Registrants, applicants and their representatives
Subject/Objet: Implementation of the Formulants Program
The purpose of this memo is to provide industry with an update on changes being made tothe formulants requirements, prior to the publication of the revised Formulants PolicyDirective. (In order to be consistent with departmental practice, the term “program” is beingreplaced by “policy” in the name of the revised directive.) This memo also provides practicalguidance on the implementation of those requirements that will soon be in effect. It coversallergen and formulation preservative disclosure labelling and clarifies labelling deadlinedates as well as recently announced changes to List 2 formulant requirements.
Background
, was published inJanuary 2004 and outlines how formulants are regulated in Canada. The directive is beingrevised for publication this summer. Policy changes are limited and pertain mostly to List 2formulant label disclosure. The PMRA was intending to publish a separate guidancedocument for industry to aid in the implementation of the formulants program. However,because the Formulants Program Directive requires revision, it was decided to includeguidance on implementation in the revised directive. The revised directive will contain twoparts. Part 1 will describe the formulants policy (previously described as formulantsprogram) and will be very similar to the current directive in both format and content. Part IIwill provide practical guidance to applicants and registrants on implementation of the policy.
LIST 2 FORMULANTS
Label disclosure of List 2 formulants will not be required for any List 2 formulants. ThePMRA will be advising registrants who have already disclosed List 2 formulants on theirlabel text that the List 2 statement can be removed through notification. Upon notification bythe registrant, the PMRA will remove the List 2 label text from the PMRA web label.
Although label disclosure of List 2 formulants will not be required, reassessment of List 2formulants remains a priority. Registrants are still encouraged to remove List 2 Formulants,replace them with formulants from List 3 or 4, or provide data/information to support a riskassessment.
IMPLEMENTATION OF ALLERGEN AND FORMULATION PRESERVATIVE
REQUIREMENTS
Labelling Disclosure Deadlines for Allergens and Formulation Preservatives
The implementation deadline date (9 July 2005) listed in the Formulants Program Regulatory
Directive (DIR 2004-01) for disclosure labelling of allergens and formulation preservatives
applies to the label text version of the product label. Registrants of products containing
allergens and/or formulation preservatives must take action to amend the label text version of
the product labels by 9 July 2005, using the options described in this memorandum. A four
month grace period will be given to registrants before the PMRA considers taking any action
for failure to meet this deadline. In order to provide registrants with additional time to
prepare for marketplace label implementation, only pest control product containers labelled
after 9 July 2006, i.e., 12 months after the implementation deadline date, are required to have
the appropriate disclosure statements.
Label Disclosure for Products with Multiple Formulations
Multiple formulations are defined as more than one formulation acceptable under the sameregistration number where the formulations differ with respect to the proportions and/oridentity and composition of formulation ingredients. When a product is registered withmultiple formulations that have differing label disclosure requirements, all formulants subjectto disclosure as well as formulation preservatives will be required to be declared on the labeltext version of the label. However, the marketplace labels must only disclose theformulant(s) or formulation preservative(s) (as required by the Formulants Program) foundin the particular formulation being labelled for sale in the marketplace. An example would beas follows: A registered product has two formulations. Formulation 1 contains an allergen(wheat) that is required to be disclosed on the product label. Formulation 2 does not containwheat; however, it does contain a formulation preservative (formaldehyde). On the label textversion of the product label, both wheat and formaldehyde would be disclosed. Themarketplace label for Formulation 1 would contain only the disclosure statement for wheat and not for formaldehyde. Similarly, the marketplace label for Formulation 2 would containonly the disclosure statement for formaldehyde and not for wheat.
ALLERGENS
Allergen Label Disclosure
Labels of products containing formulants, which are common allergenic substances knownto cause anaphylactic type reactions, (i.e., milk, eggs, fish, crustaceans [naming thecrustacean ]), shellfish (naming the shellfish), peanuts, soy, tree nuts (naming the tree nut) ortheir shells, sesame seeds, wheat or any protein-containing derivative of these substances(including hydrolyzed plant protein, starch and lecithin) as well as sulphites must carry thefollowing statement: “Warning, contains the allergen, (insert name of allergen e.g., sulphites)” This statement must be placed in proximity to, on the same label panel as, and in a type andfont size comparable to, the guarantee statement.
Allergens found in currently registered pest control products are flagged on the RegulatoryPMRA List of Formulants. When the allergenic formulant is aderivative, it is acceptable to include only the name of the allergen source (e.g., in the case ofsoya lecithin it would be sufficient to indicate “contains the allergen, soy” on the productlabel.) If the derivative’s name does not indicate the allergen source and a registrant wishesto disclose the derivative, the allergen source must also be included in brackets after thename of the derivative, [e.g., “contains the allergen, casein (milk)”].
Label Amendment Submission Timelines
By 9 July 2005, the label text version of the product label for all registered products that
contain allergens must be revised to include the required disclosure statement. Addition of
this label statement must be documented via:
the notification process, i.e., through the submission of a letter in which the registrantattests that the statement provided above has been added to the label as required. Theletter of notification must be submitted by 9 July 2005 and must identify the exactstatement that is being added and specify the location of the statement as it willappear on the marketplace label, OR an application to amend or renew the registration when the submission is beingcompleted before 9 July 2005. In this case, the registrant may opt to include thestatement at the final stage of the registration process.
Applications Received Before 9 July 2005
Applications received before 9 July 2005, for which the certificate of registration/amendedregistration is issued after this date, will require label disclosure i.e., the allergen statementmust be on the approved text label before the certificate is issued.
Applications Received After 9 July 2005
All applications to register products containing allergens or amendments involving theaddition of allergens, received after 9 July 2005 must comply with the allergen labeldisclosure requirement.
FORMULATION PRESERVATIVES
A formulation preservative added to a pest control product to protect the formulation fromdegradation or denaturation by pests is itself by definition a pest control product activeingredient under the Pest Control Products Act (PCPA). Since formulation preservatives areby definition active ingredients, they will no longer be described as formulants.
Formulation preservatives do not contribute to the intended effect of the control product towhich they are added. For example, insecticides added to rodenticide baits to prevent feedingby insects are considered formulation preservatives, and antimicrobial and antifungal agentsadded in small amounts to pesticide formulations to prevent bacterial and fungal growthwithin the container are also considered formulation preservatives.
Formulation preservatives are added to pest control products either directly as a singleingredient or by way of a formulated product that itself contains formulants in addition to theformulation preservative active ingredient(s). Formulation preservative labelling requirementspertain to the formulation preservative active ingredient. When the formulation preservativeitself is a formulated product, both the formulation preservative product and its activeingredient(s) must be declared on the statement of product specifications form (SPSF).
Please note that substances regulated as food additive preservatives under the CanadianFood and Drugs Act that do not meet the definition of active ingredient, (e.g., antioxidants),would not be subject to the formulation preservative requirements as described below.
Formulation Preservative Disclosure on the SPSF and Label
Any formulation preservative as described above must be identified as a formulationpreservative on the SPSF under purpose in the formulation and on the pest control productlabel. The following statement must be placed on the label in proximity to, on the same labelpanel as, and in a type and font size comparable to, the guarantee statement: “Contains (insert name of formulation preservative active ingredient) at (insertpercent weight/weight) % as a preservative.” This labelling requirement applies to all formulation preservatives used in pest controlproducts including those preservatives that contain registered active ingredients and thosethat contain formulation preservative active ingredients that are not registered. Please notethat the name of the formulation preservative active ingredient (common or chemical name)and not the tradename of the preservative product is to appear in the disclosure statement.
An exception to the preservative labelling requirement is being made for microbial
products. For these products label identification of the formulation preservative(s) will not be
required. The addition of formulation preservatives, often a complex system of multiple
preservatives, is critical to protecting the viability of the active ingredient (microorganism)
itself rather than to preserving the formulation.
Label and SPSF Amendment Submission Timelines
Products (containing formulation preservatives) Registered Before 9 July 2005:
The Formulants Program Directive indicates that registrants of products containingformulation preservatives are required to submit applications to amend product labels andSPSFs as well as to provide letters of confirmation of source of supply (LOCs), by9 July 2005, to address the formulation preservative requirements. In order to reduce theburden associated with this approach to addressing the preservative requirements, registrantsmay instead choose to address the formulation preservative requirements in two phases asoutlined below: Phase 1—Label Disclosure
In the first phase, formulation preservative active ingredients must be disclosed on productlabels (label text version). Label disclosure may be documented through notification and theletter of notification must be submitted by 9 July 2005. The letter must include the exactstatement being added to the label text as well as specifying the location of the statement asit will appear on the marketplace label.
When the formulation preservative(s) has been added to a pest control product(e.g., XYZ Insecticide) by way of a formulated product (e.g., ABC Microbiocide), the nameand guarantee of the formulation preservative active ingredient must be listed on the label ofthe pest control product (XYZ Insecticide). The identity and concentrations of the formulantsfound in the preservative product (ABC Microbiocide) are not to be disclosed on the labelfor XYZ Insecticide. In the case of ABC Microbiocide, the active ingredients, e.g., 5-chloro-2-methyl-4-isothiazolin-3-one, and 2-methyl-4-isothiazolin-3-one and their guarantees inXYZ Insecticide would be listed on the XYZ Insecticide label.
Phase 2—SPSF Disclosure
In the second phase, revision of SPSFs, if necessary, and submission of LOCs, whereapplicable, will be done after 9 July 2005 through the next amendment application orat registration renewal (beginning with renewal 2006, i.e., products expiring31 December 2006), whichever comes first. A revised SPSF is required if the formulationpreservative active ingredient is not currently disclosed as a preservative under the purpose inthe formulation and/or the guarantee of the preservative active ingredient is not disclosedappropriately.
When the formulation preservative(s) has been added to a pest control product(e.g., XYZ Insecticide) by way of a formulated product (e.g., ABC Microbiocide), the nameand guarantee of the formulation preservative active ingredient(s) must be listed on the SPSFfor the pest control product (XYZ Insecticide) in addition to the name and amount (%w/w)of the formulation preservative product (ABC Microbiocide). (Please refer to the attachedtwo SPSF examples.) The guarantee of the formulation preservative should be expressed interms of nominal or minimal concentration as appropriate. The identity and concentrationsof the formulants found in the preservative product (ABC Microbiocide) are not to bedisclosed on the SPSF for XYZ Insecticide. In the case of ABC Microbiocide, the activeingredients, 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one andtheir guarantees in XYZ Insecticide would be listed on the SPSF for XYZ Insecticide.
ABC Microbiocide and its %w/w in the pest control product would also be listed on theSPSF for XYZ Insecticide.
A Letter of Confirmation of Source of Supply from the supplier/registrant of the
formulation preservative must be included with the application when the formulation
preservative added to a pest control product is itself registered in Canada as a pest control
product. This applies to cases when the formulation preservative is added directly as a single
ingredient that is registered (e.g., malathion; Reg. No. XXXX) and where it is added by way
of a formulated product that is registered (e.g., ABC Microbiocide; Reg. No. YYYY).
Applications Received Before 9 July 2005
Applications received before 9 July 2005, for which the certificate of registration/amendedregistration is issued after this date, will require label disclosure i.e., the preservativestatement must be on the approved text label before the certificate is issued. Revised SPSFsand LOCs will not be required to be submitted in order to complete registration. However, ifapplicants wish to use such applications to incorporate all formulation preservativerequirements, they should first contact the PMRA Information Service.
Applications Received After 9 July 2005
All applications to register products containing formulation preservatives and amendmentsinvolving the addition of formulation preservatives, received after 9 July 2005 must complywith the formulation preservative requirements.
Registration Renewal—SPSF Amendments Involving Identification of Formulation
Preservatives
Amendments to the SPSF which involve only identification of formulation preservativesalready contained in pest control products and/or the submission of LOCs for registeredformulation preservative products, will be accepted as part of the renewal process as noted inthe section describing Phase 2 above.
Should you have any questions or require clarification on the contents of this memorandum,please contact the PMRA Information Service for more details by email at:3799 (from outside Canada).
Sample SPSF for Disclosing a Formulation Preservative Added by Way of a Formulated
Product
12. Product
15. Certified
16. Purpose
Component
Supplier
in Product
Sample SPSF for Disclosing a Formulation Preservative Added as a Single Ingredient
12. Product
15. Certified
16. Purpose
Component
Supplier
in Product

Source: http://www.snapinfo.ca/old-site-2012/html/documents/PMRA-formulants_policy_memo-e8-05.pdf