The impact of the EU REACH Regulation on the Packaging Supply Dr. - - PowerPoint PPT Presentation

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The impact of the EU REACH Regulation on the Packaging Supply Dr. - - PowerPoint PPT Presentation

Jan 03, 2023 317 likes •789 views

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

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The impact of the EU REACH Regulation

  • n the Packaging Supply
  • Dr. Hermann Onusseit

New Items for the Industry Paper 1.2

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Paper 1.2 Dr. Hermann Onusseit 2

Packaging

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Polymers

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Printing Inks

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Packaging Adhesive Applications

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Packaging Adhesive Applications

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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.

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Paper 1.2 Dr. Hermann Onusseit 8

REACH – History

White Paper 02/2001 Draft Commission proposal/internet consultation 06/2003 Official Commission proposal 10/2003 1st Parliament Reading 11/2005 1st Council Reading 07/2006 2nd Reading Parliament 13.12.2006 2nd Council Decision 18.12.2006 Adoption of the regulation (EC) No 1907/2006 REACH will enter into force on June 1, 2007

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REACH – Key Objectives

Objectives Consequences

To establish a coherent regulation

  • n the entire life cycle of

chemicals Very high complexity To reverse burden of proof from authorities to industry Every manufacturer or importer has to register all chemicals > 1t/a To introduce responsibility for downstream users to provide information on use and exposure New data requirements and communication obligations for downstream users To maintain existing restriction system and to introduce authorization procedure Substitution of hazardous chemicals will be necessary

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REACH The Regulation (EC) No 1907/2006

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Aim, Scope and Application

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Safe Use in the Entire Life Cycle

Products = Mixtures Chemicals Disposal Mixtures Articles

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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
  • f 1.2 bn €.
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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.

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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.

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Assigns Roles in the Supply Chain

Industrial Use Consumer Use Professional Use Manufacturer or Importer Downstream User

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REACH – Roles under REACH

Companies will be affected as

  • Manufacturer and importer of chemicals.
  • Downstream user of chemicals.
  • Manufacturer and importer of articles.
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REACH – Roles under REACH

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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].

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REACH – Roles under REACH

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REACH – Roles under REACH Downstream user

  • A downstream user is any natural or legal

person established within the Community

  • ther 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.

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REACH – Registration

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REACH – Registration

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REACH – Registration

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REACH – Registration

Pre-Registration

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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).

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REACH – Pre-Registration

11/2008

Pre-Registration

06/2008 06/2007

Build Up of Agency

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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.

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REACH – Pre-Registration Any legal entity in the EU

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REACH – Pre-Registration

Each European legal entity has to pre-registers and registers its substances separately

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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.

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REACH – Registration

ALL manufacturers/importers have to register each chemical

Identified uses Data on exposure of humans/environment Use Technical Dossier, Chemical Safety Report

Data requirements

Hazard Assessment

  • f Chemicals

Dossiers/Assessment M/I DU

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REACH –Registration Downstream User Obligations

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REACH – Registration Timeline

Registration 06/2018

Evaluation/Authorisation/Restriction

11/2008 11/2010 06/2013

Pre-Registration

06/2008 > 100 tons/year > 1 tons/year

Build Up of Agency

> 1000 tons/year +very hazardous chemicals Registration Registration 06/2007

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REACH – Registration

Total number of consortia: More than 17000

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REACH – Registration

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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

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REACH – Supply Chain

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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.
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REACH – Supply Chain

Timeline REACH stages Respopnsible

June 1, 2007 REACH takes effect Within 12 months set up of the Agency Pre-registration Registration (> 1000 t/a, CMR,PBT, vPvB) Registration (100- 1000 t/a) Registration (1-100 t/a) Within 18 months importer/manufacturer Within 3.5 years importer/manufacturer and downstream user Within 6 years importer/manufacturer and downstream user Within 11 years importer/manufacturer and downstream user

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REACH – Supply Chain

  • To identify relevant suppliers.
  • To request pre-registration confirmation.
  • To inform suppliers about use and exposure

and to answer supplier queries.

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REACH – Evaluation

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REACH – Authorisation

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REACH – Restriction

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The impact of the EU REACH Regulation

  • n the Packaging Supply
  • Dr. Hermann Onusseit

Thank you for your attention