European Food Safety Authority (EFSA) Novel Food Application Compliance

The European Food Safety Authority (EFSA) is a European Union agency tasked with protecting public health and consumer interests by increasing food safety standards. It evaluates, assesses and monitors potential risks posed by the food chain and provides policy advice to aid the EU.

EFSA also acts to control new and emerging foodstuffs and food ingredients that can enter into the EU food system. They do this through the novel food pathway, which was initially set up in 1997, through the promulgation of Regulation EC 258/1997, later updated in 2015 (Regulation EU 2015/2283). Companies wishing to market a novel foods must submit an application to the European Commision, including the data which demonstrates that the food is safe for consumption, which will be evaluated by EFSA. EFSA considers the safety risk of the ingredient upon human health in their assessment, including assessments of possible effects on vulnerable groups. As part of the risk assessment process, EFSA conducts a public consultation, where stakeholders can submit further data. Based on the scientific opinion published by EFSA, the European Commission decides whether to add the submitted food to its list of accepted novel foods.

The EU legislation sets in place a grandfathered date where if the ingredient was present in food or food supplements within the EU Member states prior to 17 May 1997, then it is not classified as a novel food. Similarly, novel technologies used in food production that alter the composition or structure of the food that were not used in food production prior to 17 May 1997, can constitute novel foods, even if the ingredients or foods themselves were consumed prior to this date.  Certain information, if confidential of proprietary, is supplied to EFSA as part of the novel food submission to support the scientific basis for safety, it can be protected from disclosure for a period of 5 years.  Click here to learn more about novel food notifications.

European Food Safety Authority (EFSA) Compliance

Food Supplements cover both supplements and foods. European Food Safety Authority (EFSA) regulates the Food industry. Directive 2002/46/EC provides regulatory guidance on the limits of minerals, vitamins, botanicals, and labelling. However, each 28 Member States of the European Union have crafted their own notification procedure. Timelines for product registration can vary from 6 to 9 months for one country. 

Due to the lack of harmonization, expert guidance to navigate through the different registration procedures is required. Quality Smart Solutions with an operational and delivery centre in Europe, provide assistance to manufacturers, sellers, distributors, importers and exporters with end-to-end EFSA Regulatory procedures.

What is the European Food Safety Authority?

The European Food Safety Authority (EFSA) is an independent body set up to provide public and consumer safety by assessing the potential risk of food-borne hazards in the European Union. It specifically evaluates and assesses the risks posed by food ingredients and contaminants, animal health issues, feed additives and pesticides. EFSA also develops scientific guidance which supports decision-making processes to ensure safe, legal levels are set for collection, production and sale of foodstuffs across Europe.

What Does the EFSA Do?

The EFSA is responsible for assessing the safety of food and its ingredients, as well as any potential risks posed by contaminants. This includes evaluation of pesticide residues, heavy metals, herbicides, veterinary medicines and food contact materials. In addition to risk assessments, the EFSA also carries out scientific research and develops guidance documents to ensure regulated amounts of these substances are maintained in foodstuffs.

How Does the EFSA Approach Its Work?

The EFSA employs a multidisciplinary approach to food safety, using expertise from epidemiological, toxicological and other scientific disciplines to assess potential risks posed by different ingredients and contaminants. The EFSA also works with national authorities across the European Union (EU) in order to ensure a consistent level of food safety throughout all EU countries. This enables the mutual recognition of assessments, as well as creating database standards for sharing information about potentially hazardous substances or organisms.

How Is Decision-Making Handled Within the Framework of EU Regulation?

The EFSA plays an important role in decision-making within the framework of European Union food safety regulations. Its scientists provide risk assessors with detailed and up-to-date information on potential risks posed by different substances or organisms, based on rigorous scientific research. They supply recommendations to the European Commission, which form the basis for further discussions and political agreements. Ultimately, this allows the Commission to make sound, science-based decisions about food safety regulations in the EU.

What Are Some Examples of EFSA's Recent Accomplishments and Challenges?

Two key recent accomplishments of the EFSA include the publication of its 2014-2020 Strategic Plan and its 2019 Scientific Colloquium on reducing the burden of foodborne antimicrobial resistance. In addition, the EFSA has undertaken significant outreach activities to raise public awareness and understanding of food safety risks. Challenges have included gaps in data availability and developing new methods for risk assessment. The EFSA also faces an increased workload in terms of preparing opinions, which can be difficult due to lack of resources or disagreements among stakeholders.

How We Can Help You

Our assistance for Food & Food Supplements Compliance in European Union (EFSA) is available for those willing to enter the market of European union member states. We have federal regulatory officials who provide guidelines to manufacturing facilities about legal documentation, facility requirements, standard operation procedure. We help obtain a license or get approval from EFSA to enter the European Union market. 

Services Offered by Quality Smart Solutions

With a team of federal experts, we inform and guide businesses about Food Product Classification, Food Supplement Classification, Formula Review, Label and Claims Review, Claims Consultation and Substantiation, EU Country-specific Regulatory Support, Dossier Compilation and Submission, Food products / Food Supplements Import Guidance. Our end-to-end EFSA regulatory solutions:

Product Strategy & Classification

When you partner with us, our experts will help you in crafting product strategy and classification. You’ll know which set of EFSA Regulations your products fall to meet the compliance requirements.

Compliance Consulting

Our European compliance experts will assess all your compliance facets in order for meeting the food compliance requirements of EFSA, thereby letting you enter the European Union food marketplace and grow your business.

Regulatory Compliance

Gain the benefits of our expertise in EFSA Regulatory Compliance in the European Union for a range of health and food products and be ready to cater to any changes in regulatory compliance and get your product registered.

Expert Guidance

Worried about meeting Regulatory Compliance of EFSA? Don’t worry. We will help by delivering every piece of information and guidance required to enter the European Union marketplace without facing any issue.

Auditing & Inspection

Our Compliance team consists of former EFSA compliance experts who carry out audits and inspection of your product materials, packaging, labelling, quality to determine that you meet EFSA Compliance.

Application Assistance

Get full service related to application process, documentation process and licensing process. We support both domestic and international businesses with EFSA Regulatory solutions for product registrations.

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