Whether you have an enzyme, a micro-organism or a chemically defined feed additive, Pen & Tec can assist you in gaining authorisation for your product. Our in-depth knowledge, strategic insight and ability to interpret the EU Regulations and Directives means that your product will be placed on the market as fast as possible.
Pen & Tec have a proven track record in assisting companies seeking authorisation for feed additives. Our dedicated team have many years’ experience working on various types of feed additives as well as feed materials, compound feed, medicated feed and dietetic feed.
- Technological additives
- Sensory additives
- Nutritional additives
- Zootechnical additives
- Coccidiostats and histomonostats
- Feed materials
- Compound feed, complete feed and complementary feed
- Medicated feed
- Dietetic feed (parnuts)
FEED ADDITIVES AND PREMIXTURES
Feed additives are products which are intentionally added to feed or water in order to favourably affect the quality of feed and the quality of food from animal origin. For example, they can also improve the animals’ performance and health, by providing enhanced digestibility of the feed materials.
Premixtures are mixtures of feed additives or mixtures of one or more feed additives with feed materials or water used as carriers, not intended for direct feeding to animals.
In order to protect human health, animal health and the environment, feed additives must undergo a safety assessment through a centralised procedure following Regulations (EC) Nº 1831/2003 and 429/2008 before being placed on the EU market. Such assessment is carried out by the European Food Safety Authority (EFSA) and the authorisation of the additive will be granted by the European Commission.
Pen & Tec have over 15-years’ experience in feed additive legislation. Depending on the function, properties and marketing strategy, an additive could be registered under various categories. Some categories may be cheaper or quicker compared to others, but we can help identify the best strategy taking into account the regulatory, scientific and commercial needs.
Our team covers all categories and functional groups of feed additives listed below.
- TECHNOLOGICAL ADDITIVES are substances added to feed for a technological purpose such as preservatives, antioxidants, stabilisers, anticaking agents, silage additives, acidity regulators, substances for the reduction of contamination of feed by mycotoxins, etc. We also have experience in the latest functional group “hygiene condition enhancer”, which are substances or micro-organisms which can favourably affect the hygiene characteristics of feed by reducing a specific microbiological contamination.
- SENSORY ADDITIVES are substances that improve or change the organoleptic properties of feed, or the visual characteristics of food derived from animals. Examples are colourants (to add or restore colour in feeds, to add colours to food of animal origin, or to affect the colour of ornamental fish or birds) or flavouring compounds to improve the smell or palatability of the feed.
- NUTRITIONAL ADDITIVES are substances that satisfy the nutritional needs of animals such as vitamins, compounds of trace elements, amino acids or urea.
- ZOOTECHNICAL ADDITIVES are substances that favourably affect the performance of animals in good health or the environment.
The authorisation is holder specific. In other words, it is issued to the company that submitted the application, which makes it an interesting category for various feed business operators. The following functional groups are considered zootechnical additives:
- Digestibility enhancers: substances which increase the digestibility of the diet, through action on target feed materials
- Gut flora stabilisers: micro-organisms or other chemically defined substances, which, when fed to animals, have a positive effect on the gut flora
- Substances which favourably affect the environment
- Other zootechnical additives which may improve the performance of animals
- COCCIDIOSTATS AND HISTOMONATS are substances intended to inhibit or destroy protozoa parasites which cause coccidiosis or histomoniasis in farmed animals.
FEED ADDITIVES AND PREMIXTURES SERVICES
We have a vast amount of experience in registering feed additives since we have been preparing feed additive applications since 2000. Our services include:
- Product classification based on the characteristics, intended use and legal status
- Evaluation of data requirements, financial planning and timelines, depending on the product category and the quality, safety and efficacy information available
- Help with designing and monitoring animal studies as well as review of results and reporting
- Literature searches and expert reports
- Preparation and submission of feed additive dossiers
- Help with answering post-submission questions
- Communication with relevant EU authorities: EC, EFSA, EURL.
Not sure if your product qualifies as a feed additive or which category to apply for?
Contact us if you have questions or need regulatory assistance.
OTHER FEED CATEGORIES
Besides our vast experience in feed additives, we can also help to determine whether your product is a feed material and assist in the notification procedure, if needed. Additionally, we can provide regulatory advice on compound feed, medicated feed or “dietetic” feeds, also known as PARNUTS (feed for particular nutritional purposes).
- FEED MATERIALS are products of vegetable or animal origin (in their natural state, fresh or preserved), products derived from their industrial processing, and organic or inorganic substances, intended for use in direct animal feeding, or after processing, in the preparation of compound feeding stuffs or as carriers of premixtures.
If you think you may have a feed material but are unsure how to proceed, we would could assist as follows:
- Verify the product status and identify appropriate regulatory pathway to enter the market
- Check if the feed material is listed on the EU official catalogue (Reg. 68/2013) and on the online Register and the relevant characteristics stated
- Assist with a notification in the Feed Materials Register.
- COMPOUND FEED is a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed. Complete feed is sufficient for a daily ration, while complementary feed has a high content of certain substances and is sufficient for a daily ration only if used in combination with other feed.
- MEDICATED FEED contains a premix of veterinary medicines and requires veterinary prescription. The rules for the preparation, placing on the market and use of medicated feed are set out in Council Directive 90/167/EEC. This directive will be revised to avoid differences throughout the EU for manufacturers and farmers and to align the provisions with developments in feed and veterinary medicinal products legislation.
- “DIETETIC” FEED (PARNUTS) can satisfy a particular nutritional purpose due to its particular composition or method of production, which clearly distinguishes it from standard feed. The European Commission regulated the conditions for marketing of PARNUTS (feed for particular nutritional purposes) in Regulation (EC) Nº 767/2009, and the list with the authorised intended uses can be found in Directive 2008/38/EC. Feed intended for particular nutritional purposes may only be marketed as such if its use is included in the official list of intended uses and if it meets the essential nutritional characteristics for the respective particular nutritional purpose.
GENERAL FEED SERVICES
Legislation and guidance documents are updated regularly taking into account technological progress, EFSA’s experience in handling applications and input from stakeholders. Pen & Tec can help identify and interpret the latest Regulations and Guidelines, contributing to a faster registration process.
The services that we offer are tailored to client needs, but if you are unsure how to enter the European feed market we may suggest the following approach, taking into account regulatory, commercial and scientific matters:
- Identify the feed category and distinguish from other products such as veterinary drugs
- Verify legal status and assess if the feed meets the conditions for marketing associated with a particular intended use
- Assist with a new application, and liaise with competent authorities
- Ensure correct information is included in the label, to avoid misleading the user