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
In the EU, feed additives are defined as 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.
In order to protect human health, animal health and the environment, feed additives must undergo a pre-market safety assessment via a centralised procedure following Regulations (EC) Nº 1831/2003 and 429/2008 before being placed on the EU market. The scientific safety assessment is carried out by the European Food Safety Authority (EFSA) and the authorisation of the additive is granted by the European Commission (EC).
Our team covers all categories and functional groups of feed additives listed below.
Pen & Tec has over 20-years’ experience in feed additive legislation and has submitted over 250 dossiers. There are five feed additive categories and within each category are functional groups which describe the specific function of a feed additive. Feed additives could fall under several categories and functional groups. Some categories may offer cheaper or quicker routes to market, and we can help you to identify the best strategy taking into account your regulatory, scientific and commercial needs.
Pen & Tec has extensive experience in all Feed Additive categories and functional groups and has a proven track record in helping our clients achieve regulatory success.
Pen & Tec can help you at any stage and we offer a full regulatory service from concept to approval.
- TECHNOLOGICAL ADDITIVES are substances added to feed for a technological purpose: preservatives, antioxidants, emulsifiers, stabilizers, thickeners, gelling agents, binders, substances for control of radionucleotide contamination, anticaking agents, acidity regulators, silage additives, denaturants, substances for the reduction of contamination of feed by mycotoxins, hygiene condition enhancers, other technological additives
- SENSORY ADDITIVES are substances that improve or change the organoleptic properties of feed, or the visual characteristics of food derived from animals. Colourants (restore colour to feedingstuffs, add colour to food of animal origin, favourably affects the colour of ornamental fish or birds); Flavourings
- NUTRITIONAL ADDITIVES are substances that satisfy the nutritional needs of animals such as: vitamins, pro-vitamins & chemically well-defined substances having a similar effect, compounds of trace elements, amino acids, their salts and analogues, urea & its derivatives
- ZOOTECHNICAL ADDITIVES are substances that favourably affect the performance of animals in good health or the environment. The authorisation is holder specific, which means that only the holder of the authorization can sell the product in the EU. The following functional groups are considered zootechnical additives: Digestibility enhancers: substances which increase the digestibility of the diet; 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; Physiological condition stabiliser, which are substances that when fed to animals in good health, favorably affect their physiological condition, including their resilience to stress factors: “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. Coccidiostat authorisations are also holder specific.
Not sure if your product qualifies as a feed additive or which category to apply for?
Please contact us if you have questions or need regulatory assistance.
FEED ADDITIVES AND PREMIXTURES SERVICES
We have been preparing feed additive applications since 2000 & over this time, we have amassed a great amount of experience in registering feed additives. Our services include:
- Regulatory feasibility assessments & product classification: based on the characteristics, intended use and legal status of your product, we can help you to check if your feed additive is already authorised and if not, what the steps are to get the project registered.
- Data audits, gap analyses & regulatory road maps – we can check the data and studies that you have already performed for EC/EFSA compliance and identify the studies that you will need to complete your dossier. We can build you a comprehensive regulatory roadmap that will form the backbone of your dossier and will contain all the steps you need to take to build a compliant feed additive dossier, including costings & timelines to market.
- Renewal dossiers: we can advise you on the studies you need to renew your feed additive authorisation and help you to build your dossier.
- Species extension: we can provide strategic advice on how to make the most out of your feed additive authorisation, including how to extend the authorisation to include different species.
- Evaluation of data requirements, financial planning and timelines, depending on the product category and the quality, safety and efficacy information available.
- Study design & statistics: we can help you to design EC/EFSA compliant studies and we can also monitor animal studiesas well as review of results, analyse the raw data and compile compliant study reports.
- Literature searches and expert reports. In certain cases, EFSA compliant literature searches can be used to support certain sections of your feed additive dossier, minimising the cost of performing expensive in vivo or in vitro studies.
- Preparation and submission of feed additive dossiers
- Help with answering post-submission questions. The EURL or EFSA may ask for supplementary information (SIn or a clock-stop) during their safety evaluation. Once an applicant has received a SIn, the evaluation is stopped and will not resume until the applicant has provided the supplementary information. We can help you to respond to these clock stops in a quick & efficient way to get the clock started again and avoid unnecessary delays.
- Dealing with negative opinions: we can help you and guide you through the next steps on how to deal with a negative EFSA opinion. It is never too late to rescue a dossier!
- Communication with relevant EU authorities: EC, EFSA, EURL.
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 (Regulation EU 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 Regulation (EU) 2019/4, which repeals Council Directive 90/167/EEC), which was 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