mdi ConsultantsStarting Sept 2016
All our food clients are made aware that the FDA has finally released the final rules on two regulations that will affect the human and animal foods.
These changes will be the most comprehensive and dynamic changes to the Food Industry since the 1970’s. The intent is to provide new Safety Requirements for facilities that manufacture, process, pack or hold human and animal food.
The new rules called Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals establish the current good manufacturing practice (cGMP) and preventive controls requirements – one governing human food, and the other animal food. The new rules will significantly change the way food companies operate to assure compliance to the FDA regulations.
To provide the industry information on these new rules, FDA has issued fact sheets summarizing the rules’ principal requirements
In September 2015, FDA will be hosting three online webinars to present and discuss the new regulations. There is also a scheduled public meeting on food safety rules taking place in Chicago on October 20, 2015. In addition, the Agency indicated that several guidance documents are forthcoming.
For human food facilities, larger businesses (over 500 employees) will be expected to comply with cGMP requirements and most preventive control requirements by September 19, 2016, whereas small (<500 employees) and very small businesses (<50 people) will have until September 18, 2017, and September 17, 2018, respectively.
There will be some stipulations for the FDA to allow additional time for compliance with the supply chain program requirements of the rule.
For animal food facilities, larger businesses will be expected to comply with cGMP requirements by September 19, 2016, and with most preventive controls requirements by September 18, 2017; small businesses will have an additional year after these dates, and very small businesses will have an additional two years after these dates. As with the human food regulations, the FDA is also allowing some additional time for compliance with the supply chain program requirements of the animal food rule, under certain circumstances.
We will keep you updated about these as and when there are any FDA developments pertaining to the new food regulations.
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Email us at [email protected] to understand more about these new regulations and ref: New Food Regulations.