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Where can I find residual solvents information?

The residual solvent details for products can be found in the 'Additional Technical Information' section of our technical dossier.

Directive 2009/32/EC on Extraction Solvents

Directive 2009/32/EC governs the use of extraction solvents in the production of foodstuffs and ingredients. However, this directive does not apply to solvents used in the production of food additives, vitamins, or other nutritional additives unless they are specifically listed in Annex I.

We interpret nutritional additives to include substances such as vitamins, minerals, amino acids, fatty acids, or other compounds that fulfil nutritional or physiological functions. Therefore, many of our products fall outside the scope of this directive.

Despite this, Member States must ensure that the use of food additives, vitamins, and nutritional additives does not result in extraction solvent residues at levels harmful to human health.

Where applicable, we strive to include information about the solvents used in the Additional Technical Information section of the product’s technical dossier. For example, if the solvent used is water (unless regulated substances are added to modify acidity or alkalinity), the product is considered outside the scope of this directive.

For example:

Where the solvent listed is only water, unless “substances regulating acidity or alkalinity may have been added”, the product is out of scope of this regulation.

Pharmacopoeia Standards

Many of our products comply with solvent standards set by the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP). These standards categorise solvents based on their potential risks:

  • Class 1 Solvents: Prohibited unless their use is unavoidable.
  • Class 2 Solvents: Permitted with defined limits, e.g., Hexane or Methanol.
  • Class 3 Solvents: Generally regarded as safer and without specific limits, e.g., Ethanol or Acetic Acid.

Specific solvent requirements for individual products are detailed in the Technical Dossier, including any outlined in the product monograph.

Additives and Novel Foods

Further regulations apply to solvents used in food additives and novel foods, as outlined in:

  • Commission Regulation (EU) No 231/2012: Requirements for food additives.
  • Commission Implementing Regulation (EU) 2017/2470: Establishes the Union list of novel foods.

These regulations may permit the use of certain solvents in food products not directly addressed in Directive 2009/32/EC. For instance, solvents used in E161b Lutein are governed by these additional rules.

Example for E 161 b LUTEIN

Where to Find Solvent Information

For detailed residual solvent information, refer to the Additional Technical Information section of the product’s technical dossier, where applicable. If you have specific queries, feel free to contact our technical team.