Food regulatory services from product development to reviews, registration and marketing
Medfiles offers comprehensive regulatory expertise for food business operators – from research and product development to registration, launch, and marketing. Our experts support the entire food value chain, including packaging and labelling of consumer products – guiding you all the way from farm to fork.
Our services cover foods already on the market as well as new innovations and novel sources, such as microorganism-based products (bacteria, fungi, algae) and products from side streams or cellular agriculture – not forgetting other new ingredients. We always take into account the specific features of your product and the aspects affecting its marketing, tailoring our services to your needs. You can rely on us to ensure compliance with regulatory requirements – efficiently and thoroughly managed.
Read more about our food regulatory services
Novel foods and new ingredients
Novel food registrations in the EU, UK and internationally – from regulatory classification and consultation requests to gap analyses, and registration dossiers.
GRAS, NDI and FAP registrations
New foods, ingredients and dietary supplements for the USA market – from regulatory classification and gap analyses to GRAS, NDI, and FAP registrations.
Nutrition and health claims
Nutrition and health claim services in the EU, UK and USA – from the use of available authorised claims to new claim registrations, including claim substantiating studies.
Package labelling and marketing materials
Food and food supplement package labelling and content – from design and review to translations, marketing materials, and compliance checks for the target countries in the Nordics.
Regulatory classification, consulting and strategies
Regulatory classification, consulting, and registration strategies – from identifying the correct regulatory status to defining the registration route in the EU, UK, USA, and internationally.
Foods for specific groups (FSG) and for specific medical purposes (FSMP)
Classification, labelling, and regulatory processes for foods for specific groups and foods for specific medical purposes (FSG, FSMP) in the EU, including Nordic countries, UK and medical foods in the USA.
Alcoholic beverages
Labelling, translations and composition compliance for alcoholic beverages – from beers and ciders to wines, flavoured wine products, and spirits.
Food improvement agents
Regulatory compliance of food additives, flavourings, and enzymes – including classification, , and new and renewal authorisation applications in the EU, UK.
Product development support
Support in product development – from verifying ingredient compliance to nutritional information calculations and specific requirements for target groups.
In addition to the services listed above, we provide consulting on food legislation and its interpretation across all areas of food law. When needed, we can also manage communication with the authorities on your behalf.
You can also access Medfiles’ food and food supplement experts as outsourced resources on a part-time or full-time basis. Our outsourcing service offers a flexible way to cover staff shortages or arrange replacements, for example during maternity or other leave. It is a cost-effective solution to ensure business continuity – our experts can, for instance, support you in registration specialist roles.
News and insights on food
Our expert team regularly writes blogs about food. Topics include e.g. novel foods and GRAS, health claims and packaging labelling.
Food Regulatory Classification, Consulting and Strategies
Bringing a new food ingredient or product to market requires careful planning and expert execution – taking into account both the product’s characteristics and regulatory requirements. Depending on its features and intended use, the same ingredient or product can fall under different categories, such as a food ingredient, food additive, medicinal product, feed material, feed additive, cosmetic ingredient, or biocide.
Medfiles supports you from market entry considerations to the selection of the registration pathway. We ensure you have a clear overall view and practical next steps: what a specific classification means in practice and what requirements must be fulfilled before launch.
Our support includes, among others:
- Regulatory classification of a product or ingredient
- Building a registration strategy
- Selection of the registration pathway
- Consulting on borderline products and strategies
- Food supplement or medical device?
- Flavouring or food?
- Same ingredient used in multiple applications?
We can assist in the EU, UK and EEA, the USA, and many other markets worldwide. With our extensive expert network, we provide the best possible solutions for our clients. Our specialists are happy to support you in all questions related to regulatory compliance and registration pathways.
Foods for Specific Groups (FSG) and Foods for Special Medical Purposes (FSMP)
Foods for Specific Groups (FSG) must comply with Regulation (EU) No 609/2013. This group includes, among others, infant formula and follow-on formula, cereal-based baby foods and other foods for infants and young children, total diet replacement products for weight control, as well as foods for special medical purposes (FSMP).
Medfiles supports you from product development and compliance checks of formulations to regulatory notifications, labelling, and review of marketing materials. Our team verifies the composition and compliance of your product and labelling, and provides translations into multiple languages in line with local requirements.
Several EU regulations apply simultaneously to FSMP products. We assist in assessing and justifying the classification of a product as FSMP, preparing compliant labelling, and managing the necessary notifications in the Nordics. Our expertise also covers reimbursement applications for FSMPs, which we are happy to prepare on your behalf. In addition, we provide support in reviewing and creating compliant marketing materials.
Are you developing a new FSMP and wondering about composition requirements? Our team includes several qualified nutritionists and licensed dietitians, whose expertise can be valuable already in the product development phase.
See also:
ALCOHOLIC BEVERAGES
Medfiles experts also provide regulatory support for alcoholic beverages such as beer, cider, wine, aromatised wine products and spirit drinks. We carry out label reviews and translations, formulation checks and help with claims.
The composition and labelling of alcoholic beverages must comply with the labelling requirements of both alcoholic beverages and food legislation. For example, we note:
- Classification of alcoholic beverages and labelling requirements — is the product subject to any specific legislation?
- Mandatory information on the alcoholic beverage, such as the name of the beverage and the alcohol content
- Correctness of voluntary entries, for example, claims.
We perform label translations into Finnish, Swedish and English. In addition, we have an extensive network of partners in Europe; if necessary, you can also get translations to many other European languages, such as Danish and Norwegian.
FOOD IMPROVEMENT AGENTS: ADDITIVES, FLAVORINGS, ENZYMES
Food improvement agents, i.e. additives, flavourings and enzymes, are regulated by special legislation. Within the territory of the European Union, inter alia Regulations (EC) No 1332/2008 on enzymes, 1333/2008 on additives and 1334/2008 on flavourings define the framework for the use of food improvement agents in food. Medfiles experts are happy to assist in verifying the compliance of food improvement agents, regulatory positioning and food additive, flavoring and enzyme applications.
REGULATORY POSITIONING AND COMPLIANCE REVIEW OF FOOD IMPROVEMENT AGENTS
Based on the information we have received from you, we will determine how best to position your food improvement agent in law (e.g. which food additive category your product belongs to) in accordance with the regulations of the EU or other region and the country where you want to bring your product to the market.
For example, we help in designating food improvement agents, determining conditions of use or checking raw material specification so that the composition and labelling of the final product comply with the requirements of the legislation.
ADDITIVE, FLAVOURING AND ENZYME APPLICATIONS
GAP Analysis and Literature Reviews
We will review existing documents and evaluate and compare them with the requirements of authorities in the EU or another country. Based on the GAP analysis, we will provide a report indicating which points are still worth supplementing the application.
We will also conduct comprehensive literature reviews on your behalf to ensure that all existing relevant information will be included in the application.
Pre-Application Consulting Assistance
Before writing an application and submitting it to the authorities, we will help you collect the necessary lacking information and research. We will guide you on what you need to do to obtain this information and assess the quality and suitability of your existing data and research results for a future application.
If you are seeking to market in the UK, USA or Singapore, it is often helpful to discuss the requirements of the application with the relevant authority in advance. We are happy to help with these official discussions.
Studies The European Food Safety Authority (EFSA) obliges the notification of studies for applications for food improvement agents to the EFSA system at an early stage, even before writing an application. We can make these notifications for you.
Through our extensive network of research laboratories and research institutes, we can find the right organization for you to produce the necessary research results.
Our Clinical Research Services team also has experience and expertise in food clinical trials to determine the safety of a new food improvement agent in humans. We offer flexible solutions and comprehensive service packages ranging from clinical trial planning to final reporting and scientific publications.
Preparation of a safety data sheet
The safety data sheet for your business customers can be obtained through us by our audited partner.
Applications for additives, flavourings and enzymes in different countries
We may write the product information, background information and scientific section of the application in accordance with legislation and guidelines. We can prepare applications in the EU, USA (GRAS) and the United Kingdom. If you wish, we will cooperate with the authorities during the application process with EFSA, the European Commission, the US FDA or the UK FSA. With our audited partners, we can also help with registrations in Asia (e.g. South Korea, China, Japan), Israel, India, Australia, Canada, South America and many other countries. Ask about our services for other countries!
See also: How are food enzymes regulated in the EU and what is the status of the Union List
PRODUCT DEVELOPMENT SUPPORT SERVICES
It is important to verify the regulatory compliance of the final product already at the product development stage in order to avoid possible problems, in the worst case, even unnecessary recalls. We can check the regulatory compliance of a recipe for a food product under development or guide you in the selection of raw materials. With us, you can also check the specifications of raw materials and verify the safety and suitability of the selected raw materials.
Our nutritional experts can additionally assist in the design of the food recipe, provided that
- the food product is developed for a specific target group, such as the elderly, athletes, pregnant or weight-controlling people
- the food to be developed is subject to specific legislation, such as alcoholic beverages or foods for special groups
- the final product is wanted to be marketed with certain claims or signs, such as “heart symbol” or “organic”.
A review of a product development recipe may include, depending on the need, e.g.
- product classification – which food group does the finished product belong to?
- review of the compliance of ingredients, e.g.
- ingredients do not contain unapproved novel foods
- permitted food improvement agents and quantities of their use
- fortification of food with vitamins and minerals
- review of raw material specification
- calculation of nutritional values
Food regulatory Team
Medfiles’ food regulatory experts have nearly 30 years of experience in food regulations. Our extensive expertise in food legislation, registrations, market entry, health claim substantiation and safety and risk assessment has been built through work in regulatory authorities across EU Member States, EFSA, the European Commission, Health Canada as well as in the food industry. Our dedicated team of 10+ professionals includes registration specialists, a toxicologist, a risk assessor, food and nutrition experts, and other food safety professionals.
“It feels safe to have the best experts in Finland at your disposal. For us, Medfiles has been worth its weight in gold.”
– Johanna Svensk, Harmonia Life
”We have received a thorough and professional service from Medfiles. Medfiles has shown excellent expertise and service spirit, even in complex matters. They have provided us with answers quickly and have been very helpful in moving things forward.”
– Niklas Ståhle, Orion
”I have been very happy with our co-operation with Medfiles, and I would like to keep them forever. Everything is done carefully, correctly and always on schedule. What else could you wish for from a collaboration!”
– Susanna Salo, Oriflame
”The Medfiles regulatory specialists clearly knew what they were doing and were very organised. We felt that we could trust them and that they would be honest with us. They were also able to point out the regulatory pitfalls. We felt that if we needed to ask any further questions, we would choose Medfiles again.”
– Claus Rosensparre, Algiecel
Medfiles is delighted to support the FS4EU network and to contribute to the discussions on food safety and food regulatory affairs. Our expertise fits extremely well within this FS4EU network as we cover the entire food chain from field to fork, ensuring that European food is safe and nutritious. #EUFOODSAFETYPLATFORM
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