{"id":22098,"date":"2024-05-30T12:00:20","date_gmt":"2024-05-30T10:00:20","guid":{"rendered":"https:\/\/kaeltia.com\/?p=22098"},"modified":"2024-09-06T13:31:57","modified_gmt":"2024-09-06T11:31:57","slug":"exposure-assessment-coformulants-3-kaeltia","status":"publish","type":"post","link":"https:\/\/kaeltia.com\/en\/exposure-assessment-coformulants-3-kaeltia\/","title":{"rendered":"Exposure and risk assessment for coformulants (Part 3)An urgent need detected"},"content":{"rendered":"
Following<\/span> the<\/span> post<\/span> published<\/span> on<\/span> 29\/05\/24,<\/span> we<\/span> continue<\/span> with<\/span> the<\/span> summary<\/span> of<\/span> the<\/span> items<\/span> discussed<\/span> by<\/span> the<\/span> EFSA<\/span> and<\/span> European<\/span> Commission\u2019s<\/span> staff<\/span> related<\/span> to<\/span> the<\/span> assessment<\/span> of<\/span> coformulants<\/span> in<\/span> PPP:<\/span><\/div>\n
<\/div>\n
ITEM<\/span> 1_<\/span> MAPPING<\/span> THE<\/span> CURRENT<\/span> PRACTICES<\/span> OF<\/span> THE<\/span> MEMBER<\/span> STATES<\/span><\/strong><\/div>\n
<\/div>\n
The<\/span> current<\/span> practices<\/span> to<\/span> assess<\/span> PPPs<\/span> are<\/span> usually<\/span> based<\/span> on<\/span> hazard:<\/span> SDS,<\/span> classification<\/span> is<\/span> checked<\/span> (if<\/span> the<\/span> co-<\/span>formulant<\/span> is<\/span> classified,<\/span> its<\/span> concentration<\/span> in<\/span> the<\/span> PPP<\/span> is<\/span> verified<\/span> whether<\/span> it<\/span> would<\/span> trigger<\/span> the<\/span> classification<\/span> of<\/span> the<\/span> PPP),<\/span> CMR<\/span> status<\/span> (if<\/span> CMR<\/span> category<\/span> 1<\/span> or<\/span> 2<\/span> in<\/span> some<\/span> countries,<\/span> the<\/span> assessment<\/span> is<\/span> stopped).<\/span> In<\/span> few<\/span> cases,<\/span> genotoxicity<\/span> studies<\/span> on<\/span> the<\/span> PPP<\/span> have<\/span> been<\/span> required.<\/span> If<\/span> no<\/span> hazard<\/span> identified,<\/span> no<\/span> exposure<\/span> assessment<\/span> would<\/span> be<\/span> needed.<\/span><\/div>\n
<\/div>\n
The<\/span> full<\/span> composition<\/span> of<\/span> the<\/span> PPP<\/span> is<\/span> asked<\/span> to<\/span> the<\/span> applicant,<\/span> who<\/span> does<\/span> not<\/span> always<\/span> have<\/span> the<\/span> information<\/span> mostly<\/span> in<\/span> case<\/span> when<\/span> a<\/span> co-formulant<\/span> is<\/span> a<\/span> mixture.<\/span> Therefore,<\/span> the<\/span> supplier<\/span> of<\/span> the<\/span> mixture<\/span> should<\/span> provide<\/span> the<\/span> requested<\/span> information.<\/span><\/div>\n
<\/div>\n
It<\/span> has<\/span> been<\/span> raised<\/span> the<\/span> lack<\/span> of<\/span> exposure<\/span> data<\/span> to<\/span> perform<\/span> a<\/span> risk<\/span> assessment<\/span> while<\/span> it<\/span> is<\/span> acknowledged<\/span> by<\/span> some<\/span> MSs<\/span> that<\/span> the<\/span> hazard-based<\/span> approach<\/span> may<\/span> not<\/span> be<\/span> sufficient<\/span> because<\/span> a<\/span> toxicological<\/span> risk<\/span> assessment<\/span> is<\/span> not<\/span> systematically<\/span> performed<\/span> for<\/span> the<\/span> co-formulants.<\/span> The<\/span> biocide<\/span> approach<\/span> was<\/span> also<\/span> mentioned<\/span> as<\/span> an<\/span> option<\/span> to<\/span> investigate,<\/span> based<\/span> on<\/span> the<\/span> \u2018substance<\/span> of<\/span> concern<\/span> (SoC)\u2019<\/span> approach.<\/span> Existing<\/span> scientific<\/span> i<\/span>nformation<\/span> including<\/span> monitoring<\/span> data<\/span> regarding<\/span> exposure<\/span> of<\/span> humans<\/span> and<\/span> the<\/span> environment<\/span> should<\/span> assist<\/span> in<\/span> the<\/span> assessment.<\/span> It<\/span> can<\/span> be<\/span> literature<\/span> or<\/span> monitoring<\/span> data.<\/span> However,<\/span> uncertainties<\/span> are<\/span> associated<\/span> with<\/span> the<\/span> identification<\/span> of<\/span> co-formulants<\/span> or<\/span> sometimes<\/span> only<\/span> the<\/span> active<\/span> substance<\/span> is<\/span> traceable<\/span> and<\/span> it<\/span> may<\/span> be<\/span> difficult<\/span> to<\/span> identify<\/span> the<\/span> source<\/span> of<\/span> exposure.<\/span> For<\/span> non-dietary<\/span> exposure,<\/span> the<\/span> exposure<\/span> and<\/span> risk<\/span> assessment<\/span> would<\/span> be<\/span> based<\/span> on<\/span> the<\/span> concentration<\/span> of<\/span> the<\/span> co-formulant<\/span> in<\/span> the<\/span> PPP.<\/span><\/div>\n
<\/div>\n
The<\/span> potential<\/span> concerned<\/span> linked<\/span> to<\/span> toxicokinetic<\/span> interaction<\/span> has<\/span> been<\/span> raised<\/span> by<\/span> a<\/span> MS<\/span> and<\/span> QSAR<\/span> data<\/span> should<\/span> be<\/span> provided<\/span> for<\/span> the<\/span> assessment.<\/span><\/div>\n
<\/div>\n
For<\/span> dietary<\/span> exposure,<\/span> the<\/span> question<\/span> about<\/span> the<\/span> amount<\/span> of<\/span> the<\/span> co-formulant<\/span> still<\/span> present<\/span> on<\/span> the<\/span> food<\/span> has<\/span> been<\/span> raised<\/span> and<\/span> is<\/span> difficult<\/span> to<\/span> extrapolate<\/span> from<\/span> the<\/span> concentration<\/span> in<\/span> the<\/span> PPP.<\/span> There<\/span> is<\/span> an<\/span> ongoing<\/span> work<\/span> in<\/span> one<\/span> MS<\/span> to<\/span> get<\/span> real<\/span> data<\/span> for<\/span> some<\/span> co-formulants,<\/span> but<\/span> it<\/span> is<\/span> still<\/span> at<\/span> an<\/span> early<\/span> stage.<\/span> Some<\/span> MSs<\/span> indicated<\/span> that<\/span> field<\/span> data<\/span> on<\/span> the<\/span> co-<\/span>formulant<\/span> may<\/span> be<\/span> retrieved<\/span> from<\/span> the<\/span> literature<\/span> or<\/span> may<\/span> be<\/span> requested<\/span> in<\/span> theory<\/span> with<\/span> the<\/span> PPP<\/span> in<\/span> some<\/span> cases<\/span> e.g.,<\/span> based<\/span> on<\/span> the<\/span> type<\/span> of<\/span> the<\/span> formulation.<\/span><\/div>\n
The<\/span> phys-chem<\/span> properties<\/span> of<\/span> the<\/span> co-formulant<\/span> may<\/span> help<\/span> to<\/span> understand<\/span> how<\/span> the<\/span> co-formulant<\/span> is<\/span> transformed.<\/span> However,<\/span> the<\/span> specific<\/span> environmental<\/span> conditions<\/span> (e.g.<\/span> light,<\/span> heat\u2026)<\/span> should<\/span> be<\/span> known<\/span> to<\/span> better<\/span> anticipate<\/span> the<\/span> stability<\/span> for<\/span> instance,<\/span> of<\/span> the<\/span> co-formulant.<\/span><\/div>\n
<\/div>\n
For<\/span> environment<\/span> exposure<\/span> of<\/span> individual<\/span> co-formulants,<\/span> it<\/span> would<\/span> depend<\/span> on<\/span> the<\/span> scenario,<\/span> and<\/span> it<\/span> is<\/span> essential<\/span> to<\/span> know<\/span> which<\/span> parameters<\/span> to<\/span> be<\/span> indicated<\/span> in<\/span> the<\/span> model<\/span> to<\/span> get<\/span> a<\/span> reliable<\/span> output.<\/span> ECHA<\/span> may<\/span> be<\/span> a<\/span> source<\/span> for<\/span> data<\/span> (in<\/span> case<\/span> of<\/span> high<\/span> tonnage).<\/span><\/div>\n
<\/div>\n
There<\/span> are<\/span> uncertainties<\/span> for<\/span> ecotox<\/span> risk<\/span> assessment,<\/span> if<\/span> no<\/span> reliable<\/span> data<\/span> are<\/span> coming<\/span> from<\/span> modelling<\/span> data.<\/span> It<\/span> was<\/span> also<\/span> mentioned<\/span> that<\/span> some<\/span> function<\/span> of<\/span> co-formulants<\/span> e.g.<\/span> wetting<\/span> agent,<\/span> may<\/span> be<\/span> of<\/span> potential<\/span> concern<\/span> for<\/span> certain<\/span> non-target<\/span> organisms<\/span> due<\/span> to<\/span> a<\/span> physical<\/span> effect.<\/span> Finally,<\/span> poisoning<\/span> data<\/span> for<\/span> at<\/span> least<\/span> acute<\/span> toxicity<\/span> or<\/span> data<\/span> related<\/span> to<\/span> accidental<\/span> exposure<\/span> for<\/span> environment<\/span> have<\/span> been<\/span> discussed<\/span> as<\/span> a<\/span> potential<\/span> source<\/span> of<\/span> data.<\/span> It<\/span> is<\/span> acknowledged<\/span> that<\/span> many<\/span> uncertainties<\/span> are<\/span> associated<\/span> to<\/span> this<\/span> information<\/span> as<\/span> declarative<\/span> information,<\/span> but<\/span> still<\/span> may<\/span> be<\/span> considered<\/span> as<\/span> an<\/span> indicator.<\/span> Wildlife<\/span> poisoning<\/span> investigations<\/span> are<\/span> likely<\/span> only<\/span> to<\/span> focus<\/span> on<\/span> active<\/span> substances<\/span> but<\/span> in<\/span> the<\/span> case<\/span> an a<\/span><\/span>ncident<\/span> is<\/span> linked<\/span> to<\/span> the<\/span> use<\/span> of<\/span> a<\/span> PPP<\/span> it<\/span> could<\/span> be<\/span> considered<\/span> as<\/span> to<\/span> whether<\/span> the<\/span> incident<\/span> was<\/span> a<\/span> result<\/span> of<\/span> the<\/span> active<\/span> substance<\/span> or<\/span> the<\/span> product.<\/span><\/p>\n
<\/div>\n
ITEM<\/span> 2_<\/span> ESTABLISH<\/span> THE<\/span> CRITERIA<\/span> FOR<\/span> CASES<\/span> WHEN<\/span> RISK<\/span> ASSESSMENTS<\/span> OF<\/span> CO-<\/span>FORMULANT\/PPPS<\/span> IS<\/span> (NOT)<\/span> NEEDED<\/span><\/strong><\/div>\n
<\/div>\n
Proposals<\/span> for<\/span> initial<\/span> criteria<\/span> to<\/span> build<\/span> a<\/span> list<\/span> of<\/span> co-formulants<\/span> categorised<\/span> as<\/span> no<\/span> concern.<\/span><\/div>\n
Risk<\/span> assessment<\/span> not<\/span> needed<\/span> if,<\/span> e.g.<\/span><\/div>\n
?<\/span>No\/low<\/span> Hazard<\/span><\/div>\n
?<\/span>Cut<\/span> off<\/span> criteria<\/span> for<\/span> unacceptable<\/span> co-formulants<\/span> e.g.,<\/span> Classification<\/span> CMR<\/span> cat.<\/span> 1<\/span><\/div>\n
?<\/span>No<\/span> exposure<\/span> for<\/span> specific<\/span> area<\/span> (e.g.,<\/span> ornamental<\/span> uses<\/span> for<\/span> dietary<\/span> exposure)<\/span><\/div>\n
?<\/span>Low<\/span> exposure<\/span> based<\/span> on<\/span> GAP<\/span> (threshold<\/span> to<\/span> be<\/span> defined)<\/span><\/div>\n
?<\/span>Existing<\/span> RMM<\/span> ensure<\/span> safety<\/span> of<\/span> the<\/span> PPP<\/span> on<\/span> case-by-<\/span> case<\/span> approach?<\/span> i.e.,<\/span> safety<\/span> sentences<\/span><\/div>\n
?<\/span>Regulated<\/span> in<\/span> other<\/span> EU<\/span> frameworks<\/span> case<\/span> by<\/span> case<\/span> e.g.,<\/span> feed\/food<\/span> additives<\/span><\/div>\n
<\/div>\n
When<\/span> is<\/span> the<\/span> risk<\/span> assessment<\/span> of<\/span> the<\/span> co-formulant\/PPP<\/span> needed?<\/span><\/div>\n
?<\/span>When<\/span> there<\/span> is<\/span> a<\/span> potential<\/span> concern<\/span> not<\/span> only<\/span> from<\/span> classification<\/span> but<\/span> e.g.,<\/span> derived<\/span> no<\/span> effect<\/span> level<\/span> (DNEL)<\/span> available<\/span> identified<\/span> during<\/span> the<\/span> hazard<\/span> assessment<\/span> of<\/span> the<\/span> coformulant<\/span><\/div>\n
?<\/span>When<\/span> there<\/span> is<\/span> exposure<\/span><\/div>\n
?<\/span>Critical<\/span> function<\/span> of<\/span> co-formulants<\/span> could<\/span> be<\/span> identified,<\/span> e.g.<\/span> wetting<\/span> agents,<\/span> emulsifier,<\/span> preservatives<\/span> (biocides)<\/span> \u2013<\/span> may<\/span> be<\/span> relevant<\/span> for<\/span> ecotox<\/span> aspects<\/span> as<\/span> NTO<\/span> could<\/span> be<\/span> close<\/span> to<\/span> target<\/span> pest.<\/span><\/div>\n
?<\/span>PPP<\/span> more<\/span> toxic<\/span> than<\/span> the<\/span> a.s.<\/span> based<\/span> on<\/span> hazard<\/span> (e.g.,<\/span> metabolic<\/span> biomarkers,<\/span> classification,<\/span> adversity<\/span> of<\/span> the<\/span> effects)<\/span><\/div>\n
?<\/span>Potential<\/span> for<\/span> toxicokinetic<\/span> interaction<\/span> (test<\/span> the<\/span> PPP<\/span> or<\/span> produce<\/span> toxicokinetic<\/span> data<\/span> as<\/span> \u2018longer<\/span> term\u2019<\/span> proposal)<\/span><\/div>\n
?<\/span>Follow<\/span> the<\/span> current<\/span> biocide<\/span> and<\/span> pesticide<\/span> approach<\/span> i.e.<\/span> looking<\/span> at<\/span> the<\/span> classified<\/span> component<\/span> and<\/span> triggering<\/span> the<\/span> classification<\/span> of<\/span> the<\/span> PPP<\/span><\/div>\n
?<\/span>Use<\/span> phys-chem<\/span> properties<\/span> e.g.,<\/span> LogPow,<\/span> stability\/persistence<\/span> to<\/span> be<\/span> combined<\/span> with<\/span> exposure<\/span> potential<\/span> (e.g.<\/span> availability<\/span> of<\/span> the<\/span> co-formulant)<\/span> to<\/span> understand<\/span> whether<\/span> there<\/span> is<\/span> a<\/span> need<\/span> or<\/span> not<\/span> to<\/span> perform<\/span> a<\/span> risk<\/span> assessment<\/span><\/div>\n
?<\/span>Environmental<\/span> exposure:<\/span> tool<\/span> exists<\/span> but<\/span> some<\/span> adjustments<\/span> are<\/span> needed\/confidence<\/span> on<\/span> the<\/span> parameters<\/span> -><\/span> e.g.<\/span> use<\/span> uncertainty<\/span> factors,<\/span> identification<\/span> of<\/span> threshold…<\/span><\/div>\n
In<\/span> order<\/span> to<\/span> address<\/span> these<\/span> points,<\/span> further<\/span> data<\/span> on<\/span> the<\/span> PPP<\/span> will<\/span> be<\/span> required<\/span> as<\/span> well<\/span> as<\/span> the<\/span> investigation<\/span> about<\/span> which<\/span> co-formulant<\/span> is<\/span> triggering<\/span> the<\/span> toxicity.<\/span><\/div>\n
<\/div>\n
(to<\/span> be<\/span> continued,<\/span> last<\/span> Part<\/span> 4)<\/span><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Following the post published on 29\/05\/24, we continue with the summary of the items discussed by the EFSA and European Commission\u2019s staff related to the assessment of coformulants in PPP: ITEM 1_ MAPPING THE CURRENT PRACTICES OF THE MEMBER STATES The current practices to assess PPPs are usually based on hazard: SDS, classification is checked (if the co-formulant is classified, its concentration in the PPP is verified whether it would[…]<\/p>\n","protected":false},"author":2,"featured_media":22095,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_wpscppro_custom_social_share_image":0,"_facebook_share_type":"","_twitter_share_type":"","_linkedin_share_type":"","_pinterest_share_type":"","_linkedin_share_type_page":"","_selected_social_profile":[]},"categories":[68],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts\/22098"}],"collection":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/comments?post=22098"}],"version-history":[{"count":2,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts\/22098\/revisions"}],"predecessor-version":[{"id":22100,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/posts\/22098\/revisions\/22100"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/media\/22095"}],"wp:attachment":[{"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/media?parent=22098"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/categories?post=22098"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kaeltia.com\/en\/wp-json\/wp\/v2\/tags?post=22098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}