FINDING CO-REGISTRANTS, SIEFS MANAGING THE PROCESS

REACH EXPO, BERLIN25TH APRIL 2017

Anna Forsgren,Business Unit manager Intertek Health, Environmental and Regulatory Services

About us

• Intertek is an industry leader with more than 42,000 employees in 1,000 locations in over 100 countries.

• We go beyond testing, inspecting and certifying products; we are a Total Quality Assurance provider to industries worldwide

• We deliver Quality Assurance expertise 24 hours a day, 7 days a week with our industry-winning processes and customer-centric culture Fourth level bulleted copy

TOTAL QUALITY. ASSURED

OUR INDUSTRIES & SERVICES

Aerospace & Automotive

Building Products

Chemical

Consumer Goods & Retailers

Electrical & Electronic

Energy

Food & Agriculture

Government & Institutions

IT & Telecom

Industrial

Medical & Pharmaceutical

Minerals

Petroleum

Toys, Games & Hardlines

Textile, Apparel & Footwear

Inspection

INTERTEK’S HEALTH, ENVIRONMENTAL & REGULATORY GLOBAL TEAM (HERS)

Intertek leverages off a global team of around 200 regulatory specialists delivering

o Product Safety & Risk Assessments

o Global Chemicals Notification and Use Registrations

o Restricted Substances and Substances of concern

o Life cycle assessment / GHG emission reduction

o Design for the environment / End of life / Waste

Intertek is leading REACH registration consultancy and Only Representative:

o Prepared several hundred registration dossiers; 300+ as Lead, 800+ as co-registrant

o Inspected 5 times by the competent authorities as OR, without remarks

AGENDA

Finding the right SIEF

Working in SIEFs

If no Lead registrant or SIEF

Experience from SIEF work

Advise on the way

1

5

4

3

2

• One substance – One registration

• OSOR principle enforced with EU regulation 2016/9

• Competitors need to collaborate

• Vary from 1 - 2 members and informal work to 1000´s of members with web based collaboration tools

SUBSTANCE INFORMATION EXCHANGE FORUM (SIEF)

FIND YOUR CO-REGISTRANTS

You need to

• Check your pre-registration

• Discuss substance sameness

• Join SIEF and purchase LoA

or

• If Opt-out, must be justified and may trigger a compliance check

• Consider be Lead registrant:

You need the consent of the SIEF members

• In case of difficulties; inform ECHA and bring evidence

Use REACH-IT to understand if substance has been registered already/will be and get SIEF member contacts

If not pre-registered:

• Late pre-registration still possible until 31 May 2017 for substances with registration deadline on 31 May 2018

• After that, the substance needs to be registered before it can be manufactured/imported

• First step: Inquiry to ECHA

Good way to understand if suggested approach is accepted by ECHA.

STEP 1: CHECK PRE-REGISTRATION

STEP 2: SUBSTANCE SAMENESS –THE SUBSTANCE IDENTITY PROFILE (SIP) • must be established and documented by

the lead registrant

• must be agreed upon in the pre-SIEF phase

• is the purity/impurity profile of a substance that all SIEF members can agree upon as common

• usually easy for mono-constituent substance

• for multi-constituent substances and UVCBs can be demanding and require dedicated analytics and detailed knowledge about the production process, identity of its raw materials and the process parameters

• non-disclosure agreements usually needed to share such data

List of lead registrants at ECHA – check!

STEP 3: IDENTIFY LEAD REGISTRANT THE SOONEST

Try to get as much information as possible on the Lead registrant´s work and Dossier

– a lot of poor ones exist!

STEP 4 : EVALUATE DOSSIER QUALITY

LR – Lead Registrant

The legal entity submitting the Lead RegistrationDossier to ECHA.

SSF – SIEF Formation Facilitator

Communication with all SIEF members – the role of the SFF is totally voluntary and does not entail any specific obligations

SIEF Agreements

Participation in a SIEF can be combined with thesignature of a formal SIEF Agreement or not

Consortium Agreements

A consortium is a voluntary grouping of companieswho have decided to work together to prepare theregistration material for one or several substances

Important Legal Point of view!

SIEF TERMS

Many variants:

• SIEF agreement

• Consortia agreement

• Data sharing agreement

• Letter of Access

o Vary in complexity, come in many ways

o Are usually hard/impossible to negotiate

→ Ensure to work close with legal advisers and that they have enough resources!

AGREEMENTS

EXPERIENCE REGARDINGAGREEMENTS

LoA – take it or leave it?

If there is already an existing SIEF or consortium, you usually already get a LoA proposal with estimated costs – with no possibility to negotiate

Time Frame!

Communication within big SIEF take place very slowly – just to sign a contract can sometimes take several months

Problems with little issues?

Many times important content issues are being solved relatively quickly, however, little things can become issues – e.g. determinations of analytical method or concentration limit with determination of substance identity

Legal point of view is important!

Contract as legal base (SIEF or consortium) is very important – it is necessary to determine exactly who owns what, and is the situation regarding new members or withdrawal of co-members during the preparation of contracts clear

Important is risk for the company

It is important to include experts (legal and economic) in the process of making any kind of decisions

DATA SHARING

The ECHA guidance on Data sharing is clearly defining “Fair and non discriminatory”

Should be:

• Not for profit – principle

• Reimbursement

If cost does not seem to be this:

1. Ask for explanations

2. Discuss a way forward

3. As a last resort: open a dispute

Transparency can be demonstrated by

• Regular and open SIEF communications

• Clear spreadsheets with costs related to the studies

• Clear spreadsheets with costs related to admin and technical work

• Clear communication of the number of registrants

• Clear communication on the cost-sharing system, overall

WHAT IF A DOSSIER IS SOLD WITHOUT LEAD ELECTION?

In some cases;

• very poor, not compliant dossier

• the real lead registrant cannot register its dossier

o No solution yeto No legal frameworko But you should contact ECHA and suggest a

new Lead – has worked in several cases o ECHA is working on a formal procedure for

thiso The link to report a case is:

https://echa.europa.eu/it/contact/reach

Two potential scenarios:

1. The substance has already been registered by another actor as an individual submission dossier

2. The substance has not yet been registered by anyone

If so;

➢ Contact the "individual registrant" for upgrading his dossier to a joint submission dossier

➢ Start SIEF communication and collaboration, join forces with potential co-registrants to establish a registration dossier

➢ You may need to take the lead registrant role in order to ensure that the substance gets registered in time

WHAT IF THERE IS NO LEAD REGISTRANT DOSSIER NOW?

A LOT OF UNCERTAINTIES IN THE SIEFS….

Everyone appears to hope that:

o someone else takes the lead on a substance,

o costs can be deferred to a later time,

o costs for letters of access will go down,

o internal business strategy may change,

o tonnage bands may change,

o a substance may be replaced soon by another substance and therefore may not be needed anymore,

o a substance may face restrictions or disadvantageous labelling in the EU and thus will not be viable in the future,

Although these reasons may all be valid for one case or another, the time to wait is over!

WHAT IF THERE IS NO SIEFRESPONSE?

• Only a minority of the SIEF members respond to communications

• If the SFF or Lead does not respond, contact other SIEF members

• Consider taking the Lead

• If taking the Lead; communicate to SIEF members you take the Lead and require feedback with reasonable deadline

If a lead dossier is available, focus on:

o identifying the lead registrant and establishing contact to acquire a LoA,

o agree upon a SIEF agreement and get it signed,

o check costs for a LoA and acquire such LoA,

o establish own member dossier

o establish own uses and consider own exposure scenarios to be supported,

o finalise dossier and submit,

o pay ECHA fees.

Takes approximately 6 months

STEP 5: SUBMIT REGISTRATION

If a lead dossier has not yet been established, activities to be done will focus on:

o search for SIEF to establish whether a SIEF has already been formed and is working - if so, wait for outcome and act according to scheme above,

o if a SIEF has not been formed, contact the entire SIEF, agree on substance sameness and agree on who should take the lead registrant role,

o if necessary, take the lead registrant role and start establishing a lead registrant dossier.

POTENTIAL STEP 6: TAKE THE LEAD

POTENTIAL STEP 6: TAKE THE LEAD – CONT’D

Time needed for all this should be scheduled as taking:

o approximately 2 - 6 months for SIEF communication and approval,

o 9 – 12 months for lead registration dossier preparation if needed.

Bear in mind

• submit the dossier at least 2 months prior to the registration deadline

• it is a long-term commitment also after the registration

• There are a lot of well functioning SIEFs and Lead registrants minimizing efforts for members

• Competitors have learnt to work together from the need to solve things the best way for all

• Use the opportunity to learn more aboutyour industry

POSITIVE SIDES OF THE SIEF WORK

Working towards REACH registration by May 2018 is a kind of marathon and not a short term sprint. There are many decisions to be taken along the way

After registration

• ECHA is selecting dossiers for dossier evaluation and substance evaluation

• new testing requirements do occur

• many dossiers will have to be improved or amended later

The Lead registrant must continue to be responsible for this

SIEF members must continue to monitor SIEF communication and respond!

SIEF IS A JOURNEY – NOT A SHORT ONE, REQUIRING ENDURANCE!

ADVISE ON THE WAY

• Be prepared that Substance identification and agreements takes much more resources and time than ever imagined

• Use existing experience since 2010 to make it in time, i.e. from

• ECHA

• industry associations

• consultants

• Save all important SIEF communication

• If no SIEF communication response – take contact individually

• If poor/too little response in the SIEF – take the lead

• Take the advantage of the SIEF work to learn from your industry co-players!

Questions?

anna.forsgren@intertek.com

+46 8 750 04 16

intertek.com/green