Upcoming Changes to the Cosmetic Notification Form

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Straight from the Cosmetics Mailing list:

We are writing to inform you about upcoming changes to the Cosmetic Notification form that will be implemented as a result of the coming into force of the Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients: SOR/2024-63 (amended Regulations).

Some key highlights of the changes are listed below:

Section 2 – Product

New field: “Type of product”: As per paragraph 30(2)(c) of the Cosmetic Regulations, notifiers will be required to indicate whether the cosmetic is considered leave-on or rinse-off.The field “Area of Application” must be filled out. You will be required to indicate the area of the body where the product would be applied.

Section 3 – Notifier

The field “Notifier”: The notifier can be the manufacturer, an importer or a person filling out the notification on their behalf. All correspondence regarding the notification will be sent to the notifier.

Section 4 – Manufacturing and Label Contact

Section 4 will be renamed to “Manufacturing and Label Contact”. Notifiers will be required to create a contact-Type for both the “Manufacturer” (as defined in the Regulations) and the “Label Contact”.You will have to enter the contact information for the following (as applicable):the manufacturer (as defined in the Regulations);the importer; andthe person who manufactured or formulated the cosmetic.As per the amended Cosmetic Regulations, a “manufacturer” means the:Canadian manufacturer of cosmetics who sells cosmetics under their own or a trademark, design, trade name, or other name they own or control;Responsible person in Canada acting on behalf of a manufacturer who is not in Canada; orIf no one in Canada meets the definition of the “manufacturer”, the importer or third-party manufacturer in Canada is considered the manufacturer.You can also add contacts for any additional manufacturers, importers, third parties and agents authorized to act on behalf of the notifier in this section.An address in Canada will be required in Section 4 for the form to be successfully submitted. NOTE: Please be informed that this requirement will be implemented at a later date. A date has not been set at this time; however, a message will be sent via the Cosmetics mailing list to advise stakeholders before this functionality update will occur.Use the contact-type “Label contact” to provide the contact information as it appears on the label. This can be either a telephone number, email address, website address, postal address or any other information where consumers can direct their questions about the cosmetic.

Section 5 – Product Ingredients

Using the International Nomenclature of Cosmetic Ingredients (INCI) will be mandatory except when it is unavailable, in which case chemical names must be indicated. Users will be able to initiate a search by typing the first few letters of the ingredient, select “Begins With” or “Contains”, click on “Find INCI Name” to see options and then select the appropriate INCI name from the ingredient that is present in the notified product.New Field “Exact Concentration” will be added to allow notifiers to indicate the exact concentration of each ingredient in their product.The concentration ranges will be revised to reflect the updated ranges from the amended Regulations.You can select either the concentration range or exact concentration box for each ingredient.Upon validation, if the status of one or more ingredient is described as “restricted”, you will be required to submit the copy of the label text in Section 6.The document type to be selected must be “Label – Text” or “Label – Marketplace”.As per paragraph 30(1)(b) of the Cosmetic Regulations, if a cosmetic presents an avoidable hazards and requires direction for safe use as per section 22 to 24, the labels and inserts must be provided. This is an updated functionality to help facilitate the processing of cosmetic notifications.

Section 8 – Submit (previously Section 7)

New Field “Declaration”: all notifiers will be required to check the box with the following Declaration:I hereby declare that all the information I am submitting is, to the best of my knowledge, true, accurate, current, and complete.I understand that providing false or incomplete information may result in the cosmetic notification form not being processed, which can result in compliance and enforcement actions.New Field “Signature”: All notifiers will be required to input their full name in the signature field. The name provided must match exactly with the one listed in the Contact Person field under the Notifier Section.

These updates are expected to be implemented on October 9, 2024. Thank you for your attention and continued support. If you have any questions or need further information, please do not hesitate to contact us at cosmetics@hc-sc.gc.ca.

Best regards,

Consumer Product Safety Program
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Health Canada

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

Health Canada proposed changes to Hotlist

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(le français suit…)

Cosmetics Program
Consumer Product Safety Directorate
Health Canada
Ottawa, Canada

June 29, 2017

Subject: Proposed changes to the Cosmetic Ingredient Hotlist

Dear Stakeholder:

The purpose of this notice is to inform you of substances that Health Canada is currently reviewing and that may be added to the Cosmetic Ingredient Hotlist (Hotlist). We invite you to provide any safety information or other considerations about these substances to Health Canada by August 11, 2017.

Please Note: The information in this notice is not currently reflected on the cosmetics section of canada.ca. The website is being revised and will be updated in the coming months.

Proposed Additions to the Hotlist (1)

Restrictions:

Pigment Red 4: Pigment Red 4 is being considered for addition to the list of restricted substances due to potential health concerns at previously reported concentration levels, as assessed by the Government of Canada’s Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999).  As per the information available to Health Canada, concentration levels currently being used in product formulations are below the proposed limit of 3%.

Proposed Amendments to existing entries on the Hotlist (5)

Prohibitions:

1. Chloramine T: An amendment is being considered to add related compounds to this entry. These compounds are currently prohibited under the Sulfonamides entry.

2. Oleandrin: An amendment is being considered to expand this entry to Nerium oleander, its extracts and glycosides.

Restrictions:

1. Boric Acid: An amendment to the restriction is being considered due to health concerns, as assessed by the Government of Canada’s CMP under CEPA 1999. A prohibition in products for use on or around mucous membranes and in products intended for children is proposed. Cautionary statements will be revised accordingly.

2. Methylisothiazolinone: Due to risk of sensitization, we are considering prohibiting use of Methylisothiazolinone in leave-on products and reducing the maximum allowed concentration in rinse-off products to 0.0015%, similar to the current restriction on the combination of Methylisothiazolinone and Methylchloroisothiazolinone.

3. Methylisothiazolinone / Methylchloroisothiazolinone, in combination: An amendment to the restriction is being considered to clarify that the use of the mixture of Methylchloroisothiazolinone and Methylisothiazolinone cannot be used in the same product as Methylisothiazolinone alone.

Other Miscellaneous Amendments

In addition to the above changes, existing ingredient entries will be amended to include new synonyms, Chemical Abstract Service Registry (CAS) numbers as well as other minor corrections.
 
Comments About the Proposed Amendments/Additions

The Government of Canada is committed to providing the Canadian public and stakeholders with the opportunity to participate in the development of regulatory initiatives. Health Canada invites you to submit your comments on the proposed updates to the Hotlist.

Please provide information, evidence and comments no later than August 11, 2017.

Email: cosmetics@hc-sc.gc.ca

Mail: Hotlist Coordinator
Cosmetics Program, Consumer Product Safety Directorate
Health Canada
269 Laurier Avenue West
Address Locator: 4908A
Ottawa, ON K1A 0K9

Stay Informed

Please refer to the Consumer Product Safety section of the Canada.ca website for up-to-date information.

You may also subscribe to the cosmetics mailing list to receive the latest news and information about Health Canada’s efforts in the area of cosmetics.

About the Hotlist

The Cosmetic Ingredient Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene (a) the general prohibition found in section 16 of the Food and Drugs Act (FDA) or (b) a provision of the Cosmetic Regulations (CR). In addition, the Hotlist communicates that certain substances, with no known purpose in a cosmetic formulation, make it unlikely for the product to meet the definition of a cosmetic under the FDA.

Updating the Hotlist

Proposed changes to the Hotlist are put forward as needed. The last update to the Hotlist was in December 2015. Conclusions are based on weight of evidence. Updates take into account and reflect information gathered through a review of recognized scientific journals and other scientific evidence; decisions rendered under the CMP; market survey data, as well as other actions, opinions or decisions made by international counterparts and expert panel groups, etc.

The process for updating the Hotlist is being revised. The pilot project, which may become the standard process for updates, will include:

1. Notice to Stakeholders: This notice provides information on the substances that Health Canada is currently reviewing that may be included in the next Hotlist update. This pre-consultation will be sent to stakeholders approximately three months prior to the consultation on proposed updates to the Hotlist (see below). During this time, stakeholders will be invited to provide any safety information or other considerations about the proposed substances to Health Canada.

2. Consultation: The proposed updates to the Hotlist will be posted on Health Canada’s website. Feedback from external stakeholders will be solicited during a 60 day comment period. The consultation document could include information on specific concentration limits (if applicable), suggested wording for cautionary labelling (if applicable), or if the substance is proposed to be prohibited (altogether or for a certain category of products). Prior to publication of the final revised Hotlist, Health Canada will respond to comments received during the consultation.

3. Notice of Decision and Hotlist Update:  Approximately five months after the end of the consultation, the final revised Hotlist will be posted on the Consumer Product Safety section of the Canada.ca website and a Notice of Decision will be sent to stakeholders.

 
Following posting of the Hotlist update there will be a Compliance Promotion period when Health Canada will communicate final decision on Hotlist substances and respond to questions received. Health Canada will prioritise enforcement in response to complaints/incidents received.

Efforts will be made to contact all notifiers who have previously submitted a Cosmetic Notification Form when a Notice to Stakeholders, Consultation or Final Hotlist is available. An email will also be sent through the Cosmetics Mailing List to all subscribers.

Stakeholders are reminded that, regardless of Hotlist status of ingredients, Section 16 of the FDA stipulates that cosmetics manufactured, imported or offered for sale in Canada must be safe for use (the general prohibition). In order to satisfy this requirement, manufacturers and importers are expected to:

· keep themselves informed of emerging science and potential risks associated with cosmetic ingredients;

· monitor scientific literature and post-market data both domestically and internationally (as available); and

· take appropriate corrective measures as soon as available safety information suggests the need for action (i.e. product may no longer be compliant with the FDA and the CR).

When information becomes available to industry that a substance in a product may be harmful to the user, an appropriate review and corresponding safety assessment should be undertaken to determine any potential risks. Pending the outcomes of this review, appropriate risk mitigation measures can be considered, where appropriate, such as but not limited to, monitoring, reformulation, or removal of product from the market. Health Canada can take actions at any time to enforce the FDA and CR, regardless of whether a substance is described on the Hotlist.

_________________________________________________

Programme des cosmétiques
Direction de la sécurité des produits de consommation
Santé Canada
Ottawa, Canada

le 29 juin, 2017

Objet : Modifications proposées à la Liste critique des ingrédients des cosmétiques

Madame, Monsieur,

La présente a pour but de vous informer des substances que Santé Canada examine actuellement et qui pourraient être ajoutées à la Liste critique des ingrédients des cosmétiques (Liste critique). Nous vous invitons à fournir à Santé Canada tout renseignement relatif à l’innocuité ou tout autre point à considérer concernant ces substances, au plus tard le 11 Août 2017.

Veuillez noter que l’information dans le présent avis ne se retrouve pas dans la section des cosmétiques, sur la page internet canada.ca. Le site internet est en cours de révision et sera mis à jour dans les prochains mois.

Ajouts proposés à la Liste critique (1)

Restrictions :

Pigment Red 4 : Il est envisagé d’ajouter le Pigment Red 4 (pigment rouge 4) à la liste des substances d’usage restreint en raison de préoccupations possibles pour la santé à des concentrations signalées précédemment, selon l’évaluation réalisée dans le cadre du Plan de gestion des produits chimiques (PGPC) du gouvernement du Canada en vertu de la Loi canadienne sur la protection de l’environnement, 1999 (LCPE, 1999). D’après les renseignements dont dispose Santé Canada, les concentrations utilisées actuellement dans les formulations de produits sont inférieures à la limite proposée de 3 %.

Modifications proposées aux entrées figurant déjà sur la liste critique (5)

Interdictions :

1. Chloramine-T : Il est envisagé d’apporter une modification afin d’ajouter des composés apparentés à cette entrée. Ces composés sont actuellement interdits sous l’entrée « Sulfonamides ».2. Oléandrine : Il est envisagé d’apporter une modification afin d’élargir cette entrée à Nerium oleander, à ses extraits et aux glycosides.

Restrictions :

1. Acide borique : Il est envisagé d’apporter une modification à la restriction en raison de préoccupations pour la santé, selon l’évaluation réalisée dans le cadre du PGPC du gouvernement du Canada en vertu de la LCPE, 1999. Une interdiction dans les produits utilisés sur les muqueuses ou autour de celles-ci et dans les produits destinés aux enfants est proposée. Les mises en garde seront révisées en conséquence.2. Méthylisothiazolinone : En raison du risque de sensibilisation, il est envisagé d’interdire l’utilisation du méthylisothiazolinone dans les produits sans rinçage et de réduire la concentration maximale permise dans les produits à rincer à 0,0015 %, comme dans le cas de la restriction actuelle pour la combinaison de méthylisothiazolinone et de méthylchloroisothiazolinone.3. Méthylisothiazolinone/méthylchloroisothiazolinone, en combinaison : Il est envisagé d’apporter une modification à la restriction afin de préciser que le mélange de méthylchloroisothiazolinone et de méthylisothiazolinone ne peut pas être utilisé dans le même produit contenant du méthylisothiazolinone seul.

Autres modifications

En plus des modifications susmentionnées, plusieurs entrées seront modifiées afin d’inclure de nouveaux synonymes, les numéros de registre du Chemical Abstract Service Registry (CAS), ainsi que des corrections mineures.
 
Commentaires à propos des modifications ou des ajouts proposés

Le gouvernement du Canada tient résolument à donner au public canadien et aux intervenants l’occasion de participer à l’élaboration des initiatives réglementaires. Santé Canada vous invite à soumettre vos commentaires sur les modifications proposées à la Liste critique.

Veuillez transmettre les renseignements, les données probantes et les commentaires au plus tard le 11 août 2017.

Courriel : cosmetics@hc-sc.gc.ca

Adresse : Coordonnateur de la Liste critique
Programme des cosmétiques, Direction de la sécurité des produits de consommation
Santé Canada
269, avenue Laurier Ouest
Indice de l’adresse : 4908A
Ottawa (Ontario)  K1A 0K9

Restez informés

Veuillez consulter la section Sécurité des produits de consommation du site Web de Canada.ca pour obtenir des renseignements à jour.

Vous pouvez également vous abonner à la liste de diffusion des cosmétiques pour recevoir les plus récentes nouvelles et des renseignements sur les efforts déployés par Santé Canada dans le domaine des cosmétiques.

À propos de la Liste critique

La Liste critique est un outil administratif dont se sert Santé Canada pour informer les fabricants et autres intervenants que certaines substances, lorsqu’elles sont utilisées dans un cosmétique, sont susceptibles de nuire à la santé de l’utilisateur, ce qui contrevient a) à l’interdiction générale prévue à l’article 16 de la Loi sur les aliments et drogues (LAD) ou b) à une disposition du Règlement sur les cosmétiques (RC). De plus, la Liste critique permet d’indiquer que, lorsque certaines substances ne présentant aucune utilité connue dans la composition d’un cosmétique sont présentes dans un produit, il est peu probable que ce produit respecte la définition d’un cosmétique en vertu de la LAD.

Mise à jour de la Liste critique

Les modifications proposées à la Liste critique sont présentées au besoin. La dernière mise à jour de la Liste critique remonte à décembre 2015. Des conclusions sont tirées en fonction du poids des données probantes. Les mises à jour tiennent compte des renseignements recueillis dans le cadre d’un examen des revues scientifiques reconnues et autres données probantes de nature scientifique, des décisions rendues dans le cadre du PGPC, des données tirées d’études de marché, de même que d’autres mesures, opinions ou décisions prises par des homologues internationaux et des groupes d’experts, etc.

Le processus de mise à jour de la Liste critique est en cours de révision. Le projet pilote, qui pourrait devenir le processus normalisé de mise à jour, englobera les éléments suivants :

1. Avis aux intervenants : Cet avis fournit des renseignements sur les substances que Santé Canada est en train d’examiner et qui pourraient être ajoutées à la Liste critique lors de la prochaine mise à jour. Cet avis de consultation préalable sera envoyé aux intervenants environ trois mois avant la consultation sur les modifications proposées à la Liste critique (voir ci-dessous). Pendant ce temps, les intervenants seront invités à fournir à Santé Canada tout renseignement relatif à l’innocuité ou tout autre point à considérer concernant les substances proposées.

2. Consultation : Les mises à jour proposées à la Liste critique seront affichées sur le site Web de Santé Canada. La rétroaction des intervenants de l’extérieur sera sollicitée au cours de la période de commentaires de 60 jours. Le document de consultation pourrait inclure des renseignements sur des limites de concentration précises (le cas échéant), le libellé proposé des mises en garde sur les étiquettes (le cas échéant) ou une proposition visant à interdire la substance (complètement ou pour une certaine catégorie de produits). Avant la publication de la version définitive révisée de la Liste critique, Santé Canada répondra aux commentaires reçus durant la période de consultation.

3. Avis de décision et mise à jour de la Liste critique : Environ cinq mois après la fin de la période de consultation, la version définitive révisée de la Liste critique sera affichée sur la section Sécurité des produits de consommation du site Web de Canada.ca et un avis de décision sera envoyé aux intervenants.

 
La publication de la mise à jour de la Liste critique sur le site Web sera suivie d’une période de promotion de la conformité au cours de laquelle Santé Canada communiquera une décision définitive relativement aux substances inscrites sur la Liste critique et répondra aux questions reçues. Santé Canada accordera la priorité à l’application de la loi en réponse aux plaintes/incidents reçus.

Des efforts seront déployés pour communiquer avec tous les déclarants qui ont déjà présenté un Formulaire de déclaration des cosmétiques lorsqu’un avis aux intervenants, un document de consultation ou une Liste critique définitive est disponible. Un courriel sera également transmis à tous les intervenants abonnés à la liste de diffusion des cosmétiques.

On rappelle aux intervenants que, peu importe le statut des ingrédients inscrits sur la Liste critique, l’article 16 de la LAD prévoit que les cosmétiques fabriqués, importés ou vendus au Canada doivent être sécuritaires (l’interdiction générale). Afin de répondre à cette exigence, les fabricants et les importateurs sont tenus :

· de se tenir au courant des percées scientifiques et des risques potentiels associés aux ingrédients des cosmétiques;

· de surveiller la documentation scientifique et les données post-commercialisation, autant au pays qu’à l’étranger (selon l’accessibilité);

· d’appliquer des mesures correctives appropriées dès que des renseignements disponibles sur l’innocuité semblent indiquer la nécessité de prendre des mesures (c.-à-d. que le produit n’est peut-être plus conforme à la LAD ou au RC).

Lorsque l’industrie dispose des renseignements selon lesquels une substance dans un produit peut être dangereuse pour l’utilisateur, elle doit procéder à un examen approprié et à une évaluation correspondante de l’innocuité en vue de déterminer les risques possibles. En attendant les résultats de cet examen, la mise en place de mesures appropriées d’atténuation des risques peut être envisagée, au besoin, notamment la surveillance, la modification de la formule du produit ou le retrait du produit du marché. En tout temps, Santé Canada peut prendre des mesures pour appliquer la LAD et le RC, qu’une substance soit inscrite ou non sur la Liste critique.

cosmetic notification form

New format to CNF (Cosmetic Notification Form) coming Summer 2016

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Health Canada’s Cosmetics Unit is (finally) changing their CNF format from the pdf forms we all know and love-to-avoid, to an hopefully much more user-friendly HTML (website) form. Below is the original newsletter email. Because this information is not found on their website anywhere, before we posted this, we did some fact checking and asked our Cosmetics division contact to confirm the change, and that email is below that! 

What do you think of this change? 

From: Cosmaliste <cosmaliste@HC-SC.GC.CA>
Date: April 22, 2016 at 2:50:23 PM EDT
To: COSMETICS_LIST@LIST.HC-SC.GC.CA
Subject: NEW from Health Canada’s Consumer Product Safety Program /NOUVEAUTÉ du Programme de la Sécurité des  produits de consommation de Santé Canada
Reply-To: cosmaliste@HC-SC.GC.CA

Subject: New format for online forms

Based on Government of Canada Guidelines for Web Content Accessibility, Health Canada has committed to the replacement of PDF forms with HTML forms, which are expected to be launched in Summer 2016.  Once the HTML forms are available, you will no longer be able to use or submit the PDF forms online.

This update will impact the following forms:

        • Cosmetic Notification Form
        • Incident Report Forms (for Consumers and Industry to report an incident or event involving a consumer product or cosmetic)
        • Form for submitting additional documents to Health Canada

What this means for you:  

For cosmetic industry members: If you have notified Health Canada about a cosmetic product using the PDF form and need to make an amendment/discontinuation, OR if you intend to submit additional information on an incident, you are encouraged to send the changes using the current PDF forms as soon as possible.  Note that once the HTML form is available, and you need to inform Health Canada of an amendment/discontinuation to a cosmetic notification, you will have to manually re-enter all the information related to your cosmetic product. This is due to the fact that the information from a saved PDF form cannot be imported into the new HTML form.

The current PDF Cosmetic Notification Form can be found here:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-eng.php

The current PDF Incident Report Forms & Form for submitting additional documents to Health Canada can be found here:
http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php

For all other industry members or consumers:  If you intend to submit additional information on an incident, you are encouraged to send the changes using the current PDF forms as soon as possible.
———————————————————–
Sujet: Nouveau format des formulaires en ligne
Selon les lignes directrices sur l’accessibilité du contenu des sites Web du Gouvernement du Canada, Santé Canada s’est engagé à remplacer les formulaires PDF pour des formulaires HTML, qui devraient être disponibles à l’été 2016.  Une fois les formulaires HTML disponibles, vous ne pourrez plus utiliser ni soumettre les formulaires PDF en ligne.

Cette mise à jour aura un impact sur les formulaires suivants:

        • Formulaire de Déclaration des cosmétiques
        • Formulaires de Rapport d’incident (pour le signalement d’incidents ou d’événements par les consommateurs et l’industrie concernant un produit de consommation ou un produit cosmétique)
        • Formulaire pour soumettre des documents additionnels à Santé Canada

Ce que cela signifie pour vous:

Pour les membre de l’industrie des cosmétiques: Si vous avez déclaré un produit cosmétique en utilisant le formulaire PDF et souhaitez informer Santé Canada que le produit a été modifié ou n’est plus sur le marché (arrêt de vente), OU si vous avez l’intention de soumettre de l’information additionnelle au sujet d’un incident, vous êtes encouragés à soumettre vos changements à l’aide des formulaires PDF actuels aussi rapidement que possible. Veuillez noter qu’une fois que le formulaire HTML de Déclaration des cosmétiques sera disponible et que vous devez informer Santé Canada que votre produit a été modifié ou qu’il n’est plus sur le marché, vous devrez entrer à nouveau, manuellement, toute l’information reliée à votre produit cosmétique. Cela est dû au fait que l’information provenant du formulaire PDF ne peut pas être importée dans le nouveau formulaire HTML.

Le Formulaire de déclaration des cosmétiques actuel, en format PDF, est disponible ici:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-fra.phpLe Formulaire pour soumettre des documents additionnels à Santé Canada et les formulaires de Rapport d’incident concernant un produit de consommation ou un produit cosmétique actuels, en format PDF, sont disponibles ici:
http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-fra.php

Pour tous les autres membres de l’industrie et les consommateurs: si vous avez l’intention de soumettre de l’information additionnelle au sujet d’un incident, vous êtes encouragés à soumettre vos changements à l’aide des formulaires PDF actuels aussi rapidement que possible.

 

‎Hello Ms. Garrett,
 
Please consider this email a confirmation that the information received through the Cosmetics listserv is accurate.
 
‎There is no information currently available about this on our website at this time, which is why this “heads up” email was sent.
 
‎If your members have any questions or concerns, they can contact their nearest regional Product Safety Office:
  
Regards,
 
E.C.
Head, Cosmetics Unit
Consumer Product Safety Directorate 
Health Canada
cosmetic notification form

Cosmetic Notification Forms (CNF) – Part Two

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Wow, this month is flying by! I apologize for the delay in getting Part Two of this series on CNF published, especially since I know it is on the mind of so many of you these days.

In the first part of this series we talked about what a CNF is, and when you would need to file one. If you missed it, you can find it here. Today I’m going to talk a little bit about completing the actual filing process. A blog is not a good forum to actually walk through completing a form step by step, so I’m going to answer Frequently Answered Questions in this post.

The first thing to know is that there is no fee for filing a CNF with Health Canada.

Secondly, when you sit down to file your first one, it’s going to look really confusing; don’t panic, it’s really not that bad.

To file a CNF you will need to go to this link for English, http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-eng.php, or this link for French, http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-fra.php. Before you start actually filling out the form, I would suggest that you either print or download into another window the Guide to Filing Cosmetic Notification Forms, which is found here in English, http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/guide-eng.php, and here in French, http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/guide-fra.php.  This Guide will walk you through the steps to completing a CNF, and should make the process relatively painless, but if there continues to be confusion surrounding the process, let us know and we can put together a step by step tutorial. 

Questions:

1) Am I the Notifier, the Manufacturer or the Distributor?

The answer to this is sometimes you’re all 3! It depends on how you sell your product. If you are making product and selling it directly to the public, you are the Notifier (the company that is filing the form), the Manufacturer (the company that is making the product) and the Distributor (the company that is selling the product).

If you are selling product to stores at wholesale prices and they are selling to the public, you are the Notifier and the Manufacturer, and the store(s) would be listed as the Distributor. This also applies if you are making products for Private Label customers. You would have to file 1 CNF for your direct sales to the public, then file a separate CNF for each retailer or Private Label customer that sells your product.

2) What is a Notifier’s Reference and do I have to have one?

This is a description you use to identify a product for your own use. If you make Lavender Soap, you might use that description on your website, but for selling you may have an SKU identifier, such as SPLAV or maybe a number that identifies it on your system. You don’t have to enter this on the CNF form unless you want to.

3) Do I have to file a separate CNF for each different fragrance of a product?

If the manufacturer, distributor, function, and form of the cosmetic are the same for all the variations of the product, and the base ingredients remain the same, you can file one CNF and add all of the variations in colour, fragrance, or flavour by using the “May Contain” option. If you sell wholesale and/or Private Label as well, you would have to file 1 CNF for your direct sales to the public, and a separate CNF for each store or Private Label customer that sells your product.

4)  Do I list the exact percentage of that I use of each ingredient?

No. The reason for listing the ingredients is so that Health Canada can confirm you are not using ingredients that are prohibited from use in cosmetics, or if they are permitted but restricted, you are using a safe percentage. They do not need to know what your exact recipe is. If you use 20% shea butter in your lotion, you can use any range that contains your 20%. For instance, LL (Lower Limit, or the minimum that you would use) of 10% and UL (Upper Limit, or the maximum that you would use) of 40%. As long as your recipe stays within the ranges you list for each ingredient, you won’t have to file an amendment if you adjust your recipe slightly because you were short on shea butter and added a little more cocoa butter instead. NOTE: that only applies if all of the ingredients remain the same, and the amount you use falls within the range you have listed on your CNF. You cannot substitute ingredients without filing a new CNF.

5)  I only use fragrance oils in my products; how do I fill out the CNF for that?

If you make a product where the base is always the same, but you use multiple different fragrance oils, you file one CNF and you list your fragrance oils as “Parfum”. If you make some with fragrance oils and some with essential oils, you can still file one CNF, but use the “May Contain” option to list all of the options, including one for ‘Parfum”, and one for each different essential oil.

6)  When I’m listing my ingredients for soap, do I list what goes into the pot, or what comes out of the pot?

The definition of ingredients for the purpose of filing a CNF “excludes ingredients consumed during the manufacturing process”. Since lye is used up during the soapmaking process, the proper way to list the ingredients is by using the INCI for the soap that is produced. For instance, saponified olive oil is sodium olivate, saponified coconut oil is sodium cocoate, etc. You can find an INCI listing in the Files of our Facebook group Soapz and Stuffs.

NOTE: Although glycerine is created during the soapmaking process, you do not add it to your ingredients. The definition of ingredients for the CNF is “any substance or component that is deliberately added to the formulation.” Glycerine is created during the process, not added. Please note that you DO need to add it to your label. 

7) Ok, I’ve got my number now what?

Once you’ve filed your CNF, you may receive an email or telephone call asking you to change or clarify some information. If you don’t receive any questions, at some point you will receive an email or letter containing your Cosmetic Number. File it away in a safe place. If you change your recipe, or discontinue selling the product, you will need that number to file an amendment to your CNF. You will also need to have it to show to Health Canada inspectors who may show up at a market where you’re selling, or may find you online.

8) I’ve changed my recipe, now what?

Anytime you make a change to your recipe that increases or decreases an ingredient so that it no longer falls within the range listed on the approved CNF, you will need to file an amendment. You will also need to file an amendment if you make an existing product but use a new essential oil. You don’t need to file an amendment to add a new fragrance oil or flavouring, because the generic “parfum” and “flavour” used on your original CNF will still apply.

Okay, those are the FAQs that we see most often. If any of these answers are unclear, or you have other questions, please feel free to leave a comment below, and I will answer as quickly as possible. You can also post a question in our Facebook group, as we have many people there who are experienced in filing CNFs and would be happy to help.

cosmetic notification form

Cosmetic Notification Form (CNF) : Part One.

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imageIf you are new to the handcrafted bath and body industry in Canada, you may be wondering what all the fuss is about the Cosmetic Notification Form (CNF). I started to write a short post about CNFs, which quickly turned into an encyclopedia, so I have turned it into a two or three part series. Up first, what is a CNF and why do I need one?

Health Canada requires that anyone who sells a cosmetic product in Canada must file a CNF with them within 10 days of first making the product available for sale. Anyone means everyone, from the big name sellers such as L’Oreal or Lush, all the way to your neighbour who sells a few bars to family and friends just to help cover the cost of her raw materials: no exceptions. Aside from reviewing the ingredients in your product to confirm that all of your ingredients are approved for use in cosmetics, the CNF also provides Health Canada with your contact information, which will be used in the event that your product causes an allergic reaction or other issue that is reported to them. They will contact you and ask you to recall the product.

To get you started, here are some commonly asked questions about filing a CNF:

  1. Is my product a cosmetic? Health Canada defines a cosmetic as “”Any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.” This includes bath bombs, bath salts etc.
  2. What is not considered a cosmetic? If you make any claims that your product has any therapeutic or healing effect, it is no longer a cosmetic. For example, claims that your dandelion balm treats eczema, or that your tea tree oil mask clears up acne will result in your product being regarded as a drug or Natural Health Product, which requires testing and approval. Some products, such as bug spray or sunscreen are automatically excluded from the cosmetics category even if you make no claims about them. Sunscreen is considered a drug, and bug spray is a pesticide, and they must conform to much stricter regulations. Sale of handmade sunscreen is prohibited in Canada, and sale of handmade bug spray is currently under review.
  3. If I file a CNF, can I say that my recipe is approved by Health Canada? No. The only things that are screened by Health Canada when you file a CNF is that the ingredients you are using have been approved for use in cosmetics, and that you are not exceeding the maximum usage rate of any ones that are restricted. 
  4. What happens if I sell product and don’t file a CNF? That depends on how and where you sell your product. If you are that person who is just selling to family and friends, your chances of getting “caught” are pretty slim. However, there is always the chance that your product may cause an allergic reaction in someone, and it may get reported to Health Canada. Fines for non-compliance range from $1,000 to $25,000 per offence. Now you may think, “my friends would never do that to me”, but imagine if your product caused a reaction in their young child? Or, what happens if your friend buys soap from you and gives it as a gift to someone you don’t know? Still feel confident? It is always better to be in full compliance with all regulations. There is no fee to file a CNF. If you sell your products online, in stores, or at a market, your chances of being found non-compliant are increasing every week. Health Canada has staff reviewing websites and attending markets, and you could find yourself under scrutiny at any time.
  5. Okay, I’ve filed my CNF…now what? Once you’ve filed your CNF, one of two things will happen. You may receive an email or phone call from Health Canada indicating a problem with your submission. Respond to their inquiry, and work out the problem. If you aren’t contacted, then at some point you will receive a notice that your CNF has been approved and they will provide you with a number. Keep that number in a safe place. If you ever change the product you will need that number to file an amended CNF. More importantly, this is your proof of compliance which you can show to a Health Canada inspector if one shows up at your market, or contacts you by email requesting to see your CNF.

In Part 2 of this series, we will take a closer look at the actual filing process.  In the meantime, if you have any questions about the CNF, come join our Facebook group, Soapz and Stuffs and post a question. The group is open to everyone, not just HBBG members, and someone is always around to help.