R&D and the Formulated Without policy

From a partner's brief to a testable formulation

Sikalias Pharmaceutical Laboratories connects development and reformulation with raw-material compatibility, stability, analytical documentation and transfer to manufacturing. Material selection starts with a defined product category, audience, function, specifications and target market.

What Formulated Without means

This is an ingredient-selection policy for the projects where it is agreed. Exclusions and preferences are documented in the development brief. The team assesses the function of each material and whether an alternative can meet the finished product's requirements.

Plant or biotechnology origin may be a preference in the brief. Origin alone does not demonstrate safety, effectiveness or a lower environmental footprint. Exclusion under a company policy does not mean an ingredient is universally unsafe or prohibited.

Three categories, distinct assessments

• Cosmetics: exact INCI identity, function, concentration, use conditions, microbiological protection, stability and safety assessment.
• Food supplements: raw-material identity and quality, composition, excipients, specifications and documentation of the intended use.
• Foods and specialist nutrition projects: separate evaluation of product classification, permitted uses and appropriate specifications. Cosmetic criteria are not automatically applied to food.

Reformulation requires testing

Changing a preservative, surfactant, emulsifier or packaging material can affect the entire formulation. A project-specific programme may include compatibility, stability, microbiological evaluation and pilot manufacturing. A list of absent ingredients cannot establish the performance of the finished product.

Primary sources and documentation

The European Commission describes CosIng as an information database: an INCI listing does not itself approve an ingredient for use. Applicable rules and current evidence must be assessed. Additional sources include ECHA CHEM, EUR-Lex, EFSA and EOF.

Discuss an R&D project

Start with the dosage form, market, intended functions and ingredient constraints. Agree an appropriate secure channel and, where needed, an NDA before sharing confidential formulas.

Request development or reformulation