REACH Registration - the next (big) hurdle

Keven Harlow: www.mn-consortium.org REACH registration: the next (big) hurdle Dr Keven Harlow: Manganese REACH Consortium, Paris.

Presentation overview: REACH: a very brief recap; Pre-registration update; Next steps for potential registrants; Enforcement: some obligations; Tips and experiences; What’s next? Keven Harlow: www.mn-consortium.org

REACH in brief: REACH is not only about chemicals! ….driven by substances, including metals; EU Regulation effective from June 2007; New Chemicals Agency (ECHA) in Helsinki; Affects each EU legal entity that manufacturers or imports any substance at ≥1tpa; Various registration deadlines: first is 30 Nov ‘10 You must register to keep in business. Keven Harlow: www.mn-consortium.org

Registration overview: >1,000 tpa, CMR >1tpa R50/53>100 tpa 100-1,000 tpa 1-100 tpa Most metals start Keven Harlow: www.mn-consortium.org

REACH pre-registration update: Pre-registration closed 1 Dec 2008; Total ~2.7million pre-registrations! 65,000 companies; 146,000 substances… Mn-based substances: - 5,660 pre-registrations, including - 3,350 for Mn alone … and many precautionary pre-registrations from the confused, misguided, commercial Many huge SIEFs*(communication challenge). * substance information exchange fora Keven Harlow: www.mn-consortium.org

Pre-registration: June-Dec 2008 Keven Harlow: www.mn-consortium.org

Current situation: Without pre-registration an EU-based importer or manufacturer must cease trading until a registration is submitted; SIEFs are forming – but very slowly; REACH is a low, or lower, priority for many businesses due to early 2009 trading conditions; Without the backing of a consortium or trade association there are enormous challenges for those ≥1,000tpa (2010) substances. Keven Harlow: www.mn-consortium.org

Next steps: potential registrants Remember, pre-registration only buys time - REGISTRATION is vital to continue business; First registration deadline is next year; YOU must register. Start to prepare and plan: - resources (who? when? how?) - skills and knowledge (eg IUCLID 5) - registration information/data and costs - budget ECHA’s registration fees; Enforcement has already started! Keven Harlow: www.mn-consortium.org

Budget your ECHA fees! Joint-submission 2010,>1000tpa = €23,250 (less for SME companies). Fee payable per substance , per legal entity eg: ferroalloys FeX, FeY, FeZ as preparations Fe-contained >1,000 tpa (2010) X-contained >1,000 tpa (2010) Y-contained >1,000 tpa (2010) Z-contained >1,000 tpa (2010) ECHA registration fee : € 93,000 / legal entity This is (usually) not covered by consortia fees. Keven Harlow: www.mn-consortium.org

Fantasy vs Fact in REACH: I’ve pre-registered so I can relax and do nothing. No-one has contacted me to form a SIEF so I’m safe. I want to be ‘passive’ to save money and effort. The lead registrant will do everything for me. The LR will register for me. Guidance says I’m right. REACH stops with registration A SIEF must be formed, data exchanged, C&L + LR agreed. Your obligation to form a SIEF. All potential registrants must be either active or very active. The LR only has to submit to ECHA the SIEF’s joint dossier. No, you must register. The REACH legal text must say you’re right. Be vigilant of necessary updates to your registration. Fantasy Fact Keven Harlow: www.mn-consortium.org

Brak danych, brak obrotu Zonder gegevens geen handel Ebda data, ebda suq Adatok hiányában a forgalomba hozatal tilalma Ja nav datu, nav tirgus Commercializzazione solo previa disponibilità dei dati Pas de données, pas de marché Απαγόρευση μη καταχωρισμένων ουσιών Puuduvad andmed, puudub turg Ohne Daten kein Markt Ingen data, intet marked Zákaz uvádění na trh bez údajů Brez podatkov ni trga Inga data, ingen marknad Žiadne údaje, žiadny trh Ei tietoja, ei markkinoita No data, no market Keven Harlow: www.mn-consortium.org

Enforcement: some obligations EU manufacturers/importers/Only Reps must pre-/register each substance at ≥1 tpa (Title II, Articles 6, 18); Obligation to communicate down/up the supply chain any new information on the substance (Articles 32, 33, 34…); Each M, I, DU and distributor must keep available all the information required to carry out his REACH duties for at least 10 years (Article 36) ; Obligation to submit compliance evidence to Member States/ECHA if requested (Article 36) ; Update individual registration; status, tonnage, risk profile, cessation of activities etc (Article 22). … other obligations, too. Keven Harlow: www.mn-consortium.org

Enforcement consequences:  Business stopped or interrupted;  Penalties for evasion (financial, imprisonment);  Cost associated with making good (legal)  Supply chain disruption: - liability/compensation claims; - loss of market / market share; - loss of competitive advantage; - loss of reputation; - opportunities for competitors /new entrants. Keven Harlow: www.mn-consortium.org

Tips and experiences: Maintain REACH at a high level in your organisation, re-build momentum, plan and prepare; Check your pre-registration details and keep your REACH-IT (ECHA) information current; Assemble good, auditable records of your REACH compliance actions/decisions and keep for 10 years; Introduce procedures to manage, communicate, update and retain your substance information; Budget your 2010 registration needs: - your data costs for joint-submission; - your registration fee to ECHA. Keep going, REACH will not disappear! Keven Harlow: www.mn-consortium.org

What’s next? Quite simply, ever-increasing regulation and the desire for global chemicals management: GHS: Globally Harmonised System (worldwide) CLP: Classification/Labelling/Packaging (EU) ChAMP: Chemical Assessment and Management Program ( USA) TSCA: Toxic Substance Control Act (Canada) CSCL: Chemical Substance Control Law (Japan) TCCA: Toxic Chemicals Control Act (Korea) NCRS: New chemical registration regulation (China) TCR: Turkish Chemical Regulation Others? Keven Harlow: www.mn-consortium.org

Key conclusions: Register! You could lose the EU market if you do not meet your REACH obligations. Penalties (severe) for those that try to evade REACH. Think 3-P’s: - Participate in each SIEF, communicate and co-operate; - Plan your registration needs, e.g. data, skills, timing; - Prepare : train staff, budget, record, inform customers. REACH is one more step towards ever-increasing and global control of chemicals. Competitive advantage will be available to those organisations that anticipate, plan and use best practice for chemicals management. Keven Harlow: www.mn-consortium.org

Thank you … and good luck! Dr K Harlow Manganese REACH Consortium (MARA), Paris Keven Harlow: www.mn-consortium.org

REACH Registration - the next (big) hurdle

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