REACH Project Aanpak Interactie Producenten - Afnemers

Transcription

1 REACH Project Aanpak Interactie Producenten - Afnemers Cor Verhart, 6 Mei 2014

2 Introduction Cor Verhart Organic Chemist, 1994 PhD Henkel, Sales Manager TNO, Product & Sales Manager, Heinz, Manager Scientific Services, EU, Turkey and senior advisor non food and consumer products (eg cosmetics, colorants) Royal Haskoning, Senior REACH Consultant Caesarion, Consultant now AkzoNobel, REACH Program Manager now

3 REACH Project REACH Project Aanpak AN: REACH general & status Typical facts Project Management & Observations (Tier-2 Project) Lessons learned Interactie Producenten Afnemers: Communicatie Documenten Praktijk en actuele zaken 3

4 REACH - EU Chemical legislation REACH-Purpose Purpose of Regulation No 1907/2006 (REACH): To ensure high level of protection of human health and environment, incl. promotion of alternative methods for assessment of hazards of substances and free circulation of substances on internal market while enhancing competitiveness and innovation. The legal status is a Regulation, not a Directive, meaning that is an EU decision that directly binds all Member States and citizens in the whole of the EU. 4

5 REACH EU - Chemical legislation REACH key elements Registration Evaluation Authorisation CHemicals REACH is about substances! 5

6 EU REACH - Chemical legislation REACH key elements (2) European Chemicals Agency (ECHA) Data sharing (vertebrate animal testing; in SIEFs, consortia) Access to information (central database) Better information up & down the supply chain (downstream users) Classification and labeling inventory (harmonisation of classification) SIEF = Substance Information Exchange Forum 6

7 REACH facts Tier-2 phase of the project (substances tons/year): Submission dossiers to ECHA (European Chemical Authorities Helsinki): Total of 9000 registrations 2900 substances 1400 registrations last week before 1 June 2013! More registrations to come? AN: > 150 registrations 7

8 EU REACH Tier 1 (> 1000 tpa), Tier 2 ( tpa) & Tier 3 (1-100 tpa) 8

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10 EU REACH = Business responsibility and joint effort of experts (team work) (s)bu coordination SIEF & consortium, financial responsibility and bookkeeping, communication, administration EXPERT SUPPORT substance identity, phys/chem, ecotox, tox, exposure and risk assessment (= content dossier) IT use/maintenance of mandatory software programs and tools LEGAL AFFAIRS legal issues OTHER archiving Project coordination and management 10

11 REACH Tier-2 for AkzoNobel press release Amsterdam, June 5, AkzoNobel announced today that it has successfully completed submission of 150 chemical substances that fall under scope of the REACH regulations (second phase) and require registration in June This phase of the registration process was co-ordinated by a dedicated group of regulatory professionals working throughout AkzoNobel who worked professionally and tirelessly throughout to meet this deadline and they should take the credit for this significant achievement said Eva Osterberg, Chairperson of the AkzoNobel REACH workgroup. 11

12 REACH Tier-2 for AkzoNobel press release link to Product Stewardship As current holder of the top position in the DJSA sustainability index AkzoNobel, in addition to ensuring compliance with REACH and all other regulations the company takes a proactive approach to Sustainability and Product Safety. We have learned from REACH and have adopted a similar approach when evaluating chemicals under our global product stewardship programs said Eva, This way we are using the latest evaluation techniques and can ensure we are consistent in our approach to substance management throughout the world. It fits perfectly with our Priority substances program which drives substitution of hazardous substances with more sustainable alternatives The AkzoNobel REACH team is now working towards the successful completion of the third REACH registration phase in June 2018 for chemicals manufactured or imported in quantities of between 1 and 100 metric tons per year. 12

13 Key Issues REACH Update Dossiers (data, information) Evaluation CoRAP Data Communication Authorisation Registry of Intensions (SVHC, Harmonised C&L, Restrictions) SVHC: CMR; PBT; Other: eg ED (Endocrine Disruptors, Sensitizers, ) CLP Regulation CLH (harmonised C&L) and ECHA CLP Platform >> E-SDS (manufacturer and DU) >> Communication Enforcement 13

14 Yearly Update Test results ready 2015! Not based on real uses and realistic tonnages; better information available on residues Threat? 14

15 Selection of substances for CoRAP list 2. Improve Test proposals Registration Dossier Evaluation Hazard information Suspected and known CMR/PBT/vPvB/sensitizerss Hormone disruptors Underlined AN criteria priority substances Exposure information Wide dispersive use Number of sites Consumer/vulnerable groups Aggregated tonnage Risk information CSR>1 Cumulative exposure structure related substances 1. Which substances may have a high ranking for CoRAP? Commission Action Rolling Plan Draft decision further information required Substance Evaluation Decision on request further information New data/ Update registration dossier 4. Which substances may follow fast track to Authorizations? 15

16 REACH Project management Observations (Tier-2) Observations and lessons learned: General - PM: PM tools available (eg websites) but no distinct or optimal use Data management scattered, not optimal Standardised ways of working available, but more WOW s needed. Archiving dossiers and studies: different methods IUCLID: sometimes challenge and complex Willingness of experts is high (cooperation, technical exchange) Unless absence real planning system planning is achieved. Cooperation central HSE BU experts can be improved KPI, monitoring REACH process for whole AN works fine >> REACH is team work 16

17 REACH Project management Observations (Tier-2) Observations and lessons learned: Technical: General high level of experts HSE, RD&I and BU s Some highlights from disciplines: Toxicology: dossiers and testing demanding, smart waiving and read across; do we have strategy for Testing and DNELs Eco-tox: promising results with EUSES model, results in more standardized way of working and template as part of adapted CSR s Exposure assessment (HH): models works fine. Bottleneck is providing the right information in time. Phys-Chem: timing for testing; preparation of good waiving arguments. General: uniformity of dossiers; sharing information 17

18 REACH Project management Looking forward Looking forward: Learn from our experience of Tier-2 Discussion of the (technical) themes; develop more robust way of workings and standards. Share the information. Ready and prepared for Tier-3 and all the REACH tasks towards 2018 REACH is teamwork, we do it together! Actual, two further topics: Assessments & Exposure Scenarios Lessons learned 18

19 Ongoing assessment Phys-chem data Operational conditions (OCs) Risk management measures (RMMs) Release estimation Exposure models Measurements Effects data Iterate Concentrations in the environment Risk characterisation Document and communicate Risks Controlled? No Yes 19

20 Finalizing an assessment Prepare Exposure Scenario which describes conditions for safe use for human health and the environment: - Operational conditions; - Risk Management Measures. (RMMs) To come to safe use and prepare a relevant exposure scenario for your own registration but also for your DUs can take a lot of time. Start on time! Human and environmental exposure should be integrated to have consistent information on the ES. 20

21 Interactie Producenten - Afnemers Relatie: Producenten: (importeurs) >> REACH dossier Registratieplicht - Informatieplicht Communicatie Producent DU: Reguliere kanalen (verkoop, etc) Formulieren (MSDS etc) Gebruik DU afnemers in kaart brengen >> ES 21

22 Interactie Producenten - Afnemers Afspraak - werkwijze: Producenten moeten afnemers (DU, MKB) helpen Documenten en know-how Ketenbenadering Informatieplicht: Reguliere kanalen (verkoop, etc) Juiste VIB s (MSDS etc) Juiste Blootstellingscenario s (esds) 22

23 Interactie Producenten - Afnemers Blootsellingsscenario s - ES: Producenten kiezen voor # gebruiken van producten Met bijbehorende blootstellingscenario s Juiste risicobeheersmaatregelen Wel / geen actieve communicatie Andere gebruiken zijn niet gedekt, tenzij afnemers nieuw gebruik overleggen en actief communiceren. DU blijft verantwoordelijk voor gebruik. >> We zijn op weg maar nog lerend... 23

24 VIB Distributeur - praktisch Toetspunten voor Distributeur bij VIB (inspectie): In Nederlandse taal? Van recente datum? Alle 16 rubrieken ingevuld? Rubriek 1: leverancier en NVIC ingevuld? Rubriek 2: staan er etiketteringselementen en zijn die conform het etiket? Rubriek 8: staan PBM s genoemd? 24

25 Interactie Producenten - Afnemers Informatie en verdere inlichtingen: Producenten Branchevereniging (VNCI FHI) Cor Verhart (c.verhart@caesarion.nl)

26 Vragen?