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

2 Stefanie Merenyi Overview I. (New) principles of REACh II. Approaches to realization III. Sanctions IV. Need for communication V. Summary: Effects on Non-EU manufactures

3 Stefanie Merenyi I.(New) principles of REACh 1. No marketing of substances with unknown risks: “no data no market” Reduction of animal testing (vertebrates) “only as a last resort” 2. Principle of territoriality: actors must be established within the EU

4 Stefanie Merenyi II.Approaches to realization 1. “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 Stefanie Merenyi II.Approaches to realization 1. “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 Stefanie Merenyi II.Approaches to realization 1. “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 Stefanie Merenyi Only when pre-registered between – Phase-in-System: transitional periods Entry into force (EIF) in general EIF of single duties, e. g. registration

8 Stefanie Merenyi II.Approaches to realization 1. “no data no market”: pre-registration  Care for pre-registration of existing substances  WHEN: Only 01. June – 30. November 2008  WHERE:  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 Stefanie Merenyi II.Approaches to realization 1. “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 Stefanie Merenyi II.Approaches to realization 1. “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 Stefanie Merenyi II.Approaches to realization 1. “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 Stefanie Merenyi II.Approaches to realization 2. 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 Stefanie Merenyi III.Sanctions Art. 126 REACh: Member States shall lay down the provisions on penalties  Different penalties in different Member States. 1. 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 / marketing without registration Until 5 years of imprisonment if a severe damage is caused

14 Stefanie Merenyi IV.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 Stefanie Merenyi IV.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 Stefanie Merenyi V.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 !

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