In November 2017, IFS revised the version 6 to version 6.1 The expected version 7 of IFS Food has been postponed until the end of 2018.
With this change, the standard meets the benchmarking requirements of the GFSI and will remain a GFSI reference standard. The main changes in version 6.1 focus on the following topics:
- New requirements about food fraud
- Revision of the requirement about allergens management
- Integrity Program procedures were adopted to the rules valid since 01st May 2017
- Mandatory inclusion of QR-codes on the IFS certificate to trace its authenticity
Changes for the certified organizations
A new requirement was added to IFS version 6.1. The new paragraph 4.21 Food Fraud requires the following from food organizations:
A) a documented food fraud vulnerability assessment that will take into consideration all raw materials, ingredients, packaging and outsourced processes.The basic objective of this assessment is the determination of risk level in finished products from fraudulent acts (fraud, substitution of ingredients, incorrect labeling, etc.) with the aim of economic benefit and deception of the consumer.The criteria considered within the vulnerability assessment shall be defined.
B) a documented food fraud mitigation plan. Specific control methods and criteria should bedefined and implemented C) the documented food fraud vulnerability assessment and food fraud mitigation plan shall be reviewed in the event of increased risk (e.g food fraudincidents) or at least annually.
This requirement (4.20 Allergens and specific conditions of production) defines that organizations based on hazard analysis and assessment should take measures from receipt to dispatch to ensure that the risk of allergenic substances originating from cross contamination is reduced. These control measures should be verified.
Implementation of IFS version 6.1
The version IFS 6.1 will come into force on July 1st, 2018. For Companies which are audited unannounced applies the following:
- If audit period starts on or after July 1st, 2018 the company will be audited against IFS Food 6.1.
- If audit period starts before the 1st of July, 2018 the company has to be audited against IFS Food 6 April 2014.
As consumers and government bodies continue to demand more in terms of food safety and transparency, it’s never been more important for those in the food manufacturing and processing industry to become certified. But what exactly does this mean? In the US, there are hundreds of organizations that inspect, test and certify food products based on strict standards set out by religious organizations and the U.S. government. Though different certification processes can be lengthy and costly, the benefits of being certified are often too valuable to ignore. A recent study conducted by the Organic Trade Association, for example, found that organic sales grew from $3.6 billion in 1997, to $43.3 billion in 2015. In 2015, the organic industry experienced a 10.8% growth rate, which is well above the overall food market at 3.3%. As interest in organic and other certifiable foods continues to increase, it’s important to take advantage and get certified. Below, we outline the various certifications available for US food companies and how you can go about getting your product to market accurately and in compliance with FDA and USDA standards.
In August 2013, the FDA issued a final rule that set a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. “This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten.” In addition, the FDA also rules that food labeled as “without gluten,” “free of gluten” and “no-gluten” must also be held to the same standard.
While the FDA doesn’t specifically endorse any third-party gluten-free certification programs, there are many to choose from. The Gluten-Free Certification Program states that over 100 million North Americans are currently buying gluten-free products. The program goes onto explain that by becoming gluten-free certified, “companies can benefit from the gluten-free market and its exponential growth by communicating their commitment to producing safe, reliable and trusted gluten free products for consumers.”
Organic certification in the US is regulated by the National Organic Program (NOP), a division of the United States Department of Agriculture (USDA). In order to be considered organic, a product must be produced and processed using only handling and processing methods approved by the USDA. “These methods integrate cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance and conserve biodiversity.” Only products that have been certified by the USDA may carry the USDA Organic Seal.
There are four different levels or organic claims recognized by the USDA:
- 100% Organic
- “Made With” Organic
- Specific Organic Ingredients
To begin the organic certification process, visit the USDA’s website.
A GMO, or genetically modified organism, is a plant, animal, microorganism or other organism whose genetic makeup has been modified at the DNA level. This creates unstable combinations of plant, animal, bacterial or viral genes that do not occur in nature. Deeming something non-GMO certified has become a highly-contested issue, largely due to the fact that the FDA has recently suggested that there is not enough evidence to show that foods derived from non-genetically modified plants differ from those derived from genetically modified ones in any meaningful way. The FDA also explained that there is not enough evidence suggesting that genetically engineered food presents greater health or safety concerns than food developed by traditional plant breeding. In terms of labelling and becoming non-GMO certified, the FDA’s guidance on the issue cautions against using terms like “free,” “does not contain GMOs” or “non-GMO” because of the difficulty of substantiating such claims. Although the FDA does not indicate whether it intends to enforce this, approximately 80 bills have been introduced in state legislature demanding special labelling for foods containing GMOs. The FDA does not require any special labelling at this time.
While non-GMO labelling is not required, annual sales of non-GMO verified products now exceeds $16 billion, and a 2014 consumer survey conducted by the Non-GMO Project found that 80% of consumers seek out non-GMO products.”
Before beginning the certification process, it’s important to understand the various requirements and standards your product and facility will be held to going forward. While every certification will vary in terms of these requirements and standards, the necessary functionalities and data management elements will not. Some of these functionalities include:
- Recipe management
- Ingredient formulation
- Quality management
FSMA regulations require most in the food and beverage industry to have a written food safety plan. Among other important elements, the food safety plan must contain a written hazard analysis and written preventative controls. Why is this important to an allergen control plan? Because federal regulations identify cross-contact of food allergens as a chemical hazard. Practically speaking, this means if you operate a facility that has both allergen-containing and allergen-free products, or allergen-containing products with different allergens, you have a cross-contact hazard. This hazard should be identified in your hazard analysis and a preventative control should be put in place. That preventative control will be your allergen control plan.
All preventative controls, including allergen control plans, must be in writing and must provide assurances that the applicable hazard (in our case allergen cross-contact) will be significantly minimized or prevented. When writing food allergen controls, you should consider the three Ps — procedures, practices, and processes — to control food allergens.
The goal is to control procedures, practices, and processes to prevent allergen cross-contact. This means that during storage, handling, and use of food products in the facility, reasonable steps are taken to prevent cross-contact and to prevent undeclared allergens from getting into products. This starts by forming an allergen-control team, or identifying an allergen-control captain to lead the efforts. The team should be familiar with the ingredients and products in the facility, the processes that take place there, and the sanitization requirements for the facility’s equipment. They should be empowered to propose alternative processes to prevent allergen cross-contact, and to review and analyze existing procedures to make sure they are maximally effective. In terms of practical controls, preventing allergen cross-contact starts by knowing what is in ingredients. An important first step is getting supplier verifications regarding the allergens that are in the ingredients they supply. Make sure any allergens present in an ingredient are conspicuously labeled. Color-coded labels can be an effective means to indicate the presence of an allergen. When storing ingredients, do your best to segregate allergen-containing ingredients from allergen-free ingredients. If separate facilities are not available, try separate store rooms/coolers. If that is not an option, take common sense steps, such as putting allergen-containing ingredients on the bottom shelf so that they cannot spill into anything else and making sure containers stay clearly and safely sealed.
When producing food, allergen controls should prevent as much overlap as possible between allergen-containing and allergen-free products. Where available, allergen-free products should be run on a separate production line where no allergen-containing ingredients are introduced. If an allergen-free line is near an allergen-containing line, physical barriers (i.e. a wall) should be erected to separate them and separate ventilation systems may be appropriate to avoid airborne cross-contact. Where separate lines are not possible, changeovers should be limited as much as possible. In other words, run as many allergen-free products as you can before running allergen-containing products, and then run as many allergen-containing products as you can. Sanitization should be scheduled for immediately after the completion of an allergen-containing run.
Besides segregated product runs, you can minimize cross-contact risk with reasonable employee and equipment controls. For example, tools, containers, and utensils used to handle a particular allergen or ingredient containing an allergen should be clearly marked and easily identified. Think of a purple handle for anything coming in contact with peanuts, for example. Employees who work on product runs which contain allergens should be restricted from working on products that are allergen-free. Where this is not possible, extra sanitization should take place between runs, including a change of uniform, hairnet, smock, etc. Allergen-free apparel should be colored differently than that worn when processing allergen-containing products.
Consider traffic patterns in your facility as part of your allergen control plan. Allergen-containing ingredients should be stored as close as possible to the allergen-containing production line to minimize cross-contact with other products. Likewise, employees should not be going from one line to the other without proper sanitization procedures. These controls will help “significantly minimize” the allergen cross-contact hazard in your facility.
The second component of an allergen control plan deals with the labeling of finished food products. A discussion of food labeling requirements, including the vagaries of “advisory labeling,” could go on for pages. Of importance to your allergen control plan is ensuring products are not “misbranded” pursuant to the Federal Food Drug & Cosmetic Act. A product is misbranded where it contains an undeclared major allergen. Taking the steps discussed above will help reduce the likelihood of allergen cross-contact occurring in your facility, and thus will reduce the likelihood that an undeclared allergen will make it into your product.
Like everything else, the effectiveness of an allergen control plan will depend largely on staff training and education. Let staff know the risks — and legal liabilities — of an undeclared allergen to a consumer with a serious food allergy. Provide staff training on allergen awareness and control for all employees at all levels of the company, at least annually. Specific training should also be provided to employees whose job duties would put them at greater risk of an allergen cross-contact incident. All training should be documented so it is known who has been trained and when training should be renewed. While there is no way to completely eliminate any risk of allergen cross-contact, provisions like those discussed above will help to significantly minimize the cross-contact hazard, as required by FSMA’s food safety plan regulations.
There is some confusion over Hazard Analysis and Critical Control Points and the more-recent food-safety plan, Hazard Analysis and Risk-Based Preventive Controls. Here are the key differences.
Both Hazard Analysis and Critical Control Points (HACCP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) are discussed, almost interchangeably, albeit incorrectly, in food-processing circles. The truth is that if you were to ask most food processing professionals to explain the differences between the two, the answer may not come so easily.
HACCP is a global standard, developed in the late 1950s and early 1960s by a team of engineers and scientists from three distinctly different organizations. Pillsbury, the Army’s Natick Research Labs, and the National Aeronautics and Space Administration (NASA) joined forces to draft and adopt a global, food-safety standard in keeping with, and as part of, the Codex Alimentarius. The Codex commission was established by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) in 1963. HACCP was originally developed as a way to ensure built-in quality and food safety, specifically for the manned space program, though it has evolved greatly since that point in time.
HACCP’s evolution has been continual, resulting in an effective and efficient, comprehensive food-safety management system (FSMS). Pillsbury publicly presented the HACCP concept at the 1971 National Conference on Food Protection, jointly sponsored by the Food and Drug Administration (FDA) and the American Public Health Association (APHA). In 1974, the FDA incorporated its concepts into its low-acid and acidified-food regulations. By the end of the 1980s, McDonald’s started requiring all of its suppliers to adhere to HACCP in order to ensure the safety of the food being served in its restaurants. Spurred by the marketplace, rather than legislation or regulation, other large companies followed suit and HACCP became the standard by which to measure food safety.
In 1989, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), published the first official HACCP document, standardizing the practice and presenting the seven principles of HACCP: (1) Hazard Analysis, (2) Critical Control Point Identification, (3) Establishment of Critical Limits, (4) Processes for Monitoring, (5) Corrective Actions (6) Record Keeping, and (7) Establishment of Verification Procedures . The rest, as they say, is history.
Moving forward, HARCP is not a global standard, but an updated U.S. standard incorporated into the Food Safety Modernization Act (FSMA) on July 4, 2012. Whereas HACCP generally applies to low-acid, canned food, juice, and seafood processors, HARPC applies to almost all food-processing facilities. The only facilities not required to comply with HARPC are those subject to the Standards of Produce Safety, those already governed by HACCP, and those facilities regulated by Good Manufacturing Practices (GMP) for Dietary Supplements. Small and very small business entities, as defined by the FDA are also exempt.
- HARPC mandates that facilities:
- Conduct a thorough hazard analysis for all food-processing procedures
- Develop and implement preventive controls, and then monitor the controls’ effectiveness
- Provide a detailed plan in writing, describing how the hazards will be controlled, the preventive controls put in place, and a schedule and methodology for monitoring the efficiency of the controls
- Verify the effectiveness of the controls, also maintaining written records of the verification processes
- Reanalyze the HARCP plan at least every three years; more often as new product lines are added, equipment is changed or upgraded, and/or when other changes require a new analysis
Finally, unlike HACCP, HARPC includes planning for potential terrorist acts and/or intentional adulteration and food fraud. A facility’s HARPC, food-defense plan should include additional security, such as visitor access and control.To put it even more simply, if you have an effective HARPC plan in place, you are also in compliance with HACCP mandates. If, however, you currently function under HACCP guidelines, it is your responsibility to determine if you must comply with HARPC under FSMA.