Expozicne scenare pre latky a pripravky
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1 Chemia 2009 : REACH SIEF Cas sa krati Liptovsky Jan, 25. september 2009 Expozicne scenare pre latky a pripravky Dr. Paul Vesel SGCI Chemie Pharma Schweiz paul.vesel@sgci.ch 1
2 yl no ses u ef as r of ES Development & Communication model M/I and/or M/I-DU As s ociations => determine s trateg y Systematic assessment of safe uses (use of Tier1 tool) Map uses and use conditions in supply chain M/I Communicate Uses (ES titles, Use Descriptors) to direct DU for further communication in the supply chain Initial ESs, ES titles and Use Descriptors M/I and DU partners hip via trade as s ociations M/I and s elected DU s Generic ES Development Specific ES development Input of DU Associations Development G ES library Input of selected customers Use of C efic ES template Yes No DU Wait for final ES or DU Complete feedback form Await decision M/I Communication to direct DU Final E xpos ure S cenario (M/I) Legend M/I =Manufacturer / Importer DU =Downstream User DU Use covered? DU Prepare CSA/CSR Inform Agency Distribution of e-sds For specific products and applications the appropriate (next) steps in the above diagram need to be determined bas ed on expert judgement: not always all steps are needed and/or the order can be adapted. 2
3 Komunikacia v dodavatelskom retazci Co sa zmenilo v ramci REACH? Ucinkujuci v dodavatelskom retazci 4. Hodnotenie autorizacia a obmedzovanie 3. Karta bezpecnostnych udajov s expozicnymi scenarmi 3. Karta bezpecnostnych udajov s expozicnymi scenarmi Chemicka Agentura Helsinki Vyrobca importer 1. Registracia 2. Pouzitie a expozicne scenaria oznamit nasledny uzivatel nasledny uzivatel 2. Pouzitie a expozicne scenaria oznamit 3
4 Usmernenia o poziadavkach na informacie a hodnotenie chemickej bezpecnosti Guidance on Information requirements and CSA 4
5 Dokumentovanie pouzivani Use Descriptor System und ERCs 5
6 Bezpecne zaobchadzanie s chemickymi latkami Substance properties Vlastnosti chem. latky Product Properties Vlastnosti vyrobku Operational conditions Podmienky pouzivania ako napr. trvanie a frekvencia pouzivania Risk management measures Opatrenia manazmentu rizika Klucove prvky expozicneho scenara CEFIC REACH Industry Preparation Letter No. 11 6
7 Nastroje a pomocky pre bezpecne pouzivanie chem. latok Chemical Safety Assessment (CSA) hodnotenie chemickej bezpecnosti (analyza a hodnotenie) Chemical Safety Report (CSR) sprava o chemickej bezpecnosti (dokumentacia hodnotenia) Exposure Scenario (ES) expozicne scenare (podmienky pouzivania a opatrenia manazmentu rizika) Extended Safety Data Sheet (esds) rozsirena karta bezpecnostnych udajov (komunikacny nastroj / prostriedok) 7
8 Expozicny scenar (ES) ES popisuje realne podmienky, za akych je latka vyrabana alebo pouzivana pocas jej zivotneho cyklu za predpokladu, ze riziko je adekvatne kontrolovane Adekvatna kontrola rizika znamena, ze vyrobca /dovozca ma expoziciu ludi a zivotneho prostredia pod kontrolou a ze nasledujuci uzivatel bude schopny na zaklade udajov mat tiez moznu expoziciu pod kontrolou. ES mozu byt tak rozsiahle ako je mozne a tak specificke ako je potrebne. ES zhrnaju vsetky informacie, ktore su k odhadnutiu moznej expozicie potrebne, ako aj vsetky potrebne opatrenia pre bezpecne pouzivanie. 8
9 Kedy je expozicny scenar potrebny? ES je potrebny pre chemicke latky, ktore musia byt v ramci REACH nariadenia registrovane ktore sa vyrabaju v mnozstvach 10 t /rok/registrant ktore boli v ramci hodnotenia chemickej bezpecnosti (CSA) posudene ako nebezpecne, PBT, vpvb. 9
10 Kedy netreba vypracovat ES? V dodavatelskom retazci nie je vyzadovana komunikacia expozicneho scenaru, ked: mnozstvo produkcie 10 t/a/registrant latky boli posudene ako bezpecne latky su pouzivane len ako medziprodukty ide o latky, ktore M/I pouziva len interne (pre vlastne pouzitie) ide o latky, ktore sa v zmesiach, ktore boli posudene ako bezpecne, stratia (koncentracia nie je relevantna, zreagovane latky) ide o latky, ktore uz registrant zabudoval do vyrobkov ide o latky, ktore su urcene na vyvoz do krajin mimo ES. 10
11 Pomocky pri vypracovani ES Use Description System (system deskriptorov pouzitia) Deskriptorovy system je nastroj pre start procesu expozicneho hodnotenia a komunikacie v dodavatelskom retazci. Umozni rychlu charakterizaciu identifikovanych pouziti a prve oznacenie, preco jednotlivy expozicny scenar bol vypracovany. System deskriptorov pouzitia je novy europsky harmonizovany system na strucne a pregnantne popisanie pouzitia latok. Zaklad je popisany v tabulkach, ktore su spristupnene v ECHA usmerneni (GD CSA) R12. Na zaklade niekolkych klucovych parametrov je mozne informovat o charakteristickych bodoch daneho expozicneho scenara. 11
12 Pomocky pri vypracovani ES Klucove parametre Klucove parametre su: sektor pouzitia (sector of use SUs) kategoria produktu (product categories PCs) kategoria procesu (process categories PROCs) kategoria vyrobku (article categories ACs) kategoria pre ochranu zivotneho prostredia (Environmental Release Categories ERCs) 12
13 System deskriptorov pouzitia Popis pouzivania popis sektorov chem. priemyslu 23 (SU) sektorov pouzivania mozna expozicia zamestnancov 25 PROCs mozna expozicia pouzivatelov (zmesy / zluceniny) mozna expozicia pouzivatelov (vyrobky) 40 (PC) kategorii produktov 39 (AC) kategorii vyrobkov 22 (ERC) Environmental Release Categories ochrana zivotneho prostredia 13
14 System deskriptorov pouzitia Niekolko odporucani pre prakticke prevedenie zoznamte sa so systemom a s podobnymi systemami (napr. VEK-Matrix; verwendungskategorie - matrix) (VEK-Matrix je model nemeckeho chem. zväzu, ktory buduje na scenaroch pre pouzitie a expozicii, ktore su sirsie zhrnute a zahrnuju viac podobnych alebo pribuznych procesov a pouziti) snazte sa popisat najdolezitejsie pouzitia vasich latok s pomocou PCs, PROCs, ACs a ERCs Davajte pozor na kategorie procesov, s ktorymi charakterizujete vase pouzitia. Odhadnite, ake podiely latky mozu byt uvolnene do jednotlivych oblasti zivotneho prostredia (vzduch, voda, poda). Porovnajte, ci tieto odhadnute mnozstva su v sulade s predpokladmi, ktore platia pre ERC vo vasej kategorii produktov. 14
15 Iterativny 3stupnovy postup k expozicnemu scenaru tieto 3 kroky mozno kombinovat 1. krok zakladne hodnotenie expozicie 2. krok vseobecne (genericke) hodnotenie expozicie 3. krok specificke hodnotenie expozicie vsetky 3 kroky nie su vzdy potrebne vstup je mozny na kazdom stupni Kaskadu mozno zacat aj bez znalosti pouzitia latky u nasledujuceho uzivatela Hodnotenie expozicie a rizika bude po kazdom kroku podrobnejsie a konkretnejsie. 15
16 3stupnovy postup hodnotenia rizika v praxi 1. krok zakladne hodnotenie expozicie 2. krok vseobecne (genericke) hodnotenie expozicie 3. krok specificke hodnotenie expozicie Vyber nastroja napr.: ECETOC TRA treba pouzit pre vsetky cielove skupiny lahko pouzivatelny rychle vysledky vdaka automatizacii postupu 16
17 Priklad IT-TOOLs: ECETOC TRA Co treba vlozit? tonaz kategoria pouzivania (napr. z.b. nedisperzivne pouzitie; siroko disperzivne (wide-dispersive)) tlak pary kategoria prachu Log Kow (rozsah) Molmasse 17
18 ECETOC TRA Dalsie udaje potrebne k hodnoteniu pracoviska R-veta DNEL, OEL alebo ine hranicne hodnoty Profil pouzivania kategorie procesu (PROCs) > doba prace s latkou (doba pouzivania), LEV Y/N (ventilacia, odsavanie vzduchu) atd. 18
19 Priklad: CSR pre HDDA (Hexandioldiacrylat) 19
20 Priklad: HDDA-CSR 1. krok: Vysledok hodnotenia expozicie 20
21 Priklad: HDDA-CSR 2. krok Vysledok hodnotenia expozicie 21
22 Priklad: HDDA-CSR 2. krok Vysledok hodnotenia expozicie 22
23 Priklad: HDDA-CSR 3. krok: Individualne /specificke hodnotenie expozicie 23
24 3-stupnove hodnotenie expozicie jednoduchy transfer udajov z CSR do esds 24
25 Interpretacia esds (rozsirenej karty bezpecnostnych udajov) pouzivatelom: Su procesy v nasom podniku bezpecne? (Priklad moznej diskusie) 25
26 Vyhody iterativneho resp. 3-stupnoveho postupu hodnotenia pouzitia Vyhody pre nasledujuceho pouzivatela standardizovany system - jasny navod, lahko pouzivatelne ochrana podnikovych dovernych informacii, kedze detailne informacie o procese nie su potrebne komunikovat Vyhody pre vyrobcu / dodavatela (M/I) iterativny postup ako navrhnuty v TGD (iterativne RMM) eficientna komunikacia hodnotenia rizika esds sa pouzije ako hlavny komunikacny nastroj strukturizovany system, lahko aplikovany v IT-rieseniach umoznuje intergraciu skusenosti sektorovych priemyselnych skupin (CEFIC-GES /DUCC / AISE /VCI-Aktivity atd.). 26
27 Centralny prvok: referencna zakladna 27
28 Koncept ECHA CSA/CSR Tool 28
29 Dakujem za Vasu pozornost. Otazky? Ref.: VCI Praxisführer a BASF priklad z informacneho seminara (marec 2009) 29
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