Navigating the Complexities of Global Dairy Product Compliance

With strict and evolving standards varying by country, launching and marketing new dairy products across multiple markets poses numerous challenges for manufacturers who must ensure compliance. Manufacturers need to rely on regulatory compliance tools, such as Trace One Regulatory Compliance, to avoid time losses, additional costs, or even product recalls. 

A strict global regulation and significant differences across markets 

Global regulation on dairy products is dominated by two main standards prevalent in most countries: the Codex Alimentarius, prepared by the United Nations, and the standards of the European Union, whose influence extends beyond Europe.   

Although these two sets of standards shape global standards for dairy products, impact national laws, and guarantee food safety and quality in various geographical areas, it’s important to note that other regional and national standards also regulate dairy products worldwide. This insight comes from Hamidreza Sohrabi, a Safety Regulatory and Scientific Affairs specialist at Trace One. Trace One is a global leader in PLM and Regulatory Compliance within the process manufacturing and retail CPG space, making their insights and solutions highly relevant and credible. 

Whether it’s the Codex Alimentarius or the European Union standards, dairy product regulation includes recurring elements such as regulations around quality and safety standards, hygiene practices, additives and contaminants, labeling requirements, and microbiological and chemical compliance testing. 

Hamid emphasizes that despite the presence of common standards, significant disparities in dairy product regulation can complicate the task of manufacturers launching new dairy products. For example, the regulation of additives and preservatives is not consistent across markets. This is just one of the many instances that underscore the potential risks of non-compliance with international standards. It’s crucial for manufacturers to grasp these complexities and ensure they are fully compliant to avoid any issues. “In the United States, the Food and Drug Administration (FDA) has a list of approved food additives and specific limits for their use,” while in Europe, there is a “positive list of food additives, along with strict regulations on their usage and maximum authorized levels.” “The national food safety standard in China specifies permissible additives and their maximum usage levels.” 

The challenge of simultaneous launch in multiple markets 

Launching dairy products simultaneously in multiple markets is particularly complex due to the two major international standards, which are not always aligned, as well as national and regional standards, which can lead to significant market fragmentation. Differences between countries can be significant because not all countries strictly adhere to Codex Alimentarius or EU standards, adding layers of regulation, especially regarding microbiological and chemical safety standards, labeling requirements, additives, and preservatives, or even quality standards. 

The Trace One specialist says the main challenges for manufacturers wishing to market their products across multiple markets relate to “labeling adjustments, regulatory compliance, documentation and certification, as well as trade and tariffs-related issues.” 

According to him, manufacturers must navigate multiple regulatory requirements, varied labeling demands, potential product formulation adjustments, as well as quality and safety control issues, trade barriers, and logistical importation and supply chain management issues. 

How to prepare for an international launch 

However, these difficulties and complexities do not mean that such launches are impossible, provided that “meticulous planning and robust regulatory compliance strategies, thorough preparation, and the use of technological solutions for regulatory compliance to track regulatory changes and manage documentation” are implemented. 

To succeed in their international launch, manufacturers must have precise and up-to-date knowledge of the regulatory frameworks of the various countries where they wish to operate. They must also ensure continuous product quality and meet labeling requirements while keeping their operational costs under control. 

“Using regulatory experts, flexible formulations, supply chain optimization, and a phased-entry strategy can help manufacturers to successfully launch their products internationally,” emphasizes Hamidreza Sohrabi before outlining the roadmap for a successful dairy product launch. 

“Manufacturers must invest in powerful systems for regulatory compliance that is effective cross-functional coordination, and advanced technological solutions to manage these challenges effectively. As a result, they can reduce the risks and costs involved and ensure a successful product launch in multiple markets.” 

Regulatory compliance software to support manufacturers 

Beyond intelligent design and quality products, regulatory compliance tools ensure products are brought to market as quickly as possible while meeting local food safety and quality standards, thereby minimizing the risk of recalls. “By optimizing and certifying conveying equipment, manufacturers can maintain these standards and minimize the risk of recalls through warning labels on products to inform customers of potential allergens and by establishing effective inspection protocols to detect packaging defects, which are essential steps,” adds Hamidreza Sohrabi. 

Trace One offers manufacturers a unique Trace One Regulatory Compliance database to access all relevant product information and receive real-time updates on regulatory developments, which “facilitates data integration, supporting manufacturers’ commitment to safe and high-quality production and avoiding costly recalls.” The Trace One Regulatory Compliance solution covers more than 170 countries and enables manufacturers to easily search and compare different requirements for each country and track regulatory changes. Users can generate custom regulatory queries by receiving email alerts on the news, recalls, regulatory changes, and all other relevant updates to ensure full compliance and support continuous improvement of their production processes. By leveraging Trace One, businesses can navigate complex regulatory landscapes more effectively and focus on delivering safe and high-quality products to consumers while tackling challenges such as product lifecycle sustainability or Packaging management solutions.