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FDA Addresses Nutrition Label Issue for Small Amounts of Nutrients and Dietary Ingredients in Finalized Guidance Document

Posted on October 27 2016 | Author: Admin

As of the beginning of July 2016, the FDA has finalized the draft guidance document (originally drafted and released for consultation at the end of July 2015) on its policy about Nutrition Labels and how small quantities of nutrients and dietary ingredients should be declared by food and dietary supplement manufacturers.

The finalized guidance document acknowledges the conflict that sometimes may arise when being in compliance with two distinct sections of regulations and which regulation takes precedence in the discretion of the FDA. The two sections of FDA regulations (both from Title 21 of the Code of Federal Regulations [21 CFR] 101.9) where compliance could potentially be mutually exclusive are:

  • 21 CFR 101.9(c)(1)-(8): These regulations describe the nutrition-labelling requirements in declaring the nutrient values in a serving of conventional food. It specifies that in declaring nutrients, specific “rounding” rules have to be applied, where the stated value has to be to a distinct increment (ex. the quantitative amount of total fat present at 5 g or less must be rounded to the nearest 0.5 increment).  This regulation also specifies how the FDA tests for compliance to these values.
  • 21 CFR 101.9(g)(4)(ii) and (5): These regulations describe the compliance requirements for declaring dietary ingredients and nutrients in nutrition labelling.  These compliance provisions (sometimes referred to as the “20-20” rule) describes a product to be misbranded under the following two conditions:
    1. The amount of a naturally present vitamin, mineral, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated fat, monounsaturated fat or potassium is less than 80% of the value for that nutrient declared on the label (21 CFR 101.9(g)(4)(ii)).
    2. The amount of calories, sugars, total fat, saturated fat, trans fat, cholesterol, or sodium is more than 120% of the declared value for that nutrient (21 CFR 101.9(g)(5).

The conflicting values for a nutrient can arise when small quantities of nutrients have to be declared.  The rounding requirements under 101.9(c)(1)-(8) may result in a value being declared that exceeds the 20% deviation permitted in 101.9(g)(4)(ii) and (5).  An example would be a food containing 0.70 g of saturated fat per serving.  The quantity that should be declared according to 101.9(c)(2)(i) would be  0.5 g.  However this declaration would not comply with § 101.9(g)(5) because 0.70 g is more than 20 percent in excess of 0.5 g.

The FDA’s resolution  (“to be applied to all products in a consistent way” ) is based on the rationale that as the FDA’s nutrition labelling requirements in 21 CFR 101.9(c)(1)-(8) specifies the increments and units of measure for declaring nutrient values while 21 CFR 101.9(g)(4)(ii) and (5) does not, the “FDA considers it more practical and consistent” for manufacturers to follow paragraph (c)(1)-(8) when a conflict occurs between 21 CFR 101.9(c)(1)-(8) and 21 CFR 101.9(g)(4)(ii) and (5).

 

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

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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.

Transparency
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

 

Sources
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

Photo 
Pixabay






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