Notification (2018-12-17)

2018-12-17

Notification (published 2018-12-17)

Information to our suppliers:

The following addition enters into force 2017-07-01

The addition will be made to criterion 5 – Endocrine disrupting substances, for both the BASTA- and BETA- criteria.

BASTA will from 2019-07-01 change the criterion for endocrine disrupting substances. This criterion will include substances ≥0,1 that are considered to meet definition for the EDCs as implemented by the European Commission in the criteria for identifying endocrine disrupting substances in plant protecting products[1] and biocides[2].

This means that the substance shall be considered to have endocrine disrupting properties if it meets all the following criteria:

  1. 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;
  2. b) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
  3. c) the adverse effect is a consequence of the endocrine mode of action.

This is an addition to criterion 5 – Endocrine disruptors. The criterion will continue to include substances with the overall assessment Cat 1 or Cat 2 in EU’s EDS Database as well as substances that are included in the Candidate list because they have endocrine disrupting properties in accordance with REACH Article 57f.

BASTA will initiate an industry dialogue to discuss how the new criteria for endocrine disrupting substances shall be used in practice. A guidance document will be developed in collaboration with the IVL Swedish Environmental Research Institute that will clarify its application. The guidance document will be developed during the first half of 2019.

The use of the EDS Database will continue, but will eventually be phased out as a result of the application of the new criterion. The timetable for the phase out will be decided in connection within athe completion of the guidance document.

There will be no changes to the BASTA- or BETA-criteria on the 1of January 2019. This means that the current criteria documents 2018:A2 remain valid until 2019-07-01.

[1] Criteria for the identification of endocrine disrupting substances in plant protection products, EU 2018/605, the 19th of April 2018 regarding the amendment of Annex II to Regulation EC No 1107/2009, https://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32017R2100&qid=1541403864699&from=EN

[2] Criteria for the identification of endocrine disrupting substances in biocides, EU 2017/2100, the 4th of September 2017 regarding scientific criteria for identifying endocrine disrupting properties under EU no.528/2012, https://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32018R0605&qid=1541403932813&from=EN