Our mission REACHLaw Ltd exists exclusively to provide full set of REACH services and timely solutions to its clients by offering unique combination of expertise in REACH, legal, chemistry, environmental and business REACHLaw Ltd exists exclusively to provide full set of REACH services and timely solutions to its clients by offering unique combination of expertise in REACH, legal, chemistry, environmental and business
Introductions: Our Executive Team & skills Mr Lasse Kurkilahti, Partner and Chairman of the Board, former CEO and President of Kemira Ltd, also former Chairman of Finnish Chemical Industry Association, MSc in Business Admistration Mr Lasse Musakka, Partner and CEO, MSc in Economics Mr Mathias Berner, Partner and Sales Director, D.Sc. (Tech) Mr Riku Rinta-Jouppi, Partner and Chief Legal Council, MA Law, MSc in Bioinformation Technology Mrs Ying Zhu, Partner and COO, PhD in Bio Chemistry, MBA Mr Jouni Honkavaara, Partner, CFO and CMO, MSc, MBA > 40 specialists in REACH/EU competition law, chemistry, toxicology and business Key capabilities of REACHLaw: Chemical Industry, business and legal REACH knowledge, Chemistry, Close Co-operation with ECHA and Helsinki REACH Centre, Independence
Consortium EU Manufacturers Our Service Model Non-EU Countries REACHLaw Ltd Helsinki, Finland Process development & Confidential Information Management ECHA Importers (→ DU) Downstream Users (EU Market) Consortium M LR DH OR EU Non EU Industry Associations Non–EU Manufacturers Own subsidiaries & Partners for on site support and additional competencies SIEF EU Manufacturers REACHLaw Ltd Brussels
Some of Our Partners >China >Huateng CPCIA >India >Dynamic Orbits >Russia >Petrofinn >Thailand >Pro-Application Service >USA >ChemRisk Latin America CIQyP & MOURAO ENRIQUE ASSOCIADOS With the support of: ABIQUIM, ANIQ, ASIQUR, ASIQUIM, ASOQUIM. AUSTRALIA Pamir Consulting
REACHLaw Ltd today : global, world class REACH service provider Our customers: > 200 major manufacturers in 25 countries with around 2000 substances Customers Partners
Examples on our REACH service packages Services for Manufacturers Registration Service Package Service/outsourcing/Third party agreement model for EU manufacturers and subsidiaries of non-EU manufacturers Only Representative model for non-EU manufacturers Service Package for Late Arrivals Sourcing and Supply Chain Strategies: REACH Risk Analysis Services for Lead registrants & Consortia Pre-Consortium Study for Consortia Formation Lead Registrant Support Service Package Consortium Support Service Package Services for Downstream users Downstream User Registration Package Exposure Scenarios
The presentation is built on previous REACH knowledge and only a very concise summary and key terms will be repeated Comment to the Presentation
REACH is the new chemical legislation in EU affecting the sale and manufacture of all chemicals unless specifically exempted REACH is in Force NOW! No (pre)-registration – no Market What is REACH?
All substances – on their own, in preparations or articles (if intended to be released) manufactured or imported in quantities of 1 tonne or more per year unless they are explicitly exempted from the scope of registration, notably Annex IV, V. What to register?
How to Register? 1.Independent, professional Only Representative 2.Own legal entity (subsidiary in the EU) as registrant 3.(Importer in the EU as OR/registrant) 4.(Test laboratories) 5.(Multinational companies) 6.(Non-EU Government affiliates)
When to Register? In Force June 1, 2007 1000 t/y, CMR 1&2 R50/53 t/y t/y Pre-Registration (June 1 – December ) Evaluation, SDS & Down Stream User Data maintenance Evaluation, SDS & Down Stream User… Evaluation… June June Dec Dec Milestones Pre-Registration preparations ongoing TODAY’S FOCUS
SIEF = Substance Information Exchange Forum All pre-registered substances are automatically part of the (pre)SIEF. After sameness of the substances is agreed the SIEF officially starts Purpose of SIEF: agree on CLP and data sharing Consortia “Voluntary” Formalized co-operation between companies Terminology
The context/concept/paradigma of REACH (Background:Scope of our risk analysis) Non-EU suppliers Your company Group EU – supplier Substance A Your OR / subsidiiary Independent importers EU Non-EU Your company (Group) Independent Non - EU Manufacturer Non-EU suppliers 1c. 1a EU - customers 5. 1b. Scope: topics to be covered 1a. Appointing Parties, substances, legal entities 1b. Appointment Process 1c. Appointed Party (OR) 2. Independent non-EU suppliers 3. Indirect export 4. Independent EU importers 5. Potential EU suppliers, re-import 6. New ”REACH counterparts/liabilities/risks” 7. New liabilities against your customers New counterparts ECHA, SIEF, Consortia
Comments to REACH risk analysis Understand all REACH relationships very well Especially Focus on Supply chain issues Pressure created by your customers in EU Liabilities arising from REACH
HAZARD ASSESSMENT (HA) RISK CHARACTERISATION (RC) DOCUMENTATION IN CHEMICAL SAFETY REPORT (CSR) EXPOSURE ASSESSMENT (EA) FINAL EXPOSURE SCENARIO (ES) Dangerous or PBT, vPvB Substance persistent, bioaccumulative and or toxic (PBT) IDENTIFICATION OF DATA GAPS TESTING REQUIREMENTS PREPARATION OF TESTING PROPOSALS PREPARATION AND CHECK OF CSR CHEMICAL SAFETY ASSESSMENT CSA SHARING THE EXISTING DATA EVALUATION OF THE DATA QUALITY GENERATION OF NEW DATA ORGANIZING EXISTING DATA TECHNICAL WORK IN REACH
If substance is not hazardous, only data for physicochemical properties required (Annex III) When there is an information gap which cannot be filled by any non-testing method, registrant has to take action - Annexes VII or VIII : generate new information - Annexes IX or X : prepare a testing proposal Starting point
Tests needed (1/4)
Tests Needed (2/4)
Tests Needed (3/4)
Tests Needed (4/4)
Conclusions on technical requirements There is an incredible workload coming towards substance with the 2010 deadline Numerous tests have either to be performed (Annex VII-VIII) or testing proposals submitted (Annex IX-X) Requires completely new interactions between competitors (NOTE: Competition LAW!) How is the industry coping with this?
European Chemical Industry Council (CEFIC) Alert A key warning to companies is that in practice, they should aim to submit lead registration dossiers by June six months before the deadline - to be on the safe side. This is so that it can undergo a technical completeness check and secure registration - after the registration fee has been paid - in time so that all other members of the substance information exchange forum (SIEF) that are sharing data in that dossier can refer to it. The timeline also indicates that already: SIEF formation facilitators should have been identified; codes reflecting the role companies will play within SIEFs should have been communicated; and agreement on the sameness of a substance represented by the SIEF should have been achieved. For many SIEFs this will not have happened--it is understood that only 10% of pre-SIEFs had a potential formation facilitator lined up via the pre-registration process.
Some statistics: pre-SIEF’s No of Participants No of Pre-SIEFS in range Percentage of pre- SIEF covered by consortia ? ? ? ? ? ? ? ? ? Grand Total If > 1000 ton and no existing consortia -> major difficulty in registering on time High cost? Low cost?
Which substances will be affected (=deadlines for registration)
Current status:Types of SIEF’s (according to our experiences from 2000 Pre-SIEFs) Type of SIEFActivities/statusCharacteristicsDominating players Key issues 1. ”Dormant” No progress, major type so far No leading manufacturer No one so farLeading must show up, others can just wait 2. ”Mess” Playground for commercial service providers No real leading manufacturer having industrial interest No one so farLeading must show up, 3. ”Nominal” Low activity in SIEF, leading has taken to role Major work done in existing consortia Large USA/EU based manufacturers Cost sharing issues, membership in consortium 4. ”Fighting” Discussions dominated by one manufacturer Major work done by the leading company (no consortium) One large manufacturer Cost sharing mechanism 5. ”Real” No existing examples Major work done by SIEF No oneRole in SIEF depending on existing data
CEFIC tried to help
Why so slow progress – major reason ? Big ones not taking the lead, especially non-EU manufacturers Pre-registration, basic challenges Major tasks Substance identification (chemistry) Knowledge about & interpretation of REACH regulation (legal) Volume calculation REACH-IT Registration, completely new challenges Pre-SIEF, SIEF and consortia formation: Who should take the leading position, what it means, how to cooperate in SIEF / Consortia, cost sharing etc (legal & business) Later: Evaluation of data, new research (toxicological & eco- toxicological tasks)
Current status: Pre-SIEFs have started, but… We (= our customers) have made pre-registrations for around substances Less than 200 Pre-SIEFs are running… Reason to be worried ??
Immediate Actions needed Products in over 1000 t category or CMR’s are in very real danger of missing the 2010 deadline if no one is taking the lead What is the pre(SIEF) status? Data availability? SIEF distribution? But first, let’s understand the individual role...
Our Categorization - first understand the status
Next Step: (pre)SIEF status What is the status of the pre-SIEF? Is it progressing Based on the pre-SIEF lisiting are there other major manufacturers Who is the SIEF Formation Facilitator? ECHA will not assist in this process! IF THE MAJOR MANUFACTURERS WILL NOT TAKE THE LEAD, REGISTRATION DEADLINE WILL BE MISSED
Pre-consortia Study or Lead registrant Pre-SIEF status alone LEAD REGISTRANT Others in similar position Pre-Consortium Study If successful Consortium
Substances Prioritised by ECHA for Authorisation 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) Alkanes,C10-13,chloro (short chain chlorinated paraffins; SCCPs) Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified 4,4’-Diamino diphenyl methane (MDA) Bis (2-ethylhexyl) phthalate (DEHP) Benzyl butyl phthalate (BBP) and Dibutyl phthalate (DBP)
ECHA Authorisation Process ECHA consultation now open until 14 April 2009 for evidence from industry that certain uses for these substances should still be exempted from authorisation The criteria used are: Intrinsic properties (CRM, PBT, vPvB) Volumes applied Nature of Uses
Cost components of Registration phase Pre-registration service Registration service SIEF Consulting Data Big variation ECHA 1-2%10%5% 70-80%10% Oil industry: Total average cost estimate to euro/substance
Principal model for cost estimate (simplified) Some major cost factors 1.The exported volume (= data requirement) 2.Your individual data gap (= your missing data) 3.The total data gap (cost for new research) 4.Number of potential registrants sharing the cost 5.Cost sharing mechanism 6.Consortia costs 7.Echa fees 8.External service fees Data requirement (=studies) YouOther potential Registrants Total Information gap > 10X00X00 X0XX0X X0XX0X 100X00X00 0X00X0 XXXX X00X 00x00x
Conclusions – short term All substances are covered correctly and REACH compliance exists Enforcements have started and will continue to grow in activity There is not any time to be lost of your deadline is in 2010 and no consortia exists Be careful of consultant SIEF Formation Facilitators (wrong interest) Pre-consortium study Lead registrant Are intermediates relevant?
Conclusions – long term REACH is not a short term operational issue but a very stratgic one. It will effect: Future investments at plants Process changes Supply chain changes (e.g raw material quality) REACH will be a tool for competition Non-EU suppliers will be divided into compliant vs non- compliant companies with an economic effect What will happen after 2010? Will EU buyers prefer to buy from fully REACH compliant suppliers regardless of registration deadline?
Let us not repeat the pre-registration problem…not possible now…