Memorandum on use of Human Data in risk assessment of skin sensitisation

SCCS members: U. Bernauer, Q. Chaudhry, P.-J. Coenraads, G. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, Ch. Rousselle, J. van Benthem
Contact:SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1567/15
Doi:
Adopted on: 15 December 2015

Conclusion of the opinion:

In conclusion, available and reliable data and experience with regard to contact allergy to substances in humans, such as diagnostic patch test data and if relevant dose-response elicitation studies, should be taken into account for risk management. They should be given priority over data derived from animal studies, particularly when human data demonstrate hazards and risks not identified from animal studies.

The results of animal studies should be weighed against the results of data from humans and expert judgement should be used to ensure the best protection of human health when evaluating both the animal and human data. Guidance on interpretation of animal data for skin sensitisation can be found in SCCP/0919/05.

Keywords:

SCCS, memorandum, human data, risk assessment, skin sensitisation, EC Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Memorandum on use of Human Data in risk assessment of skin sensitisation, SCCS/1567/15, 15 December 2015.