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Product Lifecycle Management – Where Does Regulatory Affairs Fit In?

Product Lifecycle Management – Where Does Regulatory Affairs Fit In?


The use of safe and effective feed additives helps to optimise the growth and health of livestock, and enhance the nutritional value of their products. It can also help to reduce the environmental impact of animal agriculture. By prioritizing food safety in the animal feed industry, we can ensure that the food we eat is of the highest quality and free from harmful contaminants.

Regulatory Affairs plays a vital role in the animal feed additive industry by ensuring that products are safe, effective, and meeting the necessary regulatory requirements. Regulatory Affairs is responsible for the interpretation and compliance of national and international regulations related to animal feed additives. This includes the evaluation of product safety, efficacy, and quality, as well as the development and submission of regulatory dossiers. By working closely with regulatory authorities, companies can ensure that their products meet the necessary standards and can be sold legally in the marketplace. Moreover, the work of Regulatory Affairs helps to ensure that consumers can have confidence in the safety and quality of the animal-derived products they eat and drink.

New and Old Products – The Correct and Most Economical Regulatory Approach

Product lifecycle management is a crucial aspect of the animal feed additive industry. It involves the planning, design, development, and deployment of a product from its inception to its eventual retirement. For feed additive companies, this process is essential in establishing the sustainability and profitability of their operations. Effective product lifecycle management enables companies to monitor the performance of their products in the market, identify areas for improvement, and make informed decisions about the future of their product offerings. By taking a comprehensive approach to product lifecycle management, feed additive companies can ensure they are delivering high-quality, safe, and effective products that meet the needs of their customers and the industry.

When developing new feed additive products, a regulatory roadmap plays a critical role in determining the success and sustainability of the proposed project. A team of experts assesses the technical, financial, and economic feasibility of a project, providing a comprehensive analysis of the project's viability. With a thorough feasibility report, clients can make informed decisions, avoid potential challenges, and capitalize on growth opportunities. Furthermore, feasibility reports serve as a valuable roadmap for the successful implementation of new feed additive products, making sure that resources are allocated efficiently and effectively. In the constantly evolving animal feed industry, the importance of a feasibility report cannot be overstated. Ideally, this is the step when feed additive companies should consider partnering with a Regulatory Affairs specialist to assist them in compiling a feasibility report on new products.

The expertise and guidance provided by a regulatory affairs consultant can be invaluable in the management of older and established feed additive products. For established products, they can assist in the review of the product's regulatory status, ensuring that it continues to meet current requirements. This may involve updates to product labelling and marketing claims, as well as a review of the product's safety and efficacy data. Additionally, they can help the company identify opportunities for reformulating or repositioning older products in response to changing market trends or consumer preferences. By staying up to date with regulatory developments and market trends, a regulatory affairs partner can provide ongoing support to a company, helping to ensure that established products remain competitive in the marketplace.

Making Sense of the European and US Regulatory Framework

Below is a brief explanation of the role of the Regulatory body within the European Union as well as the role it plays concerning the registration of feed additives:

The European Food Safety Authority (EFSA) plays a key role in the implementation of legislation on feed additives in the European Union (EU). EFSA is responsible for the scientific evaluation of the safety and efficacy of feed additives that are being considered for authorization in the EU. This includes the assessment of the data submitted by feed additive companies and the development of scientific opinions on the safety and efficacy of the additives. These scientific opinions form the basis for the decision-making process on feed additive authorizations by the European Commission and the Member States. In addition to its role in the authorization process, EFSA also provides scientific support and advice on the implementation and enforcement of the EU legislation on feed additives. EFSA works closely with regulatory authorities, industry stakeholders, and other relevant organizations to ensure that the EU legislation on feed additives is based on the latest scientific evidence and best practices, ensuring the safety, quality, and efficacy of feed additives and in promoting the health and well-being of both animals and humans.

According to the European Union (EU) Regulatory Affairs framework, animal feed additives are defined as substances or microorganisms that are added to animal feed to improve its nutritional value, or to improve the health, performance or well-being of the animals that consume it. The EU framework requires that all animal feed additives must be authorized before they can be placed on the market and used in animal feed. The authorization process involves the assessment of safety and efficacy data, as well as a comprehensive evaluation of the environmental and socio-economic impact of the additive. The EU framework also requires that animal feed additives are labelled and accompanied by a complete technical dossier that includes information about the composition, intended use, and any potential risks associated with the additive. To guarantee the safety and quality of animal feed additives in the EU market, the EU framework also establishes regular monitoring and enforcement activities to verify that authorized additives are used in compliance with the regulatory requirements.

GRAS, or Generally Recognized as Safe, is a regulatory process in the US that allows certain food and feed additives to be placed on the market and can involve a voluntary notification to the FDA. For animal feed additives, GRAS regulation is overseen by the FDA’s Center for Veterinary Medicines (CVM).

To be considered GRAS, an animal feed additive must have a long history of safe use in animal feed or be supported by scientific evidence that demonstrates its safety for use in animal feed. A manufacturer can self-affirm that an animal feed additive is GRAS by assembling and submitting a GRAS notification to the FDA, which includes information on the additive's safety and use.

The GRAS notification must contain the following information:

• A description of the substance and its intended use

• A history of the substance's use in food or feed

• Information on the substance's composition, manufacture, and specifications

• A summary of the available scientific data on the substance's safety

• A conclusion on the substance's safety for its intended use

The FDA reviews the GRAS notification to determine if the substance meets the criteria for GRAS status. If the FDA agrees that the substance is GRAS, the manufacturer can use it in animal feed without seeking further FDA approval. However, it is important to note that GRAS does not mean that the additive has been approved by the FDA as safe, only that it is not subject to premarket approval. The FDA can take action to remove GRAS status if new evidence suggests that the substance may not be safe for its intended use.

There are alternative routes that can be followed to place feed products on the market in the US: Association of American Feed Control Officials (AAFCO) procedure and Food Additive Petition (FAP).

A Brief Overview of the EU and US Legislation on Feed Additives

The European Union (EU) has established comprehensive legislation on feed additives to ensure the safety, quality, and efficacy of products used in animal feed. The main piece of legislation governing feed additives in the EU is Regulation (EC) No 1831/20031, which lays down the rules for the authorization and labelling of feed additives. This regulation requires that all feed additives must be authorized before they can be placed on the market and that they must be accompanied by a complete technical dossier containing information about the composition, intended use, and potential risks associated with the additive. In addition, the EU legislation also includes provisions for the monitoring and enforcement of feed additive usage, as well as for the ongoing assessment and re-evaluation of authorized additives to secure their continued safety and efficacy. The EU legislation on feed additives is regularly updated to reflect advancements in scientific knowledge and industry best practices that ensure the protection of animal and human health and the sustainability of the animal agriculture sector.

If an animal feed additive receives an inconclusive opinion from EFSA during the registration process, the financial implications can be significant. An inconclusive opinion from EFSA can mean that the animal feed additive has been deemed unsafe or not efficient for use in animal feed within the European Union. In this case, the additive may not be approved, and the manufacturer will not be able to sell the product and may incur additional costs to reformulate the product to meet EFSA standards. In addition, an inconclusive opinion from EFSA can harm the manufacturer's reputation and may damage its relationship with customers and suppliers. Working with a regulatory affairs expert can help reduce the risk of an inconclusive opinion from EFSA and ensure a smooth and successful registration process.

In the US, there are several pathways to achieve approval as a new animal food ingredient, including the GRAS determination, the Food Additive Petition (FAP) and the new ingredient definition via the American Association of Food Control Officials (AAFCO). Feed ingredients can follow the FDA-approved Generally Recognized as Safe (GRAS) route given that sufficient data to support the safety of the ingredient is available in peer-reviewed and published literature. For this pathway, a dossier containing the relevant data on the identity and safety of the ingredient is submitted to Food and Drug Administration (FDA), specifically by the FDA’s Center for Veterinary Medicine (CVM) for review. If the notification is successful, FDA will issue a “no-questions” letter resulting in the listing of the ingredient and GRAS notice to the Animal Food GRAS Notices Inventory. Once a feed additive has been approved by the FDA for use in animal feed, it can be legally marketed and sold to farmers and other animal producers. FDA encourages applicant companies to engage in discussion with them at the early stages of dossier compilation and submission to discuss the most suitable regulatory route and relevant data requirements. It is important for companies to work with regulatory affairs consultancies for the preparation of such discussions and to ensure that their new feed ingredients are properly evaluated and meet FDA regulatory requirements before entering the market.

Final Thoughts

A regulatory affairs expert can assist with the registration of animal feed additives with the regulatory authorities by providing expert guidance and support throughout the regulatory process. They have a thorough understanding of the regulations and guidelines set by the EU and US authorities and can help ensure that the necessary data and information required for the registration of an animal feed additive is complete, accurate, and meets the standards. They can also assist with the preparation and submission of the application for pre-market approval, as well as with any interactions with the regulatory authorities during the evaluation process. By working with a regulatory affairs expert partner, feed business operators can have peace of mind that their application is in good hands and will be handled efficiently, reducing the risk of delays or rejection. Additionally, a regulatory affairs partner can provide ongoing support and guidance to assure that the approved animal feed additive is used in compliance with regulations and guidelines, as well as regulations for any other intended markets worldwide. Also, a regulatory partner can assist in ensuring that the additives are renewed every ten years, prior to their expiry of their authorizations.

As a leading regulatory affairs consulting company within the animal feed industry, Pen & Tec understands the significance of a well-conducted regulatory roadmap and the importance of assisting our customers throughout the entire development process of their new products. Pen & Tec Consultancy S.L.U became part of Argenta in July 2022.2




Author: Dawn Botha, Technical Marketing Manager, Pen & Tec Consulting as part of the Argenta Group

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