Food regulatory services from product development to reviews, registration and marketing
Medfiles provides a wide range of professional regulatory services to food companies. We provide services for various stages of the research and development process of food products, regulatory reviews, regulatory registration, launch and marketing. Our experts help you with product development and management of food throughout the food production chain, all the way to the labelling of final products for consumers — we go with you from farm to fork.
Our regulatory services cover food products already on the market as well as new innovations based on new sources, such as micro-organism products (bacteria, fungi and algae) as well as side-stream and cellular agricultural products. We always take into account the characteristics of the food and the marketing aspects and tailor our services to the needs of our customers. We take care of the necessary things efficiently and carefully — you can be sure that your food product meets the requirements of the authorities.
Free webinar: How to get health claims approved in the EU
Do you want to stand out from the competition of food products with your own, brand new health claims? In this webinar we’ll provide an overview of the health claim approval process and the related requirements in the EU. Practical examples will also be showcased.
Free webinar: Novel food classification and route to novel food authorisation in the EU
In this practical webinar you’ll get an overview of the classification of potential novel foods, the official consultation procedure, as well as the novel food authorisation process and its requirements. We will also go through a success story of a marine novel food authorisation in which we assisted our client.
Food services
NOVEL FOODS AND NEW INGREDIENTS
Before introducing a novel food or a new ingredient on the market, it is important to determine whether entry on the market requires prior authorisation by the authority. In the EU, the key statute is Regulation (EU) 2015/2283 on novel foods. Different countries have their own licensing processes and approval procedures. If a new food or new ingredient matches the food traditionally used at an adequate level, an authority authorisation process may not be required. In this case, the company itself ensures the safe use of the new food by different categories of consumers.
We are happy to help you with all matters concerning the registration of novel foods and new ingredients. Our experts have extensive experience in classification, consultation and authorisation procedures, including novel food applications in the EU and Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) notifications in the USA. With our audited partners, we can help with registrations around the world.
REGULATORY POSITIONING AND IDENTIFYING THE ROUTE OF REGISTRATION
We will determine for you whether an ingredient can be placed on the market without a separate authorisation procedure, or whether it is a novel food or a new ingredient that requires regulatory assessment and approval. If necessary, we will compile documentation to justify that registration is not required.
If the classification of the product is open to interpretation and a formal classification decision is necessary, we may draw up a request for consultation with the EU authority on your behalf or have similar consultations with authorities in other countries. We compile and write a consultation request based on product information, literature and legislation. We can also handle the cooperation between authorities during the process.
NOVEL FOOD APPLICATIONS AND CORRESPONDING APPLICATIONS FOR REGISTRATION
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. After the analysis, we will provide a report showing which information is already compliant, what information is needed for the application or which points still need to be supplemented in the application.
We will also conduct comprehensive literature reviews on your behalf to ensure that all existing necessary information must be included in the application.
Pre-Application Consulting Assistance
Before writing an application and submitting it to the authorities, we will help you collect 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 applying to market in the United Kingdom (UK), the 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 on novel foods to the EFSA system at an early stage, even before writing a novel food 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 ingredient in humans. We offer flexible solutions and comprehensive service packages ranging from clinical trial planning to final reporting and scientific publications.
Novel food applications and corresponding applications for registration in different countries
We write the product information, background information, scientific section and holistic safety assessment of the application in accordance with legislation and guidelines. We can prepare applications in the EU, the USA (e.g. NDI, GRAS), in the UK and Singapore. We can also write peer reviewed papers required for GRAS. 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!
Free webinar: Novel food classification and route to novel food authorisation in the EU
In this practical webinar you’ll get an overview of the classification of potential novel foods, the official consultation procedure, as well as the novel food authorisation process and its requirements. We will also go through a success story of a marine novel food authorisation.
NUTRITION AND HEALTH CLAIMS
Nutrition and health claims are an important part of food marketing. In many countries, it is permissible to highlight the nutritional properties or health and wellbeing benefits of a food product when the reported benefits are truthful. In the EU, the Nutrition and Health Claims Regulation (EC) No 1924/2006 regulates the use of claims. Medfiles’ knowledgeable team has years of solid experience both in the use of ready-made claims and the application processes for new claims within the European Union.
UTILISATION OF APPROVED NUTRITION AND HEALTH CLAIMS
We help you find all nutrition and health claims, including those currently permitted in the EU, which you can use in the labelling and marketing of your food. We will also guide you in the labelling of any compulsory additional entries related to claims. During the product development phase, we are happy to guide you in the design of the recipe so that the finished product can be marketed with the desired claims.
We also check the labelling and marketing materials of the products. In addition, as a content creation service, you will receive marketing texts that meet the requirements of the claim regulation.
HEALTH CLAIM APPLICATIONS
GAP Analysis, Literature Review and Lacking Data Acquisition
We review the existing literature and research documents and evaluate and compare them with the requirements of the authorities. We will conduct a comprehensive literature review on your behalf to ensure that all existing necessary information is included in the application. We help with product characterization, background information needed for the claim application and scientific documentation.
We will assist in the formulation of the claim so that it has the best possible throughput. We will also provide our own assessment of the potential for the application to be completed when we have reviewed the research evidence. After the analysis, we submit a report indicating which points still need to be supplemented with the application.
Clinical Trials
Our Clinical Research Services team has extensive experience and expertise in food clinical trials to verify health claims, from their design to the writing of scientific papers. We offer flexible solutions and comprehensive service packages ranging from research planning to final reporting and scientific publications.
Health claim applications in different countries
We write the product information, background information, scientific section and health impact assessment of the application in accordance with legislation and guidelines. We can prepare applications in the EU. If you wish, we will take care of the cooperation between the authorities during the application process with EFSA and the European Commission. With our audited partners, we can also help with registrations in other countries, e.g. In the USA, Canada and Asia. Ask about our services for other countries!
Free webinar: How to get health claims approved in the EU
Do you want to stand out from the competition of food products with your own, brand new health claims? In this webinar we’ll provide an overview of the health claim approval process and the related requirements in the EU. Practical examples will also be showcased.
FOOD LABELLING, REVIEW AND TRANSLATION
Food labelling shall be in line with Food Information Regulation (EU) No 1169/2011 and the local legislation of the country of destination. Some foods, such as food supplements, foods for specific groups and alcoholic beverages, are additionally covered by special legislation. Thanks to our extensive experience in labelling, we prepare, review and translate food labelling efficiently, ranging from regulatory requirements to the Nordic countries, the Baltic States and several other European countries. We also take into account national guidelines.
In the amendment, we take into account, among other things, the following:
- Correct classification of food
- Mandatory food information, such as the name of the food, the amount of content, ingredients, allergens and nutrition declaration
- Review of ingredients and labelling of information to be provided, e.g.
- Compliance of ingredients (e.g. novel food status) and correct labelling of approved novel food ingredients
- Compliance of food additives and flavourings in the food category concerned and their correct labelling
- Compliance and correct labelling of vitamins and minerals used in food supplementation
- Voluntary food information, such as nutrition and health claims and any mandatory additional labelling
We are happy to check the legality of your food from the recipe already at the product development stage.
Food supplements
Food supplements are covered by food legislation, but they are also subject to their own specific legislation. Our team is always up to date on new requirements and will be happy to assist you with food supplements. We check the composition of the food supplement, the correctness and compliance of the labelling and translate the labelling texts to the Nordics, Baltic States and several other European countries if necessary. Labelling shall be in line with the national regulation based on the Food Supplement Directive 2002/46/EC. We also take into account national guidelines.
We also help with U.S. labelling in accordance with U.S. requirements. With our partners, we can also help with labelling in other countries.
In the case of food supplements, we check, among other things, the following:
- Classification — does the product meet the requirements for a food supplement?
- Mandatory food supplement information on the labelling, taking into account the language requirements of the destination country
- Name of food supplement
- Information on the composition and ingredients of the food supplement
- Compliance with nutrition and health claims and images
- Food supplement notification to the National Food Authority
We can also assist in the review of marketing materials for food supplements and content creation.
FOODS FOR SPECIFIC GROUPS
Foods for specific groups (FSG) shall be in line with Regulation (EU) No 609/2013. This category includes:
- Infant formula and follow-on formulas
- Processed ceral-based foods and baby foods
- Food for special medical purposes (FSMP)
- Total diet replacement for weight control
If you need help with these foods, our team will be happy to help you. We check the composition of the food, the correctness and compliance of the labelling and, if necessary, translate the labelling into many different countries. If necessary, we also help with the development of the food itself or in assessing the legality of the finished recipe.
For example, we note the following:
- Classification — is it a food for special medical purposes??
- Mandatory information – Are all mandatory information required by specific legislation included in the labelling, taking into account the language requirements of the destination country?
- Name of food
- Information on composition and nutrients
- Compliance of claims and images
- Notifications to the National Food Authority
We may also review marketing materials or assist in content creation when it comes to nutritionally and legally demanding topics.
FOODS FOR SPECIFIC MEDICAL PURPOSES (FSMP)
Food for special medical purposes (FSMP) is subject to several regulations in the EU, which must be taken into account at the same time. Medfiles experts have a solid knowledge of the issues to consider. We produce labelling for FSMP products in many different languages as required by legislation. We will help you when you need an expert assessment or justification for classifying a product as an FSMP in the EU. You can also ask us for help, for example, if you feel challenging to place in a suitable product category.
We handle the necessary notifications to the authorities in the Nordic countries. Our expertise also covers applications for reimbursement of FSMP products, and we are happy to prepare them for you.
Are you just developing a new FSMP product, and compositional requirements are under consideration? Our team consists of many nutritionists and licensed dietitians whose insight can be useful even at the product development stage.
ALCOHOLIC BEVERAGES
Medfiles specialists also help with alcoholic beverages such as beers, ciders, wines, flavored wines and distilled spirits. We carry out labelling checks and translations, compliance checks of compositions and help with nutrition and health claims.
The composition and labelling of alcoholic beverages must take into account the labeling requirements of both alcohol and food legislation. For example, we note:
- Classification of alcoholic beverages and labelling requirements — does the product fall under any special legislation?
- Mandatory information on the food, such as the name of the drink, the alcohol content and the amount of content
- Correctness of voluntary entries, for example, claims
We do translations of the labels into Finnish, Swedish, English, Estonian, Latvian, Lithuanian, Norwegian and Danish. In addition, we have an extensive network of partners in Europe, so if necessary, you can also get translations to many other European countries.
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!
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 CONTACT MATERIALS
From food contact materials, plastic materials, recycled plastic recycling processes, active and intelligent materials and articles and regenerated cellulose require regulatory approval at the EU level. Other food contact materials and articles, such as paper, cardboard, metal and printing ink, are subject to national approval practices, if any.
However, regardless of the material, all food contact materials and articles are subject to the General EU-level Framework Regulation (EC) No 1935/2004. If a food contact material or article is only subject to the EU framework regulation, the manufacturer of the food contact material or article shall be responsible for its safety alone without any official EU approval.
Medfiles’ experts have comprehensive knowledge of the requirements of various food contact materials and will be happy to assist you in the following matters.
REGULATORY POSITIONING OF FOOD CONTACT MATERIAL
Based on the information we receive from you, we will determine how your material is best positioned legally. This will help you know the legal status of your material and whether it is a material that requires separate EU-level approval.
APPLICATIONS AND SAFETY ASSESSMENTS FOR FOOD CONTACT MATERIALS
GAP Analysis, Literature Review and Lacking Data Acquisition
We will go through existing documents and evaluate and compare them with the requirements of the authorities. Based on the GAP analysis, we will submit a report showing which data still need to be supplemented in the application for food contact material. If the material is only subject to the EU framework act, you will receive the information for the company’s internal safety assessment report.
We can help you specify the necessary information and research results for your application. In addition, we will conduct a comprehensive literature review on your behalf to ensure that all existing relevant information must be included in the application or safety assessment.
Through our extensive network of research laboratories and research facilities, we will find the right organization for you to produce the necessary research results, such as food contact material migration tests or assess the possible presence of non-purpose-added (NIAS) compounds.
Safety Assessment or Pre-Application Consultation Assessment
For a food contact material safety assessment report or before writing and submitting a food contact material application to the authorities, we will help you collect lacking, necessary 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 safety assessment or application.
The European Food Safety Authority (EFSA) obliges the notification of studies for applications for food contact materials 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.
REACH Chemical Registration and SCIP Notification for Articles
Based on the information we have received from you, we will determine whether your food contact material requires REACH registration in the EU. We will also find out if your food contact article requires a SCIP declaration in the EU. A more detailed REACH questionnaire, REACH registration and SCIP notification can be obtained through us by an audited partner.
Life Cycle Assessment of Food Contact Materials
Through us, you will receive a Life Cycle Assessment (LCA) for your food contact material by our audited partner.
Safety assessments or applications to different countries
We may write the product information, background information and scientific section of the safety assessment or registration application for food contact material in accordance with the legislation and guidelines. We will be able to prepare safety assessments and an application in the EU. If you wish, we will take care of the cooperation between the authorities during the application process with EFSA and the European Commission. If you need notifications of food contact materials (a food contact compound in the US) to the U.S. Authority (FDA), it can be done by our audited partner.
In addition to the above-mentioned regulatory services, our food and food supplement experts can serve as part- or full-time outsourced resources at your company in challenging situations. With the help of an outsourcing regulatory service, you can patch up your staff gap or get a replacement to fill in for example for a permanent employee during maternity leave or sick leave. Our experts can assist you, for example, in the role of a regulatory affairs expert. See also:
Team
Our Food & Feed and Cosmetics team has a long and extensive experience in the legislation, regulatory registration and marketing of food, nutritional supplements, feed and cosmetics, including various innovations from completely new sources. Our team of 12 people consists of experts in regulatory registration, nutrition and food sciences and toxicology.
Clients
Our team serves food companies worldwide. Over the years, we have assisted our clients in about 20 different countries. Client satisfaction and client trust are paramount to us.
“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 Oy
“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 Cosmetics
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
Contact us
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