Understanding the Regulatory Framework

CLEAR CHECK are skilled in communicating, and explaining the requirements of Regulations.

For “next level” insights on the Regulations listed below, plus more, contact the CLEAR CHECK team.

The following list is not exhaustive; it only represents the primary directives/regulations for health products, including food supplements. Other important pieces of legislation should also be considered (e.g. hygiene rules, unfair commercial practices, contaminants, biocides etc).

General Food Regulations

  General Principles and Requirements for Food Law Regulation 178/2002

This Regulation lays down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. It also stipulates that food must not be injurious to health or unfit for human consumption and that the labelling, advertising and presentation of food shall not mislead customers.

  [Related UK pieces of legislation: The Food Safety Act 1990, The General Food Regulations 2004, The Food Safety and Hygiene Regulations 2013]

  Food Information to Consumers Regulation 1169/2011

This Regulation establishes the general principles, requirements and responsibilities governing food information, in particular food labelling. It applies to any food business operator supplying food to the public or mass caterers as well as ‘business-to-business’ transactions.

  [UK implementing Regulations: The Food Information Regulations 2014]

  Addition of Vitamins, Minerals and Other Substances Regulation 1925/2006

This Regulation harmonises the provisions regarding the addition of vitamins and minerals and of certain other substances to foods. For example, it defines the purpose for which addition of vitamins and minerals is permitted and lays down criteria for the control of other substances (by way of prohibition or restriction or by placing ‘under scrutiny’); lists permitted vitamins and minerals and their authorised sources substances; lays down purity criteria for vitamin and mineral substances; provides specific labelling requirements, including compulsory nutrition labelling.

This Regulation does not apply to food supplements or food for specific groups, except for the provisions relating to control of other substances.

  [UK implementing Regulations: The Addition of Vitamins, Minerals and Other Substances Regulations]

  Food for Specific Groups Regulation 609/2013

This Regulation establishes compositional and information requirements for food intended for vulnerable groups of the population – infants and young children, people with specific medical conditions and people undertaking energy-restricted diets to lose weight. It also aims to increase legal clarity for business and to facilitate correct application of the rules.

The Food for Specific Group Regulation came into force on 20th July 2016, repealing Directive 2009/39/EC (PARNUT). It abolished the concept of dietetic foods and transferred rules on certain food categories (e.g. sport foods, foods to replace one or two meals of the daily diet) to Regulation 1169/2011 and Regulation 1924/2006.

  [UK implementing Regulations: The Food for Specific Groups Regulations 2016]

   Food Supplements Directive 2002/46

This Directive establishes the general framework and safety rules for food supplements, including a list of permitted vitamins and minerals and their authorised sources substances. It also defines what constitute a food supplement and provides specific labelling requirements (in addition to the labelling provisions set by Regulation 1169/2011). However, not all areas have been harmonised by the Directive (e.g. maximum levels for vitamins & minerals).

   [UK implementing Regulations: The Food Supplements Regulations 2003 (and as amended)]

Health Claims

  Nutrition and Health Claims Regulation Regulation 1924/2006

This Regulation establishes the legal framework for all nutrition and health claims made in commercial communications, which includes all forms of labelling and promotion material. It also established a list of permitted nutrition claims and authorised/non-authorised health claims.

  [UK implementing Regulations: The Nutrition and Health Claims Regulations 2007]

Food Improvement

  Food Additives Regulation 1333/2008 & Food Flavourings Regulation 1334/2008

These two Regulations lay down rules on food additives & flavourings, respectively, used in foods, providing a list of authorised food additives/flavourings & their condition of use and specific labelling requirements for certain food additives/flavourings.

  [UK implementing Regulations: The Food Additives, Flavourings, Enzymes and Extraction Solvents Regulations 2013]

Novel Foods

  Novel Foods and Novel Food Ingredients Regulation 258/97

This Regulation applies to foods and food ingredients that have not been consumed to a significant degree within the EU prior to 15th May 1997 and lays out the procedures and requirements to authorise the use of a novel food in the EU. It does not apply, however, to food additives, flavourings, extraction solvents used in the production of foods and GMOs. A list of authorisations and notifications of novel foods is available on the EU Commission website.

This Regulation will be repealed on 1st January 2018 and replaced by Regulation 2015/2283, which aims to provide a simpler, faster and more efficient authorisation procedure, fully centralised at EU level.

  [UK implementing Regulations: The Novel Foods and Novel Food Ingredients Regulations 1997]

Traditional Herbal Medicines (THM)

  Traditional Herbal Medicinal Products Directive 2004/24

This Directive amends the Medicinal Products Directive [2001/83/EC] & introduces a simplified registration procedure for herbal medicinal products with a long tradition of use (sufficient evidence of the medicinal use throughout a period of at least 30 years, including at least 15 years in the EU).

  [UK implementing Regulations: The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005]