Endocrine Disruptors / Biocides | HEAL’s contribution to public consultation on proposed update of the EDC information requirements in the biocides product regulation
In the context of this update, not only is it important to stress that thorough safety testing of biocidal active substances (AS)
as well as co-formulants and products must take place before biocidal products are placed on the market, but also that it is
critical for the protection objectives of the regulation to be met.
The entry into force of the ED identification criteria for biocides and the related implementation guidance (thereafter referred
to as ECHA/EFSA guidance in 2018 makes the assessment of ED properties mandatory. The current delay in the biocides
review programme should not be used as an excuse by applicants to evade EDC assessment for active substances, coformulants (when ED concerns exist) and products. It should also not discourage evaluating authorities from requesting all the
necessary information to perform thorough assessments ahead of the placing on the market or the granting of renewed
authorisations. In cases when dossiers are incomplete in a way that prevents the clarification of ED concerns, authorities
should either consider refusing to assess them or conclude that the EDC criteria are met by default.
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