Solution — Tolerance

Prove that your product is well tolerated

Skin tolerance, safety on sensitive skin, repeated use… every safety claim must be based on solid consumer data. SYRES produces evidence that complies with European regulatory requirements.

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Challenges in the sector

Regulation (EC) No 1223/2009 requires that the safety of the finished product be documented in the Product Information File (PIF). Consumer tolerance data is essential proof for any product placed on the European market.

Safety claims ("dermatologically tested", "suitable for sensitive skin", "hypoallergenic") are subject to EU Regulation 655/2013 on cosmetic claims. They must be supported by evidence on the target population.

What SYRES brings

DIP Compliance & Claims

Tolerance data constitutes essential evidence for the Product Information File (PIF) required by EC Regulation 1223/2009. Our protocols meet the expectations of the authorities.

Sensitive populations

Panelists recruited according to the targeted profile: reactive skin, atopic skin, babies, children, mature skin — for claims representative of your end users.

Standardized monitoring

Validated questionnaires, structured skin self-assessment and, if necessary, follow-up by a doctor or dermatologist remotely for rigorous monitoring.

Defensible results

Comprehensive reports including raw data, statistical analysis and regulatory conclusions — enforceable against the DGCCRF and your distributors.

Protocols

The adapted protocol each security claim

Depending on the product, the target population and the intended claim, SYRES selects or combines the most suitable protocol.

CAP

Usage tolerance

Panelists use the product at home according to a defined protocol. Signs of intolerance are monitored via structured questionnaires and skin self-assessment at regular intervals. Typical duration: 14 to 28 days.

14 to 28 days.30 to 100 panelistsRemote monitoring

CENTER

Test in a controlled environment

Supervised application under controlled conditions with standardized monitoring for signs of intolerance. Recommended for products intended for very reactive skin, children, or mucous membranes.

1 to 4 visitsControlled conditionsSensitive skin

PATCH

patch test

Occlusive application to the back for 24 to 48 hours, standardized reading of skin reactions. Used for the detection of irritating or sensitizing components before launch.

24 to 48hOcclusive applicationScreening formula

REPEATED

Repeated test

Repeated daily applications to a defined area for 21 days. Evaluates skin tolerance to intensive or prolonged use, relevant for rinse-off or frequently used products.

21 daysHeavy duty useRinse & leave-on

Claims validated