Clarification of criteria H7.A & H7.C

Introduction

On this page there is clarification regarding criterion H7 - Sensitising".

This page exists to facilitate the assessment of whether a product meets the criteria in the BASTA system or not.

See the introductory part in the criteria document on how goods are to be assessed and how levels are to be calculated.

Criterion H7.A Respiratory sensitisers - Category 1A (H334)

For respiratory sensitizing substances, there are not yet tests to evaluate whether a substance is a strong respiratory sensitizing “1A” (criterion H7.A). But Criterion H7.B means that products labeled with H334 do not meet the criterion.

Criterion H7.C Skin sensitisers - Category 1A (H317)

According to CLP, only pure substances and tested mixtures can be classified as highly allergenic in case of skin contact (Skin Sens. 1A).

Mixtures classified using the calculation method are classified as skin sensitizers (skin sens 1 (ie without A)), see table 3.4.3.4.2 from ECHA's "Guidance on the application of the CLP criteria": https://echa.europa.eu/ documents/10162/23036412/clp_en.pdf/58b5dc6d-ac2a-4910-9702-e9e1f5051cc5

This means that a chemical product that is required to be labeled with H317 because it contains a 1A substance (for example a preservative) and is classified based on the calculation method can fulfill the criterion H7.C. However, the product does not meet criterion H7.D.