New criteria for endocrine disruptors
The implementation of the change in criterion 5 hormone disrupting substances that was announced on 2018-12-17 now comes into force. However, a transition period will be applied until 2020-07-01, in order to allow adaptation to the changed criterion. The amendment means that BASTA is now basing the assessment of endocrine disruptors on the definition of endocrine disruptors that is applied in EU chemicals legislation. This means that substances should be considered to have endocrine disrupting properties if they meet all of the following criteria:
a) it shows an adverse effect in [an intact organism or its progeny]/[non-target organisms], which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
b) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
c) the adverse effect is a consequence of the endocrine mode of action.
Procedures for the assessment of endocrine disruptors according to the above definition are based on the methodology described in the document “Guidance document for handling criteria for endocrine disruptors in the construction industry”. BASTA will construct a simple tutorial describing the application of this guidance in BASTA. The document will be published and accessible from BASTA’s website, along with a simple tutorial describing the application of this guidance in BASTA. Both documents will be published on BASTA’s website and will be available in January. We want to alert our suppliers that this change means that the EDS database will no longer form the basis for the criterion from the 1/7 2020, but an information requirement will be introduced for substances included in the EDS database at concentration levels above 0.1%.
See below for a schematic picture for handling substances with endocrine disruptors according to BASTA’s criterion 5.
Notification of information requirements for potential PBT/vPvB
From 1/7 2020, information requirements will be introduced for substances that are included in CoRAP (Community rolling action plan). This applies to substances that have been evaluated in the EU or are to be evaluated over the next three years for their suspected persistent, bioaccumulative and toxic properties. For these substances, case number and content must be stated if the substance is included in a BASTA-registered product at concentration levels above 0.1%
Yours Sincerely
The BASTA-office