Regulatory harmonisation across the EU represents a huge opportunity for food innovation firms to access numerous markets. At the same time, not all countries are in sync when it comes to certain rules. David Pineda Ereño, Managing Director of DPE International Consulting, identifies some of the key regulatory issues facing SMEs.
February 18, 2021
“The European market provides great opportunities, particularly due to the European Union (EU)’s vast regulatory harmonisation for food and beverages products,” says Pineda. “Foods and beverages do not generally require any pre-market approval to enter the EU market.”
However, those that are considered as 'novel foods or ingredients' require to be authorised before they can be marketed. In addition, it is also important to take into account, that the use of food additives or nutrition and health claims is regulated through positive lists.
“In fact, the development of positive lists is a major trend in past years in the EU,” says Pineda. “On the other hand, despite the EU harmonised regulation, there are certain aspects which are not harmonised and depend of the national regulation of EU member states.”
For SMEs looking to access the European market, there are several key legislative provisions that all suppliers and manufacturers should be aware of. Regulation (EC) 2015/2283 on Novel Foods, for example, provides a simplified authorisation process, delivering access to the whole EU internal market for products and ingredients that conform.
Other important regulatory provisions include Regulation (EC) No 1924/2006 on nutrition and health claims, which lays down the conditions for the use of nutrition and health claims on food packaging and its advertising. The decisive criterion for use of a health claim is that the health effect claimed in relation to a nutrient or substance must absolutely be based on scientific evidence.
Companies should be aware, however, that national rules concerning nutrients or other substances with nutritional or physiological effects used as ingredients of food supplements, may be applicable. Unlike for the use of vitamins and minerals in food and food supplements, there are no harmonised EU rules on herbal extracts as food supplements, leaving it up to national authorities to decide whether a product is safe.
On the other hand, another key trend worth highlighting is the further extended application by EU member states of the EU mutual recognition principle of foods and food supplements lawfully marketed in another member state.
“I monitor, analyse and evaluate key policy and regulatory developments on a daily basis to help businesses keep ahead of these developments,” explains Pineda. “This is critical for the development of an accurate and comprehensive market entry strategy for foods and beverages.”
Pineda advises small businesses to first identify and evaluate the regulatory requirements that will affect them, bearing in mind that these can be either harmonised at the European level, or at national level. A further complicating factor is Brexit.
“With the entry into force of Brexit, the United Kingdom legal system is in transit,” he notes. “For this reason, it is also important to closely follow the evolution of their food regulations.”
DPE International Consulting is an international consultancy firm that provides strategic and regulatory advice on the policy, regulation and trade of foods and beverages to companies, trade associations, and government bodies at national, regional, and international level in Europe, Latin America and the Caribbean, Asia, Middle East and Africa, and the USA.
