Feed regulatory services from product development to reviews, registration and marketing
Our regulatory team serves a wide range of feed industry operators. We assist companies in various stages of the research and development process of feed products, regulatory reviews, regulatory registration processes, product launches and marketing. We can support you from product development to the labelling of finished products and product launches, or we can assist and support you in a specific part of the project.
We will help you with feed products already on the market, as well as innovations based on new and new sources, such as micro-organism products (bacteria, fungi and algae), side-stream and cellular agricultural products. We always take into account the characteristics of the feed product and the factors affecting marketing, and tailor our regulatory services to meet the client’s needs. By selecting our experts for your convenience, you can be sure that your feed product meets the requirements of the authorities.
Free webinar: Regulatory aspects of feed labelling in the EU – overview
Our 20-minute webinar offers a concise information package on feed labelling. In this webinar, you will gain a basic understanding of the requirements of feed legislation and learn what to take into account when creating feed labelling.
Feed services
REGISTRATION OF FEED MATERIALS AND FEED ADDITIVES
In the EU or the United Kingdom (UK), no pre-market authorisation by the authorities is required for feed materials, but the new feed material must be registered. Feed additives used in animal feed in the EU, UK and USA must be authorised by the authorities. In the EU and the UK, they must also be re-approved every 10 years. The experienced team at Medfiles will be happy to assist you in the various stages of the registration process for feed materials and feed additives.
REGULATORY POSITIONING OF FEED MATERIAL AND FEED ADDITIVE
Sometimes the regulatory positioning of feed materials and feed additives can seem difficult. We can find out for you how your product is positioned legally – whether the product is feed material or feed additives/which category of feed additives the product belongs to – according to the regulations of the region or country where you want to bring your product to the market.
FEED MATERIAL REGISTRATIONS AND APPLICATIONS FOR FEED ADDITIVES
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 provide a report that allows you to know which items are ready, which are lacking and what information is still needed in the EU and the UK to guarantee the safety of the feed material, for a feed additive application or in the USA for a feed material or feed additive application. We may also compile renewal applications of EU-approved feed additives.
We can help you specify the necessary information and research results for your application. In addition, we will conduct an extensive literature review on your behalf and ensure that all ready-made information that can be used in the feed safety assessment or various applications must be included in the application.
Consultation assistance prior to a safety assessment or application for registration
We will help you collect the necessary missing information and research before writing your application and sending it to the authorities. 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.
Study notifications
The European Food Safety Authority (EFSA) obliges the study notifications for applications for feed additives 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 facilities, we can find the right organization for you to produce the necessary research results, such as production or pet feed tests or tests required for occupational safety of feed.
Preparation of a safety data sheet
Through us, you will receive a safety data sheet of feed material or additive for your business customers, prepared by our audited partner.
EU representative for non-EU companies
EU feed additive legislation requires a non-EU company to have an EU representative to submit an application. We can act on your behalf as an EU representative.
Applications for feed materials and feed additives 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 UK. The may also compile a feed safety report in Europe and the USA.
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), Canada, South America and many other countries. Ask about our services regarding other countries.
REVIEW OF THE COMPLIANCE OF RAW MATERIALS AND THE PRODUCT DEVELOPMENT RECIPE
It is important to verify the compliance of the feed product already at the product development stage in order to avoid problems in the next stages. We are happy to check the compliance of feed ingredients and guide you in the selection of raw materials for the feed in development. With us, you can check the specifications of raw materials and ensure the safety and suitability of the selected raw materials.
Depending on your need, we can include in the review
- Product classification – which feed category the product belongs to (e.g. complementary feed, feed for particular nutritional uses)
- Compliance of ingredients — feed contains only authorised feed materials and feed additives
- Classification of feed additive according to the purpose of use of the feed additive
- Nutrient calculation
- Checking raw material specifications
DRAFTING, REVIEWS AND TRANSLATIONS OF LABELLING
The labelling of feed intended for pet and food-producing animals shall be in line with, inter alia, Regulation (EC) No 767/2009 concerning the placing on the market and use of feed. In addition, the local legislation of the country of destination must be taken into account. With the help of Medfiles expert services, you can ensure that the labelling of feed is correct and compliant.
We check and, if necessary, translate labelling into different EU countries, taking into account for example:
- Classification of feed — whether complete feed, complementary feed, mineral feed or feed for particular nutritional uses
- Labelling — all mandatory information on feed must be included, taking into account the language requirements of the country of destination
- Name of feed and animal species for which the feed is intended
- Information on the composition and nutrients of the feed
- Compliance of claims and images
Free webinar: Regulatory aspects of feed labelling in the EU – overview
Our 20-minute webinar offers a concise information package on feed labelling. In this webinar, you will gain a basic understanding of the requirements of feed legislation and learn what to take into account when creating feed labelling.
In addition to the above-mentioned services, we help with marketing claims and determining the purpose of the feed. We check the compliance of marketing claims used in feed packaging and marketing materials in different EU countries. We check the correctness of the uses of feedsfor particular nutritional uses and additional labelling on packaging and marketing materials.
In addition, our experts can act 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 with tasks such as a product information or regulatory affairs expert. See also:
Team
Our Food & Feed and Cosmetics team has long and extensive experience in the legislation, regulatory registration and marketing of food, dietary supplements and feed, including various innovations from completely new sources. Our expert team of 12 people consists of regulatory experts, nutrition and food sciences, and toxicology. In addition to traditional foods, our team also has extensive experience and expertise in the legislation of alcohols, feed and cosmetics.
We serve our clients worldwide — we have helped companies with food, feed and cosmetics in about 20 countries.
