Many well-developed products encounter unexpected setbacks not because of formulation issues, but due to avoidable labelling errors.
Understanding these common mistakes and checking early can help brands streamline their approval process and reduce time-to-market.
Incorrect INCI Listing Order
One of the most frequent labelling issues is incorrect ingredient ordering in the INCI (International Nomenclature of Cosmetic Ingredients) list.
Ingredients must be declared in descending order of weight at the time of formulation, with an exception for ingredients present at very low concentrations.
Common errors include:
- Misordered ingredients due to incorrect or incomplete supplier documentation
- Missing or Incorrect Allergen Declarations
- Incorrect INCI name for intended market
Complete data on ingredients is a must – some suppliers do not include preservatives in the INCI but these must be added in the UK & EU. In many markets, especially the UK, EU and soon the USA, certain fragrance allergens must be declared when present above specified thresholds. The USA has some different INCI names for botanicals and in theory in the USA this name should be 1st if the EU name is also shown (and vice a versa).
Claims That Are Not Fully Supported
Marketing claims are a major source of regulatory delays. Common problematic claims include:
- “Clinically proven” without adequate evidence
- “Dermatologist tested” without documented testing protocols
- “Anti-ageing,” “healing,” or “treatment” type language that may cross regulatory boundaries
- Unsubstantiated performance claims (Claims include suggestions of specific action even those inherent in the product name)
Regulators require that all claims are supported by appropriate technical or clinical evidence, and failure to provide this can halt launch approval or cause serious issues once on the market. Rules vary across different markets…
Inconsistent Multi-Language Labelling
For brands launching across multiple markets, translation errors and inconsistencies are a common issue. Problems include:
- Incorrect translation of product claims
- Mismatched translation of primary and secondary packaging information
- Missing mandatory local language requirements
Incorrect Net Content or Batch Information
Regulations typically require clear indication of:
- Net volume or weight
- Batch or lot number
- Manufacturing or expiry information (where applicable)
Again, the requirements vary across different markets and need to be considered carefully.
Failure to Align Packaging and Label Space
Label design must align with physical packaging constraints, but this is often overlooked until late in the process. Common issues include:
- Insufficient space for mandatory information
- Poor readability due to design choices
- Wrapping or curvature issues on containers
- Regulatory text overcrowding
Missing Required Warnings
- Some ingredients have regulatory warnings that must be on pack. This can vary between markets.
Recycling Labelling
An increasingly important part of labelling.
- The recycling symbols and any wording must be acceptable for all markets.
The Importance of Regulatory Reviews
Many labelling issues arise because regulatory considerations are introduced too late in the development process. When regulatory and technical teams are involved early, brands can:
- Align formulation and labelling requirements from the start
- Reduce last-minute changes
- Avoid unnecessary reprints
- Improve approval timelines
This integrated approach significantly improves efficiency and reduces risk.