Product positioning and market entry options

Before even starting the process of registering a new food or animal feed product in the EU, it is important to determine the correct legal category and identify the various possibilities of how the product can be marketed.

Does the product really contain a novel food ingredient that has never been consumed in the EU? Are you using a food enzyme in the manufacturing process that may perhaps have to be approved? Is your feed product really a feed additive or is it a feed material? If it is a feed additive, what category are you going to apply for? Some categories may be quicker or cheaper compared to others.

Pen & Tec can supply you with the pros and cons of each situation, advise on the best strategy and identify the most suitable market entry options.


Aligning objectives

Once it’s clear what the correct legal pathway is to register a product, it is important to keep track of the commercial objectives. There may be a gap between what you can do with a product from a regulatory perspective and what you would like to do from a commercial point of view.

For example, can you use the type of claim you are aiming to obtain or is it perhaps better to organise more clinical studies so that the data support a stronger and more useful claim that is targeted specifically to your consumers? Or is it better to spend more money on studies so that you can apply for the feed additive category your commercial team is interested in?

Pen & Tec can help align and manage the objectives of the various interested parties such as R&D, regulatory and marketing, or explain why a certain strategy is not feasible.



Whether the product of concern is a feed additive, novel food, food enzyme, additive or flavouring, it is very likely your team will need to prepare a scientific application proving the product or ingredient is safe for consumers, animals and the environment. In some cases, it may also be required to prove that the product is effective.

Pen & Tec can assist and this is how we do it:
  • Product category assessment 
    Based on the product description and the intended use we can identify together with your team what the correct product category is. Feed additive? Food enzyme? Novel food? Something else…?
  • Identification of legal status 
    Once we know the correct category, we can identify the legal status. Perhaps it has already been approved in the EU? Or perhaps the product only has to be notified to the competent authorities and does not require an approval?
  • Data audit and GAP analysis
    If it turns out the product has to approved by the European Commission before being placed on the EU market, we will evaluate any existing data. Perhaps you already have a lot of data available, or perhaps you can use published data.

Depending on the product category, there may be certain data requirements defined by EC/EFSA which have to be included in a technical dossier in order to prove the product is safe. Our team will provide strategic advice regarding the information required and help provide justifications to omit data, whenever possible. Due to our vast experience with the preparation of EFSA dossiers, we often know which information is crucial and which can be left out.

  • Financial Planning
    We will be able to indicate how much a certain project will cost at each stage of the registration process. The more information we have about the product, existing and missing data, the more accurate the estimate will be. 
  • Timelines and time to market
    How long will it take us to prepare and submit a scientific application? What will happen afterwards? How long before you can start selling it? We can help answer these questions by providing timelines.


Life cycle management of projects

Pen & Tec ensures life cycle regulatory compliance; from initial stages of product development, identification and evaluation of gaps in the data package, budgeting and generating the data required by the authorities, through to achieving regulatory approval. The time it takes to get a new food or feed product authorised can be significantly reduced if the project is well managed. Pen & Tec can support internal regulatory affairs departments when the in-house resources are limited.

Best practices for conducting studies

Pen & Tec can help support applicants in selecting suitable sites to carry out the required studies. We can also assist with designing studies following current guidelines and legislation, preparing protocols, monitoring trials, analysing raw data and statistical output with the appropriate methods, and preparing EFSA-compliant reports.

If the right procedures are followed and checked, questions from the authorities during evaluation can be avoided and unnecessary delays prevented.

Dossier preparation & post-submission support

Pen & Tec can prepare and submit dossiers with all the required information and also help with any issues that may arise after applications are submitted at national or EU level; from providing regulatory strategies to answering questions from authorities (clock-stops). If your application is in difficulty, please contact us and we will help it get back on track!

Pen & Tec provide options for broadening product portfolios, such as the use of a feed additive in a new target animal species. Pen & Tec can also track & manage renewal applications as existing approvals expire, to ensure there are no market access gaps. 



Pen & Tec has years of experience and knowledge of current legislation that allows us to advise companies on the regulatory requirements for food and feed products in the European Union, one of the largest global markets today. We also offer additional services, which are developed and tailored to client needs, some of which are listed below:

  • Monitoring of EU legislation changes
    Regulation and guidelines change frequently. Pen & Tec monitors and anticipates legislation changes in order to give the most up-to date advice to applicants.
  • Communication with EU authorities
    Pen & Tec can be the contact person for your application and manage the communication with EU authorities. This covers services such as submission of applications and dealing with questions from the European Commission, the EU Reference Laboratory, the European Food Standards Agency, or the National Competent Authorities via e-mail, teleconference or face-to-face meetings.
  • Literature searches
    Pen & Tec can conduct literature searches for data on the food or feed products, prepare safety assessments or expert reports to strengthen your application. Literature searches are often a useful tool to justify the omission of certain studies.
  • Statistical analysis and meta-analysis
    When it comes to feed additive dossiers, it is often challenging to obtain sufficient animal studies supporting efficacy. Pen & Tec can conduct statistical analyses and meta-analyses to help complete your efficacy data package.
  • Training and in-house workshops
    We deliver in-house training and workshops for regulatory teams. These sessions can be tailored and can cover all areas of our expertise, such as study designs and study monitoring to ensure EFSA-compliance, which will prevent unnecessary investments of time and money.
  • Conference presentations
    Conference presentations can be tailor-made to client needs at international conferences. These could cover a wide range of topics, such EU regulations or nutritional support for animal and human health.
  • Preparation of techno-commercial articles
    We can prepare techno-commercial articles or manuscripts suitable for publication in peer-reviewed scientific journals.




In addition to our technical offerings, we can assist your company to develop and grow in the feed and food sector, and help to maximize your business or product/s potential in a highly competitive market.

Regulatory feasibility studies

Pen & Tec is on hand to give you the business planning and market analysis that you need. We can map your strategic and project choices, bringing clarity to a complex array of current and future regulatory challenges to make sure that pursuing a particular regulatory pathway is feasible.

Market entry strategy

Entering a new market is a complicated process and requires a clear understanding of local culture, language and regulations. Moreover, no one market entry strategy works for all international markets, so Pen & Tec can help you identify the most appropriate strategy for your product to help you gain and sustain a competitive position.

Local office set-up

There are numerous practical and legal considerations when setting up an overseas office. Working with our global network of consultants and strategic partners, Pen & Tec offer a range of services to help you.

Partner/investor research

As experts in the food & feed industry, Pen & Tec are well-placed to conduct research into potential commercial partners/investors with allied interests and vision to help develop and bring your products to market.

International public relations

Marketing your product in a new country can be challenging. Pen & Tec can help you penetrate the market and position your product to build credibility and increase sales.

Trade missions/in-country market visit

If you are considering exporting your products then a market visit is the best way to connect with potential buyers, agents, distributors and prospective business partners. Pen & Tec can assist you in planning and organising every aspect of your overseas market visit.

Trade show support

Trade shows provide an excellent opportunity to promote your company or product/s. Pen & Tec can help you get the best return from attending an international exhibition, trade show or event.

Bridging cultural gaps

For your company to establish itself and succeed in different countries/markets, it is essential to bridge cultural, language and business etiquette gaps to minimize any misunderstanding or conflict. Pen & Tec can provide training to help overcome cultural barriers that can hinder success abroad.

Representation services

If you wish to market your product abroad, but do not want to set up a local office, it is often a legal requirement to have a legal representative based in the country you wish to market your product in. Working with our global network of consultants and strategic partners, Pen & Tec can act as your authorised representative to ensure local legal compliance.

Distributor research

As experts in the global food & feed industry, Pen & Tec can help you to identify potential distributors in different countries.



The UK’s self-imposed deadline to leave the EU is looming. With just seven months to go, many organisations continue to face high levels of uncertainty and unpredictability around what is to come and what the true impact of BREXIT will mean.

The outcome of BREXIT negotiations will require fundamental changes to the UK’s legal and regulatory landscape in the long term.

By its nature, regulation can be something of a reactive enterprise. It is rightly constrained by government policy and legislation, with the speed of enacting regulatory objectives often hampered by extensive consultation, engagement and parliamentary support.

Companies are finding it difficult to take key decisions today, and to plan for the future. What should you be doing to keep your business on track and to best protect the interests of your company, the industry and your customers?

Don’t panic! – Pen & Tec can help.

We understand the challenges are many and difficult. But we also know that uncertainty can offer new opportunities for those who know how to seek them out.

That’s why we’re proud to be at the forefront of helping organisations find new and innovative ways of working that make sense of today and help get ahead of the competition.

Pen & Tec has a representative office in the EU (near Barcelona, Spain) and we are able to provide support and legal advice as BREXIT unfolds, to our clients in both the EU and UK. 

In line with the regulatory services Pen & Tec provides, we are happy to assist with:

  • Strategic advice
  • Authorisation holder transfer
  • EU and UK regulatory support
  • Track regulatory changes and impact/s on the business/product presence on the market
  • Compliance check
  • EU representative offices

Have a question?

Please feel free to give us a call on +34 936 758 015