Food and Nutrition

The ever evolving food market triggers innovations in all food sectors, from food supplements and personalized life-style products to plant-based alternatives for animal-derived foods.

Food must be safe and may not mislead consumers. That is why strict rules apply for the demonstration of safety, nutrition and health claims made on all products.

a&r’s consulting team has successfully supported its clients for more than 20 years and offers competent and flexible services on regulated food products including:

Novel Food

Foods or food ingredients that were not consumed to a significant degree within the EU before May 15, 1997 might be subject to the Novel Food Regulation (EU) 2015/2283. This means that a new food products or food ingredient, might require a substantial safety assessment by the European Food Safety Authority (EFSA) and a pre-market authorization by the European Commission (EC).

Food improvement agents

The following categories of food improvement agents require an authorization, which follows a common authorization procedure according to Regulation (EC) 1331/2008 and will be included in respective Union Lists.

Food enzymes

Enzymes are used as processing aids and ingredients in many foods. They may be derived from plants, animals or (engineered) microbes.

Food additives

Food additives are substances primarily used for technological purposes in the manufacture, processing, preparation, treatment, packaging, transport or storage of foodstuffs. Although they are normally not characteristic ingredients, they become a component of such foods.

Food flavourings

Flavourings are not intended to be consumed as such, but are added to food in order to impart or modify odour and/or taste.

Food for Special Groups (FSG)

Regulation (EU) 609/2013 establishes compositional and information requirements for the following categories of food:

  • Infant formula and follow-on formulas
  • Processed cereal-based food and baby food
  • Food for special medical purposes (FSMP)
  • Total diet replacement for weight control

a&r’s services include:

  • Competent and flexible support at any stage of the product development, from initial idea to market access
  • Regulatory evaluation of your concepts, products and claims
  • Development of a regulatory route to market, e.g. an application strategy or scientific rationale
  • One-stop support in preparing the data package and documentation for all categories, as required by the authorities
  • Evaluation, planning and execution of clinical studies for the scientific substantiation of a health claim.
  • Compilation of the respective application dossiers, submission and communication with the Authorities
  • Broad network of accredited laboratories and regulatory agencies in international markets

Health Claims

Health claims on ingredients for functional foods and food supplements are important to the consumer, especially so for food supplements in tablet or capsule form that cannot convince the consumers through taste, but through their physiological effect only.

As of July 1 2007, the requirements for nutrient and health claims are regulated by the Health Claims Regulation (EC 1924/2006). Health claims must be evaluated by the European Food Safety Authority (EFSA) and authorized by the EU Commission prior to their use.

Through years of work in this field, a&r’s consulting unit gained substantial experience in developing claim strategies, especially with respect to the scientific requirements of EFSA for the substantiation of health claims but also regarding the development of a convincing product concept using generic health claims or nutrition claims.

a&r’s services include:

  • Development of a tailor-made health claim strategy and roadmap for your product
  • Gap analyses of relevant data incl. food characterisation, pre-clinical and clinical data and evaluation of the potential to convince EFSA
  • Recommendations for the scientific substantiation of the desired health claim
  • Advice on the possibility to protect proprietary data
  • Assessment and evaluation of study protocols with regard to EFSA-relevant requirements, including reporting of studies or study statistics
  • Planning of EFSA-relevant clinical studies for the scientific substantiation of the health claim
  • Preparation and submission of a health claim dossier to EFSA including:
    • 
Statements based on new scientific data (Art. 13.5)
    • Statements concerning reduction of a health risk (Art. 14)
    • Statements concerning the development of children (Art. 14)

Marketability Check

Within the EU, many food regulations have been harmonized, with the aim to enable the free movement of goods throughout the EU. Member States usually adopt in their national legislation EU regulations, but sometimes national and EU regulations diverge.
The manufacturer or, respectively, the distributor, is responsible for complying with the relevant EU regulations and the prevailing national provisions. Therefore it is crucial to check a product’s marketability and the compliance of the product label with the requirements of the target market prior to launch.

a&r’s services include:

  • Food regulatory evaluation of all product-specific data, including the product label for the target markets
  • Country-specific assessment of the marketability as a food ingredient with regards to the demarcation criteria between food, drug, and medical device
  • Notification for food supplements and dietetic foods to the responsible national authorities