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Bioenterprise and Women in Agriculture

Posted on October 19 2016 | Author: Jennifer Kalanda

Earlier this month, members from the Bioenterprise team attended the Advancing Women in Ag Conference in Toronto, Ontario.  It was the second Annual event in Toronto and the fourth across Canada.  Our team learned of this event last year and had since heard several positive reviews, determining that this event could be a great opportunity for several of us at Bioenterprise.

The conference was sold out and the banquet room was filled with more than 400 women from the entire value chain of agriculture.  Several topics and studies presented revealed that throughout agriculture, the industry is heavily dominated by men, and even more so, in executive level positions.  The conference also presented personal and professional development opportunities.  I personally found the presentations about leadership and time management to be my most valuable take-aways from the event. 

Some of the speakers discussed the importance of reducing barriers for women in agriculture, the challenges that lie ahead to do so, and the importance of inviting both genders to contribute to the conversation.  This discussion also stood out to me and fostered a sense of pride as an employee of Bioenterprise.

Bioenterprise was formed in 2003, with one office location and a very small team.  Bioenterprise has grown significantly since then – now with six office locations across Canada, nineteen full-time employees and two part-time positions.  We are even currently looking to fill two additional full-time openings on our team!

Our team has grown a lot, but what is interesting to note is how many of our positions are held by women.  Twenty-one employees total and THIRTEEN of them are women!  We also have two extremely well established women serving on our Board of Directors.

Some of my female colleagues and I have been with Bioenterprise for several years.  For the most part, we started out new to our roles or the industry itself, but we have been fortunate enough to receive the necessary support and opportunities to grow as professionals.  Dave Smardon, President & CEO, takes an active role in identifying areas for growth and then provides us with the tools to do so.  We have all been promoted or have advanced at Bioenterprise, demonstrating that gender just doesn’t seem to be a barrier within our organization.

The issues discussed at the Advancing Women in Ag Conference were certainly not lost on me and I truly learned a lot – but I am also proud to be a part of an organization that seems to be setting a positive standard.  


Jennifer Kalanda
Marketing Manager


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Food Fax

Posted on October 14 2016 | Author: Admin


Read the lasted Food Fax newsletter from International Food Focus Ltd.’s President, Carol Culhane.  


©2016 International Food Focus Ltd., 211 Carlton Street, East Office, Toronto, ON M5A 2K9 E: focus@foodfocus.on.ca
Food Fax is archived at www.foodfocus.on.ca 

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WHO Cares About Food Safety: Red Meat

Posted on October 13 2016 | Author: Admin

It was only last October that the World Health Organization (WHO) announced, based on a report from the International Agency of Cancer Research (IACR), that processed meats and red meats were carcinogenic.

The WHO, however, did not attempt to establish the degree of risk to the public or the actual nature of the risk. While they did assign an IACR Group 1 classification to processed meats and an IACR Group 2A classification to red meats, it is important to remember that a “group” simply refers to the weight of evidence available to support the carcinogenic designation; not to the actual level of risk involved.

It is not clear, therefore, if or to what degree the risks involved can be mitigated (for example, if they can be lessened by avoiding high temperature cooking or by avoiding certain methods of preservation). As a result, and as expected, sales of processed and red meats declined immediately following the announcement. What is perhaps surprising is that within just a few weeks, sales of such meats began to return to normal, as reported in a March 2016 Global News broadcast. The reasons for such a rebound may vary – perhaps people have short term memories, perhaps they began to doubt the WHO’s findings, perhaps they decided that the health benefits of such meats to outweigh the risks, or perhaps they find such meats too delicious to give up.

Of course, the potential risks should not be so readily dismissed. Estimates of cancer deaths, based on independent research conducted by the Global Burden of Disease Project, due to diets high in processed meats are about 34,000 worldwide per year, while those attributed to diets high in red meat are estimated at 50,000 per year. On the other hand, putting this into perspective, the number of deaths worldwide per year due to ingesting contaminated foods is about 420000, with 40% of those being children under the age of 5, and an additional 500 million+  individuals falling ill each year (according to the WHO’s own statistics).

While in the case of meats it is still unclear how to mitigate the overall risks, in the case of food contamination we do know how risks can be reduced and avoided.  This involves observing simple food safety practices throughout the supply chain, from the sourcing of raw materials to the dinner table. For consumers at home, this means proper handling, refrigeration, and cooking of foods. For industry, this means implementing HACCP (Hazard Analysis Critical Control Point) and adopting effective food safety programs.

Were producers, suppliers, manufacturers, retailers, and consumers to take food safety more seriously and adopt simple but effective measures towards preventing contamination and adulteration, the global food supply would be far safer than were the WHO to declare an outright global ban of red meats.

Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 

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Proposed amendments to Canadian corporate and competition laws

Posted on October 11 2016 | Author: Admin

A bill amending the Canada Business Corporations Act (CBCA), the Competition Act and federal cooperatives and not-for-profit legislation was tabled for first reading in the Canadian parliament on September 28, 2016. The changes proposed (the Amendments) are intended to ensure that Canada continues to have a modern economic framework that allows federally regulated corporations to operate flexibly and innovatively. The Amendments are further intended to increase shareholder democracy and participation while reducing the burden of regulation.

CBCA amendments

Election of Directors

  • directors of public CBCA corporations will be required to be elected on an individual and annual basis. Currently the CBCA allows directors to be elected by slate and for up to a three-year term.
  • the Amendments introduce majority voting for the election of directors of public corporations where there is only one candidate nominated for each position available on the board. Each nominee must receive a majority of votes to be elected. If a nominee does not receive a majority of votes, he or she may not be appointed a director before the next shareholders’ meeting at which directors are elected.
  • the Amendments regarding election of directors bring the CBCA substantially in line with the requirements of the Toronto Stock Exchange (TSX). There will be prescribed exemptions for certain corporations from these requirements.  

Shareholder Communications

  • “notice-and-access” allows the notice of a shareholders’ meeting and access to related documentation to be delivered electronically. While securities legislation was amended in 2013 to introduce notice-and-access, the current provisions of the CBCA are not entirely compatible with the full use of notice-and-access by federal corporations. The Amendments, if enacted, will facilitate the use of notice-and-access by federal corporations.
  • the Amendments will simplify the time frame for a shareholder to submit proposals to a federal corporation by introducing a prescribed period for submission.

Women on Boards of Directors and in Management
To support the representation of women on the boards of directors and in senior management of federal corporations, it has been announced that the Amendments will require distributing corporations to include disclosure regarding gender diversity among their directors and senior managers. This will bring the CBCA in line with Canadian securities regulations pursuant to which TSX-listed issuers are currently required to make such disclosure on a “comply or explain” basis.

The Amendments clarify that all shares and warrants of CBCA corporations must be in registered rather than bearer form to increase transparency.

Competition Act amendments
The definition of “affiliate” in the Competition Act is proposed to be amended to reflect a broader range of non-corporate bodies such as trusts, partnerships and other unincorporated entities by referring to entities rather than corporations.

Other legislation
The bill also proposes amendments to the Canada Cooperatives Act (CCA) and the Canada Not-for-profit Corporations Act (NFP), which statutes are based on the CBCA. The Amendments to the CCA include changes regarding election of directors, transparency and shareholder communication described above. The Amendments to the NFP are largely of a technical nature.

Next steps
Regulations that will provide details of the Amendments and their application are pending. Further in its announcement of the Amendments, the federal government stated that there are important corporate governance issues that were raised in the 2014 public consultation on the CBCA by the government that require further analysis and consultation. Further changes to the CBCA may be coming.

More information to come
For more information on this development, please access the Government of Canada’s Backgrounder and FAQs.


Tracey Kernahan
Senior Knowledge Lawyer, Norton Rose Fulbright


Article provided by Norton Rose Fulbright


About Norton Rose Fulbright
Norton Rose Fulbright is a global legal practice that provides the world's pre-eminent corporations and financial institutions with a full business law service. Norton Rose Fulbright lawyers share food and agribusiness sector knowledge and experience across provincial and national borders, enabling them to support their clients anywhere in the world. To learn more about Norton Rose Fulbright, please visit www.nortonrosefulbright.com


Click here to view the original article.


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How to choose the right food & beverage co-packer

Posted on October 05 2016 | Author: Alexandra Coccari

Are you an entrepreneur in the food and beverage space? Is there an established market for your product? If so, you have probably considered scaling-up production to meet the consumer demand for your product. This can be done in one of two ways: investing and manufacturing the product in-house or outsourcing production through a contract manufacturer, otherwise known as a co-packer.

Many start-up food and beverage companies utilize co-packing facilities for a number of reasons. Some of the benefits include a lower production cost, increased efficiency, having the expertise of an experienced manufacturer on-site, and most importantly, cutting the costs of equipment and other capital purchases.

Choosing a co-packing facility may seem like a daunting task; however, creating a plan of attack will ease this process. There are a number of things to consider before deciding what co-packing facility is right for your company. The following are some tips and factors to consider before navigating the co-packing industry.

Establish your production process and needs. Understanding every detail of your production process is crucial when deciding which co-packing facility to choose. Where will you source the ingredients for your product? Does the facility have the equipment you need? Where will you source packaging materials? Does the facility have available storage space? These are just a few of the questions you should be ready to answer when seeking out the right co-packer. The more you know about your manufacturing process, the smoother the production run will be.

Consider manufacturing costs. It is extremely important to ensure that choosing to outsource the manufacturing of your product is not only efficient, but is often financially beneficial. A number of co-packing facilities have a minimum order quantity for each production run. If your start-up company is looking to do a smaller production run, it is likely that you will be charged a premium fee, which may not be feasible. On the other hand, manufacturing too much of a product in order to avoid these fees may be detrimental if you cannot sell it before the expiry date.

Confirm food safety and quality assurance policies. In addition to cleanliness and sufficient organization, it is imperative to ensure that proper safety and quality assurance policies are in place. Deciding which certifications that will appear on your product label will narrow down the co-packing facilities that are suitable for your company. Food safety certifications such as HACCP, GMP, and SQF will contribute to the quality of your product and reduce the risk of contamination. If your product requires any front-of-package certifications such as Organic, Kosher, Halal or Gluten-Free, confirm that the co-packing facility is capable of meeting these regulations.

Leverage any additional services offered. A number of co-packing facilities offer services designed to accelerate start-up companies. Many of the innovation-focused co-packing facilities will offer R&D services, including recipe development to very early-stage companies. If your company lacks in the marketing and branding development, a co-packer who offers such services would be very valuable and may save your company both money and time.

Do your research. Once you have narrowed your list of potential co-packing facilities, you should then conduct preliminary background research. What clients have they worked with in the past? Do these past clients give the facility good reviews? These are some of the questions that can be answered by asking the co-packer for a list of current clients and contacting them. This may make it easier to determine what working with the co-packer would be like.

The factors listed above are just a few considerations to review before choosing a co-packing facility. Co-packing facilities can help accelerate the growth of your company. Once you have identified and chosen a suitable co-packer, a contract outlining the details of your partnership should be drafted.  This will protect your product and may benefit your business in the long run.

Co-packing facilities are great resources for start-up food and beverage companies. Having a clear vision and a trusting relationship with your co-packer can lead to your company’s success. By leveraging the services offered, you could save valuable time and money.


Alexandra Coccari  
Junior Analyst, Food & Food Systems


5 things to consider when selecting a co-packer   
Three main steps to choosing a co-packer  
4 tips for scaling your food start-up with a co-packer  
How to choose the right co-packer for your supply chain needs


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The Growing Safety Concern of Alpha Lipoic Acid and Hypoglycemia

Posted on September 29 2016 | Author: Admin

The Growing Safety Concern of Alpha Lipoic Acid and Hypoglycemia:
Marketed Health Products Directorate Issues ALA Summary Safety Review

August 08, 2016 Marketed Health Products Directorate provides Summary Safety Review for Alpha Lipoic Acid.

In an effort to increase transparency and consumer safety, Health Canada’s Marketed Health Products Directorate published a Summary Safety Review (SSR) on Alpha Lipoic Acid (ALA) on June 30, 2016. ALA is a medicinal ingredient generally used, in Natural Health Products (NHPs), as an antioxidant for the maintenance of good health and to help promote healthy glucose metabolism. ALA can also be used in NHPs, as a non-medicinal ingredient, with a preservative function. To date, Health Canada has licensed more than 800 NHPs containing ALA as a medicinal ingredient.

The Health Canada SSR issuance on ALA was prompted by reported international cases of Insulin Autoimmune Disorder (IAS) considered to be linked to the use of ALA containing products. IAS, also known as Hirata disease, is a rare case of serious and spontaneous Hypoglycemia. It is characterized by extremely low blood glucose, and extremely high insulin and insulin autoantibody levels. Current evidence suggests exposure to certain sulfhydryl-containing oral drugs such as ALA, in individuals with specific genetic predispositions, can induce Hypoglycemia and increase the risk of IAS. The reported cases demonstrate Hypoglycemia resolution following discontinuation of ALA oral consumption. At the time of the review, no Canadian cases of Hypoglycemia were reported as a result of ALA oral use. It is however unknown how prevalent the suspected genetic predisposition may be in the diverse Canadian population.

As a result of the SSR findings, Health Canada is looking into updating the ALA labelling standard risk information to inform consumers to discontinue product use and consult a healthcare professional if they experience symptoms indicative of Hypoglycemia (sweating, paleness, chills, headache, dizziness and/or confusion). Health Canada has also committed to publish a Health Product InfoWatch article to raise awareness of this potential risk and continue to monitor safety information involving ALA.

Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 

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Management vs. Leadership: A middle manager’s perspective

Posted on September 21 2016 | Author: Jessica Bowes

The organizational structure of a company largely depends on the nature and size of the business. With innovation at the core, entrepreneurial businesses need to promote regular interaction and communication among its internal teams, regardless of how it’s structured, in order to follow through on the founder’s vision for success. For start-ups and early stage businesses that are too small to departmentalize, management resources must be maximized.

Companies need leaders
There’s a fine line between management and leadership, but there is a difference. Managers plan, organize and coordinate whereas leaders should inspire and motivate.  A successful entrepreneur needs to be both a strong leader and manager.

Strong leaders put others ahead of themselves, and the team ahead of everyone.  They make their expectations clear, even when it’s uncomfortable. They push people outside of their comfort zones. And, they hold people accountable while empowering them to learn and grow.

True leadership is like an inverted pyramid, where an entire organization relies on a single leader to support their efforts by providing vision and strategic guidance. This becomes particularly important once your business grows and you hire new staff to carry out your vision for the company.

Leadership and management must go hand-in-hand

“Management is about persuading people to do things they do not want to do, while leadership is about inspiring people to do things they never thought they could.”

-- Steve Jobs

As a manager, your duty is to implement company strategy in the most efficient way. You’re also responsible for creating an effective working environment, administrating the work process in compliance with organization’s requirements, leading people, and reporting to the highest level of management.

Functions of the role can typically be divided into 3 main categories, all of which can be profoundly impacted by the person’s leadership skills: Technical, Human Resources and Strategic.

In the agri-technology sector, there is almost always an element of technical understanding required to manufacture, market or sell a product or service. Education and/or training of staff in this capacity may then play a significant part of the managerial role.  Relationships with staff that are built through patience, creativity, and supportive collaboration are indicative of good technical leadership.

Human resources:
Managers are also responsible for administering day-to-day routines, monitoring performance and making sure everything is done in compliance with company’s needs. One of the most important functions, directly associated with operational leadership, is motivating and inspiring staff to perform well. This also includes building a cohesive team and supporting team members when necessary.

Strategic functions of a manager may involve analyzing a group in terms of productivity and financial effectiveness, creating a strategy to improve the current situation and reporting to executive management.  Strong strategic leadership is grounded in understanding the relationship between the company and its environment, then thinking, acting and influencing the team to promote success. Strategic leadership is not limited as a task for a few top executives, but is needed throughout the company.

Every employee has the opportunity to lead
Fostering an environment where people feel empowered, appreciated, and genuinely happy to be part of the team will not only allow employees to shape and create their own futures, it will create career progression opportunities for employees to adapt, innovate and ultimately lead your company to success.


Jessica Bowes
Manager, Business & Technology Analyst Group


Management vs Leadership: Five Ways They Are Different
The End of Middle Managers (And Why They’ll Never Be Missed)
The Three Strengths of a True Strategic Leader


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FSMA is Not Just Coming… FSMA is HERE!

Posted on September 15 2016 | Author: Admin

It’s been 5 years since you’ve first started hearing about looming FSMA deadlines. Now that the first deadline for 2016 has arrived, its time for you to understand how this will impact your business.

If your business is simply a retail or restaurant establishment, you initially may feel untouched by this legislation.  This assumption, however, may be very untrue.  Although FSMA is geared to food growers, manufacturers and distributors, businesses in other sectors that are not legally required to comply will still be impacted.  A supplier of ingredients to retail and restaurant business is fully impacted and so as a result, this will inevitably have an impact on all business not directly captured by the law.

It’s quite obvious that one of the main intentions of the new law is to give legislators at FDA more power to regulate and enforce.  The ultimate goal is to shift food industries from a reaction mode to a prevention mode. This shift will initially appear to be very costly and labor intensive, but the reduction in food safety incidents leading to recalls will outweigh all initial costs.

The first FSMA deadlines related to compliance to Preventative Controls for Human and Animal Feed are outlined below:

September 2016: Companies with more than 500 full-time employees
September 2017: Companies with fewer than 500 employees
September 2018: Companies with less than $1 million in average annual sales

Under FSMA each site will be required to have a “Preventative Control Qualified Individual” (PCQI).  A PCQI is required to have successfully completed training in the development and application of risk –based preventative controls.  This individual is responsible for:

  • Performing or overseeing the preparation of the food plan
  • Validating the preventative controls
  • Reviewing records for implementation and effectiveness of preventative controls
  • Appropriateness of corrective actions
  • Managing the required reanalysis of a food safety plant every three years or whenever changes occur

Being FSMA ready will mean moving from HACCP to HARPC as reviewed in previous articles.  While HACCP involves Critical Control Points (CCPs), HARPC involves controls that are not CCPs.

Supply chain control is essential and is obvious from the Foreign Supplier Verification Program.  This program has compliance deadlines in 2017, but has a huge impact on ingredients and foods coming into the U.S. from outside the country.

In order to import food from foreign suppliers, importers need to ensure they have:

#1. Determined known or reasonably foreseeable hazards with each food they are handling
#2. Evaluated the risk posed of the food they are importing based on the hazard analysis, and the foreign supplier’s performance
#3. Used the risk evaluation connected to the food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
#4. Conducted supplier verification activities
#5. Conducted corrective actions

Since importers are responsible for their own food safety plans, they are expected to reevaluate these plans every three years. This involves conducting a Hazard Analysis and Risk-Based Preventive Controls, or HARPC assessment on each item of food being imported, and verifying each supplier being used. Importers are also responsible for keeping detailed records of all data and analyses.

Under the Third Party Certification rule, FDA will be choosing accreditation bodies to implement the certification of qualified organizations who will confirm that the requirements of FSMA are being met.

This rule establishes a voluntary program for the accreditation of third party certification bodies, also known as auditors, to conduct food safety audit and issue certification of foreign facilities and the food for humans and animals they produce.  These certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP) which offers expedited review and entry of food.  To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require in specific circumstances that a food offered for import is accompanied by a certification from an accredited third party certification body.

This article has not dealt with every aspect of the FSMA requirements, but it will hopefully give you an understanding of the areas in your business that need to change in order to come into compliance with the new expectations.

Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 

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Business Networking: Tips and Results for Sustainable Growth.

Posted on September 07 2016 | Author: Elisha Amar

If you have knowledge, let others light their candles in it.
Margaret Fuller
(1810-1850, Journalist, Critic and Women’s Rights Activist)

Expanding your networks and building strategic partnerships play an integral role in successful and sustainable growth, especially in today’s society. The new economy - also called the digital economy has had, and continues to have, a remarkable impact on businesses and how they are creating awareness amongst others.

Nowadays, growing and maintaining business relationships have become much simpler thanks to technological advancements like cell phones or GoToMeeting and social media platforms such as LinkedIn. Building a network for your business is an important way to leverage different assets, create exposure, and ultimately learn in a mutually beneficial manor.

Prior to engaging in networking activities, it’s important to understand your strengths, weaknesses and what you are trying to gain from this experience. For example, if you are excellent at carrying conversations and enjoy large groups of people, consider participating in larger networking events, conferences or trade shows. If you are more the one-on-one type, meeting for coffee or smaller seminars may be more suitable for you to begin.

Take advantage of the different social platforms effectively, and make networking more efficient. For example, webinars are virtual learning sessions you can attend with others on a specific area of interest. These can be useful for a quick lunch-break networking. Another technological advancement that has impacted networking is GoToMeeting or conference programs via the Internet to communicate with people in different cities or even across the world. This makes it easy to decrease travel costs and increase connectivity.

Before choosing your networking event, it’s also important to take into consideration and determine the value in attending. What would you like to gain from this experience? Make new connections? Keep up to date on the latest industry trends? Strengthen existing relationships?

Here are several suggestions to consider, prior to engaging in a networking event:

  1. Research the organizations and key players who are attending. It demonstrates you’re prepared and keen to become connected. This can also help identify shared areas of interest, making it effortless to carry out a conversation. This can be done simply through searching LinkedIn profiles or company websites that contain employee information. After all, the information is there to be read!
  2. Make sure you’ve read about the event and know the details: time, place, what you should bring etc. It’s never a good feeling to be rushed or arrive late.
  3. Be prepared! Bring business cards, company handouts, pens, a notebook, etc. It is strongly recommended to prepare ahead of time, and decrease your chances of forgetting something.
  4. Dress to impress. This is an obvious one however there are always a few people who tend to overlook dress codes. Remember that it’s better to be slightly over dressed than under dressed. To simplify: Style is a way to say who you are without having to speak. –Rachel Zoe
  5. Consider preparing a list of people you’d like to talk to, questions or topics you may wish to discuss or what it is you want to gain from the event.
  6. Don’t go into a conversation expecting something. The best interactions are genuine and on the basis of goodwill. 
  7. Be kind, polite and sincere to everyone because you never know who could be joining in on a conversation or passing by.
  8. Keep an open mind. Opportunities arise quickly and you never know whom you’re going to meet or how you may be able to help one another.
  9. Make sure you’re rested! Sleep is obviously very important.  

Let the Networking Begin
When you’ve reached your networking event, it’s always important to be alert and aware. You don’t want to miss out on any potential opportunities. Keep your goals in mind and if necessary, take frequent breaks to ensure you’re on track.

Try to avoid hesitation when intimidated by someone you wish to speak with. We all can learn from one another so take the opportunity to seek what you are looking for, stay optimistic and keep your head up. Don’t forget to hand out your business cards or information and vice versa. Collecting others information will help with the follow-ups. Go for it and take a few risks! 

Post-networking is crucial for truly harnessing those relationships. This is the time for follow-ups and next steps. It’s important to make the effort to email or call the connections you’ve made to thank them for their time or ask any additional questions. This can further open the relationship up to future interactions and opportunities for collaboration. Add your new connections on LinkedIn to broaden your network and to stay in touch through a social media platform targeted specifically towards networking!

The benefits from networking are very helpful to sustainably grow your company. These outcomes can benefit you in a range of ways. You could meet investors who show interest in your company, professionals who want to join your team or even gain new clients. You will also continue to grow and learn as an individual. While all of this is happening, you are simultaneously creating exposure and establishing a reputable image for you and your company!

So my advice to you is to keep calm and network on!

Elisha Amar
Corporate Program Assistant

5 reasons networking is necessary for start-ups
Business quotes for sharing knowledge
Tom Farley networking tips


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Category Specific Guidance Finalized: Temporary Marketing Authorization for Supplemented Food

Posted on August 31 2016 | Author: Admin

Supplemented Food guidance document has been finalized by the Food Directorate with an extension for Supplemented Food TMAL holders

In addition to the Caffeinated Energy Drink (CED) guidance document that was finalized in 2013, the Food Directorate has published the long awaited final Temporary Marketing Authorization for Supplemented Food Guidance Document this past February. This guidance document has been long awaited by both companies currently developing new formulations, since it provides guidance on acceptable quantities of vitamins and minerals that may be added to a supplemented food, but also by companies whom currently hold TMALs set to expire August 31, 2016.

A few interesting highlights of this new guide are as follows:

  • Definition: Supplemented food has been defined as “a pre-packaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements.” A key point here is that it is now permissible to submit a product through the TMA process that contains only herbal or bioactive ingredients (with no vitamin or mineral fortification) for review. Additionally, the guide provides a subset of novel ingredients that are being permitted in the TMA pathway as per Appendix 2 of this guidance document, see more on this below.
  • Extension: TMALs set to expire on August 31, 2016 have received an extension to comply with the new guide until February 22, 2017. Although to maintain market access beyond February 22, 2017 you must be compliant with this guide, as well as any other applicable Food and Drug Regulations provisions and provide an updated copy of the TMA and label with a letter outlining the revisions to the formula by August 31, 2016. Acceptable products will then be extended until December 31, 2021.
  • 2 Pathway system: Supplemented foods will now be categorized into a pathway system based on the potential for adverse effects. In short the 2 pathways are as follows:
    • Path 1 – Intended for a general subpopulation (children ≥4 years old) with maximum levels of addition of ingredients based on a per serving
    • Path 2 – Intended for a subpopulation  ≥14 years old with maximum levels of addition of ingredients based on a per day. This pathway will also have a threshold for vitamin and mineral fortification which when exceed will trigger specific cautionary labelling statements.
  • Revision to vitamins and minerals not accepted for addition: Consistent with the feedback that Health Canada provided in several regulatory sessions, they have amended the list of ingredients not permitted for addition. Importantly calcium and manganese have been removed from this section and are now permitted in Path 2 (products not intended for children) supplemented food products in quantities specified in this guide.
  • Novel Ingredients: Appendix 2 of this guidance document has now been populated with specific novel ingredients that are eligible for consideration in a supplemented food product. Although, it is worth noting that when an ingredient from this Appendix is added, the Food Directorate cannot commit to the timelines outlined in their performance standards guidance document, and it could delay the TMAL significantly.
  • Unique Identifier: No definitive guidance has been provided yet, but Health Canada has indicated that they are exploring the possibility of a front-of-pack identifier on the label of supplemented foods so that consumers can easily identify them. Health Canada has currently developed several options, which have not yet been disclosed, and will test them with consumers.
  • Market Research Protocol (MRP): For companies that have already received TMALs they may be aware that they are required to provide data in the form of a MRP on their product to address data gaps to aid in the development of specific regulations for supplemented foods. While TMAL holders of Caffeinated Energy Drinks have been advised that they are expected to prepare a MRP and collect data in accordance with this protocol, supplemented food holders had not yet been advised that they must begin this requirement. Once a TMAL holder of a supplemented food receives their final extension, as discussed above, they will be advised of their expected research requirements to fulfil this obligation in their Letter of Agreement.

In summary, the finalized Supplemented Food guidance document is an overdue, appreciated guidance regarding the requirements of a fortified food (outside of foods that are already permitted to be fortified in the Food and Drug Regulations). This guidance should help many companies develop unique and novel products that have a legal path to market without worry of Health Canada reformulation requests.

Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 


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