Guidance on SIEF Formation

Transcription

1 Guidance n SIEF Frmatin June 2008, versin 0 Disclaimer The infrmatin cntained in this REACH Industry Preparatin Letter is intended fr guidance nly and whilst the infrmatin is prvided in utmst gd faith and has been based n the best infrmatin currently available, is t be relied upn at the user s wn risk. N representatins r warranties are made with regards t its cmpleteness r accuracy and n liability will be accepted fr damages f any nature whatsever resulting frm the use f r reliance n the infrmatin. Cpyright Cpyright f Cefic (AISBL), reprductin is authrised, except fr cmmercial purpses, prvided that the surce is mentined and acknwledged. Cefic claims n cpyright n any fficial dcument, such as the REACH guidance dcuments (whse abstract may be used in this publicatin) r infrmatin prvided by the EU Institutins and ECHA.

2 Guidance n SIEF Frmatin June 2008 WARNING Every cmpany has a respnsibility t ensure that it implements REACH in accrdance with the Regulatin. As stated in the legal ntice n RIP Guidance Dcuments, infrmatin cntained in the guidance des nt cnstitute legal advice and nly the REACH Regulatin can serve as an authentic reference. Althugh RIP guidance is issued by the Eurpean Chemicals Agency, the Agency des nt accept liability with regard t the cntent. REACH implementatin requires a case-by-case apprach. Each cmpany is respnsible fr ensuring that it is cmpliant with the REACH Regulatin. T help cmpanies implement REACH, Cefic is prducing a number f dcuments that can be used in cnjunctin with guidance frm the RIPs. It is fr each cmpany t establish the mst apprpriate and suitable methd t meet regulatry requirements. This can depend n many factrs such as its prducts, management systems, custmers, suppliers, etc. In every case, the cmpany must check that it is meeting the requirements f the REACH Regulatin. This is the secnd in a series f three guidance dcuments t be prvided by the Cefic Preregistratin Wrking Grup t guide Cefic member cmpanies thrugh the key REACH challenges in 2008 and early 2009 including pre-registratin, SIEF and data-sharing. This dcument prvides guidance fr preparatry wrk ahead f pre-registratin and wrking tgether in SIEF and cnsrtia. The third guidance n wrking tgether in SIEF and data/cst sharing is planned fr mid Octber Abut this dcument This current guidance cvers the next perid after pre-registratin thrugh t the frmatin f SIEF. In this perid the critical tasks fr ptential registrants are t: Ensure that yu have pre-registered crrectly Be aware f the different rights and bligatins f all the varius pre-sief members Prepare t cllabrate efficiently in pre-sief by: Nminating a SIEF Frmatin Facilitatr Cmplying with EC cmpetitin law Prtecting cnfidential business infrmatin Cnsidering use f the ReachLink SA SIEFreach system Agree n substance identity, thereby creating a SIEF Only when these initial yet imprtant pre-sief tasks are cmplete can the key steps t jint registratin, i.e. cllectin, evaluatin and reprting f data and cst sharing, be negtiated. 2

3 TABLE OF CONTENTS 1. PRE REGISTRATION NUMBER 6 What is a pre-registratin number? 6 Hw is a pre-registratin number used? 7 What is the difference between a pre-registratin number and a submissin number? 7 2. HOW TO ENSURE YOU PRE-REGISTER CORRECTLY? 8 Use the crrect substance identity at pre-registratin 8 If in dubt, pre-register again 8 Check the pre-sief REACH IT web page regularly 9 Avid last minute pre-registratin 10 What d I d if I find myself in the wrng pre-sief? 10 Hw d I deactivate a pre-registratin? 10 Pre-SIEF splitting and merging TYPES OF (PRE-) SIEF MEMBERS 12 Wh are the different members f a SIEF? 12 What are the duties f the different members f a SIEF? SIEF FACILITATION 15 Hw t becme a SIEF Frmatin Facilitatr (SFF)? 15 What are the duties f a SFF? 15 When shuld sameness discussins be started? 16 What wuld happen if n pre-registrant takes the rle as SFF? 16 What is the legal status f the SFF? 16 Wh can becme a SFF? 17 Are certain skills required fr a SFF? 17 Will the SFF autmatically be the lead-registrant? 17 Will the SFF be a (pre-) SIEF representative in case f jined cnsrtium? AGREEING ON SUBSTANCE SAMENESS / EQUIVALENCE 18 EINECS as a starting pint 18 3

4 Check the relevancy f hazard data 18 Wh shuld be invlved in sameness discussins? 19 Hw d I prtect cnfidential business infrmatin in substance sameness discussins? 19 D I need t sign a cnfidentiality agreement when frming a SIEF? SIEFREACH FOR EFFICIENT SIEF COMMUNICATIONS 22 What is SIEFreach? What is Reachlink? 22 What are the basic cncepts f the SIEFreach system? 22 Which IT systems are relevant fr Pre-Registratin / SIEF prcessing? 22 Imprt Pre-SIEF data int SIEFreach system 23 Set up f Cmpany and User accunts 23 User Rles and Security 23 Free access zne in SIEFreach 23 Cllabratin in (pre-) SIEF 23 What are the benefits f using the ReachLink SIEFreach system? 24 What Am I paying fr? 24 What are the benefits fr a SME and a Data hlder in using SIEFreach? 24 What are the benefits fr a member f a cnsrtium in using SIEFreach? EC COMPETITION LAW COMPLIANCE DEFINITIONS & FURTHER INFORMATION 26 4

5 1 1 June Submit Preregistratin Ptential registrants jin Pre-registratin 1 Dec 2008 Prepare fr SIEF Data hlders jin Pre SIEF Jan 2009 ASAP after end f pre-registratin SIEF 6 Agreement by ptential registrants that they intend t register the same substance Check yu have made the crrect pre-registratin Cnsider using SIEFreach system 3 Substance sameness discussins between ptential registrants Agree same substance r Split t frm multiple SIEF r Merge with ther (pre-)sief Figure 1: Overview f SIEF frmatin 5

6 1. Pre registratin number WHAT IS A PRE-REGISTRATION NUMBER? The Eurpean Chemicals Agency (ECHA) upn successful submissin f the pre-registratin infrmatin prvides a pre-registratin number assigned t each substance and legal entity cmbinatin regardless if it is a bulk r a manual n-line pre-registratin (See Chapter 5 f Cefic Guidance n Pre-registratin fr further details f hw t submit a pre-registratin and the different types). The number is cmmunicated via REACH-IT t the user wh submitted the pre-registratin. Pre-registratin numbers are nt referred t in the REACH regulatin. Pre-registratin numbers are related in structure, yet are different t registratin numbers. Bth numbers are referred t in REACH IT as reference numbers The generic structure f ECHA reference numbers is as fllws: Type - Base Number - Check Sum - Index Number Type is a 2-digit number describing: 01 - Registratin 02 Classificatin and Labelling Ntificatin 03 Substance in Article 04 Prduct and Prcess Oriented Research and Develpment (PPORD) 05 Pre-registratin 06 - Inquiry 07 On site islated Intermediate registratin 08 Transprted islated Intermediate registratin 09 Data Hlder Ntificatin Therefre all pre-registratin numbers will start with 05. Base Number is a 10-digit number Check Sum is a 2-digit number derived frm the Type and Base Number. The check sum will be the same fr the registratin number f all members f a jint submissin Index Number is a 4-digit number giving the index f a member in a jint registratin submissin. When there is n jint submissin (i.e. r when the cncept is nt applicable) 0000 will be used. Therefre the pre-registratin number will terminate in the index number The fllwing frm f pre-registratin number can therefre be anticipated: 05 xxxxxxxxxx - xx

7 HOW IS A PRE-REGISTRATION NUMBER USED? The pre-registratin number is the means f cnfirming t the pre-registrant that the preregistratin has been submitted successfully. There is n legal requirement t cmmunicate the pre-registratin number in the supply chain. The prvisin f a pre-registratin number by a supplier des nt guarantee his future cmpliance with REACH r cntinuity f supply as it is pssible t pre-register but nt fllw thrugh with registratin. In additin, nt all substances have a pre-registratin number, fr the simple reasn that they have nt been pre-registered because, they are nt a phase-in substance, that they are manufactured r imprted belw 1 tnne per year r that they are exempt frm REACH. That is why the imprtant REACH statement required by suppliers and submitted t custmers can be cmmunicated efficiently as a REACH cmpliant statement n prduct level. This apprach, in particular fr preparatins, plymer substances r plymer preparatins, is independent f the different pre-registratin numbers f substances cntained in the prduct. The pre-registratin number will nt reveal the substance identity r legal entity. The ECHA will nt publish pre-registratin numbers s there is n way t check whether pre-registratin by a specific legal entity actually tk place. Recmmendatin: Careful cnsideratin shuld be given by each Cmpany t the cmmunicatin f pre-registratin numbers in the supply chain. WHAT IS THE DIFFERENCE BETWEEN A PRE-REGISTRATION NUMBER AND A SUBMISSION NUMBER? Immediately fllwing successful n-line pre-registratin f a single substance, the party wh has submitted the pre-registratin will receive a submissin number and the substance cntact persn will then receive a pre-registratin number. Fr bulk pre-registratin via the REACH-IT system, the party wh has submitted the preregistratin will receive an internal REACH-IT message with a submissin number. This submissin number prves that the user has submitted the bulk pre-registratin file. It has been annunced by ECHA that the bulk pre-registratin ptin is nt available n entry int peratin (1 June 08). It is nt clear at this stage when this functinality will be available. Pre-registrants must use the submissin number t cmmunicate with the ECHA until a preregistratin number is prvided. The pre-registratin number shuld nt be cnfused with the submissin number. The submissin number is given every time a submissin is made. The submissin number culd cncern multiple substances per legal entity in the case f bulk pre-registratin whereas each substance will receive an individual pre-registratin number. An example f a submissin number wuld be ZD

8 2. Hw t ensure yu pre-register crrectly? Befre the main activities f SIEF, agreement n classificatin and labeling and data sharing, can cmmence, it is vital that each ptential registrant is lcated in a single, crrect SIEF per substance. This imprtant step shuld bring int cmmunicatin ptential registrants and data hlders, thereby maximizing the efficiency f future cllabratin. Belw are sme key tips t ensure yu pre-register crrectly. If yu are nt in the crrect SIEF, yu have nt preregistered yur substance crrectly, because yu have made a typing errr r have selected the wrng EINECS number. If yu d nt crrect the pre-registratin befre 1 December 2008, yu may be required t make an immediate registratin. 1 December 2008, yu wuld be required t make an immediate registratin. USE THE CORRECT SUBSTANCE IDENTITY AT PRE-REGISTRATION A precautinary apprach is advisable in rder t avid difficulties in finding ther ptential registrants f ne s substance after the pre-registratin perid has passed. Use f the crrect substance identity (see ECHA Guidance fr identificatin and naming f substances under REACH) will avid having t start a time-cnsuming search fr the right SIEF t jin. If that search were unsuccessful, yu wuld then be required t register alne befre the crrect extended deadline. This may require additinal cmpany resurce, incur a higher registratin fee than a jint submissin and ptentially result in greater scrutiny f the dssier by ECHA in the evaluatin phase. The REACH-IT system will check autmatically the elements f CAS and EINECS number recgnitin that it can (e.g. the number f digits in the CAS and EINECS numbers). The accuracy f the infrmatin hwever cannt be checked by an IT system. If the EINECS inventry is nt used t identify a substance, a typing errr in the name will mean that the wrng substance will be pre-registered. In the case the substance has a CAS number, it is advised t verify whether the name used (the ne yu wuld like t pre-register) crrespnds t the name in the CAS-database. In the case the substance has n numerical identifiers (EINECS, NLP r CAS number), verify the IUPAC name with the structural frmula and the quantitative cmpsitin f the substance. Yu can indicate synnyms fr yur substance withut EINECS/ NLP number indicating t ther pre-registrants which names are used fr yur substance. IF IN DOUBT, PRE-REGISTER AGAIN There are cnsequences t being in the wrng (pre-) SIEF s if there is any uncertainty abut substance identity (i.e. which CAS, EINECS r NLP identity r number t use), and nly in this case, it is advisable t submit multiple pre-registratins fr yur identical substance. Each pre-registratin will be checked by REACH-IT and the identifiers will be brught tgether. When there are n EINECS, NLP r CAS numbers t be used as identifiers the crrect IUPAC name shuld als bring same substances tgether, but care shuld be taken in submitting nly an IUPAC name as mistakes can easily be made and these may prevent yu finding the crrect pre-sief. The use f trade names r nn-chemical names is nt advised. If there are uncertainties abut the status f substance (multi-cnstituent substance versus preparatin r UVCB), it is advised t perfrm pre-registratin n the basis f the different ptins. Nte that preparatins cannt be (pre-) registered, but their cmpnents shall be (pre-) registered. 8

9 The use f the read-acrss ptin at pre-registratin is nt a suitable alternative t multiple pre-registratins. Yu will nt have the rights and duties f a ptential registrant in the SIEF f substance(s) yu have indicated fr read acrss. Recmmendatin: The extra wrk that multiple pre-registratins brings, utweighs the difficulties in finding the right SIEF afterward pre-registratin. After finding ne s crrect SIEF the superfluus pre-registratins can be deactivated. Fr details and cnsequences f deactivatin: see Hw d I deactivate a pre-registratin, belw. CHECK THE PRE-SIEF REACH IT WEB PAGE REGULARLY When a substance is submitted fr pre-registratin fr the first time thrugh REACH-IT a secure assciated web page will be created autmatically. This web page will then be accessible t all subsequent pre-registrants f the substance with the same name and / r ther identifiers, (the pre-sief), and will cntain certain data submitted at pre-registratin including pre-registrant cntact details, but excluding the registratin deadline and the tnnage band. Recmmendatin: D nt enter any cnfidential business infrmatin r ther data yu d nt want t share with ther members f the pre-sief. Recmmendatin: After receiving a message in the REACH-IT internal user s inbx frm ECHA giving the user the pre-registratin number, check if indeed the intended substance was pre-registered. Recmmendatin: Gd verificatin f the pre-sief webpage can alert yu t any mistakes. A further indicatin f a wrng pre-registratin culd be the presence f a number f unexpected ther ptential registrants n the assciated pre-sief webpage. In this case yu may wish t cntact the SIEF frmatin facilitatr r ther pre-sief members t verify. Cntact can be made using infrmatin prvided by ECHA r via the SIEFreach system. Fr the reasns abve, it is advisable t check the assciated pre-sief webpage regularly thrughut the pre-registratin perid when new ptential registrants jin the pre-sief. Yu can either enter the web page vluntarily, r request at pre-registratin that yu are ntified by REACH-IT message f changes t the pre-sief web page. These changes include the additin f a new pre-sief member, a change f the SFF r changes f anther member s pre-registratin infrmatin. The anticipated number f participants within the SIEF may influence yur chice f vluntary access r REACH-IT message ntificatin. 9

10 AVOID LAST MINUTE PRE-REGISTRATION By pre-registering early in the six-mnth pre-registratin perid (June 1 t December ), yu have a lnger time perid t identify any incrrect r unsuccessful pre-registratin and repeat the pre-registratin befre 1 December 2008 and deactivate the incrrect ne. Recmmendatins: Knw the identity f yur substance well and pre-register right first time; When in dubt abut substance identity, make additinal pre-registratins using ther apprpriate identifiers; Check the REACH IT pre-sief web page regularly t verify that yu have jined the crrect pre-sief. If in dubt, cntact the SFF, if available; Cntact ther pre-registrants befre December t start verifying substance identity. Take int cnsideratin the prtectin f CBI; Dn t pre-register at the last minute when time is limited. If unsuccessful r incrrect, yu will need time t pre-register again. WHAT DO I DO IF I FIND MYSELF IN THE WRONG PRE-SIEF? Befre December , it is pssible t deactivate an errneus pre-registratin (see Hw d I deactivate a pre-registratin ) and pre-register again with the crrect substance identity. After December , when the pre-registratin perid is clsed and ALL ptential registrants are present in the pre-sief a sameness discussin is needed in rder t frm a SIEF (this discussin may start prir t the end f the pre-registratin perid but cannt be cmpleted until all ptential registrants have pre-registered after 1 December 2008). During the sameness discussin it may becme evident that ne has jined the pre-sief f a different substance. If sme f the ther ptential registrants in the pre-sief are in a similar psitin and have pre-registered fr a substance f a same identity, the pre-sief may be split t create mre than ne SIEF (see Pre-SIEF splitting and merging fr details). When there are n ther pre-registrants within the pre-sief with the same substance, the pre-registrant is advised t check the list f pre-registered substances that is published by ECHA by January 1, 2009 fr the presence f similar substances. Yu may request assistance frm ECHA t establish cntact with the SIEF frmatin facilitatr r lead registrant f the mst apprpriate (pre-) SIEFs. If this search is unsuccessful the preregistrant may submit a registratin alne befre the relevant tnnage registratin deadline. HOW DO I DEACTIVATE A PRE-REGISTRATION? The REACH IT system f ECHA will allw pre-registrants t deactivate a pre-registratin. This des nt represent a deactivatin frm the pre-sief, but is an indicatin that the legal entity will nt register this substance. The cnsequence f this is that the pre-registrant still has data-sharing bligatins, but will nt participate in the jint submissin. Recmmendatin: Deactivate as sn as it is clear that yu will nt register the substance as it enables the ther participants f the (pre-) SIEF wh are willing t register t mre quickly identify wh the ther ptential registrants are. 10

11 PRE-SIEF SPLITTING AND MERGING Industry may split and merge pre-siefs t frm SIEFs in the circumstances described belw, withut the supprt f ECHA. Hwever, ECHA can questin the frmatin f the SIEF in the evaluatin phase. In practice the splitting f a pre-sief is relatively straightfrward. During the initial sameness discussins, the pre-sief will decide hw the substance identity shuld be split. Fr instance a general enzyme entry n EINECS culd result in multiple SIEFs ne fr each IUBMB (Internatinal Unin f Bichemistry and Mlecular Bilgy) number. The wrk in the pre- SIEF is then split in several SIEFs and will lead t multiple different (jint) registratins, ne fr each individual IUBMB number. The reasn fr the split shuld be justified in the jint submissin. The merging f multiple pre-sief t frm a single SIEF is mre cmplex. This may be cnsidered in the case where tw Einecs entries represent the same substance. Knwledge f the individual Industry participants f the different pre-siefs is required in rder t facilitate a merge. This prcess can be supprted if the ptential pre-registrants cnsciusly preregister such substances using the knwn different identifiers. The SIEFreach system will supprt the necessary changes required t SIEF structure, such as splitting and merging f SIEFs after pre-registratin. Further Infrmatin: See page 37 f the ECHA Guidance n data sharing. 11

12 3. Types f (pre-) SIEF members WHO ARE THE DIFFERENT MEMBERS OF A SIEF? The different categries f SIEF members are as fllws: Ptential Registrants Current and ptential manufacturers and imprters f phase-in substances having pre-registered that substance Current and ptential imprters f preparatins cntaining phase-in substances, having pre-registered that substance Current and ptential prducers and imprters f articles having pre-registered that phase-in substance if intended t be released frm articles. Only Representatives f nn-eu Manufacturers having pre-registered that phasein substance Late pre-registrants (first time manufacture r imprt > 1 tnne per year after 1 December 2008 see Article 28(6) f the REACH Regulatin) Third Party Representatives Manufacturers/imprters f phase-in substances wh have pre-registered these substances and Prducers/Imprters f articles wh have pre-registered phase-in substances intended t be released frm an article can decide t appint a Third Party Representative t hide their identity vis-à-vis the ther SIEF members. When this happens, the Third Party Representative will be a SIEF member, but this des nt mean that he then becmes a Ptential Registrant, as the legal entity nminating a Third Party Representative retains the full legal respnsibility fr cmplying with his bligatins under REACH. Hwever, the Third Party Representative will carry ut all prceedings under Title III f the REACH Regulatin Data Sharing and Avidance f unnecessary testing. Data Hlders wh have expressed their intentin t share data via REACH IT: Data hlders will jin the (pre-) SIEF via REACH-IT fllwing ECHA publicatin f the list f pre-registered substances befre 1 January They may be: Manufacturers and Imprters f phase-in substances in quantities f < 1 tnne per year wh have nt pre-registered. Dwnstream Users f phase-in substances. Third Parties hlding infrmatin n phase-in substances: Trade r industry assciatins, sectr specific grups and cnsrtia already frmed. Nn Gvernmental Organisatins (NGOs), labratries, universities, internatinal r natinal agencies. Manufacturers f a substance wh have n interest in registering a substance under REACH because they d nt prduce r place it n the market in Eurpe (e.g. a nn-eu manufacturer wh des nt exprt int the EU). Data Hlders wh autmatically jin the SIEF These data hlders nly will participate in data sharing, classificatin and labelling discussins and preparatin f data fr jint submissin Any manufacturer/imprter wh has registered a phase-in substance befre June 1, 2018, even withut pre-registratin. (Early Registrants) Parties that submitted infrmatin in the framewrk f the Plant Prtectin Prduct Directive (91/414/EC) r the Bicidal Prduct Directive (98/8/EC) Others As there are n checks in the REACH-IT system, anyne can pre-register. It is therefre pssible that a (pre-) SIEF cntains members that are nt described abve. Nte: Data hlders that have nt infrmed ECHA f their intentin t share data will nt be SIEF members but may represent a surce f data fr ptential registrants. 12

13 Ptential registrants and third party representatives may als wn data they intend t share and are knwn as data wners. Hw and when data hlders are brught int the SIEF Data Hlder Bundaries f the SIEF Decisin n sameness f substance 1. Ptential registrants enter SIEF* 2. Data hlders enter SIEF** Data sharing Agreement n C&L Infrms ECHA f data wnership fr named substance (ptinal) Infrmatin requested frm data hlders Opt ut Lead registrant fr jint submissin Registratin * Fr duties f ptential registrants see Table X ** Duties f data hlders are different frm ptential registrants - see text fr details Figure 2: Bringing data hlders int SIEF Further Infrmatin: See als sectin f the ECHA Guidance n data sharing. WHAT ARE THE DUTIES OF THE DIFFERENT MEMBERS OF A SIEF? The different categries f SIEF participant d nt share the same duties and rights in the SIEF. The majr differences between Ptential Registrants (and their Representatives) and Data Hlders are summarised in Table 1 belw. Althugh data hlders must react t any query frm Ptential Registrants if they hld data relating t this query (see Article 30 f the REACH Regulatin), they have n ther active rle in the SIEF. Data Hlders will nt decide whether a study is included in the jint submissin, nr will they participate in the substance sameness discussins r thse related t classificatin and labelling. 13

14 The duties and rights f the different members f a SIEF DUTIES RIGHTS TYPE OF SIEF MEMBER Ptential Registrants = Manufacturers/Imprters/O nly Representatives and Prducers f articles wh have pre-registered a phasein substance Third Party Representatives appinted by ptential registrants Data Hlders wh have expressed their intentin t share data via REACH IT React t requests frm ther participants yes yes yes Prvide ther participants with prf f cst and (access t) existing studies upn request Request missing infrmatin frm ther SIEF participants yes yes yes yes yes n Agree n cst sharing mechanism yes yes yes Receive financial yes yes yes cmpensatin fr data shared Cllectively identify needs fr further studies t cmply with Registratin requirements Make arrangements t perfrm the identified studies yes yes yes yes Agree n classificatin and labelling yes yes Agree n the yes yes appintment f the Lead Registrant Agree n the selectin f studies t be included in the jint submissin yes yes n n n n n Submit jint registratin (r decide t pt-ut) yes yes* n Ensure that data sharing activities d nt jepardise cmpliance with EC Cmpetitin law yes yes yes * The decisin t prepare a jint submissin r pt ut is made by the ptential registrant and cmmunicated in the SIEF by the Third Party Representative. 14

15 4. SIEF Facilitatin The first task t be cmpleted n autmatic entry int a pre-sief fllwing pre-registratin is t establish whether the ptential registrants plan t register the same substance fr the purpse f data sharing and harmnisatin f C&L. Only when this is agreed, is a SIEF created and the bligatins f data sharing as set ut in Article 30 f the REACH Regulatin and the task f preparing fr jint submissin can begin. As registratin must take place accrding t strict and tight deadlines, it is vital that the ptential registrants f the pre-sief wrk tgether effectively and rapidly frm the very start. It is recmmended that a SIEF Frmatin Facilitatr (SFF) be appinted fr each SIEF in rder t rganise and lead this initial task. HOW TO BECOME A SIEF FORMATION FACILITATOR (SFF)? It is highly recmmended taking the decisin t becme a SFF prir t pre-registratin. Allcatin f SFF in the REACH IT system is n a first cme first served basis s if yu intend t becme an SFF it is advisable t pre-register at the beginning f the pre-registratin perid (1 June 2008). Fllwing successful pre-registratin, yu can select the SFF ptin in the apprpriate pre-sief web page t indicate yur willingness t act as SFF. The first preregistrant t d s fr a substance during the 6-mnth-pre-registratin perid will be appinted t be the SFF. If an earlier pre-registrant has already selected SFF in the pre-sief web page, this ptin will nt be available. It is pssible fr ptential registrants f multiple substances t becme SFF fr mre than ne (pre-) SIEF. If mre than ne pre-registrant wuld like t becme the SFF, r the riginal SFF reviews its psitin, the pre-sief participants will have t decide internally by mutual agreement wh will take that psitin based n the mst capable vlunteer r wh will be the future lead registrant. Cnversely a SFF may nt be needed in the fllwing cases: The SIEF is small, r The lead registrant is already designated, r The substance sameness verificatin has already taken place utside the SIEF, e.g. within a cnsrtium r ther frm f cperatin in which all ptential registrants have been invlved. Recmmendatin: discuss the SFF rle after pre-registratin and make a final decisin within the pre-sief. WHAT ARE THE DUTIES OF A SFF? An SFF initiates bringing tgether f ptential registrants and third party representatives immediately fllwing pre-registratin t lead the pre-sief harmniusly and withut delay t frm a SIEF. This initially requires facilitatin f discussins t establish sameness and thereby rganise the exchange f infrmatin and data n the identity f the substance if necessary. Initially the SFF may cmmunicate with SIEF members via the details prvided in the REACH IT pre-sief webpage (see page 7 f Cefic Pre-registratin guidance). Cmmunicatins may be cntinued mre effectively in the SIEFreach system, as sn as SIEF members have established this. There are several further tasks that may be undertaken by the SFF r by the designated Lead registrant, wh shuld take up respnsibilities sn after the SIEF is created and will remain in peratin until June 1, 2018 (see Article 29 f REACH Regulatin). Examples are: Facilitate discussin between ptential registrants n the sameness f the substance Find the frm f c-peratin and internal rules fr the SIEF Launch the query fr data in SIEF Prepare an inventry f available data Perfrm the technical wrk Channel the cperatin with ther SIEFs and data hlders 15

16 Ensure a smth entry f late-pre-registrants (i.e.; first time Manufacturers and Imprters abve 1 tnne per year after December ) Facilitate an agreement n cst sharing As sn as the lead registrant is defined these SFF tasks will be transferred t the Lead registrant, unless anther agreement is cncluded. The rle f the SFF shuld nt be underestimated and may require substantial resurces. It is therefre reasnable t expect that the SIEF members will financially cmpensate the SFF fr their services; especially the services wuld have therwise been cmpensated fr. Apart frm peratinal SIEF csts, the decisin is up t the members f the SIEF. Recmmendatin: If yu intend t act as lead registrant, it is recmmended that yu take the initiative at the SIEF frmatin stage and indicate yur willingness as SFF immediately fllwing pre-registratin. WHEN SHOULD SAMENESS DISCUSSIONS BE STARTED? Substance sameness discussins may be started befre the clse f pre-registratin (1 December 2008) but shuld nt be cmpleted befre this time. Starting substance sameness discussins befre the end f the 6-mnth-pre-registratin perid wuld allw changes f pre-registratins r t pre-registratin again (and deactivate the incrrect pre-registratin) befre December , but this activity bears the fllwing threats Time is spent ineffectively if discussins start t early withut the full cmplement f input data discussins befre 2 December 2008 shuld be treated as preliminary and a way t check that yu are in the crrect pre-sief Shuld the first pre-registrants make a decisin, the sameness subject may nt be dealt with in a fair and cllabrative way All sameness discussins shall be cnducted in cmpliance with EC cmpetitin law whilst prtecting CBI. WHAT WOULD HAPPEN IF NO PRE-REGISTRANT TAKES THE ROLE AS SFF? Whilst there is n legal requirement fr a SFF, in practise it is beneficial that these initial stages f wrking tgether are facilitated. In the absence f an SFF, the EU manufacturer r EU Imprter with the highest capacity f prductin r imprt having the first registratin deadline and hence the greatest urgency, may wish t initiate the cllabratin. WHAT IS THE LEGAL STATUS OF THE SFF? The rle f the SFF is ttally vluntary and des nt entail any specific bligatins. In cntrast t the rle f the lead registrant, it has t be emphasised that the rle f SFF is nt mandatry and des nt have a frmal recgnitin in the REACH Regulatin. The SFF has the same liabilities as any ther member f the SIEF. Frm a liability pint f view their bligatins are nt different cmpared t the ther SIEF members. They are nt respnsible if the pre-sief Members fail t frm the crrect SIEFs. SIEF members, including the SFF, can nly be held liable in case f grss negligence and wilful miscnduct, but cannt be held liable neither fr nn-typical r unfreseeable damage nr fr cnsequential damage and lss f prfits. 16

17 WHO CAN BECOME A SFF? In principal any ptential registrant r third party representative can becme a SFF. Data hlders (wh have expressed their intent t share data via REACH-IT and wh are nt ptential registrants r third party representatives) and ther (pre-) SIEF members cannt becme SFF as they are nt invlved in the pre-sief discussins nr can indicate their willingness t be SFF in REACH IT. ARE CERTAIN SKILLS REQUIRED FOR A SFF? It is preferable that the SFF has prject managerial skills and knwledge f the substance, since he has t rganise/facilitate the exchange f data between participants within the (pre-) SIEF r liaises with ther SIEFs and finds mutual agreements f sameness f substances. WILL THE SFF AUTOMATICALLY BE THE LEAD-REGISTRANT? Neither in the REACH regulatin nr its guidelines are rules prvided fr appinting the lead registrant. It is up t the members t decide by mutual agreement wh will take that psitin. Such a decisin may be taken in a cnsrtium r any ther frm f cperatin. It is ptentially preferable that the SFF will becme the lead registrant, since he is already invlved in the prcess f rganising the pre-sief facilitatin and data sharing. WILL THE SFF BE A (PRE-) SIEF REPRESENTATIVE IN CASE OF JOINED CONSORTIUM? C-peratin in a cnsrtium can be cnsidered by (pre-) SIEF members n a case by case basis, e.g. in the case f structurally similar substances, r fr the specific purpse f readacrss. A single jint submissin is prepared fr each SIEF, using the relevant infrmatin shared in the cnsrtium. The SFF will act as a link between the participants f the (pre-) SIEF he represents and the cnsrtium. Further Infrmatin: abut SIEF Frmatin Facilitatrs in the ECHA Guidance n Data Sharing (Sectin 4.5.2). 17

18 5. Agreeing n substance sameness / equivalence A The leading principle in the sameness discussins is whether the pre-registered substances have the same chemical identity t the extent that they may share the same hazard data t be submitted at registratin. The chemical identity is based n the cmpsitin and / r manufacturing prcess f the substance and is represented by a chemical name (e.g. tluene). Other ways f representing the identity are fr instance the CAS (Chemical Abstracts Service) name and number, the EINECS (Eurpean Inventry f Existing Cmmercial chemical Substances) name and number r the N Lnger Plymer name r number. T establish the identity, but als t be able t participate t the pre-sief and SIEF discussins, the cmpsitin f the substance shuld in principle be knwn by the ptential registrants. EINECS AS A STARTING POINT The same substance is initially defined by the same identifier, i.e. same EINECS number equals same substance. The first step t take in the sameness discussin is the checking whether the EINECS entry (r ther identifier used) is sufficiently defined t cntinue the prcess. EINECS is an inventry f substances n the market between 1 January 1971 and 18 September It was published n 15 June 1990 and cntains sme incnsistencies. In certain cases, the descriptin in EINECS fr a substance can be brad t the extent that the physical-chemical and (ec) txiclgical prperties f the different substances cvered by the entry are nt sufficiently similar. This may particularly be the case fr UVCB substances (Substances f Unknwn r Variable cmpsitin, Cmplex reactin prducts r Bilgical materials). Other incnsistencies include substances fr which there is mre than ne entry in EINECS. In thse cases the pre-sief shuld be split r merged, which is dne by decisin f the pre-sief members. ECHA will publish the pre-registratin list and will bring the ptential registrants f the same substance tgether in the pre-sief. This will be dne based n the same EINECS number, the same CAS number r the same chemical name. ECHA is frm this pint nwards n lnger invlved int the SIEF activities until the final registratin dssier is submitted. This means that industry has the full respnsibility but als freedm fr the establishment f the SIEFs. When the EINECS entry sufficiently cvers the substances, the next step in the sameness discussin can start. The principle is straightfrward: the same name means the same substance. CHECK THE RELEVANCY OF HAZARD DATA In cases where hazard endpint data are clearly nt suitable, substances can be regarded as different (e.g. in case f very different physical prperties, fr example water slubility, which have essential impact n the hazard prperties). Hwever, in mst cases, substances will be regarded the same at this stage f the prcess. It then becmes relevant t have knwledge abut the nature f impurities, which are knwn/expected t be hazardus. Fr example, a certain impurity will influence the classificatin f the substance (e.g. carcingenic). It shuld be nted that in a case like this it culd still be feasible t share the majrity f data. Registrants can agree t have mre than ne classificatin fr their substance in the registratin dssier, which they can submit jintly. In sme cases a ptential registrant may disagree with specific endpint(s) r decide (r have t) cmpletely pt-ut f jint registratin see Article 11(3) f the REACH Regulatin. Hw this pt-ut and especially the disagreement with specific endpints will wrk in REACH-IT, is nt clear at this stage. During the data-sharing and evaluatin prcess it is up t each participant individually t assess whether the selected data is relevant fr his substance. When this is nt the case the cnsequences shuld be discussed, e.g. higher registratin fee and greater scrutiny f the dssier during evaluatin. 18

19 Whilst ptential registrants may pt ut f jint submissin fr the reasns prvided abve, this des nt negate his bligatin t share data within the SIEF as set ut in the REACH Regulatin. WHO SHOULD BE INVOLVED IN SAMENESS DISCUSSIONS? Whilst the pre-sief may cntain a number f different actrs, see types f (pre-)sief members abve, it is nly the ptential registrants and early registrants that are invlved in the substance sameness discussins. The SFF may be required t clarify the rles f the members t facilitate this discussin. HOW DO I PROTECT CONFIDENTIAL BUSINESS INFORMATION IN SUBSTANCE SAMENESS DISCUSSIONS? CBI issues relating t substance sameness discussins can usually be divided int 3 categries: 1. N CBI cncern The issues belw can be penly discussed in SIEF and may be in the public dmain: EC (EINECS Number), CAS Number, CAS and IUPAC names etc Certain physicchemical data: State f the substance (20 C and 101,3 kpa) Melting / freezing pint Biling pint Relative density Vapur pressure Surface tensin Water slubility Partitin ceffecient n-ctanl / water Flash-pint Flammability Results f studies, classificatin & labeling and utline f analytical methds used. Althugh these latter examples may nt always be relevant t sameness assessments, in certain cases they will serve as useful tls. 2. Open discussin in SIEF but nt fr public access Precise chemical identity, especially where the substance name is brad and / r generic. This may be needed t ensure the substance in questin is in the crrect pre-sief, t facilitate splitting f a pre-sief int multiple SIEFs, r t cnslidate multiple pre-siefs int ne, r a reduced number f SIEFs. Physicchemical prperties and rbust summaries when the nature f impurities needs t be penly cmpared. Hwever, it shuld nt nrmally be necessary t divulge the exact substance cmpsitin and identity f impurities. 3.Cmpany specific CBI In mst cases, ptential registrants wuld nt disclse: Full cmpsitin f the substance Chemical rute f manufacture 19

20 Purificatin prcesses Surce f substance if the substance is imprted Precise tnnages Dwn stream uses/users if cnsidered CBI by the cmpany In circumstances f sensitivity when cnducting sameness discussins, it is recmmended t cnsider signing a cnfidentiality agreement and in case f high sensitivity, t appint an independent third party. 20

21 DO I NEED TO SIGN A CONFIDENTIALITY AGREEMENT WHEN FORMING A SIEF? Agreement n substance identity at the SIEF frmatin stage may in sme cases require the exchange f detailed technical infrmatin n the cmpsitin f the substance, the raw materials used, the substance impurities, and pssibly n the manufacturing prcess, since an impurity cntent can give an indicatin f the nature f the prductin prcess. This applies in particular fr prcess-dependent impurities and fr additives necessary t preserve the stability f the substance. Given that agreeing n substance sameness may in sme cases invlve the disclsure f cnfidential data, such as knw-hw r sensitive infrmatin, cmpanies may want t preserve cnfidentiality in a secure exchange. In case the technical infrmatin t be exchanged is cnsidered cmmercially sensitive by ne r mre ptential registrants, the SFF r designated lead registrant can prpse a cnfidentiality agreement in rder t safeguard cnfidentiality. Cmpanies willing t prtect CBI may take steps during the SIEF frmatin t prtect the cnfidentiality by entering int cnfidentiality agreements that limit access t dcuments r ther infrmatin t specific named persns, r departments, e.g. nly persns wrking within a regulatry sectin are allwed t see certain infrmatin. The basic elements f a cnfidentiality agreement are the definitins f: What is regarded as cnfidential infrmatin? Wh is under an bligatin t keep the infrmatin cnfidential? Wh is cnsidered as a third party? Wh is entitled t access cnfidential infrmatin? Hw lng infrmatin is prtected? Cnfidentiality agreements can fresee implementatin measures, as fr example by allwing access t certain dcuments in a reading rm nly, where cpying is nt allwed. As REACH des nt set any cnditins in this respect, parties can agree in additin t have certain dcuments reviewed by a Third Party expert (independent cnsultant r industry assciatin), wh can handle the cnfidential infrmatin n behalf f Ptential Registrants. Cnsequently, n ne frm the ther SIEF members will see such dcuments. 21

22 6. SIEFreach fr efficient SIEF cmmunicatins WHAT IS SIEFREACH? WHAT IS REACHLINK? Cefic tk the initiative last year t develp a cmmn IT platfrm t supprt the prcessing f SIEFs acrss industry. The system, named SIEFreach at is currently being built and will be peratinal early July 2008, in rder t be available fr Pre-SIEF tasks (e.g. sameness discussins) t be carried ut by cmpanies that have submitted Pre- Registratin data t the ECHA REACH-IT system. ReachLink SA is the cmpany that has been launched by Cefic and 5 Natinal Federatins (VCI Germany, CIA UK, UIC - France, Federchimica Italy and FEIQUE Spain) in which they are the sharehlders. The cmpany will prvide IT services t make use f the tl against a fee. REACHLink SA is the wner f the SIEFreach system and will manage the nging enhancement f the system during the 10 years f its lifetime. WHAT ARE THE BASIC CONCEPTS OF THE SIEFREACH SYSTEM? The SIEFreach system is a tl t facilitate data sharing within SIEF frm immediately fllwing pre-registratin up t submissin f a jint registratin dssier. It is a ttally separate platfrm t the REACH-IT system f the ECHA that is used fr pre-registratin and registratin. Pre-registratin data can be transferred frm the REACH-IT system t the SIEFreach system t prvide the identical (pre-) SIEF structure available t pre-registrants as in the REACH-IT system. SIEFreach prvides a secure platfrm fr the sharing f data within and between discrete (pre-) SIEFs. WHICH IT SYSTEMS ARE RELEVANT FOR PRE-REGISTRATION / SIEF PROCESSING? Figure 3 belw shws the main systems supprting the Pre-Registratin and Registratin prcess: REACH-IT system, peratinal at ECHA, supprting Pre-Registratin and Registratin prcess SIEFreach system, central platfrm fr industry t supprt Pre-SIEF / SIEF prcessing IUCLID5 system, peratinal at cmpanies t maintain Substance data and prepare dssiers. IT Systems supprting Pre-Registratin / SIEF / Registratin prcesses 1 REACH-IT system Pre-Registratin / Pre-SIEF IUCLID5 (ECHA central database) Registratin ECHA 3 2 XML cnversin Pl ug-in Other surce (e.g. Excel) SIEFreach SIEF prcessing (Jint Submissin) Dss ie r Preparatin IUCLID5 system Substance / dssier database (by cmpany) Industry SIEF-IT system (SIEFreach) 20 May 2008 page 2 22

23 IMPORT PRE-SIEF DATA INTO SIEFREACH SYSTEM The ECHA Pre-SIEF data is the basis fr the SIEFreach system. Data is transferred in a 2- step actin: 1) Transfer f Pre-SIEF data fr ne substance is triggered by ne f the Pre-SIEF participants. The transfer includes data f all actrs shwn at the Pre-SIEF web page, and 2) Stre the data in the SIEFreach system. Since synchrnizatin will nt be dne autmatically, refresh f the data has t be dne by repeating the transfer prcess at regular intervals. This can be dne by any f the Pre-SIEF participants. SET UP OF COMPANY AND USER ACCOUNTS The SIEFreach system requires legal entities t be defined, as well as User Accunts t be created, in rder t allcate users t ne r multiple SIEFs. Legal entities may be gruped int ne r mre legal entity grups, prviding flexibility fr cmpanies t manage the administratin f SIEFs. A Legal Entity Grup Administratr (LEGA) is the crdinatr wh will take care f legal entity and user creatin / activatin, as well as the payment f the fees t use the SIEFreach system. USER ROLES AND SECURITY The access and update f SIEF data is dependent n the rle a user has been assigned t. In a SIEF fllwing rles can be distinguished: SIEF Frmatin Facilitatr Lead Registrant Legal Entity User Invited Expert Data Hlder FREE ACCESS ZONE IN SIEFREACH As sn as pre-sief data f cmpanies have been transferred frm the ECHA REACH-IT system int the SIEFreach system, activated users have access t these pre-sief data, and will be able t view the same display as presented at the REACH-IT system. In additin, study data may be made available by ptential registrants and data hlders in the free-access zne. As sn as data is psted in a SIEF, a SIEFreach participatin fee has t be paid, either by credit card r by purchase rder / invice prcedure. COLLABORATION IN (PRE-) SIEF Frm the start f pre-sief, the use f the cllabratin tls in the SIEFreach system will be f great help t supprt the substance sameness discussins in rder t determine whether cmpanies belng t the same SIEF. Flders are available t enter data and facilitate discussin fr sharing f pinins and decisins thrughut the life f the SIEF. Available flders include Substance Sameness Classificatin & Labelling Data Sharing in accrdance with Article 30 f the REACH Regulatin Data Availability Cst Sharing Cllabratin n the varius flders will cntinue until cmplete data will be available t prepare the Jint Submissin. 23

24 WHAT ARE THE BENEFITS OF USING THE REACHLINK SIEFREACH SYSTEM? Using an industry wide platfrm with a pre-defined structure and prcess guidelines assures cnsistency and transparency fr all SIEF participants. In additin, tracking f SIEF discussins and decisins in a single central system acrss the SIEF lifetime (11 years) will be f great value t cmpanies. Custmised rles and secure prcessing fr bth individual cmpanies and cnsrtia members will help meet the data-sharing needs f all actrs. WHAT AM I PAYING FOR? A ne-time fee has t be paid fr participatin in SIEFreach. The fee is dependent n the rle in the SIEF, i.e. a legal entity user pays mre than an invited expert and a data hlder. Payment will result in becming an active SIEFreach participant, by which the rle respnsibilities can be fulfilled. Acting as a SFF r LR des nt require additinal payment abve the nrmal legal entity user rle. The base ne-time fee fr ne legal entity user is 300 per SIEF. WHAT ARE THE BENEFITS FOR A SME AND A DATA HOLDER IN USING SIEFREACH? Wrking with ther cmpanies in SIEFreach will enable strage f data abut the substance at a central place and at the same time allws a ne-stp-shp fr cmmunicating and discussing with ther SIEF participants. Even fr a SME cmpany, SIEFreach ffers a much mre efficient and effective cmmunicatin tl than the alternative f fr example . A data hlder will be able t ffer study data t ther SIEF participants, wh may be interested t use the data in a jint submissin. If that is the case, the ther SIEF participants will cmpensate the data hlder fr the use f the data fr registratin. WHAT ARE THE BENEFITS FOR A MEMBER OF A CONSORTIUM IN USING SIEFREACH? Althugh cnsrtia members usually have discussed and agreed n a lt f tpics abut substances inside the cnsrtium, each member has the bligatin t participate in a SIEF fr data sharing purpses, after having submitted pre-registratin data t ECHA. Cnsrtia will find ways t be efficient and be represented in the SIEF by ne f their members r a TPR; hwever, they have t assure that n issues will arise n data wnership and cst sharing with regard t studies. It shuld be nted that in the event that vting takes place using the SIEFreach system, each SIEFreach user wuld have ne vte. 24

25 7. EC Cmpetitin Law Cmpliance As described in the previus Cefic guidance cmpanies have t ensure that all activities under REACH cmply with cmpetitin law; this als applies t SIEF frmatin. Therefre, the fllwing is recmmended: DO ensure, that the issue f sameness and identity check are handled by applying bjective and transparent criteria when discussing the SIEF s frmatin. DO ensure that, befre any discussin n the issue f sameness starts with ther undertakings, each undertaking individually identifies its wn substance(s) and dcuments its reasns fr this apprach. DO ensure that any deviatin frm this apprach, fllwing discussins with ther undertakings, is clearly and bjectively justified and dcumented. DO ensure that the final decisin n sameness is clearly and bjectively justified and thse reasns dcumented. Particular care shuld als be brught t the exchange f infrmatin: DO limit yur exchanges f infrmatin t what is strictly necessary under REACH, and in this case t sameness. DO reduce the frequency f exchanges. DO exchange tnnage bands instead f individual mre specific vlume infrmatin. If nt feasible, and specific vlume infrmatin r ther sensitive data needs t be cmmunicated, use precautinary measures, e.g. rganise such exchange via an independent third party r trustee. DO NOT misuse the prcess f substance sameness discussins t unduly exclude certain cmpetitrs. DO NOT exchange nn-public sensitive infrmatin such as (nn exhaustive list): Individual cmpany prices, price changes, terms f sale, industry pricing plicies, price levels, price differentials, price mark-ups, credit terms etc; Csts f prductin r distributin etc; Individual cmpany figures n surces f supply, csts, prductin, inventries, sales, etc; Infrmatin as t future plans f individual cmpanies cncerning technlgy, investments, design, prductin, capacity, distributin r marketing f particular prducts including prpsed territries r custmers; Matters relating t individual suppliers r custmers, particularly in respect f any actin that might have the effect f excluding them frm the markets. DO NOT exchange technical infrmatin if this exchange is nt necessary under REACH, especially if this exchange f technical infrmatin may prvide cmpetitrs with the ability t align their market behaviur. Mre infrmatin can be fund in Cefic REACH cmpetitin law cmpliance guidance in the Cefic Pre-registratin Guidance. 25