Substance-specific risk assessment
Article 4
1. A request shall be addressed to EFSA for a substance-specific risk assessment as to whether reference points for action are adequate to protect human health, in particular for substances: (a) that cause blood dyscrasias or allergy (excluding skin sensitisation); (b) that are high potency carcinogens; (c) for which genotoxicity cannot be excluded, if there is experimental or other evidence that the use of the toxicological screening value of 0,0025 μg/kg b.w. per day may not be adequately health protective. 2. The Commission shall, where appropriate, submit a request to EFSA for a substance-specific risk assessment as to whether a reference point for action is adequate to protect human health, where application of the method laid down in Article 3(4) indicates that the toxicological screening value, divided by the relevant food intake, is lower than the analytical capability of the official control laboratories, and that there is little or no possibility of significant improvement in the analytical capability within a short to medium time frame. 3. Where the substance specific risk assessment is inconclusive, due to uncertainties regarding certain aspects of the toxicological or exposure assessment, and no guarantees are available on whether the lowest analytically achievable concentration is sufficiently safe for consumers, the European and National Reference Laboratories shall endeavour to improve the sensitivity of analytical methods in order to be able to enforce lower concentrations and the reference points for action shall be set at levels which are low enough to stimulate improvement of the lowest achievable levels.