Leping

Helsinki,

RL/ma D(2024)0053

Ms Mari-Anne Härma

Subject:

Dear Ms Härma,

Yours sincerely,

[electronically signed] 1

Cc: Mr Andreas Lüdeke

Enclosures Service Contract n°ECA.12414-012

Timesheets template

Guidelines for invoices

Rémi Lefevre

P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 echa.europa.eu

Service Contract n°ECA.12414-012 for (Co-)Rapporteurs of the Committee for

Socio-economic Analysis

The European Chemicals Agency would like to place the above-mentioned Service Contract with

your organisation.

Please find attached one signed original of the order.

The subsequent invoice related to this service contract shall be emailed as a PDF document to:

[email protected]

Health Board

Paldiski road 81

10617 Tallinn

Estonia

Head of Risk Management Unit

1 As this is an electronic document, it is not physically signed. This communication has been approved according to ECHA’s internal

decision-approval process.

CONTRACT AND INVOICE

REFERENCE

ECA.12414-012*

Rémi Lefevre D(2024)0053

Head of Risk Management Unit

PO Box 400 Country of Origin: EE

FI-00121 Helsinki, Finland Currency of payment: Euro

Rapporteurship on an authorisation application (Annex XIV)

Rapporteur: Andreas Lüdeke

Chemical Name: Arsenic acid (358_RR1_AsA_Circuit)

Submission number: AV964834-06

Services to be delivered (according to the terms of reference for (co)rapporteurs of RAC and SEAC for authorisation applications**)

• Draft and propose an opinion on the authorisation application for adoption by SEAC

Expected deliverables: delivery of relevant draft to SEAC SECR

1. draft opinion 23/10/2024

2. final opinion, if the applicant provides comments on the draft opinion 21/05/2025

3. filled in timesheet and submission of invoice, as instructed by ECHA 11/07/2025

Amount to be remunerated according to 50/50 split between rapporteur Andreas Lüdeke

and co-rapporteur Priscilla Reale***

1642.08

* The contract and invoice reference number has to be mentioned on the invoice

** The document can be found in SCIRCABC at the following path:RAC and SEAC Committees/Library/Procedural and Administrative/

Working procedures and templates/AfA/Procedures

***MB/41/2020 Decision on the financial arrangements for transfer of a proportion of fees to the member states

VAT 0% 0.00

TOTAL : 1642.08

ECHA

Name: Rémi Lefevre

Position: Head of Risk Management Unit

Date: 09/02/2024

Signature:

[electronically signed] 1

This Service contract is governed by the Law as stipulated in Article 11 of the ECHA/MSCA/CA/2010/EE/1-Amendment2

S E R V I C E C O N T R A C T

Remuneration of Rapporteurs

Ms Mari-Anne Härma

1 As this is an electronic document, it is not physically signed. This communication has been approved according to ECHA’s internal decision-approval process.

Payment: 30 days from receipt of the invoice (as per MB/41/2020)

Health Board

Paldiski road 81

10617 Tallinn

Estonia

Payment to MSCA/MNI bank account defined in Cooperation Agreement

Exemption from VAT pursuant to Art. 151 of Directive 2006/112/EC

SIGNATURE

Place of delivery/performance: ECHA; PO Box 400; FI-00121 Helsinki

This Service Contract is based on the Cooperation Agreement ECHA/MSCA/CA/2010/EE/1-Amendment2

on the transfer of funds between ECHA and the above-mentioned Competent Authority

DESCRIPTION OF SERVICES

REPORT OF DAYS WORKED ON AUTHORISATION CASES (ECA.12414-012)

Number of days worked per month

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Total

% of

allocate

d 0 n/a

I declare that I have verified with the Competent Authority that the information in this time sheet is correct in terms of the bank account number and payment reference.

I also declare that I have worked as a rapporteur for the case as indicated in the number of days worked and that I have delivered the draft opinion.

The bank account number of the competent authority has changed (tick) No Yes

If "Yes", please confirm the new bank account of the Competent Authority*:

The competent authority will send a separate invoice (tick) No Yes `

If "No", ECHA will transfer the remuneration as per MB/41/2020 to the bank account and Payment refence given above.

Date of delivering the final version of the draft opinion (i.e. the last day of work)

* The change of bank account needs to be formalised via an amendment of the Cooperation Agreement. Andreas Lüdeke

Month

Instructions for payment

(Signed) Date

09/02/2024 n/a EE221010220027690221

(Reference on payment:

ECHA/3.5.1.358/Andreas

Lüdeke 1642.08

Contract starting date

(i.e. "Month 1")

Days allocated for the

case (MB/41/2020)

Bank account of the Competent

Authority (IBAN) Payment reference:

Contracted

amount (Euro)

Health Board Andreas Lüdeke SEAC 358_RR1_AsA_Circuit 3.5.1.358

Member State Competent

Authority Name of rapporteur Committee Case name

Case number

(contract

Restricted

Invoicing guidelines

The subsequent invoice(s) related to this Purchase Order shall be sent electronically through a compatible e-Invoicing platform. ECHA has joined the e-Invoicing module of e-PRIOR maintained by the European Commission. This enables ECHA’s suppliers to send invoices, credit notes and supporting documents electronically using the e-Invoicing module. There are two ways to submit invoices via e-PRIOR:

o The connectivity via PEPPOL platform (preferred option). PEPPOL embeds the European wide standards to harmonise processes across private and public sectors and you can find more information on www.peppol.eu.

o Via Supplier Portal (manual, free of charge). More info here: https://ec.europa.eu/isa2/solutions/open-e-prior_en

ECHA can be found in e-PRIOR/PEPPOL using the 0088:6429830036104 identifier, (ECHA’s GLN # 6429830036104). In case you have further questions regarding this matter please do not hesitate to contact us via email [email protected]. If your company needs help setting up the e-Invoicing channel, ECHA could assist you with testing. It is sufficient to send the invoices only in electronic format, please do not send duplicates (both electronic and paper versions).

If, for a duly justified reason, you are unable to send an invoice in electronic format, please email your invoice as a PDF document to [email protected]. In case you cannot send invoices electronically/via email, please send them by mail to: ECHA Mail Registration, PO Box 400, FI-00121 Helsinki.

Please make sure that the invoice includes:

o Purchase Order reference number as shown in the order;

o Milestone/deliverable in question and the project title/acronym;

o The amount of VAT or the rate of VAT applied, if applicable;

o Bank account details as they appear in the Purchase Order (Please notify ECHA of any subsequent changes to the bank account to which the payment is to be made).

Please note that the invoice cannot contain items not mentioned in this Purchase Order and cannot exceed the total cost foreseen.

Payments cannot be processed for invoices which have not been completed according to these instructions.

Helsinki, 15/11/2023

1

TERMS OF REFERENCE

FOR (CO-) RAPPORTEURS OF RAC AND SEAC FOR AUTHORISATION

APPLICATIONS

1. INTRODUCTION

In accordance with Article 64(1) of the REACH Regulation, RAC and SEAC shall give their

draft opinions on authorisation applications within ten months of the date of receipt of an

application.

Article 64(3) specifies that in preparing its opinion, each Committee shall first check that

the application includes all the information specified in Article 62 that is relevant to its

remit. If necessary, the Committees shall, in consultation with each other, make a joint

request to the applicant1 for additional information to bring the application into

conformity with the requirements of Article 62. In addition, Article 64(3) foresees that

SEAC may, if it deems it necessary, require the applicant or request third parties to

submit, within a specified time period, additional information on possible alternative

substances or technologies.

Article 64(4) specifies that the draft opinions of the Committees shall include the

following elements:

a) RAC: an assessment of the risk to human health and/or environment arising

from the use(s) of the substance, including the appropriateness and

effectiveness of the risk management measures as described in the application

and, if relevant, an assessment of the risks arising from possible alternatives;

b) SEAC: an assessment of the socio-economic factors and the availability, suitability

and technical feasibility of alternatives associated with the use(s) of the

substance as described in the application, when an application is made in

accordance with Article 62 and of any third party contributions submitted under

Article 64(2).

Article 64(5) foresees that the ECHA Secretariat shall send the draft opinions of the

Committees to the applicant by the end of the ten months deadline. Within one month of

receipt of the draft opinion, the applicant may provide written notice that he wishes to

comment2.

If the applicant does not wish to comment, the Secretariat shall send the RAC and SEAC

opinions to the Commission, the Member States (MSs) and the applicant, within 15 days

of the end of the period within which the applicant may comment or within 15 days of

receipt of notice from the applicant that he does not intend to comment.

If the applicant wishes to comment, their written comments are to be sent to the ECHA

Secretariat within two months of the receipt of the draft opinion. RAC and SEAC shall

1 In these terms of reference “applicant” means one or several applicants, who have submitted a joint application.

2 The draft opinion shall be deemed to have been received seven days after the ECHA Secretariat has sent it.

Helsinki, 15/11/2023

2

consider the comments and adopt their final opinions within two months of receipt of the

written argumentation, taking this argumentation into account where appropriate. Within

a further 15 days the Secretariat shall send the opinions, with the written argumentation

attached, to the Commission, the MSs and the applicant.

Following the requirements of Article 87(1) of REACH, both Committees shall appoint one

of its members as a rapporteur for each authorisation application and may also appoint a

second member to act as a co-rapporteur for the same application. In these terms of

reference rapporteur and co-rapporteur are referred to as “(co-) rapporteur”.

The (co-)rapporteur shall prepare the draft opinion and, if relevant, the final opinion in

dialogue with the (co-)rapporteur of the other Committee for the same application in

order to have a consistent technical and scientific basis for the respective conformity

checks and opinions.

For conducting all these tasks, the (co-) rapporteur will receive support from the ECHA

Secretariat, so that the opinions are timely, fit-for-purpose and consistent with other

opinions of similar uses.

2. TASKS

2.1 Formulation of opinion

2.1.1 Formulation of RAC and SEAC draft opinion

For formulating the RAC and SEAC draft opinion, the (co-) rapporteur will be provided by

the ECHA Secretariat with the following:

- The application for authorisation;

- Additional information provided by the applicant to bring the application in

conformity with Article 62 (if requested by RAC and SEAC);

- Additional information provided by the applicant and/or third parties on possible

alternative substances or technologies (if required from the applicant and/or

requested from third parties by SEAC);

- Information submitted by third parties during the public consultation;

- Additional information from the applicant to bring the application into conformity

with the requirements of Article 62 (if requested);

- Additional clarification from the applicant on content-related questions (if asked).

The (co-)rapporteur is required to:

• Formulate and propose a draft opinion on the submitted authorisation application for

adoption by RAC/SEAC.

The (co-)rapporteur shall carry out this task in consultation with the (co-)rapporteur

from the other Committee, both by informal exchange and by structured dialogues. To

Helsinki, 15/11/2023

3

undertake this task the (co-)rapporteur shall:

a) Review the authorisation application.

b) Identify potential issues in the application, which could compromise conformity of

the application in accordance with Article 62 of the REACH Regulation. A joint

request to the applicant for additional information to bring the application into

conformity with the requirements of Article 62 shall be prepared together with the

(co-)rapporteur of the other Committee and with the assistance of the ECHA

Secretariat3.

c) Review comments received during the public consultation. The applicant may

provide comments on this information. The ECHA Secretariat will ask the applicant

for these comments.

d) For the SEAC (co-)rapporteur: decide whether it is necessary to require the

applicant and/or request third parties to submit additional information on

alternatives, and compile these requirements and/or requests. If

required/requested, review the received information (if needed, this is done in co-

operation with the RAC (co-) rapporteur). The ECHA Secretariat will assist in this

task.

e) Consider and respond to comments received from other RAC/SEAC members on the

different versions of the draft opinion.

f) Formulate a draft opinion4 and, if necessary, modify the draft opinion in dialogue

with the (co-)rapporteur of the other Committee. If relevant, modify the draft

opinion during the plenary meetings in order to find an agreed wording to represent

the consensus or majority view of the Committee with the assistance of the ECHA

Secretariat.

g) As necessary prepare and modify any draft supporting document that supports the

technical and scientific justifications in the RAC/SEAC draft opinion. This shall be

carried out jointly with the (co-)rapporteur of the other Committee and with the

support from the ECHA Secretariat.

h) If key data submitted by the interested parties form a core element to justify the

draft opinions, verify the data with the assistance of the (co-)rapporteur of the other

Committee, other RAC and SEAC members and with the support from the ECHA

Secretariat.

i) Present the draft opinion and the technical and scientific rationale behind their

position, at a plenary (and/or working group) meetings.

3 The ECHA Secretariat will assist the (co-)rapporteur by providing a partly filled template, but the (co-) rapporteur will perform the

conformity check and is free to modify the preliminary version prepared by ECHA.

4 The opinion will consist of a standardised text together with justifications as outlined in the document "The opinions of RAC and SEAC

on Applicationhs for Authorisations".

Helsinki, 15/11/2023

4

2.1.2. Formulation of the RAC/SEAC final opinion5

For formulating the RAC/SEAC final opinion, the (co-)rapporteur will be provided by the

ECHA Secretariat with the argumentation sent by the applicant on the RAC/SEAC draft

opinion.

The (co-)rapporteur is required to:

• Consider the applicant’s comments, and draft and propose a final opinion on the

authorisation application for adoption by RAC/SEAC.

The (co-)rapporteur shall carry out this task in consultation with the (co-)rapporteur

from the other Committee. To undertake this task the (co-)rapporteur shall:

j) Review and respond to comments received from the applicant on the RAC/SEAC

draft opinion. The ECHA Secretariat will assist in this task.

k) Formulate a final opinion and, if necessary, modify the final opinion in order to find

an agreed wording to represent the consensus or majority view of the Committee

with the assistance of the ECHA Secretariat and in dialogue with the (co-)rapporteur

of the other Committee.

l) If necessary, modify any other supporting document to be in line with the RAC/SEAC

final opinion. This shall be carried out jointly with the (co-) rapporteur from the

other Committee and with the support from the ECHA Secretariat.

3. EXPECTED OUTCOMES / DELIVERABLES

Following the requirements of REACH and the RAC/SEAC working procedures for the

authorisation process, the (co-)rapporteur is expected to prepare and provide to

RAC/SEAC the following key documents (including drafts as appropriate):

1) the draft opinion,

2) the final opinion, if the applicant provides comments on the draft opinion.

4. TIMELINES AND MILESTONES

The (co-)rapporteur should provide the deliverables pointed out in the previous section

according to the timelines specified in the letter of appointment or the service contract

and which are defined in the working procedure for RAC and SEAC on conformity check

of authorisation applications and the working and the working procedure for RAC and

SEAC on developing RAC and SEAC opinions on authorisation applications. If the

applicant does not comment on the RAC and SEAC draft opinions, the draft opinions are

5 RAC/SEAC shall formulate its final opinion if the applicant provides comments on the RAC/SEAC draft opinion. If the applicant does not

provide comments within the commenting period, the adopted RAC and SEAC draft opinions are considered as the final opinions.

Helsinki, 15/11/2023

5

considered as final and the ECHA Secretariat sends the opinions to the Commission, MSs

and the applicant. If the applicant provides comments on the RAC/SEAC draft opinion,

the Committee continues the work with the application for two more months following

the receipt of the applicant’s comments until the final opinion is adopted by RAC/SEAC.

5. REVIEW OF THE QUALITY

The (co-) rapporteur shall fulfil all the assigned tasks to a high quality. All members of

the Committee and the Chairs of RAC and SEAC have the shared responsibility to ensure

a fit-for-purpose quality of the opinion and its justifications, which should demonstrate

that the opinion is based on robust and valid scientific and technical information.

6. REMUNERATION OF RAPPORTEURS

Article 87(3) of REACH stipulates that those RAC and SEAC rapporteurs that are

appointed shall receive remuneration for their rapporteurship. The amount that shall be

remunerated is laid down in the Management Board decision of 21 December 2020

(MB/41/2020) establishing the financial arrangements for transfer of proportion of fees

to the member states.

Where Co-opted members are appointed as rapporteurs, then their remuneration is

based on the Management Board decision of 16 December 2022 (MB/46/2022). The MB

decision states that the remuneration for (co-) rapporteurship of co-opted members shall

be paid per actual day of work (450 Euro/day of work) to a maximum ceiling of 9000

Euro.

The distribution of work between rapporteurs and co-rapporteurs for certain dossiers has

been pre-fixed to a 50/50 split to ensure a timely issuing of the service contracts. The

(co-) rapporteurs may indicate a change in the split of work between them before the

end of the service. In this case, the remuneration amounts will be changed accordingly,

and amendments to the service contracts will be issued with the relevant change.

The final payments shall be done upon the receipt of the report of the number of worked

days (timesheet) and the invoice which the (co-)rapporteur will send after adoption of

opinion.