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Impact of REACh on non-EU industries

Korea-EU Joint Workshop Program Seoul, Dec. 3rd 2007. Impact of REACh on non-EU industries. Attorney-at-Law, Information Scientist Chemistry Stefanie Merenyi. Society for institutional analysis University of applied sciences, Darmstadt, Germany. Overview. (New) principles of REACh

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Impact of REACh on non-EU industries

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  1. Korea-EU Joint Workshop Program Seoul, Dec. 3rd 2007 Impact of REACh on non-EU industries Attorney-at-Law, Information Scientist Chemistry Stefanie Merenyi Society for institutional analysisUniversity of applied sciences, Darmstadt, Germany

  2. Overview • (New) principles of REACh • Approaches to realization • Sanctions • Need for communication • Summary: Effects on Non-EU manufactures

  3. (New) principles of REACh • No marketing of substances with unknown risks: “no data no market” Reduction of animal testing (vertebrates) “only as a last resort” • Principle of territoriality: actors must be established within the EU

  4. Approaches to realization • “no data no market” Need for knowledge of substances Need for testing of substances REACh: by means of registration (AnnexVI-XI) WHO has to register ?

  5. Approaches to realization • “no data no market” Registration obligation: Manufacturers / Importers of 1 t/a • substances on their own • substances in preparations • Substances in articles intended to be released WHEN?

  6. Approaches to realization • “no data no market” Registration obligation starts: 01. June 2008 BUT regarding the testing of Existing Substances (EINECS= European INventory of Existing Commercial Chemical Substances) DELAY is possible Transitional periods depending on tonnage and risks of the substance (max. until 01. June 2018) Only with PRE-REGISTRATION !!!

  7. Phase-in-System: transitional periods EIF of single duties, e. g. registration Only when pre-registered between 01.06. – 30.11.2008 Entry into force (EIF) in general

  8. Approaches to realization • “no data no market”: pre-registration • Care for pre-registration of existing substances • WHEN: Only 01. June – 30. November 2008 • WHERE: http://ec.europa.eu/ • FEES ? None for pre-registration but for registration later (tonnage) no registration fee 1-10 t (data complete) • WHITHOUT: no marketing until registration (testing) = no benefit from the transitional periods

  9. Approaches to realization • “no data no market”: articles Notification obligation: Producers / Importers of articles with 0,1 % w/w SVHC (1 t/a) • Substance of very high concern (e. g. carcinogenic, mutagenic, toxic reprod.) candidate list WHEN? Not before June 2011.

  10. Approaches to realization • “no data no market”: articles Regarding SVHCs in articles: Consumers may demand information on the existence / absence of SVHCs > 0,1 % w/w in articles from any supplier (“black list”) !

  11. Approaches to realization • “no data no market”: articles The Agency may require importers of articles to submit a registration if the Agency has grounds for suspecting that: (i) the substance is released from the articles, and (ii) the release of the substance from the articles presents a risk to human health or the environment. WHO is the importer ?

  12. Approaches to realization • Principle of territoriality REACh actors are established inside the EU.  Importers must be • Company / natural person based in EU • E. g. the European customers (needs to sum up all imported amounts of a substance) • Only-Representative (based in EU) • company / natural person with sufficient background (relevant tonnage per Non-EU-manufacturer)

  13. Sanctions Art. 126 REACh: Member States shall lay down the provisions on penalties  Different penalties in different Member States. • For the Non-EU Manufacturer: --- • For REACh actors inside the EU • Depending on their national legislation • Proposal in Germany: • Until 2 years of imprisonment for manufacturing / marketingwithout registration • Until 5 years of imprisonment if a severe damage is caused

  14. Need for Communication European Importer needs all relevant data for registration / notification If • Importer = European Customer Non-EU-Manufacturer has to provide data to every European customer • Importer = Only Representative Non-EU-Manufacturer has to provide data to the only representative

  15. Need for Communication How can the European Importer get all relevant data for registration / notification ? • From the Non-EU-Exporter Non-EU-Manufacturer has to know / test substance himself  Check for synergies, e.g. from Korean ECL, Toxic Chemicals List, Observational Chem. List, … ! • EU-based Importer will test the substance himself Non-EU-Manufacturer will face “effects” on his profit margin

  16. Summary:Effects on Non-EU manufactures How to proceed to export chemicals from Korea to the EU? • Contact your European Customers (Can they become the importer?) OR • Establish an Only Representative START NOW !

  17. Further information:www.merenyi.net

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