European Conference on Endocrine Disruptor Substances

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1 Eurpean Cnference n Endcrine Disruptr Substances Rue du Luxemburg 47-51, B-1050 Brussels, Belgium Tel: +32 (0) Fax: +32 (0) Event: Eurpean cnference n EDS Date: 01/06/2015 Place: Brussels, BE Organised by: Eurpean Cmmissin EurEau representative: Bertrand Vallet Official reprt and presentatins are available here: 1. General cmments The cnference was rganised with reference t the radmap 1 and the cnsultatin made in 2015 fr a definitin f ED substances. It was divided in 5 sessins tackling the scientific knwledge, the impact n EU legislatin, the ptential impact n industry and cnsumers, n trade and agriculture, and n health and the Envirnment. The general impressin is that the prcess is lng, cmplicated, with lts f actrs and that the endcrine disruptr criteria will be perhaps ready fr the end f Scientists cannt agree n test that culd assess the hazard because the mechanism arund endcrine system are cmplex and different accrding t the substance and the persn expsed. N threshld can be defined with certainty. The result is a lng prcess t evaluate the impact f the different definitins n different sectrs. Hwever, except fr the chemical industry, the preferred ptin is the third ne f the radmap, which was als supprted by EurEau in the public cnsultatin. Actin fr EurEau: Cntinue t fllw the develpment f the discussin at bth Eurpean and Natinal level but n strng actin needed as EurEau des nt have the technical knwledge t be invlved in the details f the definitins. It culd be interesting t participate t the wrkshp frecast in Nvember 2015 in Brussels that will explain the next steps f the impact assessment. Detailed descriptin f each sessin can be fund belw. 1 ~ 1/5 ~

2 Eurpean Cnference n Endcrine Disruptr Substances 2. Message frm Vytenis Andriukaitis, Cmmissiner fr Health and Fd Safety The message f the cmmissiner was t remind that endcrine disruptive substances (EDS) are a ht tpic fr the Eurpean Cmmissin implicating a lt f actrs, different psitins and rumurs n hw the Eurpean Cmmissin will react. In this cntext, the Eurpean Cmmissin wants t act with trust and transparency with regards t all stakehlders. The decisin will be taken, driven by the prtectin f the health f citizens. 3. SESSION 1 - Scientific debate n criteria t identify endcrine disruptrs In this sessin, the visin f scientists n EDS and n hw t assess criteria in a regulatin perspective was addressed. ~ Endcrine mlecules impact depends bth n the number f receptrs and the substance cncentratin. The respnse is varying frm ne individual t anther and als fr different develpment stages. Hwever the impact is bigger and ften irreversible fr fetal develpment stage. There is n scientific evidence f threshlds that have r des nt have an effect n Endcrine system which makes regulatin difficult. When designing regulatin, it is als imprtant t distinguish mlecules that peple are taking n purpse and the ne they are expsed t invluntarily. ~ On the txiclgical side, it is difficult t distinguish a nrmal effect and adverse effect as interference with the endcrine systems is just ne f many pssible mdes f actin fr chemical substances. As an interference with endcrine system is a mde f actin f certain substances, natural r synthetic, it per se des nt represent an adverse effect. The mechanism des nt give infrmatin n txicity. If a regulatin is needed, EDS shuld nt be labelled as txic substances but the txicity limit shuld be defined. Apprpriately designed and cnducted txicity studies MUST include determinatin f the ptency by which a chemical induces adverse effects. Apprpriate txicity testing cvers ptential adverse effects n the ED system which culd manifest as reprductive and develpmental txicities. A txicity test will end with a classificatin fr the effect tested but nt a classificatin f substances. ~ Fr Eurpean Fd Safety Authrity (EFSA), which was mandated t give an pinin n scientific criteria t identify EDs, endcrine active substance are substances with direct r indirect interactin with endcrine system. An endcrine disruptr is an exgenus substance that interact and create an adverse effect. Endcrine activity is the mde f actin, adversity has t be demnstrated in viv. There is n generic criteria ~ 2/5 ~

3 Eurpean Cnference n Endcrine Disruptr Substances available. Nn-relevance n human shuld be demnstrated. ~ EFSA presented the OECD methdlgy which is cmpsed f 5 levels. Level 1: infrmatin, level 2: in vitr testing, level 3 t 5: in viv testing. Critical effect shuld be based n the effect leading t the lwest health/ ectx-based level. ~ 4 prcesses in parallel: Review f nn-mntnic dse-respnse f substances fr human risk assessment (n ging): critical literature review n evidence: end 2015, publish beginning Guidance frm EFSA scientific Cmmittee: public cnsultatin reprt 2 published in summer 2015; draft Guidance fr EFSA expert by the end 2015; testing phase fr EDCs in 2016, finalisatin f EDCs fr end The weight f evidence will take place thrugh a public cnsultatin in 2016 (prbably) and a finalisatin The bilgical relevance will be assess thrugh a public cnsultatin in early 2016 fr a finalisatin by the end SESSION 2 - Endcrine disruptrs in the EU legislatin Fr a lng time the Eurpean legislatin is taking int cnsideratin EDs: in 1999, the Eurpean Cmmissin published a cmmunicatin f n a strategy fr ED the WFD included sme ED in pririty substances REACH (review f ED in authrisatin, Identificatin f ED fr Candidate List by 2020) 120 millin eurs invested in research (identificatin and expsure) 7th Envirnmental Actin Prgram t 2020 has an actin n ED MEPs prduced an INI reprt n ED in certain Member States there are bans r restrictins f certain prducts (Bisphenl A ) r a strategy t handle ED A wrkshp is frecasted in Nvember 2015 in Brussels n pririties fr next 2 ~ 3/5 ~

4 Eurpean Cnference n Endcrine Disruptr Substances develpments (resurces time scale and expsure f animals). The adverse effect caused by EDs is already cvered by standard risk assessment. N criteria t identify EDs fr regulatry purpses have been defined utside the EU. In EU legislatin, there is already a high prtectin frm EDs (Plant Prtectin Prducts regulatin: ED is an apprval criterin (strng hazard cmpnent) and Bicide Prducts regulatin: prfessinal use (strng risk cmpnent)). Understanding the cncrete impact f the different definitins justify the impact assessment cnducted since It is cmplicated because there are diverse views f scientist n hw t set criteria t identify ED and the impact affect many sectrs (risk vs hazard issues). The radmap has been published in summer The Jint Research Center has been mandated t develp a methdlgy t identify which chemical wuld fall under which ptin f criteria defined in the radmap (700 chemicals, PPPR, BRP, REACH, Csmetic regulatin and WFD). N new study will be perfrmed and nly existing data will be used. The methdlgy shuld be defined fr the autumn 2015 and the impact assessment n PPPR and BPR will be cnducted frm Octber 2015 t July SESSION 3 - Ptential impacts n industry and cnsumers The cncern f the industry is fcused n the pssibility t guaranty safety f cnsumers by insuring the quality f the prducts prduced with help f bicides and plant prtectin prducts. Cnsumer s assciatins highlighted the evidence f the effect f multiples prducts n the envirnment, n the puberty prblems, etc They prpsed t define ED free label. Fr MEPs, the precautinary principle demnstrated fr ther chemicals that bans allw the industry t develp better mlecules. It shuld be the same fr EDs. 6. SESSION 4 - Ptential impacts n trade and agriculture Farmers are fr risk management and nt hazard. Effective plant prtectin is based n Integrated Pest Management based n gd balance between chemical availability and effectiveness f the available prducts. Ban certain prduct culd lead t a decrease f farm activities (decrease f yields, threat n crps ) Ptential impact n trade: As the precautinary principle is nt used in America, there is a risk t decrease trade activities between Eurpe and America but it is difficult t quantify it. The Eurpean Cmmissin wants t remind that ED criteria are nt part f the TTIP discussins. ~ 4/5 ~

5 Eurpean Cnference n Endcrine Disruptr Substances 7. SESSION 5 - Ptential impacts n health and envirnment Fr cnsumer assciatin, the ptins prpsed fr EDCs are nt crrectly targeting the risk fr mst expsed ppulatin (Farmers and their families, pregnant wmen and yung children). The mst stringent ptin wuld nly generate 20 bans f substances ver the 50 pesticides with ED prperties. The hazard shuld be mre scientifically defined in ptin 3 with parameters like severity, strength f evidence, reversibility, ptency ~ 5/5 ~

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