Over the last decade, while the European Union (EU) has maintained its position as a global leader in the regulatory framework for biotechnological products, other key regions around the world have also made significant strides in establishing and updating their regulations. Although the EU’s extensive legislation guarantees safety for consumers, production animals (in the case of feed additives), workers, and the environment, the majority of the world’s population lives outside the EU. For companies aiming to enter global markets, it is essential to understand and comply with the food safety regulations in other economic regions.
In this article, we explore how three major regions—the United States, China, and Latin America—have developed regulatory frameworks for biotechnological products, specifically in the context of food (including novel foods) and feed. This micro-review focuses on how these regions have evolved their regulations, leaving out medicines and pharmaceuticals, to provide a clearer understanding of global biotech regulation trends.
The United States: GRAS and a Flexible Framework
In the United States of America, biotechnological products are primarily regulated by the Food and Drug Administration (FDA), which may require premarketing approval for certain products. However, most companies rely on the Generally Recognized as Safe (GRAS) concept. This approach allows companies to bypass formal premarket approval if a product has been used in the market before 1958 or if it is deemed safe by recognised experts.
The GRAS system is primarily driven by voluntary notifications, where companies submit relevant safety and product data to the FDA. If the product meets the FDA’s safety standards, it can be added to the GRAS list, enabling companies to avoid the lengthy pre-approval process.
In cases involving genetically modified organisms (GMOs), pesticides, or biotechnological feed products, the Environmental Protection Agency (EPA) or the US Department of Agriculture (USDA) may also play a regulatory role. The US system provides flexibility for companies, especially for novel foods, while still maintaining high standards of safety.
China: A Rapidly Evolving Regulatory Environment
In the last decade, the People’s Republic of China has rapidly updated its food safety regulations to match the growing demand for innovation in biotechnology. The National Food Safety Commission oversees these efforts, with the Food Safety Law updated as recently as 2021. This update emphasizes stricter safety requirements, increased food safety standards, and more rigorous testing procedures for biotechnological products.
The regulation of genetically modified organisms (GMOs) is also evolving in China. The National Biosafety Committee (NBS) is responsible for evaluating the safety of agricultural GMOs, while the National Health Committee handles the safety of genetically modified microorganisms (GMMs) and novel foods. Over the past decade, China has published various lists of approved microbial strains and probiotics for different consumer sectors, reflecting the country's increasing focus on formalizing its biotechnological product regulations.
However, China’s regulatory framework is still under development, with gaps and challenges remaining. These challenges present opportunities for companies to engage with regulatory bodies as the country solidifies its position in the global biotech landscape.
Latin America: Argentina and Brazil Lead the Way
Among Latin American countries, Argentina and Brazil have led the way in developing biotechnological regulations, particularly focusing on genetically modified crops. Over the past decade, both countries have expanded their regulations to include microbial biotechnological products.
In Argentina, the National Food Institute (INAL) evaluates microbial biotechnology products for food safety, while Brazil entrusts this role to the National Health Surveillance Agency (ANVISA). Though their biotech regulations were initially centered around GM crops, both nations have broadened their frameworks to address novel foods and feed additives derived from biotechnology, offering a more structured regulatory path for companies entering these markets.
Looking ahead, Argentina and Brazil are well-positioned to continue leading the way in biotechnology regulation in Latin America. Their commitment to science-based regulation, coupled with ongoing investments in research and development, will likely drive further advancements in the sector. Additionally, their experiences can serve as valuable models for other countries in the region looking to develop their own biotechnological regulatory frameworks.
Common Themes in Global Regulation
Despite regional differences, a common theme emerges: most countries outside the EU require rigorous safety assessments for biotechnological products. The European regulatory framework, known for its strict standards, is often used as a reference point in global markets. However, each country or region adds its own specific requirements, meaning companies must carefully engage with local authorities to ensure compliance.
For example:
- The US system is relatively flexible, offering multiple pathways for approval, such as the GRAS system and voluntary notifications.
- China’s regulatory environment is still under construction, but it is quickly advancing toward a more formalized and stringent framework for novel foods and biotechnological products.
- In Latin America, Argentina and Brazil have well-established systems for regulating biotechnological products, although their focus has historically been on GM crops.
How Biosafe Can Help
Navigating the complex regulatory landscapes in different jurisdictions can be challenging. This is where Biosafe comes in. We specialise in developing cost-effective strategies to help companies bring biotechnological products to market across various regulatory environments. By working closely with our clients, we ensure that all applications meet the specific legal requirements of each country or region.
Our team of experts provides tailored guidance on how to:
- Prepare comprehensive regulatory dossiers that align with local safety standards.
- Avoid unnecessary costs and delays by understanding the nuances of different regulatory frameworks.
- Develop a global market entry strategy that mitigates risks and maximizes potential for success.
With our in-depth understanding of the EU, US, Chinese, and Latin American regulatory environments, Biosafe can help you navigate the complexities of the global biotech market, ensuring your products are safe, compliant, and ready for consumers worldwide.
