Food safety regulations in the European Union

The European Union (EU) has some of the most stringent food safety regulations in the world. From the General Food Law to sectorial laws and detailed guidance on how to assess safety, the EU sets high standards for food safety that affect not just its 27 Member States but also the global food industry.

This article serves as an overview of EU food safety policy, shedding light not only on food safety regulation in the European Union but also on the guidance documents that are integral to the evaluation of regulated products. It is important to note that this article functions as a glossary, elucidating industry-specific terms and concepts. While it does not delve into aspects like hygiene regulations or contamination issues, its focal point is on regulated products that undergo evaluation by EFSA. We aim to provide insights into the implications of EU food safety regulations on the food chain and the considerations for those seeking to introduce their products into the dynamic European market.

From strain discovery to regulatory success – What really matters?

Quick links to content:

Farm-to-fork food chain regulation
EU, EC and EFSA approvals, assessments and authorisations
General Food Law
Transparency Regulation
Food Safety Assessment
Food enzymes, feed additives, plant protection products
Environmental risk assessment
EFSA Guidances
EFSA Novel Food Guidance
Registering new microorganisms as novel foods
AMR policy in the EU
QPS Status
Future biotech regulations
Getting help from food safety consultancies
Conclusion

Farm-to-fork food chain regulation

The food chain begins with the production, processing, storage and transport of food products, and ends with the preparation, distribution and consumption of food.

The EU has implemented a farm-to-fork approach to food safety, meaning that the entire food chain is subject to regulation. It requires food businesses to take the necessary precautions to ensure the safety, integrity and quality of food products throughout the chain. This includes the registration of food businesses and the traceability of food products, as well as the premarket registration of certain regulated products such as food additives, food enzymes, and genetically modified food.

EU, EC and EFSA approvals, assessments and authorisations

Food and feed businesses need to seek approval for certain regulated products before placing them on the European market. In the European Union (EU), there is a hierarchical system (or framework) for getting approval for new food products to enter the market. The European Commission (EC) is the EU's executive branch, responsible for making the final decision on whether to authorise a new food product, but they rely on the scientific expertise of the European Food Safety Authority (EFSA) for scientific safety assessments.

The process begins with the submission of a food product application, which includes a technical dossier, to the European Commission via the e-submission system. The dossier should contain scientific data on its proposed uses and use levels as well as detailed information about the product, including its source and identity, raw materials, manufacturing processes, purity and nutritional value. The EU also requires that food businesses provide proof that their products meet the safety and qualityprinciples set out in the EU General Food Law.

The Commission then mandates or tasks EFSA to evaluate the safety of the substance for its intended uses. EFSA will conduct a comprehensive assessment of the food product, including a safety evaluation, and provide a scientific opinion to the EC. The EC will use EFSA's scientific opinion to make a final decision on whether to authorise the food product for sale in the EU market.

It's important to note that the EC has the final say on authorising new food products in the EU. EFSA's role is to provide scientific expertise and guidance, but they do not have the authority to approve or reject food products.

At Biosafe, we understand the complexities of navigating the regulatory framework for new food products in the EU. We can provide expert advice and guidance on the food safety assessment process, helping our customers ensure that their products meet the necessary requirements for authorization in the EU market.

General Food Law

Regulation (EC) No 178/2002 or the EU General Food Law is the starting point for all food safety regulations in the European Union.

It aims to ensure a high level of protection of human health and consumers’ interests in relation to food, while supporting the functioning of the internal market. It lays down the basic principles and requirements for EU food and feed law, including the prohibition on placing unsafe food on the market, traceability of food and feed throughout the supply chain, and the primary responsibility of food business operators for the safety of the food they place on the market.The regulation also established the European Food Safety Authority (EFSA) as an independent scientific agency responsible for providing scientific advice and risk assessments on food safety issues as opposed to national food authorities.

Read more on recent changes: How will food transparency change with the new amended EU General Food Law?

Transparency Regulation

Regulation (EU) 2019/1381 or the Transparency Regulation amends the General Food Law to strengthen public trust in the EU food safety system. The Regulation increased transparency by making the scientific studies and other information submitted to EFSA publicly available during the risk assessment process. In principle, studies, data and supporting information submitted in support of applications for regulated products, including novel foods and other products requiring EFSA assessment, are published through EFSA's electronic systems. Confidential business information may be protected where a confidentiality request is duly justified and accepted by EFSA.

There are many questions that arose when the Regulation took effect in 2021.

You can read them here: Transparency Regulation in the EU 2021 — How to Comply

Food Safety Assessment

The EU requires certain regulated food products to undergo a scientific safety assessment and obtain authorisation before they can be placed on the market. Depending on the product category, applicants may need to submit information on the identity of the product, its composition, manufacturing process, intended uses, and, where relevant, toxicological, nutritional and allergenicity data. Food business operators are also generally required to implement procedures based on HACCP principles to identify and control food safety hazards.

Food enzymes, feed additives, plant protection products

The EU also requires food businesses to seek authorisation for the use of many products in the food chain that are not foods per se. For example, food enzymes, feed additives and plant protection products all have specific regulations that apply to them. The authorisation process requires the submission of detailed data on the safety and sometimes the efficacy of the product, as well as proof that the product meets the principles and requirements set out in the EU General Food Law.

Environmental Risk Assessment

In some cases, EU legislation requires an environmental risk assessment (ERA) before regulated products such as GMOs, feed additives and certain pesticides can be authorised. Applicants submit studies and other relevant data on potential environmental impacts, which are evaluated by EFSA and, where applicable, other competent authorities. This helps ensure that the environment is protected from potential risks associated with the use of these products.

EFSA Guidances

The European Food Safety Authority (EFSA) provides guidance on the safety of food products and what studies are required for e.g. food additives, food enzymes, and genetically modified microorganisms (GMMs). These guidance documents are based on the latest scientific research and evidence and are used to help food businesses comply with the EU's regulations.

The Dos and Don’ts in the Development of Novel Microbial Products

EFSA Novel Food Guidance

EFSA also provides guidance on novel foods, which are foods that are not traditionally consumed in the European Union. These can range from new microbial products to algae in the food chain. This guidance helps food businesses identify potential hazards and risks associated with novel foods.

Registering new microorganisms as novel foods

The EU requires the registration of new microorganisms before they can be used as food. This process requires the submission of detailed information about the microorganism and the assessment of its safety, its proposed use and use levels.

AMR policy in the EU

There are stringent rules for the prevention and control of Antimicrobial Resistance (AMR) in the European Union. For regulated products containing or produced using microorganisms, applicants are required to assess the presence of antimicrobial resistance determinants and their potential for transfer. According to EFSA guidance, microorganisms intentionally added to the food chain should not contribute to the pool of antimicrobial resistance genes already present in microbial populations or otherwise increase the spread of AMR. Surveillance programmes across the EU also monitor antimicrobial resistance in selected bacteria from animals, food and humans to support risk management and policy development.

QPS Status

The EU's Qualified Presumption of Safety (QPS) status is given to microorganisms that have been assessed by the European Food Safety Authority and found to be safe for human consumption, animals, and the environment. This status allows food businesses to fast-track the assessment process of their microbial product, so they can place their product on the market without having to perform toxicological studies, provided that the overall production process does not give rise to concern.

QPS status: the golden standard of microorganism safety evaluation

Future biotech regulations

The EU and EFSA are constantly updating their regulations and guidance documents to keep up with advances in the field of biotechnology. This can include organisms derived from new genomic techniques or the authorisation of new food additives and food enzymes. Cellular agriculture holds a lot of promise as heard in this webinar on future food production.

Customers are increasingly interested in new sustainable foods and companies are increasingly looking for new solutions, which we got to experience first-hand at the latest Future Food-Tech summit.

Change in European GMO legislation is in the air

The EU's GMO legislation was developed at a time when modern genome-editing technologies did not yet exist. As scientific understanding and breeding technologies have advanced, policymakers have questioned whether the current regulatory framework remains proportionate for all genetically modified products. In response, the European Commission proposed a new regulatory framework for certain plants developed using new genomic techniques (NGTs), aiming to better align regulatory requirements with the characteristics and risk profiles of these products while maintaining a high level of protection for human health and the environment.

Getting help from food safety consultancies

Companies can turn to food safety consultants before placing food products on the market. This helps to ensure that the product meets the necessary safety and quality standards and helps to make the authorisation process as smooth as possible. Being a socially responsible corporation in the food industry is also something consultants like Biosafe can help with.

Food safety consultancy: finding out what customers really need

Conclusion

The European Union's regulations have a huge impact on the food chain and the global food industry. The EU as a huge trading block and legislative zone sways the decisions of many companies and sets standards not just for Europe but for the world.