reach usa 2008 socma cec how to implement a reach-proof system in a company!.. evonik degussa gmbh...

REACH USA 2008SOCMA CEC

How to Implement a REACH-Proof System in a Company!

..

Evonik Degussa GmbH

Shaun Clancy

Friday 16 May 2008

RAPRA Boston Volker Soballa 2008 Seite | 2

About Evonik Degussa GmbH

As an industrial group with three business sectors.

Evonik is a new name announced on September 12, 2007

Evonik Industries

Chemicals

Real EstateEnergy

2006 sales: €10,1 billionEmployees: about 32000

2006 sales: €2,6 billionEmployees: about 4600

2006 sales: €0,4 billionEmployees: About 500


Elements of REACH: Scope (2)

STRUCTURE

Elements of REACH (scope, R&D, articles)

Time frame

Roles under REACH

Evonik Degussa´s REACH Project

Implementing REACH

Where do we stand today?

Useful helpdesks


What means REACH?

REGISTRATION

EVALUATION

AUTHORISATION and RESTRICTION of

CHEMICALS



Scope:

REACH is valid for all substances, being manufactured or imported in

amounts exceeding 1 ton/year

BUT:

Completely exempt from REACH:

•Radioactive substances

•Non-isolated intermediates

•Substances under customs control

•Waste (according to 75/442/EC)

•Subject to transportation regulation

•Defence



Scope:

Exempt only from registration, evaluation and information duties:

•Annex IV: e.g.: water, starch, vitamin A, glucose….

•Annex V: e.g.: by-products, hydrates, natural substances……

•Polymers (from registration and evaluation, not from authorisation!)

•Re-imported, already registered substances

•Substances already regulated (e.g. Medical products, foodstuff,

Biocides, feedstuff….)


Elements of REACH: R&D

Special exemptions for R&D-substances

Substances of product- and process oriented R&D are exemptedfor a period of 5 years.

The Agency may extend the five-year exemption by a further maximum of five years (5+5).

The manufacturer/importer shall notify the Agency of some basic information (manufacturer, substance identity, C&L, amount, customer)


Elements of REACH: Articles

Articles

Substances in articles have to be registered only if:

- The substance in the article exceeds 1 metric ton/year per manufacturer and

- The substance is intended to be released under normal or foreseeable conditions

cartridge

mobile

tyre

pen

No intended release intended release


REACH-Time frame (pre-registration, registration)

Registration: CMR 1+2; R 50/53 > 100 mt/a; Substances > 1,000 mt/a

Registration: Substances 100 - 1,000 mt/a

+ 12 months: Start of pre-registration/registration period

End of pre-registration period

+ 3,5 years:

+ 6 years:

+ 11 years: Registration: Substances 1 - 100 mt/a

+ 18 months:

Pre-registration required for utilizing the transition periods for phase-in substances

Start of transition periods for registration of pre-registered substances (Art. 21)

1 June 2007


2009 2010 2011 2012 2013 2014 2015 2016 20172007 2008 2018

Registration acc. REACH (incl. evaluation + authorisation)

Subsequent requirements

3,5 years

11 years

6 years

5 years (+ 5 years prolongation possible)

ChemG

Transition period

Authorisation

Pre-registration of phase-in-substances

Registration of phase-in-substances

Inventory of Classification & labelling ofSubstances placed on the market

• substances >1000 t/a substances R50/R53 and >100 t/a CMR, categories 1 and 2, >1 t/a

• substances >100 – 1000 t/a

• substances 1 – 100 t/a

Registration of non-phase-in-substances

01.06.07 – REACHeffective

01.06.08 – opening of Europ. Chemicals Agency

Dossier evaluation by the Agency

30.11.08 - end of pre-registration

31.05.09 - presentation of Candidate list (every 2 years)

Registration of R&D-substances

Time frame of REACH (all parts)

missing pre-registration means registration as Non-Phase-in-substance

0,5 years


Registrant: Means the manufacturer or the importer of a substance or the

Manufacturer or importer of an article submitting a registration for a substance.

Manufacturer: Means any natural or legal person established within the

Community who manufactures a substance within the EU.

Importer: Means any natural or legal person established within the EU who is

responsible for import of substances into the EU.

Downstream user: Means any natural or legal person established within the EU,

other than the manufacturer or the importer, who uses a substance, either on its own or in

a preparation in the course of his industrial or professional activities.

- Distributor: Distributor is not a downstream user.

- Consumer: Consumer is not a downstream user.

- Re-importer: Re-importer is a downstream user.

.

Roles under REACH (1)


Import: Means the physical introduction into the customs

territory of the EU.

Who is an importer?

This definition is still under discussion! Some explanation:

Importer is the entity that pays the import duties (to be discussed). Please note

that the person responsible for the physical introduction into the EU customs

territory is not necessarily the person responsible for the customs clearance.

The responsibility for import depends on many factors such as who orders,

who pays, who is dealing with the customs formalities, but this might not be

conclusive on its own.

Possibility of using an Only Representative (OR). This option provided for in

Art 8 will be very relevant for multinational companies with major production

sites outside the EU.

Roles under REACH (2)


Steering Committee•Board/Head of ESHQ

Evonik Degussa´s REACH – Project

• Overall project coordination

• Central monitoring (pre-registration data, Group-wide processing status)

• Communication: current status of implementation (nat./internat. associations)

• Management of REACH Implementation Working Group

• Support for subgroups

• Definition and controlling of milestones

• Inclusion of Regions, Procurement, and Marketing

• Development of approaches and proposals

• SG1: Substance identification, checklists, data requirements

• SG2: Standard dossiers, CSR, exposure scenarios, categories

• SG3: Questionnaires, training, procurement, raw materials, authorization letters

• SG4: Establishment of consortia (agreements), preparation of SIEF

• SG5: System environment, IUCLID. REACH-IT, SuRe, data recording, volume

• Sponsoring

Tasks and responsibilities

Project team

•Degussa Corporate ESHQ

REACH Implementation Working Group

5 Subgroups (SG)

SG

1:

Pre

-reg

istr

ati

on

SG

2:

Evalu

ati

on

SG

3:

Com

mu

nic

ati

on

SG

4:

Con

sort

ia

SG

5:

IT T

ools

• Coordination and decision-making body for all REACH-relevant questions

• Determination of joint approaches

• Interpretation of the REACH Regulation (clearing)

• Harmonization of decentralized activities (to avoid duplication of work)

Authorized officers of the business units

(primarily product safety), IT, LI, PR …

ObjectivesPreparation, organization, tools, cost, clearinghouse, technical questions

Business Units


Evonik Degussa´s REACH - Project

Degussa REACH Implementation Working Group (assigned Jan/2006)

REACH Subgroups (assigned Nov. 2006)

Pre-registration Evaluation Communication Consortia IT tools

Pre-registration Risk assessment Procurement (checklist)

Data sharing Internal IT (SuRe, EH&S etc.)

Checklist (for Product safety)

Registration dossier

Marketing, sales Costs of studies, values

Degussa REACH-Base

Substance identification

Form of CSR (standard)

Survey, questionnaires

Competitors, contracts

Volume thresholds (SVT)

IT (Agency) CSR, ES, UEC.. Training (intern. customers..)

Contacts, letter of acc.

REACH IT (Agency)

Flyer/Letter Authorization Standardization SIEF prep. IUCLID 5


Implementing REACH (1)

Compile an inventory of all substances and preparations that the company handles (CAS, EINECS)

Product Intermediate (“On site”): simple registration (name, company, C&L,

available data, no tests) Intermediate (“transported”): simple registration, under strictly

controlled conditions, beginning with quantities of 1,000 metric tons/year: Annex VII necessary

Polymers (Register monomers!, clarify whether PBT, vPvB) Break preparations down into their individual substances Raw materials as manufacturer, importer, user (break down

according to purchased within the EU, outside the EU) Assign the names/addresses of customers/suppliers to all substances

(important for communication in the supply chain) Assign substances to the tonnage bands (observe deadlines;

“distribute” quantities, if needed) Assign applications (own use, customer)

1st Action: Inventory (done)



Degussa Database

Registration Substances

- Substance name, LE- Registration data

Pre-registration substances

- Substance name, LE- Little data

Substance Registration Decisions

- Substance name, LE-Decision data (generally, not in IUCLID 5) - cost planning

Management Data

- Substance checklists- Endpoint status- Endpoint costs

Front End (Access, Web) IUCLID5 Front End

Evaluations (e.g., Excel, Access, Web)

IUCLID5Add on

Add onAdd on

Pre-registrationRegistration

2st Action: Develop IT (in progress)



1. Step: Questionnaires (supplier), e.g. Cefic-portal “REACH-LINK”), own IT-Portal

2. Step: Questionnaires (customer), e.g. Cefic-portal “REACH-LINK”), own IT-Portal

Additional limit values, requirements etc.: • DNEL (Derived No Effect Level)• PNEC (predicted no effect concentration) (

http://chimie.ineris.fr/en/index.php/)• PEC (predicted effect concentation) (PEC/PNEC <1)• Exposure scenarios (RIP 3.2-2)• Use and exposure categories (UEC) • Wastewater, water treatment plant

Extended safety data sheets (eSDS)• For the present, change the order of Chapters 2 and 3, and

provide e-mail address. Later, the data listed above.• Necessary to modify all SDS since June 1? No:

3th Action: Information in the Supply Chain



ConclusionThe Chair of Commission Working Group (CWG) concluded that there was consensus that the content, not the format, of the SDS is the priority for the enforcement and that the changes required by REACH; that is, the changed order of Chapters 2 and 3 and the addition of the e-mail address can be introduced when (substantial) changes/updates are made of the SDS. A substantial change could be classification according to GHS or the addition of exposure scenarios. The changes required by REACH should be introduced, however, before the first deadline for registration on December 1, 2010.



Pre-registration All substances in quantities > 1 metric ton/year that will be

manufactured/imported in the future (in 11 years), including intermediates

EINECS substances (substances currently manufactured and imported)

Substances that are manufactured in the EU, but have not been marketed in the 15 years prior to REACH (e.g. intermediates, export products, R&D)

No-longer polymers (NLP) Monomers being part of polymers Substances manufactured and imported earlier (this includes all

substances that could possibly be “revived” again) -> better too many than too few!

Substances from preparations (information from suppliers, check quantities: 0.1% = 1 metric ton of 1,000 metric tons)

All legal entities (LE) within a company must pre-register! Pre-register all strategic or critical raw materials!

4nd Action: Pre-registration



Registration for phase-in substances is staggered.

Phase 1: (Jun. 2008 – Dec. 2010) Substances in quantities > 1,000 metric tons/year CMR substances in quantities > 1 metric ton/year Substances that are extremely toxic to aquatic organisms

and are produced in quantities > 100 metric tons/year

Phase 2: (Jun. 2008 – Jun. 2013) Substances in quantities > 100 metric tons/year

Phase 3: (Jun. 2008 – Jun. 2018) Substances in quantities > 1 metric ton/year

5th Action: Registration


REACH completely changes the situation for manufacturer and importer

Same data requirement for existing and new substances

In principle, substances > 1 to/year do need:

-pre-registration

-registration (dossier) per Legal Entity

-authorisation (in some cases)

-Depending on tonnage band, distinct data (toxicological, eco-toxicological,

physical-chemical) are required

-Uses must be identified and registered per Legal Entity

-Exposure scenarios must be prepared

-Chemical Safety report must be prepared

-Communication with suppliers and customers must be intensified

-The SDS must be extended (eSDS), e.g. use and exposure categories/exposure

scenarios, uses,

Where do we stand today (1)


Define your role under REACH

Check, whether you bring substances in amounts > 1to/year into the EU

Check, whether any exemption might be applicable

Seek a partner within the EU (e.g. Only Representative), who will fulfil all

requirements of REACH, e.g. pre-registration, registration dossier, risk

assessment, Chemical Safety Report (CSR), extended Safety Data Sheet,

tracking of amounts brought to EU market etc.

Prepare a registration dossier and use the official IT-tool IUCLID 5

Use the pre-registration phase properly (transition periods!)

Where do we stand today (2)

That means: You as manufacturers from outside the EU have the same duties as manufacturers from inside the EU. Therefore you need to:


BAuA (Federal Institute for Occupational Safety and Health

www.reach-helpdesk.de

Cefic (European Chemical Industry Council)

www.reachcentrum.org

BDI (German Industry Association):

www.reach.bdi.info/

IUCLID 5 program (for preparation of registration dossier)

http://ecbwbiu5.jrc.it/

ECHA (European Chemicals Agency)

http://echa.europa.eu/

Useful helpdesks


Contact:Volker J. Soballa

[email protected]


Thank you very much for your attention!

reach usa 2008 socma cec how to implement a reach-proof system in a company!.. evonik degussa gmbh...

Documents

reach usa

reachproof system

mta substances

phasein substances

natural substances polymers

evonik degussa gmbhas

transition periods

substance identity