To protect consumers against potential health risks arising from the consumption of food supplements and to ensure that they are not provided with misleading information, food supplements are covered by European and national laws and regulations on food safety.
Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses). Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic effect.
Food supplements are only intended to ‘supplement’ people’s diets and not replace healthy foods. The regulation of food supplements makes clear that food supplements are not intended to replace a varied and balanced diet and food supplements packaging is required to state this information.
Because food supplements are considered as food, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a food supplement placed on the market is safe.
EU Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. Once the product is on the market, the competent authority of the Member State may monitor its use and safety in that territory.
Following an assessment by the European Food Safety Authority (EFSA), the European Commission may take a decision to include a certain substance in a list of substances whose use in foods is prohibited, restricted or under scrutiny. This may happen when the addition of a substance in food products increases its exposure to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 partially harmonizes the rules for placing food supplements on the European market. The scope of the Directive includes all food supplements with certain requirements, in particular those relating to labeling particulars, which apply to all food supplements, whatever their composition.
The United Kingdom has taken a significant step in regulating the use of Butylated Hydroxytoluene (BHT) in cosmetic products. This move is crucial for distributors, manufacturers, and importers to ensure compliance and maintain the safety of their products in the UK market.
On March 12, 2024, the Health and Safety Executive (HSE) updated the GB Mandatory Classification List (MCL) by adding 25 new chemical substances, as mandated by Article 37 of the GB Classification, Labelling and Packaging (CLP) Regulation. This update impacts substances identified as cosmetic ingredients with proposed Carcinogen, Mutagen, or Reprotoxic (CMR) classifications under Article 15 of the UK Cosmetics Regulation (UKCR). Notably, 2-ethylhexanoic acid and its zinc salt, along with Dimethyltolylamine, are among those facing potential bans and additions to the UK Cosmetics Regulation’s Annex II. These changes will come into effect on September 2, 2025.
The Scientific Committee on Consumer Safety (SCCS) published the Preliminary Opinion on new coating for Titanium Dioxide (nano). It declared the data was not enough to draw conclusions regarding the safety of this alternative coating, as more evidence of similarity to other nanomaterials is necessary.
Conducting a clinical investigation in medical devices within the European Union (EU) requires a Sponsor, who has responsibilities before, during and after the clinical investigation.
Cyclic volatile methyl siloxanes (cVMS) have raised environmental concerns because of their persistence and bioaccumulative properties. In light of these concerns, the European Union has extended restrictions on substances like D4, D5, and D6 in cosmetic products. New regulations will further limit the concentration of these compounds in both rinse-off and leave-on products, with compliance deadlines set for 2026 and 2027.
The SCCS was tasked by the European Commission to evaluate if the safety levels for Citral, determined through QRA2 based on skin sensitization induction, are sufficient to safeguard consumers. A preliminary opinion was released.
