PRODUSE BIOCIDE - Noutati legislative si modalitati practice de avizare/ autorizare -

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1 Best Training Solution SRL Bd. 1 Mai nr. 110, Constanta Judetul Constanta CUI J13/1168/2015 office@trainingsolution.ro BEST TRAINING SOLUTION va invita la seminarul de dezvoltare profesionala: PRODUSE BIOCIDE - Noutati legislative si modalitati practice de avizare/ autorizare septembrie 2018 Hotel Arnia, IASI Sau la sediul companiei dumneavoastra DE CE SA PARTICIPATI? Sunteti producatori /distribuitori/ formulatori/ utilizatori finali implicati in activitati cu produse dezinfectante clorigene? Este bine sa cunoasteti faptul ca incepand cu trebuie respectate noile Regulamentele Europene care impun ca produsele hipoclorit de sodiu, hipoclorit de calciu si clor sa beneficieze de autorizatii de biocide pentru utilizarile aprobate la nivel european. In cadrul acestui seminar la carte va invitam sa participati, lectorul Adriana Prisacariu va explica, din experienta proprie, modalitatile practice de aplicare a cerintelor acestor Regulamente si noile conditii de fabricare si utilizare legala ale produselor biocide, precum si informatiile privind modul de functionare a pietei dezinfectantilor in Romania. Participand la acest seminar: - veti CUNOASTE: Principalele acte legislative care reglementeaza domeniul produselor biocide in Romania Noutati legislative nationale si europene intrate in vigoare in anul 2017 precum si termenele de conformare la acestea (in special pentru dezinfectantii clorigeni pentru apa potabila) Cerinte privind avizarea nationala a biocidelor in Romania Tranzitia de la avizare nationala la autorizarea europeana unui produs biocid Clarificari privind rolul substantei active versus produs biocid Conditiile pentru fabricarea si comercializarea produselor biocide in contextul actual in Romania Procedura de elaborare a unui dosar tehnic pentru avizarea nationala a produselor biocide, modificarile si completarile legislative si costurile asociate Procedura de elaborare a unui dosar tehnic pentru autorizarea produselor biocide si costurile asociate

2 Criterii privind modul de a accesa un dosar de biocid general consortii de biocide, procedura de cumparare scrisoare de acces la dosare existente (drept de proprietate intelectuala a datelor), Ghiduri ECHA, Teste de eficacitate biocida Tipuri de autorizatii de biocide (nationale, mutuale, secventiale, paralele, europene) Utilizarea Registrului de Biocide R4BP3 gestionat de catre ECHA rol, mod de utilizare si acces, transmitere aplicatii de autorizare Costuri de autorizare - taxele platite Agentiei Europene pentru Produse Chimice (ECHA) - in vederea introducerii pe piata si a utilizarii produselor biocide - va vor fi prezentate Studii de caz privind pasii concreti prin care au fost inregistrate si autorizate anumite substante chimice. - veti primi SOLUTII pentru implementarea acestor cunostinte in cadrul societatii. In AGENDA alaturata ofertei noastre veti gasi tematica ce va fi prezentata si discutata in cadrul seminarului. PENTRU CINE ESTE POTRIVIT SEMINARUL? Personalul care desfasoara diferite activitati legate de fabricare, achizitie, utilizare produse dezinfectante, distributie, manipulare, depozitare, analize de laborator, aprobare in vederea utilizarii produselor chimice, cum ar fi: Responsabilii de mediu; Responsabili de productie; Responsabili de distributie; Utilizatori industriali/profesionali produse biocide - in special responsabili statii tratare apa potabila / uzata; Personalul care efectueaza instruirea lucratorilor; Laborantii; Personalul responsabil cu receptia produselor; Personalul responsabil cu supravegherea si derularea contractelor de prestari servicii. CE PRIMITI PARTICIPAND LA ACEST SEMINAR? Toti participantii la acest seminar oferim IN MOD GRATUIT, timp de 1 an, CONSULTANTA prin . Va vom raspunde la orice intrebare sau problema legata de domeniul prezentat la seminar. (Valoarea acestui serviciu de consultanta este de 200lei/ luna, dar dumneavoastra va puteti bucura de acest beneficiu in mod gratuit timp de 1 an). Informatii utile si practice aplicabile activitatilor pe care le desfasurati in cadrul societatii; Un seminar interactiv bazat pe discutii si schimb de experienta intre lector si toti participantii la seminar; Materialul de curs - workbook; Memory stick in care sunt incluse materialele prezentate in cadrul seminarului; Diploma de participare la seminar si Supliment descriptiv cu tematica parcursa si cunostintele dobandite; Devenind clientul nostru veti beneficia de un discount de 25% la urmatoarele cursuri la care veti participa; Pranz si coffee break din partea firmei noastre.

3 CINE PREZINTA ACEST SEMINAR? ADRIANA PRISACARIU Specialist in managementul substantelor chimice, cu o experienta de peste 14 ani in domeniu; Participant la activitati de inregistrare/autorizare REACH, elaborator dosare tehnice, avizare/ autorizare produse biocide, avizare sanitara, elaborator fise cu date de securitate, etichete; Participant la numeroase workshop-uri, conferinte privind procedura REACH - CLP - BPR, desfasurate in Romania, ReachCentrum - Bruxelles, ECHA- Helsinki; Formator calificat; Detine experienta si este implicat in activitati privind monitorizarea conditiilor in care circula pe piata chimicalele periculoase, fiind calificat ca si: - Consilier substante chimice periculoase; - Auditor Intern al Sistemului de Management al Calitatii; - Specialist Securitatea Muncii. CUM VA INSCRIETI SI CAT COSTA? Pentru participare la seminar va rugam sa trimiteti Formularul de inscriere completat la adresa de ncornea@trainingsolution.ro. Termen limita pentru inscrieri: 20 SEPTEMBRIE TAXA CURSULUI este 790 lei / participant. Nu se percepe TVA.!Se acorda un DISCOUNT de: 20% din taxa de instruire, costul fiind astfel 632 lei / participant, pentru inscrierea la seminar pana pe data de 12 SEPTEMBRIE 2018, inscrierea a trei sau mai multor persoane din cadrul companiei; 25% din taxa de instruire, costul fiind astfel 593 lei / participant, daca sunteti deja clientii nostri. MERITA SA PARTICIPATI! Sunt locuri limitate. Rezervati loc din timp pentru participarea la acest seminar! In cazul in care doriti sa ne ocupam de rezervarea camerelor la Hotelul Arnia din Iasi, va rugam sa bifati checkbox-ul din Formularul de inscriere. Putem organiza cursul si la sediul companiei dumneavoastra. In acest caz va rugam sa ne contactati si va vom transmite o oferta atractiva, personalizata in functie de numarul de participanti. Pentru mai multe informatii va invitam sa ne contactati la numarul de telefon Nicoleta Cornea. Va multumim si asteptam cu interes raspunsul dumneavoastra. Nicoleta Cornea Director Evenimente Best Training Solution SRL

4 AGENDA SI TEMATICA SEMINARULUI PRODUSE BIOCIDE - Noutati legislative si modalitati practice de avizare/ autorizare septembrie Hotel Arnia, IASI 27 SEPTEMBRIE : Principalele acte legislative care reglementeaza domeniul produselor biocide Noutati legislative adoptate in anul 2017 aplicabile produselor dezinfectante clorigene; Cerinte privind avizarea/ autorizarea biocidelor in Romania, conform legislatiei nationale si europene pentru punerea pe piata si utilizarea produselor biocide; Autoritati competente cu rol de implementare si control privind domeniul biocidelor in Romania; Fabricarea si comercializarea produselor biocide: Clasificarea produselor biocide in functie de domeniul de utilizare (coduri TP), Prezentarea grupelor principale si a tipurilor de produse biocide 10:30 10:50 Pauza de cafea 10:50 13:00 Prezentarea cadrului legal privind obtinerea unui aviz national de biocid; procedura de prelungire/ extindere/ reinnoire aviz national de biocid, Definitii, clarificari privind rolul substantei active versus produs biocid formulat, Tranzitia de la avizarea nationala la autorizarea unui produs biocid; Procedura de elaborare a unui dosar tehnic pentru avizarea unui produs biocid: Documentele care trebuie incluse in dosarului tehnic, Continutul cererii de avizare, circuitul dosarului, evaluarea tehnica de catre Comisia Nationala de Evaluare din cadrul INSP Institutul National de Sanatate Publica (termene, costuri, situatii de caz intalnite), valabilitate avize; 13:00 14:00 Pauza de pranz 14:00 16:00 Procedura de elaborare a unui dosar tehnic pentru autorizarea unui produs biocid: Continut dosar de autorizare a unui produs biocid, Art. 95 scrisoare de acces, procedura de vanzare/cumparare, declaratii /obligatii producator/ distribuitor/ utilizator; Art. 54 echivalenta tehnica, 28 SEPTEMBRIE :00 10:30 Tipuri de autorizatii de biocide (nationale, unionale, succesive, paralele, simplificate, provizorii), Criterii de accesare a unui dosar de biocid general, consortii europene de biocide, Testarea eficacitatii produselor biocide, standarde aplicabile, indicatii privind utilizarea standardului pentru TP 1-5, Ghiduri ECHA; 10:30 10:50 Pauza de cafea

5 10:50 13:00 Prezentarea platformei de transmitere a unui dosar de autorizare biocida R4BP3: Rolul aplicatiei, mod de utilizare si accesare a datelor existente in registru european gestionat de ECHA, Transmiterea unei aplicatii de autorizare individuala, relatia aplicant stat membru- ECHA, Costuri de autorizare conform Reg. (UE) 564/2013 privind taxele platite ECHA; 13:00 14:00 Pauza de pranz 14:00 16:00 Conditii pentru fabricarea si comercializarea produselor biocide in contextul actual in Romania; obligatii ale detinatorilor de avize/ autorizatii de biocide: Comercializarea unui produs biocid avizat /autorizat national, Procedura de etichetare a produselor biocide, in acord cu documentele insotitoare la livrare, Ce obligatii aveti in calitate de producator/ distribuitor / utilizator pe lantul de distributie si in relatia cu autoritatile nationale (Directiile de Sanatate Publica, Garda Nationala de Mediu, ANSVSA), Lista de substante active existente la nivel european, precum si furnizorii acceptati de catre Agentia Europeana pentru Produse Chimice, Lista autorizatii europene emise de catre ECHA. Prezentarile vor contine exemple de buna practica aplicate cu succes in industrie!

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