Food and Nutrition

The demand for natural and healthy food products has clearly increased in recent years. The expanding LOHAS (lifestyles of health and sustainability) market segment is pushing the growth rates for functional foods and natural health products. With increasing regulatory requirements for food products, in-depth consultation is essential for a successful market entry. In addition, tailor-made marketing targeted to specific groups is necessary. a&r’s consulting unit has successfully proven this expertise and has supported its clients for more than 20 years.

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)

Novel Food

Foods or food ingredients that were not consumed to a significant degree within the EU before May 15, 1997 are subject to the Novel Food Regulation (EG) No. 258/97. In praxis, this means that a new food or food ingredient, prior to being introduced to the EU markets, requires a substantial safety assessment and a pre-market authorization by the EU Commission. Products that are substantially equivalent to a novel food or novel ingredient that is already authorized might qualify for a simplified authorization procedure.

a&r’s services include:

  • Analysis of all relevant data and assessment of the regulatory status (classification as novel or non-novel food, possibility to use the simplified procedure)
  • Research for data substantiating the history of safe food use of the product in the EU prior to 1997 or in countries outside the EU for at least 25 years
  • Identification of suitable product categories for a food ingredient
  • Advice on use levels for the different food categories and calculation of the anticipated overall intake of the novel food
Determination of the recommended daily allowance based on product-specific safety data and approved European consumption databases
Advice on the necessary safety evaluation of the novel food. Support with the execution of toxicological studies as well as professional interpretation of the results
  • Preparation and execution of counselling interviews with national authorities
  • Preparation and submission of applications based on substantial equivalence
  • Preparation and submission of Novel Food applications incl. follow-up during the evaluation phase

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