Staying on the REACH Road: Consultancy Support

Staying on the REACH Road: Consultancy Support

Raluca POPESCU-ERDMANN

On the REACH Road – The 5th Anniversary of REACH23-24 November 2011, Warsaw, Poland

This is me

BackgroundEnvironmental Engineer2003 Romanian Environmental Inspectorate2007 Austrian Federal Environmetal Agency (UBA)2007 ECHA2010 UMCO

Internal focusREACHInternational Cooperation

Thematic areasREACH legal issuesConsortia managementPartnerships

Raluca POPESCU-ERDMANNREACH Team

REACH Road My REACH Road

2010: 1st registration deadline

2007: entry into operation

2006: publication in OJ

2003: 1st public consultation

2001: White Paper

2003 Env. Insp.(RO)

2007UBA / EPA(AT)

2007ECHA

(FI)

2010 UMCO

Content

1. UMCO

2. Our Experience with REACH

2010 Registration Deadline

SIEFs

SMEs

Impact Outside EU

Content

1. UMCO


Facts

Foundation 1982 within the chemical industry

Sites Hamburg and Köln-Leichlingen, Germany

Shareholders Peter Duschek, Ulf Ch. Inzelmann, Hubert Oldenburg

Employees 37 (33 in Hamburg)

Clients Around 1000 companies along the chemical supply-chain, situated in Germany and worldwide

Sectors Chemical and pharmaceutical industryTrade, logistics and warehousesCompanies using chemicals

History

Foundation as Spin-Off of a medium sized coating and paint factory in Hamburg

Management Buy-Out , separation from office in Magdeburg

Focus on environmental services

Staring point of services around German Immission lrequirements and major accidents ordinance (BImSchG/TA Luft/StörfallV)

European project on REACH

Foundation office Magdeburg

Start of UMCO Compliance Solution (Software)

IT-network version for compilation of safety data sheets

24-hours emergency number "GlobalChem24" and starting point for seminar/workshop services

First IT-solution for large scale compilation of safety data sheets

Inauguration of the UMCO site in Köln

1982 1985 1987 1990 1991 1996 1997 2001 2004 2005 2008

Your situation

Regulations, acts and ordinances

Liabilities

EU-regulations

UN recommendations

Requirements and conditions

Client-audits and restrictions

Sector requirements

Public opinion

Supplier examination

Responsible Care

Developement Acquisition ProductionStorage and distribution

DistributionTransport

Review of requirements, examination and assessment of risks

Risc minimisation, assicuration of legal compliance

Definition of compliance cycle and system developement

Certification, audits, general support and supervision

Our services – All in one hand

Chemical management

REACH SHE-Management Dangerousgoods

Emergency service

Acquisition

Developement

Acquisition

Developement

Storage/distribution

Production

Storage/distribution

Production

Distribution/transport

Partnershpis

Organisations

The multi-dimensional UMCO network

REACH - Consultancy - Network

Horizontal and vertical extensions

Regional expansions Interdisciplinar

REACH

Management of the registration process

Strategic advice

Dossier compilation and submission

SIEF- and consortium management

Communication in the supply chain

Developement of strategies for communication with suppliers and customers

Implementation of exposure scenarios in the operational practice

Advice and consultation on substances of very high concern in articles

Seminars and workshops

UMCO REACH Clients

Manufacturers, importers, recyclers, formulators, re-sellers

Large companies, SMEs

EU, multinational, non-EU

Lead and non-lead registrants

Individual companies, consortia

Wide range of industries: from petrochemical to astronautics

Content

1. UMCO



UMCO experience

High number of late requests for support

SIEF* communication: high volume of information: we developed our own IT tool to handle the data

sometimes chaotic

The conditions for buying LoAs** were easily accepted

REACH understanding is good within large companies, but low for SMEs

REACH IT worked well

*SIEF = Substance Information Exchange Forum**LoA = Letter of Access


UMCO

Over 150 registrations

Registration management for 9 lead registrants

Secretariat of the Selenium & Tellurium REACH Consortium

→ First obstacle successfully passed!

SIEFs – Legal Arrangements

Mechanism

SIEF agreement Liabilities

Confidentiality

Data & Cost sharing principles

LR* (formal appointment)

Ownership rights

Jurisdiction

Access to the lead dossier via Letter of Access (LoA) upon Signing of the SIEF agreement

Payment

* LR = Lead Registrant


Available Guidance

ECHA: not involved, very limited advise

some guidance within the Draft Guidance on Data Sharing

Cefic SIEF management

Model for SIEF agreement

Cost and data sharing

Compliance with competition rules


Practice

SIEF agreements: vast majority according to Cefic model (by experience)

Recommendations for LR / consortia

Use Cefic model for SIEF agreements Known and widely accepted

Save resources (LR / consortia and non-lead members)

Validity date beyond the last registration deadline (31 May 2018) Article 29, REACH: SIEF shall be operational until 1 June 2018

but post-registration obligations

SIEFs – Cost Sharing

REACH: Article 27(3)

Registrants “shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way. (...)

Registrants are only required to share in the costs of information that they arerequired to submit to satisfy their registration requirements”

ECHA Guidance on Data Sharing: Section 7.4.

"(...) companies cannot be forced to pay for studies that they do not need and they also cannot be forced to pay before they actually need them in their respective tonnage band.“

SIEFs – Data / Cost Sharing Disputes

Before 2010 Deadline

Few data sharing disputes (UMCO:

2 cases, both settled)

No serious cost sharing disputes (by experience)

Little experience

Time pressure

Large companies

After 2010 Deadline

No concerns for data sharing disputes for now (UMCO: no case)

Already some cost sharing disputes

Expect more cost sharing disputes

SIEFs – Cost Sharing Disputes

Difficulties

Costs are not transparent enough Often, the cost sharing mechanism is clear, but the actual costs are not explained

Sometimes, the costs are provided to the SIEF members only on request and only own costs are given

→ Cost sharing might be fair - clarifications could close the dispute

“Fairness” is not legally defined and has a wide interpretation Principles known and not accepted by one party (non-lead member)

→ Can generate long, unproductive discussions

SIEFs – Cost Sharing Disputes

Example: - LoA in 2010: 35.000 Euro

- LoA in 2013: 42.000 Euro

- LoA in 2018: 49.000 Euro

Consortium UMCOdata requirements similar for all tonnage bands - same price for all

acceptable

7.000 € added per tonnage band to:-attract early payments

-compensate further administrative costs

unfair-registrants are pushed to pay well before they need to register; -administrative costs should be equally divided (balance in 2018)

data provided: total registration costs not transparent- high costs (not a hazardous substance, well known substance - data available in literature, big SIEF) and requested details – not provided

disproportionatecompanies with the lowest tonnage are the biggest contributors

SIEFs – Cost Sharing

Recommendations

Check cost sharing principles and ask for explanations if not clear

If not sure, ask for a second opinion (e.g. consultant)

If disagreement, engage a lawyer (e.g. communication to LR / consortium)

Consider / propose mediation by a neutral party

Document all communication with LR / consortium

If agreement / compromise cannot be reached, find alternative:

Opt out partly:

→ develop own dossier and ask ECHA for access to studies involving tests on animals

→ announce the SIEF of your dispute and intention to opt out

Opt out completely (not recommended, only if good justification and as a last resort)

SMEs

Main difficulties

less knowledge and experience

lack of resources

Support

within SIEFs (e.g. initiative, work and instructions by LR)

consultants (e.g. strategy, knowledge, actual work)

REACH if compliant with SME definition

(Commission Recommendation 2003/361/EC)

if can justify (documents)

SMEs Status – ECHA Verifications

Documents requested (clarified with German and ECHA Helpdesks)

Ownership structure of the enterprise

Certificate / information showing the composition of headcount

Copies of (consolidated) official annual financial accounts

Administrative fee

Support for our clients

no UMCO service, only facilitator

external financial expert involved by UMCO further clarifications on documents needed

evaluation of company size (certificate)

workflow established

Company Large Medium Small Micro

Fee (Euro) 20.700 14.500 8.300 2.070

REACH Impact Outside EU

Trade

Imports into EU - non-EU manufacturers: must provide information to EU clients

get involved in REACH processes to protect business and support EU clients

(OR appointment, contribution to registration)

Exports from EU more data available

costs include REACH compliance efforts

Legislative systems

REACH like In countries that prepare for EU membership – Turkey and Serbia

In other countries: e.g. China, Korea, Taiwan

Recognition of REACH registrations: e.g. Philippines

Objective

Ensure compliance solutions for a safe worldwide distribution of chemical substances and their usage

How?

Partners (bilateral cooperation)

Global Chemical Consultant Network

http://www.gcc-network.org/

UMCO International Cooperation

The Road to 2013 Deadline

More SME registrants

More SMEs will need to be LR (less resources & expertise)

Less known substances (more data to be generated)

Smaller SIEFs

Costs will create higher pressure - might result in higher number of consortia

cost sharing disputes

→ Lessons learned, but many challenges ahead.

The road will not be easy!


Recommendations

Check if your substance is registered ECHA website: http://apps.echa.europa.eu/registered/registered-sub.aspx

within SIEF

If not, get informed on the status of the work within your SIEF work should be on track by now to be able to meet the deadline

if there is no activity in the SIEF, ask for qualified advise (e.g. consultant)

Make sure there is somebody in charge!


Recommendations

Prepare / plan now, if not already done:

your strategy

resources

arrangements for compiling your dossier

There is not

Make sure you are equipped!


Recommendations

Start to prepare now, the road is clear!

Move ahead!


Recommendations

Do not wait until the last moment Limited number of consultants

Possible reduced LoA prices for early buyers

Don’t be late!


Recommendations

Inform yourself on developments

Follow LR / ECHA instructions

Make sure you know the way!


Recommendations

Share data: within your SIEF (mandatory)

with other SIEFs & data owners

(can reduce costs)

Do not work in isolation!


Recommendations

Be prepared for enforcement Forum projects

Regional initiatives

Ensure compliance!


Recommendations

Get support if: knowledge is not available in house

you don’t have practical experience

there are complex issues

Good aid is crucial!

Thank you for your attention and have a safe trip!

We are looking forward to cooperating with you

Hamburg UMCO Umwelt Consult GmbH

Georg-Wilhelm-Straße 183

21107 Hamburg

Tel: +49 (0)40 / 7902 363 00

Fax: +49 (0)40 / 7902 363 57

E-Mail: [email protected]

Köln

UMCO Umwelt Consult GmbH

Moltkestraße 35

42799 Leichlingen

Tel: +49 (0)21 75 / 1 69 45 0

Fax: +49 (0)21 75 / 1 69 45 12

E-Mail: [email protected]

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