Regulation on criteria for identification of a substance as persistent, bioaccumulative, toxic and very persistent and bioaccumulative.

This Regulation prescribes the criteria for the identification of certain physical substance as persistent, bioaccumulative and toxic (PBT substance) and very persistent and very bioaccumulative (vPvB substance). These rules shall apply to all organic substances, including organometals.
The following results shall be taken into account: monitoring and modeling; in vitro tests; effects on animals; application of the approach with categories (classification into groups, application of data by analogy); data obtained on the basis of biodegradation model; and occupational exposure, accident databases, epidemiological and clinical studies.
Classification criteria is laid down in article 4; for bioaccumulative substance criteria see article 5; criteria for identification of toxic substances is in article 6; criteria for the identification of a very persistent substance in article 7; and criteria for the identification of highly bioaccumulative substances is laid down in article 8.