The impact of the EU REACH Regulation on the Packaging Supply Dr. Hermann Onusseit New Items for the Industry Paper 1.2
Packaging Paper 1.2 Dr. Hermann Onusseit 2
Polymers Paper 1.2 Dr. Hermann Onusseit 3
Printing Inks Paper 1.2 Dr. Hermann Onusseit 4
Packaging Adhesive Applications Paper 1.2 Dr. Hermann Onusseit 5
Packaging Adhesive Applications Paper 1.2 Dr. Hermann Onusseit 6
REACH – Motivation • REACH: Registration, Evaluation, Authorization and Restriction of Chemicals (on their own or in mixtures). • Reasons for the REACH proposal were insufficient data on chemicals and very slow progress in risk assessments for high production volume chemicals. • Main goal was improved protection of human health and the environment. Paper 1.2 Dr. Hermann Onusseit 7
REACH – History White Paper 02/2001 Draft Commission proposal/internet consultation 06/2003 Official Commission proposal 10/2003 1 st Parliament Reading 11/2005 1 st Council Reading 07/2006 2 nd Reading Parliament 13.12.2006 2 nd Council Decision 18.12.2006 Adoption of the regulation (EC) No 1907/2006 REACH will enter into force on June 1, 2007 Paper 1.2 Dr. Hermann Onusseit 8
REACH – Key Objectives Objectives Consequences To establish a coherent regulation Very high complexity on the entire life cycle of chemicals To reverse burden of proof from Every manufacturer or importer authorities to industry has to register all chemicals > 1t/a To introduce responsibility for New data requirements and downstream users to provide communication obligations for information on use and exposure downstream users To maintain existing restriction Substitution of hazardous system and to introduce chemicals will be necessary authorization procedure Paper 1.2 Dr. Hermann Onusseit 9
REACH The Regulation (EC) No 1907/2006 Paper 1.2 Dr. Hermann Onusseit 10
Aim, Scope and Application Paper 1.2 Dr. Hermann Onusseit 11
Safe Use in the Entire Life Cycle Products = Mixtures Chemicals Disposal Mixtures Articles Paper 1.2 Dr. Hermann Onusseit 12
REACH – Dimensions REACH is the most ambitious regulation on EU level • 140 paragraphs and 17 annexes on > 800 pages. • Approximately 20.000 pages of technical guidance are expected. • About 30.000 chemicals have to be registered. • Estimated 27.000 companies have to register their chemicals. • The new agency (ECHA):> 400 employees with costs of 1.2 bn €. Paper 1.2 Dr. Hermann Onusseit 13
REACH – Dimensions REACH is the most ambitious regulation on EU level • Total costs are estimated to be 2.8 bn € to 5.2 bn € in the EU. • These costs are mainly for testing. • Cost to downstream users: 0,5 bn € to 1.3 bn €. • Cost could rise to 1,7 bn € to 2.9 bn € for substitution costs. • Withdrawal of 2-8 % of the substances currently on the market. Paper 1.2 Dr. Hermann Onusseit 14
REACH – Dimensions REACH is the most ambitious regulation on EU level • About 40 old regulations in the current chemical control system of the European Union would be replaced or consolidated by the REACH regulation. • No distinguishing between so-called “existing” and “new” chemicals, based on the cut-off date of 1981. One single system for all chemical substances. Paper 1.2 Dr. Hermann Onusseit 15
Assigns Roles in the Supply Chain Industrial Use Professional Use Manufacturer or Downstream Importer User Paper 1.2 Dr. Hermann Onusseit 16 Consumer Use
REACH – Roles under REACH Companies will be affected as • Manufacturer and importer of chemicals. • Downstream user of chemicals. • Manufacturer and importer of articles. Paper 1.2 Dr. Hermann Onusseit 17
REACH – Roles under REACH Paper 1.2 Dr. Hermann Onusseit 18
REACH – Roles under REACH Manufacturer/Importer • Manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community. • Importer means any natural or legal person established within the Community who is responsible for import. [of substances from non-EU Countries]. Paper 1.2 Dr. Hermann Onusseit 19
REACH – Roles under REACH Paper 1.2 Dr. Hermann Onusseit 20
REACH – Roles under REACH Downstream user • A downstream user is any natural or legal person established within the Community other than the manufacturer or importer who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. Paper 1.2 Dr. Hermann Onusseit 21
REACH – Registration Paper 1.2 Dr. Hermann Onusseit 22
REACH – Registration Paper 1.2 Dr. Hermann Onusseit 23
REACH – Registration Paper 1.2 Dr. Hermann Onusseit 24
REACH – Registration Pre-Registration Paper 1.2 Dr. Hermann Onusseit 25
REACH – Pre-Registration • Manufacturer and importer of chemicals –To pre-register and register chemicals manufactured in or imported into the EU (> 1t/a). –This applies to chemicals on their own, in mixtures and in articles (under special conditions). Paper 1.2 Dr. Hermann Onusseit 26
27 REACH – Pre-Registration Paper 1.2 Dr. Hermann Onusseit 11/2008 Pre-Registration 06/2008 Build Up of Agency 06/2007
REACH – Pre-Registration • Tracking of volume of imported and produced chemicals. • Pre-registration of relevant substances to be concluded by 30 November 2008. • Substances not pre-registered have to be withdrawn from the market! (1 December 2008) • Annual report of relevant substances from 2008 on. Paper 1.2 Dr. Hermann Onusseit 28
REACH – Pre-Registration Any legal entity in the EU Paper 1.2 Dr. Hermann Onusseit 29
REACH – Pre-Registration Each European legal entity has to pre-registers and registers its substances separately Paper 1.2 Dr. Hermann Onusseit 30
REACH – Pre-Registration • Manufacturer and importer of chemicals –To pre-register and register chemicals manufactured in or imported into the EU (> 1t/a). –This applies to chemicals on their own, in mixtures and in articles (under special conditions). –Failure to pre-register (register) = chemical cannot be manufactured, imported, or used in the EU. Paper 1.2 Dr. Hermann Onusseit 31
REACH – Registration ALL manufacturers/importers have to register each chemical Identified Data requirements uses Dossiers/Assessment Use M/I DU Hazard Assessment Data on exposure of of Chemicals humans/environment Technical Dossier, Chemical Safety Report Paper 1.2 Dr. Hermann Onusseit 32
REACH –Registration Downstream User Obligations Paper 1.2 Dr. Hermann Onusseit 33
REACH – Registration Timeline Registration > 1000 tons/year +very hazardous chemicals Build Up of Agency Pre-Registration Registration > 100 tons/year Registration > 1 tons/year Evaluation/Authorisation/Restriction 06/2018 06/2007 06/2008 11/2008 11/2010 06/2013 Paper 1.2 Dr. Hermann Onusseit 34
REACH – Registration Total number of consortia: More than 17000 Paper 1.2 Dr. Hermann Onusseit 35
REACH – Registration Paper 1.2 Dr. Hermann Onusseit 36
REACH – Supply Chain • Downstream user of chemicals –To ensure that use and exposure conditions of the chemical are in compliance with the use and exposure conditions registered by the manufacturer or importer Paper 1.2 Dr. Hermann Onusseit 37
REACH – Supply Chain Paper 1.2 Dr. Hermann Onusseit 38
REACH – Supply Chain • To define use and exposure categories for safe handling and use of chemical substances at site and in products. • To document use and exposure. Paper 1.2 Dr. Hermann Onusseit 39
REACH – Supply Chain Timeline REACH stages Respopnsible June 1, 2007 REACH takes effect Within 12 set up of the Agency months Within 18 Pre-registration importer/manufacturer months Within 3.5 years Registration (> 1000 t/a, importer/manufacturer CMR,PBT, vPvB) and downstream user Within 6 years Registration (100- 1000 t/a) importer/manufacturer and downstream user Within 11 years Registration (1-100 t/a) importer/manufacturer and downstream user Paper 1.2 Dr. Hermann Onusseit 40
REACH – Supply Chain • To identify relevant suppliers. • To request pre-registration confirmation. • To inform suppliers about use and exposure and to answer supplier queries. Paper 1.2 Dr. Hermann Onusseit 41
REACH – Evaluation Paper 1.2 Dr. Hermann Onusseit 42
REACH – Authorisation Paper 1.2 Dr. Hermann Onusseit 43
REACH – Restriction Paper 1.2 Dr. Hermann Onusseit 44
The impact of the EU REACH Regulation on the Packaging Supply Dr. Hermann Onusseit Thank you for your attention
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