Services Brochure

2017

EASY REACH ANALYSIS LTD | www.easy-reach.eu

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New Services – REACH Administration

With less than 18 months until the REACH deadline,

companies are beginning work in earnest to ensure that

the substances critical to their business activities are

registered in time.

Many smaller companies do not have the capacity in-

house to manage this work. In response to this gap, we

have launched a number of new services aimed

specifically at businesses who need access to

experienced consultants at affordable rates.

We can manage all of your REACH administration from

late-pre registrations, managing and monitoring SIEF

communications, through to Joint Registrations

including IUCLID Dossier creation and submission

through REACH-IT. We also have experience of

advising companies wishing to take on the Lead

Registrant role.

We are launching the following services:-

Registration Service for Joint Registrants Page 2 Supporting you through the registration process including SIEF management, arranging Substance Identification, collation of data and IUCLID administration. Registration Service for Lead Registrants Page 3 Supporting you through the registration process including SIEF management, gap analysis, Substance Identification, development of a test programme, collation of data and IUCLID administration. REACH Management Service Page 4 Similar to an Only Representative arrangement but for companies within the EU. Supporting guidance Page 5 Don’t worry our Complete Substance identification service is still available! Page 9 Impurity Monitoring Page 10 Only Representative Service Page 11 www.easy-reach.eu Tel: +44(0)1484 866777 email: info@easy-reach.eu

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Registration Service - Price List (per substance) - Joint Registrant

Supporting you through the registration process including SIEF management, arranging Substance

Identification, collation of data and IUCLID administration.

Activity Quote

SIEF Management Including: Monitoring and managing SIEF correspondence. Reviewing details of the sameness criteria from the SIEF Facilitator / Lead Registrant (LR). Reviewing details of SIEF agreement including Letter of Access (LOA) costs.

Monthly retainer fee for duration of Registration preparation based on 1 hour per month @ £60 per hour

£60 per month in advance

Substance Identification Arranging necessary analysis. Carrying out necessary analysis to provide a REACH compliant Substance Identification which can be attached to the IUCLID dossier

See details of Substance Identification Service http://www.easy-reach.eu/

IUCLID administration Creating a substance dataset. Creating a dossier. Completing all necessary sections. Attaching the Substance Identification Profile (SIP). Ensuring all business rules are passed. Submitting the dossier through REACH-IT. We will Issue a checklist of all the information required (to be completed by the client). Including: Information on manufacture, use and exposure Classification and Labelling

£599 one off payment Provided all necessary information is made available by the client – a checklist will be provided

£599

After Registration

Ongoing maintenance of the registration Updating the dossier as required due to regulatory actions or spontaneously e.g. due to a registration change

We have an OR Service or a REACH Management Service

From £120 pm in advance

External costs

ECHA Registration Fee – dependant on company size and tonnage band Letter of Access – purchased from Lead Registrant

LOA is usually subject to an annual surcharge

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Registration Service Price List (per substance) – Lead Registrant

Supporting you through the registration process including SIEF management, gap analysis, Substance

Identification, development of a test programme, collation of data and IUCLID administration.

Activity Quote

SIEF Management Including: Necessary correspondence to agree Lead Registrant (LR) role. Data request. Keeping SIEF members up to date with registration progress. Informing SIEF members of SIP when available. Informing SIEF members of LOA costs when available.

Monthly retainer fee for duration of registration preparation based on 3 hours per month @ £60 per hour

£180 per month in advance

Substance Identification Arranging necessary analysis. Carrying out necessary analysis to provide a REACH compliant Substance Identification which can be attached to the IUCLID dossier and a SIP which can be made available to other potential registrants.

See details of our Substance Identification Service

IUCLID administration Creating a substance dataset. Creating a dossier. Completing all necessary sections. Ensuring all business rules are passed. Submitting the dossier through REACH-IT.

£1,499 one off payment £1,499

Gap Analysis Providing a template of necessary information to achieve the relevant Annex VII – X requirements and all other necessary data for the IUCLID dossier. Populating with available data. Literature searches / potential read-across scenarios and possible waivers.

Monthly retainer fee for duration of registration preparation based on 8 hours per month @ £60 per hour Additional hours @ £80 per hour to be invoiced monthly in arrears with a timesheet.

£480 per month in advance Additional hours invoiced monthly in arrears

Development of a test programme for any gaps Arranging quotes for necessary testing. Organising and carrying out necessary testing.

Information on manufacture, use and exposure Collating available data on uses and current conditions of use from the supply chain.

Classification and Labelling Advising on classification. Communicating the agreed classification to SIEF members.

After Registration - optional

Ongoing maintenance of the registration Updating the dossier as required due to regulatory actions or spontaneously e.g. due to a registration change.

We have an OR Service or a REACH Management Service

From £120 per month in advance

External costs

ECHA Registration Fees – dependant on company size and tonnage band

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REACH Management Service

Easy REACH Analysis Ltd offer a REACH Management Service which is similar to an Only Representative arrangement but

for companies within the EU

We can carry out the following work on your behalf:

Make pre-registrations through REACH-IT

Deactivate pre-registrations through REACH-IT

Make registrations through REACH-IT

Create full registration dossiers in IUCLID 6

Submit C&L Notifications through REACH-IT

Create spontaneous update dossiers in IUCLID 6

Carry out other IUCLID work e.g. adding legal entities, substances, legal entity sites etc.

Provide advice on REACH related issues

Monitor and manage SIEF correspondence

Update C&L Notifications as necessary

Monitor and manage correspondence from ECHA regarding your pre-registrations and registrations

Organise and amend, as necessary, your SDSs to be consistent with registration details

Check your substances against the Candidate List / Authorisation List / Current SVHC Intentions / SVHC

Proposals

Provide updates on REACH related developments

We charge a maintenance fee monthly in advance and a project specific fee, monthly in arrears. Maintenance fee This includes:

Dealing with SIEF communication

Checking substances against the Candidate List / Authorisation List / Current SVHC Intentions / SVHC Proposals

Updating clients on ECHA correspondence

Providing updates on any REACH related developments £50 per month set admin fee – waived if more than 5 pre-registrations are included £30 per month per active pre-registration and £60 per month per registered substance

Project specific fee This fee will include two types of work: Essential and optional. Work will be charged at £60 per hour. Essential project specific work - This will be carried out as required and invoiced quarterly in arrears. Examples of essential project work:

Requests for information from ECHA

Necessary updates to pre-registrations / registrations

Necessary additional work commissioned by the SIEF on request of ECHA Optional project specific work - We will provide a quote for this type of work and only proceed once you have agreed. Examples of optional project work:

Late Pre-registration of a substance

Registration of a substance

Updating SDSs

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Supporting guidance SIEF Management

Proper management and documentation of SIEF communication flow is necessary.

An email should be circulated to all SIEF members declaring the Companies’ intention to take on the role of LR for the substance. The email should include a deadline for responses in case SIEF members disagree. It should also be specified that the absence of reaction by the given deadline means agreement with the nomination.

Once the deadline has passed, a second email should be circulated to all SIEF members confirming the LR role and requesting any data held by other SIEF members.

ECHA should then be notified using the available web form. The LR will be entitled to receive specific/ targeted information/ communication from ECHA.

Where applicable, we can ask the SFF to release the SFF box in the pre-SIEF page of REACH-IT – if available – so that we can use it for SIEF communication and posting of information, to be made available to all SIEF members (current and future).

It is important that all SIEF members are kept up to date with Registration progress e.g. Informing SIEF members of SIP or LOA costs when available. Agreeing SIEF rules via a SIEF agreement including data and cost sharing procedures.

Companies volunteering as LRs are advised that their duties and liabilities do not apply until they have entered into an

agreement with other SIEF members. Until that happens, they are advised to use the following disclaimer in their

communications: “No representations or warranties are made and no liability will be accepted for damages of any nature

whatsoever resulting from the action of the lead registrant or the results generated by it, as long as there is no contractual

arrangement in place between a SIEF member and the declared lead registrant.”

Substance Identification

Accurate identification of a substance is a pre-requisite to most REACH processes. In particular, it enables joint REACH

registrations to be prepared efficiently and correctly, and ensures that test data is appropriate for the substance

registered under REACH. This leads to a robust hazard and risk assessment of the registered substance.

For most REACH processes, you need to include the following information in your dossier to clearly identify the substance:

Substance name and related identifiers. These could be, for example, the IUPAC name, EINECS or ELINCS number or CAS

number.

Molecular and structural formulae, if applicable.

Information on the composition and purity of the substance.

Spectral data and other analytical information to verify the identity and composition of the substance.

ECHA needs to conclude that the identity you have given to your substance is correct. To do this, appropriate quality

spectra and chromatograms as well as other analytical information need to be included in the dossier. It is important that

the spectra, chromatograms and other analytical information are fully evaluated and their interpretation is presented in

the dossier.

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IUCLID Administration

IUCLID (International Uniform ChemicaL Information Database) is a software application to record, store, maintain and

exchange data on intrinsic and hazard properties of chemical substances. It is a key software application for both

regulatory bodies and the chemical industry where it is used in the implementation of various regulatory programmes.

Examples include the OECD Cooperative Chemicals Assessment Programme (CoCAP) and the EU legislation Registration,

Evaluation, Authorisation and Restriction of Chemicals (REACH). The REACH legislation states explicitly that data shall be

submitted to ECHA in IUCLID format.

We will create a substance dataset and dossier, complete all necessary fields and ensure all business rules are passed.

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Gap Analysis

Registrants are required to collect all physicochemical, toxicological and ecotoxicological information that is relevant and

available to them on the substance they are registering (regardless of whether information on a given endpoint is required

or not at the specific tonnage level). To be able to use the information for registration, companies should have permission

for it.

In addition, the registrant should collect information on the use, exposure and risk management measures of the

substance they are registering.

We can provide a template table of necessary information to achieve the relevant Annex VII – X requirements and all

other necessary data for the IUCLID dossier. We can populating the table with available data, literature searches /

potential read-across scenarios and possible waivers

The gap analysis will be presented as a table allowing all the known and estimated data relating to each of the REACH

endpoints to be viewed together to look for trends in data. It is also helpful to add to this table substances identified to

be chemically similar to help demonstrate trends in key endpoints.

Development of a test programme for any gaps identified

We can work with you to develop a test programme to fill identified gaps. Testing is a phased process with initial results

helping identify onward testing.

We can facilitate, commission and monitor testing on your behalf.

Information on manufacture, use and exposure

Information on the manufacture and use(s) of the substance, as specified under section 3 of Annex VI, must be

documented in section 3 of IUCLID. Although it is up to the registrant to decide on the level of detail to be reported, at

least the following data must be provided:

Tonnage manufactured, imported or used for article production in tonnes per year, including the tonnage used for own

purposes and for intermediates uses.

Brief description of the technological process used in the manufacture of the substance or in the production of articles

(not applicable for importers).

Information on the form (substance, mixture or article) and the physical state under which the substance is made

available in the supply chain. This includes the concentration or concentration range of the substance in mixtures and the

quantities of the substance in articles if applicable.

Information on waste quantities and composition of waste.

Brief description of the identified uses of the substance.

Information on the uses advised against and why.

In addition, for substances manufactured or imported between 1 and 10 tonnes per year for which no CSR is required,

the registrant will have to provide information on exposure as specified under section 6 of Annex VI. This information will

include at least the types of use for the substance (industrial, professional or consumer), the significant routes for human

and environmental exposure and the pattern of exposure and will be also reported in section 3 of IUCLID

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Classification and Labelling

The registrant has to determine the classification and labelling of his substance with respect to physico-chemical

properties, environment and human health.

The classification and labelling should be documented within section 2 of IUCLID as well as the rationale for the decision

for a classification can be clearly documented in each of the relevant sections of IUCLID. For example the classification for

human health should be justified under the relevant section (e.g. acute toxicity, eye irritation, etc.). Registration dossiers

submitted from 1 December 2010 onwards must include information on the classification and labelling of the substance

according to the CLP criteria.

We will advise on classification regulations and communicate the agreed classification to SIEF members.

Submitting the dossier through REACH-IT

All REACH registration dossiers are submitted through REACH-IT. We can submit the dossier on your behalf or provide

written instructions on how to so this.

Note that in case of a Joint Submission, the dossier of the Lead Registrant (which includes the joint information needed

for registering) needs to be successfully submitted before the member registrants can submit their registrations. More

precisely, member registrants can only submit their dossiers once the lead registrant dossier has been accepted for

processing (i.e the dossier passes the business rules verification step)

Ongoing Maintenance of the registration

Registrants have an obligation to keep their registration dossiers up-to-date. The need for updating the dossier may arise

either from a regulatory action, such as dossier or substance evaluation, or spontaneously if e.g. circumstances related to

the registration change. An example of the latter is a new use for a substance to be assessed or a change in the tonnage

manufactured/imported.

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Substance Identification

Easy REACH specialises in offering a Complete Substance Identification package for colourants We have compiled a team of experts in the colourants field, with over 200 years cumulative knowledge and experience. We use the expertise and facilities of a number of laboratories complimented by other partners with a background in colour chemistry, research and development and colour synthesis.

Our experience in the colourants field enables us to interpret the results of the chromatographic and spectrographic analysis to provide you with a comprehensive substance identity. Good quality analytical data and expert interpretation is essential to accurately identifying your substance.

Screening Service - £199* Our popular screening service allows clients to get an early indication of the complexity of their substance at an affordable price. *This cost will be deducted from any Complete Substance Identification Package commissioned on the same sample. For Dyes: We carry out chromatographic analysis e.g. HPLC to provide information on the purity of the sample. £199 per sample For Pigments: We carry out ICP-OES and Micro analysis £499 per sample

Complete Substance Identification Packages Complete Substance Identification Package - Starting from £2,500 Most substances can be fully identified within this budget however some substances such as UVCB's may require additional analysis.

Our packages include all analysis required for a REACH registration dossier.

The spectrographic analysis e.g. UV-Vis, FT-IR, NMR, GC-MS,SEM/EDX, DSC etc. confirms that the sample tested conforms to the chemical structure described by the Chemical name and other identifiers. The chromatographic analysis confirms the purity of the sample and identifies impurities or isomers that require reporting in the dossier. A final report is issued that can be inserted directly into the IUCLID registration dossier. The reports will contain all the spectra and a detailed interpretation of the findings.

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Impurity Monitoring Increasingly consumers are pressuring textile

manufacturers to demonstrate that their products are

environmentally friendly and socially conscious.

Various initiatives are driving this agenda forward

including ‘bluesign’ and ‘ZDHC’.

Being able to demonstrate that your products comply

provide a valuable competitive edge in the market place.

For companies wanting to achieve these standards or be included in the relevant lists, we can provide an independant

analytical service to identify, analyse and monitor impurities.

Please contact us for more details

Screening Service - £199* Our popular screening service allows clients to get an early indication of the complexity of their substance at an affordable price. *This cost will be deducted from any Complete Substance Identification Package commissioned on the same sample. For Dyes: We carry out chromatographic analysis e.g. HPLC to provide information on the purity of the sample. £199 per

sample

For Pigments: We carry out ICP-OES and Micro analysis £499 per sample

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Only Representative Service Introduction

The responsibilities for REACH rest with the person within the EU responsible for placing the substance on the market there. This means that non-EU companies cannot fulfil the requirements of REACH themselves, but instead must work with their supply chain partners and customers to make sure that the requirements are met and their substances can continue to be supplied.

Advantages of a REACH Registration

In many cases, your customers in the EU will not be able to buy your product unless you hold valid REACH registrations or pre-registrations. However even if your customers hold their own REACH registrations there are many advantages to holding your own registrations for substances you export to the EU: Holding your own registrations means you can supply any customer in the EU - not just the ones that own their own registration. Many companies see the REACH registration process as a quality check - they feel there is more certainty about the product they are buying where the supplier has gone through the REACH registration process. For this reason it is likely that many companies will only source from suppliers holding a REACH registration. Even companies outside of the EU may ask for proof of a REACH registration on this basis. Being able to demonstrate that your substances have gone through the REACH registration process and associated analytical verification can be a useful marketing tool for demonstrating quality. If a potential customer is comparing suppliers they are more likely to choose the one with a REACH registration than the one without.

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REACH Only Representative Service

Easy REACH Analysis Ltd an Only Representative Service for Non-EU suppliers.

Appointment of an Only Representative The OR must be appointed by the non-EU producer and their role must be agreed by the importers. Three stages are involved:

1 Letter from supplier naming their OR

2 Letter from importers covered by the OR arrangement recognising the OR

3 Letter from OR to supplier and importers agreeing to their role

Role of an Only Representative We can carry out the following work on your behalf:

Make pre-registrations through REACH-IT

Deactivate pre-registrations through REACH-IT

Make registrations through REACH-IT

Create full registration dossiers in IUCLID 6

Submit C&L Notifications through REACH-IT

Create spontaneous update dossiers in IUCLID 6

Carry out other IUCLID work e.g. adding legal entities, substances, legal entity sites etc.

Accept official role on SIEFs

Provide advice on REACH related issues

Monitor supply patterns (volumes of import by each importer etc)

Update C&L Notifications as necessary

Organise and agree on SDSs to be consistent with Registration details

Monitor and manage correspondence from ECHA regarding your pre-registrations and registrations

Monitor and manage correspondence with EU customers regarding REACH

Check your substances against the Candidate List / Authorisation List / Current SVHC Intentions / SVHC

Proposals

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Prices Set up costs There is an administrative cost of £60 per substance for carrying out the necessary paperwork to appoint us as your

Only Representative.

We will require information from you detailing products, ingredients lists, EU importers and import amounts before

commence.

We have standard letters and forms which we will use to streamline this process.

Ongoing - Maintenance fee We charge a maintenance fee, monthly in advance, per substance which includes the following work:

Accepting the role as Only Representative following appointment

Dealing with SIEF communication

Accepting official role on SIEFs

Providing advice on REACH related issues

Monitoring supply patterns (volumes of import by each importer etc)

Checking substances against the Candidate List / Authorisation List / Current SVHC Intentions / SVHC Proposals

Updating clients on ECHA correspondence

Providing updates on REACH related developments

£100 per month set admin fee – waived if more than 5 pre-registrations or 2 registrations are included £60 per month per active pre-registration £150 per month per registered substance

Additional work Other work will be quoted for and agreed on a commission by commission basis Examples of additional work:

Requests for information from ECHA

Necessary updates to pre-registrations / registrations

Necessary additional work commissioned by the SIEF on request of ECHA

Late Pre-registration of a substance

Registration of a substance Corresponding with suppliers

*All prices are valid on 4/1/2016 but maybe subject to change please see our website for latest details www.easy-reach.eu

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Supporting guidance

Only Representatives

The following text is extracted from ECHA’s ‘Guidance on registration document’. For the full text please use this link -

https://echa.europa.eu/documents/10162/13632/registration_en.pdf

What should a ‘non-EU manufacturer’ do when appointing an only representative?

When appointing an only representative, it is recommended that the ‘non-EU manufacturer’ provides his only

representative with up to date information on the list of EU importers which should be covered by the registration of

the only representative and the quantities imported into the EU.

The ‘non-EU manufacturer’ needs to inform all the EU importers in the same supply chain that he has appointed an only

representative to conduct the registration thus relieving the importers from their registration obligations. A ‘non-EU

manufacturer’ can only appoint one only representative per substance.

The only representative’s registration should clearly specify which quantity of the imported substance it covers – be it

the entire import into the EU from a given ‘non-EU manufacturer’, or only specified quantities within that total. In cases

where an importer is also importing quantities of the same substance from other non-EU sources, then both the only

representative and the importer must be able to clearly document to enforcement authorities which imports are

covered by the registration of the only representative; and which are covered by the importer; otherwise, the importer

remains responsible for all his imports. In other words, an importer has to submit a registration for the quantity of a

substance he imports, but does not have to cover the volume of the substance that is covered by the registration of the

only representative.

Obligations of the only representative regarding the registration of substances

REACH does not distinguish between direct and indirect imports into the EU and therefore such terms are not used in

this guidance. It is essential that there is a clear identification of:

who in the supply chain of a substance outside the EU is the manufacturer, formulator or producer of an article;

who has appointed the only representative;

which imports the only representative has responsibility for.

It should, however, be pointed out that the appointment of an only representative by the ‘non-EU manufacturer’

creates the need for importers to keep exact documentation on which imported quantities of the substance are covered

by the only representative registration and which imported quantities are not In case of import of mixtures the

importers will also need to know what quantity of the substance in a mixture is covered by an only representative

registration, as he would otherwise be subject to a registration requirement himself. This documentation will need to be

presented to the enforcement authorities upon request.

The registration dossier of the only representative should comprise all uses of the importers (now downstream users)

covered by the registration. The only representative must keep an up-to-date list of EU customers (importers) within the

same supply chain of the ‘non-EU manufacturer’ and the tonnage covered for each of these customers, as well as

information on the supply of the latest update of the safety data sheet.

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Although the only representative is legally responsible for the registration, it can be anticipated that in many cases, it

will be the ‘non-EU manufacturer’ that will provide him with all necessary data for his registration dossier.

The diagram below is also from ECHA’s ‘Guidance on registration document’ – page 23. For the full text please use this

link - https://echa.europa.eu/documents/10162/13632/registration_en.pdf

www.easy-reach.eu Tel: +44(0)1484 866777 email: info@easy-reach.eu

May 2017