KEMIKAALIAAMU

Riku Rinta-Jouppi, Partner and Head of Global Compliance,

REACHLaw Ltd.

Helsinki,11 October 2016

REACH 2018 Overview

2018 Deadline

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

3 400 substances

20 000 registrations

3 000 “new”

substances

9 000 registrations

25 000 “new”

substances

60 000 registrations

If ECHA’s estimates are correct (?),

we still have ca. 22 000 unique

substances to register,

covered by 64 000 dossiers

still to be submitted…

REACH 2018 CHALLENGES

Registering in 2018: What Will Be Different

compared to 2010/2013?

1. High number of registrations expected: 60 000 (ECHA)

2. More specialty chemicals as low volume substances

(1-10 & 10–100 t/a) affected

3. Smaller SIEFs

4. More sole-registrants (only one registrant per SIEF)

5. Many registrants are expected to be inexperienced and SMEs

needing more support

6. Less data is available for the substances (more need for even

basic tests)

7. Fewer consortia covering many substances → Mostly lead

registrant driven substance specific projects

Higher risk than in 2010 / 2013 that certain substances

remain unregistered due to lack of registrant’s capability

and / or resources to compile a registration file

Where to Start with 2018 Registrations

Know Your Substance Portfolio

1. Determine your chemical portfolio in

terms of substances

– Substances on their own

– Mixtures: which substances are in these mixtures

– (Articles: which substances are released from them,

not very common case)

Collect this information in e.g. Excel

2. Identify your substances and

determine REACH Scope

Picture courtesy of ECHA

Where to Start with 2018 Registrations

What determines the need to REACH Register a

substance (scope of registration)

1. Over 1 t/a (1 000 kg/year) manufactured / imported

before (or after) 31.5.2018 (legal requirement)

2. Part of your “core” product portfolio (Business drivers)

3. Strategically / tactically / commercially important

substance for you (Business drivers)

4. Potential substance for (business) volume increase

above 1 t/a by 31.5.2018 or “shortly” thereafter

Check whether (2010 /

2013) joint registration

is available?

Prepare Co-Registration dossier(s),

purchase LoA(s) and registers Leadership for 2018 registration is already

taken up by a company that can be trusted to

produce the registration in time ahead of the

31.5.2018 deadline?

Decide whether to participate in leader-

ship cooperation / consortium or monitor

the progress and purchase LoA later

Consider whether to take the lead registrant

role a.s.a.p. well before the 2018 registration

(No time to waste)

YES NO

YES NO

Where to Start with 2018 Registrations Way Forward for 2018 Registrations for once you know your REACH

substance portfolio

EU/EEA Manufacturer / Importer

If not already pre-registered “late”

pre-register the substance (where permitted)

= Role

= Activities

Prepare Co-Registration dossier(s),

purchase LoA(s) and registers

Prepare Lead Registration dossier and sell

LoA(s) to Co-Registrants and submits registration

= Decisions

The Only Representation

If a non competent

company has taken

the LR position

then available

options are only

difficult ones due

to the OSOR

principle

Co-Registrations 2018 Solutions

Steps to Successful Co-Registrations

1. Determine substances to be Co-Registered (as viewed earlier)

2. Contact consortia / LR for LoA. Determine final costs. This may

take some time to process.

3. Start generating / collecting your own analytical information for

substance ID purposes (more emphasis has been placed on this by

ECHA so get it right!!).

4. Start early with the work!

Recommended to start already during 2016 in order to avoid the

“rush” at the end

– A lot of substances will have to be registered and expert resources are limited and cost

will increase the closer we get to the 2018 deadline, especially true for testing and Lead

Registrant capacity!!!

5. Get support where needed e.g. from professional REACH Service

providers such as REACHLaw will assist in all of these steps

Co-Registrations 2018 Solutions

Examples of Support for Co-Registrations by

Competent REACH Service Providers (e.g. REACHLaw)

• Support your REACH Co-Registration efforts with amongst others

1. LoA negotiations and price verifications

2. Substance ID verifications and adequate analytical information

collection

3. Identified Uses check

4. Co-Registrant dossier compilations and submissions

5. (e)SDSs

6. Part / Whole CSR’s

7. Opt-Outs

8. Confidentiality requests …etc.

Lead Registrations 2018 Solutions

Steps to Successful Lead Registrations

1. Select substances to be Lead Registered – Substances to Lead register should be identified as soon as possible as

the Lead Registrant work takes time!!!

2. Grab your Lead Registrant position! In order for you to be sure you

will get the lead registrant position for your important substances,

you should nominate yourself as the Lead Registrant early to ECHA

and get your support in the (Pre-)SIEF.

3. Start generating / collecting your own analytical information for

substance ID purposes.

4. Start early with the Lead Registrant work! Recommended to start

immediately in order to avoid the “rush” at the end. – LR work will start with a data gap analysis.

5. Get support where needed e.g. from professional REACH Service

providers such as REACHLaw will assist in all of these steps

Lead Registrations 2018 Solutions

Duration of LR work

• The duration of Lead Registration work is typically:

– ca.6 – 9 months for 10-100 t/a full substances

– ca. 2 - 3 months for 1-10 t/a full substances

– ca. 1 – 2 months for 1–100 t/a t/a intermediates

• These include testing, where required to fill data gaps.

• Testing capacity is already starting to clog-up so if you

start now, expect some delays when testing can start

– Will only get worse the closer we get to 2018 deadline

The more time is available for the LR work,

always the better

1) Average of the test price from 4-5 laboratories (according to

the quotations received in Dec 2014)

2) Fleischer, M. (2007). Testing Costs and Testing Capacity

According to the REACH Requirements. Journal of Business

Chemistry 4, (3), 96-114

Lead Registrations for 2018

Testing costs

REACH number Endpoints

PHYSICOCHEMICAL PROPERTIES

7.1. State of the substance at 20⁰ C and 101,3 kPa - -

7.2. Melting/freezing point EC A.1 805 (1

7.3. Boiling point EC A.2 719 (2

7.4. Relative density EC A.3 846 (1

7.5. Vapour pressure EC A.4 4199 (1

7.6. Surface tension EC. A.5 817 (2

7.7. Water solubility EC A.6 4679 (1

7.8. Partition coefficient n-octanol/water EC A.8 3732 (1

7.9. Flash-point EC A.9 809 (2

7.10. Flammability EC A.10 633 (1

7.11. Explosive properties EC A.14 2284 (2

7.12. Self-ignition temperature EC A. 16 1338 (2

7.13. Oxidising properties EC A. 7 / A. 21 2144 (2

7.14. Granulometry OECD 110 1418 (1

TOXICOLOGICAL INFORMATION

Sensitization & Irritation

8.1. Skin irritation or skin corrosion: in vitro OECD 439 / 430 / 431 1645 (2

8.1.1. Skin irritation: in vivo OECD 404 1491 (1

8.2. Eye irritation: in vitro OECD 437 / 438 1515 (2

8.2.1. Eye irritation: in vivo OECD 405 1966 (1

8.3. Skin sensitisation OECD 429 4625 (1

8.4. Mutagenicity

8.4.1. In vitro gene mutation study in bacteria OECD 471 3257 (1

8.4.2. In vitro cytogenicity study in mammalian cells OECD 473 18148 (1

8.4.3. In vitro gene mutation study in mammalian cells OECD 476 16086 (1

8.5. Acute toxicity

8.5.1. By oral route OECD 423 1786 (1

8.5.2. By inhalation OECD 403 11743 (2

8.5.3. By dermal route OECD 402 2011 (2

8.6. Repeated dose toxicity

8.6.1. Short-term repeated dose toxicity study (28 days) OECD422 (3 95632 (1

8.7. Reproductive toxicity

8.7.1. Screening for reproductive/developmental toxicity OECD422 (3 incl. in above

8.8. Toxicokinetics

8.8.1. Assessment of the toxicokinetic behaviour of the substance No test needed 0

ECOTOXICOLOGICAL INFORMATION

9.1. Aquatic toxicity

9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) OECD 202 5600 (1

9.1.2. Growth inhibition study aquatic plants (algae preferred) OECD 201 7403 (1

9.1.3. Short-term toxicity testing on fish OECD 210 26254 (2

9.2. Degradation

9.2.1. Biotic

9.2.1.1. Ready biodegradability OECD 301 3901 (2

9.2.2. Abiotic

9.2.2.1. Hydrolysis as a function of pH OECD 111 n/a

9.3. Fate and behaviour in the environment

9.3.1. Adsorption/desorption screening OECD 106 3878 (2

ENDPOINTS 10 - 100 t/aTest Guideline

GENERIC cost

(EUR)

REACH number Endpoints

PHYSICOCHEMICAL PROPERTIES

7.1. State of the substance at 20⁰ C and 101,3 kPa - -

7.2. Melting/freezing point EC A.1 805 (1

7.3. Boiling point EC A.2 719 (2

7.4. Relative density EC A.3 846 (1

7.5. Vapour pressure EC A.4 4199 (1

7.6. Surface tension EC. A.5 817 (2

7.7. Water solubility EC A.6 4679 (1

7.8. Partition coefficient n-octanol/water EC A.8 3732 (1

7.9. Flash-point EC A.9 809 (2

7.10. Flammability EC A.10 633 (1

7.11. Explosive properties EC A.14 2284 (2

7.12. Self-ignition temperature EC A. 16 1338 (2

7.13. Oxidising properties EC A. 7 / A. 21 2144 (2

7.14. Granulometry OECD 110 1418 (1

TOXICOLOGICAL INFORMATION

Sensitization & Irritation

8.1. Skin irritation or skin corrosion: in vitro OECD 439 / 430 / 431 1645 (2

8.2. Eye irritation: in vitro OECD 437 / 438 1515 (2

8.3. Skin sensitisation OECD 429 4625 (1

8.4. Mutagenicity

8.4.1. In vitro gene mutation study in bacteria OECD 471 3257 (1

8.5. Acute toxicity

8.5.1. By oral route OECD 423 1786 (1

ECOTOXICOLOGICAL INFORMATION

9.1. Aquatic toxicity

9.1.1. Short-term toxicity testing on invertebrates (preferred species Daphnia) OECD 202 5600 (1

9.1.2. Growth inhibition study aquatic plants (algae preferred) OECD 201 6118 (1

9.2. Degradation

9.2.1.1. Ready biodegradability OECD 301 3901 (2

ENDPOINTS 1 - 10 t/aTest Guideline

GENERIC cost

(EUR)

1-10 t/a Max. ~ 107 000 €

10-100 t/a Max. ~ 231 000 €

Note: Lead Registrants will get money back once other companies join the Joint Submission and purchase the

LoA (to share the costs).

You are in charge!!!

Start early, don’t wait. There is nothing to be gained

by waiting.

Lead Registrations for 2018

What are the benefits and drawbacks of becoming

the Lead Registrant

• Pros of becoming a Lead Registrant:

– You are in control of much of the practical registration process

(assuming there is no Consortia)

– You control the timeline (in practice)

– You are in a position to make 100 % sure that your uses and

related exposures are covered (as you probably know in

detail what input data is required for the Hazard Assessment)

• Everyone should provide adequate information but in the real

world that does not happen. At least the LR can control his input!

– Despite recommendations, you will most likely not get much

inquiries / communication from the other SIEF members except

when it comes time to pay the LoA’s, so you can work in

relative peace on the LR dossier …etc.

Additional slide

Lead Registrations for 2018

What are the benefits and drawbacks of becoming

the Lead Registrant

• Neutral issues of becoming a Lead Registrant:

– You cannot exclude anyone from becoming a Co-registrant if

the agree to the SIEF agreement and share costs accordingly

• For some this might seem to be a drawback…

– You will have to be fair, transparent and non-discriminatory in

all your actions

• For some this might also seem to be a drawback…

– …etc.

Additional slide

Lead Registrations for 2018

What are the benefits and drawbacks of becoming

the Lead Registrant

• Cons of becoming a Lead Registrant:

– You have the responsibility to lead the Joint Submission work

and in the end prepare the Joint Submission Dossier (Lead Registrant dossier) → You are (most) liable of all SIEF

members

– You will have a “lifetime commitment” to keep the JS dossier

up to date

– You are in many cases responsible for the financial admin of

the SIEF work (LoA sales, reimbursements, tax liabilities, etc.)

– You might be called upon to “referee disputes” between some

members

– Someone may call upon you for data sharing disputes …etc.

Additional slide

Lead Registrations 2018 Solutions

Examples of Support for Lead Registrations by

Competent REACH Service Providers (e.g. REACHLaw)

• Support your REACH Lead Registration efforts with

amongst others 1. Substance ID verifications and SIP preparation

2. Data gap analysis

3. Data holder communications ( + Read across )

4. Testing planning and monitoring ( + organising tests )

5. Consortia / SIEF management and SIEF communication

6. Lead Registrant Dossier compilation and submission

7. CSR incl. Exposure scenarios

8. Classification & Labelling

9. Financial management (for cost sharing purposes)

10. Drafting LoA’s (fair and transparent) and SIEF agreements

11. (e)SDSs

12. Continuous Lead Registrant dossier maintenance, data sharing

management …etc.

Cannot stress enough that testing will be your bottleneck in the whole Lead Registration

process

Get it scheduled a.s.a.p. where necessary

Only Representative

Options for the Non-EU/EEA Company

• EU/EEA regulations only have direct jurisdiction on

legal subjects of EU law i.e. legal entities in the

EU/EEA

– Non-EU/EEA companies do not have any legal obligations

under REACH

• However, under REACH Article 8, certain

non-EU/EEA companies have the right to

appoint an Only Representative (OR) to take

care of the REACH obligations of importers

Additional slide

Appoint an OR to take

care of REACH

importer duties

OR needs multi-

disciplinary background:

chemistry, law, data

handling IT,

organisation

Only Representative

REACH Article 8: OR responsibilities, required

skills, enforcement

Subsequent importers

will be regarded as

Downstream Users

In summary:

Additional slide

Only Representative

Who Can Appoint an Only Representative

• Only a non-EU/EEA Company that engages in the following

activities with regards to chemicals as exported to the EU/EEA

either as such or as part of Mixtures (or Articles in special cases):

1. Manufacturers substance(s) in accordance with

the REACH definition;

AND / OR

2. Formulates mixtures from substances and/or other

mixtures in accordance with the REACH definition.

• Formulation is seen as “manufacture” only in this context which is

a peculiarity of the REACH regulation and only applicable to the

non-EU/EEA formulator.

Additional slide

Non-EU traders cannot appoint…

Additional slide

Only Representative

What Makes Only Representation so “Efficient”

M/F Non-EU/EEA Manufacturer / Formulator

1. Case of Import by Customers

EU/EEA Customer 1

EU/EEA Customer 2

EU/EEA Customer 3

Importer 3

Importer 2

Importer 1

Each importer will have to

REACH register (comply

with REACH and CLP) the

Substance AB by themselves

→ 3 x Cost and Effort and

Time lost

…Not very efficient for the

supply chain in Europe

of Substance AB

of Substance AB C 2

of Substance AB

C 1 C 2

Substance AB

Additional slide

Only Representative

What Makes Only Representation so “Efficient”

Non-EU/EEA Manufacturer / Formulator

2. Case of Only Representative taking care of import obligations

EU/EEA Customer 1

EU/EEA Customer 2

EU/EEA Customer 3

Downstream User

EU/EEA importers are

regarded as

“downstream users”

of the OR for the

tonnage covered by

the Only

Representative

→ Only 1 x Cost and

Effort and Time lost

Very efficient for the

supply chain in

Europe (No

redundant work) of Substance AB

of Substance AB C 2

of Substance AB

C 1 C 2

Downstream User Downstream User

Substance AB

Substance AB

OR

Taking care of importer

obligations “centrally”

M/F

Additional slide

EU importers within the same supply chain covered by an Only Representative are relieved from their registration obligations, as

they will be regarded as downstream users.

Additional slide

Who can become an Only

Representative:

Any natural or legal person within the

EU/EEA having ”sufficient background in the

practical handling of substances and the

information related to them” to be able to

fulfil the obligations of importers.

Only Representative

Only Representative Appointment

• Only Representative appointment in practice:

1. Contact a Competent Only Representative (e.g. REACHLaw)

(ask for e.g. an OR Service quotation)

2. REACHLaw (used in this example) draws up an

Only Representative Agreement including an

“Appointment letter of Only Representative”

– Incl. Scope of substances which can be amended with new

substances later

3. Signing of the Only Representative Agreement including the

“Appointment letter of Only Representative”

4. Done! → The Only Representative can start their work and

setting up the necessary REACH-IT accounts and inform the EU

supply chain (get their consent), etc.

Additional slide

“An only representative is fully

responsible and liable for fulfilling all

obligations of importers for the substances

he is responsible for.

These do not only pertain to registration

but also to all other obligations of

importers under REACH.”

ECHA Guidance on Registration

Additional slide

Only Representative

Responsibilities

1. All tasks of a REACH / CLP registrant, SVHC notifier,

authorisation applicant incl. updates

2. Keep available and provide up-to-date REACH-

compliant (e)SDSs

3. Keep up-to-date EU/EEA customer and volume

information

4. REACH compliance documentation (Article 36)

– E.g. appointment letters, substance list, SIEF agreements,

letters of access, confirmations of strictly controlled conditions

5. Respond to authorities, customers and SIEF/consortia

follow-up

Additional slide

Only Representative

What the ideal Only Representative does

1. Has a written OR agreement in place, which clearly sets out parties’ responsibilities

2. Runs a full company size verification of his non-EU client (incl. related enterprises)

prior to SME registration and keeps available certified translations into EU language

3. Duly (late-)pre-registers and registers his client’s substances

4. Is always available and responds duly to third party requests (from ECHA,

enforcement authorities, SIEF members, lead registrant, importers, etc.)

5. Draws up REACH compliant safety data sheets for his client’s substances

6. Keeps available information on importers and volumes synchronized with his client

7. Keeps available import volume info since 2004 (→ for later registration deadline)

8. Determines properly the importers in terms of REACH to this end

9. Tracks volumes imported ”indirectly”, e.g. via non-EU traders & protects their CBI

10. Monitors REACH (& CLP) developments: ECHA, guidance, national activities, etc.

11. Complies with continuous post-registration obligations, e.g. eSDS update

12. Has the required chemical, legal, data handling/IT, organisation & other skills to

fulfil its duties and put customer and compliance management systems in place

Additional slide

Only Representative

Means of the Only Representative to ensure that

these duties are fulfilled continuously to

IT-based

systems for

record

keeping and

communication

Access to a pool of

multi-disciplinary

expertise to maintain

compliance in case of

changes and requests

after registration

Additional slide

Great deal of competence and expertise (technical, legal,

organisational, etc.) required from the Only Representative to fulfil

its REACH obligations

Additional slide

Conclusions / Key Messages

2018 Co- and Lead Registrations / Only Representation

• Know which substances you need to register for 2018

and verify their substance ID

• If there is no Lead Registrant, there is no time to waste.

– Don’t hesitate to take the Lead Registrant role → REACHLaw can assist

you where needed

• Start to collect the information you need for your registrations now

(e.g. use applications, available studies, analytical data, etc.)

• Using an Only Representative is an efficient way of dealing with

REACH registration requirements for the non-EU/EEA manufacturer /

formulator

• The Only Representatives registration covers all importers who are

regarded as downstream users (in the same supply chain, your customers)

– High level of competence is required to become an Only Representative

Thank you for your attention

Compliance.

Sustained.

Contact:

Riku Rinta-Jouppi

Partner and Head of Global Compliance

riku.rinta-jouppi@reachlaw.fi

+358 40 773 8143

REACHLaw Ltd.

Vänrikinkuja 3

02600 Espoo

Finland

www.reachlaw.fi

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