BIOCIDES
Procedure
1 Check decisions and opinions under the BPR or PPPR if the substance fulfils the ED criteria . Check the candidate or SVHC lists under REACH and ECHA ED list for
completed or ongoing procedures with a focus on the endpoint ED . If the substance has been identified as an ED , the screening procedure can be stopped and the regulatory consequences under the BPR apply
2 Check whether the non-active substance is defined as food according to Regulation ( EC ) No . 178 / 2002 . If it is , the screening procedure can be stopped as ED properties
are highly unlikely
3 Check with a focus on the ED endpoint whether the non-active substance is subject to a procedure according to the Activities Coordination Tool ( ACT ) which shows all
REACH and CLP regulatory activities such as classification and labelling proposals , SVHC proposals , hazard assessment activities ( including ED ) and the Community Rolling Action Plan for substances under evaluation and dossier evaluation . If the substance was not found to be an ED , the same applies to the non-active substance . If the substance was found to be an ED , the non-active substance should also be considered an ED and the regulatory consequences apply . If a conclusion has not yet been agreed , authorisation can proceed with a post-authorisation condition to reassess the conclusions based on the outcome of the procedure ( s ) under REACH
4 If the substance is not ( yet ) subject to a procedure according to the ACT , check the information in REACH registration dossiers with a focus on potential ED properties . If
any are found , the non-active substance may have indications for ED properties and may be a candidate for further evaluation by procedures within the scope of REACH to substantiate this indication
5 Check whether the non-active substance been considered as an ED or as having a potential for ED properties under review programmes of other internationally
recognised ( non-EU ) organisations , e . g . WHO . If so and a concern has been identified , the product application should include a conclusion as to whether or not the nonactive substance is considered to have ED properties and thus should be considered an ED ; if so , the regulatory consequences apply
6 Check whether or not the non-active substance is part of the CompTox Chemicals Dashboard of the US EPA and whether there are indications for ED activity with
respect to EATS-related endpoints . If so and a concern has been identified , the product application should include a conclusion as to whether or not the non-active substance possesses EATS-mediated ED activity and is regarded as an ED . Further testing of the non-active substance to substantiate the EATS-mediated ED activity should be discussed in collaboration with CAs . If , based on this , it is considered to be an ED , the regulatory consequences under the BPR apply
7 If there are no indications for ED properties in Steps 1-6 above , check the classification and labelling ( C & L ) of the concerned non-active substance and the
reason for it . ED-relevant C & L comprises : reproductive toxicity ; STOT-RE ( May cause damage to the thyroid or pancreas or adrenals or other endocrine organs , through prolonged or repeated exposure ); and / or carcinogenicity . If so , a conclusion in the product application is required as to whether the reprotoxic / STOT-RE effects are endocrine-mediated , and whether the co-formulant is , therefore , considered to have ED properties , supported by dedicated testing , read across , justifications . If the nonactive substance is considered an ED , the regulatory consequences apply
8 Since information on ED-related endpoints is scarce specifically for non-target organisms ( i . e . for ecotoxicological endpoints ), a literature search should be carried
out to ensure that any current knowledge has been identified and considered . The literature search should encompass at least the last two years .
Figure 2 - Screening procedure for for potential ED properties of non-active substances in biocidal products '
When the ED properties have been identified according to Section B ( non-target organisms ) of the ED scientific criteria for biocides , such an active substance may still be used in biocidal products but will be a candidate for substitution according to Article 10 ( 1 ) and will be subject to a comparative assessment . Most importantly , biocidal products containing an active substance that is a candidate for substitution due to ED properties on non-target organisms may be authorised for a maximum period of five years ( instead of ten ) under Article 23 ( 6 ). Non-active substances identified as EDs will render the concerned biocidal products an ED and Article 19 ( 4 ) of the BPR applies . Biocidal products identified as EDs may not be made available to the general public , but may still be applied by industrial and professional users If an active substance used as a coformulant is identified as an ED , it may still be applied as a co-formulant in the concerned biocidal products and Article 19 ( 4 ) ( i . e ., no use by the general public ). The replacement of an ED co-formulant may result in the need for a reassessment of the biocidal product with respect to physical-chemical properties , shelf-life and , most importantly , efficacy in the intended uses •
References 1 : https :// www . efsa . europa . eu / en / efsajournal / pub / 5311
2 : https :// www . who . int / ipcs / publications / new _ issues / endocrine _ disruptors / en /
3 : CA-March18-Doc . 7.3 . b-final , The implementation of scientific criteria for the determination of ED properties in the context of biocidal product authorisation
4 : CG document Assessment of ED properties of co-formulants in biocidal products – instructions for applicants ” CG-34-2019-02 AP 16.5 e-consultation ED potential of co-formulants . pdf
5 : CA-March21-Doc . 4.3 , Proposal to bridge the ED assessment of biocidal non-active substances with REACH screening & assessment
Dr Michael Werner
MANAGING DIRECTOR
PROSACON GMBH k + 49 6192 979917-0 J michael . werner @ prosacon . eu j www . prosacon . de
37