Skip to content


Pen & Tec has expertise in EU novel food regulations to help overcome regulatory barriers and ensure the fastest route to market. Our services are tailored to your needs and we are available to offer assistance at any phase of a project or evaluation process. However, it is essential to decide on a realistic and correct strategy at the early stages of a novel food registration project in order to avoid delays and minimise costs.

Pen & Tec work with applicants to identify the most appropriate strategy for obtaining authorisation. Our regulatory and scientific experience also means we can often anticipate questions and potential pitfalls in order to reduce delays before a product can be taken to market.



Food or food ingredients that have not been consumed to a significant degree in the EU before 15 May 1997 are considered “novel,” as per Regulation (EU) Nº 2015/2283. This could be a newly developed food such as nutrients or extracts produced from existing food, food produced using new manufacturing processes, as well as food that is traditionally eaten outside of the EU.In the latter case, under specific conditions the product could fall under the definition of a traditional food from a third country. Novel foods or novel food ingredients cannot be sold on the EU market unless they have undergone a thorough assessment to prove that the food is safe for human consumption, and received a pre-market authorisation from the European Commission.

As of 1 January 2018 there is a centralised authorisation procedure in place for evaluation of novel food applications. All applications should be submitted to the European Commission and if a scientific safety assessment is required, it will be carried out by European Food Safety Authority (EFSA), who rigorously evaluates the information to ensure the product is safe for consumers.


  • Initial assessment of the “novelty” of a food or food ingredient: assess the regulatory status and identify correct regulatory pathway to market the product
  • Collect information to support significant degree of consumption in the EU prior to 15 May 1997, or safe history of use in a third country for at least 25 years
  • Collaborate with authorities to confirm the ‘non-novel’ status of a food
  • Evaluate existing data, identify gaps and provide expert advice for the generation of additional data or justifications for omissions
  • Assist collecting additional data, monitor studies and review study reports
  • Compile, write and submit novel food dossiers
  • Post-submission support: liaise with EFSA and European Commission, answer supplementary information requests and provide regulatory support

Not sure if the product is novel? Contact us if you have questions or need regulatory assistance.


Food labelling or advertising cannot bear claims that could mislead the consumer. Rules on nutrition and health claims have been set down by Regulation (EC) Nº 1924/2006 to protect consumers as well as to ensure fair competition. The use of health claims is not permitted in the EU unless they are approved by the European Commission, having followed a scientific evaluation from the European Food Safety Authority (EFSA). In order to obtain an authorisation of a health claim, a scientific dossier should be prepared demonstrating that there is a cause and effect relationship between the consumption of the food and the claimed effect.


  • Assess the wording of label text to ensure approved claims are used, which are understood by the average consumer

  • Review clinical studies to determine if they qualify for a health claim and identify probability of success

  • Perform thorough literature reviews, ensuring all relevant information available in the public domain is used to support a health claim

  • Compile, write and submit health claim applications

  • Post-submission support: liaise with EFSA and Member State Rapporteur, answer supplementary information requests and provide regulatory support

Do you want to be able to inform consumers that one of the ingredients used in your food or food supplement has a beneficial effect?

Pen & Tec covers all type of health claims made on foods:

  • Article 13.5 claims based on newly developed scientific data
  • Article 14 claims on disease risk reductions
  • Article 14 claims referring to children’s development and health


Food enzymes, additives and flavourings are categorised in Europe as “food improvement agents” and are permitted on the market through a common authorisation procedure whereby the EU Union List of authorised food enzymes, additives and flavourings is updated.

Union Lists are already established for food additives and flavourings indicating which additives and flavourings are permitted in food, as well as their conditions of use. The Union List of authorised food enzymes is not yet established and until then, national legislations apply. The European Food Safety Authority (EFSA) has been evaluating over 300 food enzyme applications and it will thus take some years to establish the Union List. The current deadline is 2023/2024, although EFSA and the European Commission envision it may even take longer.

Do you want to add or remove a food improvement agent to the Union List? Would you like to change the conditions of use, specifications or restrictions of one of the substances and don’t know where to start?

Pen & Tec can help unravel the complex maze of regulations and guidelines and advise which technical and scientific elements are required to amend the Union List.


  • Initial assessment of the legal status of the substance to identify the correct regulatory pathway and ensure fastest route to market
  • Evaluate existing data and identify missing information in a GAP analysis
  • Provide expert advice for the generation of additional data or justifications for omissions
  • Assist collecting technical and scientific additional data, monitor studies and review study reports
  • Estimate dietary exposure and provide scientific and regulatory support for the consumer safety assessment
  • Compile, write and submit food enzyme, additive or flavourings dossiers
  • Post-submission support: liaise with EFSA and European Commission, answer supplementary information requests and provide regulatory support


Food supplements are food marketed in dose form (capsules, pills, tablets, drop dispensing bottles, etc.) containing nutrients, plants, or other substances with a nutritional or physiological effect, and are used to complement the normal diet. At European level, food supplements are regulated by Directive 2002/46/EC although additional rules can apply at national level.

Before introducing a food supplement on the market, EU Member States may request to be formally notified that the food supplement will be placed on the market in their territory. The exact document requirements vary from country to country but Pen & Tec can assist with the notification process to ensure fastest and most direct route to market.


  • Formulation review: verify legal status of ingredients (vitamins, minerals, plants, extracts, additives, etc.) and maximum permitted limits, if applicable, in target EU countries
  • Verify compliance of labels in accordance with FIC Regulation (EU) Nº 1169/2011
  • Assess permissibility and wording of claims
  • Translate label text to major EU languages (English, French, German, Italian, Spanish, Dutch, Polish, Romanian, Greek) and ensure compliance with national rules
  • Advise and assist with notification process
  • Liaise with Member States before, during and after submission review process


On 29 June 2013, Regulation (EC) Nº 609/2013 concerning Foods intended for Special Groups (the “FSG regulation”) was published and will repeal and replace the existing legislative framework for dietetic foods, including:

  • Infant formula and follow-on formula
  • Processed cereal-based food and baby food
  • Total diet replacement for weight control
  • Food for Special Medical Purposes (FSMPs) 

FSMPs are defined as foods intended for the dietary management of patients that have:

  • problems consuming ordinary food or are malnourished because of a specific diagnosed disease, disorder or medical condition;
  • difficulties satisfying their nutritional needs through the consumption of other foods, including food supplement

As of 20 July 2016, Member States can forward notifications to the European Commission should they have doubts about the legal category of a product that will be marketed as an FSMP. In order to decide if a notified product falls within the scope of the FSG regulation and can thus be considered an FSMP, the European Commission may ask the European Food Safety Authority (EFSA) for scientific advice to evaluate the composition and proposed uses of the product to ensure their decision is based on sound scientific judgment. 


  • Assess the legal category of the product and identify whether it qualifies as an FSMP
  • Collect information to support the classification of an FSMP
  • Evaluate existing data, identify gaps and provide expert advice for the generation of additional data or justifications for omissions in case a scientific assessment by EFSA is required
  • Compile, write and submit FSMP dossiers to EFSA.
  • Liaise with Member States, European Commission and EFSA

Have a question?

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