i . e ., adverse effects with a view to ED relevance 3 . Initial analysis of the evidence : Judgement as to whether EATSmediated parameters and ED activity are sufficiently investigated and establishment of a potential biological plausible link between them 4 . MoA analysis : If EATS-mediated adversity and / or ED activity is observed , an in-depth analysis of the MoA and the cascade molecular initiating event -- > key event 1-n -- > adverse outcome ) is needed 5 . Conclusion : If a conclusion is not possible , the need and a strategy for the generation of further in vitro / in vivo data is to be considered The reassessment of all available information with a particular focus on ED properties and the establishment of a biologically plausible link between potential ED activity and observed adverse effects require considerable effort and a high level of expertise .
ED screening of biocidal products
During the approval phase of biocidal active substances , the assessment of potential ED properties lies on the active substance only , but further duties are imposed on prospective applicants for the authorisation of biocidal products in that their ED properties need to be examined . The aim here is to identify and conclude upon the potential ED properties of the non-active substances , i . e ., the co-formulants contained in the biocidal product ( s ) before a definitive decision on the conditions for their authorisation can be made in the product assessment report ( PAR ). In this regard , the biocides regime has been the first to undertake a mandatory assessment of ED properties in the context of product authorisation . Co-formulants , such as solvents , could also be biocidal active substances in their own right and have , therefore , no biocidal function in the concerned product type ( s ) ( PTs ). However , for product authorisation , the responsible competent authorities ( CAs ) do not evaluate the ED properties nor request additional data on the ED properties of actives substances in the context of product authorisation procedures . According to CA document 3 , the scientific criteria defined in 2017 / 2100 should also be applied for the identification of the potential ED properties of non-active substances . However , unless a co-formulant is an active substance on its own for other PTs where such an assessment has already been conducted during active substance approval . Thus , the application of these scientific criteria to co-formulants is hampered as most have been registered under REACH , where the data package depends on the tonnage band . Only limited information on ED relevant endpoints may be available , which does not allow for a proper identification and assessment of their ED properties of the co-formulant ( s ).
With regards to the assessment of potential ED properties of non-active substances in biocidal products , the process set out in the ECHA / EFSA guidance is , therefore , not followed . Instead , a more practical approach is applied : a screening for an indication of potential ED properties of non-active substances . The process is described in a guidance of the Coordination Group and is depicted in more detail in a CA document . 4 , 5
Figure 2 shows a screening procedure to identify potential ED properties of nonactive substances in a biocidal product . It is based on a step-wise approach by searching in different databases for decisions or ongoing evaluations with a focus on the ED assessment of substances regulated under other horizontal legislation .
Regulatory implications
In case the assessment of the ED properties of a biocidal active substance or the screening for an indication of ED properties of a non-active substance result in a positive outcome , the following regulatory consequences under the BPR will apply . For biocidal active substances , when ED properties have been identified according to Section A ( human health ) of the ED scientific criteria for biocides such an active substance fulfils the exclusion criteria according to Article 5 ( 1 ) of the BPR and may not be used as an active substance in biocidal products any more , unless the derogation statements according to Article 5 ( 2 ) apply and can be proven ( Table 1 )
Section A of Regulation ( EU ) 2017 / 2100 : Humans Section B of Regulation ( EU ) 2017 / 2100 : Non-target organisms
0 |
Exclusion criteria acc . to Art . 5 ( 1 ) of the BPR apply if : |
0 |
Substance is a candidate for substitution acc . to Art . 10 { 1 } of the BPR if : |
|
a ) Substance is meeting the ED criteria according to Section A of the Annex to Regulation ( EU ) 2017 / 2100
b ) Substance identified in accordance with Article 57 ( f ) and 59 ( 1 ) of the REACH Regulation ( EC ) No 1907 / 2006 as having ED properties .
|
|
a ) Substance is meeting the ED criteria according to Section B of the Annex to Regulation ( EU ) 2017 / 2100
b ) Substance has an intended mode of action that consists of controlling target organisms via their endocrine system ( s )
|
Consequence : Phase out of active substance if derogations acc . to Article 5 ( 2 ) of the BPR are not applicable .
Consequence : Comparative risk assessment will be required and approval and each renewal only for a period not exceeding seven years .
Table 1 - Regulatory impact on active substances identified as EDs under Regulation 2017 / 2100
36 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981